DEPARTMENT OF HEALTH AND HUMAN SERVICES 

CENTERS FOR DISEASE CONTROL AND PREVENTION 

Advisory Committee on 

Immunization Practices (ACIP) 

Business Summary 

Coronavirus Disease 2019 (COVID-19) Vaccines Session

October 30, 2020 

This document has been archived for historical purposes. (11/1/2020) 

https://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/summary-2020-10.pdf
 

 

 

 

 

 

 

 

 

 

 

 

 

Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

The Centers for Disease Control and Prevention (CDC) convened a virtual meeting of its 

Advisory Committee on Immunization Practices (ACIP) on October 28-30, 2020. This Business 

Report summarizes the third day of the meeting, which was devoted solely to the topic of 

coronavirus disease 2019 (COVID-19) vaccines. Dr. José Romero (ACIP Chair) delivered the 

opening remarks. He emphasized that faced with a crisis of historic proportion, basic scientists, 

clinical scientists, clinical investigators, and volunteers have worked with unprecedented speed 

to develop, test, evaluate, and manufacture a plethora of potential vaccines against Severe 

Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). The mandate given to the ACIP 

has been to develop equitable, just, and fair policy guidelines for the use of those vaccines that 

are proven to be safe and effective in preventing and mitigating SARS-CoV-2 disease. The 

volume of data that have been compiled, analyzed, synthesized, and presented to the ACIP 

voting members, liaisons, ex officio representatives and the public has possibly been more than 

ever presented for any other vaccine that has come before the ACIP. It can be said without 

hyperbole or exaggeration that no other national COVID-19 vaccine advisory group has 

dedicated as much time to addressing questions posed to the ACIP regarding the use of those 

COVID-19 vaccines. Over the 7 months since its creation, the ACIP’s COVID-19 Vaccine Work 

Group (WG) has met more times than any other non-standing ACIP WG. Dr. Romero publicly 

acknowledged the extraordinary work in terms of time, effort, and quality that the members of 

the COVID-19 Vaccine WG have dedicated to this effort. In addition to the official WG members, 

all ACIP members have given of their time to prepare for, attend, and meaningfully participate in 

the equivalent of 2 years’ worth of open public meetings in a 10-month timeframe. Dr. Romeo 

also acknowledged the extraordinary leadership of Dr. Nancy Messonnier, Director of the 

National Center for Immunization and Respiratory Diseases (NCIRD); Dr. Amanda Cohn, ACIP 

Executive Secretary; and Jessica McNeil, Assistant Executive Secretary for ACIP. In addition, 

he acknowledged the important support work provided by Ms. Stephanie Thomas and Ms. 

Natalie Greene who have provided much of the materials to be reviewed prior to the meetings. 

In closing, he thanked all who have dedicated, are dedicating, and will continue to dedicate their 

time to ACIP’s efforts to provide guidance for the use of safe and effective COVID-19 vaccines, 

emphasizing that he believed history would not forget their dedication to this task. 

Dr. Doran Fink (FDA) provided an update from the Vaccines and Related Biologics Products 

Advisory Committee (VRBPAC) Meeting on October 22, 2020. During that VRBPAC meeting, 

the FDA explained the considerations for manufacturing and clinical information needed to 

support licensure for Emergency Use Authorization (EUA) of COVID-19 vaccines, as described 

in two recent FDA guidance documents. The purpose of the guidance documents is to provide 

reassurance that FDA will rely on sound science, established regulatory standards, and a 

transparent process for evaluating COVID-19 vaccine candidates. Dr. Fink first explained the 

clinical considerations for an EUA in detail and then summarized the VRBPAC’s discussion. 

VRBPAC expressed concerns about public vaccine confidence. There was broad agreement 

that data to support issuance of an EUA for a COVID-19 vaccine should not be less than the 

standards outlined by the October 2020 FDA guidance. Some VRBPAC members expressed 

concerns that a median follow-up of 2 months after completion of the vaccination regimen would 

not be sufficient to support an EUA for rapid and widespread deployment. Others considered 2 

months to be sufficient and felt that rare adverse events (AEs) and waning immunity could be 

monitored by surveillance during vaccine use under an EUA. Some VRBPAC members were 

concerned about COVID-19 of any severity as the primary efficacy endpoint in current Phase 3 

trials, given that there may be limited information on severe disease. FDA and some VRBPAC 

members discussed that primary endpoints were selected based on feasibility and prior 

experience with preventive vaccines. While analyses to support EUA will include some 

information on severe disease, insisting on adequately powered analyses of severe disease 

(which has a lower incidence than less severe disease) could delay the availability of an 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

impactful vaccine. VRBPAC members expressed concern about clinical trial recruitment of, and 

accrual of data, in the populations most affected by COVID-19 (e.g., racial and ethnic minorities, 

elderly individuals, and individuals with medical comorbidities). FDA reported that published 

guidance and advice to COVID-19 vaccine manufacturers has advocated for inclusion of these 

populations in trials. While there is no regulatory mechanism for mandating trial recruitment, 

vaccine manufacturers have been publicizing enrollment demographics for their trials. This is 

important given that demographic and medical history data from trial participants will be 

considered in regulatory decisions and will be reflected in vaccine labeling to inform healthcare 

providers (HCP) and vaccine recipients. There also was discussion regarding considerations for 

pediatric development and data to support use in pediatric populations, particularly with respect 

to careful evaluation of immune-mediated reactions or enhanced disease and immunobridging 

approaches. There was broad agreement among VRBPAC members that blinded, placebocontrolled follow-up in ongoing trials should continue for as long as is feasible, including after 

EUA. VRBPAC raised questions about expanded access as an alternative to EUA. An 

expanded access treatment protocol could be considered to allow for deployment of a COVID19 vaccine. It is important to note that the benefit/risks considerations are similar to EUA, other 

considerations such as planning and implementation differ from EUA, and an expanded access 

treatment protocol would be conducted under Investigational New Drug (IND) regulations that 

require informed consent, Institutional Review Board (IRB) oversight, and investigator 

responsibilities for vaccine providers. In terms of next steps, FDA will consider the VRBPAC 

feedback provided and will re-convene the VRBPAC prior to any FDA action to approve or issue 

an EUA for a COVID-19 vaccine to evaluate and discuss data submitted in support of the 

licensure application/EUA request and vote on recommendations as to whether the data support 

vaccine licensure/proposed use of the vaccine under EUA. 

Dr. Filip Dubovsky (Novavax) reported on the Novavax NVX-CoV2373 vaccine candidate in 

terms of vaccine design, the non-human primate protection study, Phase 1 Day 35 safety and 

immunogenicity data, Phase 2 Dose 1 and Dose 2 reactogenicity data, and plans for Phase 3. 

The Phase 1 study fully enrolled and safety and immunogenicity follow-up is ongoing. The study 

sites, investigators, contract research organization (CRO), and participants are blinded to 

individual vaccine/placebo allocation. Day 35 (14 days after Dose 2) safety and immunogenicity 

data were reviewed by SMC and FDA in advance of the Phase 2 study. The Day 35 safety 

summary for NVX-CoV2373 is consistent with previous nanoparticle vaccine with Matrix-M1. No 

serious adverse events (SAEs) were identified for NVX-CoV2373. There were no adverse 

events of special interest (AESI), including potentially immune-mediated medical condition 

AESIs, and no confirmed COVID-19 AESIs. All AEs were mild and moderate and were balanced 

in active arms. In terms of reactogenicity symptoms, the majority of subjects reported “none” or 

”mild” and the mean duration was less than 2 days for both local and systemic reactogenicity 

symptoms. Novavax Phase 1 study conclusions are that reactogenicity and safety profiles are 

reassuring for both the 5 μg and 25 μg dose groups when formulated with Matrix-M1 adjuvant. 

