DEPARTMENT OF HEALTH AND HUMAN SERVICES 

CENTERS FOR DISEASE CONTROL AND PREVENTION

Advisory Committee on 

Immunization Practices (ACIP)

Summary Report

January 27, 2021

Atlanta, Georgia 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Table of Contents Page

Agenda 3

Acronyms 4-6

Welcome and Introductions 7-8

Coronavirus Disease 2019 (COVID-19) Vaccines

⬧ Introduction

⬧ AstraZeneca COVID-19 Vaccine (AZD1222)

⬧ COVID-19 Epidemiology Among Children

⬧ Pediatric COVID-19 Clinical Trials

⬧ Vaccine Safety Technical Subgroup (VaST) Introduction

⬧ COVID-19 Vaccine Safety Update

⬧ VaST Assessment of Safety Data

⬧ Update on COVID-19 Vaccine Administration

⬧ COVID-19 Vaccine Effectiveness Studies

⬧ Work Group Interpretation and Next Steps

9-55

Public Comment 55-62

Certification 63

Membership Roster 64-72
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Acronyms

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices

ACOG American College of Obstetricians and Gynecologists

ACP American College of Physicians 

Ad.26 Adenovirus 26 

ADE Antibody-Dependent Enhancement 

AE Adverse Event

AECI Adverse Events of Clinical Interest 

AESI Adverse Events of Special Interest 

AGS American Geriatric Society 

AHIP America’s Health Insurance Plans

AI/AN American Indian/Alaskan Native 

AIM Association of Immunization Managers 

AMA American Medical Association

AOA American Osteopathic Association 

APhA American Pharmacists Association 

APTR Association for Prevention Teaching and Research

ARDS Acute Respiratory Distress Syndrome 

ASTHO Association of State and Territorial Health Officers

BARDA Biomedical Advanced Research and Development Authority 

BMI Body Mass Index

CBER Center for Biologics Evaluation and Research 

CDC Centers for Disease Control and Prevention

CID Clinical Infectious Diseases 

CISA Clinical Immunization Safety Assessment 

CISA Cybersecurity and Infrastructure Security Agency

CIVICs Collaborative Influenza Vaccine Innovation Centers 

CKD Chronic Kidney Disease

CLD Chronic Liver Disease 

CMS Center for Medicare and Medicaid Services

COD Cause of Death

COI Conflict of Interest 

COID Committee on Infectious Diseases 

COPD Chronic Obstructive Pulmonary Disease 

COVID-19 Coronavirus Disease 2019 

CSTE Council of State and Territorial Epidemiologists 

CVD Center for Vaccine Development and Global Health 

DNA Deoxyribonucleic Acid 

DNI Do Not Intubate 

DNR Do Not Resuscitate 

DoD Department of Defense

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs

EHR Electronic Health Record 

EMA European Medicines Agency 

EUA Emergency Use Authorization 

EV Enterovirus 

FDA Food and Drug Administration

GACVS Global Advisory Committee on Vaccine Safety 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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GMT Geometric Mean Titers 

HCP Health Care Personnel / Providers

HCW Health Care Workers 

HHS (Department of) Health and Human Services

HRSA Health Resources and Services Administration 

IB Investigator Brochure 

ICF Informed Consent Form 

ICU Intensive Care Unit 

IDSA Infectious Disease Society of America 

IFNγ Interferon Gamma 

IHR Institute for Health Research 

IHS Indian Health Service 

IIS Immunization Information Systems 

IL Interleukin 

IM Intramuscular 

ISO Immunization Safety Office

ISTM International Society for Travel Medicine 

KFF Kaiser Family Foundation 

KPCO Kaiser Permanente Colorado 

LTCF Long-Term Care Facilities 

MAAE Medically-Attended Adverse Event

MedDRA Medical Dictionary for Regulatory Activities 

MHRA Medicines and Healthcare Products Regulatory Agency 

MIS-C Multisystem Inflammatory Syndrome in Children 

MMWR Morbidity and Mortality Weekly Report

mRNA Messenger Ribonucleic Acid 

NAAT Nucleic Acid Amplification Test 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada

NAPNAP National Association of Pediatric Nurse Practitioners 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

NCHHSTP National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention 

NCHS National Center of Health Statistics 

NCIRD National Center for Immunization and Respiratory Diseases 

NFID National Foundation for Infectious Diseases 

NHP Non-Human Primates 

NHSN National Healthcare Safety Network 

NIAID National Institute of Allergy and Infectious Diseases 

NIH National Institutes of Health

NMA National Medical Association 

NPI Non-Pharmaceutical Intervention

NS3 National SARS-CoV-2 Strain Surveillance 

NVAC National Vaccine Advisory Committee 

OID Office of Infectious Disease 

OIDP Office of Infectious Disease Policy and HIV/AIDS 

OWS Operation Warp Speed 

PALISI Pediatric Acute Lung Injury and Sepsis Investigator’s Network

PHAC Public Health Agency Canada 

PhRMA® Pharmaceutical Research and Manufacturers of America®

PI Principal Investigator

PICFLU Study Pediatric Intensive Care Influenza PICFLU Study

PIDS Pediatric Infectious Disease Society 

PPE Personal Protective Equipment 
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PreVAIL kIds Predicting Viral-Associated Inflammatory Disease Severity in Children with Laboratory 

Diagnostics and Artificial Intelligence 

PRISM Pediatric Research Immune Network on SARS-CoV-2 and MIS-C 

PT Preferred Terms (MedDRA)

RADxSM Rapid Acceleration of DiagnosticsSM

RCA Rapid Cycle Analysis

RCT Randomized Controlled Trial

RR Relative Risk

RT-PCR Reverse Transcriptase Polymerase Chain Reaction

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

SARS Severe Acute Respiratory Syndrome 

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

SHEA Society for Healthcare Epidemiology of America 

SII Serum Institute of India 

SMEs Subject Matter Experts

SNF Skilled Nursing Facilities 

SPHERES SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and 

Surveillance 

SVI Social Vulnerability Index 

TNF Tumor Necrosis Factor 

UK United Kingdom

UMB University of Maryland Baltimore 

UMMC University of Mississippi Medical Center 

UMSOM University of Maryland School of Medicine 

US United States

USG US Government 

USPHS US Public Health Service 

VA (US Department of) Veteran’s Affairs 

VA ADERS VA Adverse Drug Event Reporting System 

VAERD Vaccine-Associated Enhanced Respiratory Disease 

VAERS Vaccine Adverse Event Reporting System

VaST ACIP COVID-19 Vaccine Safety Technical Subgroup 

VE Vaccine Efficacy

VE Vaccine Effectiveness

VP Viral Particles 

VRBPAC Vaccines and Related Biological Products Advisory Committee Meeting 

VSC Vaccine Safety Coordinator 

VSD Vaccine Safety Datalink

VTEU Vaccine Treatment Evaluation Unit 

WG Work Group

WGS whole genome sequencing 

WHO World Health Organization
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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José Romero, MD, FAAP

ACIP Chair

Amanda Cohn, MD

Executive Secretary, ACIP / CDC

Dr. Romero called to order the January 27, 2021 emergency meeting of the Advisory Committee 

on Immunization Practices (ACIP), the purpose of which was to discuss Coronavirus Disease 

2019 (COVID)-19 vaccines.

Dr. Cohn welcomed everyone and noted that the final agenda and webcast link could be 

accessed on the ACIP website, and that copies of the slides for this meeting could be accessed 

at the following URL:

https://www.cdc.gov/vaccines/acip/meetings/slides-2021-1-27-21.html

Additionally, the slides to be presented during this meeting were made available through a 

ShareFile link for ACIP Voting, Liaison, and Ex-Officio members. The live webcast videos will be 

posted approximately 1 week following the meeting, and the meeting minutes also will be

posted to the ACIP website.

In terms of meeting logistics, participants were instructed to raise their hands virtually when Dr. 

Romero opened the floor for discussion and to disable their video or mute their phone lines to 

reduce issues with the Zoom connection. Dr. Cohn explained that during the discussion period, 

the order in which Dr. Romero would take questions would be first from ACIP Voting Members, 

second from Ex Officio and Liaison member representatives, and then from the audience. The 

plan was to stay on schedule with the meeting agenda as much as possible. 

The next regularly scheduled ACIP meeting will be convened on February 24-25, 2021. An 

emergency meeting will be scheduled and announced if data become available that ACIP needs 

to consider before that time. 

Dr. Cohn explained that there would be an oral public comment session at 4:30 PM EST. Given 

that many more individuals registered to make oral public comments than could be 

accommodated, selection was made randomly via a lottery. Those individuals who were not 

selected and any other individuals wishing to make written public comments may submit them 

through https://www.regulations.gov using Docket Number CDC-2021-0002. Further information 

on the written public comment process can be found on the ACIP website.

ACIP members agree to forgo participation in certain activities related to vaccines during their 

tenure on the committee. For certain other interests that potentially enhance a member’s 

expertise, CDC has issued limited conflict of interest (COI) waivers. Members who conduct 

vaccine clinical trials or serve on data safety monitoring boards (DSMBs) may present to the 

committee on matters related to those vaccines, but are prohibited from participating in 

committee votes. Regarding other vaccines of the concerned company, a member may 

participate in discussions with the provision that he/she abstains on all votes related to that 

January 27, 2021: Opening Session 
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company. At the beginning of each meeting, ACIP members state any COIs. No votes were on 

the agenda for this meeting. 

Dr. Romero indicated that Dr. Grace Lee will serve an additional term from July 2020 through 

June 2021 as a bridging period in preparation to become the next ACIP Chair. In addition, he 

introduced the following incoming ACIP members:

❑ Dr. Wilbur Chen, who is a Professor of Medicine at the Center for Vaccine Development and 

Global Health (CVD) within the University of Maryland School of Medicine (UMSOM). He 

also is the Director of the University of Maryland Baltimore (UMB) Travel Medicine Practice. 

His research interest is in developing vaccines against pathogens which afflict low and 

middle income countries. He is a Co-Investigator of the NIAID-funded Vaccine Treatment 

and Evaluation Unit (VTEU) and the NIAID-funded Collaborative Influenza Vaccine 

Innovation Centers (CIVICs).

❑ Dr. Matthew Daley is a Senior Investigator at the Institute for Health Research (IHR) within 

Kaiser Permanente Colorado (KPCO). He has extensive experience in the areas of vaccine 

safety, parental vaccine hesitancy, and immunization services delivery. He is an Investigator 

in the Vaccine Safety Datalink (VSD) and an Associate Professor of Pediatrics in the 

Department of Pediatrics at the University of Colorado School of Medicine.

❑ Dr. Camille Kotton is the Clinical Director of the Transplant and Immunocompromised Host 

Infectious Diseases in the Infectious Diseases Division of Massachusetts General Hospital, 

and an Associate Professor of Medicine at the Harvard Medical School. She is an Infectious 

Diseases Clinician with special expertise in the area of care of complex patients undergoing 

solid organ transplantation with cancer. She also is a national expert in vaccination and 

zoonotic infectious diseases in the immunocompromised host.

❑ Dr. Sarah Long is a Professor of Pediatric Infectious Diseases at Drexel University College 

of Medicine. She is an Attending Physician in Infectious Diseases at St. Christopher’s 

Hospital for Children. She has over 4 decades of contributions in the field of pediatric 

infectious diseases. She has been a member of the Food and Drug Administration (FDA) 

Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the American 

Academy of Pediatric (AAP) Committee on Infectious Diseases (COID).

Dr. Romero then conducted the roll call. No COIs were declared for this meeting. A list of 

Members, Ex Officio Members, and Liaison Representatives is included in the appendixes at the 

end of the full minutes for the January 27, 2021 ACIP meeting.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Introduction

Beth Bell, MD, MPH 

ACIP, COVID-19 Vaccine WG Chair

Clinical Professor, Department of Global Health

School of Public Health, University of Washington 

Dr. Bell introduced the session, first drawing attention to the following publications that 

appeared in December 2020:

❑ The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of

Pfizer-BioNTech COVID-19 Vaccine — United States, December 20201

❑ The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of 

Moderna COVID-19 Vaccine — United States, December 20202

❑ The Advisory Committee on Immunization Practices’ Updated Interim Recommendation for 

Allocation of COVID-19 Vaccine — United States, December 20203

In January 2021, the COVID-19 Work Group (WG) covered a number of topics in terms of the 

current situation and looking forward, including safety updates, COVID-19 in children, plans for 

clinical studies of COVID vaccine in children, plans for vaccine effectiveness studies, and a 

number of issues related to clinical guidance for the use of messenger ribonucleic acid (mRNA)

COVID-19 vaccines.

Dr. Bell indicated that the day’s agenda would include presentations on the following topics, 

which would be followed by a public comment session:

❑ AstraZeneca COVID-19 Vaccine (AZD1222) Development Program

❑ Update on COVID-19 Vaccine Administration

❑ Vaccine Safety Technical Subgroup (VaST) Introduction 

❑ COVID-19 Vaccine Safety Update

❑ VaST Assessment of Safety Data

❑ COVID-19 Epidemiology among Children

❑ Pediatric COVID-19 Clinical Trials

❑ COVID-19 Vaccine Effectiveness Studies

❑ Work Group Interpretation and Next Steps

1 MMWR Morb Mortal Wkly Rep 2020;69:1922-1924. DOI: http://dx.doi.org/10.15585/mmwr.mm6950e2

2 MMWR Morb Mortal Wkly Rep 2021;69:1653-1656. DOI: http://dx.doi.org/10.15585/mmwr.mm695152e1

3 MMWR Morb Mortal Wkly Rep 2021;69:1657-1660. 

DOI: http://dx.doi.org/10.15585/mmwr.mm695152e2externalicon 

Coronavirus Disease 2019 (COVID-19) Vaccines: January 27, 2021 
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AstraZeneca COVID-19 Vaccine (AZD1222)

Tonya Villafana, PhD, MPH 

VP Global Franchise Head, Infection

Dr. Villafana presented on the AZD1222 adenoviral vector platform and the early clinical data 

that supported moving forward into the US Phase III study, non-investigational new drug (IND)

Phase III efficacy and safety trials from which an interim analysis was recently published in The 

Lancet and for which the United Kingdom (UK) Medicines and Healthcare products Regulatory 

Agency (MHRA) issued a temporary supply authorization, and vaccine storage and handling.

The Phase III trial in the US is ongoing and enrollment is complete. This trial will be the primary 

basis for the Emergency Use Authorization (EUA) application to the FDA, with supporting data 

from the non-IND trials conducted outside the US. In April 2020, AstraZeneca committed to a 

partnership with the University of Oxford to ensure broad and equitable vaccine access globally

and not-for-profit during the pandemic. Vaccine immunogenicity, efficacy, and safety were 

demonstrated for AZD1222 in four ongoing Phase I-III non-IND trials conducted in the UK, 

Brazil, and South Africa. As mentioned, data from these trials supported UK MHRA

authorization for temporary supply. AZD1222 also has EUA in several markets. The vaccine is 

supplied in 5 ml preservative free, non-latex multidose vials to be stored at 2°-8°C for at least 6 

months.

In terms of background on the platform and the early clinical data that supported moving forward 

to Phase III, AZD1222 is a non-replicating chimp adenovirus-vectored vaccine expressing the 

spike SARS-CoV-2 antigen4. The chimp adenovirus avoids issues with pre-existing immunity 

that is commonly seen with human adenoviruses5. The vaccine has been shown to induce 

strong B- and T-cell responses after a single vaccination4. Prior to April 2020, the group at 

Oxford had conducted several Phase I studies and early stage studies with this vector platform 

used for a variety of disease pathogens. About 330 subjects had been vaccinated with various 

vaccines using the platform. These data were instrumental to leverage moving forward very 

quickly into clinical studies with the AZD1222 vaccine. The dose that was selected for clinical 

development moving forward is 5 x 1010 viral particles (VP) as an intramuscular (IM) injection, 

0.5 ml4.

In collaboration with the University of Oxford, AstraZeneca has conducted a global clinical 

development program to support the goal of equitable access. The first trial that was started in 

April 2020 began in the UK and was a Phase I/II study6. The interim results from that study 

supported moving forward into Phase II/III studies in the UK7, a Phase III study in Brazil8, and a 

Phase I/II study in South Africa. The results were instrumental in moving forward into the US 

Phase III study9, which also includes enrollment in sites in Chile and Peru10. AstraZeneca has a 

number of studies ongoing globally, which are mostly safety and safety and immunogenicity 

studies to support licensure and use in those locations.

4 Folegatti PM, et al. Lancet 2020;396:467–478

5 Dicks MDJ, et al. PLoS One 2012;7:e40385

6 Study NCT04324606. ClinicalTrials.gov website

7 Study NCT04400838. ClinicalTrials.gov website

8 Study NCT04536051. ClinicalTrials.gov website

9 Study NCT04444674. ClinicalTrials.gov website

10 Study NCT04516746. ClinicalTrials.gov website
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COV001 was the first in-human study and the Phase I/II study that enrolled in the UK. This 

study enrolled 1077 participant 18-55 years of age. The study was originally designed to 

evaluate a single dose of the vaccine candidate, but a cohort of 10 participants was initially 

included who received 2 doses of the vaccine 28 days apart. Participants were randomized to 

receive either a dose of the vaccine or a control vaccine for meningitis. After a single dose of the 

vaccine, there was a nice rise in antibody titers in response to vaccination. When given a 

second dose 28 days later, there was a boost of these antibody responses. For both a single 

and two doses of vaccines, the responses were similar in range to what is seen with 

convalescent sera antibody titers. In an assay run by Public Health England (PHE) looking at 

neutralizing activity against the SARS-CoV-2 virus, approximately 91% of vaccinees had a 

neutralizing antibody response after a single dose of the vaccine. After 2 doses, 100% of 

vaccinees had a response. These data were very supportive in moving forward with a 2-dose 

vaccine strategy, which was implemented for the rest of the clinical development program11.

Older adults are disproportionately impacted by COVID-19 with severe outcomes. They are a 

priority population for vaccination and inclusion in clinical trials. Prior to being able to enroll older 

adults in AstraZeneca’s large-scale efficacy studies, they were included in the Phase II portion 

of the COV002 trial, which is a Phase II/III study. In terms of antibody responses in older adults 

when compared to younger adults, the older adults have similar immune responses in terms of 

neutralizing antibody activity to the younger adults 18-55 years of age. These data were 

supportive in allowing AstraZeneca to move forward to older adult populations in its Phase III 

program12.

A key question for COVID-19 vaccine development regards whether vaccines causes antibodydependent enhancement (ADE). Pre-clinical animal studies demonstrated no evidence of ADE 

for AZD1222. From previous SARS-CoV-1 and other vaccines, it is known that Th2 polarization 

is associated with ADE. In terms of results from inter-cytokine staining to determine the cytokine 

profile of CD4 T-cells in vaccinated individuals, participants vaccinated with AZD1222 

demonstrated a Th1-baised T-cell response, with induction of interferon gamma (IFNγ), 

interleukin-2 (IL-2), and tumor necrosis factor (TNF) cytokines. Notably, Th2 cytokines were not 

detected. These are all spike-specific responses. These data were also supportive for moving 

into the Phase III study13.

AZD1222 was well-tolerated in Phase I/II studies. Most adverse events (AEs) were mild to 

moderate in severity and the majority resolved within 7 days. Local and systemic reactions were 

approximately 20% less frequent after the second dose. AEs were similar in nature to those 

previously reported for the viral vector platform and included injection site pain, feeling feverish, 

muscle ache, and headache. Local and systemic reactions were more common in participants 

given AZD1222 than the control vaccine (MenACWY). Less reactogenicity, both local and 

systemic, was observed in older adults. About 30% of participants >70 years of age 

experienced fewer mild/moderate local reactions than those <55 years of age. A similar trend 

was seen for systemic reactions when comparing those over 70 years of age to those less than 

55 years of age14.

11 Folegatti P et al. The Lancet. 2020

12 Ramasamy M et al. Lancet. 2020

13 Exploratory analysis; unpublished results

14 Ramasamy MN et al. Lancet. 2020. https://doi.org/10.1016/S0140-6736(20)32466-1. Accessed 

January 21, 2021
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In totality, the antibody responses observed, the Th1 cytokine profile, and the safety data were 

supportive in moving forward to the Phase III study in the US. Other data have been published 

in the Lancet and Nature that profiles the immunology of immune responses in the vaccinees in 

more detail.

The Phase III trial in the US, D8110C00001, was designed to evaluate the safety and efficacy of 

the vaccine in over 30,000 volunteers. The study began in August 2020. Volunteers were 

randomized 2:1 to receive either 2 doses of AZD1222 or a saline placebo control vaccine. This 

study is ongoing in 88 sites in the US, Chile, and Peru (Study NCT04516746; clinicaltrials.gov). 

Adults 18 years and older were included, with a target to include 25% of subjects above the age 

of 65 years. Study enrollment included diversity targets selected in agreement with the US 

Government (USG). It was very important to AstraZeneca to have a very diverse population 

represented in its Phase III study.

The primary efficacy endpoint is the first case of SARS‐CoV-2 reverse transcriptase polymerase 

chain reaction (RT-PCR)-positive symptomatic illness occurring more than 14 days postadministration of study intervention. Participants are included if they meet the following criteria 

at any point from Day 1 (initial visit) through Day 14:

Subjects will be counted as a case if they have: 1) One or more category A findings OR 2) Two or more category 

B symptoms

Specificity 

(Pathogen 

Confirmation)

Category A: Lower respiratory tract 

involvement (one or more)

Category B: Systemic/ other 

symptoms (two or more)

SARS-CoV-2 confirmed

• Positive RT-PCR

• Pneumonia diagnosed by chest x-ray, or 

CT scan 

• O2 sat of ≤ 94% on room air or 2 

percentage point drop from baseline

• New or worsening dyspnea/ shortness of 

breath

• Fever > 37.8 ̊ C (100 ̊ F) or 

feverishness

• New or worsening cough

• Myalgia/ muscle pain

• Fatigue that interferes with activities 

of daily living 

• Vomiting or diarrhea

• Anosmia or ageusia

The safety endpoint is occurrence of AEs for 28 days post-each dose and AE, medicallyattended adverse events (MAAEs), and adverse events of special interest (AESI) are assessed 

from Day 1 post-treatment throughout the study.

In terms of diversity targets and older adults, US enrollment includes 11.2% Hispanic/Latin, 

9.8% Black or African American, 5.3% Asian, 1.8% American Indian, 0.4% Hawaiian or Pacific 

Islander, and 71.5% White. Older adult enrollment came very close to the target of 25% over the 

age of 65 years, with about 23.6% 65+ years old and 76.4% <65 years old. The majority of 

participants (57.8%) had a comorbidity such as chronic kidney disease (CKD), chronic 

obstructive pulmonary disease (COPD), heart failure, coronary artery disease, diabetes, 

asthma, high blood pressure, liver disease, and/or body mass index (BMI) of 30 or higher to 

highlight a few. A total of 32,459 participants were enrolled, of whom 26,327 received a second 

dose by January 21, 2021.

