{
  "data": [
    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "Is it ethical to conduct placebo-controlled trials of new COVID-19 vaccines?",
              "id": 278960,
              "answers": [
                {
                  "answer_id": 274871,
                  "document_id": 450390,
                  "question_id": 278960,
                  "text": "Before a COVID-19 vaccine trial commences enrolment, if one or more authorized/approved\n\nCOVID-19 vaccine is locally available and the participant meets programmatic eligibility criteria,\n\nthe study team should advise the participant that they are eligible to receive the authorized\n\nvaccine(s). Participants may elect to receive the authorized vaccine at any point in the trial.\n\nThe appropriateness of conducting a placebo control trial may depend on whether the candidate\n\nvaccine is a prototype vaccine, modified vaccine or next generation vaccine.",
                  "answer_start": 1386,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are Prototype vaccines?",
              "id": 278967,
              "answers": [
                {
                  "answer_id": 274883,
                  "document_id": 450390,
                  "question_id": 278967,
                  "text": "a vaccine based on the original SARS-CoV-2 virus.",
                  "answer_start": 6054,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are modified vaccines?",
              "id": 278968,
              "answers": [
                {
                  "answer_id": 274880,
                  "document_id": 450390,
                  "question_id": 278968,
                  "text": "A vaccine against a SARS-CoV-2 variant of concern for which\n\nthe change is only in the prototype vaccine’s virus strain without changes in the manufacturing\n\nprocess, controls and the facilities for vaccine production.",
                  "answer_start": 6140,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the Next-generation COVID-19 vaccines?",
              "id": 278970,
              "answers": [
                {
                  "answer_id": 274887,
                  "document_id": 450390,
                  "question_id": 278970,
                  "text": "‘Next-generation’ COVID-19 candidate vaccines include polyvalent vaccines (covering multiple\n\nserotypes) and candidates based on novel technology platforms that may be based on different\n\nroutes of administration (for example, intradermal, intranasal or oral) in contrast to ‘first generation’\n\nvaccines, which are administered intramuscularly.",
                  "answer_start": 42008,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "When is a placebo-control COVID-19 vaccine trial “clearly unacceptable” (2013 WHO Guidance)?",
              "id": 278971,
              "answers": [
                {
                  "answer_id": 274888,
                  "document_id": 450390,
                  "question_id": 278971,
                  "text": "2013 WHO guidance notes that placebo use in vaccine trials is “clearly unacceptable” when a highly\n\nefficacious and safe vaccine exists and is currently accessible in the public health system of the\n\ncountry in which the trial is planned and the risks to participants of delaying or foregoing the\n\navailable vaccine cannot be adequately minimized or mitigated.",
                  "answer_start": 19021,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the Ethics considerations for the next generation vaccines?",
              "id": 278972,
              "answers": [
                {
                  "answer_id": 274885,
                  "document_id": 450390,
                  "question_id": 278972,
                  "text": "Under certain circumstances, it may be ethically justified to test next-generation vaccines in\n\nplacebo control clinical disease endpoint trials. In such instances, the trial design should be\n\nsupported by the national regulatory agency, governing research ethics committee(s) and the\n\nhost community. Any trial should be preceded by appropriate stakeholder and community\n\nengagement activities.",
                  "answer_start": 44214,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "When should the Next-generation vaccines be tested",
              "id": 278969,
              "answers": [
                {
                  "answer_id": 274889,
                  "document_id": 450390,
                  "question_id": 278969,
                  "text": "Next generation vaccines may be tested in placebo control clinical disease endpoint\n\ntrials, provided such trials can still be ethically performed. In such instances, the trial\n\ndesign should be supported by the national regulatory agency, governing research ethics\n\ncommittee(s) and the host community. Any trial should be preceded by appropriate\n\nstakeholder and community engagement activities.",
                  "answer_start": 3988,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            }
          ],
          "context": "COVID-19 vaccine trial designs in the context of\n\nauthorized COVID-19 vaccines and expanding global\n\naccess: ethical considerations\n\nPolicy brief\n\n29 November 2021\n\n\n\nExecutive Summary\n\nIn June 2020, global regulators convened under the auspices of the International Coalition of\n\nMedicines Regulatory Authorities (ICMRA) and co-chaired jointly by the European Medicines\n\nAgency (EMA) and United States Food and Drug Administration (FDA) reached consensus on the\n\nstudy design requirements for Phase 3 COVID-19 vaccine clinical trials. The ICMRA noted that\n\nphase 3 clinical trials should be randomized, double-blinded and controlled with a placebo or\n\nactive comparators. In September 2020, the World Health Organization (WHO ) advised: “Phase\n\nIIB/III efficacy trials should be randomized, double-blinded and placebo controlled.” Since then,\n\nmultiple COVID-19 vaccines have been authorized worldwide based on interim results of pivotal\n\nplacebo-controlled efficacy trials, and billions of COVID-19 vaccine doses have been\n\nadministered under emergency use/conditional marketing authorization or full approval\n\nregulatory mechanisms.\n\nIn December 2020, a WHO expert group advised that the placebo control arms of COVID-19\n\nvaccine trials should be progressively unblinded as authorized vaccines become available in the\n\ncommunity hosting the trial, starting with prioritized groups.\n\nBefore a COVID-19 vaccine trial commences enrolment, if one or more authorized/approved\n\nCOVID-19 vaccine is locally available and the participant meets programmatic eligibility criteria,\n\nthe study team should advise the participant that they are eligible to receive the authorized\n\nvaccine(s). Participants may elect to receive the authorized vaccine at any point in the trial.\n\nThe appropriateness of conducting a placebo control trial may depend on whether the candidate\n\nvaccine is a prototype vaccine, modified vaccine or next generation vaccine.\n\nPrototype vaccines\n\nPlacebo control trials involving prototype vaccines may be ethical if the trial design is\n\nsupported by the national regulatory agency, governing research ethics committee(s)and the\n\nhost community. Any trial should be preceded by appropriate stakeholder and community\n\nengagement activities.\n\n\n\n1\n\n\n\n\fPlacebo control COVID-19 vaccine trials involving prototype vaccines will require\n\nmodification as trial participants increasingly meet local programmatic eligibility criteria\n\nand vaccine supply increases. In any placebo control COVID-19 vaccine trial design, as\n\nsoon as an authorized vaccine becomes locally available and a trial participant mee ts\n\nlocal programmatic eligibility criteria for that authorized vaccine, the trial participant\n\nshould be offered the opportunity to be released from blinding. If they choose so, they\n\nshould be offered the authorized vaccine (or the investigational vaccine if its efficacy has\n\nbeen established by then). Investigators are advised to inform trial participants of their\n\nright to be unblinded when they meet local programmatic vaccine eligibility. Criteria for\n\nunblinding should appear in informed consent documentation, and there should be\n\nrelevant trial documentation, such as standard operating procedures, for unblinding.\n\nUntil immune correlates of protection are established, authorized prototype vaccines\n\nmay still be tested in placebo control trials in cohorts for whom the vaccines were not\n\ninitially authorized (such as children and some adolescents) and in relevant booster dose\n\ntrials.\n\nModified vaccines\n\nModified COVID-19 vaccines should not be tested in placebo control trials. Instead, the\n\nmodified vaccine may be tested in comparator efficacy trials against the authorized\n\nparent/prototype vaccine.\n\nWhen consensus is reached on humoral and/or cellular immune parameters that\n\ncorrelate with reduction in disease severity or mortality against COVID-19, modified\n\nCOVID-19 vaccines should be assessed in immunobridging trials.\n\nNext-generation vaccines\n\nNext generation vaccines may be tested in placebo control clinical disease endpoint\n\ntrials, provided such trials can still be ethically performed. In such instances, the trial\n\ndesign should be supported by the national regulatory agency, governing research ethics\n\ncommittee(s) and the host community. Any trial should be preceded by appropriate\n\nstakeholder and community engagement activities.\n\nPlacebo control COVID-19 vaccine trials involving next generation vaccines in progress\n\nwill require modification as trial participants increasingly meet local programmatic\n\neligibility criteria and vaccine supply increases. In any placebo control COVID-19 vaccine\n\ntrial design, as soon as an authorized vaccine becomes locally available and a trial\n\nparticipant meets local programmatic eligibility criteria for that authorized vaccine, the\n\ntrial participant should be offered the opportunity to be unblinded, and if they choose\n\nso, offered the authorized vaccine (or the investigational next generation vaccine, if the\n\ninvestigational vaccine’s efficacy has been established by then). Investigators are\n\nadvised to inform trial participants of their right to be unblinded when the participants\n\nmeet local programmatic vaccine eligibility criteria through informed consent\n\ndocumentation and to devise relevant trial documentation, such as standard operating\n\nprocedures, for unblinding.\n\n\n\n2\n\n\n\n\fGiven increasing COVID-19 vaccination coverage globally, the conduct of placebo control\n\nclinical disease endpoint trials for next-generation vaccines will become increasingly\n\nunjustifiable from an ethics perspective. Alternative research approaches may include\n\nrelative clinical disease endpoint efficacy studies, human challenge trials and nonefficacy studies. When consensus is reached on humoral and/or cellular immune\n\nparameters that adequately correlate with reduction in disease severity or mortality\n\nagainst COVID-19, next-generation COVID-19 vaccines should be assessed in\n\nimmunobridging trials.\n\n\n\n3\n\n\n\n\fKey terminology\n\nPrototype COVID-19 vaccine: a vaccine based on the original SARS-CoV-2 virus.\n\nModified/variant COVID-19 vaccine: A vaccine against a SARS-CoV-2 variant of concern for which\n\nthe change is only in the prototype vaccine’s virus strain without changes in the manufacturing\n\nprocess, controls and the facilities for vaccine production.\n\nNext-generation COVID-19 vaccine: A vaccine against SARS-CoV-2 that includes a polyvalent\n\nvaccine (covering multiple serotypes) and a vaccine based on novel technology platforms that may\n\nbe based on a different route of administration (for example, intradermal, intranasal or oral),\n\ncompared to first generation vaccines, which are administered intramuscularly.\n\n\n\n4\n\n\n\n\f1 Introduction\n\nWhile the degree of COVID-19 vaccine accessibility and uptake varies at both national and global\n\nlevels, increasing vaccination coverage raises questions regarding the standard of prevention that\n\nought to apply to different settings where COVID-19 vaccine trials are hosted. This document aims to\n\nhighlight ethical issues implicit in conducting placebo control COVID-19 trials in the context of\n\nmultiple authorized vaccines and expanding global vaccination coverage. It was developed by the\n\nWHO ACTA Ethics & Governance Working Group, whose members include external experts and\n\nWHO technical staff. The document is based on relevant research ethics and technical guidelines and\n\ndraws on the extensive ethics literature about the use of placebos during past decades.\n\n\n\n2 Background\n\nPivotal clinical trials provide the evidence necessary to support regulatory\n\nauthorization/licensure.(1) In June 2020, global regulators convened under the auspices of the\n\nInternational Coalition of Medicines Regulatory Authorities (ICMRA),co-chaired jointly by the\n\nEuropean Medicines Agency (EMA) and United States Food and Drug Administration (FDA). This\n\ngroup reached consensus on the study design requirements for Phase 3 COVID-19 vaccine clinical\n\ntrials. The ICMRA noted that phase 3 clinical trials should be randomized, double-blinded and\n\ncontrolled with placebo or active comparator.(2) The FDA,(3) EMA(4) and WHO(5) also published\n\nrecommendations regarding the development, emergency use listing and approval of COVID-19\n\nvaccines. With regard to early phase trials, the FDA noted that “while including a placebo control and\n\nblinding are not required for early phase studies, doing so may assist in interpretation of preliminary\n\nsafety data.”(6) For later phase trials, including efficacy trials, the FDA noted that such trials “should\n\nbe randomized, double-blinded, and placebo control” and that “an individually randomized control\n\ntrial with 1:1 randomization between vaccine and placebo groups is usually the most efficient study\n\ndesign for demonstrating vaccine efficacy.” (7) The FDA also noted: “If the availability of a COVID-19\n\nvaccine proven to be safe and effective precludes ethical inclusion of a placebo control group, that\n\nvaccine could serve as the control treatment in a study designed to evaluate efficacy with\n\nnoninferiority hypothesis testing.” In September 2020, WHO advised: “Phase IIB/III efficacy trials\n\nshould be randomized, double-blinded, and placebo controlled.”(8) Since then, multiple COVID-19\n\nvaccines have been authorized worldwide based on interim results of pivotal placebo-control\n\nefficacy trials, and billions of COVID-19 vaccine doses have been administered under emergency\n\nuse/conditional marketing authorization or full approval regulatory mechanisms.\n\n2.1 The use of randomized, placebo control arms in COVID-19 vaccine trials\n\nRandomization is a well-established research methodology(9) to deal with therapeutic or\n\nprophylactic uncertainty and to ensure the absence of systematic differences between intervention\n\nand control groups.(10) Placebos—surrogates for a control group receiving no intervention—have\n\nbeen adopted to mimic the experimental treatment in appearance, but not in substance or chemical\n\nstructure.(11) Placebos allow the consequences of attention, expectation, suggestion and natural\n\ncourse to be separated from the effects of the experimental intervention.(12) The International\n\nCouncil for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)\n\nexplicitly endorses the use of placebo controls, except in cases where an available intervention is\n\nknown to prevent serious harm, such as death or irreversible morbidity.(13) Without blinding and\n\nuse of placebos, the awareness of having been vaccinated may change behaviour and outcome risk\n\nbut also change awareness and the detection of outcomes (detection bias). Given these factors,\n\nrandomized placebo control trials are widely considered the ‘gold standard’ for evaluating the safety\n\n5\n\n\n\n\fand efficacy of experimental interventions.(14, 15) This situation will change if an immune correlate\n\nof protection (ICP) is agreed for COVID-19 vaccines. It should be noted that different ICPs may apply\n\nto different COVID-19 vaccine platforms. WHO is convening regular meetings to assess scientific\n\nprogress towards a definition of an ICP. The situation will also change if scientifically justifiable active\n\ncomparators are readily accessible for use in clinical trials. Problems with access to approved COVID19 vaccines to use as active comparators in clinical trials have recently been elucidated.(16)\n\n2.2. The position of existing global research ethics guidance documents on placebo use\n\nThe Declaration of Helsinki (2013),(17) published by the World Medical Association, offers guidance\n\non the ethical permissibility of placebo use in clinical trials. Article 33 of the Declaration of Helsinki\n\n(hereinafter DoH) states:\n\nThe benefits, risks, burdens and effectiveness of a new intervention must be tested against\n\nthose of the best proven intervention(s), except in the following circumstances:\n\n- Where no proven intervention exists, the use of placebo, or no intervention, is\n\nacceptable.\n\n- Where, for compelling and scientifically sound methodological reasons, the use of\n\nany intervention less effective than the best proven one, the use of placebo, or no\n\nintervention is necessary to determine the efficacy or safety of an intervention, and\n\nthe patients who receive any intervention less effective than the best proven one,\n\nplacebo or no intervention will not be subject to additional risks of serious or\n\nirreversible harm as a result of not receiving the best proven intervention. Extreme\n\ncare must be taken to avoid abuse of this option”.\n\nIn 2013, WHO convened an expert panel to consider the use of placebos in vaccine trials. The expert\n\npanel concluded that placebo use in vaccine trials is clearly acceptable when no efficacious and safe\n\nvaccine exists and the vaccine under consideration is intended to benefit the population in which the\n\nvaccine is to be tested.(18) In this situation, a placebo control trial addresses the locally relevant\n\nquestion regarding the extent to which the new vaccine is better than nothing, and participants in\n\nthe placebo arm of the trial are not deprived of the clinical benefits of an existing efficacious vaccine.\n\nThe expert panel concluded that placebo use in vaccine trials is clearly unacceptable when a highly\n\nefficacious and safe vaccine exists and is currently accessible in the public health system of the\n\ncountry in which the trial is planned and the risks to participants of delaying or foregoing the\n\navailable vaccine cannot be adequately minimized or mitigated (for example, by providing\n\ncounselling and education on behavioural disease prevention strategies or ensuring adequate\n\ntreatment for the condition under study to prevent serious harm). In this situation, a placebo control\n\ntrial would not address a question that is relevant in the local context: namely, how the new vaccine\n\ncompares to the one that is currently in use, and participants would be exposed to unacceptable\n\nlevels of risk from delaying or foregoing a safe and effective vaccine that is accessible through the\n\npublic health system.\n\nThe Expert Panel further concluded that the use of placebo controls in vaccine trials may be justified\n\neven when an efficacious vaccine exists, provided the risk-benefit profile of the trial is acceptable.\n\nThis applies to situations where the existing vaccine is available through the local public health\n\nsystem and to situations where the existing vaccine is not available locally or is only available on the\n\nprivate market. Specifically, the risk-benefit profile of a placebo control vaccine trial may be\n\nacceptable when:\n\n- the study question cannot be answered with an active control trial design\n\n\n\n6\n\n\n\n\f-\n\n\n\nthe risks of delaying or foregoing an existing efficacious vaccine are adequately minimized or\n\nmitigated\n\nthe use of a placebo control is justified by the potential public health or social value of the\n\nresearch\n\nthe research is responsive to local health needs.\n\n\n\nThe Expert Panel concluded that the acceptable risks of withholding or delaying administration of an\n\nexisting vaccine in the placebo arm of vaccine trials may be greater than minimal when the above\n\nconditions are met. Accordingly, the expert panel deemed the use of a placebo control to be\n\nacceptable even when an efficacious vaccine exists, provided the above four conditions are met.\n\nIn 2016, the Council for the Organisation of Medical Sciences (CIOMS), in collaboration with WHO,\n\npublished revised research ethics guidance (hereafter CIOMS Guidelines).(19) Regarding the choice\n\nof control in clinical trials, Guideline 5 of the CIOMS Guideline states:\n\nAs a general rule, the research ethics committee must ensure that research participants in\n\nthe control group of a trial of a diagnostic, therapeutic or preventive intervention receive an\n\nestablished effective intervention. Placebo may be used as a comparator when there is no\n\nestablished effective intervention for the condition under study or when placebo is added on\n\nto an established effective intervention. When there is an established effective intervention,\n\nplacebo may be used as a comparator without providing the established effective\n\nintervention to participants only if:\n\n- there are compelling scientific reasons for using placebo; and\n\n- delaying or withholding the established effective intervention will result in no more than\n\na minor increase above minimal risk to the participant and risks are minimized, including\n\nthrough the use of mitigation procedures.\n\n\n\n3 The suitability of applying existing guidance, and the rationale for new\n\nguidance on placebo control vaccine trials in the context of the COVID-19\n\npandemic\n\nWhile existing research ethics guidance documents provide a useful starting point, they were not\n\ndevised to provide guidance in the context of a rapidly evolving global pandemic, novel research\n\napproaches, emergency use regulatory pathways and inequitable vaccine access. These documents\n\nand placebo-control trials thus merit consideration in the current and future contexts of the COVID19 pandemic.\n\n3.1 What constitutes an “established effective intervention” (CIOMS Guidelines)?\n\nCIOMS notes that “an established effective intervention for the condition under study exists when it\n\nis part of the medical professional standard.” Worldwide COVID-19 candidate vaccines have been\n\ngranted conditional/emergency use authorization in many settings. Such status is time-limited and\n\nreviewable at the end of the authorization period.”(20) Once the emergency use authorization is\n\ngranted, the authorization holder must fulfil specific obligations within defined timelines, including\n\ncompleting ongoing or new studies or collecting additional data to confirm that the intervention's\n\nbenefit-risk ratio remains positive.(21) Until the authorization holder complies with the conditions\n\nattached to the authorization, and because the authorization may be revoked before the end of the\n\nreview period,(22, 23, 24) the safety and efficacy of a candidate vaccine cannot reasonably be\n\nconsidered “established” or the “medical professional standard.”\n\n7\n\n\n\n\f3.2 What constitutes a “best proven intervention” (DoH)?\n\nDespite an authorized vaccine having demonstrated high efficacy and safety in some cohorts, the\n\nsame may not necessarily be true for other cohorts. For example, evidence may emerge that\n\nsuggests that the “best proven intervention” for one cohort (such as adults) raises potential safety\n\nconcerns for another cohort (such as adolescents).(25) The consequence of reduced neutralizing\n\nactivity on COVID-19 vaccine effectiveness is also not known. SARS-CoV-2 variants of concern (VoC)\n\nmay render a candidate vaccine that is a “best proven intervention” in one or more settings(26) less\n\nefficacious in another,(27) notwithstanding its authorization and imminent rollout in the face of\n\nreduced efficacy.(28, 29)\n\n3.3 When is a placebo-control COVID-19 vaccine trial “clearly unacceptable” (2013 WHO Guidance)?\n\n2013 WHO guidance notes that placebo use in vaccine trials is “clearly unacceptable” when a highly\n\nefficacious and safe vaccine exists and is currently accessible in the public health system of the\n\ncountry in which the trial is planned and the risks to participants of delaying or foregoing the\n\navailable vaccine cannot be adequately minimized or mitigated.\n\nThe FDA, EMA and WHO conditional marketing authorization/emergency use designation for COVID19 candidate vaccines depends, among other factors, on a point estimate for a placebo control\n\nefficacy trial of at least 50%.(30, 31, 32) Various COVID-19 candidate vaccines that meet this\n\nthreshold requirement have been authorized worldwide but have reported varying efficacy in\n\ndifferent settings.(33, 34) Further, as noted earlier, authorized vaccines may not be universally\n\n“highly efficacious” given the emergence of SARS-CoV-2 VoC.(35) Nevertheless, while a placebo\n\ncontrol trial would yield the highest quality evidence and inform policymakers whether a candidate\n\nvaccine is appropriate for a particular setting, conducting a placebo control trial in some of the\n\nabove contexts would be “clearly unacceptable” according to the 2013 WHO Guidance due to the\n\naccessibility of highly efficacious and safe vaccines.\n\nBy contrast, the 2013 WHO guidance stipulates that “the risk-benefit profile of a placebo control\n\nvaccine trial may be acceptable when the study question cannot be answered with an active control\n\ntrial design”. Since the publication of the above research ethics guidance documents, a WHO Expert\n\nGroup has highlighted considerations for the design and analysis of trials and studies to evaluate\n\nexperimental vaccines during public health emergencies.(36) Variations of the traditional parallelgroup placebo-control randomized clinical trial design have also since emerged.(37, 38, 39)\n\nMoreover, to expedite vaccine availability, some regulators, such as the FDA(40) and EMA(41) and\n\nWHO(42) have adopted new approval pathways and evaluation frameworks in relation to COVID-19\n\nvaccines. Last, although multiple prototype vaccines having been authorized worldwide, the\n\nemergence of SARS-CoV-2 VoC(43) is driving the development of modified vaccines(44) and nextgeneration vaccines.(45) These developments underscore the need for updated WHO guidance on\n\nthe ethical issues implicit in placebo control trials in the context of COVID-19 prototype vaccines,\n\nmodified vaccines and next-generation vaccines. The considerations contained in this guidance are\n\nnot intended to be considered a comprehensive review of the technical merits of alternative trial\n\ndesigns. The technical aspects of alternative trial designs have been explored elsewhere in greater\n\ndetail by a WHO expert group.(46) Instead, this document will briefly highlight a sample of ethical\n\nissues implicit in some of these trial designs. This analysis should not be considered exhaustive.\n\n\n\n8\n\n\n\n\f4 Placebo-control COVID-19 vaccine trials in the context of an increasing\n\nnumber of approved prototype vaccines\n\nIn November 2020, the International Coalition of Medicines Regulatory Authorities (ICMRA), a global\n\ncollaborative coalition of medicine regulators, including the EMA and FDA, published a statement\n\nstating that follow-up for treatment and placebo arms should continue ‘for as long as possible after\n\nany regulatory approval’ and recommended a follow-up period of ‘at least one year or more from\n\ncompletion of assigned doses’.(47) Since then, multiple COVID-19 prototype vaccines have been\n\nauthorized on the basis of early interim data from ongoing pivotal placebo control randomized\n\nclinical trials. The FDA noted its expectation that, following submission of an emergency use\n\nauthorisation (EUA) request and issuance of an EUA, a sponsor would continue to collect placebocontrolled data in any ongoing trials for as long as feasible.(48) Senior FDA officials argued: “The\n\nquality of the data available to inform ongoing assessment of a vaccine’s benefits and risks will\n\ndepend on the ability to continue evaluating the vaccine against a placebo comparator in clinical\n\ntrials for as long as feasible. Moreover, evaluation of other potentially superior vaccines will depend\n\non the ability to continue to maintain placebo controls in ongoing trials. Thus, issuance of an EUA\n\nshould not, in and of itself, require unblinding of a COVID-19 vaccine trial and immediate vaccination\n\nof placebo recipients, since doing so may jeopardize approval of these products.”(49) In December\n\n2020, a WHO expert group advised that the placebo control arms of these trials should be\n\nprogressively unblinded as authorized vaccines become available in the host setting, starting with\n\nprioritized groups.(50, 51) Many trial sponsors have since offered all participants the choice to learn\n\nwhether they received the study vaccine or placebo, and for those who received the placebo to have\n\nthe option to receive the study vaccine while staying in the study.(52) Before a COVID-19 vaccine\n\ntrial commences enrolment, if an authorized/approved COVID-19 vaccine is locally available and the\n\nparticipant meets programmatic eligibility criteria, the study team should advise the participant that\n\nthey are eligible to receive the vaccine. Participants may join the study if they have no intention of\n\ngetting the locally available authorized/approved COVID-19 vaccine at the time.\n\nMultiple candidate vaccines are currently being tested in phase 1, phase 2 and phase 3 placebo\n\ncontrol trials or are in the development pipeline.(53) While regulators have indicated their\n\npreference for evidence from pivotal trials in the form of placebo control trials, increasing vaccine\n\nsupply and vaccination coverage in many settings raises concerns about whether any type of placebo\n\ncontrol trial in such settings would be ethically acceptable. Various placebo control designs have\n\nemerged.\n\n\n\n4.1 Randomized, double-blinded parallel group placebo control trial\n\nThe conduct of double-blinded placebo control randomized trials to assess vaccine efficacy against\n\nclinically relevant, pre-defined endpoints constitutes the gold-standard approach to generate\n\nevidence for vaccine licensure and policy decisions.(54) The use of a parallel group placebo control\n\nmay be unethical if an effective vaccine is authorized in the trial setting, the authorized vaccine is\n\nlocally available and accessible and trial participants meet local programmatic eligibility criteria. Until\n\nimmune correlates of protection are established, authorized prototype vaccines may still be tested\n\nin placebo control trials in cohorts for whom the vaccines have not yet been authorized (such as\n\nchildren and some adolescents).(55)\n\nPlacebo control booster-dose trials involving authorized vaccines may also be ethically acceptable\n\n(for instance, if a booster dose has not yet been authorized and/or is not yet widely available).\n\n9\n\n\n\n\fExample: A study to evaluate the safety and efficacy of a booster dose of BNT162b2\n\n(Pfizer/BioNTech vaccine) against COVID-19 in participants ≥16 years of age.(56) All trial\n\nparticipants previously received 2 doses of BNT162b2 at least 6 months prior to\n\nrandomization. Arm 1 received an additional dose of BNT162b2. Arm 2 received a placebo.\n\n\n\n4.2 Randomized, double-blinded placebo control crossover trial (57)\n\nIn placebo control crossover trials, participants are randomized to the investigational vaccine or the\n\nplacebo group. If the investigational vaccine demonstrates efficacy, the placebo group is offered\n\nvaccination so that all willing volunteers receive the efficacious investigational vaccine. To keep the\n\nblind, the original vaccine group receives placebo and vice versa. Crossover can occur whenever a\n\nparticipant becomes eligible for an available authorized vaccine outside the trial. Thus, the trial\n\nchanges into a blinded randomized crossover trial of immediate (investigational vaccine) versus\n\ndeferred (placebo) vaccination, so that two distinct remaining interventions can be contrasted.\n\nExample: Novavax SARS-CoV-2 rS with Matrix-M1 adjuvant blinded crossover trial(58)\n\nThe sponsors describe the trial as follows: “Participants in the study will randomly be\n\nassigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant\n\nin the study will receive a total of 2 intramuscular injections of either SARS-CoV-2 rS with\n\nMatrix-M1 adjuvant or placebo in the initial vaccination period. Up to 33 000\n\nparticipants will take part in the study. Following the recommendation of COVID-19\n\nvaccination for all adults 18 years of age and older, adult participants will be scheduled\n\nfor the administration of 2 injections of the alternate study material 21 days apart\n\n(\"blinded crossover\"). That is, initial recipients of placebo will receive SARS-CoV-2 rS with\n\nMatrix-M1 adjuvant and initial recipients of SARS-CoV-2 rS with Matrix-M1 adjuvant will\n\nreceive placebo. A blinded crossover will be implemented for adolescents 12 to < 18\n\nyears of age approximately 6 months after the initial vaccination.”\n\n\n\n4.3 Adaptive design trial\n\nTraditional vaccine efficacy trials usually use fixed designs with fairly large sample sizes. Recruiting a\n\nlarge number of subjects requires longer follow up time and costs. To save costs and time, adaptive\n\ntrials have been proposed as an alternative to a fixed design. An adaptive design is defined as a\n\nclinical trial design that allows for prospectively planned modification to one or more aspects of the\n\ndesign based on accumulating data from subjects in the trial.(59) Adaptive designs attempt to select\n\nthe right treatment arm and population and reduce sample size more efficiently.(60, 61)\n\nWith an adaptive platform trial of multiple vaccines and a common control, sample sizes can change,\n\nvaccines with an unfavourable benefit-harm profile can be dropped from the trial and new\n\ncandidates can be added.(62) Host sites and target cohorts can also be changed. If and when it is no\n\nlonger appropriate to continue randomization to placebo given availability of a different vaccine that\n\ndemonstrated persuasive evidence of efficacy and safety in a previous randomized placebo control\n\ntrial, a placebo control adaptive trial can switch to a ‘hybrid analysis’ trial (merging control groups\n\nreceiving placebo and an active control).\n\n\n\n10\n\n\n\n\f4.3.1 Adaptive trial involving a hybrid analysis\n\nIn a hybrid analysis trial, the trial begins as a placebo control trial and may involve more than\n\none candidate vaccine (in such instances, the trial is recommended to have a shared placebo\n\narm). During the conduct of the trial, due to emerging availability of effective vaccines in\n\nregions participating in the trial, a time-sensitive decision can be made to replace the\n\nplacebo arm with an authorized COVID-19 vaccine. In such trial designs, aggregate evidence\n\nto formally test, as well as to estimate, the efficacy of the experimental vaccine is\n\ndetermined by combining placebo control data during the first period of trial conduct, with\n\nactive-control data during the second period.(63)\n\nExample: WHO Solidarity COVID-19 Vaccine Trial.(64)\n\nThe Solidarity COVID-19 Vaccine Trial is designed to allow different candidate vaccines to\n\nenter the trial at different times. For each candidate vaccine, the primary efficacy results are\n\nexpected within three to six months of the vaccine entering the trial. The trial uses a shared\n\nplacebo/control group and a common core protocol to evaluate multiple candidates.\n\nThe design of the Solidarity COVID-19 Vaccine Trial incorporates adaptive features that\n\nrespond to changes in standards of prevention and care, varying availabilities of candidate\n\nvaccines at different times and uncertainties about the course of the epidemic in different\n\ngeographic locations and populations. The trial protocol describes the placebo comparator\n\nas “an integral component of the study design and is particularly important given new\n\nuncertainties regarding potential evasion of vaccine-induced immunity by newly discovered\n\nvariants.” Randomization to placebo will continue until it is no longer considered\n\nappropriate. In this situation, a vaccine regimen that has been found to be efficacious may\n\nserve as a positive control for the evaluation of other candidate vaccines currently in the\n\ntrial or later added to the trial and new benefit and lack-of-benefit criteria introduced.\n\nCognizant that at some point in the conduct of the trial – likely due to widespread\n\navailability of an effective vaccine in many of the countries where trial sites are located – it\n\nmay no longer be feasible to randomize sufficient participants to placebo to permit direct\n\nevaluation of efficacy of new vaccines or other vaccines already in the trial. Under those\n\ncircumstances the trial will need to introduce new efficacy/lack of benefit criteria to permit\n\ncomparison with the available vaccine. Newly randomized participants will be evaluated in a\n\nnon-inferiority comparison of each vaccine with the available vaccine.\n\n\n\n11\n\n\n\n\f5. Vaccine characteristics\n\nThe appropriateness of conducting a placebo control trial may depend on whether the candidate\n\nvaccine is a prototype vaccine, modified vaccine or next-generation vaccine.\n\n\n\n5.1. Prototype vaccines\n\nA prototype COVID-19 vaccine refers to the vaccine based on the original SARS-CoV-2 virus.(65)\n\nMultiple prototype vaccines have been authorized worldwide, and many more are under various\n\nstages of development.\n\n\n\nEthics considerations\n\nIt may be ethically justified to test COVID-19 prototype vaccines in placebo control\n\nclinical disease endpoint trials under certain circumstances. In such instances, the trial\n\ndesign should be supported by the national regulatory agency, governing research\n\nethics committee(s) and the host community. Any trial should be preceded by\n\nappropriate stakeholder and community engagement activities.(66, 67, 68, 69)\n\nBefore trial enrolment: If an authorized/approved COVID-19 vaccine is locally available\n\nand the participant meets programmatic eligibility criteria, the study team should\n\nadvise the participant that they are eligible to receive the vaccine. Participants may\n\nelect to receive the authorized vaccine at any point in the trial.\n\n1.1. Trials in progress: Placebo control COVID-19 vaccine trials in progress will\n\nrequire modification as vaccine supply increases and trial participants\n\nincreasingly meet local programmatic eligibility criteria. In any placebo\n\ncontrol COVID-19 vaccine trial design, as soon as an authorized vaccine\n\nbecomes locally available during the trial and a trial participant meets\n\nlocal programmatic eligibility criteria, the trial participant should be\n\noffered the opportunity to be unblinded and if they choose so, offered\n\nthe authorized vaccine (or the investigational vaccine, if the\n\ninvestigational vaccine’s efficacy has been established by then).\n\nInvestigators are advised to inform trial participants of their right to be\n\nunblinded when they meet local programmatic vaccine eligibility criteria.\n\nCriteria for unblinding should appear in informed consent documentation,\n\nand there should be relevant trial documentation, such as standard\n\noperating procedures for unblinding.\n\nUntil immune correlates of protection are established, authorized prototype vaccines\n\nmay still be tested in placebo control trials in cohorts for whom the vaccines were not\n\ninitially authorized (such as children and some adolescents) and in relevant booster\n\ndose trials.\n\nIn the case of crossover trials, as soon as an authorized vaccine becomes locally\n\navailable and trial participants meet local programmatic eligibility criteria for that\n\nauthorized vaccine, the participants in the placebo arm should be switched to the\n\nauthorized vaccine.\n\n12\n\n\n\n\fAs COVID-19 vaccine coverage increases, investigators and sponsors of prototype vaccines should\n\nconsider trial designs that are not based on placebo controls.(70) Annex 1 highlights examples of\n\nsuch approaches.\n\n\n\n13\n\n\n\n\f5.2. Modified vaccines\n\nA modified/variant COVID-19 vaccine is based on a prototype vaccine that has been modified to\n\nenhance its efficacy against COVID-19 caused by a SARS-CoV-2 variant(s). In a modified vaccine, the\n\nchange is only in the parent/prototype vaccine’s virus strain without changes in the manufacturing\n\nprocess, controls and the facilities for vaccine production.(71) Research on the development of\n\nmodified vaccines is prudent given the emergence of SARS-CoV-2 variants that may escape immunity\n\nconferred by prototype vaccines.(72) Modified vaccines may be intended for primary vaccination or\n\nto be administered with the parent vaccine. Modified vaccines should be assessed in comparator\n\nefficacy trials or immunobridging studies.\n\n\n\n5.2.1\n\n\n\nComparator efficacy trials\n\n\n\nModified vaccines may be assessed in two distinct populations: individuals previously vaccinated\n\nagainst SARS-CoV-2 with the parent vaccine and SARS-CoV-2-naïve individuals (who are\n\nunvaccinated and show no evidence of previous infection). WHO has proposed, as an example, an\n\nopen-label, randomized study comparing the safety and immunogenicity of an approved parent/\n\nprototype vaccine with modified SARS-CoV-2 vaccine in naïve and previously vaccinated individuals.\n\nWHO recommends a non-inferiority study that compares the immune response induced by the\n\nmodified COVID-19 vaccine to that induced by the prototype COVID-19 vaccine.(73) The FDA advises\n\nthat immunogenicity studies should compare immune responses induced by the modified vaccine\n\nagainst the SARS CoV-2 VoC with those induced by the prototype vaccine against the virus on which\n\nthe prototype vaccine was based, when administered as a primary series to previously unvaccinated\n\nand SARS CoV-2 naïve study subjects using the dose and dosing regimen as authorized for the\n\nprototype vaccine.(74) Similarly, in the absence of an ICP, the EMA recommends conducting\n\nimmunobridging studies comparing the original and modified vaccines in vaccine naïve\n\nindividuals.(75) In a trial involving unvaccinated individuals, participants could be randomized to\n\nreceive the full schedule of the authorized parent vaccine or a mixed dose of the parent vaccine and\n\nmodified vaccine or a full schedule of the modified vaccine alone. In such comparator trials, a\n\nplacebo control arm would be unnecessary. WHO has advised that the data should, as much as\n\npossible, be generated in a naïve population but recognizes that widespread infection and current\n\nefforts to vaccinate as many people as possible may mean that data from a non-naïve population\n\ncan be generated if it is difficult to identify a naïve population. The EMA recommends that trial\n\nparticipants should have participated in previous trials with the parent vaccine so that their postprimary neutralizing antibody titres are available. In a trial involving individuals who had been fully\n\nvaccinated with the parent vaccine, the modified vaccine could be tested as a booster dose. In such\n\na trial, participants could be randomized to receive a booster dose of the parent vaccine or a booster\n\ndose of the modified vaccine. A placebo control arm in such a trial would be unwarranted.\n\nAccess Consortium regulators have noted that if in-vitro assays from sera of individuals vaccinated\n\nwith the parent vaccine have shown that cross-reactivity with a new variant is not sufficient, a\n\ncomparative study of the parent and modified vaccines may not be in the best interest of trial\n\nparticipants(76) because participants randomized to receive the parent vaccine would receive an\n\ninefficacious vaccine. In such instances, a stand-alone immunogenicity and reactogenicity study of\n\nthe modified vaccine would be appropriate along with a comparison of immune measures in sera\n\nfrom individuals vaccinated with the parent vaccine.(77, 78) If it is not possible to enrol participants\n\nwho have participated in a previous trial with the parent vaccine, the EMA recommend that the\n\n14\n\n\n\n\fpost-primary neutralizing antibody titres used in the primary analysis should be drawn from a\n\npopulation that is matched at least based on age, gender and presence of important underlying\n\ncomorbidities to the population enrolled into the prospective trial to receive a dose of modified\n\nvaccine.(79) For the purposes of obtaining the data required to conduct the primary analysis, the\n\nEMA notes that it would suffice that all participants enrolled into the trial receive a dose of the\n\nmodified vaccine.(80) In such a scenario, a placebo control arm would be unnecessary.\n\nAnnex 2 highlights other potential research approaches regarding modified vaccines that do not\n\ninvolve placebo controls.\n\n\n\nEthics considerations\n\nA modified vaccine should be tested in comparator efficacy trials against the authorized\n\nparent/prototype vaccine.\n\nTrial participants should ideally have participated in a previous trial with the parent vaccine so\n\nthat their post-primary neutralizing antibody titres are available. In a trial involving individuals\n\nwho had been fully vaccinated with the parent vaccine, the modified vaccine could be tested as a\n\nbooster dose. In such a trial, participants could be randomized to receive a booster dose of the\n\nparent vaccine or a booster dose of the modified vaccine. A placebo control arm in such a trial\n\nwould be unwarranted.\n\nIf it is not possible to enrol participants who have participated in a previous trial with the parent\n\nvaccine, all participants enrolled into the trial could receive a dose of the modified vaccine. In such\n\na scenario, a placebo control arm would be unnecessary.\n\nIn a trial involving unvaccinated individuals, participants could be randomized to receive the full\n\nschedule of the authorized parent vaccine or a mixed dose of the parent vaccine and modified\n\nvaccine or a full schedule of the modified vaccine alone. In such comparator trials, a placebo\n\ncontrol arm would be unnecessary.\n\nIf in-vitro assays from sera of individuals vaccinated with the parent vaccine have shown that\n\ncross-reactivity with a new variant is not sufficient, a comparative study of the parent and\n\nmodified vaccines may not be in the best interest of trial participants because participants\n\nrandomized to receive the parent vaccine would receive a vaccine that is inefficacious against a\n\nnew variant. In such instances, a stand-alone immunogenicity and reactogenicity study of the\n\nmodified vaccine would be appropriate along with a comparison of immune measures in sera\n\nfrom individuals vaccinated with the parent vaccine. A placebo control arm in such a trial would\n\nbe unwarranted.\n\nWhen consensus is reached on humoral and/or cellular immune parameters that adequately\n\ncorrelate with reduction in disease severity or mortality against COVID-19, modified COVID-19\n\nvaccines should be assessed in immunobridging trials.\n\n\n\n15\n\n\n\n\f5.3 Next-generation vaccines\n\n‘Next-generation’ COVID-19 candidate vaccines include polyvalent vaccines (covering multiple\n\nserotypes) and candidates based on novel technology platforms that may be based on different\n\nroutes of administration (for example, intradermal, intranasal or oral) in contrast to ‘first generation’\n\nvaccines, which are administered intramuscularly. Data to support the authorization of nextgeneration vaccines may depend on whether the vaccine will be used for primary series vaccination\n\nor for booster vaccination based on primary series vaccination with a different vaccine.(81)\n\n\n\nNext-generation vaccines will need to be studied on the basis of appropriate study designs that\n\ngenerate robust data to enable regulatory decision-making. The ICMRA has noted that factors to\n\nconsider in clinical trial designs to determine the effectiveness of next-generation COVID-19 vaccines\n\ninclude the epidemiology and trajectory of the pandemic across countries and regions, including\n\nwhether there is high or low prevalence of SARS-CoV-2 and vaccine availability and vaccination\n\ncoverage.(82) The ICMRA has noted that next-generation vaccines may be tested in placebo control\n\nclinical disease endpoint trials, provided such trials can still be ethically performed. Trials of nextgeneration candidate vaccines will commence increasingly after one or more authorized (including\n\nfully approved) prototype vaccines has been publicly deployed in a proposed trial setting and in the\n\ncontext of increasing vaccine supply and increasing vaccination uptake. Placebo control trials\n\ninvolving next-generation COVID-19 vaccines in progress will require modification as trial\n\nparticipants increasingly meet local programmatic eligibility criteria and vaccine supply increases.\n\nGiven increasing COVID-19 vaccination coverage worldwide, the conduct of placebo-control clinical\n\ndisease endpoint trials for next-generation vaccines will become increasingly unjustifiable from an\n\nethics perspective. Alternative research approaches may include relative clinical disease endpoint\n\nefficacy studies, human challenge trials(83) and non-efficacy studies. Annex 3 highlights these\n\nresearch approaches.\n\n\n\nEthics considerations\n\nUnder certain circumstances, it may be ethically justified to test next-generation vaccines in\n\nplacebo control clinical disease endpoint trials. In such instances, the trial design should be\n\nsupported by the national regulatory agency, governing research ethics committee(s) and the\n\nhost community. Any trial should be preceded by appropriate stakeholder and community\n\nengagement activities.(84, 85, 86, 87)\n\nBefore trial enrolment: If an authorized/approved COVID-19 vaccine is locally available and the\n\nparticipant meets programmatic eligibility criteria, the study team should advise the participant\n\nthat they are eligible to receive the vaccine. Participants may elect to receive the authorized\n\nvaccine at any point in the trial.\n\nTrials in progress: Placebo control COVID-19 vaccine trials in progress will require modification as\n\nvaccine supply increases and trial participants increasingly meet local programmatic eligibility\n\ncriteria. In any placebo control COVID-19 vaccine trial design, as soon as an authorized vaccine\n\nbecomes locally available during the trial and a trial participant meets local programmatic\n\neligibility criteria for that authorized vaccine, the trial participant should be offered the\n\nopportunity to be unblinded and if they choose and offered the authorized vaccine (or the\n\ninvestigational vaccine, if the investigational vaccine’s efficacy has been established by then).\n\n16\n\n\n\n\fInvestigators are advised to inform trial participants of their right to be unblinded when the\n\nparticipants meet local programmatic vaccine eligibility criteria. Criteria for unblinding should\n\nappear in informed consent documentation, and there should be relevant trial documentation,\n\nsuch as standard operating procedures, for unblinding.\n\nGiven increasing COVID-19 vaccination coverage globally, the conduct of placebo-control clinical\n\ndisease endpoint trials for next-generation vaccines will become increasingly unjustifiable from\n\nan ethics perspective. Alternative research approaches may include relative clinical disease\n\nendpoint efficacy studies, human challenge trials and non-efficacy studies.\n\nWhen consensus is reached on humoral and/or cellular immune parameters that adequately\n\ncorrelate with reduction in disease severity or mortality against COVID-19, next generation\n\nCOVID-19 vaccines should be assessed in immunobridging trials.\n\n\n\n17\n\n\n\n\f6. Conclusion\n\nDeveloping multiple efficacious COVID-19 vaccines is an urgent research priority. Decision-making\n\nshould be informed by the highest quality evidence and underpinned by ethical considerations. This\n\nguidance document aims to highlight some of the ethical considerations implicit in COVID-19\n\nplacebo control trials and alternative research approaches. COVID-19 is a rapidly evolving pandemic,\n\nand this document should consequently be considered a living document, subject to revision.\n\n\n\n18\n\n\n\n\fTABLE 1: COVID-19 VACCINE PROFILE AND ETHICAL APPROPRIATENESS OF STUDY METHODOLOGY\n\nETHICAL APPROPRIATENESS OF STUDY METHODOLOGY\n\nPLACEBO\n\nCONTROL\n\nEFFICACY TRIAL\n\n(i) Parallel group\n\nrandomized\n\nclinical trial\n\n\n\n(ii) Crossover trial\n\n\n\n(iii) Deferred\n\nvaccination\n\n\n\n(iv) Adaptive trial\n\nwith hybrid\n\nanalysis plan\n\n\n\nACTIVE\n\nCONTROL\n\nEFFICACY TRIAL\n\n\n\nSYNTHETIC /\n\nEXTERNAL\n\nCONTROL TRIAL\n\n\n\nIMMUNE\n\nCORRELATES OF\n\nPROTECTION\n\n\n\nIMMUNOBRIDGING TRIAL\n\n\n\n(i) Active control\n\nindicated for\n\nanother\n\ncondition\n\n\n\n(ii) Active\n\ncontrol is\n\nanother\n\nauthorized\n\nvaccine for\n\nCOVID-19\n\n\n\n- Superiority trial\n\n- Non-inferiority\n\ntrial\n\nAppropriate only\n\nin prescribed\n\ncircumstances.\n\nNot appropriate\n\nif immune\n\ncorrelates of\n\nprotection have\n\nbeen established\n\n\n\nAppropriate, if\n\nno immune\n\ncorrelates of\n\nprotection have\n\nbeen\n\nestablished.\n\n\n\nAppropriate, if no\n\nimmune correlates\n\nof protection have\n\nbeen established.\n\nNot yet used in\n\npivotal trial for\n\nregulatory decision\n\nmaking\n\n\n\nAppropriate, if\n\nimmune correlates\n\nof protection have\n\nbeen established\n\n\n\nAppropriate, if immune\n\ncorrelates of protection\n\nhave been established\n\n\n\nMODIFIED\n\nVACCINE\n\n\n\nNot appropriate\n\n\n\nAppropriate, if\n\nno immune\n\ncorrelates of\n\nprotection have\n\nbeen established\n\n\n\nAppropriate, in\n\nrelevant\n\ncircumstances\n\n\n\nAppropriate, if\n\nimmune correlates\n\nof protection have\n\nbeen established\n\n\n\nAppropriate, if immune\n\ncorrelates of protection\n\nhave been established\n\n\n\nNEXT\n\nGENERATION\n\nVACCINE\n\n\n\nAppropriate only\n\nin prescribed\n\ncircumstances.\n\nNot appropriate\n\nif immune\n\ncorrelates of\n\nprotection have\n\nbeen established\n\n\n\nAppropriate, if\n\nno immune\n\ncorrelates of\n\nprotection have\n\nbeen established\n\n\n\nAppropriate, if no\n\nimmune correlates\n\nof protection have\n\nbeen established.\n\nNot yet used in\n\npivotal trial for\n\nregulatory decision\n\nmaking\n\n\n\nAppropriate, if\n\nimmune correlates\n\nof protection have\n\nbeen established\n\n\n\nAppropriate, if immune\n\ncorrelates of protection\n\nhave been established\n\n\n\nPROTOTYPE\n\nVACCINE\n\n\n\n19\n\n\n\n\fAcknowledgements\n\nThis policy brief was developed by the World Health Organization Access to COVID-19 Tools\n\nAccelerator Ethics and Governance Working Group. The drafting of the document was led by Jerome\n\nAmir Singh (SAGE, Academy of Science of South Africa; University of KwaZulu-Natal, South Africa and\n\nUniversity of Toronto, Canada), with guidance from the Co-Chairs, Sonali Kochhar (University of\n\nWashington, Seattle, United States; Global Healthcare Consulting, India) and Jonathan Wolff\n\n(University of Oxford, United Kingdom), and input from the members of the Working Group (ordered\n\nalphabetically by surname): Caesar Atuire (University of Ghana, Ghana), Anant Bhan (Yenepoya\n\nUniversity, India), Ezekiel Emanuel (University of Pennsylvania, USA), Ruth Faden (Johns Hopkins\n\nUniversity, USA), Prakash Ghimire (Tribhuvan University, Nepal), Dirceu Greco, (Federal University of\n\nMinas Gerais, Brazil), Calvin Ho (University of Hong Kong, China), Suerie Moon (Graduate Institute,\n\nGeneva, Switzerland), Ehsan Shamsi (Tehran University, Iran), Aissatou Touré (Institute Pasteur,\n\nSenegal, ret.), Beatriz Thomé (University of Sao Paolo, Brazil), Max Smith (Western University,\n\nCanada), Ross Upshur (University of Toronto, Canada). Dean Follmann (National Institute of Allergy\n\nand Infectious Diseases, USA), Lars Hemkens (University of Basel, Switzerland) and Peter Smith\n\n(London School of Hygiene & Tropical Medicine, UK), provided additional input on methodological\n\nissues. Katherine Littler and Andreas Reis (WHO Health Ethics & Governance Unit) provided support\n\nfor the WHO Secretariat. Contributions from Rogério Gaspar, Ryoko Miyazaki Krause, Deus\n\nMubangizi, Sergio Andrade Nishioka, David Wood (WHO Regulation and Prequalification\n\nDepartment), as well as Patrik Hummel (WHO Consultant), Owen Schaefer (National University of\n\nSingapore), and the WHO Ethics & COVID-19 Working Group are duly acknowledged.\n\nFunding source\n\nFunding in support of the WHO Secretariat under the “WHO COVID-19 SPRP R&D” grant by the\n\nMinistry of Health of Germany, is gratefully acknowledged. JAS receives support from the COVID-19\n\nAfrica Rapid Grant Fund, which has been jointly established by the National Research Foundation\n\n(NRF) of South Africa, the Canadian International Development Research Centre (IDRC), the Swedish\n\nInternational Development Cooperation Agency (SIDA), the United Kingdom (UK) Department for\n\nInternational Development (DFID), UK Research and Innovation (UKRI) through the Newton Fund,\n\nSouth Africa’s Department of Science and Innovation (DSI), and Fonds de Recherche du Québec\n\n(FRQ).\n\nDeclarations of interest\n\nAll members of the WHO Access to COVID-19 Tools Accelerator Ethics and Governance Working\n\nGroup declared their interests according to WHO standard procedures. None of the interests\n\ndeclared were found to be significant.\n\n\n\nReferences\n\n1. World Health Organisation (WHO). Guidelines on clinical evaluation of vaccines: regulatory\n\nexpectations. 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Synthetic and External Controls in Clinical Trials – A\n\nPrimer for Researchers. 8 May 2020 Volume 2020:12 Pages 457—467.\n\n(https://doi.org/10.2147/CLEP.S242097, accessed 1 November 2021).\n\n107. FDA. FDA approves first treatment for a form of Batten disease. 27 April 2017.\n\n(https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatmentform-batten-disease, accessed 1 November 2021).\n\n108. FDA. Framework for FDA’s Real-World Evidence Program. December 2018.\n\n(https://www.fda.gov/media/120060/download, accessed 1 November 2021).\n\n109. FDA. Submitting Documents Using Real-World Data and Real-World Evidence to FDA for\n\nDrugs and Biologics Guidance for Industry. 2019.\n\n(https://www.fda.gov/media/124795/download, accessed 1 November 2021).\n\n110. EMA. Guideline on clinical trials in small populations. 2006.\n\n(https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-trialssmall-populations_en.pdf, accessed 1 November 2021).\n\n111. EMA. Guideline on clinical evaluation of vaccines. Draft. 18 April 2018.\n\n(https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinicalevaluation-vaccines-revision-1_en.pdf, accessed 1 November 2021).\n\n112. Plotkin SA, Gilbert PB. Nomenclature for immune correlates of protection after vaccination.\n\nClin. Infect. Dis. 54, 1615–1617 (2012).\n\n113. Qin L, Gilbert PB, Corey L, McElrath MJ, Self SG. A framework for assessing immunological\n\ncorrelates of protection in vaccine trials. J. Infect. Dis. 2007; 196, 1304–1312.\n\n114. Jin P, Li J, Pan H, Wu Y, Zhuet F. Immunological surrogate endpoints of COVID-2019 vaccines:\n\nthe evidence we have versus the evidence we need. Sig Transduct Target Ther 2021; 6: 48.\n\n29\n\n\n\n\f115. EMA. Draft Guideline on Clinical Evaluation of Vaccines. 26 April 2018.\n\n(https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinicalevaluation-vaccines-revision-1_en.pdf, accessed 1 November 2021).\n\n116. Feng S, Phillips DJ, White T, Sayal H, Aley PK, Bibi S, et al. Correlates of protection against\n\nsymptomatic and asymptomatic SARS-CoV-2 infection. Preprint from medRxiv, 24 June 2021.\n\ndoi: 10.1101/2021.06.21.21258528 PPR: PPR361083.\n\n117. Feng S, Phillips DJ, White T, Sayal H, Aley PK, Bibi S, et al. Correlates of protection against\n\nsymptomatic and asymptomatic SARS-CoV-2 infection. Preprint from medRxiv, 24 June 2021.\n\ndoi: 10.1101/2021.06.21.21258528 PPR: PPR361083.\n\n118. Earle KA, Ambrosino DM, Fiore-Gartland A, Goldblatt D, Gilbert PB, Siberet GR, et al.\n\nEvidence for antibody as a protective correlate for COVID-19 vaccines. Vaccine 2021; 39:\n\n4423-29.\n\n119. WHO. Guidelines on clinical evaluation of vaccines: regulatory expectations. 2016.\n\n(https://www.who.int/biologicals/expert_committee/Clinical_changes_IK_final.pdf, accessed\n\n1 November 2021).\n\n120. ICMRA. COVID-19 Vaccine development: Future steps Workshop. 24 June 2021.\n\n(http://icmra.info/drupal/en/covid-19/24june2021, accessed 1 November 2021).\n\n121. Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom. Access\n\nConsortium: Alignment with ICMRA consensus on immunobridging for authorising new\n\nCOVID-19 vaccines. 15 September 2021.\n\n(https://www.gov.uk/government/publications/access-consortium-alignment-with-icmraconsensus-on-immunobridging-for-authorising-new-covid-19-vaccines, accessed 1 November\n\n2021).\n\n122. MHRA. Access Consortium: Alignment with ICMRA consensus on immunobridging for\n\nauthorising new COVID-19 vaccines. 15 September 2021.\n\n(https://www.gov.uk/government/publications/access-consortium-alignment-with-icmraconsensus-on-immunobridging-for-authorising-new-covid-19-vaccines, accessed 1 November\n\n2021).\n\n123. WHO. Considerations for evaluation of modified COVID-19 vaccines. Points to consider for\n\nmanufacturers of COVID-19 vaccines. 12 March 2021.\n\n(https://extranet.who.int/pqweb/sites/default/files/documents/Addendum_Evaluation_Mod\n\nified_Covid-19%20Vaccine.pdf, accessed 1 November 2021).\n\n124. ACCESS Consortium. Points to consider for strain changes in authorized COVID-19 vaccines in\n\nan ongoing SARS-COV-2 Pandemic. 5 March 2021. (https://www.tga.gov.au/points-considerstrain-changes-authorized-covid-19-vaccines-ongoing-sars-cov-2-pandemic, accessed 1\n\nNovember 2021).\n\n125. ICMRA. ICMRA COVID-19 Vaccine development: Future steps Workshop. 24 June 2021.\n\n(http://www.icmra.info/drupal/en/covid-19/24june2021, accessed 1 November 2021).\n\n126. ICMRA. ICMRA COVID-19 Vaccine development: Future steps Workshop. 24 June 2021.\n\n(http://www.icmra.info/drupal/en/covid-19/24june2021, accessed 1 November 2021).\n\n\n\n30\n\n\n\n\f127. MHRA. Alignment with ICMRA consensus on immunobridging for authorising new COVID-19\n\nvaccines. 15 September 2021. (https://www.gov.uk/government/publications/accessconsortium-alignment-with-icmra-consensus-on-immunobridging-for-authorising-new-covid19-vaccines, accessed 1 November 2021).\n\n128. ICMRA. ICMRA COVID-19 Vaccine development: Future steps Workshop. 24 June 2021.\n\n(http://www.icmra.info/drupal/en/covid-19/24june2021, accessed 1 November 2021).\n\n\n\n31\n\n\n\n\fANNEX 1\n\nPrototype vaccines\n\nA sample of alternative approaches to placebo control trials\n\n\n\n1. Active control trials\n\nAn active control trial is designed to compare a new intervention to an active control. The active\n\ncontrol might be a different vaccine already licensed for the indication being studied (hereafter\n\n‘active comparator’) or it might be a licensed vaccine for some other indication that does not affect\n\nthe acquisition of the study endpoint(s) and thus functions in the same way as a placebo for\n\npurposes of assessing efficacy(88) (hereafter ‘inactive comparator’). In some settings, an active\n\ncontrol design may be preferred over a placebo-control design.\n\n1.1. Inactive comparator\n\nIn the context of a vaccine trial, a licensed vaccine (unrelated to the disease in question) can\n\nbe used as an inactive comparator control, in lieu of a placebo. Some COVID-19 vaccine\n\ntrials tested prototype vaccines against vaccines licensed for another indication, and this did\n\nnot affect the acquisition of the study endpoint(s).\n\nExample: In the ChAdOx1 nCoV-19 (AstraZeneca) phase 3 trial, Meningococcal group\n\nA, C, W-135, and Y conjugate vaccine (MenACWY) – which protects against 4\n\ndifferent strains of the meningococcal bacteria that cause meningitis and blood\n\npoisoning (septicaemia) – served as the control arm. Participants were randomized\n\n(1:1 using block randomisation) to receive either the experimental vaccine (ChAdOx1\n\nnCoV-19) or the licensed control vaccine (MenACWY).(89, 90, 91)\n\n\n\nEthics considerations\n\nIf an authorized vaccine is not available in a study setting and trial participants do not\n\nmeet local programmatic eligibility criteria for the authorized vaccine, an active control\n\nCOVID-19 vaccine trial that utilizes an inactive comparator (a vaccine licensed for another\n\ncondition unrelated to the condition under study) is preferable to a placebo control\n\nbecause it allows participants to gain the potential benefit of protection against the\n\ninfectious agent(s) that the active control is indicated for, instead of receiving no benefit\n\nfrom a placebo.\n\n\n\n1.2. Active Comparator\n\nThe control in an active comparator vaccine trial can be another authorized vaccine for the\n\ndisease or condition in question. The objective in such trials may be to demonstrate:\n\n-\n\n\n\nthe superiority of the new product\n\nthe non-inferiority of the new product or\n\nthe equivalence of the two products.(92)\n\n\n\n32\n\n\n\n\f1.2.1. Active comparator superiority trial\n\nCOVID-19 vaccine trials may be designed as randomized, observer-blind comparative\n\nimmunogenicity superiority trials. The primary objective of such trials is to demonstrate the\n\nsuperiority of an investigational candidate vaccine compared to another COVID-19 candidate\n\nvaccine. A possible endpoint in such trials would be to demonstrate that the investigational\n\ncandidate vaccine is superior for geometric mean titre ratio of SARS-CoV-2-specific\n\nneutralizing antibodies at a specified time after the vaccination series.\n\nExample: Valneva’s SARS-CoV-2 vaccine candidate, VLA2001, is being tested against\n\nthe AstraZeneca / Vaxzevria vaccine.(93) Approximately 4000 participants will\n\nreceive two doses of either vaccine. The primary endpoint of the Cov-Compare trial\n\nwill be to determine the immune response (geometric mean titre [GMT] of SARSCoV-2-specific neutralizing antibodies) two weeks after completion of a two-dose\n\nimmunization schedule administered over a four-week interval.\n\n\n\n1.2.2 Active comparator non-inferiority trial\n\nIn settings where placebo-control trials are deemed no longer ethically appropriate,\n\nrandomized non-inferiority trials may enable reliable evaluations of experimental vaccines\n\nthrough direct comparison with active comparator vaccines established to have worthwhile\n\nefficacy against the same disease.(94) The objective of non-inferiority trials is to reliably\n\nassess whether the efficacy of an experimental vaccine is not unacceptably lower than that\n\nof an active control vaccine previously established as effective, likely in a placebo control\n\ntrial.(95) The FDA has noted that “if the availability of a COVID-19 vaccine proven to be safe\n\nand effective precludes ethical inclusion of a placebo control group, that vaccine could serve\n\nas the control treatment in a study designed to evaluate efficacy with noninferiority\n\nhypothesis testing.”(96) WHO has noted that phase IIB/III efficacy trials should be\n\nrandomized, blinded and conducted with placebo control or active control (when a safe and\n\neffective COVID-19 vaccine is available).(97)\n\nNon-inferiority studies have been described as an important tool in evaluating the efficacy of\n\na new vaccine when there is a vaccine introduced to a population and when randomization\n\nto placebo is not deemed inappropriate on ethics grounds. The goal in a non-inferiority trial\n\nis to assess whether the efficacy of an experimental vaccine is not unacceptably lower than\n\nthat of an active control vaccine that previously had been established to be effective (which\n\nis likely in a placebo control trial). This is formally achieved by identifying a minimum\n\nthreshold for what would constitute an unacceptable loss of efficacy, that is, a noninferiority\n\nmargin, and then designing the noninferiority trial to rule out that margin.(98) Regulators\n\nsuch as the FDA have indicated that for non-inferiority comparison to a COVID-19 vaccine\n\nalready proven to be effective, the statistical success criterion should be that the lower\n\nbound of the appropriately alpha-adjusted confidence interval around the primary relative\n\nefficacy point estimate is >-10%.(99)\n\n\n\n33\n\n\n\n\fEthics considerations for active comparator superiority and non-inferiority trials\n\nThe use of an authorized active comparator as a control ensures that those who are\n\nassigned to the active comparator arm are assured access to a safe and efficacious\n\nintervention.\n\nTo conduct active comparator trials, the developer of an authorized vaccine may\n\ndonate/sponsor their vaccine for use as the comparator. This may be challenging in the\n\ncontext of extreme vaccine shortages or supply constraints in relation to the raw\n\ningredients to manufacture the vaccine or where available production capacity is\n\ndedicated to ensuring compliance with commercial contractual obligations.\n\nIn some instances, contracts between manufacturers and governments for authorized\n\nvaccines may restrict their use to improving public health,(100) which precludes that\n\nvaccine’s use as a comparator in a clinical trial. Developers of authorized vaccines should\n\nnot directly or indirectly bar their candidate vaccine from being used as an active\n\ncomparator in a clinical trials. Doing so runs counter to the interests of global health.\n\n\n\n2. Deferred vaccination\n\nA delayed vaccination comparator offers an alternative to a placebo or active control comparator. In\n\nsuch trials, individuals/clusters are allocated to either immediate or delayed vaccination, with a\n\ndelay between the two that is shorter than the typical duration of a trial.(101) Delayed vaccination\n\ninvolves one-way crossover of participants and is related to the stepped wedge design. All\n\nparticipants obtain access to the experimental vaccine in a phased, staggered manner. In situations\n\nwhere logistical constraints mean that not all eligible persons within the same prioritized population\n\ncan be vaccinated at the same time and in a timely manner, deferred vaccination through a stepped\n\nwedge design (either individually or as a cluster) can be used to obtain information on efficacy and\n\nsafety. In combination with routinely collected data collection, this may generate randomized realworld evidence.(102)\n\nExample: An effectiveness study of the Sinovac’s Adsorbed COVID-19 (Inactivated) Vaccine (Projeto\n\nS), Serrana, Brazil.(103, 104) In this stepped-wedge trial, the town of Serrana was divided into four\n\nclusters, which were randomly allocated to one of four subsequent weeks. In each week, all enrolled\n\nadults in the cluster were offered the first shot of the vaccine. In the next week, the next cluster was\n\nvaccinated. After four weeks, all enrolled adults received the first vaccination and subsequently\n\nreceived the second dose at the scheduled dose interval. In total, more than 27 000 adults were\n\nvaccinated against COVID-19 within 4 weeks.\n\n\n\nEthics considerations\n\nIf the experimental candidate vaccine has an unfavourable benefit-risk profile, more\n\npeople may be exposed to the vaccine than would be the case in a trial with\n\nplacebo/active control. However, if safety signals are recognized before the delay period\n\nhas elapsed, then the vaccine would not be given to the delayed group, and no more\n\npeople would be exposed than in a design with a standard placebo/active control\n\ncomparator.\n\n\n\n34\n\n\n\n\f3. Synthetic or External controls (with or without real-world data)\n\nThe FDA defines real-world data (RWD) as “data relating to patient health status and/or the delivery\n\nof health care routinely collected from a variety of sources” and real-world evidence (RWE) as “the\n\nclinical evidence about the usage and potential benefits or risks of a medical product derived from\n\nanalysis of RWD.”(105) Synthetic or external control arms may leverage RWD from various sources\n\nor evaluations of historical clinical data to demonstrate the positive effects of a new intervention,\n\nwithout the need to use a placebo or standard of care as a control.(106) Instead of collecting data\n\nfrom patients recruited for a trial who have been assigned to the control or standard-of-care arm,\n\nsynthetic(107) or external control arms model those comparators using data that have previously\n\nbeen collected from sources such as previously conducted clinical trials (including pooled trial data)\n\nor RWD (e.g. health data generated during the trial but not for the purpose of research, electronic\n\nhealth records, administrative claims data, health insurance data and disease registries). The FDA\n\nand EMA have outlined frameworks to use RWD and for external controls.(108, 109, 110)The FDA\n\nrequires developers who want to utilize RWE to support their applications to highlight: the purpose\n\nof using RWE, the study designs that include RWD and all the data sources used to generate RWE.\n\nExample: RWE has been used to support authorization for COVID-19 candidate vaccines, but,\n\nto date, RWE has not yet been used as external control arms in pivotal COVID-19 vaccine\n\ntrials. This situation may change.\n\n\n\nEthics considerations\n\nThe collection, access and sharing of RWD raises privacy and confidentiality concerns.\n\n\n\n4. Non-efficacy trials: authorization based on data of an approved prototype vaccine\n\nThe EMA has proposed that a new vaccine can be authorized without an efficacy trial in two\n\ncircumstances: where there is a well-established immune correlate of protection (ICP) or where\n\nimmunobridging takes place.(111)\n\n4.1. Immune correlate of protection\n\nAn ICP is an immunological assay (either humoral or cellular immune response) that reliably\n\npredicts protection against disease or infection after vaccination or natural infection.(112,\n\n113,114) In the context of vaccine-induced immunity, the EMA defines an immune correlate of\n\nprotection as “a type and amount of immunological response that correlates with vaccineinduced protection against an infectious disease and that is considered predictive of clinical\n\nefficacy”.(115) It has been argued that correlates of vaccine efficacy could be used to extrapolate\n\nefficacy to immunogenicity data for novel vaccines where clinical efficacy results are unlikely to\n\nbe obtained.(116) The data can be used to bridge to new populations and to extrapolate efficacy\n\nestimates for new vaccines where efficacy data is unavailable or is unlikely to be obtained.(117)\n\nBeing able to rely on an ICP would simplify and accelerate vaccine development by allowing\n\ndevelopers to demonstrate that their candidate vaccines stimulate an accepted immune\n\nresponse in recipients from which efficacy can be inferred.(118)\n\n\n\n35\n\n\n\n\fEthics considerations\n\nWhen consensus is reached on valid surrogate outcomes (i.e., humoral and/or cellular immune\n\nparameters that adequately correlate with reduction in COVID-19 disease severity or mortality),\n\ninvestigational vaccines should not be tested in placebo control trials.\n\n\n\n4.2. Immunobridging\n\nImmunobridging refers to a situation where vaccine efficacy can be inferred by\n\ndemonstrating a non-inferior immune response between an investigational vaccine and an\n\nauthorized vaccine for which efficacy and/or effectiveness against a specific disease has\n\nbeen estimated.(119) WHO has noted that immunogenicity data may be used to provide\n\nevidence of efficacy when there is a well-established ICP that can be used to interpret the\n\nimmune responses to a specific antigenic component; and it is possible to use immune\n\nresponses to bridge to estimates of vaccine efficacy obtained from prior well-designed\n\nclinical trials. Following a June 2021 meeting of the ICMRA, which focused on\n\nimmunobridging, the design and use of control trials (placebo or other controls) and\n\nICPs,(120) ICMRA noted that well-justified and appropriately designed immunobridging\n\nstudies are an acceptable approach for authorizing COVID-19 vaccines.(121) Accordingly,\n\nsome aligned regulators have taken the position that the weight of evidence from studies\n\nwith authorized COVID-19 vaccines is sufficient to support using neutralizing antibody titres\n\nas a primary endpoint in cross-platform immunobridging trials.(122)\n\n\n\nEthics considerations\n\nWhen consensus is reached on valid surrogate outcomes (i.e., humoral and/or cellular immune\n\nparameters that adequately correlate with reduction in disease severity or mortality against\n\nCOVID-19), and there is broad regulatory consensus on relying on immunobridging for inferring\n\nefficacy, investigational COVID-19 vaccines should not be tested in placebo-control trials.\n\n\n\n36\n\n\n\n\fANNEX 2\n\n1. Modified vaccines\n\nAlternatives to placebo-control trials\n\n1.1. Immunobridging trial\n\nWHO has noted that bridging studies (relying on data of prototype/parent vaccines) for the modified\n\nCOVID-19 vaccine may be conducted in the 18-55 year-old age group, with extrapolation of results to\n\nother age groups for which the prototype vaccine has efficacy data.(123)\n\nSome regulators, such as members of the Access Consortium, have noted they will not require prior\n\nclinical efficacy studies to support their approval of modified vaccines.(124) These regulators have\n\nadvised developers of modified vaccines to submit bridging data on immunogenicity and safety from\n\na sufficient number of individuals.\n\n1.2. Historical control\n\nWHO has advised that studies comparing the immune response from the modified vaccine with\n\nhistorical data from the prototype vaccine may not be acceptable. However, if the prototype vaccine\n\nhas been demonstrated to be less effective / ineffective against a variant in a trial setting, its use in\n\nthe trial as a control will be unethical. In such instances, historical data of the prototype vaccine may\n\nbe used as a control. In such a situation challenge study data from animal models should also be\n\nconsidered.\n\n\n\n37\n\n\n\n\fANNEX 3\n\n1. Next-generation vaccines\n\nAlternatives to placebo control trials\n\n\n\n1.1 Active comparator efficacy trials\n\nNext-generation vaccines may be assessed in active comparator clinical endpoint efficacy trials. Such\n\ntrials would involve testing the next-generation vaccine against an authorized vaccine. Such studies\n\ncould be designed as non-inferiority immunogenicity studies if the comparator authorized vaccine\n\nhas demonstrated high efficacy in clinical diseases endpoint efficacy trials and/or superiority designs\n\nif the comparator vaccine has demonstrated modest efficacy.(125)\n\n\n\n1.2. Non-efficacy studies\n\nThe ICMRA has noted that immunogenicity bridging studies may be needed if an assessment of\n\neffectiveness of next-generation COVID-19 vaccines in clinical endpoint efficacy studies are deemed\n\nno longer feasible.(126) Some regulators, such as members of the Access Consortium, have taken\n\nthe position that the weight of evidence from studies with authorized COVID-19 vaccines is sufficient\n\nto support using neutralizing antibody titres as a primary endpoint in cross-platform\n\nimmunobridging trials to predict vaccine effectiveness.(127) Neutralizing antibody titres should be\n\ndetermined using WHO-certified reference standards.(128)\n\n\n\n© World Health Organization 2021. Some rights reserved. This work is available under the CC BY-NCSA 3.0 IGO licence.\n\nWHO reference number: WHO/2019-nCoV/Policy_brief/Vaccine_trial_design/2021.1\n\n\n\n38\n\n\n\n\f",
          "document_id": 450390
        }
      ]
    },
    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "What is deferred consent to experimental emergency interventions?",
              "id": 278951,
              "answers": [
                {
                  "answer_id": 274853,
                  "document_id": 450391,
                  "question_id": 278951,
                  "text": "In a deferred-consent procedure, at the\n\ntime of the experimental intervention, the\n\npatient is incapable of providing informed\n\nconsent and their legal representative is\n\nincapable of providing consent or is not\n\navailable. Consent for continuation of\n\ntrial enrollment and data collection is\n\nobtained only when the patient is capable\n\nof providing informed consent or the\n\nrepresentative is available, which renders\n\nthe consent ‘deferred",
                  "answer_start": 5167,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Under what conditions are deferred consent for experimental emergency interventions ethically acceptable in a pandemic?",
              "id": 278952,
              "answers": [
                {
                  "answer_id": 274857,
                  "document_id": 450391,
                  "question_id": 278952,
                  "text": "We argue that as long as researchers\n\nand sponsors have an opportunity to\n\nenroll patients in advance of intubation,\n\nsuch as admission to a COVID-19 ward, a\n\ndeferred-consent procedure in a pandemic\n\nshould not be regarded as acceptable.\n\nHowever, in the case of observational\n\nstudies investigating COVID-19, such as\n\nobtaining blood to determine viral load and\n\ncollecting inflammation-related parameters\n\nin patients who are severely ill, we believe\n\nthat the requirements that need to be met for\n\ndeferred consent may be too stringent.\n",
                  "answer_start": 10644,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            }
          ],
          "context": "comment\n\naffordable healthcare, to help address\n\nthe differences in spending that underlie\n\nthe injustices highlighted in the study by\n\nObermeyer et al.8. And although social\n\nscientists and ethicists have called for\n\nsuch transformations13,14, many health\n\npractitioners and researchers continue to\n\nlack proficiency in the basic terminologies\n\nand concepts of racial justice. These\n\ncompetencies need to be required for\n\nmedical licensing and accreditation.\n\nA radically socially conscious approach\n\nis needed to eliminate subtle but widespread\n\ndiscrimination. We urge each reader to take\n\naction in their institution today and, with\n\ncontinued vigor in the upcoming months and\n\nyears, to induce a true culture shift that would\n\nstop algorithmic design from perpetuating\n\n\n\ninequities. For this, systemic education of\n\nhealth practitioners and investigators on\n\nissues of racial justice is needed, as well as\n\nstandards for anti-racist development and\n\nanalysis of research.\n\n❐\n\nKellie Owens1 and Alexis Walker2 ✉\n\n\n\nData & Society Research Institute, New York, NY,\n\nUSA. 2Berman Institute of Bioethics, Johns Hopkins\n\nUniversity, Baltimore, MD, USA.\n\n✉e-mail: awalker@jhu.edu\n\n\n\n1\n\n\n\nPublished online: 9 September 2020\n\nhttps://doi.org/10.1038/s41591-020-1020-3\n\nReferences\n\n\n\n1. Hardeman, R., Medina, E. & Boyd, R. N. Engl. J. Med. 383,\n\n197–199 (2020).\n\n2. Cooper, H. & Fullilove, M. J. Urban Health 93, 1–7 (2016).\n\n\n\n3. Benjamin, R. Race After Technology: Abolitionist Tools for the New\n\nJim Code (John Wiley & Sons, 2019).\n\n4. Eubanks, V. Automating Inequality: How High-Tech Tools Profile,\n\nPolice, and Punish the Poor (St. Martin’s Press, 2018).\n\n5. O’neil, C. Weapons of Math Destruction: How Big Data Increases\n\nInequality and Threatens Democracy (Broadway Books, 2016).\n\n6. Vyas, D.A., Eisenstein, L.G. & Jones, D.S. N. Engl. J. Med. https://\n\ndoi.org/10.1056/NEJMms2004740 (2020).\n\n7. Noor, P. Br. Med. J. 368, m363 (2020).\n\n8. Obermeyer, Z., Powers, B., Vogeli, C. & Mullainathan, S. Science\n\n366, 447–453 (2019).\n\n9. Benjamin, R. Science 366, 421–422 (2019).\n\n10. Forscher, P. S., Lai, C. K. & Axt, J. R. et al. J. Pers. Soc. Psychol.\n\n117, 522–559 (2019).\n\n11. Noble, S. Algorithms of Oppression: How Search Engines Reinforce\n\nRacism (NYU Press, 2018).\n\n12. Boyd, D. & Crawford, K. Inf. Commun. Soc. 15, 662–679 (2012).\n\n13. Benjamin, R. Sci. Technol. Human Values 41, 967–990 (2016).\n\n14. Powers, M. & Faden, R. Social Justice: The Moral Foundations of\n\nPublic Health and Health Policy (Oxford University Press, 2006).\n\n\n\nCompeting interests\n\n\n\nThe authors declare no competing interests.\n\n\n\nThe ethics of deferred consent in times of\n\npandemics\n\nIn the current COVID-19 pandemic, many researchers are applying to research ethics committees for\n\ndeferred-consent procedures for protocols that aim either to test treatments or to obtain tissue or samples from\n\nresearch participants. However, the deferred-consent procedure has not been developed for pandemics. In this\n\nComment, we interpret existing guidance documents and argue when and under which conditions deferred consent\n\ncan be considered ethically acceptable in a pandemic.\n\n\n\nRieke van der Graaf, Marie-Astrid Hoogerwerf and Martine C. de Vries\n\n\n\nC\n\n\n\nurrently, several COVID-19 studies\n\nallow the inclusion of patients in\n\ntheir protocols on the basis of the\n\nso-called ‘deferred consent’ or Exemption\n\nfrom Informed Consent procedure used\n\nin emergency-care research settings. For\n\nexample, the RECOVERY protocol, in\n\nwhich patients are randomly assigned to\n\nvarious treatment arms (among others,\n\ndexamethasone), states “Due to the poor\n\noutcomes in COVID-19 patients who\n\nrequire ventilation (>90% mortality in\n\none cohort), patients who lack capacity to\n\nconsent due to severe disease (e.g. needs\n\nventilation), and for whom a relative to act\n\nas the legally designated representative is\n\nnot immediately available, randomisation\n\nand consequent treatment will proceed with\n\nconsent provided by a treating clinician\n\n(independent of the clinician seeking to\n\nenrol the patient) who will act as the legally\n\ndesignated representative. Consent will\n\nthen be obtained from the patient’s personal\n\nlegally designated representative (or directly\n\n1328\n\n\n\nfrom the patient if they recover promptly) at\n\nthe earliest opportunity”1.\n\nHowever, deferred-consent procedures\n\nhave not been developed for pandemics, and\n\nin the past decade there has been increasing\n\ndebate on the ethical acceptability of this\n\nprocedure2–4. Whether the inclusion of these\n\nprocedures in a study is acceptable deserves\n\nfurther scrutiny.\n\n\n\nWhat is deferred consent?\n\n\n\nThe deferred-consent procedure has been\n\ndeveloped for two types of emergency-care\n\nsettings: clear-cut cases in which patients are\n\nincapable of providing informed consent,\n\nsuch as seizures, sepsis, shock and severe\n\ntraumatic brain injuries; and a ‘gray area’\n\nof emergency-care situations in which the\n\nability of patients or their representatives\n\nto provide voluntary informed consent\n\nand to understand the information may be\n\ndiminished, such as in the case of respiratory\n\ndistress, depression or acute myocardial\n\ninfarction5.\n\n\n\nIn a deferred-consent procedure, at the\n\ntime of the experimental intervention, the\n\npatient is incapable of providing informed\n\nconsent and their legal representative is\n\nincapable of providing consent or is not\n\navailable. Consent for continuation of\n\ntrial enrollment and data collection is\n\nobtained only when the patient is capable\n\nof providing informed consent or the\n\nrepresentative is available, which renders\n\nthe consent ‘deferred’.\n\nSeveral documents legislate the right for\n\nthose carrying out the trial to use deferred\n\nconsent6–10, but by and large they have in\n\ncommon the following:\n\n•\n\n•\n\n•\n\n\n\nthe research participant suffers from an\n\nemergency condition that needs immediate treatment;\n\nthis condition renders the participant\n\nincapable of giving informed consent;\n\nan attempt has been made to obtain\n\ninformed consent from the participant’s\n\nlegal representative;\n\n\n\nNature Medicine | VOL 26 | September 2020 | 1318–1330 | www.nature.com/naturemedicine\n\n\n\n\fcomment\n\n•\n\n•\n\n•\n\n•\n\n•\n\n•\n\n\n\n•\n\n\n\nthe study cannot be conducted in a\n\npopulation that has not developed the\n\ncondition under study;\n\ninformed consent to remain in the study\n\nis obtained from the participant or the\n\nlegal representative as soon as possible;\n\nthe treatment under investigation is\n\nconsidered to be potentially beneficial\n\nfor the participant;\n\nthe research participant has not objected\n\nin advance to research participation;\n\nthe research cannot be conducted without the option of deferred consent;\n\nthe risks of receiving the intervention\n\nare minimal, at least in comparison with\n\nthe standard treatment of the research\n\nparticipant; and\n\nthe research ethics committee has\n\napproved the deferred-consent\n\nprocedure.\n\n\n\nSome guidance documents have\n\nadditional requirements, such as the\n\nneed for community engagement, the\n\nmaximum time of enrollment without\n\ninformed consent from the participant or\n\nthe representative, and the use of advance\n\ndirectives before participants become\n\nincapable of giving informed consent.\n\nAt the same time, deferred-consent\n\nprocedures are also debated. For example,\n\none of the questions is which alternatives\n\nexist when a conventional informed-consent\n\nprocess in an emergency-care situation\n\nis impossible2–4. In particular, patients\n\nwho fall into the ‘gray area’ may be\n\nable to understand aspects of the study\n\nthat could be explained in a modified\n\ninformed-consent procedure, which could\n\nbe done instead of the use of merely waivers\n\nor deferrals of consent4.\n\n\n\nDeferred consent and COVID-19\n\n\n\nIn the context of COVID-19, respiratory\n\ndistress is the prime symptom of COVID-19,\n\nand the condition of a patient may\n\ndeteriorate soon after they are admitted in a\n\nrelatively stable condition at the emergency\n\ndepartment. In the intensive care unit,\n\nthe treatment of patients with COVID-19\n\nconsists mainly of ventilator support with\n\nsupportive case measures.\n\nAdditional experimental anti-viral or\n\nanti-inflammatory medications may be\n\nadded to this standard treatment, and\n\nthese are assumed to be most effective\n\nwhen administered as soon as possible\n\nafter symptom onset11. In many settings,\n\nadditional medications are provided mainly\n\nwithin the context of clinical trials11.\n\nIn the case of COVID-19, patients may\n\nbe intubated early after admission, which\n\nmakes it impossible for them to provide\n\nconsent. The fact that this is happening as\n\n\n\npart of a pandemic, such as COVID-19,\n\nmakes contacting the legal representative\n\nmuch more complicated. They might not be\n\nimmediately available because they may not\n\nbe allowed in the intensive care unit because\n\nof lack of protective equipment, because\n\nthey are in self isolation or because travel is\n\nnot recommended. If the legal representative\n\ncannot be physically present to sign papers,\n\norganizing informed consent remotely is an\n\nalternative but can be logistically difficult,\n\nwhich may cause delays.\n\nBecause of such foreseen complications,\n\nfor some COVID-19 studies, several\n\nprotocols have included deferred-consent\n\nprocedures. However, we believe that in\n\npractice, there are very few situations in\n\nwhich deferred consent will be needed or\n\nis warranted. In our experience, only a few\n\npatients need immediate intubation, and\n\nin most cases, successfully contacting a\n\nremote legal representative does not lead\n\nto a life-threatening delay in the provision\n\nof care. In many COVID-19-related\n\nstudies there is a ‘therapeutic window’\n\n(Clinical Trial Regulation 35)6 for obtaining\n\ninformed consent. Patients may be coherent\n\nwhen they are admitted to a COVID-19\n\nward. In these COVID-19 wards, patients\n\ncan sign an informed-consent document\n\npreemptively, for inclusion at a later time\n\nwhen their condition deteriorates and\n\nauthorization is no longer possible, or they\n\nmay be pointed to potential COVID-19\n\nstudies and express their interest in\n\nparticipation, such as by means of an\n\nadvance directive (e.g., Council for\n\nInternational Organizations of Medical\n\nSciences guideline 16)7.\n\nMoreover, as has been seen with\n\nhydroxychloroquine, which has been widely\n\nused as a possible treatment for COVID-19\n\nbut has been shown to cause substantial\n\ntoxicity without any current proven\n\nbenefit12,13, some of these experimental\n\ntreatments may worsen symptoms and\n\nput the patient at higher risk than if they\n\nwere receiving supportive care only. If this\n\nis known in advance, the minimal-risk\n\nrequirement for acceptance of deferred\n\nconsent cannot be met.\n\nWe argue that as long as researchers\n\nand sponsors have an opportunity to\n\nenroll patients in advance of intubation,\n\nsuch as admission to a COVID-19 ward, a\n\ndeferred-consent procedure in a pandemic\n\nshould not be regarded as acceptable.\n\nHowever, in the case of observational\n\nstudies investigating COVID-19, such as\n\nobtaining blood to determine viral load and\n\ncollecting inflammation-related parameters\n\nin patients who are severely ill, we believe\n\nthat the requirements that need to be met for\n\ndeferred consent may be too stringent.\n\n\n\nNature Medicine | VOL 26 | September 2020 | 1318–1330 | www.nature.com/naturemedicine\n\n\n\nObtaining these data in the context\n\nof an ongoing pandemic can be of major\n\nimportance for quickly learning about the\n\ndisease, which immediately affects the\n\ntreatment of subsequent patients14. It poses\n\na minimal risk to patients but has no direct\n\nbenefit for these patients either. We think\n\nthe following conditions should apply\n\nwhen collection of tissues or samples with a\n\ndeferred-consent procedure is proposed:\n\n(a) for studies with a therapeutic intent,\n\nit is not possible to enroll patients in\n\nadvance of intubation;\n\n(b) there is no way to obtain samples (and\n\nthe related data) other than through the\n\nuse of a deferred-consent procedure;\n\n(c) the study cannot be done with competent patients (e.g., when this leads to\n\nbias in sample collection) or incompetent patients are needed to obtain the\n\nsample (subsidiarity);\n\n(d) all other conditions for deferred consent\n\nare fulfilled; and\n\n(e) applicable ethical and legal procedures\n\nfor data collection are followed, such\n\nas protection of confidentiality of the\n\npersonal data collected and mitigation\n\nof risks to privacy15.\n\nThese conditions may be relevant only\n\nto this very unique situation of a pandemic\n\nthat presents a new pathogen for which no\n\nvaccine or effective treatment is available, for\n\nwhich it may be of the utmost importance to\n\ncollect real-time data and samples to guide\n\ntreatment decisions and to understand this\n\nemerging disease. In these cases, deferred\n\nconsent should be allowed under the\n\nconditions that we have outlined.\b\n\n❐\n\nRieke van der Graaf1 ✉,\n\nMarie-Astrid Hoogerwerf\n\nMartine C. de Vries4\n\n\n\n2,3\n\n\n\nand\n\n\n\nDepartment of Medical Humanities, Julius\n\nCenter for Health Sciences and Primary Care,\n\nUniversity Medical Center Utrecht, Utrecht, the\n\nNetherlands. 2Department of Parasitology, Leiden\n\nUniversity Medical Center, Leiden, the Netherlands.\n\n3\n\nDepartment of Infectious Diseases, Leiden\n\nUniversity Medical Center, Leiden, the Netherlands.\n\n4\n\nDepartment of Medical Ethics and Health Law,\n\nLeiden University Medical Center, Leiden,\n\nthe Netherlands.\n\n✉e-mail: r.vandergraaf@umcutrecht.nl\n\n1\n\n\n\nPublished online: 10 July 2020\n\nhttps://doi.org/10.1038/s41591-020-0999-9\n\nReferences\n\n\n\n1. Randomised Evaluation of COVID19 Therapy\n\n(RECOVERY). https://www.recoverytrial.net/files/\n\nrecovery-protocol-v6-0-2020-05-14.pdf (2020).\n\n2. Johnson, L. R. & Siddaiah, R. Br. Med. J. 351, h4609\n\n(2015).\n\n3. Olsson, A. et al. Trials 21, 246 (2020).\n\n\n\n1329\n\n\n\n\fcomment\n\n4. Dickert, N. W. et al. Am. J. Bioeth. 5, 7–17 (2020).\n\n5. Baren, J.M. https://improvinghealthcare.mehp.upenn.edu/\n\nethics-policy-covid19/intersection (2020).\n\n6. The European parliament and the Council of the European\n\nUnion. Clinical Trials -Regulation (EU) No 536/2014. https://\n\nec.europa.eu/health/human-use/clinical-trials/regulation_en\n\n(2014).\n\n7. Council for International Organizations of Medical\n\nSciences (CIOMS) in collaboration with the World Health\n\nOrganization (WHO). International Ethical Guidelines for\n\nHealth-related Research Involving Humans (CIOMS,\n\n2016).\n\n\n\n1330\n\n\n\n8. European Medicines Agency. https://www.ema.europa.eu/en/\n\nich-e6-r2-good-clinical-practice (2016).\n\n9. World Medical Association. https://www.wma.net/policies-post/\n\nwma-declaration-of-helsinki-ethical-principles-for-medicalresearch-involving-human-subjects/ (2013).\n\n10. US Food and Drug Administration. Code of Federal Regulations\n\nTitle 21 §50.24. https://www.accessdata.fda.gov/scripts/cdrh/\n\ncfdocs/cfcfr/CFRSearch.cfm?fr=50.24 2019.\n\n11. Cardone, M., Yano, M., Rosenberg, A. S. & Puig, M.\n\nFront. Immunol. https://doi.org/10.3389/fimmu.2020.01131\n\n(2020).\n\n12. Torjesen, I. Br. Med. J. 369, m2263 (2020).\n\n\n\n13. Mahévas, M. et al. Br. Med. J. 369, m1844 (2020).\n\n14. Henry, B. M., Santos de Oliveira, M. H., Benoit, S., Plebani, M.\n\n& Lippi, G. Clin. Chem. Lab. Med. https://doi.org/10.1515/cclm2020-0369 (2020).\n\n15. EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/\n\nPDF/?uri=CELEX:02016R0679-20160504&from=EN\n\n(2016).\n\n\n\nCompeting interests\n\n\n\nR.G. is a member of the independent bioethics advisory\n\ncommittee for Sanofi.\n\n\n\nNature Medicine | VOL 26 | September 2020 | 1318–1330 | www.nature.com/naturemedicine\n\n\n\n\f",
          "document_id": 450391
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      ]
    },
    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "How should governments make decisions regarding difficult trade-offs in response to COVID-19?",
              "id": 278989,
              "answers": [
                {
                  "answer_id": 274922,
                  "document_id": 450695,
                  "question_id": 278989,
                  "text": "COVID-19 pandemic has forced\n\ngovernments to make difficult\n\nchoices that profoundly affect the\n\nhealth, wealth and freedoms of their\n\npopulations. To deal with the public health\n\nand economic emergencies generated by\n\nCOVID-19, these high-stakes decisions\n\nhave often been made quickly, with\n\nlittle involvement of stakeholders in the\n\ndeliberation about which policies to\n\npursue. Given the uncertain duration of\n\nthe pandemic, and even as vaccines are\n\nin the process of being approved, there\n\nare important moral, legal and practical\n\nreasons to engage in open and inclusive\n\ndecision-making processes. These include an\n\nimprovement in the quality of decisions, an\n\nincrease in legitimacy and trust, compliance\n\nwith legal obligations and improved\n\nadherence to restrictions on behavior that\n\nare necessary to curb the spread of the virus.\n\nSuch deliberative processes also respect\n\npeople’s abilities to offer, appreciate and\n\nact on reasons and are required by\n\nhuman rights and rule of law principles.\n\nTo serve their purpose and build\n\npublic trust, these processes should be\n\ninstitutionalized rather than ad hoc,\n\nthus making inclusive, transparent and\n\naccountable decision making a routine\n\nfeature of governance, now and beyond\n\nthe pandemic. We argue the case for such\n\nopen and inclusive decision making,\n\ncharacterize it and offer examples of how\n\nto put it into practice.\n",
                  "answer_start": 488,
                  "answer_category": null
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            },
            {
              "question": "What are Inclusive deliberative bodies for the response to COVID-19?",
              "id": 279015,
              "answers": [
                {
                  "answer_id": 274923,
                  "document_id": 450695,
                  "question_id": 279015,
                  "text": "Inclusive deliberative bodies that\n\nare set up to include relevant voices\n\nand produce well-considered advice.\n\nThey may consist only of randomly\n\nselected citizens or also include experts,\n\nstakeholders and/or politicians. Some\n\nare ad-hoc citizens’ assemblies, and\n\nothers are permanent citizen panels that\n\nare set up to engage with new issues as\n\nthey evolve or advisory councils with\n\nexpertise in a particular area. Such\n\ndeliberative bodies, when properly\n\nconstituted, can be particularly useful\n\nfor reaching more trustworthy and\n\nlegitimate decisions on difficult ethical\n\nquestions and complex trade-offs.",
                  "answer_start": 17800,
                  "answer_category": null
                }
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              "is_impossible": false
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          "context": "comment\n\n\n\nDifficult trade-offs in response to COVID-19: the\n\ncase for open and inclusive decision making\n\nWe argue that deliberative decision making that is inclusive, transparent and accountable can contribute to more\n\ntrustworthy and legitimate decisions on difficult ethical questions and political trade-offs during the pandemic\n\nand beyond.\n\n\n\nOle F. Norheim, Joelle M. Abi-Rached, Liam Kofi Bright, Kristine Bærøe, Octávio L. M. Ferraz,\n\nSiri Gloppen and Alex Voorhoeve\n\n\n\nT\n\n\n\nhe COVID-19 pandemic has forced\n\ngovernments to make difficult\n\nchoices that profoundly affect the\n\nhealth, wealth and freedoms of their\n\npopulations. To deal with the public health\n\nand economic emergencies generated by\n\nCOVID-19, these high-stakes decisions\n\nhave often been made quickly, with\n\nlittle involvement of stakeholders in the\n\ndeliberation about which policies to\n\npursue. Given the uncertain duration of\n\nthe pandemic, and even as vaccines are\n\nin the process of being approved, there\n\nare important moral, legal and practical\n\nreasons to engage in open and inclusive\n\ndecision-making processes. These include an\n\nimprovement in the quality of decisions, an\n\nincrease in legitimacy and trust, compliance\n\nwith legal obligations and improved\n\nadherence to restrictions on behavior that\n\nare necessary to curb the spread of the virus.\n\nSuch deliberative processes also respect\n\npeople’s abilities to offer, appreciate and\n\nact on reasons and are required by\n\nhuman rights and rule of law principles.\n\nTo serve their purpose and build\n\npublic trust, these processes should be\n\ninstitutionalized rather than ad hoc,\n\nthus making inclusive, transparent and\n\naccountable decision making a routine\n\nfeature of governance, now and beyond\n\nthe pandemic. We argue the case for such\n\nopen and inclusive decision making,\n\ncharacterize it and offer examples of how\n\nto put it into practice.\n\n\n\nWhat is at stake\n\n\n\nDespite considerable uncertainty about the\n\nhealth impacts of COVID-19, the scientific\n\nconsensus is that the health burdens of\n\nuncontrolled spread are substantial1. In the\n\nabsence of policies to lessen its spread, it\n\nis likely that in excess of 50% of countries’\n\npopulations would be infected2. Infection\n\nfatality rate (IFR) estimates vary and depend\n\non country characteristics, including\n\ndemography, but are estimated to be in the\n\n10\n\n\n\norder of 0.23–1.15%3, suggesting that the\n\ndirect effects of uncontrolled spread would\n\nbe COVID-19 deaths in the order of\n\n0.1–0.6% of the population, concentrated\n\namong the elderly, vulnerable,\n\nsocioeconomically disadvantaged and\n\nmarginalized groups4. Moreover, for\n\nmany, non-fatal infections present a\n\nsubstantial health burden, and the burden\n\nof caring for those with COVID-19 could\n\noverwhelm the health system.\n\nTo limit infections, governments have\n\nturned to general or targeted lockdowns\n\ncoupled with public health messaging,\n\ntesting and contact tracing. These policies\n\nhave a complex cluster of effects. An early,\n\nwell-executed lockdown can be highly\n\neffective at limiting the direct health\n\neffects of COVID-19. But this limits\n\nliberties and can have negative effects on\n\nshort-term economic growth, access to\n\nsocial services, employment, sociability,\n\nmental well-being and education. It is feared\n\nthe combined effect of lockdowns and\n\neconomic disruption due to illness could\n\nwipe out important gains made in the past\n\ndecade in terms of poverty reduction and\n\nlifespan, worsening the quality of life in the\n\naffected countries while widening income\n\ninequality. The World Bank estimates that as\n\nmany as 150 million people may be pushed\n\ninto extreme poverty due to the economic\n\nconsequences of the pandemic5. Moreover, if\n\nnot well executed, recurrent lockdowns and\n\nother restrictive public health measures can\n\ncause ‘pandemic fatigue’ and social unrest,\n\nespecially in fragile countries already at war\n\nor facing other crises.\n\nTherefore, while countries face dilemmas\n\ninvolving the best balance between health\n\non the one hand and income, liberties,\n\neducation and further goods on the other,\n\nthe nature of these trade-offs depends on\n\nthe country and the context of the policy.\n\nThese factors include speed, stringency and\n\ncomprehensiveness of public measures,\n\npublic health capacity, level of income and\n\n\n\ninequality, population age distribution and\n\npublic attitudes. The impacts are likely to\n\nbe diverse across and within countries and\n\nare further complicated by the presence of\n\nextensive uncertainty about the impact of\n\npolicies and their sustainability in the face of\n\nmounting costs.\n\nSome governments’ use of emergency\n\npowers in response to COVID-19 has\n\nside-lined, challenged and weakened\n\ndemocratic processes. The pandemic\n\nhas exposed and widened existing social\n\ninequalities and divisions. Trust in political\n\nand scientific authorities is eroding. At\n\nthe same time, trust in public authorities\n\nand among community members has\n\nemerged as a decisive factor in the ability of\n\nmany countries to secure compliance with\n\npandemic regulations and measures. As a\n\nconsequence, many countries have started to\n\ncritically review the way they make decisions\n\nand who should make them, both in the\n\nremaining period of this pandemic and in\n\npreparation for future health emergencies.\n\nIn the remainder of this Comment, we\n\npresent the case for making these decisions\n\nin a transparent and inclusive manner.\n\n\n\nElements of open and inclusive\n\ndecision making\n\n\n\nFor policies to be effective, they must be\n\nbased on accurate knowledge and adherence\n\nto public health recommendations. Policy\n\ndecisions have an impact on the distribution\n\nof risks and benefits and create benefits\n\nand burdens6. For people to willingly abide\n\nby them when this is burdensome, policies\n\nmust be perceived as fair, and open and\n\ninclusive decision making contributes to\n\nthis perception. This general framework\n\nis supported by political philosophy\n\nand socio-legal research on procedural\n\nfairness7–10. The essential arguments for\n\nand features of transparent and inclusive\n\ndecision making are listed in Box 1 and\n\ninvolve participation of political leaders,\n\nexperts and all affected parties.\n\n\n\nNature Medicine | VOL 27 | January 2021 | 10–16 | www.nature.com/naturemedicine\n\n\n\n\fcomment\n\nBox 1 | Open, inclusive decision-making under COVID-19\n\n\n\n(I) Supporting reasons\n\nPolitical equality and human rights\n\n• Inclusive decision making ensures\n\nthat governments act according to\n\nthe rights of political participation\n\nenshrined in national and international law, particularly human rights\n\nlaw and the principles of accountable\n\ngovernment.\n\n• Broad-based, transparent decision\n\nmaking fulfills the ideal of procedural\n\nfairness, which requires that decisions\n\nthat affect peoples’ interests be taken:\n\n(i) on the basis of evidence; (ii) with\n\nequal consideration of everyone’s\n\ninterests and perspectives; (iii) on the\n\nbasis of reasons that people can share;\n\n(iv) in an open, accessible manner;\n\nand (v) through institutional means\n\nthat permit challenge and revision\n\nof decisions.\n\n• Inclusive decision making rests on the\n\ndemocratic ideal that all people should\n\nhave a fair opportunity to participate in\n\ndecisions that affect them.\n\n• Inclusion of all those affected promotes\n\nself-esteem and mutual respect.\n\n• Transparency allows the public to form\n\ninformed opinions.\n\n• When decisions are based on reasons\n\nthat can be appreciated by all, such as\n\nthe importance of protecting health and\n\nincomes, all participants are treated as\n\ncapable of understanding and acting on\n\nthose common reasons.\n\n• Procedurally fair decision-making\n\nprocesses contribute to trust in\n\ndecision makers and to the legitimacy\n\nof the decisions.\n\n• Inclusive decision making may lessen\n\nsocial disagreement, because even in\n\nthe face of polarized opinions about\n\nwhat to do it may be possible to achieve\n\n\n\nFair process\n\n\n\nFairness can be seen in terms of the decision\n\nitself (substantive fairness) or in terms\n\nof how the decision is made (procedural\n\nfairness), or both7. The assumption behind\n\nprocedural fairness is that even though\n\nthere may be widespread disagreement\n\nabout what would be a just distribution of\n\nburdens and benefits, the affected parties\n\nmay be expected to reach an agreement\n\non what conditions must be in place to\n\nmake the decision-making process fair. In\n\ngeneral, procedural fairness requires that\n\ndecisions affecting people’s interests are\n\nmade (i) on the basis of available evidence;\n\n\n\n•\n\n\n\nagreement on fair procedures for\n\narriving at policy decisions. Policies\n\nresulting from fair procedures may then\n\nbe accepted even by those who disagree\n\nwith them on substantive grounds.\n\nRestrictions on freedom are more\n\nreadily accepted if they are the outcome\n\nof a fair process. Acceptance reduces\n\nthe burden of restrictions and renders\n\nthem more consistent with autonomy.\n\n\n\nScrutiny and communication\n\n• Policy decisions are better targeted\n\nand more effective if they are informed\n\nby accurate descriptions of the\n\ncircumstances and evidence of\n\nwhat works.\n\n• Critical scrutiny of evidence and\n\nuncertainty can improve decisions.\n\n• Communication of clear rationales\n\nand uncertainty, and making\n\nevidence publicly accessible prevents\n\ndisinformation and builds trust.\n\nTrust and adherence\n\n• Open, inclusive decision making builds\n\ntrust. This improves adherence to\n\npolicies, making them more effective.\n\nGreater effectiveness, in turn,\n\nengenders more trust in policy\n\nmakers. Open decision making can\n\ntherefore contribute to a virtuous cycle\n\nof increasing trust, adherence and\n\npolicy effectiveness.\n\n\n\n•\n\n\n\npeople with dissimilar moral and\n\npolitical outlooks.\n\nDecisions and their rationales are\n\ncommunicated in a manner that\n\neveryone can understand.\n\n\n\nExperts\n\n• Experts are drawn from a variety\n\nof fields, including the humanities,\n\nmedical and social sciences.\n\n• Experts communicate transparently\n\nabout what works and for whom and\n\nabout uncertainty and values.\n\n• Experts publish their findings and\n\nrecommendations for critical scrutiny.\n\n• Epidemiological, statistical and other\n\nrelevant data are open access.\n\n• Experts participate in fora that leave\n\nthem open to critical feedback and\n\nadjust those elements of their practice\n\nthat are legitimately challenged by\n\nmembers of the public.\n\nThe public\n\n• All affected parties are included,\n\nlistened to and have a say.\n\n• Special attention is given to vulnerable\n\nand marginalized groups and to the\n\nharms and benefits to people who cannot easily raise their voices.\n\n\n\n(II) Key elements\n\nPolitical leaders\n\n• Decision making is built on evidence.\n\n• The ethical, legal, scientific, economic,\n\nsocial and political reasons for a\n\ndecision are made transparent.\n\n• To facilitate consensus, as far as\n\npossible, these reasons are shared by\n\n\n\nAccountability\n\n• All affected individuals and groups can\n\nchallenge decisions.\n\n• Mechanisms are in place for feedback\n\nand revision when new challenges or\n\nevidence emerge.\n\n• The input of affected parties is\n\ndocumented.\n\n• Mechanisms are in place for\n\nbudgetary transparency and\n\nensuring that loans and grants are\n\nallocated appropriately.\n\n\n\n(ii) in a way that gives equal consideration\n\nto everyone’s interests and takes account\n\nof their perspectives; (iii) based on reasons\n\nthat people can share, that is, recognize as\n\nrelevant from their differing views of the\n\ngood life and of substantive fairness;\n\n(iv) in an open and accessible manner;\n\nand (v) through institutional means\n\nthat permit challenge and revision of\n\ndecisions. Fair procedures promote\n\ninclusion, require transparency and make\n\nthe decision makers accountable, which can\n\ncontribute to perceived legitimacy and trust\n\nin the decision makers and adherence to\n\nresulting policies11.\n\n\n\nTransparent, inclusive and accountable\n\ndecision making is not simply something\n\ndesirable from the perspective of ethics\n\nand efficiency. It is also required by human\n\nrights and rule of law principles that most\n\ncountries have committed to respect\n\nthrough participation in international\n\ntreaties and provisions of their own\n\ndomestic laws, including constitutions. The\n\nright to directly and indirectly participate\n\nin political and public life is recognized in\n\nthe Universal Declaration of Human Rights\n\n(article 21) and the International Covenant\n\non Civil and Political Rights (article 25),\n\namong other places. Participation rights\n\n\n\nNature Medicine | VOL 27 | January 2021 | 10–16 | www.nature.com/naturemedicine\n\n\n\n11\n\n\n\n\fcomment\n\nBox 2 | Practical examples\n\n\n\nCountries with established systems of\n\nparticipatory health governance benefit\n\nfrom a base of public trust. Together\n\nwith effective communication strategies\n\nand unified public health systems,\n\nthese systems are central to a successful\n\nresponse to COVID-19. Examples\n\ninclude New Zealand, Taiwan and\n\nSouth Korea22.\n\nElements of systems for open and\n\ninclusive decision making include\n\nthe following:\n\n(i) Inclusive deliberative bodies: ad-hoc\n\ncitizens’ assemblies, permanent\n\ncitizens’ panels, advisory councils:\n\n• Australia: COVID-19 Culturally and\n\nLinguistically Diverse Community\n\nForums in South Australia23\n\n• England: Citizens’ Panel Planning the\n\nWest Midlands’ Recovery23\n\n\n\nare also inextricably linked to other human\n\nrights such as the rights to peaceful assembly\n\nand association, freedom of expression and\n\nopinion and the rights to education and to\n\ninformation12.\n\n\n\nThe role of experts\n\n\n\nTrustworthy decision making involves\n\nexperts and is built on evidence. It is\n\ninevitable that we must sometimes act\n\nbefore scientific inquiry has led to anything\n\nlike certainty13. This is especially so in\n\nthis pandemic. There is often uncertainty\n\nsurrounding key parameter values, relevant\n\ncausal mechanisms and peoples’ responses\n\nto novel events. To sensibly reason about\n\nthese uncertainties, the public needs to be\n\nmade aware of where these uncertainties\n\narise and how they may be dealt with.\n\nFurther, a transparent and frank dialogue\n\nbetween scientists, policy makers and\n\nthe broader public can help combat the\n\n‘infodemic’ of misinformation spreading on\n\nsocial media and interfering with attempts\n\nto rationally address COVID-1914.\n\nTo justify any particular approach to\n\ndealing with these uncertainties, scientists\n\nmust often appeal to ethical or political\n\nvalues concerning which risks are worth\n\ntaking more seriously than others15. These\n\nvalue-laden decisions will affect not only\n\nwhat scientists take to be true, but also how\n\nscientists communicate their uncertainties16\n\nand which measures are used to weigh\n\nand assess key outcomes of interest17.\n\nScience communication should hence\n\nprioritize communicating the nature of\n\nthe value-laden decisions scientists must\n\n12\n\n\n\n•\n\n\n\nUSA: Oregon Citizens’ Assembly on\n\nCOVID-19 Recovery23\n\n\n\n(i) Hearings: mandated in law or optional:\n\n• France: Commission d’enquête pour\n\nl’évaluation des politiques publiques\n\nface aux grandes pandémies à la\n\nlumière de la crise sanitaire de la\n\nCOVID-19 et de sa gestion24\n\n• Norway: Corona-law and regulation\n\nhearings\n\n• USA: National Academies of\n\nSciences Engineering and Medicine\n\nPublic Comment Opportunities:\n\nDiscussion Draft of the Preliminary\n\nFramework for Equitable Allocation\n\nof COVID-19 Vaccine25\n\n(i) Open, self-selective public\n\nparticipation mechanisms: town\n\n\n\nmake, including what the stakes are and\n\nhow different parties’ legitimate interests are\n\nbeing assessed and weighed.\n\nScientists must be appropriately receptive\n\nto public feedback and to challenges. Science\n\ncommunicators should hence appreciate\n\nhow input from the public on their findings\n\ncan be legitimate and important and be\n\nreceptive to bidirectional communication\n\nbetween citizens and scientific experts18.\n\nAlthough these requirements of\n\ntransparent and inclusive deliberation may\n\nappear demanding during a crisis, fulfilling\n\nthem can contribute toward virtuous\n\ncycles of trust building and enhance\n\nimplementation and adherence.\n\n\n\nExperiences from participatory\n\ninnovations\n\n\n\nIn the context of COVID-19, when hard\n\npolicy choices and trade-offs are called\n\nfor on a regular basis, it is important to\n\nset up systems that can provide for open\n\nand inclusive decision making in an\n\ninstitutionalized manner rather than as\n\nad hoc efforts.\n\nExperimentation with inclusive and\n\ndeliberative decision-making processes\n\nprovides useful guidance on how public\n\ndeliberation can be designed to meet the\n\nrequirements of a fair decision-making\n\nprocess in the context of the pandemic19.\n\nA plethora of mechanisms have been\n\nintroduced across the globe in recent years\n\nto improve the quality and legitimacy\n\nof public decision making (see Box 2).\n\nResearch has found that these tools, when\n\ncarefully set up and implemented, have\n\n\n\n•\n\n•\n\n•\n\n•\n\n•\n\n•\n\n•\n\n\n\nhalls, village meetings (face to\n\nface or online), radio and television\n\ncall-in programs, petitions and\n\ncrowdsourcing, initiated by either\n\ngovernment or civil society.\n\nBrazil: mechanism for transparency and\n\npublic engagement on COVID-19 in\n\nthe federal health system26\n\nFrance: Citizens’ committee in\n\nGrenoble27\n\nLebanon: Independent Committee for\n\nthe Elimination of COVID-1928\n\nScotland: Coronavirus (COVID-19):\n\nNational crowd-sourcing exercise23\n\nSenegal: several citizens’ initiatives29\n\nUnited Kingdom: Independent\n\nSAGE30\n\nUnited States: Connecting to Congress,\n\ndeliberative town halls on COVID-1923\n\nand Endcoronavirus.org\n\n\n\nproven useful and robust in ways that are\n\npromising for the type of decision making\n\ncalled for in response to COVID-19 and for\n\nfuture health crises, involving value-based\n\nquestions and complex trade-offs20.\n\nThree types of inclusive, deliberative\n\nand participatory institutions are highly\n\nrelevant in this context:\n\n(i) Inclusive deliberative bodies that\n\nare set up to include relevant voices\n\nand produce well-considered advice.\n\nThey may consist only of randomly\n\nselected citizens or also include experts,\n\nstakeholders and/or politicians. Some\n\nare ad-hoc citizens’ assemblies, and\n\nothers are permanent citizen panels that\n\nare set up to engage with new issues as\n\nthey evolve or advisory councils with\n\nexpertise in a particular area. Such\n\ndeliberative bodies, when properly\n\nconstituted, can be particularly useful\n\nfor reaching more trustworthy and\n\nlegitimate decisions on difficult ethical\n\nquestions and complex trade-offs.\n\n(ii) Hearings are set up in many countries\n\nto gather relevant insights from experts\n\nand stakeholders on draft legislation\n\nand policy. Advantages of these\n\nprocesses are that, particularly where\n\nalready mandated, they are closely\n\nlinked to formal decision making and\n\nhave the potential to inform and\n\nspur public debate and to generate\n\nlegitimacy for decisions with interested\n\nstakeholders. Most importantly, they\n\ncan enhance the deliberative quality\n\nof governments and legislatures by\n\n\n\nNature Medicine | VOL 27 | January 2021 | 10–16 | www.nature.com/naturemedicine\n\n\n\n\fcomment\n\nexpanding the points of view and\n\ninterests considered. Hearings do\n\nnot, however, produce an inclusive\n\ndeliberated output as the participants\n\nin hearing processes do not jointly\n\ndeliberate hard ethical issues and\n\ntrade-offs. In most cases, institutionalized hearings are not open to the\n\ngeneral public. Mandated consultations\n\nwith indigenous peoples, set up to\n\nprotect their autonomy and rights,\n\ncould be extended to COVID-19 related\n\ndecisions, in which indigenous groups\n\nare particularly vulnerable21.\n\n(iii) Open, self-selective public participation\n\nmechanisms are designed to ensure that\n\neveryone, in principle, can make their\n\nvoice heard. These can take a variety of\n\nforms, including deliberative town halls\n\nand village or municipality meetings\n\nthat can be face to face or online via\n\n‘virtual democracy platforms’; radio\n\nand television call-in shows, calls for\n\npetitions and crowdsourcing of legal\n\nprovisions, guidelines and policies.\n\nThese mechanisms are often set up to\n\nharvest participatory input and make\n\nit available for decision makers, with\n\nefforts to show how it is taken into\n\naccount in decision making. A common\n\ncriticism of these mechanisms is that\n\nthey are more often used by those with\n\nmost resources, and they are not usually\n\nset up to ensure that the views of the\n\nmost vulnerable are enabled\n\nor represented19.\n\nThese are not alternative mechanisms.\n\nThey serve complementary purposes and\n\nare often combined. These mechanisms\n\ncan serve as independent channels of input\n\ninto legislative and policy processes, or\n\ndeliberative bodies can be embedded in\n\nbroader public participation mechanisms.\n\n\n\nConcluding remarks\n\n\n\nEvidence from before COVID-19 shows\n\nthat deliberative decision making that is\n\ninclusive, transparent and accountable\n\ncan contribute to more trustworthy and\n\nlegitimate decisions on difficult ethical\n\n\n\nquestions and political trade-offs. To\n\ninstitute and broaden deliberative processes\n\nshould therefore be a priority in the\n\ncontext of pandemic response and in\n\nanticipation of future heath crises. In the\n\nshort term, it can build legitimacy and\n\nsupport for hard decisions that need to\n\nbe made in response to the pandemic and\n\nprevent further erosion of trust. In the\n\nlonger term, it can contribute towards\n\nvirtuous cycles of trust-building and\n\nmore effective policies.\n\n❐\n\nOle F. Norheim 1,2 ✉,\n\nJoelle M. Abi-Rached3,4, Liam Kofi Bright5,\n\nKristine Bærøe 1, Octávio L. M. Ferraz6,\n\nSiri Gloppen 7 and Alex Voorhoeve 8,9\n\n\n\nBergen Centre for Ethics and Priority Setting,\n\nDepartment of Global Public Health and Primary\n\nCare, University of Bergen, Bergen, Norway.\n\n2\n\nDepartment of Global Health and Population,\n\nHarvard T.H. Chan School of Public Health,\n\nBoston, MA, USA. 3Department of Geography and\n\nTerritories, École Normale Supérieure, Paris, France.\n\n4\n\nMedialab, Sciences Po, Paris, France. 5Department\n\nof Philosophy, Logic, and Scientific Method, London\n\nSchool of Economics, London, UK. 6Transnational\n\nLaw Institute, The Dickson Poon School of Law,\n\nKing’s College London, London, UK. 7Centre on\n\nLaw and Social Transformation, Department of\n\nComparative Politics, University of Bergen, Bergen,\n\nNorway. 8Department of Philosophy, Logic, and\n\nScientific Method, London School of Economics,\n\nLondon, UK. 9Departments of Applied Economics\n\nand Philosophy, Erasmus University Rotterdam,\n\nRotterdam, Netherlands.\n\n✉e-mail: ole.norheim@uib.no\n\n1\n\n\n\nPublished online: 18 December 2020\n\nhttps://doi.org/10.1038/s41591-020-01204-6\n\nReferences\n\n\n\n1. Alwan, N. A. et al. Lancet 396, e71–e72 (2020).\n\n2. Fontanet, A. & Cauchemez, S. Nat. Rev. Immunol. 20,\n\n583–584 (2020).\n\n3. Brazeau, N. et al. https://doi.org/10.25561/83545 (2020).\n\n4. Office for National Statistics UK. https://www.ons.gov.uk/\n\npeoplepopulationandcommunity/birthsdeathsandmarriages/\n\ndeaths/bulletins/deathsinvolvingcovid19bylocalareasand\n\ndeprivation/deathsoccurringbetween1marchand31july2020\n\n(2020).\n\n5. World Bank. https://www.worldbank.org/en/news/pressrelease/2020/10/07/covid-19-to-add-as-many-as-150-millionextreme-poor-by-2021 (2020).\n\n\n\nNature Medicine | VOL 27 | January 2021 | 10–16 | www.nature.com/naturemedicine\n\n\n\n6. Gutmann, A. & Thompson, D.F. Why Deliberative Democracy?\n\n(Princeton University Press, Princeton, NJ, 2004).\n\n7. Daniels, N. & Sabin, J.E. Setting Limits Fairly: Can We Learn to\n\nShare Medical Resources? Second Edition (Oxford University\n\nPress, Oxford, 2008).\n\n8. Miller, D. T. Annu. Rev. Psychol. 52, 527–553 (2001).\n\n9. Tyler, T. R. Annu. Rev. Psychol. 57, 375–400 (2006).\n\n10. Dryzek, J. S. et al. Science 363, 1144–1146 (2019).\n\n11. Jansen, M. P. M., Baltussen, R. & Bærøe, K. Int. J. Health Policy\n\nManag. 7, 973–976 (2018).\n\n12. UN Office of the High Commissioner for Human Rights. Equal\n\nParticipation in Political and Public Affairs. Resolution Adopted by\n\nthe Human Rights Council on 30 September 2016. United Nations\n\nA/HRC/RES/33/22. (The Human Rights Council, Geneva, 2016).\n\n13. Heesen, R. Philos. Stud. 172, 2299–2313 (2015).\n\n14. Lewandowsky, S. et al. Technology and Democracy: Understanding\n\nthe Influence of Online Technologies on Political Behaviour and\n\nDecision-Making. (Publications Office of the European Union,\n\nLuxembourg, 2020).\n\n15. Ward, Z. B. On value-laden science in Stud. Hist. Philos. Sci. Part\n\nA (in the press).\n\n16. Steele, K. Philos. Sci. 79, 893–904 (2012).\n\n17. Schroeder, S. A. Public Health Ethics 10, 176–187 (2017).\n\n18. Kitcher, P. Science, Truth, and Democracy (Oxford University\n\nPress, Oxford, 2003).\n\n19. Smith, G. Democratic Innovations: Designing Institutions for Citizen\n\nParticipation (Cambridge University Press, Cambridge, 2009).\n\n20. OECD. Innovative Citizen Participation and New Democratic\n\nInstitutions: Catching the Deliberative Wave (OECD Publishing,\n\nParis, 2020); https://doi.org/10.1787/339306da-en\n\n21. Charlier, P. & Varison, L. Lancet 396, 1069–1070 (2020).\n\n22. Open Government Partnership. https://www.opengovpartnership.\n\norg/wp-content/uploads/2019/08/Global-Report_Health.pdf\n\n(Accessed November 5. 2020).\n\n23. Participedia. A global network and crowdsourcing platform for\n\nresearchers, educators, practitioners, policymakers, activists,\n\nand anyone interested in public participation and democratic\n\ninnovations https://participedia.net (accessed November 124,\n\n2020).\n\n24. Sénat. Commission d’enquête pour l'évaluation des politiques\n\npubliques face aux grandes pandémies à la lumière de la crise\n\nsanitaire de la COVID-19 et de sa gestion http://www.senat.fr/\n\ncommission/enquete/gestion_de_la_crise_sanitaire.html (2020).\n\n25. National Academies of Sciences Engineering and Medicine.\n\nhttps://www.nationalacademies.org/our-work/a-frameworkfor-equitable-allocation-of-vaccine-for-the-novel-coronavirus/\n\nannouncement/public-comment-opportunities (2020).\n\n26. Conselho National de Saúde. http://conselho.saude.gov.br/\n\nrecomendacoes-cns (2020).\n\n27. Dimitrova, A. https://www.themayor.eu/sk/grenoble-turnsto-citizens-for-the-handling-of-the-health-crisis (2020).\n\n28. Abi-Rached, J. M. et al. https://www.arab-reform.net/publication/\n\ntowards-a-zero-covid-lebanon-a-call-for-action/ (2020).\n\n29. Lucienne, M., Odiaua, I. & Yamouri, N. https://\n\nblogs.worldbank.org/youth-transforming-africa/\n\nsenegals-youth-offers-inspiring-creativity-fight-covid-19 (2020).\n\n30. Independent SAGE. https://www.independentsage.org (2020).\n\n\n\nAcknowledgements\n\n\n\nThis work was supported by Trond Mohn Foundation\n\n(BFS2019TMT02) and Norad (RAF-18/0009) through\n\nBergen Centre for Ethics and Priority Setting (BCEPS;\n\nproject number 813 596).\n\n\n\nCompeting interests\n\n\n\nThe authors declare no competing interests.\n\n\n\n13\n\n\n\n\f",
          "document_id": 450695
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          "qas": [
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              "question": "How can public health ethics values be integrated into shared medical decision making for children during the COVID-19 pandemic?",
              "id": 278987,