In terms of immunogenicity, the Matrix-M1 adjuvant is required to induce an optimal functional 

immune response, 2 doses of vaccine administered 21 days apart are superior to a single dose, 

5 μg and 25 μg induce comparable immune responses when formulated with Matrix-M1, and 

Matrix-M1 induces a Th1 biased immune response with high levels of neutralizing antibody. The 

safety and immunogenicity profile of both 5 μg and 25 μg formulated with Matrix-M1 and 

administered on Day 0, 21 is acceptable for further clinical evaluation. 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

The Phase 2 study is fully enrolled, Dose 2 has been administered, and safety and 

immunogenicity follow-up is ongoing. The study sites, investigators, CRO, and participants are 

blinded to individual vaccine/placebo allocation. Reactogenicity data were reviewed by SMEs 

and the FDA in advance of the Phase 3 study. Regarding local reactogenicity events in 2 Dose 

adjuvanted groups, pain and tenderness were reported most frequently. Increased rates were 

seen in the adjuvanted groups, especially after Dose 2, and reactogenicity was attenuated in 

adults ≥60 years of age. 

The Phase 3 pivotal safety and efficacy study will be conducted in the United States (US) and 

Mexico. This is a randomized, observer-blinded, placebo-controlled study in which participants 

are randomized 2:1 to receive 5 μg + Matrix-M1 vaccine or placebo with 2 doses 0.5ml 

administered on Day 0 and Day 21. The study will include up to 30,000 adults >18 years of age 

across the US and Mexico. The plan is to target at least 25% participants ≥ 65 years of age, at 

least 25% with high-risk co-morbidities, at least 15% black/African Americans, 10% to 20% 

LatinX, and 1% to 2% Native Americans. This is an endpoint-driven study with efficacy 

evaluations at 72, 108, and 144 cases. The primary endpoint is prevention of PCR-confirmed 

mild, moderate, or severe COVID-19 illness occurring 7 days after Dose 2 in baseline 

seronegative adults. Safety follow-up will be conducted through 2 years. 

In summary, the NVX-CoV2373 vaccine candidate is based on the baculovirus/nanoparticle 

platform technology. The safety database includes over 12,100 nanoparticle vaccinees (RSV, 

influenza, Ebola) and over 2,500 nanoparticle vaccinees adjuvanted with Matrix-M1. Vaccine 

presentation will be in 10-dose vials with transportation and storage at 20

-80 C. The vaccine is 

preservative-free and no admixing or reconstitution is required. A 0.5 ml dose is administered 

intramuscularly 21 days apart. The preliminary safety profile is reassuring with a favorable 

reactogenicity profile. A peak immune response is observed 14 days after Dose 2. There is a 

favorable immunologic phenotype, with a robust neutralizing antibody response and 

polyfunctional CD4+ Th1-biased cellular immune response. Efficacy evaluation is ongoing. 

Dr. Jerald Sadoff (Janssen) presented an update on Janssen’s investigational COVID-19 

vaccine program. The foundation of Janssen’s investigational COVID-19 vaccine is its 

proprietary AdVac® Technology Platform. Janssen uses a replication incompetent human 

adenovirus 26 (Ad26), which expresses the target antigen. They have taken a region out of the 

virus so that it cannot replicate. It invades the cells and makes the transgene and its own 

antigens, but it cannot assemble them into a replicating virus. The antigen is not on the surface 

virus. It is only on the surface of the cells that the virus is going into and it is membrane bound. 

This vaccine has induced very good humoral antibody responses against structural proteins with 

neutralizing activity and/or other unique functionalities, as well as cellular CD4-T cell responses 

with a Th1 signature and CD8 T-cell responses. There has been no sign of vaccine-associated 

enhanced respiratory disease (ERD) in pre-clinical models after breakthrough infection. Janssen 

has extensive clinical experience with its Ad26-based vaccines, with over 110,000 participants 

vaccinated. These Ad26-based vaccines have shown to have a favorable safety and tolerability 

profile in the populations studied to date. On July 1, 2020, Johnson & Johnson received 

approval from the European Medicines Agency (EMA) for Janssen’s Ad26-based preventive 

Ebola vaccine. 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

Janssen took the approach of looking at a number of vaccine constructs because of instability 

problems that were noted before, and to look at theoretical considerations. Janssen has had a 

lot of experience with its RSV and HIV programs on how to construct stable expression vectors, 

so they assessed stabilization, signal peptide, expression of antigen, manufacturability of 

vaccine, and then immunogenicity in pre-clinical animal models. Based on that, they were able 

to find a vaccine candidate that was clearly superior in terms of its immunogenicity and the other 

considerations, Ad26.COV2.S. It encodes a full length membrane-bound S-protein with 

stabilization mutations and a native initial signal sequence. After a single dose of Ad26.COV2.S, 

they were able to show protection in the lower and upper respiratory tract of SARS-CoV-2 

challenged non-human primates (NHP). In other data, they have done down dosing studies and 

have shown that even when the vaccine is reduced, they have still been able to get substantial 

protection. This leads to the belief that the immunogenicity achieved will be protective. 

Based on that, Janssen began a Phase 1/2 study, COV1001, to assess the safety, 

reactogenicity, and immunogenicity of this investigational vaccine in healthy adults 18 to 55 

(Cohort 1; N=400) years of age and adults 65 years of age and older (Cohort 3; N=375) at 2 

different dose levels (5x1010 viral particles and 1x1011 viral particles) administered as a 1 dose 

or 2 dose regimen. They have the data on the 1 dose regimen and are just accumulating the 

data on the 2 dose, so Dr. Sadoff focused mainly on the data after 1 dose. Cohort 2 is 

comprised of 270 participants 18 to 55 years of age in whom duration of the immune response, 

the ability to boost at various times if necessary, and anamnestic responses will be examined. 

There were very good seroconversion rates with the enzyme-linked immunosorbent assay 

(ELISA) at 99% at a slightly lower dose and a similar 99% with very reasonable geometric mean 

titers (GMTs) for neutralizing antibody levels. There was very little differences in the elderly and 

younger adults in terms of immune response, and there was a rise between Day 15 and Day 29. 

With the wild-type virus neutralizing antibodies (wtVNA) showing very good response rates as 

well of 92% at both doses, with a similar response in the elderly with comparable GMTs. The 

GMTs rose quicker for the neutralizing antibodies, with a very good response at Day 14. 

Therefore, in the Phase 3 trials they will start counting cases 2 weeks after single dose 

immunization. From this data, it is clear that there are not differences in immunogenicity 

between the younger and elderly groups in terms of ELISA or wtVNA, and they seem to be at 

the flat part of the dose response curve, which allows them to pick the lower dose as a single 

dose regimen going forward. There also was a very good T-cell response in both groups. Only 2 

individuals responded with Th2 and the rest were completely negative. The ratio in those 2 

between the Th1 and Th2 was 28.9 and 20.2. Clearly, a Th1-type response dominated in both 

younger adults and the elderly with practically no Th2 response at all. With this vector, they also 

are able to induce fairly high percentages of CD8 T-cell functional responses that express 

interferon gamma and may play a role in protection as well, although they have yet to prove 

that. 

This vaccine does cause some systemic AEs based on blinded data between the groups. 

Among the 402 subjects in Cohort 1, approximately 50% to 60% overall had systemic AEs. All 

were transient and lasted not more than 1 to 2 days. In terms of pyrexia, there was some fever 

in Cohort 1 that was considered Grade 3. These were very responsive to anti-pyrectics and they 

did not judge that any-pyrectics needed to be used prophylactically. In Cohort 3, there were far 

fewer systemic reactions and fever rates were very low with no Grade 3s. Once again, 

reactogenicity was much lower in the older cohort than the younger cohort but the 

immunogenicity seemed comparable. Based on this, Janssen designed a Phase 3 efficacy trial, 

COV3001. This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study 

evaluating the efficacy and safety of Ad26.COV2.S for the prevention of SARS-CoV-2-mediated 

COVID-19. The primary endpoint is moderate to severe illness. The study is being conducted in 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the US with a target of about 

50% of the subjects being in the US. From the beginning, there has been a plan to enroll a 

diverse population. This study does not have a fixed stop interim analysis. A continuous, 

sequential monitoring technique is used for safety and efficacy instead. This study is being 

conducted in healthy adults 18 years of age and above. The estimated enrollment is 60,000 in 

which participants will receive a single dose pf 5x1010 of Ad26.COV2.S or placebo. The 

endpoints are the number of participants with first occurrence of molecularly confirmed 

moderate to severe COVID-19 with seronegative status. The hope is to have a planned followup of up to 2 years. Janssen will attempt to follow participants as long as possible regardless of 

what happens, but there are plans for how analytically to deal with dropouts and people who 

want to receive the vaccine or knowing whether they received vaccine or placebo. 