There was a clinical hold during the course of study D8110C00001. The study was initiated on 

August 28, 2020. AstraZeneca paused the study on September 6, 2020 in response to an event 

of transverse myelitis that was reported in the Phase II/III study conducted by the University of 

Oxford in the UK. This was done out of an abundance of caution for the safety of participants in 

the study. During the clinical hold, AstraZeneca provided a lot of information to the FDA, 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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including additional details on neurological events in studies sponsored by AstraZeneca and the 

University of Oxford, as well as any analyses of available clinical safety data from AZD1222 and 

other ChAdOx-1 viral vector platform studies that were requested by the agency. A number of 

changes were implemented in the study conducted in response to the event. The risk language 

in the Informed Consent Form (ICF) and Investigator Brochure (IB) was updated and a number 

of protocol changes were made, including accelerated and increased safety reporting and the 

establishment of an independent expert neurology panel. Dr. Villafana emphasized that both for 

the US study and the studies conducted outside the US that were sponsored by the University 

of Oxford, there are DSMBs that review the safety information in these studies on an ongoing 

basis. The participant who experienced the event continues to recover and AstraZeneca 

continues to provide the FDA and other agencies with information requested regarding safety 

events that occur in these studies.

Regarding the non-IND Phase II/III program interim results for the outside US studies that were 

sponsored by the University of Oxford from a data cut on November 4th, the interim analysis was 

a pooled analysis across 4 ongoing studies. The analysis included 23,745 participants across 

these studies as follows: UK COV001 (N=1,077) Phase I/II single-blinded study of adults aged 

18–55 years, UK COV002 (N=12,390) Phase II/III single-blinded, ≥18 years (including elderly), 

Brazil COV003 (N=10,300), Phase III single-blinded, ≥18 years (including elderly), and S. Africa 

COV005 (N=2,070), and Phase I/II double-blinded, adults aged 18–65 years15. The primary 

endpoint of the study is nucleic acid amplification test (NAAT) positive for symptomatic COVID19. Prior to conducting any analyses, a global statistical analysis plan for pooling data across 

the studies was developed and discussed with regulators. Prespecified analyses that would 

contribute to assessment of efficacy were discussed and agreed upon. The population in the 

primary efficacy analysis included 11,636 participants from the UK/Brazil Phase III studies, 

which are the 2 studies that met the inclusion criteria for the interim analysis with 5 cases of 

COVID-19. A total of 23,745 participants were included in the safety analysis across all 4 

studies. The median for follow-up for post-Dose 1 was 105 days and for post-Dose 2 was 62 

days16.

In terms of the results for the Phase III interim efficacy analysis for AZD1222, the pooled 

analysis demonstrated 70.4% (95.8% CI: 54.8% to 80.6%) vaccine efficacy at preventing 

symptomatic COVID-19. The subgroup analysis with standard versus low dose of the vaccine 

demonstrated efficacy at preventing symptomatic COVID-19 of 62.1% (41.0% to 75.7%). There 

were no hospitalizations or severe COVID-19 in vaccinated participants from 21 days after the 

first dose. Across the 4 studies, the vaccine exhibited a favorable safety profile. SAEs occurred 

in 168 participants, 79 of whom received AZD1222 and 89 of whom received MenACWY or 

saline control. Among the 168 participants, there were 175 SAEs, of which 4 were considered 

possibly related to intervention of either the experimental vaccine or the control. In the AZD1222 

group, 1 of the SAEs was a case of pyrexia 2 days after Dose 1 that was treated with 

paracetamol and resolved the same day and the second was the case of transverse myelitis

that occurred 14 days after Dose 2. In the control group, there was 1 case of autoimmune 

hemolytic anemia 10 days after MenACWY and 1 case of transverse myelitis 2 months after the 

first control dose. The majority of SAEs resolved within a few days of vaccination. The 

reactogenicity profile was similar to the Phase I/II study conducted in the UK and were generally 

milder and reported less frequently after Dose 2 in older adults ≥65 years old15.

15 Voysey M, et al. Article and supplementary appendix. Lancet. 2020. http://dx.doi.org/10.1016/S0140-

6736(20)32661-1. Accessed January 21, 2021.

16 COVID-19 Vaccine AstraZeneca, solution for injection in multidose container COVID-19 Vaccine 

(ChAdOx1-S [recombinant]).
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Moving to vaccine storage and handling, the vaccine can be stored in the refrigerator at 2° to 

8°C. It has a shelf life of 6 months and cannot be frozen. In terms of administration, the vaccine 

will be provided as a multi-dose vial. After the first puncture, it can be stored up to 6 hours at 

room temperature or up to 48 hours at 2°-8°C, with a total storage time not to exceed 48 hours.

No dilution or reconstitution of the vaccine is needed.

In summary, AstraZeneca believes that AZD1222 offers a potential to address the global 

COVID-19 crisis. AZD1222 induces robust immune responses against the SARS-CoV-2 spike 

protein. Spike antibodies increased after a second dose with geometric mean titers (GMTs) 

comparable to convalescent sera. Neutralizing antibody titers were observed in all participants 

following Dose 2. There was a strong Th1-biased CD4+ T-cell response observed. A lot of 

immunology data have been published already on the vaccine. The US Phase III study is 

ongoing with 32,459 participants enrolled with co-morbidities, older adults, and people with 

diverse backgrounds. A total of 26,327 participants received a second dose by January 21, 

2021. Efficacy and safety were demonstrated in 4 Phase I-III studies in the UK, Brazil, and 

South Africa. AZD1222 has the potential to address the SARS-CoV-2 pandemic and has been 

authorized in 18 countries under emergency use or full approval as of January 25, 2021.

Discussion Points

Dr. Romero asked whether the vaccine’s effect has been assessed on the variants that have 

arisen and if the prevalence was known of the variants reported in the literature from South 

Africa and Brazil at the time of the study.

Dr. Villafana indicated that AstraZeneca is continuing work to understand the activity of 

AZD1222 against variants that are circulating in the places the studies are being conducted.

Dr. Pollard added that an analysis is currently underway for the UK B.1.1.7 variant that is 

assessing neutralizing antibody data, which is anticipated to be completed and submitted for 

publication in the next few days. Since the middle of December, that variant has been dominant 

in the UK since it spread so rapidly. Therefore, it should be possible to conduct an analysis on 

efficacy against that within a week. That is very much related to the ability to get sequence data. 

In parallel, they are looking at neutralizing activity against the South African variant. There is a 

possibility in the trial to look directly at efficacy against the South African variant, which has 

increased rapidly in the country since November. About 90% of the disease there is thought to 

be caused by the new variant. The trial site in Brazil is not directly around the epicenter for the 

origin of the Brazil variant, so it is not clear whether they will be able to make a direct comment 

about efficacy in Brazil. However, they are working with local teams on sequencing the virus 

from the individuals in the trials who have symptoms and are looking at neutralizing antibody 

against the virus. That will take a little longer because they are slightly behind on the 

sequencing.

In response to a question from Dr. Poehling regarding Th1 and Th2 responses, Dr. Kelly 

indicated that there were 70 participants all from the UK studies, COV001 and COV002. 

Approximately 40 subjects were between the ages of 18-64 years and 30 subjects over 65 

years of age. In that analysis, they looked at lineage markers (CD3, CD4, and CD8), functional 

markers (Th1 and Th2 cytokines), and additional phenotypic markers (CD69, CD28, CDR7, and 

CD45RA). There was strong induction of Th1 cytokines in those study participants after Dose 1. 

Those cytokines did not rise but remained elevated after Dose 2. No induction was seen of Th2 

cytokines.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Dr. Talbot inquired about the number of trial participants who have dropped out as they have 

become eligible for vaccine in the US and how that might impact data collection and duration of 

follow-up.

Dr. Gonzalaz-Lopez responded that 30,000 participants have already decided to stay in the 

study because they are susceptible to receive the vaccine in the US. This number is random 

and the potential impact on efficacy is going to be very limited because the efficacy is driven by 

the number of cases and they are very close to having the number of cases needed for the 

interim and primary analyses. If the number of cases continue to increase in the future, they 

probably will have to consider what will be the impact in the long-term safety follow-up. They are 

working on a potential plan for a safety follow-up system to guarantee they can keep as many 

participants in the study as possible.

Dr. Quach (NACI) requested information about whether there is a difference between the 

AstraZeneca vaccine and the one that is produced by the Serum Institute of India (SII), which 

seems to use the same platform, and whether they have any lot-to-lot comparisons of 

immunogenicity.

Dr. Villafana indicated that it is the same vaccine construct. AstraZeneca has a sublicense with 

the SII for them to manufacture the vaccine for India and for lower-middle income countries. The 

SII product is called COVISHIELDTM. A study was conducted in India that included 1600 

participants. Within that study, AZD1222 and COVISHIELDTM were included.

In terms of the neutralizing antibody, Dr. Long thought it seemed in the middle age group there 

was either no or very modest booster response from Dose 2. She also noted in the Lancet 

publication that there was an amendment to the protocol for the prophylactic use of paracetamol 

in some of the sites and that reactogenicity was less on the second dose, and she wondered if 

those were related. She also wondered if they assessed antibody responses in those who 

received paracetamol and those who did not. It is known that prophylactic acetaminophen in the 

US has been associated with diminished response to pneumococcal conjugate vaccine for 

instance. 

Dr. Villafana indicated that prophylactic use of paracetamol did not have any impact on 

immunogenicity in AstraZeneca’s studies.

Dr. Pollard added that they have seen consistently with the second dose of this viral vector that 

reactogenicity is lower, so they had a subgroup in which they tried the prophylactic paracetamol 

and saw that there was some impact, particularly on the more severe systemic reactogenicity. 

However, it is a modest effect so the subsequent studies have not had prophylactic 

paracetamol. It is just reactive in those who have symptoms.

Dr. Lee expressed gratitude for the investigation of the variants and how that might impact 

vaccine efficacy. Recognizing that this is a different platform from the mRNA vaccines, she 

requested comments on whether there were any severe allergic reactions, Bell’s Palsy, and 

pregnancies during the trial. If there have been pregnancies, she asked whether there is a 

registry and if the pregnancies are being followed.

Dr. Pollard noted that in the current trial of about 23,000, there are a lot of younger adults who 

are healthcare workers among whom there are a large number of pregnancies. They are being 

followed-up through the birth of the child. Because of the relatively short duration, they do not 

have the data yet. However, they are making good progress on that. It is a challenge to obtain 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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all of the sequence data from the various counties, so it make take some time before the final 

analysis is done. Dr. Lindgren added that in the University of Oxford studies, there were 3 

reports of Bell’s Palsy in the AZD1222 group and 3 in the control group. Regarding pregnancy, 

the pharmacovigilance plan calls for a pregnancy registry. In terms of severe allergic reactions, 

hypersensitivity was reported in the clinical trials. There were no reports of anaphylaxis in the 

clinical trials that could be seen as associated with the vaccine. As with any vaccine, with 

broader exposure, hypersensitivity reactions will be assessed through active surveillance postauthorization. Dr. Pollard added that from the ingredients that are in the vaccine, the only one 

that might be associated with that is polysorbate 80, which is a widely used product that is not 

particularly associated with anaphylaxis to his knowledges. It is one of the ingredients in the 

adjuvanted influenza vaccine, which does not have any excess rates of anaphylaxis associated 

with it.

Referring to Slide 15 with the racial and ethnic demographics, Dr. Kimberlin (AAP Redbook) 

requested clarification about the total number of US participants enrolled. Thinking about the 

global aspects for this particular product, he inquired as to whether there are pre-existing chimp 

adenovirus antibodies in different populations on different continents.

Dr. Villafana indicated that of the 32,459 total population enrolled in Study D8110C00001, about 

3600 were from Peru and Chile. Dr. Kelly added that there have been historic studies on the 

population from Gambia in which there was low existing immunity to the chimp adenovirus. In 

general, in populations in the Northern Hemisphere in many of their sites, they do not see preexisting immunity. Dr. Villafana added that in non-African populations, the seroprevalence is 

well under 10%. Dr. Pollard added that seroprevalence is low in all populations, but there is 

some variability. The key question regards whether that impacts on responses to spike protein. 

They have not seen any significant differences in responses in different countries in the immune 

response to spike protein. Indeed, there is no correlation after the second dose to the antivector neutralizing antibody that is induced and the response to spike protein.

Dr. Bell inquired as to whether AstraZeneca has been able to do any subgroup analyses they 

could share with ACIP either stratified by age, comorbidities, or racial/ethnic composition.

Dr. Villafana indicated that VE was about 73.4% in the comorbid population. For the interim 

analysis, they did not have a large number of older adults so the confidence intervals are wide. 

With subsequent analyses, they will be able to report out efficacy in the older adult population 

since there will be more older adults at that time.

Given that adenovirus platforms regardless of serotype can trigger innate immune responses,

Dr. Maldonado (AAP) asked about the potential for development of subsequent specific 

adaptive immunity to the adenovirus platform and the likelihood of that impacting booster 

responses over time.

Dr. Pollard responded that the fact that the data they have so far does not show a relationship 

between anti-vector immunity and the spike protein response after the second dose provides 

some reassurance. In the UK trial, there is a small subgroup who were in previous trials of the 

same viral vector who have been brought back and received 2 doses of the coronavirus vaccine 

with viral vector, so they will be able to answer that question very soon.

Dr. Maldonado (AAP) asked whether there was a possible explanation for the biological 

plausibility between the differential responses and efficacy between the 2 regimens, given that 

one is a low-dose standard versus the standard dose.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Referring to Slide 30, Dr Villafana indicated that within this study participants received 2 doses 

at varying intervals depending upon where they were located and enrolled in the study. 

Participants who received 2 of the standard doses or the low-dose/standard dose combination 

and interval was accounted for, the responses look very much the same. Therefore, they think 

that interval is probably associated with the increased efficacy being seen for the lowdose/standard dose group just because many of those participants were in the longer interval 

group.

Dr. Eckert (ACOG) asked how many pregnant women are included in the trial.

Dr. Lindgren indicated that in the dataset that was analyzed before Christmas, there were 21 

women who became pregnant during the trial who based on the exclusion criteria were not 

pregnant upon enrollment. The pregnancy registry is not yet up and running, but there is a 

commitment to establish this as quicky as possible. 

COVID-19 Epidemiology among Children

Angela Campbell, MD, MPH, FPIDS, FIDSA

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Campbell presented on COVID-19 in the US, COVID-19 epidemiology in children and teens, 

and Multisystem Inflammatory Syndrome in Children (MIS-C), which is a complication of SARSCoV-2 infection.

Beginning with the US COVID-19 epidemiology, from the CDC COVID Data Tracker as of 

January 24th, more than 24.8 million COVID-19 cases had been reported to CDC, with the most 

recent 7-day average of more than 168,000 cases per day and over 416,000 deaths, with a 7-

day moving average of 3,070 deaths per day17.

In terms of COVID-19 incidence per 100,000 population by age group, the reported incidence of 

COVID-19 cases is lowest for children 0-4 and 5-17 years. Multiple factors have contributed to 

under-detection of overall SARS-CoV-2 infections in children, including limitations in testing 

availability, assay sensitivity, testing and reporting practices, care seeking behaviors, and 

under-recognition of mild or asymptomatic infection18. Dr. Campbell’s colleagues at CDC have

published a statistical model, based on methods previously used to estimate the disease burden 

of influenza, to account for under-ascertainment and adjust nationally reported COVID-19 case 

counts to better reflect the true number of SARS-CoV-2 infections. Adjusting for under 

detection, estimated SARS-CoV-2 infection rates per 100,000 population are lowest in children 

0-4 years, but for children 5-17 years are basically the same as for adults19.

A study that evaluated SARS-CoV-2 seroprevalence in children <18 years, using residual serum 

samples from May to September, was performed by the University of Mississippi Medical Center

(UMMC) which provides clinical laboratory services for university hospitals statewide. Among 

the 1,603 people tested, the overall seroprevalence was 10.9%. Seropositivity was higher 

among non-White children. Specifically, seropositivity among Black, non-Hispanic, and Hispanic 

children was 2.4 and 4.3 times higher respectively than that among White non-Hispanic 

17 https://www.cdc.gov/covid-data-tracker/index.html#trends

18 https://www.cdc.gov/covid-data-tracker/index.html#demographics

19 https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burden.html
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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children. Seropositivity among children increased over time from 3.5% among samples collected 

in May of 2020 to 18.2% by September. These estimates help to track infections among 

children. In fact, compared with seroprevalence data from older age groups in Mississippi, data 

from this sample suggested that cumulative infection rates by mid-September among children 

were similar to those among adults 18–49 years, which was the age group with the highest 

seroprevalence20.

To gather data on susceptibility and understand the role of children in transmission, CDC is 

supporting a case-ascertained household transmission study with Vanderbilt University in 

Tennessee and Marshfield Clinic in Wisconsin. An initial analysis of the data was published in 

an MMWR. The data shown during this session included enrollments between the study start in 

April and November. In brief, index patients are enrolled from outpatient clinics if they have labconfirmed SARS-CoV-2, symptoms for <7 days, and live with at least 1 other person who has

not had acute illness in the past week. All enrolled index patients and their household members 

were followed for 14 days, with daily symptom reporting and self-collected nasal swabs to look 

for secondary transmission21.

Thus far the study sites have enrolled 147 index cases, who were enrolled a median of 3.5 days 

after illness onset, and 306 of their household contacts have been enrolled. The index patients 

are more middle-aged than the household contacts. In total, the sites have enrolled 22 index 

cases who are children and 118 household contacts who are children. For this analysis, Dr. 

Campbell showed only households that had co-primary cases and contacts who were likely 

tertiary cases were excluded. After these exclusions, 78 household contacts (49%) were 

positive for SARS-CoV-2 in follow-up. Among these 78 people with secondary infection, 

younger children <12 years, in general, were less likely to be symptomatic and had many fewer 

symptoms than adults. In terms of the secondary infection rates plotted by the age of the index 

case to help understand age-related differences in transmission from the index case, in general, 

symptomatic children in the top two age categories can transmit SARS-CoV-2. The sample size 

is most robust in the adults 18-49 years of age and there are overlapping confidence intervals 

around the estimated secondary infection rates, but in looking at the point estimates, 

symptomatic children seem to transmit SARS-Cov-2 less frequently than adults 18-49 years of 

age. Regarding the secondary infection rates by the age of the household contacts in order to 

look at how susceptible different age groups are to SARS-CoV-2 infection, children who were 

exposed in the household had a similar risk of secondary infection as adults22.

A similar study was conducted as a field investigation in Utah and Wisconsin earlier in the 

spring of 2020. These data are published in Pediatrics and they found that secondary infection 

rates were similar among pediatric and adult household contacts or, in other words, children 

were as susceptible to SARS-COV-2 infection as adults23.

Moving from an outpatient look at susceptibility and transmission to the hospital, based on data 

from the COVID-Net hospital surveillance system showing laboratory-confirmed COVID-19 

hospitalization rates per 100,000, children <18 years of age have the lowest cumulative rate of 

COVID-19 associated hospitalizations. Those are 35.4 and 21.2 per 100,000 for 0-4 and 5-17

20 C. Hobbs, et al. CDC COVID-19 Response Team, unpublished data

21 FLUTES-C Study. Grijalva, et al. MMWR 2020;69(44):1631-34

22 FLUTES-C Study. Preliminary data, subject to change

23 Laws RL, et al. Pediatrics. 2020; doi:10.1542/peds.2020-027268
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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years, respectively for simplicity compared with all people age 18 and older with a rate of 460.1 

per 100,00024.

Although children with COVID-19 may have mild or no symptoms, children can get severely ill 

from COVID-19. While there is still a lot to learn, children with certain underlying conditions may 

be more likely to have severe illness. These include asthma or chronic lung disease; diabetes; 

genetic, neurologic, or metabolic conditions; sickle cell disease; heart disease since birth; 

immunosuppression; medical complexity; and obesity25. Looking at further data from COVIDNET, 52% of Children <18 years of age hospitalized with COVID-19 had an underlying 

condition. Based on these data, the leading condition was obesity at between 35%-40% of the 

children. This is followed by asthma, and other chronic medical conditions. It is important to note 

that for influenza, the obesity proportion is more on the order of 9%-10% of hospitalized children 

with influenza. The leading underlying condition for influenza is generally asthma at about 15%-

20% of laboratory-confirmed influenza hospitalizations26. Additional data from COVID-NET show 

that children are about similarly likely to be admitted to the intensive care unit (ICU) at around 

30% of hospitalized children and adults. Children <18 years of age who are hospitalized with 

COVID-19 are less likely than adults to experience mechanical ventilation or in-hospital death27.

In terms of COVID-19 mortality rates, there is a 0.4-0.3 per 100,000 mortality rate for children, 

which increases significantly in older adults28.

Moving MIS-C, MIS-C is a severe inflammatory syndrome that was first recognized last April in 

the UK, occurring in children with current or recent infection with SARS-CoV-2. MIS-C is thought 

to result from delayed, dysregulated host immune response. It is generally delayed 3-4 weeks, 

but this can be a wider range of 2-6 weeks from preceding COVID-19 illness. Often, MIS-C 

occurs with no known preceding illness. By May of 2020, cases were reported in New York City 

and New York State. On May 14th, CDC issued a Health Advisory29 requesting healthcare 

providers to report patients <21 years of age meeting MIS-C criteria to local, state, or territorial 

health departments. This is the case definition:

An individual aged <21 years presenting with feveri, laboratory evidence of 

inflammationii, and evidence of clinically severe illness requiring hospitalization, with 

multisystem (>2) organ involvement (cardiac, renal, respiratory, hematologic, 

gastrointestinal, dermatologic or neurological); AND

No alternative plausible diagnoses; AND

Positive for current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen 

test; or exposure to a suspected or confirmed COVID-19 case within the 4 weeks prior to 

the onset of symptoms.

An MMWR published on August 14, 2020 reported results from a latent class analysis to identify 

similarities and group the first 570 MIS-C cases reported from March through July into distinct 

classes. Patients in Class 1 had a “typical” MIS-C picture in which 98% tested positive for 

SARS-CoV-2 by serology. All patients had cardiovascular and nearly all had gastrointestinal 

24 https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html

25 https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/children/symptoms.html

26 https://gis.cdc.gov/grasp/COVIDNet/COVID19_5.html

27 https://gis.cdc.gov/grasp/COVIDNet/COVID19_5.html

28 https://www.cdc.gov/covid-data-tracker/index.html#demographics

29 https://emergency.cdc.gov/han/2020/han00432.asp; https://www.cdc.gov/mis-c/hcp/
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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manifestations, often with a number of additional organ systems involved and markedly elevated 

laboratory values of inflammation and markers of cardiac damage. These patients had 

significantly higher frequencies of shock and myocarditis relative to the other two classes with a 

very high percentage of ICU admissions. Patients in Class 2 had more of an acute COVID19/MIS-C combination picture in that 100% tested positive by PCR and patients were 

significantly more likely to have to have respiratory involvement with cough, shortness of breath, 

pneumonia, and acute respiratory distress syndrome (ARDS). Patients in Class 3 were 

generally younger with a median age of 6 years compared with 9 and 10 year olds in the 

previous two classes. They had milder illness and relatively higher frequency of rash and 

mucocutaneous lesions, most similar to Kawasaki disease30.