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                  "answer_id": 274924,
                  "document_id": 450696,
                  "question_id": 278987,
                  "text": "Interventions offering high chances of benefit to the\n\npopulation and low risks to individuals may be ethically\n\nmandated by pediatricians and legally mandated by public\n\nhealth officials under ethical and legal public health\n\nframeworks. As risks to the individual patient increase in likelihood or in degree of harmfulness, a more traditional SDM\n\nmodel emphasizing individual goals may be most appropriate. By integrating public health law and ethics into traditional models of SDM, pediatricians can guide families\n\nthrough decisions affecting public health and their children.\n\nIndividual health care decisions related to COVID-19 that\n\nimpact public health goals may require more directive counseling and education by pediatricians when the benefits to the\n\npublic are widespread and certain and harms to individual\n\nchildren are minimal and unlikely. Reconciling public health\n\ngoals and SDM frameworks may sometimes require balancing\n\ncompeting values, preferences, and medical considerations.\n\nPediatricians have a special responsibility to guide and\n\neducate caregivers in navigating these situations, which\n\nincludes balancing individual preferences and public health\n\ngoals, encouraging information sharing, and ultimately preserving the caregiver role in SDM. Additionally, pediatricians\n\nhave an important role in addressing unique considerations\n\nfor children facing disproportionate burdens in the current\n\npandemic. To effectively navigate these responsibilities,\n\npediatricians must have an understanding of individual\n\nSDM and public health ethics and law and in which situations\n\none framework might take precedence over the other.",
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          "context": "COMMENTARY\n\nIntegrating Public Health Ethics into Shared Decision Making for Children\n\nDuring the Novel Coronavirus Disease-19 Pandemic\n\nAngira Patel, MD, MPH1, Dalia M. Feltman, MD, MA2,3, and Erin Talati Paquette, MD, JD, MBe1\n\n\n\nP\n\n\n\nediatricians often serve as interpreters and mediators\n\nof health guidelines when discussing vaccines, health\n\nscreening, and lifestyle choices with parents of our\n\npatients. Outside of public health emergencies, these discussions nearly exclusively focus on optimizing the health of the\n\nindividual child and a focus on family preferences. However,\n\nin the current pandemic, nearly everyone has experienced\n\nlimitations of personal activities for the population health\n\ngoal of curbing the spread of the novel coronavirus disease2019 (COVID-19). New information continues to become\n\navailable about infrequent but serious COVID-19 complications in children, including neurologic and inflammatory sequalae from illness, as well as the role children play in the\n\nspread of the virus.1-3 Moreover, children of color experience\n\na greater proportion of severe COVID-19-related disease,\n\nincluding higher rates of hospitalization and death.4 We\n\nalso know that the measures helping to control COVID-19\n\ninfection rates have negatively impacted the health of children through delays in routine vaccination and well-child\n\ncare, the mental health consequences of school closures,\n\nand heightened concerns about the risk of child abuse in socially isolated children.5-7 These unintended consequences\n\nare presumed to be acceptable harms to protect the public\n\nhealth.\n\nAs children return to medical care and some return to inperson schooling, pediatricians are now tasked with navigating concepts in public health ethics when helping parents\n\nmake decisions affecting their children and the larger community. The American Academy of Pediatrics (AAP) has\n\nreleased guidance on face coverings, testing protocols, and\n\nthe use of personal protective equipment in the context of\n\ncommunities and schools trying to reopen even as rates of\n\nnew COVID-19 infections increase.8 Nonetheless, questions\n\nfor pediatricians remain problematic. How can pediatricians\n\nbalance the needs of their patients with those of the population at large during the COVID-19 public health crisis? How\n\nshould pediatricians respond when parents’ preferences do\n\nnot align with public health strategies? What adjustments\n\nmust be made to the typical model of pediatric shared\n\ndecision-making (SDM) when guiding parents through clinical decisions that benefit the population as a whole, but lead\n\nto limiting choices of the individual patient?\n\nIn this commentary, we examine how values typically\n\nprioritized in public health ethics such as solidarity and\n\n\n\nAAP\n\nCOVID-19\n\nSDM\n\n\n\nAmerican Academy of Pediatrics\n\nNovel coronavirus disease-2019\n\nShared decision making\n\n\n\njustice can be integrated into SDM, where the individual\n\nchild’s best interest and caregiver preferences are often paramount. Additionally, we suggest a framework to integrate\n\npublic health ethics into the traditional SDM continuum using 4 scenarios that we examine for risks, benefits, settings,\n\nand appropriate levels of directiveness. Although maintaining an awareness of the evolving epidemiology of COVID19, and in particular, its impact on vulnerable groups,\n\npediatricians must have a solid working knowledge of public\n\nhealth ethics and law to allow them to navigate these conversations effectively.\n\n\n\nApproaches to Guide Pediatricians\n\nCounseling Families\n\nSDM\n\nWhen multiple ethically reasonable approaches to care exist,\n\nparents or legal guardians (caregivers) and pediatricians typically engage in SDM, grounded in principles of caregiver authority (respect for autonomy) and the child’s best interests\n\n(beneficence).9 Both parties bring knowledge, values, and\n\npreferences to the discussion and work collaboratively, negotiating the contributions of each party to the decision making\n\nprocess and facilitating information exchange to decide what\n\nis best for the child, within the context of family goals. The\n\nprocess is highly value sensitive and, importantly, relies on\n\nthe provider encouraging a bidirectional exchange of information to elicit patient and caregiver preferences.10 SDM\n\ngenerally defers the decision to caregiver views of what is\n\n“best” provided they are reasonable and do not lead to\n\nharm for the child.11\n\nPublic Health Ethics\n\nIn public health emergencies, the principles of beneficence\n\n(maximizing benefit), and nonmaleficence (avoiding harm)\n\nthat commonly guide individual decisions in health care\n\nare viewed instead through the lens of impact at the population level. Values of justice (the fair distribution of societal\n\nburdens and benefits) and solidarity increase in importance.\n\nSolidarity is characterized as affirming the moral standing of\n\nothers and their membership in a community of equal\n\n\n\nFrom the 1Ann & Robert H. Lurie Children’s Hospital of Chicago, Northwestern\n\nUniversity Feinberg School of Medicine, Chicago, IL; 2NorthShore University\n\nHealthSystem Evanston Hospital, Evanston, IL; and the 3University of Chicago,\n\nPritzker School of Medicine, Chicago, IL\n\nThe authors declare no conflicts of interest.\n\n0022-3476/$ - see front matter. ª 2020 Elsevier Inc. All rights reserved.\n\nhttps://doi.org/10.1016/j.jpeds.2020.11.061\n\n\n\n259\n\n\n\n\fTHE JOURNAL OF PEDIATRICS\n\n\n\n\u000f\n\n\n\nwww.jpeds.com\n\n\n\ndignity and respect. As Jennings summarizes, solidarity emphasizes an “attention to the moral (and mortal) being of\n\nothers and their needs, suffering, and vulnerability.”12 Solidarity can also be understood as a call to stand with or assist\n\ncommunity members for overall community good and a\n\nmethod to combat structural and systemic injustices.13\n\nApplying these values may at times conflict with principles\n\nguiding individual health decisions, such as autonomy.14 The\n\nstate’s police powers to safeguard its people permit paternalistic restrictions on individual liberties when the populationlevel benefits of the interventions outweigh the harms of\n\nindividual restrictions. Protection is sometimes achieved\n\nthrough restrictions to individual liberties to actively prevent\n\n1 person from making choices that increase the risk of harm\n\nto others. When public health authorities legally mandate a\n\npublic health practice, the intervention must prevent an\n\navoidable harm, have a “real or substantial relation” to protecting public health, ensure that burdens are not disproportionate to expected benefits, and not pose undue risks.15\n\nInterventions are also justified under frameworks of public\n\nhealth ethics when the intervention is effective, offers significant public health benefit, confers minimal individual\n\nburden and risk, and distributes burdens and benefits fairly.16\n\nWhen such conditions are met, pediatricians (within their\n\npractices) and public health officials may have more authority to impose such interventions. However, these interventions may run counter to caregiver preferences under\n\ntraditional SDM.\n\n\n\nThe Integration of Public Health Goals with\n\nTraditional Shared Decision Making\n\nAs described elsewhere in the Commentary, the traditional\n\nSDM framework is guided by caregiver and patient goals\n\nand values. The public health framework requires serious\n\nattention to population-level goals and, therefore, heavily relies on the consideration of risks or burdens and benefits at\n\nthe population level, even if these measures require subsuming some individual interests to meet the goals of justice and\n\nsolidarity. Pediatricians accustomed to the traditional SDM\n\nframework need to navigate these discussions of risk, burden,\n\nand benefit at both the individual and population levels when\n\nguiding parents through individual health decisions and considerations of various public health interventions. Contributions to SDM may shift from the traditional model, as\n\ndemonstrated in the Figure. Under traditional SDM,\n\npediatricians defer to caregiver choices, offering more\n\ndirective recommendations as interventions present\n\nchildren lower risks and higher benefits. Contributions to\n\ndecision making will be most equally distributed between\n\nphysician and caregiver when neither benefits nor risks to\n\nthe child predominate, with differential ratios of risks and\n\nbenefits shifting contributions to decision making more\n\ntoward physician or caregiver. Public health decision\n\nmaking prioritizes solidarity, justice, and law, resulting in\n\nmore physician directiveness when interventions present\n\nhigh population benefits, fairly distributed burdens\n\n260\n\n\n\nVolume 231\n\n\n\n\u000f\n\n\n\nApril 2021\n\n\n\nproportionate to benefits, and low risks or harms to child.\n\nTo this end, pediatricians will need become facile in\n\ndiscussing justice considerations with families and older\n\nchildren and explain how following public health\n\nguidelines benefits communities as a whole and those that\n\nmight be at greater risk.\n\n\n\nReconciling Public Health Goals and\n\nTraditional Shared Decision Making\n\nWe discuss 4 applications of the combined SDM and public\n\nhealth frameworks relevant to COVID-19. These examples,\n\nalthough not exhaustive, were chosen to illustrate varying\n\nrisk-benefit profiles to the individual and population. Under\n\nthis framework, information exchange that occurs in SDM\n\nwill need to include a discussion of the risks and benefits to\n\npublic health when appropriate. Contributions to SDM will\n\ndiffer depending on the population-level benefits of particular interventions and the risks and benefits to the child.\n\nSuch conversations should nonetheless incorporate patient\n\nand caregiver preferences to the greatest extent possible,\n\nrespecting traditional principles of SDM.\n\nMasking\n\nBecause people may be asymptomatic carriers of COVID-19,\n\nmasks are recommended to prevent transmission when social\n\ndistancing is not possible, except in very young children\n\nor those with medical conditions precluding their use.17\n\nHowever, there is no national masking policy and recommendations remain variable across different regions.18 Pediatricians may encounter decisions about mask wearing both\n\nwithin the context of policies and practices within their own\n\nclinical environment and in helping families navigate the potential need for mask wearing in other settings. Public health\n\nethics principles described above would support pediatricians who mandate mask wearing in clinical settings given\n\nthe minimal burden to wearers and collective benefits for\n\nother patients and staff.\n\nMasking can be thought of as a universal precaution\n\nsimilar to immunizations; both are intended to afford the individual protection, but also to diminish disease transmission to others. Similar to the case of vaccinations,\n\npediatricians may be asked by some caregivers to allow exceptions to rules for mask wearing. Permissible exceptions\n\nwill require strong medical justification, such as medical conditions in which the mask would make breathing difficult or\n\nif an individual lacks the capacity to remove the mask, such as\n\nchildren younger than 2 years of age or those with severe neurodevelopmental impairments. One might also consider\n\nallowing exceptions for a child with strong behavioral challenges that practically make wearing a mask very difficult—\n\nif the struggle to continue the mask wearing could actually\n\nincrease transmission of viral particles, clearly the benefit of\n\nthe mask would be lost. In such circumstances, alternatives\n\nto masks such as face shields or alternatives to visits in the\n\nclinical setting, such as a telehealth appointment, should be\n\nconsidered when feasible. Negotiating such conversations\n\nPatel, Feltman, and Paquette\n\n\n\n\fCOMMENTARY\n\n\n\nApril 2021\n\n\n\nFigure. How does integrating public health considerations relevant to COVID-19 impact shared decision making for children?\n\nUnder all circumstances, there is a range of shared decision making based on the question, the stakeholders’ goals and values.\n\nIn traditional SDM counseling by pediatricians becomes more directive as interventions present children lower risks and higher\n\nbenefits. In contrast, public health decision making prioritizes solidarity, justice and law, resulting in more physician directiveness\n\nwhen interventions present population benefits, fairly distributed burdens proportionate to benefits, and low risks/harms to child.\n\n\n\nrequires balancing the public health benefits of mask wearing\n\nwith the potential individual risks and benefits associated\n\nwith the practice. Only when there are compelling risks to\n\nthe patient or loss of benefit to the public would it be ethically\n\nacceptable for pediatricians to accommodate requests to\n\nexempt patients from mask wearing requirements or to\n\nrecommend against mask wearing generally.17\n\nCommunity rates of disease and acceptance of masking\n\nvaries across regions and at different points in time. Compliance becomes more critical as rates of infection increase. Exceptions to masking, therefore, may vary in impact based on\n\nthe local disease burden at the time in question. However, the\n\nbest practice remains to counsel universal masking, regardless of rates of COVID-19, so that when exceptions are necessary, those surrounding the child are in compliance and\n\nmaking the situation as safe as possible. Conversely, pediatricians may need to support patients seeking to protect themselves and others but who are struggling with family or\n\ncommunity members who do not comply with public health\n\nrecommendations. Pediatricians can equip families with evidence, information, and tools to help facilitate conversations\n\nwith family members or community members (eg, how to get\n\n\n\na child to become comfortable with mask wearing, why\n\nmasking protects others, airborne transmission in indoor\n\ngathering vs outdoor gatherings, etc).19\n\nTargeted COVID-19 Testing of Asymptomatic\n\nChildren\n\nMany hospitals require COVID-19 testing of asymptomatic\n\nchildren before certain invasive procedures and hospital admissions. Although some patients may individually benefit\n\nfrom knowing test results, the primary benefit of testing is\n\nnot to the individual, but to facilitate appropriate levels of\n\ninfection control, including proper room assignment, judicious use of personal protective equipment, and optimizing\n\nhospital operations.20 Some parents may prefer to forego\n\ntesting to avoid the perceived burden of discomfort to the\n\nchild. Although this is a small but real burden to the child,\n\nthe benefits of protecting health care resources and other patients make mandating COVID-19 testing ethically permissible. However, accommodations may need to be\n\nconsidered as burdens and risks to patient increase (eg, for\n\nchildren who may have such significant aversions that they\n\nwould require sedation to tolerate testing).\n\n\n\nIntegrating Public Health Ethics into Shared Decision Making for Children During the Novel Coronavirus\n\nDisease-19 Pandemic\n\n\n\n261\n\n\n\n\fTHE JOURNAL OF PEDIATRICS\n\n\n\n\u000f\n\n\n\nwww.jpeds.com\n\n\n\nAs testing methods become less invasive, more rapid and\n\nreliable, and available in greater volumes, risks and benefits\n\nwill continue to evolve. The AAP has recently advocated\n\nfor continued asymptomatic testing after contact exposure\n\nbecause of the high rates of many (but not all) asymptomatic\n\nchildren.21 Mandating repeated testing protocols such as\n\nthose proposed to allow for safer activities (eg, testing every\n\nfew days of on-campus college students) should improve\n\nthe calculus of the benefits over risks, although even despite\n\nsuch a program, for example, at the University of Illinois at\n\nUrbana-Champaign, surges have forced temporary inperson instruction closures.22\n\nCOVID-19 Vaccination\n\nWhen a vaccine is available, supplies will likely be limited,\n\nrequiring consideration of whom should be prioritized for\n\nvaccination. Children will be an important population to\n\nvaccinate, given potential for spreading through asymptomatic carrier children, particularly as schools and daycares\n\nreopen. Pediatricians will need to engage families in SDM\n\nand directive counseling to the weigh benefits of viral protection for the child and others against possible unknown risks.\n\nThere also exists a need from professional societies and the\n\npublic health infrastructure to provide clear guidance and\n\nmessaging on the importance of vaccination specifically in\n\nthe context of COVID-19.23 Returning children to school\n\nsafely is important for academics and the healthy development and well-being of children, and although this goal remains elusive for many reasons, mass vaccination of\n\nchildren may need to be an important consideration.24\n\nNevertheless, mandating vaccination soon after release\n\nwould be fraught with challenges given the accelerated vaccine development timeline, potential unknown risks and\n\ncomplications, and evolving understanding of COVID-19\n\nepidemiology.25,26 The US Food and Drug Administration’s\n\noptions for approving a new vaccine (whether a vaccine\n\nworks) will depend on its efficacy, its proportional uptake,\n\nand the rates of the virus in that community. Whether a vaccine is safe will be gauged by risks and degrees of harm agreed\n\nupon as acceptable.27 Despite the anticipated public health\n\nbenefits of achieving herd immunity and the possibility of returning to school faster, prematurely mandating COVID-19\n\nvaccination could also aggravate hesitancy and refusals pediatricians already face with vaccines.28 These considerations\n\nare likely to be more salient in communities of color, who\n\nhave already suffered a disproportionate burden of disease.\n\nFor COVID-19, involvement in vaccine trials has also been\n\nlower for Black participants, which may also contribute to\n\nincreasing vaccine hesitancy in the future.29 Therefore, parents should be allowed to refuse any potential COVID-19\n\nvaccine until the risks and efficacy are well-established in\n\nchildren.\n\nWhen a COVID-19 vaccine is deemed to be safe and available for distribution to children, pediatricians will be asked to\n\nhelp interpret for families the guidance from federal agencies\n\nand professional societies such as the AAP to make thoughtful decisions for their children. Pediatricians who have\n\n262\n\n\n\nVolume 231\n\n\n\nalready established trusting relationships with their patients\n\nwill be the best ambassadors for vaccine-related questions.\n\nFamilies who display vaccine hesitancy for existing immunizations will benefit from pediatricians who strengthen families’ health literacy and who use proven methods to ensure\n\nunderstanding of information, including information\n\ntechnology.30-32\n\nResearch\n\nTherapeutics for COVID-19 remain under investigation, and\n\nsome children suffer serious postinfectious complications.2\n\nPediatricians should anticipate counseling families about\n\ncurrent knowledge on alternative treatments and assist\n\nthem in understanding the risks and benefits of enrolling infected children in pediatric studies. Participation of children\n\nin COVID-19 research studies remains important so that\n\nchildren have appropriate and early access to future medical\n\ntreatments and support for psychological sequelae; such\n\nsequelae have been reported during and after natural disasters. For observational studies (eg, tracking outcomes for\n\nchildren with multisystem inflammatory syndrome in children) that pose minimal risk to the child, pediatricians\n\nmay be more directive in recommending participation while\n\nbeing mindful that children may have special vulnerabilities\n\nafter a traumatic event like this pandemic.33 In contrast,\n\ninvestigational treatments with higher potential harms but\n\npossible benefits such as an unproven medication to prevent\n\nmultisystem inflammatory syndrome in children in a child\n\ninfected with COVID-19 or a vaccine trial will likely pose\n\ngreater risks to the child and require careful exploration by\n\npediatrician and caregiver with more deference to caregiver\n\npreferences.\n\nSpecifically, the AAP has advocated for the inclusion of\n\nchildren in research on potential COVID-19 vaccine and\n\nsaid:\n\n[I]t is counter to the ethical principle of distributive justice to allow\n\nchildren to take on great burdens during this pandemic but not have\n\nthe opportunity to benefit from a vaccine, or to delay that benefit for\n\nan extended period of time, because they have not been included in vaccine trials. Children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety\n\nconcerns.34\n\n\n\nRecently, children older than age 12 years are eligible to\n\nparticipate in COVID-19 vaccine clinical trials.35 Families\n\nconsidering participating will need to weigh risk to their child\n\nas well as the potential public health benefit; pediatricians can\n\nsupport caregivers’ decision making by helping the family to\n\nunderstand the potential overall benefit to the adolescent and\n\nensure there is assent from the adolescent. Ultimately, deference should be given to caregiver choices.\n\n\n\nSpecial Considerations for Adolescents\n\nAdolescents have developing autonomy and some may have\n\ndecision making capacity similar to that of an adult and\n\nshould participate in SDM as it pertains to their own health\n\nPatel, Feltman, and Paquette\n\n\n\n\fCOMMENTARY\n\n\n\nApril 2021\n\ncare. When adolescent values differ from that of their family\n\nand impact health care choices, pediatricians need to share\n\ninformation, practice good communication, ensure\n\ntransparency, and sometimes engage in conflict resolution.\n\nIf there is a disagreement related to COVID-19 where a\n\nfamily endorses masking, social distancing, and testing, but\n\nthe adolescent does not, the pediatrician may need to explore\n\npersonal and community barriers and provide best practice\n\nguidance through evidence-based current public health\n\nrecommendations. Although state laws differ in adolescents’\n\nability to give sole consent for immunizations, the pediatrician can strive to help parents and the patient arrive at a\n\nshared decision by providing a space for clarifying concerns,\n\nmedical facts, and goals in a way that respects both\n\nstakeholders. Finally, the pediatrician may need to help\n\nsupport decision making that allows the adolescent to feel\n\nsafe, such as if the patient attends school in a region where\n\nthere is no masking requirement. In each scenario, the\n\npediatrician will need to assess the adolescent’s level of\n\nevolving decision-making capacity to help titrate information delivery, the deliberation over risks and benefits, and\n\nthe degree of adolescent participation in decision making.\n\n\n\nSpecial Considerations for Groups at Risk for\n\nExperiencing Disproportionate Burdens from\n\nCOVID-19 Illness and Public Health\n\nMeasures in Response to the Pandemic\n\nMinority groups have experienced higher rates of illness and\n\nmortality from COVID-19. Higher rates of infection and\n\nmortality are due, in large part, to systemic biases and\n\nstructural inequities that create baseline disparate health\n\ncare access, quality, and outcomes for certain groups of\n\npeople.36 Of the nearly 800 reported cases of multisystem\n\ninflammatory syndrome in children, 70% occurred in Black\n\nand Hispanic/Latino children.37 The very same groups that\n\nwould most likely benefit from an effective vaccine or study\n\nof this disease have also shown greater rates of mistrust in\n\nthe health system and in research attributable to historical\n\nexperiences of unethical treatment.38 Given this delicate\n\njuxtaposition of need and trust, public health efforts that\n\naim to address health equity have the best chances of\n\nrestoring faith in general medical care.\n\nThis dynamic generates additional considerations and\n\nchallenges for pediatricians who counsel minority families\n\nin situations where public health goals may differ from\n\nindividual preferences. Pediatricians need to use models\n\nthat bridge the gaps between health care professionals and\n\nthe families they serve, especially in the face of different\n\ncultural experiences.39 Preserving and respecting SDM\n\nrequires that pediatricians engage in thoughtful and informed\n\ndialogue with special attention to reflective listening,\n\nincorporation of health-literate sensitive educational\n\nmaterials, acknowledgement of explicit and implicit biases,\n\nawareness and validation of current and past mistreatment,\n\nand with attention to the potential for institutional inequities\n\nto build trust and to avoid perpetuating existing disparities.40\n\n\n\nAny consideration of mandatory interventions in particular\n\nshould include specific attention to measuring the impact\n\non groups at risk for disparities and gauging whether changes\n\nin structural and systemic practices may have unintended\n\nconsequences that worsen existing disparities and mistrust.41\n\nIt is important to note that, in addition to considerations for\n\ntheir interpersonal interactions with caregivers and families,\n\nto further principles of public health ethics, pediatricians\n\nalso have a special role in addressing these structural and\n\nsystemic issues as advocates for children. It is especially\n\nimportant that existing disparities are not worsened when\n\nnegotiating public health goals and SDM.\n\n\n\nConclusion\n\nInterventions offering high chances of benefit to the\n\npopulation and low risks to individuals may be ethically\n\nmandated by pediatricians and legally mandated by public\n\nhealth officials under ethical and legal public health\n\nframeworks. As risks to the individual patient increase in likelihood or in degree of harmfulness, a more traditional SDM\n\nmodel emphasizing individual goals may be most appropriate. By integrating public health law and ethics into traditional models of SDM, pediatricians can guide families\n\nthrough decisions affecting public health and their children.\n\nIndividual health care decisions related to COVID-19 that\n\nimpact public health goals may require more directive counseling and education by pediatricians when the benefits to the\n\npublic are widespread and certain and harms to individual\n\nchildren are minimal and unlikely. Reconciling public health\n\ngoals and SDM frameworks may sometimes require balancing\n\ncompeting values, preferences, and medical considerations.\n\nPediatricians have a special responsibility to guide and\n\neducate caregivers in navigating these situations, which\n\nincludes balancing individual preferences and public health\n\ngoals, encouraging information sharing, and ultimately preserving the caregiver role in SDM. Additionally, pediatricians\n\nhave an important role in addressing unique considerations\n\nfor children facing disproportionate burdens in the current\n\npandemic. To effectively navigate these responsibilities,\n\npediatricians must have an understanding of individual\n\nSDM and public health ethics and law and in which situations\n\none framework might take precedence over the other. n\n\nWe thank Craig Klugman, PhD, for his review of this report.\n\nSubmitted for publication Sep 14, 2020; last revision received Nov 23, 2020;\n\naccepted Nov 24, 2020.\n\nReprint requests: Angira Patel, MD, MPH, Ann & Robert H. Lurie Children’s\n\nHospital of Chicago, 225 E Chicago Ave, Box 21, Chicago, IL 60611. E-mail:\n\nanpatel@luriechildrens.org\n\n\n\nReferences\n\n1. Abdel-Mannan O, Eyre M, L€\n\nobel U, Bamford A, Eltze C, Hameed B, et al.\n\nNeurologic and radiographic findings associated with COVID-19\n\ninfection in children. 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Developing a SARS-CoV-2 vaccine\n\nat warp speed. JAMA 2020;324:437-8.\n\nLurie N, Sharfstein JM, Goodman JL. The development of COVID-19\n\nvaccines: safeguards needed. JAMA 2020;324:439-40.\n\nShah A, Marks PW, Hahn SM. Unwavering regulatory safeguards for\n\nCOVID-19 vaccines. JAMA 2020;324:931-2.\n\nGidengil C, Chen C, Parker AM, Nowak S, Matthews L. Beliefs around\n\nchildhood vaccines in the United States: a systematic review. Vaccine\n\n2019;37:6793-802.\n\nFarmer B. As Covid-19 vaccine trials move at warp speed, recruiting\n\nblack volunteers takes time. www.npr.org/sections/health-shots/2020/\n\n09/11/911885577/as-covid-19-vaccine-trials-move-at-warp-speed-recru\n\niting-black-volunteers-takes. Accessed November 20, 2020.\n\nMarti M, de Cola M, MacDonald NE, Dumolard L, Duclos P. Assessments of global drivers of vaccine hesitancy in 2014-Looking beyond\n\nsafety concerns. PLoS One 2017;12:e0172310.\n\nGianfredi V, Moretti M, Lopalco PL. Countering vaccine hesitancy\n\nthrough immunization information systems, a narrative review. Hum\n\nVaccin Immunother 2019;15:2508-26.\n\nGoodman JL, Grabenstein JD, Braun MM. Answering key\n\nquestions about COVID-19 vaccines. JAMA 2020 [Epub ahead of print].\n\nFerreira RJ, Buttell F, Cannon C. Ethical issues in conducting research\n\nwith children and families affected by disasters. Curr Psychiatry Rep\n\n2018;20:42.\n\nAmerican Academy of Pediatrics. Letter to HHS and FDA-Children\n\nin COVID 19 Vaccine Trials. https://downloads.aap.org/DOFA/\n\nAAPLettertoHHSandFDAChildreninCOVID19VaccineTrials.pdf. Accessed November 20, 2020.\n\nAubrey A. Will kids get a COVID-19 vaccine? Pfizer to expand trial\n\nto ages 12 and up. www.npr.org/sections/health-shots/2020/10/13/\n\n923248377/will-kids-get-a-covid-19-vaccine-pfizer-to-expand-trial-toages-12-and-up. Accessed November 20, 2020.\n\nAbedi V, Olulana O, Avula V, Chaudhary D, Khan A, Shahjouei S,\n\net al. Racial, economic and health inequality and COVID-19\n\ninfection in the United States. J Racial Ethn Health Disparities\n\n2020;1-11.\n\nCenter for Disease Control and Prevention. Health department-reported\n\ncases of multisystem inflammatory syndrome in children (MIS-C) in the\n\nUnited States. www.cdc.gov/mis-c/cases/ind37,ex.html. Accessed\n\nNovember 20, 2020.\n\nSullivan LS. Trust, risk, and race in American medicine. Hastings Cent\n\nRep 2020;50:18-26.\n\nEllis WR, Dietz WH. A new framework for addressing adverse childhood\n\nand community experiences: the building community resilience model.\n\nAcad Pediatr 2017;17:S86-93.\n\nDerrington SF, Paquette E, Johnson KA. Cross-cultural interactions and\n\nshared decision-making. Pediatrics 2018;142:S187-92.\n\nTrent M, Dooley DG. Doug\u0002e J, Section on Adolescent Health,\n\nCouncil on Community Pediatrics, Committee on Adolescence. The\n\nimpact of racism on child and adolescent health. Pediatrics 2019;144:\n\ne20191765.\n\n\n\nPatel, Feltman, and Paquette\n\n\n\n\f",
          "document_id": 450696
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      "paragraphs": [
        {
          "qas": [
            {
              "question": "What public health measures are most effective in reducing transmission of SARS-CoV-2 virus?",
              "id": 279021,
              "answers": [
                {
                  "answer_id": 274931,
                  "document_id": 450697,
                  "question_id": 279021,
                  "text": "The authors concluded based on meta-analyses, there are benefits of physical distancing, mask\n\nwearing and handwashing (though meta-analysis results were non-significant for handwashing),\n\nfor reducing COVID-19 incidence. Narrative synthesis results indicate nearly all individual\n\ninterventions and packages of public health interventions provide some beneficial effects on\n\nreducing transmission of SARS-CoV-2, COVID-19 incidence or COVID-19 mortality. Travel and\n\nborder restrictions, and screening for fever have insufficient evidence to determine\n\neffectiveness.",
                  "answer_start": 8129,
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          "context": "SYNOPSIS\n\n\n\nReview of “Effectiveness of Public Health\n\nMeasures in Reducing the Incidence of COVID19, SARS-CoV-2 transmission, and COVID-19\n\nMortality: Systematic Review and Metaanalysis”\n\n12/23/21\n\nArticle citation: Talic S, Shah S, Wild H, Gasevic D, Maharaj A, Ademi Z, et al. Effectiveness of public\n\nhealth measures in reducing the incidence of COVID-19, SARS-CoV-2 transmission, and COVID-19\n\nmortality: systematic review and meta-analysis. BMJ. 2021;375:e068302. Available from:\n\nhttps://doi.org/10.1136/bmj-2021-068302\n\n\n\nOne-minute summary\n\n\n\n\n\nThe authors conducted a systematic review of evidence examining the effectiveness of various\n\npublic health interventions for reducing coronavirus disease 2019 (COVID-19) incidence, severe\n\nacute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission and COVID-19 mortality. A\n\ntotal of 72 studies were included in the final synthesis, 35 assessed individual public health\n\ninterventions and 37 assessed multiple public health interventions implemented as a package.\n\n\n\n\n\n\n\nDue to the heterogeneous outcome measures reported by included studies, meta-analysis was\n\nonly possible for few studies with consistent reported measures (i.e., odds ratios or relative risks\n\n[RR] with corresponding confidence intervals [CI]) which could be statistically combined. The\n\nremaining studies for which meta-analysis was not appropriate were synthesized narratively.\n\n\n\n\n\n\n\nEight studies were included in the meta-analyses of three individual public health measures’\n\neffectiveness for reducing COVID-19 incidence.\n\n\n\n\n\nSix studies, four with moderate risk of bias and two with serious-critical risk of bias,\n\nwith a total 389,228 participants (2,627 infected with SARS-CoV-2) assessed mask\n\nwearing: the pooled RR = 0.47 (95% CI: 0.29, 0.75; I2=84%), an estimated 53%\n\nreduction in COVID-19 incidence.\n\n\n\n\n\n\n\nFive studies, four with moderate risk of bias and one with serious-critical risk of bias,\n\nwith a total 108,933 participants (2,727 infected with SARS-CoV-2) assessed physical\n\ndistancing: pooled RR = 0.75 (95% CI: 0.59, 0.95; I2=87%), an estimated 25% reduction\n\nin COVID-19 incidence.\n\n\n\nReview of “Effectiveness of Public Health Measures in Reducing the Incidence of COVID-19, SARS-CoV-2\n\ntransmission, and COVID-19 Mortality: Systematic Review and Meta-analysis”\n\nPage 1 of 7\n\n\n\n\f\n\n\n\n\n\n\n\nThree studies, two with moderate risk of bias and one with serious-critical risk of bias,\n\nwith a total 10,345 participants (292 infected with SARS-CoV-2), assessed\n\nhandwashing: pooled RR = 0.47 (95% CI: 0.19, 1.12; I2=12%), an estimated 53%\n\nreduction in COVID-19 incidence. Of note, the CI for this result includes 1, therefore\n\ndoes not achieve statistical significance.\n\n\n\nMeta-analysis was not possible for select studies assessing mask wearing and physical\n\ndistancing, as well as studies investigating other individual public health measures, these results\n\nwere synthesized narratively.\n\n\n\n\n\nMask wearing was assessed in five studies not included in the meta-analysis, all with\n\nmoderate risk of bias ratings. Overall these studies found mask wearing to be\n\nassociated with reduced COVID-19 incidence, SARS-CoV-2 transmission and COVID-19\n\nmortality. Most compared jurisdictional regions or time periods when mask wearing\n\nwas mandatory versus not mandatory, and one cross-sectional study collected selfreported data related to mask wearing.\n\n\n\n\n\n\n\nPhysical distancing was assessed in three studies not included in the meta-analysis,\n\ntwo received moderate risk of bias ratings and one received serious-critical. These\n\ngenerally reported positive effects of physical distancing on reducing SARS-CoV-2\n\ntransmission and COVID-19 mortality. Study designs included a natural experiment, a\n\nquasi-experiment and a cross-sectional study.\n\n\n\n\n\n\n\nHousehold disinfection was assessed in one retrospective cohort study with moderate\n\nrisk of bias, which found an association between self-reported daily use of chlorine or\n\nethanol-based disinfectant in households and reduced SARS-CoV-2 transmission.\n\n\n\n\n\n\n\nStay at home or isolation measures were assessed in four studies, one received a low\n\nrisk of bias rating and the other three were rated moderate to serious or critical. All\n\nfour reported reductions in SARS-CoV-2 transmission as a result of isolation measures.\n\nDesigns included a retrospective cohort study, a natural experiment and two crosssectional studies.\n\n\n\n\n\n\n\nQuarantine was assessed in two cohort studies with low and moderate risk of bias\n\nratings. One Saudi Arabia study assessed COVID-19 incidence eight weeks after\n\nimplementation of mandatory quarantine for returning travellers, and a study in India\n\ncompared a period of no quarantine to strict home quarantine in an unspecified\n\npopulation. Results found decreases in SARS-CoV-2 transmission in travellers and\n\ndecreased COVID-19 incidence after home quarantine was implemented.\n\n\n\n\n\n\n\nSchool closures were assessed in five studies, all with moderate risk of bias. Three\n\nUnited States (US) studies included evidence of school closures (implemented at state\n\nlevels) being associated with reduced SARS-CoV-2 transmission, COVID-19 incidence\n\nand COVID-19 mortality. One study in Japan found no significant effect of nation-wide\n\nschool closures on COVID-19 incidence. A Swedish study reported impacts of schools\n\nremaining open, and found slight increases in SARS-CoV-2 infections in parents, and\n\nthat infections were more likely in secondary school teachers compared to elementary\n\nschool teachers.\n\n\n\nReview of “Effectiveness of Public Health Measures in Reducing the Incidence of COVID-19, SARS-CoV-2\n\ntransmission, and COVID-19 Mortality: Systematic Review and Meta-analysis”\n\nPage 2 of 7\n\n\n\n\f\n\n\n\n\n\n\n\n\n\n\n\nBusiness closures were assessed in two studies with moderate risk of bias ratings, both\n\nUS based natural experiment studies reported reductions in SARS-CoV-2 transmission\n\nfollowing business closures.\n\n\n\n\n\n\n\nUniversal lockdowns were assessed in 10 studies, risk of bias was low in two studies,\n\nmoderate in seven and high in one. All reported some level of reduction in COVID-19\n\nincidence, mortality, and SARS-CoV-2 transmission. Study designs included natural\n\nexperiments and quasi-experiments.\n\n\n\n\n\n\n\nRestricted travel and border closures were assessed in two studies, the first with\n\nserious-critical risk of bias and the second with moderate risk of bias. First, a natural\n\nexperiment study involving nine African countries reported increases in COVID-19\n\nincidence following border closures, whereas one US natural experiment reported a\n\ndecrease in SARS-CoV-2 transmission after restricting travel between states.\n\n\n\n\n\n\n\nEntry and exit screening for fever was assessed in one retrospective cohort study with\n\nmoderate risk of bias. Results found screening for fever (setting and population not\n\nspecified) had poor sensitivity for detecting people with SARS-CoV-2 infections when\n\ntested 24 hours later, estimating up to 86% of SARS-CoV-2 infections remain\n\nundetected when screening for fever.\n\n\n\nMultiple public health interventions implemented as a package were investigated in 37\n\nobservational studies which are briefly summarized in this review. Meta-analysis was not\n\npossible. Outcome measures varied between studies, and authors described overall\n\neffectiveness by reporting the percentage difference (i.e., reduction) in outcomes before and\n\nafter implementation, or between regions compared in the studies.\n\n\n\n\n\nEleven studies found reductions between 26-50% in SARS-COV-2 transmission and\n\nCOVID-19 incidence; nine studies found reductions between 51-75% in SARS-COV-2\n\ntransmission, COVID-19 incidence and COVID-19 mortality; and 14 studies found a\n\nreduction >75% in SARS-COV-2 transmission, COVID-19 incidence and COVID-19\n\nmortality.\n\n\n\n\n\n\n\nIn the paper's supplementary file, the authors present a table listing estimated\n\neffectiveness of package interventions from each study (e.g., border closures,\n\nlockdowns, school closures, etc.), which indicates varying levels of effectiveness for\n\nsimilar packages implemented in different settings.\n\n\n\nThe authors concluded based on meta-analyses, there are benefits of physical distancing, mask\n\nwearing and handwashing (though meta-analysis results were non-significant for handwashing),\n\nfor reducing COVID-19 incidence. Narrative synthesis results indicate nearly all individual\n\ninterventions and packages of public health interventions provide some beneficial effects on\n\nreducing transmission of SARS-CoV-2, COVID-19 incidence or COVID-19 mortality. Travel and\n\nborder restrictions, and screening for fever have insufficient evidence to determine\n\neffectiveness.\n\n\n\nReview of “Effectiveness of Public Health Measures in Reducing the Incidence of COVID-19, SARS-CoV-2\n\ntransmission, and COVID-19 Mortality: Systematic Review and Meta-analysis”\n\nPage 3 of 7\n\n\n\n\fAdditional information\n\n\n\n\n\nThe systematic review and meta-analysis followed a registered a priori protocol and reporting of\n\nfindings was in accordance with Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA).\n\n\n\n\n\n\n\nStudies excluded from this review were: case reports, case studies, modelling and simulation\n\nstudies, studies with graphical summaries but no clear statistical assessments or outputs,\n\necological studies with descriptive outcome measures without assessing linearity or having\n\ncomparators, non-empirical studies (e.g., commentaries, editorials, government reports),\n\nreviews, articles investigating only non-SARS-CoV-2 pathogens, and articles not published in\n\nEnglish.\n\n\n\n\n\n\n\nDuplicate independent risk of bias assessments were conducted and appraisal items are\n\nreported for each included study. Authors note moderate to severe risk of bias across most\n\nincluded studies. Confounding variables were challenging to control for in natural setting studies\n\nduring the COVID-19 pandemic when multiple public health interventions were implemented at\n\nthe same time.\n\n\n\n\n\n\n\nOf 35 studies assessing individual interventions, only one randomized controlled trial (RCT) was\n\nidentified and the other 34 studies were observational in design. Using the risk of bias in nonrandomised studies of interventions (ROBINS-I) tool for observational studies, risk of bias was\n\nlow in three studies, moderate in 24 studies, and high-serious in seven studies. Using the Risk of\n\nBias 2 (ROB-2) tool, risk of bias was moderate for the RCT.\n\n\n\n\n\n\n\nOf 37 observational studies assessing multiple public health interventions implemented as a\n\npackage, risk of bias was low in two studies, moderate in 31 studies, and high-serious in four\n\nstudies using the ROBINS-I tool.\n\n\n\nPHO reviewer’s comments\n\n\n\n\n\nA comprehensive search strategy was conducted however it is worth noting the search was last\n\nupdated in June of 2021. Most included studies were conducted in 2020 before COVID-19\n\nvaccination was widely implemented across populations, before Delta became the dominant\n\nstrain and before the emergence of Omicron. The authors acknowledge further research will be\n\nneeded to determine effectiveness of public health interventions after adequate vaccination\n\ncoverage is achieved, and that emerging variants may also impact transmission.\n\n\n\n\n\n\n\nThis detailed systematic review and meta-analysis identified few high quality or prospective and\n\ncontrolled studies of public health interventions which limits the certainty in the point estimates\n\npresented. Notably, there were no studies evaluating ventilation, air filtration or test-to-stay\n\nstrategies as public health interventions.\n\n\n\n\n\n\n\nWhile a detailed independent risk of bias assessment is conducted for each included study, an\n\noverall quality of evidence assessment at the outcome level (such as a GRADE assessment) is not\n\nformally conducted. Based on nearly all evidence being drawn from observational studies, high\n\nheterogeneity across studies’ designs and outcome measures, and the majority of individual\n\nstudies being rated at moderate-high risk of bias, the level of certainty in this body of evidence\n\nwould likely be considered low or very low.1 Authors do acknowledge in the limitations that\n\nfindings are likely to be updated as new and higher quality evidence becomes available.\n\n\n\nReview of “Effectiveness of Public Health Measures in Reducing the Incidence of COVID-19, SARS-CoV-2\n\ntransmission, and COVID-19 Mortality: Systematic Review and Meta-analysis”\n\nPage 4 of 7\n\n\n\n\f\n\n\n\nDescriptions of limitations beyond the risk of bias rating for each study are not explored in detail\n\nin this review, however should be kept in mind when interpreting results of any synthesis.\n\nConfounding variables are acknowledged by Talic et al. (2021) as a common limitation across\n\nstudies, and this should be emphasized for the reported results of individual interventions\n\nbecause it is unlikely for a single public health intervention to be truly implemented in isolation\n\nduring the COVID-19 pandemic. For example, upon review of the studies included for the\n\nindividual intervention of school closures, limitations reported by primary study authors\n\nincluded but are not limited to: possible inappropriate choice of linear trend model for the\n\npandemic context; inability to single out the effects of school closures from other public health\n\ninterventions; not accounting for confounders such as hygiene and air pollution; and uncertainty\n\naround testing strategies for studies using data from regional public health testing or outcome\n\ninformation databases.2-6\n\n\n\n\n\n\n\nThe estimated 53% risk reduction associated with handwashing, while non-significant, may be\n\nconsidered unexpected given the understanding that SARS-CoV-2 is predominantly spread via\n\ninhalation of respiratory particles rather than through fomites.7,8 Glasziou et al. (2021) suggest in\n\na commentary discussing this review that handwashing may serve as a marker for other\n\npersonal health behaviours such as avoiding crowds, physical distancing and mask wearing.1\n\n\n\n\n\n\n\nIt may be reasonable to expect that most public health interventions intended to reduce the\n\nimpact of SARS-CoV-2 and COVID-19 will have at least a partial beneficial effect. While it is\n\nuseful to see this review’s results generally supporting this, application of these findings may be\n\nlimited without more readily comparable effectiveness results across outcomes and\n\ninterventions, and without careful benefit-harm considerations. In addition, it has been\n\ndemonstrated throughout the pandemic that multiple layered prevention measures are key to\n\neffective mitigation.9\n\n\n\n\n\n\n\nFactors that are important to consider when implementing widespread public health measures\n\nare the potential inequitable health and social harms or benefits for certain populations over\n\nothers (e.g., people who work in environments where physical distancing is not possible; school\n\nclosures disproportionately harming children, families and women; price of masks for members\n\nof the general public; economic impacts on businesses; etc.). Talic et al. (2021) do acknowledge\n\nthat, for example, despite evidence of reduced COVID-19 mortality following universal\n\nlockdowns, this is an unsustainable intervention and the population’s adherence and\n\ncompliance with public health measures is key to effective and sustainable interventions.\n\n\n\n\n\n\n\nThe authors provide a relatively brief summary of the multiple intervention package studies,\n\nindicating most studies found >25% differences in overall effectiveness of package\n\ninterventions. Package interventions are not described in detail, though supplementary\n\nsummary tables show varying levels of effectiveness of similar packages (e.g., school and\n\nworkplace closures) when applied in different study settings. There may have been a role for the\n\nauthors to explore these discrepancies in the narrative results or discussion sections.\n\n\n\nReview of “Effectiveness of Public Health Measures in Reducing the Incidence of COVID-19, SARS-CoV-2\n\ntransmission, and COVID-19 Mortality: Systematic Review and Meta-analysis”\n\nPage 5 of 7\n\n\n\n\fAdditional references\n\n1. Glasziou PP, Michie S, Fretheim A. Public health measures for covid-19. BMJ. 2021;375:n2729.\n\nAvailable from: https://doi.org/10.1136/bmj.n2729\n\n2. Iwata K, Doi A, Miyakoshi C. Was school closure effective in mitigating coronavirus disease 2019\n\n(COVID-19)? Time series analysis using Bayesian inference. Int J Infect Dis. 2020;99:57-61.\n\nAvailable from: https://doi.org/10.1016/j.ijid.2020.07.052\n\n3. Auger KA, Shah SS, Richardson T, Hartley D, Hall M, Warniment A, et al. Association between\n\nstatewide school closure and COVID-19 incidence and mortality in the US. JAMA.\n\n2020;324(9):859-70. Available from: https://doi.org/10.1001/jama.2020.14348\n\n4. Guo C, Chan SHT, Lin C, Zeng Y, Bo Y, Zhang Y, et al. Physical distancing implementation, ambient\n\ntemperature and Covid-19 containment: an observational study in the United States. Sci Total\n\nEnviron. 2021;789:147876. Available from: https://doi.org/10.1016/j.scitotenv.2021.147876\n\n5. Liu X, Xu X, Li G, Xu X, Sun Y, et al. Differential impact of non-pharmaceutical public health\n\ninterventions on COVID-19 epidemics in the United States. BMC Public Health. 2021;21(1):965.\n\nAvailable from: https://doi.org/10.1186/s12889-021-10950-2\n\n6. Vlachos J, Hertegård E, B Svaleryd H. The effects of school closures on SARS-CoV-2 among\n\nparents and teachers. Proc Natl Acad Sci U S A. 2021;118(9):e2020834118. Available from:\n\nhttps://doi.org/10.1073/pnas.2020834118\n\n7. Ontario Agency for Health Protection and Promotion (Public Health Ontario). Additional routes\n\nof COVID-19 transmission – what we know so far [Internet]. Toronto, ON: Queen’s Printer for\n\nOntario; 2021 [cited 2021 Dec 20]. Available from: https://www.publichealthontario.ca//media/documents/ncov/covid-wwksf/2020/12/routes-transmission-covid-19.pdf?sc_lang=en\n\n8. Ontario Agency for Health Protection and Promotion (Public Health Ontario). COVID-19\n\ntransmission through large respiratory droplets and aerosols…what we know so far [Internet].\n\nToronto, ON: Queen’s Printer for Ontario; 2021 [cited 2021 Dec 20]. Available from:\n\nhttps://www.publichealthontario.ca/-/media/documents/ncov/covid-wwksf/2021/05/wwksftransmission-respiratory-aerosols.pdf?sc_lang=en\n\n9. Public Health Agency of Canada. Coronavirus disease (COVID-19): prevention and risks\n\n[Internet]. Ottawa, ON: Her Majesty the Queen in Right of Canada; 2021 [cited 2021 Dec 20].\n\nAvailable from: https://www.canada.ca/en/public-health/services/diseases/2019-novelcoronavirus-infection/prevention-risks.html\n\n\n\nReview of “Effectiveness of Public Health Measures in Reducing the Incidence of COVID-19, SARS-CoV-2\n\ntransmission, and COVID-19 Mortality: Systematic Review and Meta-analysis”\n\nPage 6 of 7\n\n\n\n\fCitation\n\nOntario Agency for Health Protection and Promotion (Public Health Ontario). Review of “Effectiveness of\n\npublic health measures in reducing the incidence of COVID-19, SARS-CoV-2 transmission, and COVID-19\n\nmortality: systematic review and meta-analysis”. Toronto, ON: Queen’s Printer for Ontario; 2021.\n\n\n\nDisclaimer\n\nThis document was developed by Public Health Ontario (PHO). PHO provides scientific and technical\n\nadvice to Ontario’s government, public health organizations and health care providers. PHO’s work is\n\nguided by the current best available evidence at the time of publication. The application and use of this\n\ndocument is the responsibility of the user. PHO assumes no liability resulting from any such application\n\nor use. This document may be reproduced without permission for non-commercial purposes only and\n\nprovided that appropriate credit is given to PHO. No changes and/or modifications may be made to this\n\ndocument without express written permission from PHO.\n\n\n\nPublic Health Ontario\n\nPublic Health Ontario is an agency of the Government of Ontario dedicated to protecting and promoting\n\nthe health of all Ontarians and reducing inequities in health. Public Health Ontario links public health\n\npractitioners, front-line health workers and researchers to the best scientific intelligence and knowledge\n\nfrom around the world.\n\nFor more information about PHO, visit publichealthontario.ca.\n\n\n\n©Queen’s Printer for Ontario, 2021\n\n\n\nReview of “Effectiveness of Public Health Measures in Reducing the Incidence of COVID-19, SARS-CoV-2\n\ntransmission, and COVID-19 Mortality: Systematic Review and Meta-analysis”\n\nPage 7 of 7\n\n\n\n\f",
          "document_id": 450697
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      "paragraphs": [
        {
          "qas": [
            {
              "question": "Given the likely increased transmissibility, indications of vaccine/immune escape and uncertain severity of the Omicron variant, how can we improve the effectiveness of mask-wearing in community settings?",
              "id": 279022,
              "answers": [
                {
                  "answer_id": 274932,
                  "document_id": 450698,
                  "question_id": 279022,
                  "text": "experimental data\n\nsupport 3-layer/multilayer non-medical masks, medical masks and respirators (i.e., N95s) as providing\n\nbetter filtering efficiency (compared to single or double layer cloth masks), which may translate to a\n\nreduction in SARS-CoV-2 transmission. The evidence comparing non-medical masks and medical masks is\n\nlargely limited to experimental studies evaluating filtering efficiency and is not based on clinical or realworld settings. Considerations for the type of mask used for source control and personal protection\n\nshould include filtration efficiency, fit, breathability, comfort and adherence to optimize the protection\n\nof those around the mask wearer.",
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          "context": "EVIDENCE BRIEF\n\n\n\nSARS-CoV-2 Omicron Variant and Community\n\nMasking\n\n12/15/2021\n\n\n\nKey Messages\n\n\n\n\n\nEmerging evidence suggests that the SARS-CoV-2 Omicron (B.1.1.529) variant of concern (VOC)\n\nis highly transmissible, as it has higher growth rates and secondary household attack rates\n\ncompared to the Delta variant, and associated with lower vaccine effectiveness. It is currently\n\nunclear if the observed increase in transmissibility could be related to an increase in\n\ninfectiousness of aerosols.\n\n\n\n\n\n\n\nPrevention measures should be optimized with a layered approach to mitigate against\n\nconditions conducive to transmission such as the “3 C’s”: closed spaces, crowded places, and\n\nclose contact. This approach includes wearing well-fitting and well-constructed masks.\n\n\n\n\n\n\n\nWith the emergence of Omicron, multiple European jurisdictions (i.e., Denmark, England,\n\nFrance, Finland, Germany, Ireland and Norway) have maintained or strengthened masking\n\nrecommendations and requirements in public settings where they may have previously relaxed\n\nor were considering relaxing masking policies. Some jurisdictions (i.e., France, Germany and\n\nItaly) have recommended masks with specific filtering levels (i.e., medical masks or respirators\n\ninstead of cloth masks) in select settings such as public transit and schools.\n\n\n\n\n\n\n\nIn the current Omicron risk context, it is recommended that mask fit and filtration are\n\noptimized. This can be achieved by wearing a non-fit tested respirator (N95s, KN95s) or wellfitted medical mask. A high quality 3-layer non-medical mask (i.e., cloth masks) can be a\n\nreasonable alternative if it promotes adherence. Respirators are designed to closely fit or seal to\n\nthe face, and while fit-testing is not required for use in the community, N95s without fit-testing\n\nand KN95s cannot be assumed to filter all of the air inhaled (i.e., respiratory protection).\n\n\n\n\n\n\n\nGiven the early evidence that Omicron variant is more highly transmissible than the Delta\n\nvariant with potential increased contribution of aerosol transmission, and is associated with\n\nreduced vaccine effectiveness and increased risk of re-infection, selecting a mask that optimizes\n\nfit and filtration that can be worn correctly and comfortably by the general public in community\n\nsettings may enhance the current public health measures.\n\n\n\nSARS-CoV-2 Omicron Variant and Community Masking\n\n\n\nPage 1 of 18\n\n\n\n\fIssue and Research Question\n\nOn November 26, 2021, based on possible increased risk of reinfection and increased ease of\n\ntransmission, the World Health Organization (WHO) designated the SARS-CoV-2 B.1.1.529 lineage as a\n\nvariant of concern (VOC) and named it Omicron. The first known and confirmed Omicron positive\n\nspecimen globally was collected on November 8, 2021 in South Africa, although the precise timing and\n\nlocation of Omicron emergence remain unknown. At the time of publishing, the Omicron variant is the\n\ndominant variant in Ontario.1\n\nThe evidence concerning the SARS-CoV-2 Omicron variant is rapidly changing; therefore, public health\n\nmust re-evaluate the current measures used to combat transmission in order to protect the health of\n\nOntarians and the healthcare system. Given the likely increased transmissibility, indications of\n\nvaccine/immune escape and uncertain severity of the Omicron variant, how can we improve the\n\neffectiveness of mask-wearing in community settings?\n\n\n\nMethods\n\nIn considering feasibility, scope and timelines, we undertook a rapid review to update our summary of\n\nSARS-CoV-2 Omicron transmission and masking. A rapid review is a knowledge synthesis where certain\n\nsteps of the systematic review process are omitted in order to be timely (e.g., duplicate screening).\n\nWe conducted literature searches on December 13, 2021, in MEDLINE and National Institutes of Health\n\nCOVID-19 Portfolio (preprints). Search strategies are available upon request. English-language peerreviewed and non-peer-reviewed records that described Omicron variant transmission and masking\n\nwere included.\n\nThe jurisdictional scan of masking policies was informed by keyword searches in the Google search\n\nengine and government websites for literature related to Omicron and masking. A formal database\n\nsearch was not conducted due to time constraints; thus, some relevant articles may not be included. The\n\nfollowing jurisdictions were searched: Denmark, England, Finland, France, Germany, Ireland, Israel, Italy\n\nand Norway.\n\nPrior to publishing, Public Health Ontario (PHO) subject-matter experts review all knowledge products.\n\nAs the scientific evidence is expanding rapidly, the information provided in this document is only current\n\nas of the date of respective literature searches. PHO will continue to assess the latest scientific evidence\n\nconcerning public health measures targeting transmission of the Omicron variant.\n\nOut-of-scope for this document was a review of infection prevention and control (IPAC) practices for\n\nhealthcare and workplace settings. For guidance on IPAC practices in healthcare settings, please refer to\n\nPHO’s Interim IPAC recommendations for use of personal protective equipment for care of individuals\n\nwith suspect or confirmed COVID‑19.2 For guidance on IPAC practices for workplaces, please refer to the\n\nPHO COVID-19 Workplace Resources webpage.3\n\n\n\nSARS-CoV-2 Omicron Variant and Community Masking\n\n\n\nPage 2 of 18\n\n\n\n\fMain Findings\n\nSARS-CoV-2 Transmission Dynamics\n\nSARS-CoV-2 is transmitted at short range through exposure to respiratory particles that range in size\n\nfrom large droplets to smaller aerosols.4,5 Short-range transmission generally occurs within 2 metres (m)\n\nof an infectious individual (e.g., during a conversation with inadequate distancing, no barriers, no\n\npersonal protective equipment). Short-range transmission may occur due to droplets or aerosols, but\n\nthe relative contribution of either is specific to each case-contact interaction, which varies based on\n\ncontextual factors including source/receptor and pathway characteristics.4\n\nThere is evidence supporting long-range aerosol transmission, particularly under favourable conditions\n\n(e.g., Chen et al. 2021, Grudlewska-Buda et al. 2021, Palmer et al. 2021).6-8 Epidemiological and\n\nmodelling studies support that long-range transmission via aerosols occurs, especially when there are\n\ncombinations of favourable source/receptor and pathway conditions such as indoor settings,\n\ninadequate ventilation, prolonged exposure time, high viral load, with certain activities (e.g., singing,\n\nexercising, yelling), and a lack of masking for source control.6-8 SARS-CoV-2 RNA has been detected at\n\nvarying distances from patients and at a higher prevalence and concentration in aerosols compared to\n\ndroplets; therefore, transmission is likely possible at both short distances with large respiratory droplets\n\nand aerosols (<2 m), and at longer distances with small aerosols (≥2 m) (e.g., Cherrie et al. 2021, Dinoi et\n\nal. 2021, Ribaric et al. 2021).9-11 Transmission can also occur from contact of mucous membranes with\n\nhands contaminated with infectious virus, although this is not the predominant mode of transmission.12\n\n\n\nOmicron Variant Epidemiology and Masking\n\nOmicron carries the highest number of novel mutations documented (>50), compared to other VOCs.13\n\nThe significance of these mutations is not yet clear;8,9 however, some of the mutations have been\n\nassociated with infectivity, immune escape, transmissibility and reduced susceptibility to monoclonal\n\nantibody treatment.10\n\nOn December 8, 2021, the Scientific Advisory Group for Emergencies (SAGE) in the United Kingdom (UK)\n\nreported that the Omicron variant has a growth advantage over the Delta variant, a doubling time of\n\napproximately 3 days (d) and higher household secondary attack rates.14 The report also notes that\n\nsome superspreading events involving Omicron suggest aerosol transmission may be playing a bigger\n\npart of overall transmission compared to previous variants (low confidence). SAGE notes that Omicron\n\ncirculation means that prevention of aerosol transmission (short- and long-range transmission) requires\n\nenhancement of existing preventative strategies, including ventilation and filtration, well-fitting masks\n\nand distancing or reduced density of people in indoor environments.\n\nRecently, Gu et al. (2021) report on the detection of the Omicron variant in an asymptomatic, fullyvaccinated traveller (case A) in a quarantine hotel in Hong Kong, China, along with potential\n\ntransmission to a fully vaccinated traveller in a room across the corridor (case B).15 Viral sequencing\n\nconfirmed both cases were the Omicron VOC, and sequencing between cases differed by only one\n\nnucleotide. Authors suggest airborne transmission across the corridor is the most probable mode of\n\ntransmission. Please see PHO Synopsis of this article for further details.16\n\n\n\nSARS-CoV-2 Omicron Variant and Community Masking\n\n\n\nPage 3 of 18\n\n\n\n\fLittle epidemiological information is currently available for outbreaks involving the Omicron variant. In\n\nan epidemiological summary of Omicron cases reported in the United States (US) (December 1–8, 2021),\n\n43 cases were reported of which 33% (14/43) reported international travel (Centers for Disease Control\n\nand Prevention COVID-19 Response Team 2021).17 While the report did not provide exact numbers,\n\nexposures for non-travel cases were related to household transmission or large public events. No\n\ninformation on personal protective behaviours (e.g., mask-wearing) was reported for those infected,\n\nexcept that 79.0% (34/43) of cases were vaccinated.17\n\nThe literature search did not return any published or preprint studies related to the Omicron variant and\n\nmasking. While much remains unknown for Omicron, we have utilized knowledge of Delta, which can\n\nhelp inform policies surrounding Omicron masking and transmission prevention. Previously, PHO\n\nassessed potential mechanisms for the increased transmission of VOCs.18 Evidence has emerged that\n\nother VOCs, such as Delta, have higher aerosol and surface stability, meaning that Delta may be more\n\neasily transmitted via long-range aerosols and fomites, respectively.19,20 Recently, several case studies of\n\nsuperspreading events involving Delta occurred in various settings (i.e., hospitals, school) with high\n\nsecondary attack rates despite use of appropriate personal protection and physical distancing.21-23 In a\n\nmatched case-control study on household transmission (≥2 cases within 14 d) in England that compared\n\nDelta variant and Alpha variant cases (March to June 2021), Allen et al. (2021) included 5,976 index\n\ncases and 11,952 contacts.24 The odds ratio of household transmission was 1.7 among Delta variant\n\ncases (95% confidence interval [CI]: 1.48–1.95), compared to Alpha variant cases.24 In a preliminary\n\nstudy using updated data, the UK Health Security Agency (2021) reported an increased risk of household\n\ntransmission from an Omicron index case compared to a Delta index case (adjusted odds ratio [aOR]:\n\n3.2, 95% CI: 2.0–5.0).25 In addition, there was an increased risk of a close contact becoming a secondary\n\ncase (aOR: 2.1, 95% CI: 1.54–2.79). The household secondary attack rate of Omicron using routine\n\ncontact tracing data was 21.6% (95% CI: 16.7–27.4), compared to Delta at 10.7% (95% CI: 10.5–10.8).25\n\n\n\nMasking Policies in other Jurisdictions\n\nAlthough this scan focused on masking guidance in response to Omicron, some of the guidance reported\n\nmay also be in response to the ongoing Delta resurgence in Europe, which coincides with the emergence\n\nof Omicron. Wherever possible, the language used in guidance documents was retained (e.g., “should”\n\nor “required” or “it is recommended”); however, if primary sources were not found, the scan retained\n\nthe language used in the secondary, grey literature (i.e., media).\n\nWith the emergence of the Omicron variant, most jurisdictions included in this rapid scan (i.e., Denmark,\n\nEngland, France, Finland, Germany, Ireland, Norway) have maintained or strengthened\n\nrecommendations or requirements for masks in public settings where they may have previously relaxed\n\nor were considering relaxing masking policies. No mask policy updates were found for Israel beyond\n\nthose published in June of 2021.\n\nThere is heterogeneity in the jurisdictions scanned, in terms of masking policies and recommendations.\n\nIn terms of types of masks, France, Germany, and Italy are examples of jurisdictions with masking\n\npolicies that specify the requirement for masks with a certain level of filtering, with France and Germany\n\nintroducing these recommendations or requirements in January 2021 when it became clear variants\n\ncould lead to increased transmissibility.26 Currently, France recommends masks with 90% filtration for\n\nuse in public settings and in schools, and recommends cloth masks no longer be used. 27,28 Germany was\n\none of the first countries to mandate use of either single-use filtering face piece (FFP) respirators (e.g.,\n\nN95s) or medical masks in January 2021.26 In Italy, since the Delta resurgence and emergence of\n\nOmicron, FFP2 (the European equivalent of N95) are required for bus drivers to wear on public transit.29\n\n\n\nSARS-CoV-2 Omicron Variant and Community Masking\n\n\n\nPage 4 of 18\n\n\n\n\fDENMARK\n\n\n\n\n\nCurrent guidance states face masks or shields (mask type not specified) are required on public\n\ntransport; at restaurants, bars and cafes when guests are not sitting down; in grocery stores,\n\nshops and shopping centres; in any health sector setting (i.e., hospitals, clinics); at social services\n\nand nursing homes in common areas with public access; and personal businesses (e.g., massage,\n\nhaircut, tattoo) may implement their own masking requirements.30\n\n\n\n\n\n\n\nAt time of writing, face masks are not required at the following settings which do require a\n\nCOVID-19 Certificate to attend: museums, amusement parks, theatres, cinemas, concert venues,\n\nzoos and aquariums, stadiums or other sports venues, swimming pools and play and water parks\n\nwith more than 100 visitors indoors or 1,000 visitors outdoors.30\n\n\n\n\n\n\n\nChildren under 12 years old are generally exempt from wearing face masks.31 Children in\n\nprimary school will be sent home from December 15, 2021 to January 4, 2022, and boarding\n\nschool students are to be sent home December 19, 2021 to January 7, 2022 with virtual\n\neducation to be made available.30 Guidelines when children physically attend school do not\n\ninclude information related to masks, but strongly recommend students in grade one onwards\n\nbe tested on a weekly basis unless they are fully vaccinated or had a previous COVID-19\n\ninfection.30,32 Plans for the return to school in January, as of December 15, 2021, also do not\n\ninclude masking requirements for children in schools but emphasize vaccination, increased\n\ntesting and cohorting students when possible.33\n\n\n\nENGLAND\n\n\n\n\n\nEffective November 29, 2021, face coverings should be worn in communal areas in all education\n\nsettings by staff, visitors and students in year seven and above, unless they are exempt.34\n\nEffective November 30, 2021, face coverings are legally required in shops and on public\n\ntransport. This temporary measure will be reviewed after three weeks.35 Effective December 10,\n\n2021, face masks are a legal requirement in more public indoor areas, including theatres,\n\ncinemas, hairdressers, tattoo studios and nail bars, takeaways (curbside pick-up of food and\n\ndrink) and other settings.36 As of December 10, 2021, face masks are not required in pubs,\n\nrestaurants or gyms, and they can be removed when it is \"reasonably necessary\"; for example, if\n\nin a choir or on stage.37\n\n\n\n\n\n\n\nThe UK’s Department of Education updated their education and childcare settings contingency\n\nframework on December 15, 2021.38 As a temporary measure, it is recommended staff, adult\n\nvisitors and students age 11 and older should wear masks when moving around the school\n\noutside of classrooms and must wear masks when travelling on public transport. Masks in\n\nclassrooms may be temporarily advised in settings managing outbreaks or enduring\n\ntransmission settings. Children of primary school age and early years should not be advised to\n\nwear face coverings.38\n\n\n\nSARS-CoV-2 Omicron Variant and Community Masking\n\n\n\nPage 5 of 18\n\n\n\n\fFINLAND\n\n\n\n\n\nThe first weekend of October 2021, several COVID-19 public health measures were lifted, with\n\nsome exceptions, including mask use on public transport and when indoors and distancing\n\ncannot be maintained, and mask use outdoors in crowded situations.39 Effective November 26,\n\n2021, the health authority recommended masks continue to be used especially in public indoor\n\nsettings where many people are gathered close to each other.40 The recommendation applies to\n\nboth vaccinated and unvaccinated persons. In addition, individuals are encouraged to follow the\n\nmasking guidance provided by their health care district and municipality.40\n\n\n\n\n\n\n\nMasking rules generally apply to children aged 12 years and older.40 National school-specific\n\nmasking guidance was not identified, but in a City of Helsinki source dated September 8, 2021,\n\nstudents in grade six and upwards are asked to wear a face mask while in school.41\n\n\n\nFRANCE\n\n\n\n\n\nFrance recommends masks with 90% filtration for use in public settings and recommends cloth\n\nmasks no longer be used.27 Effective November 26, 2021, masks became mandatory in all indoor\n\nspaces – even those that require a valid health pass (i.e., immunity certificate) for entry, as well\n\nas for large gatherings outdoors, such as Christmas markets.42,43\n\n\n\n\n\n\n\nEffective November 15, 2021, wearing a mask was again mandatory in elementary schools.44 The\n\nMinistry of National Education, Youth and Sports has established a health framework to guide\n\nCOVID-19 precautions in schools and includes four levels.45 As of December 9, Level 3 applies to\n\nall schools which mandates mask wearing for elementary, middle and high school students in\n\nconfined spaces and outdoors.28,45 Guidance also notes in relation to student mask\n\nrequirements, given the appearance of SARS-CoV-2 variants only surgical masks or consumer\n\nmasks with filtration capacity greater than 90% can be worn.28\n\n\n\nGERMANY\n\n\n\n\n\nGermany was one of the first countries to mandate use of either single-use surgical masks or\n\nFFP2 respirators (i.e., N95), in January 2021.26 Masks and FFP2 respirators are mandatory for the\n\ngeneral public on public transport and when shopping.46 In addition, masks and respirators must\n\nbe worn during indoor large-scale sports, culture and similar events, as well as at outdoor\n\nevents.47\n\n\n\n\n\n\n\nIn schools, masks are compulsory for all grades.46\n\n\n\nIRELAND\n\n\n\n\n\nEffective October 22, 2021, Ireland eased several restrictions; however, face masks remained\n\nmandatory in retail, banks, on all forms of public transport and for customer-facing workers in\n\ncafés, libraries, entertainment venues (e.g., cinemas), museums, personal services (e.g., salons),\n\nbars and restaurants.48\n\n\n\n\n\n\n\nMask guidance updated as of December 1, 2021 requires masks in the following settings: retail\n\noutlets, banks, credit unions and post offices, in taxis, in bus and rail stations, on public\n\ntransport and for workers in customer facing roles in cafés, bars and restaurants.49\n\n\n\nSARS-CoV-2 Omicron Variant and Community Masking\n\n\n\nPage 6 of 18\n\n\n\n\f\n\n\n\nGuidance also recommends masks in the following settings: visiting homes of people over age\n\n70 or who are medically vulnerable (visitors and residents); travelling in a vehicle with someone\n\nyou do not live with; crowded workplaces; places of worship; busy or crowded outdoor spaces\n\nwhere there is significant congregation; in circumstances where 2 m distance can’t be\n\nmaintained.49\n\n\n\n\n\n\n\nMedical grade masks are recommended for: vulnerable people in indoor or outdoor crowded\n\nspaces; people age over 70 in crowded spaces; people with confirmed COVID-19 diagnosis;\n\npeople with symptoms of COVID-19; and close contacts of confirmed COVID-19 cases.49\n\n\n\n\n\n\n\nChildren in grade three and above should wear a face covering in primary school. This new\n\nmeasure has been introduced on a temporary basis and will be reviewed in mid-February\n\n2022.50\n\n\n\nISRAEL\n\n\n\n\n\nThe most recent announcements from Israel’s Ministry of Health are from the summer. On June\n\n15, 2021, Israel dropped its mask mandate.51 Soon after, on June 26, 2021, masks were again\n\nrequired in all indoor settings, except for permanent places of residence, and are recommended\n\nduring large outdoor gatherings.52\n\n\n\n\n\n\n\nChildren under the age of seven years are exempt from masking requirements.52\n\n\n\nITALY\n\n\n\n\n\nAs of December 13, 2021, all but three regions in Italy are in the White Zone (i.e., lowest risk\n\nlevel).53 In the White Zone, masks must be worn in indoor public places such as bars,\n\nrestaurants, museums and public transport. Masks are not mandatory outdoors.54 In response\n\nto Omicron, Italian authorities are considering bringing back outdoor mask mandates; however,\n\nlocal authorities in several Italian cities have already announced their own outdoor mask\n\nmandates in response to Omicron.55 On public transport, bus drivers must wear an FFP2\n\nrespirator (European equivalent of N95) or equivalent.29\n\n\n\n\n\n\n\nIn Italy, surgical masks are provided to staff and students in schools.56\n\n\n\nNORWAY\n\n\n\n\n\nAs of December 9, 2021, the Norwegian Ministry of Health and Care Services published updated\n\nnational rules and recommendations.57 In restaurants, night clubs, retail settings, personal\n\nservice settings, public buildings and on public transport, masks are required if a 1 m physical\n\ndistance cannot be maintained. Masks are recommended in workplace settings and outdoor\n\nevents when 1 m distance cannot be maintained.57\n\n\n\n\n\n\n\nIn Norway, there are no mask mandates for children in kindergarten and primary school (levels\n\n1-7).58 Masks (cloth at least) are recommended for students in junior high school or high school\n\n(in yellow or red action levels, when advised by the respective municipality, when 1-m physical\n\ndistancing cannot be maintained). Children aged 12 years and under are not recommended to\n\nuse face masks, and children under two years should not use face masks.59 Mask use is advised\n\nfor employees in certain situations.58\n\n\n\nSARS-CoV-2 Omicron Variant and Community Masking\n\n\n\nPage 7 of 18\n\n\n\n\fMasking for Reducing SARS-CoV-2 Transmission\n\nOn November 1, 2021, PHO published Community non-medical and medical mask use for reducing SARSCoV-2 transmission.60 One of the key points from that evidence review was that experimental data\n\nsupport 3-layer/multilayer non-medical masks, medical masks and respirators (i.e., N95s) as providing\n\nbetter filtering efficiency (compared to single or double layer cloth masks), which may translate to a\n\nreduction in SARS-CoV-2 transmission. The evidence comparing non-medical masks and medical masks is\n\nlargely limited to experimental studies evaluating filtering efficiency and is not based on clinical or realworld settings. Considerations for the type of mask used for source control and personal protection\n\nshould include filtration efficiency, fit, breathability, comfort and adherence to optimize the protection\n\nof those around the mask wearer.60\n\nMasking has been an important component of a layered approach to mitigating SARS-CoV-2\n\ntransmission and is an important public health strategy.\n\n\n\n\n\nIn a systematic review and meta-analyses of eight studies (2,627 people with COVID-19 and\n\n389,228 participants), Talic et al. (2021) reported that COVID-19 incidence was reduced when\n\nmask-wearing (any mask type) policies were in place (relative risk [RR]: 0.5, 95% CI: 0.29–0.75),\n\nfollowed by physical distancing (RR: 0.8, 95% CI: 0.59–0.95).61 The authors noted that it was not\n\npossible to evaluate the impact of mask type, compliance and wear frequency due to a lack of\n\ndata.\n\n\n\n\n\n\n\nIn a modelling study, Bagheri et al. (2021) calculated risk of infection and exposure and reported\n\nthat when an infectious person is speaking with another person for 1 hour and both are wearing\n\na surgical mask, the upper bound risk is 30%. This upper bound conservative risk calculation is\n\nreduced to 0.4% if a FFP2 is worn.62 For an exposure period of 20 minute, fitted FFP2 reduce the\n\nrisk of infection by a factor of 30 (compared to loosely worn FFP2s) and by a factor of 75\n\n(compared with fitted surgical masks).62\n\n\n\n\n\n\n\nDuncan et al. (2021) investigated aerosol particle (<5 µm diameter) penetration and total inward\n\nleakage through face masks (i.e., re-usable fabric two-layer masks, re-useable fabric multi-layer\n\nmasks, disposable procedure/surgical masks, KN95 masks and fit-tested and seal-checked N95\n\nFFR).63 The percent overall penetration of particles was highest for 2-layer masks (≈56%),\n\nfollowed by multi-layer (≈28%), procedure (≈10%), N95 FFR (≈1.4%) and KN95 (≈0.7%).\n\nModelling a viral concentration of 0.01% and particle size of 0.3 µm, the percent reduction in\n\nviral penetration, compared to a 2-layer mask, was 99.2% for N95 FFRs, 96% for disposable\n\nprocedure/surgical masks, and 59% for multi-layer masks. The authors concluded that N95 FFRs\n\nwere the only devices investigated that provided both high fabric protection factor (FPF) and\n\ntotal inward leakage protection factor (TILPF). Further, N95 FFRs are the best option to protect\n\nindividuals from exposure to aerosols in high-risk settings.63 In addition, mask fit with an\n\neffective face seal is more important to increasing TILPF than the mask material. Please see\n\nPHO’s Synopsis for this article for further information.64\n\n\n\nSARS-CoV-2 Omicron Variant and Community Masking\n\n\n\nPage 8 of 18\n\n\n\n\fImplications for Practice and Recommendations\n\nUntil we have a better understanding of Omicron transmission, disease severity, immune escape and\n\nvaccine effectiveness, we recommend a precautionary approach to preventing spread and to protect the\n\nhealthcare system. This cautious approach underlines the importance of layered measures to prevent\n\nSARS-CoV-2 transmission, with the aim of reducing morbidity and mortality. Several resources exist for\n\ncommunity guidance (e.g., non-health care workplaces, public and private spaces) on how to reduce the\n\nrisk of SARS-CoV-2 transmission through a layered approach of multiple public health measures\n\ndesigned to mitigate transmission.65-67\n\nThe cornerstone of a layered approach to preventing SARS-CoV-2 is measures to mitigate exposure to\n\nsettings with the “3 C’s”: closed spaces, crowded places, and close contact. The degree to which various\n\nmitigation layers are necessary or possible will depend on the setting and risk context, noting that not\n\neveryone can avoid the 3 C’s. Transmission can be mitigated through layers encompassing:68 getting\n\nvaccinated including third doses when eligible; staying home if you have symptoms of COVID-1969 or if\n\nyou have been exposed to someone with SARS-CoV-2 infection and following current testing advice;\n\nlimiting the number and duration of contacts with individuals outside your household; physical\n\ndistancing and avoiding crowded, indoor spaces where possible; improving ventilation and/or filtration\n\nto the extent possible (including natural ventilation) and using outdoor environments; rapid antigen\n\nscreen testing where appropriate and available; hand hygiene and respiratory etiquette; and wearing a\n\nwell-fitted and well-constructed mask.\n\nWhile there are limited real-world data to support a preference for wearing a 3- or multi-layer nonmedical masks or medical masks or respirators, given Omicron’s concerning increased transmissibility,\n\npotential for vaccine/immune escape and uncertain severity, we recommend the following as a\n\nprecautionary approach to the masking layer of prevention:\n\n\n\n\n\nOptimizing fit and filtration for masks worn in community settings, particularly for “3 C” settings\n\nthat cannot be avoided, such as public transportation or crowded public indoor settings such as\n\nlarge retail or event venues.\n\n\n\n\n\n\n\nOptimizing fit and filtration can be achieved with the use of non-fit tested respirators and\n\nmedical masks. A well-fitting, well-constructed three-layer cloth mask (i.e., two layers of tightly\n\nwoven fabric and a third filter-type layer such as non-woven polypropylene)70 can still be used,\n\nand may be preferable in situations where it leads to increased adherence (e.g. younger\n\nchildren).\n\n\n\n\n\n\n\nSingle–layer, scarf-style masks and 2-layer masks are not recommended for optimizing the\n\nmasking layer because they do not include a filter layer and are not made of effective\n\nmaterials.70\n\n\n\n\n\n\n\nOther considerations in choosing a mask should incorporate the relative risk of the maskwearer, such as medical mask/respirator use for those at higher risk of infection due to older\n\nage or immune compromise.\n\n\n\n\n\n\n\nWhile mask use in children and in school or childcare settings was out of scope for this review,\n\nconsiderations of comfort, tolerability, adherence, and fit are important when selecting an\n\nappropriate mask for use by children.\n\n\n\nSARS-CoV-2 Omicron Variant and Community Masking\n\n\n\nPage 9 of 18\n\n\n\n\fGenerally, in terms of mask fit, the mask should completely cover the nose and mouth and be\n\ncomfortable enough to wear for long periods to improve adherence. Individuals should aim to ensure as\n\ngood a seal as possible for their mask or respirator. Medical masks and respirators have benefits of\n\nimproved filtration and fit; however, the effectiveness of any mask or respirator is highly dependent on\n\nappropriate use by the wearer and in community settings respirator use should not be expected to\n\nprovide total filtration of inhaled air. Respirator function (complete filtration of inhaled air) may not be\n\nachieved in the absence of fit-testing and seal-checking procedures. The additional benefits of KN95 and\n\nN95 respirators will be dependent on consistent appropriate use, the degree of fit and inward leakage.\n\nRecommendations for masking in public settings are drawn from existing PHO guidance and messaging\n\nfrom the Public Health Agency of Canada, with recommendations applied to the current Omicron risk\n\ncontext in Ontario. 13,60,70 Medical masks and respirators that fit well can provide better filtration than\n\nnon-medical masks, if they are worn consistently and correctly. A well-fitting 3-layer cloth mask of\n\neffective materials is a reasonable alternative in populations where its use will lead to increased mask\n\nadherence. 1- or 2-layer non-medical masks are not recommended to protect others or the wearer.\n\nEquity considerations must be taken into account when making recommendations on medical masks\n\nand respirators to the public, and should consider settings where provision may be reasonable to\n\nsupport equitable access.\n\n\n\nSARS-CoV-2 Omicron Variant and Community Masking\n\n\n\nPage 10 of 18\n\n\n\n\fReferences\n\n1. Ontario Agency for Health Protection and Promotion (Public Health Ontario). Early dynamics of\n\nomicron in Ontario, November 1 to December 9, 2021 [Internet]. Toronto, ON: Queen’s Printer for\n\nOntario; 2021 Dec 14 [cited 2021 Dec 15]. Available from: https://www.publichealthontario.ca//media/documents/ncov/epi/covid-19-early-dynamics-omicron-ontario-epi-summary.pdf?sc_lang=en\n\n2. 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Review of “The\n\nprotective performance of reusable cloth face masks, disposable procedure masks, KN95 masks and N95\n\nrespirators: filtration and total inward leakage” [Internet]. Toronto, ON: Queen’s Printer for Ontario;\n\n2021 Nov 2 [cited 2021 Dec 13]. Available from: https://www.publichealthontario.ca//media/documents/ncov/research/2021/11/synopsis-duncan-plosmasks.pdf?sc_lang=en&hash=B2E697DD60CEF7A19502C5E0F49C15C3\n\n65. Government of Ontario. Resources to prevent COVID-19 in the workplace [Internet]. Toronto, ON:\n\nQueen's Printer for Ontario; 2020 [updated 2021 Apr 30; cited 2021 Dec 14]. Available from:\n\nhttps://www.ontario.ca/page/resources-prevent-covid-19-workplace\n\n66. Canadian Centre for Occupational Health and Safety. COVID-19: workplace health and safety guide\n\n[Internet]. Hamilton, ON: Canadian Centre for Occupational Health and Safety; 2020 [cited 2021 Dec 14].\n\nAvailable from: https://www.ccohs.ca/products/publications/pdf/pandemiccovid19/covid-health-safetyguide.pdf\n\n67. Ontario Agency for Health Protection and Promotion (Public Health Ontario). Reduce your risk from\n\nCOVID-19 [Internet]. Toronto, ON: Queen’s Printer for Ontario; 2021 [cited 2021 Dec 14]. Available from:\n\nhttps://www.publichealthontario.ca/-/media/documents/ncov/factsheet/2020/12/reducerisk/factsheet-covid-19-reduce-your-risk.pdf?la=en\n\n68. Public Health Agency of Canada. Routine practices and additional precautions for preventing the\n\ntransmission of infection in healthcare settings [Internet]. Ottawa, ON: Her Majesty the Queen in Right\n\nof Canada; 2016 [cited 2021 Dec 14]. Available from: https://www.canada.ca/content/dam/phacaspc/documents/services/publications/diseases-conditions/routine-practices-precautions-healthcareassociated-infections/routine-practices-precautions-healthcare-associated-infections-2016-FINALeng.pdf\n\n69. Ontario. Ministry of Health. COVID-19 reference document for symptoms [Internet]. Toronto, ON:\n\nQueen's Printer for Ontario; 2021 [cited 2021 Dec 15]. Available from:\n\nhttps://www.health.gov.on.ca/en/pro/programs/publichealth/coronavirus/docs/2019_reference_doc_s\n\nymptoms.pdf\n\n70. Public Health Agency of Canada. COVID-19 mask use: advice for community settings [Internet].\n\nOttawa, ON: Her Majesty the Queen in Right of Canada; 2021 [cited 2021 Dec 15]. Available from:\n\nhttps://www.canada.ca/en/public-health/services/diseases/2019-novel-coronavirusinfection/prevention-risks/about-non-medical-masks-face-coverings.html\n\n\n\nSARS-CoV-2 Omicron Variant and Community Masking\n\n\n\nPage 17 of 18\n\n\n\n\fCitation\n\nOntario Agency for Health Protection and Promotion (Public Health Ontario). SARS-CoV-2 Omicron\n\nvariant and community masking. Toronto, ON: Queen's Printer for Ontario; 2021.\n\n\n\nDisclaimer\n\nThis document was developed by Public Health Ontario (PHO). PHO provides scientific and technical\n\nadvice to Ontario’s government, public health organizations and health care providers. PHO’s work is\n\nguided by the current best available evidence at the time of publication. The application and use of this\n\ndocument is the responsibility of the user. PHO assumes no liability resulting from any such application\n\nor use. This document may be reproduced without permission for non-commercial purposes only and\n\nprovided that appropriate credit is given to PHO. No changes and/or modifications may be made to this\n\ndocument without express written permission from PHO.\n\n\n\nFor Further Information\n\nContact epir@oahpp.ca\n\n\n\nPublic Health Ontario\n\nPublic Health Ontario is an agency of the Government of Ontario dedicated to protecting and promoting\n\nthe health of all Ontarians and reducing inequities in health. Public Health Ontario links public health\n\npractitioners, front-line health workers and researchers to the best scientific intelligence and knowledge\n\nfrom around the world.\n\nFor more information about PHO, visit publichealthontario.ca.\n\n\n\n©Queen’s Printer for Ontario, 2021\n\n\n\nSARS-CoV-2 Omicron Variant and Community Masking\n\n\n\nPage 18 of 18\n\n\n\n\f",
          "document_id": 450698
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    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "What is the prevalence of Long-COVID?",
              "id": 279024,
              "answers": [
                {
                  "answer_id": 274935,
                  "document_id": 450699,
                  "question_id": 279024,
                  "text": "\nThe prevalence of persistent symptoms ranges widely by study and depends largely on the population\n\nstudied. Overall, the prevalence of patients with at least one persistent symptom ranged from 31–51%:\n\n31.1% (n=234 patients),11 38.5% (n=431),12 45.9 (n=246),13 49.6% (n=538),14 50.9% (n=422),15 51.0%\n\n(n=478)16 and 51.4% (n=767).17\n\nThe prevalence of persistent symptoms decreased with increasing time since symptom-onset. Sudre et\n\nal. (2021) noted that the prevalence of persistent symptoms decreased over time (n=558 patients) from\n\n13.3% experiencing persistent symptoms 28 days after symptom-onset, to 4.5% at 56 days, and 2.3% at\n\n84 days.18 In a study of 20,000 patients in the United Kingdom (UK), 21.0% experienced at least one\n\npersistent symptom 45 days after symptom-onset, 13.7% at 84 days.19 In a cohort study of 323\n\nseropositive cases (mild disease) and 1,072 seronegative cases in Sweden, Havervall et al. (2021)\n\nreported on persistent symptoms in healthcare workers, where at least one moderate to severe\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n3\n\n\n\n\fpersistent symptom was reported at 56 days since initial serological test in 26.0% of seropositive cases\n\n(seronegative cases: 8.9%), 21.4% (7.2%) at 112 days, and 14.9% (3.4%) at 224 days.20",
                  "answer_start": 8408,
                  "answer_category": null
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            },
            {
              "question": "What are the symptoms and signs of Long-COVID?",
              "id": 279025,
              "answers": [
                {
                  "answer_id": 274936,
                  "document_id": 450699,
                  "question_id": 279025,
                  "text": "The most prevalent persistent (>21 days since symptom-onset) symptoms in patients with postacute COVID-19 (range of mean or median in the included studies, noting high heterogeneity\n\namong studies) were:\n\n Fatigue: 30–78%\n\n Cough: 20–27%\n\n Joint and/or muscle pain: 19–44%\n\n Headache: 18–50%\n\n Shortness of breath: 16–55%\n\nThe primary risk factors for having persistent post-acute COVID-19 symptoms were the presence\n\nof comorbidities (6 out of 11 studies), increased disease severity during acute infection (6 out of\n\n11 studies), and female sex (3 out of 11 studies). The presence of these comorbidities increased\n\nthe risk of persistent symptoms by at least 70%.",
                  "answer_start": 1262,
                  "answer_category": null
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          "context": "SYNTHESIS\n\n04/09/2021\n\n\n\nPersistent Symptoms and Post-Acute COVID-19\n\nin Adults – What We Know So Far\n\nIntroduction\n\nPublic Health Ontario (PHO) is actively monitoring, reviewing and assessing relevant information related\n\nto Coronavirus Disease 2019 (COVID-19). “What We Know So Far” documents are intended to provide a\n\nrapid review of the evidence on a specific aspect or emerging issue related to COVID-19.\n\n\n\nUpdates to Latest Version\n\nThis document replaces the previous version COVID-19 – What We Know So Far About… Long-Term\n\nSequelae (July 10, 2020).1 Since the previous version, meta-analyses, case series and cohort studies with\n\nlarger sample sizes have been published on the topic. The previous version concentrated on long-term\n\nsequelae such as smell and taste dysfunction and multisystem inflammatory syndrome in children (MISC), while postulating that other neurological, respiratory and cardiovascular sequelae could emerge\n\nbased on the pathology of other respiratory viral pathogens.\n\nThis rapid review updates the evidence on the persistent symptoms of post-acute COVID-19 by organ\n\nsystem, explores the risk factors associated with persistent symptoms, and outlines the implications of\n\npost-acute COVID-19.\n\n\n\nKey Findings\n\n\n\n\n\n\n\n\n\n\n\n\n\nThe most prevalent persistent (>21 days since symptom-onset) symptoms in patients with postacute COVID-19 (range of mean or median in the included studies, noting high heterogeneity\n\namong studies) were:\n\n Fatigue: 30–78%\n\n Cough: 20–27%\n\n Joint and/or muscle pain: 19–44%\n\n Headache: 18–50%\n\n Shortness of breath: 16–55%\n\nThe primary risk factors for having persistent post-acute COVID-19 symptoms were the presence\n\nof comorbidities (6 out of 11 studies), increased disease severity during acute infection (6 out of\n\n11 studies), and female sex (3 out of 11 studies). The presence of these comorbidities increased\n\nthe risk of persistent symptoms by at least 70%.\n\nCentral to planning for the healthcare and social support of recovering patients, there needs to\n\nbe a standardized definition of post-acute COVID-19. Further research is required to better\n\ncharacterize post-acute COVID-19, including longitudinal research into the risk factors\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n1\n\n\n\n\fcontributing to an increased risk of persistent symptoms, taking into consideration racial and\n\nethnic disparities.\n\n\n\nBackground\n\nFor the purposes of this “What We Know So Far”, we consider persistent symptoms (sequelae) as those\n\nthat develop or last beyond 3 weeks or 21 days since symptom-onset. The three-week period is\n\nconsistent with evidence that live or viable virus is rarely detected past 10 days in mild to moderate\n\ncases and rarely detected past 20 days in severe cases.2 Some patients with persistent symptoms have\n\nbeen termed “long-haulers” and the condition called “long COVID”.3,4 Others have described a “postacute” phase of the disease with symptoms persisting 3–4 weeks after symptom-onset (or after\n\ndischarge from inpatient care), or a “chronic” phase with symptoms persisting past 12 weeks.5-7 There\n\nare no agreed-upon definitions for these time points after initial infection.7-9\n\nAmenta et al. (2021) described three categories of post-acute COVID-19: 1) residual symptoms that\n\npersist after recovery from acute infection; 2) organ dysfunction that persists after initial recovery; and\n\n3) new symptoms or syndromes that develop after initial asymptomatic or mild infection.6 For the\n\npurposes of this rapid review, post-acute COVID-19 will include all these subcategories. Shah et al.\n\n(2021) noted that post-acute symptoms can be “singular, multiple, constant, transient, or fluctuating,\n\nand can change in nature over time.”9\n\nIn order to plan for a potential increased use of healthcare resources post-COVID-19, the healthcare\n\nsystem needs to understand the post-acute symptoms of recovering patients. Risk factors that can\n\ncontribute to post-acute COVID-19 can be used to monitor patients at risk of further morbidity and\n\ndirect resources appropriately. The purpose of this document is to examine what is known about the\n\npersistent symptoms of post-acute COVID-19, along with the associated risk factors for post-acute\n\ndisease.\n\n\n\nMethods and Scope\n\nIn considering feasibility, scope, and a need for responsiveness, we chose a rapid review as an\n\nappropriate approach to understanding the persistent symptoms of post-acute COVID-19. A rapid\n\nreview is a knowledge synthesis where certain steps of the systematic review process are omitted (e.g.,\n\nquality assessment) in order to be timely.10\n\nLiterature searches were conducted in MEDLINE (March 1, 2021), National Institutes of Health COVID-19\n\nPortfolio (Preprints) (March 5, 2021), Embase (March 2, 2021) and Global Health/Scopus (March 4,\n\n2021) (search strategies available upon request). We searched PubMed and Google Scholar on April 7,\n\n2021 for additional articles of interest.\n\nEnglish-language peer-reviewed and non-peer-reviewed records that described persistent symptoms\n\npost-acute COVID-19 were included. We restricted the search to articles published after January 1, 2020.\n\nThis rapid review concentrated on evidence from systematic reviews and meta-analyses, supplemented\n\nby primary literature where appropriate and necessary. We reviewed citations from included articles to\n\nidentify additional research.\n\nWhere prevalence data were reported for multiple end-points for follow-up, we report the latest followup period. To limit the amount of reviewed studies, we excluded primary research studies with less than\n\n200 patients. Unless otherwise stated and to limit the number of relatively rare symptoms, we only\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n2\n\n\n\n\fincluded symptoms reported in at least 10% of patients in a study. Studies were restricted to those with\n\nadult patients greater than 17 years of age. Several symptoms were potentially associated with multiple\n\norgan systems; however, we reported these symptoms with the organ system where they were most\n\noften reported in the literature (e.g., fatigue in neuropsychiatric section, chest pain in cardiovascular\n\nsection).\n\nPrior to posting, PHO subject-matter experts review all “What We Know So Far” documents. As the\n\nCOVID-19 outbreak continues to evolve and the scientific evidence rapidly expands, the information\n\nprovided in this document is only current as of the date of the respective literature searches.\n\nThis document does not report on the indirect impacts of pandemic public health measures on longterm sequelae; e.g., impact of social distancing on mental health or the consequences of deferred health\n\ncare on chronic disease management. In addition, this “What We Know So Far” does not address the\n\nmanagement of patients with long-term sequelae, the underlying mechanisms for the emergence of\n\nsequelae, or sequelae related to treatment (e.g., post-intensive care unit [ICU] admission, invasive\n\nmechanical ventilation, therapeutics). For information on post-acute COVID-19 in children, please see\n\nPHO’s upcoming review Post-Acute COVID-19 and Multisystem Inflammatory Syndrome in Children (MISC) – What We Know So Far.\n\n\n\nResults\n\nWe screened 2,705 articles identified from database searches: MEDLINE (n=1,523 articles), Global\n\nHealth and Scopus (n=663), Embase (n=398), and National Institutes of Health COVID-19 Portfolio\n\n(Preprints) (n=121). After screening and full-text review, we included four systematic reviews and metaanalyses, and 22 primary research articles. Seven of the 26 (26.9%) articles were non-peer-reviewed\n\npreprints.\n\nOne-third of the studies included patients from multiple countries (30.8%, 8/26), followed by Italy\n\n(15.4%, 4/26), China (11.5%, 3/26), France/England/United States (US) (7.7% each, 2/26), and\n\nGermany/Spain/Sweden/Switzerland/Russia (3.8% each, 1/26) (Appendix A). Half of studies included\n\ninpatients and outpatients (“mixed”) (50.0%, 13/26), followed by inpatients only (46.2%, 12/26) and\n\noutpatients only (3.8%; 1/26). Thirteen (50.0%) studies used objective measures of symptoms, seven\n\n(26.9%) used a mix of subjective and objective measures, and six (23.1%) used objective measures only.\n\nPlease refer to Appendix A for additional details on each study (e.g., inpatient vs. outpatient).\n\n\n\nPrevalence of Post-acute COVID-19\n\nThe prevalence of persistent symptoms ranges widely by study and depends largely on the population\n\nstudied. Overall, the prevalence of patients with at least one persistent symptom ranged from 31–51%:\n\n31.1% (n=234 patients),11 38.5% (n=431),12 45.9 (n=246),13 49.6% (n=538),14 50.9% (n=422),15 51.0%\n\n(n=478)16 and 51.4% (n=767).17\n\nThe prevalence of persistent symptoms decreased with increasing time since symptom-onset. Sudre et\n\nal. (2021) noted that the prevalence of persistent symptoms decreased over time (n=558 patients) from\n\n13.3% experiencing persistent symptoms 28 days after symptom-onset, to 4.5% at 56 days, and 2.3% at\n\n84 days.18 In a study of 20,000 patients in the United Kingdom (UK), 21.0% experienced at least one\n\npersistent symptom 45 days after symptom-onset, 13.7% at 84 days.19 In a cohort study of 323\n\nseropositive cases (mild disease) and 1,072 seronegative cases in Sweden, Havervall et al. (2021)\n\nreported on persistent symptoms in healthcare workers, where at least one moderate to severe\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n3\n\n\n\n\fpersistent symptom was reported at 56 days since initial serological test in 26.0% of seropositive cases\n\n(seronegative cases: 8.9%), 21.4% (7.2%) at 112 days, and 14.9% (3.4%) at 224 days.20\n\n\n\nPersistent Symptoms in Post-Acute COVID-19 by System\n\nNeuropsychiatric\n\nThe most commonly reported persistent neuropsychiatric symptoms were fatigue (range: 30–78%)\n\nand headache (18–50%), followed by cognitive symptoms (e.g., attention disorder, memory loss,\n\nanxiety [11–55%]), sleep disorder (11–65%), and smell/taste dysfunction (10–43%).\n\nSevere Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-associated long-term neuropsychiatric\n\nsymptoms may occur through direct viral neuroinvasion or inflammatory mediators.21,22 In a systematic\n\nreview of 35 articles and 123 patients, Parsons et al. (2020) (preprint) modelled and quantified the\n\nlocations of neurological events using magnetic resonance imaging.23 77.2% (95/123) of patients had\n\nwhite matter changes (i.e., corticospinal tract), 74.0% (91/123) had grey matter changes (i.e., bilateral\n\nsuperior temporal cortices, precentral cortices, pallidum), and 58.5% (72/123) had cerebral microbleeds.\n\nIn a systematic review of seven articles and 1,643 patients, Neishaboori et al. (2020) investigated central\n\nnervous system (CNS) neurological complications.24 The incidence of any CNS complication was 6.3%\n\n(95% confidence interval [CI]: 3.32–9.98), with encephalopathy in 2.6% (95% CI: 1.31–4.25) of patients.\n\nOther CNS findings (i.e., brain leptomeningeal enhancement, dysexecutive syndrome, brain perfusion\n\nabnormalities and ataxia) were found in 13.4% (95% CI: 0.90–35.5) of patients.\n\n\n\nSYSTEMATIC REVIEWS AND META-ANALYSES (N=2)\n\n\n\n\n\n\n\n\n\nIn a systematic review and meta-analysis of 28 studies and 9,442 patients, Michelen et al. (2020)\n\n(preprint) reported the most common and persistent neuropsychiatric symptom was smell/taste\n\ndysfunction (43%), followed by fatigue (39%) and anxiety (25%).25 Follow-up of patients\n\noccurred a median of 14–111 days from illness-onset, diagnosis or hospital discharge.\n\nIn a systematic review of 15 articles, Lopez-Leon et al. (2021) (preprint) reported on the longterm effects of COVID-19, including neurological sequelae.26 Fatigue was reported in 58% (95%\n\nCI: 42–73), followed by headache (44%; 95% CI: 13–78), attention disorder (27%; 95% CI: 19–36),\n\ntaste dysfunction (23%; 95% CI: 14–33), smell dysfunction (21%; 95% CI: 12–32), memory loss\n\n(16%; 95% CI: 0–0.55), hearing loss/tinnitus (15% (95% CI: 10–20), anxiety (13%; 95% CI: 3–26),\n\ndepression (12%; 95% CI: 3–23) and sleep disorder (11%; 95% CI: 3–24). Follow-up of patients\n\nranged from a mean of 14–110 days post-viral infection.\n\n\n\nPRIMARY RESEARCH ARTICLES (N=14)\n\n\n\n\n\n\n\n\n\nRetrospective cohort study and time-to-event analysis of 236,379 patients, Taquet et al. (2021)\n\nreported on neuropsychiatric symptoms in patients assessed 168 days after initial diagnosis.27\n\nApproximately a third of patients at follow-up had a neuropsychiatric diagnosis (33.6%; 95% CI:\n\n33.2–34.1), and 12.8% (95% CI: 12.4–13.3) of patients received a neuropsychiatric diagnosis for\n\nthe first time. Mood, anxiety or psychotic disorder was reported for the first time in 8.6% (95%\n\nCI: 8.3–9.0) of patients.\n\nDavis et al. (2020) (preprint) reported on an international web-based survey of 3,767 suspected\n\nand confirmed COVID-19 cases.28 168 days after illness-onset, the most common\n\nneuropsychiatric symptoms were fatigue (77.7%, 95% CI: 74.9–80.3), cognitive dysfunction\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n4\n\n\n\n\f\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n(55.4%; 95% CI: 52.4–58.8), memory problems (50.5%; 95% CI: 47.3–53.6), headache (50%),\n\nspeech and language issues (38.0%; 95% CI: 34.5–41.0), smell and taste dysfunction (25.2%; 95%\n\nCI: 22.5–28.0), and tinnitus (26.2%; 95% CI: 23.5–29.1).\n\nIn an ambidirectional cohort study of 1,733 patients in China, Huang et al. (2021) reported on\n\nsequelae at 168 days post-hospitalization.29 The most commonly reported neuropsychiatric\n\nsequelae were fatigue and muscle weakness (63%), sleep difficulties (26%), and smell\n\ndysfunction (11%).\n\nIn a study of 1,363 patients assessed 60 days after symptom-onset, Lechien et al. (2021)\n\nreported that 24.1% of patients did not subjectively recover from smell dysfunction. In a subset\n\nof 233 patients, 15.3% did not recover objectively from smell dysfunction (4.7% not recovered at\n\n168 days).30\n\nIn a prospective survey of 751 patients re-examined at a mean 47±7 days (range: 30–71) since\n\nfirst consultation, Chiesa‐Estomba et al. (2020) reported that 37% of patients had persistent\n\nsubjective loss of smell.31\n\nAnastasio et al. (2021) reported on 595 patients assessed at a median of 135 days (interquartile\n\nrange [IQR]: 102–175) after the onset of symptoms, where 10.3% of patients reported\n\nsmell/taste dysfunction (10.3%).32\n\nXiong et al. (2021), in a single-centre longitudinal study of 538 survivors, reported on sequelae\n\nexperienced 97.0 days (IQR: 95.0–102.0) after hospital discharge.14 The most common\n\nneuropsychiatric sequelae were fatigue (28.3%) and sleep disorder (17.7%).\n\nVenturelli et al. (2021) reported on persistent symptoms in 510 patients evaluated at a median\n\nof 105 days (IQR: 84–127) since symptom-onset, where 36.5% had fatigue.17\n\nIn a prospective observational cohort study in the UK, Sudre et al. (2021) reported on symptoms\n\nthat persisted 28 days or more since illness-onset in 558 patients.18 Fatigue was reported in 68%\n\nof patients, followed by headache (40%), loss of smell (39%) and delirium (11%).\n\nIn a prospective uncontrolled cohort study of 478 patients assessed 112 days after hospital\n\ndischarge, 31.1% of patients reported fatigue and 12.1% reported tingling in their extremities.16\n\nIn a population-based prospective cohort study of 431 patients assessed at 7 months (IQR: 6–8)\n\nsince diagnosis, Menges et al. (2021) (preprint) reported the most common neuropsychiatric\n\npersistent symptom was fatigue (54.7%), followed by mild to moderate anxiety (24.2%), mild to\n\nmoderate depression (19.9%), and mild to moderate stress (12.0%).12\n\nIn a cohort study of 323 seropositive cases and 1,072 seronegative cases in Sweden, Havervall et\n\nal. (2021) reported on persistent symptoms in healthcare workers.20 At 56 days since initial\n\nserological test, 14.6% of seropositive cases (seronegative: 0.6%) had smell dysfunction,\n\nfollowed by fatigue (8.4% vs. 5.3%) and taste dysfunction (7.7% vs. 0.6%).\n\nIn a cross-sectional study of 276 patients with a follow-up at a median of 54 days (IQR: 47–59)\n\nsince hospital discharge, Mandal et al. (2021) reported 67.3% experienced fatigue and 61.1%\n\nhad sleeping problems (for those that required at least oxygen supplementation during\n\nhospitalization).33\n\nIn a prospective cohort study of 277 patients assessed 56–84 days after symptom-onset,\n\nMoreno-Perez et al. (2021) reported 34.8% of patients reported fatigue, followed by smell/taste\n\ndysfunction (21.4%) and headache (17.8%).15\n\n\n\nRespiratory\n\nThe most commonly reported persistent respiratory symptoms were cough (range: 20–27%) and\n\nshortness of breath (16–55%).\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n5\n\n\n\n\fPost-mortem studies and reviews have noted diffuse alveolar damage, indicating that longer-term\n\npulmonary sequelae are also possible from COVID-19; for example, interstitial pulmonary fibrosis and\n\npulmonary hypertension.34-37\n\n\n\nSYSTEMATIC REVIEWS AND META-ANALYSES (N=3)\n\n\n\n\n\n\n\n\n\n\n\nIn a systematic review and meta-analysis of 28 studies and 9,442 patients, Michelen et al. (2020)\n\n(preprint) described 46% of patients reported shortness of breath.25 Follow-up of patients\n\noccurred a mean/median of 14–111 days from illness-onset, diagnosis or hospital discharge.\n\nIn a systematic review and meta-analysis of 15 articles, Lopez-Leon et al. (2021) (preprint)\n\nreported on the long-term effects of COVID-19, including respiratory sequelae.26 Shortness of\n\nbreath was reported in about a quarter of patients (24%; 95% CI: 14–36), followed by cough\n\n(19%; 95% CI: 7–34). Follow-up of patients ranged from a mean of 14–110 days post-viral\n\ninfection.\n\nIn a systematic review and meta-analysis of seven articles and 380 patients, Torres-Castro et al.\n\n(2020) reported that the most common persistent respiratory findings (14–84 days after\n\ndischarge, measured by spirometry) were altered diffusion capacity of the lungs for carbon\n\nmonoxide (39%; 95% CI: 24–56) and restrictive pattern (15%; 95% CI: 9–22).38\n\n\n\nPRIMARY RESEARCH ARTICLES (N=10)\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nDavis et al. (2020) (preprint) reported on an international web-based survey of 3,767 suspected\n\nand confirmed COVID-19 cases.28 168 days after illness-onset, the most common respiratory\n\nsequelae were sore throat (59.5%, 95% CI: 57.9–61.1), shortness of breath (37.9%, 95% CI: 34.8–\n\n41.0), and cough (20.1%; 95% CI: 17.8–22.8).\n\nAnastasio et al. (2021) reported on 595 patients assessed at a median of 135 days (IQR: 102–\n\n175) after the onset of symptoms, where 42.7% of patients reported shortness of breath.32\n\nIn a prospective observational cohort study in the UK, Sudre et al. (2021) reported on symptoms\n\nthat persisted 28 days or more since illness-onset in 558 patients.18 The most common\n\nrespiratory sequelae reported were shortness of breath (37%), followed by persistent cough\n\n(27%), sore throat (27%) and hoarse voice (17%).\n\nXiong et al. (2021), in a single-centre longitudinal study of 538 survivors, reported on sequelae\n\nexperienced at 97.0 days (IQR: 95.0–102.0) since hospital discharge.14 The most common\n\nrespiratory sequela was post-activity shortness of breath (21.4%).\n\nVenturelli et al. (2021) reported on persistent symptoms in 510 patients evaluated at a median\n\nof 105 days (IQR: 84–127) since symptom-onset, where 29.8% had shortness of breath.17\n\nIn a prospective uncontrolled cohort study of 478 patients assessed 112 days after hospital\n\ndischarge, 16.3% had shortness of breath.16\n\nIn a population-based prospective cohort study of 431 patients assessed at 7 months (IQR: 6–8)\n\nsince diagnosis, Menges et al. (2021) (preprint) reported the most common respiratory sequela\n\n(objectively measured using the modified Medical Research Council [mMRC] dyspnea scale) was\n\nshortness of breath (24.3%).12\n\nIn a cohort study of 323 seropositive cases and 1,072 seronegative cases in Sweden, Havervall et\n\nal. (2021) reported on persistent symptoms in healthcare workers.20 At 56 days since initial\n\nserological test, the most common respiratory symptom was shortness of breath (seropositive:\n\n4.3%; seronegative: 1.1%).\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n6\n\n\n\n\f\n\n\n\n\n\n\n\nIn a prospective cohort study of 277 patients assessed 56–84 days after symptom-onset,\n\nMoreno-Perez et al. (2021) reported the most common respiratory sequelae were shortness of\n\nbreath (34.4%) and cough (21.3%).15\n\nIn a cross-sectional study of 276 patients with a follow-up at a median of 54 days (IQR: 47–59)\n\nsince hospital discharge, Mandal et al. (2021) reported 54.8% experienced shortness of breath\n\n(for those requiring oxygen supplementation or respiratory support).33\n\nIn a follow-up study of 246 patients assessed at 68 ± 16 days since infection, Trinkmann et al.\n\n(2021) reported there was decreased lung function in approximately 50% of patients, as\n\nmeasured by spirometry.13\n\n\n\nCardiovascular and Cerebrovascular\n\nThe most commonly reported persistent cardiovascular and cerebrovascular symptoms were chest\n\npain (range: 12–24%), tachycardia (11–34%), and palpitations (10–40%).\n\nThe expression of the angiotensin-converting enzyme 2 (ACE2) receptor on myocytes, coronary\n\nendothelial cells and arterial smooth muscle increases the risk of organ damage in individuals with\n\nCOVID-19, as the virus uses these receptors to gain entry into cells.39-41 Thrombosis and acute ischemic\n\nstroke are recognized complications of COVID-19.42,43 In a systematic review and meta-analysis of seven\n\nstudies and 970 patients, Vakhshoori et al. (2020) reported that acute cardiac injury occurred in 15%\n\n(95% CI: 11–20) of patients.44 In autopsies of 41 patients that died from COVID-19, evidence of cardiac\n\ninfection was found in 30 patients, resulting in cardiac inflammation and electrocardiographic changes.45\n\n\n\nSYSTEMATIC REVIEWS AND META-ANALYSES (N=2)\n\n\n\n\n\n\n\nIn a systematic review and meta-analysis of 35 studies and 9,249 patients, Kunutsor and\n\nLaukkanen (2020) reported the prevalence of venous thromboembolism was 18.4% (95% CI:\n\n12.0–25.7).46 Patient follow-up occurred 2–30 days after hospital discharge.\n\nIn a systematic review and meta-analysis of 15 articles, Lopez-Leon et al. (2021) (preprint)\n\nreported on the long-term effects of COVID-19.26 The most common cardiovascular symptom\n\nwas chest pain (16%; 95% CI: 10–22), followed by tachycardia (11%; 95% CI: 9–14) and\n\npalpitations (11%, 95% CI: 6–17). Follow-up of patients ranged from a mean of 14–110 days\n\npost-viral infection.\n\n\n\nPRIMARY RESEARCH ARTICLES (N=4)\n\n\n\n\n\n\n\n\n\n\n\n\n\nDavis et al. (2020) (preprint) reported on an international web-based survey of 3,767 suspected\n\nand confirmed COVID-19 cases.28 168 days after illness-onset, the most common cardiovascular\n\nsymptoms were palpitations (40.1%; 95% CI: 37.9–44.1), tachycardia (33.7%, 95% CI: 30.8–36.8)\n\nand chest pain (23.7%; 95% CI: 20.7–26.0).\n\nQin et al. (2021), in a prospective cohort study of 647 patients assessed 84 days following\n\nhospital discharge, reported the most persistent symptom was palpitations (10%).47\n\nAnastasio et al. (2021) reported on 595 patients assessed at median of 135 days (IQR: 102–175)\n\nafter the onset of symptoms, with 11.9% of patients reporting chest pain.32\n\nXiong et al. (2021), in a single-centre longitudinal study of 538 survivors, reported on sequelae\n\nexperienced at 97.0 days (IQR: 95.0–102.0) since hospital discharge.14 The most common\n\ncardiovascular sequelae were chest pain (12.3%) and tachycardia (11.2%).\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n7\n\n\n\n\fOther Organ Systems\n\nThe most commonly reported persistent symptoms (among other organ systems) were joint and/or\n\nmuscle pain (range: 19–44%), fever/chills/sweats (12–24%), and gastrointestinal symptoms\n\n(diarrhea/vomiting/nausea/loss of appetite) (12–21%).\n\nFor this section, we included the following systems: immune, endocrine, musculoskeletal, reproductive,\n\nurinary, digestive, metabolic, and integumentary.\n\n\n\nSYSTEMATIC REVIEWS AND META-ANALYSES (N=1)\n\n\n\n\n\nIn a systematic review of 15 articles, Lopez-Leon et al. (2021) (preprint) reported on the longterm effects of COVID-19.26 The most common persistent symptom for other organ systems in\n\nthis review was hair loss (25%; 95% CI: 17–43), followed by arthralgia (19%; 95% CI: 7–34),\n\nsweats (17%; 95% CI: 6–30), nausea/vomiting (16%; 95% CI: 10–23) and weight loss (12%; 95%\n\nCI: 7–18). Follow-up of patients ranged from a mean of 14–110 days post-viral infection.\n\n\n\nPRIMARY RESEARCH ARTICLES (N=6)\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nDavis et al. (2020) (preprint) reported on an international web-based survey of 3,767 suspected\n\nand confirmed COVID-19 cases.28 168 days after illness onset, myalgia (43.7%; 95% CI: 40.6–\n\n46.9) was commonly reported among patients, followed by diarrhea (20.5%, 95% CI: 18.1–23.2),\n\nfever (15.0%) and loss of appetite (13.7%, 95% CI: 11.6–16.0).\n\nIn an ambidirectional cohort study of 1,655 patients in China, Huang et al. (2021) reported on\n\nsequelae at 168 days post-hospitalization, in which 22% reported hair loss.29\n\nIn a prospective observational cohort study in the UK, Sudre et al. (2021) reported on symptoms\n\nthat persisted 28 days or more since illness-onset in 558 patients.18 Reported sequelae included\n\nwere muscle pain (20%), diarrhea (15%), abdominal pain (15%), loss of appetite (13%) and fever\n\n(12%).\n\nXiong et al. (2021), in a single-centre longitudinal study of 538 survivors, reported on sequelae\n\nexperienced at 97.0 days (IQR: 95.0–102.0) since hospital discharge, with 23.6% of patients\n\nreporting sweating.14\n\nIn a population-based prospective cohort study of 431 patients assessed at 7 months (IQR: 6–8)\n\nsince diagnosis, Menges et al. (2021) (preprint) reported 35.3% of patients experienced pain and\n\ndiscomfort.12\n\nIn a prospective cohort study of 277 patients assessed 56–84 days after symptom-onset,\n\nMoreno-Perez et al. (2021) reported that 19.6% of patients experienced myalgia/arthralgia and\n\n10.5% reported diarrhea.15\n\n\n\nRisk Factors\n\nThe primary risk factors for having persistent symptoms during post-acute COVID-19 are the presence\n\nof comorbidities (e.g., obesity, asthma) (6/11 studies), increased disease severity (6/11 studies), and\n\nfemale sex (3/11).\n\nWe reviewed the literature investigating risk factors associated with long-term sequelae. Advanced age,\n\ncomorbidities, hypertension, diabetes and obesity were risk factors for developing severe disease as\n\nwell as for subsequent cognitive decline (Baker et al. 2020).4\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n8\n\n\n\n\fPRIMARY RESEARCH ARTICLES (N=11)\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nRetrospective cohort study and time-to-event analysis of 236,379 patients, Taquet et al. (2021)\n\nreported on neuropsychiatric symptoms in patients assessed 168 after initial diagnosis.27\n\nPatients that were admitted to an ICU or hospitalized had a higher risk of neuropsychiatric\n\nsequelae, compared to outpatients (see article for full account of neuropsychiatric diagnoses\n\nmade). The risk of neuropsychiatric first diagnosis was higher in those admitted to an ICU\n\ncompared to those who were not (hazard ratio [HR]: 2.9; 95% CI: 2.5–3.4).\n\nIn an observational, retrospective, matched cohort study of 47,780 patients, Ayoubkhani et al.\n\n(2021) (preprint) reported 29.4% were readmitted after discharge.48 The risk of respiratory\n\ndisease after discharge was higher for non-white patients (relative risk [RR]: 11.4; 95% CI: 9.8–\n\n13.3) compared to white patients (RR: 5.2; 95% CI: 5.0–5.5). The mean follow-up period was\n\n140±50 days since hospital discharge.\n\nIn a longitudinal cohort study of 2,649 patients, Munblit et al. (2021) (preprint) reported on\n\nassessments performed at a median follow-up time since hospital discharge of 218 days (IQR:\n\n200–236).49 Having pre-existing asthma was associated with an increased risk of persistent\n\nneurological (odds ratio [OR]: 2.0; 95% CI: 1.3–3.0) and mood/behavioural (OR: 2.0; 95% CI: 1.2–\n\n3.2) symptoms (unclear in paper if OR was adjusted for disease severity). Chronic pulmonary\n\ndisease was associated with chronic fatigue (OR: 1.7; 95% CI: 1.2–2.3). Female patients were at\n\ngreater risk of long-term sequelae (all symptom groups).\n\nIn an ambidirectional cohort study of 1,655 patients in China, Huang et al. (2021) reported on\n\nsequelae at 168 days post-hospitalization.29 Comparing those with non-invasive or invasive\n\nventilation to those who did not receive supplementary oxygen, there was a higher risk of\n\npersistent fatigue/muscle weakness (OR: 2.7; 95% CI: 1.5–5.0), difficulty walking (OR: 2.5; 95%\n\nCI: 1.1–5.5), pain (OR: 1.9; 95% CI: 1.2–3.2), anxiety/depression (OR: 1.8; 95% CI: 1.1–3.0), and\n\ndecreased walking distance (OR: 2.2; 95% CI: 1.2–4.0).\n\nQin et al. (2021), in a prospective cohort study of 647 patients assessed 84 days following\n\nhospital discharge, reported there was an increased risk of persistent symptoms as disease\n\nseverity increased (OR: 1.7; 95% CI: 1.1–2.6) and as hospitalization duration increased (OR: 1.0;\n\n95% CI: 1.0–1.1).47\n\nIn a study of 558 patients with symptoms lasting 28 days or more since symptom-onset, Sudre et\n\nal. (2021) reported patients that experienced more than five symptoms during the first week of\n\nillness had a higher risk of persistent symptoms (OR: 3.5; 95% CI: 2.8–4.5).18 The only\n\ncomorbidity that was predictive of persistent symptoms was asthma (OR: 2.1; 95% CI: 1.6–3.0).\n\nIn a population-based prospective cohort study of 431 patients assessed at 7 months (IQR: 6–8)\n\nsince diagnosis, Menges et al. (2021) (preprint) reported in a multivariable analysis that women,\n\nthose with more severe disease, and those with comorbidities were at higher risk of persistent\n\nsymptoms.12\n\n Increased risk of fatigue was associated with younger age (less than 40 years).\n\n Increased risk of shortness of breath body mass index [as associated with being female,\n\nhospitalization during acute infection, higher body mass index and the presence of\n\ncomorbidities.\n\nIn a study of 364 patients assessed 28 days after hospital discharge, Chen et al. (2020) reported\n\nphysical impairment was associated with being non-obese overweight (OR: 3.7; 95% CI: 1.4–9.7)\n\nor obese (OR: 3.9; 95% CI: 1.5–10.5).50 Risk of neuropsychiatric impairment was higher in\n\nfemales (OR: 2.2; 95% CI: 1.3–3.8).\n\nIn a study of 270 patients that responded to a follow-up questionnaire on their recovery 14–21\n\ndays after their initial test, Tenforde et al. (2020) reported an increased risk of sequelae in those\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n9\n\n\n\n\f\n\n\n\n\n\n\n\n>50 years old (adjusted odds ratio [aOR]: 2.3; 95% CI: 1.1–4.6), those with ≥3 underlying\n\nconditions (aOR: 2.3; 95% CI: 1.1–4.9), obesity (body mass index [BMI] >30 kg/m2) (aOR: 2.3;\n\n95% CI: 1.2–4.4) and having a pre-existing psychiatric condition (aOR: 2.3; 95% CI: 1.2–4.6).51\n\nIn a study of 208 patients that have recovered from COVID-19, Pilotto et al. (2021) (preprint)\n\nfollowed up with patients 168 days after initial onset of symptoms.52 Using logistic regression,\n\nthose who were hospitalized longer and with comorbidities were the best predictors of\n\nneurological impairments.\n\nIn a cross-sectional study of 204 patients assessed 84–168 days after hospital discharge, Baricich\n\net al. (2021) reported physical impairment was associated with and increased risk of ICU\n\nadmission and mechanical ventilation (OR: 3.1; 95% CI: 1.3–7.9).53\n\n\n\nImplications\n\nCare for post-acute COVID-19 patients will likely place added stresses on the healthcare and social\n\nsupport systems, including increased emergency department visits, outpatient care, inpatient care and\n\nrehabilitation involving multidisciplinary teams.17,54-56 To date, there is evidence that COVID-19 can lead\n\nto decreased health-related quality of life (e.g., decreased ability to perform daily tasks, reduced\n\ncapacity for physical activity, missing work).15,20,29,57-59 Given the wide variety of persistent symptoms,\n\nguidance is currently being developed for the assessment and management of patients with post-acute\n\nCOVID-19.5 In addition to healthcare implications, there are economic implications for those unable to\n\nwork or new requirements for social supports and disability insurance.\n\nParticular attention is needed for those admitted to ICU because recovery usually involves postintensive care syndrome.60 Hosey et al. (2020) noted that ICU survivors will require help overcoming\n\ncognitive, psychiatric and physical sequelae.60 In a population-based prospective cohort study in\n\nSwitzerland, Menges et al. (2021) (preprint) noted that survivors were more likely to require post-acute\n\ncare, including readmission to hospital, outpatient care and rehabilitation.12 Even in non-hospitalized\n\npatients assessed about 80 days after symptom-onset, continued help with performing daily tasks was\n\ncommon (31%).61\n\nJohnson et al. (2020) recognized that ethnic and racialized communities are more impacted by COVID19, case prevalence and economic hardship.62 In post-acute COVID-19, the authors suggest that more\n\nresources should be provided to racialized communities, given these communities experience higher\n\nrisks from post-intensive care syndrome (persistent neuropsychiatric and cognitive symptoms).\n\nHealthcare workers recovering from COVID-19 and experiencing persistent symptoms can place added\n\nstress on an already fragile healthcare system.63 Praschan et al. (2021) has recognized that post-acute\n\nCOVID-19 needs to be addressed in recovering healthcare workers who may need support to return and\n\nremain in the workplace.64 In a cohort study of 323 seropositive cases (mild disease) and 1,072\n\nseronegative cases in Sweden, Havervall et al. (2021) reported on persistent symptoms in healthcare\n\nworkers. Seropositive cases had a higher risk of moderate to markedly disrupted work life (RR: 1.8; 95%\n\nCI: 1.2–2.9), social life (RR: 2.5; 95% CI: 1.8–3.6) and home life (RR: 2.3; 95% CI: 1.6–3.4).20\n\nThere have been 367,602 diagnosed cases and 7,458 deaths from COVID-19 in Ontario as of April 6\n\n2021.65 Based on numbers from Sudre et al. (2021), 2.3% have persistent symptoms at 84 days, which is\n\nover 8,000 Ontarians with persistent COVID-19-associated symptoms, and growing, which may require\n\nongoing healthcare resources and multidisciplinary support.18\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n10\n\n\n\n\fLimitations\n\nWe should acknowledge that a relatively large proportion (29%) of the research articles in this rapid\n\nreview were non-peer-reviewed, preprint articles. Considering the rapid emergence of the COVID-19\n\npandemic, the volume of pre-print research is expected given the need for rapid dissemination of data.\n\nWe did not check systematic reviews for overlap among reviews in the studies that they included.\n\nFurther, we did not check if our included primary studies were included in the systematic reviews. Thus,\n\nthere is some duplication of findings.\n\nA limitation is that symptoms at baseline or before COVID-19 are unknown, except where comorbidities\n\nwere reported. Without pre-COVID-19 clinical assessments, it is difficult to attribute post-acute\n\nsymptoms solely to COVID-19. As highlighted in the Background, there was no consistent definition of\n\npersistent symptoms. In most studies, it was not possible to determine the proportion of cases that had\n\npersistent symptoms but who had completely recovered, in contrast to those with ongoing symptoms\n\nfrom a lack of complete recovery from infection.\n\nIt remains unclear the extent to which some persistent neuropsychiatric symptoms are due to public\n\nhealth measures (lockdowns, physical distancing) rather than infection itself; further case-control\n\nstudies would help disentangle the contribution of public health measures and infection to persistent\n\nsymptoms. Most studies used subjective assessments of symptoms, which may be limited by recall bias.\n\nIn addition, ICU admission, invasive mechanical ventilation, corticosteroids, and other medical\n\ntreatments may contribute to persistent symptoms in recovering patients, and not necessarily due to\n\ninfection itself. Self-selection bias was likely to occur in studies where people more concerned with their\n\nhealth may have participated, potentially inflating symptom prevalence. In addition, the majority of\n\npatients studied were hospitalized and likely had more severe disease, leading to higher prevalence of\n\npersistent symptoms. The numbers presented in this review may not be generalizable to all COVID-19\n\npatients.\n\n\n\nConclusions\n\nThe literature identified that a significant proportion of people experience post-acute COVID-19. The\n\nmost commonly reported persistent symptoms were neuropsychiatric or respiratory in nature; however,\n\nthe results were highly heterogeneous. Neuropsychiatric sequelae following illness, including other\n\nviruses has been previously described. For example, following historical influenza pandemics, Severe\n\nAcute Respiratory Syndrome (SARS, caused by SARS-CoV-1) and Middle East Respiratory Syndrome\n\n(MERS, MERS-CoV) pandemics, common long-term consequences included delirium, psychosis and\n\nanxiety.3,66 Sullivan (2021) noted that SARS and MERS left patients with fatigue, shortness of breath,\n\ndecreased quality of life and mental health problems, and suggested that planning is required for the\n\ncurrent pandemic to address rehabilitation needs of survivors.67\n\nCurrently, there are a number of longitudinal studies underway to better characterise post-acute COVID19, leading to better guidance on managing patients with persistent symptoms. For example, in a\n\nviewpoint article, del Rio et al. (2020) stated “Longer-ranging longitudinal observational studies and\n\nclinical trials will be critical to elucidate the durability and depth of health consequences attributable to\n\nCOVID-19 and how these may compare with other serious illnesses.”8 In addition to longitudinal studies,\n\nresearch should focus on comparing symptoms present before and after infection, distinguishing\n\npersistent symptoms from chronic symptoms. To better plan and prepare health and social services for\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n11\n\n\n\n\frecovering patients, there is a need to study the factors contributing to increased risk of developing\n\npersistent symptoms, including how post-acute COVID-9 affects racialized communities. A central part of\n\nunderstanding the long-term sequelae is a unified definition of post-acute or long COVID-19.\n\nOn February 23, 2021, the National Institutes of Health (NIH) announced a study of the causes of longCOVID, in which they hope to improve prevention and treatment of persistent symptoms.68 The NIH-led\n\nstudy looks to address the following questions:\n\n\n\n\n\n\n\n\n\n\n\n\n\nWhat does the spectrum of recovery from SARS-CoV-2 infection look like across the population?\n\nHow many people continue to have symptoms of COVID-19, or even develop new symptoms,\n\nafter acute SARS-CoV-2 infection?\n\nWhat is the underlying biological cause of these prolonged symptoms?\n\nWhat makes some people vulnerable to this but not others?\n\nDoes SARS-CoV-2 infection trigger changes in the body that increase the risk of other conditions,\n\nsuch as chronic heart or brain disorders?\n\n\n\nGuidance for managing the symptoms of post-acute COVID-19 is emerging. George et al. (2020)\n\ndeveloped a guidance document outlining considerations in the respiratory follow-up of patients\n\ndischarged after COVID-19 pneumonia.37 Shah et al. (2021) have summarized guidance for managing\n\nthose with post-acute COVID-19, as developed by The National Institute for Health and Care Excellence,\n\nthe Scottish Intercollegiate Guidelines Network, and the Royal College of General Practitioners.9\n\nWe expect, based on the emerging available data, that post-acute COVID-19 will impact the physical and\n\nmental health of a substantial proportion of Ontario’s population as well as impact healthcare system\n\nresources in the coming years.\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n12\n\n\n\n\fReferences\n\n1. Ontario Agency for Health Protection and Promotion (Public Health Ontario). Long-term sequelae and\n\nCOVID-19 – what we know so far [Internet]. Toronto, ON: Queen’s Printer for Ontario; 2020 [cited\n\n2021 Apr 12]. Available from: https://www.publichealthontario.ca/-/media/documents/ncov/covidwwksf/2020/07/what-we-know-covid-19-long-term-sequelae.pdf\n\n2. Ontario Agency for Health Protection and Promotion (Public Health Ontario). COVID-19 overview of\n\nthe period of communicability – what we know so far [Internet]. Toronto, ON: Queen’s Printer for\n\nOntario; 2021 [cited 2021 Apr 12]. Available from: https://www.publichealthontario.ca//media/documents/ncov/covid-wwksf/2021/03/wwksf-period-of-communicabilityoverview.pdf?la=en\n\n3. Butler M, Pollak TA, Rooney AG, Michael BD, Nicholson TR. Neuropsychiatric complications of COVID19. BMJ. 2020;371:m3871. Available from: https://doi.org/10.1136/bmj.m3871\n\n4. Baker HA, Safavynia SA, Evered LA. The 'third wave': impending cognitive and functional decline in\n\nCOVID-19 survivors. Br J Anaesth. 2021;126(1):44-7. Available from:\n\nhttps://doi.org/10.1016/j.bja.2020.09.045\n\n5. Greenhalgh T, Knight M, A'Court C, Buxton M, Husain L. 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Disparities in the recovery from critical illness\n\ndue to COVID-19. Lancet Psychiatry. 2020;7(8):e54-5. Available from: https://doi.org/10.1016/s22150366(20)30292-3\n\n63. Ladds E, Rushforth A, Wieringa S, Taylor S, Rayner C, Husain L, et al. Developing services for long\n\nCOVID: lessons from a study of wounded healers. Clin Med. 2021;21(1):59-65. Available from:\n\nhttps://doi.org/10.1101/2020.11.13.20231555\n\n64. Praschan N, Josephy-Hernandez S, Kim DD, Kritzer MD, Mukerji S, Newhouse A, et al. Implications of\n\nCOVID-19 sequelae for health-care personnel. Lancet Respir Med. 2021;9(3):230-1. Available from:\n\nhttps://doi.org/10.1016/S2213-2600(20)30575-0\n\n65. Ontario Agency for Health Protection and Promotion (Public Health Ontario). Daily epidemiologic\n\nsummary: COVID-19 in Ontario – January 15, 2020 to April 5, 2021 [Internet]. Toronto, ON: Queen’s\n\nPrinter for Ontario; 2021 [cited 2021 Apr 12]. Available from: https://www.publichealthontario.ca//media/documents/ncov/epi/covid-19-daily-epi-summary-report.pdf?la=en\n\n66. Stefano GB. Historical insight into infections and disorders associated with neurological and\n\npsychiatric sequelae similar to long COVID. Med Sci Monit. 2021;27:e931447. Available from:\n\nhttps://doi.org/10.12659/msm.931447\n\n67. O'Sullivan O. Long-term sequelae following previous coronavirus epidemics. Clin Med. 2021;21:e6870. Available from: https://doi.org/10.7861/clinmed.2020-0204\n\n68. National Institutes of Health (NIH). NIH launches new initiative to study “Long COVID” [Internet].\n\nBethesda, MD: National Institutes of Health; 2021 [cited 2021 Mar 23]. Available from:\n\nhttps://www.nih.gov/about-nih/who-we-are/nih-director/statements/nih-launches-new-initiativestudy-long-covid\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n18\n\n\n\n\fAppendix A. Study characteristics of included studies\n\nStudy first\n\nauthor\n\n\n\nStudy\n\ncountry\n\n\n\nStudy population\n\nduring acute\n\nstage\n\n\n\nPatient age*\n\n\n\n% female\n\npatients\n\n\n\nWas there an\n\nobjective assessment\n\nof symptoms?\n\n\n\nAnastasio\n\n\n\nItaly\n\n\n\nMixed\n\n\n\n55 (IQR: 49–\n\n63)\n\n\n\n44.1\n\n\n\nYes\n\n\n\nAyoubkhani\n\n\n\nEngland\n\n\n\nInpatient\n\n\n\n64.5±19.2\n\n\n\n45.1\n\n\n\nYes\n\n\n\nBaricich\n\n\n\nItaly\n\n\n\nInpatient\n\n\n\n57.9±12.8\n\n\n\n40.0\n\n\n\nYes\n\n\n\nChen KY\n\n\n\nMultiple\n\n\n\nMixed\n\n\n\nNot reported\n\n\n\nNot\n\nreported\n\n\n\nMixed\n\n\n\nChiesa‐\n\nEstomba\n\n\n\nMultiple\n\n\n\nMixed\n\n\n\n41±13\n\n\n\n63.5\n\n\n\nMixed\n\n\n\nCOMEBAC\n\n\n\nFrance\n\n\n\nInpatient\n\n\n\n61±16\n\n\n\n57.9\n\n\n\nMixed\n\n\n\nDavis\n\n\n\nMultiple\n\n\n\nMixed\n\n\n\n>17\n\n\n\n78.9\n\n\n\nNo\n\n\n\nHavervall\n\n\n\nSweden\n\n\n\nOutpatient\n\n\n\nVaried by\n\ngroup\n\n\n\nVaried by\n\ngroup\n\n\n\nMixed\n\n\n\nHuang\n\n\n\nChina\n\n\n\nInpatient\n\n\n\n57 (IQR: 47–\n\n65)\n\n\n\n48.2\n\n\n\nYes\n\n\n\nKunutsor\n\n\n\nMultiple\n\n\n\nInpatient\n\n\n\nRange: 53–\n\n71\n\n\n\nNot\n\nreported\n\n\n\nYes\n\n\n\nLechien\n\n\n\nFrance\n\n\n\nInpatient\n\n\n\n41±13\n\n\n\n64.9\n\n\n\nYes\n\n\n\nLopez-Leon\n\n\n\nMultiple\n\n\n\nMixed\n\n\n\nRange: 17–\n\n87\n\n\n\nNot\n\nreported\n\n\n\nNo\n\n\n\nMandal\n\n\n\nEngland\n\n\n\nInpatient\n\n\n\n59.9±16.1\n\n\n\n38.0\n\n\n\nNo\n\n\n\nMenges\n\n\n\nSwitzerland\n\n\n\nMixed\n\n\n\n47 (IQR: 33–\n\n58)\n\n\n\n50.0\n\n\n\nMixed\n\n\n\nMichelen\n\n\n\nMultiple\n\n\n\nMixed\n\n\n\nMean range:\n\n37.7–73.9\n\n\n\nNot\n\nreported\n\n\n\nMixed\n\n\n\nMorenoPerez\n\n\n\nSpain\n\n\n\nMixed\n\n\n\n62 (IQR: 53–\n\n72)\n\n\n\n47.3\n\n\n\nYes\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n19\n\n\n\n\fStudy first\n\nauthor\n\n\n\nStudy\n\ncountry\n\n\n\nStudy population\n\nduring acute\n\nstage\n\n\n\nPatient age*\n\n\n\n% female\n\npatients\n\n\n\nWas there an\n\nobjective assessment\n\nof symptoms?\n\n\n\nMunblit\n\n\n\nRussia\n\n\n\nInpatient\n\n\n\n56 (IQR: 46–\n\n66)\n\n\n\n51.1\n\n\n\nMixed\n\n\n\nPilotto\n\n\n\nItaly\n\n\n\nInpatient\n\n\n\n64.8±12.6\n\n\n\n30.3\n\n\n\nYes\n\n\n\nQin\n\n\n\nChina\n\n\n\nInpatient\n\n\n\n58±15\n\n\n\n56.0\n\n\n\nYes\n\n\n\nSudre\n\n\n\nMultiple\n\n\n\nMixed\n\n\n\n42 (IQR: 32–\n\n53)\n\n\n\n71.5\n\n\n\nNo\n\n\n\nTaquet\n\n\n\nUSA\n\n\n\nMixed\n\n\n\n46±19.7\n\n\n\n55.6\n\n\n\nNo\n\n\n\nTenforde\n\n\n\nUSA\n\n\n\nMixed\n\n\n\n43 (IQR: 31–\n\n54)\n\n\n\n51.8\n\n\n\nNo\n\n\n\nTorresCastro\n\n\n\nMultiple\n\n\n\nMixed\n\n\n\nAverage:\n\n46.7–69.1\n\n\n\n46.0\n\n\n\nYes\n\n\n\nTrinkmann\n\n\n\nGermany\n\n\n\nMixed\n\n\n\n48±15\n\n\n\n56.1\n\n\n\nYes\n\n\n\nVenturelli\n\n\n\nItaly\n\n\n\nInpatient\n\n\n\n63±13.6\n\n\n\n32.9\n\n\n\nYes\n\n\n\nXiong\n\n\n\nChina\n\n\n\nInpatient\n\n\n\n52 (IQR: 41–\n\n62)\n\n\n\n54.5\n\n\n\nNo\n\n\n\n*Means reported with standard deviation; IQR, interquartile range\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n20\n\n\n\n\fCitation\n\nOntario Agency for Health Protection and Promotion (Public Health Ontario). Persistent symptoms and\n\npost-acute COVID-19 in adults – what we know so far. Toronto, ON: Queen’s Printer for Ontario; 2021.\n\n\n\nDisclaimer\n\nThis document was developed by Public Health Ontario (PHO). PHO provides scientific and technical\n\nadvice to Ontario’s government, public health organizations and health care providers. PHO’s work is\n\nguided by the current best available evidence at the time of publication.\n\nThe application and use of this document is the responsibility of the user. PHO assumes no liability\n\nresulting from any such application or use.\n\nThis document may be reproduced without permission for non-commercial purposes only and provided\n\nthat appropriate credit is given to PHO. No changes and/or modifications may be made to this document\n\nwithout express written permission from PHO.\n\n\n\nPublic Health Ontario\n\nPublic Health Ontario is an agency of the Government of Ontario dedicated to protecting and promoting\n\nthe health of all Ontarians and reducing inequities in health. Public Health Ontario links public health\n\npractitioners, front-line health workers and researchers to the best scientific intelligence and knowledge\n\nfrom around the world.\n\nFor more information about PHO, visit publichealthontario.ca.\n\n\n\n©Queen’s Printer for Ontario, 2021\n\n\n\nPersistent Symptoms and Post-Acute COVID-19 in Adults – What We Know So Far\n\n\n\n21\n\n\n\n\f",