In terms of the Phase 3 pause, pauses are not uncommon in these types of studies. Janssen is 

dedicated to the safety of its participants. This particular pause was in an individual who had a 

safety event and was subject to automatic stopping or pausing rules. This was judged by the 

Data Safety and Monitoring Board (DSMB) to be appropriate. Janssen evaluated this case 

extensively with the DSMB and outside experts. It is a complicated case that had multiple 

potential causes, which have not completely been determined. However, it is believed that there 

is no relationship between the vaccination and the event. In consultation with the FDA, the 

DSMB agreed to restart the trials. The trial has restarted in the US and enrollment is continuing. 

Janssen plans to disclose the clinical data for its COVID-19 trials once those data are presented 

or published at prespecified milestones, and will proactively disclose the regulated trial holds as 

requested by health authorities. Janssen is planning to deploy this vaccine widely once a signal 

is reached and there is approval from the FDA and other regulatory agencies. The plan is to put 

it in a 2R glass vial that has 5 doses per vial, 10 doses per carton, and 8 cartons per shipper. 

The anticipated storage conditions under an EUA would be stored by Janssen at -200 C for up 

to 2 years, in end-user storage at 20 to 80 C for up to 3 months, and after first use at 200 to 80 C 

for up to 6 hours. More data are evolving with the hope that there will be much longer stability of 

up to 9 months or longer like Janssens other vaccines in this platform. 

Dr. Janell Routh (CDC/NCIRD) provided an update on vaccine implementation planning. She 

reminded everyone that the overarching objectives for the COVID-19 vaccination program are 

to: 1) ensure the safety and effectiveness of COVID-19 vaccines; 2) reduce mortality, morbidity, 

and incidence of COVID-19 disease; 3) help minimize disruption to society and the economy, 

including maintaining healthcare capacity; and 4) ensure equity in vaccine allocation and 

distribution. She shared an illustrative scenario for planning purposes, explaining that it would 

be adapted based on clinical and manufacturing information and that distribution would adjust 

as the volume of vaccine doses increases. Final prioritization will be decided by ACIP. On 

September 16, 2020, CDC published the “COVID-19 Vaccination Program Interim Playbook for 

Jurisdiction Operations.” All 64 jurisdictions returned a COVID-19 vaccination plan and federal 

agency plans have been received from the Veteran’s Affairs (VA), Indian Health Services (IHS), 

Department of Defense (DoD), Department of State (DOS), and the Bureau of Prisons (BOP). 

The plans were reviewed by at least three CDC subject matter experts (SMEs) and feedback 

was returned. Information about plans will be updated on the CDC website. Jurisdictional plans 

showed strengths and challenges. Jurisdictions have organized their planning around the 

allocation phasing assumptions, set out clear plans to train and equip providers on the Vaccine 

Adverse Event Reporting System (VAERS), laid out deep operational details for second dose 

reminders (e.g., text, email, automated call) some of which are already live. Challenges include 

ensuring that public health messaging plans and expedited procedures for emergency 

communications are in place, that all data systems to administer and track vaccine have been 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

identified, and that additional planning is in place to ensure equitable access to vaccine 

distribution in later phases. 

In terms of next steps for vaccine implementation, the goal is for jurisdictions to be ready by 

November 15, 2020. This includes having signed Data Use Agreements (DUAs) to ensure 

tracking of uptake, identifying pockets of low vaccination, identifying and intervening in coverage 

disparities, and allocating vaccine product. By this time, vaccination provider sites should be 

identified and enrolled, especially of those sites that can administer vaccine product to Phase 1 

populations and that can position ultra-cold product after possible EUA. Jurisdictions are to 

confirm that the selected facilities are enrolled in the Vaccine Tracking System (VTrckS) to order 

and receive product. State capacity will be augmented through federal pharmacy partnerships to 

support vaccination in long-term care facilities (LTCF). Microplanning will continue to ensure 

readiness across various scenarios. Pharmacies can help to increase access to vaccines. Once 

there is an adequate supply of COVID-19 vaccine to support broader vaccination efforts, it will 

be important to help jurisdictions increase access to COVID-19 vaccine for the general 

population in Phase 2. The federal government is partnering with pharmacies nationwide to 

increase access to vaccine. Partners who enroll in this program will receive a direct allocation of 

COVID-19 vaccine when supply is sufficient and vaccine is recommended for use beyond the 

initial critical populations. Pharmacy partners under consideration include national chains, large 

regional chains, and networks of independent pharmacies and regional chains. Of the eligible 

US pharmacies, 55% have already enrolled. A list of partners will be shared with jurisdictions 

shortly. Leveraging all resources and public and private partners will allow for the successful 

administration of the COVID-19 vaccination program. The CDC vaccine website contains 

information and resources for the general public, providers, and jurisdictions. 

Dr. Amanda Cohn (CDC/NCIRD) provided an update on CDC’s Vaccine with Confidence 

strategy. There has been a considerable decline in COVID-19 vaccine acceptability in the past 4 

months due to concerns about side effects, efficacy, risk perception/need for vaccine, and 

associated costs. Attributes that make COVID-19 vaccine more acceptable include an HCP 

saying that the vaccine is safe, that there is no cost for the vaccine to individuals, the potential 

for the vaccine to help get people back to work and school, and easy access to the vaccine. 

Individuals across the demand continuum will have concerns, which are understandable and 

must be addressed with empathy and transparency. Concerns among HCP is a risk for overall 

vaccine confidence, given that HCP are the most trusted source for health information. Various 

communities will have unique experiences informing COVID-19 vaccine perceptions, which can 

be addressed through engagement with community organizations and leaders to communicate 

clear and accurate information about COVID-19 vaccines. Vaccinate with Confidence is a 

national strategy to reinforce confidence in COVID-19 vaccines with the key priorities to protect 

communities, empower families, and stop myths. It is not an advertising, marketing or 

communications campaign. Instead, it is a cohesive framework to support health departments, 

healthcare providers, immunization partners, and community partners and leaders’ promotion of 

COVID-19 vaccines. This national strategy includes evidence-based content to amplify 

messages that enable an individual to make the decision to vaccinate, which is critical to 

ensuring that safe and effective COVID-19 vaccines can help control and reduce the impact of 

this pandemic. CDC is seeking feedback from a wide range of partners on the Vaccinate 

with Confidence for COVID-19 Vaccines Framework, and will send a short email to share with 

colleagues to review and provide input. 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

Dr. Steve Anderson (FDA) reviewed FDA’s active post-licensure safety surveillance systems 

and Center for Biologics Evaluation and Research (CBER) plans for monitoring COVID-19 

vaccine safety and effectiveness. FDA and CDC have weekly and bi-weekly coordination 

meetings on VAERS and pharmacovigilance activities between the CBER Office of Biostatistics 

and Epidemiology (OBE) and the OBE Division of Epidemiology (DE) and the CDC 

Immunization Safety Office (ISO). CBER DE physicians will be reviewing the serious adverse 

event (SAE) reports from VAERS for COVID-19 vaccines. This will include review of individual 

reports, death reports, aggregate analyses, case-series, et cetera. FDA will utilize statistical 

data-mining methods to detect disproportional reporting of specific vaccine AE combinations to 

identify AEs that are more frequently reported. COVID-19 vaccine monitoring data 

considerations include rapid data access for near real time surveillance, large databases 

comprised of tens of millions of patients for evaluating vaccine rare SAEs, data representing the 

integrated care spectrum (e.g., outpatient, physician, inpatient, et cetera), high quality data to 

assess and confirm potential AEs or safety concerns for COVID-19 vaccines, and data with 

significant clinical detail or medical chart access. The FDA Biologics Effectiveness and Safety 

(BEST) system includes several partners, represents a variety of healthcare settings, and has 

an emphasis on inclusion of electronic health records (EHR), some claims, and linked claimsEHR data. BEST is a modern surveillance system that is able to perform a diversity of queries 

and studies. There has been an ongoing FDA-CMS partnership on vaccine safety since 2002. 