The CDC MIS-C website shows the health department-reported cases. The most recent 

January update shows 1659 cases reported and 26 deaths from 47 states, New York City, and 

Washington, DC. The average age is 8 years, 57% are male, 33% are Hispanic/Latino, and 

30% Black, non-Hispanic persons. In terms of the epidemiologic curve of daily MIS-C cases, the 

first peak was from March to June, primarily in the Northeast. The second peak was from June

to September, largely in the South and to a lesser extent the Western US. These peaks followed 

the first two national COVID-19 peaks by 2-5 weeks. These patterns were consistent by US 

Census Region. The most recent third peak of the COVID-19 pandemic rose in December and 

into January in the US and may result in another MIS-C peak, although such an increase may 

not be apparent for several months because of the delay in the occurrence of MIS-C and 

additional delays associated with identification and reporting of cases. A surge is beginning to 

be observed in many states31.

Based on data in which CDC estimated the incidence of MIS-C cases from that first peak time 

period from April to June 2020 in 7 participating jurisdictions, the population-based incidence 

estimates using a denominator of population of persons <21 years were 1 to 8.5 MIS-C cases 

per million person-months across the jurisdictions. In addition to population-based incidence 

estimates, CDC estimated the incidence of MIS-C across groups using a denominator 

representing total SARS-CoV-2 infections in children, for which the incidence would be 

expected to be much higher than in the general population. CDC wanted to assess whether 

certain racial and ethnic groups may be disproportionately represented among MIS-C cases in 

these groups, even controlling for total SARS-CoV-2 infections, and found that indeed there is a 

6-fold higher incidence of MIS-C among Black/African American children relative to White 

children and a 4- and 3-fold higher incidence among Hispanic and Asian/PI children compared 

with White children32.

In summary, as of January 24th, over 24 million cases of COVID-19 and over 410,000 COVID19-associated deaths were reported in the US. Children <18 years have lower rates of COVID19 reported incidence, hospitalization, and mortality than adults. Children are susceptible to 

SARS-CoV-2, though younger children tended to have fewer respiratory symptoms than adults.

Symptomatic children can transmit SARS-CoV-2. MIS-C is a complication of COVID-19 and has 

varied clinical presentations. MIS-C is highest, and disproportionately so, among Black/African 

American children and Hispanic/Latino children. Further studies are needed to fully understand 

the role of children and teens in SARS-CoV-2 transmission and risk factors for severe illness 

and complications of COVID-19.

30 Godfred-Cato, et al. MMWR 3030;69:1074-80

31 https://www.cdc.gov/mis-c/cases/index.html; last updated January 8, 2021

32 A. Payne, et al, CDC COVID-19 Response Team, unpublished data
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Discussion Points

Dr. Poehling requested more details about the percentage of MIS-C cases that were Types 1, 2, 

and 3.

Dr. Campbell said that while she did not have the actual percentage, 570 total cases were 

included. Class 1 included 203, Class 2 had 169, and Class 3 had 198.

Dr. Romero inquired as to whether Dr. Campbell had any information on the impact of the 

variants that are being seen around the world on the number of cases and/or severity of MIS-C.

Dr. Campbell said that all she could say at this point is that they do not know, but are very 

interested in this question. There is no evidence to support this right now, but CDC is certainly 

concerned and is encouraging its partners to submit samples for surveillance MIS-C 

surveillance for SARS-CoV-2. There is enhanced surveillance now to which they can submit up 

to 20 additional samples for sequencing per week. There have been discussions with a couple 

of states about considering submitting additional samples for sequences if they think they are 

seeing something different. For example, one state was concerned that perhaps they were 

seeing more severe MIS-C. It is just not possible to figure that out right now because the 

expected surge following the rise in COVID-19 cases through the winter is being experienced 

right now.

Dr. Lee expressed appreciation for the deeper dive into understanding the epidemiology in 

children a little better. Regarding understanding the disproportionate burden of MIS-C in Black 

and Hispanic children accounting for two-thirds of cases, she wondered if there is any further 

exploration about whether there is biologic plausibility for that versus disparities in testing rates, 

particularly in communities of color. If the disparities in testing rates are impacting the 

denominator in terms of estimating the proportion of MIS-C cases by race/ethnicity, she 

wondered if perhaps that has an impact on under-ascertainment regarding the overall burden of 

infection.

Dr. Campbell said she thinks that the information on race/ethnicity is somewhat limited. For 

example, in the incidence study she showed, there was considerable missing data for 

race/ethnicity on many of the children, certainly for the reported cases and somewhat from the 

MIS-C. They are putting out an encouraging call for more complete race/ethnicity data. With 

respect to the under-ascertainment bias, she did not think the multipliers that take into account 

all of the different factors related to under-detection for the different races/ethnicities have been 

done yet. They suspect that there are multiple factors involved that are not all biologic by any 

means. The CDC analysis is not the only one that has found this, but if it is a testing bias, other 

analyses would show it also. Nevertheless, they are trying to get a finer level of detail. She is 

happy to follow-up more about what is being done to help get at under-ascertainment of various 

races and ethnicities.

Dr. Kimberlin (AAP Redbook) expressed gratitude of the expansion of focus at this appropriate 

time to be considering children and adolescents moving forward through this pandemic. 

Regarding the list of risk factors, the CDC website generally lists “Diabetes Type 2,” though Dr. 

Campbell’s slides focused on Diabetes. He wondered whether Type 1 diabetics could be 

considered to be at the same risk as Type 2 diabetics. With the potential to expand over the 

next several months to recommend COVID-19 vaccine to adolescents, down into children, and 

perhaps using a phased approach that could include risk factors, he thinks of Type 1 diabetes. 

He was concerned that the Type 2 listing of risk factors for COVID disease or severe COVID 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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disease is simply a bias that this is what most adults have. Perhaps the listing on the CDC 

website should simply be “Diabetes” instead of “Diabetes Type 2.”

Dr. Campbell said that she generally thinks of Type 1 more with regard to children. COVID-NET 

does not differentiate between Types 1 and 2 diabetes mellitus. Given that these are children, 

Type 1 is likely to be predominantly represented. There is a separate COVID-19 in children 

webpage where she got the list that she showed.

Dr. Oliver added that the general list with “Diabetes Type 2” is not managed by anybody on the 

Vaccine Task Force, but they will take this feedback back to the people who manage the list.

Dr. Long noted that they see children who are identified as having MIS-C but who are not sick 

enough to be treated for it who get better, and it is known that this virus causes a signature 

innate immune response. If they looked at Class 2 and applied the criteria to adults with COVIDlung disease, she wondered whether a considerable percent would have MIS-A. Regarding the 

epidemiology, as she looked at the MMWR in January of the trends in the latest surge, she 

observed that 14 to 17 year olds are as commonly affected as those over 65 years of age. She 

wondered if the data that showed 14 to 17 year olds included the latest surge in the younger 

population (Slide 35).

Dr. Campbell indicated that several of her colleagues are looking through adult charts with a 

general case definition searching for MIS-A and not necessarily excluding those with primarily 

respiratory involvement, but also looking for the multi-system involvement and other more 

classic features. It is harder in adults because there is so much more of the severe COVID 

spectrum. Cases of MIS-A have been reported in adult patients, but they are still in the 

information gathering stage about adults because there is certainly some aspects that seem 

quite classic, but then there is also the spectrum that is harder to tease out.

Referring to Slide 7, Dr. Campbell clarified that the COVID-19 cases went through January 24th, 

so it did include the latest surge. The younger section of that age group and the children 0 to 4 

years of age were under-tested early in the pandemic. To speculate, the bar for 14 to 17 year 

olds may be so low just because it had a long way to catch up, but they have certainly increased 

and essentially lead in percent positive now.

Dr. Maldonado (AAP) emphasized the importance of these data as their colleagues begin to dig 

into the different social and biological determinants of COVID disease for prevention and 

therapeutic interventions in these populations. She asked about the status of the MIS-C studies 

from the Request for Applications (RFA) released last year focused on more biological bases for 

MIS-C and in particular whether there are racial or ethnic differences in expressions of different 

biological markers for risk and evolution of this disease.

Dr. Campbell said that she did not want to speculate. They recently had MIS-C in a Broad 

Agency Announcement (BAA) topic list that went out. Those white papers are under review. In 

addition to national surveillance, one large system that she did not mention that is CDC-funded 

is the network called Overcoming COVID that initially was the Pediatric Acute Lung Injury and 

Sepsis Investigator’s (PALISI) Network then the Pediatric Intensive Care Influenza (PICFLU) 

Study, which basically is a pediatric ICU network that CDC already had been working with to 

assess severe influenza and vaccine effectiveness against severe influenza outcomes. That 

pivoted to include COVID and MIS-C surveillance and a number of scientific questions 

pertaining to COVID and MIS-C in children last year. CDC is still working closely with that 

network. NIH has a number of MIS-C focused studies that they published funding requests for 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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and have since awarded, such as the Pediatric Research Immune Network on SARS-CoV-2 

and MIS-C (PRISM), the Rapid Acceleration of Diagnostics (RADxSM) initiative, and Predicting 

Viral-Associated Inflammatory Disease Severity in Children with Laboratory Diagnostics and 

Artificial Intelligence (PreVAIL kIds). There is a lot going on in that sphere.

Dr. Romero noted that while there was a lot of focus on MIS-C, less than 5% of adults have 

freestanding myocarditis which has been seen in athletes. He asked whether there are any data 

on myocardial inflammatory disease in children as a freestanding condition not related to MIS-C. 

With enterovirus (EV), there is a syndrome of chronic debilitative cardiomyopathy that appears 

years after a primary infection, which can many times be asymptomatic. He wondered if they 

could see this in 5 to 10 years in young athletes who are developing myocardial disease 

isolated without MIS-C.

Dr. Campbell indicated that those data are coming from the Overcoming COVID-19 study. 

There is a paper under review comparing MIC to severe COVID-19 children who were 

hospitalized. They do have quite a bit of information on the cardiac outcomes in that manuscript. 

There is an entire Community of Practice at CDC devoted to long COVID-19 outcomes. While 

they do not want to lose sight of acute COVID and its complications, so they are thinking 

through these things.

COVID-19 Vaccines for Children 

Emily Erbelding, M.D., M.P.H.

Director, Division of Microbiology and Infectious Diseases

National Institute of Allergy and Infectious Diseases 

National Institutes of Health

Dr. Erbelding reported that the USG effort in vaccine trials that was previously called Operation 

Warp Speed (OWS) is in the process of transitioning to a different name. The goal of the OWS 

effort was to bring about SARS-CoV-2 vaccines for the whole of the US population. The USG is 

committed to providing the resources for vaccine trials in pregnant women and the pediatric

population. Under the framework of the USG effort, a company can elect to be the sponsor and 

most do. The protocols must be approved by USG partners, including the National Institute of 

Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development 

Authority (BARDA), and those on the protocol team. The protocol chairs include NIAID-funded 

investigators. The USG partners and company jointly oversee operationalization of the studies. 

A joint oversight team has been stood up to resolve any conflicts that might arise in the course 

of the protocol.

In terms of the rationale for conducting studies in pediatrics, the pediatric burden of disease is 

significant even though it is not as high as in adults and there is a disproportionate burden 

among children in minority communities. There are direct and indirect effects to children and all 

of society. This burden will continue if vaccination is not done and natural “herd” effects are 

waited for to occur over time. There are early data from the Moderna VRBPAC briefing package 

that suggests that the vaccines that we have might actually prevent asymptomatic carriage. If 

this can be done safely, it would reverse the pandemic more rapidly and be good for everyone. 

As far as clinical trials go, safety data do need to be collected and this is best done in clinical 

trial settings.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

24

A number of pediatricians months ago thought that this was a very important issue to begin to 

plan for as soon as possible. Anderson et al published a thought piece in Clinical Infectious 

Diseases (CID) and made the case for this based upon not even a full year of surveillance data 

in the US that the impact on the children, including the burden of hospitalizations and deaths in 

some cases, compared to other diseases for which childhood immunization is standard in the 

pediatric schedule33. Based on this and the thought pieces of others, the importance was 

realized of beginning to plan for pediatric trials even before adult efficacy trials could be 

completed.

NIAID asked a number of pediatric investigators and their colleagues in obstetrics and 

gynecology who had previously conducted vaccine studies to work off of pandemic 

preparedness protocols for influenza that were designed but not implemented in prior times of 

pandemic threat for influenza. They were asked to develop a shell protocol that would define 

approaches to age de-escalation and have healthy children for testing these vaccines and to 

have maternal protocols for immunization in pregnant women should those be required as 

vaccines were proven to be efficacious and rolled out.

This table depicts the status of the efficacy trials that initially were recruiting only adults and how 

the timeline in those products in the US might relate to clinical development plans for testing 

these vaccines in children:

The EUA for the Pfizer/BioNTech mRNA vaccine allowed for authorized use in individuals aged 

16 years and up because Pfizer amended their efficacy trial protocol to expand from age 18 and 

up down to age 12 and up. By the time that they applied for EUA, they had sufficient data in the 

age 16 and up category to have its use authorized in that age group. They announced the 

previous week that they have fully enrolled down to 12 years of age. In public statements, they 

have anticipated that this vaccine may be licensed for use down to 12 years of age sometime in 

the first half of 2021. It also has been publicly reported that they are planning studies in children 

under 12 years of age some time in 2021.

33 Anderson EJ, Campbell JD, Creech CB, Frenck R, Kamidani S, Munoz FM, Nachman S, Spearman P. 

Warp Speed for COVID-19 Vaccines: Why are Children Stuck in Neutral? Clin Infect Dis. 2020 Sep 

18:ciaa1425. doi: 10.1093/cid/ciaa1425. Epub ahead of print. PMID: 32945335; PMCID: PMC7543330.

 

 

 

mRNA encodes

stabilized spike lipid NP

mRNA encodes 2P 

stabilized spike lipid NP

Replication incompetent

Ad26 stabilized spike

Replication incompetent

ChAdO 1 chimp Ad 

wild type spike

 

 

IM 2 doses 30 g

21 days apart

IM 2 doses 100 g

28 days apart

IM 1 dose at 5 1010 vp

(also testing 2 doses (0,

56 days)

IM 2 doses at 5 1010

vp , (0, 28 days)

 EUA ages 16 and up EUA ages 18 and up Phase 3 adults Phase 3 adults

 Fully enrolled TeenCOVE Start 4 6wks after

results from adult trials

Begin Early 2021

 

 

Planning early 2021 Planning early 2021 Planning early 2021 Planning early 2021

 Platform used widely in

teens, infants, children

 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

25

The Moderna mRNA vaccine was authorized for use in those 18 years of age and up and they 

now have launched a standalone adolescent protocol that will recruit a cohort of ages 12 to 18 

years called TeenCOVE. They have announced that they are planning to begin studies in 

younger age groups sometime in early 2021.

The Janssen product is an Ad26 non-replicating viral platform that is being tested with 2 dosing 

schedules in efficacy studies. The schedule supported by the USG is a single dose and the one 

being supported by other sources that is recruiting globally is 2 sequential doses spread 56 

days apart. Both of those studies are in Phase III efficacy trials in the US and beyond. It has 

been announced publicly that there is an expectation for Janssen to announce the main results 

of their US-supported trial very soon. They also have announced publicly that they plant to start 

trials that would gather data for use in adolescents 12 to 17 years of age and younger age 

groups, which would be initiated 4 to 6 weeks after the results from their adult trials. It is worth 

noting that the Janssen Ad26 platform has already been used widely in infants, children, and 

teens. It is licensed for use by European Medicines Agency (EMA) for Ebola, so there is a lot of 

clinical experience and safety data related to this platform in younger age groups.

They heard earlier in the day about the AstraZeneca chimp Ad vaccine, which is a replication 

incompetent adenovirus vector vaccine. The efficacy trial is fully enrolled in the US and the 

company has plans to test the vaccine in adolescent trials and younger children. However, the 

details of those trials have not yet been announced.

In terms of additional products, Novavax is the fifth vaccine that is in efficacy trials in the US. It 

is currently about halfway enrolled. However, Dr. Eberlding did not have details on the 

company’s plans for conducting clinical trials in younger age populations at this time. Sanofi will 

probably be the next USG-supported vaccine to enter clinical trials sometime in early 2021.

To recapitulate the three approaches to getting a label indication for SARS-CoV-2 vaccination in 

younger age cohorts and the teenage cohort 12 to 17 years of age, there was the 

Pfizer/BioNTech approach that was to expand the eligibility in the adult efficacy trials down to 

younger ages while they were ongoing. It seems as though that approach was relatively 

efficient. Their vaccine was proven to be safe enough down to age 16 and now they are 

accruing more safety down to age 12. There is the approach that was chosen by Moderna, the 

TeenCOVE standalone trial for safety using the adult dose, which has been proven to be 

efficacious in the adult efficacy trial. Then there are other approaches to expand eligibility into 

lower age groups from Phase II trials that originally enrolled adult participants. The outcome 

measures of these would be immunogenicity and safety and they might explore different dosing 

schedules. In order for these perhaps to get regulatory approval, there may need to be a 

correlate of protection of efficacy from completed adult trials.

The TeenCOVE study, which focuses on the adolescent group, opened around December 8th or 

so and is currently recruiting. The target enrollment is 3000 teenagers with 2:1 randomization of 

active product to placebo given in 2 100μg doses spread 28 days apart that has been 

demonstrated to have efficacy and is authorized for use in adults in the US. That is one 

approach to a standalone teen protocol.

An example of a dose-ranging study that would occur in younger children uses an age deescalation approach with children divided into 3 age groups. The traditional divisions are 6 to 

<12 years of age, 2 to <6 years of age, and infants to <2 years of age. This is more complicated 

because there are 3 different cohorts. In some cases, the vaccine developers are testing 2 

different doses, with the idea being that many of these vaccines are relatively reactogenic in the 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

26

adult population and may be more so in younger age groups, and the immunogenicity and level 

of protection with lower doses might be very good in children. Full, half, and quarter doses will 

be considered by age group. The idea is that once a dose is identified that is safe and appears 

to be immunogenic, the study would move from a smaller sample size in the dose-finding and 

age de-escalation study to a safety and immunogenicity study over time. If the trials begin in 

early 2021, it is possible to infer when the results might become available in younger aged 

children based on the fact that typically these trials are designed to be 13 months long.

Discussion Points

Given the significant burden of MIS-C alone in pediatric disease, Dr. Romero inquired as to 

whether there is an effort as with the adult trials to ensure that there is a very robust inclusion of 

Latino, African American, and Asian children in these studies. In addition, he inquired as to 

whether children of African descent and Latino children experience similar incidence of MIS-C in 

countries outside of the US.

Dr. Erbelding emphasized that the trials funded by the USG certainly would try to help optimize 

recruitment strategies so that diverse populations would be well-represented. She said she did 

not know about the similarity of MIS-C among children inside versus outside the US.

Dr. Poehling expressed appreciation for the concept of the shell protocols. She recalled that in 

the prior presentation they saw that children with high-risk medical conditions had an increased 

incidence of severe disease for COVID-19 similar to that seen in adults. It appeared that the 

focus was on healthy children in the shell protocols for children and pregnant women, so she 

wondered if there would be an attempt to be diverse on the medical conditions as well.

Dr. Erbelding indicated that in the adult efficacy trials, recruitment targeted people at high-risk 

for poor outcomes of COVID illness and complications of COVID because they were all 

supposed to be powered to prevent disease not just prevent asymptomatic infection. Because 

children have a much lower rate overall of COVID illness, the focus would be on the safety 

profile of the vaccine. If the indication for a lower dose was part of the objective of the clinical 

development plan, immunogenicity would be the other outcome in some of these protocols. It 

would be important to have the children who are likely to get vaccinated when vaccines are 

allowed to be included in the clinical trials. The effort should be made to include ambulatory 

children who might represent the US population enrolling in these trials.

Dr. Hayes (ACNM) requested elucidation on what is occurring with OWS in terms of whether it 

is just changing its name or is changing its structure within NIH. In addition, she requested a 

presentation in the near future about what the protocol will be for enrolling pregnant women.

Dr. Erbelding clarified that NIH was a partner in what was formerly known as OWS along with 

the Department of Defense (DoD), BARDA, and CDC. The partnership remains intact and they 

still meet on a regular basis many times weekly to continue to move the vaccine development 

effort and therapeutics forward as fast as can possibly be done safely. All of that is the same, 

but the branding may be changing. In terms of a presentation on the protocol for pregnant 

women, ACIP could invite a representative of the protocol team to present on that as the 

planning evolves.

Dr. Cohn added that CDC would continue to keep ACIP and everyone listening informed on 

trials in pregnant women.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

27

Ms. Stinchfield (NAPNAP) expressed excitement about the forward path for children and 

vaccines. In terms of the age de-escalation studies, she requested information about what 

placebos will be considered.

Dr. Erbelding indicated that none of these trials have launched yet. The active vaccine to 

placebo ratio is usually 2:1 or 3:1. In the US, the control condition has not been proposed to be 

another vaccine such as tetanus or meningococcal. While she has not heard that being 

proposed as a control condition, but it would be a consideration if that is the best approach 

ethically. It also might be a true saline placebo.

Regarding the slide on label indication approaches for vaccination into teenage cohorts 12 to 17 

years of age, Dr. Kimberlin (AAP Redbook) observed that the third bullet was “to e pand age 

eligibility in Phase II trials for immunogenicity and safety and there was mention of a correlate of 

immune protection. He requested a status on where that stood if possible in the multitude of 

studies and data coming in, and whether they were closer to getting a correlate of protection in 

adults.

Dr. Erbelding clarified that that was from the outset when the government was planning these 

studies together with the companies. They knew that the correlates of protection would be a 

high priority. Identifying a correlate of protections usually requires breakthrough infections in the 

vaccine arm. The first two vaccines authorized for use, the mRNA vaccines, were so highly 

efficacious that there were very few vaccine breakthroughs. More data accrued because a lot of 

virus is being transmitted and there were a lot of COVID cases in the trial after the authorization 

was granted. Groups of laboratorians, biostatisticians, and the companies are actively engaged 

in identifying correlates of protection for the authorized vaccines. There are also non-human 

primate (NHP) studies underway with all of these vaccines that are in efficacy trials to determine 

whether correlates can be identified with breakthrough infections in those groups. That might 

actually provide more robust data once a correlate is identified or implicated in the efficacy trials 

in humans. If the correlate correlates with what was seen in NHP, then there would be even 

more validity in using that for a marker of protection moving forward into studies for licensure 

that might rely upon a correlate of protection. People are hopeful that a correlate of protection 

will be identified in the next month or two for these early authorized vaccines. The question 

remains whether it will be different for a different platform.

Dr. Maldonado (AAP) said she just learned that the MIS-C studies were just recently awarded 

and looks forward to hearing updates on them because they are biological correlates that 

potentially could be useful for understanding some correlates of protection as well. AAP is 

excited that the pediatric trials are moving forward and hopes that they will move forward 

quickly, efficiently, and safely. Some of AAP’s community partners, OB/GYNs particularly, have 

expressed concern about the potential ethical implications of enrolling pregnant women in a 

placebo-controlled trial when vaccines are already being given to pregnant women, especially in 

the healthcare Phase 1a sector. Perhaps it would be helpful to partner with ACOG and other 

groups to make sure that these trials are carefully spelled out and are ethical. There already is 

refusal among this important group to participate in trials.