          "document_id": 450699
        }
      ]
    },
    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "What are  Acute COVID symptoms?",
              "id": 279026,
              "answers": [
                {
                  "answer_id": 274942,
                  "document_id": 450701,
                  "question_id": 279026,
                  "text": "Acute COVID symptoms\n\ninclude fever, throat pain, cough, muscle or body aches, loss of taste\n\nor smell and diarrhea.",
                  "answer_start": 2326,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the symptoms and signs of Long-COVID?",
              "id": 279025,
              "answers": [
                {
                  "answer_id": 274939,
                  "document_id": 450701,
                  "question_id": 279025,
                  "text": "Fatigue, cough, chest tightness, breathlessness, palpitations, myalgia and difficulty to focus are\n\nsymptoms reported in long COVID.",
                  "answer_start": 1046,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are six clusters of symptoms identified by the COVID Symptom Study group?",
              "id": 279027,
              "answers": [
                {
                  "answer_id": 274943,
                  "document_id": 450701,
                  "question_id": 279027,
                  "text": "COVID Symptom Study group identified six clusters of symptoms [3]. They are:\n\n\u0001 “Flu-like” with no feverdheadache, loss of smell, muscle pains,\n\ncough, sore throat, chest pain, no fever\n\n\u0001 “Flu-like” with feverdheadache, loss of smell, cough, sore\n\nthroat, hoarseness, fever, loss of appetite\n\n\u0001 Gastrointestinaldheadache, loss of smell, loss of appetite,\n\ndiarrhea, sore throat, chest pain, no cough\n\n\u0001 Severe level one, fatiguedheadache, loss of smell, cough, fever,\n\nhoarseness, chest pain, fatigue\n\n\u0001 Severe level two, confusiondheadache, loss of smell, loss of\n\nappetite, cough, fever, hoarseness, sore throat, chest pain, fatigue, confusion, muscle pain\n\n\u0001 Severe level three, abdominal and respiratorydheadache, loss\n\nof smell, loss of appetite, cough, fever, hoarseness, sore throat,\n\nchest pain, fatigue, confusion, muscle pain, shortness of breath,\n\ndiarrhea, abdominal pain\n",
                  "answer_start": 3086,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is long COVID?",
              "id": 279028,
              "answers": [
                {
                  "answer_id": 274938,
                  "document_id": 450701,
                  "question_id": 279028,
                  "text": "The term long COVID was first used by Perego in social media to\n\ndenote persistence of symptoms weeks or months after initial\n\nSARS-CoV-2 infection and the term ‘long haulers’ was used by\n\nWatson and by Yong",
                  "answer_start": 4957,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are  Risk factors for long COVID?",
              "id": 279029,
              "answers": [
                {
                  "answer_id": 274940,
                  "document_id": 450701,
                  "question_id": 279029,
                  "text": "he risk of long COVID is twice common in women\n\ncompared to men [9]. Increasing age is also a risk factor and it is\n\nfound that patients with long COVID are around four years older\n\nthan those without [9]. Presence of more than 5 symptoms in the\n\nacute stage of illness is associated with increased risk of developing\n\nlong COVID [20]. Symptoms most commonly associated with long\n\nCOVID include fatigue, headache, dyspnea, hoarse voice and\n\nmyalgia [20]. Presence of co morbidities also increases the risk of\n\ndeveloping post COVID syndrome. Even those with mild symptoms\n\nat initial presentation were noted to develop long COVID.",
                  "answer_start": 10524,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is Profound fatigue in the context of Long-Covid?",
              "id": 279030,
              "answers": [
                {
                  "answer_id": 274937,
                  "document_id": 450701,
                  "question_id": 279030,
                  "text": "Profound fatigue is a common problem and one study showed\n\nthat at 10 weeks of follow up after SARS-CoV-2 infection; more than\n\n50% of people were suffering from fatigue. ",
                  "answer_start": 12109,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are minor symptoms of long-COVID?",
              "id": 279031,
              "answers": [
                {
                  "answer_id": 274941,
                  "document_id": 450701,
                  "question_id": 279031,
                  "text": "cough, pain, myalgia can be treated symptomatically with paracetamol, cough suppressants and oral antibiotics (if secondary\n\nbacterial infection is suspected).",
                  "answer_start": 18686,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            }
          ],
          "context": "Diabetes & Metabolic Syndrome: Clinical Research & Reviews 15 (2021) 869e875\n\n\n\nContents lists available at ScienceDirect\n\n\n\nDiabetes & Metabolic Syndrome: Clinical Research & Reviews\n\njournal homepage: www.elsevier.com/locate/dsx\n\n\n\nLong COVID: An overview\n\nA.V. Raveendran a, b, *, Rajeev Jayadevan c, S. Sashidharan d\n\na\n\n\n\nGovt. Medical College, Manjeri,Kottayam, Kozhikode, Kerala, India\n\nSpecialist in Internal Medicine, Badr Al Samaa, Barka, Oman\n\nc\n\nSunrise Hospital, Kakkanad, Kerala, India\n\nd\n\nKoyas Hospital, Kozhikode, Kerala, India\n\nb\n\n\n\na r t i c l e i n f o\n\n\n\na b s t r a c t\n\n\n\nArticle history:\n\nReceived 9 March 2021\n\nReceived in revised form\n\n26 March 2021\n\nAccepted 6 April 2021\n\n\n\nBackground and aims: Long COVID is the collective term to denote persistence of symptoms in those who\n\nhave recovered from SARS-CoV-2 infection.\n\nMethods: WE searched the pubmed and scopus databases for original articles and reviews. Based on the\n\nsearch result, in this review article we are analyzing various aspects of Long COVID.\n\nResults: Fatigue, cough, chest tightness, breathlessness, palpitations, myalgia and difficulty to focus are\n\nsymptoms reported in long COVID. It could be related to organ damage, post viral syndrome, post-critical\n\ncare syndrome and others. Clinical evaluation should focus on identifying the pathophysiology, followed\n\nby appropriate remedial measures. In people with symptoms suggestive of long COVID but without\n\nknown history of previous SARS-CoV-2 infection, serology may help confirm the diagnosis.\n\nConclusions: This review will helps the clinicians to manage various aspects of Long COVID.\n\n© 2021 Diabetes India. Published by Elsevier Ltd. All rights reserved.\n\n\n\nKeywords:\n\nLong COVID”\n\n“Long haulers”\n\n“Post COVID syndrome”\n\n\n\n1. Introduction\n\nSARS-CoV-2 infection (COVID-19) is a major pandemic resulting\n\nin substantial mortality and morbidity worldwide. Of the individuals affected, about 80% had mild to moderate disease and\n\namong those with severe disease, 5% develop critical illness [1]. A\n\nfew of those who recovered from COVID-19 develop persistent or\n\nnew symptoms lasting weeks or months; this is called “long\n\nCOVID”, “Long Haulers” or “Post COVID syndrome.”\n\n1.1. Acute COVID\n\nThose infected with SARS-CoV-2 virus commonly develop\n\nsymptoms 4e5 days after exposure. Acute COVID symptoms\n\ninclude fever, throat pain, cough, muscle or body aches, loss of taste\n\nor smell and diarrhea. A study from England, Wales and Scotland\n\nidentified three clusters of symptoms during acute illness [2]. They\n\nare.\n\n\u0001 respiratory symptom cluster: with cough, sputum, shortness of\n\nbreath, and fever;\n\n\n\n* Corresponding author. Govt. Medical College, Manjeri,Kottayam, Kozhikode,\n\nKerala, India.\n\nE-mail address: raveendranav@yahoo.co.in (A.V. Raveendran).\n\nhttps://doi.org/10.1016/j.dsx.2021.04.007\n\n1871-4021/© 2021 Diabetes India. Published by Elsevier Ltd. All rights reserved.\n\n\n\n\u0001 musculoskeletal symptom cluster: with myalgia, joint pain,\n\nheadache, and fatigue\n\n\u0001 enteric symptom cluster: with abdominal pain, vomiting, and\n\ndiarrhea\n\nCOVID Symptom Study group identified six clusters of symptoms [3]. They are:\n\n\u0001 “Flu-like” with no feverdheadache, loss of smell, muscle pains,\n\ncough, sore throat, chest pain, no fever\n\n\u0001 “Flu-like” with feverdheadache, loss of smell, cough, sore\n\nthroat, hoarseness, fever, loss of appetite\n\n\u0001 Gastrointestinaldheadache, loss of smell, loss of appetite,\n\ndiarrhea, sore throat, chest pain, no cough\n\n\u0001 Severe level one, fatiguedheadache, loss of smell, cough, fever,\n\nhoarseness, chest pain, fatigue\n\n\u0001 Severe level two, confusiondheadache, loss of smell, loss of\n\nappetite, cough, fever, hoarseness, sore throat, chest pain, fatigue, confusion, muscle pain\n\n\u0001 Severe level three, abdominal and respiratorydheadache, loss\n\nof smell, loss of appetite, cough, fever, hoarseness, sore throat,\n\nchest pain, fatigue, confusion, muscle pain, shortness of breath,\n\ndiarrhea, abdominal pain\n\nRecovery from mild SARS-CoV-2 infection commonly occurs\n\n\n\n\fDiabetes & Metabolic Syndrome: Clinical Research & Reviews 15 (2021) 869e875\n\n\n\nA.V. Raveendran, R. Jayadevan and S. Sashidharan\n\n\n\nsymptoms in those who had never checked for COVID is a challenge\n\n[12]. Similarly, residual symptoms in those checked negative for\n\nCOVID (false negative as testing may be done too early or too late in\n\nthe disease course) may also add to diagnostic dilemma [13].\n\nAntibody response to infection also varies and about 20% does not\n\nseroconvert. Antibody level may decrease over time challenging the\n\nretrospective diagnosis of recent SARS-CoV-2 infection [14,15].\n\n\n\nwithin 7e10 days after the onset of symptoms in mild disease; it\n\ncould take 3e6 weeks in severe/critical illness [4]. However,\n\ncontinued follow up of patients who recovered from COVID-19\n\nshowed that one or more symptoms persist in a substantial percentage of people, even weeks or months after COVID-19.\n\n1.2. “Long COVID”\n\nThe term long COVID was first used by Perego in social media to\n\ndenote persistence of symptoms weeks or months after initial\n\nSARS-CoV-2 infection and the term ‘long haulers’ was used by\n\nWatson and by Yong [5e7].\n\n“Long COVID” is a term used to describe presence of various\n\nsymptoms, even weeks or months after acquiring SARS-CoV-2\n\ninfection irrespective of the viral status [8]. It is also called “postCOVID syndrome”. It can be continuous or relapsing and remitting\n\nin nature [9]. There can be the persistence of one or more symptoms of acute COVID, or appearance of new symptoms. Majority of\n\npeople with post-COVID syndrome are PCR negative, indicating\n\nmicrobiological recovery. In other words, post COVID syndrome is\n\nthe time lag between the microbiological recovery and clinical recovery [10]. Majority of those with long COVID show biochemical\n\nand radiological recovery. Depending upon the duration of symptoms, post COVID or Long COVID can be divided into two stagespost acute COVID where symptoms extend beyond 3 weeks, but\n\nless than 12 weeks, and chronic COVID where symptoms extend\n\nbeyond 12 weeks [11]. (Fig. 1).\n\nThus, among people infected with SARS-CoV-2 the presence of\n\none or more symptoms (continuous or relapsing and remitting;\n\nnew or same symptoms of acute COVID) even after the expected\n\nperiod of clinical recovery, irrespective of the underlying mechanism, is defined as post COVID syndrome or Long COVID.\n\nThere are several challenges in the diagnosis of long COVID. The\n\ntime taken for the clinical recovery varies depending upon the\n\nseverity of illness; while associated complications make it difficult\n\nto define the cut-off time for the diagnosis. A significant proportion\n\nof SARS-CoV-2 infected individuals are asymptomatic, and many\n\nindividuals would not have undergone any test to confirm SARSCoV-2 infection. If these individuals develop multiple symptoms\n\nsubsequently, making a diagnosis of long COVID without a preceding evidence of SARS-CoV-2 infection is challenging. The testing\n\npolicy varies in different countries and it is a common practice\n\nduring a pandemic to diagnose clinically based on symptoms\n\nwithout any confirmatory tests. Therefore, persistence of\n\n\n\n1.3. “Long COVID”-real world scenario\n\nA report from Italy found that 87% of people recovered and\n\ndischarged from hospitals showed persistence of at least one\n\nsymptom even at 60 days [16]. Of these 32% had one or two\n\nsymptoms, where as 55% had three or more. Fever or features of\n\nacute illness was not seen in these patients. The commonly reported problems were fatigue (53.1%), worsened quality of life\n\n(44.1%), dyspnoea (43.4%), joint pain, (27.3%) and chest pain (21.7%).\n\nCough, skin rashes, palpitations, headache, diarrhea, and ‘pins and\n\nneedles’ sensation were the other symptoms reported. Patients also\n\nreported inability to do routine daily activities, in addition to\n\nmental health issues such as anxiety, depression and posttraumatic stress disorder.\n\nAnother study found that COVID-19 patients discharged from\n\nhospital experience breathlessness and excessive fatigue even at 3\n\nmonths [17].\n\nThe prevalence of residual symptoms is about 35% in patients\n\ntreated for COVID-19 on outpatient basis, but around 87% among\n\ncohorts of hospitalized patients [16,18].\n\nThe percentage of people, who failed to return to their job at\n\n14e21 days after becoming COVID positive, was 35% according to\n\none survey [18]. It is more common in older age groups (26% in\n\n18e34 years, 32% in 35e49 years and 47% in 50 years and above),\n\nand among those with co morbidities (28% with nil or one comorbidity, 46% with two and 57% with three or more co morbidities). Obesity (BMI>30) and presence of psychiatric conditions\n\n(anxiety disorder, depression, posttraumatic stress disorder, paranoia, obsessive-compulsive disorder and schizophrenia) are associated with greater than two-fold odds of not returning to job by\n\n14e21 days after a positive result [18]. Fever and chills present in\n\nthe acute stage of infection resolved in 97% and 96% of individuals\n\nrespectively. But cough, fatigue and shortness of breath did not\n\nresolve in 43%, 35% and 29% of patients during interview. Loss of\n\ntaste and loss of smell took longer duration for resolution (8 days).\n\nAs per a recent meta analysis the 5 most common manifestations of\n\n\n\nFig. 1. Classification of long COVID.\n\n870\n\n\n\n\fDiabetes & Metabolic Syndrome: Clinical Research & Reviews 15 (2021) 869e875\n\n\n\nA.V. Raveendran, R. Jayadevan and S. Sashidharan\n\n\n\nLong COVID-19 were fatigue (58%), headache (44%), attention disorder (27%), hair loss (25%), dyspnea (24%) [19].\n\nAmong patients admitted to critical care unit who were on\n\nventilator for a prolonged time, residual symptoms are common.\n\nHowever, COVID patients who had mild disease also report not\n\nregaining their pre-COVID health status, effectively questioning the\n\nterminology of “mild” disease.\n\n\n\nsymptoms [26e28]. The social and financial impact of COVID-19\n\nalso contributes to post COVID issues including psychological issues. Differentiating residual symptoms from re-infection is\n\nimportant in the public health perspective. Persistently elevated\n\ninflammatory markers point towards chronic persistence of\n\ninflammation. It is helpful to remember that in any patient, multiple mechanisms may contribute to long COVID symptoms.\n\n\n\n1.4. Risk factors for long COVID\n\n\n\n1.6. Common symptoms in “Long COVID”\n\n\n\nFollow up of patients recovered from COVID identified a few\n\nfactors which are commonly associated with development of long\n\nCOVID. The risk of long COVID is twice common in women\n\ncompared to men [9]. Increasing age is also a risk factor and it is\n\nfound that patients with long COVID are around four years older\n\nthan those without [9]. Presence of more than 5 symptoms in the\n\nacute stage of illness is associated with increased risk of developing\n\nlong COVID [20]. Symptoms most commonly associated with long\n\nCOVID include fatigue, headache, dyspnea, hoarse voice and\n\nmyalgia [20]. Presence of co morbidities also increases the risk of\n\ndeveloping post COVID syndrome. Even those with mild symptoms\n\nat initial presentation were noted to develop long COVID.\n\n\n\nCommon symptoms in people with “Long COVID” are profound\n\nfatigue, breathlessness, cough, chest pain, palpitations, headache,\n\njoint pain, myalgia and weakness, insomnia, pins and needles,\n\ndiarrhea, rash or hair loss, impaired balance and gait, neurocognitive issues including memory and concentration problems\n\nand worsened quality of life. In people with “Long COVID” one or\n\nmore symptoms may be present.\n\nResearchers identified two main patterns of symptoms in people\n\nwith long COVID: they are 1) fatigue, headache and upper respiratory complaints (shortness of breath, sore throat, persistent\n\ncough and loss of smell) and 2) multi-system complaints including\n\nongoing fever and gastroenterological symptoms [20]. Survivor\n\nCorps report shows that 26.5% of people with Long COVID experienced painful symptoms [27-PP45] [29]. In patients with long\n\nCOVID some of the symptoms are first reported 3e4 weeks after the\n\nonset of acute symptoms [20].\n\nProfound fatigue is a common problem and one study showed\n\nthat at 10 weeks of follow up after SARS-CoV-2 infection; more than\n\n50% of people were suffering from fatigue. There was no association\n\nbetween development of fatigue, COVID-19 severity and level of\n\ninflammatory markers. Female sex and diagnosis of depression/\n\nanxiety is more common in those with fatigue [30]. Post viral fatigues are commonly reported in people with viral infections like\n\nEBV, Ebola, influenza, SARS and MERS. In the absence of any other\n\nreason, if fatigue persists for 6 months or longer it is called chronic\n\nfatigue syndrome. Up to 40% of patients who recovered from SARS\n\nof 2003 have chronic fatigue. The presence of chronic oxidative and\n\nnitrosative stress, low-grade inflammation and impaired heat\n\n\n\n1.5. Pathophysiology of “Long COVID”\n\nThe exact mechanism behind the persistence of symptoms has\n\nto be identified. Reason for the persistence of symptoms can be the\n\nsequelae of organ damage, varying extent of injury (organ damage)\n\nand varying time required for the recovery of each organ system,\n\npersistence of chronic inflammation (convalescent phase) or immune response/auto antibody generation, rare persistence of virus\n\nin the body, nonspecific effect of hospitalization, sequelae of critical\n\nillness, post-intensive care syndrome, complications related to\n\ncorona infection or complications related to co morbidities or\n\nadverse effects of medications used [21,22].(Fig. 2) Persistence of\n\ninfection can be due to persistent viremia in people with altered\n\nimmunity, re-infection or relapse [23e25]. Deconditioning, psychological issues like post-traumatic stress also contribute to\n\n\n\nFig. 2. Various pathophysiological mechanism of “Long COVID”.\n\n871\n\n\n\n\fDiabetes & Metabolic Syndrome: Clinical Research & Reviews 15 (2021) 869e875\n\n\n\nA.V. Raveendran, R. Jayadevan and S. Sashidharan\n\n\n\nLong COVID can be divided into different categories depending\n\nupon the predominant residual symptoms as post COVID cardiorespiratory syndrome, post COVID fatigue syndrome and post\n\nCOVID neuro-psychiatric syndrome [13,41,42]. (See Table 1). Categorization of symptoms according to the organ system involved\n\nwill help to identify the etiology. For example, in people with\n\nbreathlessness, evaluation mainly focuses on cardiac and respiratory system involvement. Severe fatigue necessitates ruling out\n\ncommon causes like anemia, hyperglycemia, electrolyte imbalance\n\nand hypothyroidism, depending upon the clinical scenario. Any\n\nnew onset symptoms after recovery from COVID-19 should be\n\nproperly addressed to rule out life threatening complications such\n\nas pneumothorax, pulmonary embolism, coronary artery disease\n\nand stroke (see Table 1).\n\nDuring each visit, the overall improvement in symptoms can be\n\nassessed by using score of 0e10, where 0 represents no improvement, and 10 represents complete recovery. In patients with multiple symptoms, each symptom can be documented using a similar\n\nscore. Overall functional status improvement and overall\n\nimprovement in mental wellbeing can also be represented by a\n\nscore of 0e10 (see Table 2). Appearance of new symptoms can also\n\nbe assessed by a score of 0e10, with a prefix of “N\" to indicate new\n\nsymptoms. Enquiring about the patient’s health and functional\n\nstatus before SARS-CoV-2 infection helps to understand the impact\n\nof long COVID.\n\n\n\nshock protein production were among the proposed mechanisms\n\nfor muscle fatigue. Profound fatigue is a challenge not only to the\n\npatient but also the healthcare provider, as there are no objective\n\nmethods to diagnose it with certainty. Disruption of trust in the\n\ndoctor-patient relationship can occur in such settings [31].\n\nInfection with SARS-CoV-2 can leads to various pulmonary\n\ncomplications like chronic cough, fibrotic lung disease (post-COVID\n\nfibrosis or post-ARDS fibrosis), bronchiectasis, and pulmonary\n\nvascular disease [32]. Chronic shortness of breath could be the\n\nresult of residual pulmonary involvement, which is known to clear\n\nslowly with time. Unfortunately, many asymptomatic patients with\n\nCOVD-19 have significant lung involvement, as shown on CT scans.\n\nCOVID-19 may lead to pulmonary fibrosis, which can result in\n\npersistence of dyspnea and need for supplementary oxygen.\n\nCommon cardiac issues in patients from COVID 19 include labile\n\nheart rate and blood pressure responses to activity, myocarditis and\n\npericarditis, impaired myocardial flow reserve from micro vascular\n\ninjury, myocardial infarction, cardiac failure, life-threatening arrhythmias and sudden cardiac death. Coronary artery aneurysm,\n\naortic aneurysm, accelerated atherosclerosis, venous and arterial\n\nthromboembolic disease including life threatening pulmonary\n\nembolism can also occur [33]. Several of these may manifest as\n\nLong-COVID after recovery from acute illness.\n\nPresence of SARS-CoV-2 in CSF shows its neuro-invasive features and there is possible disruption to micro-structural and\n\nfunctional brain integrity in patients recovered from COVID-19\n\n[34,35]. Headache, tremor, problem with attention and concentration; cognitive blunting (“brain fog”), dysfunction in the peripheral\n\nnerves; and mental health problems like anxiety, depression and\n\nPTSD are common in people with long COVID. Neuropsychiatric\n\nmanifestations of COVID-19 have been documented in a British\n\nstudy. Stroke and altered mental status were the commonest\n\namong this group. Multiple psychiatric symptoms stemming from\n\nencephalopathy or encephalitis and primary psychiatric diagnoses,\n\nwere noted commonly in young patients [36]. Acquired focal or\n\nmultifocal peripheral nerve injury (PNI) was noticed in those who\n\nreceived prone ventilation for COVID related ARDS [37]. Critical\n\nillness and prolonged mechanical ventilation due to any cause can\n\nresults in ICU-acquired weakness, deconditioning, myopathies,\n\nneuropathies and delirium.\n\nPost COVID inflammation can result in various symptoms. Inflammatory arthralgia has to be differentiated from other similar\n\nconditions like Rheumatoid arthritis and SLE [38]. Severe infection\n\nwith SARS-CoV-2 can results in autoreactivity against a variety of\n\nself-antigens [39]. COVID-19 associated coagulopathy (CAC) can\n\nresults in both arterial and venous thrombosis [40].\n\n\n\n1.8. Management of patients with long COVID\n\nTreatment of people with long COVID requires a multidisciplinary approach including evaluation, symptomatic treatment, treatment of underlying problems, physiotherapy, occupational therapy and psychological support [11]. Minor symptoms like\n\ncough, pain, myalgia can be treated symptomatically with paracetamol, cough suppressants and oral antibiotics (if secondary\n\nbacterial infection is suspected). Etiology behind the symptoms, if\n\nany, like pulmonary embolism, cerebrovascular accident, coronary\n\nartery disease, has to be treated as per the standard protocol. Chest\n\nphysiotherapy and neuro rehabilitation is important in patients\n\nwith pulmonary and neuromuscular sequelae. Since it is a new\n\ndisease, the knowledge regarding long term effects and treatment\n\noptions is still evolving. Worsening of underlying co-morbidities\n\nlike diabetes, hypertension and cardiovascular illness could occur\n\nin people after SARS-CoV-2 infection, requiring optimization of\n\ntreatment.\n\nThe ideal frequency and duration of follow up is also not clearly\n\ndefined. In people with COVID-19 interstitial pneumonia, in the\n\nfirst 12 months, 7 interactions with healthcare professionals (4\n\nface-to-face) are recommended, alongside 4 HRCTs, 4 6MWT, 4\n\nblood tests (including blood count and metabolic panel) and 2\n\nSARS-CoV-2-IgG tests [43]. In our experience, majority of people\n\nwith mild-moderate symptoms and those who show improvement\n\nin symptoms can be followed up with online or telephonic\n\nconsultation, with fewer face-to-face interactions. Those with severe symptoms and progressive worsening need frequent inperson review. Those developing acute worsening of symptoms\n\nor acute onset of new symptoms should be advised to report the\n\nemergency department immediately. Frequency of follow up has to\n\nbe individualized according to patient’s clinical profile.\n\nChronic persistence of symptoms in people with SARS-CoV-2\n\ninfection has significant social and economic impact. As the disease continues to spread, more people may need health care support in the near future, which could overburden the health care\n\nsystem. Clear guidelines regarding management of long COVID-19\n\nwill help clear the confusion among health care providers. Long\n\nterm follow up of COVID recovered patients will throw more light\n\n\n\n1.7. Approach to patients with long COVID\n\nDetailed history and clinical examination help with the diagnosis in people with recent SARS-CoV-2 infection. In patients with\n\nsymptoms suggestive of long COVID, without previous evidence of\n\nSARS-CoV-2 infection, demonstration of antibody positivity helps\n\nto confirm the diagnosis. However, antibody levels are known to\n\ndrop with time; therefore a negative serology test does not rule out\n\na past SARS-CoV-2 infection. In such scenario diagnosis of long\n\nCOVID can be challenging. Raveendran’s criteria for the diagnosis of\n\nlong COVID-19, helps to categorise as confirmed, probable, possible\n\nor doubtful long COVID-19 syndrome [12]. Majority of the people\n\nwith long COVID does not require extensive evaluation. Investigations may be directed by symptoms.\n\nClinical evaluation of patients presenting with long COVID starts\n\nwith documentation of the existing problem-its improvement or\n\ndeterioration, and also documentation of new problems, if any\n\n(Fig. 3).\n\n872\n\n\n\n\fDiabetes & Metabolic Syndrome: Clinical Research & Reviews 15 (2021) 869e875\n\n\n\nA.V. Raveendran, R. Jayadevan and S. Sashidharan\n\n\n\nFig. 3. Approach to patients with Long COVID.\n\n\n\nTable 1\n\nPost COVID syndrome categories.\n\nPost COVID syndrome\n\n\n\nPredominant clinical features\n\n\n\nPost COVID fatigue syndrome\n\nPost COVID cardio-respiratory\n\nsyndrome\n\n\n\nProfound fatigue\n\nCough, low grade fever, shortness of breath, chest pain,\n\n\n\nPost COVID neuro-psychiatric\n\nsyndrome\n\nPost COVID gastro-intestinal\n\nsyndrome\n\nPost COVID hepato-biliary\n\nsyndrome\n\nPost COVID musculo-skeletal\n\nsyndrome\n\n\n\nPost COVID thromboembolic\n\nsyndrome\n\nPost COVID multisystem\n\ninflammatory syndrome/post\n\nCOVID autoimmune syndrome\n\nPost COVID genito-urinary\n\nsymptoms\n\nPost COVID dermatological\n\nsyndrome\n\n\n\nRemarks\n\n\n\nRule out causes like anaemia, hypothyroidism, electrolyte imbalance\n\nSudden increase in dyspnoea can be due to tension pneumothorax,\n\npulmonary embolism, coronary artery disease or heart failure in\n\npatients recovered from COVID-19\n\nHeadaches, anosmia, neurocognitive difficulties, insomnia, In patients with acute onset neurological symptoms consider vasculitis,\n\ndepression and other mental health conditions\n\nthrombosis or demyelination. Post COVID psychological issues have to\n\nbe addressed properly.\n\nAbdominal discomfort, diarrhea, constipation, vomiting,\n\nGI symptoms can be a sequelae of the disease. Various drugs used\n\nduring acute COVID, especially lopinavir/ritonavir produces GI\n\nsymptoms\n\nNausea, jaundice, deranged LFT\n\nDrugs used in the treatment of COVID-19 like remdesivir, favipiravir,\n\nlopinavir/ritonavir and tocilizumab can cause hepatic impairment.\n\nMuscle pains and weakness, arthralgia\n\nMay be due to disease, prolonged ICU care, neurological problems,\n\nmyopathy or electrolyte imbalance. Usually subside during follow up.\n\nInflammatory arthralgia has to be differentiated from other causes like\n\nRA, SLE\n\nEarly diagnosis and treatment is life saving. Follow the standard\n\nDepending upon the vascular territory of involvement\n\nbreathlessness in PE, chest pain in CAD and limb weakness treatment protocol.\n\nand neurological deficit in CVA\n\nFever, gastrointestinal symptoms, rash, chest pain,\n\nElevated levels of markers of inflammation.\n\npalpitations\n\nProteinuria, haematuria, development of kidney injury\n\n\n\nEndothelial dysfunction, coagulopathy, complement activation, direct\n\neffect of virus on kidney, sepsis and multi-organ dysfunction contribute\n\nto the development\n\n\n\nVesicular, maculopapular, urticarial, or chilblain-like lesions\n\non the extremities (COVID toe)\n\n\n\ninto “long COVID” and its management [44].\n\n\n\nworldwide. It could be due to various mechanisms such as postintensive care syndrome, post-viral fatigue syndrome, permanent\n\norgan damage or others. Proper clinical evaluation will help identify the etiology, and to customize treatment. As the disease is new,\n\nit is too early to know the true long-term outlook.\n\n\n\n2. Conclusion\n\nPersistence of various symptoms in people who recovered from\n\nCOVID-19 (collectively called Long COVID) is a major health issue\n\n873\n\n\n\n\fDiabetes & Metabolic Syndrome: Clinical Research & Reviews 15 (2021) 869e875\n\n\n\nA.V. Raveendran, R. Jayadevan and S. Sashidharan\n\nTable 2\n\nPost COVID status assessment scale.\n\n\n\nReferences\n\n\n\n[18] Tenforde MW, Kim SS, Lindsell CJ, et al. Symptom duration and risk factors for\n\ndelayed return to usual health among outpatients with COVID-19 in a\n\nmultistate health care systems networkdUnited States, MarcheJune 2020.\n\nMMWR Morb Mortal Wkly Rep 2020;69:993e8.\n\n[19] Lopez-Leon S, Wegman-Ostrosky T, Perelman C, Sepulveda R, Rebolledo PA,\n\nCuapio A, Villapol S. More than 50 Long-term effects of COVID-19: a systematic review and meta-analysis [Preprint] medRxiv 2021 Jan 30. https://\n\ndoi.org/10.1101/2021.01.27.21250617.PMID:33532785.\n\n2021.01.27.21250617, PMCID: PMC7852236.\n\n[20] Sudre CH, Murray B, Varsavsky T, et al. Attributes and predictors of LongCOVID: analysis of COVID cases and their symptoms collected by the Covid\n\nSymptoms\n\nStudy\n\nApp.\n\nmedRxiv;\n\n2020.\n\nhttps://doi.org/10.1101/\n\n2020.10.19.20214494.\n\n[21] Colafrancesco S, Alessandri C, Conti F, Priori R. COVID-19 gone bad: a new\n\ncharacter in the spectrum of the hyperferritinemicsyndrome? Autoimmun\n\nRev 2020;19. https://doi.org/10.1016/j.autrev.2020.102573.pmid:32387470.\n\n\u0013nia L, MacAry PA, Ng LFP. The trinity of COVID-19: im[22] Tay MZ, Poh CM, Re\n\nmunity, inflammation and intervention. Nat Rev Immunol 2020;20:363e74.\n\nhttps://doi.org/10.1038/s41577-020-0311-8.pmid:32346093.\n\n[23] Wu F, Wang A, Liu M, et al. 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COVID-19 pandemic in the Italian\n\npopulation: validation of a post-traumatic stress disorder questionnaire and\n\nprevalence of PTSD symptomatology. Int J Environ Res Publ Health 2020;17:\n\n4151. https://doi.org/10.3390/ijerph17114151.pmid:32532077.\n\n[28] Jiang H-j, Nan J, Lv Z-y, etal. Psychological impacts of the COVID-19 epidemic\n\non Chinese people: exposure, post-traumatic stress symptom, and emotion\n\nregulation. Asian Pac J Trop Med 2020;13:252.\n\n[29] Lambert NJ, Corps Survivor. COVID-19 “long Hauler”Symptoms survey report.\n\nIndiana University School of Medicine; 2020.\n\n[30] Townsend L, Dyer AH, Jones K, Dunne J, Mooney A, Gaffney F, et al. Persistent\n\nfatigue following SARS-CoV-2 infection is common and independent of\n\nseverity of initial infection. PloS One 2020;15(11). https://doi.org/10.1371/\n\njournal.pone.0240784. e0240784.\n\n[31] Gerwyn M, Maes M. Mechanisms explaining muscle fatigue and muscle pain\n\nin patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/\n\nCFS): a review of recent findings. Curr Rheumatol Rep 2017 Jan;19(1):1.\n\nhttps://doi.org/10.1007/s11926-017-0628-x.PMID:28116577.\n\n[32] Fraser Emily. Long term respiratory complications of covid-19. BMJ 2020;370:\n\nm300.\n\n[33] Becker RC. Toward understanding the 2019 Coronavirus and its impact on the\n\nheart. J Thromb Thrombolysis 2020. https://doi.org/10.1007/s11239-02002107-6.\n\n[34] Moriguchi T, Harii N, Goto J, et al. A first case of meningitis/encephalitis\n\nassociated with SARS-Coronavirus-2. Int J Infect Dis 2020;94:55e8.\n\n\n\n[1] Wu Z, McGoogan JM. Characteristics of and important lessons from the\n\ncoronavirus disease 2019 (COVID-19) outbreak in China: summary of a report\n\nof72 314 cases from the Chinese Center for Disease Control and Prevention.\n\nJAMA2020; 323: 1239-1242.\n\n[2] Docherty AB, Harrison EM, Green CA, Hardwick HE, Pius R, Norman L, et al.\n\nFeatures of 20 133 UK patients in hospital with covid-19 using the ISARIC\n\nWHO Clinical Characterisation Protocol: prospective observational cohort\n\nstudy. BMJ 2020;369:m1985.\n\n[3] Sudre C, Lee K, Lochlainn M, et al. Symptom clusters in covid 19: a potential\n\nclinical prediction tool from the COVID Symptom study app. Sci Adv 2021 Mar\n\n19;7(12):eabd4177.\n\nhttps://doi.org/10.1126/sciadv.abd4177.\n\nPMID:\n\n33741586; PMCID: PMC7978420.\n\n[4] Who-China Joint Mission Members. Report of the WHO-China joint mission\n\non coronavirus disease 2019 (COVID-19). World Health Organization; 2020.\n\n[5] Perego E. Twitter 20 May. 2020. https://twitter.com/elisaperego78/status/\n\n1263172084055838721?s¼20.\n\n[6] Edwards E. COVID-19 “long-haulers” report nearly 100 symptoms for more\n\nthan 100 days. NBC News; 2020 [cited 2020 Jul 31]https://www.nbcnews.\n\ncom/health/health-news/covid-19-long-haulers-report-nearly-100symptoms-more-100-n1235217.\n\n[7] Yong E. COVID-19 can last for several months. The Atlantic, [cited 2020 Jul 31],\n\nhttps://www.theatlantic.com/health/archive/2020/06/covid-19-coronaviruslongterm-symptoms-months/612679/; 2020.\n\n[8] Geddes L. Why strange and debilitating coronavirus symptoms can last for\n\nmonths. New Sci 2020. https://www.newscientist.com/article/mg24632881400-why-strange-and-debilitatingcoronavirus-symptoms-can-last-formonths/.\n\n[9] NabaviNikki. Long covid: how to define it and how to manage it. BMJ\n\n2020;370. https://doi.org/10.1136/bmj.m3489. m3489.\n\n[10] Garg P, Arora U, Kumar A, Wig N. The \"post-COVID\" syndrome: how deep is\n\nthe damage? J Med Virol 2020 Aug. https://doi.org/10.1002/jmv.26465.\n\n[11] Greenhalgh Trisha, Knight Matthew, A’Court Christine, Buxton Maria,\n\nHusain Laiba. Management of post-acute covid-19 in primary care. BMJ\n\n2020;370. https://doi.org/10.1136/bmj.m3026. m3026.\n\n[12] Raveendran AV. Long COVID-19: challenges in the diagnosis and proposed\n\ndiagnostic criteria. Diabetes Metab Syndr 2020;15(1):145e6. https://doi.org/\n\n10.1016/j.dsx.2020.12.025. Epub ahead of print. PMID: 33341598.\n\n[13] Assaf G, Davis H, McCorkell L, et al. An analysis of the prolonged COVID-19\n\nsymptoms survey by Patient-Led Research Team. Patient Led Research;\n\n2020. https://patientresearchcovid19.com/.\n\n[14] Van Elslande J, Vermeersch P, Vandervoort K, Wawina-Bokalanga T,\n\nVanmechelen B, Wollants E, et al. Symptomatic SARS-CoV-2 reinfection by a\n\nphylogenetically distinct strain. Clin Infect Dis 2020:ciaa1330. https://doi.org/\n\n10.1093/cid/ciaa1330.\n\n[15] Falahi S, Kenarkoohi A. COVID-19 reinfection: prolonged shedding or true\n\nreinfection? New Microbes and New Infections 2020;38. https://doi.org/\n\n10.1016/j.nmni.2020.100812. 100812, ISSN 2052-2975.\n\n[16] Carfì A, Bernabei R, Landi F. Persistent symptoms in patients after acute\n\nCOVID-19. J Am Med Assoc 2020;324(6):603e5.\n\n[17] Arnold DT, Hamilton FW, Milne A, et al Patient outcomes after hospitalisation\n\nwith COVID-19 and implications for follow-up: results from a prospective UK\n\ncohort thorax Published Online First: 03 December 2020. doi: 10.1136/thoraxjnl-2020-216086.\n\n874\n\n\n\n\fDiabetes & Metabolic Syndrome: Clinical Research & Reviews 15 (2021) 869e875\n\n\n\nA.V. Raveendran, R. Jayadevan and S. Sashidharan\n\n[35] Lu, Yiping; Li, Xuanxuan; Geng, Daoying; Mei, Nan; Wu, Pu-Yeh; Huang, ChuChung; Jia, Tianye; Zhao, Yajing; Wang, Dongdong; Xiao, Anling; Yin,\n\nBo.Cerebral micro-structural changes in COVID-19 patients - an MRI-based 3month follow-up study.EClinicalMedicine: 100484, 2020 Aug 03.\n\n[36] Varatharaj A, Thomas N, Ellul MA, Davies NWS, Pollak TA, otros Tenorio EL y.\n\nNeurological and neuropsychiatric complications of COVID-19 in 153 patients: a UK-wide surveillance study. The Lancet Psychiatry 2020 oct 1;7(10).\n\nhttps://doi.org/10.1016/S2215-0366(20)30287-X.\n\n[37] Malik GR, Wolfe AR, Soriano R, Rydberg L, Wolfe LF, Deshmukh S, et al. Injuryprone: peripheral nerve injuries associated with prone positioning for COVID19-related acute respiratory distress syndrome. 2020 Jun 01. https://doi.org/\n\n10.1101/2020.07.01.20144436. medRxiv 20144436 [Preprint], [cited 2020 Jul\n\n06]. Available from:.\n\n[38] Chandrashekara S, Jaladhar P, Paramshetti S, Ramachandran V, Nizar SF,\n\nKori D. Post COVID inflammation syndrome: different manifestations caused\n\nby the virus. J Assoc Phys India 2020 Dec;68(12):33e4. PMID: 33247640.\n\n[39] Woodruff Matthew C, Ramonell Richard P, Eun-Hyung Lee F, Sanz Ignacio.\n\nClinically identifiable autoreactivity is common in severe SARS-CoV-2\n\n\n\n[40]\n\n\n\n[41]\n\n\n\n[42]\n\n\n\n[43]\n\n\n\n[44]\n\n\n\n875\n\n\n\nInfection. medRxiv 2020;10. https://doi.org/10.1101/2020.10.21.20216192.\n\n21.20216192.\n\nMucha Simon R, Dugar Siddharth, Keith McCrae, Douglas Joseph,\n\nJohn Bartholomew, Sacha Gretchen L, Militello Michael. Coagulopathy in\n\nCOVID-19: manifestations and management. Cleve Clin J Med 2020;87(8):\n\n461e8. https://doi.org/10.3949/ccjm.87a.ccc024.\n\nDasgupta A, Kalhan A, Kalra S. Long term complications and rehabilitation of\n\nCOVID-19 patients. J Pakistan Med Assoc 2020;70:S131e5. https://doi.org/\n\n10.5455/JPMA.32.pmid:32515393.\n\n\u0012 A, Carretero Herna\n\n\u0013ndez G, etal. Classification of the\n\nGalv\u0013\n\nan Casas C, Catala\n\ncutaneous manifestations of COVID-19: a rapid prospective nationwide\n\nconsensus study in Spain with 375 cases. Br J Dermatol 2020;183:71e7.\n\nhttps://doi.org/10.1111/bjd.19163.pmid:32348545.\n\nRaghu G, Wilson KC. COVID-19 interstitial pneumonia: monitoring the clinical\n\ncourse in survivors. Lancet Respir Med 2020. https://doi.org/10.1016/S22132600(20)30349-0.\n\nThe post-hospitalisation COVID-19 study (PHOSP-COVID). https://www.\n\nphosp.org.\n\n\n\n\f",
          "document_id": 450701
        }
      ]
    },
    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "What is COVID-19? ",
              "id": 279121,
              "answers": [
                {
                  "answer_id": 275128,
                  "document_id": 450749,
                  "question_id": 279121,
                  "text": "COVID-19 is a disease caused by a virus called SARS-CoV-2. Most people with COVID-19 have mild symptoms, but some\n\npeople can become severely ill. Although most people with COVID-19 get better within weeks of illness, some people\n\nexperience post-COVID conditions. Post-COVID conditions are a wide range of new, returning, or ongoing health\n\nproblems people can experience more than four weeks after first being infected with the virus that causes COVID-19.\n\nOlder people and those who have certain underlying medical conditions are more likely to get severely ill from COVID-19.\n\nVaccines against COVID-19 are safe and effective.\n",
                  "answer_start": 286,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How does the virus spread? ",
              "id": 279122,
              "answers": [
                {
                  "answer_id": 275129,
                  "document_id": 450749,
                  "question_id": 279122,
                  "text": "COVID-19 spreads when an infected person breathes out droplets and very small particles that contain the virus. These\n\ndroplets and particles can be breathed in by other people or land on their eyes, noses, or mouth. In some\n\ncircumstances, they may contaminate surfaces they touch. People who are closer than 6 feet from the infected person\n\nare most likely to get infected.",
                  "answer_start": 965,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is community spread?",
              "id": 279123,
              "answers": [
                {
                  "answer_id": 275130,
                  "document_id": 450749,
                  "question_id": 279123,
                  "text": "Community spread means people have been infected with the virus in an area, including some who are not sure how or\n\nwhere they became infected. Each health department determines community spread differently based on local\n\nconditions. For information on community spread in your area, please visit your local health department’s website.",
                  "answer_start": 2089,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Should I use soap and water or hand sanitizer to protect against COVID-19?",
              "id": 279124,
              "answers": [
                {
                  "answer_id": 275131,
                  "document_id": 450749,
                  "question_id": 279124,
                  "text": "Handwashing is one of the best ways to protect yourself and your family from getting sick. Wash your hands often with\n\nsoap and water for at least 20 seconds, especially after blowing your nose, coughing, or sneezing; going to the bathroom;\n\nand before eating or preparing food. If soap and water are not readily available, use an alcohol-based hand sanitizer with\n\nat least 60% alcohol.",
                  "answer_start": 2695,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What should I do if I get sick or someone in my house gets sick?",
              "id": 279125,
              "answers": [
                {
                  "answer_id": 275132,
                  "document_id": 450749,
                  "question_id": 279125,
                  "text": "People who have been in close contact with someone who has COVID-19—excluding people who have had COVID-19\n\nwithin the past 3 months or who are fully vaccinated\n\n\n\n•\n\n\n\nPeople who have tested positive for COVID-19 within the past 3 months and recovered do not have to quarantine\n\n\n\n•\n\n\n\nPeople who develop symptoms again within 3 months of their first bout of COVID-19 may need to be tested again\n\nif there is no other cause identified for their symptoms.\n\n\n\n•\n\n\n\nPeople who have been in close contact with someone who has COVID-19 are not required to quarantine if they\n\nhave been fully vaccinated against the disease and show no symptoms.\n\n\n\nor get tested again as long as they do not develop new symptoms.",
                  "answer_start": 3243,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the recommendations for someone who has symptoms of COVID-19?",
              "id": 279126,
              "answers": [
                {
                  "answer_id": 275133,
                  "document_id": 450749,
                  "question_id": 279126,
                  "text": "Stay at home (except to get medical care).\n\nSeparate yourself from others.\n\nMonitor your symptoms.\n\nWear a mask over your nose and mouth when around others.\n\nCover your coughs and sneezes.\n\nWash your hands often.\n\nClean high-touch surfaces every day.\n\nAvoid sharing personal household items.",
                  "answer_start": 4468,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is the risk of my child becoming sick with COVID-19?",
              "id": 279127,
              "answers": [
                {
                  "answer_id": 275134,
                  "document_id": 450749,
                  "question_id": 279127,
                  "text": "Children can be infected with the virus that causes COVID-19 and can get sick with COVID-19. Most children with COVID19 have mild symptoms or they may have no symptoms at all (“asymptomatic”). Fewer children have been sick with\n\nCOVID-19 compared to adults. Babies younger than 1 and children with certain underlying medical conditions may be\n\nmore likely to have serious illness from COVID-19. Some children have developed a rare but serious disease that is linked\n\nto COVID-19 called multisystem inflammatory syndrome (MIS-C).",
                  "answer_start": 4898,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is multisystem inflammatory syndrome in children (MIS-C)?",
              "id": 279128,
              "answers": [
                {
                  "answer_id": 275135,
                  "document_id": 450749,
                  "question_id": 279128,
                  "text": "Multisystem inflammatory syndrome in children (MIS-C) is a serious condition associated with COVID-19 where different\n\nbody parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs",
                  "answer_start": 5614,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the symptoms and complications that COVID-19 can cause?",
              "id": 279129,
              "answers": [
                {
                  "answer_id": 275136,
                  "document_id": 450749,
                  "question_id": 279129,
                  "text": "\nPeople with COVID-19 have reported a wide range of symptoms – from mild symptoms to severe illness. Symptoms may\n\nappear 2-14 days after exposure to the virus. If you have fever, cough, or other symptoms, you might have COVID-19.",
                  "answer_start": 6053,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "When should I seek emergency care if I have COVID-19?",
              "id": 279130,
              "answers": [
                {
                  "answer_id": 275138,
                  "document_id": 450749,
                  "question_id": 279130,
                  "text": "Trouble breathing\n\nPersistent pain or pressure in the chest\n\nNew confusion\n\nInability to wake or stay awake\n\nPale, gray, or blue-colored skin, lips, or nail beds, depending on skin tone\n\n\n\n*This list is not all possible symptoms. Please call your medical provider for any other symptoms that are severe or\n\nconcerning to you.\n\n",
                  "answer_start": 6585,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Is at-home specimen collection or testing available? ",
              "id": 279131,
              "answers": [
                {
                  "answer_id": 275141,
                  "document_id": 450749,
                  "question_id": 279131,
                  "text": "Yes. At-home testing and collection allow you to collect a specimen at home and either send it to a testing facility or\n\npreform the test at home.\n\nYou and your healthcare provider might consider either an at-home collection kit or an at-home test if you have signs and\n\nsymptoms of COVID-19 or if you can’t get testing at a local healthcare facility.",
                  "answer_start": 6986,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Should I be tested for a current infection?",
              "id": 279132,
              "answers": [
                {
                  "answer_id": 275142,
                  "document_id": 450749,
                  "question_id": 279132,
                  "text": "People who have symptoms of COVID-19. People who have had a known exposure to someone with suspected or\n\nconfirmed COVID-19. People who have come into close contact with someone with COVID-19 should be tested to\n\ncheck for infection:\n\n\n\n-\n\n\n\nFully vaccinated people should be tested 5–7 days after their last exposure.\n\nPeople who are not fully vaccinated should get tested immediately when they find out they are a close\n\ncontact. If their test result is negative, they should get tested again 5–7 days after their last exposure or\n\nimmediately if symptoms develop.\n\n\n\n•\n\n\n\nPeople not fully vaccinated with COVID-19 vaccine who are prioritized for expanded community screening for\n\nCOVID-19.\n\n\n\n•\n\n\n\nPeople not fully vaccinated with COVID-19 vaccine who have been asked or referred to get testing by their school,\n\nworkplace, healthcare provider, state, tribal, local  , or territorial health department.”\n\n\n",
                  "answer_start": 7518,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can someone test negative and later test positive on a viral test for COVID-19?",
              "id": 279133,
              "answers": [
                {
                  "answer_id": 275157,
                  "document_id": 450749,
                  "question_id": 279133,
                  "text": "Yes, it is possible. You may test negative if the sample was collected early in your infection and test positive later during\n\nthis illness. You could also be exposed to COVID-19 after the test and get infected then. Even if you test negative, you still\n\nshould take steps to protect yourself and others. See Testing for Current Infection for more information.\n",
                  "answer_start": 8893,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is contact tracing?",
              "id": 279134,
              "answers": [
                {
                  "answer_id": 275143,
                  "document_id": 450749,
                  "question_id": 279134,
                  "text": "Contact tracing has been used for decades by state and local health departments to slow or stop the spread of infectious\n\ndiseases.\n\nContact tracing slows the spread of COVID-19 by\n\n\n\n•\n\n\n\nLetting people know they may have been exposed to COVID-19 and should monitor their health for signs and\n\nsymptoms of COVID-19\n\n\n\n•\n",
                  "answer_start": 9309,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What will happen with my personal information during contact tracing?",
              "id": 279135,
              "answers": [
                {
                  "answer_id": 275144,
                  "document_id": 450749,
                  "question_id": 279135,
                  "text": "Discussions with health department staff are confidential. This means that your personal and medical information will be\n\nkept private and only shared with those who may need to know, like your health care provider.\n\nIf you have been diagnosed with COVID-19, your name will not be shared with those you came in contact with. The health\n\ndepartment will only notify people you were in close contact with that they might have been exposed to COVID-19. Each",
                  "answer_start": 10098,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Who is considered a close contact of someone with COVID-19?",
              "id": 279136,
              "answers": [
                {
                  "answer_id": 275145,
                  "document_id": 450749,
                  "question_id": 279136,
                  "text": "For COVID-19, a close contact is anyone who was within 6 feet of an infected person for a total of 15 minutes or more\n\nover a 24-hour period (for example, three individual 5-minute exposures for a total of 15 minutes). An infected person",
                  "answer_start": 10784,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "I have COVID-19. How do I tell the people I was around?",
              "id": 279137,
              "answers": [
                {
                  "answer_id": 275146,
                  "document_id": 450749,
                  "question_id": 279137,
                  "text": "If you have COVID-19, tell your close contacts  [93 KB, 2 Pages] you have COVID-19 so that they can quarantine at home\n\nand get tested. By letting your close contacts know they may have been exposed to COVID-19, you are helping to protect\n\nthem and others within your community.\n\nYou can call, text, or email your contacts. If you would like to stay anonymous, there is also an online tool that allows you",
                  "answer_start": 11532,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is community mitigation?",
              "id": 279146,
              "answers": [
                {
                  "answer_id": 275155,
                  "document_id": 450749,
                  "question_id": 279146,
                  "text": "Community mitigation is a set of actions that people and communities can take to slow the spread of infectious diseases\n\nlike COVID-19. The goal of community mitigation in areas with local COVID-19 transmission is to slow its spread and to\n\nprotect all individuals, especially those at increased risk for severe illness, while minimizing the negative impacts of these\n\nstrategies",
                  "answer_start": 16226,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Does mask use help determine if someone is considered a close contact?",
              "id": 279138,
              "answers": [
                {
                  "answer_id": 275147,
                  "document_id": 450749,
                  "question_id": 279138,
                  "text": "A person is still considered a close contact even if one or both people wore a mask when they were together.\n",
                  "answer_start": 12197,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "If I am a close contact, will I be tested for COVID-19?",
              "id": 279139,
              "answers": [
                {
                  "answer_id": 275148,
                  "document_id": 450749,
                  "question_id": 279139,
                  "text": "If you have been in close contact with someone who has COVID-19, you should be tested, even if you do not have\n\nsymptoms of COVID-19. The health department may be able to provide resources for testing in your area.\n\nFor more information, see COVID-19 Contact Tracing.\n\nWatch for or monitor your symptoms of COVID-19. If your symptoms worsen or become severe, you should seek medical\n\ncare.",
                  "answer_start": 12309,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can I get COVID-19 from my pets or other animals?",
              "id": 279140,
              "answers": [
                {
                  "answer_id": 275158,
                  "document_id": 450749,
                  "question_id": 279140,
                  "text": "Based on the available information to date, the risk of animals spreading COVID-19 to people is considered to be low",
                  "answer_start": 12780,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can I use hand sanitizer on pets?",
              "id": 279142,
              "answers": [
                {
                  "answer_id": 275152,
                  "document_id": 450749,
                  "question_id": 279142,
                  "text": "Do not wipe or bathe your pet with chemical disinfectants, alcohol, hydrogen peroxide, or other products, such as hand\n\nsanitizer, counter-cleaning wipes, or other industrial or surface cleaners.",
                  "answer_start": 13309,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What should I do if my pet gets sick and I think it’s COVID-19? ",
              "id": 279143,
              "answers": [
                {
                  "answer_id": 275153,
                  "document_id": 450749,
                  "question_id": 279143,
                  "text": "f your pet gets sick after contact with a person with COVID-19, call your veterinarian and let them know the pet was\n\naround a person with COVID-19. If you are sick with COVID-19, do not take your pet to the veterinary clinic yourself. Some\n\nveterinarians may offer telemedicine consultations or other plans for seeing sick pets. Your veterinarian can evaluate",
                  "answer_start": 14452,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can wild animals spread the virus that causes COVID-19 to peopl",
              "id": 279144,
              "answers": [
                {
                  "answer_id": 275156,
                  "document_id": 450749,
                  "question_id": 279144,
                  "text": "Currently, there is no evidence to suggest that wildlife might be a source of infection for people in the United States. The\n\nrisk of getting COVID-19 from wild animals is low.",
                  "answer_start": 15150,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can bats in United States get the virus that causes COVID-19, and can they spread it back to\npeople?\n",
              "id": 279145,
              "answers": [
                {
                  "answer_id": 275154,
                  "document_id": 450749,
                  "question_id": 279145,
                  "text": "Other coronaviruses have been found in North American bats in the past, but there is currently no evidence that the virus\n\nthat causes COVID-19 is present in bats in the United States. In general, coronaviruses do not cause illness or death in\n\nbats, but we don’t yet know if this new coronavirus would make North American species of bats sick. Bats are an\n\nimportant part of natural ecosystems, and their populations are already declining in the United States. Bat populations\n\ncould be further threatened by the disease itself or by harm inflicted on bats resulting from a misconception that bats are\n\nspreading COVID-19. However, there is no evidence that bats in the United States are a source of the virus that causes\n\nCOVID-19 for people. Further studies are needed to understand if and how bats could be affected by COVID-19.",
                  "answer_start": 15330,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can animals carry the virus that causes COVID-19 on their skin or fur?",
              "id": 279141,
              "answers": [
                {
                  "answer_id": 275149,
                  "document_id": 450749,
                  "question_id": 279141,
                  "text": "Although we know certain bacteria and fungi can be carried on fur and hair, there is no evidence that viruses, ",
                  "answer_start": 13050,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            }
          ],
          "context": "Coronavirus (COVID-19) frequently asked questions | CDC\n\n\n\nCOVID-19\n\n\n\nFrequently Asked Questions\n\nUpdated Oct. 21, 2021\n\n\n\nWhat are you looking for?\n\nEnter a word or phrase below to locate questions and answers that match.\n\nSearch all FAQs\n\n\n\nGo\n\n\n\nWhat is COVID-19?\n\n\n\n\n\n\n\nBasics\n\n\n\nCOVID-19 is a disease caused by a virus called SARS-CoV-2. Most people with COVID-19 have mild symptoms, but some\n\npeople can become severely ill. Although most people with COVID-19 get better within weeks of illness, some people\n\nexperience post-COVID conditions. Post-COVID conditions are a wide range of new, returning, or ongoing health\n\nproblems people can experience more than four weeks after first being infected with the virus that causes COVID-19.\n\nOlder people and those who have certain underlying medical conditions are more likely to get severely ill from COVID-19.\n\nVaccines against COVID-19 are safe and effective.\n\n\n\nHow does the virus spread?\n\n\n\n\n\n\n\nSpread\n\n\n\nCOVID-19 spreads when an infected person breathes out droplets and very small particles that contain the virus. These\n\ndroplets and particles can be breathed in by other people or land on their eyes, noses, or mouth. In some\n\ncircumstances, they may contaminate surfaces they touch. People who are closer than 6 feet from the infected person\n\nare most likely to get infected.\n\nCOVID-19 is spread in three main ways:\n\n\n\nhttps://www.cdc.gov/coronavirus/2019-ncov/faq.html#Basics\n\n\n\n1/8\n\n\n\n\f1/6/22, 3:41 PM\n\n\n\nCoronavirus (COVID-19) frequently asked questions | CDC\n\n\n\n•\n\n\n\nBreathing in air when close to an infected person who is exhaling small droplets and particles that contain the\n\n\n\n•\n\n\n\nHaving these small droplets and particles that contain virus land on the eyes, nose, or mouth, especially through\n\nsplashes and sprays like a cough or sneeze.\n\n\n\n•\n\n\n\nTouching eyes, nose, or mouth with hands that have the virus on them.\n\n\n\nvirus.\n\n\n\nFor more information about how COVID-19 spreads, visit the How COVID-19 Spreads page to learn how COVID-19\n\n\n\nWhat is community spread?\n\n\n\n\n\n\n\nspreads and how to protect yourself\n\n\n\nCommunity spread means people have been infected with the virus in an area, including some who are not sure how or\n\nwhere they became infected. Each health department determines community spread differently based on local\n\nconditions. For information on community spread in your area, please visit your local health department’s website.\n\n\n\nHow can I protect myself?\n\n\n\n\n\n\n\nPrevention\n\n\n\nShould I use soap and water or hand sanitizer to protect against COVID-19?\n\n\n\n\n\n\n\nVisit the How to Protect Yourself & Others page to learn about how to protect yourself from respiratory illnesses, like\n\nCOVID-19.\n\n\n\nHandwashing is one of the best ways to protect yourself and your family from getting sick. Wash your hands often with\n\nsoap and water for at least 20 seconds, especially after blowing your nose, coughing, or sneezing; going to the bathroom;\n\nand before eating or preparing food. If soap and water are not readily available, use an alcohol-based hand sanitizer with\n\nat least 60% alcohol.\n\n\n\nWhat should I do if I get sick or someone in my house gets sick?\n\n\n\n\n\n\n\nIf You or Someone You Know is Sick or Had Contact with\n\nSomeone who Has COVID-19\n\n\n\nPeople who have been in close contact with someone who has COVID-19—excluding people who have had COVID-19\n\nwithin the past 3 months or who are fully vaccinated\n\n\n\n•\n\n\n\nPeople who have tested positive for COVID-19 within the past 3 months and recovered do not have to quarantine\n\n\n\n•\n\n\n\nPeople who develop symptoms again within 3 months of their first bout of COVID-19 may need to be tested again\n\nif there is no other cause identified for their symptoms.\n\n\n\n•\n\n\n\nPeople who have been in close contact with someone who has COVID-19 are not required to quarantine if they\n\nhave been fully vaccinated against the disease and show no symptoms.\n\n\n\nor get tested again as long as they do not develop new symptoms.\n\n\n\nFor more information, see COVID-19: When to Quarantine and What to Do If You Are Sick.\n\n\n\nhttps://www.cdc.gov/coronavirus/2019-ncov/faq.html#Basics\n\n\n\n2/8\n\n\n\n\fCoronavirus (COVID-19) frequently asked questions | CDC\n\n\n\n\n\n\n\n1/6/22, 3:41 PM\n\n\n\nWhat are the recommendations for someone who has symptoms of COVID-19?\n\nIf you are sick with COVID-19 or think you might have COVID-19, follow the steps below to care for yourself and to help\n\nprotect other people in your home and community.\n\n\n\n•\n\n•\n\n•\n\n•\n\n•\n\n•\n\n•\n\n•\n\n\n\nStay at home (except to get medical care).\n\nSeparate yourself from others.\n\nMonitor your symptoms.\n\nWear a mask over your nose and mouth when around others.\n\nCover your coughs and sneezes.\n\nWash your hands often.\n\nClean high-touch surfaces every day.\n\nAvoid sharing personal household items.\n\n\n\nFor more information, see What to Do If You Are Sick.\n\n\n\nWhat is the risk of my child becoming sick with COVID-19?\n\n\n\n\n\n\n\nChildren\n\n\n\nChildren can be infected with the virus that causes COVID-19 and can get sick with COVID-19. Most children with COVID19 have mild symptoms or they may have no symptoms at all (“asymptomatic”). Fewer children have been sick with\n\nCOVID-19 compared to adults. Babies younger than 1 and children with certain underlying medical conditions may be\n\nmore likely to have serious illness from COVID-19. Some children have developed a rare but serious disease that is linked\n\nto COVID-19 called multisystem inflammatory syndrome (MIS-C).\n\n\n\nWhat is multisystem inflammatory syndrome in children (MIS-C)?\n\n\n\n\n\n\n\nFor more information about how people get sick with the virus that causes COVID-19, see How COVID-19 Spreads.\n\n\n\nMultisystem inflammatory syndrome in children (MIS-C) is a serious condition associated with COVID-19 where different\n\nbody parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs. For\n\ninformation, see MIS-C.\n\n\n\nWhat are the symptoms and complications that COVID-19 can cause?\n\n\n\n\n\n\n\nSymptoms & Emergency Warning Signs\n\n\n\nWhen should I seek emergency care if I have COVID-19?\n\n\n\n\n\n\n\nPeople with COVID-19 have reported a wide range of symptoms – from mild symptoms to severe illness. Symptoms may\n\nappear 2-14 days after exposure to the virus. If you have fever, cough, or other symptoms, you might have COVID-19.\n\n\n\nLook for emergency warning signs* for COVID-19. If someone is showing any of these signs, seek emergency medical care\n\nhttps://www.cdc.gov/coronavirus/2019-ncov/faq.html#Basics\n\n\n\n3/8\n\n\n\n\f1/6/22, 3:41 PM\n\n\n\nCoronavirus (COVID-19) frequently asked questions | CDC\n\n\n\nimmediately\n\n\n\n•\n\n•\n\n•\n\n•\n\n•\n\n\n\nTrouble breathing\n\nPersistent pain or pressure in the chest\n\nNew confusion\n\nInability to wake or stay awake\n\nPale, gray, or blue-colored skin, lips, or nail beds, depending on skin tone\n\n\n\n*This list is not all possible symptoms. Please call your medical provider for any other symptoms that are severe or\n\nconcerning to you.\n\n\n\nIs at-home specimen collection or testing available?\n\n\n\n\n\n\n\nTesting\n\n\n\nYes. At-home testing and collection allow you to collect a specimen at home and either send it to a testing facility or\n\npreform the test at home.\n\nYou and your healthcare provider might consider either an at-home collection kit or an at-home test if you have signs and\n\nsymptoms of COVID-19 or if you can’t get testing at a local healthcare facility.\n\n\n\nShould I be tested for a current infection?\n\n\n\n\n\n\n\nFor more information, see At-Home Testing.\n\n\n\nThe following people should get tested for current COVID-19 infection:\n\n\n\n•\n\n\n\nPeople who have symptoms of COVID-19. People who have had a known exposure to someone with suspected or\n\nconfirmed COVID-19. People who have come into close contact with someone with COVID-19 should be tested to\n\ncheck for infection:\n\n\n\n-\n\n\n\nFully vaccinated people should be tested 5–7 days after their last exposure.\n\nPeople who are not fully vaccinated should get tested immediately when they find out they are a close\n\ncontact. If their test result is negative, they should get tested again 5–7 days after their last exposure or\n\nimmediately if symptoms develop.\n\n\n\n•\n\n\n\nPeople not fully vaccinated with COVID-19 vaccine who are prioritized for expanded community screening for\n\nCOVID-19.\n\n\n\n•\n\n\n\nPeople not fully vaccinated with COVID-19 vaccine who have been asked or referred to get testing by their school,\n\nworkplace, healthcare provider, state, tribal, local  , or territorial health department.”\n\n\n\nFor more information on testing, see\n\nTesting for COVID-19\n\nSelf-Testing\n\nTest for Current Infection\n\nTest for Past Infection\n\n\n\nCan someone test negative and later test positive on a viral test for COVID 19?\n\nhttps://www.cdc.gov/coronavirus/2019-ncov/faq.html#Basics\n\n\n\n\n\n\n\n•\n\n•\n\n•\n\n•\n\n\n\n4/8\n\n\n\n\fCoronavirus (COVID-19) frequently asked questions | CDC\n\n\n\nCan someone test negative and later test positive on a viral test for COVID-19?\n\n\n\n\n\n\n\n1/6/22, 3:41 PM\n\n\n\nYes, it is possible. You may test negative if the sample was collected early in your infection and test positive later during\n\nthis illness. You could also be exposed to COVID-19 after the test and get infected then. Even if you test negative, you still\n\nshould take steps to protect yourself and others. See Testing for Current Infection for more information.\n\n\n\nWhat is contact tracing?\n\n\n\n\n\n\n\nContact Tracing\n\n\n\nContact tracing has been used for decades by state and local health departments to slow or stop the spread of infectious\n\ndiseases.\n\nContact tracing slows the spread of COVID-19 by\n\n\n\n•\n\n\n\nLetting people know they may have been exposed to COVID-19 and should monitor their health for signs and\n\nsymptoms of COVID-19\n\n\n\n•\n\n•\n\n\n\nHelping people who may have been exposed to COVID-19 get tested\n\nAsking people to self-isolate if they have COVID-19 or self-quarantine if they are a close contact of someone with\n\nCOVID-19\n\n\n\nDuring contact tracing, the health department staff will not ask you for\n\nMoney\n\nSocial Security number\n\nBank account information\n\nSalary information\n\nCredit card numbers\n\n\n\nWhat will happen with my personal information during contact tracing?\n\n\n\n\n\n\n\n•\n\n•\n\n•\n\n•\n\n•\n\n\n\nDiscussions with health department staff are confidential. This means that your personal and medical information will be\n\nkept private and only shared with those who may need to know, like your health care provider.\n\nIf you have been diagnosed with COVID-19, your name will not be shared with those you came in contact with. The health\n\ndepartment will only notify people you were in close contact with that they might have been exposed to COVID-19. Each\n\n\n\nWho is considered a close contact of someone with COVID-19?\n\n\n\n\n\n\n\nstate and jurisdiction use their own method for collecting and protecting health information. To learn more, contact your\n\nstate or local health department.\n\n\n\nFor COVID-19, a close contact is anyone who was within 6 feet of an infected person for a total of 15 minutes or more\n\nover a 24-hour period (for example, three individual 5-minute exposures for a total of 15 minutes). An infected person\n\n\n\nI have COVID 19 How do I tell the people I was around?\n\nhttps://www.cdc.gov/coronavirus/2019-ncov/faq.html#Basics\n\n\n\n\n\n\n\ncan spread COVID-19 starting from 2 days before they have any symptoms (or, if they are asymptomatic, 2 days before\n\ntheir specimen that tested positive was collected), until they meet the criteria for discontinuing home isolation.\n\n\n\n5/8\n\n\n\n\fCoronavirus (COVID-19) frequently asked questions | CDC\n\n\n\nI have COVID-19. How do I tell the people I was around?\n\n\n\n\n\n\n\n1/6/22, 3:41 PM\n\n\n\nIf you have COVID-19, tell your close contacts  [93 KB, 2 Pages] you have COVID-19 so that they can quarantine at home\n\nand get tested. By letting your close contacts know they may have been exposed to COVID-19, you are helping to protect\n\nthem and others within your community.\n\nYou can call, text, or email your contacts. If you would like to stay anonymous, there is also an online tool that allows you\n\n\n\nDoes mask use help determine if someone is considered a close contact?\n\n\n\n\n\n\n\nto tell your contacts by sending out emails or text notifications anonymously (www.tellyourcontacts.org  ).\n\n\n\nIf I am a close contact, will I be tested for COVID-19?\n\n\n\n\n\n\n\nA person is still considered a close contact even if one or both people wore a mask when they were together.\n\n\n\nIf you have been in close contact with someone who has COVID-19, you should be tested, even if you do not have\n\nsymptoms of COVID-19. The health department may be able to provide resources for testing in your area.\n\nFor more information, see COVID-19 Contact Tracing.\n\nWatch for or monitor your symptoms of COVID-19. If your symptoms worsen or become severe, you should seek medical\n\ncare.\n\n\n\nCan I get COVID-19 from my pets or other animals?\n\n\n\n\n\n\n\nPets and Animals\n\n\n\nBased on the available information to date, the risk of animals spreading COVID-19 to people is considered to be low. See\n\n\n\nCan animals carry the virus that causes COVID-19 on their skin or fur?\n\n\n\n\n\n\n\nIf You Have Pets for more information about pets and COVID-19.\n\n\n\nAlthough we know certain bacteria and fungi can be carried on fur and hair, there is no evidence that viruses, including\n\n\n\nCan I use hand sanitizer on pets?\n\n\n\n\n\n\n\nthe virus that causes COVID-19, can spread to people from the skin, fur, or hair of pets.\n\n\n\nDo not wipe or bathe your pet with chemical disinfectants, alcohol, hydrogen peroxide, or other products, such as hand\n\nsanitizer, counter-cleaning wipes, or other industrial or surface cleaners. If you have questions about appropriate\n\nproducts for bathing or cleaning your pet, talk to your veterinarian. If your pet gets hand sanitizer on their skin or fur,\n\n\n\nWhat should I do if my pet gets sick and I think it’s COVID-19?\n\n\n\n\n\n\n\nrinse or wipe down your pet with water immediately. If your pet ingests hand sanitizer (such as by chewing the bottle) or\n\nis showing signs of illness after use, contact your veterinarian or pet poison control immediately.\n\n\n\nMost pets that have gotten sick from the virus that causes COVID 19 were infected after close contact with a person with\n\nhttps://www.cdc.gov/coronavirus/2019-ncov/faq.html#Basics\n\n\n\n6/8\n\n\n\n\f1/6/22, 3:41 PM\n\n\n\nCoronavirus (COVID-19) frequently asked questions | CDC\n\n\n\nMost pets that have gotten sick from the virus that causes COVID-19 were infected after close contact with a person with\n\nCOVID-19. Talk to your veterinarian about any health concerns you have about your pets.\n\nIf your pet gets sick after contact with a person with COVID-19, call your veterinarian and let them know the pet was\n\naround a person with COVID-19. If you are sick with COVID-19, do not take your pet to the veterinary clinic yourself. Some\n\nveterinarians may offer telemedicine consultations or other plans for seeing sick pets. Your veterinarian can evaluate\n\n\n\nCan wild animals spread the virus that causes COVID-19 to people?\n\n\n\n\n\n\n\nyour pet and determine the next steps for your pet’s treatment and care. Routine testing of animals for COVID-19 is not\n\nrecommended at this time.\n\n\n\nCan bats in United States get the virus that causes COVID-19, and can they spread it back to\n\npeople?\n\n\n\n\n\n\n\nCurrently, there is no evidence to suggest that wildlife might be a source of infection for people in the United States. The\n\nrisk of getting COVID-19 from wild animals is low.\n\n\n\nOther coronaviruses have been found in North American bats in the past, but there is currently no evidence that the virus\n\nthat causes COVID-19 is present in bats in the United States. In general, coronaviruses do not cause illness or death in\n\nbats, but we don’t yet know if this new coronavirus would make North American species of bats sick. Bats are an\n\nimportant part of natural ecosystems, and their populations are already declining in the United States. Bat populations\n\ncould be further threatened by the disease itself or by harm inflicted on bats resulting from a misconception that bats are\n\nspreading COVID-19. However, there is no evidence that bats in the United States are a source of the virus that causes\n\nCOVID-19 for people. Further studies are needed to understand if and how bats could be affected by COVID-19.\n\n\n\nCommunity Mitigation\n\n\n\n\n\nWhat is community mitigation?\n\n\n\nCommunity mitigation is a set of actions that people and communities can take to slow the spread of infectious diseases\n\nlike COVID-19. The goal of community mitigation in areas with local COVID-19 transmission is to slow its spread and to\n\nprotect all individuals, especially those at increased risk for severe illness, while minimizing the negative impacts of these\n\nstrategies. For more information, see Community Mitigation Framework.\n\n\n\nOther Frequently Asked Questions and Answers About:\n\n\n\n•\n\n•\n\n•\n\n•\n\n\n\nVaccines\n\nTravel\n\nHealthcare Professionals\n\nLaboratories\n\n\n\n•\n\n•\n\n•\n\n•\n\n\n\nPersonal Protective Equipment\n\nCorrectional and Detention Facilities\n\nEvent Organizers & Individuals\n\nHIV\n\n\n\nHelp control the spread of rumors and be aware of fraud schemes.\n\n\n\n•\n\n•\n\n\n\nCoronavirus Rumor Control  (FEMA)\n\nCOVID-19 Fraud Alert  (Office of the Inspector General)\n\n\n\nhttps://www.cdc.gov/coronavirus/2019-ncov/faq.html#Basics\n\n\n\n7/8\n\n\n\n\f1/6/22, 3:41 PM\n\n\n\nCoronavirus (COVID-19) frequently asked questions | CDC\n\n\n\nLast Updated Oct. 21, 2021\n\n\n\nhttps://www.cdc.gov/coronavirus/2019-ncov/faq.html#Basics\n\n\n\n8/8\n\n\n\n\f",
          "document_id": 450749
        }
      ]
    },
    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "Which inequities have emerged, and where is \nthe necessary first step in planning health equity-informed health policy and interventions?",
              "id": 279148,
              "answers": [
                {
                  "answer_id": 275160,
                  "document_id": 450750,
                  "question_id": 279148,
                  "text": "On average in Canada, 17% (“F”) of data elements were available across identified equity-oriented social markers and vulnerable settings at the province and territory level (Fig. 1).\n\nScores were lower for equity data reporting across health regions and local areas (average scores of 16% and 15%, respectively, for Canada overall).",
                  "answer_start": 20931,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How Canada is doing, overall, in health equity informed COVID-19 data reporting across jurisdictions?\n",
              "id": 279147,
              "answers": [
                {
                  "answer_id": 275161,
                  "document_id": 450750,
                  "question_id": 279147,
                  "text": "Though several “best practices” in health equity-oriented\n\nreporting were observed in Canada, equity data reporting is\n\nsparse and large gaps remain. Since jurisdictions that have explored potential social inequities in COVID-19 indicators have\n\nfound stark gradients in outcomes across individual- and localarea level characteristics, the absence of reporting of data according to vulnerable settings or social markers may be\n\nconcealing broader COVID-19-related inequities in Canada.\n",
                  "answer_start": 39457,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            }
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          "context": "Canadian Journal of Public Health (2021) 112:352–362\n\nhttps://doi.org/10.17269/s41997-021-00496-6\n\n\n\nSPECIAL SECTION ON COVID-19: QUANTITATIVE RESEARCH\n\n\n\nIdentifying gaps in COVID-19 health equity data reporting in Canada\n\nusing a scorecard approach\n\nAlexandra Blair 1\n\n\n\n&\n\n\n\nKahiye Warsame 1 & Harsh Naik 1,2 & Walter Byrne 1 & Abtin Parnia 1 & Arjumand Siddiqi 1,3\n\n\n\nReceived: 16 September 2020 / Accepted: 9 February 2021 / Published online: 19 March 2021\n\n# The Canadian Public Health Association 2021\n\n\n\nAbstract\n\nObjective To assess health equity-oriented COVID-19 reporting across Canadian provinces and territories, using a scorecard\n\napproach.\n\nMethods A scan was performed of provincial and territorial reporting of five data elements (cumulative totals of tests, cases, hospitalizations, deaths, and population size) across three units of aggregation (province or territory level, health regions, and local areas) (15\n\n“overall” indicators), and for four vulnerable settings (long-term care and detention facilities, schools, and homeless shelters) and eight\n\nsocial markers (age, sex, immigration status, race/ethnicity, healthcare worker status, occupational sector, income, and education) (180\n\n“equity-related” indicators) as of December 31, 2020. Per indicator, one point was awarded if case-delimited data were released, 0.7\n\npoints if only summary statistics were reported, and 0 if neither was provided. Results were presented using a scorecard approach.\n\nResults Overall, information was more complete for cases and deaths than for tests, hospitalizations, and population size\n\ndenominators needed for rate estimation. Information provided on jurisdictions and their regions, overall, tended to be more\n\navailable (average score of 58%, “D”) than that for equity-related indicators (average score of 17%, “F”). Only British Columbia,\n\nAlberta, and Ontario provided case-delimited data, with Ontario and Alberta providing case information for local areas. No\n\njurisdiction reported on outcomes according to patients’ immigration status, race/ethnicity, income, or education. Though several\n\nprovinces reported on cases in long-term care facilities, only Ontario and Quebec provided detailed information for detention\n\nfacilities and schools, and only Ontario reported on cases within homeless shelters and across occupational sectors.\n\nConclusion One year into the pandemic, socially stratified reporting for COVID-19 outcomes remains sparse in Canada.\n\nHowever, several “best practices” in health equity-oriented reporting were observed and set a relevant precedent for all jurisdictions to follow for this pandemic and future ones.\n\nRésumé\n\nObjectif Évaluer les pratiques de déclaration des données de surveillance de la COVID-19 axée sur l’équité en matière de santé\n\ndans les provinces et territoires canadiens, en utilisant une fiche de pointage.\n\nMéthodes Les sites webs et rapports officiels des provinces et territoires ont été analysés pour identifier la présence de cinq\n\néléments de données sur la COVID-19 (totaux cumulatifs des tests, cas, hospitalisations et décès ainsi que la taille de la\n\npopulation évaluée, nécessaire pour l’estimation de taux), déclarées au niveau de trois unités d’agrégation populationnelle (de\n\nla province/du territoire, des régions socio-sanitaires, et des localités/quartiers) (15 indicateurs de données « globales »); ainsi\n\nqu’au niveau de quatre milieux à risque d’éclosions (les établissements de soins de longue durée et de détention, les écoles, et les\n\nrefuges pour personnes en situation d’itinérance) et de huit marqueurs sociaux (l’âge, le sexe, le statut d’immigration, la\n\nrace/ethnicité, le statut de travailleur de santé, le revenu, le niveau d’éducation, et le secteur de travail) (180 indicateurs\n\nd’équité en matière de santé) à compter du 31 décembre 2020. Pour chaque indicateur, un point a été attribué si des données\n\ndélimitées par cas ont été publiées, 0,7 points si seules les statistiques sommaires ont été communiquées, et 0 si aucune\n\ninformation n’a été fournie. Les résultats sont présentés sous la forme d’une fiche de pointage.\n\n\n\n* Alexandra Blair\n\nalexandra.blair@utoronto.ca\n\n1\n\n\n\nDivision of Epidemiology, Dalla Lana School of Public Health,\n\nUniversity of Toronto, Toronto, Ontario, Canada\n\n\n\n2\n\n\n\nFaculty of Medicine, University of Toronto, Toronto, Ontario,\n\nCanada\n\n\n\n3\n\n\n\nGillings School of Global Public Health, University of North\n\nCarolina-Chapel Hill, Chapel Hill, NC, USA\n\n\n\n\fCan J Public Health (2021) 112:352–362\n\n\n\n353\n\n\n\nRésultats Dans l’ensemble, les informations sur les cas et les décès étaient plus complètes que celles pour les tests, les\n\nhospitalisations et les tailles de population. Les éléments de données étaient plus disponibles au niveau global des provinces et\n\nterritoires et de leurs régions socio-sanitaires (note moyenne de 58 % ou « D ») que pour les indicateurs liés à l’équité en matière\n\nde santé (note moyenne de 17 % ou « F »). Seuls la Colombie-Britannique, l’Alberta et l’Ontario ont fourni des données\n\ndélimitées par cas, et seuls l’Alberta et l’Ontario ont fourni des données au niveau local. Aucune juridiction n’a fait état de\n\ndonnées en fonction du statut d’immigration, de la race/l’ethnicité, du revenu ou du niveau d’éducation des patients. Plusieurs\n\njuridictions ont fourni des informations au sujet des cas au sein des établissements de soins de longue durée, mais seuls l’Ontario\n\net le Québec ont fourni des informations détaillées au sujet des établissements de détention et des écoles. L’Ontario était unique\n\nen rapportant sur les cas par secteur occupationnel et pour les refuges pour les personnes en situation d’itinérance.\n\nConclusion Un an après le début de la pandémie, la disponibilité des données sur la COVID-19, stratifiées par marqueurs sociaux, reste\n\ntrès limitée au Canada. Cependant, plusieurs « bonnes pratiques » en matière de déclaration axée sur l’équité en matière de santé ont été\n\nobservées, ce qui constitue un précédent pertinent que les juridictions pourront suivre pendant cette pandémie et celles à venir.\n\nKeywords COVID-19 . Disease outbreaks . Health equity . Social determinants of health . Socio-economic conditions . Canada\n\nMots-clés COVID-19 . épidémies . équité en matière de santé . déterminants sociaux de la santé . conditions socio-économiques .\n\nCanada\n\n\n\nIntroduction\n\nEarly reporting by regional and provincial jurisdictions in\n\nCanada suggests that, as has been the case in other countries such\n\nas the United States (USA) (Chen et al. 2020; Moore et al. 2020),\n\nsocial inequities in COVID-19 outcomes have emerged. In\n\nOntario, for instance, higher rates of COVID-19 incidence, hospitalization, and death have been observed in lower-income areas\n\nand areas with higher densities of immigrant and racialized residents (Chung et al. 2020). Toronto has reported that 83% of\n\nCOVID-19 cases with available race/ethnicity data, identified\n\nbetween mid-May and mid-July 2020, occurred among racialized residents, despite these residents representing 52% of the\n\ncity’s population (Toronto Public Health 2020).\n\nThese early reports of social inequities in COVID-19 outcomes beg several questions for public health policy and intervention. Since the identification of these inequities is predicated on the availability and release of COVID-19 surveillance data according to social markers, one fundamental question is how Canada is doing, overall, in health equityinformed COVID-19 data reporting across jurisdictions?\n\nKnowing which inequities have emerged, and where, is a\n\nnecessary first step in planning health equity-informed health\n\npolicy and interventions (Blair et al. 2018; Frank and\n\nMatsunaga 2020; Moore et al. 2020).\n\nIndeed, public release and reporting on surveillance data\n\nhave been essential to inform epidemiologic research and\n\nmodelling and public health interventions since the start of the\n\nCOVID-19 pandemic. Presenting data disaggregated by social\n\nmarkers, such as sex or race/ethnicity, can ensure that social and\n\npolitical responses to the health crisis are sensitive to and designed to be effective against social disparities in outcomes\n\n(Childs and Palmieri 2020). Data transparency also serves to\n\nprotect the public’s trust in public health guidelines and ensure\n\n\n\naccountability (Brison 2018). However, given that provincial\n\nand territorial rather than federal public health authorities are\n\nthe primary entities collecting and reporting on health data in\n\nCanada, public-facing output on local- or social markerdisaggregated data can vary across Canadian jurisdictions. An\n\nassessment of both overall and health equity-oriented COVID19 data reporting in each Canadian province and territory is\n\nneeded to identify both best practices and reporting gaps.\n\nThe objective of this study was to perform an environmental\n\nscan of COVID-19 data reporting across Canadian provinces\n\nand territories and to assess health equity-focused reporting\n\nusing a scorecard approach. Scorecards can be used to help\n\ntrack health-related trends or the quality of data reporting across\n\njurisdictions (MHASEF Research Team 2018). Here, we build\n\non the USA-based Coronavirus in Kids (COVKID) Tracking\n\nand Education Project’s recently proposed COVKID State Data\n\nQuality Report Card (Pathak et al. 2020) which was designed to\n\nidentify gaps in COVID-19 surveillance in children. We propose the Canadian COVID-19 Health Equity Data Scorecard as\n\nan evaluation framework for the Canadian context.\n\n\n\nMethod\n\nData\n\nA detailed environmental scan of official provincial and territorial public health websites and published reports was performed to identify data reporting content. Reference websites\n\nused were those provided by the Public Health Agency of\n\nCanada on their centralized reporting website (Public Health\n\nAgency of Canada 2020a). Provincial and territorial websites\n\nwere searched for data summaries, figures, and tables as well\n\nas downloadable reports (most often available in portable\n\n\n\n\f354\n\n\n\ndocument (PDF) format), by navigating through websites and\n\ndownloading and reviewing reports. The results are accurate\n\nup to December 31, 2020. This scan represents a summary of\n\nCanadian reporting as of approximately one year after the\n\nidentification of the first cases of COVID-19 (World Health\n\nOrganization 2020).\n\n\n\nScorecard indicators\n\nBased on the minimum data requirements proposed by extant\n\nCOVID-19 data quality assessments, such as the COVKID\n\nProject Data Quality Report Card (Pathak et al. 2020), we\n\nassessed provinces’ and territories’ reporting of five data elements: cumulative totals of tests performed, case counts, hospitalizations, and deaths, as well as the availability of data on\n\nthe size of populations of interest. Population size was not\n\nincluded in the COVKID Report Card assessment. However,\n\nit is included here insofar as it is necessary for rate estimation\n\nand relative comparisons across jurisdictions and groups.\n\nAs the COVKID Report Card does for each state, we\n\nassessed the availability (and the availability of explicit operational definitions) of these five data elements across provinces and territories, overall. We also assessed reporting on\n\ntwo additional levels of population aggregation: health region\n\nor unit level, and Forward Sortation Area-level or small\n\nneighbourhood area equivalent. Reporting on various levels\n\nof spatial aggregation was assessed given that transmission\n\nepidemiology and distributions of risk factors can vary across\n\njurisdictions and localities.\n\nAcross these levels of aggregation, we also assessed data\n\nreporting across eight equity-related indicator strata. Building\n\non the COVKID Report Card’s assessment of reporting across\n\nage and race/ethnicity, we assessed reporting across\n\nindividual-level exposure to four congregate living and institutional settings that are vulnerable to COVID-19 outbreaks\n\n(long-term care and detention facilities, homeless shelters, and\n\nschools) (Blair et al. 2020; Hsu et al. 2020; Public Health\n\nOntario 2020a; Richard et al. 2021) and eight individuallevel social markers (age, sex, immigration status,\n\nrace/ethnicity, healthcare worker status, occupational sector,\n\nand income and education groups). The latter social markers\n\nhave been identified as key social determinants of health and\n\ninfectious disease burden (Semenza et al. 2016; Solar and\n\nIrwin 2010). These individual-level social, economic, and occupational data would typically be obtained at testing, during\n\ncase interviews, or via data linkage to existing provincial or\n\nterritorial health and social administrative databases. With the\n\nfive data elements across three units of population\n\naggregation—overall and across twelve social strata—195 indicators were used (5 * 3 * (1 “overall” population-level stratum + 12 social strata) = 195).\n\nAs done for other scorecards, these indicators were selected\n\nfor being measurable, relevant for health equity surveillance,\n\n\n\nCan J Public Health (2021) 112:352–362\n\n\n\nactionable, and interpretable (Institute for Clinical Evaluative\n\nSciences 2018). Indeed, precedent exists for surveillance\n\nreporting across all social markers used, including by race/\n\nethnicity (CDC 2020; New Zealand Ministry of Health\n\n2020) and occupational sector (Iowa Department of Public\n\nHealth 2020)—if not for COVID-19, for other common health\n\noutcomes (Agic et al. 2013; Public Health Agency of Canada\n\n2020a; Stachenko 2008).\n\n\n\nAnalysis\n\nFor each of the 195 indicators, 1 point was awarded if raw,\n\nanonymized individual case-delimited data were released and\n\npublicly available (i.e., where each case represented one data\n\nrow, available in a downloadable, and editable file format,\n\nsuch as in Comma Separated Values (.csv) format). A total\n\nof 0.7 points was awarded if summary statistics were reported\n\nfor the indicator, but no raw case-delimited data were publicly\n\navailable, and a score of 0 was awarded if neither information\n\nwas reported nor data made publicly available. To contrast\n\nsurveillance reporting across jurisdictions at a national scale,\n\npoints were only awarded if the data element was available for\n\nthe entire jurisdiction (i.e., not if data were only available for\n\ncertain regions).\n\nWe used a near-complete (0.7 points; intentionally higher\n\nthan a half-point) and complete (1 point) scoring system rather\n\nthan a binary (present/absent, 0 vs. 1 point) method to acknowledge the relevance of summary statistic reporting, while\n\nrewarding jurisdictions that opted for full data transparency\n\nfor public use—as done in peer nations such as the United\n\nKingdom (UK Data Service 2020) and the USA (USA Facts\n\n2020). Raw data sharing has been identified as a best practice\n\nin supporting innovation and research, advancing government\n\naccountability and evidence-informed decision-making\n\n(Brison 2018; Lindquist and Huse 2017; Roy 2014). It also\n\nallows for an intersectional assessment of indicators. For example, the child health-focused COVKID scorecard found\n\nthat though many states report on COVID-19 outcomes by\n\nage and race, a limited number of states report on the race of\n\ncases by age group (thereby allowing for an assessment of\n\nracial disparities among children) (Pathak et al. 2020). The\n\nsharing of case-delimited data allows users to pursue these\n\nmore precise lines of inquiry.\n\nFor each level of aggregation, a percent score was estimated based on overall population-level data availability (score\n\nout of 5 data elements) and based on “equity” data across\n\nsocial strata (5 data elements * 12 social strata = score out of\n\n60). A summary percent score was computed for populationlevel data overall (5 data elements * 3 population aggregation\n\nunits = total score out of 15) and for equity-related data (5 data\n\nelements * 3 population aggregation units * 12 social strata =\n\ntotal score out of 180).\n\n\n\n\fCan J Public Health (2021) 112:352–362\n\n\n\nWe adjusted score denominators to take into account that\n\nreporting on some of the indicators, such as the cumulative\n\ntotal of deaths or hospitalizations, is less relevant in jurisdictions without any recorded cases or when case numbers are so\n\nlow (i.e., n < 5) that reporting may jeopardize patient confidentiality. When the total number of observations needed to\n\nestimate the indicator was less than 5, the indicator was removed from the score’s denominator total. In that way, if one\n\njurisdiction had not recorded any COVID-19 cases, for example, it was not penalized for not reporting on cases by age and\n\nsex. Last, the following letter grades were associated with\n\ndocumented percent scores: 0–39% as “F” (very poor),\n\n40–59% as “D” (poor), 60–69% as “C” (fair), 70–79% as\n\n“B” (good), 80–89% as “A” (very good), and 90–100% as\n\n“A+” (excellent).\n\n\n\nResults\n\nScores were estimated for each province and territory, and\n\nCanada overall (Fig. 1, with detailed scores and sources in\n\nSupplementary File, eTable 1). On average, over half (58%,\n\n“D” score) of the data elements were available at the overall\n\njurisdictional, health region, and local neighbourhood levels,\n\nwhile just under one in five (17%, “F” score) equity-related\n\ndata elements were available.\n\nThough all jurisdictions reported on the types of tests used to\n\nidentify SARS-CoV-2 infections, clear case definitions were not\n\nalways available, and definitions of what was counted as a\n\nCOVID-19 hospitalization or death were often missing\n\n(eTable 2).\n\n\n\nOverall population-level data reporting\n\nBy province and territory\n\nAt the province and territory level, data availability scores\n\nranged from “C” (62–68%) for Nova Scotia, Prince Edward\n\nIsland, Newfoundland and Labrador, Nunavut, and the Yukon\n\nto “A” (82–88%) for British Columbia, Alberta, and Ontario.\n\nOn average, 73% (“B”) of data elements were available at the\n\nprovince and territory level in Canada (Fig. 1).\n\nAll provinces and territories reported on the total number of\n\ntests, cases, and deaths (Fig. 2), with British Columbia, Alberta,\n\nand Ontario providing case-delimited data for all cases observed\n\n(Fig. 2b). Alberta and Ontario were the only two provinces that\n\nalso reported on the outcomes (recovery or death) for each case,\n\nin a downloadable case-delimited format. Though most jurisdictions reported on the total number of hospitalizations that have\n\noccurred, these data were not provided by Nova Scotia, Prince\n\nEdward Island, Newfoundland and Labrador, nor the three territories (Fig. 2c). Population denominators for all jurisdictions\n\nwere available through the Canadian Census.\n\n\n\n355\n\n\n\nBy health region\n\nFor reporting by health regions within jurisdictions, population data availability scores ranged from “F” (25–34%) for\n\nNova Scotia, Nunavut, and the Yukon to “A” (82–88%) for\n\nBritish Columbia, Alberta, and Ontario (Fig. 1). On average in\n\nCanada, 59% (“D”) of data elements were available for regions within jurisdictions.\n\nThe overall number of tests conducted per health region\n\nwas available for 8 out of 13 jurisdictions (Fig. 3a). Quebec,\n\none of the provinces hit hardest by the pandemic (Public\n\nHealth Agency of Canada 2020a), did not report on total tests\n\nconducted per region. In contrast, reporting on the total number of cases per health region was more complete, with British\n\nColumbia, Alberta, and Ontario standing out as provinces that\n\nprovide data on the region of residence for all identified cases\n\n(Fig. 3b). Overall, most provinces that reported on overall\n\nhospitalizations (Fig. 2c) also provided summaries of hospitalizations per health region (Fig. 3c)—New Brunswick was\n\nthe exception to this rule. Except for Nova Scotia, data on\n\ndeaths per health region were available for all jurisdictions\n\nreporting over five deaths (Fig. 3d). Last, population denominators for all health regions within jurisdictions were available from Statistics Canada’s Canadian Census.\n\nBy Forward Sortation Area or the local neighbourhood area\n\nequivalent\n\nPopulation denominators are made available by Statistics\n\nCanada for all Forward Sortation Areas in Canada.\n\nOverall, no jurisdictions reported on the cumulative total of\n\nhospitalizations at the local area level. None but Nunavut reported on the overall number of tests undertaken at the local\n\nlevel. Very few jurisdictions reported on the number of cases\n\nor deaths by local area. Exceptions were Alberta, with its\n\nreporting on the number of cases and deaths for all local areas\n\nof residence, and Ontario’s case-delimited dataset, which included the postal code associated with each death.\n\nOverall, data availability scores for population data at the\n\nlocal area level ranged from “F” (20–25%) for most jurisdictions to “D” (48%) for Alberta and “C” (60%) for Ontario. On\n\naverage in Canada, 27% (“F”) of data elements were available\n\nfor local areas within jurisdictions (Fig. 1).\n\n\n\nEquity-oriented reporting by social markers and\n\nvulnerable settings\n\nOn average in Canada, 17% (“F”) of data elements were available across identified equity-oriented social markers and vulnerable settings at the province and territory level (Fig. 1).\n\nScores were lower for equity data reporting across health regions and local areas (average scores of 16% and 15%, respectively, for Canada overall).\n\n\n\n\f356\n\n\n\nCan J Public Health (2021) 112:352–362\n\n\n\nCanadian COVID-19 Health Equity Data Scorecard\n\n\n\nASSESSMENT OF REPORTING ON FIVE DATA ELEMENTS:\n\nTOTAL TESTS, CASES, HOSPITALIZATIONS, DEATHS AND POPULATION COUNTS\n\nFor the Province/Territory\n\nPOPULATION DATA\n\n\n\nNUNAVUT\n\nNWT\n\n\n\nC\n\n\n\nYUKON\n\n\n\nC\n\n\n\nBRITISH COLUMBIA\n\n\n\nA\n\n\n\nALBERTA\n\n\n\nA\n\n\n\nSASKATCHEWAN\n\n\n\nB\n\n\n\nMANITOBA\n\n\n\nB\n\n\n\nONTARIO\n\n\n\nA\n\n\n\nQUEBEC\n\n\n\nB\n\n\n\nNEW BRUNSWICK\n\n\n\nB\n\n\n\nNOVA SCOTIA\n\n\n\nC\n\n\n\nNEW BRUNSWICK\n\n\n\nPEI\n\n\n\nC\n\n\n\nNOVA SCOTIA\n\n\n\nF\n\n\n\n68%\n\nNUNAVUT\n\n68%\n\nNWT\n\n\n\n68%\n\n\n\nYUKON\n\n\n\n82%\n\n\n\nBRITISH COLUMBIA\n\n\n\nF\n\nF\n\nF\n\nF\n\n\n\n88%\n\n\n\nCANADA\n\nCANADA\n\n\n\nB\n\n\n\nALBERTA\n\n\n\n76%\n\n\n\nSASKATCHEWAN\n\n\n\n76%\n\n\n\nMANITOBA\n\n\n\n88%\n\n\n\nONTARIO\n\n\n\n76%\n\n\n\nQUEBEC\n\n\n\n76%\n\n\n\n62%\n\n\n\n62%\n\n62%\n\n\n\nPEI\n\n\n\nNEWFOUNDLAND\n\n\n\n73%\n\n\n\nF\n\nF\n\n\n\n15%\n\n\n\nC\n\n\n\n15%\n\n\n\nF\n\n\n\n26%\n\n24%\n\n18%\n\n16%\n\n\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\n\n\nF\n\n\n\n15%\n\n\n\n36%\n\n27%\n\n14%\n\n14%\n\n18%\n\n\n\nPOPULATION DATA\n\n\n\nDATA ELEMENT\n\nREPORTING\n\nOVERALL\n\n\n\nEQUITY DATA*\n\n\n\nC\n\n\n\nC\n\n\n\nFor Local Areas\n\n\n\nPOPULATION DATA\n\n\n\nDATA ELEMENT\n\nREPORTING\n\nOVERALL\n\n\n\nNEWFOUNDLAND\n\n\n\nFor Health Regions\n\n\n\nF\n\n\n\n25%\n\nNUNAVUT\n\n\n\n60%\n\n\n\nNWT\n\n\n\n25%\n\n\n\nA\n\nA\n\n\n\nYUKON\n\n\n\n82%\n\n\n\nBRITISH COLUMBIA\n\n\n\n88%\n\n\n\nB\n\n\n\nALBERTA\n\n\n\n76%\n\n\n\nB\n\n\n\nSASKATCHEWAN\n\n\n\nA\n\n\n\nMANITOBA\n\n\n\n76%\n\n\n\n88%\n\n\n\nC\n\nD\n\nF\n\nD\n\n\n\n19%\n\n\n\nC\n\n\n\n20%\n\n\n\nD\n\n\n\nONTARIO\n\n\n\n62%\n\n48%\n\n\n\nQUEBEC\n\n\n\nNEW BRUNSWICK\n\n\n\n34%\n\n\n\n43%\n\n\n\nDATA ELEMENT\n\nREPORTING\n\nOVERALL\n\n\n\nEQUITY DATA*\n\n\n\nNOVA SCOTIA\n\n\n\n62%\n\n\n\nPEI\n\n\n\nNEWFOUNDLAND\n\n\n\n59%\n\n\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\n\n\nF\n\nF\n\nF\n\nF\n\nF\n\n\n\nNUNAVUT\n\n\n\n15%\n\n\n\nNWT\n\n\n\n15%\n\n\n\nYUKON\n\n\n\n17%\n\n\n\nBRITISH COLUMBIA\n\n\n\n21%\n\n\n\nALBERTA\n\n\n\n14%\n\n14%\n\n\n\nF\n\nF\n\n\n\nF\n\n\n\n15%\n\n\n\nSASKATCHEWAN\n\n\n\n32%\n\n\n\n19%\n\n\n\nONTARIO\n\n\n\nQUEBEC\n\n\n\n12%\n\n12%\n\n\n\nMANITOBA\n\n\n\nNEW BRUNSWICK\n\n\n\n15%\n\n15%\n\n\n\nNOVA SCOTIA\n\n\n\nPEI\n\n\n\nNEWFOUNDLAND\n\n\n\n16%\n\n\n\nF\n\nF\n\nF\n\nD\n\nF\n\nF\n\n\n\nF\n\nF\n\nF\n\nF\n\nF\n\n\n\nNUNAVUT\n\n\n\nNWT\n\n\n\n25%\n\n\n\nYUKON\n\n\n\n20%\n\n\n\nBRITISH COLUMBIA\n\n\n\n48%\n\n\n\n20%\n\n\n\nALBERTA\n\n\n\n20% SASKATCHEWAN\n\n\n\nC\n\nF\n\n\n\nF\n\n\n\n25%\n\n25%\n\n\n\nMANITOBA\n\n\n\n60%\n\n\n\n20%\n\n\n\nONTARIO\n\n\n\n20%\n\n\n\nQUEBEC\n\n\n\n20%NEW BRUNSWICK\n\n25%\n\n25%\n\n\n\nTOTAL\n\n\n\nEQUITY DATA*\n\n\n\nNOVA SCOTIA\n\n\n\nPEI\n\n\n\nNEWFOUNDLAND\n\n27%\n\n\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\n\n\n15%\n\n15%\n\n15%\n\n14%\n\n12%\n\n12%\n\n12%\n\n25%\n\n19%\n\n12%\n\n12%\n\n15%\n\n15%\n\n15%\n\n\n\nPOPULATION\n\n\n\nEQUITY*\n\n\n\nD\n\n\n\nF\n\n\n\nD\n\nD\n\n\n\n49%\n\n58%\n\n49%\n\n\n\nC\n\n\n\n64%\n\n\n\nA\n\nD\n\nD\n\n\n\n80%\n\n59%\n\n59%\n\n\n\nA\n\nD\n\nD\n\nD\n\nD\n\nD\n\nD\n\n\n\n85%\n\n59%\n\n53%\n\n42%\n\n\n\n43%\n\n49%\n\n58%\n\n\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\nF\n\n\n\nF\n\nF\n\n\n\n15%\n\n\n\n15%\n\n15%\n\n19%\n\n19%\n\n14%\n\n14%\n\n31%\n\n22%\n\n12%\n\n12%\n\n16%\n\n16%\n\n17%\n\n\n\n*EQUITY DATA REPORTING: BY AGE, SEX, RACE/ETHNICITY, IMMIGRATION, HEALTHCARE WORKER, OCCUPATION, INCOME, EDUCATION, CARE/DETENTION/SCHOOL/HOMELESS SHELTER SETTING\n\n\n\nREPORTING SCORES: A+ “EXCELLENT” (90-100%) A “VERY GOOD” (80-89%) B “GOOD” (70-79%) C “FAIR” (60-69%) D “POOR” (50-59%) F “VERY POOR” (0-39%) (DATA AS OF DECEMBER 31, 2020)\n\n\n\nFig. 1 Scores for multi-level population and equity-related data in Canada, by province and territory. PEI, Prince Edward Island. NWT, Northwest\n\nTerritories\n\n\n\nBy age and sex\n\nInformation on population sizes by age and sex overall, and\n\nfor regions and local areas is made available by Statistics\n\nCanada, through the Canadian Census. Of all the social\n\nmarkers studied, age and sex were the characteristics for\n\nwhich COVID-19 data reporting was most common. All provinces except for New Brunswick reported on cases’ age and\n\nsex distribution at the population level (Fig. 4). None of the\n\nterritories reported on cases’ age or sex (Fig. 4). British\n\nColumbia, Alberta, and Ontario were the only three provinces\n\nthat provided age and sex characteristics of all cases, in a casedelimited format.\n\nIn contrast, age- and sex-related information was sparser\n\nfor testing, hospitalizations, and deaths across all jurisdictions\n\noverall and by health regions. Only Ontario consistently reported on all data elements by age and sex at the overall\n\nprovincial and health region level (Fig. 4).\n\nSex disaggregation was mostly done according to designations of “male” and “female.” However, Ontario also included\n\n\n\ncategories of “Other” and “Unspecified” and British\n\nColumbia included the category “Unknown” (eTable 2).\n\nAge disaggregation was mostly done for 10-year age\n\ngroups—consistently from ages <20, 20–39, 40–49, etc. to\n\n80 years and above (eTable 2). New Brunswick, Quebec,\n\nManitoba, Alberta, and British Columbia also included categories for those under 10 years—with Alberta also reporting\n\non data for additional age ranges of <1, 1–4, and 5–9 years\n\n(eTable 2).\n\n\n\nImmigration, race/ethnicity, income, education\n\nThough information on population sizes by\n\nimmigration status, race/ethnicity, income, and education is\n\navailable through the Canadian Census for jurisdictions overall, as well as by region and local area, no province or territory\n\nreported on any of the data elements according to these social\n\nmarkers (Fig. 4).\n\n\n\n\fCan J Public Health (2021) 112:352–362\n\n\n\n357\n\n\n\nFig. 2 Overall, province- and territory-level reporting (data availability) on the cumulative total of tests (panel a), cases (panel b), hospitalizations (panel\n\nc), and deaths (panel d)\n\n\n\nHealthcare worker status and occupational sector\n\nAt the overall provincial level, British Columbia,\n\nAlberta, Saskatchewan, Manitoba, and Ontario provided\n\ninformation on cases among essential healthcare\n\nworkers—with Alberta and Ontario providing this information at both the province and territory and regional\n\nlevels (Fig. 4). However, the total number of healthcare\n\nworkers at the provincial or territorial level, or by region or local area, was missing for all jurisdictions.\n\nOnly Ontario provided details on the number of cases\n\nacross occupational sectors beyond the healthcare setting\n\n(e.g., farm, food processing, retail) (eTable 1).\n\n\n\nVulnerable settings (long-term care and detention facilities,\n\nhomeless shelters, schools)\n\nOntario, Quebec, Newfoundland and Labrador, British\n\nColumbia, Saskatchewan, and Manitoba reported on the number of cases associated with long-term care (LTC) facilities—\n\nwith British Columbia, Ontario, and Quebec also reporting on\n\ndeaths within these facilities. Ontario and Quebec listed precise facilities (that could be geolocated in local areas) that had\n\nor were experiencing outbreaks. Saskatchewan provided current case counts for precise LTC facilities on a weekly, rather\n\nthan cumulative, basis. In Ontario and Quebec, the total number of tests and hospitalizations recorded for patients or staff in\n\n\n\n\f358\n\n\n\nCan J Public Health (2021) 112:352–362\n\n\n\nFig. 3 Reporting (data availability) on the cumulative total of tests (panel a), cases (panel b), hospitalizations (panel c), and deaths (panel d), overall, for\n\neach health region or health unit within the province/territory\n\n\n\nthese settings was missing. Only Ontario provided data on\n\ntests within LTC facilities, as well as the total number of beds\n\nper facility experiencing an outbreak—which could be used as\n\na proxy for patient population size.\n\nQuebec and Ontario were the only provinces that reported\n\non the total number of cases for each provincial detention\n\nfacility. Of these two, Quebec was the only province to report\n\non the total number of tests, deaths, number of prisoners, and\n\ncases among staff per facility. Missing, however, was information on cases’ potential hospitalization status.\n\nFor school settings, only case totals were reported in\n\nOntario and Quebec. Ontario was also the only province to\n\nexplicitly report on case totals associated with homeless\n\nshelters.\n\n\n\nDiscussion\n\nThis paper provides the first summary of health equity-related\n\nCOVID-19 data reporting in Canada within the first year since\n\nthe first COVID-19 case was identified in Wuhan, China. In\n\nCanada, information on cases and deaths was more complete\n\nthan that for tests, hospitalizations, and population denominators for all indicators. Jurisdictions tended to report more\n\ncompletely on overall statistics than on information for regions or local areas, or according to population subgroups.\n\nThe scan suggests that large gaps in reporting remain, even\n\nfor more standard social disaggregation markers such as age\n\nand sex. Though relatively uncommon across the country,\n\ncertain “best practices” in reporting emerged. For example,\n\n\n\n\fCan J Public Health (2021) 112:352–362\n\n\n\n359\n\n\n\nBY PROVINCE / TERRITORY\n\nReporting by:\n\n\n\nBY HEALTH REGION\n\n\n\nBC\n\n\n\nAB\n\n\n\nSK\n\n\n\nMB\n\n\n\nON\n\n\n\nQC\n\n\n\nNB\n\n\n\nNS\n\n\n\nPE\n\n\n\nNL\n\n\n\nNU\n\n\n\nNT\n\n\n\nYT\n\n\n\nBC\n\n\n\nAB\n\n\n\nSK\n\n\n\nMB\n\n\n\nON\n\n\n\nQC\n\n\n\nNB\n\n\n\nNS\n\n\n\nPE\n\n\n\nNL\n\n\n\nNU\n\n\n\nNT\n\n\n\nYT\n\n\n\nBC\n\n\n\nAB\n\n\n\nSK\n\n\n\nMB\n\n\n\nON\n\n\n\nQC\n\n\n\nNB\n\n\n\nNS\n\n\n\nPE\n\n\n\nNL\n\n\n\nNU\n\n\n\nNT\n\n\n\nYT\n\n\n\nBC\n\n\n\nAB\n\n\n\nSK\n\n\n\nMB\n\n\n\nON\n\n\n\nQC\n\n\n\nNB\n\n\n\nNS\n\n\n\nPE\n\n\n\nNL\n\n\n\nNU\n\n\n\nNT\n\n\n\nYT\n\n\n\nBC\n\n\n\nAB\n\n\n\nSK\n\n\n\nMB\n\n\n\nON\n\n\n\nQC\n\n\n\nNB\n\n\n\nNS\n\n\n\nPE\n\n\n\nNL\n\n\n\nNU\n\n\n\nNT\n\n\n\nYT\n\n\n\nBC\n\n\n\nAB\n\n\n\nSK\n\n\n\nMB\n\n\n\nON\n\n\n\nQC\n\n\n\nNB\n\n\n\nNS\n\n\n\nPE\n\n\n\nNL\n\n\n\nNU\n\n\n\nNT\n\n\n\nYT\n\n\n\nBC\n\n\n\nAB\n\n\n\nSK\n\n\n\nMB\n\n\n\nON\n\n\n\nQC\n\n\n\nNB\n\n\n\nNS\n\n\n\nPE\n\n\n\nNL\n\n\n\nNU\n\n\n\nNT\n\n\n\nYT\n\n\n\nBC\n\n\n\nAB\n\n\n\nSK\n\n\n\nMB\n\n\n\nON\n\n\n\nQC\n\n\n\nNB\n\n\n\nNS\n\n\n\nPE\n\n\n\nNL\n\n\n\nNU\n\n\n\nNT\n\n\n\nYT\n\n\n\nAge\n\nSex\n\nImmigration\n\n\n\nTESTS\n\n\n\nRace/ethnicity\n\n\n\nHealth worker\n\nIncome\n\nEducation\n\nOccupation sector\n\nHomeless shelter\n\nSchools\n\nLTC\n\nDetention\n\nReporting by:\n\n\n\nAge\n\nSex\n\nImmigration\n\n\n\nCASES\n\n\n\nRace/ethnicity\n\nHealth worker\n\nIncome\n\nEducation\n\nOccupation sector\n\nHomeless shelter\n\nSchools\n\nLTC\n\nDetention\n\nReporting by:\n\n\n\nAge\n\n\n\nHOSPITALIZATIONS\n\n\n\nSex\n\nImmigration\n\nRace/ethnicity\n\nHealth worker\n\nIncome\n\nEducation\n\nOccupation sector\n\nHomeless shelter\n\nSchools\n\nLTC\n\nDetention\n\nReporting by:\n\n\n\nAge\n\nSex\n\nImmigration\n\n\n\nDEATHS\n\n\n\nRace/ethnicity\n\nHealth worker\n\nIncome\n\nEducation\n\nOccupation sector\n\nHomeless shelter\n\nSchools\n\nLTC\n\nDetention\n\nCase data available\n\n\n\nInformation reported\n\n\n\nFig. 4 Reporting on the cumulative total of tests, cases, hospitalizations,\n\nand deaths by social markers and settings. BC, British Columbia; AB,\n\nAlberta; SK, Saskatchewan; MB, Manitoba; ON, Ontario; QC, Quebec;\n\n\n\nInformation not available\n\n\n\nN≤ 5 observations total\n\n\n\nNB, New Brunswick; NS, Nova Scotia; PE, Prince Edward Island; NL,\n\nNewfoundland and Labrador; NU, Nunavut; NT, Northwest Territories;\n\nYT, Yukon; LTC, long-term care settings\n\n\n\n\f360\n\n\n\nthree provinces (Alberta, British Columbia, and Ontario) provided case-delimited data on cases for external users to study.\n\nAlberta and Ontario provided case-delimited data that included cases’ local area-level identifiers, enabling localized spatial\n\nanalyses. Almost half of the provinces provided case counts\n\nassociated with LTC settings, with Ontario and Quebec listing\n\nindividual facilities that had or were experiencing outbreaks in\n\nthe province—which can enable the precise geo-location of\n\nfacilities within neighbourhoods, for use in socio-spatial analyses of transmission risk. Ontario stood out in its reporting of\n\ncases across the largest range of equity strata, including across\n\nschools, homeless shelters, and occupational sectors outside\n\nof healthcare. Last, though Ontario and Quebec both provided\n\ndetails on cases within provincial detention facilities, Quebec\n\nwas alone in providing detailed information on COVID-19\n\ntests, deaths, prisoner population size, and cases within staff\n\npopulations per detention facilities. These examples set important precedents and guidance for other jurisdictions to follow, especially as emerging evidence suggests that if COVID19 outcomes are properly examined across population subgroups, underlying inequities can be revealed and addressed\n\n(Chung et al. 2020; Toronto Public Health 2020).\n\nHeterogeneities in reporting observed across Canada are\n\naligned with previous findings that public health surveillance\n\ninfrastructures and capacities tend to vary across jurisdictions\n\nin Canada—which had been identified as an area of concern\n\nfor pandemic planning and preparedness following the SARS\n\noutbreak in 2003 (Naylor 2003). This variability in resources\n\nacross jurisdictions may limit capacities to collect necessary\n\nsocial data and report on findings across settings or social\n\nmarkers. Since the availability of individual-level equity-related data would typically be obtained at testing, during case\n\ninterviews, or via data linkage to existing administrative databases, several situations may jeopardize equity-related data\n\ncollection and reporting. For example, there may be provinces\n\nor territories for which these types of databases may not exist\n\nor be limited in scope, or for which COVID-19 testing intake\n\nor case interview questionnaires are missing items on social,\n\neconomic, or occupational characteristics. When faced with\n\nelevated testing and caseloads and limited time to collect\n\nand report on a wide range of indicators, lower personnel\n\ncapacity can require the prioritization of a subset of case interview elements that exclude equity-related items. For settings such as long-term care homes, detention facilities,\n\nschools and homeless shelters, collection and reporting on\n\ncases and population sizes requires intersectoral collaboration\n\nand communication between public health and other governmental sectors, as well as with the private or community\n\nsectors.\n\nTo overcome these challenges, formal exchange of promising practices, through meetings at federal and provincial and\n\nterritorial levels, between public health, healthcare, and\n\ncommunity-level stakeholders may be beneficial. These can\n\n\n\nCan J Public Health (2021) 112:352–362\n\n\n\nfoster communication on existing barriers to equity-related\n\ndata collection and reporting, as well as promising\n\npractices—be it on equity-related data collection and reporting\n\nguidelines (Government of Ontario 2019), questionnaires for\n\nsocial data collection (Agic et al. 2013), intersectoral collaboration strategies, or data communication. National guidance\n\ncan be developed to ensure the quality and comparability of\n\ndata collected across jurisdictions, which respects fundamental principles such as those pertaining to Indigenous data sovereignty. An example of this is the Canadian Institute for\n\nHealth Information’s Proposed Standards for Race-Based\n\nand Indigenous Identity Data Collection and Health\n\nReporting in Canada (Canadian Institute for Health\n\nInformation 2020). Indeed, the Public Health Agency of\n\nCanada’s COVID-19 Case Report Form was updated in\n\nOctober 2020 to include more detailed items on cases’ dwelling type (including correctional facility, long-term care,\n\nhomeless shelter), race/ethnicity, temporary foreign worker\n\nstatus, and occupation, which can be used across provinces\n\nand territories for more detailed reporting (Public Health\n\nAgency of Canada 2020b). Additional equity-informed elements (e.g., education level) could be added to this case report\n\nform or those for use in future pandemics. It will also be\n\nessential to assess how these guidelines and tools are applied\n\nacross jurisdictions, to allow for national reporting on social\n\ninequalities.\n\nIn the context of other major public health phenomena, such\n\nas rising diabetes rates in Canada, successful strategies to guide\n\npublic health practice included the development of a national\n\naction plan, which yielded the development of performance\n\nmeasures, knowledge mobilization strategies, funding mechanisms to support research and community programs, a joint\n\nsurveillance plan with First Nations, Métis, and Inuit partners,\n\nand feasibility studies of the use of health administrative data\n\nlinkages for surveillance (Public Health Agency of Canada,\n\nHealth Canada, & Canadian Institutes of Health Research\n\n2013). Similar steps may also be fruitful for determining what\n\ndata should be collected, and how they can be collected and\n\nshared to improve equity-informed reporting and decisionmaking on COVID-19 and other health phenomena.\n\nThe scorecard approach presented here can be used for\n\ncontinued assessments of COVID-19 surveillance reporting\n\nor adapted for use in future infectious disease outbreaks. The\n\nCOVKID scorecard database has been updated twice (August\n\nand May 2020) (Pathak et al. 2020). An update of a scan and\n\nscorecard such as the one presented here would be beneficial\n\nevery year, at minimum, which corresponds to the frequency\n\nof reporting for infectious disease-related outcomes and targets in Canada (Public Health Agency of Canada 2020c).\n\nUpdating the scan as of December of every year would provide a useful portrait of reporting progress since the first cases\n\nof COVID-19 were identified on December 31, 2019 (World\n\nHealth Organization 2020).\n\n\n\n\fCan J Public Health (2021) 112:352–362\n\n\n\nHowever, the scorecard approach used has certain limitations. For one, a restricted list of social marker indicators was\n\nused. Future expanded versions of an equity-oriented scorecard could assess COVID-19 outcome reporting according to\n\nindicators such as preferred language, year of immigration,\n\ndisability status, sexual orientation, household crowding, gender, or Indigenous identity (Agic et al. 2013). Second, by\n\nevaluating provincial or territorial reporting, this scorecard\n\nassessment did not address more detailed reporting efforts in\n\nspecific public health units within jurisdictions. For instance,\n\ndetailed neighbourhood-level reporting efforts have been\n\nmade by Montreal Public Health (Direction de la santé\n\npublique de Montréal 2020) and several public health units\n\nin Ontario (Public Health Ontario 2020b), including Toronto\n\nPublic Health’s reporting on cases by income and race/\n\nethnicity (Toronto Public Health 2020). In Manitoba, First\n\nNations partners have collaborated to provide a report of tests,\n\ncases, hospitalizations, and deaths among First Nations people\n\nliving on and off reserve (Manitoba First Nations COVID-19\n\nPandemic Response Coordination Team 2021). The present\n\nscan was restricted to provincial and territorial reporting to\n\ncontrast among jurisdictions on a national scale. Future scans\n\nof best data collection and reporting practices across levels of\n\ngovernance may be warranted. Further, this scan excludes\n\ninformation sharing by federal bodies, such as the\n\nCorrectional Service of Canada’s reporting on cases within\n\nfederal penitentiaries (CSC 2020). Future assessments of\n\nfederal-level reporting may also be warranted.\n\n\n\nConclusion\n\nThough several “best practices” in health equity-oriented\n\nreporting were observed in Canada, equity data reporting is\n\nsparse and large gaps remain. Since jurisdictions that have explored potential social inequities in COVID-19 indicators have\n\nfound stark gradients in outcomes across individual- and localarea level characteristics, the absence of reporting of data according to vulnerable settings or social markers may be\n\nconcealing broader COVID-19-related inequities in Canada.\n\nThe proposed scorecard format and examples of “best practices” identified herein can be used to guide surveillance and\n\nreporting during this pandemic and in future ones, and monitor\n\nprogress on health equity-informed reporting overall.\n\nSupplementary Information The online version contains supplementary\n\nmaterial available at https://doi.org/10.17269/s41997-021-00496-6.\n\nAuthor contributions AB, AP, and AS designed the scorecard framework. KW, HN, WB, and AB performed the environmental scan and\n\ncollected the data for the study. AB drafted the manuscript, which was\n\nrevised by AS, AP, KW, HN, and WB.\n\n\n\n361\n\nFunding AB receives postdoctoral funding from the Fonds de Recherche\n\ndu Québec-Santé. AS is supported by the Canada Research Chair in\n\nPopulation Health Equity.\n\nData Availability Results are summarized in the Supplementary File\n\n(eTable 1).\n\nCode Availability Not applicable.\n\n\n\nDeclarations\n\nEthics approval None required.\n\nConsent to participate Not applicable.\n\nConsent for publication Not applicable.\n\nConflict of interest The authors declare no competing interests.\n\n\n\nReferences\n\nAgic, B., McKeown, D., McKenzie, K., Pinto, A., & Sinha, S. (2013).\n\nWe ask because we care: the Tri-Hospital + TPH Health Equity Data\n\nCollection Research Project Report. Toronto, Canada. http://www.\n\nstmichaelshospital.com/quality/equity-data-collection-report.pdf.\n\nAccessed 22 Feb 2021.\n\nBlair, A., Siddiqi, A., & Frank, J. (2018). 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C., Lindgren, E., Balkanyi, L., Espinosa, L., Almqvist, M. S.,\n\nPenttinen, P., & Rocklov, J. (2016). Determinants and drivers of\n\ninfectious disease threat events in Europe. Emerging Infectious\n\nDiseases, 22(4), 581–589. https://doi.org/10.3201/eid2204.\n\nSolar, O., & Irwin, A. (2010). A conceptual framework for action on the\n\nsocial determinants of health. WHO Document Production Services.\n\nhttps://www.who.int/sdhconference/resources/\n\nConceptualframeworkforactiononSDH_eng.pdf. Accessed\n\n22 Feb 2021.\n\nStachenko, S. (2008). Challenges and opportunities for surveillance data\n\nto inform public health policy on chronic non-communicable diseases: Canadian perspectives. Public Health, 122(10), 1038–1041.\n\nhttps://doi.org/10.1016/j.puhe.2008.05.006.\n\nToronto Public Health. (2020). COVID-19 infection in Toronto: ethnoracial identity and income. COVID-19: Status of Cases in Toronto.\n\nhttps://www.toronto.ca/home/covid-19/covid-19-latest-city-oftoronto-news/covid-19-status-of-cases-in-toronto/. Accessed\n\n11 Aug 2020.\n\nUK Data Service. (2020). COVID-19 data. https://www.ukdataservice.\n\nac.uk/get-data/themes/covid-19/covid-19-data.aspx. Accessed\n\n19 June 2020.\n\nUSA Facts. (2020). Coronavirus Locations: COVID-19 Map by County\n\nand State - COVID-19 deaths dataset. https://usafacts.org/visualizations/coronavirus-covid-19-spread-map/. Accessed 23 June 2020.\n\nWorld Health Organization. (2020). Pneumonia of unknown cause –\n\nChina, 5 January 2020. Disease outbreak news. [Web Archive]\n\nhttps://web.archive.org/web/20200130204239/; https://www.who.\n\nint/csr/don/05-january-2020-pneumonia-of-unkown-cause-china/\n\nen/. Accessed 27 Jan 2021.\n\nPublisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.\n\n\n\n\f",