CMS data cover a very large population of approximately 55 million elderly US beneficiaries ≥65 

years of age. Given that over 92% of US elderly individuals use Medicare, this database 

represents the elderly population and not a sample. It represents a variety of healthcare settings 

and consists of claims data with access to medical charts. Not all claims and EHR data systems 

can be used to address a vaccine safety or effectiveness regulatory question and each data 

system has its limitations in terms of the populations, healthcare settings, clinical detail, 

necessary parameters, data lag, exposures, and outcomes that are captured. 

In terms of COVID-19 vaccine safety surveillance planning, the FDA will utilize rapid-cycle 

analyses (RCA) to monitor 10 to 20 safety outcomes of interest to be determined based on: 1) 

pre-market review of sponsor safety data submitted to the FDA; 2) coordination with federal 

partners, international regulatory partners and organizations, academic experts, and others; and 

3) literature and regulatory experience with similar vaccines, novel vaccine platforms, and using 

other relevant data. Dr. Anderson shared a draft working list of possible AE outcomes. In terms 

of experience, the FDA has conducted near real-time surveillance for annual influenza vaccine 

and Guillain-Barre Syndrome (GBS) since 2007 and Sentinel rapid surveillance for the 2017-

2018 seasonal influenza vaccine to evaluate 6 health outcomes of interest. Epidemiological 

analyses will require the capability to resolve potential safety signals identified from near realtime surveillance, TreeScan® signal detection efforts, and other sources. This may involve rapid 

queries and small epidemiological studies and/or larger self-controlled, cohort, comprehensive 

protocol-based studies. There may be limited information available at the time of licensure on 

the level and duration of effectiveness. Manufacturers may conduct certain COVID-19 vaccine 

effectiveness (VE) post-licensure studies. FDA may conduct COVID-19 general effectiveness 

studies, including subpopulations of interest; duration of protection studies; or other types of 

studies. FDA is coordinating COVID-19 VE efforts with the CDC/NCIRD through monthly and bimonthly meetings. The FDA, CMS, and CDC have extensive experience with the data and 

methods needed to conduct VE studies having produced several VE and relative VE for 

influenza and zoster vaccines and duration of effectiveness analysis of Zostavax® vaccine. Dr. 

Anderson emphasized that COVID-19 vaccine monitoring is a large US government effort that 

involves regular meetings, planned sharing of protocols, discussion of safety and effectiveness 

outcomes of interest, and coordinated planning and conduct of surveillance activities between 

the FDA, CDC, CMS, VA, and DoD. 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

Dr. Tom Shimabukuro (CDC/NCEZID) continued the discussion of post-authorization/postlicensure safety monitoring of COVID-19 vaccines. He reported that ACIP has established a 

COVID-19 Vaccine Safety Technical Sub-Group (VaST) to advise CDC and other federal 

partners on planning and preparation for post-authorization/post-licensure safety monitoring of 

COVID-19 vaccines and independently review and evaluate safety data. Postauthorization/post-licensure safety data on COVID-19 vaccines will be presented regularly 

during public ACIP meetings. During this meeting, he provided updates on Vaccine Safety 

Datalink (VSD) monitoring and the CISA Project clinical consult service and HCP’s role in 

reporting AEs to VAERS and facilitating patient enrollment into the v-safe smartphone-based 

active surveillance system. VSD planned monitoring and evaluation for COVID-19 vaccine 

safety includes: 1) near real-time sequential monitoring using RCA; 2) monitoring for vaccinemediated enhanced disease (VMED); 3) studies to evaluate COVID-19 vaccine safety during 

pregnancy, including fetal death and infant outcomes; tree-temporal scan data mining; and 4) a 

variety of projects to assess changes in healthcare utilization during COVID-19 and impact on 

AE monitoring; utility of smartphone technology to enhance vaccine safety monitoring; 

multisystem inflammatory syndrome in children and adults (MIS-C and MIS-A) as vaccine AEs; 

safety in an expanded underserved VSD population; and knowledge, attitudes, and beliefs 

around acceptance/refusal of COVID-19 vaccination. 

CISA Project clinical consult service supports US HCP and health departments on complex 

clinical vaccine safety questions and assists with evaluations of patients with AEs after receiving 

COVID-19 vaccine or in making clinical decisions about administering COVID-19 vaccine to a 

person who may be at increased risk for an AE. Advice from CDC and the CISA Project is 

meant to assist in decision-making versus providing direct patient management and is available 

to US healthcare providers and health departments by contacting CDC-INFO. HCPs have been 

CDC’s longstanding partners for reporting vaccine AEs to VAERS. VAERS depends upon HCPs 

to identify and report suspected AEs, even if they are not sure if a vaccine caused an AE. The 

Health Insurance Portability and Accountability Act (HIPAA) permits reporting of vaccine AEs 

and medical documentation to VAERS for public health purposes. HCP participation in VAERS 

reporting will enable public health officials to have accurate and timely information on the safety 

of COVID-19 vaccines. Specific guidance on VAERS reporting for vaccines authorized for use 

under EUA will be forthcoming. 

V-safe is a new smartphone-based active surveillance program for COVID-19 vaccine safety 

that uses text messaging to initiate web-based survey monitoring and conducts electronic health 

checks on vaccine recipients. Health checks are conducted daily for the first week postvaccination and weekly thereafter until 6 weeks post-vaccination. There are additional health 

checks at 3, 6, and 12 months post-vaccination. V-safe includes active telephone follow-up 

through the VAERS program with vaccine recipients reporting a clinically important event during 

any v-safe health check. A VAERS report will be taken during telephone follow-up, if 

appropriate. V-safe captures information on pregnancy status and enables follow-up on 

pregnant women as well. V-safe will allow for estimation of rates of local and systemic 

reactogenicity and rates of clinically important AE following COVID-19 vaccination and 

symptoms and conditions associated with these AEs. HCPs will play an important role in v-safe 

enrollment by providing a one-page information sheet to patients at the time of vaccination (to 

be created by CDC) and counseling patients on the importance of enrolling in v-safe. CDC will 

provide information on how to briefly counsel patients on v-safe. Of note, v-safe will be 

translated into at least 5 other languages. 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

Dr. Melinda Wharton (CDC/NCIRD) described the ACIP COVID-19 VaST in more detail. VaST 

was organized in June 2020 and is comprised of independent expert consultants, ACIP 

members, liaison representatives, and federal agency SMEs. The focus of VaST is to prioritize 

AESI, develop USG plans for safety monitoring, and create a communication framework. VaST 

was built off of lessons learned from H1N1 vaccine safety monitoring. There was consensus 

that a Federal Advisory Committee Act (FACA)-chartered subgroup would ensure transparency, 

independence, and public accountability. VaST is currently comprised of ACIP and National 

Vaccine Advisory Committee (NVAC) representation, 7 independent expert consultants, ACIP 

ex officio members (NIH, FDA, OIDP, CMS, HRSA, IHS), and a VA and DoD liaison. The 

VaST’s post-implementation objectives are to: 1) review, evaluate, and interpret postauthorization/approval COVID-19 vaccine safety data; 2) serve as the central hub for technical 

SMEs from federal agencies conducting post-authorization/approval safety monitoring to share 

vaccine safety surveillance data; 3) advise on analyses, interpretation, and data presentation; 

and 4) liaise with the ACIP COVID-19 Vaccines WG on issues of safety data presentation to the 

ACIP and application of safety data to policy decisions. The VaST’s deliverables include 

development of frequent COVID-19 vaccine safety technical reports for internal ACIP and CDC 

and federal partner use, and frequent COVID-19 vaccine safety data summaries for public 

release. 