Dr. Daley request further information about the steps involved in getting to authorization for 12 

to 15 year olds for Pfizer and 12 to 17 year olds for Moderna and the anticipated timing of that.

Dr. Erbelding indicated that Pfizer announced that it was fully enrolled down to age 12, so one 

could infer that they have had prior discussions with the FDA on what an adequate number 

would be and that they achieved enough enrollment to reach their objective, which is going to 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

28

get authorization down to that age group. It would depend upon what the required follow-up for 

safety would be and what Pfizer’s timeline is for moving forward to licensure. Based on what 

she has read in the newspaper, it is anticipated that vaccination might be an option for down to 

age 12 in the first half of 2021. The Moderna approach was to conduct a teen-specific trial, 

which also is open and enrolling. However, it is not fully enrolled so the timeline there would 

depend upon how quickly they can enroll and what they would view as a sufficient amount of 

safety data for that age group.

Dr. Fink (FDA) added that FDA is continuing to engage with individual vaccine manufacturers 

regarding the contours of their pediatric development programs, not just the studies that are 

currently underway. Some of the issues being considered include the number of subjects in 

certain pediatric age groups that would support an acceptable safety database or a regulatory 

decision that might first involve EUA, and then with some longer-term follow-up be supportive of 

biologic licensure. They also are continuing to discuss the immune marker parameters that 

would support bridging of effectiveness from the adult population into pediatric age groups. 

Certainly if there were to be an immune marker scientifically established to predict protection 

against COVID-19, that would make the job easier. However, the absence of such an 

established marker is not necessarily prohibited. There is regulatory experience with 

immunobinding approaches in situations where there is no immune marker that is established to 

predict protection. Although there are a variety of considerations that make it more or less easy 

to navigate such an approach, including a safe dosing regimen as was evaluated in the adult 

efficacy population, and also whether there is reason to believe that the parameters of the 

immune response in the pediatric age group would be similar to that in adults or different, and 

that in the adolescent group there is a high degree of confidence with the immune response 

parameters would be similar to those in younger adults.

Introduction of the New CDC Director

Rochelle P. Walensky, MD, MPH

Director, Centers for Disease Control and Prevention

Administrator, Agency for Toxic Substances and Disease Registry

Dr. Walensky thanked Dr. Cohn and ACIP for the invitation to address the committee. She said 

she is very proud to serve as the new CDC Director and is grateful to be part of the incredible 

CDC community. She recognized the critical importance of immunization practices. While CDC 

and ACIP have doubled down during COVID-19, she also recognized that their work is critical 

not only during times of COVID-19, but also in terms of childhood and adult immunization 

practices overall. She is happy to have ACIP as the advising body for CDC guidelines and 

recommendations, and recognized the very important and independent role that the committee 

plays in the review of safety and efficacy data prior to recommending vaccines to the American 

public. She also recognized the enormous dedication that this represents on the part of all of the 

ACIP members. The timely assessment of safety data and detailed plans for real-world 

effectiveness being discussed during ACIP meetings are really value-added for CDC and are 

critical to what ACIP provides. Everyone recognizes that this is a dynamic process and that as 

more is learned, implementations and recommendations may change as the vaccines are used 

to their maximize benefits. She especially thanked ACIP for its commitment to this process and

for the members’ ability and scientific expertise to deliberate on all of this in real-time and in a 

systemic way. Dr. Walensky highlighted the importance of health equity in all CDC discussions 

and recommendations. She realizes that there is a huge amount of work ahead to communicate 

the effectiveness and safety of vaccines—not just for COVID-19, but vaccines for all Americans 

and to support immunization as part of the COVID-19 pandemic response. She looks forward to 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

29

learning more from ACIP as they continue to deliberate new vaccines that are on the horizon. 

She e pressed appreciation for ACIP’s work to date. Until about a month ago, she was a 

practicing infectious disease physician who has relied on ACIP throughout her career and is 

proud to call many of the ACIP members colleagues and friends. She expressed gratitude for 

the opportunity to address ACIP and recognized that this was a newly planned meeting and that 

everyone had put in an extraordinary amount of time and energy throughout their careers and 

over this last year especially in thinking about vaccine safety and effectiveness, and probably 

would have a lot more of that to come as new vaccines emerge. She thanked ACIP for all that 

they offer to CDC and to the American public.

On behalf of the ACIP voting members, ex officio members, and liaisons, Dr. Romero welcomed 

Dr. Walensky and said that they were happy to hear that ACIP’s work is recognized and is 

beneficial in advising CDC. ACIP looks forward to working with Dr. Walensky and providing her 

recommendations into the future. Dr. Romero thanked Dr. Walensky for taking time out of a very 

busy schedule to address the committee. 

Vaccine Safety Technical Subgroup (VaST) Introduction

Grace M. Lee, MD MPH

VaST Co-Chair

Associate Chief Medical Officer for Practice Innovation

L k ’ H 

Professor of Pediatrics, Stanford University School of Medicine

Dr. Lee thanked Dr. Walensky for her leadership and emphasized that ACIP is very much 

looking forward to collaborating with her moving forward. During this session, Dr. Lee provided 

an update on behalf of the Vaccine Safety Technical Subgroup (VaST) group, which includes 

her Co-Chair, Dr. Bob Hopkins who is the current Chair of the National Vaccine Advisory 

Committee (NVAC).

As a reminder, the objectives of the COVID-19 VaST Subgroup are to: 1) review, evaluate, and 

interpret post-authorization/approval COVID-19 vaccine safety data; 2) serve as the central hub 

for technical subject matter expertise from federal agencies conducting postauthorization/approval safety monitoring; 3) advise on analyses, interpretation, and data 

presentation; 4) provide updates to the ACIP COVID-19 Vaccines WG and the ACIP on COVID19 vaccine safety; and 5) ensure independence, transparency, and public accountability for 

COVID-19 vaccine safety monitoring. The composition of the VaST Subgroup includes Dr. Lee 

from ACIP, Dr. Hopkins from NVAC, members from ACIP and NVAC serving as independent 

expert consultants, 2 CDC Co-Leads (Drs. Lauri Markowitz and Melinda Wharton), and 8 ACIP 

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

providing critical expertise through their work and surveillance systems.

In the pre-authorization phase from June to October 2020, VaST met 10 times to prepare for

COVID-19 vaccine safety surveillance. In November, VaST transitioned its membership to the 

current Vaccine Safety Data Review Group focused on reviewing the safety data. Between 

November and mid-December 2020, they had 4 meetings to review the methods for vaccine 

safety monitoring and to finalize VaST procedures. As a reminder, the ACIP voted to 

recommend use of the Pfizer/BioNTech vaccine on December 12, 2020. On December 14, 

2020, the very first dose of COVID-19 vaccine was administered in the US. On December 19, 

2020, the ACIP voted to recommend use of the Moderna vaccine. On December 21, 2020, 

VaST convened its first call to review the safety data exactly one week after the start of vaccine 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

30

administration in the US. From December 21, 2020 to the present, VaST has had 6 meetings to 

review the post-authorization data—just 6 weeks into the vaccination program in the US.

At this point in the vaccination program, VaST has been primarily reviewing information from VSAFESM, the VA Adverse Drug Event Reporting System (VA ADERS), which feeds into the 

national Vaccine Adverse Event Reporting System (VAERS) data bases and the Clinical 

Immunization Safety Assessment (CISA) system. VaST is just beginning to see some very early 

data from the two systems that have population-based data available.

As a brief description of its process, VaST is currently conducting a weekly review of available 

data on vaccine administration and AESI. VaST believes in a model of shared learning with 

regard to safety. All members, federal partners, and subject matter experts (SMEs) are present 

for presentation of data from multiple systems. In order to ensure independence, VaST 

members also have a separate session to discuss the findings independently. Finally, VaST 

provides a summary and interpretation of the aggregate data to the ACIP Secretariat on a 

regular basis and is committed to ensuring ongoing and regular communication with ACIP 

COVID-19 Vaccines WG and the ACIP in its open public meetings.

In closing, Dr. Lee expressed gratitude to the VaST members, CDC Co-Leads, and ACIP Ex 

Officio and Liaison Representatives. All of these individuals have gone above and beyond in 

dedicating their time and expertise to support the vaccine safety system in the US since day 1 of 

the vaccination program. 

COVID-19 Vaccine Safety Update

Tom Shimabukuro, MD, MPH, MBA

CDC COVID-19 Vaccine Task Force 

Vaccine Safety Team

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

Dr. Shimabukuro provided an update pm v-safeSM, VAERS, CISA, VSD, anaphylaxis following 

COVID-19 vaccination, and reports of deaths and mortality following COVID-19 vaccination. 

As a reminder, v-safeSM is CDC’s smartphone-based text to web survey monitoring system. For 

the data presented during this session, Dr. Shimabukuro focused on Week 1, Days 0 to 7, when 

daily check-ins are done and questions are asked about reactogenicity and a health impact 

assessment is conducted. After the first week, weekly check-ins and health impact assessments 

are done for up to 6 weeks and then at 3, 6, and 12 months. A VAERS customer service 

representative conducts active telephone follow-up on any medically-attended health impact 

events identified by participants during a check-in and takes a report if appropriate. As of 

1/20/21, about 21.8 million people had received 1 or more doses in the US. Of the registrants 

completing at least 1 v-safeSM health check-in, just under 1 million received the Pfizer-BioNTech 

vaccine and just over 1 million received the Moderna vaccine. To date, just over 15,000 

pregnancies have been reported to v-safeSM. Individuals have been enrolled into the v-safeSM

pregnancy registry, and not all of these 15,000 are actually pregnancy reports. People do make 

mistakes on the smartphone, so there are some males or individuals who are out of the age 

group. That is just one of the limitations of the system.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

31

In terms of the reactogenicity that enrolled individuals are reporting in Days 0-7 for all vaccines 

combined, pain is a commonly reported reaction as are systemic reactions such as fatigue, 

headache, myalgia, chills, fever, swelling, joint pain, nausea. The reactogenicity profiles for 

Dose 1 are very similar for the Pfizer-BioNTech vaccine versus Dose 1 of the Moderna vaccine. 

Pain and other systemic reactions are commonly reported at similar proportions for both 

vaccines.

Because Pfizer-BioNTech began earlier and the doses are 21 days apart, there are meaningful 

Dose 2 data only for that vaccine at this point. Comparing Doses 1 and 2 for the PfizerBioNTech vaccine, substantially more reactogenicity is being reported after Dose 2 from 2-fold 

to 3-fold higher. If the data are broken down further, it is primarily on Day 1 of the 0-7 

observation period. That is consistent with what was observed during the clinical trials in that 

there was more reactogenicity reported after Dose 2. Follow-up phone calls are ongoing to vsafeSM participants who report medically-attended health impact events. The pregnancy registry

had enrolled 227 pregnancies as of January 22, 2021.

As a reminder, VAERS is the nation’s early warning system for vaccine safety. It is a 

spontaneous reporting or passive system that is co-managed by the CDC and FDA. The 

strengths of VAERS is that it can rapidly detect safety signals and rare AEs. The main limitation 

for VAERS is that it is not designed to assess causality. However, VAERS accepts all reports 

from anyone regardless of the plausibility of the vaccine causing the event or the clinical 

seriousness of the event. As a hypothesis-generating system, VAERS identifies potential 

vaccine safety concerns that can be studied in more robust data systems if necessary.

In terms of a general breakdown of the reports in VAERS for the two vaccines, there are 

substantially more Pfizer-BioNTech reports than Moderna and a difference in the serious versus 

non-serious. This is thought to be an artifact of report processing times in that the PfizerBioNTech came out earlier and that as more reports continue to accrue, the focus is on 

processing, reviewing, and coding of the serious reports initially. Looking at the total of the two 

combined, about 90% are non-serious AEs. The median age is 43 years and there are about 

77% females, which likely represents the demographics of the healthcare workforce. In general, 

there are more female reporters in VAERS than males. The reporting rates for non-serious AEs 

are 372 per million doses administered and serious AEs are 45 per million doses administered. 

These are comparable to what is observed to other vaccines that are given to adults. Looking at 

the specific AEs being reported for the two vaccines, systemic and injection site reactions are 

the most commonly reported AEs. These are not mutually exclusive, meaning that an individual 

can have more than one AE in a single report. The AE profiles for the reporting to VAERS are 

remarkably similar for both Pfizer-BioNTech and Moderna vaccines.

CDC’s colleagues at FDA conduct empirical Bayesian data mining in VAERS. FDA uses data 

mining to identify disproportional AEs reporting for vaccines, including COVID-19 vaccines. This 

identifies, with a high degree of confidence, AE-vaccine pairs reported at least twice as

frequently as expected for a COVID-19 vaccine compared to the VAERS database. That means 

that the lower bound of the 90% confidence interval surrounding the empirical Bayesian

geometric mean, EB05, is 2 or more compared to all other US-licensed vaccines. No empirical 

Bayesian data mining alerts (EB05 ≥2) were detected for any AE-COVID-19 vaccine pairs as of 

the January 22, 2021 weekly results.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

32

The CISA project, is a collaboration between CDC and 7 medical research centers with vaccine 

safety experts34. CISA has implemented Project COVIDvax, which is an extension of the CISA 

Project’s clinical consultation service for US healthcare providers and health departments for 

complex COVID-19 vaccine safety questions/issues that are about an individual patients

residing in the US that are not readily addressed by CDC or ACIP guidelines. The CISA Project 

has vaccine safety SMEs with expertise in multiple specialties and sub-specialties (e.g., 

infectious diseases, allergy/immunology, neurology, OB/GYN, pediatrics, geriatrics). Requests 

for a CISA consult about COVID-19 vaccine safety can be made by contacting CDC-INFO: 800-

CDC-INFO (800-232-4636) or webform and indicating that the request is for a “CDC CISA” 

consult. No patient identifiers should be included35.

As of January 24, 2021, CISA has responded to 143 clinical inquiries or consultation requests 

about COVID-19 vaccine safety. Many of these have been about allergic reactions and 

anaphylaxis or about individuals who might be at high-risk for AEs. They also have assisted 

state health departments with evaluation of complex medical issues pertaining to COVID-19 

vaccines safety. They convened a CISA Project WG with allergy and immunology specialists

who provided input for CDC’s guidance on clinical considerations for use of the mRNA COVID19 vaccines and how to prepare for managing anaphylaxis after vaccination. They also have 

contributed to MMWR publications on anaphylaxis and allergic reactions after Dose 1 of both 

the Pfizer-BioNTech and Moderna COVID-19 vaccines. The CISA Project also is engaged in 

ongoing work to investigate possible mechanism for anaphylaxis in collaboration with FDA, NIH,

and other partners.

The VSD is a collaboration between CDC and 9 participating integrated healthcare 

organizations with data on over 12 million persons per year. The VSD has electronic health 

record (EHR) and administrative data on immunization records, encounters with the healthcare 

system, birth and death certificate information, and demographics all linked by unique study IDs. 

The VSD also has access to charts and EHR for review of cases if necessary to confirm incident 

cases. The VSD Rapid Cycle Analysis (RCA) aims are to: 1) monitor the safety of COVID-19 

vaccines weekly using pre-specified outcomes of interest among VSD members; 2) assess 

each pre-specified outcome for a 1-21 and 1-42 day risk interval; and 3) describe the uptake of 

COVID-19 vaccines over time among eligible VSD members. The 1-21 day risk interval is 

largely based on the dosing interval for the Pfizer-BioNTech vaccine, which has a 

recommendation to obtain Dose 2 within 3 weeks. The 1-42 risk interval is the more traditional 

window used for vaccine safety.

As of January 16, 2021, the total number of the two vaccines combined were 162,575 doses 

administered of Dose 1 and 34,182 doses administered of Dose 2. Substantial vaccine is 

anticipated in the VSD population once the immunization program moves to more broad-based 

administration to begin vaccinating the general population. This graphic breaks down the 

number of doses through this time period by age group:

34 http://www.cdc.gov/vaccinesafety/Activities/CISA.html

35 https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

33

The smaller numbers in the 65- to 84-year-old and 85+ age groups likely represents the VSD 

vaccinating a lot of healthcare workers, many of whom fall into the 18 to 49 year old age group.

In terms of the preliminary results of the VSD unvaccinated concurrent comparator analyses for 

COVID-19 vaccine safety, 22 outcomes are being monitored. The type of analysis that is being 

done right now, the unvaccinated concurrent comparator analyses, allows CDC to get the 

quickest data. Other analyses will come online fairly shortly. The signal is currently based on a 

rate ratio and the p-value. For a lot of the 22 outcomes, there have been no events in the 

vaccinated individuals so an analysis cannot be done. For the ones that can be analyzed, there 

have been no signals as of January 16, 2021.

In terms of the next steps for the VSD RCA, the vaccinated concurrent comparator analysis will 

begin when informative comparator follow-up data are available. These data are expected to be 

available within a week or so. Dose 1 and Dose 2 analyses will be performed for each vaccine

with both the 1-21- and 1-42-day risk intervals. A historical comparator analysis will come online 

around mid-March 2021 and will assess general age comparable background rates and rates 

following well care visits among those who received influenza vaccine in the past 18 months.

Suspected anaphylaxis reports to VAERS through the analytic period January 18, 2021 were 

detected through early screening to identify suspected anaphylaxis reports prior to formal 

processing and Medical Dictionary for Regulatory Activities (MedDRA) coding, and also were 

detected through a MedDRA code search strategy after formal processing and coding. This is 

like a Venn diagram. There are two categories of reports and for most of these two methods, 

there is overlap. CDC has reported all of the reports captured through both of these methods. 

The suspected anaphylaxis reports were assessed by physicians at CDC who conducted 

medical record review and additional follow-up as necessary by contacting the treating 

physician, the healthcare facility where they were treated, and in some cases the patients 

themselves—many of whom were healthcare providers. These cases were classified according 

to the Brighton Collaboration case definition criteria. Brighton Levels 1, 2, and 3 are considered 

cases, with 1 being the highest level of diagnostic certainty. Cases classified as 4 and 5 are 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

34

considered not to be cases. CDC and FDA met daily to discuss and further adjudicate cases if 

necessary36.

In terms of the characteristics of the confirmed cases through January 18th, there were 50 cases 

for the Pfizer-BioNTech vaccine and 21 cases for the Moderna vaccine that met the Brighton 

criteria. The median age and range were very similar between the two vaccines, which might be 

expected given that this was during a time when basically Phase 1a groups were being targeted 

and included a large number of healthcare workers. There is a strong female predominance for 

both vaccines, with 94% of the cases for Pfizer-BioNTech and 100 % of the cases for Moderna 

being female. Just over 60% of the initial doses have been administered in women. Prior 

surveillance reviews in VAERS of anaphylaxis also have noticed this female predominance at 

as high as 80% on a previous review that examined mostly influenza vaccine. These cases 

tended to occur quickly after vaccination, with a median onset of 10 minutes for both vaccines. 

The overwhelming majority had symptom onset within 15 minutes and 90% for both had onset 

within 30 minutes. High percentages of cases for both of the vaccines had documented histories 

of common allergies and allergic reactions, including to drugs and foods. A substantial 

percentage had a history of prior anaphylaxis cases following drugs, foods, contrast media, 

vaccines, insect stings, and unspecified sources in some cases. Most of the cases for both 

vaccines occurred after Dose 1, which likely represents where we are in the immunization 

program. There were a handful of Dose 2 anaphylaxis cases as well.

Based on updated vaccine doses administered counts and updated anaphylaxis cases, with 

approximately 9.9 million doses of Pfizer-BioNTech vaccine and 7.5 million doses of Moderna 

vaccine administered through the analytic period, CDC estimates a reporting rate of 5.0 per 

million doses for Pfizer-BioNTech doses administered and 2.8 per million for Moderna doses 

administered. The previously reported rate for the Pfizer-BioNTech vaccine was 11.1 per million 

doses administered (Dec 14-Dec 23)37 and 2.5 per million doses administered for Moderna (Dec 

21-Jan 10)

38. The rate for the Pfizer-BioNTech vaccine has come down substantially and the 

rate for the Moderna vaccine has remained about the same as more information has continued 

to be gathered.

Upon receipt or notification of a reported death after COVID-19 vaccine, the VAERS contractor

expedites processing of the report the day of report, contacts the reporter for additional 

information (e.g., medical records, death certificate, autopsy report, et cetera), notifies the state 

Vaccine Safety Coordinator (VSC) of the death, and provides a copy of the initial report to the 

VSC via Epi-X. Physicians in CDC’s Immunization Safety Office (ISO) and at FDA review all 

reports of deaths following COVID-19 vaccination as soon as notified in the daily VAERS priority 

report and make an assessment if any immediate action is necessary. Attempts, multiple if 

necessary, are made to obtain death certificates and autopsy reports when an autopsy is 

conducted to ascertain the cause of death (COD). Through January 18th, there have been 196 

reports to VAERS of deaths due to any cause following COVID-19 vaccination. The median age 

is 79 (25–104), 22% of the 196 deaths were in individuals less than 65 years of age, 66% of the 

reports were in LTCF residents, and 113 were reported following receipt the Pfizer-BioNTech 

vaccine and 83 following receipt of the Moderna vaccine. These reports to VAERS involve 

36 Rüggeberg et al.; Brighton Collaboration Anaphylaxis Working Group. Anaphylaxis: case definition and 

guidelines for data collection, analysis, and presentation of immunization safety data. Vaccine. 

2007;25(31):5675-84.

37 https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm

38 https://www.cdc.gov/mmwr/volumes/70/wr/mm7004e1.htm
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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temporally associated deaths following vaccination due to any cause. AE reports to VAERS, 

including deaths, should not be assumed to be causally related to vaccination.

Focusing first on reports of death, it is important to know about background mortality in general 

to put the reports into perspective. Focusing on LTCF, it is estimated that about 2 million 

COVID-19 vaccine doses have been administered in LTCFs through January 18, 2021 based 

on the CDC COVID Data Tracker. Based on National Healthcare Safety Network (NHSN) data, 

it is assumed that 65% of dose were administered to LTCF residents and that about a third were 

administered to employees. That is about 1.3 million residents vaccinated during the analytic 

period. A 22% annual mortality rate (n = 286,000) is assumed based on published literature39. 

The risk period assumes that December 21st was when vaccinations commenced in LTCFs. 

Therefore, the risk period is 29 days (December 21-January 18). Because some people could 

have 1 day of risk and others could have 29 days of risk, the difference was split to assume that 

each resident contributed 14.5 person-days or the approximate mid-point of the risk period. The 

14.5 days equates to 4% of a calendar year.

Among the 1.3 million LTCF residents (2 million x 65%) vaccinated over the 29-day risk period

of December 21-January 18th, about 11,440 deaths would be expected among LTCF residents 

following vaccination due to chance alone due to natural causes/background all-cause mortality 

rate in this population. By comparison, VAERS has received 129 reports of deaths following 

COVID-19 vaccination in LTCF residents through January 18, 2021. Mortality in LTCF residents 

is high and substantial numbers of deaths in this population will occur following vaccination as 

temporally-associated coincidental events.