          "document_id": 450750
        }
      ]
    },
    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "How is the COVID-19 pandemic affecting the mental health of parents and children and what subgroups are most impacted by the pandemic? ",
              "id": 279149,
              "answers": [
                {
                  "answer_id": 275162,
                  "document_id": 450752,
                  "question_id": 279149,
                  "text": "The majority of parents (59.7%; 95% CI 55.7 to 63.6)\n\nreported their children’s mental health had stayed\n\nthe same since the onset of the COVID-19 pandemic;\n\nhowever, 24.8% (95% CI 21.4 to 28.4) indicated that their\n\nchildren’s mental health had worsened.\n\nOverall, due to the COVID-19 pandemic, parents\n\nreported more negative interactions with their children,\n\nincluding more conflicts (22.2%; 95% CI 19.0 to 25.7),\n\nyelling/shouting (16.7%; 95% CI 13.8 to 19.8), disciplining (16.0%; 95% CI 13.2 to 19.2) and using harsh\n\nwords (10.7%; 95% CI 8.4 to 13.4). However, overall,\n\nparents also reported that they experienced increased\n\npositive interactions with their children, including\n\nhaving more quality time (65.4%; 95% CI 61.5 to 69.1),\n\nfeeling closeness (49.7%; 95% CI 45.7 to 53.7), showing\n\nlove or affection to their children (44.5%; 95% CI 40.5\n\nto 48.5) and observing increased resilience",
                  "answer_start": 24950,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            }
          ],
          "context": "Original research\n\n\n\nExamining the impacts of the COVID-19\n\npandemic on family mental health in\n\nCanada: findings from a national cross-­\n\nsectional study\n\nAnne C Gadermann ‍ ‍,1,2 Kimberly C Thomson ‍ ‍,1,2 Chris G Richardson ‍ ‍,2,3\n\nMonique Gagné ‍ ‍,1,2 Corey McAuliffe ‍ ‍,4 Saima Hirani ‍ ‍,4 Emily Jenkins ‍ ‍4\n\n\n\nTo cite: Gadermann AC,\n\nThomson KC, Richardson CG,\n\net al. Examining the impacts\n\nof the COVID-19 pandemic on\n\nfamily mental health in Canada:\n\nfindings from a national cross-­\n\nsectional study. BMJ Open\n\n2021;11:e042871. doi:10.1136/\n\nbmjopen-2020-042871\n\n►► Prepublication history and\n\nadditional material for this paper\n\nis available online. To view these\n\nfiles, please visit the journal\n\nonline (http://​dx.d​ oi.​org/​10.​\n\n1136/b​ mjopen-​2020-0​ 42871).\n\n\n\nReceived 21 July 2020\n\nRevised 21 November 2020\n\nAccepted 14 December 2020\n\n\n\n© Author(s) (or their\n\nemployer(s)) 2021. Re-­use\n\npermitted under CC BY-­NC. No\n\ncommercial re-­use. See rights\n\nand permissions. Published by\n\nBMJ.\n\nFor numbered affiliations see\n\nend of article.\n\nCorrespondence to\n\nDr Anne C Gadermann;\n\n​anne.​gadermann@u​ bc.​ca\n\n\n\nABSTRACT\n\nObjectives In the first wave of the COVID-19 pandemic,\n\nsocial isolation, school/child care closures and\n\nemployment instability have created unprecedented\n\nconditions for families raising children at home. This study\n\ndescribes the mental health impacts of the COVID-19\n\npandemic on families with children in Canada.\n\nDesign, setting and participants This descriptive study\n\nused a nationally representative, cross-­sectional survey of\n\nadults living in Canada (n=3000) to examine the mental\n\nhealth impacts of the COVID-19 pandemic. Outcomes\n\namong parents with children <18 years old living at home\n\n(n=618) were compared with the rest of the sample. Data\n\nwere collected via an online survey between 14 May to 29\n\nMay 2020.\n\nOutcome measures Participants reported on changes to\n\ntheir mental health since the onset of the pandemic and\n\nsources of stress, emotional responses, substance use\n\npatterns and suicidality/self-­harm. Additionally, parents\n\nidentified changes in their interactions with their children,\n\nimpacts on their children’s mental health and sources of\n\nsupport accessed.\n\nResults 44.3% of parents with children <18 years living\n\nat home reported worse mental health as a result of the\n\nCOVID-19 pandemic compared with 35.6% of respondents\n\nwithout children <18 living at home, χ2 (1, n=3000)=16.2,\n\np<0.001. More parents compared with the rest of the\n\nsample reported increased alcohol consumption (27.7% vs\n\n16.1%, χ2 (1, n=3000)=43.8, p<0.001), suicidal thoughts/\n\nfeelings (8.3% vs 5.2%, χ2 (1, n=3000)=8.0, p=0.005)\n\nand stress about being safe from physical/emotional\n\ndomestic violence (11.5% vs 7.9%, χ2 (1, n=3000)=8.1,\n\np=0.005). 24.8% (95% CI 21.4 to 28.4) of parents reported\n\ntheir children’s mental health had worsened since the\n\npandemic. Parents also reported more frequent negative\n\nas well as positive interactions with their children due to\n\nthe pandemic (eg, more conflicts, 22.2% (95% CI 19.0\n\nto 25.7); increased feelings of closeness, 49.7% (95% CI\n\n45.7 to 53.7)).\n\nConclusions This study identifies that families with\n\nchildren <18 at home have experienced deteriorated\n\nmental health due to the pandemic. Population-­level\n\nresponses are required to adequately respond to families’\n\ndiverse needs and mitigate the potential for widening\n\nhealth and social inequities for parents and children.\n\n\n\nStrengths and limitations of this study\n\n►► Survey items were informed by a longitudinal\n\n\n\nCOVID-19 mental health survey, first commissioned\n\nby the UK Mental Health Foundation and developed\n\nin consultation with people with lived experience of\n\nmental health conditions; adaptations were made\n\nfor the Canadian context and to support analyses\n\nfocussed on issues of equity.\n\n►► The large sample size enabled subgroup analyses in\n\nmental health according to gender, age, pre-­existing\n\nmental health conditions, disabilities and household\n\ndemographics.\n\n►► Targeted sampling supported participation from\n\nfamilies of diverse backgrounds.\n\n►► Cross-­sectional observational design and lack of adjustment for potential confounding prohibits causal\n\ninference.\n\n\n\nINTRODUCTION\n\nThe COVID-19 pandemic has led to unprecedented global morbidity and mortality, with\n\npopulation mental health impacts recognised\n\nas a growing concern,1 and particular risks\n\nidentified within the family context.2–4 Specifically, the COVID-19 pandemic has posed new\n\nthreats to families through social isolation\n\ndue to physical distancing measures, school/\n\nchild care closures, financial and employment\n\ninsecurity, housing instability and changes to\n\nhealth and social care access.3–5 These shifts\n\nhave profoundly interrupted the systems and\n\nstructures that previously operated to both\n\nsupport the mental health and well-­being of\n\nfamilies and mitigate the risks that contribute\n\nto health and social inequities.\n\nDuring the pandemic, many parents have\n\nexperienced increased pressures and erosions\n\nto social supports, with implications for their\n\nmental health. In a US survey, the majority of\n\nparents expressed that during the pandemic,\n\nconcerns about finances, social isolation,\n\n\n\nGadermann AC, et al. BMJ Open 2021;11:e042871. doi:10.1136/bmjopen-2020-042871\n\n\n\n1\n\n\n\nBMJ Open: first published as 10.1136/bmjopen-2020-042871 on 12 January 2021. Downloaded from http://bmjopen.bmj.com/ on June 15, 2021 at University of Toronto Libraries AFMC.\n\nProtected by copyright.\n\n\n\nOpen access\b\n\n\n\n\fcriticism from others, as well as emotional experiences\n\nof sadness and loneliness were affecting their parenting.6\n\nGlobally, school and child care closures and the hiatus\n\nof after-­school activities has added to parental pressure\n\nto balance responsibilities, including becoming the sole\n\nproviders of supervision and education for their children—all while experiencing heightened financial and\n\nemotional stress.7 Families, generally, are affected by the\n\ndisruptions of the pandemic. However, these pressures\n\ndisproportionately affect families who experience health\n\nand social inequities, including fewer financial and social\n\nresources, crowded homes and limited technology and\n\nInternet access.7–9 The collision of these stressors has\n\ncontributed to increases in domestic violence,10 11 and\n\nemerging studies have shown increased frequency of\n\nshouting and physical punishment of children since the\n\npandemic began.6\n\nIn Canada, federal and provincial governments began\n\nimplementing lockdown measures mid-­\n\nMarch 2020\n\nincluding border closures and restricted travel, restrictions on group gatherings, school/child care closures,\n\nmandatory working from home and temporary suspension of non-­\n\nessential health and public services.12\n\nNational COVID-19 incidence rates first peaked in April\n\n2020 with nearly 3000 new cases confirmed daily.13 By\n\nearly May 2020, incidence rates were decreasing and\n\nprovinces began easing lockdown measures including\n\nre-­\n\nopening businesses and encouraging rehiring of\n\nemployees.12 However, there were indications that the\n\npandemic was already impacting the mental health and\n\nwell-­being of Canadian children.i For example, by April\n\n2020, reports showed a dramatic surge in calls documented by Kids Help Phone, a national helpline for\n\nyoung people, with a 48% increase in calls about social\n\nisolation, a 42% increase in calls about anxiety and\n\nstress and a 28% increase in calls about physical abuse.14\n\nExperts raised alarms that disruptions to routines and\n\nservices, combined with increased family stressors, social\n\nisolation and domestic violence, were creating conditions\n\nthat risked increasing child mental health problems on\n\nan unprecedented scale, with children from marginalised\n\nand socioeconomically disadvantaged backgrounds likely\n\nto be disproportionately affected.15 16 Thus, while young\n\npeople initially appear to be less susceptible to the physical effects of the virus, they are experiencing significant\n\nchallenges, likely resulting from the social and economic\n\nimpacts of the pandemic within their family contexts.4 17\n\nThis is particularly concerning as research consistently\n\ndemonstrates that children’s early exposures to stress can\n\nhave lasting effects.18–21\n\nFamilies and children are furthermore supported by\n\na social ecological system that has been forced to adapt\n\nquickly to support families’ needs, often with limited\n\ninformation or evaluation. School and child care closures\n\ndue to the pandemic are concerning not only for the\n\ni\n\nFor the context of this study, children are defined as children\n\nand youth below the age of 18.\n\n\n\n2\n\n\n\ndisruption to typical classroom learning, but also for\n\nthe loss of systems-­\n\nlevel safeguards such as nutrition\n\nprogrammes, after-­school care, school health and counselling services and vaccination clinics22 23 that seek to\n\nmitigate some consequences of health and social inequities among structurally vulnerable children and families. And yet, even as schools and workplaces started to\n\nre-­open, concerns were raised about the health risks of\n\nreturning to populated spaces (including public transit)\n\ndisproportionally affecting families with lower incomes,\n\nfewer resources and with limited options for returning\n\nto work.24 Furthermore, families, child care settings and\n\nschools are nested within health authorities and government structures that determine many of the policies,\n\nservices and financial and employment supports available to parents as well as the availability of these supports\n\nbeyond the pandemic.\n\nThis paper presents findings on the impact of the\n\nCOVID-19 pandemic on families from the first wave of\n\na nationally representative cross-­sectional survey monitoring the mental health of people living in Canada.\n\nThe study aimed to answer three questions: (1) How is\n\nthe COVID-19 pandemic affecting the mental health\n\nof parents and children and what subgroups are most\n\nimpacted by the pandemic? (2) How have parent–child\n\ninteractions changed due to the pandemic? and (3)\n\nWhat are the factors that support mental health in the\n\nfamily context? The findings provide critical evidence to\n\ninform rapid, data-­driven public health responses to meet\n\nthe mental health needs of families and children in the\n\ncontext of the COVID-19 pandemic and beyond.\n\n\n\nMETHODS\n\nSurvey development and approach\n\nThis investigation focusses on data from the initial wave\n\nof our cross-­sectional survey, ‘Assessing the Impacts of\n\nCOVID-19 on Mental Health’. The study represents a\n\nunique collaboration between academic researchers from\n\nthe University of British Columbia, the Canadian Mental\n\nHealth Association (Canada) and by an international\n\nresearch partnership with the Mental Health Foundation\n\n(UK).\n\nPatient and public involvement\n\nSurvey items were informed by a longitudinal survey first\n\ncommissioned by the Mental Health Foundation in March\n\n2020 and developed in consultation with people with lived\n\nexperience of mental health conditions via a citizen’s jury\n\nparticipatory methodology process. The citizen’s jury was\n\na collaborative process that engaged people with diverse\n\nexperiences and backgrounds in the development and\n\ninterpretation of the research to enhance its relevance\n\nand impact, including insights on stressors, coping strategies and mental health.25 26 Items on family mental health\n\nwere adapted from previously developed community\n\nsurvey items related to the COVID-19 pandemic from\n\nthe University of Michigan.6 Modifications were made\n\nGadermann AC, et al. BMJ Open 2021;11:e042871. doi:10.1136/bmjopen-2020-042871\n\n\n\nBMJ Open: first published as 10.1136/bmjopen-2020-042871 on 12 January 2021. Downloaded from http://bmjopen.bmj.com/ on June 15, 2021 at University of Toronto Libraries AFMC.\n\nProtected by copyright.\n\n\n\nOpen access\b\n\n\n\n\fTable 1 Sociodemographic characteristics of the parent\n\nsubsample (n=618)\n\nSample distribution\n\n \u0007\n\n\n\nTable 1\n\n\n\nContinued\n\nSample distribution\n\n\n\n \u0007\n\n\n\nn\n\n\n\n%\n\n\n\n  \u0007Visible minority (eg, Asian, Latin\n\nAmerican, Middle Eastern,\n\nAfrican)\n\n\n\n122\n\n\n\n19.7%\n\n\n\n  \u0007European origins (eg, British,\n\nGerman, Russian)\n\n\n\n394\n\n\n\n63.8%\n\n\n\n  \u0007Living with a spouse or partner\n\n\n\n500\n\n\n\n80.9%\n\n\n\n26\n\n\n\n4.2%\n\n\n\n11\n\n\n\n1.8%\n\n\n\nn\n\n\n\n%\n\n\n\n  \u0007\n\nMen\n\n\n\n294\n\n\n\n47.6%\n\n\n\n  \u0007\n\nWomen\n\n\n\n324\n\n\n\n52.4%\n\n\n\n  \u0007\n\n18–34\n\n\n\n130\n\n\n\n21.1%\n\n\n\n  \u0007\n\n35–44\n\n\n\n214\n\n\n\n34.6%\n\n\n\n  \u0007\n\n45–54\n\n\n\n235\n\n\n\n38.0%\n\n\n\n  \u0007Living with other adult family\n\nmembers (eg, parents,\n\ngrandparents)\n\n\n\n  \u0007\n\n55+\n\n\n\n39\n\n\n\n6.3%\n\n\n\n  \u0007Living with grandchildren\n\n\n\n  \u0007\n\nAlberta\n\n\n\n86\n\n\n\n13.9%\n\n\n\n \u0007Child age (check all that apply)\n\n\n\n  \u0007\n\nBritish Columbia/Territories\n\n\n\n81\n\n\n\n13.1%\n\n\n\n  \u00074 years and under\n\n\n\n183\n\n\n\n29.6%\n\n\n\n  \u0007\n\nManitoba/Saskatchewan\n\n\n\n49\n\n\n\n7.9%\n\n\n\n  \u00075 to 11 years\n\n\n\n292\n\n\n\n47.2%\n\n\n\n  \u0007\n\nOntario\n\n\n\n243\n\n\n\n39.3%\n\n\n\n  \u000712 to 17 years\n\n\n\n309\n\n\n\n50.0%\n\n\n\n  \u0007\n\nAtlantic provinces\n\n\n\n43\n\n\n\n7.0%\n\n\n\n  \u000718 years and over\n\n\n\n70\n\n\n\n11.3%\n\n\n\n  \u0007\n\nQuebec\n\n\n\n116\n\n\n\n18.8%\n\n\n\n \u0007Child siblings at home\n\n  \u0007\n\nYes\n\n\n\n325\n\n\n\n52.6%\n\n\n\n  \u0007\n\nUrban\n\n\n\n531\n\n\n\n85.9%\n\n\n\n  \u0007\n\nRural\n\n\n\n87\n\n\n\n14.1%\n\n\n\nParent demographics\n\n \u0007Gender*\n\n\n\n \u0007Age\n\n\n\n \u0007Province of residence\n\n\n\n \u0007Household Living\n\n\n\nChild demographics\n\n\n\n \u0007Rural vs urban\n\n\n\n*Other gender identity options were available but not endorsed in\n\nthis sample\n\n\n\n \u0007Education\n\n  \u0007High school or less\n\n\n\n62\n\n\n\n10.0%\n\n\n\n  \u0007\n\nSome college/university\n\n\n\n226\n\n\n\n36.6%\n\n\n\n  \u0007\n\nUniversity+\n\n\n\n330\n\n\n\n53.4%\n\n\n\n  \u0007Single, never married\n\n\n\n39\n\n\n\n6.3%\n\n\n\n  \u0007Married or partnered\n\n\n\n517\n\n\n\n83.7%\n\n\n\n  \u0007Separated, divorced, widowed\n\n\n\n62\n\n\n\n10.0%\n\n\n\n  \u0007\n\n<$50K\n\n\n\n108\n\n\n\n17.5%\n\n\n\n  \u0007$50K to <$100K\n\n\n\n197\n\n\n\n31.9%\n\n\n\n  \u0007\n\n$100K+\n\n\n\n313\n\n\n\n50.6%\n\n\n\n86\n\n\n\n13.9%\n\n\n\n \u0007Marital status\n\n\n\n \u0007Household Income\n\n\n\n \u0007Employment status\n\n  \u0007Unemployed (due to COVID-19)\n\n\n\n  \u0007Unemployed (prior to COVID-19) 21\n\n\n\n3.4%\n\n\n\n \u0007Lesbian, gay, bisexual, transgender, two-­Spirit and queer\n\nor questioning\n\n24\n\n\n\n3.9%\n\n\n\n111\n\n\n\n18.0%\n\n\n\n  \u0007\n\nYes\n\n\n\n45\n\n\n\n7.3%\n\n\n\n \u0007Ethnicity\n\n  \u0007Indigenous origins (eg, First\n\nNations, Inuit, Métis)\n\n\n\n17\n\n\n\n2.8%\n\n\n\n  \u0007\n\nYes\n\n \u0007Pre-­existing mental health condition\n\n  \u0007\n\nYes\n\n \u0007Disability\n\n\n\nContinued\n\nGadermann AC, et al. BMJ Open 2021;11:e042871. doi:10.1136/bmjopen-2020-042871\n\n\n\nby the research team in consultation with collaborators\n\nfrom the Canadian Mental Health Association to reflect\n\nthe Canadian context, aimed at examining indicators of\n\nmental health, stress and coping related to the COVID-19\n\npandemic among the Canadian population. Modifications included adding items on the impacts on young\n\npeople’s mental health, potential sources of support,\n\nfamily dynamics, financial interventions introduced by\n\nthe Government of Canada in response to the pandemic\n\n(eg, Canada Emergency Response Benefit) and food\n\nsecurity systems. Survey items are provided in online\n\nsupplemental file 1.\n\nProcedure\n\nData were collected between 14 May to 29 May 2020, via a\n\nrapid online survey distributed by polling vendor Maru/\n\nMatchbox. Maru/Matchbox maintains the Maru Voice\n\nCanada panel consisting of approximately 125 000 adults.\n\nPanel participants were recruited through direct email,\n\nwith targeted sampling through affiliate community partners to increase inclusion of populations that may be difficult to reach via the Internet (eg, older adults, racialized\n\npopulations).27 Surveys were distributed to 3558 panel\n\nmembers to reach a total of 3000 respondents, yielding an\n\ninvitation-­to-­response rate of 84%. Members of the panel\n\nwere randomly invited by Maru/Matchbox to participate\n\nin the survey using Canadian national census informed\n\nstratifications defined by sociodemographic characteristics (age, gender, household income and region) with\n\n3\n\n\n\nBMJ Open: first published as 10.1136/bmjopen-2020-042871 on 12 January 2021. Downloaded from http://bmjopen.bmj.com/ on June 15, 2021 at University of Toronto Libraries AFMC.\n\nProtected by copyright.\n\n\n\nOpen access\n\n\n\n\f60.0%* 43.1%\n\n\n\n51.2% 43.2%\n\n66.7%† 39.4%\n\n39.5%\n\n48.8%*\n\n\n\n53.8%*\n\n\n\n44\n\n27\n\n200\n\n\n\nWorse mental health combines slightly and significantly worse mental health. Differences in proportions within groups were tested with χ2 tests.\n\nDue to small sample sizes, Indigenous origins and sexuality (lesbian, gay, bisexual, transgender, two-­spirit and queer or questioning) are not reported.\n\n*p<.05\n\n†p<0.001.\n\n\n\n127\n\n\n\n37.8%\n\n52.1%†\n\n42.5%\n\n\n\n(n=336)\n\n\n\n41.8%\n\n\n\n55.2%†\n\n\n\n39.8%\n\n\n\n42.5%\n\n\n\n46.0%\n\n\n\n39.2%*\n\n\n\n49.5%\n\n\n\n46.4%\n\n\n\n147\n\n\n\n(n=293) (n=282)\n\n\n\n136\n\n138\n\n\n\n(n=309) (n=325)\n\n\n\n153\n\n121\n\n150\n\n124\n\n\n\n(n=435) (n=292) (n=326) (n=309)\n\n\n\n173\n\n101\n\n\n\n(n=183)\n\n\n\n247\n\n74\n\n204\n\n\n\n230\n\n\n\n(n=573) (n=86) (n=532)\n\n(n=488) (n=111) (n=507) (n=45)\n\n\n\n70\n\n116\n\n\n\n(n=618) (n=324)\n\n \u0007\n\n\n\n(n=294) (n=130)\n\n\n\nWomen Men\n\nTotal\n\n \u0007\n\n\n\n158\n\n\n\nNo\n\n<35\n\nyears\n\n\n\nWorse 274\n\nmental 44.3%\n\nhealth\n\n\n\nYes\n\nYes\n\nNo\n\nYes\n\nNo\n\nYes\n\nNo\n\nYes\n\nNo\n\nNot yes Yes\n\nNot yes Yes\n\n\n\nAge\n\nGender\n\n \u0007\n\n\n\n35+\n\nyears\n\n\n\nYes\n\n\n\nDisability\n\n\n\nNot yes\n\n\n\nFinancial concerns\n\nParent with\n\nmultiple children\n\nat home\n\nParent to a child\n\n12–17 years old\n\nParent to a child\n\n5–11 years old\n\nParent to a child\n\n<4 years old\n\nUnemployed\n\ndue to\n\nCOVID-19\n\nPre-­existing\n\nmental health\n\ncondition\n\n\n\nChanges in parent self-­reported mental health since the onset of the COVID-19 pandemic\n\nTable 2\n\n\n\n4\n\n\n\nadjustments for response propensity to generate a representative sample by age, gender, income and region.27\n\nThe data collection period captured the first phases of\n\n‘re-­opening’ across many Canadian provinces and territories, emerging from approximately 2 months of mandated\n\nphysical distancing, school/child care and work closures\n\nand related disruptions.\n\nAll participants completed an online consent process\n\nprior to beginning the survey and were provided with a\n\nsmall honorarium through Maru/Matchbox to compensate for their time.\n\nMeasures and analyses\n\nThis investigation focusses on a subsample of participants who identified as parents with children <18 years\n\nold currently living at home (n=618). Changes in mental\n\nhealth due to the pandemic were compared between this\n\nparent subsample and the rest of the sample (ie, respondents who were not parents with children <18 living at\n\nhome). Comparisons were also conducted within the\n\nsubsample of parents. Participants completed sociodemographic questions as well as questions about their mental\n\nhealth, emotional responses to the pandemic, changes\n\nin substance use, experiences of suicidal thoughts and\n\nself-­harm. Parents also completed questions on changes\n\nto parent–child interactions, impacts of the pandemic on\n\ntheir children’s mental health and were asked to identify\n\nsources of stress and support for themselves and their\n\nchildren.\n\nDescriptive and bivariate analyses (frequencies, χ2\n\ntests) were used to examine self-­\n\nreported changes in\n\nmental health since the onset of the pandemic across\n\ngroups defined by gender, age, disability and pre-­existing\n\nmental health conditions, as well as frequently identified stressors, supports and changes in parent–child\n\ninteractions. Data were analysed using SPSS V.26.28 The\n\nmaximum margin of error for proportions derived from\n\nthe parent subsample was ±3.9% at a 95% level of confidence. This was a complete case analysis. In χ2 analyses,\n\n‘don’t know’, ‘not applicable’ and ‘prefer not to answer’\n\nresponses were treated as ‘not yes’.\n\n\n\nRESULTS\n\nSample description\n\nOf the 3000 respondents, 618 identified as parents to a\n\nchild <18 living at home.ii The average age of the parent\n\nsubsample was 43.0 years (SD=9.0 years) and 52.4%\n\nidentified as women. Further sample characteristics are\n\npresented in table 1.\n\nPandemic-related changes in parent mental health\n\nParents identified more pandemic-­related risks and vulnerabilities compared with respondents without children <18\n\nii\n\n\n\nIn the following when we refer to parents, these are parents\n\nliving with children <18 years old unless otherwise specified.\n\n\n\nGadermann AC, et al. BMJ Open 2021;11:e042871. doi:10.1136/bmjopen-2020-042871\n\n\n\nBMJ Open: first published as 10.1136/bmjopen-2020-042871 on 12 January 2021. Downloaded from http://bmjopen.bmj.com/ on June 15, 2021 at University of Toronto Libraries AFMC.\n\nProtected by copyright.\n\n\n\nOpen access\b\n\n\n\n\fFigure 1 Parent stressors in the past 2 weeks as a result of the COVID-19 pandemic. Note: Maximum margin of error for\n\nproportions was ±3.9% at a 95% level of confidence.\n\n\n\nyears living at home across a number of mental health\n\nconstructs. Since the onset of the COVID-19 pandemic, a\n\nsignificantly higher proportion of parents reported deteriorated mental health (44.3%) compared with 35.6%\n\namong their counterparts without children <18 years at\n\nhome, χ2 (1, n=3000)=16.2, p<0.001. Changes to mental\n\nhealth furthermore varied across sociodemographic characteristics within the parent subsample. Table 2 presents\n\nthe proportions of parents reporting deteriorated mental\n\nhealth since the pandemic according to parent gender,\n\nage, pre-­existing mental health conditions, disabilities,\n\nchild age and employment and financial circumstances.\n\nAmong parents with children at home, deteriorated\n\nmental health was significantly more prevalent among\n\nwomen, parents under age 35, parents with a pre-­existing\n\nmental health condition, parents with a disability, parents\n\nof younger children (≤4 years) and parents reporting\n\nfinancial stress. When asked about their emotions in\n\nGadermann AC, et al. BMJ Open 2021;11:e042871. doi:10.1136/bmjopen-2020-042871\n\n\n\nthe past 2 weeks as a result of the COVID-19 pandemic,\n\nthe most frequent response from parents was anxious\n\nand worried (51.9%; 95% CI 47.9 to 55.9), followed by\n\nstressed (46.1%; 95% CI 42.1 to 50.1) and bored (39.5%;\n\n95% CI 35.6 to 43.5).\n\nOverall, 8.3% of parents reported experiencing suicidal\n\nthoughts/feelings as a result of the COVID-19 pandemic\n\nin the past 2 weeks compared with 5.2% among their counterparts without children at home, χ2 (1, n=3000)=8.0,\n\np=0.005. Furthermore, 2.6% of parents reported deliberately hurting themselves as a result of the pandemic in the\n\npast 2 weeks compared with 1.3% among their counterparts, χ2 (1, n=3000)=4.8, p=0.028.\n\nAs a means of coping with deteriorations in mental\n\nhealth and stressors of the pandemic, many parents\n\nidentified an increase in alcohol use. Specifically, 27.7%\n\nof parents reported increased alcohol consumption\n\ncompared with 16.1% among those without children at\n\n5\n\n\n\nBMJ Open: first published as 10.1136/bmjopen-2020-042871 on 12 January 2021. Downloaded from http://bmjopen.bmj.com/ on June 15, 2021 at University of Toronto Libraries AFMC.\n\nProtected by copyright.\n\n\n\nOpen access\n\n\n\n\fFigure 2 Parent-­identified supports for coping with stress related to the COVID-19 pandemic in the past 2 weeks. Note:\n\nMaximum margin of error for proportions was ±3.9% at a 95% level of confidence.\n\n\n\nhome, χ2 (1, n=3000)=43.8, p<0.001. Within the parent\n\nsubsample, increased alcohol consumption was more\n\nprevalent among men (32.3%) compared with women\n\n(23.5%), χ2 (1, n=618)=6.0, p=0.014.\n\nPandemic-related stressors\n\nAs shown in figure 1, when asked about stressors and\n\nworries resulting from the COVID-19 pandemic in the\n\npast 2 weeks, parents frequently reported mental health\n\nimpacts, physical health threats related to the pandemic\n\nand relational and financial concerns. Being able to\n\ncope with uncertainty (59.2%; 95% CI 55.2 to 63.1),\n\nfear of a family member getting sick or dying (58.9%;\n\n95% CI 54.9 to 62.8) and being separated from friends\n\nand family (58.7%; 95% CI 54.7 to 62.7) were the most\n\nfrequent responses. A large proportion also reported\n\nbeing stressed about financial concerns (45.6%; 95% CI\n\n41.2 to 49.7), losing/loss of job (31.4%; 95% CI 27.8 to\n\n35.2) and having enough food to meet their household’s\n\nbasic needs (20.4%; 95% CI 17.3 to 23.8). Further, 36.9%\n\n(95% CI 33.1 to 40.8) of parents reported being stressed\n\nabout looking after children while continuing to work\n\nand 27.8% (95% CI 24.3 to 31.6) were stressed that the\n\npandemic would make their existing mental health problems worse.\n\nRelationship challenges were also a prominent concern\n\namong parents. For example, 28.3% (95% CI 24.8 to 32.1)\n\nof parents reported being stressed about experiencing\n\nrelationship challenges with their partner and 11.5%\n\n6\n\n\n\n(95% CI 9.1 to 14.3) reported being stressed about being\n\nsafe from physical or emotional domestic violence during\n\nthe 2 weeks prior. This proportion identifying concern\n\nabout being safe from domestic violence was significantly\n\nhigher among parents compared with the rest of the\n\nsample (7.9%), χ2 (1, n=3000)=8.1, p=0.005. Within the\n\nparent subsample, a higher proportion of men (14.6%)\n\nreported being stressed about being safe from physical\n\nor emotional domestic violence compared with women\n\n(8.6%), χ2 (1, n=618)=5.4, p=0.020.\n\nChild mental health and parent–child interactions\n\nThe majority of parents (59.7%; 95% CI 55.7 to 63.6)\n\nreported their children’s mental health had stayed\n\nthe same since the onset of the COVID-19 pandemic;\n\nhowever, 24.8% (95% CI 21.4 to 28.4) indicated that their\n\nchildren’s mental health had worsened.\n\nOverall, due to the COVID-19 pandemic, parents\n\nreported more negative interactions with their children,\n\nincluding more conflicts (22.2%; 95% CI 19.0 to 25.7),\n\nyelling/shouting (16.7%; 95% CI 13.8 to 19.8), disciplining (16.0%; 95% CI 13.2 to 19.2) and using harsh\n\nwords (10.7%; 95% CI 8.4 to 13.4). However, overall,\n\nparents also reported that they experienced increased\n\npositive interactions with their children, including\n\nhaving more quality time (65.4%; 95% CI 61.5 to 69.1),\n\nfeeling closeness (49.7%; 95% CI 45.7 to 53.7), showing\n\nlove or affection to their children (44.5%; 95% CI 40.5\n\nto 48.5) and observing increased resilience (strength\n\nGadermann AC, et al. BMJ Open 2021;11:e042871. doi:10.1136/bmjopen-2020-042871\n\n\n\nBMJ Open: first published as 10.1136/bmjopen-2020-042871 on 12 January 2021. Downloaded from http://bmjopen.bmj.com/ on June 15, 2021 at University of Toronto Libraries AFMC.\n\nProtected by copyright.\n\n\n\nOpen access\b\n\n\n\n\fFigure 3 Parent-­identified supports for helping their children cope with stress related to the COVID-19 pandemic in the past\n\n2 weeks. Note: Maximum margin of error for proportions was ±3.9% at a 95% level of confidence.\n\n\n\nand perseverance) in their children (38.2%; 95% CI\n\n34.3 to 42.2). Parents often reported increases in both\n\nnegative and positive interactions due to the COVID-19\n\npandemic. For example, a higher proportion of parents\n\nwho reported more conflicts with children also reported\n\nincreased feelings of closeness (59.1%) compared with\n\nparents who did not report more conflicts with children\n\n(47.0%), χ2 (1, n=618)=6.3, p=0.012.\n\nChanges in parent–child interactions also varied\n\naccording to salient sources of stress (ie, financial\n\nconcerns and worries that the pandemic would make\n\nexisting mental health problems worse). A higher proportion of parents reported increased harsh words with children when they were stressed about finances (13.8%)\n\ncompared with parents who did not report this stressor\n\n(8.0%), χ2 (1, n=618)=5.4, p=0.020. Parents who reported\n\nstress that the pandemic would make an existing mental\n\nhealth problem worse, compared with parents without\n\nthis stressor, also more frequently reported increased\n\nharsh words with children since the pandemic (20.9% vs\n\n6.7%), as well as increased discipline (23.8% vs 13.0%),\n\nconflicts (33.1% vs 17.9%) and yelling/shouting (31.4%\n\nvs 11.0%), χ2 (1, n=618)=10.8 to 37.2, p’s ≤0.001.\n\nInterestingly, a higher proportion of parents stressed\n\nabout financial concerns, compared with parents who did\n\nGadermann AC, et al. BMJ Open 2021;11:e042871. doi:10.1136/bmjopen-2020-042871\n\n\n\nnot report this stressor, also reported increased quality\n\ntime with children (71.6% vs 60.1%), showing more love\n\nand affection to their children (49.3% vs 40.5%) and\n\nobserving resilience in their children (43.3% vs 33.9%), χ2\n\n(1, n=618)=4.82 to 8.98, p’s<0.028. A higher proportion of\n\nparents stressed about an existing mental health problem\n\nalso reported showing more love and affection to children as a result of the pandemic (53.5%) compared with\n\nparents without this stressor (41.0%), χ2 (1, n=618)=7.8,\n\np<0.005.\n\nSources of support\n\nFigure 2 presents sources of support identified by parents\n\nthat had helped them cope with stress related to the\n\nCOVID-19 pandemic in the past 2 weeks. Parents most\n\nfrequently identified going for a walk/exercise (59.1%;\n\n95% CI 55.1 to 63.0), connecting with family and friends\n\nvia phone and video chat (50.5%; 95% CI 46.5 to 54.5),\n\nconnecting with those in their household (47.6%; 95% CI\n\n43.6 to 51.6) and maintaining a healthy lifestyle (37.9%;\n\n95% CI 34.0 to 41.8) as strategies that had helped them.\n\nFigure 3 presents sources of support identified by parents\n\nthat had helped their children cope with stress related to\n\nthe pandemic in the past 2 weeks. Parents most frequently\n\nidentified these same strategies, as well as maintaining\n\n7\n\n\n\nBMJ Open: first published as 10.1136/bmjopen-2020-042871 on 12 January 2021. Downloaded from http://bmjopen.bmj.com/ on June 15, 2021 at University of Toronto Libraries AFMC.\n\nProtected by copyright.\n\n\n\nOpen access\n\n\n\n\ffamily routines (53.9%; 95% CI 49.9 to 57.9), playing inside\n\n(47.2%; 95% CI 43.2 to 51.3) and playing outdoors (45.8%;\n\n95% CI 41.8 to 49.8) as having helped their children.\n\nFurthermore, 34.0% (95% CI 30.3 to 37.9) of parents identified staying in touch with teachers, school adults and child\n\ncare workers as a source of support during the pandemic,\n\nand 5.8% (95% CI 4.1 to 8.0) identified accessing virtual\n\neducational or self-­\n\nhelp mental health resources (eg,\n\nwebsites, applications) as a strategy that had helped their\n\nchildren. Additionally, 4.2% (95% CI 2.8 to 6.1) of parents\n\nhad contacted a school or community-­based mental health\n\nworker or counsellor virtually (eg, via phone or video chat).\n\nRegarding structural supports, a significantly higher\n\nproportion of parents (23.3%) identified having a\n\nsupportive employer as a factor that helped their stress\n\nrelated to the pandemic in the past 2 weeks, compared\n\nwith respondents without children at home (14.1%),\n\nχ2 (1, n=3000)=30.9, p<0.001. Although overall access\n\nof structural supports was low, a significantly higher\n\nproportion of parents reported accessing federal financial benefits to help cope with stress in the past 2 weeks\n\n(13.6%) compared with the rest of the sample (9.2%),\n\nχ2 (1, n=3000)=10.2, p=0.001. When restricted to parents\n\nstressed about financial concerns due to the COVID-19\n\npandemic (n=282), this proportion increased to 19.1%\n\n(95% CI 14.7 to 24.2). Finally, a significantly higher\n\nproportion of parents (7.9%) reported that they or a\n\nmember of their household had accessed a food-­based\n\ncommunity programme since the onset of the pandemic\n\nsuch as the Food Bank, free meal programmes, community kitchens or food vouchers from a charity, compared\n\nwith the rest of the sample (4.4%), χ2 (1, n=3000)=12.5,\n\np<0.001. When restricted to parents stressed about\n\nhaving enough food to meet household needs due to the\n\nCOVID-19 pandemic (n=126), this proportion increased\n\nto 17.5% (95% CI 11.3 to 25.2).\n\nDISCUSSION\n\nThis study identifies that following the first lockdown\n\nphase in Canada, 44.3% of parents of children <18 living\n\nat home reported worse mental health as a result of the\n\npandemic. This aligns with research in the US identifying\n\nsimilar deteriorations in family mental health due to\n\nthe COVID-19 pandemic.29 International studies monitoring mental health trends in the general population\n\nthroughout the first 5 months of the pandemic estimated\n\nprevalence rates of up to 51% for anxiety symptoms, up to\n\n48% for depressive symptoms and up to 54% for symptoms\n\nof psychological distress.30 Within parts of Canada during\n\nthe same period, the prevalence of depressive symptoms in the general population had more than doubled\n\ncompared with previous national estimates,31 with experts\n\nprojecting national increases in suicide based on trends\n\nin unemployment.32 To our knowledge, the current\n\nstudy is the first national Canadian survey to identify that\n\nparents of children <18 living at home are a group at\n\ndisproportionate risk of worsened mental health due to\n\n8\n\n\n\nthe COVID-19 pandemic. Compared with the rest of the\n\npopulation, a larger proportion of parents with children\n\n<18 at home reported increased alcohol consumption as\n\na result of the pandemic, and suicidal thoughts or feelings, self-­harm and stress about being safe from physical\n\nor emotional domestic violence in the past 2 weeks. These\n\ndata validate early public health concerns regarding\n\nthese mental health consequences of the pandemic.2 10 33\n\nWithin our parent subsample, women, younger parents,\n\nparents of small children, those living with a disability\n\nand those with a pre-­existing mental health condition\n\nreported worsened mental health since the start of the\n\npandemic compared with other parents.\n\nWithin the subsample of parents with children living\n\nat home, more men reported increased alcohol use and\n\nbeing stressed about domestic violence compared with\n\nwomen. This gender difference in alcohol use aligns\n\nwith pre-­pandemic research findings that men generally\n\nconsume more alcohol than women and are more likely\n\nthan women to externalise distress through increased\n\nalcohol consumption.34 35 However, the finding that men\n\nreported greater worry and stress from domestic violence\n\nthan women is contrary to pre-­pandemic studies showing\n\nthat women are disproportionately affected by domestic\n\nviolence.36 37 Our survey question specifically asked\n\nabout stress/worries about being safe from physical or\n\nemotional domestic violence as a result of the COVID-19\n\npandemic, which may not be comparable to the examination of this experience in other studies. This necessitates further research to unpack this association in the\n\ncontext of social isolation, financial stress and parenting\n\nresponsibilities.\n\nParents with children <18 at home reported unique\n\npressures, including worrying about their children’s\n\nhealth, mental health, education and being stressed\n\nabout looking after children while continuing to work. A\n\nhigh proportion of parents reported being stressed about\n\nfinancial concerns (45.6%), about the pandemic making\n\ntheir existing mental health problems worse (27.8%) and\n\nabout having enough food to meet their household’s\n\nbasic needs (20.4%). A larger proportion of parents\n\nindicating stress about financial concerns or worsening\n\nof existing mental health problems due to the pandemic\n\nreported increased negative interactions with their children, including increased conflicts, discipline, use of\n\nharsh words and yelling/shouting compared with parents\n\nwithout these stressors. This aligns with other research\n\nshowing that children have been relatively overlooked as\n\na population vulnerable to the impacts of the COVID-19\n\nvirus, but are particularly vulnerable to stressful conditions exacerbated by the pandemic including financial\n\nstress, food insecurity, domestic violence and disrupted\n\nsystems of care and education.38 39\n\nHowever, the majority of parents also reported increased\n\npositive interactions at home, including having more\n\nquality time together, feeling closeness, showing love\n\nand affection and observing resilience in their children.\n\nParents often reported increases in both negative and\n\nGadermann AC, et al. BMJ Open 2021;11:e042871. doi:10.1136/bmjopen-2020-042871\n\n\n\nBMJ Open: first published as 10.1136/bmjopen-2020-042871 on 12 January 2021. Downloaded from http://bmjopen.bmj.com/ on June 15, 2021 at University of Toronto Libraries AFMC.\n\nProtected by copyright.\n\n\n\nOpen access\b\n\n\n\n\fpositive interactions with children due to the COVID-19\n\npandemic, possibly due to increased opportunities for\n\nfamily interactions overall. Furthermore, a larger proportion of parents stressed about financial concerns due to\n\nthe pandemic reported having more quality time, showing\n\nmore love and affection and observing resilience in their\n\nchildren. A larger proportion of parents stressed about\n\nworsening mental health problems reported showing\n\nmore love and affection with their children. Increased\n\ntime and flexibility at home has created conditions for\n\nfamilies to engage in more conversations and activities\n\ntogether.40 41 Previous research has found that while\n\nparenting pressures during the pandemic have increased,\n\nso have opportunities to strengthen family connectedness.7 Our results indicate that strengthened connectedness may be particularly salient for families experiencing\n\nheightened stress due to the pandemic, although the\n\nspecific mechanisms underlying these associations are\n\nunclear.\n\nFree digital technologies have furthermore facilitated\n\nconnecting with others outside the home, as well as\n\ntools for managing parenting stress and enabling children to participate in school and child-­friendly activities\n\nonline.7 8 41 However, digital technologies and online\n\nlearning are not easily accessible for everyone, particularly for families with limited Internet or digital device\n\naccess and language barriers, and for children with\n\nlearning difficulties and special needs. In the current\n\nstudy, fewer than 6% of families reported accessing virtual\n\nmental health supports as strategies for addressing children’s stress related to the pandemic. Although online\n\nmental health services have been found to be effective,\n\nfeasible and acceptable among adults and youth,42 real-­\n\nworld uptake and retention has generally been found to\n\nbe low.43 44 Early COVID-­specific research from China\n\nhas found that uptake of any mental health services since\n\nthe start of the pandemic has been as low as 3.7%, with\n\nconcerns raised that online mental health services may\n\nstill not address present needs due to existing digital\n\ndivides, appropriateness for all populations and quality\n\nassurance.45\n\nConsidering the needs of diverse families, as well\n\nas issues of health equity, early examinations of the\n\nCOVID-19 pandemic have also emphasised the importance of community organisations and governments in\n\nproviding access to economic and social supports.46 47\n\nIn the current study, a significantly greater proportion\n\nof parents with children <18 living at home compared\n\nwith the rest of the population had relied on supportive\n\nemployers and government financial supports in the\n\npast 2 weeks, and had accessed food programmes since\n\nthe start of the pandemic. Parents also frequently identified school, community and government supports that\n\nhad helped them and their children cope with stress\n\nrelated to the COVID-19 pandemic. Other studies have\n\nalso identified supports such as paid emergency leave,\n\nunemployment insurance, rent protection and access to\n\nsafe and secure housing and outdoor spaces as critical in\n\nGadermann AC, et al. BMJ Open 2021;11:e042871. doi:10.1136/bmjopen-2020-042871\n\n\n\nsupporting parents to have the time and resources necessary to care for their children.46 47 Although these policies\n\nand relief systems may not have been designed specifically for families and children, they hold the potential to\n\nhelp address some of the underlying causes48 of compromised parent and child mental health at the population\n\nlevel, including family financial stress, employment and\n\nfood insecurity, stigma, overcrowding and violence. The\n\neffectiveness of these policies, however, will depend on\n\nthe human resources to organise, distribute and implement services when workforces are already overloaded.\n\nFor example, in the current study, fewer than one in five\n\nfamilies with financial stress or concerns about having\n\nenough food to meet their household basic needs had\n\nrecently accessed federal benefits or food programmes,\n\nrespectively, warranting further investigation into the\n\nease of access to these services.49 Furthermore, many of\n\nthese underlying causes of health inequities will remain\n\nafter the COVID-19 crisis has subsided,50 suggesting that\n\nmany of these interventions should be sustained irrespective of the pandemic.\n\nStrengths and limitations\n\nA notable strength of this study was the large, nationally\n\nrepresentative sample that enabled population subgroup\n\nanalyses to examine disparities in mental health for\n\nparents and across parent subgroups. The study was\n\ndesigned to include participation from families of diverse\n\nbackgrounds, although small numbers of parents identifying as Indigenous or LGBT2Q+ ((lesbian, gay, bisexual,\n\ntransgender, two-­\n\nspirit and queer) prohibited us from\n\nexamining these populations of interest. We also did not\n\nhave a reliable measure of single parent status to investigate mental health trends among this group. Although\n\nstrategies including oversampling and community partnerships were used to minimise selection bias and reduce\n\npossible technology barriers, it is possible that survey\n\nrespondents differed from survey non-­\n\nrespondents on\n\nkey measures of interest including mental health, financial security or family conflict, which may have affected\n\nour estimates. The study design was cross-­sectional, therefore we cannot determine if outcomes such as parent–\n\nchild interactions and parent stressors were causally\n\nrelated, only that they were associated. We also did not\n\ncontrol for potential confounding variables that might\n\nhave introduced bias; further in-­\n\ndepth investigations\n\nwould complement this study by providing more understanding of these associations. This study did not measure\n\nthe prevalence of specific mental health outcomes or\n\ninclude clinical assessments of mental illness which may\n\nlimit comparability with other research. This study also\n\ndid not take into account baseline measures of mental\n\nhealth or multiple comorbidities and was specific to the\n\nCanadian context during the first re-­opening phase of\n\nthe COVID-19 pandemic. It will be important to monitor\n\nthe impact of the pandemic on family mental health over\n\ntime and in different contexts. We were also unable to\n\nassess the impact of the pandemic from the perspectives\n\n9\n\n\n\nBMJ Open: first published as 10.1136/bmjopen-2020-042871 on 12 January 2021. Downloaded from http://bmjopen.bmj.com/ on June 15, 2021 at University of Toronto Libraries AFMC.\n\nProtected by copyright.\n\n\n\nOpen access\n\n\n\n\fof children and youth themselves, including children’s\n\nreactions to parents’ stress during the pandemic and\n\nchildren’s reported supports including use of mental\n\nhealth services. This is a critical knowledge gap for future\n\nresearch to address. The purpose of the current study was\n\nto assess preliminary impacts of the COVID-19 pandemic\n\non families’ general mental health at a community level\n\nand to provide early data to inform relevant policy and\n\nprogramming actions. Examining specific impacts on the\n\nprevalence of mental health disorders and effective clinical responses is an important focus for future research.\n\nCONCLUSIONS AND IMPLICATIONS\n\nIn response to the COVID-19 pandemic, policymakers\n\nand service providers globally have been faced with the\n\nchallenge of having to make rapid decisions that will have\n\nimmediate and long-­term effects on the mental health\n\nand well-­being of families and children. In the early days\n\nof the first ‘re-­opening’ phase in Canada, nearly two in\n\nevery five people reported worse mental health since\n\nthe pandemic began, with this proportion increasing\n\nto nearly one in every two people for parents with children <18 living at home. Schools/child care, communities and government systems play an essential role in\n\nprotecting and supporting parents and children, particularly for families without reliable access to the Internet\n\nor virtual technologies. While pressure is put on parents,\n\nit is important to remember that families exist within a\n\nsocial ecosystem with opportunities to promote child and\n\nyouth mental health. Supports such as affordable child\n\ncare, low barrier Internet access, publicly-­funded stepped\n\ncare and psychotherapy and easily available financial\n\nsupports are interventions that can directly benefit families.41 51 Continuations of financial interventions beyond\n\nthe pandemic have also been suggested, including the\n\nidea of a universal basic income.52 The effectiveness of\n\nthese systems further depends on intersectoral communication, collaboration and action, and therefore seeking\n\nfeedback and advice from community stakeholders will\n\nbe critical for monitoring whether these systems are\n\nworking for families and children during the remainder\n\nof the pandemic and beyond.\n\nAuthor affiliations\n\n1\n\nHuman Early Learning Partnership, School of Population and Public Health,\n\nUniversity of British Columbia, Vancouver, British Columbia, Canada\n\n2\n\nCentre for Health Evaluation and Outcome Sciences, Providence Health Care\n\nResearch Institute, Vancouver, British Columbia, Canada\n\n3\n\nSchool of Population and Public Health, University of British Columbia, Vancouver,\n\nBritish Columbia, Canada\n\n4\n\nSchool of Nursing, University of British Columbia, Vancouver, British Columbia,\n\nCanada\n\nAcknowledgements We are appreciative of the support and partnership we\n\nreceived in mobilising this project from the Canadian Mental Health Association\n\n(CMHA) and Mental Health Foundation. We are grateful for the financial support\n\nprovided by CMHA to fund Maru/Matchbox to deploy the survey. AG and EJ would\n\nalso like to thank the Michael Smith Foundation for Health Research for financial\n\nsupport (Scholar Awards) and KT would like to thank the Canadian Institutes of\n\nHealth Research and Michael Smith Foundation for Health Research for financial\n\n\n\n10\n\n\n\nsupport (Fellowship Awards). Special thanks to Katherine Janson, Margaret Eaton\n\nand Jonathan Morris (CMHA) for facilitating study communications and government\n\nrelations outreach and to Jacqueline Campbell, Neesha Mathew and Stacey Kinley\n\n(Maru/Matchbox) for supporting survey deployment and data preparation. We also\n\nthank Dr Antonis Kousoulis for his role in the early conceptualisations of the study,\n\nincluding survey design.\n\nContributors AG, KT, MG, EJ and CM co-­led the conceptualisation of this\n\ninvestigation. AG directed the data analyses, interpretation and writing of this\n\nmanuscript. KT conducted the data analyses and contributed to data interpretation\n\nand writing of this manuscript. EJ, CGR, MG, CM and SH contributed to the\n\ninterpretation and writing of this manuscript.\n\nFunding The Canadian Mental Health Association (CMHA) funded survey data\n\ncollection through national polling vendor, Maru/Matchbox. Collaborators from\n\nCMHA also contributed to the survey development. CMHA had no further role in the\n\nstudy design, data collection, data analysis or interpretation.\n\nConflict of Interest Declaration CGR reports receiving personal fees from the\n\nUniversity of British Columbia during the conduct of this study. All other authors\n\nreport no competing interests.\n\nPatient consent for publication Not required.\n\nEthics approval Ethics approval was provided by the Behavioural Research Ethics\n\nBoard at the University of British Columbia (H20-01273).\n\nData availability statement Data are available upon reasonable request.\n\nSupplemental material This content has been supplied by the author(s). It has\n\nnot been vetted by BMJ Publishing Group Limited (BMJ) and may not have been\n\npeer-­reviewed. Any opinions or recommendations discussed are solely those\n\nof the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and\n\nresponsibility arising from any reliance placed on the content. Where the content\n\nincludes any translated material, BMJ does not warrant the accuracy and reliability\n\nof the translations (including but not limited to local regulations, clinical guidelines,\n\nterminology, drug names and drug dosages), and is not responsible for any error\n\nand/or omissions arising from translation and adaptation or otherwise.\n\nOpen access This is an open access article distributed in accordance with the\n\nCreative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which\n\npermits others to distribute, remix, adapt, build upon this work non-­commercially,\n\nand license their derivative works on different terms, provided the original work is\n\nproperly cited, appropriate credit is given, any changes made indicated, and the use\n\nis non-­commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/.\n\nORCID iDs\n\nAnne C Gadermann http://​orcid.​org/​0000-​0001-​6947-​1052\n\nKimberly C Thomson http://​orcid.​org/​0000-​0002-​4508-​2463\n\nChris G Richardson http://​orcid.​org/​0000-​0002-​7641-​7027\n\nMonique Gagné http://​orcid.​org/​0000-​0002-​3220-​7351\n\nCorey McAuliffe http://​orcid.​org/​0000-​0002-​7868-​564X\n\nSaima Hirani http://​orcid.​org/​0000-​0003-​1084-​3039\n\nEmily Jenkins http://​orcid.​org/​0000-​0003-​4649-​2904\n\n\n\nREFERENCES\n\n\n\n1 Jenkins E, McAuliffe C, Hirani S, et al. A portrait of the early and\n\ndifferential mental health impacts of the COVID-19 pandemic in\n\nCanada: findings from the first wave of a nationally representative\n\ncross-­sectional survey. Prev Med 2020;Accepted.\n\n2 Holmes EA, O'Connor RC, Perry VH, et al. Multidisciplinary research\n\npriorities for the COVID-19 pandemic: a call for action for mental\n\nhealth science. Lancet Psychiatry 2020;7:547–60.\n\n3 Coller RJ, Webber S. COVID-19 and the well-­being of children and\n\nfamilies. Pediatrics 2020;146:e2020022079.\n\n4 Gassman-­Pines A, Ananat EO, Fitz-­Henley J. COVID-19 and parent-­\n\nchild psychological well-­being. Pediatrics 2020;146:e2020007294.\n\n5 Canadian Human Rights Commission. Statement - Inequality\n\namplified by COVID-19 crisis, 2020. Available: https://www.​chrc-​\n\nccdp.​gc.​ca/​eng/​content/​statement-​inequality-​amplified-​covid-​19-​\n\ncrisis\n\n6 Lee SJ, Ward KP. Research brief: stress and parenting during\n\nthe coronavirus pandemic. Ann Arbor, MI:University of Michigan\n\nParenting in Context Research Lab; 2020.\n\n7 Cluver L, Lachman JM, Sherr L, et al. Parenting in a time of\n\nCOVID-19. Lancet 2020;395:e64.\n\n\n\nGadermann AC, et al. BMJ Open 2021;11:e042871. doi:10.1136/bmjopen-2020-042871\n\n\n\nBMJ Open: first published as 10.1136/bmjopen-2020-042871 on 12 January 2021. Downloaded from http://bmjopen.bmj.com/ on June 15, 2021 at University of Toronto Libraries AFMC.\n\nProtected by copyright.\n\n\n\nOpen access\b\n\n\n\n\f8 Smith EE. 5 ways to keep human connections when moving learning\n\nonline due to coronavirus, 2020;The Conversation. Available: https://​\n\ntheconversation.​com/​5-​ways-​to-​keep-​human-​connections-​when-​\n\nmoving-​learning-​online-​due-​to-​coronavirus-​134351\n\n9 Shim RS, Compton MT. The social determinants of mental health:\n\npsychiatrists’ roles in addressing discrimination and food insecurity.\n\nFocus 2020;18:25–30.\n\n10 Pfefferbaum B, North CS. Mental health and the COVID-19\n\npandemic. N Engl J Med 2020:1–3.\n\n11 Kofman YB, Garfin DR. Home is not always a Haven: the domestic\n\nviolence crisis amid the COVID-19 pandemic. Psychological Trauma:\n\nTheory, Research, Practice, and Policy 2020;12:S199–201.\n\n12 Vogel L. COVID-19: A timeline of Canada’s first-­wave response,\n\n2020;Canadian Medical Association Journal (CMAJ) News. Available:\n\nhttps://​cmajnews.​com/​2020/​06/​12/​coronavirus-​1095847/\n\n13 Dong E, Du H, Gardner L. An interactive web-­based dashboard to\n\ntrack COVID-19 in real time. Lancet Infect Dis 2020;20:533–4.\n\n14 Children First Canada. Children and youth living with family violence,\n\n2020. Available: https://​educ.​ubc.​ca/​sos/\n\n15 Fegert JM, Vitiello B, Plener PL, et al. Challenges and burden of the\n\ncoronavirus 2019 (COVID-19) pandemic for child and adolescent\n\nmental health: a narrative review to highlight clinical and research\n\nneeds in the acute phase and the long return to normality. Child\n\nAdolesc Psychiatry Ment Health 2020;14:1–11.\n\n16 Waddell C, Schwartz C, Barican J, Yung D, Gray-­Grant D.\n\nCOVID-19 and the Impact on Children’s Mental Health. Vancouver,\n\nBC:Children’s Health Policy Centre, Simon Fraser University; 2020.\n\n17 Russell BS, Hutchison M, Tambling R, et al. Initial challenges of\n\ncaregiving during COVID-19: caregiver burden, mental health,\n\nand the parent–child relationship. Child Psychiatry Hum Dev\n\n2020;51:671–82.\n\n18 Shonkoff JP, Garner AS, Siegel BS, et al. The lifelong effects of early\n\nchildhood adversity and toxic stress. Pediatrics 2012;129:e232–46.\n\n19 Hertzman C, Boyce T. How experience gets under the skin to\n\ncreate gradients in developmental health. Annu Rev Public Health\n\n2010;31:329–47.\n\n20 Benner AD, Mistry RS. Child development during the COVID-19\n\npandemic through a life course theory lens. Child Dev Perspect\n\n2020;14:236–43.\n\n21 Elder GH. The life course as developmental theory. Child Dev\n\n1998;69:1–12.\n\n22 Armitage R, Nellums LB. Considering inequalities in the school\n\nclosure response to COVID-19. Lancet Glob Health 2020;8:e644.\n\n23 Golberstein E, Gonzales G, Meara E. How do economic downturns\n\naffect the mental health of children? Evidence from the National\n\nhealth interview survey. Health Econ 2019;28:955–70.\n\n24 Shah V, Shaker E. When proximity is a problem: what reopening\n\nmeans for schools and child care centres, 2020;Canadian Centre for\n\nPolicy Alternatives. Available: https://​behindthenumbers.​ca/​2020/​\n\n05/​26/​when-​proximity-​is-​a-​problem-​what-​reopening-​means-​for-​\n\nschools-​and-​child-​care-​centres/\n\n25 Kousoulis A, McDaid S, Crepaz-­Keay D, et al. Smaller boats in\n\nthe COVID-19 storm: how different groups are coping with the\n\ncoronavirus pandemic. London, UK: Mental Health Foundation;\n\n2020: In press.\n\n26 Kousoulis A, McDaid S, Crepaz-­Keay D, et al. The COVID-19\n\npandemic, financial inequality and mental health: a briefing from\n\nthe “Coronavirus: Mental Health in the Pandemic” study. London,\n\nUK:Mental Health Foundation; 2020.\n\n27 Maru/Blue. 28 questions to help research buyers of online samples.\n\nESOMAR; 2018.\n\n28 IBMSPSS statistics for MacIntosh. version 26.0. 2019.\n\n29 Patrick SW, Henkhaus LE, Zickafoose JS, et al. Well-­Being of parents\n\nand children during the COVID-19 pandemic: a national survey.\n\nPediatrics 2020;146:e2020016824.\n\n30 Xiong J, Lipsitz O, Nasri F, et al. Impact of COVID-19 pandemic on\n\nmental health in the general population: a systematic review. J Affect\n\nDisord 2020;277:55–64.\n\n\n\nGadermann AC, et al. BMJ Open 2021;11:e042871. doi:10.1136/bmjopen-2020-042871\n\n\n\n31 Schmitz N, Holley P, Meng X, et al. COVID-19 and depressive\n\nsymptoms: a community-­based study in Quebec, Canada. Can J\n\nPsychiatry 2020;65:733–5.\n\n32 McIntyre RS, Lee Y. Projected increases in suicide in Canada as a\n\nconsequence of COVID-19. Psychiatry Res 2020;290:113104.\n\n33 Gunnell D, Appleby L, Arensman E, et al. Suicide risk and\n\nprevention during the COVID-19 pandemic. Lancet Psychiatry\n\n2020;7:468–71.\n\n34 Palmer RHC, Young SE, Hopfer CJ, et al. Developmental\n\nepidemiology of drug use and abuse in adolescence and young\n\nadulthood: evidence of generalized risk. Drug Alcohol Depend\n\n2009;102:78–87.\n\n35 Bronte-­Tinkew J, Moore KA, Matthews G, et al. Symptoms of\n\nmajor depression in a sample of fathers of infants. J Fam Issues\n\n2007;28:61–99.\n\n36 Winstok Z, Straus MA. Bridging the two sides of a 30-­year\n\ncontroversy over gender differences in Perpetration of physical\n\npartner violence. J Fam Violence 2016;31:933–5.\n\n37 Melton HC, Belknap J. He hits, she hits: assessing gender\n\ndifferences and intimate partner violence. Crim Justice Behav\n\n2003;30:328–48.\n\n38 Sinha I, Bennett D, Taylor-­Robinson DC. Children are being sidelined\n\nby covid-19. BMJ 2020;369:1–2.\n\n39 Chanchlani N, Buchanan F, Gill PJ. Addressing the indirect effects\n\nof COVID-19 on the health of children and young people. CMAJ\n\n2020;192:1–7.\n\n40 Johnson K. Parenting during COVID-19: a new frontier. Canadian\n\nPaediatric Society; 2020.\n\n41 Ye J. Pediatric mental and behavioral health in the period of\n\nquarantine and social distancing with COVID-19. JMIR Pediatr Parent\n\n2020;3:e19867.\n\n42 Bashshur RL, Shannon GW, Bashshur N, et al. The empirical\n\nevidence for telemedicine interventions in mental disorders. Telemed\n\nJ E Health 2016;22:87–113.\n\n43 Baumel A, Muench F, Edan S, et al. Objective user engagement\n\nwith mental health apps: systematic search and panel-­based usage\n\nanalysis. J Med Internet Res 2019;21:e14567–15.\n\n44 Fleming T, Bavin L, Lucassen M, et al. Beyond the trial: systematic\n\nreview of real-­world uptake and engagement with digital self-­help\n\ninterventions for depression, low mood, or anxiety. J Med Internet\n\nRes 2018;20:e199–11.\n\n45 Yao H, Chen J-­H, Xu Y-­F. Rethinking online mental health services\n\nin China during the COVID-19 epidemic. Asian J Psychiatr\n\n2020;50:102015.\n\n46 Benfer EA, Wiley LF. Health justice strategies to combat COVID-19:\n\nprotecting vulnerable communities during a pandemic. Health Affairs\n\nBlog 2020;March.\n\n47 Rummo PE, Bragg MA, Yi SS. Supporting equitable food access\n\nduring national emergencies—the promise of online grocery\n\nshopping and food delivery services. JAMA Health Forum\n\n2020;1:e200365.\n\n48 Rose G. Sick individuals and sick populations. Int J Epidemiol\n\n1985;14:32–8.\n\n49 Black J. The worst time for food banks to raise barriers to food,\n\n2020. The Province. Available: https://​theprovince.​com/​opinion/​\n\njennifer-​black-​the-​worst-​time-​for-​food-​banks-​to-​raise-​barriers-​to-​\n\nfood\n\n50 Eaves S. The housing affordability crisis will still be here after\n\nCOVID-19, 2020. Generation squeeze. Available: https://www.​\n\ngensqueeze.​ca/​housing-​after-​covid-​19\n\n51 Galea S, Merchant RM, Lurie N. The mental health consequences of\n\nCOVID-19 and physical distancing: the need for prevention and early\n\nintervention. JAMA Intern Med 2020;180:817–8.\n\n52 Canadian Mental Health Association. The universal basic income: an\n\nidea whose time has come, 2020. Available: https://​cmha.​ca/​news/​\n\nthe-​universal-​basic-​income-​an-​idea-​whose-​time-​has-​come\n\n\n\n11\n\n\n\nBMJ Open: first published as 10.1136/bmjopen-2020-042871 on 12 January 2021. Downloaded from http://bmjopen.bmj.com/ on June 15, 2021 at University of Toronto Libraries AFMC.\n\nProtected by copyright.\n\n\n\nOpen access\n\n\n\n\f",
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                  "text": "Burnout is an occupational hazard caused by cumulative workplace stress that\n\nwas recognized as a substantial problem in healthcare prior to the COVID-19\n\npandemic. It consists of emotional exhaustion (feeling drained and fatigued),\n\ndepersonalization (becoming indifferent or emotionally distant), and a diminished\n\nsense of professional achievement.",
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                  "text": "Hospital-based healthcare workers have experienced substantially increased\n\nburnout during the COVID-19 pandemic. Sustained burnout will likely contribute to\n\nstaff retention challenges due to healthcare providers leaving their workplaces and\n\nprofessions. A vicious circle may be underway where understaffing leads to increased\n\nburnout and an even weaker healthcare workforce.",
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          "context": "SCIENCE BRIEFS\n\n\n\nBurnout in Hospital-Based\n\nHealthcare Workers during\n\nCOVID-19\n\n\n\nRobert G. Maunder, Natalie D. Heeney, Gillian Strudwick, Hwayeon Danielle Shin,\n\nBraden O’Neill, Nancy Young, Lianne P. Jeffs, Kali Barrett, Nicolas S. Bodmer, Karen\n\nB. Born, Jessica Hopkins, Peter Jüni, Anna Perkhun, David J. Price, Fahad Razak,\n\nChristopher J. Mushquash, Linda Mah on behalf of the Ontario COVID-19 Science\n\nAdvisory Table and Mental Health Working Group\n\n\n\nVersion: 1.0\n\nPublished: October 7, 2021\n\nCitation: Maunder RG, Heeney ND, Strudwick\n\nG, et al. Burnout in hospital-based healthcare\n\nworkers during COVID-19. Science Briefs\n\nof the Ontario COVID-19 Science Advisory\n\nTable. 2021;2(46). https://doi.org/10.47326/\n\nocsat.2021.02.46.1.0\n\nAuthor Affiliations: The affiliations of the\n\nmembers of the Ontario COVID-19 Science\n\nAdvisory Table can be found at https://\n\ncovid19-sciencetable.ca/.\n\nDeclarations of Interest: The declarations\n\nof interest of the members of the Ontario\n\nCOVID-19 Science Advisory Table, its Working\n\nGroups, or its partners can be found at https://\n\ncovid19-sciencetable.ca/. The declarations\n\nof interest of external authors can be found\n\nunder additional resources at https://doi.\n\norg/10.47326/ocsat.2021.02.46.1.0\n\nAbout Us: The Ontario COVID-19 Science\n\nAdvisory Table is a group of scientific experts\n\nand health system leaders who evaluate and\n\nreport on emerging evidence relevant to\n\nthe COVID-19 pandemic, to inform Ontario’s\n\nresponse. Our mandate is to provide weekly\n\nsummaries of relevant scientific evidence for\n\nthe COVID-19 Health Coordination Table of the\n\nProvince of Ontario, integrating information\n\nfrom existing scientific tables, Ontario’s\n\nuniversities and agencies, and the best global\n\nevidence. The Science Table summarizes its\n\nfindings for the Health Coordination Table and\n\nthe public in Science Briefs.\n\nThe Mental Health Working Group comprises\n\nscientific experts and public health leaders\n\nwith specific expertise in mental health. Their\n\nexpertise spans mental health of children\n\nand youth, adults and geriatric populations,\n\nmental health of health care providers,\n\nwomen’s health, mental health among\n\nLGBTQ persons, mental health among Black,\n\nIndigenous, and other racialized populations,\n\nand COVID-19. The Working Group evaluates\n\nemerging scientific evidence related to\n\nmaintaining mental health during COVID-19,\n\nthe mental health burden of disease and public\n\nhealth interventions on individuals across the\n\nlifespan, including children and adolescents,\n\nand the older adult population, as well as the\n\nneed for assessment and recommendations\n\n\n\nKey Message\n\nBurnout is an occupational hazard in healthcare, which harms the healthcare system,\n\npatients, and healthcare workers. In the COVID-19 pandemic, burnout has increased\n\nto levels that pose a threat to maintaining a functioning healthcare workforce.\n\nElevated burnout and other indicators of stress are anticipated to persist long after\n\nthe pandemic.\n\nThe COVID-19 pandemic has created a cycle of understaffing alongside difficult work\n\nconditions which can drive burnout. Robust interventions to bolster individuals,\n\nimprove work environments and address health system drivers of burnout are\n\nimportant to maintain and support hospital-based healthcare workers. Interventions\n\nneed to target those most at risk and affected by burnout: nurses, intensive care unit\n\nand emergency department staff, women, recent graduates and trainees.\n\nInterventions to reduce burnout need to be implemented at organizational and\n\nstructural level of healthcare systems, complemented by intervention at the individual\n\nlevel. Further, leadership is a vital enabler to address burnout from organizational\n\nleaders and managers as well as policymakers.\n\nOrganizations need to ensure adequate staffing through ongoing evaluation of\n\nworkload including mitigation of data entry and administrative burdens, efforts to\n\nreduce overtime and avoid long shifts, and staff deployment in areas where they\n\nlack training.\n\nApproaches to mitigate, reduce and address burnout should be multi-faceted and\n\ninclude interventions to improve workplace conditions by fostering a supportive\n\nculture, relationships and leadership, as well as individual-level interventions (e.g.,\n\neducation, stress reduction tools, access support for moral distress).\n\n\n\nSummary\n\nBackground\n\nBurnout is characterized by emotional exhaustion, depersonalization, and diminished\n\nprofessional achievement. Prior to the COVID-19 pandemic, severe burnout was\n\ntypically found in 20%-40% of healthcare workers. Contributors include workplace\n\nfactors (e.g., workload, interpersonal conflict, moral distress, administrative\n\nburdens and documentation) and provider factors (e.g., low self-efficacy, emotional\n\nexhaustion, reduced sense of personal accomplishment,). Burnout is harmful for the\n\nhealthcare system, workers, and patients. Risk factors have been exacerbated during\n\nthe pandemic, resulting in an urgent need for intervention.\n\nThis brief focuses on healthcare workers in hospitals. Similar challenges exist in other\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 1\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\nregarding the mental health of communities\n\nand populations disproportionately impacted\n\nby COVID-19, including Black, Indigenous, and\n\nother racialized populations. The Working\n\nGroup reports its findings to the public\n\nand the Science Table. Its findings are also\n\nsummarized in Science Briefs.\n\n\n\nhealthcare settings (e.g., long-term care, primary health care, public health), which\n\nare not reviewed here.\n\n\n\nCorrespondence to: Secretariat of the\n\nOntario COVID-19 Science Advisory Table\n\n(info@covid19-sciencetable.ca)\n\n\n\nHow has the prevalence of burnout changed during the COVID-19 pandemic for\n\nhospital-based healthcare workers?\n\n\n\nCopyright: 2021 Ontario COVID-19 Science\n\nAdvisory Table. This is an open access\n\ndocument distributed under the terms of the\n\nCreative Commons Attribution License, which\n\npermits unrestricted use, distribution, and\n\nreproduction in any medium, provided that\n\nthe original work is properly cited.\n\nThe views and findings expressed in this\n\nScience Brief are those of the authors and do\n\nnot necessarily reflect the views of all of the\n\nmembers of the Ontario COVID-19 Science\n\nAdvisory Table, its Working Groups, and its\n\npartners.\n\n\n\nQuestions\n\nWhat is burnout and what are the risk factors for burnout?\n\n\n\nWhich hospital-based healthcare workers are at particular risk?\n\nWhat interventions for burnout are supported by evidence?\n\nWhat modifiable mediators of burnout are appropriate targets for intervention?\n\nFindings\n\nIn spring 2020, the prevalence of severe burnout was 30%-40%. By spring 2021, rates\n\n>60% were found in Canadian physicians, nurses, and other healthcare professionals.\n\nHealthcare professionals in intensive care settings, COVID-19 units or hospitals,\n\nand emergency departments have had elevated risk of burnout compared to other\n\nhospital healthcare workers. Nurses and younger healthcare professionals or trainees\n\nhave been at greater risk of burnout.\n\nOrganizational interventions have larger effects on reducing burnout than individual\n\nones. Individual-level interventions include education and stress reduction techniques\n\nand should be complementary to organization-level interventions. Interventions that\n\nreduce burnout by even a small amount reduce adverse consequences.\n\nGroups that have been most affected should be prioritized: nurses, those in intensive\n\ncare and emergency departments, recent graduates and trainees.\n\nTargets for intervention include (i) maintaining adequate staffing, (ii) leadership, (iii)\n\nwork conditions, (iv) confidence in performing relevant tasks, (v) support networks,\n\nand (vi) moral distress (about constraints on doing the right thing).\n\nSystem- and organization-level interventions to reduce burnout include visible and\n\nauthentic senior leadership and managerial support, training to increase worker\n\nconfidence with unfamiliar tasks, addressing workplace characteristics (e.g., overtime\n\nand scheduling shifts >12 hours) and supporting workers experiencing moral distress.\n\nInterpretation\n\nHospital-based healthcare workers have experienced substantially increased\n\nburnout during the COVID-19 pandemic. Sustained burnout will likely contribute to\n\nstaff retention challenges due to healthcare providers leaving their workplaces and\n\nprofessions. A vicious circle may be underway where understaffing leads to increased\n\nburnout and an even weaker healthcare workforce.\n\nMaintaining the healthcare workforce will benefit from increasing the number of new\n\ngraduates and by retaining current staff through financial compensation and fostering\n\nsupportive workplace characteristics including supportive leadership at executive,\n\ndirector, and manager levels, continued professional development, effective\n\ncommunication, appropriate autonomy, and collegial relationships among workers\n\nand managers.\n\nOptimal reduction and prevention of burnout depends on stronger evidence. Research\n\nevaluating organization and system-level interventions should be promoted.\n\n\n\nBackground\n\nBurnout affects a wide range of healthcare workers, including those in hospitals,1,2\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 2\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\nprimary care and community settings,3–5 public health,6 long-term care,7 and first\n\nresponders in emergency medical services.8,9 Each of these groups have been adversely\n\naffected by the COVID-19 pandemic. Given the diversity of these settings and of\n\nhealthcare providers, this brief focuses on hospitals, where the evidence needed to\n\nassess the impact and to guide interventions is richer. However, many of the principles\n\nand recommendations may be applicable to those in practice in non-hospital settings.\n\nQuestions\n\nWhat is burnout and what are the risk factors for burnout?\n\nHow has the prevalence of burnout changed during the COVID-19 pandemic for\n\nhospital-based healthcare workers?\n\nWhich hospital-based healthcare workers are at particular risk?\n\nWhat interventions for burnout are supported by evidence?\n\nWhat modifiable mediators of burnout are appropriate targets for intervention?\n\n\n\nFindings\n\nDefining and Measuring Burnout\n\nBurnout is an occupational hazard caused by cumulative workplace stress that\n\nwas recognized as a substantial problem in healthcare prior to the COVID-19\n\npandemic. It consists of emotional exhaustion (feeling drained and fatigued),\n\ndepersonalization (becoming indifferent or emotionally distant), and a diminished\n\nsense of professional achievement.10\n\nBurnout is associated with worse patient outcomes and reduced workplace satisfaction\n\nand productivity for healthcare professionals and trainees of all disciplines. For the\n\nhealthcare system, burnout poses a risk to adequate staffing by contributing to\n\nabsenteeism, higher workforce turnover, and greater likelihood that professionals\n\nwill consider leaving their work.11–14 Burnout also results in lost productivity and is\n\nconsistently correlated with depressive symptoms,15–18 and, in some cases, with\n\nthoughts of suicide.19 Emotional exhaustion, in particular, has been found to be\n\nassociated with substance use and poor self-reported physical health in physicians,20\n\nand with anxiety, lower self-esteem, and poor quality of life in nurses.17 Burnout\n\nof healthcare professionals and trainees is also associated with diminished safety,\n\nincreased medical errors, reduced quality of care, and lower patient satisfaction.11,21–25\n\nRates of burnout have been measured as the rate of cases (prevalence) in crosssectional surveys of healthcare professionals in many settings. Although most\n\nstudies survey nurses and/or physicians, studies of other healthcare professions have\n\ncomparable findings. The prevalence of burnout is sensitive to how it is measured\n\n(e.g., scales and cut-off values used to define a case),26 which makes comparing the\n\nresults of prevalence studies that have used different methodology challenging. This\n\nbrief has been based on evidence that identified burnout as defined by the Maslach\n\nBurnout Inventory (MBI-EE), so as to identify data from the widest range of research\n\nusing clear and replicable methods. The MBI-EE is a psychological assessment tool that\n\nmeasures an individual’s experience of burnout along three dimensions: emotional\n\nexhaustion, depersonalization, and personal accomplishment. When reporting case\n\nrates we focus on burnout defined as a score >26 on the emotional exhaustion scale\n\nof the MBI-EE.\n\nPrior to the COVID-19 pandemic, the prevalence of burnout in healthcare workers\n\nranged from <20% to >50%,27–29 with many studies of hospital-based nurses and\n\nphysicians reporting rates of severe burnout in the range of 20-40%,26 including\n\nmeta-analyses of nurses in oncology (17 studies of 9959 RNs with severe burnout at\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 3\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\n30%), emergency medicine (13 studies of 1,566 RNs with severe burnout at 31%),31\n\nand primary care (8 studies of 1,110 RNs with severe burnout at 28%) and physicians\n\nin emergency medicine (17 studies of 1,943 MDs with severe burnout at 40%).32,33\n\nCollectively, the range of 20-40% serves as a benchmark for burnout identified using\n\nthis case definition.\n\n30\n\n\n\nIn a global meta-analysis of nurses (113 studies of 45,539 RNs), the prevalence of\n\nburnout in North American nurses was similar to that found in Europe, Latin American,\n\nand Central Asia, with the highest rates found in Southeast Asia and the lowest in\n\nAfrica and the Middle East. Among specialties, the highest rates were in intensive/\n\ncritical care, emergency medicine, and pediatric nursing.34\n\nRisk Factors for Burnout\n\nWorkplace-associated risk factors are related to the culture, environment and\n\nstructure present in hospital workplaces. Figure 1 highlights the interplay between\n\nthese factors, individual characteristics and burnout.\n\n\n\nFigure 1. Burnout Framework\n\nReview of the pre-COVID literature identified contributing factors, which are synthesized in this framework. These\n\ninclude workforce risk factors (e.g. workload, role and processes); workforce protective factors (e.g. autonomy and\n\ncontrol, leadership, and scheduling flexibility); and healthcare provider (e.g. self-efficacy, age, gender, resilience,\n\npersonality traits) emerged. This framework also includes the impact of burnout on organizations, healthcare\n\nproviders, and patients.\n\n\n\nWorkload\n\nBurnout is consistently associated with high workload. Approaches to operationalizing\n\nworkload include measuring direct care time, clinician-patient ratio, patient acuity,\n\nand patient turnover.35 There is a strong relationship between nurse-patient ratio and\n\nburnout,1,11,36 but this ratio, in itself, does not consider patient acuity or the presence of\n\nsupportive services, both of which contribute to workload.37 A cross-sectional study of\n\n472 British Columbia nurses considered several aspects of workload and found patient\n\nacuity was associated with higher emotional exhaustion, whereas job satisfaction was\n\nassociated with perceived heavy workload which was measured by asking about the\n\nfrequency of factors such as arriving early/staying late and working through breaks.38\n\nA similar finding was identified in a U.S. study.39 Studies of physicians also found a\n\nconsistent relationship between burnout and workload, variously defined according\n\nto daily or weekly work hours, overnight duty, schedule inflexibility, patient load, or\n\nconsultations per day or week.21\n\nImportantly, to the extent that burnout challenges recruitment and retention of\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 4\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\nhealthcare professionals, a vicious circle may arise in which understaffing is both a\n\ncause and consequence of burnout.\n\nHours and Shifts\n\nAs a short-term solution to nursing shortages, nurses are asked to work overtime on\n\ndays off or to work extended hours. Working extended hours is linked to poor intershift recovery and fatigue, amplified stress responses, and increased likelihood of\n\nmaking errors, resulting in adverse patient outcomes.40–42 It has been recommended,\n\nbased on a systematic review of nurse work schedules and adverse outcomes, that\n\nnursing shifts should not be longer than 12 hours.43 However, for medical residents,\n\nreducing shift length alone has not resulted in improved well-being.44\n\nPresenteeism\n\nPresenteeism is working when in poor mental or physical health. A prospective study\n\nof 258 hospital nurses over three years found that job demands, including workload\n\nand perceived demands from patients, contributed to working when sick, which in\n\nturn was associated with burnout.45\n\nJob Insecurity\n\nAt times of restructuring and economic downturn, perceived job insecurity is\n\nassociated with higher burnout.46 This may also be present for workers hired during\n\nthe pandemic on a temporary basis.\n\nRole Characteristics\n\nRole conflict, significance, variety, and reward. Greater risk of burnout in nurses\n\nis associated with role conflict whereby workers have multiple roles which have\n\ncontradictory, competing, or incompatible expectations and when there is ambiguity\n\nabout role expectations.11 Roles characterized by low perceived task significance and\n\nvariety,47–49 and high-effort/low reward are also associated with greater burnout.50–52\n\nMoral Distress\n\nMoral distress is the psychological state that arises when external constraints prevent\n\none from pursuing the right course of action (e.g. when a shortage of resources\n\nprevents one from maintaining the usual standard of care or frequent contact with\n\nfutile care in an ICU setting).53 In nurses, burnout is correlated with the frequency of\n\nsuch events and with experiencing moral distress.54–56\n\nInterpersonal Conflict and Lack of Support\n\nThere is an association between interpersonal conflict and increased burnout.11,57–61\n\nThis conflict is more frequently documented occurring between colleagues with\n\nsimilar levels of authority,57,58,62 and in relationships with a power or hierarchy\n\nimbalance, such as nurse-physician or nurse-manager relationships.57–59 In addition,\n\nnurses and physicians who do not feel supported by their colleagues and managers\n\nhave increased levels of burnout.11,21,58\n\nViolence and Abuse\n\nVarious forms of violence and abuse in healthcare workplaces are common. A 2019\n\nsurvey of 4462 British Columbia nurses reported these rates: emotional abuse 83%,\n\nthreat of assault 78%, physical assault 67%, verbal sexual harassment 55% and sexual\n\nassault 11%.63 Similar rates were found in the U.S for nurses.64 Bullying is commonly\n\nexperienced by young physicians, especially women (rates 30-95% in a review of 18\n\nstudies).65 These experiences were consistently correlated with burnout.66–68\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 5\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\nDocumentation and Information Technology\n\nAmong physicians, burnout is more common among those who report having\n\ninsufficient time for documentation (2.8 times odds ratio), spending excessive time\n\non electronic health records at home (1.9 times odds ratio) or experiencing daily\n\nfrustration with electronic health records (2.4 times odds ratio).69 In a survey of 5,197\n\nU.S. physicians, physician-rated usability of electronic health records had a strong\n\nrelationship with burnout.70\n\nThere is evidence of protective factors including culture, leadership and supportive\n\nsystems alongside staff autonomy and control that can protect workers from burnout.\n\nAuthentic Senior or Executive Leadership\n\nA meta-analysis and a systematic review of leadership style in nursing concluded that\n\neffective leadership is associated with lower burnout and other positive effects on\n\nnurses’ well-being.71,72 Fourteen studies found protective effects of organizational\n\nleaders who are “authentic” (e.g., self-aware, transparent, ethical, respectful, and who\n\nseek information and insights from a variety of sources when making decisions).11,69,73\n\nAuthentic executive leadership was of increasing importance to a healthy workforce\n\nas healthcare complexity increased.74\n\nSupport from Managers\n\nEvidence for a relationship between feeling support from managers and lower\n\nburnout was provided by most studies of nurses,11 but not all,75 and was also been\n\nfound for other healthcare professionals.76 Other qualities of nurse managers\n\nassociated with lower burnout in the staff reporting to them were trustworthiness\n\nand perceived competence.11\n\nAutonomy and Control\n\nStudies of physicians,77 social workers,78 and nurses,11,79 have all found that a high level\n\nof autonomy or control over one’s practice (e.g., the perception that nurses have the\n\nfreedom to make important patient care and work decisions) was associated with less\n\nburnout, both in Ontario and in international studies.80–82\n\nScheduling Flexibility\n\nFlexibility in scheduling, including the ability to schedule days off, was associated with\n\nlower burnout.11\n\nThere is limited evidence regarding characteristics of health care workers that\n\npredispose them to burnout. Fewer individual-level risk characteristics for burnout\n\nhave been identified. Most are not readily modifiable (sex, gender, age, personality\n\ntraits), although one modifiable characteristic has been identified, self-efficacy.\n\nSelf-Efficacy\n\nThis refers to specifically focused confidence: a person’s beliefs about their capabilities\n\nto perform relevant tasks and to influence events.83 It can be measured as a general\n\ntrait, or as self-efficacy with respect to a specific challenge (e.g., working in critical\n\ncare nursing, doing healthcare work during a pandemic). Self-efficacy can be improved\n\nwith training in specific, relevant tasks and challenges. For example, training in\n\ncommunication skills increases self-efficacy for that task,84 and training in managing\n\ninterpersonal and coping challenges related to a pandemic increases pandemic selfefficacy.85 A 2016 meta-analysis of 57 studies involving 22,773 teachers, healthcare\n\nworkers, and other professionals found an association of medium strength (effect size\n\n-0.33) between low self-efficacy and burnout. There was no difference between general\n\nand specific measures of self-efficacy.86 Studies specific to healthcare professionals\n\nreplicate this result.18,87\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 6\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\nGender\n\nGender differences in burnout for healthcare professionals depend on context.\n\nFor example, a meta-analysis shows that among nurses, men are at higher risk of\n\nburnout,30 whereas among physicians, women may be at higher risk.88 A meta-analysis\n\nfound greater emotional exhaustion in women and greater depersonalization in men\n\nacross disciplines, although both effects were small.89\n\nAge and Experience\n\nA systematic review of 41 studies of surgeons and a study of 473 general hospital\n\nnurses and nursing students each found that younger professionals and trainees\n\nwere at elevated risk of burnout. This was consistent with the 2018 Canadian Medical\n\nAssociation survey, which found that residents had 48% higher risk of burnout than\n\npracticing physicians.90–92 Possible explanations which have been suggested included\n\nlonger work hours, less autonomy and discretion, or a “survival” bias introduced\n\nbecause those with high burnout leave the profession.90\n\nResilience\n\nThis is the ability to “bounce back” after stress. It can be understood at organizational\n\nand individual levels.93 For individual healthcare workers, resilience has been\n\nconceptualized as a composite of attitudes (e.g., living authentically, maintaining\n\nperspective) and behavioural skills (e.g., managing stress, building social networks),\n\nand was associated with measures of health.94 A resilient organization is one that has\n\nmatched job demands to resources for workers and fosters a culture of connection\n\nand transparency. Resilient organizations are well positioned to achieve strategic\n\nobjectives and face challenges during crises.95\n\nPersonality Traits\n\nThere is some literature from psychology which suggests an association between\n\nburnout and personality traits. Personality traits including extraversion (level of energy\n\nand sociability), agreeableness (interpersonal skills to approach or reject others) , and\n\nconscientiousness (energy and sociability) serve as protective factors.96,97\n\nCOVID-19 has Exacerbated Risk Factors for Burnout and Increased Prevalence\n\nMany risk factors for burnout have been exacerbated during the pandemic, including\n\nincreased patient acuity, understaffing due to staff with COVID-19 compatible\n\nsymptoms, exposure leading to quarantine, increased overtime, presenteeism,\n\nreassignment to unfamiliar roles, and circumstances that provoke moral distress.\n\nIn addition, working in healthcare during the pandemic has introduced circumstances\n\nthat are expected to contribute to burnout. These include health risk to oneself and\n\none’s family and uncertainty about infectious risks and precautions. Further public\n\nhealth measures such as school and business closures also may impact health care\n\nworkers and create strain between work and personal or family obligations.\n\nAs burnout results from cumulative occupational stress,98 its impact is expected to\n\nincrease over time during the pandemic, and appears to be doing so. Early in the\n\npandemic, representative studies of hospital workers in April/May 2020 in Italy and\n\nBelgium reported severe emotional exhaustion (MBI-EE >26) in 32-41%,99–101 which is\n\nsimilar to the pre-pandemic benchmark. A weekly survey of 231 Canadian emergency\n\nphysicians for 10 weeks from March to May, 2020 found emotional exhaustion and\n\ndepersonalization did not change, consistent with the expectation that COVID-19related burnout would build slowly.102\n\nOne study of intensive care nurses and physicians in the Netherlands reported\n\nthat burnout had risen in the first wave of the pandemic (from November 2019 to\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 7\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\nApril 2020). Using a different case definition, so rates are not comparable to others\n\nreported here, they found rates had risen from 26% to 38% in nurses and 13% to 29%\n\nin physicians.103\n\nAs the pandemic persists, increased levels of burnout are being reported. A survey of\n\n250 internal medicine specialist physicians in two Vancouver hospitals conducted from\n\nAugust to October 2020, found a prevalence of severe emotional exhaustion (MBIEE >26) of 63%.104 A longitudinal survey of a single cohort of 422 staff representing\n\ndiverse roles (nurses, doctors, professionals of other disciplines, support services,\n\nresearchers, learners etc.) in a downtown Toronto hospital repeated three times\n\nat three-month intervals from November 2020 to May 2021 found high and rising\n\nburnout. The prevalence of severe emotional exhaustion (MBI-EE >26) in nurses was\n\n54% (Fall 2020), 62% (Winter 2021), and 63% (Spring 2021), while the prevalence in\n\nall other healthcare professionals at the same time points was 43%, 56%, and 62%\n\nrespectively (Hunter J, personal communication).105\n\nNurses and Workers in Intensive Care and Emergency Department Settings are at\n\nHigher Risk of Burnout\n\nIdentifying groups at higher risk may serve to focus or sequence interventions. Evidence\n\nis consistent across diverse settings that healthcare professionals in intensive care\n\nsettings have been at higher risk during the pandemic compared to other healthcare\n\nsettings.106–110 Working in a COVID-19 unit or hospital or in an emergency department\n\nhas also been associated with elevated burnout.108,111,112\n\nDuring the pandemic, higher levels of burnout have consistently been reported\n\nin nurses than in other hospital-based healthcare professionals in Canada and\n\ninternationally.103,105,113–116 Younger healthcare professionals and trainees have also\n\nbeen at elevated risk in all healthcare disciplines.107,112,114,117–119 Healthcare workers’\n\nethnicity, culture, and race have not received wide study. One Canadian study of\n\ninternal medicine specialists found that visible minority physicians were more likely to\n\nreport lower personal accomplishment than others, but these groups did not differ in\n\nemotional exhaustion.104\n\nRegarding sex differences, women healthcare personnel (including nurses,\n\nphysicians, pharmacists, and other healthcare workers) have had higher emotional\n\nexhaustion,104,112,114,117,119–121 whereas males report higher depersonalization.112,114,117,121,122\n\nRegarding gender, a study of U.S. anesthetists in March 2020 found that those who\n\nidentify as LGBTQ2S+ experienced greater burnout.123 Similarly, burnout was greater\n\nin individuals identifying as having non-binary gender in a nationwide U.S. survey of\n\ndiverse healthcare professions between May and October 2020.124 Among internal\n\nmedicine specialist physicians at two Vancouver hospitals, there was no difference in\n\nemotional exhaustion or depersonalization by sexual orientation.104\n\nEvidence-Based Interventions for Burnout\n\nSystematic reviews and meta-analyses summarize evidence for interventions at the\n\nlevel of organizations, individual interventions, and their combination.2,125,126 Since\n\nmost known risk factors for burnout occur at the organization-level, it is consistent that\n\na pre-pandemic meta-analysis of interventions for physicians found that organizational\n\ninterventions were more effective than individual interventions (organizational mean\n\ndifference -12.46[-17.47, -7.45 95%CI], individual mean difference -3.36[-9.90, 3.17\n\n95%CI, p=0.03).2 The interventions included shortened length of rotations for attending\n\nstaff, reduced hours of duty shifts, and modifications to clinical work processes (e.g.,\n\ncommunication improvements through monthly clinical meetings; medical assistants\n\nto enter electronic health record data; automating prescriptions). Another metaanalysis suggested the combination of organizational and individual interventions\n\nresulted in larger and/or longer-lasting benefits.127 The interventions reviewed in\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 8\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\nthese meta-analyses are too heterogeneous to support specific recommendations.128\n\nProfessional organizations have also emphasized the importance of system level\n\nresponses to burnout, including streamlining documentation, ensuring equitable\n\ncompensation, and promoting the seamless integration of digital tools.3\n\nDespite substantially less evidence for individual-level burnout risk factors, individual\n\ninterventions are more widely studied. On the whole, studies of these interventions\n\nindicate that they provide significant, but only moderately large, short-term benefits,\n\nwith no evidence to support greater effectiveness of any particular intervention.2,125\n\nThose studied include small group education, stress management/self-care (yoga,\n\nmindfulness, relaxation techniques), communication skills training, coping skills\n\ntraining.2,125 Regarding prevention, cognitive behavioural therapy interventions have\n\nresulted in modest benefits with small to medium effect sizes.125\n\nImportantly, interventions that reduce burnout by even a small amount are\n\nmeaningfully associated with reducing adverse consequences of burnout including\n\nhealthcare system turnover and absenteeism;2,11,129 medical errors, reduced patient\n\nsafety and satisfaction;25 healthcare provider depression,17 suicide,130 substance use,\n\nand decreased physical health.20\n\nModifiable Mediators of Burnout that are Appropriate Targets for Intervention\n\nGiven the limitations of evidence for specific interventions, we have reviewed the\n\nliterature to identify the most plausible modifiable risk factors for pandemic-related\n\nburnout, based on consistent evidence of association with burnout prior to COVID-19\n\nand evidence of correlation with burnout during the pandemic.\n\nWork Conditions, Workload, and Fatigue\n\nLonger shifts (more than 12 hours,131 for nurses) and a greater workload were\n\nassociated with increased burnout in physicians and nurses in several settings during\n\nthe pandemic.99,112,118,132 A meta-analysis of studies of nurses spanning 11 countries\n\namong Europe, Asia, and North America during COVID-19 identified higher burnout in\n\nsettings that reported insufficient material resources and understaffing.112 Poor sleep\n\nand fatigue have also been identified as potential exacerbating factors.105,116,121\n\nSelf-Efficacy\n\nIn a study of 2,014 nurses in hospitals in Wuhan, China in February, 2020, both general\n\nself-efficacy and specific confidence in one’s own and one’s institution’s readiness\n\nto deal with COVID-19 were associated with lower burnout.106 A Romanian study\n\nfound that lower self-efficacy, in addition to a lack of access to training, professional\n\ndevelopment, and continuing education, were significant predictors of burnout during\n\nthe COVID-19 pandemic.133 In a Toronto hospital, self-efficacy with respect to pandemicrelated challenges (e.g. “How confident are you that you will be able to perform duties\n\nthat are outside your usual job”) in Fall 2020 was a strong predictor of lower burnout\n\nat two time points over the following six months in healthcare professionals of all\n\ndisciplines.105 A meta-analysis of nurses found lower levels of specialized training were\n\nassociated with greater burnout.112\n\nMoral Distress\n\nMoral distress has been a prominent theme for healthcare workers during the\n\npandemic.134–137 In a study in the Netherlands, two sources of moral distress that\n\nincreased in COVID-19 (scarcity of resources and the perception of colleagues acting\n\nunsafely) were significant predictors of burnout.103 In a Toronto hospital, moral distress\n\nwas strongly related to emotional exhaustion and accounted for most of the difference\n\nin burnout between roles (nurses vs. other health professionals vs. other staff with\n\nregular patient contact; Hunter J, personal communication). Interventions that have\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 9\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\nbeen suggested to reduce the harmful effects of moral distress include education\n\nabout the concept and critical reflective practice that allows cognitive reframing.138\n\nMore research is needed to evaluate such interventions.\n\nSupport Networks\n\nInsufficient support at work, in the form of peer social support or institutional support,\n\nhas been a risk factor for burnout during COVID-19.112,123 Support from leadership or\n\nsupervisors, in the form of feedback and recognition, has also mediated burnout.133\n\nIn a study of Malaysian healthcare workers, increased burnout during COVID-19 was\n\nassociated with perceived inadequate psychosocial support at work and feelings of\n\nstretched work relationships with superiors and colleagues.139\n\n\n\nInterpretation\n\nBurnout was a significant problem for hospital-based healthcare workers prior to\n\nthe COVID-19 pandemic and has increased substantially. Multiple Canadian studies\n\nindicate that by the fall of 2020 and afterwards, more than 60% of healthcare workers\n\nsurveyed were experiencing severe emotional exhaustion.\n\nIt is not known how long elevated levels of burnout will persist. Two considerations\n\nsuggest that elevated levels of burnout will not resolve quickly: (1) After the severe\n\nacute respiratory syndrome (SARS) outbreak of 2003, which was much more\n\ncircumscribed in scope and severity, elevated burnout and other indicators of chronic\n\nstress persisted in affected healthcare workers for as long as they were studied (18-24\n\nmonths);140 (2) the pre-pandemic benchmark of 20-40% of hospital based healthcare\n\nworkers with severe emotional exhaustion suggests that a “return to normal” would\n\nbe a return to conditions that are not optimal for recovery.\n\nA marked and sustained increase in burnout is likely to lead healthcare professionals\n\nto seek work that involves less direct patient contact, shorter or more predictable\n\nhours, or to leave the profession altogether. The likelihood of a workforce reduction\n\nis supported by survey data indicating that 43% of members of the 1,716 Registered\n\nNurses Association of Ontario members surveyed in January-February 2021 were\n\nconsidering leaving nursing after the pandemic (27% somewhat likely, 7% likely, 9%\n\nvery likely).141 This concern is also supported by a survey of 131 physicians and nurses\n\nin a Montreal hospital where the intention to quit was reported by 50% of nurses and\n\n20% of physicians and a survey of 257 physicians in Vancouver of whom 21% were\n\nconsidering quitting.104,113 In a Toronto hospital in Spring 2021, 30% of nurses and 13%\n\nof physicians surveyed reported considering leaving their jobs, specifically because\n\nof moral distress (Hunter J, personal communication). Observation indicates that\n\nprofessionals are acting on their intention to leave. Media accounts have reported\n\nmany Canadian nurses leaving their profession as a result of COVID-19 stresses,142\n\nemergency department closures due to understaffing,143–146 and an Ontario hospital\n\nemergency department offering a large “signing bonus” to attract new nurses.147\n\nA vicious circle of understaffing leading to burnout, which in turn leads to further\n\nchallenges to recruitment and retention creates the potential for a sustained and\n\nworsening problem in healthcare, which may be underway. A further challenge is that\n\nthese conditions are present outside Ontario as well, indeed globally, which reduces\n\nthe pool of healthcare workers available to replace those who reduce or cease direct\n\npatient care.\n\nMulti-Faceted Mitigation Strategies are Needed for Burnout\n\nThe below recommendations align with a previous review of best practices.148 A\n\nnumber of professional organizations have developed recommendations for system\n\nlevel responses to burnout. While it is challenging to assess the evidence of impact\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 10\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\nof such recommendations, they are worth noting given the challenges identified\n\nin this document. In August, 2021 the Ontario Medical Association (OMA) Burnout\n\nTask Force released 5 system level recommendations to physician burnout which\n\nhighlighted the need to reduce documentation and administrative work,3 fairly and\n\nequitably compensate work, make organizational policy changes to improve worklife balance, promote integration of digital health tools into workflows and provide\n\ninstitutional wellness supports.\n\nThe Registered Nurses’ Association of Ontario (RNAO) released a series of\n\nrecommendations related to nurse well-being and burnout related to increasing\n\nsupport for early, mid-career and senior nursing positions, increase overall staffing\n\nof nurses, bolster admission to nursing programs to ensure adequate workforce and\n\nincrease nurse practitioner positions.141\n\nIn the long-term, maintaining an adequate healthcare workforce will benefit from\n\nsupport for an expansion of training opportunities to increase the number of new\n\ngraduates. Planning for adequate health human resources will necessitate interministerial collaboration (including, for example, the Ministry of Colleges and\n\nUniversities) to ensure that university and college-based training programs tasked\n\nwith producing the next generations of healthcare workers (e.g., nurses, physicians,\n\npsychologists, and other allied healthcare workers) are able to meet the needs of the\n\nbroader health system and patient needs. The health human resources strategy can\n\nalso recognize risks to a healthy workforce such as burnout,149 and mitigate healthcare\n\nworker shortages due to changing careers, and the impending health human resource\n\ncrisis as a consequence of retirements due to an aging workforce.\n\nGiven evidence that high stress and the intention to leave nursing is particularly\n\ncommon among recent graduates,150–152 it is relevant that transition to practice\n\nprograms consisting of formal teaching, preceptorship, and mentorship, lasting 27–52\n\nweeks, appear to promote retention and reducing turnover among novice nurses.153\n\nIn an environment in which there is competition between organizations for staff,\n\nfinancial compensation is likely to influence where professionals choose to work.\n\nRegarding opportunities to make the workplace more attractive, there is clear\n\nevidence for the “magnet” characteristics which lead nurses to choose one workplace\n\nover another. These include: nursing leadership which is visible, supportive, visionary,\n\nand holds high status in the organization; processes for continuing professional\n\ndevelopment; clear communication and responsiveness from leaders; a relatively\n\nflat organizational hierarchy, local autonomy, and control of decision-making and\n\nscheduling; and collegial nurse-physician relationships.154 Importantly, magnet\n\ncharacteristics are also associated with lower burnout and better patient outcomes.155,156\n\nIndividual-Level Interventions to Reduce Burnout\n\nIndividual-level interventions to reduce burnout should be complemented by\n\norganizational interventions. There is no evidence for the superiority of any one type\n\nof intervention and so it is recommended to provide access to a variety of evidencesupported resources. Interventions that have been supported in well-designed\n\nresearch trials include small group education, stress management, yoga, mindfulness,\n\nrelaxation techniques, communication skills training, coping skills training, and\n\ncognitive-behavioural therapy interventions.\n\nProviding individual resources to professionals who have been harmed by\n\ncircumstances beyond their control risks the perception of assigning responsibility for\n\nrepair to the person who has been harmed (e.g., blaming the victim). Individual-level\n\ninterventions should be understood to be complementary to organization and system\n\nlevel approaches.\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 11\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\nFurther research should be promoted to determine if understanding individuals’\n\ncontext (e.g. family circumstances, race, ethnicity) would allow for effectively tailored\n\ninterventions.\n\nOrganizational-Level Interventions\n\nThe most appropriate targets for system- and organization-level interventions are\n\naddressing shift length and scheduling, ensuring adequate training, offering education\n\nand support for moral distress.\n\nShift Length and Scheduling\n\nShifts should not be longer than 12 hours for nurses, and overtime hours should be\n\navoided. Scheduling should ensure adequate inter-shift recovery. Avoiding overtime\n\nhours requires maintaining sufficient numbers of staff. For all disciplines, appropriate\n\nlevels of staffing depend on numerous factors including patient acuity, direct care\n\ntime, and availability of supportive services. Ongoing monitoring and evaluation of\n\nworkload is necessary to inform shift length, scheduling, and staffing levels.\n\nTraining and Self-Efficacy\n\nTraining and support should be provided to promote healthcare providers’ competence\n\nand confidence with respect to (1) unfamiliar work tasks, such as those that result from\n\nreassignment to new areas, and (2) challenges that are directly related to burnout,\n\nsuch as managing interpersonal conflict, dealing with workplace violence and abuse,\n\nand responding to moral distress.\n\nLeadership\n\nLeaders have a critical role in creating a supportive work environment and culture.157\n\nLeaders should be visible, transparent, ethical, respectful, and should seek information\n\nfrom a variety of sources, including frontline staff, when making decisions. Support of\n\nstaff by managers is crucial and should be promoted by organizational leaders. Such\n\nsupport may include fostering a culture that promotes well-being (e.g. discourages\n\npresenteeism), actively working to reduce systemic contributors to burnout, openness\n\nand responsiveness to feedback, and recognition of achievements and sacrifices.\n\nSupport Networks\n\nA positive workplace culture should facilitate mutual support between colleagues. The\n\ndevelopment of peer support programs is also recommended. In addition, individual\n\npsychological assessment and treatment should be available for those who wish it.\n\nMoral Distress\n\nOrganizations should recognize that the COVID-19 pandemic has increased healthcare\n\nprofessionals’ exposure to moral distress. Although interventions to reduce the\n\nharmful effects of moral distress are not yet well-studied, education about the\n\nconcept and group-based critical reflective practice that allows cognitive reframing\n\nmay be valuable.\n\nInterventions to reduce burnout should be first directed towards groups who have\n\nbeen most affected. These include nurses, early career professionals and trainees,\n\nhealthcare workers in intensive care and emergency departments, and those who have\n\nworked in high acuity settings with large numbers of COVID-19 patients or outbreaks.\n\n\n\nMethods Used for This Science Brief\n\nWe searched PubMed, Google Scholar, the COVID-19 Rapid Evidence Reviews, LitCovid\n\nin PubMed, and the World Health Organization’s Global Literature on Coronavirus\n\nDisease. In addition, we retrieved reports citing relevant articles through Google Scholar\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 12\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\nand reviewed references from identified articles for additional studies. Selected media\n\nreports of recent trends were included when relevant. The search was last updated\n\non [July 31, 2021]. The COVID-19 Evidence Synthesis Network performed a research\n\nevidence scan for this Science Brief, published in an Evidence Synthesis Briefing Note.\n\nThe COVID-19 Evidence Synthesis Network is comprised of organizations in Ontario’s\n\nevidence synthesis and knowledge translation community who collectively provide\n\nhigh-quality, relevant, and timely synthesized research evidence about COVID-19.\n\n\n\nAuthor Contributions\n\nThe Mental Health Working Group conceived the Science Brief. RGM, NDH, GS, HDS\n\nwrote the first draft of the Science Brief. LJ, CM and LM reviewed and revised the\n\ndraft. All authors revised the Science Brief critically for important intellectual content\n\nand approved the final version.\n\n\n\nReferences\n\n1. Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse staffing and\n\npatient mortality, nurse burnout, and job dissatisfaction. JAMA. 2002;288(16):19871993. https://doi.org/10.1001/jama.288.16.1987\n\n2. West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and\n\nreduce physician burnout: A systematic review and meta-analysis. The Lancet.\n\n2016;388(10057):2272-2281. https://doi.org/10.1016/S0140-6736(16)31279-X\n\n3. Ontario Medical Association. Healing the Healers: System-Level Solutions to\n\nPhysician Burnout. Ontario Medical Association; 2021:48. https://www.oma.org/\n\nuploadedfiles/oma/media/pagetree/advocacy/health-policy-recommendations/\n\nburnout-paper.pdf\n\n4. Quick COVID-19 survey. 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Hunt S, Producer Ctvn ca D, Contact F|. Elective surgeries cancelled in Calgary,\n\nFort Macleod emergency room closed as COVID-19 surge continues. CTV News.\n\nPublished September 8, 2021. https://calgary.ctvnews.ca/elective-surgeriescancelled-in-calgary-fort-macleod-emergency-room-closed-as-covid-19-surgecontinues-1.5578056\n\n145. Stevenson V. Another Quebec ER had to shut down because of a lack of\n\nnurses, who are exhausted. CBC. Published September 16, 2021. https://www.\n\ncbc.ca/news/canada/montreal/suroit-hospital-er-closes-overnight-1.6178786\n\n146. Cox A. Staff shortages at 2 N.B. hospitals lead to closures of labour, obstetrics\n\nunits. CBC. Published August 19, 2021. https://www.cbc.ca/news/canada/newbrunswick/hospital-labour-obstetrics-new-brunswick-1.6146501\n\n147. Payne E. Signing bonuses are a sign of the times as desperate hospitals seek\n\nnurses. ottawacitizen. Published June 11, 2021. https://ottawacitizen.com/news/\n\nlocal-news/signing-bonuses-are-a-sign-of-the-times-as-desperate-hospitals-seeknurses\n\n148. Research, Analysis, and Evaluation Branch. Evidence synthesis briefing note:\n\nBest practices for supporting health care worker burnout following intense\n\nprofessional commitment. COVID-19 Evidence Synthesis Network; 2021. https://\n\nesnetwork.ca/wp-content/uploads/2021/05/61.-BN-on-Health-Care-WorkerBurnout_17-June-21_v1.pdf\n\n149. Moat KA, Waddell K, Lavis JN. Planning for the future health workforce of\n\nOntario.;\n\n2016:60.\n\nhttps://www.mcmasterforum.org/docs/default-source/\n\nproduct-documents/evidence-briefs/workforce-planning-eb.pdf\n\n150. Goh Y-S, Lee A, Chan SW-C, Chan MF. Profiling nurses’ job satisfaction,\n\nacculturation, work environment, stress, cultural values and coping abilities: A\n\ncluster analysis. Int J Nurs Pract. 2015;21(4):443-452. https://doi.org/10.1111/\n\nijn.12318\n\n151. Labrague L j., McEnroe-Petitte D m. Job stress in new nurses during the\n\ntransition period: An integrative review. Int Nurs Rev. 2018;65(4):491-504. https://\n\ndoi.org/10.1111/inr.12425\n\n152. Zhang Y, Wu J, Fang Z, Zhang Y, Wong FKY. Newly graduated nurses’ intention to\n\nleave in their first year of practice in Shanghai: A longitudinal study. Nurs Outlook.\n\n2017;65(2):202-211. https://doi.org/10.1016/j.outlook.2016.10.007\n\n153. Brook J, Aitken L, Webb R, MacLaren J, Salmon D. Characteristics of successful\n\ninterventions to reduce turnover and increase retention of early career nurses:\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 23\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBurnout in Hospital-Based Healthcare Workers during COVID-19\n\n\n\nA systematic review. Int J Nurs Stud. 2019;91:47-59. https://doi.org/10.1016/j.\n\nijnurstu.2018.11.003\n\n154. Scott JG, Sochalski J, Aiken L. Review of magnet hospital research: Findings\n\nand implications for professional nursing practice. JONA J Nurs Adm. 1999;29(1):919.\n\nhttps://journals.lww.com/jonajournal/Abstract/1999/01000/Review_of_\n\nMagnet_Hospital_Research__Findings_and.3.aspx\n\n155. Kelly LA, McHugh MD, Aiken LH. Nurse outcomes in magnet and non-magnet\n\nhospitals. JONA J Nurs Adm. 2012;42(10):S44. https://doi.org/10.1097/01.\n\nNNA.0000420394.18284.4f\n\n156. McHugh MD, Kelly LA, Smith HL, Wu ES, Vanak JM, Aiken LH. Lower mortality in\n\nmagnet hospitals. JONA J Nurs Adm. 2013;43(10):S4. https://doi.org/10.1097/01.\n\nNNA.0000435145.39337.d5\n\n157. Jeffs L, Merkley J, Canzian S, Taggart R, Harris IA and A. Balancing resiliency\n\nand new accountabilities: Insights from chief nurse executives amid the\n\nCOVID-19 pandemic. Nurs Leadersh. 2020;33(4). https://www.longwoods.\n\ncom/content/26425/nursing-leadership/balancing-resiliency-and-newaccountabilities-insights-from-chief-nurse-executives-amid-the-covid-1\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nOctober 7, 2021 | 24\n\n\n\n\f",
          "document_id": 445557
        }
      ]
    },
    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "Who are critically III patients?",
              "id": 275172,
              "answers": [
                {
                  "answer_id": 273762,
                  "document_id": 445558,
                  "question_id": 275172,
                  "text": "Patients requiring ventilatory\n\nand/or circulatory support,\n\nincluding high-flow nasal oxygen,\n\nnon-invasive ventilation, invasive\n\nmechanical ventilation, or ECMO",
                  "answer_start": 546,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Who are moderately III patients?",
              "id": 275175,
              "answers": [
                {
                  "answer_id": 273765,
                  "document_id": 445558,
                  "question_id": 275175,
                  "text": "Patients newly requiring low-flow\n\nsupplemental oxygen",
                  "answer_start": 1973,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Which drug should be recommended to critically III patients?",
              "id": 275174,
              "answers": [
                {
                  "answer_id": 273774,
                  "document_id": 445558,
                  "question_id": 275174,
                  "text": "Dexamethasone 6 mg PO/IV daily for 10 days (or until discharge if sooner) is recommended",
                  "answer_start": 428,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Which drug should be recommended to moderately III patients?",
              "id": 275176,
              "answers": [
                {
                  "answer_id": 273768,
                  "document_id": 445558,
                  "question_id": 275176,
                  "text": "Remdesivir 200 mg IV on day 1, then 100 mg IV daily for 4 days is recommended",
                  "answer_start": 1866,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Which drug should be recommended to mildly III patients?",
              "id": 275185,
              "answers": [
                {
                  "answer_id": 273766,
                  "document_id": 445558,
                  "question_id": 275185,
                  "text": "Sotrovimab 500 mg IV x 1 dose is recommended for mildly ill patients",
                  "answer_start": 2458,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Who are mildly III patients? ",
              "id": 275177,
              "answers": [
                {
                  "answer_id": 273763,
                  "document_id": 445558,
                  "question_id": 275177,
                  "text": "Patients who do not require\n\nnew or additional supplemental\n\noxygen from their baseline status",
                  "answer_start": 3267,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            }
          ],