Dr. Matthew Biggerstaff (CDC Data, Analytics, and Modeling Task Force) presented modeling 

strategies for the initial allocation of SARS-CoV-2 vaccines. The question posed to the group to 

model was, “What is the potential impact, in terms of preventing COVID-19 infections and 

deaths, of initially allocating vaccine to one of the following groups after vaccinating HCP in 

Phase 1A: Adults aged 65+, adults with high-risk medical conditions, and essential workers?” 

He described in detail the population stratification, vaccine product assumptions, completeness 

of protection, vaccine allocation assumptions for Phase 1 and Phase 1b, epidemic dynamics, 

administration assumptions, and approximate timing of vaccine rollout (before incidence rises, 

as incidence rises, as incidence falls). In terms of findings, initially vaccinating high-risk adults or 

essential workers in Phase 1B averts approximately 1% to 5% more infections compared to 

targeting age 65+. This difference is greatest in the scenario in which the vaccine is introduced 

before incidence rises. The findings are robust to assumptions of reduced VE in older 

populations. Initially vaccinating age 65+ in Phase 1b averts approximately 1% to 4% more 

deaths compared to targeting high-risk adults or essential workers. As before, this difference is 

greatest in the scenario in which the vaccine is introduced before incidence rises. The 

percentage of deaths averted changes if VE is reduced in older populations. Initially vaccinating 

high-risk adults, age 65+, or essential workers in Phase 1b averts a similar percentage of 

deaths across the scenarios. Initially vaccinating age 65+ in Phase 1b averts approximately 2% 

to 11% more deaths compared to targeting high-risk adults or essential workers. Again, this 

difference is greatest in the scenario where the vaccine is introduced before incidence rises. 

The findings are robust to assumptions of reduced VE in older populations, but the percentage 

averted drops. 

There are limitations to the study. The efficacy and ability of the vaccine candidates to prevent 

transmission, as well as the time vaccine may become available, is currently unknown. Modeled 

epidemic trajectories are only for illustration and are not forecasts. Overall averted burden 

should be interpreted cautiously, given that it will be sensitive to the future trajectory of the 

epidemic; findings reflect an idealized rollout with minimal delays and 100% uptake; and the aim 

of this study was to demonstrate the relative impact of different initial vaccine allocation 

strategies. The following inputs were assumed and will require reassessment as more 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

information becomes available: 1) all infections confer protective immunity; 2) immunity, either 

naturally- or vaccine-acquired, does not wane significantly within a year of infection or 

immunization; 3) given exposure, younger age groups are just as likely to become infected as 

older age groups (susceptibility independent of age); 4) individuals with comorbidities are just as 

likely as their peers to practice social distancing and other protective behaviors; and 5) there 

was no reduction in VE among those with high-risk medical conditions. The findings are 

consistent in sensitivity analyses where the percentage of the population infected prior to 

vaccine introduction was varied. In terms of consistency with external literature, a review of 

peer-reviewed and pre-publication studies that model the impact of vaccination under different 

initial allocation strategies shows generally agreement across study results with the results 

presented here. 

Dr. Megan Wallace (CDC/NCIRD) provided updates to COVID-19 immunity and epidemiology 

to inform vaccine policy, including an overview of US COVID-19 epidemiology, COVID-19 postinfection immunity, COVID-19 reinfection, and epidemiology of COVID-19 in pregnant women. 

As of October 29th, there were 8,834,393 cases of COVID-19 and 227,045 COVID-19 deaths. 

From March 1, 2020 through October 17, 2020, the number of specimens tested and percent 

positive for SARS-CoV-2 from combined laboratories reporting to CDC was 6.3% at Week 42. In 

terms of what happens to anti-SARS-CoV-2 antibodies after infection, Rhesus macaques 

challenged with SARS-CoV-2 developed binding and neutralizing antibody responses. Rechallenge of rhesus macaques boosted SARS-CoV-2 antibody responses. In humans with 

SARS-CoV-2 infection, serum antibodies decline between the acute phase and 2 months postdischarge. In HCP with a history of mild SARS-CoV-2 infection, serum antibodies waned 2 

months post-infection. Among hospitalized persons with SARS-CoV-2, neutralizing antibody 

titers demonstrated little to no decrease over 75 days since symptom onset. Pertaining to 

whether persons infected with SARS-CoV-2 mount cellular immune responses, in symptomatic 

COVID-19 patients, SARS-CoV-2 memory B-cells did not wane at the same rate as serum 

antibodies. Recovered COVID-19 patients have SARS-CoV-2-specific CD4+ T-cells and CD8+ 

T-cells. In conclusion, repeat exposure to SARS-CoV-2 may cause boosting of immune 

response. Several studies have now observed waning of serum antibodies in COVID-19 

patients after a few months. However, the implications for protection are unknown. Neutralizing 

antibody titers demonstrated little or no decrease at 75 days post-symptom onset. SARS-CoV-2 

specific cellular B- and T-cell responses have been detected in COVID-19 patients. Memory B 

cells did not wane as fast as serum antibody titers. 

Dr. Mary Chamberland (CDC/NCIRD) discussed ethical principles for phased allocation of 

COVID-19 vaccines, which the COVID-19 Vaccine WG developed to assist ACIP in the 

identification of groups for early allocation of COVID-19 vaccine in the setting of a constrained 

supply. During the September 2020 ACIP meeting, 5 interim ethical principles were endorsed: 

Maximizing Benefits and Minimizing Harms, Equity, Justice, Fairness, and Transparency. 

During the July through August ACIP meetings, possible groups for Phase 1 vaccination were 

explored, including HCP in Phase 1a and essential workers (non-HCP), persons with high-risk 

underlying medical conditions, and adults aged ≥65 years in Phase 1b. The WG reviewed 

COVID-19 vaccine allocation frameworks including those from Johns Hopkins University (JHU), 

National Academies, and the World Health Organization (WHO). In addition, they reviewed the 

ethical literature and consulted with experts in health equity, ethics, and Grading of 

Recommendation Assessment, Development and Evaluation (GRADE). The interim ethical 

principles were updated to guide phased allocation and a manuscript was drafted on ethical 

principles to address key questions to guide allocation planning, and a health equity domain 

was incorporated into the Evidence to Recommendations (EtR) Framework. There are now 4 

ethical principles (Maximizing Benefits and Minimizing Harms, Promote Justice, Mitigate Health 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

Inequities, and Promote Transparency), and updates to the interim version included folding 

fairness into justice and styling the principles as action phrases. A series of Key Questions was 

developed to: 1) facilitate “translation” of the ethical principles; 2) assist ACIP in developing its 

national recommendations for early phase COVID-19 vaccine allocation; and 3) serve as a tool 

for State, Tribal, Local, and Territorial (STLT) health authorities as they develop vaccination 

implementation plans. Although ethical principles are fundamental for stewardship of a limited 

supply of vaccine, they also will be applicable when COVID-19 vaccines are more widely 

available. Dr. Mary Chamberland described in detail each Key Question for COVID-19 vaccine 

allocation planning stratified by ethical principles. 

Application of the principle of transparency across the entirety of the allocation decision-making 

process is essential for building public trust and confidence and being clear about the level of 

certainty in available evidence. Methods and data used for ACIP recommendations are publicly 

available and include public participation. ACIP meetings are open to the public and are 

available on-line. Comments can be made to the Federal Register and/or during ACIP meetings 

and when ACIP engages with stakeholders and partners. Allocation of a limited supply of 

vaccine is complicated by efforts to address multiple goals, most notably reducing morbidity and 

mortality and minimizing disruption to society, the economy, and healthcare capacity. If the 

goals of a vaccination program are not clearly prioritized, it will be difficult to draw distinctions 

between groups for early phase allocation. There is increasing consensus among allocation 

frameworks for early vaccination of HCP, suggesting that maintenance of healthcare capacity as 

the highest priority. If vaccine supply remains constrained, ethical principles can help to guide 

identification of subsets of other groups for subsequent early phase allocation. The next steps 

for the WG are to seek ACIP’s views on the updated ethical principles and key questions, 

publish ACIP’s ethical principles, and engage in further discussion about application of the 

ethical principles to help inform Phase 1 allocation recommendations. The WG requested 

feedback on how application of these principles and key questions could be made more useful 

to STLT health authorities for COVID-19 vaccine allocation planning. 

Dr. Sara Oliver (CDC/NCIRD) presented the ACIP COVID-19 Vaccine WG’s interpretation of 

the data. In terms of COVID-19 vaccine and prior infection, data from Phase 3 trials for any 

possible vaccine-associated enhanced disease or reactogenicity after prior infection are not yet 

available. In the absence of concerning data from Phase 3 trials, having positive PRC, antigen, 

or antibody results is not a contraindication to receive COVID-19 vaccine. Any vaccine 

recommendations that rely on knowledge of prior immunity/antibody testing would be difficult to 

implement. In terms of COVID-19 vaccine and breastfeeding women in Tier 1a, most WG 

members agreed that breastfeeding would not be a contraindication to receive a COVID-19 

vaccine. However, this needs to be evaluated for each vaccine, especially if any live virus/vector 

vaccines are authorized/licensed. Regarding pregnant women in Tier 1a, limited data on 

pregnancy are expected from Phase 3 trials. The WG did not reach a consensus. The majority 

felt that if a woman is recommended to receive the vaccine in an early allocation phase, 

pregnancy should be a precaution but not a contraindication to receive a COVID-19 vaccine. 

The WG emphasized the need to allow women to make an informed decision, providing all 

current knowledge of COVID-19 vaccines/platforms with pregnancy and risk of disease. 

Concerning pregnancy diagnosed after receipt of the first dose of COVID-19 vaccine, the 

majority of the WG felt that the second dose could be given at the recommended interval. A 

minority of the WG felt that the second dose should be postponed until the second trimester or 

until after pregnancy, emphasizing the need to allow women to make an informed decision. 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

Regarding the WG’s interpretation of the modeling data, the differences among the 3 strategies 

are thought to be minimal. Ethical principles and implementation considerations may greatly 

contribute to selecting the optimal sequence in Phase Ib. The largest impact in averted deaths 

and infections is the timing of vaccine introduction in relation to increases in COVID-19 cases. It 

is important to emphasize the need to continue non-pharmaceutical interventions (e.g., wearing 

a mask, social distancing) while awaiting available vaccine. Many factors will inform 

interpretation of modeling data and allocation decisions, such as VE in older adults, a vaccine’s 

ability to prevent severe disease or transmission, and whether the goal is to prevent the greatest 

number of infections or greatest number of deaths. For vaccine candidates, both Novavax and 

Jenssen are planning and enrolling large Phase 3 efficacy trials of 30,000 to 60,000 people. The 

primary endpoints include symptomatic, virologically confirmed COVID-19 disease. Both 

companies are attempting to enroll diverse populations in terms of race and ethnicity, age (<65 

years and ≥65 years of age), and underlying medical conditions. 

Concerning implementation and distribution, the WG’s interpretation is that Phase 2/3 data from 

the vaccines show induction of binding and neutralizing antibodies as well as T-cell responses, 

favorable safety/reactogenicity profiles, supporting advance to Phase 3 trials. Both platforms 

have prior experience from other vaccines. Safety pauses are expected with large clinical trials, 

indicating the process is working appropriately. For the current Phase 3 clinical trials, the WG 

stressed the importance of enrolling diverse study participants, the importance of harmonizing 

safety and efficacy endpoints across all Phase 3 trials to the extent possible, and the need to 

report maternal and fetal outcomes for women who become pregnant during the clinical trials. 

The WG supports FDA’s guidance for ensuring that Phase 3 trials conduct ongoing assessment 

of long-term safety and efficacy, and that issuance of an EUA is not grounds to unblind followup in an ongoing clinical trial. 

Dr. Kathleen Dooling (CDC/NCIRD) reviewed the COVID-19 vaccine policy questions for the 

EtR framework and critical and important outcomes. As a reminder, the goals of the COVID-19 

vaccine program are to: 1) ensure the safety and effectiveness of COVID-19 vaccines; 2) 

reduce transmission, morbidity, and mortality of COVID-19 disease; 3) help minimize disruption 

to society and economy, including maintaining healthcare capacity; and 4) ensure equity in 

vaccine allocation and distribution. The two ACIP policy questions proposed by the WG are: 1) 

Should COVID-19 Vaccine “A” be recommended to adults in the US?; and 2) Who should be 

recommended to receive COVID-19 Vaccine “A” during Phase 1? The EtR framework assesses 

the domains of Public Health Problem, Benefits and Harms, Values, Acceptability, Feasibility, 

Resource Use, and Equity. Dr. Dooling reviewed the population, intervention, comparison, 

outcomes (PICO) for vaccine policy for Question #1, including the critical and important benefits 

and harms identified by the WG. The WG’s next steps for Policy Question #1 (Vaccine 

Recommendations) are to populate the EtR framework, start GRADEing the vaccine evidence 

and incorporating Phase 3 data when available, and discuss clinical guidance for special 

populations, concomitant administration, and scheduling. For Policy Question #2 (Allocation 

Recommendations), the WG’s next steps are to publish the ethical principles manuscript and 

incorporate the latest information regarding science, implementation, and ethics to further refine 

Phase 1 allocation. For the health equity domain criterion question, the following sub-questions 

were posed: 1) Are there any groups or settings that might be disadvantaged in relation to the 

problem or options that are considered?; 2) Are there plausible reasons for anticipating 

differences in the relative effectiveness of the option for disadvantaged groups or settings?; 3) 

Are there different baseline conditions across groups or settings that affect the absolute 

effectiveness of the option or the importance of the problem for disadvantaged groups or 

settings? Are there important considerations that should be made when implementing the 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

intervention (option) in order to ensure that inequities are reduced, if possible, and that they are 

not increased? 

Discussion Points/Comments/Questions/Suggestions 

 Regarding vaccine candidates: 

Blinded, placebo-controlled follow-up in ongoing trials should continue for as long as 

is feasible, including after EUA. 

Safety and vaccine hesitancy must continue to be addressed. 

With all of the vaccine candidates, it seems that local and systemic reactions are 

extremely common and should be anticipated. 

As with other vaccines, there is concern that COVID-19 vaccines may not work as 

well in adults ≥65 years of age.

Inclusion of individuals with human immunodeficiency virus (HIV) in vaccine trials is 

imperative. 

There continue to be concerns about the potential for ERD. 

Safe and effective vaccines for children and pregnant women are a high priority. 

Transparency is crucial in all aspects of COVID-19 vaccines, including information 

about the cases that result in trial pauses, as this will impact sentiments pertaining to 

vaccines in general, vaccine confidence downstream, and the ability to control 

preventable diseases. 

Ultra-cold vaccines remain troubling in terms of logistics (transportation, storage, 

venues for administration). 

Diversity among trial participants and in terms of outreach and communication must 

be addressed. 

Standardization of convalescent sera would be useful for the field. 

From the broader healthcare perspective, there has been under-investment in vaccine 

implementation planning: 

ACIP expressed hope that going forward, CDC and others would be fully supported 

in this endeavor versus adding one more task to the already complex delivery 

system. Funding investments in this type of work is critical. 

Assuming that COVID-19 vaccine implementation will ramp up from January through 

March and more to do in April, there is concern that the Coronavirus Aid, Relief, and 

Economic Security (CARES) Act Provider Relief Fund that has paid for increases in 

the workforce will run out on December 31, 2020. Consideration must be given to 

what can be done at the state and local health department levels in terms of 

implementing COVID-19 vaccine activities if additional funding is not forthcoming. 

State and local jurisdiction funds are likely to depend upon local legislatures. 

There are major deficits in the healthcare delivery system, especially in primary care. 

More targeted support is needed for private practice to continue to deliver all types of 

vaccines. 

Implementation is where actual impact will happen or not. The same level of 

investment that has been made in vaccine development must be made in 

implementation. There must be national investment. While state support is important, 

federal support is crucial. This cannot be done in everyone’s “free time.” In order for 

implementation to be successful, the federal government must make a significant 

investment. 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

 Typically, ACIP approves a vaccine and then leaves implementation up to the states. 

This situation offers a good opportunity for ACIP to permanently change the model 

by which it operates. 

 The planning process for delivering vaccines to children will be very different from the 

process for adults, given that the majority of children’s vaccines are given in pediatric offices 

and many providers do no participate in Vaccines for Children (VFC). Although children are 

likely to be the last in line and pediatric trials are just beginning, planning for delivery to 

children should be done now. 

 Much can be learned from influenza vaccines (e.g., make vaccination simple and easy, use 

reminders, use already planned visits, fund and support these activities where possible). 

 While each of the 64 jurisdictions presented creative and unique plans based on their own 

jurisdictional issues that should be beneficial, it is crucial to keep in mind that different 

communities have different issues regarding vaccine acceptance, such as communities of 

color and Tribes: 

 Many communities of color experience issues due to ongoing systemic racism and 

disparities that lead them to have distrust. Therefore, it is critical to work with 

communities of color to engender and earn trust, while being completely up front. It is 

particularly important to engage with community-based organizations (CBOs) and 

doctors of color who practice in these communities. 

 Concerns from Tribes focus on the very compressed timeline that does not allow for 

the IHS to engage in meaningful conversations. Tribes are being asked to make 

decisions about distribution, prioritization, et cetera without having all of the 

information they feel they need. Despite efforts to address these concerns, issues 

remain about how vaccine will be distributed, ordered, and reported on. Many Tribes 

want to be ready, but they are challenged by whether to choose distribution through 

states or through HIS. It is preferable to have both doors open. 

 Confidence in receiving COVID-19 vaccine must be increased within the HCP workforce. If 

the group they trust the most will not take these vaccines, patients are not going to want to 

take them either: 

 Lack of confidence among HCPs can be boosted by providing them with language 

that helps them answer questions about such topics as how vaccine was licensed so 

quickly when other vaccines take 15 years. 

 HCPs are constantly being asked about whether they trust COVID-19 vaccines, to 

which some respond that when CDC and FDA say they trust it is when HCPs will 

recommend it. 

 Given that HCPs are the most trusted vaccine deliverers, perhaps language should 

be included that permits them to be vaccinated in the first phase. Many private 

practitioners do not have access to personal protective equipment (PPE), yet they 

are the ones on the frontline to whom patients turn. 

 Workers Compensation must be addressed. 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

 CDC is producing content that will be shared with partners in the near future. It is imperative 

for partners, HCP organizations, and community partners to amplify these messages as this 

will be much more powerful than messages coming just from CDC or HHS. 

 Private practitioners have expressed interest in being able to order and receive vaccines 

through VTrckS. CDC encouraged them to speak with their local jurisdictions to enroll as 

providers in VTrckS, through which they can also order/receive vaccine. 

 The two components of DUAs, identified and de-identified data, need to be separated in 

order to move quickly as vaccines become available. 

 Many COVID-19 vaccines will require 2 doses, making it critical to be able to ascertain what 

vaccine was given for Dose 1 and when Dose 2 is needed: 

 Efforts to determine this information with existing Immunization Information Systems 

(IIS) can be frustrating. 

 State IIS for adults have lagged behind. 

 Ensuring that people received both doses and the correct products is very important 

to CDC, so immunization cards will accompany ancillary kits in order to have both IIS 

records and paper and pen solutions. 

 In terms of safety surveillance systems and safety monitoring plans: 

 Given that safety surveillance is critical, this immense and collaborative effort is 

impressive. 

 While the EHR can be a useful tool for data mining, finding AEs, and ensuring 

vaccines are distributed, it also has pitfalls that need to be stressed. Confidentiality 

goes without saying, but the biggest concern is that use of the EMR is burdensome 

in terms of implementation and use when data registration or data mining are 

involved. For private practice, this is burdensome and costly. If this is required and 

there is a cost to integrate it into the health record, it could fail in the community 

setting. 

 The emphasis on collaboration among government agencies and groups working on 

vaccine safety in terms of harmonizing outcomes of interest, regular communication, 

and sharing data is very important and is applauded. This type of collaboration and 

coordination should continue through the entire process so that signals are 

investigated. This also should help to ensure that communicating to the public is 

well-coordinated, transparent, and consistent. 

 It was observed that safety monitoring may be difficult in settings outside of VAERS 

and registries, such as monitoring vaccines administered in workplaces where 

employers have their own health insurance plans. This is an area that FDA is 

exploring. 

 Concern was expressed about the ability of the systems described to monitor for 

MIS-C, wild-type or vaccine-induced, particularly with respect to the case definition 

requirement of a positive test or exposure to a suspected or confirmed case within 4 

weeks prior to symptom onset. 

 Concern was expressed about access to v-safe in under-served areas. It is important 

to be mindful that while most people have access to some form of communication, 

indigent populations may not have ongoing access to care. In addition, v-safe 

communication must be culturally sensitive. 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

 Lessons learned from children being at home and not in school is that there are 

many barriers. As hard as it may be to believe, not everybody has internet access 

and many people purchase phone minutes for phones that are not smartphones. It 

would be beneficial to track or record v-safe use, perhaps by Zip Code, to ensure 

that it is inclusive of all communities in terms of access and recording long-term 

effects from the vaccine. 

 Consideration should be given to modernizing VAERS to accept data from EHRs 

and/or registries. 

 Regarding modeling strategies for the initial allocation of SARS-CoV-2 vaccines: 

 This is an incredible, elegant, and impressive analysis and enormous amount of 

work. 

 From a clinical and public health medical consultant point of view, the assumptions in 

the model make sense. VE may be somewhat high, but it is reasonable. 

 Consider modeling the impact of poor nutrition, falling behind in school, and possible 

abuse and neglect if older adults are vaccinated first and schools remain closed. The 

modeling team noted that this is possible but may require more complex framework 

such as agent-based models that model people and societal parameters. 

 Consider modeling hospitalizations not just deaths. The modeling team noted that 

they started with infections and deaths because those estimates are easier to obtain, 

but infections and hospitalizations can be incorporated in future versions. 

 Consider modeling congregate care settings. The modeling team indicated that this 

was already done and was presented by Dr. Slayton during the August 2020 ACIP 

meeting. The take-away from that study was that vaccinating staff in these settings 

may be more beneficial than just vaccinating residents, likely because of infectionblocking such that the infection is not introduced into the congregate setting. 

 It is critical for ACIP to address equity and disproportionate impact on disadvantaged 

populations. Approaching this from a race/ethnicity standpoint is probably not the 

best approach. 

 With respect to COVID-19 immunity and epidemiology to inform vaccine policy: 

 Pregnant and lactating women should not be excluded from high priority populations 

for COVID strategies and treated separately. More than 75% of the HCP workforce 

are females. For instance, pregnant HCP and first responders who are pregnant 

should be prioritized alongside their non-pregnant peers. 

 Though reinfection appears to be uncommon at this point, it will be beneficial to have 

further guidance on this as soon as possible. 

 The summary about what is known and unknown about reinfection was phenomenal. 

However, using language such as reinfection is “likely uncommon within 3 months” 

suggests more is known that actually is. Perhaps “may be uncommon within 3 

months” would be less challenging for management. 

 It is imperative for messaging around vaccine to emphasizes that vaccines are not 

likely to be 100% effective and that other measures must be utilized in combination 

with vaccines. The vaccine is not a panacea and will not result in immediate full herd 

immunity. 

 Dr. James Lee invited health care institutions and local/state public health entities 

interesting in discussing more about reinfections to email eocevent461@cdc.gov. 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

 Pertaining to ethical principles: 

 While there was agreement with and endorsement of the principles, some members 

were struggling with how they fit into the overall pandemic response—especially 

having seen projections earlier showing that it seems to matter less who gets the 

vaccine first as far as numbers of infections and deaths. That is, the principles seem 

less important than how soon the vaccine gets deployed. 

 The WG pointed out that the modeling work measured only one dimension of the 

impact, aversion of cases and deaths. The ethical principles takes a more holistic 

view of several dimensions in the context of limited vaccine supply being guided by 

ethnical, scientific, and implementation considerations. 

 The Key Questions to help guide and integrate the process seem beneficial and are 

greatly appreciated. 

 One thing that will go a long way with the general population, especially in terms of 

trust and disparities, is a mechanism for reporting how vaccine products are actually 

being allocated. 

 One decision with which ACIP will be faced will be assessing the data in terms of 

benefits and risks for various groups once a vaccine is available. If a vaccine 

becomes available in the next month or two, this will be a relatively short timeframe 

for efficacy and safety data. With no long-term safety data, it will be difficult to 

balance the benefits versus long-term issues that historically have arisen. Balancing 

the scientific and ethnical aspects is going to be difficult. 

 The slide on promoting transparency harkens back to the earlier comments about 

Tribes and the dynamic tension that a compressed timeline is going to create. 

 With respect to the WG’s interpretation of the data: 

 The American College of Obstetricians and Gynecologists (ACOG) urged ACIP to 

incorporate pregnant and lactating women clearly and explicitly in the prioritization 

framework should an EUA be issued. 

 The American Academy of Pediatrics (AAP) agreed with the ACOG statement and 

defers to them on matters of pregnancy and pregnant women. AAP also emphasized 

the need to move to pediatric trials when the data suggest that it is safe to do so and 

should monitor fetal outcomes. 

 It is important for pregnant and lactating women to make an informed decision. CDC 

is engaging ACOG and AAP and is working with colleagues with expertise in this 

area to development materials that can be provided at the time of vaccination. 

 Related to the unblinding of clinical trials should an EUA become available, 

particularly for participants in vaccine trials in which efficacy and safety are 

demonstrated, it is troubling that participants potentially will not have the benefit of 

receiving vaccine once efficacy is demonstrated. These volunteers have assumed 

the risk of study participation and in most clinical trial circumstance would be among 

the first to potentially benefit once efficacy is demonstrated. It is recognized that this 

is an issue that must be dealt with by FDA and VRBPAC. 

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

 Regarding whether ACIP members agree with the proposed COVID-19 vaccine policy 

questions and outcomes for the EtR framework: 

 There was support for the two policy questions being evaluated separately and the 

important and beneficial outcome of serial PCRs for asymptomatic infection. 

 This is an unprecedented situation in which consideration may need to be given to 

conditional recommendations, which should incorporate the principles of informed 

consent and some higher level of clinical decision-making. 

 Perhaps consideration should be given to getting the vaccine out as quickly as 

possible to react to the modeling that says the faster vaccines are administered, the 

more death that will be prevented. 

 This does not take into consideration any time-phased protection or safety other 

than the data that will be provided should an EUA come through in a relatively short 

period of time. This is a virus like nothing they have seen previously, so the 

unknown and bad possibilities are always a consideration. They can look at 

objective information and arrive at a conclusion to move forward with allocation, but 

that presumes that there is not going to be some later problem. 

 Following participants for a mean of 2 months after the second dose as a timepoint 

to start making final decisions about safety is troubling. Concerns prevailed on 

making quick decisions on safety. While it is true that most AEs of interest will be 

captured in the first 6 weeks, there will be a need for long-term studies, particularly 

due to the potential for vaccine-enhanced disease. This highlights the need for a 

dynamic decision-making process. 

 The WG has considered mortality, morbidity, and preventing spread in a lumped 

manner. In the context of unknowns, perhaps those should be disaggregated. 

 The questions fit the PICO perfectly, with the caveat that there may be changes. 

There must be flexibility over time and flexibility in implementation. Local areas will 

have to deal with the reality of whether to save doses for Dose 2. 

 Given the uncertainties, perhaps the WG should review the data on a monthly basis 

and update the recommendations to account for concerns in balance with benefits 

and harms. 

 While the focus on safety is very important, it is also crucial to understand durability 

of the immune response. 

 The ethical principles will be very important to local jurisdictions. Concrete guidance 

will be needed in terms of equity and a sense of fairness in terms of how allocations 

actually are implemented. 

 Frequent messaging of information about COVID-19 vaccines will be very important 

to public confidence. 

19 
 

 

 

 

Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

Acronyms 

AAP American Academy of Pediatrics 

ACIP Advisory Committee on Immunization Practices 

ACOG American College of Obstetricians and Gynecologists 

AE Adverse Event 

AECI Adverse Events of Clinical Interest 

AESI Adverse Events of Special Interest 

BEST Biologics Effectiveness and Safety 

BOP Bureau of Prisons 

CBER Center for Biologics Evaluation and Research 

CDC Centers for Disease Control and Prevention 

CMS Center for Medicare and Medicaid Services 

COI Conflict of Interest 

COU Clinical Operations Unit 

COVID-19 Coronavirus Disease 2019 

CoVPN COVID-19 Prevention Network 

CRO Contract Research Organization 

DE Division of Epidemiology 

DFO Designated Federal Official 

DNA Deoxyribonucleic Acid 

DoD Department of Defense 

DOS Department of State 

DSMB Data Safety Monitoring Board 

EHR Electronic Health Record 

ELISA Enzyme-Linked Immunosorbent Assay 

EMA European Medicines Agency 

EMR Electronic Medical Record 

ET Eastern Time 

EtR Evidence to Recommendation 

EUA Emergency Use Authorization 

FDA Food and Drug Administration 

GMT Geometric Mean Titers 

GRADE Grading of Recommendation Assessment, Development and Evaluation 

HCoVs Human Coronaviruses 

HCP Healthcare Personnel / Providers 

HCW Healthcare Workers 

HHS (Department of) Health and Human Services 

HIPAA Health Insurance Portability and Accountability Act 

HIV Human Immunodeficiency Virus 

IDCRP Infectious Disease Clinical Research Program 

IHS Indian Health Service 

IIS Immunization Information Systems 

IM Intramuscular 

IND Investigational New Drug 

IRB Institutional Review Board 

ISO Immunization Safety Office 

JHU Johns Hopkins University 

LTCF Long-Term Care Facilities 

This document has been archived for historical purposes. (11/1/2020) 

https://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/summary-2020-10.pdf

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Advisory Committee on Immunization Practices (ACIP) Business Summary October 30, 2020 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

NCIRD National Center for Immunization and Respiratory Diseases 

NVAC National Vaccine Advisory Committee 

OBE Office of Biostatistics and Epidemiology 

PCP Primary Care Practitioner 

PCR Polymerase Chain Reaction 

PICO Population, Intervention, Comparison, Outcomes 

PPE Personal Protective Equipment 

RSV Respiratory Syncytial Virus 

RT-PCR Reverse Transcriptase Polymerase Chain Reaction 

SAE Serious Adverse Event 

SARS Severe Acute Respiratory Syndrome 

SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus-2 

SLU Saint Louis University 

SME Subject Matter Expert 

STLT State, Tribal, Local, and Territorial 

US United States 

USG US Government 

VA (US Department of) Veteran’s Affairs 

VAERS Vaccine Adverse Event Reporting System 

VaST ACIP COVID-19 Vaccine Safety Technical Sub-Group 

VE Vaccine Efficacy 

VE Vaccine Effectiveness 

VMED Vaccine-Mediated Enhanced Disease 

VRBPAC Vaccines and Related Biological Products Advisory Committee Meeting 

VSD Vaccine Safety Datalink 

VTU Vaccine Treatment Evaluation Unit 

WG Work Group 

WHO World Health Organization 

21