Dr. Shimabukuro discussed some additional analyses from CDC’s colleagues at Brown 

University using the Genesis Healthcare data. Genesis Healthcare is the largest nursing home 

company in the US, spanning 24 states. The analysis included 284 Skilled Nursing Facilities 

(SNF) with about 25,000 residents. COVID-19 vaccination began in these facilities on 

December 18, 2021. By December 31st, the first dose of vaccine was administered in 118 

facilities among 7006 residents (61.4% in those facilities). The Brown University investigators 

assessed 7-day mortality rates among the vaccinated and unvaccinated residents in these 118 

facilities as well as 17,076 residents in the 166 facilities that started vaccinating after January 1, 

2021. After excluding residents with a positive SARS-CoV-2 diagnostic test within 20 days prior 

to their 7-day observation window, mortality was lower among vaccinated versus unvaccinated 

residents within the same facilities and compared to residents in not-yet-vaccinated facilities, 

with overlapping 95% confidence intervals. The findings suggest that short-term mortality rates 

appear unrelated to vaccination for COVID-19 in SNF residents. This study underscores the 

value of having an analytic infrastructure to support near real-time monitoring of AEs and safety 

during rapid vaccine deployment in this vulnerable population40.

As mentioned earlier, there were 129 reports of deaths following COVID-19 vaccination in LTCF 

residents based on VAERS data through January 18th. The median age was 84 years and about 

half of these were female. About a third of these reported deaths involved individuals in hospice 

or who had Do Not Resuscitate (DNR) or Do Not Intubate (DNI) status. Very few of these were 

autopsy cases (n=2). Death certificates were available for 18 cases. A death certificate was 

unavailable or autopsy results were pending for 112 cases. The initial assessment indicated that 

many case reports documented ill health and a history of multiple co-morbidities and common 

39 Thomas et al, J Gerontol A Biol Sci Med Sci, 2019, Vol. 74, 219–225

40 Presented on behalf of: Barbara Bardenheier, PhD, MPH, MA; Assistant Professor of Health Services, 

Policy, and Practice; Assistant Professor of Epidemiology; Brown University School of Public Health
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

36

age-related diseases (e.g., heart disease, type 2 diabetes, dementia, et cetera). The causes of 

death from the death certificates in the 18 individuals for whom death certificates were available 

are shown in the following table:

Cause of Death From the Death Certificate

Hypertension, leading to acute myocardial infarction, leading to anoxic brain injury

Atherosclerotic cardiovascular disease, acute myocardial infarction

Arteriosclerotic Disease

Cardiac arrest, cardiopulmonary arrest

Acute congestive heart failure, non-ischemic cardiomyopathy

Congestive heart failure, non-ischemic cardiomyopathy

Congestive heart failure

Congestive heart failure

Heart failure, hypertension

End stage chronic obstructive pulmonary disease

Acute kidney failure, resulting from acute liver failure, resulting from liver masses

Hypertension, hypothyroidism, bipolar disorder, peripheral vascular disease

Pneumonia, cardiac arrest and shock

Aspiration, frontotemporal dementia

Hypertension, mi ed Alzheimer’s and vascular dementia

Dementia

Chronic alcohol abuse and severe malnutrition, alcohol withdrawal, electrolyte derangement, 

ventricular arrhythmia, cardiogenic shock

Failure to thrive

The overall impression on deaths and mortality in LTCF residents following COVID-19 

vaccination is that mortality in LTCF residents is high due to the underlying health status of the 

LTCF resident population. The available evidence from VAERS monitoring and Genesis 

population-based surveillance does not suggest a safety problem with respect to deaths in older 

adults residing in LTCFs. Case reports of deaths in LTCF residents following COVID-19 

vaccination to VAERS include many persons such as those with multiple co-morbidities, 

including some with cognitive impairment, those in ill health and in declining states of health, 

and those in hospice or DNR or DNI status. Deaths in LTCF residents following COVID-19 

vaccination are consistent with expected all-cause mortality in this population. CDC’s findings 

are consistent with the findings of the World Health Organization (WHO) Global Advisory 

Committee on Vaccine Safety (GACVS) COVID-19 Vaccine Safety Subcommittee that the data 

do not suggest any unexpected or any untoward increases in fatalities in frail elderly individuals 

and that the causes of death were consistent with expected numbers of all-cause mortality in 

this population41.

There have been reports of deaths following COVID-19 vaccination in community-dwelling 

adults aged <65 years. The background rate of sudden cardiac death among communitydwelling individuals is 29.6 per 100,000 person-years. This estimate is based on a study by 

Tseng et al that looked at out-of-hospital cardiac arrest in people 18–90 years of age in San 

Francisco County. The study inclusion criteria were sudden unexpected death either within 1 

hour of symptom onset for witnessed events, or within 24 hours of having been observed alive 

and symptom free for unwitnessed events. Exclusions criteria included subjects with 

41 https://www.who.int/news/item/22-01-2021-gacvs-review-deaths-pfizer-biontech-covid-19-vaccinebnt162b2
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

37

chronic/terminal illness in which imminent death was not unexpected; hospice residents; 

subjects with identifiable non-cardiac etiology of death at presentation, including drug 

abuse/overdose, trauma, homicide, or suicide; and subjects with hospital admission within the 

prior 30 days for noncardiac illness or surgical procedure42.

Using similar calculations to assess the number of individuals vaccinated, the risk period, and 

calculated person years, CDC calculated an expected number of sudden cardiac deaths of 168 

in the 13.7 million community residents estimated to have been vaccinated between December 

14, 2020 –January 18, 2021 based on the CDC COVID Data Tracker. The risk period was 35 

days, it was assumed that each resident contributes 15 person-days (~ mid-point of risk period, 

adjusted downward to account for Moderna not used until December 21), and total person-years 

contributed of 566,650 ([13.7million*15 days]/365.25). Based on these calculations, the 

expected sudden cardiac death count was 168 deaths. The sudden cardiac death count 

reported to VAERS following COVID vaccination was 18, or substantially more expected than 

reported to VAERS.

In the VAERS database through January 18th, there are 28 reports of deaths following COVID19 vaccination in community-dwelling adults less than 65 years of age. The median age in these 

reports is 54 years (range 25–63) and the median time from vaccination to death is 5 days 

(range day of vaccination to 25 days after). Death certificates and autopsy reports are available 

for 11 of these deaths. There is 1 completed autopsy and 4 pending. This table lists the causes 

of deaths following COVID-19 vaccination in the community dwelling adults aged <65 years with 

death certificate or autopsy report available: 

Cause of Death from Death Certificate or Autopsy Report

Atherosclerotic cardiovascular disease

Atherosclerotic cardiovascular heart disease, hypertension

Cardiac arrest, COVID-19

Cardiac arrest, hypertension, morbid obesity

Cardiopulmonary arrest, hypertensive heart disease, hypertension, DM type II

Hypertensive cardiovascular disease

Myocardial infarction, ventricular fibrillation

Drug overdose

Pulmonary hemorrhage from squamous cell cancer of the lung

Subarachnoid hemorrhage, intraparenchymal hemorrhage, intraventricular hemorrhage

COVID-19 stroke, COVID-19 acute respiratory failure

In summary, 23.5 million COVID-19 vaccine doses have been administered in the US as of 

January 26, 2020. During this time, the US government has implemented the most intense and 

comprehensive vaccine safety monitoring program in history. Overall, the safety profiles of 

COVID-19 vaccines are reassuring and consistent with that observed from the pre-authorization 

clinical trials. Though rarely, anaphylaxis has been observed following mRNA COVID-19 

vaccines. The data do not suggest a signal with respect to overall safety or deaths following 

vaccination in older adult residents of LTCFs. Additional population-based monitoring systems 

will continue to gather safety data as vaccination increases and the immunization program 

broadens, including CDC’s VSD, FDA monitoring in CMS data, and VA EHR data.

42 Tseng et al, Circulation. 2018;137:2689–2700
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

38

VaST Assessment of Safety Data

Grace M. Lee, MD MPH

VaST Co-Chair

Associate Chief Medical Officer for Practice Innovation

L k ’ H 

Professor of Pediatrics, Stanford University School of Medicine

Dr. Lee reported that VaST believes that these well-established vaccine safety surveillance 

systems remain the cornerstone of COVID-19 vaccine safety monitoring in the US. In addition, 

novel approaches to surveillance such as v-safesm have enriched the understanding of COVID19 vaccine safety in the early phases of vaccine deployment. As mentioned earlier, VaST meets 

weekly to review all available data and to ensure a coordinated approach across multiple safety 

surveillance systems.

Consistent with previously published clinical trial data, local and systemic reactions are 

commonly reported following vaccination in v-safesm and VAERS. This appears to be 

qualitatively similar at this point for both the Pfizer-BioNTech and Moderna vaccines. During the 

early phases of the US vaccination program, particularly in first few months, reliance is primarily 

on data reported to VAERS. However, the limitations of these data are that they are numerator 

only data, they are descriptive in nature, and they are subject to reporting bias. As the COVID19 vaccination program matures, it will be possible to rely more on the data from populationbased surveillance systems (e.g., VSD, CMS, Genesis) to understand the risk of AESIs 

following vaccination. These systems have both numerator and denominator data in a welldefined population and comparison groups are available to ensure that there is a good 

contextual understanding of the benefit-risk balance.

Anaphylaxis following COVID-19 vaccination is being closely monitored. The estimated rates 

currently range from 2.8 to 5.0 per million doses using Brighton Collaboration criteria. In 

response, CDC has recommended risk mitigation strategies, including screening for risk prior to 

vaccination, monitoring for symptoms post-vaccination, and early recognition and management 

of anaphylaxis on-site. In addition, provider and patient education is ongoing by CDC and 

partners.

As an example of the timeliness of the response to potential vaccine safety signals, federal 

safety colleagues published the available data on allergic reactions following the PfizerBioNTech vaccine on 6 January43, the Moderna vaccine on 22 January44, and a clinical update 

in the Journal of the American Medical Association (JAMA) on 21 January45. In addition, 

anaphylaxis has been a topic of discussion during ACIP meetings, on COCA calls, and on other 

calls with broad clinical audiences to ensure that vaccines are being safely delivered to patients 

and the public. CDC has developed a pre-vaccination checklist that incorporates questions 

43 Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 

Vaccine — United States, December 14–23, 2020. MMWR Morb Mortal Wkly Rep 2021;70:46–51. DOI: 

http://dx.doi.org/10.15585/mmwr.mm7002e1

44 Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine 

— United States, December 21, 2020–January 10, 2021. MMWR Morb Mortal Wkly Rep 2021;70:125–

129. DOI: http://dx.doi.org/10.15585/mmwr.mm7004e1external icon

45 Shimabukuro T, Nair N. Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of 

Pfizer-BioNTech COVID-19 Vaccine. JAMA. Published online January 21, 2021. 

doi:10.1001/jama.2021.0600
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

39

about prior known history of severe allergic reactions46. Clinical guidance documents are 

continually and in real-time updated to ensure that individuals who are at risk for an allergic 

reaction are monitored for 30 minutes post-vaccination47, and that all vaccination sites are 

prepared to diagnosis and manage severe allergic reactions on site48. Over the course of the 

past 6 weeks, it is clear to see that safety systems are working quickly to ensure a timely 

response.

Serious AEs following COVID-19 vaccination are being closely monitored. Data in the US and 

Europe suggest that case reports of deaths are consistent with all-cause mortality rates, 

particularly in frail, elderly individuals. It is important to remember that COVID-19 vaccines are 

designed to prevent COVID-19-related mortality, but not mortality due to other causes. It is 

anticipated that additional vaccine safety surveillance systems will begin reporting data as a 

larger proportion of the US population begins to be vaccinated. VaST will continue to update the 

ACIP COVID-19 Vaccines WG, the ACIP Secretariat, and the ACIP on a regular basis.

Discussion Points (Lee & Shimabukuro)

Dr. Ault inquired as to when the pregnancy data generated from v-safesm, VAERS, and VSD are 

anticipated to be assessed.

Dr. Shimabukuro indicated that VAERS data are being reviewed as they come in. Limited data 

are available at this point, but they would be happy to present those data during a future ACIP 

meeting. For the v-safesm, they are in the process of enrolling individuals into the pregnancy 

registry and hope to begin assessing those data pretty quickly. There would be an opportunity to 

present those data during a future ACIP meeting as well. A couple of surveillance projects are 

planned in the VSD. Once they feel that there are sufficient data to present meaningful results, 

they will be happy to present that information to the ACIP. 

Dr. Chen noted that there was recent updated guidance about severe but non-anaphylaxis 

reactions. Some of his colleagues in the allergy and immunology community have mentioned 

desensitization protocol guidelines or something like that to offer further guidance for these nonanaphylaxis events. He wondered whether there is any movement within the safety group to 

discussion some of these approaches or if any of these events were Brighton Classification 

Level 4 or 5.

In terms of the allergic reactions that were in the publications, Dr. Shimabukuro said that they 

cast a very wide net to look for any allergic reactions that were severe or suggestive of 

anaphylaxis and then reviewed those. These basically fell into 3 categories. Either they were 

anaphylaxis according to the Brighton, or they did not meet Brighton criteria but were judged to 

be allergic reactions, or they were judged to be non-allergic reactions like vasovagal anxietyrelated reactions.

Dr. Goldman (ACP) emphasized that it is incumbent upon those who are vaccinating patients to 

stress to them and make them well aware of the potential reactions. He personally experienced 

fever and chills after the second dose and they were quite severe. They must make patients 

aware of it so they will return for their second dose. He wondered if patients who experienced 

46 https://www.cdc.gov/vaccines/covid-19/downloads/pre-vaccination-screening-form.pdf

47 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html

48 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/testing-after-allergic-reaction.html
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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reactogenicity or anaphylaxis had been assessed for having previously had COVID-19 infection 

and received the vaccine.

Dr. Shimabukuro said that while they did not specifically assess this, that information may be 

captured in the VAERS reports. Anecdotally, they have heard about previous infection and the 

possibility of more severe reactogenicity when getting a dose of COVID-19 vaccine. Options are 

being explored to use the v-safesm data to determine whether it is possible to further investigate 

that potential safety issue. There are limited data on that now, they are looking at ways to obtain 

better information on that.

Dr. Sanchez said that he too has heard a lot of anecdotes about people who have had COVID19 previously who are having reactions to the vaccine that are worse than the original infection. 

It is very important to be able to capture that in v-safesm. In addition, he inquired as to whether 

breastfeeding mothers and infant outcomes would be assessed in the pregnancy registry in 

terms of women who were vaccinated while breastfeeding. In terms of reactogenicity being 

reported out to 7 days, it was reported in the New England Journal of Medicine (NEJM) that 

erythema and swelling has been noted 7 to 14 days out.

Dr. Shimabukuro said that recognizing the concern about prior infection, they are exploring 

some options for conducting a nested study within v-safesm to further assess that issue. In terms 

of maternal safety activities, the v-safesm pregnancy registry is enrolling women through the 

duration of their pregnancies and then following the infants out for 3 months, so there will be 

information on infant outcomes. Regarding erythema and swelling, he believes there are ways 

to get at AEs beyond the 7-day period and into the 7- to 14-day window in v-safesm.

Dr. O’Leary (PIDS) asked whether there have been any reports of any MIS-like syndromes in 

younger adults, and if CDC is monitoring vaccination in patients with so-called “long COVID” 

with persistent symptoms long after an initial COVID infection.

Dr. Shimabukuro indicated that MIS-C and MIS-A are AESIs that are being monitored in VAERS 

and the VSD and that he was not aware of any reports of MIS-A in younger adults to date that 

met the case definition. The “long COVID” individuals would be captured in VAERS, provided 

that the past medical history was documented. There is information about COVID infection in 

VSD. While this may not have been incorporated specifically into the monitoring, it is certainly 

something that could be considered in the future more as a research project.

Knowing that these data are early and the risk estimates continue to change as more data come 

in, Dr. Drees (SHEA) wondered what criteria would need to be met to cease the 

recommendation for 15 minutes of monitoring post-vaccination, particularly among those without 

a known allergy history. The risk for anaphylaxis seems exceptionally low and as vaccination is 

expanded and high throughput events are being planned, a limiting factor is often finding space 

for people to hang out following vaccination, as well as the need for additional clinical staff to 

perform the monitoring.

Dr. Shimabukuro said he thought there were sufficient data to say that anaphylaxis can occur 

following mRNA vaccines. Anaphylaxis can occur following any vaccine. As far as adjusting the 

post-vaccination observation period, he deferred to those who developed the clinical guidance 

on if and when that would be warranted.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

41

Dr. Daley emphasized that the presentations by Drs. Lee and Shimabukuro were important 

reminders to them all that vaccine safety knowledge certainly would evolve over time. It is 

important to keep in mind that as Dr. Shimabukuro described, this is the most intense and 

comprehensive vaccine undertaking ever by the USG. This also seems to be the timeliest safety 

evaluation, given that this has all occurred in just the last 5 or 6 weeks. It is very fortunate to 

have such well-established systems in place and to have been able to add new systems like vsafesm. These safety data are critical for public confidence and clinical considerations around 

vaccination, so it is reassuring to know what careful attention is being paid to vaccine safety. 

COVID-19 Vaccine Implementation

Amanda Cohn, MD

CAPT, U.S. Public Health Service

Lead, Vaccine Planning Unit

COVID-19 Response

Centers for Disease Control and Prevention

Dr. Cohn provided a high-level update on the status of vaccine administration. As of January 25, 

2021, there are 11 states that report being in Phase 1a, 38 states that report being in Phase 1b, 

and 2 states that report being in Phase 1c. The Kaiser Family Foundation (KFF) publishes a 

report that updates this regularly and also talks about variation between the different phases, 

including age group and differences in essential worker populations. That is very helpful in 

terms of getting a sense of all the different things that the states are doing49.

The ACIP prioritization recommendations are intended as a framework to support equitable and 

efficient administration of COVID-19 vaccine and jurisdictional flexibility. As discussed during 

multiple other ACIP meetings, it is not necessary to complete one phase before expanding to 

the next group. Jurisdictions should start to move into other age groups as, for example,

demand starts to decrease in persons aged greater than 75 years. A critical part of this is to use 

all available doses and to minimize waste, even if that means giving doses to somebody who 

may not be in an eligible group at that moment. However, a key principle is to continue to offer 

vaccine to persons in earlier phases—even if they refused vaccine the first time they were

offered.

CDC is committed to transparency on vaccine administration data. Vaccine administration is 

getting to somewhat of a steadier state with vaccine ramping up and with reporting. On 

February 1, 2021, CDC will be publishing two MMWRs showing early administration data in 

LTCFs and general demographic characteristics of the early groups who have been vaccinated. 

Vaccines have been shipped to over 18,000 providers. It is important to understand that these 

vaccines require larger minimal doses of 100 doses for Moderna and over 950 doses for Pfizer. 

This results in high inventory when doses are received. For example, if a vaccination site 

receives 100 doses of Pfizer vaccine once or twice a week, there will always be days when they 

are reporting a large amount of inventory. Social distancing requirements reduce throughput 

and necessitates scheduling of vaccine appointments and an increased workforce to manage 

the need to watch patients in a socially distanced way for 15 minutes after vaccination and other 

requirements of remaining socially distanced. Finally, it is important to understand that doses 

administered per day increased, especially after the holidays, which means an increased

number of doses now at 3 to 4 weeks later are being assigned to be administered as second 

doses.

49 https://www.kff.org/other/state-indicator/state-COVID-19-vaccine-priority-populations/
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Overall COVID-19 vaccine distribution and initiation are posted on CDC’s COVID Data Tracker. 

In the very near future, CDC will be increasing the amount of data that can be shown in the

COVID Data Tracker. As of January 26, 2021, over 44 million doses of vaccines have been 

distributed. “Doses distributed” means that this number of doses have been received by the 

jurisdictions. “Doses administered” refers to the number of vaccine doses that have been 

reported to have gotten into arms. The total doses administered is over 23 million. This includes 

nearly 20 million persons receiving one or more doses and nearly 3.5 million people who are 

fully vaccinated with two doses. As expected, Pfizer vaccine was being administered slightly 

earlier, but both products are now being used broadly50.

In terms of the total number of doses administered by date of administration, it is important to 

note that it takes time for vaccines to be reported. Doses are administered and then have to be 

entered through a reporting system. Since early January, over 1 million doses of vaccine have 

been administered most days of the week. The Saturday number of doses administered 

declines, and the Sunday doses administered is extremely low and continues to be low. 

However, in the last week after Martin Luther King Day on January 18th, over 1.2 million doses

were administered per day over several days51. 

Through the Federal Pharmacy Partnership for Long-Term Care (LTC) Vaccination Program, 

over 2.7 million doses have been administered overall. Over 2.4 million people have received 

one dose and just under 250,000 have received both doses. Over 1.2 million residents of LTCFs 

have been vaccinated and over 800,000 staff have been vaccinated. These LTCF clinics and 

LTCFs are reporting low vaccine uptake and vaccine hesitancy among LTCF staff, especially in 

some states. Vaccination clinics will go to the LTCFs 3 times. Early information is showing that 

when the clinics return for the second or third time, additional staff are accepting vaccine. 

Therefore, continuing to capture those staff who do not accept vaccine early will be really 

important in terms of eliminating outbreaks and protecting both staff and residents in LTCFs.

There are a lot of questions about why it appears that more doses are being distributed 

compared to the number of doses administered. A couple of reasons for this are time from 

administration to reporting and inventory being resupplied on a regular basis. However, there is 

clearly a need to improve efficiency of vaccination at administration sites. It is important to 

ensure the demonstration sites can handle the supply they have and better match demand to 

where supply is. CDC is working with jurisdiction and administration sites to improve throughput 

at sites through workflow and additional staffing, improve scheduling, better match of supply to 

throughput capabilities, improve vaccine supply and demand mismatch, and share best 

practices from states that are doing this well. This sounds super straightforward and incredibly 

rational, but it is it takes a very large amount of work.

In conclusion, unprecedented roll-out of a new vaccination program has reached nearly 20 

million people over a short period of time during a surge in the epidemic. However, supply 

continues to be a rate-limiting factor. While everything possible can be done to increase 

efficiency and get doses into arms more rapidly, there is likely to be limited supply for the near 

future. As vaccination expands and vaccine uptake continues to increase, it is important to focus 

on rapidly administering doses and reducing bottlenecks in the system. These bottlenecks can

occur anywhere in the system from manufacturing, to shipping, to distribution, to administration. 

No person should be left behind. It is important to continue to focus on equitable access, even

50 https://covid.cdc.gov/covid-data-tracker

51 Data Source: IIS, Federal Pharmacy Program, Federal Entities Program
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

43

with the focus on vaccinating as many people as rapidly as possible. This means it will be 

necessary to reduce barriers to vaccination and increase engagement to build trust in

communities. Particular communities of concern in terms of access and demand include 

essential worker populations, homebound adults, and persons with disabilities. It is much easier 

to communicate and get older adults vaccinated than it is essential workers, so vaccinating 

essential workers is going to require an incredible amount of work. Many persons with 

disabilities will not be able to go to vaccination clinics that are currently available, so it will be 

important to find ways to vaccinate in people’s homes or to set up designated spaces that can 

vaccinate persons with disabilities. CDC continues to focus efforts on increasing demand, but 

also bringing vaccinations to racial and ethnic minority communities. Access and building trust 

are both needed, so it is critical to continue to listen to and engage with these communities. 