          "context": "Ontario COVID-19 Drugs and Biologics Clinical Practice Guidelines Working Group\n\n\n\nTherapeutic Management of Adult Patients with COVID-19\n\nRecommendations apply to patients >18 years of age. Recommendations are based on the best available data and may change as additional data becomes available. Science Briefs can be found on the Ontario COVID-19 Science Advisory Table website.\n\n\n\nRECOMMENDATIONS\n\n\n\nSEVERITY OF ILLNESS\n\n\n\nn Dexamethasone 6 mg PO/IV daily for 10 days (or until discharge if sooner) is recommended.\n\n\n\nCritically Ill Patients\n\nPatients requiring ventilatory\n\nand/or circulatory support,\n\nincluding high-flow nasal oxygen,\n\nnon-invasive ventilation, invasive\n\nmechanical ventilation, or ECMO\n\n\n\nn Tocilizumab is recommended for patients who are on recommended doses of\n\ndexamethasone therapy (or a dose-equivalent corticosteroid) AND are within 14 days of\n\nhospital admission (or within 14 days of a new COVID-19 diagnosis if the infection was\n\nnosocomially acquired).\n\n\n\n• In drug shortage situations, a single dose of tocilizumab 400 mg IV or sarilumab 400 mg\n\nIV should be used for all eligible patients. A second dose of tocilizumab or sarilumab\n\nshould not be given to any patient.\n\n\n\np\n\n\n\nBaricitinib 4 mg PO/NG daily for 14 days (or until discharge if sooner) may be considered in\n\npatients who are on recommended doses of dexamethasone therapy (or a dose-equivalent\n\ncorticosteroid) or who have a contraindication to corticosteroid treatment. The panel does\n\nnot recommend combined use of baricitinib and IL-6 inhibitors due to absence of safety and\n\nefficacy evidence.\n\n\n\nn Dexamethasone 6 mg PO/IV daily for 10 days (or until discharge if sooner) is recommended.\n\np If patients are discharged with home-based oxygen therapy, dexamethasone 6 mg PO daily\n\nuntil oxygen is no longer required (for a maximum of 10 days) may be considered.\n\nn Remdesivir 200 mg IV on day 1, then 100 mg IV daily for 4 days is recommended.\n\n\n\nModerately Ill Patients\n\nPatients newly requiring low-flow\n\nsupplemental oxygen\n\n\n\np\n\n\n\nTherapeutic dose anticoagulation may be considered over prophylactic dose anticoagulation\n\nin patients who are felt to be at low risk of bleeding.\n\nn All other patients should receive prophylactic dose anticoagulation.\n\ng SARS-CoV-2 neutralizing antibodies are not recommended for moderately ill patients.\n\n\n\nFor symptomatic inpatients with nosocomial infection, see mildly ill recommendations below\n\nfor sotrovimab.\n\n\n\nn Sotrovimab 500 mg IV x 1 dose is recommended for mildly ill patients who present within\n\n7 days of symptom onset and meet any one of the following criteria:\n\n\n\n• Symptomatic residents of long-term care facilities, retirement homes, and other congregate\n\ncare living settings\n\n• Symptomatic inpatients with nosocomial infection\n\n• High-risk patients: (a) ≥70 years of age AND have at least one additional risk factor; or\n\n(b) ≥50 years of age AND First Nations, Inuit, or Métis, AND have at least one additional risk\n\nfactor (e.g., obesity (BMI ≥30), dialysis or stage 5 kidney disease (eGFR <15 mL/min/1.73 m2),\n\ndiabetes, cerebral palsy, intellectual disability of any severity, sickle cell disease, receiving\n\nactive cancer treatment, solid organ or stem cell transplant recipients)\n\n\n\nMildly Ill Patients\n\nPatients who do not require\n\nnew or additional supplemental\n\noxygen from their baseline status\n\n\n\np\n\n\n\nSotrovimab may be considered in patients who do not meet the above criteria if they present\n\nwithin 7 days of symptom onset and if, in the opinion of a physician, they have other important\n\nrisk factors for disease progression (e.g., immunosuppression, receipt of immunosuppressants).\n\n\n\nn Prophylactic dose low molecular weight or unfractionated heparin is recommended.\n\ng These patients should not receive therapeutic dose anticoagulation unless they have a\n\nseparate indication for this treatment.\n\ng Remdesivir is not recommended for patients receiving mechanical ventilation.\n\n\n\np\n\n\n\nRemdesivir 200 mg IV on day 1, then 100 mg IV daily for 4 days may be considered in\n\npatients requiring high-flow oxygen (i.e., oxygen by mask, oxygen by high-flow nasal cannula,\n\nor non-invasive mechanical ventilation).\n\n\n\ng SARS-CoV-2 neutralizing antibodies are not recommended for critically ill patients.\n\n\n\nFor symptomatic inpatients with nosocomial infection, see mildly ill recommendations below\n\nfor sotrovimab.\n\n\n\ng Bacterial co-infection is uncommon in COVID-19 pneumonia at presentation.\n\n\n\nDo not add empiric antibiotics for bacterial pneumonia unless bacterial infection is strongly\n\nsuspected. Continue empiric antibiotics for no more than 5 days, and de-escalate on the\n\nbasis of microbiology results and clinical judgment.\n\n\n\nn Tocilizumab is recommended for patients who have evidence of systemic inflammation,\n\ndefined as a serum CRP of 75 mg/L or higher, AND have evidence of disease progression\n\n(i.e., increasing oxygen or ventilatory requirements) despite 24-48 hours of recommended\n\ndoses of dexamethasone therapy (or a dose-equivalent corticosteroid), AND are within\n\n14 days of hospital admission (or within 14 days of a new COVID-19 diagnosis if the infection\n\nwas nosocomially acquired).\n\n\n\n• In drug shortage situations, a single dose of tocilizumab 400 mg IV or sarilumab 400 mg\n\nIV should be used for all eligible patients. A second dose of tocilizumab or sarilumab\n\nshould not be given to any patient.\n\n\n\np\n\n\n\nBaricitinib 4 mg PO daily for 14 days (or until discharge if sooner) may be considered\n\nin patients who are on recommended doses of dexamethasone (or a dose-equivalent\n\ncorticosteroid) or who have a contraindication to corticosteroid treatment. The panel does\n\nnot recommend combined use of baricitinib and IL-6 inhibitors due to absence of safety and\n\nefficacy evidence.\n\n\n\np\n\n\n\nBudesonide 800 mcg inhaled twice daily for 14 days may be considered for symptomatic\n\nhigh-risk outpatients (as described under sotrovimab recommendation for mildly ill patients).\n\n\n\np\n\n\n\nFluvoxamine 50 mg PO daily titrated up to 100 mg PO TID for 15 days may be considered for\n\nmildly ill patients presenting within 7 days of symptom onset. This recommendation is based\n\non very low certainty evidence of reduction in hospitalization, and the need for outpatient\n\ntreatment options with a reasonable safety profile during an anticipated spike in COVID-19\n\ncases due to the Omicron variant. Pharmacist consultation and outpatient provider follow-up\n\nis important to avoid any significant adverse drug interactions with fluvoxamine.\n\n\n\nCURRENTLY NOT\n\nRECOMMENDED\n\nThere is insufficient evidence\n\nto support the use of the\n\nfollowing therapies in the\n\ntreatment of COVID-19 outside\n\nof clinical trials or where other\n\nindications would justify its use:\n\n\n\nu Colchicine\n\nu Interferon (with or without\n\nlopinavir-ritonavir and\n\nribavirin)\n\n\n\nu Vitamin D\n\n\n\nRECOMMENDED\n\nAGAINST\n\nThe following therapies are not\n\nrecommended for treatment of\n\nCOVID-19 due to lack of\n\nbenefit, potential harm, and\n\nsystem implications of overuse:\n\ng Antibiotics (azithromycin)\n\ng Casirivimab-imdevimab\n\n\n\ndue to lack of neutralizing\n\nactivity against the\n\nOmicron variant\n\n\n\ng Hydroxychloroquine or\n\n\n\nchloroquine\n\n\n\ng Ivermectin\n\ng Lopinavir/ritonavir\n\n\n\nu There is currently insufficient evidence to make a recommendation around anticoagulation for mildly ill patients.\n\ng The following therapies are not recommended in mildly ill patients: dexamethasone, remdesivir, tocilizumab, and baricitinib.\n\n\n\nPrevious SARS-CoV-2 infection and vaccination status do not need to be considered. Serologic\n\ntesting does not need to be done.\n\nIt is recommended that monoclonal antibody therapy be administered to non-hospitalized\n\nindividuals across Ontario using a hybrid network that includes, but is not limited to, mobile\n\nintegrated healthcare services, community paramedicine, and outpatient infusion clinics.\n\n\n\nClick here for dosing and pharmacologic considerations for medications approved or under investigation for COVID-19\n\nVersion 6.0 | Updated December 20, 2021 | https://doi.org/10.47326/ocsat.cpg.2021.6.0 | Design by Tiffany Kan PharmD\n\n\n\n\f",
          "document_id": 445558
        }
      ]
    },
    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "How have people with disabilities been prioritized in Ontario's COVID-19 vaccination plan, including for second dose interval exemptions?  ",
              "id": 275169,
              "answers": [
                {
                  "answer_id": 273777,
                  "document_id": 445559,
                  "question_id": 275169,
                  "text": "With current vaccine supply, people with disabilities included in the highest-, high-,\n\nand at-risk",
                  "answer_start": 52586,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How have people with disabilities been impacted by COVID-19?",
              "id": 275168,
              "answers": [
                {
                  "answer_id": 273776,
                  "document_id": 445559,
                  "question_id": 275168,
                  "text": "People with disabilities have been disproportionately impacted by the COVID-19\n\npandemic and are at a higher risk of contracting SARS-CoV-2. Several factors increase\n\nthe risk of contracting SARS-CoV-2 for people with disabilities, including in-person care\n\nrequirements, living in congregate settings including group and long-term care (LTC)\n\nhomes, inaccessible public health messaging, and difficulty following some public\n\nhealth measures, among other factors. Furthermore, people with disabilities have\n\nhigher rates of several chronic health conditions that are associated with COVID-19\n\noutcomes such as hospitalization and death. These conditions can be associated with\n\nan individual’s disability but can also be the result of or exacerbated by poor access\n\nto health care",
                  "answer_start": 10912,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            }
          ],
          "context": "SCIENCE BRIEFS\n\n\n\nCOVID-19 Vaccination for People\n\nwith Disabilities\n\n\n\nSara Rotenberg, Matthew B. Downer, Hilary Brown, Jane Cooper, Sabrina Campanella,\n\nYousef Safar, Gabrielle M. Katz, Sandi Bell, Wendy Porch, Fahad Razak, Paula A. Rochon,\n\nMichael Schull, Nathan M. Stall, Yona Lunsky on behalf of the Ontario COVID-19\n\nScience Advisory Table\n\n\n\nVersion: 1.1\n\nPublished: June 8, 2021\n\nUpdated on June 15, 2021. Version\n\n1.0\n\nis\n\navailable\n\nunder\n\nAdditional\n\nResources at https://doi.org/10.47326/\n\nocsat.2021.02.35.1.0\n\nCitation: Rotenberg S, Downer MB, Brown\n\nHK et al. COVID-19 Vaccination for People with Disabilities. Science Briefs of the\n\nOntario COVID-19 Science Advisory Table.\n\n2021;2(35).\n\nhttps://doi.org/10.47326/ocsat.2021.02.35.1.0\n\nAuthor Affiliations: The affiliations of the\n\nmembers of the Ontario COVID-19 Science\n\nAdvisory Table can be found at https://\n\ncovid19-sciencetable.ca/.\n\nDeclarations of Interest: The declarations\n\nof interest of the members of the Ontario\n\nCOVID-19 Science Advisory Table, its Working\n\nGroups, or its partners can be found at https://\n\ncovid19-sciencetable.ca/. The declarations\n\nof interest of external authors can be found\n\nunder additional resources at https://doi.\n\norg/10.47326/ocsat.2021.02.35.1.0\n\n\n\nKey Message\n\nInternationally, people with disabilities have been disproportionately impacted by\n\nCOVID-19, accounting for nearly 60% of COVID-19 deaths in the UK and overall higher\n\nmortality rates based on social, clinical, and demographic factors.\n\nOntario has prioritized people with disabilities across the three phases of its COVID-19\n\nvaccination program, but there is a difference between availability and accessibility\n\nof vaccination. Ontario’s 34 public health units are responsible for leading the local\n\ndistribution and administration of COVID-19 vaccines, and their public facing websites\n\nserve as entry points for information on the accessibility of vaccination. On average,\n\nthese websites contain information about 5 of 18 key accessibility features, across\n\nthree domains: accessible communication, physical accessibility, and accessible social\n\nand sensory environments.\n\nOntario needs a multi-pronged strategy to reach all people with disabilities that includes\n\nimproving information about communication accessibility, physical accessibility, and\n\nsocial and sensory environment accessibility throughout the COVID-19 vaccination\n\njourney. Ontario’s progress on vaccinating people with disabilities needs to also be\n\nmeasured through enhanced data monitoring efforts.\n\n\n\nAbout Us: The Ontario COVID-19 Science\n\nAdvisory Table is a group of scientific experts\n\nand health system leaders who evaluate and\n\nreport on emerging evidence relevant to\n\nthe COVID-19 pandemic, to inform Ontario’s\n\nresponse. Our mandate is to provide weekly\n\nsummaries of relevant scientific evidence for\n\nthe COVID-19 Health Coordination Table of the\n\nProvince of Ontario, integrating information\n\nfrom existing scientific tables, Ontario’s\n\nuniversities and agencies, and the best global\n\nevidence. The Science Table summarizes its\n\nfindings for the Health Coordination Table and\n\nthe public in Science Briefs.\n\nCorrespondence to: Secretariat of the\n\nOntario COVID-19 Science Advisory Table\n\n(info@covid19-sciencetable.ca)\n\nCopyright: 2021 Ontario COVID-19 Science\n\nAdvisory Table. This is an open access\n\ndocument distributed under the terms of the\n\nCreative Commons Attribution License, which\n\npermits unrestricted use, distribution, and\n\nreproduction in any medium, provided that\n\nthe original work is properly cited.\n\nThe views and findings expressed in this\n\nScience Brief are those of the authors and do\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 1\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nnot necessarily reflect the views of all of the\n\nmembers of the Ontario COVID-19 Science\n\nAdvisory Table, its Working Groups, and its\n\npartners.\n\n\n\nFigure 1. Map of Sample Accessible Out-of-Home COVID-19 Vaccination Process for Persons with Disabilities\n\nPresents the possible paths through out-of-home vaccination. Accessible information, booking processes, travel to the\n\nclinic, waiting in line, registration, vaccination, post-care, and second dose preparations are the critical steps where\n\ncommunications, physical and social and sensory environmental communications are important. For further details on\n\nimportant considerations within each of these steps, see Table 1. ASL, American Sign Language.\n\n\n\nFigure 2. Map of Sample Accessible In-Home COVID-19 Vaccination Process for Persons with Disabilities\n\nPresents the possible paths through in-home vaccination. The steps are similar on information, booking, post-care,\n\nand preparing for the second dose as for out-of-home vaccination, but vaccinators coming into the home should wear\n\nappropriate PPE and understand accessibility needs to support people with disabilities getting vaccinated in their\n\nhome.\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 2\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nSummary\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nBackground\n\nOne in five Ontarians has a disability — a physical, mental, intellectual, or sensory\n\nimpairment — with the rate increasing to 40% of Ontarians over 65 years of age.\n\nA growing body of global evidence indicates people with disabilities have been\n\ndisproportionately impacted by COVID-19. For instance, 59% of COVID-19 deaths in\n\nthe UK occurred in people with disabilities, despite comprising 17% of the population.\n\nWhile Canadian data are limited, there is a link between disability status and\n\nCOVID-19 related hospitalizations and mortality. This has led Ontario and many other\n\njurisdictions to prioritize specific groups of people with disabilities for COVID-19\n\nvaccination. However, without supporting the accessibility and acceptability of\n\nvaccination, from providing information about vaccination the vaccination process\n\nto the actual vaccine administration, people with disabilities may face barriers in\n\nreceiving their COVID-19 vaccine.\n\nQuestions\n\nHow have people with disabilities been impacted by COVID-19?\n\nHow have people with disabilities been prioritized in Ontario’s COVID-19 vaccination\n\nplan, including for second dose interval exemptions?\n\nWhat are the key considerations for making COVID-19 vaccinations accessible for\n\npeople with disabilities?\n\nWhat are the barriers to people with disabilities receiving the COVID-19 vaccine?\n\nHow can data monitoring on COVID-19 vaccination and disability inform accessibility\n\ninitiatives?\n\nFindings\n\nInternational data suggest disproportionate impacts of COVID-19 on people with\n\ndisabilities with a greater risk of morbidity and mortality as well as serious mental\n\nhealth and social impacts. Given these experiences, Ontario has prioritized many\n\npeople with disabilities in the early phases of its vaccination rollout. Key considerations\n\nrelated to communication, the physical and the social and sensory environment can\n\nmake vaccination more accessible for people with disabilities.\n\nAs a proxy for perceived and actual accessibility, a framework measuring 18\n\naccessibility dimensions was developed and applied to review publicly available\n\ninformation on the websites of Ontario’s 34 public health units (PHUs) as of May\n\n7, 2021. While this may not be fully representative of all accessibility initiatives, it\n\nsimulates the user experience in trying to get information about available vaccination\n\naccommodations. Overall, the website review identified multiple potential barriers, as\n\nthe median number of accessibility dimensions listed as available was 5 of 18 (interquartile range (IQR) 4-6), or 28% of the identified dimensions. Only five of the PHUs\n\nhad more than 50% of the identified dimensions, while nine of the PHUs had less than\n\n25% of the identified dimensions publicly available online. In addition to having some\n\nof these accessibility features within mass vaccination sites, some PHUs have also\n\ndeveloped more specialized clinics focused on vaccinating people with disabilities and\n\nhave offered mobile clinics to certain individuals.\n\nOntario has yet to track and report publicly on COVID-19 vaccination rates among all\n\npeople with disabilities. Using people with intellectual and developmental disabilities—\n\none of the high-risk subgroups prioritized in Phase 2—as an example, recent data from\n\nICES demonstrate the feasibility and value of monitoring vaccination rates.\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 3\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nInterpretation\n\nMaking Ontario’s COVID-19 vaccination sites more accessible should build upon\n\nexisting initiatives to improve communication-related, physical, and social and\n\nsensory accessibility at each stage of the vaccination process for all types of clinics.\n\nIt is important to include all accessibility information in multiple formats on PHU\n\nwebsites to reduce barriers to vaccination, from booking to attending the vaccination\n\nclinics. Although accommodations may be available upon request, by phone or at\n\nspecific clinics, if such information is difficult to access, this may prevent individuals\n\nwith disabilities from pursuing vaccination. Accommodation request forms and other\n\nnavigational supports at the time of booking and ‘accessibility champions’ on-site for\n\nevery location can support people with disabilities in getting vaccinated.\n\nPHUs can continue to provide and expand opportunities for acceptable and accessible\n\ncare for people with disabilities at existing clinical vaccination sites, as well as through\n\nimplementing more targeted approaches to reach people with disabilities, such as\n\nmobile in-home vaccination and specialized clinics. Collecting and publicly reporting\n\ndata on vaccinations for people with disabilities can inform ongoing accessibility efforts.\n\n\n\nBackground\n\nPeople with disabilities make up an estimated 22% of Ontarians.1 In Canada, the\n\nterm ‘people with disabilities’ describes individuals who have long-term impairments\n\nthat are physical, mental, intellectual, or sensory in nature and who face barriers to\n\nfull and equal participation in society.2 Accessibility considerations address certain\n\nbarriers to participation. While accessibility is often thought of in terms of physical\n\naccessibility (i.e., wheelchair accessibility, step-free access, etc.), it also encompasses\n\ncommunication and social and sensory environment-based accessibility. Many\n\naccommodations are simple, low- or no-cost, easy to implement and consistent with\n\nthe requirements in the Accessible Canada Act, 2019; Canada Health Act, 1984; and\n\nAccessibility for Ontarians with Disabilities Act, 2005.\n\nPeople with disabilities have been disproportionately impacted by the COVID-19\n\npandemic and are at a higher risk of contracting SARS-CoV-2. Several factors increase\n\nthe risk of contracting SARS-CoV-2 for people with disabilities, including in-person care\n\nrequirements, living in congregate settings including group and long-term care (LTC)\n\nhomes, inaccessible public health messaging, and difficulty following some public\n\nhealth measures, among other factors. Furthermore, people with disabilities have\n\nhigher rates of several chronic health conditions that are associated with COVID-19\n\noutcomes such as hospitalization and death. These conditions can be associated with\n\nan individual’s disability but can also be the result of or exacerbated by poor access\n\nto health care.\n\nWhile many provinces, including Ontario, have prioritized people with disabilities\n\nand those living in congregate settings for early COVID-19 vaccination, there is a\n\ndifference between availability and accessibility of vaccines. Simply being eligible is\n\nnot sufficient to ensure access to vaccines for people with disabilities, making it critical\n\nto address accessibility across the COVID-19 vaccination journey. Ultimately, many of\n\nthese accessibility features will improve the vaccination experience for everyone —\n\nparticularly having clear communication, easy to use resources and booking, and a\n\nmore sensory friendly and physically accessible environment — making it important\n\nto implement universal accessibility into Ontario’s vaccination roll-out.\n\nQuestions\n\nHow have people with disabilities been impacted by COVID-19?\n\nHow have people with disabilities been prioritized in Ontario’s COVID-19 vaccination\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 4\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nplan, including for second dose interval exemptions?\n\nWhat are the key considerations for making COVID-19 vaccinations accessible for\n\npeople with disabilities?\n\nWhat are the barriers to people with disabilities receiving the COVID-19 vaccine?\n\nHow can data monitoring on COVID-19 vaccination and disability inform accessibility\n\ninitiatives?\n\n\n\nFindings\n\nEvidence on COVID-19 and Disability\n\nInternational data illustrate the disproportionate impact COVID-19 has had on people\n\nwith disabilities. Data from the UK demonstrate that 59% of COVID-19 deaths have\n\nbeen among people with disabilities.6 After adjusting for age, socio-demographic, and\n\nother risk-factors, in the pandemic’s first wave, people with disabilities, as measured\n\nby census data, were found to have mortality rates 2.4 and 2.0 times higher for women\n\nand men, respectively, regardless of disability type.6,7\n\nFurthermore, mortality rates are higher for people with certain specific disabilities.\n\nFor example, a US study showed that intellectual disability is the strongest predictor\n\nfor COVID-19 mortality after age,5 and other studies have estimated the mortality for\n\npeople with Down syndrome is five to ten times that of the general population.6,7 In\n\nNew York, people with schizophrenia spectrum disorder were found to have a death\n\nrate 2.67 times higher than others in the general population. In addition, certain\n\nconditions predispose individuals with disabilities to adverse outcomes of COVID-19,\n\nsuch as neuromuscular conditions that impact breathing, but limited data are available\n\nto assess the full impact and outcomes of these individuals.8 For example, people\n\nwith multiple sclerosis who were non-ambulatory were 2.8 times more likely to be\n\nhospitalized,9 3.5 times more likely to require ICU admission/ventilation, and 25 times\n\nmore likely to die from COVID-19. Data from Spain demonstrate that individuals with\n\nchronic neurological conditions were more likely to go to the emergency department\n\nearlier (average of 1.4 days) for milder symptoms and nonetheless experienced higher\n\nin-hospital mortality.10\n\nAge is a well-established risk factor for COVID-19 mortality. Older adults with\n\ndisabilities are more likely to die than younger adults with disabilities if they contract\n\nCOVID-19. However, there is an increased risk of mortality in younger age groups of\n\npeople with disabilities than younger people in the general population.3,11 People with\n\ndisabilities also often have poorer social determinants of health, which impacts their\n\nsusceptibility to SARS-CoV-2 infection and risk of COVID-19 mortality. For example,\n\nplace of residence has significant impacts on COVID-19 mortality. In addition to\n\nchallenges experienced by those living in poverty in close quarters, UK and US studies\n\nhave highlighted that one of the strongest predictors of COVID-19 mortality for people\n\nwith intellectual or developmental disabilities is living in a congregate setting.3,12,13\n\nWhile published data have focused on people with developmental disabilities, many\n\npeople with disabilities live in congregate settings or receive in-home support through\n\ncommunity-based care. Ontario has prioritized congregate settings for people with\n\ndisabilities such as LTC homes – where 6% of residents are younger adults with\n\ndisabilities – for early COVID-19 vaccination in December 2020 and January 2021.14 In\n\ncontrast to LTC homes, vaccinations in group homes and other supported residential\n\nsettings only began during Phase 2 (March to May 2021); most, if not all of these\n\nsettings have only been partially vaccinated, despite their high-risk populations and\n\ncongregate nature.\n\nFinally, people with disabilities have higher rates of a number of chronic health\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 5\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nconditions that may be associated with one’s disability and may require home and\n\ncommunity care supports. Many people with disabilities who live in the community\n\nhave an increased risk of contracting SARS-CoV-2 because of in-person care\n\nrequirements, such as personal care attendants who also serve multiple clients or\n\nunpaid family caregivers. Multimorbidity and comorbidities further increase the risk of\n\nCOVID-19 incidence and mortality among people with disabilities. Health care access,\n\nespecially during the pandemic, is more difficult for people with disabilities who are\n\nalso racialized, newcomers, or living in poverty. Together, these demographic, social,\n\nand clinical risk factors may contribute to these disproportionate COVID-19 mortality\n\ntrends for people with disabilities.\n\nImportantly, the COVID-19 pandemic has also had a social impact on people with\n\ndisabilities. For instance, poverty is more common for people with disabilities,15\n\nwith an estimated 58% of people with disabilities currently unemployed. During the\n\npandemic, approximately 44% of employed Canadians with disabilities have had their\n\nhours reduced, have been laid off, or have been furloughed and remained ineligible\n\nfor income support.16 In addition, people with disabilities faced barriers to accessing\n\nsocial support and other necessary care, as well as significant adverse outcomes of\n\nprolonged isolation.\n\nA recent Canadian survey found that, because of the pandemic, people with disabilities’\n\nunmet needs for social and non-COVID-19 related health services increased,\n\nparticularly in the areas of home care; general, specialized, and mental health care;\n\ntransportation; internet and technology; and equipment and medical supplies.16\n\nWhile it is too soon to measure the long-term impacts of the loss of these services, it\n\nis likely that people with disabilities will be negatively impacted by functional, health,\n\nwellbeing, and learning losses for many years to come.17\n\nVaccination Accessibility in Ontario\n\nPeople with disabilities fall into all three categories of Ontario’s COVID-19 vaccine\n\nprioritization framework. People with disabilities living in LTC homes, Indigenous\n\nOntarians with disabilities, and adults with disabilities receiving chronic home care\n\nwere eligible to be vaccinated in Phase 1, though individuals who stopped chronic\n\nhome care to reduce the risk of infection were no longer eligible for Phase 1, even if\n\nvaccination would allow them to restart these critical services. People with disabilities\n\nin congregate settings or hot spot communities, and those with the highest-, high, and at-risk conditions and their caregivers were included in Phase 2. Within these\n\nPhase 2 conditions, some specific disabilities, including ‘neurological diseases that\n\nimpact breathing (i.e., multiple sclerosis, muscular dystrophy, etc.)’, “intellectual or\n\ndevelopmental disabilities (i.e., Down syndrome)”, and “other disabilities requiring direct\n\nsupport care in the community”, were explicitly named. Other people with disabilities\n\nwho do not fall into these categories should receive their vaccine in Phase 3, alongside\n\nthe general population, unless they live in one of Ontario’s 114 ‘hot spot’ areas.\n\nAlthough the province develops the provincial prioritization strategy, each PHU is\n\nresponsible for determining community needs, and for leading the local distribution\n\nand administration of COVID-19 vaccines.18\n\nGiven that some people with disabilities are receiving their first vaccine doses\n\nalongside the general population, we identified key accessibility considerations to\n\nmake vaccinations accessible to all people with disabilities. The considerations listed\n\nare consistent with Provincial Health Care Standards currently under public review.\n\nMany of these features are low- or no-cost and would also benefit people without\n\ndisabilities. These include accessibility in the communications, physical, and social\n\nand sensory environment domains throughout each step involved in a vaccination\n\nprogram (Table 1).\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 6\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\nPhase\n\n\n\nCommunication\n\n\n\nPhysical\n\n\n\nSocial and sensory\n\nenvironment\n\nƒ Web, phone, text, and\n\nprimary care physicianbased alternatives for\n\nbooking vaccination\n\nand/or information\n\nabout vaccination.\n\n\n\nInformation about the\n\nvaccine, decision to get\n\nvaccinated, and booking\n\nprocess\n\n\n\nƒ Plain language\n\nand easy-to-read\n\ntranslation about\n\nwhen to get\n\nvaccinated, how\n\nvaccines work, how to\n\nget vaccinated, how\n\nto understand media\n\nabout rare vaccination\n\nside effects, and the\n\nvaccination journey.\n\nƒ Multiple,\n\naccessible formats\n\nof information,\n\nadvertisements, and\n\nbooking modalities\n\n(including information\n\nin multiple languages,\n\nplain text, pictorial\n\nrepresentation,\n\nand text-to-speech\n\ncompatible).\n\nƒ Provide videos,\n\npictures, site maps,\n\nand written easy-toread documents to\n\nguide the vaccination\n\njourney, especially if\n\npeople cannot preview\n\nthe site ahead of time.\n\n\n\nƒ Accessible booking\n\nwebsite (i.e., screen\n\nreadable, keyboard\n\ninput, alternative\n\ntext, no flashing\n\ncomponents, etc.).\n\n\n\nEligibility/burden of proof\n\n\n\nƒ Information on\n\nrequired documents\n\nor processes for\n\nvaccination should\n\nbe available online, if\n\nabsolutely necessary.\n\n\n\nƒ Allow for paper\n\nor electronic\n\ndocumentation, if\n\nabsolutely necessary.\n\n\n\nƒ Service providers do\n\nnot ask for proof of\n\ndisability.\n\n\n\nAccessible line, approach,\n\nand entrance to\n\nvaccination center\n\n\n\nƒ Clear, large highcontrast signage\n\nindicating location of\n\nvaccination centre, line\n\nstart/end, directional\n\ntraffic, protocols,\n\nrequired questions,\n\netc.\n\nƒ International Symbol\n\nof Accessibility at\n\naccessible entrance.\n\nƒ Clipboards to\n\nallow for written\n\ncommunication,\n\nclear masks, and sign\n\nlanguage interpreters\n\nto communicate with\n\npeople who are d/Deaf\n\nor hard of hearing.\n\n\n\nƒ Accessible entrance\n\n(wide doorway, lowforce or automatic\n\ndoors, ramp, no steps,\n\netc.).\n\nƒ Signage indicating\n\naccessibility and\n\nhow to request\n\naccommodations.\n\nƒ Nearby accessible\n\nparking and\n\ntransportation stops.\n\nƒ Accessible waiting\n\nareas with chairs for\n\nthose unable to stand\n\nin long lines.\n\nƒ Option to be\n\nvaccinated in a car for\n\ndrive-through sites.\n\n\n\nƒ Provide a number\n\nto call/text before\n\narrival to get support,\n\naccommodations, or\n\nimmediate service\n\non arrival (i.e., mask\n\nwearing exemption,\n\nwheelchair assistance,\n\netc.).\n\nƒ Have greeters present\n\nto assist patients with\n\nvisual, physical, or\n\ncognitive disabilities.\n\nƒ Ensure public health\n\nmeasures are strictly\n\nadhered to or enhance\n\nat certain locations for\n\nsafety of higher-risk\n\nindividuals.\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 7\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\nƒ Any critical written\n\ncommunication should\n\nbe available in braille\n\ncards or read to\n\nindividuals who cannot\n\nread.\n\n\n\nƒ Availability of\n\nwheelchairs on site to\n\nbe used if needed, and\n\ncleaned between uses.\n\nƒ Adequate spacing and\n\nstrict public health\n\nmeasures to reduce\n\nexposure.\n\nƒ Tactile paving to guide\n\npeople with visual\n\ndisabilities.\n\nƒ Space/seat for support\n\nperson and resting\n\narea for support\n\nanimal with water\n\nbowls available.\n\nƒ Accessible washrooms\n\nshould be available.\n\n\n\nƒ Provide a scent-free\n\nenvironment.\n\nƒ Allow a support person\n\nto accompany people\n\ninto the vaccination\n\nsite (i.e., sign language\n\ninterpreter, family\n\nmember, PSW, etc.).\n\nƒ Allow service/support\n\nanimals to accompany\n\nindividual\n\n\n\nVaccination experience\n\n\n\nƒ Ensure informed\n\nconsent is obtained\n\nand the vaccination\n\nprocess is explained in\n\nclear, plain language.\n\nƒ Clipboards, clear\n\nmasks, and sign\n\nlanguage interpreters\n\nto communicate with\n\nd/Deaf or hard of\n\nhearing patients.\n\n\n\nƒ Option to lie-down for\n\nvaccination.\n\nƒ Option to receive\n\nvaccine in the thigh\n\n(anterolateral thigh\n\nis authorized as a\n\nsecondary injection\n\nsite).\n\nƒ Allow caregiver or\n\nsupport person to sit\n\nbeside the individual.\n\n\n\nƒ Provide safe\n\nenvironment for\n\nindividuals who have\n\ndifficulty wearing face\n\nmasks.\n\nƒ Separate table at\n\neach site that can\n\naccommodate\n\nindividuals with\n\ndisabilities (i.e.,\n\nextra time, caregiver\n\nsupport, etc.).\n\nƒ Ensure that a quiet,\n\nreduced sensory\n\nenvironment is\n\navailable.\n\nƒ Provide a rapid line\n\nor expedited service\n\nfor people with\n\ndisabilities who have\n\ndifficulty waiting,\n\nbeing in a sensory\n\nenvironment, or have\n\nscheduled accessible\n\ntransportation.\n\n\n\nWaiting period\n\n\n\nƒ Bulleted, largeprint handouts and\n\nalternative formats\n\nare available for key\n\ninformation.\n\nƒ Plain language\n\nand easy-to-read\n\ntranslation about postvaccination protocols\n\nand monitoring side\n\neffects.\n\nƒ Provide risk\n\ncommunication about\n\nany side effects.\n\n\n\nƒ Allow caregiver or\n\nsupport person to sit\n\nbeside the individual.\n\nƒ Have non-seated\n\nspaces for wheelchair\n\nusers and clear\n\npathways in between\n\nareas for people with\n\nvisual impairments.\n\n\n\nƒ Provide opportunities\n\nto ask questions or\n\ndiscuss concerns about\n\npost-vaccine side\n\neffects.\n\nƒ Provide a safe space\n\nwithin the setting\n\nif the sensory or\n\nphysical environment\n\nis overwhelming or the\n\nindividual is stressed\n\nand needs space to\n\ndecompress.\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 8\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\nƒ Ensure waiting area\n\nis not a far walk from\n\nthe vaccination site\n\nor provide the option\n\nof staying in-place,\n\ninstead of moving\n\nfrom station to station.\n\nƒ Provide a space to\n\nmove during waiting\n\nperiod if staying in one\n\nplace is hard.\n\nFollow-up information\n\nand second appointment\n\n\n\nƒ Accessible and easyto-read follow-up\n\ninformation with\n\ninstructions for second\n\ndose of a two-dose\n\nvaccine booking or\n\nchanges to booking\n\n(i.e., timing, location,\n\netc.) communication.\n\nƒ Individuals who do not\n\nshow up for/book a\n\nsecond dose of a twodose vaccine should be\n\nsupported to arrange\n\na second accessible\n\ndose.\n\n\n\nƒ Endeavour to keep first\n\nand second doses of\n\na two-dose vaccine at\n\nthe same location and\n\ntime.\n\nƒ Allow people with\n\ndisabilities to\n\nprovide feedback\n\non accessibility in\n\naccessible formats.\n\n\n\nTable 1. Key Accessibility Pillars Throughout the Vaccination Process in the Domains of Communications, Physical,\n\nand Social and Sensory Environment\n\nKey accessibility considerations through each phase of the vaccination process. This table was adapted from McKee et\n\nal.19 PSW, personal support worker.\n\n\n\nEighteen accessibility dimensions that could be monitored through reviewing publicly\n\navailable website information across three accessibility categories were examined on\n\nPHU websites:\n\n1. Communication: accessible website; multiple booking options; phone number\n\navailable; sign language interpretation; information about requirements to move\n\nbetween stations at the vaccination centre; second appointment provided during\n\nfirst appointment.\n\n2. Physical Accessibility: ability to book appointments for pop-up clinics; private\n\nbooths available; accessible entrance at site; wheelchair available on site;\n\naccessible post-vaccination waiting area, drive-through available; mobile in-home\n\nvaccination offered.\n\n3. Social/Sensory Environment: ability to bring a care partner; specialized clinic\n\nor hours for people with disabilities; no requirement/burden to offer proof of\n\ndisability; ability to move around while waiting during the observation period;\n\nface mask exemption policy in place.\n\nThese dimensions were chosen as they were considered both feasible to assess\n\nonline and captured important accessibility considerations for potential users seeking\n\nvaccination through PHU websites. They were also consistent with Ontario Health Care\n\nAccessibility Standards initial recommendations recently made available for public\n\ncomment. No further research, such as individual site visits, phone calls, interviews\n\nwith PHUs were conducted in order to ascertain the amount of accessibility information\n\nprovided to a potential user seeking vaccination information. While this simulates the\n\nuser’s experience, it does not capture additional accessibility information that may be\n\navailable via phone call or visit to a specific vaccination site.\n\nThe breakdown of the accessibility information provided by Ontario PHU websites\n\nare detailed in Tables 2 to 4. Overall, the proportion of PHUs that provided various\n\naccessibility related information on their websites varied widely based on the specific\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 9\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\naccessibility dimension in question.\n\n\n\nTable 2. Breakdown of Communication Accessibility Features of Ontario PHU Websites\n\nTable reporting the communications accessibility features publicly available on Ontario’s 34 PHU websites. Coding is\n\nbased on information publicly available PHU websites, as of May 7, 2021 (see methods section below). However, this\n\nmay not sufficiently capture the full degree of accessibility or inaccessibility of a vaccination site. In addition, several\n\nlocations noted that additional needs could be met to accommodate people with disabilities, but where the measures\n\nwere not clear or publicly available online, were not included in this analysis. PHU, public health unit.\n\n\n\nTable 3. Breakdown of Physical Accessibility Features of Ontario PHU Websites\n\nTable reporting the communications accessibility features available on Ontario’s 34 PHU websites. Coding is based on\n\ninformation publicly available on PHU websites, as of May 7, 2021 (see methods section below). However, this may not\n\nsufficiently capture the full degree of accessibility or inaccessibility of a vaccination site. In addition, several locations\n\nnoted that additional needs could be met to accommodate people with disabilities, but where the measures were not\n\nclear or publicly available online, were not included in this analysis. PHU, public health unit.\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 10\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nTable 4. Breakdown of Social and Sensory Environment Accessibility Features of Vaccination Options Described on\n\nthe Websites of Ontario’s 34 PHUs\n\nTable reporting the communications accessibility features available on Ontario’s 34 PHU websites. Coding is based on\n\ninformation publicly available PHU websites, as of May 7, 2021 (see methods section below). However, this may not\n\nsufficiently capture the full degree of accessibility or inaccessibility of a vaccination site. In addition, several locations\n\nnoted that additional needs could be met to accommodate people with disabilities, but where the measures were not\n\nclear or publicly available online, were not included in this analysis. PHU, public health unit.\n\n\n\nAccessibility information provided by specific Ontario PHUs are detailed in Figure 3.\n\nAccessibility information provided on the respective websites varied widely.\n\n\n\nFigure 3. Number of Accessibility Dimensions for COVID-19 Vaccination Described on Each Ontario PHU Website\n\nThe number of accessibility dimensions described on each PHU website ranged from 1 to 10, out of the 18 key\n\ndimensions measured. The median was 5 (IQR 4-6). PHU, public health unit. IQR, inter-quartile range.\n\n\n\nCommunication Accessibility\n\nCommunication is a central tenet of the COVID-19 vaccination program – from\n\ninformation about vaccination benefits and risks, to eligibility, booking, and information\n\nregarding potential side effects.20 Any websites with information about the vaccine at\n\nboth the provincial and PHU levels needs to be accessible and comply with the AODA,\n\n2005. Presenting public health messaging in easy-to-read formats--using pictures, text,\n\nand audio formats – will support access to information. In particular, providing a guided\n\ntour of the process through captioned videos, words, and pictures can help ease anxiety\n\nabout going into an unfamiliar place or process for many people with disabilities.\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 11\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nAccessible communication is one of the areas where Ontario’s vaccination program\n\nhas been lacking, as only 32% of PHUs had some form of accessible format available\n\non their websites (i.e., easy-to-read information about vaccines, walking tours/\n\npictures of the process, etc.) and only 9% had noted sign language interpretation was\n\navailable. Moreover, information on eligibility, and booking processes has evolved\n\nover time. Providing regularly updated information available in accessible formats\n\n(i.e., easy-to read, sign language interpretation, text, and audio, etc.) will be helpful\n\nfor all Ontarians, particularly for people with disabilities.\n\nCommunication needs to outline various vaccine side effects clearly, the risk of side\n\neffects, how to monitor for side effects, and when one should seek care for specific\n\nsymptoms in multiple formats. Furthermore, messaging and communication must\n\ninclude some guidance on when the vaccine will confer protection after vaccination,\n\nand how to stay safe after the first dose. This is particularly salient for people whose\n\ndisabilities are associated with impaired immune function, such as Down syndrome,\n\nas well as people with disabilities that are traditionally excluded from clinical trials\n\nand/or for whom there are insufficient data on immune response or effectiveness of\n\nCOVID-19 vaccines.21,22 Providing clear, risk-based guidance in accessible formats can\n\nhelp people with disabilities safely navigate the interval between doses.\n\nAccessibility Considerations for Mass Vaccination Clinics and Community Pop-up\n\nClinics\n\nBooking is a critical barrier to accessing vaccination. While most PHUs had web and\n\nphone-based booking (88%) or phone numbers available (91%), a few relied exclusively\n\non the provincial website, which can be inaccessible to people with literacy issues\n\nand screen reader users. Phone attendants may not be familiar with the accessibility\n\nof each PHU or vaccination location, or the website itself may be Web Content\n\nAccessibility Guidelines (WCAG) inaccessible,23 meaning it is unusable to people with\n\nvisual impairments or those who use screen readers or other adaptive technology.\n\nWebsites had a median of two total WCAG accessibility score errors (IQR 0-6) and one\n\ncontrast error (IQR 0-10), as measured through the WAVE web accessibility evaluation\n\ntool. If websites are the only way to find phone numbers or are the only way someone\n\ncan book a vaccination appointment in a PHU, these errors will inhibit access for\n\nsome people with disabilities. Importantly, there is no option at the booking stage\n\nto indicate needed accommodations on the provincial site or most PHU sites and no\n\nstandard mechanism for someone to assist in ensuring that these accommodations\n\ncan be provided prior to the appointment or a helpline for accessibility issues.\n\nSome people with disabilities require someone to support them leading up to\n\nand during the vaccination process, and two-thirds of PHUs explicitly permitted\n\ncare partners. In contrast, information about which physical, sensory and social\n\naccommodations were available at clinics was frequently missing and what was listed\n\nwas limited. This can result in confusion and uncertainty and additional barriers\n\nfor people with disabilities in accessing vaccinations. In line with ensuring clear\n\ncommunication about mass immunization clinics, websites should clearly state not\n\nonly which accessibility accommodations are available but also indicate which are\n\nunavailable and provide the registrant with a phone or web-based opportunity to\n\ndiscuss alternative accommodations. For example, few PHUs mentioned whether or\n\nnot they had face mask exemption policies (91% had no information), and the ones\n\nthat did explicitly stated there were no exemptions to the face masks policy (9%),\n\nwhich can be inaccessible for some people with disabilities unable to wear, change, or\n\nrequire assistance when putting on face masks. Few PHU’s (9%) listed they had private\n\nvaccination stations for those with needle phobias or sensory impairments, while\n\nthe remainder had no information (91%). Similarly, 12% described that movement\n\nbetween stations was required as part of the vaccination process, while the majority\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 12\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nhad no information (88%). Several mass clinics have been set up for individuals to stay\n\nin the same place throughout the vaccination process; such features should be noted\n\nonline so that individuals know where these accessibility features are available.24\n\nThese are important components of the vaccine experience that, if unlisted and/or\n\nunavailable, may deter an individual from seeking vaccination in that environment.\n\nImportantly, there needs to be a mechanism, such as accommodation request forms\n\nwithin each vaccination website and phone number, to share information about\n\naccommodations so the clinic will be alerted to these needs prior to the appointment\n\nand can respond with additional information if required. Someone physically present\n\nat the clinic should also be able to follow up on accommodation requests.\n\nPop-up locations have been an effective strategy to reach individuals in ‘hot spot’\n\nareas of high COVID-19 incidence and transmission, and have generally used a walk-in\n\nmodel.25 Data from Toronto show that allowing walk-in appointments through popup vaccination clinics, in some areas, have helped to reduce race-based disparities in\n\nCOVID-19 vaccine access.26,27 However, while these have improved access for residents\n\nof high SARS-CoV-2 risk areas, many images of these locations reveal opportunities\n\nto improve accessibility, particularly for at-risk people with disabilities. For example,\n\nlong wait times, no seating, sensory-heavy environments including ambient noise and\n\nmusic, and limited communication support present substantial barriers. In addition,\n\nshort-notice pop-up clinics may not allow people with disabilities sufficient time to\n\norganize transportation, attendants/in-person support, or other accommodations.\n\nRapid lines or specialized hours/options for people with disabilities who cannot wait\n\nin line can be implemented alongside a walk-in model; advertising a clinic phone\n\nnumber to call ahead or ask about accommodations would also be helpful. Information\n\nabout accessible options can also be communicated through these local community\n\nand hospital-based partners, to assist communities in reaching those with disabilities.\n\nOtherwise, people may not realize that the pop-up clinic can offer accommodations\n\nto meet their needs.\n\nAll clinics, regardless of their format (i.e., mass, specialized, pop-up) should have a\n\ndesignated contact or ‘accessibility champion’ to answer questions about accessibility\n\n(at booking, prior to the appointment, and onsite), to implement accommodations,\n\nand support people with disabilities in being vaccinated.\n\nTargeted Approaches\n\nSpecialized Clinics\n\nSpecialized clinics serving the accessibility needs of specific populations have been\n\na useful tool around the world, and were listed as options for individuals on three\n\nPHU websites (9%). There are several examples of innovations across the province\n\nin this regard, although the information about accessible efforts may not have been\n\nhighlighted on the PHU websites. Some examples of recently publicized clinics include:\n\ndesignated vaccination dates across two sites and an in-car option in York Region for\n\n2000 people with developmental disabilities and their caregivers;28 the Centre for\n\nAddiction and Mental Health (CAMH) in Toronto prioritized vaccinating individuals\n\nwith mental illness and developed a specialized clinic for youth and adults with\n\ndevelopmental disabilities;29 and a special low-sensory pop-up clinic for adults with\n\ndisabilities and caregivers in the Region of Waterloo.30 The City of Toronto’s Accessibility\n\nTask Force on COVID-19 Vaccines also partnered with Toronto Public Health to organize\n\na cross-disability accessible COVID-19 vaccination clinic, which offered supports such\n\nas sighted guides, attendant care, sign language interpretation and mobility support.31\n\nFor this clinic, people could register in advance and list accommodation requests,\n\nwhich were followed-up on as required. Specialized clinics have also been developed\n\nfor children with disabilities and medical complexities who are now eligible for\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 13\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nvaccination. Community outreach and lead time is important for these specialized\n\nclinics so that clinics and community partners can assist with registration and give\n\npeople extra time to prepare, and arrange necessary supports. Where designated\n\nclinics are not feasible or there is insufficient demand, PHUs can work with people\n\nwith disabilities and community partners to find accessible solutions. Increasing the\n\navailability of specialized clinics, as well as having appointments available in more\n\nfamiliar settings, such as primary health clinics or pharmacies can reduce barriers or\n\nanxiety over new, large, sensory-heavy, and unfamiliar environments.33\n\n32\n\n\n\nMobile and In-Home Clinics\n\nAs previous Science Briefs have shown,34,35 mobile clinics can be effective in reaching\n\npeople who may face barriers accessing traditional vaccination sites. Mobile and inhome clinics were noted as being available in 15 (44.1%) PHUs, though many said\n\nthey would start these in the near future. These clinics may be especially important\n\nin remote areas without comprehensive accessible transit systems or where vaccines\n\nare only available at mass clinics. It is important that these options are available to\n\npeople who may not be considered ‘homebound’ (i.e., cannot leave their homes in any\n\ncircumstances), but would find the process of out-of-home vaccination inaccessible\n\neven with accommodations and would otherwise not get vaccinated, despite their\n\nrisk. In addition, mobile approaches are critical to reach those in congregate care,\n\nbut communication or a schedule should be provided to residents,36 families, and\n\ncaregivers so that there is adequate support and planning to ensure the vaccination\n\nexperience is comfortable and accessible. There are currently many individuals waiting\n\nfor mobile in-home vaccination, so increasing mobile vaccine resources is critical.\n\nMonitoring of Vaccinations for People with Disabilities in Ontario\n\nDisability specific algorithms can be created using existing administrative health data\n\nto monitor and publicly report on vaccination rates for people with disabilities. These\n\nalgorithms use diagnostic codes in outpatient, emergency, and inpatient databases\n\nto indicate the presence of disability.37–39 Although currently available algorithms\n\nhave been verified to reflect conditions likely to result in functional limitations, it is\n\nimportant to note that they only capture diagnosed disability, and not self-reported\n\nactivity limitations or participation restrictions. Therefore, it will be important in the\n\nfuture to link administrative health data with other sources of information on disability\n\nsuch as disability-related income supports, or to add questions about disability (e.g.,\n\nmobility, vision, hearing, cognition, self-care, or independent living) to COVID-19related surveillance systems, including vaccination uptake data.\n\nFor example, it is possible to look at vaccination rates for people with intellectual and\n\ndevelopmental disabilities (IDD), using some of these methods. Figure 4 is a bar graph\n\nsummarizing COVID-19 vaccination uptake (at least first dose) for adults with IDD\n\n(n=96,465) broken down by age group, relative to adults without IDD (n=12,064,929)\n\nin the Ontario population as of June 7, 2021. Overall, 65% of adults with IDD have\n\nreceived their first vaccine compared to 69% of the general population. Vaccination\n\nrates are slightly higher for adults with IDD across age groups. However, differences\n\nare not as great as one might expect given that all adults with IDD, regardless of age,\n\nwere prioritized as a high-risk group during Phase 2 and adults under age 40 without\n\ndisabilities were only invited to register provincially in Phase 3. It is worth noting that\n\nthe overall rate is lower for individuals with IDD despite rates being higher across age\n\ngroups with IDD. This is because the age distribution of adults with IDD is younger, on\n\naverage, than the general population, and so unvaccinated young people make up a\n\ngreater proportion of the population with IDD than without IDD.\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 14\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nFigure 4. Adults with IDD with at Least One Dose of COVID-19 Vaccine, as Compared to Adults without IDD\n\nBar graph presenting the percentage of Ontario adults with IDD, with at least one dose of COVID-19 vaccine, by age, as\n\ncompared to Ontario adults without IDD, from December 15, 2020, to June 7, 2021. IDD, intellectual or developmental\n\ndisabilities.\n\n\n\nFigure 5 illustrates how vaccination rates by disability group can be monitored over\n\ntime, to assess where gaps are, and indicate the impact of targeted initiatives. The\n\nfigure shows a line graph measuring the proportion of all adults with IDD (n=96,465)\n\nvaccinated with at least one dose by age group each week between March 29 and\n\nJune 7, 2021. Overall, cumulative coverage increased from 12% with one dose to 65%.\n\nAdults with IDD aged 65 years and older saw the greatest increase in vaccination rates\n\nearlier in the observation window, as compared to younger age groups.\n\n\n\nFigure 5. Adults with IDD with at Least One Dose of COVID-19 Vaccine, by Age, in Ontario, from March 29 to June\n\n7, 2021\n\nLine graph presenting the percentage of Ontario adults with IDD with at least one dose of COVID-19 vaccine, by age,\n\nfrom March 29 to June 7, 2021. IDD, intellectual or developmental disabilities.\n\n\n\nInterpretation\n\nPeople with disabilities are prioritized for COVID-19 vaccination in Ontario, yet there\n\nare still many barriers to universal access. As of May 7, 2021, PHU websites provided\n\npublic information about 28% of critical accessibility features of vaccination locations,\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 15\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\non average. Recognizing that websites are just one way of informing about accessibility\n\nand that websites are dynamic and continually updated as new information and\n\nappointments become available, this serves as an illustration of perceived accessibility\n\nat one point in time. It would be important complement this index of perceived\n\naccessibility with other measures, such as through obtaining feedback on accessibility\n\nfrom people with disabilities.\n\nThere are several steps that could be taken in the realms of communication, physical\n\naccessibility, and the social and sensory environment to reduce barriers to vaccination\n\nclinics, including training staff to support people with disabilities in getting vaccinated.\n\nEven if accommodations are available upon request, by phone, or at specific clinics,\n\nthe lack of availability in multiple formats of this information may create barriers\n\nor discourage some individuals with disabilities from seeking vaccination. Many of\n\nthese considerations are no- or low-cost (i.e., pen and paper for communication, no\n\nrequirement/burden to offer proof of disability, rapid line for people with disabilities,\n\netc.) or can be made with easy adaptations (i.e., selecting accessible locations when\n\nbooking the vaccine, noting on the website that mobility devices are available to\n\nbe used at clinics, or mentioning that there is an option to stay in-place for the 15\n\nminutes following vaccination). Table 5 highlights measures that could be effective in\n\nimproving the accessibility of Ontario’s COVID-19 vaccination both in the immediate\n\nfuture as well as in the medium-term.\n\nImmediate\n\nPopulationLevel\n\nBenefits\n\n\n\nMedium-Term\n\n\n\n Information about accessibility avail-  Publicly reported disability-disaggregatable on all PHU and vaccination clinic\n\ned vaccination uptake data.\n\nwebsites.\n\n Primary care vaccination programs for\n\n Accommodation request form and\n\npeople with disabilities who require a\n\nother navigational supports with\n\nmore tailored and familiar response.\n\ncontact information available during  Enhanced accessibility resources on PHU\n\nbooking process.\n\nwebsites (vaccination clinic picture/video\n\n Designated ‘Accessibility Champion’\n\navailable at each clinic.\n\n\n\nwalk-through, accessible websites, standardized, accessible booking, etc.).\n\n\n\n Specialized disability training for vaccine\n\nclinic staff.\n\nTargeted\n\nApproaches\n\n\n\n Specialized clinics for people with  Mobile in-home vaccination for hardest\n\ndisabilities.\n\nto reach people with disabilities.\n\n Drive-through clinics advertised to  Outreach to support people with disabilpeople with disabilities.\n\nities in booking and preparing for vaccination, in partnership with community\n\n Pop-up clinics include contact numorganizations.\n\nber to address accessibility requests\n\nand provide information on accessibility.\n\n\n\nTable 5. Measures that Could be Effective in Improving the Accessibility of Ontario’s COVID-19 Vaccination Program\n\nTable highlighting measures that could be effective in improving the accessibility of Ontario’s COVID-19 vaccination\n\nboth in the immediate future as well as in the medium-term.\n\nGiven the substantial risks of contracting SARS-CoV-2, higher rates of adverse outcomes from COVID-19, and social\n\nimpacts of the pandemic on people with disabilities, vaccination is critical for Ontarians with disabilities. Therefore,\n\nusing these findings to monitor and improve accessibility and shorten second dose intervals to better protect this\n\nat-risk population are critical steps moving forward. To implement these considerations, Ontario should use a twopronged approach: improve general accessibility for mass-clinics and community pop-up clinics and use targeted\n\napproaches to reach people with disabilities through partnerships with community organizations, disability groups\n\nand health providers.40\n\n\n\nSecond Dose Considerations\n\nWhile the focus has been to offer the first vaccination to as many people as possible,\n\nthese data and lessons on accessibility are particularly salient for improving the\n\nsecond dose experience. Ontario previously extended the COVID-19 dose interval for\n\nup to 16 weeks to maximize the number of Ontarians receiving first doses, except for\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 16\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nthose with reduced immunological response and some very high risk individuals.18,41,42\n\nWith current vaccine supply, people with disabilities included in the highest-, high-,\n\nand at-risk and congregate setting Phase 2 groups should be prioritized for early\n\nsecond doses amongst those now eligible to rebook expedited second doses. For\n\nexample, some people with disabilities living in congregate care outside of LTC have\n\nsimilar clinical characteristics and setting-based risk factors that enhance their risk\n\nof contracting SARS-CoV-2. These settings have experienced similar restrictions and\n\nCOVID-19 outbreaks but have not yet been given an expedited dose schedule shorter\n\nthan the 16-week interval. Given the substantial restrictions placed on these settings\n\n(i.e., minimal in-person contact with family, cessation of regular activities, etc.), the\n\nmental health impacts, and continued outbreaks, there are marked benefits to reducing\n\nthe interval to the second dose. Several other jurisdictions have recently shifted their\n\npolicy to include some people with disabilities for prioritized second doses, such as\n\npeople with Down syndrome and those living in disability based congregate care in\n\nManitoba, all adults deemed ‘clinically extremely vulnerable’ in BC, and people in the\n\nequivalent of Ontario’s highest-, high-, and at-risk categories in the UK.43,44\n\nFurthermore, certain disabilities are associated with reduced immune system function,\n\nwhile some neuromuscular conditions that impact respiratory function are already\n\nassociated with high mortality rates from breathing disorders, including pneumonia\n\nand influenza,45 despite annual access to the influenza vaccine. These individuals have\n\nbeen in the highest risk provincial categories and many have not left their homes or\n\nsocialized since the pandemic began, leading to substantial negative impacts on their\n\nmental health and that of their caregivers. An estimated 83% of disabled Canadians\n\nsaid that the pandemic has negatively impacted their mental health, while 80%\n\nreport greater social isolation.16,46 Given the significant risk, social harms of prolonged\n\nisolation, and lack of evidence of sufficient protection after one dose for these\n\npopulations, when vaccine supply allows, people with disabilities already included in\n\nthe highest-, high, and at-risk groups listed in Phase 2 should be prioritized for earlier\n\nsecond doses of COVID-19 vaccine and supported to rebook appointments.\n\nMonitoring Vaccine Distribution Among People with Disabilities\n\nPublicly available data on COVID-19 vaccination rates for people with disabilities at the\n\nprovincial and PHU levels are important metrics, given that many people with disabilities\n\nfall into the provincially designated highest, high, and at-risk categories. The example\n\nprovided of COVID-19 vaccination rates for people with intellectual or developmental\n\ndisabilities through linked health administrative data held at ICES, could be expanded\n\nto include other disability groups to better understand how Ontario is reaching people\n\nwith disabilities. Given the high-risk nature of this group, one might have expected a\n\nsustained increase over time in all groups, in Figure 5, rather than increases in vaccination\n\nrates associated with provincial age group eligibility. While there are limitations when\n\nstudying a population using health administrative data, it can offer some insights into\n\ninequities and can be combined with other data collection efforts, such as including the\n\ntracking of disability within the COVaxON system itself, or the monitoring of vaccination\n\nrates for Ontario Disability Support Plan or Ontario Assistive Device Program recipients.\n\nAs vaccinations are extended to children and youth with disabilities, tracking information\n\ncould be collected in conjunction with other child-based data collection efforts. Public\n\nmonitoring of vaccination information could be part of a broader disability-based data\n\nreporting strategy which could also include the sharing of data on disability specific\n\ntesting, positivity rates, and COVID-19 related hospital use and mortality. In addition\n\nto monitoring vaccination rates, there should be mechanisms including an accessible\n\nfeedback form and a helpline to assist, monitor and improve the overall accessibility of\n\nvaccination for Ontarians with disabilities.\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 17\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nMethods Used for This Science Brief\n\n\n\nThe description of PHU accessibility was based on a scan of all Ontario PHU websites\n\nperformed on May 7, 2021. At each PHU website, information was extracted based on\n\nthree accessibility categories in the framework: physical accessibility, communication\n\nfor accessibility, and social/sensory environment. Specifically, for each category, the\n\nfollowing information was extracted:\n\n1. Communication: accessible website; multiple booking options; phone number\n\navailable; sign language interpretation; information about requirements to move\n\nbetween stations in the vaccination centre; second appointment provided during\n\nfirst appointment.\n\n2. Physical Accessibility: ability to book appointments for pop-up clinics; private\n\nbooths available; accessible entrance at site; wheelchair available on site;\n\naccessible post-vaccination waiting area; drive-through available; mobile in-home\n\nvaccination offered.\n\n3. Social/Sensory Environment: ability to bring a care partner; specialized clinic\n\nor hours for people with disabilities; no requirement/burden to offer proof of\n\ndisability; ability to move around while waiting during the observation period;\n\nface mask exemption policy in place.\n\nWebsite accessibility was checked using the WAVE web accessibility evaluation tool,\n\nwhich measures the number of items that do not meet Web Content Accessibility\n\nGuideline (WCAG) accessibility standards. The tool provides a number of total errors,\n\nand the total score and the number of contrast errors were used in this analysis.\n\nTo analyze information about COVID-19 vaccine distribution for adults with intellectual\n\nor developmental disabilities, health administrative records from various databases\n\nwere linked using unique encoded identifiers and analyzed at ICES. ICES is a non-profit,\n\nindependent organization that reports on the health and health care utilization of\n\nOntario residents. Data stored at ICES were in an anonymized format before they were\n\naccessed by the authors. All datasets were linked using unique encoded identifiers\n\nand analyzed at ICES. The use of data in this project was authorized under section\n\n45 of Ontario’s Personal Health Information Protection Act, which does not require\n\nreview by a Research Ethics Board.\n\nAdults aged 18 years and older were considered to have intellectual or developmental\n\ndisabilities if a diagnosis of intellectual disability, fetal alcohol syndrome, autism,\n\nand/or other pervasive developmental disorders and chromosomal and autosomal\n\nanomalies (i.e., Down syndrome, Fragile X syndrome) was recorded in health\n\nadministrative databases held at ICES. To be included in this IDD group, they had to\n\nhave these diagnoses recorded in either ≥ 2 physician visits (Ontario Health Insurance\n\nPlan, OHIP) or ≥ 1 ED visit (National Ambulatory Care Reporting System, NACRS) or\n\nhospitalization (Discharge Abstract Database, DAD or Ontario Mental health Reporting\n\nSystem, OMHRS) since birth or inception of each database (whichever occurred\n\nlater) until June 7, 2021. More details on diagnostic codes capturing intellectual or\n\ndevelopmental disabilities can be found here.47 Reliance on administrative health data\n\nonly to create a cohort of adults with intellectual or developmental disabilities may\n\nnot include all such adults.\n\nVaccination results were recorded in COVaxON between December 15, 2020, and\n\nJune 7, 2021.\n\n\n\nAuthor Contributions\n\nSR conceived the Science Brief. SR and YL wrote the first draft of the Science Brief. SR,\n\nJC, SC, YS, and GMK collected the data on PHUs, and MD performed analyses of PHU\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 18\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nwebsite reviews. Vaccination rate analysis was performed at ICES and interpreted by\n\nHKB and YL. All authors revised the Science Brief critically for important intellectual\n\ncontent and approved the final version.\n\nThe ICES analysis was supported by the Applied Health Research Questions (AHRQ)\n\nProgram at ICES, which is funded by the Ontario Ministry of Health, and by the Ontario\n\nHealth Data Platform (OHDP), a Province of Ontario initiative to support Ontario’s\n\nongoing response to COVID-19 and its related impacts. Parts of this material are based\n\non data and information compiled and provided by Ontario Ministry of Health, the\n\nCanadian Institute for Health Information and Public Health Ontario. The analyses,\n\nconclusions, opinions, and statements expressed herein are those of the authors and\n\ndo not reflect those of ICES, OHDP, or the funding or data sources; no endorsement is\n\nintended or should be inferred. We would like to acknowledge Public Health Ontario\n\nfor access to case level data from iPHIS Plus and COVID-19 laboratory data, as well as\n\nassistance with data interpretation. We also thank the staff of Ontario’s PHUs who are\n\nresponsible for COVID-19 case and contact management and data collection within\n\niPHIS Plus.\n\n\n\nReferences\n\n1. Statistics Canada. A demographic, employment and income profile of Canadians\n\nwith disabilities aged 15 years and over, 2017. Government of Canada. Published\n\nNovember 28, 2018. 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Ontario CLRI Accessed May 18, 2021.\n\nhttps://clri-ltc.ca/files/2019/01/Younger-Residents-in-LTC-Handout.pdf\n\n15. IC/ES. COVID-19 Dashboard. Published April 6, 2021. Accessed April 7, 2021.\n\nhttps://www.ices.on.ca/DAS/AHRQ/COVID-19-Dashboard\n\n16. Martin K, Gee C, Hoekstra F, et al. COVID-19 Disability Survey. Abilities Centre;\n\n2020:21. https://abilitiescentre.org/Abilities/media/Documents/Covid-survey-report-Dec-18_1.pdf\n\n17. Shakespeare T, Ndagire F, Seketi QE. Triple jeopardy: disabled people and the\n\nCOVID-19 pandemic. The Lancet. 2021;397(10282):1331-1333. https://doi.\n\norg/10.1016/S0140-6736(21)00625-5\n\n18. McGrath JM. Here’s Ontario’s May 12 vaccine update. TVO.org. Published May 12,\n\n2021. https://www.tvo.org/article/heres-ontarios-may-12-vaccine-update\n\n19. McKee M, Okanlami O, Zazove P. Guidelines for Accessible COVID-19 Testing &\n\nVaccination Sites. Ann Fam Med COVID-19 Collect. Published online February 17,\n\n2021. https://doi.org/10.7302/231\n\n20. Courtenay K, Perera B. COVID-19 and people with intellectual disability: impacts\n\nof a pandemic. Ir J Psychol Med. 2020;37(3):231-236. https://doi.org/10.1017/\n\nipm.2020.45\n\n21. Spaul SW, Hudson R, Harvey C, Macdonald H, Perez J. Exclusion criterion: learning disability. The Lancet. 2020;395(10223). https://doi.org/10.1016/S01406736(20)30051-9\n\n22. Illouz T, Biragyn A, Frenkel-Morgenstern M, et al. Specific susceptibility to\n\nCOVID-19 in adults with Down Syndrome. NeuroMolecular Med. Published online\n\nMarch 4, 2021. https://doi.org/10.1007/s12017-021-08651-5\n\n23. W3C Web Accessibility Initiative (WAI). Web Content Accessibility Guidelines\n\n(WCAG) Overview. Web Accessibility Initiative (WAI). Published 2021. https://\n\nwww.w3.org/WAI/standards-guidelines/wcag/\n\n24. Weikle B. Made-in-Canada solution: “Hockey hub” vaccine clinics are getting the\n\njob done faster. CBC Radio. Published May 22, 2021. Accessed May 23, 2021.\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 20\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\nhttps://www.cbc.ca/radio/whitecoat/made-in-canada-solution-hockey-hub-vaccine-clinics-are-getting-the-job-done-faster-1.5953312\n\n25. Choi KH, Denice P, Haan M, Zajacova A. Studying the social determinants of\n\nCOVID-19 in a data vacuum. Can Rev Sociol Can Sociol. Published online 2021.\n\nhttps://doi.org/10.1111/cars.12336\n\n26. Huynh T. Hot spot tracker. The Local. Published May 14, 2021. Accessed May 12,\n\n2021. https://thelocal.to/hot-spot-tracker/\n\n27. Carter A. COVID-19 vaccine rollout improving in hardest-hit areas but inequities remain, research shows | CBC News. CBC. Published April 23, 2021. https://\n\nwww.cbc.ca/news/canada/toronto/covid-toronto-vaccination-rates-neighbourhoods-1.6000197\n\n28. Kelly D. Southlake, Mackenzie Health, Reena partner to vaccinate residents\n\nwith developmental disabilities. NewmarketToday.ca. Published March 5, 2021.\n\nhttps://www.newmarkettoday.ca/local-news/southlake-mackenzie-health-reena-partner-to-vaccinate-residents-with-developmental-disabilities-3744773\n\n29. Yousif N. CAMH urges province to send more COVID-19 vaccine after dwindling\n\nsupply forces closure of clinic for mentally ill, disabled. thestar.com. Published\n\nApril 30, 2021. https://www.thestar.com/news/gta/2021/04/30/camh-urgesprovince-to-send-more-covid-19-vaccine-after-dwindling-supply-forces-closureof-clinic-for-mentally-ill-disabled.html\n\n30. Wong C. COVID-19 vaccine clinic pops up for weekend in Kitchener. Kitchener.\n\nPublished March 27, 2021. https://kitchener.ctvnews.ca/covid-19-vaccine-clinicpops-up-for-weekend-in-kitchener-1.5365207\n\n31. City of Toronto. City of Toronto and partners increase vaccine access and uptake\n\nfor vulnerable residents through community mobilization and engagement. City\n\nof Toronto. Published May 12, 2021. https://www.toronto.ca/news/city-of-toronto-and-partners-increase-vaccine-access-and-uptake-for-vulnerable-residents-through-community-mobilization-and-engagement/\n\n32. Henry M. Families of medically fragile children ‘so excited’ to end a year of high\n\nanxiety with long-awaited jab. thestar.com. Published May 22, 2021. Accessed\n\nMay 23, 2021. https://www.thestar.com/news/gta/2021/05/22/families-of-medically-fragile-children-so-excited-to-end-a-year-of-high-anxiety-with-long-awaited-jab.html\n\n33. Kiran T. Why have family doctors been overlooked in vaccine rollout? thestar.\n\ncom. Published March 5, 2021. https://www.thestar.com/opinion/contributors/2021/03/05/why-have-family-doctors-been-overlooked-in-vaccine-rollout.\n\nhtml\n\n34. Stall NM, Nakamachi Y, Chang M, et al. Mobile in-home COVID-19 vaccination of\n\nOntario homebound older adults by neighbourhood risk. Sci Briefs Ont COVID-19\n\nSci Advis Table. 2021;1(19). https://doi.org/10.47326/ocsat.2021.02.19.1.0\n\n35. Huynh T, Sava N, Hahn-Goldberg S, et al. Mobile on-site COVID-19 vaccination\n\nof naturally occurring retirement communities by neighbourhood risk in Toronto.\n\nSci Briefs Ont COVID-19 Sci Advis Table. 2021;1(14). https://doi.org/10.47326/ocsat.2021.02.14.1.0\n\n36. CBC. Eliminating barriers through mobile COVID-19 vaccine clinic. Published April\n\n7, 2021. https://www.cbc.ca/player/play/1882291267587\n\n37. Brown HK, Ray JG, Chen S, et al. Association of Preexisting Disability With Severe Maternal Morbidity or Mortality in Ontario, Canada. JAMA Netw Open.\n\n2021;4(2):e2034993. https://doi.org/10.1001/jamanetworkopen.2020.34993\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 21\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 Vaccination for People with Disabilities\n\n\n\n38. Brown HK, Carty A, Havercamp SM, Parish S, Lunsky Y. Identifying reproductive-aged women with physical and sensory disabilities in administrative health\n\ndata: A systematic review. Disabil Health J. 2020;13(3):100909. https://doi.\n\norg/10.1016/j.dhjo.2020.100909\n\n39. Lin E, Balogh R, Cobigo V, Ouellette-Kuntz H, Wilton AS, Lunsky Y. Using administrative health data to identify individuals with intellectual and developmental disabilities: a comparison of algorithms. J Intellect Disabil Res. 2012;57(5):462-477.\n\nhttps://doi.org/10.1111/jir.12002\n\n40. Health Care Access Research and Developmental Disabilities. Including people\n\nwith developmental disabilities as a priority group in Canada’s COVID-19 vaccination program: key considerations: Part 2. Published March 29, 2021. https://www.\n\nporticonetwork.ca/web/hcardd/news/-/blogs/including-people-with-developmental-disabilities-as-a-priority-group-in-canada-s-covid-19-vaccination-program-key-considerations-part-2\n\n41. Ministry of Health. Extension of the Second Dose Interval. Government of Canada;\n\n2021. https://www.health.gov.on.ca/en/pro/programs/publichealth/coronavirus/docs/vaccine/COVID_19_vaccine_dose_intervals.pdf\n\n42. Ministry of Health. Vaccine Clinical Advisory Group (VCAG) Recommendations on\n\nExceptions to Extended Dose Intervals for COVID-19 Vaccines. Government of Canada; 2021:9. https://www.health.gov.on.ca/en/pro/programs/publichealth/coronavirus/docs/vaccine/COVID_19_medical_exceptions_vaccine_dose_intervals.\n\npdf\n\n43. Government of Manitoba. Province of Manitoba: Second dose eligibility. Province\n\nof Manitoba. https://www.gov.mb.ca/covid19/vaccine/eligibility-criteria.html\n\n44. BC Centre for Disease Control. Vaccine considerations. bccdc.ca. Published May\n\n13, 2021. http://www.bccdc.ca/health-info/diseases-conditions/covid-19/covid19-vaccine/vaccine-considerations\n\n45. Benditt JO, Boitano LJ. Pulmonary issues in patients with chronic neuromuscular disease. Am J Respir Crit Care Med. 2013;187(10):1046-1055. https://doi.\n\norg/10.1164/rccm.201210-1804CI\n\n46. Pettinicchio D, Maroto M, Chai L, Lukk M. Findings from an online survey on the\n\nmental health effects of COVID-19 on Canadians with disabilities and chronic\n\nhealth conditions. Disabil Health J. Published online February 24, 2021:101085.\n\nhttps://doi.org/10.1016/j.dhjo.2021.101085\n\n47. Lunsky Y, Klein-Geltink JE, Yates EA. H-CARDD Cohort Cerivation: An Overview.\n\nICES & CAMH; 2013. https://www.ices.on.ca/flip-publication/Atlas-on-the-Primary-Care-of-Adults-with-Developmental-Disabilities/files/assets/basic-html/index.\n\nhtml#165\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 8, 2021 | 22\n\n\n\n\f",
          "document_id": 445559
        }
      ]
    },
    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "What has been the impact of COVID-19 on essential workers and Ontario workplaces?",
              "id": 275178,
              "answers": [
                {
                  "answer_id": 273779,
                  "document_id": 445563,
                  "question_id": 275178,
                  "text": "While information about workplace transmission in Ontario remains incomplete,\n\ndata from regions with high concentrations of essential workplaces, such as\n\nmanufacturing facilities and warehouses, highlight workplaces as a significant sites\n\nfor SARS-CoV-2 transmission.12,13 In Ontario’s Peel Region, 66% of community\n\noutbreaks from September to December 2020 occurred in workplaces.14\n\nOccupational exposure was the most common likely source of infection that\n\nresulted in secondary household transmission in August 2020 in the Peel Region.\n\nBetween August and December 2020, 1,993 out of 7,874 surveyed workers (25%) in\n\nPeel reported attending a workplace outside of their home for one or more days\n\nfollowing symptom onset, 80 of whom continued to work after the date that their\n\npositive SARS-CoV-2 result was reported to public health.14\n\nMany workplaces experiencing outbreaks use temporary workers who tend to have\n\nfewer worker income supports than permanent employees, and work in multiple\n\nsettings",
                  "answer_start": 11859,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is the economic impact of paid sick leave?",
              "id": 275183,
              "answers": [
                {
                  "answer_id": 273782,
                  "document_id": 445563,
                  "question_id": 275183,
                  "text": "Data from the COVID-19 pandemic and other epidemics demonstrate that paid sick\n\nleave is an important strategy for public health containment as well as for economic\n\nstability and recovery.20,36,37 Paid sick leave can increase productivity, and reduces\n\nabsenteeism by preventing outbreaks and the chance of workplace closures. Job\n\nlosses and working hour reductions during the COVID-19 pandemic have been larger\n\nin American states without a paid sick leave system",
                  "answer_start": 19819,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How can paid sick leave support COVID-19 vaccination among essential workers?",
              "id": 275182,
              "answers": [
                {
                  "answer_id": 273780,
                  "document_id": 445563,
                  "question_id": 275182,
                  "text": "Evidence from the United States indicates that paid sick leave is associated with\n\nincreased influenza vaccination rates among workers, since they are guaranteed to\n\nreceive paid time off to get immunized.30,31 A survey of 8,634 health care workers\n\nreported that they were much more likely to get vaccinated if direct financial\n\nsupport like paid sick leave were available.",
                  "answer_start": 18899,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            }
          ],
          "context": "SCIENCE BRIEFS\n\n\n\nBenefits of Paid Sick Leave\n\nDuring the COVID-19 Pandemic\n\nAlison Thompson, Nathan M. Stall, Karen B. Born, Jennifer L. Gibson, Upton Allen,\n\nJessica Hopkins, Audrey Laporte, Antonina Maltsev, Roisin McElroy, Sharmistha\n\nMishra, Laveena Munshi, Ayodele Odutayo, Menaka Pai, Andrea Proctor, Fahad\n\nRazak, Robert J. Reid, Arjumand Siddiqi, Janet Smylie, Peter Jüni, Brian Schwartz on\n\nbehalf of the Ontario COVID-19 Science Advisory Table\n\nVersion 1.1\n\nPublished: April 28, 2021\n\nUpdated on May 4, 2021. Version 1.0 is\n\navailable under Additional Resources at\n\nhttps://doi.org/10.47326/ocsat.2021.02.25.1.0.\n\nCitation: Thompson, Alison, Stall NM, Born\n\nKB, et al. Benefits of paid sick leave during\n\nthe COVID-19 pandemic. Science Briefs of the\n\nOntario COVID-19 Science Advisory Table.\n\n2021;2(25).\n\nhttps://doi.org/10.47326/\n\nocsat.2021.02.25.1.0\n\nAuthor Affiliations: The affiliations of the\n\nmembers of the Ontario COVID-19 Science\n\nAdvisory Table can be found at https://\n\ncovid19-sciencetable.ca/.\n\n\n\nDeclarations of Interest: The declarations of\n\ninterest of the members of the Ontario\n\nCOVID-19 Science Advisory Table can be\n\nfound at https://covid19-sciencetable.ca/. The\n\ndeclarations of interest of external authors\n\ncan be found under additional resources at\n\nhttps://doi.org/10.47326/ocsat.2021.02.25.1.0\n\nAbout Us: The Ontario COVID-19 Science\n\nAdvisory Table is a group of scientific experts\n\nand health system leaders who evaluate and\n\nreport on emerging evidence relevant to the\n\nCOVID-19 pandemic, to inform Ontario’s\n\nresponse. Our mandate is to provide weekly\n\nsummaries of relevant scientific evidence for\n\nthe COVID-19 Health Coordination Table of\n\nthe Province of Ontario, integrating\n\ninformation from existing scientific tables,\n\nOntario’s universities and agencies, and the\n\nbest global evidence. The Science Table\n\nsummarizes its findings for the Health\n\nCoordination Table and the public in Science\n\nBriefs.\n\nCorrespondence to: Secretariat of the\n\nOntario COVID-19 Science Advisory Table\n\n(info@covid19-sciencetable.ca)\n\nCopyright: 2021 Ontario COVID-19 Science\n\nAdvisory Table. This is an open access\n\ndocument distributed under the terms of the\n\nCreative Commons Attribution License,\n\nwhich permits unrestricted use, distribution,\n\nand reproduction in any medium, provided\n\nthat the original work is properly cited.\n\n\n\nKey Message\n\nMultiple jurisdictions have adopted or adapted paid sick leave policies to reduce the\n\nlikelihood of employees infected with SARS-CoV-2 presenting to work, which can\n\nlead to the spread of infection in workplaces.\n\nDuring the COVID-19 pandemic, paid sick leave has been associated with an\n\nincreased likelihood of workers staying at home when symptomatic. Paid sick leave\n\ncan support essential workers in following public health measures. This includes\n\npaid time off for essential workers when they are sick, have been exposed, need to\n\nself-isolate, need time off to get tested, when it is their turn to get vaccinated, and\n\nwhen their workplace closes due to an outbreak, with guaranteed salary payment\n\nregardless of duration of absence (minimum 2 hours, maximum 2 workweeks).\n\n\n\nIn the United States, the introduction of a temporary paid sick leave, was associated\n\nwith an estimated 50% reduction in the number of COVID-19 cases per state per\n\nday.\n\nThe existing Canada Recovery Sickness Benefit (CRSB) cannot financially protect\n\nessential workers in following all public health measures, places the administrative\n\nburden of applying for the benefit on essential workers, and neither provides\n\nsufficient, nor timely payments. Table 1 lists the characteristics of a model paid sick\n\nleave program as compared with the CRSB. Implementation of the model program\n\nshould be done in a way that is easy to navigate and quick for employers.\n\nExisting Federal\n\nProgram\n\n\n\nModel Program\n\n\n\nAdministrative burden placed on employer and not on\n\nemployee\n\n\n\nNo\n\n\n\nYes\n\n\n\nSalary payment during absence provided by employer;\n\nprogram reimburses employer\n\n\n\nNo\n\n\n\nYes\n\n\n\nAmount of salary maintained in case of symptoms,\n\nisolation after exposure, vaccination, or testing\n\n\n\nNo\n\n\n\nYes\n\n\n\nUninterrupted salary payment in case of symptoms,\n\nisolation after exposure, vaccination, or testing\n\n\n\nNo\n\n\n\nYes\n\n\n\nGuaranteed salary payment regardless of duration of\n\nabsence (minimum 2 hours, maximum 2 workweeks)\n\n\n\nNo\n\n\n\nYes\n\n\n\nCharacteristics\n\n\n\nTable 1. Comparison of Existing Canada Recovery Sickness Benefit (CRSB) with Model Paid Sick Leave Program\n\nTable comparing the characteristics of the existing CRSB with the characteristics of the model paid sick leave\n\nprogram.\n\n\n\nThe views and findings expressed in this\n\nScience Brief are those of the authors and do\n\nScience Briefs | https://covid19-sciencetable.ca/science-briefs\n\n\n\nApril 28, 2021 | 1\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\nnot necessarily reflect the views of all of the\n\nmembers of the Ontario COVID-19 Science\n\nAdvisory Table, its Working Groups, and its\n\npartners.\n\n\n\nBenefits of Paid Sick Leave During the COVID-19 Pandemic\n\n\n\nSummary\n\nBackground\n\nCOVID-19 in the workplace causes a substantial burden of illness among essential\n\nworkers and their families, and is a significant contributor to community\n\ntransmission driving the third wave in Ontario. Workplace outbreaks result in\n\neconomic loss and disruption of essential services. Public health measures such as\n\nworkplace screening and testing, isolation of people with SARS-CoV-2 infection and\n\ntheir contacts can reduce transmission, and prevent workplace outbreaks.1 Many\n\nessential workers lack paid sick leave that would support them in following these\n\npublic health measures.\n\nQuestions\n\n\n\nWhat has been the impact of COVID-19 on essential workers and Ontario\n\nworkplaces?\n\nWhat paid sick leave policies have been implemented nationally and internationally\n\nto support essential workers in following public health measures during the COVID19 pandemic?\n\nWhat is the evidence for the effectiveness of paid sick leave in supporting essential\n\nworkers in following public health measures, preventing SARS-CoV-2 infection\n\namong essential workers, and mitigating COVID-19 outbreaks in essential\n\nworkplaces?\n\nWhat evidence can be extrapolated from the impact of paid sick leave in mitigating\n\nother infectious diseases such as influenza-like illness?\n\n\n\nHow can paid sick leave support COVID-19 vaccination among essential workers?\n\nWhat is the economic impact of paid sick leave?\n\nWhich ethical principles and considerations should inform public policy on paid sick\n\nleave in Ontario?\n\nFindings\n\nOntario workplaces are significant sites of SARS-CoV-2 transmission, and essential\n\nworkers have experienced disproportionately higher rates of SARS-CoV-2 infection.\n\nNational and international jurisdictions have implemented paid sick leave to support\n\nessential workers in following public health measures.\n\nReal-world evidence from the COVID-19 pandemic and from influenza-like illnesses\n\nindicates that paid sick leave can support workers in following public health\n\nmeasures, reduce viral transmission and workplace outbreaks, promote higher\n\nvaccination rates among essential workers, increase work productivity, and reduce\n\nworker absenteeism. Paid sick leave also protects the larger public from harm by\n\ncontaining the spread of infectious diseases and optimizing economic stability. Paid\n\nsick leave is also supported by public health ethics principles.\n\nIn the United States, the introduction of a temporary paid sick leave, the Families\n\nFirst Coronavirus Response Act (FFCRA), was associate with an estimated 50%\n\nreduction in the number of COVID-19 cases per state per day.\n\nInterpretation\n\nDuring the COVID-19 pandemic, paid sick leave can support essential workers in\n\nfollowing public health measures. This includes paid time off for essential workers\n\nScience Briefs | https://covid19-sciencetable.ca/science-briefs\n\n\n\nApril 28, 2021 | 2\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBenefits of Paid Sick Leave During the COVID-19 Pandemic\n\n\n\nwhen they are sick, have been exposed, need to self-isolate, need time off to get\n\ntested or vaccinated, and when their workplace closes due to an outbreak, with\n\nguaranteed salary payment regardless of duration of absence (minimum 2 hours,\n\nmaximum 2 workweeks). Paid sick leave will reduce overall cases, protect\n\ncommunities from the burden of COVID-19, and keep businesses open.\n\n\n\nBackground\n\nWorkplace spread of SARS-CoV-2, the virus responsible for COVID-19, causes a\n\nsubstantial burden of illness among essential workers and their families, and is a\n\nsignificant contributor to community transmission driving the third wave in Ontario.\n\nWorkplace outbreaks result in economic loss, and disruption of essential services.\n\nPublic health measures such as workplace screening and testing, isolation of people\n\nwith SARS-CoV-2 infection, and quarantine of their contacts, can reduce SARS-CoV-2\n\ntransmission, and prevent workplace outbreaks.1,2 Cumulatively, these measures\n\ncontribute toward reduced cases of SARS-CoV-2 infection, COVID-19\n\nhospitalizations, and COVID-19 deaths among both workers and their household and\n\ncommunity contacts.\n\nWhile many members of the Ontario workforce are able to work from home or have\n\naccess to paid sick leave while ill or self-isolating, this is far from universal. In Ontario,\n\n60% of workers do not have paid sick leave apart from the federal CRSB program.3\n\nEssential workers cannot work from home, and they most commonly work in trades,\n\ntransport, equipment, manufacturing, utilities, sales, services, agriculture sectors, and\n\nhealth care.4–6 An estimated 42% of Ontario’s workforce is employed in occupations\n\nthat could be conducted remotely.7 Moreover, essential workers are\n\ndisproportionately represented in jobs that do not include sick leave benefits.8\n\n\n\nIn Canada most people without paid sick leave earn less than $50,000 in annual\n\nincome, and more than 60% of seasonal, casual, or contract workers have no paid\n\nsick leave at all.8,9 In Ontario, the highest proportion of SARS-CoV-2 infections are in\n\nneighbourhoods with the highest proportion of essential workers.10,11 Financial\n\nsupport that enables Ontario workers to follow public health measures can limit\n\nSARS-CoV-2 transmission, reduce COVID-19 illness, and minimize economic loss.8,9\n\nThe intersection between the absence of paid sick leave and lower or inconsistent\n\nlevels of income creates a situation where essential workers face a tension between\n\nmeeting basic needs (e.g., food and rent), and following public health measures\n\n(e.g., self-isolation, quarantine, testing, and vaccination).\n\nQuestions\n\nWhat has been the impact of COVID-19 on essential workers and Ontario\n\nworkplaces?\n\nWhat paid sick leave policies have been implemented nationally and internationally\n\nto support essential workers in following public health measures during the COVID19 pandemic?\n\nWhat is the evidence for the effectiveness of paid sick leave in supporting essential\n\nworkers in following public health measures, preventing SARS-CoV-2 infection\n\namong essential workers, and mitigating COVID-19 outbreaks in essential\n\nworkplaces?\n\nWhat evidence can be extrapolated from the impact of paid sick leave in mitigating\n\nother infectious diseases such as influenza-like illness?\n\nHow can paid sick leave support COVID-19 vaccination among essential workers?\n\nScience Briefs | https://covid19-sciencetable.ca/science-briefs\n\n\n\nApril 28, 2021 | 3\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBenefits of Paid Sick Leave During the COVID-19 Pandemic\n\n\n\nWhat is the economic impact of paid sick leave?\n\n\n\nWhich ethical principles and considerations should inform public policy on paid sick\n\nleave in Ontario?\n\n\n\nFindings\n\nImpact of COVID-19 on Essential Workers and in Ontario Workplaces\n\nWhile information about workplace transmission in Ontario remains incomplete,\n\ndata from regions with high concentrations of essential workplaces, such as\n\nmanufacturing facilities and warehouses, highlight workplaces as a significant sites\n\nfor SARS-CoV-2 transmission.12,13 In Ontario’s Peel Region, 66% of community\n\noutbreaks from September to December 2020 occurred in workplaces.14\n\nOccupational exposure was the most common likely source of infection that\n\nresulted in secondary household transmission in August 2020 in the Peel Region.\n\nBetween August and December 2020, 1,993 out of 7,874 surveyed workers (25%) in\n\nPeel reported attending a workplace outside of their home for one or more days\n\nfollowing symptom onset, 80 of whom continued to work after the date that their\n\npositive SARS-CoV-2 result was reported to public health.14\n\nMany workplaces experiencing outbreaks use temporary workers who tend to have\n\nfewer worker income supports than permanent employees, and work in multiple\n\nsettings.14\n\nOverview of Paid Sick Leave Policies in Canada and Internationally\n\nThe CRSB provides $450 after taxes per week for up to four weeks for workers who\n\nmiss at least 50% of their work week because they are unwell or isolating from\n\nCOVID-19.15 This allocation is $100 lower per week than a full time (37.25 hour)\n\nweekly salary at Ontario minimum wage ($14.25 hourly).16 Payments are not timely\n\nas it can take up to 4 weeks for workers to receive funds (see Table 1 above).17\n\nThere are additional concerns that the CRSB cannot financially support workers in\n\nfollowing public health measures. Because the CRSB does not cover shorter absences,\n\nit excludes worker time off to get tested or vaccinated, or those workers who stay\n\nhome due to symptoms or exposure, subsequently test negative for SARS-CoV-2\n\ninfection, and are then cleared for return to work within 50% of their work week.\n\nSince CRSB is limited to a 1-week period, is not renewable, and can only be used\n\nfour times per year, it may not be enough for workers in high SARS-CoV-2 exposure\n\noccupations. The CRSB application places the administrative burden of applying for\n\nthe benefit on essential workers, and requires computer access, internet literacy\n\nand an understanding of English or French. Taken together, these limitations and\n\nbarriers of the CRSB may hinder adequate protection of essential workers and\n\neffective mitigation of workplace outbreaks during the COVID-19 pandemic.\n\nA number of provinces and territories introduced unpaid sick leave of varying\n\ndurations in response to the COVID-19 pandemic.18 Only Yukon provides a paid sick\n\nleave benefit for workers who become sick, or who must quarantine or isolate,\n\nwhich guarantees 10 days of wages per employee. Employers can only access the\n\nprogram once per employee.19\n\nDuring the COVID-19 pandemic, paid sick leave has been implemented in several\n\njurisdictions internationally to support essential workers in following public health\n\nmeasures.20 In response to the COVID-19 pandemic, 16 of 38 Organization for\n\nEconomic Cooperation and Development (OECD) countries temporarily expanded or\n\ninitiated paid sick leave policies.20 For example, countries like France and Ireland\n\nScience Briefs | https://covid19-sciencetable.ca/science-briefs\n\n\n\nApril 28, 2021 | 4\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBenefits of Paid Sick Leave During the COVID-19 Pandemic\n\n\n\nwaived waiting periods for sick pay and benefits. Australia and Spain introduced\n\nadditional dedicated sick benefits for workers with COVID-19 who exhausted\n\naccrued employer‑provided sick-pay entitlements. The United States introduced the\n\nFFCRA, a temporary measure for employers to provide paid sick leave for reasons\n\nrelated to COVID-19.21\n\nEvidence for the Effectiveness of Paid Sick Leave\n\nReduction in mobility is a proxy for measuring the time individuals stay at home, and\n\nis associated with reductions in SARS-CoV-2 transmission and COVID-19 cases.22 A\n\nstudy using GPS data from cellular devices found that the introduction of the FFCRA\n\nin the United States increased the average number of hours at home by 4.2%.23\n\nFigure 1 shows the estimated daily number of COVID-19 cases per state in states\n\nthat introduced the FFCRA, relative to comparator states. After adjustment for a\n\nvariety of factors, the introduction of FFCRA was associated with an approximately\n\n50% decrease in confirmed COVID-19 cases per state per day.24 This is equivalent to\n\nabout 1 prevented case per day per 1,300 workers.\n\n\n\nFigure 1. Association Between a Two Week Paid Sick Leave Program and the Number of Daily COVID-19 Cases per\n\nState in the United States\n\nBar chart showing the association between the introduction of FFCRA, a two-week paid sick leave program enacted\n\non March 18, 2020, in the United States, and the number of daily COVID-19 cases per state, relative to comparator\n\nstates. From March 8 to May 11, 2020, in 30 U.S. States. The analysis was adjusted for the presence of a stay-athome order, number of tests per day, calendar week, day of the week, and state. FFCRA, Families First Coronavirus\n\nResponse Act. Data sourced from Pichler et al.24\n\n\n\nSurvey data from the United Kingdom found that non-adherence to public health\n\nguidelines for patients with COVID-19 was associated with factors including\n\ndependent children in the household, lower socioeconomic status, and being an\n\nessential worker.25 Financial support, and wrap around services, are in particular\n\nassociated with improved ability to self-isolate.25,26\n\nFigure 2 shows risk factors for influenza-like illness among a nationally representative\n\nsample of 2,042 adults from the United States during the H1N1 influenza pandemic in\n\n2009.27 Inability to work from home and absence of paid sick leave were associated with\n\nan approximately 50% increase in the risk of influenza-like illness.\n\nScience Briefs | https://covid19-sciencetable.ca/science-briefs\n\n\n\nApril 28, 2021 | 5\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBenefits of Paid Sick Leave During the COVID-19 Pandemic\n\n\n\nFigure 2. Percentage of Workers With Influenza-Like Illness by Risk Factor in the United States\n\nBar chart showing the percentage of workers in the United States with influenza-like illness in 2009 during the H1N1\n\ninfluenza pandemic by the presence or absence of structural risk factors for exposure to influenza at work on in\n\ntransit to work. Data sourced from Kumar et al.27\n\n\n\nThere are many studies demonstrating that paid sick leave policies at the state and\n\nmunicipal levels are associated with reduced transmission and outbreak prevention\n\nfor respiratory infections. For example, influenza surveillance data in the United\n\nStates shows that access to paid sick leave led to a decline of 290 influenza-like\n\nillnesses per 100,000 individuals per week.28 An OECD report notes that that paid\n\nsick leave reduced influenza-like illness rates by 10% and total work absence by 18%\n\nin some American cities.29\n\nPaid Sick Leave and COVID-19 Vaccination\n\nEvidence from the United States indicates that paid sick leave is associated with\n\nincreased influenza vaccination rates among workers, since they are guaranteed to\n\nreceive paid time off to get immunized.30,31 A survey of 8,634 health care workers\n\nreported that they were much more likely to get vaccinated if direct financial\n\nsupport like paid sick leave were available.32\n\nAs part of the Centers for Disease Control and Prevention (CDC) best practices for\n\nworkplace COVID-19 vaccination, it is suggested that employers allow workers to\n\ntake paid leave to get vaccinated and financially support transportation to off-site\n\nvaccination clinics. They further suggest that employers provide flexible leave\n\npolicies for those who may have post-vaccination symptoms.33 Recently,\n\nSaskatchewan and British Columbia mandated employers to provide paid time off\n\nfor vaccination.34,35\n\nEconomic Impact of Paid Sick Leave\n\nData from the COVID-19 pandemic and other epidemics demonstrate that paid sick\n\nleave is an important strategy for public health containment as well as for economic\n\nstability and recovery.20,36,37 Paid sick leave can increase productivity, and reduces\n\nabsenteeism by preventing outbreaks and the chance of workplace closures. Job\n\nlosses and working hour reductions during the COVID-19 pandemic have been larger\n\nin American states without a paid sick leave system.38\n\nSmall businesses that provide paid sick leave for their employees require compensation\n\nto ensure economic viability. Many OECD countries have lowered the costs for\n\nScience Briefs | https://covid19-sciencetable.ca/science-briefs\n\n\n\nApril 28, 2021 | 6\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBenefits of Paid Sick Leave During the COVID-19 Pandemic\n\n\n\nemployers through government subsidization.20 In the United States, California has\n\nrecently extended eligibility criteria for paid sick leave to include being in quarantine,\n\ncaring for a family member in quarantine, experiencing symptoms of COVID-19 and\n\nseeking a medical diagnosis, or missing work to receive the COVID-19 vaccine.39\n\nEthical Principles Supporting Paid Sick Leave in Ontario\n\nPaid sick leave as a critical public health measure is supported by public health\n\nethics principles as summarized in Table 2.40,41 It demonstrates efficiency by\n\nreducing worker absenteeism overall, and protects the public from harm by\n\ncontaining the spread of infectious diseases and optimizing economic stability and\n\nrecovery. Moreover, it provides mutual support by reducing the burden on those\n\ndisproportionately affected by their type of work and overall compensation; it is a\n\nfair, reasonable, and proportional response to the health and economic threats of\n\nthe pandemic; and minimizes damage to collateral groups by isolating infectious and\n\npotentially infectious workers from others who are susceptible. Finally paid sick\n\nleave builds a common purpose in society when viewed as supporting critical public\n\nhealth measures, and building public trust in decision-makers.\n\nEthical Principle\n\n\n\nProtection of the\n\npublic from harm\n\n\n\nBrief interpretation in the context of paid sick leave in Ontario\n\nA foundational principle of public health ethics is the governmental obligation\n\nto protect the public from harm. In a pandemic, this includes effective public\n\nhealth measures to contain the spread of infectious diseases and to reduce the\n\nburden of illness in workplaces. It also includes protecting the public from\n\neconomic harms related to worker absenteeism, enhancing business continuity,\n\nand enabling economic stability and recovery.\n\nThe protective effects of paid sick leave will be important as the economy\n\nmoves into recovery.\n\nReciprocity requires that society supports those who face a disproportionate\n\nburden when protecting the public good. During the COVID-19 pandemic,\n\nindividuals who must self-isolate, and their families, may experience significant\n\nsocial, economic, and emotional burdens.\n\n\n\nReciprocity\n\n\n\nProvincially mandated sick leave that is immediately accessible and eliminates\n\nor greatly reduces the financial burdens of compliance with public health\n\nmeasures meets the duty of reciprocity for essential workers.\n\nSmall businesses that provide sick pay for their employees should also be\n\nappropriately supported if the costs of doing so put their business in jeopardy.\n\nEquity requires that measures be taken to redress health and other social\n\ninequities that are unfair and exacerbated by public health measures like\n\nquarantine and isolation.\n\n\n\nEquity\n\n\n\nMany essential workers are from disadvantaged groups who have fewer\n\nresources with which to protect themselves and their families and are therefore\n\nunfairly and disproportionately burdened by the impacts of COVID-19.\n\nPolicymakers are urged to consider the health risks not only to workers but also\n\nto those with whom they live.\n\nSupporting workers to quarantine and isolate by providing paid sick leave also\n\nreduces harm for co-workers by reducing their exposure to COVID-19 and by\n\nrespecting their right to a healthy workplace.\n\nProportionality requires that measures taken to mitigate the pandemic should\n\ncorrespond to the actual level of risk, or critical needs of the community.\n\n\n\nProportionality\n\n\n\nScience Briefs | https://covid19-sciencetable.ca/science-briefs\n\n\n\nAs a public health measure, paid sick leave is a proportionate response to both\n\nhealth and economic threats posed by COVID-19 and will play an important role\n\nin maintaining safety, productivity, and business continuity as the relaxation of\n\npublic health measures begins.\n\nApril 28, 2021 | 7\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBenefits of Paid Sick Leave During the COVID-19 Pandemic\n\n\n\nGovernment has a moral imperative to prevent population level health\n\nharms. Anticipating public health threats and preparing for them is an\n\nethical requirement for good public health governance. Paid sick leave will\n\nSystemic resilience need to be considered with stepwise relaxation of public health measures,\n\ninto the post-COVID-19 period. Preparing for future pandemics requires\n\nimproving the adaptability of paid sick leave to the economic and health\n\nchallenges posed by pandemics.\n\nPaid sick leave reflects a sense of common purpose in society when viewed as\n\nan important public health measure. It also can help build public trust, which is\n\nessential for public health compliance.\n\n\n\nSolidarity\n\n\n\nTo foster solidarity, we must protect the income and jobs of society’s most\n\neconomically and biologically vulnerable. Paid sick leave provides reassurance\n\nto workers that their wellbeing and dignity are being respected but it also\n\nrepresents what we would all want if we were in the same position.\n\n\n\nStopping COVID-19 requires a collective effort. Providing paid sick leave is a\n\ncritical example of a public health measure that builds a sense of common\n\npurpose between workers, between workers and employers, between\n\nbusinesses and the public and between the public and government.\n\nWhen public trust is increased through compensatory mechanisms, such as\n\npaid sick leave, it is beneficial for other aspects of outbreak response such as\n\nvaccine uptake.\n\n\n\nTable 2. Relevant Ethical Principles and Considerations for Public Policy on Paid Sick Leave\n\nFigure adapted from the Ontario COVID-19 Bioethics Table.42\n\n\n\nInterpretation\n\nObservational real-world evidence suggests that paid sick leave is associated with a\n\nreduction in SARS-CoV-2 transmission and COVID-19 illness among essential\n\nworkers, and an improvement in productivity. This has been found both during the\n\nCOVID-19 pandemic and in observational studies reporting of paid sick leave for\n\ninfluenza-like illness, including increased influenza vaccination rates. No randomized\n\ntrials are available to inform public health decisions about the implementation of\n\nthis or any other public health measure used throughout the COVID-19 pandemic.\n\nMost Ontario COVID-19 workplace outbreaks outside of long-term care homes have\n\noccurred in the manufacturing sector, as well as forestry, agriculture, fishing/\n\nhunting, transportation and warehousing.43,44 These services are essential to the\n\nfunctioning of society and to the Ontario economy. Workers in these sectors are\n\npaid relatively low wages and are often members of disadvantaged communities.8\n\nFurther, these workers may live with other people who work in essential services,\n\nputting more individuals and workplaces at risk.45\n\nPaid sick leave preserves the jobs of workers who cannot work from home and\n\nprevents harms related to loss of income while following public health measures. In\n\nOntario it is estimated that this accounts for 3 million essential workers.46 Paid sick\n\nleave also increases job security and improves population health overall.47 The\n\nabsence of paid sick leave is often characteristic of insecure work, which is\n\ncorrelated with poorer overall health and worse occupational health and safety\n\noutcomes, and which contributes to health inequities in Ontario and\n\ndisproportionate burdens from COVID-19 being born by essential workers.48,49\n\nThe existing federal CRSB cannot financially protect essential workers in following all\n\npublic health measures, places the administrative burden of applying for the benefit\n\non essential workers, and neither provides sufficient, nor timely payments. Table 1\n\nabove lists the characteristics of a model paid sick leave program as compared with\n\nScience Briefs | https://covid19-sciencetable.ca/science-briefs\n\n\n\nApril 28, 2021 | 8\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBenefits of Paid Sick Leave During the COVID-19 Pandemic\n\n\n\nthe CRSB. Figure 3 presents a proposed process for an essential worker and their\n\nemployer accessing the model paid sick leave program. Implementation of the model\n\nprogram should be done in a way that is easy to navigate and quick for employers.\n\n\n\nFigure 3. Proposed Process for Accessing the Model Paid Sick Leave Program in Ontario\n\nThe proposed process presents the division of responsibilities between the essential worker and their employer in\n\naccessing the model paid sick leave program.\n\n\n\nOntario’s essential workers require paid sick leave that offers more money, is easily\n\naccessible, is immediately paid, and supports them in following all public health\n\nmeasures. This includes providing essential workers with paid leave when they are\n\nsick, have been exposed, need to self-isolate, need time off to get tested or\n\nvaccinated, and when their workplace closes due to an outbreak, with guaranteed\n\nsalary payment regardless of duration of absence (minimum 2 hours, maximum 2\n\nworkweeks).50\n\nReducing SARS-CoV-2 transmission is a collective effort across all sectors of society.\n\nEnabling employers to provide paid sick leave to employees during the pandemic\n\nensures workplace safety, and protection of the public. Moreover, it is a measure that\n\nfosters a sense of common purpose among workers, employers, the public and\n\ngovernment, and builds public trust which is essential for COVID-19 vaccine uptake.51\n\nPaid sick leave is an essential public health measure that, if applied in Ontario, will\n\nboth help control the third wave of the COVID-19 pandemic and prevent the\n\nemergence of further workplace and community outbreaks prior to the vaccination\n\nof every willing Ontarian.\n\n\n\nMethods Used in This Science Brief\n\nThe COVID-19 Evidence Synthesis Network performed a research evidence scan for\n\nthis Science Brief, published in an Evidence Synthesis Briefing Note. The COVID-19\n\nEvidence Synthesis Network is comprised of organizations in Ontario’s evidence\n\nsynthesis and knowledge translation community who collectively provide highquality, relevant, and timely synthesized research evidence about COVID-19. The\n\nMethods for the evidence scan can be found in the methods section of the Briefing\n\nNote. The evidence scan was last updated on February 17, 2021.19\n\n\n\nAuthor Contributions\n\nAT, NMS, JG, PJ, BS conceived the Science Brief. AT, NMS, KB, AM, PJ, BS wrote the\n\nfirst draft of the Science Brief. AM and PJ performed the analyses. All authors\n\nrevised the Science Brief critically for important intellectual content and approved\n\nthe final version.\n\n\n\nReferences\n\n1. Government of Ontario. Ethical framework for COVID-19 vaccine distribution.\n\nScience Briefs | https://covid19-sciencetable.ca/science-briefs\n\n\n\nApril 28, 2021 | 9\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBenefits of Paid Sick Leave During the COVID-19 Pandemic\n\n\n\nPublished January 11, 2021. https://www.ontario.ca/page/ethical-frameworkcovid-19-vaccine-distribution\n\n2. Iddins BO, Waugh MH, Buck B, et al. Benchmarking SARS CoV-2 infection in the\n\nworkplace to support continuity of operations. J Occup Environ Med. Published\n\nonline March 19, 2021. https://doi.org/10.1097/JOM.0000000000002188\n\n3. Decent Work and Health Network. Health experts, teachers, frontline workers\n\nsound the alarm for paid sick days. Decent Work and Health Network. Published\n\nAugust 19, 2020. https://www.decentworkandhealth.org/beforetoolate\n\n4. Government of Canada. Occupational classifications. Statistics Canada.\n\nPublished November 21, 2011. https://www.statcan.gc.ca/eng/concepts/\n\noccupation\n\n5. Government of Canada. Percentage of workforce teleworking or working\n\nremotely, and percentage of workforce anticipated to continue primarily\n\nteleworking or working remotely after the pandemic, by business\n\ncharacteristics. Statistics Canada. Published November 13, 2020. https://\n\nwww150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=3310027401\n\n6. Angus Reid Group. 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Universal paid leave increases influenza\n\nvaccinations among employees in the U.S. Vaccine. 2014;32(21):2441-2445.\n\nhttps://doi.org/10.1016/j.vaccine.2014.02.084\n\n32. Desveaux L, Savage RD, Tadrous M, et al. Beliefs associated with intentions of\n\nnon-physician healthcare workers to receive the COVID-19 vaccine in Ontario,\n\nCanada. medRxiv. Published online February 26, 2021:2021.02.19.21251936.\n\nhttps://doi.org/10.1101/2021.02.19.21251936\n\n33. Centers for Disease Control and Prevention (CDC). Workplace vaccination\n\nprogram. Centers for Disease Control and Prevention. Published March 25,\n\n2021.\n\nhttps://www.cdc.gov/coronavirus/2019-ncov/vaccines/\n\nrecommendations/essentialworker/workplace-vaccination-program.html\n\n34. Government of Saskatchewan. Phase 2 of vaccine delivery plan launches, special\n\nvaccination leave introduced. Government of Saskatchewan. https://\n\nwww.saskatchewan.ca/government/news-and-media/2021/march/18/phase-2of-vaccine-delivery-plan-launches-special-vaccination-leave-introduced\n\n35. Government of British Columbia. Paid leave for workers to get COVID-19\n\nvaccine. BC Gov News. Published April 19, 2021. https://news.gov.bc.ca/\n\nreleases/2021LBR0018-000739\n\n36. Stearns J, White C. Can paid sick leave mandates reduce leave-taking? Labour\n\nEcon. 2018;51:227-246. https://doi.org/10.1016/j.labeco.2018.01.002\n\n37. Pichler S, Ziebarth NR. The pros and cons of sick pay schemes: testing for\n\ncontagious presenteeism and noncontagious absenteeism behavior. J Public\n\nEcon. 2019;171:86-104. https://doi.org/10.1016/j.jpubeco.2019.03.005\n\n38. Chen S, Igan D, Pierri N, Presbitero A. The economic impact of Covid-19 in\n\nEurope and the US: outbreaks and individual behaviour matter a great deal, non\n\n-pharmaceutical interventions matter less. VoxEU.org. Published May 11, 2020.\n\nhttps://voxeu.org/article/economic-impact-covid-19-europe-and-us\n\n\n\n39. The National Law Review. Statewide COVID-19 paid sick leave returns to\n\nCalifornia. The National Law Review. Published March 27, 2021. https://\n\nwww.natlawreview.com/article/statewide-covid-19-paid-sick-leave-returns-tocalifornia\n\n40. Thompson AK, Faith K, Gibson JL, Upshur RE. Pandemic influenza preparedness:\n\nan ethical framework to guide decision-making. BMC Med Ethics. 2006;7(1):12.\n\nhttps://doi.org/10.1186/1472-6939-7-12\n\n41. Upshur REG, Faith K, Gibson JL, et al. Stand on Guard for Thee: Ethical\n\nConsiderations in Preparedness Planning for Pandemic Influenza.; 2005:29.\n\nhttps://jcb.utoronto.ca/wp-content/uploads/2021/03/stand_on_guard.pdf\n\n42. Ontario COVID-19 Bioethics Table. Ethics of paid sick leave for the COVID-19\n\npandemic. Joint Centre for Bioethics University of Toronto. Published April 23,\n\n2021.\n\nhttps://jcb.utoronto.ca/ethics-of-paid-sick-leave-for-the-covid-19Science Briefs | https://covid19-sciencetable.ca/science-briefs\n\n\n\nApril 28, 2021 | 12\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBenefits of Paid Sick Leave During the COVID-19 Pandemic\n\n\n\npandemic/\n\n\n\n43. Smith B, Warren C. The Inequitable Burden of COVID-19 Exposure at Work: The\n\nOccupational Exposure to COVID-19 Risk Tool. Public Health Ontario; 2020.\n\nhttps://www.publichealthontario.ca/-/media/event-presentations/2021/covid19-rounds-inequitable-risk-of-exposure-at-work.pdf?la=en\n\n44. Murti M, Achonu C, Smith BT, et al. COVID-19 Workplace Outbreaks by Industry\n\nSector and their Associated Household Transmission, Ontario, Canada, January –\n\nJune,\n\n2020.\n\nmedRxiv.\n\nPublished\n\nonline\n\nNovember\n\n30,\n\n2020:2020.11.25.20239038. https://doi.org/10.1101/2020.11.25.20239038\n\n45. Messacar D. Inequality in the Feasibility of Working from Home during and after\n\nCOVID-19. Statistics Canada; 2020. https://www150.statcan.gc.ca/n1/en/\n\npub/45-28-0001/2020001/article/00029-eng.pdf?st=MAYr4LGs\n\n46. Institute for Work and Health. Incidence of COVID-19 Transmission in Ontario\n\nWorkplaces.;\n\n2021.\n\nhttps://www.iwh.on.ca/sites/iwh/files/iwh/reports/\n\niwh_issue_briefing_covid19_workplace_ontario_2021.pdf\n\n47. Hill HD. Paid sick leave and job stability. Work Occup. 2013;40(2). https://\n\ndoi.org/10.1177/0730888413480893\n\n48. Rao A, Ma H, Moloney G, et al. A disproportionate epidemic: COVID-19 cases\n\nand deaths among essential workers in Toronto, Canada. medRxiv. Published\n\nonline\n\nMarch\n\n11,\n\n2021:2021.02.15.21251572.\n\nhttps://\n\ndoi.org/10.1101/2021.02.15.21251572\n\n49. Scott-Marshall H, Tompa E. The health consequences of precarious employment\n\nexperiences. Work Read Mass. 2011;38(4):369-382. https://doi.org/10.3233/\n\nWOR-2011-1140\n\n50. Ontario COVID-19 Science Advisory Table. Fighting COVID-19 in Ontario: the way\n\nforward. Ont COVID-19 Sci Advis Table. 2021;2(23). https://doi.org/10.47326/\n\nocsat.2021.02.23.1.0\n\n51. Yaqub O, Castle-Clarke S, Sevdalis N, Chataway J. Attitudes to vaccination: A\n\ncritical review. Soc Sci Med. 2014;112:1-11. https://doi.org/10.1016/\n\nj.socscimed.2014.04.018\n\n\n\nScience Briefs | https://covid19-sciencetable.ca/science-briefs\n\n\n\nApril 28, 2021 | 13\n\n\n\n\f",
          "document_id": 445563
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    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "What information is needed to track and minimize the impact of COVID-19-related disruptions on education and students in Ontario?",
              "id": 275187,
              "answers": [
                {
                  "answer_id": 273785,
                  "document_id": 445565,
                  "question_id": 275187,
                  "text": "the UNESCO Institute for Statistics suggests:\n\n1. rapid data collection formats focusing on key indicators, sampling schools and\n\nstudents rather than the full population;  \n\n2. monitoring equity by over-representing vulnerable students (e.g., girls, students\n\nin poverty, students with disabilities or accessing special education services,\n\nminority or linguistic groups);  \n\n3. frequent and low-stakes learning measurement.202\n\nThis type of system-level monitoring is not underway at the provincial level in Ontario.",
                  "answer_start": 70540,
                  "answer_category": null
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              "is_impossible": false
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              "question": "What are the impacts of COVID-19-related school disruption on students and schooling in Ontario? ",
              "id": 279023,
              "answers": [
                {
                  "answer_id": 274934,
                  "document_id": 445565,
                  "question_id": 279023,
                  "text": "International evidence and emerging local evidence suggest school closures impact\n\nchildren’s academic achievement and lead to learning losses. The duration of closures\n\nimpacts academic achievement and learning. There is widespread consensus from\n\nfamilies, educators, and children themselves that students learn better in person than\n\nonline, and that access to online learning is a challenge for many due to technical,\n\neconomic, or other barriers.\n\nMost evidence suggests a greater impact of school closures on vulnerable populations.\n\nClosures have interacted with other COVID-related hardships to disproportionately\n\naffect students with lower socioeconomic backgrounds, racialized children and youth,\n\nnewcomers, and students with disabilities.\n\nClosures, as well as periods of education disruption have increased absenteeism,\n\nwhich is a measure of engagement in education and ability of schools to meet\n\nstudents’ needs. School closures disrupted access to specialized educational services\n\nand programs for students with disabilities as well as English language learners.\n\nClosures have affected students’ educational transitions, which affect students’ later\n\noutcomes. There is evidence of decreased enrollment in kindergarten and reduced\n\naccess to developmental services. There are concerns about increased streaming and\n\nwhether students are ‘on track’ in early high school, as well as students’ ability to\n\naccess College or employment after graduation.\n\nSchool closures have multi-dimensional consequences, including impacts on\n\nchildrens’ well-being, physical and mental health. Normally, school personnel are\n\nthe largest group reporting suspected cases of abuse and neglect. COVID-19-related\n\nschool closures have led to decreased reporting. Closures have immediate and future\n\neconomic costs, with modelling data suggesting an impact on future lifetime earnings,\n\nas well as depressed labour force participation for parents, particularly mothers. Each\n\nmonth of skill loss is predicted to cause a ~1% drop in lifetime earnings for affected\n\ncohorts and is estimated to decrease the national income by 0.5 percent per year,\n\nwhich would translate to a GDP loss for Canada of 1.6 trillion CAD.",
                  "answer_start": 5615,
                  "answer_category": null
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          "context": "SCIENCE BRIEFS\n\n\n\nCOVID-19 and Education\n\nDisruption in Ontario: Emerging\n\nEvidence on Impacts\n\n\n\nKelly Gallagher-Mackay, Prachi Srivastava, Kathryn Underwood, Elizabeth Dhuey,\n\nLance McCready, Karen B. Born, Antonina Maltsev, Anna Perkhun, Robert Steiner, Kali\n\nBarrett, Beate Sander on behalf of the Ontario COVID-19 Science Advisory Table\n\n\n\nVersion: 1.1\n\nPublished: June 4, 2021\n\nUpdated on June 16, 2021. Version\n\n1.0\n\nis\n\navailable\n\nunder\n\nAdditional\n\nResources at https://doi.org/10.47326/\n\nocsat.2021.02.34.1.0\n\nCitation: Gallagher-Mackay K, Srivastava\n\nP, Underwood K, et al. COVID-19 and\n\neducation disruption in Ontario: emerging\n\nevidence on impacts. Science Briefs of the\n\nOntario COVID-19 Science Advisory Table.\n\n2021;2(34).\n\nhttps://doi.org/10.47326/\n\nocsat.2021.02.34.1.0\n\nAuthor Affiliations: The affiliations of the\n\nmembers of the Ontario COVID-19 Science\n\nAdvisory Table can be found at https://\n\ncovid19-sciencetable.ca/.\n\nDeclarations of Interest: The declarations\n\nof interest of the members of the Ontario\n\nCOVID-19 Science Advisory Table, its Working\n\nGroups, or its partners can be found at https://\n\ncovid19-sciencetable.ca/. The declarations\n\nof interest of external authors can be found\n\nunder additional resources at https://doi.\n\norg/10.47326/ocsat.2021.02.34.1.0\n\nAbout Us: The Ontario COVID-19 Science\n\nAdvisory Table is a group of scientific experts\n\nand health system leaders who evaluate and\n\nreport on emerging evidence relevant to\n\nthe COVID-19 pandemic, to inform Ontario’s\n\nresponse. Our mandate is to provide weekly\n\nsummaries of relevant scientific evidence for\n\nthe COVID-19 Health Coordination Table of the\n\nProvince of Ontario, integrating information\n\nfrom existing scientific tables, Ontario’s\n\nuniversities and agencies, and the best global\n\nevidence. The Science Table summarizes its\n\nfindings for the Health Coordination Table and\n\nthe public in Science Briefs.\n\nCorrespondence to: Secretariat of the\n\nOntario COVID-19 Science Advisory Table\n\n(info@covid19-sciencetable.ca)\n\nCopyright: 2021 Ontario COVID-19 Science\n\nAdvisory Table. This is an open access\n\ndocument distributed under the terms of the\n\nCreative Commons Attribution License, which\n\npermits unrestricted use, distribution, and\n\nreproduction in any medium, provided that\n\nthe original work is properly cited.\n\n\n\nKey Message\n\nThe COVID-19 pandemic has led to significant education disruption in Ontario. This\n\nhas included mass and localized school closures, multiple models of educational\n\nprovision and gaps in support for students with disabilities. The unequal distribution of\n\nschool closures and pandemic-associated hardships, particularly affecting low-income\n\nfamilies in which racialized and Indigenous groups, newcomers and people with\n\ndisabilities are overrepresented, appear to be deepening and accelerating inequities\n\nin education outcomes, wherever data have been collected. Further, there are health\n\nrisks associated with closures including significant physical, mental health and safety\n\nharms for students and children. Modelling suggests long-term impacts on students’\n\nlifetime earnings and the national economy.\n\nThere are substantial data gaps on the impact of closures on Ontario’s children.\n\nHowever, existing information and analysis can inform strategies to minimize further\n\npandemic disruptions to children’s education and development. Identifying or tracking\n\nareas where students are facing the greatest challenges in the wake of COVID-19\n\nand implementing systematic supports to address pandemic-associated educational\n\nharms are critical to minimizing the overall impact and supporting recovery.\n\n\n\nSummary\n\nBackground\n\nEducation and schooling in Ontario have been profoundly disrupted by the COVID-19\n\npandemic. From March 14, 2020, to May 15, 2021, Ontario schools have been closed\n\nfor 20 weeks total, longer than any other Canadian province or territory.\n\nAfter a first school closure announcement on March 12, 2020, on March 17, 2020,\n\nOntario declared a state of emergency. All schools and childcare centres were closed\n\nuntil June 30, 2020. Emergency remote learning was instituted during this time. During\n\nthe 2020-21 school year, schooling experiences were more differentiated across the\n\nprovince because of diverse models of educational delivery and localized school closures.\n\nVarious models of educational delivery were instituted – fully remote, during closures\n\nor by parent choice; blended online and face to face learning, mostly in secondary; and\n\nfully in-person. The 2020-21 school year began with a phased and staggered reopening\n\nof schools in September. On January 8, 2021, as the province entered the second\n\nwave of the pandemic, schools in some public health regions were closed, with a full\n\nreopening as of February 16. On April 12, the province announced Ontario-wide closure\n\nof elementary and secondary schools with no end period announced.\n\n\n\nThe views and findings expressed in this\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 1\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\nScience Brief are those of the authors and do\n\nnot necessarily reflect the views of all of the\n\nmembers of the Ontario COVID-19 Science\n\nAdvisory Table, its Working Groups, and its\n\npartners.\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nQuestions\n\nWhat are the impacts of COVID-19-related school disruption on students and schooling\n\nin Ontario?\n\nWhat information is needed to track and minimize the impact of COVID-19-related\n\ndisruptions on education and students in Ontario?\n\nFindings\n\nInternational evidence and emerging local evidence suggest school closures impact\n\nchildren’s academic achievement and lead to learning losses. The duration of closures\n\nimpacts academic achievement and learning. There is widespread consensus from\n\nfamilies, educators, and children themselves that students learn better in person than\n\nonline, and that access to online learning is a challenge for many due to technical,\n\neconomic, or other barriers.\n\nMost evidence suggests a greater impact of school closures on vulnerable populations.\n\nClosures have interacted with other COVID-related hardships to disproportionately\n\naffect students with lower socioeconomic backgrounds, racialized children and youth,\n\nnewcomers, and students with disabilities.\n\nClosures, as well as periods of education disruption have increased absenteeism,\n\nwhich is a measure of engagement in education and ability of schools to meet\n\nstudents’ needs. School closures disrupted access to specialized educational services\n\nand programs for students with disabilities as well as English language learners.\n\nClosures have affected students’ educational transitions, which affect students’ later\n\noutcomes. There is evidence of decreased enrollment in kindergarten and reduced\n\naccess to developmental services. There are concerns about increased streaming and\n\nwhether students are ‘on track’ in early high school, as well as students’ ability to\n\naccess College or employment after graduation.\n\nSchool closures have multi-dimensional consequences, including impacts on\n\nchildrens’ well-being, physical and mental health. Normally, school personnel are\n\nthe largest group reporting suspected cases of abuse and neglect. COVID-19-related\n\nschool closures have led to decreased reporting. Closures have immediate and future\n\neconomic costs, with modelling data suggesting an impact on future lifetime earnings,\n\nas well as depressed labour force participation for parents, particularly mothers. Each\n\nmonth of skill loss is predicted to cause a ~1% drop in lifetime earnings for affected\n\ncohorts and is estimated to decrease the national income by 0.5 percent per year,\n\nwhich would translate to a GDP loss for Canada of 1.6 trillion CAD.\n\nInterpretation\n\nThe far-reaching impact of disruption necessitate explicit educational recovery\n\nstrategies. Two key strategies can minimize the impact of COVID-19 related disruptions\n\non schooling. First, a strong priority, as expressed by numerous Medical Officers of\n\nHealth, on keeping schools open wherever circumstances allow – a ‘last closed, first\n\nopen’ policy. Keeping schools open in the context of new, more transmissible and\n\nmore deadly variants of concern requires renewed and intensified commitment to a\n\nrange of safety practices and accelerated vaccination of all education workers, parents\n\nand children as vaccines are shown to be safe and effective.\n\nSecond there is a need for explicit education recovery strategies to be funded in\n\naddition to regular schooling budgets. Strategies may include active measures to\n\nensure appropriate universal responses (overall curriculum adaptations, instruction,\n\nand student supports), and targeted intensive accelerated learning programs for groups\n\nthat have been most disadvantaged by health and education effects of COVID-19.\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 2\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nBackground\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nOntario is in its second academic year of education disruption resulting from COVID-19\n\nand COVID-19 related policy responses, affecting over two million elementary and\n\nsecondary school students.1 Education disruption has resulted from mass closure\n\nof all schools, partial closures in specific geographies, and closures of individual\n\naffected schools and classrooms. Evolving policy and implementation responses to\n\npublic health risks associated with COVID-19 – including emergency remote learning,\n\nvirtual schools, blended learning, cohorting and moves to quadmester/octomester\n\nscheduling, limits on students’ in-school activities, and shifting requirements – have\n\nalso disrupted students’ educational experiences.\n\nUnder Ontario’s Education Act, the purpose of schooling is to ‘provide students with\n\nthe opportunity to realize their potential’. Partners in the education system have\n\nresponsibility to promote student ‘achievement and well-being’.2\n\nThis Science Brief reviews the growing body of literature that points to substantial,\n\nmulti-dimensional consequences of COVID-19-related education disruptions.\n\nConsequences include depressed achievement relative to previous years,3–21 negative\n\npsycho-social and mental health impacts and increased child protection risks.22–37\n\nThese consequences have potential for substantial longer-term social and economic\n\nimpacts.38 The effects are more pronounced in communities and for individuals that\n\nare more negatively affected by COVID-19, and for those who entered the pandemic\n\nin pre-existing vulnerable circumstances.39 In Ontario, as elsewhere, the impact of\n\nCOVID-19 has been more severe on racialized groups, people with disabilities, and\n\nthose with lower incomes.40,41\n\nThe purpose of this brief is to provide a high-level overview of key education\n\nimpacts associated with COVID-19. Many of the topics considered in this brief\n\nare worthy of their own, distinct treatment, but given the paucity of Ontario or\n\nCanadian data on educational experiences and outcomes during COVID-19, we\n\nhave focused on an overview of education issues. This brief does not address\n\nevidence relating to safety and school reopening, nor evidence or data on schoolbased transmission of COVID-19.\n\nTerminology\n\nThe terminology associated with the different educational models during the\n\nCOVID-19 pandemic is inconsistent and can be confusing. In this Science Brief, we use\n\nthe following definitions.\n\nAsynchronous Instruction\n\n“Learning that is not delivered in real time. Asynchronous learning may involve students\n\nwatching pre-recorded video lessons, completing assigned tasks, or contributing to\n\nonline discussion boards.”\n\nBlended Learning\n\nAn adapted educational model where students spend part of the school week in faceto-face instruction, and engage in part of their instruction remotely.\n\nHybrid Instruction\n\nSituations where a teacher simultaneously teaches some students who are physically\n\npresent in class, while other students participate in learning activities remotely,\n\ntypically through video conferencing.\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 3\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nRemote Learning\n\n“Learning that occurs when classes are taught at a distance and when students and\n\neducators are not in a conventional classroom setting. Remote learning takes place\n\nin times of extended interruption to in-person learning – for example, as a result of\n\na pandemic or natural disaster. Classes can be synchronous or asynchronous and\n\ncan be taught online through a Learning Management System (LMS) or by using\n\nvideoconferencing tools. In some cases, they may be delivered through emails, print\n\nmaterials, broadcast media, or telephone calls.”\n\nSchool Closure\n\nThe suspension of face-to-face, in-school instruction for the majority of students. This\n\nterminology is in line with global education practices monitoring disruption during\n\nCOVID-19.42 It also provides a more internally consistent unit for policy tracing, in view\n\nof varied responses to education continuity.\n\nSynchronous Instruction\n\n“Learning that happens in real time. Synchronous learning involves using text, video,\n\nor voice communication in a way that enables educators and other members of the\n\nschool- or board-based team to instruct and connect with students in real time.” The\n\nuse of the term synchronous instruction is limited to remote contexts.\n\nVirtual Schools\n\nDescribes schooling provided to students whose families have opted not to have their\n\nchildren return to in-person learning, even where it is otherwise offered. In some\n\ncases, boards have created separate administrative teams for virtual schools.\n\nQuoted definitions are from the Ministry of Education, Policy and Program\n\nMemorandum 164.43\n\nQuestions\n\nWhat are the impacts COVID-19-related school disruptions on students and education\n\nin Ontario?\n\nWhat information is needed to track and minimize the impact of COVID-19-related\n\nclosures and disruption on education and students in Ontario?\n\n\n\nFindings\n\nOverview of Education Policy Response to COVID-19\n\nThe 2019-20 and 2020-21 school years had two different education policy responses.\n\nProvincewide school closures and the suspension of face-to-face instruction were\n\ninstituted between March and June 2020. The system moved to emergency remote\n\nvirtual instruction during this time. The 2020-21 school year had both province-wide\n\nand localized school closures. Three models of educational delivery were instituted –\n\nfully remote, with minimum standards for synchronous and asynchronous instruction;\n\nblended; and in-person.44 Due to the varying extent of school closures and the diverse\n\nmodels of educational delivery, the experiences and effects of education disruption\n\nare likely to be highly differentiated across student groups in Ontario.\n\nSchool Closures and Reopening: Policy Tracing\n\nSchool closures have the greatest immediate impact on education disruption. Figure\n\n1 traces the main Ontario-level school closure and reopening periods between March\n\n2020 and April 2021 affecting publicly funded elementary and secondary schools.\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 4\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nPublicly funded schools in Ontario account for 94% of enrolment in the province.45,46\n\nPolicy responses for private schools are beyond the scope of this brief. Further,\n\nindividual schools and classes were affected by localized closures during full or partial\n\nreopening throughout 2020-21.47,48\n\n\n\nFigure 1. Ontario-Level School Closures and Reopening Policy Tracing, from March 2020 to April 2021\n\nSchool closures are defined as the suspension of in-school, face-to-face instruction. Only public school closures are\n\npresented. Further localized municipal, regional, and board-level school closures are not presented. January 8, 2021:\n\nAll schools in PHUs of Algoma, North Bay Parry Sound, Northwestern, Porcupine, Sudbury, Thunder Bay, Timiskaming.\n\nJanuary 25, 2021: All schools in PHUs of Grey Bruce, Haliburton, Kawartha, Pine Ridge, Hastings and Prince Edward\n\nCounties, Kingston, Frontenac and Lennox & Addington, Leeds, Grenville and Lanark, Peterborough, Renfrew County.\n\nFebruary 1, 2021: All schools in PHUs of Eastern Ontario, Middlesex-London, Ottawa, Southwestern. February 8, 2021:\n\nAll schools in PHUs of: Brant County, Chatham-Kent, Durham, Haldimand-Norfolk, Halton, Hamilton, Huron Perth,\n\nLambton, Niagara, Simcoe-Muskoka, Waterloo, Wellington-Dufferin-Guelph, Windsor-Essex. February 16, 2021: All\n\nschools in PHUs of Peel, Toronto, York. Data extracted from official provincial government announcements49–52 and\n\nverified on the ICES COVID-19 Dashboard. Srivastava P, Taylor PJ. (2021). COVID-19 school dashboard (1.1 May 2021).\n\nhttp://covid19schooldashboard.com/48 (See also Appendix A).\n\n\n\nSimilar to the majority of jurisdictions globally,42 Ontario instituted mass school\n\nclosures in the first phase. Basic measures for education continuity were instituted.\n\nThe first school closure announcement was issued on March 12, 2020, for an initial\n\nperiod from March 14, to April 5, 2020, applicable to all publicly funded elementary\n\nand secondary schools.53 On 17 March 2020, the government declared an official\n\nstate of emergency under section 7.0.1 (1) of the Emergency Management and Civil\n\nProtection Act.54 This extended the immediate closure to all private schools as defined\n\nin the Education Act and to all licensed childcare centres. Public school closures were\n\nextended another three times, to May 4, May 31, and finally, June 30, 2020.55–57\n\nSchool closure and reopening during the 2020-21 school year were largely characterised\n\nby localized responses and increased variability, until April 2021. The 2020-21 school\n\nyear began with a phased and staggered reopening of schools, which school boards\n\nwere directed to implement. Comprehensive, centralized, publicly available data are\n\nlacking on the dates and order of phased reopening.\n\nFollowing the winter break, there was a short period of extended virtual learning for\n\nall schools (January 4 to 8, 2021), followed by five localised and partial reopening\n\nphases (January 11 to February 16, 2021). Full system-wide reopening was as of\n\nFebruary 16, 2021, and March break was rescheduled to the week of April 12, 2021.58\n\nDuring the week of April 5, 2021, municipal governments in Peel and Toronto issued\n\norders to close all schools before the rescheduled spring break.59–61 On April 12, 2021,\n\nthe province announced that schools would be closed after the rescheduled spring\n\nbreak for an indeterminate period.52\n\nWhenever schools were fully or partially open for in-person schooling throughout\n\n2020-21, individual schools and classes were affected by localized closures.47,48\n\nSchool Closures in Ontario Compared to the Rest of Canada\n\nThe extent of school closures has been highly variable across Canadian jurisdictions\n\nfrom March 14, 2020 to May 15, 2021. Figure 2 illustrates school closures across\n\nCanada for elementary schools, and Figure 3 for secondary schools. They illustrate\n\nthe relatively heavy reliance on system-wide school closures, in Ontario relative to the\n\nrest of Canada.\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 5\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nFigure 2. Provincial and Territorial-Level Elementary School Closures in Canada, from March 14, 2020, to May 15, 2021\n\nSchool closures are defined as the suspension of in-school, face-to-face instruction. Only public school closures are\n\npresented. Municipal and regional school closures are not presented. School closures due to holidays are not presented.\n\nPartial school closures and blended learning models are not presented. Information presented is approximate. Sourced\n\nfrom multiple Canadian news outlets, provincial/territorial government websites and other online sources announcing\n\nCOVID-19 related school closures.\n\n\n\nFigure 3. Provincial and Territorial-level Secondary School Closures in Canada, from March 14, 2020, to May 15, 2021\n\nSchool closures are defined as the suspension of in-school, face-to-face instruction. Only public school closures\n\nare presented. Municipal and regional school closures are not presented. School closures due to holidays are not\n\npresented. Partial school closures and blended learning models (which are more common in secondary school) are not\n\npresented. Information presented is approximate. Sourced from multiple Canadian news outlets, provincial/territorial\n\ngovernment websites and other online sources announcing COVID-19 related school closures.\n\n\n\nEducational Provision Through Pandemic Emergency\n\nThe period from March to June 2020 has been characterised by ‘emergency remote\n\nlearning’.62 This involved efforts to institute basic measures for educational continuity\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 6\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nunder extremely uncertain circumstances. Expectations for synchronous and\n\nasynchronous teaching, student workload and feedback were inconsistent between\n\nclassrooms, schools, and boards.63 However, Ministry policy established that students’\n\nmarks would not be lower than a baseline mark established by March 13, 2020, and\n\nstudents’ graduation would not be jeopardized because of COVID-19.64\n\nBy the end of the 2019-20 school year, it was clear that COVID-19 would pose a community\n\nhealth risk into the 2020-21 school year, and that there would be continued education\n\nand welfare risks for children. The need to balance risks to children’s educational and\n\nsocial development with risks of infection and spread of COVID-19 was increasing.65 In\n\nits June 19, 2020 policy document, Approach to reopening schools for the 2020-2021\n\nschool year, the government expressed a preference for conventional, in-person delivery\n\nand explicitly restricted the requirement that school boards offer remote learning “as\n\nlong as public health circumstances require adapted delivery of education”.66\n\nOn 30 July 2020, the Ministry of Education released a plan that publicly funded schools\n\nwere to operate in the fall according to one of three models: fully in-person (K-8 and\n\nsecondary schools in areas with low COVID-19 risk), with safety-related adaptations;\n\nan ‘adapted model of part-time attendance, alternating between attending in-person\n\nand online’ (in secondary schools where there is higher COVID-risk); and fully remote\n\nlearning. Parents would ‘have the option to enroll their children in remote delivery,\n\nwhich respects their fundamental role in making the final determination of whether\n\nthey feel safe with their children returning to school.’44 An implication of the parental\n\nchoice option was that virtual and in-person school are interchangeable.\n\nMinimum requirements for asynchronous and synchronous remote delivery, and\n\nfor the delivery of the full Ontario curriculum and assessment, as set out under the\n\nexisting Growing Success policy, were communicated in August 2020.43 They include:\n\nƒ\n\n\n\nExpectations for teachers to provide differentiated support to all students, including English and French language-learners and students with disabilities or who\n\nhave an individual education plan (IEP).\n\n\n\nƒ\n\n\n\nIntroduction of blended learning and quadmester or octomester scheduling in\n\nsecondary school schedules to limit students’ exposure to smaller cohorts of students.\n\n\n\nƒ\n\n\n\nRestrictions for in-person learners on gatherings and extremely limited clubs or\n\nsports or other extra-curriculars were required as infection control measures.43\n\n\n\nSchool boards were charged with developing locally contextualized implementation\n\nplans to deliver multiple models of schooling, and to ensure devices and connectivity\n\nfor students in need. Complete guidance program and operational requirements,67\n\nMinisterial approvals of board implementation plans (e.g., in-person requirements\n\nfor blended learning,68,69 or changing length of school day to reduce class sizes)70\n\nand availability of additional funding to support safe re-opening came between midAugust and early October 2020 for fall 2020.71–74\n\nThis brief review of policy changes in education during COVID-19 demonstrates the\n\nrapidly evolving changes to educational structures and to teaching, learning and\n\nstudent experiences in COVID-19 that extend far beyond the question of whether\n\nschools are open or closed.\n\nRemote Learning in the 2020-21 School Year\n\nThere are no publicly available aggregate data on how many students are enrolled\n\nin remote or in-person schooling during the 2020-21 school year. Reports suggest\n\nthere was considerable variation between and within boards. For example, it was\n\nreported that 16% of students opted for virtual school in Lakehead District School\n\nBoard in October 2020,75 while 49% of students opted for virtual school by October 1,\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 7\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\n2020 in Peel District School Board.76 Students have switched between in-person and\n\nremote learning during the school year, although there are no aggregate data for the\n\nnumber of students who switched between options or the direction of that switch.\n\nThis created disruptions within schools, such as classroom reorganizations, alongside\n\nadditional transitions for individual students.\n\nThere is considerable variation in how remote schooling was delivered. For example,\n\nsome school boards adopted a ‘hybrid’ model,77 while others have rejected\n\nsimultaneous online and in-person instruction. There are no systemwide data on the\n\nextent of this model in Ontario, nor evaluations of learning impacts of hybrid relative\n\nto other forms of remote learning.\n\nThe percentage of students choosing remote learning compared to in-person schooling\n\nmay reflect the racial geographies of Canadian urban centres. A number of reports from\n\nthe Greater Toronto Area analyzed the demographics of schooling choice during the\n\nCOVID-19 pandemic.78 These analyses showed that families living in neighbourhoods\n\nwith lower incomes and with more racialized residents were more likely to choose online\n\nschooling.78 Canadian analyses showed that COVID-19 risks were disproportionately\n\nhigher in communities with higher household density, higher proportion of essential\n\nworkers, lower educational attainment, lower income and more racialized residents.40\n\nUS survey data suggested that Black and ethnic minority parents had greater concerns\n\nabout school safety, consistent with higher exposure to COVID-19.79\n\nThere is a substantial international literature on schooling continuity during emergencies,\n\nincluding the use of technology, much of which pre-dated COVID-19.80,81 However, there\n\nis little evidence on the effects of online-only schooling on learning at elementary and\n\nsecondary levels,82 or on the overall social development and well-being of students.\n\nEvidence in the COVID-19 pandemic context is in its infancy despite the fact that there\n\nare a large number of students in emergency online-only settings globally.\n\nA key indicator of educational equity is students’ access to non-segregated learning\n\nenvironments.83 Policy changes which tend to increase de facto segregation between\n\nstudents along lines of race or socio-economic status merit sharp scrutiny, particularly\n\nwhen there is little evidence for the educational approach which is disproportionately\n\nbeing used with racialized and low-income students.\n\nImpact on Educators\n\nThese policy changes had direct and indirect effects on students’ classroom context, and,\n\non their teachers. In general, the strongest in-school influence on students’ learning is\n\ntheir teacher.84,85 Teacher effectiveness is deeply shaped by the contexts in which they\n\nwork.86–88 COVID-19 has radically disrupted these contexts, with considerable impacts\n\non teachers’ work as well as their own health and well-being. Teachers have needed to\n\ndramatically change how they teach, with limited time or specific training provided.89\n\nThey are supporting students, many of whom are themselves under exceptional\n\nstress.90,91 Furthermore, they assumed new responsibilities associated with ensuring\n\nsafety in-school under conditions that were considered by many to be unsafe.92\n\nA highly feminized workforce,93 educators as a group were particularly affected by\n\ncaring responsibilities for their own children at home, while continuing to work. A\n\nnational survey suggests that teachers have experienced considerable stress and\n\nburnout during COVID-19.94 There are further reports of teacher shortages resulting\n\nfrom leaves and attrition from the profession in light of COVID-19 contexts.95 As a result\n\nof these shortages, exceptional measures such as allowing student teachers temporary\n\nteaching certificates, and in some cases, hiring non-teachers were undertaken.96 There\n\nmay be long-term effects on the profession in terms of teacher supply.\n\nThere is an ongoing need for research on how the COVID-19 pandemic has affected\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 8\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nOntario educators and the education workforce,97 and how these challenges affect\n\nstudent learning and well-being.\n\nImpact on Students’ Educational Outcomes: Learning Loss, Educational Opportunities,\n\nand Transitions\n\nAs the policy summary above demonstrates, opportunities for students in Ontario\n\nto develop knowledge, skills and attitudes through education have been profoundly\n\naffected by COVID-19. Here we examine short-term and potential longer-term effects\n\nof these changes, recognizing that the nature of collective responses to COVID-19 will\n\nshape the longer-term picture.\n\nImpacts and Social and Family Context\n\nWhile there are long-standing debates about the relative importance of different\n\nfactors, the inextricable interconnection between families, communities and\n\neducation success is a central finding of the sociology of education and developmental\n\npsychology literatures.98–101 In the context of COVID-19, the relative impact of family and\n\ncommunity on achievement and well-being has likely been heightened. Restrictions\n\non movement mean that children and youth have spent unprecedented amounts\n\nof time within their households, at the same time as the impacts of COVID-19 have\n\nstruck in deeply unequal and complex ways.102\n\nThe mental health of families with children has declined overall, affecting the home\n\nclimate in which children are spending more time.103 New research conducted during\n\nCOVID-19 showed that approximately half of parents with children learning remotely\n\nhad at least one child struggling with distance learning, which in turn was associated\n\nwith higher parental stress.104 Results from Statistics Canada crowdsourcing initiatives\n\nshow that among participants, youth, recent immigrants, certain groups designated\n\nas visible minorities, gender diverse people, and Indigenous people, were also more\n\nlikely to report symptoms consistent with moderate or severe generalized anxiety.105\n\nData from Statistics Canada highlight that stress on families is unequally distributed.\n\nGroups designated as visible minorities, recent immigrants and people with disabilities\n\nare overrepresented among those with low incomes, and therefore, are more\n\nvulnerable to infection and to indirect effects of COVID-19.105 Families with lower\n\nincomes tend to experience living spaces that are more crowded,106 making quiet study\n\nmore difficult. Parents have less ability to work from home and supervise learning.\n\nWealthier parents have greater capacity to pay for or arrange private supports for\n\nlearning such as tutors – reports suggest demand has increased substantially during\n\nthe COVID-19 pandemic107 – or support services for young people with disabilities.108\n\nDeclines in Achievement Relative to Previous Years, and Growing Gaps\n\nSchools have broad purposes. In Ontario and internationally, there is growing\n\nacknowledgement of the vital importance of broad, non-cognitive or social-emotional\n\nskills, creativity, and capacity for collective action to prepare students for a fastchanging world.109 However, the literature on learning loss concentrates primarily on\n\nstudents’ test performance, mostly in literacy and numeracy. There are critics of this\n\nrelatively narrow, and non-transformative focus of the learning loss discussion.5 Others\n\nfocus on non-school learning where students may have gained knowledge that is not\n\nreflected in current ways of thinking about achievement.7 At the same time, these\n\nfundamental skills are clearly linked to present and future prospects for employment,\n\nhealth, and democratic participation.9,10,110\n\nOntario data: To date, there are no provincial data on learning loss available in\n\nOntario. The administration of province-wide Education Quality and Accountability\n\nOffice (EQAO) tests and the Early Development Index were paused in 2020-21.43 There\n\nis one large-scale study of grade 1 reading conducted in the Toronto District School\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 9\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nBoard using recognized diagnostic reading assessments administered by teachers.11\n\nReading assessments were administered in October 2020 to students in in-person\n\nschooling, and in January 2021 to students in virtual schooling. The study showed\n\ngrade 1 students in in-person schooling in October 2020 were 3 percentage points\n\nbehind where grade 1 students were in October 2019. Students in virtual schooling\n\nin January 2021 were 9 percentage points behind where grade 1 students were in\n\nJanuary 2020.11,111\n\nProvincially, there have not been sample-based assessments of students using\n\nstandardized measures against which it would be possible to measure relative progress.\n\nSeveral school boards in Ontario have published results from surveys or thought\n\nexchanges to solicit parent and student perspectives on the online experience. While\n\nsurveys of this type may tend to over-represent less disadvantaged and more engaged\n\nmembers of the school community, the samples are large, and they provide important\n\ninsight. A Toronto District School Board survey in February 2021 found that while\n\n60% of students thought their progress this year was good or excellent, 66% were\n\nworried that they would fall behind because of COVID-19 (n=36,000), and 53% of\n\nparents (n=96,500) shared that concern; 84% of students thought they learn better inperson than online.12 A Canadian survey of 9,500 educators conducted in spring 2021\n\nfound that 55% of elementary and secondary teachers reported fewer students were\n\nmeeting learning objectives compared to other years, 75% said they were behind\n\nschedule in covering curriculum, and 70% were worried that some students will not\n\ncatch up academically.112\n\nQuébec economists estimated a decrease in overall learning of approximately\n\n1.4 months due to the 3.2 months of school closures in the spring and that the\n\nsocioeconomic skills gap could increase by as much as 30%.113\n\nInternational evidence: There is a growing and broadly consistent body of evidence\n\nemerging from England and the US, supported by additional data from Belgium and\n\nthe Netherlands, indicating the serious effects that school shutdowns have had on\n\nchildren. While the nature of school interruptions varied widely and the education\n\nsystems themselves differ across jurisdictions, the data provide insight on what may\n\nbe relevant for Ontario. Most importantly, they indicate the likelihood of differential\n\neffects on disadvantaged students (or schools).\n\nAppendix B provides a detailed summary of the scope and findings of 14 largescale international studies published in 2020-21. The review for this brief searched\n\nbroadly the peer-reviewed and grey literature for any reported assessments during\n\nthe COVID-19 period that used consistent measures of achievement, including results\n\nfrom standardized tests and aggregated results from diagnostic assessments used for\n\nclassroom purposes.\n\nThe studies document considerably lower achievement levels in 2020 than in\n\npreceding years. While there are numerous differences in how studies measure the\n\nimpact of COVID-19-related disruptions on learning (i.e., standard deviations, months\n\nbehind, scaled points behind, percentages of students not at grade level), most point\n\nto average achievement that was well behind that of earlier cohorts, measured at\n\nthe same point in preceding school year(s). There were significant losses,3 even in\n\nsituations that would be considered relatively ideal, i.e., populations with relatively\n\nlow levels of income inequality, school closures as short as two months, and excellent\n\nbroadband access.\n\nƒ\n\n\n\nSeveral studies report learning loss in months.3,13–15,114 Most of these report losses, in fall 2020, of approximately two months behind where students would have\n\nbeen at the same time in earlier years (Figure 6).\n\n\n\nƒ\n\n\n\nA number of studies, based on teacher-administered diagnostic assessments,\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 10\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nshow substantial increases in the number of students who started 2020 well below grade level.17–20\n\nƒ\n\n\n\nYounger students had greater losses than those in upper grades, or in secondary\n\nschool.15,17–19,21,114,115\n\n\n\nƒ\n\n\n\nMath achievement was further behind than reading achievement.3,13,18,39,114,115\n\n\n\nƒ\n\n\n\nThree studies have shown that a return to in-person schooling is associated with\n\nsome recovery of learning losses.19–21\n\n\n\nFigure 4. Evidence from International Assessments Reporting Average Learning Loss in Months, Fall 2020\n\nData for the Netherlands sourced from Engzell, P., Frey, A., & Verhagen, M. D.3 Data for England (NFER) sourced\n\nfrom Rose S, Twist L, Lord P, et al.13 Data for Ohio, United States sourced from Kogan V, Lavertu S.14 Data for Britain\n\nsourced from Department for Education (DfE).16 Data for California, United States sourced from Pier L, et al.15 NFER,\n\nNational Foundation for Educational Research. PACE, Policy Analysis for California Education. Renaissance refers to the\n\nRenaissance Learning and Education Policy Institute.\n\n\n\nOne large-scale study, in Ohio, compared the effects online and in-person learning.14\n\nAn analysis of statewide test data in grade 3 Language Arts showed students learning\n\nremotely were behind their in-person classmates, even controlling for unemployment\n\nshocks and county-level COVID-19 severity (0.278 standard deviations loss in students\n\nlearning remotely, 0.233 for blended learning, and 0.182 loss for in-person instruction).14\n\nThese large-scale studies substantiate early concerns that learning losses are unequally\n\ndistributed. Different assessments focus on different subpopulations of students. The\n\nrange of studies found that students from lower-income backgrounds,13,16,19,21,116 or,\n\nwhose parents have less education,3,116 or, who are Black or Hispanic,14,39 or English\n\nlanguage learners,15 or have been identified with special education needs,19 or who\n\nattend schools with a high percentage of low-income,18,21,115,116 or racialized students\n\nor schools where there is significant unemployment - have fallen further behind their\n\npeers.14,18,115 These patterns hold for studies that focus on differences between schools\n\n(in most of the studies),116 or between students.13,39\n\nWhile there are many differences in both measurement and context, international\n\nassessments suggest substantial learning loss during initial school closures, potential\n\nongoing learning loss through the disruptions of the current school year, and unequal\n\ndistribution of learning loss.\n\nIt is possible that the investments of resources in remote learning, and teachers’\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 11\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nskill and energy adapting to it during 2020-21 has mitigated learning loss. However,\n\neven internationally, with the exception of the Ohio study,14 there is no data on\n\nhow sustained, full-time remote learning is affecting students’ academic skills. Any\n\nevidence of improved outcomes when schooling resumes19-21 is associated with inperson schooling.\n\nStudents with Disabilities and Special Education Services\n\nDisability rights organisations have declared a global “catastrophic failure” to protect\n\nthe rights of people with disabilities throughout the COVID-19 pandemic.117 Schools\n\nare one site of access to disability-related services; however, equally important to\n\nsocial and academic participation is the access gained through health, social services\n\nand recreational organizations.118 Within schools, special education comprise a set\n\nof services and practices that are locally articulated through school board policy. For\n\nthe most part, these services include teacher-led adaptations and modifications,\n\nbut also access to staffing of educational assistants, resource consultants, and\n\nother professionals for direct service to students, and support for teachers to make\n\nadaptations and modifications in their classrooms. There are very few system-wide\n\nsources of data about referral to special education,118 or about how services and\n\naccommodations are provided.119\n\nIn Canada, several studies indicate that there has been a disruption to services for\n\nstudents with disabilities and those accessing special education prior to COVID-19.120\n\nIn a rapid review up to August 2020, researchers in British Colombia noted concerns\n\nabout significant changes to services for students with disabilities, neurodiverse\n\nstudents and students with specific health care needs, with particular concern about\n\naccess to technology and adaptive equipment, and disruption in access to important\n\nlearning resources.22 An analysis of service closures in a Manitoba community suggests\n\nthat families with young children with disabilities are likely to have lost more services\n\nthan other children and families.121 One US-based survey found that the majority of\n\nfamilies with a child with an intellectual disability had lost one or more education or\n\nhealth service during COVID-19.122\n\nThere is debate about the efficacy and effects of special education in general.123–125\n\nWhether these services lead to better educational outcomes is unclear and under\n\nresearched. More widely researched is the negative effects of placement in segregated\n\nspecial education classrooms as compared to in inclusive placements.123 We know,\n\nhowever, that the implementation of special education has been altered by COVID-19.126\n\nIn a longitudinal study of family experiences with childhood disability services in\n\ncommunities across Canada, the Inclusive Early Childhood Service System (IECSS) project\n\nfound multiple sites of disruption across early years and elementary schooling. Teachers\n\nand students had less access to itinerant and specialist staff; individual planning including\n\nformal creation of and updating of Individual Education Plans were slow or not being\n\ndone at all; and waitlists for services were slowed or removed altogether (Underwood K,\n\nvan Rhijn T, Balter A, personal communication).127 The same study showed that families\n\nwith the lowest income were less likely to be accessing services from multiple sites or\n\nsystems, a situation which has been exacerbated by the COVID-19 pandemic, leaving\n\nsome families with little to no access to services (Underwood K, van Rhijn T, Balter A,\n\npersonal communication).127 The circumstances of families are important to consider\n\nsince family advocacy and engagement across all learning environments is known to be\n\nimportant to qualify for and access disability services.128\n\nFor those children who worked harder to make gains in academic and social\n\ndevelopment, learning loss is likely to be greater and recovery slower – consistent\n\nwith the outcomes of a UK assessment of 1.4 million students in 6,000 schools that\n\nwas conducted directly after the summer following spring closures, and again at the\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 12\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nend of in-person schooling in fall.19\n\nMany children with underlying health conditions are at increased risk should they\n\ncontract COVID-19, but these same students may also be losing special education\n\nservices, or appropriate education, in online environments. Some special education\n\nprograms have continued to operate in-person, even during the school closures,129\n\nbut concerns about staffing and safety for all stakeholders have been documented.130\n\nThere are no Ontario data about co-morbidities of those accessing special education\n\nservices and the degree to which they have disrupted learning for particular\n\npopulations of students. Further, there is no data on whether students will need more\n\naccess to support and disability services due to the circumstances of the COVID-19\n\npandemic. It is much easier to identify disruptions to existing services than to track\n\nwhether students are able access appropriate support, and who needs services.\n\nEnglish Language Learners\n\nIn 2019, the EQAO reported that 7% of grade 9 students,131 and 14% of grade 3\n\nstudents in Ontario are English-language learners.132\n\nA study of 18 school districts in California showed that by fall 2020, English-language\n\nlearners had fallen far behind the average student in the study – almost three times\n\nas many months behind (30% vs. 10% of a school year).15 English Language Learners\n\nare particularly affected by isolation from peers and teachers, which limits immersion\n\nand slows down learning. Adapting to remote schooling is particularly difficult in these\n\ncircumstances. English-language learners are more likely to live in poverty, which\n\nadds to stress; it is more challenging to support home learning when the language\n\nof instruction is different from the home language; home-school communication can\n\nbe more difficult; and some parents who are English language learners may also need\n\nhelp to develop digital skills to support home learning.133\n\nWhere English language learners are also newcomers, they face additional challenges:\n\nstudents and their families may experience isolation from support networks, precarious\n\ncitizenship status and navigation of often complex systems without the benefit of faceto-face interaction, which is particularly important if there are language barriers.134\n\nOpportunity to Learn: Attendance and Digital Divides\n\nAttendance is a measure of engagement in school, and the school’s ability to meet\n\nstudent needs,135 as well as a remarkably strong predictor of positive education\n\noutcomes.136–139 A recent Ontario study showed that chronic absenteeism, usually\n\ndefined as missing more than 10% of days in a school year, is more strongly\n\nassociated with students graduating and transitioning to post-secondary education\n\nthan grades, test scores, or holistic assessments of early development.135,140–142 There\n\nhave been significant successes with ambitious efforts by school boards working\n\nwith public health to decrease absenteeism.143–145 Nonetheless, missed school is a\n\ndirect effect of school closures. Further, students learning in person may miss school\n\ndue to isolation requirements.146\n\nThere are local reports suggesting increased absences during the pandemic,147 but no\n\nprovince-wide data. Many students also lost school due to delays associated with the\n\nremote schooling option, including such factors as hiring new staff after the school\n\nyear began in some regions.148,149 There are also concerns about what ‘attendance’\n\nmeans during remote schooling: are students merely turning their computers on and\n\n‘tuning out’ or ‘ghosting’ their virtual classes?150,151\n\nSince the COVID-19 pandemic began, a key concern has been the impact of an ongoing\n\n‘digital divide’,152,153 or the relative access to devices and the internet required to power\n\nthe government’s model of remote learning, with multiple hours of synchronous\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 13\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nactivities every day. The provincial government asked boards to distribute devices\n\nthey had and made a CAD 15 million investment with a goal of providing devices and/\n\nor internet to any student in need. However, there remain significant gaps.\n\nAccording to an estimate by the Ontario Ministry of Infrastructure, 12% of Ontarians had\n\neither inadequate or no broadband access in 2020.154 Pre-pandemic, 58% of households\n\nhad fewer than one device per person, and 24% of households in the lowest income\n\nquartile reported using only mobile devices to access the internet.105 Furthermore, not\n\nall families have the digital literacy skills to support a child’s remote learning.155\n\nEducational Transitions\n\nStudents’ academic trajectories are not only determined by subject-matter knowledge\n\nor test scores. Educational transitions can shape outcomes and be particularly\n\nsignificant for students who are more vulnerable or marginalized within the school\n\nsystem.156–158 Transitions are social and developmental processes that lead to new\n\nand different roles in relation to education, family and/or employment, with key roles\n\nfor peers, families, schools, and community, which also reflect and reinforce unequal\n\nsocial structures. COVID-19 has impacted social and developmental processes that\n\nundergird educational transitions, specifically transitions to early childhood education,\n\nhigh school, postsecondary education, and work.\n\nEarly years: High quality early childhood education and care (ECEC),159 as well as early\n\nintervention,160 are known to be effective in long-term developmental outcomes.161\n\nChildcare is one of many early childhood programs in Ontario. ECEC in Ontario includes\n\nfamily support, kindergarten, and nursery school, as well as early intervention in\n\nboth clinical and community settings. Most of these programs have been either\n\ninterrupted or adapted to online environments during COVID-19. In Ontario, play is\n\na key foundation of the early years and primary division curriculum,162 which reflects\n\na balance between social-emotional learning and academic skill development. Playbased learning is particularly difficult to deliver remotely, or, even face-to-face,\n\nwithout the ability to share materials.\n\nChildcare returned to operations relatively quicker than schools. However, we do not\n\nknow how many children have not entered or continued in childcare due to concerns\n\nabout COVID-19. There are no data on other forms of ECEC. A recent Canadian study\n\nindicates that in communities with higher childcare fees, families were more likely to\n\nkeep their children out of childcare during COVID-19.163\n\nThe magnitude of the toll COVID-19 has had on quality or effectiveness of the childcare\n\nyoung children have experienced since March 2020, because of the rapid reshuffling\n\nof programs and overall service levels, is unknown. It is likely that the quality of care\n\nand early learning has decreased overall while families struggled to find care or had\n\nto resort to minding their children at the same time as working from home. Publicly\n\nfunded early intervention programs have also been significantly disrupted,164 pointing\n\nto the disparity in access to a range of early years income-based services.\n\nEarly reports from some school boards in Ontario, and across the United States, suggest\n\nthere has been a considerable drop in kindergarten enrollment.165–168 Reporting in the\n\nUnited States suggests a national drop in kindergarten enrollment of 16%.169 Junior and\n\nsenior kindergarten are not mandatory in Ontario. Significant drops in the numbers\n\nof children with access to childcare, or attending kindergarten may have an impact on\n\nstudents’ development, and, potentially, long-term success.170\n\nTransitions to high school: The shift from elementary to high school is an important\n\ntransition marking increased independence of adulthood alongside social and\n\nemotional growth.168 Friends, caring adults, and positive school cultures are\n\nparticularly important in navigating these transitions. COVID-19 has deeply affected\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 14\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nthe social world of young people entering high school.\n\nAcademically, grade 9 achievement (credit accumulation plus marks) is a particularly\n\nstrong predictor of students staying ‘on track’ for graduation, and proceeding into\n\nand through post-secondary education.171 Given concerns that students have fallen\n\nbehind during the COVID-19 pandemic, it will be important to monitor whether there\n\nis renewed pressure directing students towards applied courses. These have been\n\nshown to have worse outcomes and to depress achievement, limiting students’ future\n\noptions.172–174 Although applied math has been eliminated in Ontario, effective fall\n\n2021, other academic courses will still be offered at the applied level.175\n\nGraduation and beyond: There are presently no data on how COVID-19 affects\n\nstudents’ graduation rates (87% in 2019), or on their progress into post-secondary.\n\nThe rate of post-secondary access is not published at the provincial level.\n\nFor the minority of students who enter the workforce directly, there are extensive labour\n\nforce data available from Statistics Canada on the challenges facing students who are\n\nentering the job market. Youth not attending school and a decrease in employment\n\ncontributed to historic highs in rates of those not in education, employment, or\n\ntraining (NEET), rising to 24% in April 2020, the highest in 20 years. NEET rates among\n\n20- to 24-year-olds, measured in September, October, and November 2020, were up\n\nto 3.5 percentage points higher than in January 2020. However, by December 2020,\n\nthese rates were comparable to pre-pandemic levels.176\n\nSecondary school programs designed to prove a smoother transition into the job market\n\nappear to have been profoundly affected by the COVID-19 pandemic, although data are\n\nlimited. Local reports on co-op programs point to cancellations due to business closures\n\nor health and safety requirements, while some students have gained experience with\n\n‘virtual co-op’ or work for teachers where students were unable to secure workplace\n\nexperience.177 Youth apprenticeships were suspended during the initial lockdown period.\n\nPrograms designed to give students early exposure to post-secondary learning, such as\n\ndual-credit courses, had to be negotiated on a course-by-course basis, and hands-on\n\nprogram offerings were limited. Publicly supported paid work or volunteer experiences,\n\nwhich build skills, contribute to students’ social capital, and can contribute to meeting\n\nstudents’ basic needs, did not materialize at a large scale.\n\nAccess to support services, such as guidance counsellors, to assist in the process of\n\napplying for post-secondary may have been compromised by both remote learning\n\nand adapted schedules in high school, particularly for students who may have needed\n\nextra support and encouragement.178 Students who were undecided about postsecondary may have been less likely to apply, given the end of the free tuition program\n\nfor low-income families and the harsher economic climate. Provincial data from the\n\nOntario Universities Application Centre shows that overall university applications were\n\nup in 2020,179 a trend that differs from the United States.180 Province-wide college\n\napplications data, which typically includes more students facing greater barriers,\n\nare not yet available; although in the initial COVID-19 period, there was a twentypercent decline in students’ intention to attend post-secondary in the fall.181 US data\n\nshows significant declines in students applying to two-year college programs, with\n\nparticularly large drops among Native American, Asian and Latinx students.180\n\nImpact of School Closures on Overall Well-being\n\nEducation is a central determinant of health and well-being.23 While the emphasis has\n\nbeen on the immediate student health and safety in light of COVID-19, motivating\n\nschool closures and shifts to remote learning, there are nonetheless, a range of\n\nadverse health effects associated with those changes.\n\nA rapid review by Public Health Ontario, capturing evidence up to June 2020 on the\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 15\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\neffects of community health measures on children and families found a number of\n\nnegative impacts of school closures on children and youth:24\n\nƒ\n\n\n\nLoss of access to free or low-cost meals provided by schools can lead to lack of\n\nadequate nutrition. During COVID-19, the rate of Canadian families reporting food\n\ninsecurity increased to 14.6% from 10.5%.76 Some schools were able to redirect\n\nfood program funds into support for families at home but there was not a province-wide approach.\n\n\n\nƒ\n\n\n\nLack of access to school-based healthcare services in Ontario is of concern. Many\n\nimportant services are sought via this mode including initial assessments, system\n\nnavigation and access to information and referrals. This is in addition to losing access to the myriad of service providers themselves, which in turn may pose a risk\n\nfor children’s physical and mental health.\n\n\n\nƒ\n\n\n\nSchools provide an environment for children with routine and structure where\n\nthey can work on their ability to socialize, do physical activities, and participate in\n\nenriching extra-curricular activities. This disruption can have a significant impact\n\non their emotional and mental wellbeing.\n\n\n\nThe British Columbia Centre for Disease Control identified concerns associated with\n\ndecreased ‘school connectedness’. School connectedness is associated with a number\n\nof major positive impacts on well-being: “higher self-esteem and life satisfaction, lower\n\nrates of substance use and violence, participation in fewer risk-taking behaviours,\n\nincreased likelihood of completing secondary school, and greater feelings of positive\n\nmental health.”22 School closures may trigger social isolation and loneliness for\n\nchildren and youth, which is associated with emerging mental health challenges.25\n\nData from People for Education show the vast majority of schools offered no sports,\n\nclubs and co-curricular activities at elementary and secondary levels in 2020-21,\n\neven where in-person schooling continued, compared to 90% of schools offering\n\nthese broader opportunities in previous years.182 There is a strong body of literature\n\nassociating these activities with social emotional skill development, more physical\n\nactivity, and higher levels of engagement in school.26–28\n\nA number of pieces of evidence suggest adverse health impacts on children during\n\nCOVID-19, although not directly linked to school disruption. Cross-sectional survey\n\nevidence shows a decline during the lockdowns in children’s levels of physical activity.29\n\nSimilarly, heightened mental health challenges have been identified among children\n\nduring the COVID-19 pandemic.30 Youth, aged 15-24 years, saw the greatest declines\n\nin self-reported mental health of any age group.31 The percentage of young people\n\nwho reported their mental health was excellent or very good dropped from 60% to\n\n40% between March 2019 and July 2020.31 Other concerns include extensive screen\n\ntime and a lack of outdoor play.32\n\nA Canadian study of 2,100 youth-parent pairs found that students reported changed\n\nbehaviours associated with school closures.33 Most youth were found to be spending\n\nless time on homework, sleeping more than before, and almost half find school less\n\ninteresting than before COVID-19. Multiple research projects into school-related\n\npandemic effects on physical and mental health, health behaviours, and healthrelated service disruptions in Ontario are underway, but results are not yet published\n\n(Georgiades K, Leatherdale S, Tremblay M, personal communication).\n\nSchools are an essential element of systems in place to prevent, detect and respond\n\nto child maltreatment.34 School closures related to the COVID-19 pandemic may\n\nincrementally increase risks of maltreatment by increasing social isolation of children,\n\nyouth and caregivers, and by creating a need for care during the day that may be\n\nparticularly challenging for parents among low socioeconomic groups, who are\n\noverrepresented in the child welfare system.35\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 16\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nPre-pandemic, school personnel were the largest group of those who reported\n\nsuspected cases of abuse and neglect.36 COVID-19-linked school closures have been\n\nshown to be correlated with decreased reporting.183,184 Remote schooling, especially if\n\nstudents’ cameras are off, may reduce opportunity for educators to observe risks, or\n\nto provide practical supports and relationships to promote resilience.\n\nAt the same time, UNICEF warns that increased time spent online due to isolation,\n\nschool closures, and stay at home orders may also put children at heightened risk of\n\nsusceptibility to predatory online behavior such as sexual exploitation, cyberbullying,\n\nonline risk-taking behavior, exposure to potentially harmful content (e.g., violent\n\ncontent, misinformation about COVID-19, targeted marketing), and inappropriate\n\ncollection, use and sharing of data.37\n\nEconomic Cost of School Closures and Learning Disruptions\n\nEconomic Cost of Learning Loss for School-aged Children\n\nEducation and the development of skills have significant economic value, and an\n\nestablished, strong relationship exists between skills gained in school and future labour\n\nmarket wages and opportunities.185–189 Therefore, it is important to understand the\n\nextent to which learning loss associated with education disruption in Ontario during the\n\nCOVID-19 pandemic may affect children’s labour market outcomes as an adults.\n\nWhile there is a paucity of evidence in the context of COVID-19 given the\n\nunprecedented nature of the pandemic, there is substantial evidence on the effects of\n\nschool disruptions and learning loss on individuals in other contexts. The international\n\nevidence reviewed in this brief points to a clear pattern showing that, even as early\n\nas fall 2020, on average, students in the US, the UK, Belgium, and the Netherlands\n\nhad experienced significant learning loss associated with education disruption during\n\nCOVID-19. Further, all studies found that learning losses were unequally distributed,\n\nand disadvantaged students tend to experience greater gaps.\n\nWe have direct evidence of the consequences of school disruptions in Ontario by\n\nexamining the impact of previous teacher strikes on learning loss.190 In particular,\n\n“long” strikes (10+ teaching days) in length, negatively affected math and reading\n\nby between 0.20-0.33 standard deviations of test scores. To put these numbers into\n\ncontext, in Canada, a one standard deviation decrease in numeracy skills is associated\n\nwith a wage gap in adulthood between 20-30%.191 While teacher strike disruptions are\n\nnot directly comparable to the disruption caused by COVID-19, this evidence illustrates\n\nthat even schooling disruptions at a smaller scale can have large measurable effects\n\non learning loss in Ontario.\n\nFor context, it is estimated that the that an additional year of schooling increases\n\nlifetime earnings by approximately 11 to 12% in Canada.189,192 Assuming that decreasing\n\na student’s level of education by one school year decreases lifetime earnings in a\n\nsimilar manner, the school closures associated with the COVID-19 pandemic, which\n\naffect the total amount of schooling children receive, will have lifelong negative effects\n\non students’ earnings. This relationship implies that if students receive 10 months of\n\ninstruction per year and each year of instruction provides the same return, a student’s\n\nlifetime earnings could decrease 1.1–1.2% per month of complete learning loss with\n\nno remediation. This simple calculation assumes that each year of education (primary\n\nand secondary) are equivalent.\n\nUsing more conservative estimates, a recent study mapped COVID-19 lost learning to\n\nthe reduction of earnings.193 They estimated that, in high-income countries, such as\n\nCanada, the present value lifetime loss in earnings at the individual level is 21,372 USD.\n\nWhile predicting the specific impact of COVID-19 in Ontario associated with school\n\nclosures in terms of earnings and income based on historical data is challenging due\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 17\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nto the unprecedented global mass disruption, the established link between skills\n\nand later labour market opportunities is strong and consistent in the economics of\n\neducation literature. This relationship is expected to disadvantage children affected\n\nby the COVID-19 pandemic.\n\nEffect on Economic Growth\n\nSkills and knowledge of a population directly impacts labour productivity and\n\ninnovation which in turn effects economic growth. Skill losses due to school closures\n\ndue to COVID-19 will impact the Canadian economy through labour productivity and\n\nloss of innovation. Without remediation, this impact may be felt for a very long time.\n\nResearchers estimated a total long-term GDP loss of approximately CAD 1.6 trillion for\n\nCanadian student cohorts affected by the spring 2020 school closures and associated\n\nskills loss, assuming that gaps do not continue to grow after school resumes.38 To put\n\nthese numbers into perspective, the entire GDP of Canada was CAD 1.6 trillion in 2019.\n\nAnother recent study, estimates losses of about 4 to 9 percent over the effected\n\ncohort’s lifetime as the percentage of current year GDP.193 This translates to an annual\n\nloss in national income growth of 0.5 percent per year. It is important to note that these\n\nestimates do not consider the impact of lost early childhood education opportunities.\n\nEffect on Female Labour Force Participation\n\nCOVID-19 is having an increasingly large economic impact on women, in part, due to\n\nclosures of schools and childcare centres which have shifted additional hours of unpaid\n\nfamily care to parents, and disproportionately on mothers.194 In addition, racialized\n\nCanadians were twice as likely as white Canadians to stop looking for paid work or\n\nreduce time spent on paid work as a result of increased domestic responsibilities.195\n\nNew evidence from Canada uses the geographical pattern of primary school reopenings during COVID-19 to estimate the impact of school re-openings on parental\n\nemployment and found positive impacts of school re-openings on employment and\n\nhours worked.196\n\nFemale labour force participation is associated with economic growth.197 Using data\n\nfrom Canadian provinces, Petersson et al. estimated that real GDP would increase\n\nby 4% if the labour force participation gap between men and women with high\n\neducational attainment was eliminated.198 Unfortunately, the opposite effect is\n\noccurring, and women in Canada continue to exit the labour force, which will, in turn,\n\nnegatively affect GDP moving forward.199\n\nData Gaps and Needs\n\nThis review on the education impacts of COVID-related disruptions highlights preexisting challenges with the data infrastructure for education in Ontario. More than\n\na year into the COVID-19 pandemic, there are very little data on key processes or\n\noutcomes of pandemic schooling, at either the board or provincial level.\n\nInternational best practices suggest localized strategies are preferable to system-wide\n\nshut-down, as they promote maximum continuity.200,201 However, they will inevitably\n\nresult in different groups of students experiencing different levels of disruption,\n\nand, likely, require different levels of support educationally and in the broader social\n\nservice sector. Accordingly, this strategy requires careful data collection on schools and\n\nstudents that are directly affected, and ongoing monitoring of learning. The context of\n\nthe COVID-19 pandemic highlights the extent to which key education data, important\n\nfor strategic planning and resource allocation decisions, are not available in a timely\n\nor transparent way.\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 18\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nData Gaps\n\nThis review highlights gaps in baseline data required to understand how the school\n\nsystem has responded in a time of unprecedented crisis, and on the short and longterm effects on students’ well-being and progress. To collect relevant education data,\n\nthe UNESCO Institute for Statistics suggests:\n\n1. rapid data collection formats focusing on key indicators, sampling schools and\n\nstudents rather than the full population;  \n\n2. monitoring equity by over-representing vulnerable students (e.g., girls, students\n\nin poverty, students with disabilities or accessing special education services,\n\nminority or linguistic groups);  \n\n3. frequent and low-stakes learning measurement.202\n\nThis type of system-level monitoring is not underway at the provincial level in Ontario.\n\nSome key questions for understanding system responses and education effects in\n\nOntario include:\n\nƒ\n\n\n\nHow many days of face-to-face instruction have been missed in 2021, across all\n\nmodels?\n\n\n\nƒ\n\n\n\nWhat percentage of Ontario students are learning remotely? How has that percentage changed over time? Under what conditions? What are the demographic\n\ncharacteristics of those students?\n\n\n\nƒ\n\n\n\nHave there been major changes in attendance and enrollment in Ontario schools?\n\n\n\nƒ\n\n\n\nRelative to earlier years, how have Ontario students’ learning outcomes been affected by COVID-19 and related policy responses? Do those outcomes vary by\n\nschooling model, and if so, how and for whom?\n\n\n\nƒ\n\n\n\nHow has the COVID-19 pandemic affected key indicators of educational equity?83\n\nThe U.S. National Academies of Science have identified the following key measures of equitable outcomes and opportunities: Students’ engagement in school,\n\nperformance on tests and coursework, on-time graduation and post-secondary\n\npreparedness, access to rigorous curriculum and academic breadth, access to\n\nhigh quality supports, and access to non-segregated learning environments.\n\n\n\nOn this point, only three school boards in Ontario (Durham District School Board,\n\nGrand Erie District School Board, Toronto District School Board) have published data\n\ndisaggregated by race, Indigeneity, gender identity, etc. Disaggregated data are key to\n\nunderstanding equity in opportunities and outcomes.\n\nƒ\n\n\n\nIf there are significant inequalities of outcome, where is the need for support\n\nthe greatest? What supports are being employed, and where? Are they helping\n\nstudents?\n\n\n\nƒ\n\n\n\nAre students with disabilities able to access the special education services to\n\nwhich they are entitled under the Education Act? Are they being fully included\n\nand accommodated under COVID-related learning conditions?\n\n\n\nIt is critical that analyses are conducted on the comparative experiences and effects of\n\nthe various models instituted to different degrees for education continuity in Ontario,\n\nvirtual schools vs. in-person learning; hybrid models vs. purely online delivery;\n\nand the impact of condensed semesters in secondary. Any such analysis requires\n\ndata collection on both educational opportunities and outcomes in a systematic,\n\ncomparable way and over time.\n\nMinimizing the Impact of COVID-19 on Education\n\nEducation and schooling has been called ‘children’s essential work’.203 Emerging\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 19\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nmodels to balance COVID-19 mitigation with educational continuity suggest, where\n\npossible, that phased and localised approaches to school closures and reopening\n\nwith appropriate mitigation strategies are preferable to blanket systems-wide\n\nshutdowns.204,205 They reduce the number of students directly affected by welldocumented harms associated with mass school closures.206 However, they are not\n\nwithout their challenges.\n\nGlobal best practices suggest localised closures should be part of clear, crisis-sensitive\n\neducation planning, and best take place in the context of longer-term strategy for\n\neducation recovery.200,201 Clear-crisis sensitive education planning requires sufficient\n\nlead time to minimize disruption.\n\nAdopting localised strategies necessarily means that the length and nature of school\n\ndisruption will be variable. Segments of the school population will experience greater\n\neducation disruption than others. This variability has implications for the extent\n\nof potential education and social harms associated with the closures, for the need\n\nfor educational responses, and for data collection requirements to inform tailored\n\nresponses and evaluate the impact of interventions.\n\nThere are two key strategies to minimize the impact of COVID-related disruptions\n\non schooling.\n\nFirst, a strong priority, as expressed by numerous Medical Officers of Health, on keeping\n\nschools open wherever circumstances allow – a ‘last closed, first open’ policy, based\n\non local conditions rather than a systemwide shut-down. Keeping schools open in\n\nthe context of new, more transmissible and more deadly variants of concern requires\n\nrenewed and intensified commitment to a range of safety practices and accelerated\n\nvaccination of all education workers, parents and children as vaccines are shown to\n\nbe safe and effective.\n\nSecond, major international organisations, such as the World Bank, UNESCO, and the\n\nG20, of which Canada is a constituent, have called for explicit education recovery\n\nstrategies, and for these strategies to be funded in addition to regular schooling\n\nbudgets. Strategies may include active measures to ensure appropriate universal\n\nresponses (overall curriculum adaptations, instruction, and student supports), and\n\ntargeted intensive accelerated learning programs for groups that have been most\n\ndisadvantaged by health and education effects of COVID-19. Internationally, there\n\nare numerous initiatives underway to identify effective approaches and to scale\n\nthem.207,208 These activities fall outside the scope of this review.\n\nThere are major efforts and funding commitments in place in other OECD countries:209\n\nƒ\n\n\n\nThe government of the Netherlands committed USD 278 million to provide extra\n\nacademic support due to COVID-19 in June 2020.210 (2.5 million students)\n\n\n\nƒ\n\n\n\nThe English Government has committed £1 billion for educational “catch up” in\n\nthe wake of the first reports on learning loss, including the creation of a £350\n\nmillion tutoring fund where schools with demonstrated need could contract with\n\nqualified providers.211 (11.7 million students)\n\n\n\nƒ\n\n\n\nThe recent US stimulus package included a commitment of USD 22 billion,\n\nequivalent to 20 days of extra schooling, to support learning recovery.212,213 (56.6\n\nmillion students)\n\n\n\nEstablishing large-scale initiatives such as tutoring, summer school, or extended hours\n\nprograms alongside tailored support for students with disabilities or official language\n\nlearners requires both financial investment and planning.\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 20\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nInterpretation\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nIt is critically important that all stakeholders understand and respond to the\n\ndifferentiated educational impacts of these disruptions, which will be an ongoing\n\nchallenge. The social and economic costs of education disruption in Ontario are\n\npotentially devastating, and as evidence shows, can far outlive the immediate period\n\nof the COVID-19 pandemic.\n\n\n\nAuthor Contributions\n\nKGM and BS conceived the Science Brief. KGM, PS, KU, ED, and LMC wrote the first draft\n\nof the Science Brief. KB, AM, AP performed the analyses. All authors revised the Science\n\nBrief critically for important intellectual content and approved the final version.\n\nThe authors would like to thank Lisa Hawke, Sarah Oates, Peter J. Taylor, Norm Di\n\nPasquale and Nisha Thampi for their contribution to this Science Brief.\n\n\n\nReferences\n\n1. Government of Ontario. Education Facts, 2019-2020* (Preliminary). Published\n\n2021. http://www.edu.gov.on.ca/eng/educationfacts.html\n\n2. Government of Ontario. Education Act, R.S.O. 1990, c. E.2. Published April 19,\n\n2021. https://www.ontario.ca/laws/statute/90e02\n\n3. Engzell P, Frey A, Verhagen MD. 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J Educ Finance. 2006;32(2):113-136. http://www.heart-resources.\n\norg/wp-content/uploads/2015/10/0-psacharopoulos-value-of-investing-ineducation.pdf\n\n189.\n\nPsacharopoulos G, Patrinos HA. Returns to investment in education: a\n\ndecennial review of the global literature. Educ Econ. 2018;26(5):445-458. https://\n\ndoi.org/10.1080/09645292.2018.1484426\n\n190.\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nBaker M. Industrial actions in schools: strikes and student achievement.\n\nJune 4, 2021 | 34\n\n\n\n\fOntario COVID-19 Science Advisory Table\n\n\n\nCOVID-19 and Education Disruption in Ontario: Emerging Evidence on Impacts\n\n\n\nCan J Econ Can Déconomique. 2013;46(3):1014-1036. https://doi.org/10.1111/\n\ncaje.12035\n\n191.\n\nHampf F, Wiederhold S, Woessmann L. Skills, earnings, and employment:\n\nexploring causality in the estimation of returns to skills. 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Accessed May 28, 2021. https://www.edcan.ca/articles/learning-ourway-out-of-the-pandemic/\n\n210.\n\nCatch-up programmes to repair learning loss in the Netherlands: interventions\n\nand literature review of effectiveness. Research Institute LEARN! Published\n\nAugust 27, 2020. Accessed May 28, 2021. https://www.researchinstitutelearn.\n\nnl/en/professionals-en/catch-up-programmes-repair-learning-loss-netherlandsoverview-interventions-literature-review-of-effectiveness/\n\n211.\n\nDepartment for Education. Catch-up premium. GOV.UK. Published April 27,\n\n2021. Accessed May 28, 2021. https://www.gov.uk/government/publications/\n\ncatch-up-premium-coronavirus-covid-19/catch-up-premium\n\n212.\n\nYarmuth JA. Text - H.R.1319 - 117th Congress (2021-2022): American Rescue\n\nPlan Act of 2021. Published November 3, 2021. Accessed May 28, 2021. https://\n\nwww.congress.gov/bill/117th-congress/house-bill/1319/text\n\n213.\n\nNierenberg A, Taylor K. How Can Schools Use $129 Billion in Covid Relief\n\nFunds? The New York Times. Published March 24, 2021. Accessed May 28, 2021.\n\nhttps://www.nytimes.com/2021/03/24/us/covid-schools-federal-funding.html\n\n\n\nScience Briefs | www.covid19-sciencetable.ca/science-briefs\n\n\n\nJune 4, 2021 | 36\n\n\n\n\f",
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              "question": "Did national alcohol sales increase in Canada during COVID-19 compared to before COVID-19?",
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                  "answer_id": 279573,
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                  "question_id": 283916,
                  "text": "In this economic evaluation, mean monthly national retail sales of alcohol, with notable stockpiling,\n\nexhibited a monthly increase of 5.5%",
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          "context": "Research Letter | Psychiatry\n\n\n\nNational Retail Sales of Alcohol and Cannabis During the COVID-19 Pandemic\n\nin Canada\n\nJames MacKillop, PhD; Alysha Cooper, MSc; Jean Costello, PhD\n\n\n\nIntroduction\n\n\n\nAuthor affiliations and article information are\n\nlisted at the end of this article.\n\n\n\nThere is concern that the societal consequences of the COVID-19 pandemic will be associated with\n\nincreased substance use.1 Data to date have primarily been self-reported changes, but objective sales\n\ndata may inform this question. Here, we examined national retail sales of alcohol and cannabis prior\n\nto and during the pandemic in Canada.\n\n\n\nMethods\n\nWhere applicable, the report for this economic evaluation is consistent with the Consolidated Health\n\nEconomic Evaluation Reporting Standards (CHEERS) reporting guideline. The Hamilton Integrated\n\nResearch Ethics Board determined that ethical review board approval and informed consent were\n\nnot needed because the data were publicly available sales metrics. The data were seasonally\n\nadjusted national monthly retail sales (ie, North American Industry Classification System codes\n\n4453, for beer, wine, and liquor stores, and 453993, for cannabis stores) from November 2018 to\n\nJune 2021 in Canadian dollars.2 The period was selected to provide a sizable prepandemic window\n\nand because of the timing of cannabis legalization (ie, mid-October 2018). Principal analyses were\n\ncontrasts between intrapandemic sales and a counterfactual intrapandemic linear trend based on\n\nprepandemic sales. A subanalysis quantified stockpiling, operationalized as the proportionate\n\nchange in March 2020, when states of emergency were declared, compared with the counterfactual\n\nestimate. Because the data were population level, null hypothesis significance testing was a\n\nsecondary priority, but overall differences and intrapandemic trends in poststockpiling data were\n\nexamined statistically using analysis of variance (ANOVA) and segmented regression, respectively.\n\nSignificance tests used P < .05 and were 2-sided, and analyses were conducted from May to August\n\n2021 using Excel version 2019 (Microsoft), SPSS statistical software version 26.0 (IBM), and R\n\nstatistical software version 4.1.1 (R Project for Statistical Computing).\n\n\n\nResults\n\nMean (SD) monthly prepandemic alcohol sales were $2.02 billion ($26.24 million), exhibiting a\n\npositive slope of $4.45 million/month (Figure 1). Putative stockpiling in March 2020 was an increase\n\nof $330 million (15.97%) from the counterfactual estimate of $2.06 billion. Intrapandemic\n\npoststockpiling alcohol national monthly sales were $2.09 billion in April 2020 and $2.29 billion in\n\nJune 2021. Mean (SD) monthly intrapandemic alcohol sales during the intra–COVID-19 period were\n\n$2.214 billion ($87 million), which was an increase of $116 million (5.54%) vs the mean (SD)\n\ncounterfactual estimate of $2.098 billion ($21 million), reflecting an increase of $1.86 billion over the\n\n16-month period. Based on ANOVA, mean monthly prepandemic sales were statistically significantly\n\nlower than intrapandemic sales ($2.02 billion; 95% CI, $1.99-$2.06 billion vs $2.21 billion; 95% CI,\n\n$2.18-$2.25 billion; P < .001). In segmented regression, there was an increasing trend in the\n\ntime × COVID-19 interaction (B = 7.78; standard error [SE] = 3.07; P = .02) (Figure 1).\n\n\n\nOpen Access. This is an open access article distributed under the terms of the CC-BY License.\n\nJAMA Network Open. 2021;4(11):e2133076. doi:10.1001/jamanetworkopen.2021.33076 (Reprinted)\n\n\n\nDownloaded From: https://jamanetwork.com/ on 01/21/2022\n\n\n\nNovember 4, 2021\n\n\n\n1/4\n\n\n\n\fJAMA Network Open | Psychiatry\n\n\n\nCanadian Retail Sales of Alcohol and Cannabis During the COVID-19 Pandemic\n\n\n\nMonthly prepandemic cannabis sales exhibited an increase (Figure 2), from $55.40 million in\n\nNovember 2018 to $150.75 million in February 2020 (slope, $6.36 million/month), associated with\n\nthe expanding legal marketplace. Stockpiling was estimated at an increase of $23.59 million (15.02%)\n\ngreater than the counterfactual estimate of $157.10 million. Mean (SD) monthly intrapandemic\n\ncannabis sales were $255.51 million ($47.71 million), which was 24.78% greater than the mean (SD)\n\ncounterfactual estimate of $204.78 million ($30.26 million) and reflected an increase of $811.74\n\nmillion over the 16-month period. The difference in mean monthly prepandemic sales ($100.58\n\nmillion [95% CI, $78.56-$122.61 million]) vs intrapandemic sales ($255.51 million [95% CI, $233.48$277.54 million]) was significant (P < .001) but uninformative because of the steep postlegalization\n\nslope. In segmented regression, there was no statistically significant increasing trend (B = 1.82;\n\nSE = 1.43; P = .22) Figure 2).\n\n\n\nDiscussion\n\nIn this economic evaluation, mean monthly national retail sales of alcohol, with notable stockpiling,\n\nexhibited a monthly increase of 5.5% vs the counterfactual estimate during the intrapandemic\n\nperiod. For cannabis, although stockpiling was similar, the general intrapandemic increase in mean\n\nmonthly sales vs the counterfactual estimate was substantially higher, approaching 25%.\n\n\n\nFigure 1. National Alcohol Retail Sales 16 Months Prior to and During the First 16 Months of the COVID-19 Pandemic in Canada\n\nA Prepandemic and intrapandemic alcohol sales\n\n\n\nNational alcohol retail sales, million CAD$\n\n\n\n3000\n\nCounterfactual slope\n\n\n\nStockpiling = 15.97%\n\n\n\nPrepandemic sales\n\n\n\n2500\n\n\n\nIntrapandemic sales\n\n2000\n\n\n\n1500\n\n\n\n1000\n\n\n\n500\n\n\n\n0\n\nNov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun\n\n\n\n2018\n\n\n\n2019\n\n\n\n2020\n\n\n\n2021\n\n\n\nMonth and year\n\nB\n\n\n\nSegmented regression\n\n\n\nNational alcohol retail sales, million CAD$\n\n\n\n3000\n\nIntra—COVID-19 trend\n\nCounterfactual trend\n\n\n\n2500\n\n\n\n2000\n\n\n\n1500\n\n\n\n1000\n\n\n\n500\n\n\n\n0\n\nNov\n\n2018\n\n\n\nApr\n\n2019\n\n\n\nSep\n\n2019\n\n\n\nFeb\n\n2020\n\n\n\nJul\n\n2020\n\n\n\nNov\n\n2020\n\n\n\nApr\n\n2021\n\n\n\nMonth and year\n\n\n\nA, Dark blue bars indicate prepandemic alcohol sales; light blue bars, intrapandemic alcohol sales; orange line, linear counterfactual trend. B, Circles indicate monthly sales; solid line,\n\nintrapandemic trend; dashed line, counterfactual trend; shaded area, COVID-19 period.\n\nJAMA Network Open. 2021;4(11):e2133076. doi:10.1001/jamanetworkopen.2021.33076 (Reprinted)\n\n\n\nDownloaded From: https://jamanetwork.com/ on 01/21/2022\n\n\n\nNovember 4, 2021\n\n\n\n2/4\n\n\n\n\fJAMA Network Open | Psychiatry\n\n\n\nCanadian Retail Sales of Alcohol and Cannabis During the COVID-19 Pandemic\n\n\n\nInterestingly, these results converge with a national study of self-reported pandemic-associated\n\nchanges that found a similar dissociation between alcohol and cannabis.3\n\nThe public health and clinical significance of these changes cannot be directly inferred. National\n\nretail sales cannot be directly converted into person-level expenditures, consumption behavior, or,\n\nmore importantly, the extent to which individuals transition to higher-risk levels of use. Additionally,\n\nsome subpopulations have reported decreases in alcohol involvement during the pandemic,4 and\n\naggregate sales necessarily conflate increases, decreases, and stable patterns. A limitation of this\n\nstudy is that these macroeconomic indicators represent large proportions of the market but not its\n\nentirety (eg, illegal sales and alcohol sold through ferment-on-premises operations). This is\n\nparticularly significant for cannabis, for which a large contraband market remains,5 and it is possible\n\nthat the pandemic pushed consumers from illegal terrestrial purchasing to legal online purchasing.\n\nThese results nonetheless offer one of the first national perspectives on changes in alcohol and\n\ncannabis use during the COVID-19 pandemic. Whether similar patterns are present in other nations\n\nis an open question, but these findings suggest the value of sales data as a strategy to characterize\n\nthe pandemic’s associations with substance use.\n\n\n\nFigure 2. National Cannabis Retail Sales 16 Months Prior to and During the First 16 Months of the COVID-19 Pandemic in Canada\n\nA Prepandemic and intrapandemic cannabis sales\n\n\n\nNational cannabis retail sales, million CAD$\n\n\n\n350\n\nCounterfactual slope\n\nPrepandemic sales\n\n\n\n300\n\n\n\nIntrapandemic sales\n\n250\n\n\n\nStockpiling = 15.02%\n\n200\n\n150\n\n100\n\n50\n\n0\n\nNov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun\n\n\n\n2018\n\n\n\n2019\n\n\n\n2020\n\n\n\n2021\n\n\n\nMonth and year\n\nB\n\n\n\nSegmented regression\n\n\n\nNational cannabis retail sales, million CAD$\n\n\n\n400\n\nIntra—COVID-19 trend\n\nCounterfactual trend\n\n300\n\n\n\n200\n\n\n\n100\n\n\n\n0\n\nNov\n\n2018\n\n\n\nApr\n\n2019\n\n\n\nSep\n\n2019\n\n\n\nFeb\n\n2020\n\n\n\nJul\n\n2020\n\n\n\nNov\n\n2020\n\n\n\nApr\n\n2021\n\n\n\nMonth and year\n\n\n\nA, Dark blue bars indicate prepandemic cannabis sales; light blue bars, intrapandemic cannabis sales; orange line, linear counterfactual trend. B, Circles indicate monthly sales; solid\n\nline, intrapandemic trend; dashed line, counterfactual trend; shaded area, COVID-19 period.\n\nJAMA Network Open. 2021;4(11):e2133076. doi:10.1001/jamanetworkopen.2021.33076 (Reprinted)\n\n\n\nDownloaded From: https://jamanetwork.com/ on 01/21/2022\n\n\n\nNovember 4, 2021\n\n\n\n3/4\n\n\n\n\fJAMA Network Open | Psychiatry\n\n\n\nCanadian Retail Sales of Alcohol and Cannabis During the COVID-19 Pandemic\n\n\n\nARTICLE INFORMATION\n\nAccepted for Publication: August 31, 2021.\n\nPublished: November 4, 2021. doi:10.1001/jamanetworkopen.2021.33076\n\nOpen Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 MacKillop J\n\net al. JAMA Network Open.\n\nCorresponding Author: James MacKillop, PhD, Peter Boris Centre for Addictions Research, St Joseph’s Healthcare\n\nHamilton/McMaster University, 100 W Fifth St, Hamilton, ON L8N 3K7, Canada (jmackill@mcmaster.ca).\n\nAuthor Affiliations: Peter Boris Centre for Addictions Research, St Joseph's Healthcare Hamilton/McMaster\n\nUniversity, Hamilton, Ontario, Canada (MacKillop); Michael G. DeGroote Centre for Medicinal Cannabis Research,\n\nMcMaster University/St Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada (MacKillop); Homewood\n\nResearch Institute, Guelph, Ontario (MacKillop, Cooper, Costello).\n\nAuthor Contributions: Dr MacKillop and Ms Cooper had full access to all of the data in the study and take\n\nresponsibility for the integrity of the data and the accuracy of the data analysis.\n\nConcept and design: MacKillop.\n\nAcquisition, analysis, or interpretation of data: All authors.\n\nDrafting of the manuscript: MacKillop, Cooper.\n\nCritical revision of the manuscript for important intellectual content: MacKillop, Costello.\n\nStatistical analysis: All authors.\n\nAdministrative, technical, or material support: MacKillop.\n\nSupervision: MacKillop.\n\nConflict of Interest Disclosures: Dr MacKillop reported serving as principal and senior scientist at Beam\n\nDiagnostics and receiving consulting fees from Clairvoyant Therapeutics outside the submitted work. No other\n\ndisclosures were reported.\n\nFunding/Support: This work was supported by the Peter Boris Chair in Addictions Research and Homewood\n\nResearch Institute, an independent charitable organization funded through a variety of sources, including\n\nHomewood Health, community stakeholders, corporations, and private foundations.\n\nRole of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection,\n\nmanagement, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and\n\ndecision to submit the manuscript for publication.\n\nAdditional Contributions: Kyla Belisario, MA (Peter Boris Centre for Addictions Research, St Joseph's Healthcare\n\nHamilton/McMaster University), provided insights on an earlier data set and was not compensated for this work.\n\nREFERENCES\n\n1. Clay JM, Parker MO. Alcohol use and misuse during the COVID-19 pandemic: a potential public health crisis?\n\nLancet Public Health. 2020;5(5):e259. doi:10.1016/S2468-2667(20)30088-8\n\n2. Statistics Canada. Retail trade sales by industry (x1,000). Accessed August 23, 2021. https://www150.statcan.gc.\n\nca/t1/tbl1/en/tv.action?pid=2010000802\n\n3. Imtiaz S, Wells S, Rehm J, et al. Cannabis use during the COVID-19 pandemic in Canada: a repeated crosssectional study. J Addict Med. Published online December 14, 2020. doi:10.1097/ADM.0000000000000798\n\n4. Minhas M, Belisario K, González-Roz A, Halladay J, Murphy JG, MacKillop J. COVID-19 impacts on drinking and\n\nmental health in emerging adults: longitudinal changes and moderation by economic disruption and sex. Alcohol\n\nClin Exp Res. 2021;45(7):1448-1457. doi:10.1111/acer.14624\n\n5. Ontario Cannabis Store. A year in review: April 1, 2020-March 31, 2021. Accessed June 12, 2021. https://cdn.shopify.\n\ncom/s/files/1/2636/1928/files/OCS-InsightsReport_____2020-21.pdf?v=1625075546\n\n\n\nJAMA Network Open. 2021;4(11):e2133076. doi:10.1001/jamanetworkopen.2021.33076 (Reprinted)\n\n\n\nDownloaded From: https://jamanetwork.com/ on 01/21/2022\n\n\n\nNovember 4, 2021\n\n\n\n4/4\n\n\n\n\f",
          "document_id": 455835
        }
      ]
    },
    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "What is \"long-COVID\"?\n\n",
              "id": 283934,
              "answers": [
                {
                  "answer_id": 279590,
                  "document_id": 455837,
                  "question_id": 283934,
                  "text": "\"Long-COVID,\" also referred to as post-COVID conditions, post-COVID syndrome, or postacute sequelae of SARS-CoV-2 infection (PASC), generally refers to symptoms that develop during or after acute COVID-19 illness, continue for ≥2 months (ie, 3 months from symptom onset), and are not explained by an alternative diagnosis. It is not yet known whether \"long-COVID\" represents a new syndrome unique to COVID-19 or overlaps with recovery from similar illnesses. (See \"COVID-19: Evaluation and management of adults following acute viral illness\", section on 'Terminology and stages of recovery'.)\n\nPersistent physical symptoms following acute COVID-19 are common and typically include fatigue, dyspnea, chest pain, and cough. Headache, joint pain, dysgeusia, myalgias, and diarrhea have also been reported. Common psychological and cognitive symptoms include poor concentration, insomnia, anxiety, and depression. The time to symptom resolution depends primarily on premorbid risk factors, the severity of the acute illness, and the spectrum of initial symptoms. However, prolonged symptoms are common even in patients with less severe disease who were never hospitalized. (See \"COVID-19: Evaluation and management of adults following acute viral illness\", section on 'Expected recovery time course'.)",
                  "answer_start": 12893,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the recommendations for someone who has symptoms of COVID-19?",
              "id": 279126,
              "answers": [
                {
                  "answer_id": 279588,
                  "document_id": 455837,
                  "question_id": 279126,
                  "text": "inflammatory ",
                  "answer_start": 11617,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How is SARS-CoV-2 (the virus that causes COVID-19) transmitted?\n\n",
              "id": 283924,
              "answers": [
                {
                  "answer_id": 279574,
                  "document_id": 455837,
                  "question_id": 283924,
                  "text": "Direct person-to-person respiratory transmission is the primary means of transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is thought to occur mainly through close-range contact (ie, within approximately six feet or two meters) via respiratory particles; virus released in the respiratory secretions when a person with infection coughs, sneezes, or talks can infect another person if it is inhaled or makes direct contact with the mucous membranes. Infection might also occur if a person's hands are contaminated by these secretions or by touching contaminated surfaces and then they touch their eyes, nose, or mouth, although contaminated surfaces are not thought to be a major route of transmission.\n\nSARS-CoV-2 can also be transmitted longer distances through the airborne route (through inhalation of particles that remain in the air over time and distance), but the extent to which this mode of transmission has contributed to the pandemic is unclear. Scattered reports of SARS-CoV-2 outbreaks (eg, in a restaurant, on a bus) have highlighted the potential for longer-distance airborne transmission in enclosed, poorly ventilated spaces.\n\nWhile SARS-CoV-2 RNA has been detected in non-respiratory specimens (eg, stool, blood), neither fecal-oral nor bloodborne transmission appear to be significant sources of infection. SARS-CoV-2 infection has been described in animals, but there is no evidence to suggest that animals are a major source of transmission. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Transmission'.)",
                  "answer_start": 675,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is the incubation period for COVID-19?\n\n",
              "id": 283925,
              "answers": [
                {
                  "answer_id": 279575,
                  "document_id": 455837,
                  "question_id": 283925,
                  "text": "The incubation period for COVID-19 is thought to be within 14 days following exposure, with most cases occurring approximately three to five days after exposure. The incubation period also varies by viral variant. For example, the incubation period for the Omicron variant (B.1.1.159) appears to be slightly shorter than other variants, with symptoms first appearing around three days after exposure. (See \"COVID-19: Clinical features\", section on 'Incubation period'.)",
                  "answer_start": 2300,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are some of the important SARS-CoV-2 variants?\n\n",
              "id": 283926,
              "answers": [
                {
                  "answer_id": 279577,
                  "document_id": 455837,
                  "question_id": 283926,
                  "text": "Multiple SARS-CoV-2 variants are circulating globally. Some variants contain mutations in the surface spike protein, which mediates viral attachment to human cells and is a target for natural and vaccine-induced immunity. Thus, these variants have the potential to be more transmissible, cause more severe disease, and/or evade natural or vaccine-induced immune responses. Some of the more important circulating variants are:\n\n●Alpha (B.1.1.7 lineage), also known as 20I/501Y.V1, was first identified in the United Kingdom in late 2020. This variant is estimated to be more transmissible than wild-type virus. Some studies suggest this variant may cause more severe illness.\n\n●Delta (B.1.617.2 lineage), also known as 20A/S:478K, was identified in late 2020 in India. This variant is more transmissible than B.1.1.7 and is also associated with more severe disease.\n\n●Omicron (B.1.1.529 lineage) was first reported from southern Africa in November 2021, and it was promptly identified in multiple other countries. The variant contains >30 mutations in the spike protein, including mutations that have been found in other variants of concern and that have been associated with increased transmissibility and decreased susceptibility to neutralizing antibodies (including therapeutic monoclonal antibodies). Emerging data suggest that Omicron has a replication advantage over the Delta variant and evades infection- and vaccine-induced humoral immunity to a greater extent than prior variants. The risk of severe disease with the Omicron variant is more uncertain.\n\nThese and other variants are listed in this table (table 1) and discussed separately. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Variants of concern' and \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Efficacy against variants of concern'.)",
                  "answer_start": 2824,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What factors are associated with severe COVID-19?\n\n",
              "id": 283928,
              "answers": [
                {
                  "answer_id": 279581,
                  "document_id": 455837,
                  "question_id": 283928,
                  "text": "Severe illness can occur in otherwise healthy individuals of any age, but it predominantly occurs in adults with advanced age and/or certain underlying medical comorbidities and among those who are not vaccinated. These comorbidities and other less common comorbidities are compiled in a table by the United States Centers for Disease Control and Prevention (CDC); the strength of evidence informing each association varies (table 2). (See \"COVID-19: Clinical features\", section on 'Risk factors for severe illness'.)",
                  "answer_start": 6596,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Is COVID-19 caused by the Omicron variant less severe than infection caused other variants?\n\n",
              "id": 283929,
              "answers": [
                {
                  "answer_id": 279582,
                  "document_id": 455837,
                  "question_id": 283929,
                  "text": "Early data suggest that COVID-19 caused by the Omicron variant is less severe than infection caused by prior variants. Some studies have shown a reduced risk of hospitalization, intensive care unit admission, and in-hospital mortality. The relative mildness of disease reported in these studies may reflect the younger age of individuals impacted at this stage of the surge or a higher proportion of reinfections. While illness due to the Omicron may be milder, the high volume of cases continues to lead to high hospitalization rates and may result in excess burden on the health care system. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Omicron (B.1.1.529 lineage)'.)",
                  "answer_start": 7208,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the major cardiac complications in patients with COVID-19? And how often do they occur?\n\n",
              "id": 283930,
              "answers": [
                {
                  "answer_id": 279584,
                  "document_id": 455837,
                  "question_id": 283930,
                  "text": "Cardiac manifestations are common in hospitalized patients and occur most frequently in critically ill patients. The most common complications are listed here:\n\n●Cardiac troponin elevation, which is a biomarker of myocardial injury, occurs in approximately 10 to 35 percent of hospitalized patients. In the majority of these patients, cardiac signs and symptoms are not present and the cause of the troponin rise is not acute myocardial infarction (MI). However, patients with a clinical presentation (including history or electrocardiogram) suggestive of acute MI require prompt evaluation and treatment.\n\nUsually, troponin elevation in COVID-19 patients is due to other causes of myocardial injury including stress cardiomyopathy, hypoxic injury, myocarditis, right heart strain, microvascular dysfunction, and systemic inflammatory response syndrome. For those without suspected acute MI, further evaluation is focused on testing expected to impact management.\n\nThe following complications may occur with or without troponin elevation:\n\n●Arrhythmias have been reported in approximately 5 to 20 percent of hospitalized cases, and most are asymptomatic. Causes may include hypoxia, electrolyte abnormalities, myocardial injury, and drug effects (such as QT-prolonging agents).\n\n●Heart failure is the most common symptomatic cardiac complication. Data on its incidence are limited; however, its presence is associated with increased mortality. Heart failure in patients with COVID-19 may be precipitated by acute illness in patients with pre-existing known or undiagnosed heart disease (eg, coronary artery disease or hypertensive heart disease) or incident acute myocardial injury (eg, stress cardiomyopathy or acute MI).\n\n(See \"COVID-19: Evaluation and management of cardiac disease in adults\" and \"COVID-19: Myocardial infarction and other coronary artery disease issues\" and \"COVID-19: Arrhythmias and conduction system disease\".)",
                  "answer_start": 8041,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the major thrombotic complications in patients with COVID-19?\n\n",
              "id": 283931,
              "answers": [
                {
                  "answer_id": 279585,
                  "document_id": 455837,
                  "question_id": 283931,
                  "text": "COVID-19 is a hypercoagulable state associated with an increased risk of venous thromboembolism (VTE; including deep vein thrombosis and pulmonary embolism) and arterial thrombosis, including stroke, myocardial infarction, and possibly limb ischemia. The risk is highest in individuals in the intensive care unit (ICU), often despite prophylactic anticoagulation. Bleeding is not common but has been seen, especially in the setting of trauma and/or anticoagulation. (See \"COVID-19: Hypercoagulability\", section on 'VTE'.)",
                  "answer_start": 10049,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the most common dermatologic syndromes associated with COVID-19?\n\n",
              "id": 283932,
              "answers": [
                {
                  "answer_id": 279587,
                  "document_id": 455837,
                  "question_id": 283932,
                  "text": "The most common cutaneous findings reported in patients with COVID-19 include an exanthematous (morbilliform) rash, pernio-like acral lesions, livedo-like lesions, retiform purpura, necrotic vascular lesions, urticaria, vesicular (varicella-like) eruptions, and erythema multiforme-like lesions. An erythematous, polymorphic rash has also been associated with a related multisystem inflammatory syndrome in children. The frequency of cutaneous findings is estimated to range from less than 1 percent to 20 percent of patients with COVID-19.\n\nUncertainty remains about the strength and mechanisms of associations between reported skin findings and COVID-19. The timing of the appearance of cutaneous findings in relation to the course of COVID-19 has varied, with reports describing skin changes occurring prior to, concomitantly, or following symptoms of COVID-19. (See \"COVID-19: Cutaneous manifestations and issues related to dermatologic care\".)\n",
                  "answer_start": 10647,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is multisystem inflammatory syndrome associated with COVID-19?\n\n",
              "id": 283933,
              "answers": [
                {
                  "answer_id": 279591,
                  "document_id": 455837,
                  "question_id": 283933,
                  "text": "Multisystem inflammatory syndrome in children (MIS-C) is a rare but serious condition that has been reported in patients with current or recent COVID-19 infection or exposure. It shares clinical features with Kawasaki disease (KD), KD shock, and toxic shock syndrome. Clinical features include persistent fever, severe illness with involvement of multiple organ systems, and elevated inflammatory markers (table 3). Most children with MIS-C have survived, although some have required intensive care. Intravenous immune globulin is suggested in all patients who meet criteria for MIS-C, along with glucocorticoids in those with moderate or severe manifestations (algorithm 1). (See \"COVID-19: Multisystem inflammatory syndrome in children (MIS-C) clinical features, evaluation, and diagnosis\" and \"COVID-19: Multisystem inflammatory syndrome in children (MIS-C) management and outcome\".)\n\nA very similar syndrome has also been reported in adults in association with COVID-19 infection or exposure and is termed multisystem inflammatory syndrome in adults (MIS-A). (See \"COVID-19: Care of adult patients with systemic rheumatic disease\", section on 'COVID-19 as a risk factor for rheumatologic disease'.)",
                  "answer_start": 11666,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "When should patients with confirmed or suspected COVID-19 be advised to stay at home? Have an in-person clinical evaluation?",
              "id": 283936,
              "answers": [
                {
                  "answer_id": 279621,
                  "document_id": 455837,
                  "question_id": 283936,
                  "text": "Home management is appropriate for most patients with mild symptoms (eg, fever, cough, and/or myalgias without dyspnea), provided they can be adequately isolated, monitored, and supported in the outpatient setting. There should be a low threshold to clinically evaluate patients who have any risk factors for more severe illness, even if they have only mild symptoms. In addition, certain outpatients who have mild to moderate symptoms and risk factors for severe disease (table 2) are candidates for early treatment with COVID-19-specific therapy. (See 'Are there any COVID-19-specific therapies available for non-hospitalized patients?' below.)\n\nPatients being managed at home should be educated about the potential for worsening disease and advised to closely monitor for symptoms of more serious disease, including dyspnea or persistent chest pain. The development of these symptoms should prompt clinical evaluation and possible hospitalization",
                  "answer_start": 14659,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What laboratory abnormalities are commonly seen in patients with COVID-19?\n\n",
              "id": 283937,
              "answers": [
                {
                  "answer_id": 279623,
                  "document_id": 455837,
                  "question_id": 283937,
                  "text": "Common laboratory abnormalities among hospitalized patients with COVID-19 include:\n\n●Lymphopenia\n\n●Elevated aminotransaminase levels\n\n●Elevated lactate dehydrogenase levels\n\n●Elevated inflammatory markers (eg, ferritin, C-reactive protein, and erythrocyte sedimentation rate)\n\nAbnormalities in coagulation testing, elevated procalcitonin levels, and elevated troponin levels have also been reported. The degree of these abnormalities tends to correlate with disease severity. ",
                  "answer_start": 15850,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the major coagulation abnormalities in patients with COVID-19?\n\n",
              "id": 283938,
              "answers": [
                {
                  "answer_id": 279624,
                  "document_id": 455837,
                  "question_id": 283938,
                  "text": "A number of laboratory abnormalities have been reported, including high fibrinogen and D-dimer and mild prolongation of the prothrombin time (PT) and activated partial thromboplastin time (aPTT). Abnormal coagulation studies are mainly used to monitor clinical status and to help determine level of care. Very high D-dimer is associated with a high mortality rate. Atypical findings (eg, severe thrombocytopenia) should be further evaluated.",
                  "answer_start": 16458,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the different types of tests for COVID-19?\n\n",
              "id": 283939,
              "answers": [
                {
                  "answer_id": 279626,
                  "document_id": 455837,
                  "question_id": 283939,
                  "text": "There are three major types of tests for COVID-19 (table 4):\n\n●Nucleic acid amplifications tests (NAATs; eg, reverse transcription polymerase chain reaction [RT-PCR]) – RT-PCR for SARS-CoV-2 is the primary test used to diagnose active COVID-19. The test is performed primarily on upper respiratory specimens (including nasopharyngeal swabs, nasal swabs, and saliva) but can also be performed on lower respiratory tract samples. Sensitivity and specificity are generally high, although performance varies based on the specific assay used, specimen quality, and duration of illness.\n\n●Antigen tests – Antigen tests can also be used to diagnosis active infection. Antigen tests are less sensitive than NAATs, and their performance varies by the specific antigen test. These tests are typically performed on nasopharyngeal or nasal swabs.\n\n●Serology – Serologic tests measure antibodies to SARS-CoV-2 and are primarily used to identify patients who have had COVID-19 in the past as well as patients with current infection who have had symptoms for three to four weeks. Sensitivity and specificity are highly variable, and cross-reactivity with other coronaviruses has been reported.\n\nBoth NAATs and antigen tests can be used to screen patients in congregate settings, such as long-term care facilities.",
                  "answer_start": 17052,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How accurate is RT-PCR for SARS-CoV-2? Should two tests be performed or one?\n\n",
              "id": 283940,
              "answers": [
                {
                  "answer_id": 279594,
                  "document_id": 455837,
                  "question_id": 283940,
                  "text": " positive RT-PCR for SARS-CoV-2 generally confirms the diagnosis of COVID-19. However, false-negative tests from upper respiratory specimens have been well documented. If initial testing is negative, but the suspicion for COVID-19 remains, and determining the presence of infection is important for management or infection control, we suggest repeating the test. For hospitalized patients with evidence of lower respiratory tract involvement, the repeat test can be performed on expectorated sputum or a tracheal aspirate, if available.\n\nIn settings where testing is not readily available, the diagnosis of COVID-19 can be made presumptively based on a compatible clinical presentation in the setting of an exposure risk, particularly when no other cause of the symptoms is evident. (See \"COVID-19: Diagnosis\", section on 'Diagnostic approach'.)",
                  "answer_start": 18595,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the indications for testing asymptomatic individuals?\n\n",
              "id": 283941,
              "answers": [
                {
                  "answer_id": 279595,
                  "document_id": 455837,
                  "question_id": 283941,
                  "text": "Indications for testing asymptomatic individuals include close contact with an individual with COVID-19, screening in congregate settings (eg, long-term care facilities, correctional and detention facilities, homeless shelters), and screening hospitalized patients in high-prevalence regions. Screening may also be indicated prior to time-sensitive surgical procedures or aerosol-generating procedures and prior to receiving immunosuppression. If resources allow, the United States Centers for Disease Control and Prevention (CDC) suggests serial testing of select groups of asymptomatic individuals (eg, residents and staff in congregate settings, workers with public interactions or large numbers of close contacts) to help prevent transmission by quickly identifying cases so that infected individuals can be isolated and contacts quarantined. (See \"COVID-19: Diagnosis\", section on 'Whom to test'.)\n",
                  "answer_start": 19506,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can SARS-CoV-2 variants be reliably detected by available diagnostic assays?\n\n",
              "id": 283942,
              "answers": [
                {
                  "answer_id": 279597,
                  "document_id": 455837,
                  "question_id": 283942,
                  "text": "Thus far, yes. Most circulating SARS-CoV-2 variants have mutations in the S gene, which encodes the viral spike protein (table 1).\n\nWhile many nucleic acid amplification tests target the S gene, they also target other genes. Thus, if a mutation alters one gene target, the other gene targets still function and the test will detect the virus, including the Omicron variant.\n\nNotably, the Omicron variant contains a mutation that results in S gene target failure for some assays. S gene failure can be used as a marker for the Omicron variant; however, it is nonspecific and can occur with other variants, such as Alpha. Most antigen tests target nucleocapsid protein, so mutations in the spike protein would not impact the accuracy of these tests. While the Omicron variant does contain mutations in the gene that encodes the nucleocapsid, antigen testing is thought to be unaffected. (See \"COVID-19: Diagnosis\", section on 'Impact of SARS-CoV-2 mutations/variants on test accuracy'.)",
                  "answer_start": 20488,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Are there any COVID-19-specific therapies available for non-hospitalized patients?\n\n",
              "id": 283943,
              "answers": [
                {
                  "answer_id": 279598,
                  "document_id": 455837,
                  "question_id": 283943,
                  "text": "Among adult outpatients with mild to moderate COVID-19 and risk factors for progression to severe disease (table 2), we recommend treatment with COVID-19-specific therapy. We do not use COVID-19-specific therapy for individuals without risk factors or in those with asymptomatic SARS-CoV-2 infection.\n\nWe recommend nirmatrelvir-ritonavir, monoclonal antibody therapy active against circulating variants (table 1), or remdesivir as first-line therapies. Each treatment has been demonstrated to substantially reduce the risk of hospitalization (and with some interventions, mortality) in outpatients with mild to moderate COVID-19 and risk factors for progression to severe disease. The choice between therapies depends upon local availability, ease of prompt access to treatment (as all therapies must be given early in the course of illness), susceptibility to prevalent viral variants, and specific patient factors (eg, comorbid conditions, potential drug-drug interactions with nirmatrelvir-ritonavir). Additionally, monoclonal antibodies and remdesivir are administered parenterally, which may be operationally complicated in many outpatient settings.\n\nIf nirmatrelvir-ritonavir, monoclonal antibody therapy, and remdesivir are not feasible options, molnupiravir is an alternative. However, it may not be as effective as the other interventions, and there are other safety considerations.\n\nWhen the incidence of SARS-CoV-2 infection is high, supplies of these agents (and the resources required to administer them) may be insufficient to offer treatment to all eligible patients. In such circumstances, these treatments should be prioritized for individuals most likely to benefit (ie, immunocompromised individuals who are likely to have a suboptimal response to vaccination, and unvaccinated or incompletely vaccinated individuals with the highest risk for progression to severe disease) (table 5). (See \"COVID-19: Outpatient evaluation and management of acute illness in adults\", section on 'COVID-19-specific therapies'.)",
                  "answer_start": 21569,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What advice should be given to patients with known or presumed COVID-19 managed at home?\n\n",
              "id": 283944,
              "answers": [
                {
                  "answer_id": 279599,
                  "document_id": 455837,
                  "question_id": 283944,
                  "text": "For most patients with COVID-19 who are managed at home, we advise the following:\n\n●Supportive care with antipyretics/analgesics (eg, acetaminophen) and hydration\n\n●Close contact with their health care provider\n\n●Monitoring for clinical worsening, particularly the development of new or worsening dyspnea, which should prompt clinical evaluation and possible hospitalization\n\n●Separation from other household members, including pets (eg, staying in a separate room when possible and wearing a mask when in the same room)\n\n●Frequent hand washing for all family members\n\n●Frequent disinfection of commonly touched surfaces",
                  "answer_start": 23689,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How long should patients cared for at home stay isolated?\n\n",
              "id": 283945,
              "answers": [
                {
                  "answer_id": 279600,
                  "document_id": 455837,
                  "question_id": 283945,
                  "text": "The United States Centers for Disease Control and Prevention (CDC) has issued recommendations for discontinuing home isolation in the general community. A symptom- or time-based strategy is preferred for most patients.\n\nFor symptomatic immunocompetent patients with mild disease who are cared for at home, isolation can usually be discontinued when the following criteria are met:\n\n●At least five days have passed since symptoms first appeared AND\n\n●At least one day (24 hours) has passed since resolution of fever without the use of fever-reducing medications AND \n\n●There is improvement in symptoms (eg, cough, shortness of breath)\n\nAfter discontinuing home isolation, patients should continue to wear a well-fitting mask around others. The total duration of isolation plus strict masking is 10 days. During this time, patients should avoid people who are immunocompromised or at high risk for severe disease. Additional information on restrictions (eg, travel) after the five-day isolation period can be found on the CDC website.\n\nFor patients who did not have symptoms at the time of laboratory-confirmed SARS-CoV-2 infection, home isolation can usually be discontinued when at least five days have passed since the positive COVID-19 test (followed by strict mask wearing for an additional five days), as long as there was no evidence of subsequent illness.\n\nAlthough this strategy can be used for many patients, home isolation should continue for a total of 10 days if a viral test was performed toward the end of the five-day isolation and is positive, if strict mask wearing is not possible, or if the patient had moderate disease. In addition, this strategy should not be used for those who had severe disease or are immunocompromised; for such patients, the duration of isolation may need to be extended and/or testing may be needed to confirm resolution. ",
                  "answer_start": 24514,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is the significance of a persistently positive RT-PCR for weeks after illness?\n\n",
              "id": 283946,
              "answers": [
                {
                  "answer_id": 279601,
                  "document_id": 455837,
                  "question_id": 283946,
                  "text": "Patients diagnosed with COVID-19 can have detectable SARS-CoV-2 RNA in upper respiratory tract specimens for weeks after the onset of symptoms. However, prolonged viral RNA detection does not necessarily indicate prolonged infectiousness. According to the CDC, isolation of infectious virus more than 10 days after illness onset is rare in patients whose symptoms have resolved.\n\nThere is no standardized approach to management of patients with persistently positive reverse transcription polymerase chain reaction (RT-PCR) 10 days or more after resolution of symptoms. However, such patients are generally felt to have low infectiousness, particularly after mild to moderate disease and in the absence of immunocompromise. This is why symptom- and time-based approaches for discontinuation of precautions are recommended for most patients. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Viral shedding and period of infectiousness'.)",
                  "answer_start": 26588,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is the preferred approach to oxygenation?\n\n",
              "id": 283947,
              "answers": [
                {
                  "answer_id": 279576,
                  "document_id": 455837,
                  "question_id": 283947,
                  "text": "As a general approach, we target a peripheral oxygen saturation between 90 and 96 percent using the lowest possible fraction of inspired oxygen. We also encourage patients to self-prone, when possible, based on data that suggest improved oxygenation and minimal downside to proning.\n\n●For most patients, we use low-flow oxygen (eg, low-flow nasal cannula, simple face mask), which minimizes risk of viral aerosolization. Because exertional desaturation is common and can be profound, providing additional support with activity (eg, going to the bathroom) may be needed.\n\n●For those with acute hypoxemic respiratory failure and higher oxygen needs than low-flow oxygen can provide, we suggest selective use of noninvasive measures rather than routinely proceeding directly to intubation. Among the noninvasive modalities, we prefer high-flow nasal cannula (HFNC) over non-invasive ventilation (NIV), unless there is separate indication for NIV (eg, acute exacerbation of chronic obstructive pulmonary disease, heart failure).\n\n●We have a low threshold for intubation in patients who have any of the following: rapid progression over a few hours; failure to improve despite HFNC >60 L/min and FiO2 >0.6; development of hypercapnia; and/or hemodynamic instability or multiorgan failure.\n\n●When mechanical ventilation is required, we use low tidal volume ventilation (LTVV) targeting ≤6 mL/kg predicted body weight (PBW; range 4 to 8 mL/kg PBW (table 6 and table 7)) that targets a plateau pressure ≤30 cm H2O and applies positive end-expiratory pressure (PEEP) as outlined in the table (table 8).\n\n●For patients with COVID-19 who fail LTVV, prone ventilation is the preferred next step (table 9 and table 10).\n\n●For those who fail LTVV and prone ventilation, rescue strategies include alveolar recruitment maneuvers, high PEEP, neuromuscular blocking agents, inhaled pulmonary vasodilators, and, rarely, extracorporeal membrane oxygenation.",
                  "answer_start": 27609,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "When are antiviral treatment, glucocorticoids, and other COVID-19-specific therapies indicated? And which agents are preferred?",
              "id": 283948,
              "answers": [
                {
                  "answer_id": 279602,
                  "document_id": 455837,
                  "question_id": 283948,
                  "text": "Our approach to COVID-19-specific therapy in hospitalized patients depends on the presence of hypoxia (O2 saturation ≤94 percent on room air), need for oxygenation or ventilatory support, and the patients’ clinical and laboratory risk factors for severe disease (algorithm 2).\n\n●For patients who do not require oxygen and do not have clinical (table 2) or laboratory (table 11) risk factors for severe disease, care is primarily supportive, with close monitoring for disease progression.\n\n●For patients who do not require oxygen but have clinical (table 2) or laboratory (table 11) risk factors for severe disease and were hospitalized for COVID-19, we suggest remdesivir. Individuals who have risk factors but were hospitalized for other reasons (ie, have incidental SARS-CoV-2 infection) may be eligible for monoclonal antibody therapy, similar to high-risk outpatients.\n\n●For patients who are receiving low-flow supplemental oxygen, we suggest low-dose dexamethasone and remdesivir. For those who have significantly elevated inflammatory markers (eg, C-reactive protein [CRP] level ≥75 mg/L), have increasing oxygen requirements despite dexamethasone, and are within 96 hours of hospitalization, we suggest adding tocilizumab or baricitinib. If supplies of tocilizumab or baricitinib are limited, we prioritize them for more severely ill patients on higher levels of oxygen support. For immunocompromised patients, we also evaluate whether monoclonal antibody therapy is available through an investigational new drug application.\n\n●For hospitalized patients who are receiving high-flow supplemental oxygen or non-invasive ventilation, we recommend low-dose dexamethasone. For those who are within 24 to 48 hours of admission to an intensive care unit (ICU) or receipt of ICU-level care (and within 96 hours of hospitalization), we suggest adding tocilizumab or baricitinib. We also suggest adding remdesivir; however, if supplies are limited, we prioritize remdesivir for patients who are on low-flow oxygen supplementation at baseline.\n\n●For hospitalized patients who require mechanical ventilation or extracorporeal membrane oxygenation, we recommend low-dose dexamethasone. For those who are within 24 to 48 hours of admission to an ICU (and within 96 hours of hospitalization), we suggest adding tocilizumab. We suggest not routinely using remdesivir in this population.\n\n●If dexamethasone is not available, other glucocorticoids at equivalent doses are reasonable alternatives.\n\nIn addition to these therapies (or if individual patients cannot take these therapies), we refer them to a clinical trial for other therapies when available. Other investigational therapies include other antiviral agents, cytokine and kinase inhibitors, and other immunomodulatory agents. Clinicians may also be able to obtain convalescent plasma for use outside a trial setting; however, we suggest not using convalescent plasma for mechanically ventilated patients and not using it outside the context of clinical trials for most other hospitalized patients because of lack of clear benefit. We generally do not use other agents off label for treatment of COVID-19. In particular, we suggest not using hydroxychloroquine, chloroquine, or ivermectin, given the lack of benefit and potential for toxicity. (See \"COVID-19: Management in hospitalized adults\" and \"COVID-19: Management in hospitalized adults\", section on 'COVID-19-specific therapy'.)\n",
                  "answer_start": 29863,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Is anticoagulation indicated in all hospitalized patients? And if so, how much?\n\n",
              "id": 283949,
              "answers": [
                {
                  "answer_id": 279603,
                  "document_id": 455837,
                  "question_id": 283949,
                  "text": "Yes, all hospitalized patients with COVID-19 should receive at least prophylactic-dose anticoagulation unless contraindicated (algorithm 3).\n\n●For thromboprophylaxis, we suggest standard prophylactic dosing rather than higher intensity (intermediate- or full-dose) anticoagulation for most inpatients, including in the ICU. Individuals already receiving full-dose anticoagulation for another indication should continue it. Thromboprophylaxis is typically discontinued upon hospital discharge, with rare exceptions.\n\n●We have a low threshold for evaluating for venous thromboembolism (VTE; including deep vein thrombosis, pulmonary embolism, or other sites). If VTE is documented or strongly suspected, full-dose anticoagulation is used for at least three months.\n\nOur approach to the evaluation and management of COVID-19 hypercoagulability is presented in the table (table 12) and discussed in detail separately.",
                  "answer_start": 33381,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Should I use acetaminophen or NSAIDs when providing supportive care?\n\n",
              "id": 283950,
              "answers": [
                {
                  "answer_id": 279604,
                  "document_id": 455837,
                  "question_id": 283950,
                  "text": "Nonsteroidal anti-inflammatory drugs (NSAIDs) have been theorized to cause harm in patients with COVID-19, but clinical data are limited. Given the uncertainty, we use acetaminophen as the preferred antipyretic agent for most patients rather than NSAIDs. If NSAIDs are needed, we use the lowest effective dose. We do not routinely discontinue NSAIDs in patients using them for the management of chronic illnesses.\n\nThe US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO) do not recommend that NSAIDs be avoided when clinically indicated. (See \"COVID-19: Management in hospitalized adults\", section on 'NSAID use'.)",
                  "answer_start": 34462,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Should patients using inhaled glucocorticoids for asthma or COPD be advised to stop these medications to prevent COVID-19?",
              "id": 283951,
              "answers": [
                {
                  "answer_id": 279606,
                  "document_id": 455837,
                  "question_id": 283951,
                  "text": "No, patients with asthma or chronic obstructive pulmonary disease (COPD) who need inhaled glucocorticoids to maintain control of their asthma or COPD should continue them at their usual dose. When indicated, inhaled steroids help to minimize risk of an asthma or COPD exacerbation and the associated need for interaction with the health care system. There is no good evidence that inhaled glucocorticoids increase susceptibility to COVID-19 or have an adverse effect on the course of infection. Stopping them may worsen asthma or COPD control and thereby increase the risk for complications of COVID-19, if acquired. (See \"An overview of asthma management\", section on 'Advice related to COVID-19 pandemic' and \"Stable COPD: Overview of management\", section on 'Advice related to COVID-19'.)",
                  "answer_start": 36122,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Should patients with COVID-19 and an acute exacerbation of asthma or COPD be treated with systemic glucocorticoids?",
              "id": 283952,
              "answers": [
                {
                  "answer_id": 279627,
                  "document_id": 455837,
                  "question_id": 283952,
                  "text": "Yes, patients with COVID-19 infection and a concomitant acute exacerbation of asthma or COPD should receive prompt treatment with systemic glucocorticoids as indicated by usual guidelines. Delaying therapy can increase the risk of a life-threatening exacerbation. While the World Health Organization (WHO) and United States Centers for Disease Control and Prevention (CDC) recommend glucocorticoids not be routinely used in the treatment of COVID-19 infection, exacerbations of asthma and COPD are considered appropriate indications for use. Overall, the known benefits of systemic glucocorticoids for exacerbations of asthma and COPD outweigh the potential harm in COVID-19 infection",
                  "answer_start": 37032,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What special considerations are there for children?\n\n",
              "id": 283954,
              "answers": [
                {
                  "answer_id": 279608,