Vaccinating the country will take all of society working together and requires persistence, 

engagement, and community. 

In closing, Dr. Cohn called upon all who were listening to this meeting to take action and do 

something to support the vaccination program, whether it is checking in with neighbors who may 

be eligible for vaccine and driving them to their appointment or working with a community to set 

up a vaccination clinic in a school or church. This takes more than a village. It takes an entire 

country and it will be a lot of work, but vaccination remains one of the best ways to end this 

pandemic and get life back to normal.

Discussion Points

Dr. Duchin (NACCHO) expressed gratitude for the update and the tremendous work that CDC is 

doing to support states, and emphasized how gratifying it was to hear President Biden

acknowledging that the unpredictable supply of vaccine and the inability to forecast from week 

to week is a major barrier for getting vaccines into the communities and the eligible populations 

at the local level throughout the country. He requested additional information about the vaccine 

supply in terms of what states can expect and how the inability to forecast can be overcome. He 

heard the President say that more reliable information and predictable data would be provided.

Dr. Cohn stressed that one of the more challenging barriers is not knowing the prediction and 

being able to predict and forecast out supplies so that people know when they'll be getting 

doses and can schedule more than just a couple of weeks out. The question about resolving

this issue is being worked on currently. There was additional discussion about that on a White 

House briefing earlier in the day. They are trying to understand the data better and work with 

companies to have a better sense of forecasting and to increase the supply to jurisdictions when 

possible. It is important to be careful not to increase supply so much that it is too close to the 

edge of supply management. While she did not have specifics on ways that is being managed, 

she is hoping to get more details in the coming days. That will be a collaborative process with 

HHS, CDC, and the White House Task Force to resolve this.

Dr. Duchin (NACCHO) asked whether CDC would be providing any guidance to states about 

how to manage the second dose issues. Initially those doses were being reserved, so there was 

no need to do anything special to ensure that everyone who got a first dose would be

guaranteed a second dose. At this point, that is no longer being done so he wondered if CDC 

would be recommending strategies to ensure that second doses are received and administered 

on time. 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

44

Dr. Cohn clarified that second doses are still being allocated when the initial doses are 

allocated. Second doses are made available 3 or 4 weeks out depending on the product. This is 

being managed to ensure that there is a second dose for everyone who gets the first dose. It is 

not being held back in that inventory is not being held back, but inventory is being prioritized and 

directed through the supply management system to ensure that there are second doses 

available.

Dr. Romero thanked CDC for being very flexible in allowing states to use vaccine that was 

dedicated to LTCFs where that dosing was over-calculated. In his state, the formula used to 

calculate the amount of doses given for the LTCFs provided extra doses that were sitting there 

and they were able to reach out to CDC to have that moved out of the category and used in the 

community. There still is a deficit in the ability to reach out to communities that are linguistically 

challenged or have cultural differences that need to be addressed. He stressed that this is very 

important as they begin the move out of the Phase 1a groups and into Phased 1b and 1c. They 

must continue to focus on that and provide guidance and materials for the states in order to 

forward on that.

In terms of equity and allocating doses, Ms. Bahta expressed concern that speed is being 

pushed over equity. Based on working specifically with African American and Latino 

communities and liaisons from the health department, there is a lot of hesitancy that is due to 

historical trauma, past injustices by public health and the healthcare system, and current 

injustices that are occurring. There needs to be a lot more conversation at both the local and 

national levels in order to give people the information they need to make the best decision for

vaccination. In her state, those who are 65 and older are starting to get the vaccine but they

consist of 97% white individuals. So, this vaccine is not getting into the communities that have 

been the most severely impacted by COVID-19. While she heard the commitment in the 

presentation, it is important to keep acting as well.

Dr. Cohn stressed that the CDC and USG approach is to not leave anyone behind and continue 

to focus on equity while expanding vaccination into new populations, They are monitoring this 

very closely and will be reviewing the data as it comes in on race and ethnicity to ensure that. 

They are also looking at the data to help jurisdictions identify which parts geographically of their 

state may be getting under-served either because of access or because of hesitancy, so looking 

at distribution compared to uptake in socially vulnerable communities, rural communities, and 

other places. In response to the comments about racial and ethnic minority communities and the 

large amount of vaccine hesitancy in those communities, one of the key things that CDC thinks 

is critical is to engage national and local Black organizational partners, such as 

BlackDoctors.org, the National Medical Association (NMA), the National Black Nurses 

Association (NBNA), organizations that support Latina communities, and many others to give 

them what they need to talk to and engage and vaccinate their communities. It is important for 

jurisdictions to work with these organizations that really understand the challenges that their 

communities face, and for CDC to do this at a national level. The agency will be laser-focused 

on this in the coming weeks.

Dr. Sonja Hutchins (NMA) indicated that she is a Professor in the Department of Community 

Health and Preventive Medicine at Morehouse School of Medicine and a retired Captain in the 

United States Public Health Service (USPHS) where she spent her entire 30-year career at 

CDC working on vaccines, prevention of vaccine-preventable diseases, and emergency public 

health preparedness and response, particularly as it related to vulnerable populations. As a 

member of the NMA and also someone who has a lot of experience in working with the most 

vulnerable populations in our society, NMA has been working on hesitancy from the very 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

45

beginning of the pandemic as the oldest and largest organization of African American 

physicians. They have had webinars as early as the end of March and throughout the year and 

set up a COVID-19 Task Force that has been meeting with the manufacturers, CDC, and other 

organizations to combat the hesitancy problem. It was gratifying for her to hear of the robust 

vaccine safety monitoring, because that really helps communities better understand the safety 

of the vaccines and that goes a long way in promoting confidence in the vaccinations. They are 

also concerned about the administration of the vaccine in their communities and know that there 

are supply issues that need to be overcome so that the vaccine is equitably administered in the 

underserved populations throughout the country. The NMA spoke with CDC the previous week 

about that, shared some ideas, and are continuing to work on distribution and administration of 

vaccines in the communities where people are accepting the vaccines. The NMA is very hopeful 

that they will continue to work together with CDC and other partners to reach the most 

vulnerable sectors and communities and the nation.

Dr. Goldman (ACP) expressed concern that while many of his colleagues want to be able to 

provide the vaccine, have access to communities, but are being denied the ability to do that. 

Plus, it is known that on a state-by-state level each Governor can choose to follow the 

guidelines or not. Many Governors are completely ignoring the CDC’s Ethical Framework and

healthcare workers on the frontline and essential workers are being denied the ability to get a 

vaccine in favor of different guidelines being enacted. With that and the unethical occurrences of 

those with a lot of money donating to facilities and getting vaccinated above and beyond those 

who should get it first based on the Ethical Framework, he wondered whether CDC anticipated 

any stronger federal involvement or a more national strategy to take over in some of the states 

that are not quite following an ethical framework so that they can ensure equity and actual 

vaccine distribution in a more fair manner for some of the states that are not following the 

framework. For example, firefighters are eligible but policemen and teachers are not allowed to 

get vaccines.

Dr. Cohn said that incorporating primary care physicians to be vaccinators and administrators of 

COVID-19 vaccine is something CDC would really like to do in the near future as supply 

increases enough. She thinks there are ways that they can do it in a limited way so that 

providers who serve large portions of the population or can act as vaccinators for other 

practices. There are a lot of challenges right now with the limited number of doses and the high

minimal requirement to order. There are groups of people that they need primary care doctors to 

vaccinate and many people still will want to wait to get vaccinated at their primary care doctors, 

or someplace that an individual recognizes as a provider. CDC is absolutely thinking about 

several ways that they can support jurisdictions to get vaccine distributed and administered 

equitably and efficiently. There are lots of reports about certain administration sites and 

locations where individuals who are not eligible for vaccination are getting vaccinated. They do 

not want to be so rigid that doses are wasted, but they do believe that for any vaccination there 

should be provider fairness. Fairness should be a critical factor. CDC’s preference would be for 

pharmacies and other organizations that are vaccinating to have wait lists of people who are 

eligible for vaccine. Most organizations are doing this. They are just hearing the stories of some 

places. From a federal perspective, CDC is there to support the jurisdictions and anticipate 

continuing to provide them guidance as needed, but primarily around improving their programs. 

ACIP has made the recommendations and provided a framework for people to use, but 

jurisdictions do have flexibility in how they implement those recommendations.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Dr. Lee requested that they keep two metrics visible. The one they are all aware of and should 

be aware of is the one on efficiency. She absolutely agreed that they do not want doses in 

freezers or any wasted doses. But they also have to bring into view measures of equity. Holding 

them to both standards is really important in order to be sure that there is accountability for how

vaccines are being delivered. In addition, having a standard way to measure equity and 

recognizing all the challenges with measuring equity, will allow them to redouble the efforts in 

communities where there are known to be high rates of disease and high rates of vaccine 

hesitancy, and it will allow them to focus those efforts in a more specific manner as opposed to

a general approach, which is needed as well. Race/ethnicity was mentioned specifically as one 

dimension. In the past there have been discussions about zip code, the Social Vulnerability 

Index (SVI), or the COVID-19 Pandemic Index as a proxy for understanding risk in communities 

and how well they are doing in vaccinating those communities. They also need to ensure that 

healthcare delivery systems are also looking at primary or preferred language to ensure that

rates of vaccination are similar among English and non-English speakers. Having examples of 

these measures of equity, even if they are not ideal or the thing they want to measure, anything 

they bring into vision will help ensure that they are doing a good job.

Dr. Cohn indicated that CDC is actively working on the measures Dr. Lee was speaking about 

and anticipates being able to report in those ways in the near future. Race and ethnicity are 

about 50% unreported, so provider reporting of race and ethnicity is critical. CDC is also 

attempting to use SVI and other measures and proxies.

Carol Hayes (ACNM) expressed gratitude to HHS and CDC for the funding that has come along 

not only with the vaccines themselves, but also the other types of monies that have been given. 

In the state where she resides, the vast majority of how they have been able to roll out the 

COVID vaccine was from federal funding. She suggested assessing the Immunization 

Information Systems (IIS) systems in different states. For instance, her state is the worst in 

vaccinating individuals in the US because their IIS system is from 1996 and it has not been 

updated since. They are so slow at reporting doses given, OWS would not give them more 

doses. So, they are in a horrible catch-22. Her state also has punted the vast majority of how to 

roll out the vaccine to the counties. Some of their counties are so poor and so underfunded that 

they have had a difficult time developing their own registration systems and their own drive 

through systems. Her state has 159 counties. This feudalism presents a horrible situation where 

no one is really coordinating in a really global way, so she was very happy to hear that CDC is 

going to recommend that the states that have had an efficient system can share their best 

practices with other states.

Dr. Long emphasized that they all have different experiences and have all been very concerned 

about being sure that disparities, deaths, and disease do not get any worse. Despite the best

attempts, they will because those who have colleagues, family, members, friends who are not 

paid by a healthcare institution know how much self-advocacy it takes to get an immunization. 

Even when someone is on the right list and in the right ballpark, it is very difficult. It took hours 

for her to get an immunization for her husband who is now retired because by the time she 

completed all of the information to try to get an appointment online, there were no more slots for 

that time. This is happening in lots of ways. She suggested that President Biden’s administration 

could be very useful. She does not think it will help to educate people who do not trust the 

system about how safe the vaccines are if is the government telling them. She thinks a 

grassroots organization is needed with people knocking on doors talking to their neighbors. 

Perhaps an Obama-Biden approach might be the way to do this, because she thinks there are 

going to be very disparate numbers in who is able to get immunized. The other thing where she 

thinks there has been a complete failure, at least in Philadelphia, is that the big university 
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47

institutions who take care of millions of patients still have no plans for immunizing their patients. 

Perhaps they could get people who have some time like retired physician, nurses, et cetera to 

be able to give immunizations on weekends. It is not clear why vaccines are not being given on 

weekends when people are dying on weekends. She felt great relief when she and her husband 

got their first dose and said that if they were not infected in the next 10 days, they would not die 

from coronavirus. There are people who still will, so she is upset and passionate about the 

haves still getting more vaccine than that have nots.

COVID-19 Vaccine Effectiveness Studies

Katherine Fleming-Dutra, MD

Vaccine Effectiveness Team, Vaccine Evaluation Unit

Vaccine Task Force, COVID-19 Response

Centers for Disease Control and Prevention 

Dr. Fleming-Dutra explained the reasons COVID-19 post-authorization VE estimates are 

needed. First, real-world performance of vaccines can vary from efficacy in control trial settings. 

This can only be understood from observational VE studies. Both authorized COVID-19 

vaccines have recommended 2-dose schedules with dosing intervals of 3 and 4 weeks. It is 

known that outside of clinical trials and actual practice, the timing and coverage of second 

doses can vary from what is recommended. Both authorized vaccines have specific cold-chain 

requirements that may be difficult to implement in practice. Additionally, post-authorization VE 

estimates also will build on evidence from the Phase III clinical trials, including VE in key subpopulations and outcomes for which the trials may have had limited power, follow-up time, or 

were not designed to address. Examples of these outcomes include severe disease, SARSCoV-2 infection and transmission, and duration of protection.

While it would be ideal to have observational data on all outcomes in all populations, the need is 

recognized to prioritize and focus on information that will be most useful for guiding policy. The 

Vaccine Effectiveness Team’s priorities have been developed based on the results of internal 

and external input. The most immediate priority in the first 2 to 4 months of vaccination is to 

answer the question, “Does vaccine protect against symptomatic disease as expected?” After 

that, the subsequent priorities include: 1) estimating VE against key outcomes of severe 

disease, non-severe disease, and SARS-CoV-2 infection and transmission; estimating VE in 

key sub-populations, including for adults 65 years of age, those living in LTCFs; people with key 

underlying health conditions, such as those who are immunocompromised or have obesity or 

diabetes; and racial and ethnic populations that have been disproportionately affected by 

COVID-19; and 2) estimating VE for regimen-related questions, such as single dose and 

prolonged dosing intervals and mixed-dose schedules. In the later stage, additional key policy 

questions include those around viral evolution and whether genome changes threaten VE, 

duration of protection, and estimating comparative VE in terms of whether one product is better 

than another.

While there is undoubtedly a need for post-authorization VE studies, there are some challenges 

inherent to observational COVID-19 VE studies that can bias VE estimates. One of the biggest 

challenges is that the decision to be vaccinated may correlate with the risk of disease and 

people who choose to get vaccinated may also adopt other prevention behaviors that would 

decrease the risk of disease, or they may engage in more risky behavior because they feel 

protected. Prior infection may bias the VE estimates as it confers protection against disease and

known prior infection may be associated with the likelihood of vaccination. In addition, COVID19 epidemiology is highly dynamic, which makes it tricky to plan when and where to do VE 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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studies. Multiple products are in use simultaneously, further complicating VE studies. Given 

these inherent limitations, a portfolio has been developed using a diversity of methods to 

address policy priorities.

The following table provides a summary of currently planned COVID-19 VE assessments. For 

each of the policy priorities listed in the left column, there are plans to start both studies with 

prospective data collection, which are listed in the middle column, and settings that leverage big 

data such as EHRs or claims datasets listed in the right column: 

Prospective studies allow for richer data through interviews or surveys of participants and chart 

review, while larger datasets offer greater statistical power and efficiently make use of existing 

data resources. For this work, the aim is to facilitate rapid launches of these assessments by 

leveraging existing platforms and to harmonize across platforms and USG.

Starting with the most immediate question of whether vaccine works as expected to prevent 

symptomatic disease, a prospective assessment will be conducted among HCP using a 

prospective test-negative design among HCP. A test-negative design is a type of case-control 

study which enrolls people with a certain clinical syndrome, in this case HCP with a COVID-like 

illness who are tested for the disease of interest, in this case COVID-19. Cases are those who 

test positive and controls are those who test negative. The primary objective of this assessment 

is to evaluate the VE of a complete schedule of COVID-19 vaccine against laboratoryconfirmed, symptomatic COVID-19. If feasible, this will be done by vaccine product. The 

secondary objectives are several and will include assessing VE by the number of doses 

received if this is feasible based on the number of participants who received 1 or 2 doses 

assessment. This assessment launched in January 2021 and will enroll until sites have reached 

a vaccine coverage of greater than 80% with 2 doses. Interim analysis may occur as early as 

March, but the timing depends on vaccine coverage at the sites and the rate of case accrual.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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This VE assessment is being conducted across 26 states in 34 sites that have over 500,000 

HCP.

Turning toward the next priority of assessing VE among older adults, including residents of 

LTCs facilities, several assessments are planned among adults 65 years of age and older. 

These include a CDC-led case-control assessment of VE linking hospitalized COVID-19 cases 

from CDC’s COVID-NET surveillance system with claims data from CMS and an FDA-led cohort 

analysis of CMS claims data. Both of these assessments will conduct separate analyses among 

adults 65 years of age and older who reside in the community and those who reside in LTCFs. 

For these analyses, the results are not expected until at least this summer to allow time for 

vaccination to occur in this age group, cases to accrue, and the data to be available.

Among residents of LTCFs, the plan is to use data from the National Healthcare Safety Network

(NHSN) LTCF surveillance and vaccine coverage modules. These data will have weekly 

aggregate counts at the facility level of new laboratory-confirmed COVID-19 cases and 

vaccination status among all residents and among new COVID-19 cases. Using these data, 

weekly attack rates will be calculated among vaccinated and unvaccinated to estimate VE 

among residents of LTCFs. The first transmissions with these data will be available starting in 

early February. The initial analysis will require at least 8 weekly transmission from facilities with 

at least 50% vaccine coverage. There are plans to conduct ongoing analyses as reporting into 

these NHSN modules will be ongoing. 

Additionally, there are plans for assessments of vaccine impact in LTCFs facilities that have the 

potential to be more rapid, including ecologic analyses of vaccine coverage and COVID-19 

disease rates among residents of LTCFs. Assessments of vaccine impact may also come from 

outbreaks with descriptive analyses before and after vaccine use. Another key priority is to 

assess the VE against infection, including asymptomatic infection, and importantly against 

transmission, which can only be evaluated prospectively. In order to do this, an ongoing cohort 

of more than 5000 HCP and first responders will be leveraged with weekly testing for SARSCoV-2 infection and assessment of secondary transmission among household members. The 

cohort began in July 2020 and will continue through March 2022. Work is currently underway to 

expand case-ascertained household transmission studies to include the general population 

during widespread adult vaccination.

A test-negative design and conventional case-control design with hospitalized controls will be 

used for the outcomes of severe disease, hospitalization, and non-severe disease and the key 

subpopulations of those with underlying health conditions, such as immunocompromising 

conditions, and racial and ethnic groups who are disproportionately affected by COVID-19. 

These VE evaluations will be designed to assess severe disease and hospitalization and nonsevere disease, and they will utilize sites selected to include populations with underlying health 

conditions, racial and ethnic groups who have been disproportionately affected by COVID-19,

and American Indian and Alaska Native (AI/AN) populations. Screening method analyses also 

will be conducted, which are assessments that look at vaccination coverage among a group of 

cases, for example cases detected through ongoing COVID-19 surveillance, and compared with 

vaccination coverage among the overall population from which the cases arose (e.g., people 

from the same state). The data analyses to be conducted will include EHRs and claims-based 

assessments.
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Assessments are also planned to measure the vaccine impact in a population. For this, ecologic 

analyses are planned of the association of disease incidence and/or seroprevalence with 

vaccine coverage, as well as comparisons of expected vaccine impact from mathematical 

models with actual observed impact. Important questions include assessing VE for regimenrelated questions, including use of a single dose or prolonged dosing intervals, meaning more 

than 3 to 4 weeks between doses or even mixed dose schedules, meaning use of more than 

one product in a 2-dose series. The ability to answer these questions using observational 

studies will depend on whether enough of these events are captured, which may occur in 

practice even though they may not be recommended. All of the platforms, with the exception of 

the NHSN will collect individual level information on dose dates and vaccine-type. Thus, they 

have the potential to answer these questions. However, for the early phase vaccination among 

HCP and residents of LTHFs, it is anticipated that there will be adherence to dosing 

recommendations, including the use of 2 doses of the same product, and the dosing intervals.

Therefore, it is unlikely that there will be enough variation in the data from HCP and residents of 

LTCFs to answer these questions. Thus, the best opportunity to answer these questions may 

come from large prospective HER- and claims-based assessments among the general adult 

population.

In terms of assessing whether viral genome changes threaten VE, the prospective platforms for

the general adult population will collect specimens from cases where possible for whole genome 

sequencing (WGS). It is important to note that this will not be performed in real time and these 

evaluations may not be powered for variant-specific VE assessments. Nonetheless, the hope is 

that these specimens can be leveraged to help answer this question. Additionally, a separate 

team in the Vaccine Evaluation Unit is dedicated to assessment of vaccine breakthrough cases,

including investigating whether SARS-CoV-2 variants lead to breakthrough cases and have the 

potential to impact VE. Dr. Fleming-Dutra emphasized that this work is part of broader CDC 

efforts to monitor the impact of SARS-CoV-2 variants and that this would be addressed more 

fully in the next presentation.

In terms of assessing VE among children and pregnant women, for children a prospective testnegative design assessment is planned to evaluate VE against COVID-19 hospitalizations. This 

work will leverage an existing surveillance network of approximately 20 to 40 sites for pediatric 

COVID-19 hospitalizations, including Intensive Care Units (ICUs), step-down, and general inpatient admissions and MIS-C. Additionally, EHRs and claims database analyses will be used to 

estimate VE in children. For pregnant women, EHR cohort and prospective case-control VE 

assessments are being explored.

In conclusion, there is an urgent need for VE data to guide policy. The VE portfolio leverages

multiple platforms, data sources, and methods. Early VE assessments will focus on HCP and 

residents of LTCFs. The portfolio will continue to evolve as more information from Phase III 

trials and real-world evidence become available.
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Work Group Interpretation and Next Steps

Sara Oliver, MD

LCDR, U.S. Public Health Service

Co-lead, Advisory Committee for Immunization Practices COVID-19 Vaccines WG

COVID-19 Response

Centers for Disease Control and Prevention

Dr. Oliver presented the WG’s interpretation of the data and next steps. To summarize the 

clinical trial data that was presented earlier from AstraZeneca, the WG reviewed the 

immunogenicity data for neutralizing and binding antibodies that were measured in participants 

after 1-dose and 2-dose series. The responses were similar to convalescent sera comparison 

and Th1-biased T-cell response was documented. A 5x1010 dose series delivered as a 2-dose 

series 28 days apart was selected for the US Phase III clinical trials.

The WG also reviewed safety data for the AstraZeneca. From the Phase I/II studies, local and 

systemic symptoms were mild to moderate in severity. Injection site pain, feeling feverish,

muscle aches, and headaches were the most common symptoms reported. Reactogenicity 

symptoms were lower after the second dose, although small numbers of individuals received a 

second dose in those trials, and lower in older adults. No vaccine-related SAEs were reported. 

The interim results from the global Phase III trial shows similar results to the early phase clinical 

trials. Reactogenicity symptoms were milder and reported less frequently after the second dose 

and in adults 65 years of age and older. Results also were reported from the clinical hold where 

the study was paused due to the report of transverse myelitis in the UK. The FDA reviewed

neurological events in all of the trials. After this independent review, the study was allowed to be 

resumed with changes, including an independent expert neurology panel.