                  "document_id": 455837,
                  "question_id": 283954,
                  "text": "Specific considerations for children, including an overview of multisystem inflammatory syndrome, are discussed separately. (See \"COVID-19: Clinical manifestations and diagnosis in children\" and \"COVID-19: Management in children\" and \"COVID-19: Multisystem inflammatory syndrome in children (MIS-C) clinical features, evaluation, and diagnosis\" and \"COVID-19: Multisystem inflammatory syndrome in children (MIS-C) management and outcome\".)\n",
                  "answer_start": 38352,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Are any medications available to prevent COVID-19 following exposure?\n\n",
              "id": 283956,
              "answers": [
                {
                  "answer_id": 279611,
                  "document_id": 455837,
                  "question_id": 283956,
                  "text": "In the United States, the Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to use the monoclonal antibodies casirivimab-imdevimab and bamlanivimab-etesevimab to prevent SARS-CoV-2 infection in select individuals over 12 years of age. However, since these combinations are not expected to retain activity against the Omicron variant, their distribution to states or territories that have >80 percent prevalence of the Omicron variant has been paused. Although the monoclonal antibody sotrovimab may retain activity against Omicron, it has not been studied for post-exposure prophylaxis and should not be used for this purpose.\n\nOther agents (eg, hydroxychloroquine, ivermectin, tixagevimab-cilgavimab [another monoclonal antibody combination]) have not been shown to be effective. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Post-exposure prophylaxis for select individuals'.)",
                  "answer_start": 39785,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What PPE is recommended for health care personnel taking care of patients with suspected or confirmed COVID-19?",
              "id": 283957,
              "answers": [
                {
                  "answer_id": 279612,
                  "document_id": 455837,
                  "question_id": 283957,
                  "text": "Any personnel entering the room of a patient with suspected or confirmed COVID-19, regardless of COVID-19 vaccination status, should wear the appropriate personal protective equipment (PPE): gown, gloves, eye protection (full face shield preferred rather than goggles or a surgical mask with an attached eye shield), and a respirator (eg, an N95 respirator). If the supply of respirators is severely limited, medical masks are an acceptable alternative, except during aerosol-generating procedures (eg, tracheal intubation and extubation, tracheotomy, bronchoscopy, noninvasive ventilation, cardiopulmonary resuscitation).",
                  "answer_start": 40834,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What type of room should patients with known or suspected COVID-19 be placed in?\n\n",
              "id": 283958,
              "answers": [
                {
                  "answer_id": 279613,
                  "document_id": 455837,
                  "question_id": 283958,
                  "text": "Most hospitalized patients should be placed in a well-ventilated, single-occupancy room with a closed door and dedicated bathroom. When this is not possible, patients with confirmed COVID-19 can be housed together. (See \"COVID-19: Infection prevention for persons with SARS-CoV-2 infection\", section on 'Type of room'.)\n\nPatients undergoing aerosol-generating procedures (eg, tracheal intubation and extubation, tracheotomy, bronchoscopy, noninvasive ventilation) should be placed in an airborne isolation room (ie, a single-patient, negative-pressure room), except when these procedures are performed in the operating room or when such rooms are unavailable",
                  "answer_start": 41764,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Should individuals who are fully vaccinated continue to wear masks and physically distance?\n\n",
              "id": 283959,
              "answers": [
                {
                  "answer_id": 279614,
                  "document_id": 455837,
                  "question_id": 283959,
                  "text": "Although SARS-CoV-2 infection might still occur despite vaccination, the risk is substantially lower. Recommendations on public health precautions following vaccination have evolved with new developments in the pandemic (eg, emergence of the highly transmissible Delta and Omicron variants), and the approach should be tailored to the overall rate of transmission in the community.\n\nIn the United States, the Centers for Disease Control and Prevention (CDC) suggests that all individuals wear masks in indoor public settings in areas where community transmission is substantial (ie, ≥50 cases/100,000 people over the prior seven days or >8 percent positive nucleic acid amplification test [NAAT] rate). Masks are also recommended on all forms of public transportation, regardless of vaccination status. We also counsel immunocompromised individuals to maintain personal preventive measures even if they have been vaccinated, particularly when contact with unvaccinated individuals is possible, because they may have suboptimal responses to COVID-19 vaccination. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Wearing masks in the community' and \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Post-vaccine public health precautions'.)",
                  "answer_start": 43067,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Does protective immunity develop after SARS-CoV-2 infection? Can reinfection occur?\n\n",
              "id": 283960,
              "answers": [
                {
                  "answer_id": 279630,
                  "document_id": 455837,
                  "question_id": 283960,
                  "text": "Protective SARS-CoV-2-specific antibodies and cell-mediated responses are induced following infection. Evidence suggests that some of these responses can be detected for at least a year following infection. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Immune responses following infection'.)\n\nIn general, the short-term risk of reinfection (eg, within the first several months after initial infection) is low. However, the risk of reinfection with the Omicron variant following infection with other variants is higher",
                  "answer_start": 44485,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How efficacious is vaccination at preventing symptomatic COVID-19?\n\n",
              "id": 283961,
              "answers": [
                {
                  "answer_id": 279616,
                  "document_id": 455837,
                  "question_id": 283961,
                  "text": "●BNT162b2 (Pfizer-BioNTech COVID-19 vaccine) had 95 percent efficacy in preventing symptomatic COVID-19 at or after day 7 following completion of a two-dose series. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'BNT162b2 (Pfizer-BioNTech COVID-19 vaccine)'.)\n\n●mRNA-1273 (Moderna COVID-19 vaccine) had 95 percent efficacy in preventing symptomatic COVID-19 at or after day 7 following completion of a two-dose series. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'mRNA-1273 (Moderna COVID-19 vaccine)'.)\n\n●Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine) had 66 percent efficacy against moderate to severe COVID-19 and 85 percent efficacy against severe COVID-19 at or after 28 days following administration of a single dose. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine)'.)\n\n●ChAdOx1 nCoV-19/AZD1222 (AstraZeneca COVID-19 vaccine) had 70 percent efficacy in preventing symptomatic COVID-19 at or after two weeks following completion of a two-dose series. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'ChAdOx1 nCoV-19/AZD1222 (University of Oxford, AstraZeneca, and the Serum Institute of India)'.)\n\nSubsequent data suggest that immunity may wane over time and varies for viral variants; mRNA vaccines may be slightly more effective at preventing severe disease than other vaccine types. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Immunogenicity, efficacy, and safety of select vaccines'.)\n\nAvailable data and the efficacy of other vaccines types are discussed separately. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Immunogenicity, efficacy, and safety of select vaccines'.)",
                  "answer_start": 45265,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How effective is vaccination against the Delta and Omicron variants?\n\n",
              "id": 283962,
              "answers": [
                {
                  "answer_id": 279631,
                  "document_id": 455837,
                  "question_id": 283962,
                  "text": "Vaccine effectiveness against Delta is reduced against overall infection but largely retained against severe disease. Preliminary evidence suggests reduced vaccine effectiveness, particularly against overall infection, with Omicron (table 1). (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Efficacy against variants of concern'.)\n\nHave breakthrough infections been reported following vaccination?\n\nYes, breakthrough infection after vaccination has been reported but occurs much less frequently than infection in unvaccinated individuals, and a high proportion of breakthrough infections may be asymptomatic.\n\nSome reports suggest a higher rate of breakthrough infections with the Delta variant; however, the risk of severe breakthrough infection with the Delta variant remains low. The Omicron variant appears to evade vaccine-induced humoral immunity more than other variants. The risk of severe disease associated with the Omicron variant is uncertain",
                  "answer_start": 47131,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Which vaccines are currently available in the United States? Worldwide?\n\n",
              "id": 283964,
              "answers": [
                {
                  "answer_id": 279632,
                  "document_id": 455837,
                  "question_id": 283964,
                  "text": "In the United States, these vaccines are available:\n\n●BNT162b2 (Pfizer-BioNTech COVID-19 vaccine)\n\n●mRNA-1273 (Moderna COVID-19 vaccine)\n\n●Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine)\n\nBNT162b2 and mRNA-1273 are mRNA vaccines and are delivered in lipid nanoparticles. Once injected and taken up into muscle cells, the mRNA expresses the SARS-CoV-2 surface spike protein. Spike protein mediates viral attachment to human cells (figure 3). Expression of the spike protein induces binding and neutralizing antibody responses. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'BNT162b2 (Pfizer-BioNTech COVID-19 vaccine)' and \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'mRNA-1273 (Moderna COVID-19 vaccine)'.)\n\nAd26.COV2.S is based on a replication-incompetent adenovirus 26 vector that expresses a stabilized spike protein. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\".)\n\nOutside of the United States, vaccine availability varies regionally. One of the most widely available vaccines is ChAdOx1 nCoV-19/AZD1222 (University of Oxford, AstraZeneca, and the Serum Institute of India vaccines), an adenovirus vector-based DNA vaccine that also expresses the surface spike protein. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Other countries'.)\n\nNumerous additional vaccine candidates are being evaluated for prevention of COVID-19, including nucleic acid-based (mRNA and DNA) vaccines, viral-vector vaccines, and inactivated or recombinant protein vaccines (figure 4 and table 13). (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\".)\n\nAvailable vaccines and vaccine candidates are also catalogued on the World Health Organization website.",
                  "answer_start": 48354,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the indications and contraindications to vaccination?\n\n",
              "id": 283965,
              "answers": [
                {
                  "answer_id": 279633,
                  "document_id": 455837,
                  "question_id": 283965,
                  "text": "For patients in the United States, we recommend vaccination with BNT162b2 (Pfizer-BioNTech COVID-19 vaccine), mRNA-1273 (Moderna COVID-19 vaccine), or Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine).\n\n●Individuals ≥5 years old are eligible for BNT162b2.\n\n●Individuals ≥18 years old are eligible for mRNA-1273 and Ad26.COV2.S.\n\nIf availability is not an issue, we suggest one of the mRNA vaccines (BNT162b2 or mRNA-1273) rather than Ad26.COV2.S.\n\nContraindications to these vaccines are:\n\n●For the mRNA COVID-19 vaccines:\n\n•A history of a severe allergic reaction, such as anaphylaxis, after a previous dose of an mRNA COVID-19 vaccine or to any of its components (including polyethylene glycol).\n\n•An immediate allergic reaction of any severity (including hives) to a previous dose of an mRNA COVID-19 vaccine, to any of its components, or to polysorbate (with which there can be cross-reactive hypersensitivity to polyethylene glycol). Such individuals should not receive an mRNA COVID-19 vaccine unless they have been evaluated by an allergy expert who determines that it can be given safely.\n\nComponents of the mRNA COVID-19 vaccines are listed on the United States Centers for Disease Control and Prevention (CDC) website.\n\nThe United States Advisory Committee on Immunization Practices lists history of severe allergic reaction to any other vaccine or injectable therapy (that does not share the same components as the mRNA COVID-19 vaccines) as a precaution, but not contraindication, to mRNA COVID-19 vaccination.\n\n●For Ad26.COV2.S:\n\n•A history of a severe allergic reaction, such as anaphylaxis, to the vaccine or any of its components.\n\n•A history of thrombosis with thrombocytopenia following an Ad26.COV2.S or any other adenoviral vector COVID-19 vaccine.\n\nIndividuals with a precaution to vaccination, as well as any individual with a history of anaphylaxis that does not result in a contraindication to vaccination, should be monitored for 30 minutes after vaccination. All other recipients should be monitored for 15 minutes. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Indications and vaccine selection' and \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Contraindications and precautions (including allergies)'.)",
                  "answer_start": 50154,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Are vaccine recommendations different for immunocompromised patients?\n\n",
              "id": 283966,
              "answers": [
                {
                  "answer_id": 279634,
                  "document_id": 455837,
                  "question_id": 283966,
                  "text": "The United States Advisory Committee on Immunizations Practices (ACIP) recommends that patients with certain moderate to severe immunocompromising conditions receive three mRNA vaccine doses as part of the primary series rather than two doses. Immunocompromising conditions that warrant the third dose include active chemotherapy for cancer, hematologic malignancies, hematopoietic cell transplantation (HCT) or solid organ transplantation, advanced or untreated HIV infection with a CD4 count ‹200 cell/microL, moderate or severe primary immunodeficiency disorder, and use of immunosuppressive medications (eg, mycophenolate mofetil, rituximab, prednisone >20 mg/day for >14 days) (table 14). For those who received COVID-19 vaccination prior to HCT or CAR-T cell therapy, the CDC recommends repeat vaccination with a full primary series at least three months after the transplant or CAR-T administration. Such patients meet criteria for receiving a three-dose primary series with the mRNA vaccines.\n\nThe third dose should be given at least 28 days after the second dose. Individuals >5 years of age are eligible for BNT162b2 (Pfizer-BioNTech COVID-19 vaccine), and individuals >18 years of age are eligible for mRNA-1273 (Moderna COVID-19 vaccine). Immunocompromised individuals who received three doses of a primary mRNA vaccine series may also receive a booster dose five months later. Patients who received Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine) should receive a booster vaccine dose after the primary series. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Immunocompromised individuals'.)",
                  "answer_start": 52510,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Who is eligible for a booster dose? And when should it be administered?\n\n",
              "id": 283967,
              "answers": [
                {
                  "answer_id": 279635,
                  "document_id": 455837,
                  "question_id": 283967,
                  "text": "Because of the possibility of waning immunity and decreased efficacy against variants that might escape the immune response directed against spike proteins targeted by the original vaccines, several countries have initiated or announced plans to administer a booster vaccine for individuals who have been fully vaccinated. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\".)\n\nIn the United States, the Food and Drug Administration (FDA) has authorized and the CDC recommends a booster dose be given for individuals 12 years of age or older.\n\n●For those who previously received BNT162b2 [Pfizer COVID-19 vaccine]), the CDC recommends a booster dose at least five months after completion of the primary series.\n\n●For those who previously received mRNA-1273 (Moderna COVID-19 vaccine), the CDC recommends a booster dose at least five months after completion of the primary series.\n\n●For those who previously received Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine), the CDC recommends a booster dose at least two months after completion of the primary series.\n\nAny one of the vaccines can be given as a booster dose. However, we prefer one of the mRNA vaccines. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Role of booster vaccinations/waning efficacy' and \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Mixing vaccine types'.)\n\nBooster doses following a primary vaccine series are a distinct issue from administering a third dose of an mRNA vaccine for the primary series in certain immunocompromised patients. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Immunocompromised individuals'.)",
                  "answer_start": 54221,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What adverse effects are associated with vaccination?\n\n",
              "id": 283968,
              "answers": [
                {
                  "answer_id": 279636,
                  "document_id": 455837,
                  "question_id": 283968,
                  "text": "The more common adverse effects for all vaccine types include local injection site reactions, fever, headache, fatigue, chills, myalgias, and arthralgias (table 13). These reactions are more common in younger individuals and after the second dose (when a two-dose series is given).\n\nAnaphylaxis is a rare adverse event reported following receipt of mRNA vaccines. Most cases evaluated to date have been determined not to be caused by IgE-mediated reactions, and some patients have successfully received the second dose of the same vaccine without incident. Patients with apparent anaphylaxis to a first dose of an mRNA vaccine should be referred to an allergy specialist if possible. Alternatively, a non-mRNA vaccine could be given in place of the second dose of mRNA vaccine, followed by 30 minutes of observation. (See \"COVID-19: Allergic reactions to SARS-CoV-2 vaccines\".)\n\nThe potential associations between thromboembolism and ChAdOx1 nCoV-19/AZD1222 (AstraZeneca COVID-19 vaccine) and Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine) are discussed below and in detail in the UpToDate text. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Thrombosis with thrombocytopenia' and \"COVID-19: Vaccine-induced immune thrombotic thrombocytopenia (VITT)\".)\n\nThere are rare reports of myocarditis and pericarditis following receipt of the mRNA vaccines, BNT162b2 (Pfizer vaccine) and mRNA-1273 (Moderna vaccine), though not following receipt of Ad26.COV2.S (Janssen/Johnson & Johnson vaccine). Most reported cases were mild and occurred more commonly in males and in adolescents and young adults. Onset was generally within the first week after vaccine receipt, more commonly after the second dose. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Myocarditis'.)\n\nThere is also a possible association between Ad26.COV2.S (Janssen/Johnson & Johnson vaccine) and Guillain-Barre syndrome. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Guillain-Barre syndrome'.)\n\nA detailed list of adverse event rates and how they vary by vaccine type and patient age can be found on the CDC website. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Approach to vaccination' and \"COVID-19: Allergic reactions to SARS-CoV-2 vaccines\", section on 'mRNA vaccines'.)",
                  "answer_start": 55969,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How does the risk-benefit ratio for COVID-19 vaccination differ in children?\n\n",
              "id": 283969,
              "answers": [
                {
                  "answer_id": 279638,
                  "document_id": 455837,
                  "question_id": 283969,
                  "text": "The individual benefit of COVID-19 vaccination in young children may be somewhat less than in adults because COVID-19 tends to be less severe in children than in adults.\n\nNevertheless, there are several compelling reasons to vaccinate children, including the potential to reduce risk of the following:\n\n●Multisystem inflammatory syndrome in children (MIS-C) following acute COVID-19\n\n●Other potential sequelae (eg, \"long COVID-19\" and indirect effects on mental health and education)\n\n●Severe disease in children with underlying medical conditions\n\n●Acute COVID-19 of any severity\n\nFurthermore, even with the lower risk of severe disease among children, the number of COVID-19 deaths among those 5 to 11 years old from 2020 to 2021 exceeds the prevaccination era mortality rates of infections for which childhood vaccines are routinely provided (eg, rotavirus, meningococcal disease, varicella).\n\nThe risks of vaccination in children are less clearly defined than in adults and adolescents. Concern about the risk of myocarditis in children has been raised because of the association of mRNA COVID-19 vaccines with myocarditis, particularly in adolescents and young adults. While the precise risk of vaccine-associated myocarditis among 5- to 11-year-olds is unknown, based on the historical age distribution of myocarditis in the pre-COVID-19 era, it is expected to be lower than that among adolescents and young adults, which is already low. In addition, most myocarditis cases following receipt of a COVID-19 mRNA vaccine are mild and short lived. The benefits of COVID-19 vaccination in children are estimated to exceed this risk.\n\nGiven the hypothesis that MIS-C is associated with immune dysregulation precipitated by SARS-CoV-2 infection, similar immune-related side effects following vaccination in children are another concern. Vaccine trials in this age group have not identified a potential signal, although rare case reports of MIS in adults following vaccination highlight the importance of monitoring for this possible adverse effect. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Children'.)",
                  "answer_start": 58390,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Are COVID-19 vaccines associated with thrombotic complications? If so, which vaccines?\n\n",
              "id": 283970,
              "answers": [
                {
                  "answer_id": 279619,
                  "document_id": 455837,
                  "question_id": 283970,
                  "text": "Extremely rare cases of thrombotic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis, cerebral venous sinus thrombosis) associated with thrombocytopenia have been reported 5 to 30 days following vaccination with ChAdOx1 nCoV-19/AZD1222 (AstraZeneca COVID-19 vaccine) and Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine), a syndrome referred to as vaccine-induced immune thrombotic thrombocytopenia (VITT). The mechanism is similar to autoimmune heparin-induced thrombocytopenia (HIT). There are no known risk factors; individuals with risk factors for or a history of venous or arterial thromboembolism do not appear to be at increased risk for VITT.\n\nThe features suggestive of VITT are summarized in the table and diagnostic algorithm (table 15 and algorithm 4). (See \"COVID-19: Vaccine-induced immune thrombotic thrombocytopenia (VITT)\".)\n\nBecause of the rarity of VITT and the potential severity of COVID-19, the overall benefit of vaccination outweighs the risk of VITT for most individuals. Nevertheless, several countries have suspended use of ChAdOx1 nCoV-19/AZD1222 pending additional data, and some are limiting it to individuals over a certain age.",
                  "answer_start": 60611,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can analgesics or antipyretics be taken for side effects following vaccination?\n\n",
              "id": 283971,
              "answers": [
                {
                  "answer_id": 279639,
                  "document_id": 455837,
                  "question_id": 283971,
                  "text": "Analgesics or antipyretics (eg, nonsteroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) can be taken for local or systemic side effects following vaccination. However, pre-emptive use of these agents prior to vaccination is not recommended because of the uncertain impact on immune response to the vaccine. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Expected adverse effects and their management'.)",
                  "answer_start": 61992,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can other vaccines be given with COVID-19 vaccine?\n\n",
              "id": 283972,
              "answers": [
                {
                  "answer_id": 279640,
                  "document_id": 455837,
                  "question_id": 283972,
                  "text": "Although there are no data regarding safety and efficacy when COVID-19 vaccines are coadministered with other vaccines, the CDC has stated that COVID-19 vaccines can be administered at any time in relation to other non-COVID-19 vaccines, and if needed, can be administered on the same day as other vaccines. It is unknown if local and systemic side effects are more frequent or more intense with coadministration on the same day, but this will be monitored. The Advisory Committee on Immunization Practices (ACIP) had previously suggested that non-COVID-19 vaccines not be administered within 14 days of COVID-19 vaccination, but the recommendation was revised because of concerns of resulting delays in vaccination. The updated approach was also influenced by experience with other vaccines that suggests that coadministration does not compromise safety or immunogenicity. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Timing with relation to non-COVID-19 vaccines'.)",
                  "answer_start": 62504,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            }
          ],
          "context": "COVID-19: Questions and answers\nWritten by the physician editors at UpToDate\n\nAll topics are updated as new evidence becomes available and our peer review process is complete.\n\nLiterature review current through: December 2021. | This topic last updated: January 18, 2022.\n\nThis topic provides answers to some of the most commonly asked questions by UpToDate users. Additional content on coronavirus disease 2019 (COVID-19) is provided separately and can be accessed through the UpToDate COVID-19 homepage or through the links provided below. (See 'Related UpToDate content' below.)\n\nVIROLOGY AND TRANSMISSION\n\nHow is SARS-CoV-2 (the virus that causes COVID-19) transmitted?\n\nDirect person-to-person respiratory transmission is the primary means of transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is thought to occur mainly through close-range contact (ie, within approximately six feet or two meters) via respiratory particles; virus released in the respiratory secretions when a person with infection coughs, sneezes, or talks can infect another person if it is inhaled or makes direct contact with the mucous membranes. Infection might also occur if a person's hands are contaminated by these secretions or by touching contaminated surfaces and then they touch their eyes, nose, or mouth, although contaminated surfaces are not thought to be a major route of transmission.\n\nSARS-CoV-2 can also be transmitted longer distances through the airborne route (through inhalation of particles that remain in the air over time and distance), but the extent to which this mode of transmission has contributed to the pandemic is unclear. Scattered reports of SARS-CoV-2 outbreaks (eg, in a restaurant, on a bus) have highlighted the potential for longer-distance airborne transmission in enclosed, poorly ventilated spaces.\n\nWhile SARS-CoV-2 RNA has been detected in non-respiratory specimens (eg, stool, blood), neither fecal-oral nor bloodborne transmission appear to be significant sources of infection. SARS-CoV-2 infection has been described in animals, but there is no evidence to suggest that animals are a major source of transmission. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Transmission'.)\n\nWhat is the incubation period for COVID-19?\n\nThe incubation period for COVID-19 is thought to be within 14 days following exposure, with most cases occurring approximately three to five days after exposure. The incubation period also varies by viral variant. For example, the incubation period for the Omicron variant (B.1.1.159) appears to be slightly shorter than other variants, with symptoms first appearing around three days after exposure. (See \"COVID-19: Clinical features\", section on 'Incubation period'.)\n\nWhat are some of the important SARS-CoV-2 variants?\n\nMultiple SARS-CoV-2 variants are circulating globally. Some variants contain mutations in the surface spike protein, which mediates viral attachment to human cells and is a target for natural and vaccine-induced immunity. Thus, these variants have the potential to be more transmissible, cause more severe disease, and/or evade natural or vaccine-induced immune responses. Some of the more important circulating variants are:\n\n●Alpha (B.1.1.7 lineage), also known as 20I/501Y.V1, was first identified in the United Kingdom in late 2020. This variant is estimated to be more transmissible than wild-type virus. Some studies suggest this variant may cause more severe illness.\n\n●Delta (B.1.617.2 lineage), also known as 20A/S:478K, was identified in late 2020 in India. This variant is more transmissible than B.1.1.7 and is also associated with more severe disease.\n\n●Omicron (B.1.1.529 lineage) was first reported from southern Africa in November 2021, and it was promptly identified in multiple other countries. The variant contains >30 mutations in the spike protein, including mutations that have been found in other variants of concern and that have been associated with increased transmissibility and decreased susceptibility to neutralizing antibodies (including therapeutic monoclonal antibodies). Emerging data suggest that Omicron has a replication advantage over the Delta variant and evades infection- and vaccine-induced humoral immunity to a greater extent than prior variants. The risk of severe disease with the Omicron variant is more uncertain.\n\nThese and other variants are listed in this table (table 1) and discussed separately. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Variants of concern' and \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Efficacy against variants of concern'.)\n\nCLINICAL PRESENTATION\n\nWhat are the clinical presentation and natural history of COVID-19?\n\nThe spectrum of illness associated with COVID-19 is wide, ranging from asymptomatic infection to life-threatening respiratory failure. When symptoms are present, they typically arise approximately four to five days after exposure. Symptoms are mild in approximately 80 to 85 percent of cases and often include fever, fatigue, dry cough, myalgias, and headache. Loss of taste or smell is commonly reported, and these symptoms are most strongly associated with a positive SARS-CoV-2 test. Gastrointestinal symptoms are uncommon but may be the presenting feature in some patients. Rhinorrhea and sore throat are less common.\n\nDyspnea affects approximately 20 to 30 percent of patients, typically arising five to eight days after symptom onset. Progression from dyspnea to acute respiratory distress syndrome (ARDS) can be rapid; thus, the onset of dyspnea is generally an indication for hospital evaluation and management.\n\nPneumonia is the most common manifestation of severe disease. ARDS develops in a sizable minority of symptomatic patients and can be associated with an exuberant inflammatory response, which is characterized by fever, progressive hypoxia and/or hypotension, and markedly elevated inflammatory markers. ARDS is the leading cause of death, followed by sepsis, cardiac complications, and secondary infections.\n\nThe overall case fatality rate in unvaccinated individuals is estimated to be between 0.15 and 1 percent, although it varies widely by age and other patient characteristics. While severe and fatal illness can occur in anyone, the risk rises dramatically with age and the presence of chronic illnesses, including cardiovascular disease, pulmonary disease, diabetes mellitus, kidney disease, and cancer (table 2). (See \"COVID-19: Clinical features\".)\n\nWhat factors are associated with severe COVID-19?\n\nSevere illness can occur in otherwise healthy individuals of any age, but it predominantly occurs in adults with advanced age and/or certain underlying medical comorbidities and among those who are not vaccinated. These comorbidities and other less common comorbidities are compiled in a table by the United States Centers for Disease Control and Prevention (CDC); the strength of evidence informing each association varies (table 2). (See \"COVID-19: Clinical features\", section on 'Risk factors for severe illness'.)\n\nIs COVID-19 caused by the Omicron variant less severe than infection caused other variants?\n\nEarly data suggest that COVID-19 caused by the Omicron variant is less severe than infection caused by prior variants. Some studies have shown a reduced risk of hospitalization, intensive care unit admission, and in-hospital mortality. The relative mildness of disease reported in these studies may reflect the younger age of individuals impacted at this stage of the surge or a higher proportion of reinfections. While illness due to the Omicron may be milder, the high volume of cases continues to lead to high hospitalization rates and may result in excess burden on the health care system. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Omicron (B.1.1.529 lineage)'.)\n\nCOMPLICATIONS AND ASSOCIATED SYNDROMES\n\nWhat are the major cardiac complications in patients with COVID-19? And how often do they occur?\n\nCardiac manifestations are common in hospitalized patients and occur most frequently in critically ill patients. The most common complications are listed here:\n\n●Cardiac troponin elevation, which is a biomarker of myocardial injury, occurs in approximately 10 to 35 percent of hospitalized patients. In the majority of these patients, cardiac signs and symptoms are not present and the cause of the troponin rise is not acute myocardial infarction (MI). However, patients with a clinical presentation (including history or electrocardiogram) suggestive of acute MI require prompt evaluation and treatment.\n\nUsually, troponin elevation in COVID-19 patients is due to other causes of myocardial injury including stress cardiomyopathy, hypoxic injury, myocarditis, right heart strain, microvascular dysfunction, and systemic inflammatory response syndrome. For those without suspected acute MI, further evaluation is focused on testing expected to impact management.\n\nThe following complications may occur with or without troponin elevation:\n\n●Arrhythmias have been reported in approximately 5 to 20 percent of hospitalized cases, and most are asymptomatic. Causes may include hypoxia, electrolyte abnormalities, myocardial injury, and drug effects (such as QT-prolonging agents).\n\n●Heart failure is the most common symptomatic cardiac complication. Data on its incidence are limited; however, its presence is associated with increased mortality. Heart failure in patients with COVID-19 may be precipitated by acute illness in patients with pre-existing known or undiagnosed heart disease (eg, coronary artery disease or hypertensive heart disease) or incident acute myocardial injury (eg, stress cardiomyopathy or acute MI).\n\n(See \"COVID-19: Evaluation and management of cardiac disease in adults\" and \"COVID-19: Myocardial infarction and other coronary artery disease issues\" and \"COVID-19: Arrhythmias and conduction system disease\".)\n\nWhat are the major thrombotic complications in patients with COVID-19?\n\nCOVID-19 is a hypercoagulable state associated with an increased risk of venous thromboembolism (VTE; including deep vein thrombosis and pulmonary embolism) and arterial thrombosis, including stroke, myocardial infarction, and possibly limb ischemia. The risk is highest in individuals in the intensive care unit (ICU), often despite prophylactic anticoagulation. Bleeding is not common but has been seen, especially in the setting of trauma and/or anticoagulation. (See \"COVID-19: Hypercoagulability\", section on 'VTE'.)\n\nWhat are the most common dermatologic syndromes associated with COVID-19?\n\nThe most common cutaneous findings reported in patients with COVID-19 include an exanthematous (morbilliform) rash, pernio-like acral lesions, livedo-like lesions, retiform purpura, necrotic vascular lesions, urticaria, vesicular (varicella-like) eruptions, and erythema multiforme-like lesions. An erythematous, polymorphic rash has also been associated with a related multisystem inflammatory syndrome in children. The frequency of cutaneous findings is estimated to range from less than 1 percent to 20 percent of patients with COVID-19.\n\nUncertainty remains about the strength and mechanisms of associations between reported skin findings and COVID-19. The timing of the appearance of cutaneous findings in relation to the course of COVID-19 has varied, with reports describing skin changes occurring prior to, concomitantly, or following symptoms of COVID-19. (See \"COVID-19: Cutaneous manifestations and issues related to dermatologic care\".)\n\nWhat is multisystem inflammatory syndrome associated with COVID-19?\n\nMultisystem inflammatory syndrome in children (MIS-C) is a rare but serious condition that has been reported in patients with current or recent COVID-19 infection or exposure. It shares clinical features with Kawasaki disease (KD), KD shock, and toxic shock syndrome. Clinical features include persistent fever, severe illness with involvement of multiple organ systems, and elevated inflammatory markers (table 3). Most children with MIS-C have survived, although some have required intensive care. Intravenous immune globulin is suggested in all patients who meet criteria for MIS-C, along with glucocorticoids in those with moderate or severe manifestations (algorithm 1). (See \"COVID-19: Multisystem inflammatory syndrome in children (MIS-C) clinical features, evaluation, and diagnosis\" and \"COVID-19: Multisystem inflammatory syndrome in children (MIS-C) management and outcome\".)\n\nA very similar syndrome has also been reported in adults in association with COVID-19 infection or exposure and is termed multisystem inflammatory syndrome in adults (MIS-A). (See \"COVID-19: Care of adult patients with systemic rheumatic disease\", section on 'COVID-19 as a risk factor for rheumatologic disease'.)\n\nWhat is \"long-COVID\"?\n\n\"Long-COVID,\" also referred to as post-COVID conditions, post-COVID syndrome, or postacute sequelae of SARS-CoV-2 infection (PASC), generally refers to symptoms that develop during or after acute COVID-19 illness, continue for ≥2 months (ie, 3 months from symptom onset), and are not explained by an alternative diagnosis. It is not yet known whether \"long-COVID\" represents a new syndrome unique to COVID-19 or overlaps with recovery from similar illnesses. (See \"COVID-19: Evaluation and management of adults following acute viral illness\", section on 'Terminology and stages of recovery'.)\n\nPersistent physical symptoms following acute COVID-19 are common and typically include fatigue, dyspnea, chest pain, and cough. Headache, joint pain, dysgeusia, myalgias, and diarrhea have also been reported. Common psychological and cognitive symptoms include poor concentration, insomnia, anxiety, and depression. The time to symptom resolution depends primarily on premorbid risk factors, the severity of the acute illness, and the spectrum of initial symptoms. However, prolonged symptoms are common even in patients with less severe disease who were never hospitalized. (See \"COVID-19: Evaluation and management of adults following acute viral illness\", section on 'Expected recovery time course'.)\n\nCLINICAL EVALUATION\n\nIs there a way to distinguish COVID-19 clinically from other respiratory illnesses, particularly influenza?\n\nNo, the clinical features of COVID-19 overlap substantially with influenza and other respiratory viral illnesses. There is no way to distinguish among them without testing. (See \"COVID-19: Clinical features\".)\n\nWhen should patients with confirmed or suspected COVID-19 be advised to stay at home? Have an in-person clinical evaluation?\n\nHome management is appropriate for most patients with mild symptoms (eg, fever, cough, and/or myalgias without dyspnea), provided they can be adequately isolated, monitored, and supported in the outpatient setting. There should be a low threshold to clinically evaluate patients who have any risk factors for more severe illness, even if they have only mild symptoms. In addition, certain outpatients who have mild to moderate symptoms and risk factors for severe disease (table 2) are candidates for early treatment with COVID-19-specific therapy. (See 'Are there any COVID-19-specific therapies available for non-hospitalized patients?' below.)\n\nPatients being managed at home should be educated about the potential for worsening disease and advised to closely monitor for symptoms of more serious disease, including dyspnea or persistent chest pain. The development of these symptoms should prompt clinical evaluation and possible hospitalization. (See \"COVID-19: Outpatient evaluation and management of acute illness in adults\", section on 'Determine if in-person evaluation warranted'.)\nLABORATORY EVALUATION\n\nWhat laboratory abnormalities are commonly seen in patients with COVID-19?\n\nCommon laboratory abnormalities among hospitalized patients with COVID-19 include:\n\n●Lymphopenia\n\n●Elevated aminotransaminase levels\n\n●Elevated lactate dehydrogenase levels\n\n●Elevated inflammatory markers (eg, ferritin, C-reactive protein, and erythrocyte sedimentation rate)\n\nAbnormalities in coagulation testing, elevated procalcitonin levels, and elevated troponin levels have also been reported. The degree of these abnormalities tends to correlate with disease severity. (See \"COVID-19: Epidemiology, virology, and prevention\".)\n\nWhat are the major coagulation abnormalities in patients with COVID-19?\n\nA number of laboratory abnormalities have been reported, including high fibrinogen and D-dimer and mild prolongation of the prothrombin time (PT) and activated partial thromboplastin time (aPTT). Abnormal coagulation studies are mainly used to monitor clinical status and to help determine level of care. Very high D-dimer is associated with a high mortality rate. Atypical findings (eg, severe thrombocytopenia) should be further evaluated. (See \"COVID-19: Hypercoagulability\", section on 'Coagulation abnormalities'.)\n\nDIAGNOSTIC TESTING\n\nWhat are the different types of tests for COVID-19?\n\nThere are three major types of tests for COVID-19 (table 4):\n\n●Nucleic acid amplifications tests (NAATs; eg, reverse transcription polymerase chain reaction [RT-PCR]) – RT-PCR for SARS-CoV-2 is the primary test used to diagnose active COVID-19. The test is performed primarily on upper respiratory specimens (including nasopharyngeal swabs, nasal swabs, and saliva) but can also be performed on lower respiratory tract samples. Sensitivity and specificity are generally high, although performance varies based on the specific assay used, specimen quality, and duration of illness.\n\n●Antigen tests – Antigen tests can also be used to diagnosis active infection. Antigen tests are less sensitive than NAATs, and their performance varies by the specific antigen test. These tests are typically performed on nasopharyngeal or nasal swabs.\n\n●Serology – Serologic tests measure antibodies to SARS-CoV-2 and are primarily used to identify patients who have had COVID-19 in the past as well as patients with current infection who have had symptoms for three to four weeks. Sensitivity and specificity are highly variable, and cross-reactivity with other coronaviruses has been reported.\n\nBoth NAATs and antigen tests can be used to screen patients in congregate settings, such as long-term care facilities. (See \"COVID-19: Diagnosis\", section on 'Diagnostic approach' and \"COVID-19: Epidemiology, virology, and prevention\", section on 'Screening in high-risk settings'.)\n\nHow accurate is RT-PCR for SARS-CoV-2? Should two tests be performed or one?\n\nA positive RT-PCR for SARS-CoV-2 generally confirms the diagnosis of COVID-19. However, false-negative tests from upper respiratory specimens have been well documented. If initial testing is negative, but the suspicion for COVID-19 remains, and determining the presence of infection is important for management or infection control, we suggest repeating the test. For hospitalized patients with evidence of lower respiratory tract involvement, the repeat test can be performed on expectorated sputum or a tracheal aspirate, if available.\n\nIn settings where testing is not readily available, the diagnosis of COVID-19 can be made presumptively based on a compatible clinical presentation in the setting of an exposure risk, particularly when no other cause of the symptoms is evident. (See \"COVID-19: Diagnosis\", section on 'Diagnostic approach'.)\n\nWhat are the indications for testing asymptomatic individuals?\n\nIndications for testing asymptomatic individuals include close contact with an individual with COVID-19, screening in congregate settings (eg, long-term care facilities, correctional and detention facilities, homeless shelters), and screening hospitalized patients in high-prevalence regions. Screening may also be indicated prior to time-sensitive surgical procedures or aerosol-generating procedures and prior to receiving immunosuppression. If resources allow, the United States Centers for Disease Control and Prevention (CDC) suggests serial testing of select groups of asymptomatic individuals (eg, residents and staff in congregate settings, workers with public interactions or large numbers of close contacts) to help prevent transmission by quickly identifying cases so that infected individuals can be isolated and contacts quarantined. (See \"COVID-19: Diagnosis\", section on 'Whom to test'.)\n\nCan SARS-CoV-2 variants be reliably detected by available diagnostic assays?\n\nThus far, yes. Most circulating SARS-CoV-2 variants have mutations in the S gene, which encodes the viral spike protein (table 1).\n\nWhile many nucleic acid amplification tests target the S gene, they also target other genes. Thus, if a mutation alters one gene target, the other gene targets still function and the test will detect the virus, including the Omicron variant.\n\nNotably, the Omicron variant contains a mutation that results in S gene target failure for some assays. S gene failure can be used as a marker for the Omicron variant; however, it is nonspecific and can occur with other variants, such as Alpha. Most antigen tests target nucleocapsid protein, so mutations in the spike protein would not impact the accuracy of these tests. While the Omicron variant does contain mutations in the gene that encodes the nucleocapsid, antigen testing is thought to be unaffected. (See \"COVID-19: Diagnosis\", section on 'Impact of SARS-CoV-2 mutations/variants on test accuracy'.)\n\nHOME CARE\n\nAre there any COVID-19-specific therapies available for non-hospitalized patients?\n\nAmong adult outpatients with mild to moderate COVID-19 and risk factors for progression to severe disease (table 2), we recommend treatment with COVID-19-specific therapy. We do not use COVID-19-specific therapy for individuals without risk factors or in those with asymptomatic SARS-CoV-2 infection.\n\nWe recommend nirmatrelvir-ritonavir, monoclonal antibody therapy active against circulating variants (table 1), or remdesivir as first-line therapies. Each treatment has been demonstrated to substantially reduce the risk of hospitalization (and with some interventions, mortality) in outpatients with mild to moderate COVID-19 and risk factors for progression to severe disease. The choice between therapies depends upon local availability, ease of prompt access to treatment (as all therapies must be given early in the course of illness), susceptibility to prevalent viral variants, and specific patient factors (eg, comorbid conditions, potential drug-drug interactions with nirmatrelvir-ritonavir). Additionally, monoclonal antibodies and remdesivir are administered parenterally, which may be operationally complicated in many outpatient settings.\n\nIf nirmatrelvir-ritonavir, monoclonal antibody therapy, and remdesivir are not feasible options, molnupiravir is an alternative. However, it may not be as effective as the other interventions, and there are other safety considerations.\n\nWhen the incidence of SARS-CoV-2 infection is high, supplies of these agents (and the resources required to administer them) may be insufficient to offer treatment to all eligible patients. In such circumstances, these treatments should be prioritized for individuals most likely to benefit (ie, immunocompromised individuals who are likely to have a suboptimal response to vaccination, and unvaccinated or incompletely vaccinated individuals with the highest risk for progression to severe disease) (table 5). (See \"COVID-19: Outpatient evaluation and management of acute illness in adults\", section on 'COVID-19-specific therapies'.)\n\nWhat advice should be given to patients with known or presumed COVID-19 managed at home?\n\nFor most patients with COVID-19 who are managed at home, we advise the following:\n\n●Supportive care with antipyretics/analgesics (eg, acetaminophen) and hydration\n\n●Close contact with their health care provider\n\n●Monitoring for clinical worsening, particularly the development of new or worsening dyspnea, which should prompt clinical evaluation and possible hospitalization\n\n●Separation from other household members, including pets (eg, staying in a separate room when possible and wearing a mask when in the same room)\n\n●Frequent hand washing for all family members\n\n●Frequent disinfection of commonly touched surfaces\n\n(See \"COVID-19: Outpatient evaluation and management of acute illness in adults\", section on 'Management and counseling for all outpatients'.)\n\nHow long should patients cared for at home stay isolated?\n\nThe United States Centers for Disease Control and Prevention (CDC) has issued recommendations for discontinuing home isolation in the general community. A symptom- or time-based strategy is preferred for most patients.\n\nFor symptomatic immunocompetent patients with mild disease who are cared for at home, isolation can usually be discontinued when the following criteria are met:\n\n●At least five days have passed since symptoms first appeared AND\n\n●At least one day (24 hours) has passed since resolution of fever without the use of fever-reducing medications AND \n\n●There is improvement in symptoms (eg, cough, shortness of breath)\n\nAfter discontinuing home isolation, patients should continue to wear a well-fitting mask around others. The total duration of isolation plus strict masking is 10 days. During this time, patients should avoid people who are immunocompromised or at high risk for severe disease. Additional information on restrictions (eg, travel) after the five-day isolation period can be found on the CDC website.\n\nFor patients who did not have symptoms at the time of laboratory-confirmed SARS-CoV-2 infection, home isolation can usually be discontinued when at least five days have passed since the positive COVID-19 test (followed by strict mask wearing for an additional five days), as long as there was no evidence of subsequent illness.\n\nAlthough this strategy can be used for many patients, home isolation should continue for a total of 10 days if a viral test was performed toward the end of the five-day isolation and is positive, if strict mask wearing is not possible, or if the patient had moderate disease. In addition, this strategy should not be used for those who had severe disease or are immunocompromised; for such patients, the duration of isolation may need to be extended and/or testing may be needed to confirm resolution. (See \"COVID-19: Infection prevention for persons with SARS-CoV-2 infection\", section on 'Discontinuation of precautions'.)\n\nWhat is the significance of a persistently positive RT-PCR for weeks after illness?\n\nPatients diagnosed with COVID-19 can have detectable SARS-CoV-2 RNA in upper respiratory tract specimens for weeks after the onset of symptoms. However, prolonged viral RNA detection does not necessarily indicate prolonged infectiousness. According to the CDC, isolation of infectious virus more than 10 days after illness onset is rare in patients whose symptoms have resolved.\n\nThere is no standardized approach to management of patients with persistently positive reverse transcription polymerase chain reaction (RT-PCR) 10 days or more after resolution of symptoms. However, such patients are generally felt to have low infectiousness, particularly after mild to moderate disease and in the absence of immunocompromise. This is why symptom- and time-based approaches for discontinuation of precautions are recommended for most patients. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Viral shedding and period of infectiousness'.)\n\nHOSPITAL CARE\n\nWhat is the preferred approach to oxygenation?\n\nAs a general approach, we target a peripheral oxygen saturation between 90 and 96 percent using the lowest possible fraction of inspired oxygen. We also encourage patients to self-prone, when possible, based on data that suggest improved oxygenation and minimal downside to proning.\n\n●For most patients, we use low-flow oxygen (eg, low-flow nasal cannula, simple face mask), which minimizes risk of viral aerosolization. Because exertional desaturation is common and can be profound, providing additional support with activity (eg, going to the bathroom) may be needed.\n\n●For those with acute hypoxemic respiratory failure and higher oxygen needs than low-flow oxygen can provide, we suggest selective use of noninvasive measures rather than routinely proceeding directly to intubation. Among the noninvasive modalities, we prefer high-flow nasal cannula (HFNC) over non-invasive ventilation (NIV), unless there is separate indication for NIV (eg, acute exacerbation of chronic obstructive pulmonary disease, heart failure).\n\n●We have a low threshold for intubation in patients who have any of the following: rapid progression over a few hours; failure to improve despite HFNC >60 L/min and FiO2 >0.6; development of hypercapnia; and/or hemodynamic instability or multiorgan failure.\n\n●When mechanical ventilation is required, we use low tidal volume ventilation (LTVV) targeting ≤6 mL/kg predicted body weight (PBW; range 4 to 8 mL/kg PBW (table 6 and table 7)) that targets a plateau pressure ≤30 cm H2O and applies positive end-expiratory pressure (PEEP) as outlined in the table (table 8).\n\n●For patients with COVID-19 who fail LTVV, prone ventilation is the preferred next step (table 9 and table 10).\n\n●For those who fail LTVV and prone ventilation, rescue strategies include alveolar recruitment maneuvers, high PEEP, neuromuscular blocking agents, inhaled pulmonary vasodilators, and, rarely, extracorporeal membrane oxygenation.\n\n(See \"COVID-19: Respiratory care of the nonintubated hypoxemic adult (supplemental oxygen, noninvasive ventilation, and intubation)\" and \"COVID-19: Management of the intubated adult\".)\n\nWhen are antiviral treatment, glucocorticoids, and other COVID-19-specific therapies indicated? And which agents are preferred?\n\nOur approach to COVID-19-specific therapy in hospitalized patients depends on the presence of hypoxia (O2 saturation ≤94 percent on room air), need for oxygenation or ventilatory support, and the patients’ clinical and laboratory risk factors for severe disease (algorithm 2).\n\n●For patients who do not require oxygen and do not have clinical (table 2) or laboratory (table 11) risk factors for severe disease, care is primarily supportive, with close monitoring for disease progression.\n\n●For patients who do not require oxygen but have clinical (table 2) or laboratory (table 11) risk factors for severe disease and were hospitalized for COVID-19, we suggest remdesivir. Individuals who have risk factors but were hospitalized for other reasons (ie, have incidental SARS-CoV-2 infection) may be eligible for monoclonal antibody therapy, similar to high-risk outpatients.\n\n●For patients who are receiving low-flow supplemental oxygen, we suggest low-dose dexamethasone and remdesivir. For those who have significantly elevated inflammatory markers (eg, C-reactive protein [CRP] level ≥75 mg/L), have increasing oxygen requirements despite dexamethasone, and are within 96 hours of hospitalization, we suggest adding tocilizumab or baricitinib. If supplies of tocilizumab or baricitinib are limited, we prioritize them for more severely ill patients on higher levels of oxygen support. For immunocompromised patients, we also evaluate whether monoclonal antibody therapy is available through an investigational new drug application.\n\n●For hospitalized patients who are receiving high-flow supplemental oxygen or non-invasive ventilation, we recommend low-dose dexamethasone. For those who are within 24 to 48 hours of admission to an intensive care unit (ICU) or receipt of ICU-level care (and within 96 hours of hospitalization), we suggest adding tocilizumab or baricitinib. We also suggest adding remdesivir; however, if supplies are limited, we prioritize remdesivir for patients who are on low-flow oxygen supplementation at baseline.\n\n●For hospitalized patients who require mechanical ventilation or extracorporeal membrane oxygenation, we recommend low-dose dexamethasone. For those who are within 24 to 48 hours of admission to an ICU (and within 96 hours of hospitalization), we suggest adding tocilizumab. We suggest not routinely using remdesivir in this population.\n\n●If dexamethasone is not available, other glucocorticoids at equivalent doses are reasonable alternatives.\n\nIn addition to these therapies (or if individual patients cannot take these therapies), we refer them to a clinical trial for other therapies when available. Other investigational therapies include other antiviral agents, cytokine and kinase inhibitors, and other immunomodulatory agents. Clinicians may also be able to obtain convalescent plasma for use outside a trial setting; however, we suggest not using convalescent plasma for mechanically ventilated patients and not using it outside the context of clinical trials for most other hospitalized patients because of lack of clear benefit. We generally do not use other agents off label for treatment of COVID-19. In particular, we suggest not using hydroxychloroquine, chloroquine, or ivermectin, given the lack of benefit and potential for toxicity. (See \"COVID-19: Management in hospitalized adults\" and \"COVID-19: Management in hospitalized adults\", section on 'COVID-19-specific therapy'.)\n\nIs anticoagulation indicated in all hospitalized patients? And if so, how much?\n\nYes, all hospitalized patients with COVID-19 should receive at least prophylactic-dose anticoagulation unless contraindicated (algorithm 3).\n\n●For thromboprophylaxis, we suggest standard prophylactic dosing rather than higher intensity (intermediate- or full-dose) anticoagulation for most inpatients, including in the ICU. Individuals already receiving full-dose anticoagulation for another indication should continue it. Thromboprophylaxis is typically discontinued upon hospital discharge, with rare exceptions.\n\n●We have a low threshold for evaluating for venous thromboembolism (VTE; including deep vein thrombosis, pulmonary embolism, or other sites). If VTE is documented or strongly suspected, full-dose anticoagulation is used for at least three months.\n\nOur approach to the evaluation and management of COVID-19 hypercoagulability is presented in the table (table 12) and discussed in detail separately. (See \"COVID-19: Hypercoagulability\", section on 'Management'.)\n\nOTHER MEDICATION CONSIDERATIONS\n\nShould I use acetaminophen or NSAIDs when providing supportive care?\n\nNonsteroidal anti-inflammatory drugs (NSAIDs) have been theorized to cause harm in patients with COVID-19, but clinical data are limited. Given the uncertainty, we use acetaminophen as the preferred antipyretic agent for most patients rather than NSAIDs. If NSAIDs are needed, we use the lowest effective dose. We do not routinely discontinue NSAIDs in patients using them for the management of chronic illnesses.\n\nThe US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO) do not recommend that NSAIDs be avoided when clinically indicated. (See \"COVID-19: Management in hospitalized adults\", section on 'NSAID use'.)\n\nDo ACE inhibitors and ARBs increase the likelihood of severe COVID-19?\n\nPatients receiving angiotensin-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) should continue treatment with these agents if there is no other reason for discontinuation (eg, hypotension, acute kidney injury). Despite speculation that patients with COVID-19 who are receiving these agents may be at increased risk for adverse outcomes, accumulating evidence does not support an association of ACE inhibitors and ARBs with more severe disease. In addition, stopping these agents in some patients can exacerbate comorbid cardiovascular or kidney disease and increase mortality. (See \"COVID-19: Issues related to acute kidney injury, glomerular disease, and hypertension\", section on 'Renin angiotensin system inhibitors'.)\n\nSPECIAL POPULATIONS\n\nAsthma/COPD\n\nShould patients using inhaled glucocorticoids for asthma or COPD be advised to stop these medications to prevent COVID-19?\n\nNo, patients with asthma or chronic obstructive pulmonary disease (COPD) who need inhaled glucocorticoids to maintain control of their asthma or COPD should continue them at their usual dose. When indicated, inhaled steroids help to minimize risk of an asthma or COPD exacerbation and the associated need for interaction with the health care system. There is no good evidence that inhaled glucocorticoids increase susceptibility to COVID-19 or have an adverse effect on the course of infection. Stopping them may worsen asthma or COPD control and thereby increase the risk for complications of COVID-19, if acquired. (See \"An overview of asthma management\", section on 'Advice related to COVID-19 pandemic' and \"Stable COPD: Overview of management\", section on 'Advice related to COVID-19'.)\n\nShould patients with COVID-19 and an acute exacerbation of asthma or COPD be treated with systemic glucocorticoids?\n\nYes, patients with COVID-19 infection and a concomitant acute exacerbation of asthma or COPD should receive prompt treatment with systemic glucocorticoids as indicated by usual guidelines. Delaying therapy can increase the risk of a life-threatening exacerbation. While the World Health Organization (WHO) and United States Centers for Disease Control and Prevention (CDC) recommend glucocorticoids not be routinely used in the treatment of COVID-19 infection, exacerbations of asthma and COPD are considered appropriate indications for use. Overall, the known benefits of systemic glucocorticoids for exacerbations of asthma and COPD outweigh the potential harm in COVID-19 infection. (See \"An overview of asthma management\", section on 'Advice related to COVID-19 pandemic' and \"Stable COPD: Overview of management\", section on 'Advice related to COVID-19'.)\n\nPregnancy, delivery, and breastfeeding\n\nWhat special considerations are there for pregnant and breastfeeding women?\n\nIssues related to COVID-19 during pregnancy, delivery, and the postpartum period are discussed separately. (See \"COVID-19: Pregnancy issues and antenatal care\" and \"COVID-19: Labor, birth, and postpartum issues and care\" and \"COVID-19 and pregnancy: Questions and answers\".)\n\nPediatrics\n\nWhat special considerations are there for children?\n\nSpecific considerations for children, including an overview of multisystem inflammatory syndrome, are discussed separately. (See \"COVID-19: Clinical manifestations and diagnosis in children\" and \"COVID-19: Management in children\" and \"COVID-19: Multisystem inflammatory syndrome in children (MIS-C) clinical features, evaluation, and diagnosis\" and \"COVID-19: Multisystem inflammatory syndrome in children (MIS-C) management and outcome\".)\n\nOther special populations\n\nWhat considerations are there for other special populations?\n\nIssues related to the care of other special populations during the COVID-19 pandemic are discussed separately. Refer to the UpToDate COVID-19 homepage and the topics linked below.\n\n●(See \"COVID-19: Considerations in patients with cancer\".)\n\n●(See \"COVID-19: Care of adult patients with systemic rheumatic disease\".)\n\n●(See \"COVID-19: Issues related to diabetes mellitus in adults\".)\n\n●(See \"COVID-19: Issues related to gastrointestinal disease in adults\".)\n\n●(See \"COVID-19: Issues related to acute kidney injury, glomerular disease, and hypertension\".)\n\n●(See \"COVID-19: Issues related to liver disease in adults\".)\n\n●(See \"COVID-19: Issues related to solid organ transplantation\".)\n\n●(See \"COVID-19: Issues related to wound care and telehealth management\".)\n\n●(See \"COVID-19: Management in nursing homes\".)\n\nINFECTION PREVENTION\n\nAre any medications available to prevent COVID-19 following exposure?\n\nIn the United States, the Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to use the monoclonal antibodies casirivimab-imdevimab and bamlanivimab-etesevimab to prevent SARS-CoV-2 infection in select individuals over 12 years of age. However, since these combinations are not expected to retain activity against the Omicron variant, their distribution to states or territories that have >80 percent prevalence of the Omicron variant has been paused. Although the monoclonal antibody sotrovimab may retain activity against Omicron, it has not been studied for post-exposure prophylaxis and should not be used for this purpose.\n\nOther agents (eg, hydroxychloroquine, ivermectin, tixagevimab-cilgavimab [another monoclonal antibody combination]) have not been shown to be effective. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Post-exposure prophylaxis for select individuals'.)\n\nWhat PPE is recommended for health care personnel taking care of patients with suspected or confirmed COVID-19?\n\nAny personnel entering the room of a patient with suspected or confirmed COVID-19, regardless of COVID-19 vaccination status, should wear the appropriate personal protective equipment (PPE): gown, gloves, eye protection (full face shield preferred rather than goggles or a surgical mask with an attached eye shield), and a respirator (eg, an N95 respirator). If the supply of respirators is severely limited, medical masks are an acceptable alternative, except during aerosol-generating procedures (eg, tracheal intubation and extubation, tracheotomy, bronchoscopy, noninvasive ventilation, cardiopulmonary resuscitation).\n\nHealth care personnel should be aware of the appropriate sequence of putting on (figure 1) and taking off (figure 2) PPE to avoid contamination. (See \"COVID-19: Infection prevention for persons with SARS-CoV-2 infection\".)\n\nWhat type of room should patients with known or suspected COVID-19 be placed in?\n\nMost hospitalized patients should be placed in a well-ventilated, single-occupancy room with a closed door and dedicated bathroom. When this is not possible, patients with confirmed COVID-19 can be housed together. (See \"COVID-19: Infection prevention for persons with SARS-CoV-2 infection\", section on 'Type of room'.)\n\nPatients undergoing aerosol-generating procedures (eg, tracheal intubation and extubation, tracheotomy, bronchoscopy, noninvasive ventilation) should be placed in an airborne isolation room (ie, a single-patient, negative-pressure room), except when these procedures are performed in the operating room or when such rooms are unavailable. (See \"COVID-19: Infection prevention for persons with SARS-CoV-2 infection\", section on 'Aerosol-generating procedures/treatments'.)\n\nSpecial considerations for patients undergoing aerosol-generating procedures in the operating room are discussed elsewhere. (See \"COVID-19: Anesthetic concerns, including airway management and infection control\".)\n\nOutside of the operating room, patients with suspected or known COVID-19 should not be placed in positive-pressure rooms. (See \"COVID-19: Infection prevention for persons with SARS-CoV-2 infection\".)\n\nShould individuals who are fully vaccinated continue to wear masks and physically distance?\n\nAlthough SARS-CoV-2 infection might still occur despite vaccination, the risk is substantially lower. Recommendations on public health precautions following vaccination have evolved with new developments in the pandemic (eg, emergence of the highly transmissible Delta and Omicron variants), and the approach should be tailored to the overall rate of transmission in the community.\n\nIn the United States, the Centers for Disease Control and Prevention (CDC) suggests that all individuals wear masks in indoor public settings in areas where community transmission is substantial (ie, ≥50 cases/100,000 people over the prior seven days or >8 percent positive nucleic acid amplification test [NAAT] rate). Masks are also recommended on all forms of public transportation, regardless of vaccination status. We also counsel immunocompromised individuals to maintain personal preventive measures even if they have been vaccinated, particularly when contact with unvaccinated individuals is possible, because they may have suboptimal responses to COVID-19 vaccination. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Wearing masks in the community' and \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Post-vaccine public health precautions'.)\n\nVACCINATION AND IMMUNITY\n\nImmunity and vaccine efficacy\n\nDoes protective immunity develop after SARS-CoV-2 infection? Can reinfection occur?\n\nProtective SARS-CoV-2-specific antibodies and cell-mediated responses are induced following infection. Evidence suggests that some of these responses can be detected for at least a year following infection. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Immune responses following infection'.)\n\nIn general, the short-term risk of reinfection (eg, within the first several months after initial infection) is low. However, the risk of reinfection with the Omicron variant following infection with other variants is higher. (See \"COVID-19: Epidemiology, virology, and prevention\", section on 'Risk of reinfection'.)\n\nHow efficacious is vaccination at preventing symptomatic COVID-19?\n\nVaccine efficacy varies by type (table 13). Based on phase III trial data:\n\n●BNT162b2 (Pfizer-BioNTech COVID-19 vaccine) had 95 percent efficacy in preventing symptomatic COVID-19 at or after day 7 following completion of a two-dose series. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'BNT162b2 (Pfizer-BioNTech COVID-19 vaccine)'.)\n\n●mRNA-1273 (Moderna COVID-19 vaccine) had 95 percent efficacy in preventing symptomatic COVID-19 at or after day 7 following completion of a two-dose series. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'mRNA-1273 (Moderna COVID-19 vaccine)'.)\n\n●Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine) had 66 percent efficacy against moderate to severe COVID-19 and 85 percent efficacy against severe COVID-19 at or after 28 days following administration of a single dose. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine)'.)\n\n●ChAdOx1 nCoV-19/AZD1222 (AstraZeneca COVID-19 vaccine) had 70 percent efficacy in preventing symptomatic COVID-19 at or after two weeks following completion of a two-dose series. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'ChAdOx1 nCoV-19/AZD1222 (University of Oxford, AstraZeneca, and the Serum Institute of India)'.)\n\nSubsequent data suggest that immunity may wane over time and varies for viral variants; mRNA vaccines may be slightly more effective at preventing severe disease than other vaccine types. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Immunogenicity, efficacy, and safety of select vaccines'.)\n\nAvailable data and the efficacy of other vaccines types are discussed separately. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Immunogenicity, efficacy, and safety of select vaccines'.)\n\nHow effective is vaccination against the Delta and Omicron variants?\n\nVaccine effectiveness against Delta is reduced against overall infection but largely retained against severe disease. Preliminary evidence suggests reduced vaccine effectiveness, particularly against overall infection, with Omicron (table 1). (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Efficacy against variants of concern'.)\n\nHave breakthrough infections been reported following vaccination?\n\nYes, breakthrough infection after vaccination has been reported but occurs much less frequently than infection in unvaccinated individuals, and a high proportion of breakthrough infections may be asymptomatic.\n\nSome reports suggest a higher rate of breakthrough infections with the Delta variant; however, the risk of severe breakthrough infection with the Delta variant remains low. The Omicron variant appears to evade vaccine-induced humoral immunity more than other variants. The risk of severe disease associated with the Omicron variant is uncertain. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Breakthrough infections after vaccination'.)\n\nVaccine availability and indications for vaccination\n\nWhich vaccines are currently available in the United States? Worldwide?\n\nIn the United States, these vaccines are available:\n\n●BNT162b2 (Pfizer-BioNTech COVID-19 vaccine)\n\n●mRNA-1273 (Moderna COVID-19 vaccine)\n\n●Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine)\n\nBNT162b2 and mRNA-1273 are mRNA vaccines and are delivered in lipid nanoparticles. Once injected and taken up into muscle cells, the mRNA expresses the SARS-CoV-2 surface spike protein. Spike protein mediates viral attachment to human cells (figure 3). Expression of the spike protein induces binding and neutralizing antibody responses. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'BNT162b2 (Pfizer-BioNTech COVID-19 vaccine)' and \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'mRNA-1273 (Moderna COVID-19 vaccine)'.)\n\nAd26.COV2.S is based on a replication-incompetent adenovirus 26 vector that expresses a stabilized spike protein. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\".)\n\nOutside of the United States, vaccine availability varies regionally. One of the most widely available vaccines is ChAdOx1 nCoV-19/AZD1222 (University of Oxford, AstraZeneca, and the Serum Institute of India vaccines), an adenovirus vector-based DNA vaccine that also expresses the surface spike protein. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Other countries'.)\n\nNumerous additional vaccine candidates are being evaluated for prevention of COVID-19, including nucleic acid-based (mRNA and DNA) vaccines, viral-vector vaccines, and inactivated or recombinant protein vaccines (figure 4 and table 13). (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\".)\n\nAvailable vaccines and vaccine candidates are also catalogued on the World Health Organization website.\n\nWhat are the indications and contraindications to vaccination?\n\nFor patients in the United States, we recommend vaccination with BNT162b2 (Pfizer-BioNTech COVID-19 vaccine), mRNA-1273 (Moderna COVID-19 vaccine), or Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine).\n\n●Individuals ≥5 years old are eligible for BNT162b2.\n\n●Individuals ≥18 years old are eligible for mRNA-1273 and Ad26.COV2.S.\n\nIf availability is not an issue, we suggest one of the mRNA vaccines (BNT162b2 or mRNA-1273) rather than Ad26.COV2.S.\n\nContraindications to these vaccines are:\n\n●For the mRNA COVID-19 vaccines:\n\n•A history of a severe allergic reaction, such as anaphylaxis, after a previous dose of an mRNA COVID-19 vaccine or to any of its components (including polyethylene glycol).\n\n•An immediate allergic reaction of any severity (including hives) to a previous dose of an mRNA COVID-19 vaccine, to any of its components, or to polysorbate (with which there can be cross-reactive hypersensitivity to polyethylene glycol). Such individuals should not receive an mRNA COVID-19 vaccine unless they have been evaluated by an allergy expert who determines that it can be given safely.\n\nComponents of the mRNA COVID-19 vaccines are listed on the United States Centers for Disease Control and Prevention (CDC) website.\n\nThe United States Advisory Committee on Immunization Practices lists history of severe allergic reaction to any other vaccine or injectable therapy (that does not share the same components as the mRNA COVID-19 vaccines) as a precaution, but not contraindication, to mRNA COVID-19 vaccination.\n\n●For Ad26.COV2.S:\n\n•A history of a severe allergic reaction, such as anaphylaxis, to the vaccine or any of its components.\n\n•A history of thrombosis with thrombocytopenia following an Ad26.COV2.S or any other adenoviral vector COVID-19 vaccine.\n\nIndividuals with a precaution to vaccination, as well as any individual with a history of anaphylaxis that does not result in a contraindication to vaccination, should be monitored for 30 minutes after vaccination. All other recipients should be monitored for 15 minutes. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Indications and vaccine selection' and \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Contraindications and precautions (including allergies)'.)\n\nAre vaccine recommendations different for immunocompromised patients?\n\nThe United States Advisory Committee on Immunizations Practices (ACIP) recommends that patients with certain moderate to severe immunocompromising conditions receive three mRNA vaccine doses as part of the primary series rather than two doses. Immunocompromising conditions that warrant the third dose include active chemotherapy for cancer, hematologic malignancies, hematopoietic cell transplantation (HCT) or solid organ transplantation, advanced or untreated HIV infection with a CD4 count <200 cell/microL, moderate or severe primary immunodeficiency disorder, and use of immunosuppressive medications (eg, mycophenolate mofetil, rituximab, prednisone >20 mg/day for >14 days) (table 14). For those who received COVID-19 vaccination prior to HCT or CAR-T cell therapy, the CDC recommends repeat vaccination with a full primary series at least three months after the transplant or CAR-T administration. Such patients meet criteria for receiving a three-dose primary series with the mRNA vaccines.\n\nThe third dose should be given at least 28 days after the second dose. Individuals >5 years of age are eligible for BNT162b2 (Pfizer-BioNTech COVID-19 vaccine), and individuals >18 years of age are eligible for mRNA-1273 (Moderna COVID-19 vaccine). Immunocompromised individuals who received three doses of a primary mRNA vaccine series may also receive a booster dose five months later. Patients who received Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine) should receive a booster vaccine dose after the primary series. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Immunocompromised individuals'.)\n\nWho is eligible for a booster dose? And when should it be administered?\n\nBecause of the possibility of waning immunity and decreased efficacy against variants that might escape the immune response directed against spike proteins targeted by the original vaccines, several countries have initiated or announced plans to administer a booster vaccine for individuals who have been fully vaccinated. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\".)\n\nIn the United States, the Food and Drug Administration (FDA) has authorized and the CDC recommends a booster dose be given for individuals 12 years of age or older.\n\n●For those who previously received BNT162b2 [Pfizer COVID-19 vaccine]), the CDC recommends a booster dose at least five months after completion of the primary series.\n\n●For those who previously received mRNA-1273 (Moderna COVID-19 vaccine), the CDC recommends a booster dose at least five months after completion of the primary series.\n\n●For those who previously received Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine), the CDC recommends a booster dose at least two months after completion of the primary series.\n\nAny one of the vaccines can be given as a booster dose. However, we prefer one of the mRNA vaccines. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Role of booster vaccinations/waning efficacy' and \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Mixing vaccine types'.)\n\nBooster doses following a primary vaccine series are a distinct issue from administering a third dose of an mRNA vaccine for the primary series in certain immunocompromised patients. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Immunocompromised individuals'.)\n\nAdverse effects\n\nWhat adverse effects are associated with vaccination?\n\nThe more common adverse effects for all vaccine types include local injection site reactions, fever, headache, fatigue, chills, myalgias, and arthralgias (table 13). These reactions are more common in younger individuals and after the second dose (when a two-dose series is given).\n\nAnaphylaxis is a rare adverse event reported following receipt of mRNA vaccines. Most cases evaluated to date have been determined not to be caused by IgE-mediated reactions, and some patients have successfully received the second dose of the same vaccine without incident. Patients with apparent anaphylaxis to a first dose of an mRNA vaccine should be referred to an allergy specialist if possible. Alternatively, a non-mRNA vaccine could be given in place of the second dose of mRNA vaccine, followed by 30 minutes of observation. (See \"COVID-19: Allergic reactions to SARS-CoV-2 vaccines\".)\n\nThe potential associations between thromboembolism and ChAdOx1 nCoV-19/AZD1222 (AstraZeneca COVID-19 vaccine) and Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine) are discussed below and in detail in the UpToDate text. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Thrombosis with thrombocytopenia' and \"COVID-19: Vaccine-induced immune thrombotic thrombocytopenia (VITT)\".)\n\nThere are rare reports of myocarditis and pericarditis following receipt of the mRNA vaccines, BNT162b2 (Pfizer vaccine) and mRNA-1273 (Moderna vaccine), though not following receipt of Ad26.COV2.S (Janssen/Johnson & Johnson vaccine). Most reported cases were mild and occurred more commonly in males and in adolescents and young adults. Onset was generally within the first week after vaccine receipt, more commonly after the second dose. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Myocarditis'.)\n\nThere is also a possible association between Ad26.COV2.S (Janssen/Johnson & Johnson vaccine) and Guillain-Barre syndrome. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Guillain-Barre syndrome'.)\n\nA detailed list of adverse event rates and how they vary by vaccine type and patient age can be found on the CDC website. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Approach to vaccination' and \"COVID-19: Allergic reactions to SARS-CoV-2 vaccines\", section on 'mRNA vaccines'.)\n\nHow does the risk-benefit ratio for COVID-19 vaccination differ in children?\n\nThe individual benefit of COVID-19 vaccination in young children may be somewhat less than in adults because COVID-19 tends to be less severe in children than in adults.\n\nNevertheless, there are several compelling reasons to vaccinate children, including the potential to reduce risk of the following:\n\n●Multisystem inflammatory syndrome in children (MIS-C) following acute COVID-19\n\n●Other potential sequelae (eg, \"long COVID-19\" and indirect effects on mental health and education)\n\n●Severe disease in children with underlying medical conditions\n\n●Acute COVID-19 of any severity\n\nFurthermore, even with the lower risk of severe disease among children, the number of COVID-19 deaths among those 5 to 11 years old from 2020 to 2021 exceeds the prevaccination era mortality rates of infections for which childhood vaccines are routinely provided (eg, rotavirus, meningococcal disease, varicella).\n\nThe risks of vaccination in children are less clearly defined than in adults and adolescents. Concern about the risk of myocarditis in children has been raised because of the association of mRNA COVID-19 vaccines with myocarditis, particularly in adolescents and young adults. While the precise risk of vaccine-associated myocarditis among 5- to 11-year-olds is unknown, based on the historical age distribution of myocarditis in the pre-COVID-19 era, it is expected to be lower than that among adolescents and young adults, which is already low. In addition, most myocarditis cases following receipt of a COVID-19 mRNA vaccine are mild and short lived. The benefits of COVID-19 vaccination in children are estimated to exceed this risk.\n\nGiven the hypothesis that MIS-C is associated with immune dysregulation precipitated by SARS-CoV-2 infection, similar immune-related side effects following vaccination in children are another concern. Vaccine trials in this age group have not identified a potential signal, although rare case reports of MIS in adults following vaccination highlight the importance of monitoring for this possible adverse effect. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Children'.)\n\nAre COVID-19 vaccines associated with thrombotic complications? If so, which vaccines?\n\nExtremely rare cases of thrombotic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis, cerebral venous sinus thrombosis) associated with thrombocytopenia have been reported 5 to 30 days following vaccination with ChAdOx1 nCoV-19/AZD1222 (AstraZeneca COVID-19 vaccine) and Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine), a syndrome referred to as vaccine-induced immune thrombotic thrombocytopenia (VITT). The mechanism is similar to autoimmune heparin-induced thrombocytopenia (HIT). There are no known risk factors; individuals with risk factors for or a history of venous or arterial thromboembolism do not appear to be at increased risk for VITT.\n\nThe features suggestive of VITT are summarized in the table and diagnostic algorithm (table 15 and algorithm 4). (See \"COVID-19: Vaccine-induced immune thrombotic thrombocytopenia (VITT)\".)\n\nBecause of the rarity of VITT and the potential severity of COVID-19, the overall benefit of vaccination outweighs the risk of VITT for most individuals. Nevertheless, several countries have suspended use of ChAdOx1 nCoV-19/AZD1222 pending additional data, and some are limiting it to individuals over a certain age. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Thrombosis with thrombocytopenia'.)\n\nCan analgesics or antipyretics be taken for side effects following vaccination?\n\nAnalgesics or antipyretics (eg, nonsteroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) can be taken for local or systemic side effects following vaccination. However, pre-emptive use of these agents prior to vaccination is not recommended because of the uncertain impact on immune response to the vaccine. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Expected adverse effects and their management'.)\n\nVaccine administration\n\nCan other vaccines be given with COVID-19 vaccine?\n\nAlthough there are no data regarding safety and efficacy when COVID-19 vaccines are coadministered with other vaccines, the CDC has stated that COVID-19 vaccines can be administered at any time in relation to other non-COVID-19 vaccines, and if needed, can be administered on the same day as other vaccines. It is unknown if local and systemic side effects are more frequent or more intense with coadministration on the same day, but this will be monitored. The Advisory Committee on Immunization Practices (ACIP) had previously suggested that non-COVID-19 vaccines not be administered within 14 days of COVID-19 vaccination, but the recommendation was revised because of concerns of resulting delays in vaccination. The updated approach was also influenced by experience with other vaccines that suggests that coadministration does not compromise safety or immunogenicity. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Timing with relation to non-COVID-19 vaccines'.)\n\nWhat if the second dose of an mRNA vaccine cannot be given because of a prior reaction?\n\nFor individuals who received a first dose of an mRNA vaccine but cannot receive either mRNA vaccine for the second dose (eg, because of contraindications), Ad26.COV2.S (Janssen/Johnson & Johnson COVID-19 vaccine) can be given as long as there is not also a contraindication to Ad26.COV2.S.\n\nThe CDC suggests giving Ad26.COV2.S at least 28 days after the mRNA vaccine dose. Such individuals should be considered to have received a complete AD26.COV2.S vaccine regimen. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Administration'.)\n\nShould people who have had SARS-CoV-2 infection be vaccinated? If so, when? What if a patient acquires COVID-19 after the first dose?\n\nYes, most individuals with a history of SARS-CoV-2 infection should be vaccinated. However, for individuals who had SARS-CoV-2 infection complicated by multisystem inflammatory syndrome (MIS), the decision to vaccinate should weigh the risk of exposure, reinfection, and severe disease with infection against the uncertain safety of vaccination in such individuals. Given the hypothesis that MIS is associated with immune dysregulation precipitated by SARS-CoV-2 infection, it is unknown if a SARS-CoV-2 vaccine could trigger a similar dysregulated response.\n\nIn general, vaccination can be given as soon as the individual has recovered from acute infection (if symptomatic) and meets criteria for discontinuation of isolation precautions. Pre-vaccination serologic screening is not recommended. If infection is diagnosed after receipt of the first vaccine of a two-dose series (eg, with the mRNA COVID-19 vaccines), the second dose should still be given.\n\nDelaying vaccination for 90 days from the time of infection is also reasonable; the risk of reinfection during this time period is low, and delaying vaccination allows other people to receive the vaccination sooner. Delaying vaccination for 90 days is also suggested for individuals who were treated with monoclonal antibodies or convalescent plasma. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'History of SARS-CoV-2 infection'.)\n\nWhen administering a third dose of an mRNA vaccine to eligible individuals as part of the primary series, should the same vaccine type as the initial two doses be used?\n\nYes, the same mRNA vaccine type should be used when possible. For example, individuals who received mRNA-1273 (Moderna COVID-19 vaccine) for their first two doses should receive mRNA-1273 for their third dose. If the initial vaccine formulation is not available or not known, either mRNA COVID-19 vaccine type can be given. (See \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Immunocompromised individuals' and \"COVID-19: Vaccines to prevent SARS-CoV-2 infection\", section on 'Mixing vaccine types'.)\n\nBLOOD DONATION\n\nWhat should I tell patients about donating blood or plasma during the pandemic?\n\nBlood donation is particularly important during the pandemic due to concerns that the supply could become critically low. Having a history of COVID-19 is not an exclusion to donation as long as the illness resolved at least 14 days prior to donation. (See \"Blood donor screening: Medical history\", section on 'COVID-19 pandemic considerations'.)\n\nVaccination for COVID-19 is also not a contraindication to blood donation. Individuals who have received an mRNA vaccine or other noninfectious vaccine (nonreplicating, inactivated) can donate immediately; those who have received a live-attenuated viral vaccine (or who are unsure if they have) should refrain from donating blood for a short waiting period (eg, 14 days) after receiving the vaccine.\n\nMost blood donation facilities are no longer collecting convalescent plasma. (See \"COVID-19: Convalescent plasma and hyperimmune globulin\".)",
          "document_id": 455837
        }
      ]
    },
    {
      "paragraphs": [
        {
          "qas": [
            {
              "question": "How do mRNA vaccines work?",
              "id": 284014,
              "answers": [
                {
                  "answer_id": 279677,
                  "document_id": 455839,
                  "question_id": 284014,
                  "text": "People make mRNA all the time. In our cells, DNA in the nucleus is used to make mRNA, which is sent to the cytoplasm where it serves as a blueprint to make proteins. Most of the time, the proteins that are produced are needed to help our bodies function.\n\nmRNA vaccines take advantage of this process by introducing the mRNA for an important protein from the virus that the vaccine is trying to protect against. In the case of COVID-19, the important protein is the spike protein of the SARS-CoV-2 virus. The mRNA that codes for the SARS-CoV-2 spike protein is taken up by cells called dendritic cells, which express the spike protein on the cell surface, travel to a local lymph node, and stimulate other cells of the immune system (B cells) to make antibodies. These antibodies protect us, so that if we are exposed to SARS-CoV-2 in the future, our immune system is ready and we don’t get sick.\n\nThe vaccine is processed over a 1- to 2-week period after vaccination during which time the immune response develops. However, the mRNA only directs protein production in the cell for 1 to 3 days before it breaks down. Once it breaks down, the cell stops making the spike protein.",
                  "answer_start": 34943,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Is there a way to distinguish COVID-19 clinically from other respiratory illnesses, particularly influenza?\n\n",
              "id": 283935,
              "answers": [
                {
                  "answer_id": 279657,
                  "document_id": 455839,
                  "question_id": 283935,
                  "text": "vaccine ",
                  "answer_start": 14827,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Why are booster doses being recommended?",
              "id": 283987,
              "answers": [
                {
                  "answer_id": 279648,
                  "document_id": 455839,
                  "question_id": 283987,
                  "text": "The goal of vaccination is to prevent serious illness. This is achieved by generating immune memory cells, such as B cells and T cells. These cells are typically long-lived and reside in the bone marrow, bloodstream, and lymph glands to monitor for exposure to a pathogen. If the pathogen is detected, these memory cells quickly become activated and stimulate the immune response to efficiently fight the infection before the infection can get out of control and cause serious illness. In the case of COVID-19 mRNA vaccines, studies demonstrated that high levels of memory cells are generated, and as the delta variant has emerged, we have seen that the levels of memory cells generated by both the mRNA (Pfizer and Moderna) and adenovirus-based (J&J/Janssen) vaccines have been sufficient to prevent serious illness in most cases. As such, these findings would not warrant a booster dose.\n\nHowever, a second goal of vaccination could be to prevent any level of illness, meaning that vaccinated people would not even experience mild or asymptomatic infection. To accomplish this, people need to have high levels of neutralizing antibodies circulating in their bloodstream. Neutralizing antibodies prevent the virus from attaching to and entering cells. Typically, neutralizing antibody levels fade over time. When this happens, a booster dose can stimulate the memory B and T cells to cause production of neutralizing antibodies, thereby increasing the level of detectable antibodies in the bloodstream and decreasing the chance for any level of illness.\n\nWhile prevention of any level of illness is a noble goal, historically, prevention of serious illness has been the goal of vaccination, particularly for respiratory infections, like COVID-19. These two goals have been at the heart of the scientific “debate” over the need for booster doses in recent weeks.",
                  "answer_start": 91,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Do I need another dose of the COVID-19 vaccine?",
              "id": 283989,
              "answers": [
                {
                  "answer_id": 279651,
                  "document_id": 455839,
                  "question_id": 283989,
                  "text": "J&J/Janssen adenovirus vector vaccine\n\nPeople who received the J&J/Janssen vaccine should get a second dose of vaccine separated by at least 8 weeks, regardless of their health status. They are not currently recommended to get a third dose of the J&J/Janssen vaccine.\n\nPfizer or Moderna mRNA vaccine\n\nA third dose of COVID-19 mRNA vaccine may be recommended for one of two reasons:\n\nTo address waning immunity, traditionally called a booster dose.\nTo enhance the immune response of an individual who did not develop sufficient immunity following receipt of the recommended number of doses of COVID-19. In this case, the third dose can be considered as an additional primary dose.\nHow the third dose is implemented will be affected by which of these reasons are the cause for the additional dose.\n\nIn the case of COVID-19 vaccines, most people who received mRNA vaccines do not currently need an additional dose. However, the Centers for Disease Control and Prevention (CDC) has either recommended, or is allowing, a third dose of mRNA vaccine for particular groups of people, including:\n\nAdditional primary dose: Immune-compromised individuals, 18 and older (Moderna or Pfizer); those 12 to 17 years of age (Pfizer) (recommended)\nBooster dose: People 65 years of age and older (recommended)\nBooster dose: People 50-64 years of age with medical conditions putting them at higher risk for severe COVID-19 disease (recommended)\nBooster dose: People 18-49 years of age with underlying medical conditions that increase their risk for experiencing severe COVID-19 (should be considered)\nBooster dose: People 18 years and older who work in institutions or have occupations that put them at higher risk of transmitting the virus (should be considered)\nThose getting an additional primary dose should get the same type and dose of vaccine they received initially when possible.\n\nThose getting a booster dose can get any type of vaccine. Importantly, booster doses of Moderna should be half the quantity of the primary dose. Pfizer booster doses are the same quantity as the primary dose (purple cap for those 12 and older).\n\nThose younger than 12 years of age should only get two doses of lower-dose Pfizer vaccine (orange cap) separated by at least 21 days, even if they fall into one of the above health-related categories.\n\nImmune-compromised individuals (additional primary dose)\n\nIndividuals 12 years of age and older in this category should get the same brand of mRNA vaccine that their original vaccine was whenever possible. The second and third doses should be separated by at least 28 days. The third dose in this scenario should be the same quantity as the first two doses.\n\nPeople in this category include the following:\n\nPeople currently being treated for cancers of the blood or organs (so-called “solid tumor” cancers)\nPeople who received an organ transplant and take immunosuppressive medications to prevent rejection of the organ\nPeople who had a stem cell transplant or received CAR-T-cell therapy less than 2 years ago or who are taking immunosuppressive medications\nPeople with conditions that are considered to cause permanent immune deficiency because the condition affects cells of their immune system, such as DiGeorge syndrome or Wiskott-Aldrich syndrome\nPeople infected with HIV whose infection is untreated or considered to be at an advanced stage\nPeople currently being treated with one of the following types of medications:\nHigh-dose corticosteroids (more than 20 mg prednisone or similar medications per day)\nAlkylating agents\nAntimetabolites\nTransplant-related immunosuppressive medications\nCancer chemotherapeutic medications that are considered severely immunosuppressive (e.g., tumor-necrosis, or TNF, blockers)\nBiologic agents that suppress or modulate the immune response\nPeople in this category who should work with their healthcare provider to determine their need for a third dose include:\n\nPeople taking medications that make them uncertain whether they would be included in the list of individuals mentioned above\nPeople with immune-system-related conditions not specifically mentioned above\nPeople preparing to start one of the above-mentioned medications\nPeople not considered to be in this category include:\n\nPeople who do not have compromised immunity.\nPeople without a spleen.\nPeople who had cancer but are no longer being treated.\nPeople with chronic conditions that do not involve the immune system or require treatment with high doses of corticosteroids, such as diabetes, asthma, COPD, kidney disease, heart conditions, sickle cell disease, among others. If you are not sure, check with your healthcare provider.\nPeople 65 years of age and older (booster dose; recommended)\n\nIndividuals who received the mRNA vaccine should get a third dose, separated by at least 6 months from the second dose. Booster doses of Moderna should be half doses.\n\nPeople 18-64 years of age with underlying medical conditions (booster dose; recommended for 50- to 64-year-olds; should be considered for 18- to 49-year-olds)\n\nIndividuals between 50 and 64 years of age who received the mRNA vaccine and have an underlying medical condition, as described below, are recommended to get a booster dose at least 6 months after their second dose. Those between 18 and 49 years of age may get a third dose if they so choose. Booster doses of Moderna should be half doses.\n\nPeople with the following conditions would be considered part of this group:\n\nChronic kidney disease\nChronic lung disease (COPD, asthma, interstitial lung disease, cystic fibrosis, and pulmonary hypertension)\nDementia or other neurologic conditions\nDiabetes (Types 1 or 2)\nDown syndrome\nHeart conditions (Heart failure, coronary artery disease, cardiomyopathies, or hypertension)\nLiver disease\nObesity or overweight\nSickle cell disease or thalassemia\nCerebrovascular disease\nThis list is not exhaustive. For more information about any of these conditions or to see the complete CDC list, consult their “COVID-19 – Medical Conditions” page.\n\nPeople 18 years and older who live or work in high-risk settings (booster dose; should be considered)\n\nIndividuals 18 years of age and older who received an mRNA vaccine and live in a long-term care setting are encouraged to get a booster dose at least 6 months after their second dose. Those 18 years of age and older who are at increased risk because of where they live or work, as described below, may also get a third dose if they so choose.\n\nPeople who live in the following settings would be considered part of this group:\n\nHealth care institutions\nSchools\nCorrectional facilities\nHomeless shelters\nPeople who work in the following occupations would be considered part of this group:\n\nFirst responders (healthcare workers, firefighters, police, congregate care staff)\nEducation staff (teachers, support staff, daycare workers)\nFood and agriculture workers\nManufacturing workers\nCorrections workers\nU.S. Postal Service workers\nPublic transit workers\nGrocery store workers\nTo find out more or check for updates to these categories, visit the CDC’s “COVID-19 Booster Shot” page.",
                  "answer_start": 2081,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can I get my flu vaccine at the same time as my COVID-19 vaccine?",
              "id": 283990,
              "answers": [
                {
                  "answer_id": 279652,
                  "document_id": 455839,
                  "question_id": 283990,
                  "text": "Yes. The CDC has indicated that people can get influenza vaccine and COVID-19 vaccine during the same visit, but in different locations, such as one in each arm or separated by at least one inch on the same arm. However, for those who are willing to come back to get one of the vaccines, it is prudent to wait two weeks between getting an influenza or COVID-19 vaccine. This way if there is a safety concern, it would be clear which vaccine might have caused the problem.",
                  "answer_start": 9352,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "When will COVID-19 vaccines be available for children younger than 5 years of age?",
              "id": 283991,
              "answers": [
                {
                  "answer_id": 279653,
                  "document_id": 455839,
                  "question_id": 283991,
                  "text": "COVID-19 vaccine trials are in progress for children younger than 5 years of age but have not yet been completed.\n\nThe Pfizer vaccine was approved for use in children as young as 5 years of age by the FDA in late October 2021 and recommended by the CDC in early November 2021.",
                  "answer_start": 10020,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is the difference between emergency use authorization and the normal process of vaccine approval?",
              "id": 283992,
              "answers": [
                {
                  "answer_id": 279654,
                  "document_id": 455839,
                  "question_id": 283992,
                  "text": "The main difference between emergency use authorization, or EUA, and the normal process, which is via a biologic licensure application, or BLA, is how long data were collected prior to the vaccines being reviewed for use. So, when considered quite literally, the vaccines being used today (under EUA) will be no different than those that are being used the day after the vaccines get full approval (BLA). The reason for the shortened timeline was, of course, because of the pandemic. But, at this point, the vaccines have been given safely to millions of people and the companies have been monitoring vaccine recipients for months. As such, at this point, delaying vaccination until the vaccines get “full approval” is taking an unnecessary risk.",
                  "answer_start": 10693,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Were the COVID-19 vaccines approved by the FDA?",
              "id": 283993,
              "answers": [
                {
                  "answer_id": 279655,
                  "document_id": 455839,
                  "question_id": 283993,
                  "text": "Even though the COVID-19 vaccines were initially released under Emergency Use Authorization (EUA), they were still approved by the Food and Drug Administration (FDA). The review process was the same, but because of the pandemic, the data could be submitted after a shorter period of participant follow-up than usual. However, even after submitting data (and getting an EUA), those studies continued. Pfizer’s vaccine has now been licensed for those 18 years of age and older, and at some point, the other companies will submit the additional follow-up data to request licensure under Biologics Licensure Application (BLA).",
                  "answer_start": 11566,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Is it safe for my teen to get the COVID-19 vaccine given the stories about myocarditis?",
              "id": 283994,
              "answers": [
                {
                  "answer_id": 279656,
                  "document_id": 455839,
                  "question_id": 283994,
                  "text": "Cases of myocarditis, or inflammation of the heart, have been reported in a small number of teens after receipt of the COVID-19 mRNA vaccine. The condition is continuing to be investigated. Here is what we know to date:\n\nThe cases of myocarditis that have occurred so far were more often in boys and young men and more often after the second dose. Symptoms occurred within 4 days after receipt of the dose. Recently immunized teens and young adults who experience chest pain or shortness of breath should be seen by a healthcare provider and report recent their vaccination.\nMyocarditis is somewhat common, particularly as a result of viral infections. In fact, cases tend to occur more often in the spring due to viruses that circulate at this time of year (specifically, coxsackie B viruses). Typically, about 100-200 cases occur per million people per year.\nAvailable data suggest that the incidence of myocarditis following mRNA vaccines is about 1 per 50,000 vaccine recipients; however, this risk increases in males between 16 and 29 years of age to about 1 per 20,000 vaccine recipients. Of interest, myocarditis also occurs more commonly after either acute COVID-19 or as part of the multisystem inflammatory syndrome of children (MIS-C). For example, if 100,000 males between 16 and 29 years of age got the mRNA vaccine, about 5 would experience myocarditis. However, if 100,000 males between 16 and 29 years of age were infected with the virus that causes COVID-19, about 59 would experience myocarditis. These numbers are lower in females (See “My teen is a student-athlete and already had COVID-19, so does he need the COVID-19 vaccine?” for more detailed information.)\nParents and teens should watch for symptoms that may include chest pain, pressure, heart palpitations, difficulty breathing after exercise or lying down, or excessive sweating. One or more of these symptoms may also be accompanied by tiredness, stomach pain, dizziness, fainting, unexplained swelling, or coughing. If a recently vaccinated teen develops these symptoms or you are unsure, contact the child’s doctor or seek more immediate medical assistance if needed.\nThe CDC will continue to monitor the situation related to myocarditis, but for now, there is not a reason to stop vaccinating kids. The American Heart Association has also released a statement encouraging continued vaccination.",
                  "answer_start": 12396,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can I get the COVID-19 vaccine if I have COVID-19?",
              "id": 283995,
              "answers": [
                {
                  "answer_id": 279658,
                  "document_id": 455839,
                  "question_id": 283995,
                  "text": "In the U.S., the CDC recommends waiting until COVID-19 symptoms go away and the individual is done isolating. However, they indicate that it is okay to get the COVID-19 vaccine shortly after recovering from the disease as long as the patient was not treated with antibody-based treatments (convalescent plasma or monoclonal antibodies).\n\nDue to limited supplies of vaccine in some countries and the experience that people who recently had COVID-19 rarely get re-infected in the months immediately after recovery, some areas may be delaying vaccination of recently recovered individuals. As such, we recommend talking with your healthcare provider or health officials to see what the recommendations are in your area.",
                  "answer_start": 14906,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Is it safe for my adolescent or teen to get the COVID-19 vaccine?",
              "id": 283996,
              "answers": [
                {
                  "answer_id": 279659,
                  "document_id": 455839,
                  "question_id": 283996,
                  "text": "The Pfizer COVID-19 mRNA vaccine is approved for those 5 years of age and older. Other COVID-19 vaccines are still being tested in those younger than 18 years of age.\n",
                  "answer_start": 15778,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "When the Pfizer vaccine was tested in 5- to 11-year-olds, it was found to be safe:?",
              "id": 283997,
              "answers": [
                {
                  "answer_id": 279660,
                  "document_id": 455839,
                  "question_id": 283997,
                  "text": "More than 15 million teens between 12 and 18 years of age had received one dose of COVID-19 vaccine, and more than 12.5 million had received both doses by Nov. 9, 2021.\nThe clinical trial in 5- to 11-year-olds evaluated about 1,300 children who received the vaccine and compared them with about 660 children who got placebo (a salt solution). Three vaccinated individuals got infected with COVID-19 compared with 16 in the placebo group (about 91% efficacy). Side effects were similar to those in older children and adults, including pain, swelling and redness at injection site; fever; tiredness; headache; muscle aches; chills; and occasionally, swelling of the under arm on the side the vaccine was given. However, children tended to experience side effects less often and those with previous infection were less likely to experience side effects.\nNo cases of myocarditis were identified in the clinical trial; however, because the trials were small, it will be important to monitor for this rare, but serious side effect when more children are immunized.",
                  "answer_start": 16030,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What side effects will my child experience from the COVID-19 vaccine?",
              "id": 283998,
              "answers": [
                {
                  "answer_id": 279661,
                  "document_id": 455839,
                  "question_id": 283998,
                  "text": "Side effects in children 5 to 11 years of age were similar to what has been found in other age groups, including pain at the injection site, fatigue, headache, fever, chills, muscle pain, or joint pain. However, side effects tended to be less frequent than in other age groups.\n\nBecause a small number of cases of myocarditis, or heart inflammation, have been identified in teens and young adults, particularly in the 4 days after receipt of the second dose of the vaccine, it will be important to monitor younger children for this potential side effect. Chest pain, shortness of breath, or related symptoms should be reported to a healthcare provider.",
                  "answer_start": 17259,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "If a person has allergic reactions to a food or medication, can they get the vaccine?",
              "id": 283999,
              "answers": [
                {
                  "answer_id": 279662,
                  "document_id": 455839,
                  "question_id": 283999,
                  "text": "People with severe allergies to a COVID-19 vaccine ingredient (see list here) or a previous dose of COVID-19 vaccine should not get that type of COVID-19 vaccine (mRNA or adenovirus-based). They may be able to get the alternative type after consultation with an allergist or immunologist. Individuals with a known allergy to polysorbate should not get the COVID-19 vaccine made by Johnson & Johnson/Janssen.\n\nPeople with immediate allergic reactions to an injectable medication can most often get the COVID-19 vaccine; however, they should remain at the site where they were vaccinated for 30 minutes of observation, instead of the 15 minutes that the general public is recommended to wait. Anyone with this type of allergy who has questions or concerns should discuss the situation with their healthcare provider to assess the potential risks and benefits of receiving the COVID-19 vaccine. ",
                  "answer_start": 18325,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How well does the COVID-19 vaccine work in adolescents?",
              "id": 284000,
              "answers": [
                {
                  "answer_id": 279663,
                  "document_id": 455839,
                  "question_id": 284000,
                  "text": "he clinical trial measured two things to evaluate how the vaccine worked:\n\nDisease – While 18 participants (12-15 years of age) in the placebo group got COVID-19 at least seven days after having the second dose of the vaccine, none in the vaccinated group were infected. This represents 100% efficacy. In the 5- to 11-year-old group, three vaccinated children got COVID-19 compared with 16 children in the placebo group; this represents a 90.7% efficacy.\nImmune response – Now that we know what antibody levels adults experience following vaccination, studies can compare the levels in other groups to see if the vaccine works as well. These are often referred to as “non-inferiority studies,” meaning the vaccine is being tested in the study group to make sure it works at least as it does in another group previously studied. In the Pfizer study, average neutralizing antibody responses were similar in 5- to 11-year-olds compared with older children and young adults even though the dose was lower. While we still do not know if a certain level of virus-neutralizing antibodies indicates that an individual is protected against infection, we can be confident that vaccinated children respond equally well compared with older children and young adults.",
                  "answer_start": 20889,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Why do kids need the COVID-19 vaccine since they don’t get that sick if they are infected?",
              "id": 284001,
              "answers": [
                {
                  "answer_id": 279664,
                  "document_id": 455839,
                  "question_id": 284001,
                  "text": "While children and teens may not be as likely to get severely ill from COVID-19, it can still happen and, in fact, the average age of hospitalizations decreased as the oldest members of our communities were vaccinated. With this in mind, parents and teens should consider the following:\n\nConditions such as obesity, asthma, and developmental delay, as well as other pre-existing conditions, increase the chance for hospitalization.\nAs of mid-October 2021, almost 700 children and teens up to 17 years of age have died from COVID-19.\nAs of early October 2021, more than 5,200 cases of multisystem inflammatory syndrome in children (MIS-C) have been diagnosed and 50 deaths occurred. MIS-C typically occurs 2 to 6 weeks after having COVID-19, can occur following a mild infection, tends to be more severe in adolescents and teens, and causes about 6 or 7 of every 10 individuals to be placed in intensive care. MIS-C can also affect heart function.\nFinally, this age group can also transmit the infection to more vulnerable family and community members, such as those who are unable to get the vaccine.",
                  "answer_start": 22355,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can the COVID-19 vaccine affect puberty or fertility in my child?",
              "id": 284002,
              "answers": [
                {
                  "answer_id": 279665,
                  "document_id": 455839,
                  "question_id": 284002,
                  "text": "No, the rumors related to COVID-19 vaccines affecting puberty or fertility are unfounded. The mRNA vaccines are processed near the injection site and activated immune system cells travel through the lymph system to nearby lymph nodes. In this manner, they are not affecting hormone levels, nor are they traveling to other parts of the body. As such, there would not be a biological reason to expect that maturation or reproductive functionality of either males or females would be negatively affected by COVID-19 vaccination now or in years to follow.\n",
                  "answer_start": 23617,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "If I got a COVID-19 vaccine in another country, can I get one in the U.S.?",
              "id": 284003,
              "answers": [
                {
                  "answer_id": 279666,
                  "document_id": 455839,
                  "question_id": 284003,
                  "text": "For individuals vaccinated in another country, they may or may not be recommended to get a COVID-19 vaccine in the U.S. based on the situation:\n\nIf you received the recommended number of doses of a U.S.-approved vaccine (2 doses Pfizer, 2 doses Moderna, or 1 dose of J&J/Janssen), you are considered fully vaccinated and do not need additional doses.\nIf you received the recommended number of doses of a WHO-approved vaccine, you do not need additional doses.\nIf you received an mRNA vaccine in a country that only gives the vaccine as a single dose, you are not considered fully vaccinated in the U.S., and you should get an additional dose\nIf you started, but did not finish a WHO-approved vaccine, you can get the recommended doses of a U.S.-approved vaccine as long as at least 28 days have passed since your previous dose.\nIf you got a vaccine that is not FDA- or WHO-approved, you can get the recommended number of doses of a U.S.-approved vaccine at least 28 days after your most recent dose of the non-approved vaccine.\nIf you are considered fully vaccinated with an FDA-approved vaccine, but did not receive a booster or additional dose according to U.S.-based recommendations and would like to do so, you may. People who received WHO-approved vaccines are not included in this recommendation.",
                  "answer_start": 24536,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What should I do if I had the J&J vaccine?",
              "id": 284005,
              "answers": [
                {
                  "answer_id": 279667,
                  "document_id": 455839,
                  "question_id": 284005,
                  "text": "People who had a single dose of the J&J/Janssen vaccine are recommended to get a second dose at least 8 weeks after the first dose.\n\nRelated to side effects\n\nIf you had the J&J/Janssen vaccine within the last 3 weeks, although the risk is low, you should monitor yourself for unusual symptoms, including severe headache, severe abdominal pain, unexplained leg pain, or shortness of breath, which may result from TTS, or muscle weakness or paralysis, which may result from GBS. If you develop unusual symptoms, you should seek medical attention and be certain to tell the healthcare provider the date you received the J&J/Janssen vaccine. For TTS, the physician can very quickly determine whether your problem is related to the vaccine by performing a simple complete blood count. If the platelet count is extremely low, the symptoms might be related to the vaccine. We would also recommend registering for v-safe, the CDC’s vaccine monitoring system if you have not done so already.\n\nIf you had the J&J/Janssen vaccine more than 3 weeks ago, you are extremely unlikely to experience either thrombosis with thrombocytopenia syndrome (TTS) or Guillain-Barré syndrome (GBS).\n",
                  "answer_start": 25955,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Should I stop using my birth control if I got the J&J vaccine?",
              "id": 284006,
              "answers": [
                {
                  "answer_id": 279668,
                  "document_id": 455839,
                  "question_id": 284006,
                  "text": "It is not necessary to stop taking birth control pills. Individuals affected by thrombotic thrombocytopenic syndrome (TTS), which is an unusual combination of low platelet count (thrombocytopenia) and clotting (thrombosis) did not share common medical histories, such as use of birth control pills; therefore, stopping usage would not change your risk for TTS.",
                  "answer_start": 27283,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are CVST and thrombocytopenia?",
              "id": 284007,
              "answers": [
                {
                  "answer_id": 279669,
                  "document_id": 455839,
                  "question_id": 284007,
                  "text": "Cerebral venous sinus thrombosis (CVST) is a condition that causes blood clots in large vessels that drain blood from the brain. Although it is uncommon, the condition more often affects women between 20 and 50 years of age.\n\nThrombocytopenia is low numbers of cells called platelets. Platelets are cells that help our blood clot. When a person has this condition, they are at risk for bleeding since their body lacks the ability to efficiently stop the bleeding.\n\nIt is very uncommon for CVST and thrombocytopenia to occur at the same time, which is what makes this diagnosis following receipt of the J&J vaccine so unusual. Likewise, the clots have not just occurred in the large vessels near the brain in some of the affected individuals.",
                  "answer_start": 27746,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What is the difference between TTS and CVST?",
              "id": 284008,
              "answers": [
                {
                  "answer_id": 279671,
                  "document_id": 455839,
                  "question_id": 284008,
                  "text": "Thrombosis with thrombocytopenia syndrome, or TTS, is the name that has been given to the condition identified in a small number of individuals after receipt of the COVID-19 J&J/Janssen or AstraZeneca vaccines. TTS is distinct from cerebral venous sinus thrombosis, or CVST, because in TTS not all of the clots are associated with the large vessels of the brain. Some individuals had clots in their lungs, heart, intestines, spleen, or large blood vessels in their legs. However, CVST was originally used, and may still be used to refer to the condition by some individuals, because the original cases closely resembled this previously defined conditi",
                  "answer_start": 28797,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Are some people at higher risk of having the clotting after the J&J vaccine?",
              "id": 284009,
              "answers": [
                {
                  "answer_id": 279672,
                  "document_id": 455839,
                  "question_id": 284009,
                  "text": "n the U.S. women between 30 and 49 years of age have most often been affected by this condition compared with other groups; however, both men and women between 18 to 64 years of age have been affected.\n\nData regarding the race of all affected in the U.S. have not been shared, but at the time of the pause, those which were known were White. With this said, a large percentage of the recipients of the J&J vaccine at the time of the pause had also been White (about 63%), so there is no reason to think that people of other races would be exempt from this side effect.",
                  "answer_start": 29930,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Could the mRNA vaccines from Pfizer and Moderna cause the same clotting problem as the J&J vaccine did?",
              "id": 284010,
              "answers": [
                {
                  "answer_id": 279673,
                  "document_id": 455839,
                  "question_id": 284010,
                  "text": "The Johnson & Johnson (J&J)/Janssen COVID-19 vaccine is an adenovirus vector vaccine, which is different from the Pfizer and Moderna mRNA vaccines. At the time of the J&J/Janssen pause, more than 182 million doses of the mRNA vaccines had been administered and no cases of thrombosis with thrombocytopenia syndrome, or TTS, had been reported. Three people out of about 85 million doses of Moderna had blood clots, but they did not have low platelets. The number of blood clots experienced by those who got the Moderna vaccine would be expected based on the background rate of clotting in the general population.",
                  "answer_start": 30736,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can I get the COVID-19 vaccine during my menstrual cycle?",
              "id": 284011,
              "answers": [
                {
                  "answer_id": 279674,
                  "document_id": 455839,
                  "question_id": 284011,
                  "text": "Yes. Women do not need to schedule their COVID-19 vaccine around their menstrual cycle:\n\nThe immune system is not sufficiently compromised by either the COVID-19 vaccine or the menstrual cycle that scheduling them around one another would be of benefit. Indeed, delaying vaccination around a woman’s cycle may only leave her unprotected from COVID-19 for a longer time without offering any known benefit.\nThe mRNA and adenovirus vaccines are processed in immune system cells near the injection site and then those cells travel through the lymph system to nearby lymph nodes, where additional cells of the immune system are activated. As such, the vaccines would not be expected to affect the menstrual cycle. If a woman experiences a delayed cycle following vaccination, one possible explanation could be hormonal changes caused by stress, which in turn can affect a woman’s cycle. However, women with concerns should speak with their doctor since cycles can be delayed for other reasons as well. \nThe COVID-19 vaccine is not shed after vaccination, so being around recently vaccinated individuals would not be expected to affect someone’s cycle.\nYou can read more about menstruation and COVID-19 vaccines in this Vaccine Update article.",
                  "answer_start": 31493,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Do the COVID-19 vaccines contain live virus?",
              "id": 284012,
              "answers": [
                {
                  "answer_id": 279675,
                  "document_id": 455839,
                  "question_id": 284012,
                  "text": "Neither the mRNA (Moderna and Pfizer) nor adenovirus (J&J/Janssen and AstraZeneca) vaccines contain live virus. Each of these contain a single gene from the virus that causes COVID-19. The gene instructs our cells to make the protein, but no other proteins from the virus are made, so the whole virus particles are never present. In this manner, people who were vaccinated cannot shed, or spread, the virus to other people.",
                  "answer_start": 32850,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Do the COVID-19 vaccines cause viral shedding?",
              "id": 284013,
              "answers": [
                {
                  "answer_id": 279676,
                  "document_id": 455839,
                  "question_id": 284013,
                  "text": "Viral shedding occurs when a person is infected with a virus and whole viral particles produced during the infection are transmitted in the individual’s secretions. For viruses that infect the respiratory tract, these particles are often found in secretions from the nose and mouth, such as saliva or mucus.\n\nSome people wonder whether they can shed the virus as a result of vaccination. In the case of mRNA and adenovirus-based vaccines approved for use in the U.S., the short answer is no. Both of these types of vaccines only introduce a single protein from the virus that causes COVID-19 – the spike protein. As such, whole viral particles are never produced during vaccine processing. Indeed, people are not considered to be infected when they are vaccinated because the virus does not replicate in them. Further, the vaccines are processed near the site of injection, so the spike protein produced during processing would not be found in nasal or oral secretions. As such, they cannot “shed” the single protein either.\n\nWhile people who are vaccinated are less likely to be infected, there is a still a small chance that the virus could replicate at low levels in the nasal or oral cavity before the immune system stops it. If this happens, the individual may be able to shed the virus produced during the brief period of replication.\n",
                  "answer_start": 33397,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How do adenovirus vector vaccines work?",
              "id": 284016,
              "answers": [
                {
                  "answer_id": 279678,
                  "document_id": 455839,
                  "question_id": 284016,
                  "text": "Adenovirus vector vaccines take advantage of a class of relatively harmless viruses, called adenoviruses. Some adenoviruses cause the common cold, but others can infect people without causing illness. To use these viruses for vaccine delivery, scientists choose types of adenovirus that do not cause illness and to which most people have not been exposed. They alter the virus by removing two of the genes that enable adenovirus to replicate in people, and they replace one of those genes with the one for the SARS-CoV-2 spike protein.\n\nLike human cells, adenoviruses contain DNA as their genetic material. So, when an adenovirus vaccine is administered, it enters cells of the immune system called dendritic cells where it releases the DNA that includes the gene for the spike protein, and the genetic material enters the nucleus of the cell. In the nucleus, the DNA is used to make messenger RNA (mRNA), which is released into the cytoplasm to serve as a blueprint for making proteins. The DNA from the viral vector, however, cannot insert into the cell’s DNA. The mRNA causes the SARS-CoV-2 protein to be produced. The dendritic cells puts pieces of the SARS-CoV-2 spike protein on their surface and travel to a draining lymph node where they stimulate other cells of the immune system; specifically, B cells that make antibodies, T cells that help B cells make antibodies, and other T cells that can kill virus-infected cells. Antibodies against the spike protein will now prevent the virus from causing an infection in the future.\n",
                  "answer_start": 36385,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "How did the vaccine companies (e.g., Pfizer and Moderna) decide which mRNA to use?",
              "id": 284017,
              "answers": [
                {
                  "answer_id": 279680,
                  "document_id": 455839,
                  "question_id": 284017,
                  "text": "In order for a virus to reproduce and cause infection, it must get into cells and take over the cellular machinery. Because viruses attach to cells using a particular protein on their surface, in this case the SARS-CoV-2 spike protein, scientists understood that blocking that attachment would be a direct way to prevent infection. One way to block this attachment is with antibodies that bind to the surface protein. As such, when the genome was published, scientists developing the nucleic acid or protein subunit vaccines (i.e., those that only used part of the virus) chose the gene for the spike protein, anticipating that this would be the most direct route to developing an effective vaccine.",
                  "answer_start": 38268,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Who should NOT get the COVID-19 vaccine?",
              "id": 284018,
              "answers": [
                {
                  "answer_id": 279681,
                  "document_id": 455839,
                  "question_id": 284018,
                  "text": "Most people are able to get COVID-19 vaccine. But, a few groups of people either should not get the vaccine or should get a particular version. Likewise, some individuals should consult with their doctor or follow special procedures.\n\nPeople who should NOT get any COVID-19 vaccine:\n\nThose younger than 5 years of age\nPeople currently isolating or experiencing symptoms of COVID-19; these people can get vaccinated once they are finished isolation and their primary symptoms have resolved.\nPeople who cannot get the mRNA vaccine (Pfizer or Moderna), but may be able to get the J&J/Janssen vaccine:\n\nAnyone with a previous severe or immediate allergic reaction (i.e., one that causes anaphylaxis or requires medical intervention) to a COVID-19 mRNA vaccine dose or an mRNA vaccine component.\nAnyone with a known allergy to polyethylene glycol\nPeople who cannot get the adenovirus vaccine (J&J/Janssen), but may be able to get the mRNA vaccine (Pfizer or Moderna):\n\nAnyone with a previous severe or immediate allergic reaction (i.e., one that causes anaphylaxis or requires medical intervention) to the COVID-19 adenovirus vaccine or one of its components\nAnyone with a known polysorbate allergy\nThose 5-18 years of age can get the Pfizer mRNA vaccine, but not other versions (as long as they do not have other contraindications that prevent receipt of the vaccine).\nPeople who may get the vaccine after considering risks and benefits and/or consulting with their healthcare provider:\n\nIndividuals with a history of severe or immediate allergic reaction to any vaccine or injectable medication (These individuals should be observed for 30 minutes after receipt of the vaccine.)\nPeople who have a severe or immediate allergic reaction to one of the types of vaccines and for whom the cause of the reaction is unknown (i.e., which component caused the reaction) should consult an allergist or immunologist to determine whether the individual can get the other version. If they proceed, they should be vaccinated at a location with medical facilities and staff prepared to respond to medical emergencies.\nPeople with certain immune-compromising conditions\nPeople on anticoagulants\nPeople who should follow special procedures\n\nSomeone with a history of severe or immediate allergic reaction (requiring medical intervention) to anything other than a vaccine or injectable medication can get the vaccine, but they should remain at the vaccination location for medical observation for 30 minutes after receipt of the vaccine.\nPregnant women who develop a fever after vaccination should take acetaminophen. (See more in the pregnancy-related questions lower on this page.)\nPeople who recently had COVID-19 and were treated with antibody-based therapies (e.g., monoclonal antibodies or convalescent plasma) should wait until 90 days after treatment to be vaccinated against COVID-19.\nPeople who received an antibody-based therapy following COVID-19 exposure (but not infection) should wait 30 days after treatment to be vaccinated.\nPeople treated with convalescent plasma should not receive measles- or varicella-containing vaccines until at least 7 months after receipt of the plasma.\nChildren (C) or adults (A) diagnosed with multisystem inflammatory syndrome (MIS-C or MIS-A) should seek guidance from their treatment team regarding vaccination and if getting vaccinated, delay vaccination until they recover and at least 90 days have passed from their diagnosis of this condition.\nPeople with a known COVID-19 exposure should wait until their quarantine is over before getting vaccinated (unless they live in a group setting, such as a nursing home, correctional facility, or homeless shelter, in which case they can be vaccinated during the quarantine period).",
                  "answer_start": 39080,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What are the side effects of the COVID-19 vaccine?",
              "id": 284019,
              "answers": [
                {
                  "answer_id": 279682,
                  "document_id": 455839,
                  "question_id": 284019,
                  "text": "Side effects from both the mRNA and adenovirus vaccines are caused as part of the immune response to the vaccine.\n\nThe most common side effects from the mRNA vaccines (Pfizer and Moderna) are:\n\nFatigue\nHeadache\nMuscle aches\nSide effects occurred during the first week after vaccination but were most likely one or two days after receipt of the vaccine. Side effects were more frequent following the second dose and more likely to be experienced by younger, rather than older, recipients. Although most people will not have significant side effects, some people may wish to schedule their vaccination, so that they will not need to call out of work the next day if they don’t feel well.\n\nA small number of people who get the mRNA vaccine experience mild, short-lived inflammation of the heart, called myocarditis. About 1 of every 50,000 mRNA vaccine recipients experience this condition, but it is most likely in adults 29 years and younger and more often occurs in males. This condition tends to occur within 4 days of receipt of the second dose. Recently vaccinated individuals who experience chest pain or shortness of breath should seek medical care. This condition tends to resolve within 2-3 weeks and does not cause long-term heart damage. Importantly, COVID-19 infections can also cause myocarditis, and this tends to occur more frequently after infection compared with vaccination. (See “My teen is a student-athlete and already had COVID-19, so does he need the COVID-19 vaccine? We are worried about myocarditis.” on this page for more detailed information.)\n\nThe most common side effects from the adenovirus vaccine (Johnson & Johnson/Janssen) are:\n\nInjection site pain and less often redness or swelling\nHeadache\nFatigue\nMuscle aches\nFever\nSide effects occurred during the first seven to eight days after vaccination but were most likely to occur one or two days after receipt of the vaccine. Side effects were more often experienced by younger, rather than older vaccine recipients.\n\nTwo rare, but potentially dangerous conditions, have been identified following receipt of the adenovirus-based vaccines, such as the J&J/Janssen version:\n\nThrombosis with thrombocytopenia syndrome, or TTS, occurs in about 1-2 of every 1 million vaccine recipients and develops up to 3 weeks after getting vaccinated. Individuals between 18 and 64 years of age, both female and male, who got the J&J/Janssen vaccine have experienced this condition; however, women between the ages of 30 and 49 years of age are at the greatest risk. To date, four deaths have been attributed to this side effect. Anyone who got the J&J/Janssen vaccine less than 3 weeks ago should seek medical care if they develop severe headache, shortness of breath, severe abdominal pain, unexplained leg pain, easy bruising, or small red spots on the skin. Anyone seeking medical care with one or more of these symptoms should mention their recent receipt of the vaccine, so healthcare providers can order the appropriate diagnostic tests and treatments.\nGuillain-Barré syndrome, or GBS, occurs in about 1 of every 100,000 vaccine recipients, most often during the first 3 weeks after getting vaccinated. The condition has most often been identified in males between 50 and 64 years of age, but it can occur in females and those 65 years and older on occasion. While rare, most cases have required hospitalization and, to date, one person has died. Anyone who recently received an adenovirus-based COVID-19 vaccine and experiences muscle weakness or paralysis should seek medical treatment and inform the healthcare provider of the recent vaccination. It should also be noted that COVID-19 has also been associated with GBS; so, natural infection with SARS-CoV-2 also appears to be a rare cause of GBS.\nIllustration of who is most at risk for these side effectsCheck out this infographic [PDF, 157KB] to see a visual representation of this information.",
                  "answer_start": 43540,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "Can I take medicine for the side effects after I get the vaccine?",
              "id": 284020,
              "answers": [
                {
                  "answer_id": 279684,
                  "document_id": 455839,
                  "question_id": 284020,
                  "text": "The CDC has indicated that you can take anti-fever or anti-inflammatory medications if necessary following COVID-19 vaccination, but it is important to know that doing so could diminish the level of immunity that develops. This is true anytime you take these types of medications, whether following vaccination or to treat illness. Generally speaking, the “symptoms” people experience following vaccination or during illness, such as fever, redness, or fatigue, are caused by your immune system responding. For example, fever is your body turning up its “thermostat” to make the immune system more efficient and the pathogen less efficient. For these reasons, if you are not very uncomfortable, it is better not to take these medications.\n\nSome wonder how long they should wait after vaccination before taking these types of medicines, so their immune response is not affected. As a rule of thumb, the immune response for the mRNA vaccines develop over a week or two after vaccination and for the adenovirus vaccines over the course of about four weeks, but the greatest chance of affecting your immune response would be in the first few days after receipt of the vaccine. Indeed, in the adenovirus vaccine studies, about 1 in 4 vaccine recipients took fever-reducing medication (antipyretics), and most people were still protected from severe disease and all were protected against hospitalization.",
                  "answer_start": 47623,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "If I don’t have side effects, does that mean the vaccine did not work?",
              "id": 284021,
              "answers": [
                {
                  "answer_id": 279685,
                  "document_id": 455839,
                  "question_id": 284021,
                  "text": "Many people will get the vaccine and not experience side effects. This does not mean that the vaccine did not work for them. In the clinical trials side effects occurred at varying rates, for example only about 1 to 20 of every 100 people who received the mRNA vaccine had a fever, but we know that the mRNA vaccine worked for more than 90 of every 100 people.",
                  "answer_start": 49298,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "\nShould I stop taking my daily dose of aspirin before getting the COVID-19 vaccine?",
              "id": 284023,
              "answers": [
                {
                  "answer_id": 279688,
                  "document_id": 455839,
                  "question_id": 284023,
                  "text": "If your daily dose of aspirin was prescribed by your physician following a stroke or heart attack, we recommend speaking to that doctor about whether to stop taking your medication for a day or two prior to vaccination. If, however, your daily dose of aspirin is because you have risk factors for a stroke or heart attack (such as high blood pressure or high levels of “bad” cholesterol) but have never had a stroke or heart attack, you should consider discontinuing the aspirin not only prior to your COVID-19 vaccine, but all together. The data show that while daily aspirin helps prevent second strokes or heart attacks, it does not help prevent first occurrences, even in people who are at increased risk. Our director, Dr. Paul Offit, carefully reviewed the data related to this topic for his book, Overkill: When Modern Medicine Goes Too Far.",
                  "answer_start": 51008,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What should I do if I took pain medicine before getting the COVID-19 vaccine?",
              "id": 284024,
              "answers": [
                {
                  "answer_id": 279689,
                  "document_id": 455839,
                  "question_id": 284024,
                  "text": "While your initial immune response may have been lower, you will likely still have developed some immunity. Even if your immune response is somewhat lower overall, you are likely to develop sufficient levels of immunity to reduce your chance for infection. In addition, even if you were infected, you would be likely to experience disease that is less severe and of shorter duration.",
                  "answer_start": 52146,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "What if I can’t get the second dose 21 (Pfizer) or 28 (Moderna) days after the first dose?",
              "id": 284025,
              "answers": [
                {
                  "answer_id": 279690,
                  "document_id": 455839,
                  "question_id": 284025,
                  "text": "The Centers for Disease Control and Prevention (CDC) allows for a 4-day grace period when assessing on-time receipt. This means the following ranges of days are considered “on-time” for receipt of the second dose:\n\nPfizer vaccine: 17 to 25 days after the first dose\nModerna vaccine: 24 to 32 days after the first dose\nPeople should try to get the second dose during this period or as soon after as possible. However, if your second dose is given later than this, you do not need to restart the vaccine. You still only need to get the second dose. However, it is important to note that the first dose did not protect as many people as were protected after the second dose, so if you are exposed to SARS-CoV-2 during the delay, you may or may not have enough immunity to prevent you from experiencing symptoms.",
                  "answer_start": 52741,
                  "answer_category": null
                }
              ],
              "is_impossible": false
            },
            {
              "question": "\nWhat is the difference between the first and second dose of the COVID-19 mRNA vaccine?",
              "id": 284026,
              "answers": [
                {
                  "answer_id": 279692,
                  "document_id": 455839,
                  "question_id": 284026,
                  "text": "In the United States, the ingredients in the vial for dose 1 and dose 2 of the same brand are exactly the same. When people talk about dose 1 doses and dose 2 doses, they are just talking about vaccine supply. If you arrive for dose 1 and the person behind you is getting dose 2, they can come out of the same vial.\n\nOne vaccine used in some other countries, Sputnik V, has different components in dose 1 and dose 2. Both are adenovirus vector vaccines, but dose 1 uses adenovirus 26 (Ad26) and dose 2 uses adenovirus 5 (Ad5).",
                  "answer_start": 53754,
                  "answer_category": null
                }
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          "context": "COVID QA\nWhy are booster doses being recommended?\nWhy are booster doses being recommended?\nThe goal of vaccination is to prevent serious illness. This is achieved by generating immune memory cells, such as B cells and T cells. These cells are typically long-lived and reside in the bone marrow, bloodstream, and lymph glands to monitor for exposure to a pathogen. If the pathogen is detected, these memory cells quickly become activated and stimulate the immune response to efficiently fight the infection before the infection can get out of control and cause serious illness. In the case of COVID-19 mRNA vaccines, studies demonstrated that high levels of memory cells are generated, and as the delta variant has emerged, we have seen that the levels of memory cells generated by both the mRNA (Pfizer and Moderna) and adenovirus-based (J&J/Janssen) vaccines have been sufficient to prevent serious illness in most cases. As such, these findings would not warrant a booster dose.\n\nHowever, a second goal of vaccination could be to prevent any level of illness, meaning that vaccinated people would not even experience mild or asymptomatic infection. To accomplish this, people need to have high levels of neutralizing antibodies circulating in their bloodstream. Neutralizing antibodies prevent the virus from attaching to and entering cells. Typically, neutralizing antibody levels fade over time. When this happens, a booster dose can stimulate the memory B and T cells to cause production of neutralizing antibodies, thereby increasing the level of detectable antibodies in the bloodstream and decreasing the chance for any level of illness.\n\nWhile prevention of any level of illness is a noble goal, historically, prevention of serious illness has been the goal of vaccination, particularly for respiratory infections, like COVID-19. These two goals have been at the heart of the scientific “debate” over the need for booster doses in recent weeks.\n\nLast updated: Sept. 29, 2021\n\nDo I need another dose of the COVID-19 vaccine?\nDo I need another dose of the COVID-19 vaccine?\nJ&J/Janssen adenovirus vector vaccine\n\nPeople who received the J&J/Janssen vaccine should get a second dose of vaccine separated by at least 8 weeks, regardless of their health status. They are not currently recommended to get a third dose of the J&J/Janssen vaccine.\n\nPfizer or Moderna mRNA vaccine\n\nA third dose of COVID-19 mRNA vaccine may be recommended for one of two reasons:\n\nTo address waning immunity, traditionally called a booster dose.\nTo enhance the immune response of an individual who did not develop sufficient immunity following receipt of the recommended number of doses of COVID-19. In this case, the third dose can be considered as an additional primary dose.\nHow the third dose is implemented will be affected by which of these reasons are the cause for the additional dose.\n\nIn the case of COVID-19 vaccines, most people who received mRNA vaccines do not currently need an additional dose. However, the Centers for Disease Control and Prevention (CDC) has either recommended, or is allowing, a third dose of mRNA vaccine for particular groups of people, including:\n\nAdditional primary dose: Immune-compromised individuals, 18 and older (Moderna or Pfizer); those 12 to 17 years of age (Pfizer) (recommended)\nBooster dose: People 65 years of age and older (recommended)\nBooster dose: People 50-64 years of age with medical conditions putting them at higher risk for severe COVID-19 disease (recommended)\nBooster dose: People 18-49 years of age with underlying medical conditions that increase their risk for experiencing severe COVID-19 (should be considered)\nBooster dose: People 18 years and older who work in institutions or have occupations that put them at higher risk of transmitting the virus (should be considered)\nThose getting an additional primary dose should get the same type and dose of vaccine they received initially when possible.\n\nThose getting a booster dose can get any type of vaccine. Importantly, booster doses of Moderna should be half the quantity of the primary dose. Pfizer booster doses are the same quantity as the primary dose (purple cap for those 12 and older).\n\nThose younger than 12 years of age should only get two doses of lower-dose Pfizer vaccine (orange cap) separated by at least 21 days, even if they fall into one of the above health-related categories.\n\nImmune-compromised individuals (additional primary dose)\n\nIndividuals 12 years of age and older in this category should get the same brand of mRNA vaccine that their original vaccine was whenever possible. The second and third doses should be separated by at least 28 days. The third dose in this scenario should be the same quantity as the first two doses.\n\nPeople in this category include the following:\n\nPeople currently being treated for cancers of the blood or organs (so-called “solid tumor” cancers)\nPeople who received an organ transplant and take immunosuppressive medications to prevent rejection of the organ\nPeople who had a stem cell transplant or received CAR-T-cell therapy less than 2 years ago or who are taking immunosuppressive medications\nPeople with conditions that are considered to cause permanent immune deficiency because the condition affects cells of their immune system, such as DiGeorge syndrome or Wiskott-Aldrich syndrome\nPeople infected with HIV whose infection is untreated or considered to be at an advanced stage\nPeople currently being treated with one of the following types of medications:\nHigh-dose corticosteroids (more than 20 mg prednisone or similar medications per day)\nAlkylating agents\nAntimetabolites\nTransplant-related immunosuppressive medications\nCancer chemotherapeutic medications that are considered severely immunosuppressive (e.g., tumor-necrosis, or TNF, blockers)\nBiologic agents that suppress or modulate the immune response\nPeople in this category who should work with their healthcare provider to determine their need for a third dose include:\n\nPeople taking medications that make them uncertain whether they would be included in the list of individuals mentioned above\nPeople with immune-system-related conditions not specifically mentioned above\nPeople preparing to start one of the above-mentioned medications\nPeople not considered to be in this category include:\n\nPeople who do not have compromised immunity.\nPeople without a spleen.\nPeople who had cancer but are no longer being treated.\nPeople with chronic conditions that do not involve the immune system or require treatment with high doses of corticosteroids, such as diabetes, asthma, COPD, kidney disease, heart conditions, sickle cell disease, among others. If you are not sure, check with your healthcare provider.\nPeople 65 years of age and older (booster dose; recommended)\n\nIndividuals who received the mRNA vaccine should get a third dose, separated by at least 6 months from the second dose. Booster doses of Moderna should be half doses.\n\nPeople 18-64 years of age with underlying medical conditions (booster dose; recommended for 50- to 64-year-olds; should be considered for 18- to 49-year-olds)\n\nIndividuals between 50 and 64 years of age who received the mRNA vaccine and have an underlying medical condition, as described below, are recommended to get a booster dose at least 6 months after their second dose. Those between 18 and 49 years of age may get a third dose if they so choose. Booster doses of Moderna should be half doses.\n\nPeople with the following conditions would be considered part of this group:\n\nChronic kidney disease\nChronic lung disease (COPD, asthma, interstitial lung disease, cystic fibrosis, and pulmonary hypertension)\nDementia or other neurologic conditions\nDiabetes (Types 1 or 2)\nDown syndrome\nHeart conditions (Heart failure, coronary artery disease, cardiomyopathies, or hypertension)\nLiver disease\nObesity or overweight\nSickle cell disease or thalassemia\nCerebrovascular disease\nThis list is not exhaustive. For more information about any of these conditions or to see the complete CDC list, consult their “COVID-19 – Medical Conditions” page.\n\nPeople 18 years and older who live or work in high-risk settings (booster dose; should be considered)\n\nIndividuals 18 years of age and older who received an mRNA vaccine and live in a long-term care setting are encouraged to get a booster dose at least 6 months after their second dose. Those 18 years of age and older who are at increased risk because of where they live or work, as described below, may also get a third dose if they so choose.\n\nPeople who live in the following settings would be considered part of this group:\n\nHealth care institutions\nSchools\nCorrectional facilities\nHomeless shelters\nPeople who work in the following occupations would be considered part of this group:\n\nFirst responders (healthcare workers, firefighters, police, congregate care staff)\nEducation staff (teachers, support staff, daycare workers)\nFood and agriculture workers\nManufacturing workers\nCorrections workers\nU.S. Postal Service workers\nPublic transit workers\nGrocery store workers\nTo find out more or check for updates to these categories, visit the CDC’s “COVID-19 Booster Shot” page.\n\nLast updated: Nov. 10, 2021\n\nCan I get my flu vaccine at the same time as my COVID-19 vaccine?\nCan I get my flu vaccine at the same time as my COVID-19 vaccine?\nYes. The CDC has indicated that people can get influenza vaccine and COVID-19 vaccine during the same visit, but in different locations, such as one in each arm or separated by at least one inch on the same arm. However, for those who are willing to come back to get one of the vaccines, it is prudent to wait two weeks between getting an influenza or COVID-19 vaccine. This way if there is a safety concern, it would be clear which vaccine might have caused the problem.\n\nLast updated: Oct. 11, 2021\n\nWhen will COVID-19 vaccines be available for children younger than 5 years of age?\nWhen will COVID-19 vaccines be available for children younger than 5 years of age?\nCOVID-19 vaccine trials are in progress for children younger than 5 years of age but have not yet been completed.\n\nThe Pfizer vaccine was approved for use in children as young as 5 years of age by the FDA in late October 2021 and recommended by the CDC in early November 2021.\n\nFind out more about COVID-19 clinical trials in children in this Parents PACK article, including how the trials are being done, what will be learned and more.\n\nLast updated: Nov. 10, 2021\n\nWhat is the difference between emergency use authorization and the normal process of vaccine approval?\nWhat is the difference between emergency use authorization and the normal process of vaccine approval?\nThe main difference between emergency use authorization, or EUA, and the normal process, which is via a biologic licensure application, or BLA, is how long data were collected prior to the vaccines being reviewed for use. So, when considered quite literally, the vaccines being used today (under EUA) will be no different than those that are being used the day after the vaccines get full approval (BLA). The reason for the shortened timeline was, of course, because of the pandemic. But, at this point, the vaccines have been given safely to millions of people and the companies have been monitoring vaccine recipients for months. As such, at this point, delaying vaccination until the vaccines get “full approval” is taking an unnecessary risk.\n\nLast updated: Aug. 10, 2021\n\nWere the COVID-19 vaccines approved by the FDA?\nWere the COVID-19 vaccines approved by the FDA?\nEven though the COVID-19 vaccines were initially released under Emergency Use Authorization (EUA), they were still approved by the Food and Drug Administration (FDA). The review process was the same, but because of the pandemic, the data could be submitted after a shorter period of participant follow-up than usual. However, even after submitting data (and getting an EUA), those studies continued. Pfizer’s vaccine has now been licensed for those 18 years of age and older, and at some point, the other companies will submit the additional follow-up data to request licensure under Biologics Licensure Application (BLA).\n\nLast updated: Sept. 28, 2021\n\nIs it safe for my teen to get the COVID-19 vaccine given the stories about myocarditis?\nIs it safe for my teen to get the COVID-19 vaccine given the stories about myocarditis?\nCases of myocarditis, or inflammation of the heart, have been reported in a small number of teens after receipt of the COVID-19 mRNA vaccine. The condition is continuing to be investigated. Here is what we know to date:\n\nThe cases of myocarditis that have occurred so far were more often in boys and young men and more often after the second dose. Symptoms occurred within 4 days after receipt of the dose. Recently immunized teens and young adults who experience chest pain or shortness of breath should be seen by a healthcare provider and report recent their vaccination.\nMyocarditis is somewhat common, particularly as a result of viral infections. In fact, cases tend to occur more often in the spring due to viruses that circulate at this time of year (specifically, coxsackie B viruses). Typically, about 100-200 cases occur per million people per year.\nAvailable data suggest that the incidence of myocarditis following mRNA vaccines is about 1 per 50,000 vaccine recipients; however, this risk increases in males between 16 and 29 years of age to about 1 per 20,000 vaccine recipients. Of interest, myocarditis also occurs more commonly after either acute COVID-19 or as part of the multisystem inflammatory syndrome of children (MIS-C). For example, if 100,000 males between 16 and 29 years of age got the mRNA vaccine, about 5 would experience myocarditis. However, if 100,000 males between 16 and 29 years of age were infected with the virus that causes COVID-19, about 59 would experience myocarditis. These numbers are lower in females (See “My teen is a student-athlete and already had COVID-19, so does he need the COVID-19 vaccine?” for more detailed information.)\nParents and teens should watch for symptoms that may include chest pain, pressure, heart palpitations, difficulty breathing after exercise or lying down, or excessive sweating. One or more of these symptoms may also be accompanied by tiredness, stomach pain, dizziness, fainting, unexplained swelling, or coughing. If a recently vaccinated teen develops these symptoms or you are unsure, contact the child’s doctor or seek more immediate medical assistance if needed.\nThe CDC will continue to monitor the situation related to myocarditis, but for now, there is not a reason to stop vaccinating kids. The American Heart Association has also released a statement encouraging continued vaccination.\n\nLast updated: Nov. 10, 2021\n\nCan I get the COVID-19 vaccine if I have COVID-19?\nCan I get the COVID-19 vaccine if I have COVID-19?\nIn the U.S., the CDC recommends waiting until COVID-19 symptoms go away and the individual is done isolating. However, they indicate that it is okay to get the COVID-19 vaccine shortly after recovering from the disease as long as the patient was not treated with antibody-based treatments (convalescent plasma or monoclonal antibodies).\n\nDue to limited supplies of vaccine in some countries and the experience that people who recently had COVID-19 rarely get re-infected in the months immediately after recovery, some areas may be delaying vaccination of recently recovered individuals. As such, we recommend talking with your healthcare provider or health officials to see what the recommendations are in your area.\n\nLast updated 8/10/21\n\nIs it safe for my adolescent or teen to get the COVID-19 vaccine?\nIs it safe for my adolescent or teen to get the COVID-19 vaccine?\nThe Pfizer COVID-19 mRNA vaccine is approved for those 5 years of age and older. Other COVID-19 vaccines are still being tested in those younger than 18 years of age.\n\nWhen the Pfizer vaccine was tested in 5- to 11-year-olds, it was found to be safe:\n\nMore than 15 million teens between 12 and 18 years of age had received one dose of COVID-19 vaccine, and more than 12.5 million had received both doses by Nov. 9, 2021.\nThe clinical trial in 5- to 11-year-olds evaluated about 1,300 children who received the vaccine and compared them with about 660 children who got placebo (a salt solution). Three vaccinated individuals got infected with COVID-19 compared with 16 in the placebo group (about 91% efficacy). Side effects were similar to those in older children and adults, including pain, swelling and redness at injection site; fever; tiredness; headache; muscle aches; chills; and occasionally, swelling of the under arm on the side the vaccine was given. However, children tended to experience side effects less often and those with previous infection were less likely to experience side effects.\nNo cases of myocarditis were identified in the clinical trial; however, because the trials were small, it will be important to monitor for this rare, but serious side effect when more children are immunized.\n\nLast updated: Nov. 10, 2021\n\nWhat side effects will my child experience from the COVID-19 vaccine?\nWhat side effects will my child experience from the COVID-19 vaccine?\nSide effects in children 5 to 11 years of age were similar to what has been found in other age groups, including pain at the injection site, fatigue, headache, fever, chills, muscle pain, or joint pain. However, side effects tended to be less frequent than in other age groups.\n\nBecause a small number of cases of myocarditis, or heart inflammation, have been identified in teens and young adults, particularly in the 4 days after receipt of the second dose of the vaccine, it will be important to monitor younger children for this potential side effect. Chest pain, shortness of breath, or related symptoms should be reported to a healthcare provider.\n\nOther serious side effects have not been identified, nor have long-term effects. Find additional information:\n\nLong-term Side Effects of COVID-19 Vaccine? What We Know.\nReproductive Health and COVID-19 Vaccines\nLast updated: Nov. 10, 2021\n\nIf a person has allergic reactions to a food or medication, can they get the vaccine?\nIf a person has allergic reactions to a food or medication, can they get the vaccine?\nPeople with severe allergies to a COVID-19 vaccine ingredient (see list here) or a previous dose of COVID-19 vaccine should not get that type of COVID-19 vaccine (mRNA or adenovirus-based). They may be able to get the alternative type after consultation with an allergist or immunologist. Individuals with a known allergy to polysorbate should not get the COVID-19 vaccine made by Johnson & Johnson/Janssen.\n\nPeople with immediate allergic reactions to an injectable medication can most often get the COVID-19 vaccine; however, they should remain at the site where they were vaccinated for 30 minutes of observation, instead of the 15 minutes that the general public is recommended to wait. Anyone with this type of allergy who has questions or concerns should discuss the situation with their healthcare provider to assess the potential risks and benefits of receiving the COVID-19 vaccine. \n\nPeople who have had an anaphylactic reaction to anything else (medications, foods, bees, etc.) are allowed to get the COVID-19 vaccine, but should remain at the site where the injection was given for 30 minutes, instead of the 15 minutes that the general population are recommended to wait.\n\nThe CDC published information about allergic reactions that caused anaphylaxis after almost 2 million doses of the Pfizer vaccine were given. They estimate that about 30% of the population has allergies. However, only 21 anaphylactic allergic reactions occurred in those 2 million vaccine recipients. Of these 21 people, 17 of 21 had previously identified allergies, but 4 of 21 had no previously identified allergies at all. Of those who had allergies, no significant pattern emerged, suggesting that there is not a causal association between allergies (or specific allergies) and an anaphylactic reaction to the vaccine. Further, since millions more doses have been administered, this rate of allergic reaction has not continued, suggesting that the likelihood of having an allergic reaction following receipt of the COVID-19 vaccine is not likely to differ from background rates.\n\nIf a person with history of allergies continues to have concerns about whether or not it is safe to get the COVID-19 vaccine, they should contact their primary care provider or allergist, who has the benefit of their complete medical history and will, therefore, be in the best position to discuss any potential risks and benefits for that individual.\n\nLast updated: May 27, 2021\n\nHow well does the COVID-19 vaccine work in adolescents?\nHow well does the COVID-19 vaccine work in adolescents?\nThe clinical trial measured two things to evaluate how the vaccine worked:\n\nDisease – While 18 participants (12-15 years of age) in the placebo group got COVID-19 at least seven days after having the second dose of the vaccine, none in the vaccinated group were infected. This represents 100% efficacy. In the 5- to 11-year-old group, three vaccinated children got COVID-19 compared with 16 children in the placebo group; this represents a 90.7% efficacy.\nImmune response – Now that we know what antibody levels adults experience following vaccination, studies can compare the levels in other groups to see if the vaccine works as well. These are often referred to as “non-inferiority studies,” meaning the vaccine is being tested in the study group to make sure it works at least as it does in another group previously studied. In the Pfizer study, average neutralizing antibody responses were similar in 5- to 11-year-olds compared with older children and young adults even though the dose was lower. While we still do not know if a certain level of virus-neutralizing antibodies indicates that an individual is protected against infection, we can be confident that vaccinated children respond equally well compared with older children and young adults.\nLast updated: Nov. 10, 2021\n\nWhy do kids need the COVID-19 vaccine since they don’t get that sick if they are infected?\nWhy do kids need the COVID-19 vaccine since they don’t get that sick if they are infected?\nWhile children and teens may not be as likely to get severely ill from COVID-19, it can still happen and, in fact, the average age of hospitalizations decreased as the oldest members of our communities were vaccinated. With this in mind, parents and teens should consider the following:\n\nConditions such as obesity, asthma, and developmental delay, as well as other pre-existing conditions, increase the chance for hospitalization.\nAs of mid-October 2021, almost 700 children and teens up to 17 years of age have died from COVID-19.\nAs of early October 2021, more than 5,200 cases of multisystem inflammatory syndrome in children (MIS-C) have been diagnosed and 50 deaths occurred. MIS-C typically occurs 2 to 6 weeks after having COVID-19, can occur following a mild infection, tends to be more severe in adolescents and teens, and causes about 6 or 7 of every 10 individuals to be placed in intensive care. MIS-C can also affect heart function.\nFinally, this age group can also transmit the infection to more vulnerable family and community members, such as those who are unable to get the vaccine.\nLast updated: Nov. 10, 2021\n\nCan the COVID-19 vaccine affect puberty or fertility in my child?\nCan the COVID-19 vaccine affect puberty or fertility in my child?\nNo, the rumors related to COVID-19 vaccines affecting puberty or fertility are unfounded. The mRNA vaccines are processed near the injection site and activated immune system cells travel through the lymph system to nearby lymph nodes. In this manner, they are not affecting hormone levels, nor are they traveling to other parts of the body. As such, there would not be a biological reason to expect that maturation or reproductive functionality of either males or females would be negatively affected by COVID-19 vaccination now or in years to follow.\n\nWatch this short video in which Dr. Paul Offit discusses COVID-19, the vaccines and infertility.\n\nYou can read more about fertility and COVID-19 vaccines in this Vaccine Update article.\n\nLast updated: Nov. 10, 2021\n\nIf I got a COVID-19 vaccine in another country, can I get one in the U.S.?\nIf I got a COVID-19 vaccine in another country, can I get one in the U.S.?\nFor individuals vaccinated in another country, they may or may not be recommended to get a COVID-19 vaccine in the U.S. based on the situation:\n\nIf you received the recommended number of doses of a U.S.-approved vaccine (2 doses Pfizer, 2 doses Moderna, or 1 dose of J&J/Janssen), you are considered fully vaccinated and do not need additional doses.\nIf you received the recommended number of doses of a WHO-approved vaccine, you do not need additional doses.\nIf you received an mRNA vaccine in a country that only gives the vaccine as a single dose, you are not considered fully vaccinated in the U.S., and you should get an additional dose\nIf you started, but did not finish a WHO-approved vaccine, you can get the recommended doses of a U.S.-approved vaccine as long as at least 28 days have passed since your previous dose.\nIf you got a vaccine that is not FDA- or WHO-approved, you can get the recommended number of doses of a U.S.-approved vaccine at least 28 days after your most recent dose of the non-approved vaccine.\nIf you are considered fully vaccinated with an FDA-approved vaccine, but did not receive a booster or additional dose according to U.S.-based recommendations and would like to do so, you may. People who received WHO-approved vaccines are not included in this recommendation.\n\nLast updated: Nov. 10, 2021\n\nWhat should I do if I had the J&J vaccine?\nWhat should I do if I had the J&J vaccine?\nPeople who had a single dose of the J&J/Janssen vaccine are recommended to get a second dose at least 8 weeks after the first dose.\n\nRelated to side effects\n\nIf you had the J&J/Janssen vaccine within the last 3 weeks, although the risk is low, you should monitor yourself for unusual symptoms, including severe headache, severe abdominal pain, unexplained leg pain, or shortness of breath, which may result from TTS, or muscle weakness or paralysis, which may result from GBS. If you develop unusual symptoms, you should seek medical attention and be certain to tell the healthcare provider the date you received the J&J/Janssen vaccine. For TTS, the physician can very quickly determine whether your problem is related to the vaccine by performing a simple complete blood count. If the platelet count is extremely low, the symptoms might be related to the vaccine. We would also recommend registering for v-safe, the CDC’s vaccine monitoring system if you have not done so already.\n\nIf you had the J&J/Janssen vaccine more than 3 weeks ago, you are extremely unlikely to experience either thrombosis with thrombocytopenia syndrome (TTS) or Guillain-Barré syndrome (GBS).\n\nLast updated: Nov. 10, 2021\n\nShould I stop using my birth control if I got the J&J vaccine?\nShould I stop using my birth control if I got the J&J vaccine?\nIt is not necessary to stop taking birth control pills. Individuals affected by thrombotic thrombocytopenic syndrome (TTS), which is an unusual combination of low platelet count (thrombocytopenia) and clotting (thrombosis) did not share common medical histories, such as use of birth control pills; therefore, stopping usage would not change your risk for TTS.\n\nLast updated: Apr. 23, 2021\n\nWhat are CVST and thrombocytopenia?\nWhat are CVST and thrombocytopenia?\nCerebral venous sinus thrombosis (CVST) is a condition that causes blood clots in large vessels that drain blood from the brain. Although it is uncommon, the condition more often affects women between 20 and 50 years of age.\n\nThrombocytopenia is low numbers of cells called platelets. Platelets are cells that help our blood clot. When a person has this condition, they are at risk for bleeding since their body lacks the ability to efficiently stop the bleeding.\n\nIt is very uncommon for CVST and thrombocytopenia to occur at the same time, which is what makes this diagnosis following receipt of the J&J vaccine so unusual. Likewise, the clots have not just occurred in the large vessels near the brain in some of the affected individuals.\n\nWatch this short video in which Dr. Offit discusses the differences between typical blood clots and those occasionally reported following receipt of the COVID-19 adenovirus-based vaccine.\n\nLast updated: Apr. 16, 2021\n\nWhat is the difference between TTS and CVST?\nWhat is the difference between TTS and CVST?\nThrombosis with thrombocytopenia syndrome, or TTS, is the name that has been given to the condition identified in a small number of individuals after receipt of the COVID-19 J&J/Janssen or AstraZeneca vaccines. TTS is distinct from cerebral venous sinus thrombosis, or CVST, because in TTS not all of the clots are associated with the large vessels of the brain. Some individuals had clots in their lungs, heart, intestines, spleen, or large blood vessels in their legs. However, CVST was originally used, and may still be used to refer to the condition by some individuals, because the original cases closely resembled this previously defined condition.\n\nWatch this short video in which Dr. Offit discusses the differences between typical blood clots and those occasionally reported following receipt of the COVID-19 adenovirus-based vaccine.\n\nFor more information about TTS, watch this short animation from the Melbourne Vaccine Education Centre.\n\nLast updated: July 6, 2021\n\nAre some people at higher risk of having the clotting after the J&J vaccine?\nAre some people at higher risk of having the clotting after the J&J vaccine?\nIn the U.S. women between 30 and 49 years of age have most often been affected by this condition compared with other groups; however, both men and women between 18 to 64 years of age have been affected.\n\nData regarding the race of all affected in the U.S. have not been shared, but at the time of the pause, those which were known were White. With this said, a large percentage of the recipients of the J&J vaccine at the time of the pause had also been White (about 63%), so there is no reason to think that people of other races would be exempt from this side effect.\n\nLast updated: May 13, 2021\n\nCould the mRNA vaccines from Pfizer and Moderna cause the same clotting problem as the J&J vaccine did?\nCould the mRNA vaccines from Pfizer and Moderna cause the same clotting problem as the J&J vaccine did?\nThe Johnson & Johnson (J&J)/Janssen COVID-19 vaccine is an adenovirus vector vaccine, which is different from the Pfizer and Moderna mRNA vaccines. At the time of the J&J/Janssen pause, more than 182 million doses of the mRNA vaccines had been administered and no cases of thrombosis with thrombocytopenia syndrome, or TTS, had been reported. Three people out of about 85 million doses of Moderna had blood clots, but they did not have low platelets. The number of blood clots experienced by those who got the Moderna vaccine would be expected based on the background rate of clotting in the general population.\n\nLast updated: May 13, 2021\n\nCan I get the COVID-19 vaccine during my menstrual cycle?\nCan I get the COVID-19 vaccine during my menstrual cycle?\nYes. Women do not need to schedule their COVID-19 vaccine around their menstrual cycle:\n\nThe immune system is not sufficiently compromised by either the COVID-19 vaccine or the menstrual cycle that scheduling them around one another would be of benefit. Indeed, delaying vaccination around a woman’s cycle may only leave her unprotected from COVID-19 for a longer time without offering any known benefit.\nThe mRNA and adenovirus vaccines are processed in immune system cells near the injection site and then those cells travel through the lymph system to nearby lymph nodes, where additional cells of the immune system are activated. As such, the vaccines would not be expected to affect the menstrual cycle. If a woman experiences a delayed cycle following vaccination, one possible explanation could be hormonal changes caused by stress, which in turn can affect a woman’s cycle. However, women with concerns should speak with their doctor since cycles can be delayed for other reasons as well. \nThe COVID-19 vaccine is not shed after vaccination, so being around recently vaccinated individuals would not be expected to affect someone’s cycle.\nYou can read more about menstruation and COVID-19 vaccines in this Vaccine Update article.\n\nLast updated: May 25, 2021\n\nDo the COVID-19 vaccines contain live virus?\nDo the COVID-19 vaccines contain live virus?\nNeither the mRNA (Moderna and Pfizer) nor adenovirus (J&J/Janssen and AstraZeneca) vaccines contain live virus. Each of these contain a single gene from the virus that causes COVID-19. The gene instructs our cells to make the protein, but no other proteins from the virus are made, so the whole virus particles are never present. In this manner, people who were vaccinated cannot shed, or spread, the virus to other people.\n\nLast updated Apr. 23, 2021\n\nDo the COVID-19 vaccines cause viral shedding?\nDo the COVID-19 vaccines cause viral shedding?\nViral shedding occurs when a person is infected with a virus and whole viral particles produced during the infection are transmitted in the individual’s secretions. For viruses that infect the respiratory tract, these particles are often found in secretions from the nose and mouth, such as saliva or mucus.\n\nSome people wonder whether they can shed the virus as a result of vaccination. In the case of mRNA and adenovirus-based vaccines approved for use in the U.S., the short answer is no. Both of these types of vaccines only introduce a single protein from the virus that causes COVID-19 – the spike protein. As such, whole viral particles are never produced during vaccine processing. Indeed, people are not considered to be infected when they are vaccinated because the virus does not replicate in them. Further, the vaccines are processed near the site of injection, so the spike protein produced during processing would not be found in nasal or oral secretions. As such, they cannot “shed” the single protein either.\n\nWhile people who are vaccinated are less likely to be infected, there is a still a small chance that the virus could replicate at low levels in the nasal or oral cavity before the immune system stops it. If this happens, the individual may be able to shed the virus produced during the brief period of replication.\n\nRead more about viral shedding in this Parents PACK article, “Viral Shedding and COVID-19 — What Can and Can’t Happen.\"\n\nLast updated: June 14, 2021\n\nHow do mRNA vaccines work?\nHow do mRNA vaccines work?\nPeople make mRNA all the time. In our cells, DNA in the nucleus is used to make mRNA, which is sent to the cytoplasm where it serves as a blueprint to make proteins. Most of the time, the proteins that are produced are needed to help our bodies function.\n\nmRNA vaccines take advantage of this process by introducing the mRNA for an important protein from the virus that the vaccine is trying to protect against. In the case of COVID-19, the important protein is the spike protein of the SARS-CoV-2 virus. The mRNA that codes for the SARS-CoV-2 spike protein is taken up by cells called dendritic cells, which express the spike protein on the cell surface, travel to a local lymph node, and stimulate other cells of the immune system (B cells) to make antibodies. These antibodies protect us, so that if we are exposed to SARS-CoV-2 in the future, our immune system is ready and we don’t get sick.\n\nThe vaccine is processed over a 1- to 2-week period after vaccination during which time the immune response develops. However, the mRNA only directs protein production in the cell for 1 to 3 days before it breaks down. Once it breaks down, the cell stops making the spike protein.\n\n\n\nSee more about dendritic cells and the adaptive immune system in this animation.\nWatch this short video of Dr. Offit describing how mRNA vaccines work.\nLast updated July 29, 2021\n\nHow do adenovirus vector vaccines work?\nHow do adenovirus vector vaccines work?\nAdenovirus vector vaccines take advantage of a class of relatively harmless viruses, called adenoviruses. Some adenoviruses cause the common cold, but others can infect people without causing illness. To use these viruses for vaccine delivery, scientists choose types of adenovirus that do not cause illness and to which most people have not been exposed. They alter the virus by removing two of the genes that enable adenovirus to replicate in people, and they replace one of those genes with the one for the SARS-CoV-2 spike protein.\n\nLike human cells, adenoviruses contain DNA as their genetic material. So, when an adenovirus vaccine is administered, it enters cells of the immune system called dendritic cells where it releases the DNA that includes the gene for the spike protein, and the genetic material enters the nucleus of the cell. In the nucleus, the DNA is used to make messenger RNA (mRNA), which is released into the cytoplasm to serve as a blueprint for making proteins. The DNA from the viral vector, however, cannot insert into the cell’s DNA. The mRNA causes the SARS-CoV-2 protein to be produced. The dendritic cells puts pieces of the SARS-CoV-2 spike protein on their surface and travel to a draining lymph node where they stimulate other cells of the immune system; specifically, B cells that make antibodies, T cells that help B cells make antibodies, and other T cells that can kill virus-infected cells. Antibodies against the spike protein will now prevent the virus from causing an infection in the future.\n\n\n\nFind out more about adenovirus vaccines in this Vaccine Update article, “Getting Familiar with COVID-19 Adenovirus-replication-deficient Vaccines.”\n\nLast updated: Nov. 10, 2021\n\nHow did the vaccine companies (e.g., Pfizer and Moderna) decide which mRNA to use?\nHow did the vaccine companies (e.g., Pfizer and Moderna) decide which mRNA to use?\nIn order for a virus to reproduce and cause infection, it must get into cells and take over the cellular machinery. Because viruses attach to cells using a particular protein on their surface, in this case the SARS-CoV-2 spike protein, scientists understood that blocking that attachment would be a direct way to prevent infection. One way to block this attachment is with antibodies that bind to the surface protein. As such, when the genome was published, scientists developing the nucleic acid or protein subunit vaccines (i.e., those that only used part of the virus) chose the gene for the spike protein, anticipating that this would be the most direct route to developing an effective vaccine.\n\nLast updated: Mar. 31, 2021\n\nWho should NOT get the COVID-19 vaccine?\nWho should NOT get the COVID-19 vaccine?\nMost people are able to get COVID-19 vaccine. But, a few groups of people either should not get the vaccine or should get a particular version. Likewise, some individuals should consult with their doctor or follow special procedures.\n\nPeople who should NOT get any COVID-19 vaccine:\n\nThose younger than 5 years of age\nPeople currently isolating or experiencing symptoms of COVID-19; these people can get vaccinated once they are finished isolation and their primary symptoms have resolved.\nPeople who cannot get the mRNA vaccine (Pfizer or Moderna), but may be able to get the J&J/Janssen vaccine:\n\nAnyone with a previous severe or immediate allergic reaction (i.e., one that causes anaphylaxis or requires medical intervention) to a COVID-19 mRNA vaccine dose or an mRNA vaccine component.\nAnyone with a known allergy to polyethylene glycol\nPeople who cannot get the adenovirus vaccine (J&J/Janssen), but may be able to get the mRNA vaccine (Pfizer or Moderna):\n\nAnyone with a previous severe or immediate allergic reaction (i.e., one that causes anaphylaxis or requires medical intervention) to the COVID-19 adenovirus vaccine or one of its components\nAnyone with a known polysorbate allergy\nThose 5-18 years of age can get the Pfizer mRNA vaccine, but not other versions (as long as they do not have other contraindications that prevent receipt of the vaccine).\nPeople who may get the vaccine after considering risks and benefits and/or consulting with their healthcare provider:\n\nIndividuals with a history of severe or immediate allergic reaction to any vaccine or injectable medication (These individuals should be observed for 30 minutes after receipt of the vaccine.)\nPeople who have a severe or immediate allergic reaction to one of the types of vaccines and for whom the cause of the reaction is unknown (i.e., which component caused the reaction) should consult an allergist or immunologist to determine whether the individual can get the other version. If they proceed, they should be vaccinated at a location with medical facilities and staff prepared to respond to medical emergencies.\nPeople with certain immune-compromising conditions\nPeople on anticoagulants\nPeople who should follow special procedures\n\nSomeone with a history of severe or immediate allergic reaction (requiring medical intervention) to anything other than a vaccine or injectable medication can get the vaccine, but they should remain at the vaccination location for medical observation for 30 minutes after receipt of the vaccine.\nPregnant women who develop a fever after vaccination should take acetaminophen. (See more in the pregnancy-related questions lower on this page.)\nPeople who recently had COVID-19 and were treated with antibody-based therapies (e.g., monoclonal antibodies or convalescent plasma) should wait until 90 days after treatment to be vaccinated against COVID-19.\nPeople who received an antibody-based therapy following COVID-19 exposure (but not infection) should wait 30 days after treatment to be vaccinated.\nPeople treated with convalescent plasma should not receive measles- or varicella-containing vaccines until at least 7 months after receipt of the plasma.\nChildren (C) or adults (A) diagnosed with multisystem inflammatory syndrome (MIS-C or MIS-A) should seek guidance from their treatment team regarding vaccination and if getting vaccinated, delay vaccination until they recover and at least 90 days have passed from their diagnosis of this condition.\nPeople with a known COVID-19 exposure should wait until their quarantine is over before getting vaccinated (unless they live in a group setting, such as a nursing home, correctional facility, or homeless shelter, in which case they can be vaccinated during the quarantine period).\nLast updated Nov. 10, 2021\n\nWhere can I get the vaccine?\nWhere can I get the vaccine?\nCOVID-19 vaccines are generally widely available. As such, we recommend checking for vaccine at your provider’s office, local pharmacies, healthcare facilities, mass vaccination sites or mobile clinics. For children 5 to 11 years of age, we recommend contacting facilities in advance to ensure that they are vaccinating that age group.\n\nYou can find your state’s information about COVID-19 vaccine distribution using this information prepared by our colleagues at Vaccinate Your Family.\n\nLast updated: Nov. 10, 2021\n\nWhat are the side effects of the COVID-19 vaccine?\nWhat are the side effects of the COVID-19 vaccine?\nSide effects from both the mRNA and adenovirus vaccines are caused as part of the immune response to the vaccine.\n\nThe most common side effects from the mRNA vaccines (Pfizer and Moderna) are:\n\nFatigue\nHeadache\nMuscle aches\nSide effects occurred during the first week after vaccination but were most likely one or two days after receipt of the vaccine. Side effects were more frequent following the second dose and more likely to be experienced by younger, rather than older, recipients. Although most people will not have significant side effects, some people may wish to schedule their vaccination, so that they will not need to call out of work the next day if they don’t feel well.\n\nA small number of people who get the mRNA vaccine experience mild, short-lived inflammation of the heart, called myocarditis. About 1 of every 50,000 mRNA vaccine recipients experience this condition, but it is most likely in adults 29 years and younger and more often occurs in males. This condition tends to occur within 4 days of receipt of the second dose. Recently vaccinated individuals who experience chest pain or shortness of breath should seek medical care. This condition tends to resolve within 2-3 weeks and does not cause long-term heart damage. Importantly, COVID-19 infections can also cause myocarditis, and this tends to occur more frequently after infection compared with vaccination. (See “My teen is a student-athlete and already had COVID-19, so does he need the COVID-19 vaccine? We are worried about myocarditis.” on this page for more detailed information.)\n\nThe most common side effects from the adenovirus vaccine (Johnson & Johnson/Janssen) are:\n\nInjection site pain and less often redness or swelling\nHeadache\nFatigue\nMuscle aches\nFever\nSide effects occurred during the first seven to eight days after vaccination but were most likely to occur one or two days after receipt of the vaccine. Side effects were more often experienced by younger, rather than older vaccine recipients.\n\nTwo rare, but potentially dangerous conditions, have been identified following receipt of the adenovirus-based vaccines, such as the J&J/Janssen version:\n\nThrombosis with thrombocytopenia syndrome, or TTS, occurs in about 1-2 of every 1 million vaccine recipients and develops up to 3 weeks after getting vaccinated. Individuals between 18 and 64 years of age, both female and male, who got the J&J/Janssen vaccine have experienced this condition; however, women between the ages of 30 and 49 years of age are at the greatest risk. To date, four deaths have been attributed to this side effect. Anyone who got the J&J/Janssen vaccine less than 3 weeks ago should seek medical care if they develop severe headache, shortness of breath, severe abdominal pain, unexplained leg pain, easy bruising, or small red spots on the skin. Anyone seeking medical care with one or more of these symptoms should mention their recent receipt of the vaccine, so healthcare providers can order the appropriate diagnostic tests and treatments.\nGuillain-Barré syndrome, or GBS, occurs in about 1 of every 100,000 vaccine recipients, most often during the first 3 weeks after getting vaccinated. The condition has most often been identified in males between 50 and 64 years of age, but it can occur in females and those 65 years and older on occasion. While rare, most cases have required hospitalization and, to date, one person has died. Anyone who recently received an adenovirus-based COVID-19 vaccine and experiences muscle weakness or paralysis should seek medical treatment and inform the healthcare provider of the recent vaccination. It should also be noted that COVID-19 has also been associated with GBS; so, natural infection with SARS-CoV-2 also appears to be a rare cause of GBS.\nIllustration of who is most at risk for these side effectsCheck out this infographic [PDF, 157KB] to see a visual representation of this information.\n\nLast updated: Nov. 18, 2021\n\nCan I take medicine for the side effects after I get the vaccine?\nCan I take medicine for the side effects after I get the vaccine?\nThe CDC has indicated that you can take anti-fever or anti-inflammatory medications if necessary following COVID-19 vaccination, but it is important to know that doing so could diminish the level of immunity that develops. This is true anytime you take these types of medications, whether following vaccination or to treat illness. Generally speaking, the “symptoms” people experience following vaccination or during illness, such as fever, redness, or fatigue, are caused by your immune system responding. For example, fever is your body turning up its “thermostat” to make the immune system more efficient and the pathogen less efficient. For these reasons, if you are not very uncomfortable, it is better not to take these medications.\n\nSome wonder how long they should wait after vaccination before taking these types of medicines, so their immune response is not affected. As a rule of thumb, the immune response for the mRNA vaccines develop over a week or two after vaccination and for the adenovirus vaccines over the course of about four weeks, but the greatest chance of affecting your immune response would be in the first few days after receipt of the vaccine. Indeed, in the adenovirus vaccine studies, about 1 in 4 vaccine recipients took fever-reducing medication (antipyretics), and most people were still protected from severe disease and all were protected against hospitalization.\n\nFind out more in this Parents PACK article, \"Medications and COVID-19 Vaccines: What You Should Know.\"\n\nLast updated: Mar. 1, 2021\n\nIf I don’t have side effects, does that mean the vaccine did not work?\nIf I don’t have side effects, does that mean the vaccine did not work?\nMany people will get the vaccine and not experience side effects. This does not mean that the vaccine did not work for them. In the clinical trials side effects occurred at varying rates, for example only about 1 to 20 of every 100 people who received the mRNA vaccine had a fever, but we know that the mRNA vaccine worked for more than 90 of every 100 people.\n\nLast updated: Mar. 1, 2021\n\nWhat are the expected long-term side effects of the vaccination for COVID-19?\nWhat are the expected long-term side effects of the vaccination for COVID-19?\nMost negative effects occur within 6 weeks of receiving a vaccine, which is why the FDA asked the companies to provide 8 weeks of safety data after the last dose.\nmRNA vaccines: The mRNA in the vaccine breaks down pretty quickly because our cells need a way to stop mRNA from making too many proteins or too much protein. But, even if for some reason our cells did not breakdown the vaccine mRNA, the mRNA stops making the protein within about a week, regardless of the body’s immune response to the protein.\n\nRead more about COVID-19 mRNA vaccines in this Parents PACK article, “Long-term Side Effects of COVID-19 Vaccine? What We Know.”\n\nWatch a short video of Dr. Paul Offit explaining why COVID-19 vaccines would not be expected to cause long-term side effects.\n \nAdenovirus-based vaccines: Although the DNA from adenovirus-based vaccines does not break down as quickly as mRNA, the DNA cannot alter our DNA because a gene for the enzyme, integrase, is not present.\nLast updated: Mar. 1, 2021\n\nShould I stop taking my daily dose of aspirin before getting the COVID-19 vaccine?\nShould I stop taking my daily dose of aspirin before getting the COVID-19 vaccine?\nIf your daily dose of aspirin was prescribed by your physician following a stroke or heart attack, we recommend speaking to that doctor about whether to stop taking your medication for a day or two prior to vaccination. If, however, your daily dose of aspirin is because you have risk factors for a stroke or heart attack (such as high blood pressure or high levels of “bad” cholesterol) but have never had a stroke or heart attack, you should consider discontinuing the aspirin not only prior to your COVID-19 vaccine, but all together. The data show that while daily aspirin helps prevent second strokes or heart attacks, it does not help prevent first occurrences, even in people who are at increased risk. Our director, Dr. Paul Offit, carefully reviewed the data related to this topic for his book, Overkill: When Modern Medicine Goes Too Far.\n\nFind out more in this Parents PACK article, \"Medications and COVID-19 Vaccines: What You Should Know.\"\n\nLast updated: Feb. 1, 2021\n\nWhat should I do if I took pain medicine before getting the COVID-19 vaccine?\nWhat should I do if I took pain medicine before getting the COVID-19 vaccine?\nWhile your initial immune response may have been lower, you will likely still have developed some immunity. Even if your immune response is somewhat lower overall, you are likely to develop sufficient levels of immunity to reduce your chance for infection. In addition, even if you were infected, you would be likely to experience disease that is less severe and of shorter duration.\n\nLast updated: Mar. 1, 2021\n\nWhat if I can’t get the second dose 21 (Pfizer) or 28 (Moderna) days after the first dose?\nWhat if I can’t get the second dose 21 (Pfizer) or 28 (Moderna) days after the first dose?\nThe Centers for Disease Control and Prevention (CDC) allows for a 4-day grace period when assessing on-time receipt. This means the following ranges of days are considered “on-time” for receipt of the second dose:\n\nPfizer vaccine: 17 to 25 days after the first dose\nModerna vaccine: 24 to 32 days after the first dose\nPeople should try to get the second dose during this period or as soon after as possible. However, if your second dose is given later than this, you do not need to restart the vaccine. You still only need to get the second dose. However, it is important to note that the first dose did not protect as many people as were protected after the second dose, so if you are exposed to SARS-CoV-2 during the delay, you may or may not have enough immunity to prevent you from experiencing symptoms.\n\nLast updated: Jan. 19, 2021\n\nWhat is the difference between the first and second dose of the COVID-19 mRNA vaccine?\nWhat is the difference between the first and second dose of the COVID-19 mRNA vaccine?\nIn the United States, the ingredients in the vial for dose 1 and dose 2 of the same brand are exactly the same. When people talk about dose 1 doses and dose 2 doses, they are just talking about vaccine supply. If you arrive for dose 1 and the person behind you is getting dose 2, they can come out of the same vial.\n\nOne vaccine used in some other countries, Sputnik V, has different components in dose 1 and dose 2. Both are adenovirus vector vaccines, but dose 1 uses adenovirus 26 (Ad26) and dose 2 uses adenovirus 5 (Ad5).\n\nLast updated: Mar. 1, 2021\n\nCan I get the second dose of COVID-19 mRNA vaccine in my other arm?\nCan I get the second dose of COVID-19 mRNA vaccine in my other arm?\nYes. It is okay to get the second dose in the other arm as the immunity generated by the first dose will be circulating in your body watching for a potential exposure.\n\nIndeed, individuals who experience a delayed reaction at the injection site (a rash that develops a few days to a couple of weeks after receipt of the vaccine) are recommended to get the second dose in the opposite arm.\n\nLast updated: Mar. 1, 2021\n\nCan additional doses of the COVID-19 vaccine be from a different company?\nCan additional doses of the COVID-19 vaccine be from a different company?\nThe CDC recommends that people get the same version for all primary doses (first two doses of Pfizer or Moderna and first dose of J&J/Janssen).\n\nPeople getting an additional dose of mRNA vaccine for an immune-compromising condition should also seek the same version as originally received when possible.\n\nPeople getting boosters can change their version, but if no compelling reason exists to change and the previous version is available, they may try to get the same type. Of note, people getting a booster dose of Moderna should only receive a half dose.\n\nLast updated: Nov. 10, 2021\n\nHow long do I need to wait if I had or need to get a non-COVID-19 vaccine?\nHow long do I need to wait if I had or need to get a non-COVID-19 vaccine?\nThe Centers for Disease Control and Prevention (CDC) has updated their recommendations, so that individuals do not need to delay between receipt of COVID-19 vaccine and other vaccines.\n\nWatch this short video in which Dr. Hank Bernstein explains the benefits of receiving routine vaccines at the same time as the COVID-19 vaccine.\n\nLast updated: May 13, 2021\n\nAre young children susceptible to COVID-19, especially if a parent tests positive?\nAre young children susceptible to COVID-19, especially if a parent tests positive?\nIf a parent tests positive, they should still try to isolate from other members of the household, and all others in the home, including any children, should quarantine and be monitored for symptoms, as per CDC recommendations for exposure. \n\nLikewise, even after parents are vaccinated, they should be aware that their children could be infected and follow public health guidance to ensure that the children are not inadvertently exposed to the virus.\n\nLast updated: Nov. 10, 2021\n\nWhat is multisystem inflammatory syndrome (MIS-C or MIS-A)?\nWhat is multisystem inflammatory syndrome (MIS-C or MIS-A)?\nMultisystem inflammatory syndrome can occur in children (MIS-C) or adults (MIS-A). Development of symptoms typically occurs about 4 to 6 weeks after SARS-CoV-2 infection and can occur even in those who did not experience symptoms of COVID-19. Often multiple organs and body systems are involved, including effects on the gastrointestinal tract, heart, kidneys, skin, lungs, and eyes. Individuals with unexplained rash, vomiting or diarrhea, shortness of breath or chest pain or palpitations should seek medical care. Some people with MIS-C or MIS-A will require admission to intensive care and a small number may require mechanical ventilation.\n\nWatch this short video in which Dr. Offit discusses MIS-C, MIS-A, and long COVID.\n\nLast updated: Nov. 10, 2021\n\nWhat is long COVID?\nWhat is long COVID?\nLong COVID, also known as COVID syndrome or long-term COVID, is a condition characterized by long-lasting symptoms related to previous SARS-CoV-2 infection. Symptoms can last for weeks or months after viral clearance and resolution of the initial infection. Examples of the types of symptoms that affected individuals report include fatigue, difficulty thinking or concentrating (“brain fog”), headache, loss of taste or smell, dizziness, heart palpitations, chest pain, shortness of breath, cough, joint or muscle pain, anxiety, depression, or fever. Symptoms sometimes appear or worsen after physical or mental activity. The reasons for or susceptibility to these long-lasting effects remain uncertain but are being studied.\n\nWatch this short video in which Dr. Offit discusses MIS-C, MIS-A, and long COVID.\n\nLast updated: June 16, 2021\n\nDoes a vaccinated person present a risk to unvaccinated family members in the same house?\nDoes a vaccinated person present a risk to unvaccinated family members in the same house?\nVaccinated people do not shed virus as a result of vaccination. Neither the mRNA nor the adenovirus vaccines are composed of live viruses, so there is no infectious virus to spread from a vaccinated person to someone else.\n\nBut a vaccinated person who encounters the virus can still experience what is referred to as “asymptomatic infection.” An asymptomatic infection occurs when a person is exposed to the virus in the community and the virus can still replicate in their body, but they don’t have symptoms because their immune system stifles the infection as a result of vaccination. In this scenario, the person could potentially spread the virus without even knowing they are infected. While it is not anticipated that vaccinated individuals would be a source of significant spread of the virus, they may still spread the virus in a limited manner. Therefore, we need to practice caution.\n\nGiven that young children and possibly family members and friends will not all be vaccinated, vaccinated individuals should continue to follow public health guidance when they are out in the community to decrease spread of the virus. Even when a whole family is vaccinated, continuing to practice these measures will be important for two reasons:\n\nThe vaccine will not work for everyone, so someone in the home who has been vaccinated may still be susceptible.\nPeople outside of the family’s “bubble,” like co-workers, extended family members, neighbors, and others they come into contact with, may not have been vaccinated (or may be in the group for whom the vaccine does not work).\nThis approach will be important until we can get control over the spread of virus. Once enough people have been vaccinated to slow the spread of the virus, we will all be able to move away from these public health measures.\n\nRead more in the January 2021 Parents PACK newsletter article, “When the Whole Family Has Not Yet Been Vaccinated Against COVID-19.”\n\nLast updated: Nov. 10, 2021\n\nWhat ingredients are in the COVID-19 mRNA vaccine?\nWhat ingredients are in the COVID-19 mRNA vaccine?\nThe mRNA vaccines include:\n\nmRNA – This mRNA is for the spike protein of SARS-CoV-2, the virus that causes COVID-19.\nLipids - These are molecules that are not able to dissolve in water. They protect the mRNA, so that it does not break down before it gets into our cells. These can be thought of as little “bubbles of fat,” which surround the mRNA like a protective wall. There are four different lipids in the Pfizer vaccine and three in the Moderna vaccine. One of the lipids in both vaccines is cholesterol. The lipids are the most likely components of the vaccine to cause allergic reactions.\nSalts and amines - The Pfizer vaccine contains four salts. One is table salt. The salts are used to keep the pH of the vaccine similar to that found in the body, so that the vaccine does not damage cells when it is administered. The Moderna vaccine also contains four chemicals to balance the pH, but two are in a class of organic compounds known as “amines” and two are acetic acid and its salt form, sodium acetate. Acetic acid is the main component of vinegar (other than water).\nSugar – This ingredient is literally the same as that which you put in your coffee or on your cereal. It is used in both of the vaccines to help keep the “bubbles of fat” from sticking to each other or to the sides of the vaccine vial.\nThese are the only ingredients in the mRNA vaccines.\n\nNOT in the COVID-19 mRNA vaccines:\n\nAnimal Products\nAntibiotics\nBlood products\nDNA\nEgg Proteins\nFetal material\nGluten\nMicrochips\nPork products\nPreservatives, like thimerosal\nSoy\nThe CDC has the list of specific lipids and salts posted on its website.\n\nWatch this short video in which Dr. Paul Offit talks about the ingredients of COVID-19 mRNA vaccines.\n\nLast updated Feb. 19, 2021\n\nWhat ingredients are in the COVID-19 adenovirus-based vaccine?\nWhat ingredients are in the COVID-19 adenovirus-based vaccine?\nThe adenovirus vaccine includes:\n\nAdenovirus type 26 (Ad26) containing SARS-CoV-2 spike protein gene and altered so that it cannot replicate\nStabilizers – Salts, alcohols, polysorbate 80, and hydrochloric acid\nManufacturing by-products – amino acids\nNOT in the COVID-19 adenovirus vaccines:\n\nAnimal Products\nAntibiotics\nBlood products\nEgg Proteins\nGluten\nMicrochips\nPork products\nPreservatives, like thimerosal\nSoy\nLast updated: Mar. 4, 2021\n\nDo COVID-19 vaccines contain antibiotics?\nDo COVID-19 vaccines contain antibiotics?\nNo. Neither the mRNA vaccines (Pfizer and Moderna) nor the adenovirus vaccine (Johnson & Johnson/Janssen) contain antibiotics.\n\nWatch this short video in which Dr. Hank Bernstein discusses which ingredients are and are not in the COVID-19 mRNA vaccines.\n\nLast updated: Mar. 1, 2021\n\nCan mRNA vaccines change the DNA of a person?\nCan mRNA vaccines change the DNA of a person?\nSince mRNA is active only in a cell’s cytoplasm and DNA is located in the nucleus, mRNA vaccines do not operate in the same cellular compartment that DNA is located.\n\nFurther, mRNA is quite unstable and remains in the cell cytoplasm for only a limited time (See “What stops the body from continuing to produce the COVID-19 spike protein after getting an mRNA vaccine?” below.) mRNA never enters the nucleus where the DNA is located so it can’t alter DNA.\n\nWatch this short video in which Dr. Paul Offit explains why it’s not possible for mRNA vaccines to alter a person’s DNA.\n\nLast updated Dec. 15, 2020\n\nCan adenovirus-based vaccines change the DNA of a person?\nCan adenovirus-based vaccines change the DNA of a person?\nAdenovirus-based vaccines contain DNA, which enters the nucleus of cells after vaccination, but the virus cannot replicate and the vaccine does not include a necessary enzyme, called integrase. Therefore, the vaccine cannot change a person’s DNA.\n\nLast updated: Mar. 1, 2021\n\nWhat stops the body from continuing to produce the COVID-19 spike protein after getting a COVID-19 mRNA or adenovirus- based vaccine?\nWhat stops the body from continuing to produce the COVID-19 spike protein after getting a COVID-19 mRNA or adenovirus- based vaccine?\nBoth vaccines result in production of spike protein that results from mRNA blueprints. Because our cells are continuously producing proteins, they need a way to ensure that too many proteins do not accumulate in the cell. So, generally speaking, mRNA is always broken down fairly quickly. Even if for some reason our cells did not breakdown the vaccine mRNA, the mRNA stops making the protein within about a week, regardless of the body’s immune response to the protein. Once the mRNA is broken down, the blueprint is gone, so the cell can no longer continue to make spike proteins.\n\nLikewise, while the adenovirus-based vaccine delivers DNA and the DNA lasts longer than mRNA, studies have shown that adenovirus-based DNA does not last longer than a few weeks.\n\nWatch this short video in which Dr. Hank Bernstein explains how the mRNA from the COVID-19 vaccine is broken down and removed from the body.\n\nLast updated Apr. 23, 2021\n\nWill the spike protein from current vaccines cause an issue if there are future variants?\nWill the spike protein from current vaccines cause an issue if there are future variants?\nThis question has two aspects – longevity of the spike protein and effects of current immune responses to future variants. While related, these are not cumulative issues, meaning they involve separate considerations:\n\nLongevity of the spike protein - The spike protein does not remain in the body for an extended time, nor does it travel around the body. The only thing that remains after the vaccine is processed are antibodies and memory immune cells that will recognize the virus if we are exposed in the future. The antibodies and memory cells will or will not recognize the variant spike protein. If they do, great – we will have some protection. If they don’t, it will be just like an antibody to flu or measles, it will have no effect.\nEffects of current immune responses to future variants - As the virus evolves, it changes, so we might find ourselves dealing with different versions of the virus in the future. Current variants have not changed significantly enough that our antibodies have stopped being protective, so for now, we do not need additional doses of vaccine. If, however, one (or more) of these variants changes enough that the vaccine-induced immunity (or disease-induced immunity) is no longer protective, we will need to make new COVID-19 vaccines that protect against the new version of the virus. As described above, in this scenario the existing immunologic memory (antibodies or memory cells) will no longer be effective, but it will not be problematic either. A new vaccine would induce new immunity and the process would begin anew.\nLast updated: May 25, 2021\n\nIs it safe to get the COVID-19 vaccine if I have COVID-19?\nIs it safe to get the COVID-19 vaccine if I have COVID-19?\nThe CDC recommends waiting until your symptoms go away and you are no longer isolating. If you happen to be infected, but don’t know because you have not yet developed symptoms or you have an infection without symptoms, the vaccine is not likely to be harmful. It would increase your body’s immune response against the virus.\n\nLast updated Jan. 19, 2021\n\nCan I drink alcohol after getting the COVID-19 vaccine?\nCan I drink alcohol after getting the COVID-19 vaccine?\nAlcohol suppresses the immune system, so it would be advisable not to drink alcoholic beverages for about 2 weeks after getting vaccinated.\n\nLast updated: Dec. 31, 2020\n\nIs it okay to donate blood after getting the COVID-19 vaccine?\nIs it okay to donate blood after getting the COVID-19 vaccine?\nGiving blood after getting the COVID-19 vaccine will not diminish the resulting immune response, which mostly builds in the lymph nodes near the injection site. Likewise, the American Red Cross (ARC) does not require a delay following vaccination with the vaccines currently approved for use in the U.S.; however, individuals must know which brand of vaccine they received and show the immunization card if possible. More details about blood donation are available on the ARC website.\n\nLast updated: Mar. 18, 2021\n\nAre COVID-19 vaccines made in fetal cells?\nAre COVID-19 vaccines made in fetal cells?\nThe mRNA vaccines (those by Pfizer and Moderna) do not contain fetal cells.\n\nBut, the adenovirus-based vaccines, like Johnson & Johnson/Janssen’s, use cells originally isolated from fetal tissue (often referred to as fetal cells). These fetal cells are used to grow the vaccine virus.\n\nTo replicate, a virus needs to take over a cell’s machinery (See this animation); however, the adenoviruses used in these vaccines have been altered, so that they cannot replicate. So, to make virus to use as the vaccine, these altered viruses need to infect cells that have been altered in a way to allow the defective virus to reproduce. The special cells for this process were isolated decades ago from one of two terminated fetuses and later adapted for the adenovirus reproduction process. Neither of these are used to produce any existing vaccines grown in fetal cells:\n\nHEK-293 — This is a kidney cell line that was isolated from a terminated fetus in 1972.\nPER.C6 — This is a retinal cell line that was isolated from a terminated fetus in 1985.\nThese two cell lines have been maintained in the laboratory, and no additional fetuses are needed to produce adenovirus-vector vaccines.\n\nIn this short video, Dr. Paul Offit addresses fetal cells and COVID-19 vaccines.\n\nLast updated Mar. 1, 2021\n\nHow many doses of a COVID-19 vaccine will be needed?\nHow many doses of a COVID-19 vaccine will be needed?\nThe mRNA vaccines require two doses, and some sub-groups of individuals are recommended to get, or can consider getting, a third dose (see “Do I need another dose of the COVID-19 vaccine?” for more details). For the Pfizer vaccine, the two doses should be separated by 21 days. For Moderna’s vaccine, the two doses should be separated by 28 days. The timing and quantity of the third dose depends on the reason for it (See aforementioned question and answer.).\n\nThe adenovirus vaccine (Johnson & Johnson/Janssen) is recommended as two doses separated by at least 8 weeks.\n\nLast updated: Nov. 10, 2021\n\nHow long will vaccine immunity last?\nHow long will vaccine immunity last?\nWe are still learning how long immunity lasts after infection or vaccination. The latest information shows that:\n\nFollowing infection people are not likely to be re-infected within 90 days of infection. However, they are working to learn more about immunity following infection. While some people have been re-infected after recovering from COVID-19, the number of people who have experienced this is small compared with the total number of people who have been infected.\nFollowing vaccination , people are immune for at least 6 months and likely much longer. Based on the elements of the immune response activated after vaccination with either the mRNA or adenovirus vaccines, it is likely that immunity will be long-lived. However, decreasing antibody levels in some individuals have prompted a recommendation for some groups of people to get a third dose (See more details in “Do I need another dose of COVID-19 vaccine?” question on this page).  Also, of note, if the virus continues to change, new variants may be able to evade immunity generated by vaccination, which would also affect the duration of protection.\nLast updated: Nov. 10, 2021\n\nIf you had the virus, do you still need to get the vaccine?\nIf you had the virus, do you still need to get the vaccine?\nPeople who had COVID-19 are recommended to get the vaccine after they have recovered. The vaccine trials included people who were previously infected with SARS-CoV-2, and the vaccine was found to be safe. Because we do not know how long antibodies last after infection and a small number of people have had more severe second bouts of infection, the vaccine can be beneficial in boosting a person’s existing immunity from infection.\n\nWatch this video of Dr. Paul Offit explaining why those infected with SARS-CoV-2 should still get the COVID-19 vaccine.\n\nWatch this short video in which Dr. Offit discusses what is known about COVID-19 reinfection.\n\nLast updated: Sept. 28, 2021\n\nIf a person is vaccinated against COVID-19, will they be able to spread the virus to susceptible people?\nIf a person is vaccinated against COVID-19, will they be able to spread the virus to susceptible people?\nPeople will not spread the virus after vaccination with the mRNA or adenovirus vaccines. The vaccines do not deliver live virus nor do they cause the body to produce virus, so there is no chance for a vaccinated person to spread the vaccine virus to others, even if they have side effects.\n\nOf note, however, we do not yet know to what extent a vaccinated individual who gets infected may spread the virus. While an outbreak in Provincetown, MA, suggested that infected vaccinated people may have as much viral antigen as infected, previously unvaccinated individuals, the study had important limitations. Read more in this “In the Journals” article from our Vaccine Update for healthcare providers.\n\nFind out more about viral shedding in the Parents PACK article, \"Viral Shedding and COVID-19 — What Can and Can’t Happen.\"\n\nLast updated: Sept 28, 2021\n\nCould taking two different vaccines boost the effectiveness?\nCould taking two different vaccines boost the effectiveness?\nCurrently, the Centers for Disease Control and Prevention (CDC) recommends getting two doses of the same mRNA vaccine unless the supply does not allow for them to get the second dose of the same brand.\n\nPeople are also recommended to get the same brand for the third dose of mRNA vaccine if they are receiving it because of an immune-compromising condition. However, if they are receiving a second dose following J&J/Janssen or a third dose following mRNA as a booster, they can get a different type if they so choose.\n\nLast updated: Nov. 10, 2021\n\nIs a coronavirus vaccine necessary?\nIs a coronavirus vaccine necessary?\nSARS-CoV-2 infections can be a minor hindrance or lead to severe disease or even death. While hygiene measures such as social distancing, handwashing, and wearing masks offer some help, the best way to stop this virus is to generate SARS-CoV-2-specific immunity. No virus has ever eliminated itself by inducing natural immunity in a large percentage of the population. Only herd immunity induced by vaccination can eliminate viruses, as has now been shown for smallpox and two of the three different types of poliovirus.\n\nFor more information, watch this short video of Dr. Paul Offit addressing “Why does it matter if I don’t get the COVID-19 vaccine?”\n\nLast updated: Dec 15, 2020\n\nHow long before a coronavirus vaccine takes effect?\nHow long before a coronavirus vaccine takes effect?\nThe mRNA vaccines require two doses. While people will have some immunity after the first dose, protection will be most likely about one week after receipt of the second dose and the individual will be considered “fully vaccinated” two weeks after the second dose.\n\nThe adenovirus vaccine (Johnson & Johnson/Janssen) requires one dose. While people will have some immunity about two weeks after being vaccinated (and be considered “fully vaccinated”), protection will be more robust about one month after receipt of the vaccine. Likewise, individuals are recommended to get a second dose at least 8 weeks after the first dose to further bolster their immunity.\n\nLast updated: Nov 10, 2021\n\nDo the variants affect vaccine effectiveness?\nDo the variants affect vaccine effectiveness?\nCurrent variants circulating in the U.S. are being monitored for their ability to spread, cause more severe disease, and evade vaccines and treatments. To date, most of the changes have allowed for easier spread or had minor effects on vaccines or treatments. So far, none of the variants have changed enough that they require new vaccines; however, scientists are working on vaccines that would be able to protect against the most concerning variants in case additional doses become necessary.\n\nRead more about why variants are concerning to scientists, why they should concern individuals, and how they are classified in this article from the April 2021 Vaccine Update for Healthcare Providers.\n\nWatch this video in which Dr. Hank Bernstein provides more information about coronavirus mutations and the COVID-19 vaccines.\n\nLast updated: Apr 23, 2021\n\nCan pregnant women get the COVID-19 vaccine?\nCan pregnant women get the COVID-19 vaccine?\nPregnant women were not included in the early COVID-19 vaccine studies, but some participants were either pregnant and did not know it or became pregnant during the course of the study. Likewise, tens of thousands of pregnant women have been immunized since the COVID-19 mRNA vaccines became available, and many of them are also being monitored through the CDC’s V-safe program.\n\nWith data from thousands of these women now in hand, no concerns have been identified and the vaccine works. While pregnant women and their babies will continue to be monitored, the CDC recently changed its statement about COVID-19 vaccines for pregnant women to more clearly recommend these vaccines for pregnant women.\n\nTwo factors, in addition to the vaccine data, were important for informing vaccine recommendations for pregnant women:\n\nFirst, some pregnant women are at high risk for COVID-19 because of their jobs, such as healthcare workers, or existing health conditions.\nSecond, pregnant women are more likely to be hospitalized and be admitted to the intensive care unit with COVID-19 than women of the same age who were infected but weren’t pregnant.\nAll pregnant women should keep these two important points in mind:\n\nPregnant women who get the COVID-19 vaccine should take acetaminophen if they develop a fever after vaccination, as fever during pregnancy can negatively affect a developing baby. Taking acetaminophen during pregnancy has been found to be safe.\nLikewise, regardless of vaccination status, pregnant women should practice recommended public health measures, particularly because of their increased risk if infected with COVID-19.\nIn this short video, Dr. Hank Bernstein discusses COVID-19 vaccination during pregnancy.\n\nYou can read more about pregnancy and COVID-19 vaccines in this Vaccine Update article.\n\nLast updated: May 25, 2021\n\nCan I get the COVID-19 vaccine if I am breastfeeding?\nCan I get the COVID-19 vaccine if I am breastfeeding?\nYes. Although women who are breastfeeding were not included in the clinical trials, current data suggest that COVID-19 is not transmitted through breast milk, so it is not expected that vaccination would cause a concern either. On the other hand, some women who are breastfeeding will be at higher risk for exposure, so they could benefit from receiving the vaccine.\n\nIn addition, women do not need to delay breastfeeding for any period of time before or after they have been vaccinated.\n\nBabies may also benefit from antibodies or immune cells that may be introduced through breast milk after the mother is vaccinated. This is called passive immunity.\n\nBoth the Academy of Breastfeeding Medicine and the American College of Obstetricians and Gynecologists support this approach.\n\nIn this short video, Dr. Hank Bernstein discusses COVID-19 vaccination when breastfeeding.\n\nYou can read more about breastfeeding and COVID-19 vaccines in this Vaccine Update article.\n\nLast updated: May 25, 2021\n\nCan I get the COVID-19 vaccine if I am trying to get pregnant?\nCan I get the COVID-19 vaccine if I am trying to get pregnant?\nYes, women who are trying to get pregnant can get the vaccine. Likewise, if a woman finds out she is pregnant after getting the first dose, but before getting the second dose, she can still get the second dose on time.\n\nLast updated: Dec 15, 2020\n\nShould I delay getting pregnant if I got the COVID-19 vaccine?\nShould I delay getting pregnant if I got the COVID-19 vaccine?\nNo, you do not need to delay pregnancy. But, if you become pregnant within 30 days of receiving a dose of vaccine, you should consider registering for V-safe, a mobile-app based program being offered by the CDC that is tracking the safety of COVID-19 vaccines.\n\nLast updated: Mar 1, 2021\n\nWhy was I told to wait a month after getting the COVID-19 vaccine before getting a mammogram?\nWhy was I told to wait a month after getting the COVID-19 vaccine before getting a mammogram?\nSome people experience swelling of lymph nodes under their arm after getting the COVID-19 mRNA vaccine, which on occasion has been falsely identified as spread of breast cancer to lymph nodes. Therefore, delaying the mammogram can prevent the chance of this happening.\n\nLast updated: Mar. 1, 2021\n\nIs it necessary to wait to get blood work done after getting the COVID-19 vaccine?\nIs it necessary to wait to get blood work done after getting the COVID-19 vaccine?\nGenerally speaking, it would be recommended to wait about a week after getting the mRNA vaccine and a few weeks after getting the adenovirus-based vaccine before getting bloodwork. However, it would be better to inquire with the healthcare provider who ordered the bloodwork as they have the benefit of knowing the reason for the bloodwork, the type of tests ordered, and the patient’s medical history. As such, they will be in the best position to offer this guidance for each individual situation.\n\nLast updated: Mar. 18, 2021\n\nIs the coronavirus vaccine being studied in children?\nIs the coronavirus vaccine being studied in children?\nYes. The Pfizer mRNA vaccine is now approved for use in those 5 years of age and older. Studies of the Pfizer vaccine are ongoing in those younger than 5 years of age. The Moderna and J&J/Janssen vaccines are also being studied in those younger than 18 years of age.\n\nIt is important that COVID-19 vaccines be thoroughly tested in children before they are given in this group because we cannot assume that they will act the same way in younger children, particularly since we have seen that children are not affected in the same way by COVID-19 infections.\n\nLast updated: Nov. 10, 2021\n\nIf I have an autoimmune or immune-compromising condition, can I be vaccinated?\nIf I have an autoimmune or immune-compromising condition, can I be vaccinated?\nPeople with immune-compromising conditions may get the COVID-19 vaccine as long as they are not in one of the following categories:\n\nSevere allergy to a vaccine component (i.e., one that causes anaphylaxis or requires medical intervention)\nHistory of severe allergy to any vaccine or injectable medication\nHowever, it is recommended that individuals with compromised immune systems discuss their personal risks and benefits with a healthcare provider to determine whether to receive the vaccine or if they may need an additional dose.\n\nKnowing the potential for a lower immune response, if someone with an immune-compromising condition decides to get vaccinated, it will be important to get both doses (if they receive the mRNA vaccine) and possibly a third dose, depending on their condition (See “Do I need another dose of COVID-19 vaccine?” for more details). They may also choose to practice other public health measures until more is known about their protection against SARS-CoV-2, the virus that causes COVID-19.\n\nLast updated: Nov. 10, 2021\n\nCan I get the COVID-19 vaccine if I had Guillain-Barré Syndrome (GBS)?\nCan I get the COVID-19 vaccine if I had Guillain-Barré Syndrome (GBS)?\nPeople with a history of Guillain-Barré Syndrome (GBS) can get the COVID-19 mRNA or adenovirus vaccine, as long as they do not have another condition that puts them among the people recommended against vaccination. While a small number of cases of GBS have been identified following receipt of the adenovirus-based COVID-19 vaccine (J&J/Janssen), the cases have been rare and COVID-19 remains widespread, so the benefits still outweigh the risks.\n\nSome people wonder if they can get the COVID-19 vaccine if they developed GBS following receipt of an influenza vaccine. Since COVID-19 and influenza (flu) vaccines are made differently, people with this history would not be expected to have an issue with COVID-19 vaccine. As such, they are still recommended to get COVID-19 vaccine.\n\nFinally, many people are incorrectly told that if they had GBS, they cannot get a flu vaccine. However, most people with a history of GBS can get the flu vaccine. Only people who were diagnosed with GBS less than 6 weeks after receipt of influenza vaccine are considered to have a “precaution” for receipt of influenza vaccine, meaning that the patient and the healthcare provider should discuss the relative risks and benefits associated with getting the influenza vaccine. In fact, studies have shown that influenza disease presents a greater risk of GBS than influenza vaccination:\n\n”Vaccines and Guillain-Barré Syndrome” webpage\nGuillain-Barré Syndrome (GBS) & Vaccines: The Risks and Recommendations, September 14, 2021, Parents PACK newsletter\nLast updated: Sept. 28, 2021\n\nCan I still get vaccinated if I have a cold?\nCan I still get vaccinated if I have a cold?\nPeople with mild cold-like symptoms are not prevented from getting the vaccine. However, if they are not feeling well, their symptoms just started, or their symptoms are getting worse, they may want to delay vaccination until they feel better; otherwise, they might not be able to tell effects of illness from those of the vaccine. If they are uncertain, they should speak to their doctor, who has the benefit of their medical history and will be in the best position to help them weigh the potential pros and cons.\n\nLast updated: Mar. 1, 2021\n\nIf I had dermal fillers, can I get the COVID-19 vaccine?\nIf I had dermal fillers, can I get the COVID-19 vaccine?\nThe receipt of dermal fillers does not prevent someone from getting the COVID-19 vaccine. While a few people with dermal fillers have experienced swelling in the area of the fillers following receipt of the mRNA vaccine (most often, but not exclusively, Moderna), these events have been extremely rare and have responded to treatment. Likewise, at least one case has also been identified following COVID-19 infection.\n\nYou can read more from the The Aesthetic Society, the American Society of Plastic Surgeons, and the American Society for Dermatologic Surgery.\n\nLast updated: Oct. 13, 2021\n\nIf I am taking anticoagulants (blood thinners), can I get the COVID-19 vaccine?\nIf I am taking anticoagulants (blood thinners), can I get the COVID-19 vaccine?\nPatients on blood thinners can get the COVID-19 vaccine. However, because the vaccine is given intramuscularly, the risk for bleeding is slightly greater for these individuals. As such, they should tell the healthcare provider administering the vaccine about their use of an anticoagulant. The vaccine itself does not increase the risk for this group of patients.\n\nFind out more in this Parents PACK article, \"Medications and COVID-19 Vaccines: What You Should Know.\"\n\nLast updated: Sept 28, 2021\n\nIf I am currently taking antibiotics, can I get the COVID-19 vaccine?\nIf I am currently taking antibiotics, can I get the COVID-19 vaccine?\nAs long as you are not still sick from your recent infection, you can get the COVID-19 mRNA or adenovirus-based vaccine even if you are taking an antibiotic. But, if you are still having symptoms, you should wait until you are feeling better, so that it is easier to tell if any new symptoms are from your infection or the vaccination.\n\nFind out more in this Parents PACK article, \"Medications and COVID-19 Vaccines: What You Should Know.\"\n\nLast updated: Sept. 28, 2021\n\nIf I am taking antivirals, can I get the COVID-19 vaccine?\nIf I am taking antivirals, can I get the COVID-19 vaccine?\nYou do not need to stop taking antiviral medication before vaccination. Because the mRNA and adenovirus-based vaccines does not rely on viral replication, antivirals should not affect development of the immune response. However, if you are still experiencing symptoms of the infection for which the antivirals were prescribed, you should wait until you are feeling better before getting the vaccine.\n\nFind out more in this Parents PACK article, \"Medications and COVID-19 Vaccines: What You Should Know.\"\n\nLast updated: Mar. 1, 2021\n\nIf I am taking biologics, can I get the COVID-19 vaccine?\nIf I am taking biologics, can I get the COVID-19 vaccine?\nTaking biologics, like Humira, is not a reason to forgo COVID-19 vaccination as per CDC guidelines. However, patients taking these types of medication may wish to consult with their doctor to discuss the potential risks and benefits of getting the COVID-19 vaccine, given that these types of medications are often prescribed for individuals with immune-compromising conditions. As a result, there may be other considerations related to the potential risks and benefits of vaccination.\n\nFor general information about vaccines and biologics, check out this printable Q&A sheet.\n\nFind out more in this Parents PACK article, \"Medications and COVID-19 Vaccines: What You Should Know.\"\n\nLast updated: Jan. 25, 2021\n\nIf I need a dental procedure, can I get the COVID-19 vaccine, or should I delay my procedure?\nIf I need a dental procedure, can I get the COVID-19 vaccine, or should I delay my procedure?\nPeople can have dental procedures after receipt of the COVID-19 vaccine. Vaccine-induced immunity should not be affected by nitrous oxide or antibiotics that might be prescribed after the procedure.\n\nLast updated: Jan. 25, 2021\n\nHow long should I wait to get the COVID-19 vaccine after getting a steroid injection or vice versa?\nHow long should I wait to get the COVID-19 vaccine after getting a steroid injection or vice versa?\nYou should speak with your doctor to determine whether the quantity of steroids that you are receiving is suppressing your immune system. If so, you should hold off on receiving vaccines until the effect of the steroids has worn off.\n\nFind out more in this Parents PACK article, \"Medications and COVID-19 Vaccines: What You Should Know.\"\n\nLast updated: Jan. 25, 2021\n\nDoes the COVID-19 vaccine cross the blood-brain barrier?\nDoes the COVID-19 vaccine cross the blood-brain barrier?\nIt would not be expected that the COVID-19 vaccines would cross the blood-brain barrier (BBB) for a few reasons.\n\nmRNA vaccines:\n\nMost of the protein that is made is bound to cells - The vaccine is injected into muscle, where dendritic cells in the area use the mRNA to make the COVID-19 spike protein. These dendritic cells, after making the spike protein, put the protein (not the mRNA) on the cell surface, travel to the nearest lymph node, and stimulate other cells of the immune system to make an immune response against the protein. This process is typical of our adaptive immune system, which you can find out more about in this animation.\nThe protein itself is too large to cross the BBB.\nAdenovirus vaccine:\n\nThe virus is too large to cross the BBB.\nLast updated: Mar. 3, 2021\n\nDoes the COVID-19 vaccine cause antibody-dependent enhancement (ADE)?\nDoes the COVID-19 vaccine cause antibody-dependent enhancement (ADE)?\nAntibody-dependent enhancement (ADE) has not been identified as a concern related to SARS-CoV-2 infection or following COVID-19 vaccination. In fact, a body of evidence has suggested that ADE will not be a concern:\n\nFirst, most people have been infected with other coronaviruses in their lifetime, and ADE has not been identified as a result of these infections.\nSecond, in human studies, people previously infected with coronavirus were infected with different types of coronavirus, and they did not experience enhanced disease.\nThird, experimental animals vaccinated against SARS-CoV-2 did not develop enhanced disease when challenged, or infected, with the virus.\nFourth, when people with COVID-19 received plasma containing SARS-CoV-2 antibodies, they did not experience enhanced disease.\nFinally, millions of people have been vaccinated against COVID-19, and some of them have subsequently been infected with SARS-CoV-2, or one of its variants, and none of them have shown evidence of ADE.\nFor these reasons, ADE is not a concern for SARS-CoV-2 infections or vaccination. Scientists will continue to monitor the SARS-CoV-2 variants; however, it would not be expected that ADE will become an issue with the rise of new variants, as it has not been with the many types of coronaviruses and the existing SARS-CoV-2 variants to date.\n\nWatch a short video in which Dr. Paul Offit explains why COVID-19 vaccines are unlikely to cause ADE.\n\nLast updated: Sept. 9, 2021\n\nDoes the COVID-19 vaccine cause fertility issues?\nDoes the COVID-19 vaccine cause fertility issues?\nInfertility has not been found to be an issue in women or men infected with COVID-19, so it would not be expected to be a concern for the vaccine.\n\nUnfortunately, misinformation about fertility-related issues has been circulating online. These concerns take two forms:\n\nCompromised fertility in the vaccine recipient – Original concerns related to a placental protein, called syncytin-1. This protein is associated with the placenta during pregnancy. Online claims promoted a paper suggesting that a small number of similar amino acids in the spike protein and the placental protein would cause vaccine-induced antibodies to react against syncytin-1.  Recent concerns have expanded to include males, suggesting that the vaccines can decrease sperm count. While fever can cause a temporary decrease in sperm count, there is no biologically plausible reason to expect that the vaccines would cause any long-term effect on sperm count.\nCompromised fertility in individuals near someone who recently received COVID-19 vaccine – This misperception conflates two concepts: effects on fertility and viral shedding. As mentioned above, the vaccines do not affect fertility in the vaccinated person, so there would not be a reason to expect that they would affect someone else’s fertility. Second, it assumes that recently vaccinated individuals shed virus or spike protein. Neither of these occur. While these vaccines cause the body to generate spike protein, they do not cause production of whole virus particles, nor do parts of the vaccine migrate to the nasal cavity. As such, a recently vaccinated person does not shed any part of the virus and cannot, therefore, spread vaccine-related components to another person.\nWatch this short video in which Dr. Paul Offit discusses COVID-19, the vaccines and infertility.\n\nYou can read more about fertility and COVID-19 vaccines in this Vaccine Update article.\n\nThis Parents PACK article about vaccination of children 5 to 11 years of age also addresses fertility-related concerns. Additional resources related to COVID-19 vaccination of young children are also shared in the accompanying News & Notes article.\n\nLast updated: Nov. 10, 2021\n\nWill I be able to get the coronavirus vaccine at the same time as other vaccines?\nWill I be able to get the coronavirus vaccine at the same time as other vaccines?\nThe CDC recommendations allow people to get COVID-19 vaccines at the same time as other vaccines. This decision was made due to experience with more than one vaccine given close in time with COVID-19 vaccines during emergency situations and with more understanding of the effects of the COVID-19 vaccines, suggesting a low likelihood of interference. However, studies will continue to monitor responses during these situations to ensure that unexpected events do not occur. The CDC change also took into account the increased susceptibility of individuals who missed routinely recommended vaccines during the pandemic. If an individual is uncomfortable getting both vaccines at once and can conveniently return for a second visit, the vaccines can be separated by two weeks, but if the individual can’t return in a timely manner, it is acceptable to give both vaccines at the same visit but in separate locations.\n\nWatch this short video in which Dr. Hank Bernstein explains the benefits of receiving routine vaccines at the same time as the COVID-19 vaccine.\n\nLast updated: Nov. 10, 2021\n\nIs there any hope that a vaccine will help people with lingering after effects from coronavirus?\nIs there any hope that a vaccine will help people with lingering after effects from coronavirus?\nThe lingering effects of COVID-19 are concerning, and we still have much to learn about them. A vaccine will help from the point of view that if it decreases infections, fewer people will experience illness and, therefore, fewer people will experience long-term effects. But, it is not likely that a vaccine will address these effects in someone who was already infected.\n\nLast updated: Dec. 15, 2020\n\nHow much does the coronavirus vaccine cost?\nHow much does the coronavirus vaccine cost?\nCoronavirus vaccines are free; however, the Federal Trade Commission (FTC) has warned of scams in which people are charging for vaccines. Read more here.\n\nAlso, of note, while the vaccines are free, insurance companies may have to cover the cost of administering the vaccine. You should not, however, be charged any out-of-pocket fees when you go for your vaccine.\n\nLast updated: Apr. 23, 2021\n\nDoes the COVID-19 vaccine contain blood products?\nDoes the COVID-19 vaccine contain blood products?\nThe COVID-19 mRNA and adenovirus vaccines do not contain any blood products, including red blood cells, white blood cells or platelets. \n\nWatch this short video in which Dr. Offit talks about the ingredients used in the COVID-19 mRNA vaccines.\n\nLast updated: Mar. 1, 2021\n\nHow can I know about COVID-19 disease in my community or where I am traveling?\nHow can I know about COVID-19 disease in my community or where I am traveling?\nSeveral tools have been developed to help public health officials, governments, businesses, and individuals make informed decisions. These tools use county-level data to provide guidance. Two that may be particularly helpful include:\n\nCOVID-Lab: Mapping COVID-19 in your community — Developed by PolicyLab at Children’s Hospital of Philadelphia, this tool allows you to see COVID-19 test positivity in counties throughout the United States. The tool also offers projections for how levels of disease are expected to change in the next four weeks based on current social distancing practices, population density, testing capacity, and anticipated temperature and humidity.\nCOVID-19 event risk assessment planning tool — Developed by teams at Georgia Institute of Technology and Applied Bioinformatics Laboratory, this tool offers information about gatherings by county throughout the U.S., showing the percent chance that at least one person will be COVID-19 positive in gatherings of different sizes. The calculations are based on results of data from COVID-19 antibody blood tests.\nLast updated: Dec. 15, 2020\n\nWe don't talk about \"herd immunity\" for protection against influenza or other common viral infections, so why is it discussed so much with COVID?\nWe don't talk about \"herd immunity\" for protection against influenza or other common viral infections, so why is it discussed so much with COVID?\nHerd immunity is a concept used in public health to describe a situation in which the more people in a community immune to a particular pathogen, the fewer people available for that pathogen to infect. As the infectious agent spreads through a community, it has more trouble finding susceptible people if most of those around them are immune. In this manner, we rely on herd immunity for viruses, such as measles, rubella, polio, and chickenpox, among others, even if we are not having conversations about it. Influenza is more difficult because the virus changes so much from one year to the next and as such, vaccination does not offer long-term protection.\n\nRelated to COVID-19, herd immunity has been discussed more frequently for a couple of reasons. First, because this is a completely new virus, no one had pre-existing immunity. People can become immune to SARS-Co-V2, the virus that causes COVID-19, in two ways — through disease or through vaccination. By monitoring how many people are immune relative to the entire population, public health officials can offer informed guidance related to easing restrictions meant to stem spread of the virus.\n\nHerd immunity can only be induced by vaccination. Never in history has any virus infection been eliminated because of immunity induced by natural infection.\n\nLast updated: Mar. 1, 2021\n\nWas the genome of the virus subject to peer review or FDA/CDC oversight?\nWas the genome of the virus subject to peer review or FDA/CDC oversight?\nThe viral genome is not a product; it represents scientific knowledge, so organizations like the FDA or CDC would not have “oversight” over the information. However, this question gets at the heart of how science is done. Scientists by their nature are skeptics, and the scientific process is designed to challenge rather than accept results. In this manner, several points offer reassurance that the genomic sequence was vetted for accuracy:\n\nThe scientists who reported the genome isolated samples from several patients to examine the genome. Said another way, their data were not based on a single person’s infection. They had to confirm for themselves and for the quality of their research that what they found was accurate. They could not assume that the same virus was causing infections without actually gathering evidence of such.\nOnce they completed their study, they had to share it with colleagues, who would critically review it and maybe even ask for more experiments or clarifications before they could publish a paper sharing their results with the world. Peer-review is critical to the scientific process, which is why you may have heard about data that were not yet peer-reviewed during the pandemic. For scientists, that means that the work has not yet been vetted.\nSeveral other labs also isolated samples from patients and reproduced the process. Their papers were also peer reviewed before publication. Reproducibility is a second critical component of the scientific process. Even if the genomic information passed peer review and was published, if other labs did not find the same thing, the information would be called into question.\nIn this manner, the pillars of scientific integrity — peer review and reproducibility — can offer everyone reassurance that the genomic sequence was accurate— not to mention the fact that vaccines based on the information have been effective at preventing infection.\n\nLast update: Mar. 31, 2021\n\nI heard that steps were skipped to make a vaccine more quickly. Is that true?\nI heard that steps were skipped to make a vaccine more quickly. Is that true?\nWhile COVID-19 vaccines have been developed more quickly than has ever been done in the past, it was imperative that speed did not decrease safety.\n\nIn this case, the timeline was shortened without sacrificing quality by:\n\nSkipping phase I or combining phase I with phase II trials — Since phase I studies include a small number of people and evaluate whether the candidate vaccine causes an immune response and is safe, scientists could look at data from a group of people as phase II was progressing to make these evaluations.\nManufacturing “at risk” — While completing the large phase III clinical trials, manufacturers began producing the vaccine, so that if it was shown to be safe and effective, they would have large numbers of doses ready. The reason this is not typically the approach is because if the vaccine does not work, the manufacturer will have spent a significant amount of money to produce something that needs to be thrown away.\nSupport efforts — While waiting for a vaccine to be ready, many other aspects of vaccine delivery were prepared, including:\nDeveloping plans for how to distribute the first, limited quantities available\nEnsuring adequate supplies for distributing and administering vaccine, like vaccine vials, syringes and other equipment needed to vaccinate\nEstablishing mechanisms for distribution to large subsets of the population, especially in countries in which mechanisms may not currently be in place. For example, many countries do not have standard programs for vaccinating older adults. So, planning how to reach those people, without unintentionally exposing them to a crowd in which the virus may be spread, was something that could be planned during vaccine development.\nWatch this video in which Dr. Paul Offit explains the COVID-19 vaccine trials.\n\nLast updated: Dec. 15, 2020\n\nDo COVID-19 vaccines contain a microchip?\nDo COVID-19 vaccines contain a microchip?\nCOVID-19 vaccines do not contain microchips. This idea is based on a false narrative and misinformation campaign waged online. You can find out more about where this idea came from on snopes.com.\n\nLast updated: Dec. 15, 2020\n\nIf my baby has had some of her vaccines, is she protected from COVID-19? We are anxious for her to meet family members.\nIf my baby has had some of her vaccines, is she protected from COVID-19? We are anxious for her to meet family members.\nA baby’s vaccines should not be anticipated to protect the baby from COVID-19. So, when trying to decide when it may be safe for family to meet the baby during COVID, parents should not rely on other vaccinations as a source of protection. While some have hypothesized that other vaccines may be protective, this protection would not be specific to COVID-19, and no studies have actually been completed to test this theory.\n\nLast updated: Dec. 15, 2020\n\nCOVID-19 video resources\nCOVID-19 video resources\nThis section of the page will house video resources and interviews related to COVID-19.\n\nMyths and misinformation surrounding COVID-19 vaccines\nVaccine Education Center (VEC) Current Issues in Vaccines webinar, Sept. 28, 2021 (Please note that you will need to register to gain immediate access to the recording. If you are a healthcare professional seeking continuing education credits for viewing this event, please review the continuing education information on this page.)\n\nTalking about Vaccines with Dr. Paul Offit: COVID-19\nThis VEC playlist features several short videos in which Dr. Offit addresses common questions about COVID-19.\n\nTalking about Vaccines with Dr. Hank Bernstein: COVID-19\nThis playlist features a series of short videos in which Dr. Hank Bernstein answers common questions about COVID-19 vaccines.\n\nMy COVID-19 Vaccine Experience\nThese short videos share personal experiences and decision-making related to receipt of the COVID-19 vaccine.\n\nPerspectives on COVID-19 Vaccine for Kids\nThese short videos feature personal experiences from clinicians caring for kids with COVID-19; families affected by flu, another virus sometimes perceived as insignificant in kids; and survivors of polio, another virus that causes long-term effects.\n\nVaccinate Your Family’s COVID-19 Vaccine Updates: Zoom Series Featuring Top Officials from FDA and CDC, series hosted by Vaccinate Your Family\n\nLast updated: Nov. 10, 2021",
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