In addition, AstraZeneca presented preliminary data from the interim global efficacy analysis. 

Over 11,000 participants in the UK and Brazil were included in this interim analysis. There were 

several dose regimens and inter-dose intervals included in this analysis. The VE estimate for 

the standard dose/standard dose regimen, which is what is currently being studied in the US 

Phase III trials was 62% of pooled VE estimates, including individuals with a lower dose as the 

first dose as well as a more delayed do schedule with 70%. They also discussed their plans for 

the US Phase III trials, which will be the primary basis the EUA application. To date, they 

reported over 32,000 people enrolled in the Phase III trials. The primary endpoint is 

symptomatic, virologically-confirmed COVID disease. The presentation earlier in the day 

discussed trial enrollment and diverse populations, including diversity in race and ethnicity, age, 

and underlying medical conditions.

Overall, the WG felt that the early Phase I/II data shows induction of binding and neutralizing 

antibodies as well as T-Cell responses with a favorable safety and reactogenicity profile, 

supporting the advance to Phase III trials. Safety pauses are expected with large clinical trials 

and indicate that the processes working appropriately. However, transparency around the safety 

pause and resolution is critical. Overall, the WG awaits the results of the US Phase III trial for an 

EUA application with 2 doses of the standard dose of vaccine 28 days apart.

In terms of the WG interpretation of COVID-19 in children, while the overall burden of COVID

may be lower among children, preventable infections, hospitalizations, and long-term sequelae 

and deaths are an important public health problem. Clinical trials to evaluate safety and 

immunogenicity of COVID vaccines in children are essential. Given disparities noted among

COVID cases in children and MIS-C, it will be crucial for pediatric clinical trials to enroll a 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

52

diverse population. The WG looks forward to reviewing data from these clinical trials as they 

become available.

Real-world VE studies are needed for a variety of populations, ages, and underlying medical 

conditions. Diverse trial designs also will be important to address a variety of questions. The 

WG discussed many of these that can hopefully be addressed through these studies, including 

VE after a single dose or a mixed series, VE in immunocompromised individuals, and duration 

of protection. In addition, isolates obtained through the VE platforms can help address concerns 

around SARS-CoV-2 variants.

For more on the SARS-CoV-2 variants, in the Fall of 2020, several SARS-CoV-2 variants

emerged with changes in the receptor-binding domain of the spike protein. Preliminary studies 

indicate that these changes can confer increased transmissibility. Three of the concerning 

variants include the B.1.1.7 variant from the UK, B.1.351 from South Africa, and P.1 from Brazil. 

While changes in the virus over time are expected, these have been of particular concern for 

this specific issue. These variants have the ability to evade vaccine-induced immunity52.

Several pre-print studies have been made available over the past several weeks. Following 

vaccination, limited numbers of study participants’ sera were tested in neutralization assays. 

Regarding the Pfizer vaccine, studies have demonstrated equivalent neutralization titers against 

a panel of 19 individual SARS-CoV-2 spike variants53 and N501Y (variant)54 compared to 

wildtype virus. Reductions to neutralization titers have been noted against the UK variant with 

1.255 or 3.9-fold56 reduction. One study found a modest reduction for some neutralization 

against certain site mutations from the South African and Brazil variants57. However, these were 

tested against individual mutations. Regarding the Moderna vaccines, the same study again 

found modest reduction for neutralization for mutations in the South Africa and Brazil variants5. 

Another study found no significant impact on neutralization titers against the UK variant, but a 6-

fold reduction for the South African variant

58

. The links to each of the pre-prints are located in 

the footnote.

Surveillance is critical in monitoring these and possibly other future variants in the US. These 

surveillance efforts are detailed on the CDC website1, but the WG wanted to highlight them here 

as well. The National SARS-CoV-2 Strain Surveillance (NS3) is being scaled to sample 

hundreds of samples per week and will allow for broad characterization of the viruses. 

Surveillance is also underway in partnership with national reference laboratories and 

universities occurring within state and local health departments and through a national 

consortium of around 160 laboratories called the SARS-CoV-2 Sequencing for Public Health 

Emergency Response, Epidemiology and Surveillance (SPHERES) Consortium. Additional 

investigations will be conducted as vaccine breakthrough cases are identified.

52 https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/scientific-brief-emergingvariants.html

53 Sahin et al. medRxiv preprint (Dec 11, 2020a); doi: https://doi.org/10.1101/2020.12.09.20245175

54 Xie et al. bioRxiv preprint (Jan 07, 2021) ; doi: https://doi.org/10.1101/2021.01.07.425740

55 Muik et al. bioRxiv preprint (Jan 19, 2021); doi: https://doi.org/10.1101/2021.01.18.426984

56 Collier et al. medRxiv preprint (Jan 20, 2021); doi: https://doi.org/10.1101/2021.01.19.21249840

57 Wang et al. bioRxiv preprint (Jan 15, 2021) ; doi: https://doi.org/10.1101/2021.01.15.426911

58 Wu et al. BioRxiv preprint ((Jan 25, 2021); doi: https://doi.org/10.1101/2021.01.25.427948
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Overall, in most of the studies reviewed, there was minimal to moderate reduction in 

neutralization activity for vaccine-immune sera in some persons. The implication for real-world 

effectiveness are unclear. Sera from mRNA vaccine recipients had higher neutralization activity 

than COVID convalescent human sera in the early phase clinical trials. In addition, a minimal 

reduction in neutralization activity may not be clinically relevant. Most of the studies mentioned 

previously were conducted using pseudo viruses, which are more sensitive to neutralization. 

Importantly, these are limited studies with small numbers. The evidence is quickly evolving, so 

there will need to be a continued review of the data. Studies evaluating full sets of mutation from 

the variants are likely more informative than studies of single mutations. Studies of vaccine 

breakthrough cases are planned and these may serve as an early warning. Finally, Moderna 

announced this week that they are in the process of developing a vaccine against the South 

African variant.

In terms of some recent updates to the clinical guidance around COVID vaccine dosing and 

schedules, the mRNA vaccines are recommended for a 2-dose series administered 

intramuscularly. The Pfizer vaccine doses are recommended to be given 3 weeks apart and the 

Moderna vaccine is recommended to be given 4 weeks apart. Persons should not be scheduled 

to receive the second dose earlier than the recommended intervals. Overall, the second dose 

should be administered as close to the recommended interval as possible. However, if it is not 

feasible to adhere to the recommended interval, the second dose of the Pfizer or Moderna 

vaccines may be scheduled for administration up to 6 weeks or 42 days after the first dose. To 

address discussions of alternative dosing or schedules, the currently recommended schedules

and doses are from the Phase III trials where safety and high efficacy were demonstrated. If 

data become available for alternate schedules or doses, ACIP can review data and consider 

new recommendations. However, in the absence of additional data to support alternative 

schedules or doses, the current recommendations will remain. The mRNA vaccines are not 

interchangeable with each other or with other COVID vaccines. Either vaccine series may be 

uses. ACIP does not state a product preference and every effort should be made to determine 

which vaccine product was received as the first dose. In exceptional situations in which the first 

dose of the vaccine product cannot be determined or is no longer available, any available 

mRNA COVID vaccine may be administered at a minimum interval of 28 days between doses. 

This longer interval was chosen since it is presumed that at least one of the doses may be the 

Moderna product59.

While the vaccines are being used under an EUA, to allow for appropriate safety surveillance, 

the mRNA vaccines should be administered alone with a minimum interval of 14 days before or 

after administration with other vaccines. This is a reflection of the lack of data regarding coadministration and the need for careful safety surveillance, not because there any known 

problems with safety or efficacy with concomitant administration. Along those lines, mRNA 

COVID vaccines and other vaccines may be administered within a shorter period in situations 

where the benefits of vaccination are deemed to outweigh the potential unknown risks of

vaccine co-administration, such as Tdap after a dirty wound, Tdap during pregnancy, vaccines 

during an outbreak, et cetera. If mRNA vaccines are administered within 14 days of another 

vaccine, the doses do not need to be repeated for either vaccine.

In terms of next steps for the WG, any votes on the use of additional COVID vaccines will take 

place at an emergency ACIP meeting once FDA has authorized the vaccine and data are 

reviewed by ACIP, including safety and efficacy results from the Phase III trials. The Janssen 

vaccine may have results from their Phase III trial within the next several weeks based on public 

59 https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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statements by the company and others. This is an adenovirus 26 (Ad.26) vector vaccine. The 

current US Phase III trials are evaluating a single dose. To provide a very quick overview of 

adenovirus vector vaccines since this is where the WG and ACIP will be pivoting for future 

COVID-19 discussions, the Ad.26 vector in the Jansen/J&J product is a non-replicating vector. It 

has been used in other vaccines. J&J has Ebola vaccine that has been used in broader 

populations, including pregnant women and children. Unlike the mRNA platform, there will be a 

little more experience with this platform in various populations. However, one of the lessons 

learned previously through adenoviral vector vaccines is that prior exposure to the vector could 

possibly reduce effectiveness. The chimpanzee adenovirus vector is also non-replicating. The 

chimpanzee adenovirus vector can circumvent pre-existing immunity to human adenovirus 

vectors. The WG looks forward to providing updates from the Phase III trials of these vaccines 

as they become available.

Discussion Points 

In terms of the variants mentioned, Dr. Ault asked whether the changes are in the antibody 

binding sites where the hosts would recognize the spike protein that would cause concern that 

vaccination is not going to protect against that.

Dr. Oliver said that the reason these particular variants are of concern is because amino acid 

changes have been noted in the receptor binding domain of the spike protein. That is why of all 

changes that the virus might make, these are the ones the WG has been talking about more 

frequently over the last several weeks. It is her understanding that the binding domain is the 

same thing that the host antibody recognizes.

Dr. Thornburg added that the answer to that is somewhat complicated because some of those 

mutations are in areas where neutralizing antibodies do bind in general, but everyone makes a 

different set of antibodies. Any one individual who is vaccinated might have an antibody binding 

that site or might not. They might have neutralizing antibodies that bind other residues. Also,

people make a swarm of antibodies so they will make dozens of neutralizing antibodies. If one 

of those antibodies drops out from a mutation, the other antibodies can still be active. On a 

population whole an individual mutation may not truly escape, but for an individual it could.

Dr. Kimberlin (AAP Redbook) recalled that Slide 22 showed how the mRNA vaccine should be 

administered alone and Dr. Oliver mentioned that this was due to lack of data, which is fully 

understandable. As they begin to anticipate the day when these vaccines can be used in 

adolescents and even in younger children, it is important to remember that many children and

adolescents across the country have fallen significantly behind on their immunization schedules.

If there is an opportunity to catch them up on the vaccines they have missed during the 

pandemic and administer the COVID vaccine when they are approved to receive those 

vaccines, it would be highly beneficial. He inquired as to whether there would be an opportunity 

between now and several months from now, when hopefully there will be authorization for the 

use of the vaccines in children and adolescents, that some of those kinds of studies can be 

done in order to be better prepared for the more global health that they try to generate in

patients. He emphasized that the sooner this could be done the better so that opportunities can 

be leveraged for catch-up on standard vaccination when patients touch the healthcare system 

for any reason.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Dr. Oliver said that there are ongoing discussions currently regarding additional studies that 

could be done in the pediatric and adolescent populations overall and then including 

coadministration. The current clinical considerations are for the use of mRNA vaccines in the 

adult population. Those considerations are being updated regularly, so when vaccines are 

authorized for routine use in children, there will be additional thoughts for clinical considerations 

in that population as well.

Overview

The floor was opened for public comment during the January 27, 2021 ACIP emergency 

meeting at 4:30 PM ET. Given that many more individuals registered to make oral public 

comments than could be accommodated, selection was made randomly via a lottery. The 

comments made during the meeting are included here. Members of the public also were invited 

to submit written public comments to ACIP through the Federal eRulemaking Portal under 

Docket No. CDC-2021-0002. Visit http://www.regulations.gov for access to the docket or to 

submit comments or read background documents and comments received. 

Public Comments

Lindsay Clarke, JD

Vice President

Health Education and Advocacy

Alliance for Aging Research

Thank you so much. Good afternoon. I’m Lindsay Clarke, Vice President of Health Education 

and Advocacy at the Alliance for Aging Research. The Alliance is one of the convening 

members of the COVID-19 Vaccine Education and Equity Project, along with Healthy Women 

and the National Caucus & Center on Black Aging (NCBA). We are joined by more than 125 

partner organizations representing patients, caregivers, families, diverse communities, health 

care professionals, older Americans, veterans, frontline workers, and scientists. The project is 

focused on promoting widespread and equitable access to COVID-19 vaccination information,

particularly among those on the front lines and the communities that have been hit hardest by 

the pandemic. You can learn more and join us at https://covidvaccineproject.org/

While we are excited to see vaccine administration ramping up in recent weeks, we also need to 

continue to be aware of and look out for those that may be left behind. Vaccine hesitancy still 

exists in many communities, but as discussed earlier, the primary obstacle right now seems to 

be access. Older adults, Black Americans, and other vulnerable populations are more eager 

than ever to get vaccinated. However, in order to make vaccine appointments, they often are 

asked to go online, download, apps, and check back frequently for availability. Those who don’t 

have internet access or are uncomfortable with technology or who don’t have the time to devote 

to getting an appointment are being left out. We’re glad to see the committee addressing this 

and encourage use of the CDC Social Vulnerability Index (SVI) to offer vaccines according to 

zip codes. Just because a COVID-19 vaccine clinic is set up in an underserved area does not 

ensure vaccine access unless appointments are limited to those residents. We also need more 

targeted outreach on the ground in underserved communities, as well as appointment 

Public Comments
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

56

assistance. All of these strategies will help get vaccines into the arms of the most vulnerable in 

the communities that have been hit the hardest.

Even if they are able to navigate the appointment system, there are still many who are reluctant 

to get a vaccine. According to a survey that the Alliance recently conducted on behalf of the 

Vaccine Education and Equity Project, when asked about preferences on where to receive a 

COVID-19 vaccine, the majority of responds (64%) indicated that they would prefer to get it at 

their health care provider’s office, 29% prefer a pharmacy, and 20% a drive-through vaccine 

clinic, while only 13% would like to receive the vaccine at a grocery store pharmacy. Older 

adults are much more likely to cite a preference for COVID-19 vaccine administration in their 

health care provider’s office. Those preferences seem to relate to trust and familiarity, with 

nearly two-thirds of respondents saying they would prefer to get vaccinated from a healthcare 

provider they know. While the focus is primarily on large-scale distribution sites in these early 

phases of administration, we encourage the ACIP and CDC to consider these barriers and 

preferences in future phases so that we can reduce barriers for individuals who are harder to 

reach or who are reluctant to actively seek out a COVID-19 vaccine. We are ready and willing to 

help the committee in any way, so please reach out. Thank you for the opportunity to comment.

Mark Gibbons

President/CEO

RetireSafe

Mr. Chairman. Good afternoon. My name is Mark Gibbons. I’m the President and Chief 

Executive Office (CEO) of an organization called RetireSafe. RetireSafe is a non-profit 

grassroots organization whose mission is to educate and advocate on behalf of older 

Americans. We address many key issues, including Social Security, Medicare, Medicaid 

protecting our health, and financial wellbeing by making sure the concerns as well as the 

wisdom of older generations are given voice. The COVID virus has impacted all of us in many 

unexpected and devastating ways, but the stats for those over 65 are harsh, indeed. 

Approximately 1 in 7 adults in the United States are over 65, but CDC reports that 6 out of every 

8 COVID-related deaths have occurred in this age group. That is 6 out of 8. Older persons also 

have higher infection, hospitalization, and death rates from other infectious diseases, such as 

influenza and also pneumonia. In short, advanced age tragically also means advanced risk.

RetireSafe thanks ACIP and its advisors for their tireless work for being invited to speak today. 

As new vaccines for COVID and other diseases are developed, it is so important that the highrisk status of more than 50 million older Americans be addressed. We respectfully ask that ACIP 

consider the addition of adding a few more gerontological experts to its membership. I 

understand that 4 new members have been added; however, none were from this category.

This is a little disappointing for my membership. I attended a meeting back in 2019, and one of 

the members stated that the committee’s only concerns were younger children and young 

adults—not the aging adults. I don’t think that is really what was meant to be said, but that’s 

what was said. So, please consider adding some more doctors that handle the aging. Thank 

you for your time and have a good afternoon.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Dr. Justin Gregory

Division of Pediatric Endocrinology

Vanderbilt University Medical Center

Good afternoon. My name is Justin Gregory. I’m a Pediatric Endocrinologist at Vanderbilt 

University Medical Center (VUMC). Currently, the CDC categorization has Type 1 diabetes as a 

condition that may increase risk for severe COVID-19. In light of recent clinical evidence, I urge 

my colleagues on this committee to recommend revising this categorization to a condition that 

does increase risk for severe COVID-19. At present, the CDC appropriately list Type 2 diabetes 

as a high-risk condition. As we summarized in an article in the Annals of Internal Medicine

published yesterday, clinical evidence unequivocally suggest that CDC should likewise 

categorize Type 1 diabetes as a high-risk medical condition. In our prospective cohort study of 

COVID-19 outcomes at Vanderbilt, originally published last month in Diabetes Care, we found 

hospitalization with COVID-19 is 4.6 times more likely to occur in patients with Type 1 diabetes 

than patients who do not have diabetes. By comparison, hospitalization is 3.4 times more likely 

to occur in patients with Type 2 diabetes than patients who do not have diabetes. Moreover, we 

found that even when patients with Type 1 diabetes maintain blood sugar at ideal levels, they 

were still 3 times more likely to be hospitalized than patients without diabetes.

Our international colleagues similarly found having Type 1 diabetes increases the risk of 

mortality. A recent population-wide study of England published in Lancet Diabetes and 

Endocrinology found COVID-19 mortality was 3.5 times more likely among patients with Type 1 

diabetes than patients without diabetes By comparison, COVID-19 mortality was 2 times more 

likely in patients with Type 2 diabetes. Fortunately, randomized clinical trials (RTCs) showed 

that both currently approved vaccines were just as efficacious in preventing COVID-19 

complications in people with diabetes as they were in protecting the entire study cohort. 

Moreover, severe COVID-19 occurred only once among all of the vaccinated participants. Thus,

while patients with Type 1 diabetes are at greater risk for severe COVID-19, the vaccine 

appears to have a profoundly protective effect against this outcome in these patients.

In conclusion, the data are clear. I join the Juvenile Diabetes Research Foundation (JDRF), the 

largest charitable supporter of Type 1 diabetes research to urge this committee to recommend

that CDC revise its categorization of people with certain medical conditions to reflect that 

individuals with Type 1 diabetes are at increased risk of severe illness from the virus which 

causes COVID-19. As individual states will soon transition into Phase 1c of COVID-19 

vaccination, this revision can play a critical role in appropriately prioritizing patients with Type 1 

diabetes for immunization. Such action will allow the medical community to maximize the benefit 

of the vaccine by protecting over 1.6 million Americans with Type 1 diabetes through an 

increased risk for morbidity and mortality from this virus. Thank you.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Michaela Jackson, MS

Prevention Policy Manager

Hepatitis B Foundation

My name is Michaela Jackson. I am the Prevention Policy Manager for the Hepatitis B 

Foundation. On behalf of the hepatitis B and liver disease communities, I am speaking today to 

encourage ACIP to share available subgroup data, particularly for people living with hepatitis B 

and liver disease that has been presented by companies developing COVID-19 vaccines. ACIP 

has responded to the coronavirus pandemic swiftly and we applaud the dedication to ensuring 

the safety and efficacy of each vaccine. However, there remains great uncertainty and 

confusion among patients and providers about who should receive the vaccines. Lack of 

publicly available data plays a large role in this uncertainty. We are aware that people living with 

HepB and liver disease have been included in clinical trials, but representation matters little if 

the groups represented are not able to see the information relevant to them. Establishing trust in 

the efficacy of these vaccines is absolutely critical to ending the pandemic. While the public 

health community has made great strides with this endeavor, there is still a long way to go. 

Throughout the course of this pandemic, an increasing number of people living with HepB have 

approached us with questions about how effective the vaccine is for them and if they should 

even receive it given their health condition. Simply put, these communities have expressed an 

interest in getting immunized against COVID-19, but are hesitant due to a lack of information 

currently available to them. Presenting evidence on people living with HepB and liver disease 

from clinical trials will help improve access to approved vaccines and will broaden trust and 

acceptance as well. Too often, the medical community has neglected to listen to the concerns of 

under-represented groups and the consequences have been devastating. We must remember 

that data is one of the most powerful tools we have to build back some confidence among 

vulnerable populations, and it’s one that we must fully utilize in order to earn the trust of 

consumer communities. Thank you for your time today.

Kelly Shanahan, MD

Member at Large

METAvivor

I’m Kelly Shanahan. Before my metastatic breast cancer diagnosis, I was an OB/GYN. Now, I’m 

an advocate on the Board of Directors of METAvivor, which raises money for metastatic breast 

cancer research, including the $4.4 million dollars we awarded in the midst of this pandemic. I’m 

speaking for the adult cancer community as there is no such representation on ACIP. From the 

first paper from the COVID-19 Cancer Consortium published online in The Lancet last year, it 

has been clear that people with cancer are at increased risk of severe illness and death if

infected with SARS-CoV-2. This is true whether the cancer is active or not, although people 

currently being treated for cancer with a metastatic diagnosis fared the worst. Work from the 

United Kingdom Coronavirus Cancer Monitoring Project (UKCCMP) confirmed this. Desai et al, 

in an article from December, performed a meta-analysis of people with cancer hospitalized with 

COVID-19. Thirty percent of those hospitalized died. For studies that included a mix of in- and 

outpatients, the mortality rate was 15%. Currently in the US, the case fatality rate of COVID-19 

is 1.7%. We know that the risk of dying increases with age. Levin et al in the December 

European Journal of Epidemiology calculated an infection fatality rate of 0.4% at age 55, 1.4%

at 65, and a staggering 15% at 85. What does that 15% remind us of? The 15% to 30% 

mortality of people with cancer who also have COVID-19. It’s not just death that we need to 

consider. People with cancer who become ill with COVID-19 are more likely to require 

hospitalization at 47% according to an analysis of electronic health records (EHRs) by Wang et 

al published in Jama Oncology in December—almost double the rate of people without cancer 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

59

and almost 4 times the rate of people with cancer who did not also have COVID-19. People with 

cancer have increased exposure risk because staying home and skipping treatments and scans

is not an option for us. If the goal is to vaccinate those at greatest risk of severe illness or death

should they contract COVID-19, shouldn’t people with metastatic and active cancers who die at 

a rate equal to and perhaps twice as high as octogenarians be vaccinated with that group? I’ve 

heard experts say that we should move to vaccinating based on age alone—that it’s just too 

hard to prioritize by risk. They said it was too hard to go to the moon, but we did that. It’s not 

rocket science to devise a system where people with metastatic and active cancers are 

vaccinated at their cancer center or oncology office. We’re going for treatments and scans and 

follow-ups already. Our oncologists know our diagnosis. Who gets vaccinated when is all over 

the map. State and local public health organizations look to you for guidance. If you truly believe 

that the most vulnerable must be prioritized for vaccination, then that must include people who 

have a 15% to 30% chance of dying—the active and metastatic cancer population. Thank you.

Allison Winnike, JD

President & CEO

The Immunization Partnership

Good afternoon Chair Romero and members of the committee. My name is Alison Winnike. I’m 

President and CEO of the immunization partnership. Our nonprofit mission is to eradicate 

vaccine-preventable diseases by educating the community, advocating for evidence-based 

public policy, and supporting immunization best practices. Thank you for developing vaccine 

recommendations to keep all Americans safe and healthy. Your scientific recommendations are 

an important tool that states use to carry out their constitutional duty to protect the public’s 

health. Today, I have two recommendations for the committee. First, I recommend giving 

greater weight to vaccine availability through the supply chain in the priority-based group 

recommendations. ACIP recommendations should be a solid data-driven guide for states as 

they implement their COVID-19 vaccine administration plans. However, it is notable that outside 

of the Phase 1a recommendations that were recommended by ACIP, and that were nearly 

universally adopted by the states, only a small minority of states are exactly following the Phase 

1b and 1c recommendations. Many were frustrated by the committee’s prioritization of essential 

workers in Phase 1b over those at high-risk for severe COVID-19 at a time when vaccine 

supplies were so limited and deaths were mounting in those aged 65 and older and people with 

high-risk medical conditions.

With nearly 425,000 deaths so far and a surge impacting our most vulnerable, states need more 

detailed recommendations to help them prioritize within phase groups as we struggle with such 

limited vaccine supply. My second recommendation is to continue your practice of transparency 

and deliberations for forthcoming COVID-19 vaccines. We were very fortunate that the first two 

vaccines authorized for emergency use demonstrated extremely high efficacy rates for the adult 

population, but future vaccines may not meet the efficacy levels of our current vaccines or they 

may have varying rates for different age groups. I am concerned that as new vaccines enter the 

market, people may fear they are receiving an inferior product if the efficacy rates do not meet 

the vaccines that are currently available. The community should take extra efforts to sufficiently 

explain the science behind your recommendations, both to states executing their vaccine plans 

and to the public. Americans are frustrated, they’re scared, they’re sick, and many feel forgotten 

if they wait their turn to be vaccinated against this novel coronavirus. Please make sure that 

future COVID-19 vaccine recommendations take into account the vaccine access and equity 

issues Americans face. Strong communications from the committee on the science may help 

combat the perception that future vaccines may be of lower quality or rushed through to 
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

60

distribute to those with high social vulnerabilities and few resources. Thank you so much for 

your important work and the opportunity to share our comments.

Edward Nirenberg

Vaccine Advocate

Hello. Thank you for the opportunity and privilege you granted me today in permitting me an oral 

public comment. My name is Edward Nirenberg and I am a vaccine advocate who focuses 

primarily on debunking and pre-bunking harmful disinformation and misinformation pertaining to 

vaccines. I am immeasurably grateful for your labors in ensuring the safety of the American 

people and your transparency of these proceedings, as they have helped me personally 

tremendously. I’d like to call out a few issues to the attention of ACIP in this short window of

time. Firstly, the Pfizer-BioNTech vaccine in preclinical and clinical data showed robust 

activation of CD-8 T-cells, while for Moderna’s vaccine the response was undetectable. Notably,

efficacy for both vaccines in the Phase III trials were very similar. Due to the exigency of our 

present crisis, people should absolutely take the first vaccine offered to them provided they 

have no contraindications. However, preclinical models in macaques implicate CD8 T-cells as 

important correlates of recovery from COVID-19. Epidemiological data show low CD8 T-cells 

are associated with poor prognosis. Many patients with certain blood as well as those with 

certain autoimmune diseases are placed on anti B-cell therapies such as Rituxan, Rituximab, or 

Ranibizumab. Operating under the assumption of a neutralizing antibody-mediated mechanism 

as a correlate protection, this presents many patients without protection against COVID-19. I 

ask that the committee consider, in light of the evidence available, a recommendation that those 

patients on anti-B-cell therapy should whenever possible preferentially receive the PfizerBioNTech vaccine over Moderna as a way to recognize of the evidence-based considerations.

Secondly, increasingly I’m seeing concerns regarding apparent functional movement issues

following the receipt of COVID-19 vaccine. These have gone viral and several videos are 

provoking profound anxiety. The Functional Neurological Disorder Society (FNDS) has issued a 

statement describing the nature of these reactions. I believe it would be valuable for the 

committee to enhance communications regarding possible cytogenic issues related to

immunization as this has been observed before with, for example, the human papillomavirus 

(HPV) vaccine. Lastly, the anti-vaccine movement sees the pandemic an opportunity to 

undermine vaccine confidence and is thus working tirelessly to correlate any adverse outcomes

from anyone who receives the vaccine as a causal relationship to vaccinations. I believe it 

would be helpful for the committee to put out communications elucidating the inadequacy of 

temporal associations in establishing causality and adverse event following immunization. I 

have been able to rely on several excellent summaries such as one from Dr. Bob Walker 

showing how many adverse health outcomes can be expected in any given 2-month window for 

10 million people irrespective of vaccination status. These are subject to the assumption of 

vaccine distribution stories with statistical average across the entire population, which as the 

committee is aware, would represent an underestimate with vaccine preferentially going to the 

elderly and those with comorbidities since such outcomes are at baseline much more likely. 

Thank you for your time.
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Peter Matz

Director, Food & Health Policy

Food Industry Association

Good afternoon. My name is Peter Matz and I’m here representing FMI, the Food Industry 

Association where I’m the Director of Food and Health Policy. By way of background, as the 

Food Industry Association, FMI works on behalf of the entire industry from retailers who sell to 

consumers, to producers who supply the food, to supermarket pharmacies and beyond. The 

total FMI member companies operate around 3000 grocery stores and 12,000 pharmacies,

touching the lives of more than 100 million US households per week and representing an 

industry with nearly 6 million workers. First, FMI strongly supports ACIP’s recommendation to 

prioritize food and agriculture industry essential workers in Phase 1b. However, states and 

jurisdictions should be strongly encouraged to adhere to the federal recommendations. As a 

result of many states developing their own prioritization frameworks in the face of federal 

guidance, food industry essential workers are struggling to access vaccinations. For 

manufacturing and production employees working in close proximity, to grocery workers who 

have a higher contact rate with the public, to certain transportation workers and food safety 

auditors who ensure food, beverages, and packaged foods are safe for consumer consumption

our industry’s essential workforce has gone above and beyond in demonstrating their continued 

resilience. But to keep supply chains operating and Americans nourished until all can receive 

the vaccine, it is imperative that they receive vaccinations.

Furthermore, as supermarket pharmacies across the country step up in support of vaccinations 

plans, changes to federal prioritization guidelines across states are impeding efficiency in 

vaccine delivery causing confusion and undermining the national vaccination effort. With that in 

mind, FMI urges the Biden Administration to designate a Federal COVID-19 Vaccine 

Coordinator in each state and jurisdiction to coordinate at all levels of government and help 

ensure the deployment of vaccines among priority populations. Also, to the extent that 

jurisdictions have already made revisions to federal vaccine allocation guidance, FMI asks that 

the CDC compile and store all state plans so the information is easily accessible to all 

stakeholders. Separately, supermarket pharmacies administered roughly 25% of the nation’s flu 

vaccinations this year and now they stand ready to play an expanded role in increasing access 

to COVID vaccines. A number of FMI pharmacy members have been providing vaccinations 

through the Federal Pharmacy Partnership (FPP), and a majority are enrolled as providers in 

the states where they operate. All of them have pharmacists prepared to administer COVID

vaccinations in their stores and many pharmacists available and ready to provide vaccinations 

off-site as well. Many are also utilizing their parking lots and outdoor tents as COVID vaccination 

clinics capable of administering nearly a 1000 shots in a day. However, our members are not 

yet receiving vaccine supplies anywhere close to their capacity. Finally, in order for vaccine 

providers to fully utilize the Limited supply of vaccines they do receive, they must have visibility

into the expected availability of future doses. We really appreciate the opportunity and thank you 

to ACIP.
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Claire Hannan

Executive Director

Association of Immunization Managers

Good afternoon. I’m Claire Hannan, Executive Director of the Association of Immunization 

Managers (AIM). AIM members are the dedicated public health immunization directors currently 

working to help coordinate the COVID vaccine roll out, fighting to maintain and increase other 

immunization rates, writing grants on both the COVID response and routine immunization, and 

coordinating response to state legislation, including an array of bills threatening to compromise 

school requirements and add barriers to vaccination. It is a critical time. I’d like to thank the 

committee and CDC for their dedication to thoroughly reviewing all pre-decisional data and postauthorization safety data, building public trust and vaccines. The vaccine campaign, in the use 

of second doses, must be driven by science. Our success in just 5 weeks of vaccinating is

incredible, with more than 23 million doses administered, more than 3 million people fully 

vaccinated, tens of thousands of private providers enrolled and trained. But, in the context of 

people dying of the virus and people suffering anxiety and frustration searching for the vaccine,

our accomplishments don’t feel incredible. So, we will continue to address our challenges and 

learn from them.

Vaccination strategies are evolving as jurisdictions work to improve efficiency and reporting. 

Large scale, high throughput vaccination clinics are more common. Jurisdictions are benefiting 

from public and private partnerships, collaboration with large companies such as Starbucks, and 

local and chain pharmacies. In our rush to improve efficiency though, we cannot lose sight of 

equity. Program managers are driven to ensure this vaccine receives widespread acceptance 

and protects everyone in all of our communities. Listening to the discussion today, we are so 

pleased to hear ACIP focusing on equity as well. State and local health agencies have received 

funding and resources to support COVID vaccination. We are grateful, but we also see these 

resources as just a down payment on the needed larger investment in our future in information 

technology (IT) modernization, public health workforce, routine adult vaccination, and continuing 

the critical work of building confidence in all vaccines in all communities. The key to COVID

vaccination success is increased supply, increase transparency and communication, and most

importantly, increased collaboration. Federal, state, and local public health must work together,

not in competition, united by the same vision and goals. Our country is in a COVID emergency, 

but our entire immunization infrastructure is at stake. Combating myths and dangerous 

legislative initiatives require all of us. Let’s start with the scientific expertise of this committee 

and the CDC. Thank you for your continued guidance and expertise.
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Upon reviewing the foregoing version of the January 27, 2021 ACIP meeting minutes, Dr. Jose 

Romero, ACIP Chair, certified that to the best of his knowledge, they are accurate and 

complete. His original, signed certification is on file with the Management Analysis and Services 

Office (MASO) of CDC.

Certification
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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Department of Health and Human Services 

Centers for Disease Control and Prevention 

Advisory Committee on Immunization Practices 

December 23, 2020 – June 30, 2021 

CHAIR

ROMERO, José R, MD, FAAP 

Arkansas Secretary of Health 

Director, Arkansas Department of Health 

Professor of Pediatrics, Pediatric Infectious Diseases 

University of Arkansas for Medical Sciences 

Little Rock, Arkansas 

Term: 10/30/2018-06/30/2021 

EXECUTIVE SECRETARY

COHN, Amanda, MD 

Senior Advisor for Vaccines 

National Center for Immunization and Respiratory Diseases 

Centers for Disease Control and Prevention 

Atlanta, GA 

MEMBERS

AULT, Kevin A, MD, FACOG, FIDSA 

Professor and Division Director 

Department of Obstetrics and Gynecology University of 

Kansas Medical Center 

Kansas City, KS 

Term: 10/26/2018 – 6/30/2022 

BAHTA, Lynn, RN, MPH, CPH 

Immunization Program Clinical Consultant 

Infectious Disease, Epidemiology, Prevention & Control Division 

Minnesota Department of Health 

Saint Paul, Minnesota 

Term: 7/1/2019 – 6/30/2023

BELL, Beth P, MD, MPH 

Clinical Professor 

Department of Global Health, School of Public Health 

University of Washington 

Seattle, WA 

Term: 7/1/2019 – 6/30/2023 

ACIP Membership Roster
Advisory Committee on Immunization Practices (ACIP) Summary Report January 27, 2021

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BERNSTEIN, Henry, DO, MHCM, FAAP 

Professor of Pediatrics 

Zucker School of Medicine at Hofstra/Northwell 

Cohen Children’s Medical Center 

New Hyde Park, NY 

Term: 11/27/2017-06/30/2021 

CHEN, Wilbur H, MD, MS, FACP, FIDSA 

Professor of Medicine 

Center for Vaccine Development and Global Health 

University of Maryland School of Medicine 

Baltimore, MD 

Term: 12/23/2020 – 6/30/2024 

DALEY, Matthew F, MD 

Senior Investigator 

Institute for Health Research, Kaiser Permanente Colorado 

Associate Professor of Pediatrics 

University of Colorado School of Medicine 

Aurora, CO 

Term: 1/4/2021 – 6/30/2024 

FREY, Sharon E, MD 

Professor and Associate Director of Clinical Research 

Clinical Director, Center for Vaccine Development 

Division of Infectious Diseases, Allergy and Immunology 

Saint Louis University Medical School 

Saint Louis, MO 

Term: 11/27/2017-06/30/2021 

KOTTON, Camille Nelson, MD, FIDSA, FAST 

Clinical Director, Transplant and Immunocompromised Host Infectious Diseases 

Infectious Diseases Division, Massachusetts General Hospital 

Associate Professor of Medicine, Harvard Medical School 

Boston, MA 

Term: 12/23/2020 – 6/30/2024 

LEE, Grace M, MD, MPH 

Associate Chief Medical Officer for Practice Innovation 

Lucile Packard Children’s Hospital 

Professor of Pediatrics, Stanford University School of Medicine 

Stanford, CA 

Term: 7/1/2016 – 6/30/2021 
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LONG, Sarah S, MD 

Professor of Pediatrics 

Drexel University College of Medicine 

Section of Infectious Diseases 

St. Christopher’s Hospital for Children 

Philadelphia, Pennsylvania 

Term: 12/24/2020 – 6/30/2024 

MCNALLY, Veronica V, JD 

President and CEO Franny 

Strong Foundation 

West Bloomfield, Michigan 

Term: 10/31/2018 – 6/30/2022 

POEHLING, Katherine A, MD, MPH 

Professor of Pediatrics and Epidemiology and Prevention 

Director, Pediatric Population Health 

Department of Pediatrics 

Wake Forest School of Medicine 

Winston-Salem, NC 

Term: 7/1/2019 – 6/30/2023 

SÁNCHEZ, Pablo J, MD 

Professor of Pediatrics 

The Ohio State University – Nationwide Children’s Hospital 

Divisions of Neonatal-Perinatal Medicine and Pediatric Infectious Diseases 

Director, Clinical & Translational Research (Neonatology) 

Center for Perinatal Research 

The Research Institute at Nationwide Children's Hospital Columbus, Ohio 

Term: 7/1/2019 – 6/30/2023 

TALBOT, Helen Keipp, MD 

Associate Professor of Medicine 

Vanderbilt University 

Nashville, TN 

Term: 10/29/2018 – 6/30/2022 

EX OFFICIO MEMBERS 

Centers for Medicare and Medicaid Services (CMS)

HANCE, Mary Beth 

Senior Policy Advisor 

Division of Quality, Evaluations and Health Outcomes 

Children and Adults Health Programs Group 

Center for Medicaid, CHIP and Survey & Certification Centers 

for Medicare and Medicaid Services Baltimore, MD 
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Food and Drug Administration (FDA) 

FINK, Doran, MD, PhD 

Deputy Director, Clinical, Division of Vaccines and Related Products Applications 

Office of Vaccines Research and Review 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

Silver Spring, MD 

Health Resources and Services Administration (HRSA) 

RUBIN, Mary, MD 

Chief Medical Officer 

Division of Injury Compensation Programs 

Rockville, MD 

Indian Health Service (IHS) 

WEISER, Thomas, MD, MPH 

Medical Epidemiologist 

Portland Area Indian Health Service 

Portland, OR 

Office of Infectious Disease and HIV/AIDS Policy (OIDP)

KIM, David, MD, MA 

Director, Division of Vaccines, OIDP 

Office of the Assistant Secretary for Health 

Department of Health and Human Services 

Washington, DC 

National Institutes of Health (NIH) 

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) Bethesda, MD 

LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP)

ROCKWELL, Pamela G, DO 

Associate Professor, Department of Family Medicine, University of 

Michigan Medical School 

Medical Director, Dominos Farms Family Medicine 

Ann Arbor, MI 

American Academy of Pediatrics (AAP) 

MALDONADO, Yvonne, MD 

Senior Associate Dean for Faculty Development and Diversity 

Professor of Pediatrics and Health Research and Policy 

Chief, Division of Pediatric Infectious Diseases 

Stanford University School of Medicine Stanford, CA 
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American Academy of Pediatrics (AAP) 

Red Book Editor

KIMBERLIN, David, MD 

Professor of Pediatrics 

Division of Pediatric Infectious Diseases 

The University of Alabama at Birmingham School of Medicine Birmingham, AL 

American Academy of Physician Assistants (AAPA) 

LÉGER, Marie-Michèle, MPH, PA-C 

Senior Director, Clinical and Health Affairs 

American Academy of Physician Assistants Alexandria, VA 

American College Health Association (ACHA) 

CHAI, Thevy S., MD 

Director of Medical Services 

Campus Health Services 

University of North Carolina at Chapel Hill Chapel Hill, 

NC 

American College Health Association (ACHA) (alternate) 

MCMULLEN, Sharon, RN, MPH, FACHA 

Assistant Vice President of Student & Campus Life for Health and Wellbeing Cornell Health 

Ithaca, NY 

American College of Nurse Midwives (ACNM) 

HAYES, Carol E., CNM, MN, MPH 

Lead Clinician 

Clinical Quality Compliance and Management 

Planned Parenthood Southeast Atlanta, GA 

American College of Nurse Midwives (ACNM) (alternate) 

MEHARRY, Pamela M., PHD, CNM 

Midwifery Educator, Human Resources for Health 

In partnership with University of Rwanda and University of Illinois, Chicago 

American College of Obstetricians and Gynecologists (ACOG) 

ECKERT, Linda O, MD, FACOG 

Professor, Department of Obstetrics & Gynecology 

Adjunct Professor, Department of Global Health 

University of Washington 

Seattle, WA

American College of Physicians (ACP) 

GOLDMAN, Jason M, MD, FACP 

Affiliate Assistant Professor of Clinical Biomedical Science, Florida Atlantic University, Boca 

Raton, Florida 

Private Practice 

Coral Springs, FL 
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American Geriatrics Society (AGS) 

SCHMADER, Kenneth, MD 

Professor of Medicine-Geriatrics Geriatrics 

Division Chief 

Duke University and Durham VA Medical Centers 

Durham, NC 

 ’ H I HI 

GLUCKMAN, Robert A, MD, MACP 

Chief Medical Officer, Providence Health Plans 

Beaverton, OR 

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA Washington, DC 

American Medical Association (AMA)

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine Emory 

University School of Medicine 

Atlanta, GA 

American Nurses Association (ANA) 

RITTLE, Charles (Chad), DNP, MPH, RN Assistant 

Professor, Nursing Faculty 

Chatham University, School of Health Sciences 

Pittsburgh, PA 

American Osteopathic Association (AOA) 

GROGG, Stanley E, DO 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA) 

FOSTER, Stephan L, PharmD CAPT 

(Ret) USPHS 

Professor, College of Pharmacy 

University of Tennessee Health Sciences Center 

Memphis, TN 

Association of Immunization Managers (AIM) 

HOWELL, Molly, MPH 

Immunization Program Manager 

North Dakota Department of Health

Bismarck, ND 
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Association for Prevention Teaching and Research (APTR) 

McKINNEY, W Paul, MD 

Professor and Associate Dean 

University of Louisville School of Public Health and Information Sciences

Louisville, KY 

Association of State and Territorial Health Officials (ASTHO) 

SHAH, Nirav D, MD, JD 

Director

Maine Center for Disease Control and Prevention

Augusta, ME 

Biotechnology Industry Organization (BIO) 

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

Council of State and Territorial Epidemiologists (CSTE) (alternate) 

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 

Canadian National Advisory Committee on Immunization (NACI) 

QUACH, Caroline, MD, MSc 

Pediatric Infectious Disease Specialist and Medical Microbiologist 

Medical Lead, Infection Prevention and Control Unit 

Medical Co-director – Laboratory Medicine, Optilab 

Montreal-CHUM 

Montreal, Québec, Canada 

Infectious Diseases Society of America (IDSA) 

BAKER, Carol J., MD 

Professor of Pediatrics 

Molecular Virology and Microbiology 

Baylor College of Medicine 

Houston, TX 
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International Society for Travel Medicine (ISTM) 

BARNETT, Elizabeth D, MD Professor of 

Pediatrics 

Boston University School of Medicine 

Boston, MA 

National Association of County and City Health Officials (NACCHO)

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 

National Association of County and City Health Officials (NACCHO) (alternate)

DUCHIN, Jeffrey, MD 

Health Officer and Chief, Communicable Disease

Epidemiology and Immunization Section 

Public Health - Seattle and King County 

Professor in Medicine 

Division of Allergy and Infectious Diseases 

University of Washington School of Medicine and School of Public Health

Seattle, WA 

National Association of Pediatric Nurse Practitioners (NAPNAP) 

STINCHFIELD, Patricia A, RN, MS, CPNP 

Director 

Infectious Disease/Immunology/Infection Control

Children's Hospitals and Clinics of Minnesota 

St. Paul, MN 

National Foundation for Infectious Diseases (NFID) 

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 

National Foundation for Infectious Diseases (NFID) (alternate)

DALTON, Marla, PE, CAE 

Executive Director & CEO 

National Foundation for Infectious Diseases (NFID) 

Bethesda, MD 

National Medical Association (NMA) 

WHITLEY-WILLIAMS, Patricia, MD Professor and Chair 

University of Medicine and Dentistry of New Jersey Robert Wood 

Johnson Medical School 

New Brunswick, NJ 
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Pediatric Infectious Diseases Society (PIDS) 

O’LEARY, Sean, MD, MPH 

Associate Professor of Pediatrics 

Pediatric Infectious Diseases 

General Academic Pediatrics 

Children’s Hospital Colorado 

University of Colorado School of Medicine 

Pediatric Infectious Diseases Society (PIDS) (alternate)

SAWYER, Mark H, MD 

Professor of Clinical Pediatrics 

University of California, San Diego School of Medicine 

San Diego, CA 

Pharmaceutical Research and Manufacturers of America (PhRMA) 

ROBERTSON, Corey, MD, MPH 

Senior Director, US Medical, Sanofi Pasteur 

Swiftwater, PA 

Society for Adolescent Health and Medicine (SAHM) 

MIDDLEMAN, Amy B, MD, MSEd, MPH 

Professor of Pediatrics 

Chief, Section of Adolescent Medicine 

University of Oklahoma Health Sciences Center

Oklahoma City, OK 

Society for Healthcare Epidemiology of America (SHEA)

DREES, Marci, MD, MS 

Chief Infection Prevention Officer & Hospital Epidemiologist 

ChristianaCare 

Wilmington, DE 

Associate Professor of Medicine 

Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA