Advisory Committee on 

Immunization Practices (ACIP)

Summary Report

July 29, 2020

Atlanta, Georgia

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

CENTERS FOR DISEASE CONTROL AND PREVENTION 

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Table of Contents Page

Agenda 3 

Acronyms 4-7 

Agency Updates 10-13

Update: Dr. Romero’s Presentation to the National Academy of Medicine (NAM) 13 

Coronavirus Disease 2019 (COVID-19)

 Introduction

 Operation Warp Speed (OWS): Overview of COVID-19 Vaccine Clinical Trials

 COVID-19 Vaccine Safety Considerations

 Considerations for Food and Drug Administration (FDA) Licensure vs. Emergency Use Authorization 

(EUA) of COVID-19 Vaccines

 Consideration for Vaccine Implementation

 Epidemiology of COVID-19 in Essential Workers, Including Healthcare Personnel (HCP)

 COVID-19 Vaccine Prioritization: Work Group Considerations

 COVID-19 Vaccine Work Group Considerations: Evidence to Recommendations (EtR) Framework 

13-59 

Certification 60

Membership Roster 61-70

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Agenda

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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 

Action Plan National Viral Hepatitis Action Plan 

AE Adverse Event

AFM Acute Flaccid Myelitis 

AHIP America’s Health Insurance Plans

AI/AN American Indian/Alaskan Native 

AIM Association of Immunization Managers 

AIRA American Immunization Registry Association 

AMA American Medical Association

ANA American Nurses Association

AOA American Osteopathic Association 

APhA American Pharmacists Association 

ASTHO Association of State and Territorial Health Officers 

ATS American Thoracic Society 

BARDA Biomedical Advanced Research and Development Authority 

BLA Biologics License Application

BLS Bureau of Labor Statistics 

CARES Act Coronavirus Aid, Relief, and Economic Security Act

CCN Community Care Network 

CDC Centers for Disease Control and Prevention

CI Confidence Interval 

CICP Countermeasures Injury Compensation Program 

CISA Clinical Immunization Safety Assessment 

CKD Chronic Kidney Disease

CMS Center for Medicare and Medicaid Services

COI Conflict of Interest 

CONUS Continental United States

COPD Chronic Obstructive Pulmonary Disease

COU Clinical Operations Unit 

COVID-19 Coronavirus Disease 2019 

CoVPN COVID-19 Prevention Network 

CRO Contract Research Organization 

CSTE Council of State and Territorial Epidemiologists 

DFO Designated Federal Official

DHA Defense Health Agency 

DHS Department of Homeland Security 

DNA Deoxyribonucleic Acid 

DoD Department of Defense

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs

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ED Emergency Department

EIS Epidemic Intelligence Service

ELISA Enzyme-Linked Immunosorbent Assay 

EMT Emergency Medical Technicians

ET Eastern Time

EtR Evidence to Recommendation 

EUA Emergency Use Authorization 

FDA Food and Drug Administration

FEMA Federal Emergency Management Agency 

FRN Federal Register Notice 

FY Fiscal Year 

GRADE Grading of Recommendation Assessment, Development and Evaluation 

HCoVs Human Coronaviruses 

HCP Healthcare Personnel / Providers

HCW Healthcare Workers 

HHS (Department of) Health and Human Services

HIV Human Immunodeficiency Virus 

HPV Human Papillomavirus

HRSA Health Resources and Services Administration 

ICU Intensive Care Unit

ID Intradermal

IDSA Infectious Disease Society of America 

Ig Immunoglobulin

IHS Indian Health Service 

IIS Immunization Information Systems 

IM Intramuscular 

IND Investigational New Drug 

IRB Institutional Review Board

ISO Immunization Safety Office

IT Information Technology 

JCVI Joint Committee on Vaccination and Immunisation 

LAIV Live Attenuated Influenza Vaccine

LTCF Long-Term Care Facilities 

ME Medical Examiner

MenACWY Meningococcal Conjugate Vaccine 

MHD Milwaukee Health Department 

MERS Middle East Respiratory Syndrome

MIS-C Multisystem Inflammatory Syndrome in Children 

MMWR Morbidity and Mortality Weekly Report

mRNA-1273 Messenger Ribonucleic Acid-1273 

NAAT Nucleic Acid Amplification Test 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada

NAIP National Adult Immunization Plan 

NAM National Academy of Medicine 

NAP National Action Plan 

NAPNAP National Association of Pediatric Nurse Practitioners 

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NAS National Academy of Sciences 

NASEM or the 

National 

Academies

National Academies of Sciences, Engineering, and Medicine 

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 

NEJM New England Journal of Medicine

NFID National Foundation for Infectious Diseases 

NIAID National Institute of Allergy and Infectious Diseases 

NIH National Institutes of Health

NIP National Immunization Program 

NMA National Medical Association 

NPI Non-Pharmaceutical Intervention

NPRM Notice of Proposed Rulemaking 

NVSN New Vaccine Surveillance Network 

NVAC National Vaccine Advisory Committee 

NVP National Vaccine Plan

NVPO National Vaccine Program Office 

NYC New York City

OID Office of Infectious Disease 

OIDP Office of Infectious Disease Policy and HIV/AIDS 

OWS Operation Warp Speed 

PAIVED Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD 

PCP Primary Care Practitioner

PCR Polymerase Chain Reaction 

PHAC Public Health Agency Canada 

PHEIC Public Health Emergency of International Concern 

PhRMA® Pharmaceutical Research and Manufacturers of America®

PI Principal Investigator

PICO Population, Intervention, Comparison, Outcomes 

PIDS Pediatric Infectious Disease Society 

PPE Personal Protective Equipment 

PRNT Plaque Reduction Neutralization Test 

Project COVERED Evaluation of Risk in Emergency Departments 

RCT Randomized Controlled Trial

RN Registered Nurse

RNA Ribonucleic Acid 

ROA Route of Administration 

RR Relative Risk

rRT-PCR Real-Time Reverse Transcription Polymerase Chain Reaction 

RSV Respiratory Syncytial Virus 

RT-PCR Reverse Transcriptase Polymerase Chain Reaction

SAE Serious Adverse Event 

SAGE Strategic Advisory Group of Experts on Immunization

SAHM Society for Adolescent Health and Medicine 

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SARS Severe Acute Respiratory Syndrome 

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

SCR Seroconversion Rate

SHEA Society for Healthcare Epidemiology of America 

SIRVA Shoulder Injury Related to Vaccine Administration 

SME Subject Matter Expert

STI Plan National Strategic Plan for Sexually Transmitted Infections

TA Technical Assistance 

UK United Kingdom

US United States

USG US Government 

USPHS US Public Health Service 

VA (US Department of) Veteran’s Affairs 

VAERS Vaccine Adverse Event Reporting System

VE Vaccine Efficacy

VE Vaccine Effectiveness

VFC Vaccines For Children

VICP Vaccine Injury Compensation Program 

VRBPAC Vaccines and Related Biological Products Advisory Committee Meeting 

VSD Vaccine Safety Datalink

WG Work Group

WHO World Health Organization

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Call To Order, Welcome, Overview, Announcements, & Introductions

José Romero, MD, FAAP

ACIP Chair

Amanda Cohn, MD

Executive Secretary, ACIP / CDC

Dr. Romero called to order the July 29, 2020 virtual Advisory Committee on Immunization 

Practices (ACIP) meeting. He thanked everyone for taking time out of their busy schedules to 

participate and for working with the Centers for Disease Control and Prevention (CDC) and 

ACIP on this virtual meeting.

Dr. Cohn extended her welcome to those present, reminding everyone that this was an 

emergency meeting called to discuss only the issue of Coronavirus Disease 2019 (COVID-19) 

vaccines that, in addition to being virtual, did not coincide with ACIP’s regular schedule. She 

noted that the slides to be presented during this meeting were made available through a 

ShareFile link for ACIP voting, liaison, and ex-officio members and for members of the public on 

the ACIP website at the following URL, which would be taken down at 5:00 PM following the 

end of the meeting and eventually would be replaced with a 508-compliant version: 

https://www.cdc.gov/vaccines/acip/meetings/slides-2020-07.html

The 508-compliant slides presented during this meeting will be posted on the ACIP website 

approximately 4 weeks after the meeting. The live webcast videos also will be posted in about 4 

weeks following the meeting, and the meeting minutes are posted to the ACIP website generally 

within about 120 days following the meeting.

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

Romero opened the floor for discussion and to keep their video off to reduce problems with the 

Zoom format. 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 even if they were running early.

The next regularly scheduled ACIP meeting will be convened at CDC or virtually on October 28-

29, 2020. Additionally, two virtual meetings have been added to the ACIP calendar that are 

tentatively scheduled for August 26, 2020 and September 22, 2020. These will likely be 

scheduled for 10:00 AM to 4:00 PM Eastern Time (ET). Registration for these meetings is not 

required as they are virtual meetings. The link to the live virtual meeting can be found on the 

website the day of the meeting.

Call To Order, Welcome, Overview, Announcements, & Introductions 

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Dr. Cohn emphasized that ACIP is, at its heart, a public body. Engagement with the public and 

transparency in ACIP’s processes is vital to the Committee’s work. As part of ACIP’s 

commitment to continuous improvement, ACIP has strengthened its oral and written public 

comment process to accommodate increased public interest in ACIP’s work, maximize 

opportunities for comment, and make public comment more transparent and efficient. She 

announced that for this meeting, one oral public comment period would be held during the first 

afternoon at approximately 3:00 PM. Because there are typically more people wishing to make 

public comments than there is time during meetings, people interested in making an oral 

comment were asked to submit a request online in advance of the meeting via the ACIP 

website. If more people request to speak than can be accommodated, a blind lottery is 

conducted to determine who will be the speakers. Speakers selected for this meeting were

notified in advance of the meeting. Written public comments may be made via regulations.gov

using the docket number ID CDC-2020-0081. Information on the written public comment 

process, including information about how to make a public comment, can be found on the ACIP 

website.

As noted in the ACIP Policies and Procedures manual, members of the ACIP 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 while serving on the 

committee, 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 these vaccines, but are prohibited from participating in 

committee votes on issues related to these vaccines. Regarding other vaccines of the 

concerned company, a member may participate in discussions with the provision that he/she 

abstains on all votes. Dr. Cohn indicated that for this meeting, no particular vaccine products 

would be discussed. However, ACIP members were requested to indicate any COIs related to a 

company that has a vaccine under development for COVID-19. Given that specific products 

would not be discussed, no members were to be excluded from the discussion.

Dr. Romero conducted a roll call of ACIP members, during which the following COIs were 

declared:

 Dr. Robert Atmar is serving as the Co-Director of the Clinical Operations Unit (COU) of the 

National Institutes of Health (NIH)-funded Infectious Diseases Clinical Research Consortium

(IDCRC) that is working within the COVID-19 Prevention Network (CoVPN) to evaluate 

Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) vaccine candidates in 

Phase 3 clinical trials, including those produced by Moderna and Astra Zeneca.

 Dr. Sharon Frey will be conducting multiple vaccine trials through the NIH CoVPN. The two

trials that she is currently aware of are for Moderna and Janssen products. 

 Dr. Paul Hunter owns a small amount of stock in Pfizer and has received a small amount of 

funding for a Pfizer-funded quality improvement project.

 Dr. Pablo Sánchez receives funding from Merck for research focused on global antibiotic 

use.

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Dr. Romero requested that the Liaison and Ex Officio members introduce themselves. A list of

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

end of the full minutes for the July 2020 ACIP meeting. 

Agency Updates

Centers for Disease Control and Prevention (CDC)

Dr. Messonnier presented the CDC agency update. To follow-up from discussions during the 

last ACIP meeting regarding routine vaccination, there continue to be signs of improvement in 

pediatric vaccine ordering and uptake. This is not consistent across the whole country and there 

are still several states that seem to be lagging behind, but month-by-month families are 

beginning to return to their pediatricians for well-child check-ups and routine vaccinations. That 

is encouraging news and hopefully everyone will continue working together to keep up that 

momentum. Regarding influenza, the agency is busily preparing for influenza season. While 

they certainly hope that social distancing will lead to a mild influenza season, everyone needs to 

be prepared for a potentially severe influenza season. Influenza on top of COVID-19 certainly 

would be devastating this Fall. CDC hopes that everyone will continue to work with them to 

strongly advocate for all patients to get their influenza vaccines. The agency is working on a 

number of expanded efforts this year with a variety of partners, including health departments, to 

broaden their reach and to specifically target activities toward those at higher risk for COVID-19 

and those with traditionally lower influenza vaccination coverage such as long-term care facility 

(LTCF) residents, LTCF staff, and communities of color. While COVID-19 is obviously in the 

front of everyone’s minds, it also is important to be aware that the time is nearing when acute 

flaccid myelitis (AFM) cases normally would be seen. There has been an every-other-year 

cycle, so 2020 has been anticipated to be a year in which a lot of cases would be seen. The 

impact that social distancing may have is unknown, but hopefully it will result in less cases. 

Early recognition of AFM is key. CDC and its partners will launch a variety of activities, including 

a VitalsignsTM in the Morbidity and Mortality Weekly Report (MMWR) to get the word out to 

frontline clinicians and parents about what symptoms to look for so that cases can be rapidly 

identified and reported to health department and clinical networks so that children identified to 

have AFM receive the best care possible. 

Department of Defense (DoD)

Dr. Deussing conveyed the DoD’s appreciation to ACIP and CDC for continued inclusion of the 

DoD in this meeting and the ACIP working groups. As mentioned during the February 2020 

ACIP meeting, the DoD is interested in the use of Food and Drug Administration (FDA)-

approved Southern Hemisphere influenza vaccine. This program began in May 2020 and this 

vaccine is now required for all Active Duty, Select Reserve Component, and National Guard 

members and is recommended for all of their beneficiaries who are permanently or temporarily 

assigned to an areas designated as a Southern Hemisphere influenza zone by the World Health 

Organization (WHO). Their assignment must be in this zone for at least 14 contiguous days 

during the period of 1 April through 30 September. The Pragmatic Assessment of Influenza 

Vaccine Effectiveness in the DoD (PAIVED) is beginning its third research year for the 2020-

2021 influenza season. The DoD also is working toward approval of an evaluation of the 

Bavarian Nordic smallpox and monkeypox vaccine for cardiac safety, interaction with other 

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common readiness vaccines, and optimum booster interval. With respect to COVID-19, the DoD 

plans to participate in Investigational New Drug (IND) studies of SARS-CoV-2 vaccine 

candidates with a start date pending. As a result of the COVID-19 pandemic, there has been a 

noted decrease in children beneficiaries receiving scheduled immunizations on time. This is 

similar to what has been described in the broader civilian population as Dr. Messonnier 

mentioned earlier. In response, the DoD developed resources on providing immunization during 

the COVID-19 pandemic, as well as options to provide immunizations outside of military 

treatment facilities.

Department of Veterans Affairs (DVA)

Ms. Lori Hoffman-Hogg reported that the DVA developed and released a new national 

decision support tool, or clinical reminder, for influenza immunization on July 20, 2020. Use of 

this national immunization reminder is required for all Defense Health Agency (DHA) sites in 

order to ensure uniform documentation and data capture across the enterprise. In addition, VA 

updated the national clinical reminder for meningococcal B vaccine to align with the ACIP 

recommendations for booster doses. VA is preparing for the 2020-2021 seasonal influenza 

campaign. These preparations include the development of a national toolkit to support VA 

facilities in standing up drive-through influenza clinics and promotion of Community Care 

Network (CCN) sites where veterans can obtain no-cost influenza vaccine at retail pharmacies 

and urgent care centers. VA ordered more than 2.8 million doses of influenza vaccine for the 

2020-2021 season, which is an 8% increase over last season, with 50% of the initial supply 

arriving at VA facilities by September 15, 2020. This report is submitted on behalf of Dr. Jane 

Kim, Chief Consultant for Preventive Medicine in the DHA National Center for Health Promotion 

and Disease Prevention, United States (US) DVA.

Food and Drug Administration (FDA)

Dr. Fink reported that FDA continues to work around the clock seemingly at times to review and 

facilitate development programs for numerous vaccine candidates intended for prevention of 

COVID-19 and/or SARS-CoV-2 infection. These include candidates such as those that are still 

in pre-clinical development to several that have recently entered into Phase 3 studies in the US. 

There are no licensure actions to report since the last ACIP meeting in June 2020. At the end of 

June 2020, FDA released new guidance for industry titled, “Development and Licensure of 

Vaccines to Prevent COVID-19: Guidance for Industry.” This guidance provides information on 

the data in terms of manufacturing, non-clinical information, and clinical information that would 

be needed to support the development of COVID-19 vaccine candidates at various phases of 

development; post-licensure safety; diagnostic and serological assays; and additional 

considerations related to licensure and other mechanisms to make the vaccine available such 

as Emergency Use Authorization (EUA). Dr. Fink indicated that he would say more about 

licensure and EUA during his presentation later in the day.

Health Resources and Services Administration (HRSA)

Dr. Rubin reported that as of July 1, 2020 in this fiscal year (FY), petitioners have filed 843 

claims with the National Vaccine Injury Compensation Program (VICP) and $180 million was 

awarded to petitioners and attorneys for fees and costs. As of July 20, 2020, HRSA had a 

backlog of 922 claims alleging vaccine injury that are awaiting review. More data about the 

program can be obtained on the HRSA website. On July 20, 2020, the Notice of Proposed 

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Rulemaking (NPRM) proposing to remove Shoulder Injury Related to Vaccine Administration 

(SIRVA) and syncope from the Vaccine Injury Table was published in the Federal Register. As a 

result of the publication of this NPRM, the public is able to submit comments on or before 

January 12, 2021. Also, a public hearing will be held to allow the public to present comments. 

Information about this public hearing will be forthcoming and will be announced in the Federal 

Register. As of July 1, 2020, the Countermeasures Injury Compensation Program (CICP) has 

compensated 40 claims totaling $5.7 million.

Indian Health Service (IHS)

Dr. Weiser reported that the Incident Command System/Emergency Operations Center 

ICS/EOC remain activated at all levels of the agency. IHS and CDC are finalizing an agreement 

for IHS for COVID-19 vaccine adverse event (AE) monitoring. IHS appreciates CDC reaching 

out to make this happen. Members of Operation Warp Speed (OWS) have recently reached out 

to IHS to ensure appropriate inclusion of American Indian/Alaska Native (AI/AN) populations in 

vaccine distribution planning, and those discussions are ongoing. A preliminary review of 

national immunization coverage reported to the IHS National Immunization Reporting System 

demonstrates fairly stable coverage for 2-year-olds who are up-to-date overall in most areas. 

Receipt of measles-containing vaccines for 2-year-olds also has been preserved. The battle 

against COVID-19 continues with over 30,000 positive tests so far in IHS. The largest number of 

cases to date have been reported in the Southwest and Oklahoma areas. To data, IHS has 

conducted almost a half a million tests. IHS continues to coordinate with states, CDC, Federal 

Emergency Management Agency (FEMA), and other partners in responding to the pandemic.

National Institutes of Health (NIH)

Dr. Beigel reported that on Monday, July 27, 2020, the National Institute of Allergy and 

Infectious Diseases (NIAID) announced the Phase 3 clinical trail for the vaccine against SARSCoV-2. The vaccine is called Messenger Ribonucleic Acid-1273 (mRNA-1273) and it is a 

combination of a lot of work even before COVID-19 started plus rapid implementation of the 

Phase 1, Phase 2, and now the Phase 3 studies. Phase 3 involves multiple US government 

agencies and the company, Moderna, to get this 30,000 participant study implemented. He 

indicated that more updates would be provided in the afternoon and that the remainder of NIH’s 

updates would be submitted in written format.

Office of Infectious Disease Policy and HIV/AIDS (OIDP)

Dr. Kim indicated that the National Vaccine Advisory Committee (NVAC) met on June 9, 2020 

with an agenda that centered on the COVID-19 pandemic. The discussion included vaccine 

development, insurance coverage under the Coronavirus Aid, Relief, and Economic Security 

(CARES) Act, and efforts to promote routine childhood immunization during the pandemic. The 

work on recommendations for vaccine confidence and immunization equity continues for NVAC. 

The subcommittees will submit their reports by February 2021. The next NVAC meeting is 

scheduled for September 23-24, 2020. Work is in progress on the National Vaccine Plan (NVP) 

for 2020-2025. Although some of the work was disrupted by the COVID-19 pandemic, the intent 

is to release the NVP in December 2020. Updates were provided during the February 2020 

ACIP meeting on the National Strategic Plan for Sexually Transmitted Infections (STI Plan) and 

the National Viral Hepatitis Action Plan (Action Plan). The intent is to develop strategies for 

Hepatitis A and B and human papillomavirus (HPV) vaccination and to integrated issues such 

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as stigma, disparities, and social inequities. These plans are scheduled for release in late Fall 

2020.

Update: Presentation to the National Academy of Medicine (NAM)

José Romero, MD, FAAP

ACIP Chair

Chief Medical Officer

Arkansas Department of Health

Dr. Romero provided an update on comments he was requested to present during the Open 

Session of the July 24, 2020 meeting of the National Academies of Sciences, Engineering, and 

Medicine (NASEM or the National Academies) Committee on Equitable Allocation of Vaccines 

for the Novel Coronavirus. He presented a brief history of the ACIP, the mechanism by which 

ACIP arrives at its recommendations, the structure of the ACIP, the topics ACIP has covered 

with regard to COVID-19 vaccines, and previous and future meeting dates. There was a brief 

discussion afterwards, during which there was certainly a sense of collegiality and cooperation 

between the two groups. Dr. Art Reingold suggested that perhaps members of the ACIP and the 

Committee on Equitable Allocation of Vaccines for the Novel Coronavirus could appoint 

members to sit on each other’s committees. While it is not known whether this will go forward, it 

was clearly a meeting of cooperative interaction. 

Coronavirus Disease 2019 (COVID-19) Vaccines

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 indicated that there are over 200 COVID-19 vaccines currently under development, 

including three in clinical trials in the US. The ACIP is responding to this ongoing pandemic and 

accelerated vaccine development through scheduling of monthly emergency ACIP meetings. As 

a reminder, during the June 24, 2020 meeting, ACIP reviewed the following: 

 An overview of the COVID-19 Vaccine Workgroup (WG) and Terms of Reference

 SARS-CoV-2 disease, immunology, and epidemiology

 COVID-19 vaccine development and the vaccine landscape

 Considerations pertaining to COVID-19 vaccine prioritization 

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The COVID-19 Vaccine WG is now meeting weekly. During the July 2020 meeting, the COVID19 Vaccine WG:

 Reviewed published Phase I clinical trial results

 Considered safety issues regarding COVID-19 vaccines (the COVID-19 Vaccine WG has a 

Technical Subgroup that is Chaired by Dr. Grace Lee, which is specifically focused on safety 

issues) 

 Reviewed regulatory mechanisms for the deployment of COVID-19 vaccines with the help of 

the FDA liaison

 Received epidemiology updates, including focusing on COVID-19 in healthcare personnel 

(HCP)

 Continued consideration of COVID-19 vaccine prioritization

 Continued to work to fill in the Evidence to Recommendations (EtR) framework to guide 

COVID-19 vaccine policy

The agenda for the July 29, 2020 ACIP meeting included presentations on the following topic 

areas:

 Overview of COVID-19 Vaccine Clinical Trials

 COVID-19 Vaccine Safety Considerations

 Considerations for FDA Licensure vs. Emergency Use Authorization (EUA) of COVID-19 

Vaccines

 Considerations for Vaccine Implementation

 Epidemiology of COVID-19 in Essential Workers, Including HCP

 COVID-19 Vaccine Prioritization: WG Considerations

 EtR Recommendations Framework and WG Next Steps

The WG is reviewing considerations for vaccine prioritization in specific groups using a phased 

approach, and spent quite a lot of time in July assessing essential workers and HCP. Plans are 

currently underway to review persons at increased risk for severe COVID-19 disease (e.g., older 

adults, persons with underlying conditions, racial/ethnic minority groups). There is a collection of 

specific background and evidence that will be examined for this group. The WG will focus on the 

general population thereafter. As mentioned earlier, the focus of this session would be on 

essential workers, including HCP. Prioritization considerations for other groups will be reviewed 

at upcoming ACIP meetings. 

They just heard a little from Dr. Romero about NASEM’s Committee on Equitable Allocation of 

Vaccine for the Novel Coronavirus, which is co-sponsored by the NIH and CDC and meant to 

inform the decisions of health authorities, including the ACIP by developing an overarching

framework to assist policymakers in the US and global health communities in planning for

equitable allocation of vaccines against COVID-19. The Committee is charged with addressing 

the following questions, which essentially focus on equity: 

 What criteria should be used in setting priorities for equitable allocation of vaccine?

 How should the criteria be applied in determining the first tier of vaccine recipients?

 How can countries ensure equity in allocation of COVID-19 vaccines?

 For the US, how can communities of color be assured access to vaccination?

 What steps should be taken to mitigate vaccine hesitancy, especially among high-priority 

populations?

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Operation Warp Speed (OWS): Overview of COVID-19 Vaccine Clinical Trials

Julie Ledgerwood, DO

Deputy Director & Chief Medical Officer

Vaccine Research Center

National Institute of Allergy and Infectious Diseases

National Institutes of Health

Dr. Ledgerwood noted that she was presenting during this session as part of the OWS Team, 

indicated that she would provide an update on the efficacy of trial efforts, and expressed 

appreciation for the invitation. In May 2020, Drs. Corey, Mascola, Fauci, and Collins published a 

plan, or vision really, of the public-private partnership to accelerate the evaluation of primarily 

Department of Health and Human Services (HHS)-funded vaccine candidates, with an end goal 

of accelerating licensure and, therefore, availability of the vaccines. This plan has served as the 

blueprint for the ongoing and upcoming OWS trials.

Among the entities launched by the US Government (USG) to combat COVID-19, OWS was 

established in May 2020. OWS is a multi-agency, or all of government, USG effort being 

conducted in collaboration with the private sector to provide COVID-19 vaccine, therapeutic, 

and diagnostic development. The effort is led by Dr. Moncef Slaoui and General Gustave F. 

Perna. Vaccine leadership includes Drs. Anthony Fauci, Francis Collins, and John Mascola from 

the NIH and Dr. Matt Hepburn (Maj Gen, USAF Ret) from the DoD. Many hundreds of team 

members are involved as well.

Within OWS, the Vaccine Development Team supports pre-clinical testing, clinical development, 

safety monitoring, manufacturing, immune assays, and distribution and access. The funding of 

these trials is largely through the Biomedical Advanced Research and Development Authority

(BARDA) and NIH funding. NIH established the public-private partnership for coordinating the 

COVID-19 response known as Accelerating COVID-19 Therapeutic Interventions and Vaccines 

(ACTIV). The idea for ACTIV came primarily from Dr. Collins and was established early in the 

outbreak to bring together top scientists, manufacturers, and others to coordinate the medical 

countermeasures. The COVID-19 Prevention Network (CoVPN) was formed by the NIAID at 

NIH to respond to the global pandemic by using the infectious disease expertise of almost all of 

the existing NIH research networks that had experience conducting this type of research 

throughout the country and the world. These groups under the CoVPN are now charged with 

helping to plan and execute large-scale USG-funded trials The vaccine efforts within the CoVPN 

are led by Drs. Larry Corey and Kathy Neuzil and their teams. A snapshot of the CoVPN clinical 

sites throughout the world is shown here:

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Multiple networks emerged to implement these trials and these have been supplemented with 

groups from the DoD, including the VA, from academia, and from private or contract research 

organization (CRO)-managed sites. That combination has led to an expansive network of site 

options where many trials with large numbers of subjects are being launched this year. For 

example, the CoVPN now includes about 117 US sites, which is an increase from about 50 sites 

just a little over a month ago. The sites are also accommodating the growing needs of these 

upcoming trials. Many have increased their floor space, members of staff, and added mobile or 

temporary units to accommodate the trial or adhere to any social distancing requirements in 

place or necessary where they are. Importantly, as these trials are seeking to enroll volunteers 

from diverse populations, including minority populations at higher risk of COVID-19, the OWS, 

NIH, DoD, and the CoVPN teams; the vaccine developers; and the sites are implementing 

impressive recruitment and community outreach efforts to reach these populations. 

Internationally, the CoVPN has about 189 sites to offer to the OWS efficacy trial efforts. Many of 

those are shown on the above map. Some of the trials will occur in the Continental US 

(CONUS) and some will occur in the CONUS with additional international site involvement.

For any given trial, the CoVPN sites are being heavily augmented by private or contracted CRO 

sites. The team broadly has identified almost 900 potential sites that could be activated using a 

variety of contracting mechanisms through various companies to enroll large multi-site efficacy 

trials. Potential sites as of July 26, 2020 shown here: 

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Sites continue to be added to this list, with a particular focus on counties in the country that are 

being hardest hit by the outbreak to ensure that those area are especially engaged in these 

efficacy trial efforts for multiple reasons.

To address the basis of these efforts to serve the US population and enable rapid vaccine 

development, a series of underlying principles was formulated. These are derived largely from 

the publication in May 2020, but have been expanded over the last months. These are referred 

to as “Semi-Independent Harmonized Trials.” Multiple vaccine candidates are being tested in 

this way. Specifically, what that means is that the FDA regulatory or Investigational New Drug 

(IND) sponsorship is with the vaccine developer or company. Because of this tremendous 

responsibility, the OWS leadership has been designating teams of experts within the USG to 

assist each of the public partners or vaccine developers in the planning and execution of the 

trials. Part of that is largely from the CoVPN.

Enshrined in that principle the common elements applied to all trials are use of common 

endpoints; use of collaborating networks, such as CoVPN; use of common, validated immune 

assays among collaborating laboratories to ensure consistency and high-quality virologic and 

immunologic readouts among the trials; use of a common DSMB stood up by NIAID for all OWS 

vaccine trials, which have the charge to oversee with a strict eye for safety and efficacy; and a 

between-trial immune and statistical analysis of correlates of protection to enable critical 

understanding about vaccine responses and protection incurred from a vaccine or multiple 

vaccines. Of note, a DSMB is a body of experts integrated to oversee the study. They already 

have been involved ahead of trial launches and during trial design. They will have access to 

unblinded safety and efficacy data throughout the trial, and will evaluate the interim data for 

safety and efficacy at multiple timepoints during the study.

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The FDA played a large role in the effort to harmonize trial design. In June 2020, the FDA 

published, “Development and Licensure of Vaccines to Prevent COVID-19: Guidance for 

Industry.” In that publication is very clear guidance for trial design and implementation that is 

being adhered to by the OWS vaccine teams and developers. This has offered a great deal of 

insight into the FDA’s requirements. All of this is in an effort to advance development of 

vaccines more rapidly for the public.

Six of the OWS Phase 3 efficacy trial principles that are being used to design the efficacy trials 

in a consistent manner include the following:

 The trials are randomized and placebo-controlled with efficacy endpoints

 While the sample size of each trial varies, it is approximately 30,000 volunteers for testing

one vaccine

 Study populations at this time are set to be adults ≥18 years of age, targeting a subset of

individuals who are at high-risk of both disease and severe disease and making an effort to

enroll diverse populations

 The primary endpoint is prevention of symptomatic COVID-19 disease, which is virologically

confirmed by polymerase chain reaction (PCR)

 The primary efficacy endpoint point-estimate is at least 50% as defined by the FDA

guidance document

 The statistical success criterion should be the lower bound of the confidence interval (CI)

>30%

 The use of harmonized OWS-directed immunogenicity assays and correlates analysis plan

 Use of a common DSMB that is NIAID-managed and will work with all of these trials as an

independent body to oversee safety and efficacy

Although BARDA supports multiple groups in the development of COVID-19 medical 

countermeasure development, among those groups there are 4 products for which OWS is 

working toward launching efficacy trials this year. The first is the Moderna mRNA vaccine. That 

trial was launched on July 27, 2020. Moderna will enroll that trial of about 30,000 participants at 

89 sites in the US. Additionally, AstraZeneca is developing product with OWS based on an 

adenoviral (Ad) vector. While that trial will occur in 2020, the projected start date has not yet 

been identified. The Janssen Ad vector vaccine trial also will start this year, ideally in 

September. Novavax has a recombinant protein with adjuvant vaccine, which OWS is protecting 

to begin in October 2020.

About 4 months after the Phase 1 trial launch, Moderna launched their efficacy trial on July 27, 

2020. As mentioned earlier, this trial aims to enroll 30,000 subjects at approximately 89 US 

sites. This trial is now fully activated and more details are available on clinicaltrials.gov. Dr. 

Ledgerwood encouraged everyone to seek accurate information about trials from that site. As 

each trial is approved and launched, that information will be presented there as well.

With multiple large efficacy trials to occur and launch within a timeframe of just a few months, 

OWS knew that a lot of public engagement would be required. The CoVPN and NIAID 

established a website that was recently stood up to describe some of these efforts and to 

engage the public with basic information in a way that a large group of people could understand 

what is occurring. This site is: coronaviruspreventionnetwork.org. Within that website, an 

opportunity has been embedded for people who are interested in trials to link to an Institutional 

Review Board (IRB)-approved, volunteer, click to consent registry where people can indicate 

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their interest in a vaccine trial in general. They provide their information and assess their risk 

using a series of questions that were pre-determined to have some validity in assessing risk. In 

just the first 20 days of the website launch, there were over 4 million views of the website as of 

July 28, 2020. Over 200,000 potential participants have registered their personal information, 

information about their risks, and their willingness to be contacted by a site for potential 

enrollment into a clinical trial. This has been augmented with nationwide broad and local 

community outreach engagement activities by OWS, DoD, NIH, and the individual vaccine 

developers and their CROs and sites. The key to success will be the recruitment of volunteers 

who have risk of disease among very diverse populations. The outbreak has hit many minority 

populations in hard ways, so it is important to engage them to be fully active in these trials as 

they proceed. This trial site map shows broad US coverage:

A concerted effort was made to have sites represent multiple areas of the country. Some areas 

are obvious in that they are metropolitan and known to have active outbreaks or be in the view 

of experts of being at risk of having outbreaks. Others are in more rural areas but have the 

potential to have outbreaks for various reasons. Sites have been established broadly in an effort 

to find a large, diverse population at risk for disease.

Discussion Points

Dr. Romero asked whether there are data on the ethnicity and race of the individuals who have 

demonstrated interest in participating in vaccine trials through the registry portal, and whether 

information is available in the registry portal in languages other than English.

Dr. Ledgerwood indicated that the site was initially launched with a soft launch ahead of most of 

the community engagement efforts. A large group of the people who have registered are not 

minorities, but there has been a fairly robust minority response. The data are still being 

calculated for the week. Parameters are being established with the registry host, Oracle, to be 

able to look at the demographic data, population information, and risk level in a more robust way 

in the coming weeks. Therefore, it is somewhat early to be able to indicate the specifics on that. 

The ongoing community engagement efforts over the next 2 weeks are anticipated to have a 

major impact on the diversity of the registry population. An impressive effort is being 

undertaken. The registry site is fairly general at this point, because it was launched ahead of 

any trial openings. The site is actively being translated into Spanish. In the coming days and as 

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specific trials become active, information about those will be highlighted in the registry website 

as well.

Dr. Kimberlin (AAP Red Book) said that he and others have heard about the possibility of 

challenge studies for testing vaccines, though not recently. He asked Dr. Ledgerwood to 

comment whether that is under consideration.

Dr. Ledgerwood indicated that there was a lot of discussion about that and there were some 

publications regarding those deliberations. OWS’s efforts are targeted at traditional efficacy 

trials, though others in the group could comment on disposition of the challenge studies. 

Dr. Lee asked whether there would be ongoing information posted on the website about who is 

registered so that they can continue to assess risk and the diversity of the populations enrolled, 

with location as a proxy, to get an understanding of where disease activity might be highest. 

Also, it would be great to hear more about the nationwide community engagement efforts 

already being undertaken, and whether there are opportunities to sustain that as vaccine is 

being distributed in order to continue to understand and learn how to optimally work with 

communities in ways that get vaccine where it is needed.

Dr. Ledgerwood indicated that she would take the question about posting demographics back to 

the team. She did not think there was a plan to post that information publicly, but they are 

certainly tracking it. As of now, the 200,000 registrants are from all over the country. Obviously, 

the metropolitan areas have large numbers associated with them. However, there is no part of 

the country where there are no registrants seeking information about the trials. The efforts for 

community engagement are led by Dr. Nelson Michael from DoD, Dr. Jim Kublin from the 

CoVPN, and Dr. Hilary Marston from NIAID have taken a great deal of responsibility in the area 

of community engagement. It is a great idea to try to link what they are doing with eventual 

success in distribution of vaccination. She asked whether ACIP would like to talk to one of them 

in the coming month or two about what they are doing.

Dr. Messonnier indicated that CDC is already linked into that effort, and she agreed completely 

with Dr. Lee’s thoughts. Several CDC staff are on those WGs looking at community 

engagement and specifically looking to make sure that community engagement seamlessly 

transitions into the future phases of vaccination. CDC can certainly provide an update about 

that, but as a general principle, she would say that CDC is well-linked.

Dr. Bell asked what information Dr. Ledgerwood could provide to ACIP about at least the other 

BARDA-sponsored vaccine development programs that are not under the umbrella of OWS in 

terms of their plans for clinical trials, use of the same sites, sense of their general strategies, 

whether they are using similar study designs even though they are not under the umbrella of the 

harmonized vaccine trial design, et cetera.

Dr. Ledgerwood said they recognize that there are many other groups being funded under 

BARDA for various components of their work. She noted that because she is completely locked 

in essentially fulltime on this effort with these 4 companies, she is probably not the best source 

of information about other efforts. The FDA guidance on trial design is pretty clear and OWS is

following it to the letter. Most, if not all companies in the US, would be doing that. 

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COVID-19 Vaccine Safety Considerations

Kathryn M. Edwards MD

Sarah H. Sell and Cornelius Vanderbilt Professor

Division of Infectious Diseases

Department of Pediatrics

Vanderbilt University Medical Center 

Dr. Edwards indicated that she is the Principal Investigator (PI) of the CDC-funded Clinical 

Immunization Safety Assessment (CISA) Project, and that the findings and conclusions in this 

presentation are hers and do not represent the official position of CDC. During this presentation, 

she discussed COVID-19 vaccine safety considerations in terms of previous vaccine enhanced 

disease to explain what is known and what they want to prevent; animal vaccines for SARS; 

animal models for SARS-2 (e.g., challenge/rechallenge studies and chimp, adenovirus vaccine); 

and vaccine studies in humans (chimp adenovirus vaccine and 2 mRNA vaccines).

Respiratory syncytial virus (RSV) was isolated in the late 1950s. At that time, it was felt that 

perhaps an RSV vaccine could be made in the same way that influenza vaccine had been made 

by formalin inactivation of the whole virus. In the 1960s, there was a large clinical trial that 

administered RSV formalin inactivated whole virus vaccine to infants. In this study, infants were 

given 3 injections and antibody responses were measured by both complement fixation (CF) 

and neutralizing antibody (NA). Dr. Edwards focused on NA because only a small percentage of 

the infants who received the 3 injections actually developed NA.

The mean fold rise of that NA titer compared with natural infection after recovery from the virus 

was much lower. Those children were followed very closely for the next 2 years. When the RS 

lot 100 (formalin inactivated RSV vaccine) was compared to Para 1 lot 23 (formalin inactivate 

parainfluenza vaccine), the number of hospitalizations of the children who were vaccinated was 

actually larger than those who received Para 1 lot 23 and more importantly, 80% of those 

children who were vaccinated were hospitalized and 2 children died [Hyun Wha Kim, Jose G. 

Canchola, Carl D. Brandt, et al, Respiratory syncytial virus disease in infants despite prior 

administration of antigenic inactivated vaccine, American Journal of Epidemiology, Volume 89, 

Issue 4, April 1969, Pages 422–434, https://doi.org/10.1093/oxfordjournals.aje.a120955].

In terms of the autopsy findings of the 2 children who died compared to the controlled, a 

deposition of antibody and complement was seen in the actual airways. This suggests that there 

was an immune-mediated problem that was not seen in the control individuals. In addition, 

eosinophils were noted in the lung tissue quite prominently in Patients 1 and 2 [The Journal of 

Experimental Medicine; Volume 196, Number 6, September 16, 2002 859–865].

Over the intervening 3 decades, a lot of information has been acquired to understand what 

happened in the immune-mediated pathologic reaction that occurred. As depicted in the 

following illustration in the upper left corner, crystallography shows that the virus has binding 

sites that are very important for neutralization of the virus. The red and orange are at the tip of 

the virus that the individual would see when infected with the virus:

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In contrast, the crystal structure of the fused membrane on the lower left is what occurs when 

there is formalin inactivation of the virus such that the epitopes shown in red and orange are 

really gone and now there are purple and blue. The function of the neutralization of the purple 

and the blue is much less, suggesting that it is necessary to understand the structure of the 

virus and not destroy it when the vaccine is made.

Another adverse event (AE) with vaccines was shown several years ago with the dengue 

vaccine. In a trial by Sridhar et al in 2018, the actual serostatus of the vaccine was examined in 

terms of the efficacy of the vaccine. In terms of the risk of hospitalization for virologically 

confirmed dengue (VCD) and of severe VCD in children 2 to 4 years of age, children who were 

seropositive from natural virus before they were immunized were boosted and protected against 

disease. In contrast, the dengue vaccine was not as functional in neutralizing the virus in 

children who were seronegative prior to vaccination and those children had worse outcomes 

than those who were not vaccinated. That is, the control children did better than the vaccination 

seronegative children in terms of dengue disease [Sridhar et al, Effect of Dengue Serostatus on 

Dengue Vaccine Safety and Efficacy, N Engl J Med 2018; 379:327-340; DOI:

10.1056/NEJMoa1800820, July 26, 2018].

In terms of how to put these findings into context, in an article titled “Rapid COVID-19 Vaccine 

Development: Finding the fastest pathway to vaccine availability includes the avoidance of 

safety pitfalls,” that appeared in 2020 in Science by Dr. Graham does a nice job of explaining 

this. Regarding enhanced disease that is antibody-mediated, through dengue it has been shown 

that antibody-dependent enhancement (ADE) increases the amount of virus into the cells if 

antibody is not directed to the neutralizing epitope. As with RSV, vaccine-induced respiratory 

disease also can occur as a function of antibody and also T-cells. The mechanisms are Fcmediated increase in viral entry that is seen with dengue or immune complex formation with 

complement deposition as seen with RSV. The T-cell response in those situations with 

enhanced respiratory disease is TH2-biased immune response. The effectors are macrophage 

activation inflammatory cytokines and complement activation inflammatory cytokines. The 

mitigation or prevention of those vaccine-enhanced diseases would be administering vaccines 

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cell responses to mitigate against these AEs are TH1-biasing immunization with strong CD8+ Tcell responses.

Turning to what is known about vaccines and coronavirus, a consensus meeting was convened 

in mid-March that was sponsored by the Coalition for Epidemic Preparedness Initiative (CEPI) 

and the Brighton Collaboration (BC). This meeting included two 5-hour sessions during which 

the experts who had conducted vaccines studies with coronaviruses presented information and 

discussed the actual data that were available. They assessed the models of enhanced disease 

in vaccine studies after SARS-CoV-1 vaccines, all of which were animal models. Most were 

Murine and a couple were non-human primates (NHP). A number of the studies included Alum 

adjuvants, which often primes for a TH2 response, and all of them were associated with 

immunopathology. One of the studies assessed was by Dr. Ralph S. Baric, who is a leader in 

coronavirus research. Baric et al inactivated a whole SARS-CoV-1 virus, administered it to mice, 

and then challenged the mice with SARS-CoV-1. This study found that the lung titer of the 

immunized was clearly less than it was in the control. In addition, eosinophils were seen in the 

slides of the tissue. This is reminiscent of the RSV-enhanced disease. Again, this documented 

that the antibody did have a functional activity in decreasing viruses, but immunopathology was 

noted.

The CEPI/Brighton Collaboration Consensus Meeting had a number of conclusions. One is that 

they considered that demonstration of some immune enhancement with any vaccine candidate 

after a viral challenge in animal models should not necessarily represent a no-go signal for 

deciding whether to progress in clinical development. But continuous monitoring of this risk 

during clinical trials in an epidemic context will be needed, and that each observed effect should 

be discussed by the developers with their regulators who will ultimately define the actual 

requirements for clinical studies. They wholeheartedly endorsed the mitigation strategy of 

functional neutralizing antibody and a TH1 response [1

Lambert, et al (2020). Consensus 

summary report for CEPI/BC March 12–13, 2020 meeting: Assessment of risk of disease 

enhancement with COVID-19 vaccines. Vaccine. 38. 10.1016/j.vaccine.2020.05.064].

Shortly after the identification of the SARS-CoV-2 virus, a number of NHP studies were 

conducted. One of the first that appeared in Science by Rockx et al (May 2020) showed that if 

the SARS-CoV-2 virus is given to NHP, there is an infection. The infection in old primates is 

greater than in young primates, which may be somewhat reflective of what is observed in 

humans. A lot of virus is present in the lung, suggesting that this is a really nice model to assess 

vaccines and vaccine challenges to see whether there might be enhanced pathology. In terms 

of pathologic findings in the lung after the NHP challenge, pneumonia was demonstrated, there 

was edema in the lungs, and there was virus in the lung tissue and the ciliated epithelial cells. 

This again confirms that this was a really good model showing that pulmonary pathology could 

be assessed.

Several studies followed that examined whether this actual SARS infection protected against rechallenge in NHP. Group 1 got 106 of virus, Group 2 got 105

, and Group 3 got 104. Neutralizing 

antibody and TH1 responses were seen after the initial infection, which suggests and reassures

that the type of antibody and T-cell responses desired were present with natural infection. In the 

actual challenge of the NHP who were infected, by and large, no virus at all was detected in the 

bronchoalveolar lavage (BAL) on re-challenge. Some virus was detected initially in the nose as 

in the nasal swab, suggesting again that in this natural infection, when the animals were rechallenged, they were protected from lung disease and increased virus in the nose. Pathologic 

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findings in these animals did not indicate any kind of eosinophilic infiltrate, which might be seen 

if there was a pathologic response.

In a study in which vaccines being used in humans now were studied in non-human primates, 

the chimp adenovirus produced by Oxford (ChAdOx1 nCoV-19 or the AstraZeneca vaccine) 

was used to vaccinate rhesus macaques. The enzyme-linked immunosorbent assay (ELISA) 

antibody titers after the inoculation were robust with the chimp adenovirus vaccine. The 

neutralizing titer, functional antibody, was very good. The ability to generate the TH1 response in 

the chimp adenovirus recipients also was robust. This was a 1-dose vaccine that showed that 

both humoral and cellular immune responses were generated. When the animals were 

challenged, some clinical symptoms were seen. However, they were markedly less and in terms 

of the BAL fluids, there were few copies of the virus in the lungs. There was some virus in the 

lungs and nose in the ChAdOx1 nCoV-19 group, but that rapidly decreased and was largely 

gone by 5 to 7 days. 

On July 28, 2020, a beautiful paper was published in the New England Journal of Medicine

(NEJM) that discussed the immunization with the Moderna mRNA vaccine and the challenge 

with natural disease. This study showed very much the same kind of information, which is 

reassuring in terms of the ability of the vaccine to prevent pulmonary disease and a neutralizing 

TH1 immune response. The histologic pictures of the control animals who were not given 

vaccine compared to the immunized animals show again that there was no infiltrate, no immune 

deposition, and no eosinophilia noted in these animals. This provides additional reassurance 

that the immune response is appropriate.

Moving to vaccine studies in humans, there have been reports of 3 Phase 1 vaccine trials in the 

past 2 weeks that are very reassuring. In terms of the safety of the vaccine, the chimp 

adenovirus study that appeared in The Lancet showed that with the single dose that was given 

in this study, there was some pain and tenderness in the local injection sites and a number of 

these individuals needed to take paracetamol for those symptoms. This suggests that there was 

local reaction. It was also apparent that there was generation of a good antibody response. This 

vaccine study had a control, the meningococcal conjugate vaccine (MenACWY). No antibody 

was generated to SARS-2 with the MenACWY vaccine. Within 14 days after vaccination, 

recipients of the single dose had a very good immune response. Among the recipients, 10 

individuals got a boost of the vaccine and again showed that that ELISA antibody was very good 

and was comparable to what was seen in individuals who were convalescent from natural 

COVID-19 infections. The study also showed that immune responses were generated. There 

were Interferon-γ ELISpot responses, which is consistent with the TH1 response being seen in 

both the prime recipients as early as 14 days and in the 10 prime boost individuals who received 

2 doses of vaccine. This again suggests that this vaccine, as in the NHP, generated a functional 

antibody response and a TH1 T-cell response [Folegatti et al, Safety and immunogenicity of the 

ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, singleblind, randomised controlled trial; Open Access Published:July 20, 2020; DOI:

https://doi.org/10.1016/S0140-6736(20)31604-4].

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A study by Jackson et al published in the NEJM enrolled a total of 45 participants, with 15 

participants in each of the following dosing groups: 25μg, 100μg, or 250μg. The participants 

who participated in the study were largely Caucasian (40/45; 89%) with a mean age of 30 to 35 

years. As seen with the chimp adenovirus, mild and moderate local and systemic responses 

were seen after the first dose. After the second dose, more severe local and systemic 

responses were seen in only those individuals who received the highest dose. Again, this 

suggests that there are some local and mild responses such as fever, headache, et cetera. 

However, there were no symptoms or complaints of any kind of respiratory issues that might 

been seen if there was enhanced disease. In a functional neutralizing assay in which the sera of 

the individuals were actually taken into the laboratory and neutralized with wild-type 

coronavirus, the neutralizing titers were very high in the lower and higher dose. This suggests 

again that the vaccine was generating neutralizing and TH1 types of responses [Jackson, et al; 

N Engl J Med; An mRNA Vaccine against SARS-CoV-2 - Preliminary Report. 2020 Jul 

14;NEJMoa2022483. doi: 10.1056/NEJMoa2022483. Online ahead of print].

A Phase 1/2 Pfizer study of a COVID-19 RNA vaccine candidate (BNT162b1) included a total of 

45 individuals, comprised of 12 individuals in each dosing group and 9 in the placebo group 

(10μg, 30μg, or 100μg). The local reactions after Dose 1 and Dose 2 are reminiscent of those 

seen in the earlier studies. The systemic reactions of pain, headache, and others also were 

consistent with what was seen before. However, there were no Grade 4 reactions. Immune 

responses were assessed in receptor binding domain (RBD) assays. Interestingly, almost all of 

the doses at 10μg, 30μg, and 100μg gave really robust binding functional antibody compared 

with human convalescent sera. This suggests that robust functional neutralizing antibody was 

present [Mulligan et al; Phase 1/2 Study to Describe the Safety and Immunogenicity of a 

COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim 

Report; medRxiv preprint doi: https://doi.org/10.1101/2020.06.30.20142570].

In order to attenuate or alleviate risks, Dr. Edwards emphasized the importance of thinking 

about the correct antigens, high-quality neutralizing antibody, and TH1-biasing immunization and 

CD8+ T-cells. It is also important to ensure that there are standardized, comprehensive safety 

assessments of local and systemic reactions. There has been a concerted effort to standardize 

those, certainly in the NIH-funded studies. There is a commonality in the other studies as well. 

Biomarkers of vaccine-enhanced disease must be measured, including: ratios of neutralizing 

versus non-neutralizing antibodies (shown to be so important in RSV disease), antibody 

isotypes and affinities, proinflammatory cytokine levels, and polarity of T-cell responses.

Dr. Edwards conclusions are that an effective vaccine likely will be achieved with at least one of 

the vaccine approaches. The data available from the 3 initial Phase 1 studies are very 

encouraging for all 3 vaccines. Vaccine safety will be meticulously assessed in terms of 

examining the mechanisms. At each level of study, the DSMBs are meticulously evaluating all of 

the reactions that are seen. If enhanced disease or an indication of that occurs, it will be 

carefully assessed and the immune mechanisms that might be involved will be investigated. A 

safe and effective vaccine that is widely available likely would induce herd immunity, and herd 

immunity to SARS 2 would allow normal activities to resume.

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Discussion Points

Dr. Atmar asked whether Dr. Edwards could speculate on the differences that have been seen 

between what she showed with the SARS-1 coronavirus vaccine efforts in animal models and 

the data that are available for the constructs that have been reported for SARS-CoV-2. He 

observed that all of the trials she discussed showed some immunopathology with the SARS-1 

vaccines in various formats, but that has not been seen or reported to his knowledge with the 

SARS-CoV-2 candidates yet.

Dr. Edwards confirmed that this was correct and that it is important to note a couple of things. 

One is that a number of the studies were in mice. One of the discussion points that was made 

was that indeed these mouse models can be somewhat difficult and sometimes there can be 

the development of emerging components to parts of media and some of the other issues in 

terms of that. Also, the experts in coronavirus felt that in general there was gradation, but 

certainly the adverse responses in animal models were seen more commonly with SARS-1 than 

with Middle East Respiratory Syndrome (MERS). Whether that was a function of advances in 

terms of the animal studies is hard to know. Those kinds of AEs have not been seen in the 

animal models of SARS-2. Another thing that probably is important to note is that there are 

some other SARS-1 studies that were conducted in humans, such as a couple of DNA studies 

that did not induce any kind of adverse human response. Obviously, the numbers were small. 

There also have been some MERS vaccine candidates, including an mRNA MERS vaccine 

candidate that has been examined in animals. That does not appear to be associated with the 

signal. Whether it is a function of the time the studies were conducted or their methodology was 

not quite as rigid, and whether it was a function of mice being studied and not humans is 

unclear. This certainly cannot be dismissed, but Dr. Edwards emphasized that what she would 

like people to hear is that this is not being dismissed. Investigators, such as those in the 

consortium, are digging down to try to determine what all of this information reveals. 

Dr. Bell asked Dr. Edwards to reflect on the issue of detection of these AEs, expected timing of 

AEs, potential difficulties in identify AEs—understanding that there have been some efforts to 

standardize case definitions, and what her feelings are about detecting a serious adverse event 

(SAE) if it were to occur.

Dr. Edwards acknowledged that these are hard questions, but there is work underway in the 

Brighton Collaboration to identify and characterize AEs. That will include appropriate experts to 

help determine what might be expected. There also will be an active effort by the DSMBs that 

will be examining each AE as Phase 2 and Phase 3 studies are rolled out. Each AE will be 

carefully considered by the DSMBs that are independent of the investigators and 

manufacturers, and that there will be a clear understanding of what the background rate for 

these AEs is in the population. For instance, if the background rate in the population is 1 in 1000 

but is 1 in 10 in the study population, that certainly would be a concern that will be 

characterized. There also will need to be a characterization of the severity of diseases seen. 

The NIH has spent a fair amount of time in their studies thinking about how to characterize 

disease after it occurs. If there are individuals among vaccine recipients who acquire COVID-19 

who have severe disease, it is important to understand why. There will be an ability in those 

individuals to assess cytokines and immune mechanisms, which will be very important. 

Certainly, the Immunization Safety Office (ISO) at CDC is thinking about how to respond to 

questions once a vaccine is licensed. The FDA also has been thinking carefully about how they 

are going to look at large databases for symptoms. Everyone is working hard and with great 

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care to ensure that if there is a signal, it will be investigated meticulously pre- and postlicensure.

Dr. Sanchez emphasized that the inflammatory changes seen with re-challenge are of major 

concern. He asked whether any of the individuals enrolled in the 3 vaccine trials thus far have 

developed severe disease requiring hospitalization, and whether any have been infected 

naturally. He also noted that the highest risk groups are among the elderly and wondered what 

the age groups would be for the planned Phase 3 trials, pointing out that it is known that 

individuals above 55 to 60 years of age may not respond immunologically to other vaccines. 

Also, an adolescent study in Korea showed that there is was potential for being vectors among 

children 10 years of age and older.

Dr. Edwards indicated that to her knowledge, no cases have been reported in these recipients 

or any SAEs requiring hospitalization. If there is an SAE, the studies likely would be halted. 

Each of the studies has specific halting criteria. In terms of older adults, each of the Phase 3 

trials recruited older individuals. However, the timeframe to report the younger group was very 

tight so those were reported. Most of the studies indicate that they are interim reports. Older 

individuals were included in the Phase 1 trials for all of the vaccine candidates. She has not 

seen the published data about immune responses in the various ages. Immune responses to 

natural disease are fascinating in that it seems like the oldest individuals have antibody 

responses that are higher than in the youngest individuals. Protocols are being designed for the 

use of vaccines in children and pregnant women through the NIH and probably from the other 

companies.

Dr. Fink (FDA) added that as outlined in the FDA guidance released at the end of June, FDA’s 

expectation is that in order to advance clinical development to include individuals at greater risk 

of more severe COVID-19 and to advance clinical trials to very large numbers of subjects with 

medical comorbidities to Phase 3 trials, safety and immunogenicity data will be required that is 

specific for age subgroups, including elderly subgroups to support the potential for vaccine 

effectiveness and vaccine-associated disease.

Dr. Bernstein asked whether there are any theoretical safety concerns for individuals who 

receive a COVID-19 vaccine subsequent to having received an influenza vaccine.

Dr. Edwards does not believe there are any theoretical concerns that there would be 

interference. However, the individuals participating in the Phase 3 trials with all of the 

companies will not be permitted to get the influenza vaccine simultaneously with the 

experimental vaccine. With all trials, receipt of the experimental vaccine and influenza vaccine 

would have to be separated by 14 days for inactivated influenza vaccine (IIV) or 1 month for live 

attenuated influenza vaccine (LAIV). She does believe everyone will be encouraged to get their 

influenza vaccine, but these will not be given concurrently. Dr. Edwards applauded FDA’s 

wonderful guidance document, which will be helpful for everyone moving forward.

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Dr. O’Leary said it was his understanding the seronegative individuals are being enrolled in 

these trials, and he wondered what Dr. Edwards’ thoughts were on the implications for that once 

the vaccines are rolled out into the larger population in terms of whether people will need an 

antibody test before being vaccinated. Somewhat related, he asked for her thoughts on the 

potential for a vaccine in children to trigger or not multisystem inflammatory syndrome in 

children (MIS-C), given the level of uncertainty pertaining to that condition. His concern with 

MIS-C is that the immune trigger is unknown, which could be the vaccine.

Dr. Edwards responded that there is no serological screening in the studies and there will be no 

screening in the Phase 3 trials. This would be too difficult with 30,000 people. There are blood 

draws before and after the vaccine is given. Since the vaccines are primarily spike proteinrelated, there are other parts of the virus that could be used to serologically prove whether 

people are infected. It also would be possible before vaccine receipt to look at antibody 

responses. She has not heard that any of the participants enrolled already were seropositive, 

but perhaps some were. It would be interesting to see how the vaccine performs in someone 

who was seropositive before receipt. If it is like the challenge boost seen in the chimp 

adenovirus, there probably would be a big boost. There is no evidence to suggest that there 

would be an enhanced problem with that. Obviously, the pediatric studies will be done in a very 

careful way. The start time for those will be a function of the findings in the Phase 3 adult 

studies when there is a larger safety database. It also will be important to assess the burden of 

disease in each population. The risk/benefit of a pediatric vaccine may be greater for teenagers 

than children 2 to 5 years of age. If enhanced disease is seen, she would hope they would be 

able to dissect what is occurring with that. She also hopes that the understanding of MIS-C can 

be greatly enhanced. The fact that a lot of the COVID-19 disease looks somewhat 

immunologically mediated is also a concern, so she thinks they have to proceed very carefully. 

Obviously, more research is needed with MIS-C to understand what kind of response is 

triggered.

Dr. Sanchez asked how Dr. Edwards envisions the vaccine being utilized among 

immunocompromised patients, if consideration should be given to monoclonal antibodies, and 

what the plans are for these groups.

Dr. Edwards agreed that this is an important question. There has been discussion about human 

immunodeficiency virus (HIV)-infected people and whether they can participate in Phase 3 trials 

if their viral loads are controlled, but she did not know whether that had been determined yet. It 

may be that certain vaccines work better for certain individuals, and there may need to be an 

adjuvant for individuals whose immune responses are not sufficient. There is a lot of excitement 

about and effort going into monoclonal antibodies. At this point, monoclonal antibodies will be 

studied in terms of people who have been exposed or in nursing home recipients. This seems to 

be a great group of people who are immunocompromised to participate in some of those studies 

as well.

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Considerations for FDA Licensure vs. EUA of COVID-19 Vaccines

Doran Fink, MD, PhD

Deputy Director

Clinical Division, Vaccines and Related Products Applications

Office of Vaccines Research and Review

Center for Biologics Evaluation and Research

Dr. Fink noted that to make sure everybody is on the same page in terms of expectations for 

licensure of COVID-19 preventive vaccines, the applicable statutes and regulations that FDA 

has to follow require a demonstration of vaccine safety, effectiveness, and controlled and 

consistent manufacturing to ensure continued safety and effectiveness of the licensed vaccine. 

At this time, given the epidemiology of COVID-19 and its trajectory, the FDA expects that at 

least the first COVID-19 vaccines to be licensed if successful will be licensed under the FDA’s

“Traditional” approval pathway. Under this pathway, the FDA expects that substantial evidence 

of effectiveness required to support licensure would be demonstrated in clinical disease 

endpoint efficacy trials that directly show that the vaccine prevents either COVID-19 disease 

and/or SARS-CoV-2 infection. 

There are other FDA licensure pathways that are applicable in certain situations. These are the 

“Accelerated” and “Animal Rule” licensure pathways. However, at this time, these alternative 

licensure pathways would not apply to COVID-19 vaccines, given sufficient COVID-19 incidence 

to allow for clinical disease endpoint efficacy trials and the limited and evolving understanding of 

SARS-CoV-2 immunology and immune response biomarkers that might predict protection 

against COVID-19. Because of these two current conditions, the criteria for these alternative 

licensure pathways would not be satisfied at this time. 

The FDA has received a lot of questions and has heard a lot in the press about what level of 

vaccine efficacy will be necessary to support licensure of a COVID-19 preventive vaccine. 

Certainly, demonstrating efficacy is necessary and critical, but in and of itself is not sufficient to 

support the licensure application. One reason is that a large efficacy trial conducted in areas of 

high disease activity, such as have been initiated in the US, could rapidly accrue enough cases 

to achieve the specified efficacy success criterion before additional data that are important to 

inform benefit risk considerations for review of the licensure application are available. These 

data could include, among other things, longer term safety data as well as data to support the 

manufacturing processes, facilities, product characterization, and demonstration of lot-to-lot 

consistency. Related to the licensure requirement, there needs to be controlled and consistent 

manufacturing to ensure that vaccine produced in the future will continue to be as safe and as 

effective as the vaccine that was studied in the trials to provide data to support licensure.

Additionally, the licensure review process takes some time. This is because it must address a 

number of statutory and regulatory requirements for approval. The licensure review process 

involves review of complex clinical, non-clinical, and manufacturing data. Review of the data 

does not involve just review of clinical study reports and the applicant’s assessments of the 

data. It also involves review of the datasets themselves to ensure that there are no issues with 

data integrity, and to ensure that FDA scientists and statisticians can replicate the results of the

key analyses that the applicant has submitted to support licensure. As part of this review 

process, the FDA often engages in back and forth exchanges with the applicant that include 

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information requests and meetings to resolve issues and questions that come up. There are 

inspections of facilities and clinical trial sites to ensure adherence to good clinical trial and 

manufacturing practices. There is often a safety update with longer term safety data.

Sometimes, all of the safety data that are submitted to a licensure application are available at 

the time the application is submitted. But sometimes, there are additional safety data coming in 

during the review. Almost certainly that would be the case with COVID-19 vaccines. The review 

process also includes negotiations with the applicant for a pharmacovigilance plan to continue 

evaluating vaccine safety after licensure. Additionally, the FDA and applicant need to agree on 

plans to satisfy pediatric study requirements. The ongoing studies for COVID-19 vaccines that

have reached later stage development do not yet include pediatrics subjects. The FDA must 

have a clear idea of when pediatric subjects will undergo participation in vaccine studies and 

which age groups will be appropriate to study. 

Finally, and certainly not least important for new vaccines, the FDA often convenes an external 

scientific advisory committee called the Vaccines and Related Biological Products Advisory 

Committee (VRBPAC) to get their input on the data available to support licensure. This process 

is critical to ensure transparency in FDA decision-making processes. Certainly, there is a need 

for transparency for regulatory decisions related to COVID-19 vaccines. The downside of 

convening this committee is that it requires a lot of work, both on the part of the FDA and the 

applicant. These are the same staff and personnel who are participating in the review. Looking 

at all of these activities in aggregate, the usual timeframe for licensure review is on the order of 

12 months for a standard review or 8 months for a priority review or expedited review. Certainly, 

there are things that can be done to be flexible within this review process to have information 

submitted ahead of a licensure application to pre-position the review team to conduct a more 

expedited review that can be done to cut down on this review clock time. Even with maximal 

adjustments to speed up a review, it would be very difficult to imagine a licensure application 

review process that lasts only a few weeks or even a month. Dr. Fink emphasized that they 

must be realistic in their expectations of how long the license review process will take.

There are other regulatory mechanisms for making vaccines available that do not involve 

licensure. One of these, the one that is perhaps most pertinent to addressing the COVID-19 

pandemic in the US, is the FDA’s authority to grant an EUA. EUAs are authorized under a set of 

qualifying criteria that are outlined in the FDA guidance document and also reflected in the FDA 

regulations and general law. The qualifying criteria are first of all a declaration by the HHS 

Secretary of an emergency situation leading to serious or life-threatening disease or condition.

That certainly is happening now. But, there has to be evidence of effectiveness for the product 

intended to address the emergency. As noted earlier, the standard for licensure is substantial 

evidence of effectiveness. The EUA standard is worded differently. For EUA, it has to be 

determined that a product “may be effective.” The FDA has flexibility in interpreting that

standard and it relates to FDA determining whether the known and potential benefits of the 

product outweigh the known and potential risks of the product; and the intended use of the 

product, including the number of individuals to be treated under the EUA and uncertainties in 

the risks and benefits.

For instance, in the case of a drug being authorized to treat individuals with severe COVID-19

disease that has a very well-characterized safety profile based on extensive experience either 

pre-licensure or post-licensure for a different indication, the effective standard could be lower 

than the standard required to support licensure. However, in the case of a vaccine that is 

intended to be used in tens to hundreds of millions of individuals who are not infected at the 

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time they are vaccinated, limited safety data are available for that vaccine, and there are 

additional uncertainties and risks, the effective standard would be much closer to the type of 

evidence that the FDA would require to support our licensure of the vaccine. The final criterion 

to quality for an EUA is that there has to be no adequate, approved, and available alternative. 

All of those three words (adequate, approved, and available) are important. Certainly, if there is 

no licensed COVID-19 preventive vaccine, then that standard is met. If there is a vaccine that 

has been being used under an EUA that is not approved, the availability of the vaccine does not 

count against that criterion. Similarly, if there is a licensed vaccine but there is not a sufficient 

supply of that vaccine to address the emergency situation, that also is not counted against the 

qualifying criteria.

In terms of how an EUA works, it is requested by an entity outside of FDA. Typically, it is from a 

government stakeholders (e.g., CDC, BARDA, DoD) or manufacturer. The EUA submission to 

FDA must include a number of items, such as the specific details of the requested product use 

under EUA (e.g., population, dose, regimen); supportive safety, effectiveness, and 

manufacturing information on which the FDA will make its recommendation; and fact sheets to 

inform patients and fact sheets to inform healthcare providers (HCP) of the conditions of the 

EUA and the potential risks and benefits of use under the EUA. This list is certainly not 

exhaustive. All of the requested product use under the EUA must include the specific 

population, dose, and regimen. Many of the elements that would be reviewed under a license 

application also will be revised under an EUA request, but the regulations and law allow for a 

more rapid review of EUA requests as compared to a licensure application. If the FDA does 

agree to authorize emergency use, this authorization comes with certain conditions. While this is 

not an exhaustive list, some of the key considerations include monitoring and reporting of 

adverse events “to the extent practicable;” specification of the duration of the authorization, 

which can be renewed as necessary or terminated early if the criteria for EUA are no longer 

met; and other conditions as applicable (e.g., distribution or advertising conditions).

The FDA’s “FDA Guidance for Industry: Development and Licensure of Vaccines to Prevent 

COVID-19” released in June 2020 discusses additional considerations. One concern is that 

issuance of an EUA based on very preliminary safety and efficacy data from randomized

controlled trials (RCTs) could reduce the ability to demonstrate effectiveness and assess 

benefits versus risks of the vaccine to support licensure. There have been questions about 

whether an EUA could be authorized based on just immunogenicity data or if it could be based 

on a very early signal of efficacy that just meets statistical significance criteria. The FDA thinking 

on those questions is that it could not be. More definitive data are needed that are closer to 

what the FDA would expect to support licensure. One situation in which the FDA thinks that an 

EUA could be considered is for a vaccine for which there is adequate manufacturing 

information. In this case, issuance of an EUA may be appropriate once studies have 

demonstrated the safety and effectiveness of the vaccine but before the manufacturer has 

submitted and/or FDA has completed its formal review of the Biologics License Application 

(BLA). Finally, the considerations for EUA authorization are going to be data-driven regardless 

of the vaccine. Any assessment regarding an EUA would be made on a case-by-case basis 

considering the target population, characteristics of the product, preclinical and human clinical 

study data, and the totality of available relevant scientific evidence. 

Additional resources include the FDA’s “Guidance for Industry and Other Stakeholders: 

Emergency Use Authorization of Medical Products and Related Authorities” and the FDA EUA 

Website. 

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Discussion Points

Dr. Frey requested more specifics on how OWS and the EUA have affected the rapidity and 

timing of the review of the Phase 1 and 2 trial data for this very first vaccine for which the Phase 

3 study was initiated this week in terms of what specific data was reviewed and how much data 

there were.

Dr. Fink responded that he did not think that the EUA considerations really play a role in the 

FDA’s review of data to support initiation of Phase 1, Phase 2, or even Phase 3 trials. Those are 

all geared toward advancing clinical development with the ultimate goal of supporting licensure

of COVID-19 vaccines. Based on his understanding, OWS is working to facilitate and de-risk 

vaccine development by providing funding, and helping to harmonize amongst different vaccine 

manufacturers. He left it to others involved in OWS to address any more detailed information 

about their involvement. Needless to say, the FDA’s role is entirely independent from OWS. The 

FDA has been conducting its usual data-driven review process for FDA oversight of clinical 

development of these vaccine candidates. The standards that the FDA has been using are 

really not very different from its usual standards for clinical development of preventive vaccines 

in general. It is just that things have been progressing much more quickly, with seamless and 

adaptive clinical trial design and review scientists and other staff at FDA working much harder to 

review much more information in much shorter periods of time. The FDA guidance documents

provide more detailed information about the types of non-clinical and clinical data that the FDA 

expect to see at each stage of development to support advancement to the next stage. The 

guidance is reflective of and consistent with the types of data that the FDA routinely requires to 

support development of preventive vaccines. 

Dr. Szilagyi inquired about the extent to which the EUA differs in terms of the level of evidence 

for efficacy and safety for specific age groups. In other words, if the trials shows a significant 

amount of efficacy and high safety for a broader age group, he wondered to what extent the 

guidance differs under the EUA for certain major groups such as age, underlying conditions, 

pregnancy, et cetera. 

Dr. Fink said he does not think there is a meaningful difference in terms of age groups or other 

demographic or medical factors by which the populations might be classified. The difference lies 

in the standard where the licensure standard is safe and effective, with “effective” meaning 

substantial evidence of effectiveness. For EUA, the standard is “may be effective” and known 

and potential benefits outweigh the known and potential risks. He emphasized that for 

preventive vaccines, the EUA standards in practice are going to be closer to the licensure 

standard than for some other drug products that have been or would be considered under EUA. 

For both licensure and EUA, the FDA does consider subpopulations independently. That does

not mean that studies have to be adequately powered to meet statistical success criteria for 

specific subpopulations, but there does need to be sufficient evidence of effectiveness to 

support use under EUA for all of the populations included.

Dr. Bell expressed gratitude for a very useful, helpful, and informative presentation and for the 

FDA’s guidance and responsiveness to the difficulties ACIP faces. In terms of some of the 

concerns that already have been raised in general about public confidence, she asked what 

incentives exist for manufacturers to continue to speed the process of licensure once an EUA a 

is issued. Her understanding is that, at least theoretically, an EUA could be continued for the 

extent of an emergency. That is not to say that the manufacturers want to have an EUA 

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indefinitely, but there are variations in speed of submission and responsiveness to FDA’s

request and such.

Dr. Fink said that by the time an EUA would be seriously considered for a COVID-19 vaccine, 

that vaccine likely would be at a place that is very close to being ready for a licensure 

application in terms of the outstanding data that are still in the clinical development process. 

Dr. Atmar said that he was very pleased to see that the FDA has considered what the potential 

impact on conducting and completing clinical trials could be by issuing an EUA. It was his 

understanding that for the Phase 3 efficacy studies, the planned follow-up period is a couple of 

years and at least part of that would be to address some of the concerns that Dr. Edwards 

spoke about in the morning from a safety standpoint (e.g., dengue vaccine). It could be that later 

this year or early next year, there may be substantial evidence of effectiveness of one or more 

of the vaccines being investigated that would occur well before the planned safety follow-up has 

been completed. Though it may be an unanswerable question, he wondered how one weighs 

the potential short-term efficacy that is demonstrated versus the unanswered and unknown 

safety questions that would be answered by a longer follow-up.

Dr. Fink indicated that the FDA has thought about and struggled with that excellent question 

quite a bit, and that the best answer he could give at this point would be that they will really 

have to consider the totality of the evidence available at the time that they are considering a 

licensure action or decision. The totality of evidence will include clinical trial data from Phase 1, 

Phase 2, and Phase 3 trials; the extent of longer term follow-up data for safety and efficacy that 

are available from those subjects; the non-clinical data that are available that will help to inform 

the potential risk of enhanced disease; and immune response biomarkers and animal models, 

which might include challenge models with longer intervals between vaccinations and challenge 

to help inform what happens when the antibody titers wane. Decisions will be made for an EUA 

or licensure based on all of the available data. Certainly, waiting a full year or two years before 

taking a regulatory action to make a vaccine widely available would really be counterproductive 

to addressing the current situation.

Dr. Foster (APhA) asked whether ACIP would be permitted to make a recommendation for a 

vaccine under an EUA that will have implications on people who operate under standing orders. 

Dr. Cohn indicated that under the ACIP’s Charter, there is a provision that in an emergency 

situation, the ACIP can issue recommendations under an EUA or other type of approval that is 

not for licensure.

Consideration for Vaccine Implementation

Nancy Messonnier, MD 

Center Director

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Messonnier presented considerations for COVID-19 vaccine implementation. She 

emphasized that the success of this endeavor requires not only safe and effective vaccines, but 

also a safe and effective vaccine program. As a starting place, an effective vaccine program 

needs to ensure access and high coverage in all segments of the population. This begins by 

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appreciating that there are racial and ethnic disparities in current routine immunization 

coverage, especially in adults. Influenza vaccination coverage in adults ≥18 years of age by 

race and ethnicity is consistently lower in Blacks and Hispanics. This disparity has existed for a 

long time, and the current social situation likely exacerbates the issues that surround those 

lower vaccine coverages. In planning for immunization with COVID-19 vaccine, it is necessary 

to be more mindful of this as a starting place and to take seriously that novel and more robust 

strategies are needed to increase uptake of COVID-19 vaccine once it becomes available 

[Vaccination Coverage among Adults in the United States, National Health Interview Survey, 

CDC, 2017].

The COVID-19 vaccine landscape is complex and evolving, and all of the answers needed in 

order to start planning are not going to be available. Even along the way, the landscape is likely 

to change. Some of these complexities follow:

 There are multiple products, some of which are 1-dose and some of which are 2-dose, and 

the products are not interchangeable. 

 The vaccines have varying presentations.

 Vaccine efficacy and adverse event profiles are different in different populations. 

 The cold-chain requirements are different.

 The initial studies are not being done in children and pregnant women. It always has been 

one of ACIP’s principles to want early studies in children and pregnant women and they are 

not going to have the benefit of that for this vaccine.

 Implementation plans needs to account for socially distanced vaccine practices, adding yet 

another complexity to program planning.

 Communication and education are always key parts of any of CDC’s programs, but for this 

vaccine in this situation, they understand that that need is greater than ever. Even now, the 

rumors and misinformation about COVID-19 vaccine are circulating. Certainly, the need to 

move quickly may lead folks to have incorrect assumptions about cutting corners, which they 

certainly are not doing.

 Again, the issues around communities of color and the current social situation also will 

exacerbate these problems. Some high-risk groups for COVID-19 vaccine may distrust 

public health as a starting point. This has been seen already in some of CDC’s early focus 

groups being conducted to understand attitudes about COVID-19 vaccine.

CDC is aware that they are asking for planning in an incredibly complex environment, yet it is 

critical to start planning. In fact, many feel that planning is already late and that there is a need 

to move forward quickly—even given the current environment. This graphic attempts to show all 

of the different aspects of vaccine implementation and a vaccine program:

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While these appear to be in sequence, it clearly does not work that way. Starting in the middle in 

the blue on the left, CDC greatly appreciates ACIP’s work in helping to prioritize populations and 

the assistance of the National Academies. But it is important to understand that this is going to 

be an iterative process. As more is understood about the vaccines, it will impact prioritization. 

That will then impact every other aspect of planning. After prioritization, vaccine will need to be 

allocated. This involves distributing it from the manufacturer, to a distributor, to a state to 

administer it. CDC appreciates the importance of gathering additional data on safety and 

effectiveness, as well as uptake and the need for a second dose. They also understand the 

importance of planning for vaccine recovery. In gray at the bottom of the graphic are the data 

requirements.

While the importance of data in any vaccine endeavor are understood, especially for this 

vaccine CDC believes it is very important to have end-to-end vaccine tracking and dose level 

accountability. Those data are crucial to allow for flexibility in targeting, allocation, ordering, and 

vaccine management. Data pertaining to AEs and VE post-licensure are always important, but 

this is going to be of increased importance for this vaccine, especially as rapidly as it needs to

be rolled out. In terms of regulatory considerations, CDC appreciates the FDA’s partnership and 

understands the need to consider how the regulatory requirements impact all of the other 

components of vaccine implementation. The green bar at the top of the graphic depicts the

importance of communication and stakeholder guidance at every level. This is always important 

in part of everything that CDC handles, but this is of increased importance for this vaccine in the 

current situation. 

One of the unknowns is what quantities of which vaccine with which characteristics is going to 

be available and when. While having more discrete data would be beneficial, as anybody who is 

involved in vaccine development knows, there are a lot of uncertainties. CDC is generally 

planning for the eventuality, that there will be a constrained supply. That may be because there 

are limited doses or because, although there is more vaccine available, the doses that are 

released are somewhat constrained. When there is constrained supply, administration will need 

to be focused on some target populations. In general, ACIP, multiple other countries, and WHO

have said that there needs to be some focus on populations where high coverage will be 

essential to public health. CDC looks forward to continuing dialogue with ACIP about how to 

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approach this issue. But even when there is maximum vaccine supply available, it will still be 

necessary to target immunization program efforts. The USG and state and local health 

departments will need to focus their efforts on the places where, from a public health 

perspective, they think it is most important. CDC also looks forward to ACIP’s guidance about 

how, when there is greater supply, they would propose that the agency focus its efforts. At the 

same time, CDC will work to ensure physical and financial access for everybody to this vaccine.

CDC is planning for centralized distribution because they believe that it is the best way to allow 

full visibility and control, and to be able to shift assets based on the available data to drive 

vaccine allocation. The agency understands the importance of making sure that ancillary 

supplies are available. Vaccine will be allocated to jurisdictions as per the normal programs, but 

in addition, everyone recognizes that this is an unprecedented situation. As a community, they 

are being asked to do something that they have never done before, which is get vaccine out to 

the entire population in a very compressed timeline. This will require thinking outside of

traditional boxes.

While it will be necessary to rely on routine systems, it also will be necessary to go beyond 

them. For example, CDC will be planning for allocation to some private partners in order to 

expand access. Similarly, they will be planning for administration sites in traditional sectors but 

also believe that they need to be planning for innovative sectors to reach certain target 

populations. While relying on traditional systems is crucial, it also is important to learn from what 

has gone right and not right in the past, consider every possible way to make sure that systems 

are as robust as possible, and be open to many partners that all want to queue up to help CDC 

figure out how to do an unprecedented thing.

Dr. Messonnier asked that everyone be open to the possibilities of thinking beyond the normal 

traditional approaches. To distribute and administer COVID vaccines, they must leverage many 

partners. There are public health experts and assets across all of the federal, state, and local 

USG that are part of the normal public health infrastructure, but there also are a variety of 

private partners. CDC works every day with private partners in its routine work. Now they need 

to expand those partnerships across distribution, administration, and guidance and best 

practices. CDC will be working with a variety of traditional and new partners in new ways that 

should result in a more robust COVID-19 vaccination program. Ultimately, this also may result in 

identification of ways to enhance and expand routine systems. 

A key part of all of CDC’s programs is always going to be monitoring the safety of vaccines. A 

key part of what CDC relies upon ACIP to do is continue to review the safety data pre- and postlicensure. The agency recognizes the importance of a highly robust system to monitor safety 

post-licensure and is working with all of its USG and multiple other partners to build out a plan 

for how to monitor safety. CDC, FDA, Indian Health Service (IHS), Veteran’s Administration 

(VA), and DoD are just some of the inside government groups. However, CDC also is relying on 

many of its private partners that are already working with the agency in this space. They 

recognize the need to build out these systems now in order to be ready when vaccine is 

licensed, ready, and starts to be used routinely. It is necessary to be able to reassure the 

American public that they have their eyes on this and will continue to have robust evaluation all 

along the way. This graphic showcases the different stages of vaccine safety evaluation: 

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CDC launched a program last year known as Vaccine with Confidence, which is a strategic 

framework to strengthen vaccine confidence and prevent outbreaks of vaccine-preventable 

diseases in the US. The idea is that this has to be a “whole of community” enterprise as 

illustrated here:

The concerns people are voicing about COVID-19 vaccination can be addressed by some of 

these same principles. The approach needs to be holistic—that it is not just about COVID-19

vaccination. It also is about the public’s trust in overall vaccine programs and the people who 

recommended vaccines. A broad approach is needed to stakeholder engagement in order to 

ensure that the right information gets to the people who need to know at the time that they need 

it, and barriers to access to vaccines must be decreased in every community—especially those 

who already are known to have resistance to vaccination. It is imperative to start now in order to 

make sure those individuals are ready to accept the vaccine when it becomes available.

There is a long road between now and when the vaccine becomes available. It is going to take 

all of CDC’s partners working together to make sure that they are ready. CDC is highly 

optimistic about the early data on these vaccines and wants to ensure that the delivery systems 

are equally ready when the vaccines become available. They do not want there to be any gaps 

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from the time that the vaccines are recommended by ACIP. Instead, CDC wants to be able to 

start these programs the next day, which is why they are talking about scaling up now. 

Discussion Points

Dr. Hunter said that he is looking at influenza vaccine events this fall as practice for COVID-19 

vaccine events later. Traditional mass clinics by local health departments that take place 

indoors and without social distancing are not necessarily the best model for any mass clinics for 

influenza or COVID-19 vaccination during the COVID pandemic. Traditionally, these kinds of 

mass clinics take place at venues away from facilities that have established vaccines or 

refrigerators, such as in schools rather than next door to pharmacies or clinics. He is part of a 

community-wide effort in Milwaukee in his role as a medical consultant for the City of Milwaukee 

Health Department (MHD). And as part of that effort, he is encouraging folks who are starting on 

pilots already to expand the idea of walk-through or drive-through events that occur outside and 

adjacent to pharmacies and clinics.

Dr. Messonnier said that one of the concepts CDC has been talking about is the concept of 

microplanning, which is something that is typically not discussed in the US. Globally, 

microplanning is utilized when a country is planning for a vaccination campaign, such as for 

polio or measles. This is much more detailed planning than has traditionally been done in the 

US—even with influenza vaccines. The agency thinks this is what needs to be done in the 

COVID-19 situation. There must be much more concrete microplanning with each state and 

local health department so that they can take into account their local factors to develop creative 

solutions. CDC is trying to work on some information technology (IT) solutions that would help 

for example in terms of scheduling clinics, and working with a variety of partners across OWS in 

terms of creative solutions to how mobile or mass pop-up clinics might be conducted. There are 

a variety of private partners who have some innovative approaches to this. It is those in the field 

who are going to have to operationalize this, which is why CDC wants to get past where they 

are now quickly in order to start that level of planning with every locale. This is a huge challenge 

and it is going to require a lot of lot of advanced planning and a lot of “boots on the ground.” 

Dr. Lee found the graphic depicting the ramp-up to be extremely helpful, intuitive, and useful for 

ACIP because while they understand that recommendations will drive implementation, they also 

are cognizant of the fact that implementation is in the EtR framework. Some of those

implementation considerations might impact recommendations in different phases. With that in 

mind, she wondered what the feasibility is of implementation during the ramp-up phase of 

traditional versus innovative strategies in terms of thinking about the efforts that will be required 

to distribute vaccines efficiently to as many people as possible.

Dr. Messonnier emphasized that the graphic makes it look like it is simple, but they all know that 

it will not be like this. There are any number of iterations that one could imagine and plan for. It 

reminds her of the language that “all models are wrong and some models are useful.” The intent 

was to show a paradigm to start thinking about it since they cannot know all of the possibilities. 

In terms of traditional versus innovative, in some ways traditional vaccination in her mind is 

people going to a doctor’s office to get vaccinated. Some innovative approaches would be, for 

example, if ACIP recommends a focus on essential workers, partnering with pharmacies to be 

able to deliver vaccine to essential workers in a way that decreases barriers to access. Many 

hospitals already do vaccination, but a lot of them probably administer mass vaccinations in 

mass vaccination availabilities. CDC is working on some IT solutions that would allow folks to 

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sign up in advance to identify their eligibility and then to schedule a time to get vaccinated. That 

was perhaps what she was thinking of in terms of innovation. She does not expect that this will 

be a black-white, either/or approach. For example, there are many complexities with vaccinating 

people in LTCFs, one of which is the need to go to these facilities. There will be issues related 

to informed consent or assent to vaccination and complexities in terms of underlying medical 

conditions that will complicate matters. Some private groups already have the ability to 

vaccinate in LTCFs, so CDC is considering those groups. Again, many of these private groups 

are very interested in and willing to do their part. Consideration is being given to how to activate 

all private and less traditional providers who could be part of the solution.

As a state program planner, Dr. Finley (AIM) acknowledged that many states are actively 

planning and coordinating with preparedness and their state emergency operation committees

to build upon the active structure in place. They are making use of what is available because 

they already are in an emergency action to develop IT, communications, and other pieces.

Dr. Messonnier said she appreciated that some states and locales are farther ahead. She has 

had some conversations with state Health Officers who, like sometimes at CDC, are always 

dealing with the “crisis of the day.” Those crises are huge and it is hard sometimes for folks to 

wall off a team to think about something that in some ways folks feel like is 6 months away. Part 

of the messaging to local health departments is going to be the importance of starting this 

planning now. Some states already have embraced that and are actively working on it, which is 

great. However, plans are needed in every state and locale. The goal always should be to be 

prepared before the vaccine becomes available.

Dr. Maldonado (AAP) requested additional information about who CDC is engaging with now in 

terms of focus groups and who the key stakeholders are, particularly in communities of color. It 

is important to think about other partner organizations and how to engage with them and their 

constituents to build trust.

Dr. Messonnier said that CDC has its traditional immunization partners. Especially with respect 

to communities of color, she believes they need to think way “outside the box” in terms of 

trusted stakeholders. For her, one of the lessons from some of the work that CDC has been 

doing recently and in thinking about the measles outbreaks about a year ago is that much of this 

is local. She thinks they need to get past the national, traditional organizations and be much 

more cognizant of who they need to engage. There must be much broader and deeper 

stakeholder engagement than already exists. While she feels that they already are behind, this 

is where we are today and this is the agency’s call to action for everyone. It is critical to get 

moving on stakeholder engagement. Organizing across such a broad and deep set of 

stakeholders and partners is going to be complicated, and CDC definitely will be looking for 

advice, input, and help from the traditional partners in immunization. 

Dr. Fryhofer (AMA) said that speaking as a private practicing general internist and primary care 

physician, she appreciates the thinking “outside of the box” about non-traditional ways to 

distribute and administer vaccination. However, she implored CDC not to leave off the traditional 

methods of delivery. It is important to remember that physician recommendation is a major 

motivator of vaccination, especially with this vaccine. The warp speed in which these vaccines 

are being developed has raised concerns of possible cost-cutting. Right now, especially with 

this vaccine, physician recommendation is so important in getting patients vaccinated. 

Therefore, it is imperative for primary care physicians to have access to the vaccine.

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Dr. Messonnier wholeheartedly agreed, acknowledging that private physicians are a key part of 

the routine immunization infrastructure and are key partners in in talking to their patients about 

immunization. She clarified that when she is talking about some of these non-traditional 

methods, she did not intend to imply that she meant separated from private providers. 

Optimally, private providers will be part of some of the innovations. The hope is that local public 

health will engage private providers in thinking through what the options are such that private 

providers become major visible stakeholders in implementing some of the non-traditional 

approaches.

Ms. McNally expressed specific interest in understanding whether, if a vaccine becomes 

available through traditional FDA approval or an EUA, whether CDC anticipates any changes to 

the current mechanisms that are in place for safety monitoring. 

Dr. Messonnier said that she would not say “changes” but would say “enhancements.” CDC 

certainly will rely on some of the tried and true systems that the agency uses for monitoring AE, 

but needs to enhance them in terms of speed, robustness, and penetration of all of the 

populations who may be getting access to vaccine. Part of the planning for CDC is imagining 

what groups might get vaccinated first and making sure that especially in those populations, AE 

monitoring has been built out. Certainly, AEs in those populations could derail the whole effort.

Incorrect AEs have derailed immunization efforts. There will be more presentations to ACIP 

about this. CDC relies on ACIP to review its safety monitoring plans and point out any holes that 

they see, because they want to make sure that ACIP, CDC partners, and the American public 

are confident in the agency’s plans. 

Dr. Duchin (NACCHO) said that he was somewhat surprised to hear the discussion about 

detailed implementation planning given all the unknowns, and asked whether guidance has 

been issued to state and local health departments to guide them on what is appropriate to do at 

this stage given the unknowns and limited resources. In addition, he wondered whether 

additional funding would be allocated to support local immunization program implementation.

Dr. Messonnier said that even in the setting of so many unknowns, planning must begin. CDC 

believes that the moment is now to plan and that planning needs to be flexible to accommodate 

the range of possibilities in a parsimonious way in terms of which vaccine with which 

characteristics and how many doses are available. She wished she could say that if they waited 

another month, there would be absolute clarity about those things. However, knowing that they 

will not, they believe they need to get started in planning. CDC has not yet put out detailed 

guidance, which is the launch of the next phase. The agency will be developing more detailed 

guidance, but equally important is that they will be providing technical assistance (TA) to state 

and local health departments as they develop their plans and are working very closely with the 

variety of partners, including our colleagues in the DoD who have tremendous expertise in 

logistics and planning and asks CDC lots of hard, great questions to ensure that there is nothing 

that they are missing. CDC will be moving into the next phase of more detailed planning, 

working with state and local health department, providing technical expertise, and engendering 

more of a community of practice (CoP) in which CDC can apply lessons from states that already 

have started their planning to help states that are less far along. This planning is not going to be 

easy. They need to rely on the things that are planned for already. Given that the context of 

COVID-19 is very different, more flexibility will be required—even up until the moment when 

those vaccines become available, because there are still many things that may look different on 

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that day. While it is not going to be easy, CDC is going to count on all of its partners to work with 

them.

Epidemiology of COVID-19 in Essential Workers, Including Healthcare Personnel

Sara Oliver MD, MSPH

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Oliver presented a brief update on overall US COVID-19 epidemiology and the epidemiology

among some essential workers, including healthcare personnel (HCP) and workers at LTCFs, 

workers in food processing and agriculture, workers in correctional facilities, and military 

personnel. As of July 27, 2020, a total of 4.2 million cases have been reported to CDC, with 

146,00 deaths. This map shows the cumulative case counts by county, with the darker red 

representing larger numbers of cases: 

In terms of trends in the number of COVID-19 cases reported per day in the US, there has been 

a clear increase in cases reported per day since mid-June [https://www.cdc.gov/covid-datatracker/index.html#trends].

Regarding the number of specimens tested for SARS-CoV-2, using a molecular assay and 

reported to CDC by public health laboratories, the overall percent positive at public health 

laboratories was 8% during the past week. The percentage of specimens testing positive has 

been increasing since June. The percentage positive is higher in children and younger adults 

18-49 years of age compared to older adults. The percentage of specimens testing positive in

commercial laboratories also has been increasing since June, with a peak in early July at

10.4%. This past week the percent positive was 9.1%. The National Center for Health Statistics

(NCHS) collects death certificate data from vital statistics offices for all US deaths. Through the

week ending July 18th, 9.1% of all deaths were due to pneumonia, influenza, or COVID-19. The

percentage remains above the epidemic threshold and will likely change as more death

certificates are processed [https://www.cdc.gov/coronavirus/2019-ncov/coviddata/covidview/index.html].

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With regard to the results from several sero-surveys looking at antibody to SARS-CoV-2 in 

various populations, data recently were published evaluating the seroprevalence of SARS-CoV2 antibodies from a cross-sectional study with a convenience sample of residual sera from over 

16,000 persons. Samples were collected from March 23 to May 12. Estimates were 

standardized to site populations by age and sex. The estimates ranged from 1.0% to 6.9%, with 

the highest seroprevalence in the New York City (NYC) metro area. These data estimate that

greater than 10 times the number of SARS-CoV-2 infections occurred than the number of 

reported cases, ranging from 6 to 24 times the number of reported cases per site [Havers FP, et 

al. JAMA IM 2020].

In addition, a large scale serologic study was conducted in healthcare workers (HCW) and first 

responders at two locations. Specimens were collected from mid-May through June in Detroit 

and through July in NYC. In Detroit, the overall seroprevalence among HCW and first 

responders was 6.9%, but varied by county. Overall, the seroprevalence among HCP and first 

responders in NYC is 22.5%. It was highest among staff at correctional facilities and fire 

departments. Hospitals and police department staff had a seroprevalence around 20%, with 

medical examiners (MEs) at 11%.

Another seroprevalence survey among HCW was conducted in 13 hospitals in April and May, 

with a focus on individuals providing care in COVID-19 clinical areas. Serum will be collected at 

baseline and 60 days after enrollment. The objective is to: 1) estimate the seroprevalence of 

SARS-CoV-2 infection among HCW (e.g., MDs, RN, respiratory therapists, phlebotomists) 

working in COVID-19 care areas; and 2) explore risk factors for infection and immune response. 

The design is a convenience sample of ~3250 HCWs across ~13 hospitals (250 per site). The 

assay is the CDC Pan-Ig ELISA against spike protein. Within the baseline data collected, 

seroprevalence ranged from 0.8% to 31%, with the highest seroprevalence again in NYC with 

the other locations at 10% or less.

Turning to COVID-19 epidemiology among HCP, for background, CDC’s definition of HCP is as 

follows:

Healthcare Personnel (HCP) are essential workers defined as paid and unpaid

persons serving in healthcare settings who have the potential for direct or indirect 

exposure to patients or infectious materials. 

CDC reports and routinely updates cases and deaths among healthcare personnel on the CDC 

website. As of July 27th, there have been 113,000 cases and 576 deaths among healthcare 

personnel. This is likely an underestimate, as HCP status was only available on 22% of cases.

The Emerging Infections Program (EIP) is a network of 10 state health departments and local 

health and academic partners that conduct sentinel or population-based surveillance for COVID19 in HCP. The breakdown and type of surveillance among the 10 sites are listed here:

 7 sites (Connecticut, Colorado, Maryland, Minnesota, New Mexico, Oregon, Tennessee) 

conduct sentinel surveillance 

 2 sites (California, Georgia) conduct population-based surveillance

 1 site (New York—Rochester) uses a hybrid approach that includes sentinel hospitals, with 

population-based surveillance for nursing home HCP with COVID-19

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These projects including surveillance for and interviews of HCP cases. Through June, over 

1000 cases have been reported and 464 interviews have been conducted. Regarding the 

demographics of the HCP cases, stratified by facility type, most were female in all facility types.

In hospital-based settings, over 40% of cases were nurses, while over 40% were assistants or 

technicians in nursing home-based facilities, likely representing differences in the workforce in 

these two settings. Risk factors for COVID-19 acquisition are shown here: 

Through hospital and nursing home-based settings, around 3⁄4 of cases had close contact with a 

COVID-19 case in any setting and 60% to 70% had contact through the workplace. Compliance 

with personal protective equipment (PPE) varied across settings and was highest among 

hospital-based personnel in the first column compared to nursing home-based personnel. The 

proportion using eye protection, the bottom row in this box, is lower than other PPE items, 

especially in nursing home settings.

Another study underway among HCP is COVID-19 Evaluation of Risk in Emergency 

Departments (Project COVERED) that is evaluating COVID risk in emergency departments

(EDs), with a goal of 1600 participants enrolled in 20 medical centers for 20 weeks. Preliminary 

data through the first several weeks of data collection show that at baseline, 2% had positive 

serology, with none positive by PCR. Of the 29 who were positive at baseline, 75% reported 

previous symptoms compatible with COVID. Most had previously worked in the ED with 

symptoms. These interim results show that through the first 2 weeks of enrollment, there have 

been 9 incident cases of COVID-19. None who developed infection participated in an intubation 

of a COVID-positive patient. Using the preliminary data, there is a projected 2.4% infection rate 

over the 20-week observation period [https://medicine.uiowa.edu/content/covid-evaluation-riskemergency-departments-covered-project].

As discussed at the previous ACIP meeting, COVID-NET conducts hospitalization surveillance 

with 14 states, representing around 10% of the US population. Patients must be a resident of 

the surveillance area and have a positive SARS-CoV-2 test within 14 days prior to or during 

hospitalization, and chart reviews are conducted. Information on whether the patient is a HCP is 

collected as a part of the chart review [MMWR April 17, 2020; https://www.cdc.gov/mmwr/

volumes/69/wr/mm6915e3.htm].

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Of the 36,000 hospitalizations within COVID-NET, 9195 cases had data on HCP status. Of 

those, 512, or 5.6%, were documented as HCP. Median age of HCP patients was 48 years.

Among HCP, there was a higher proportion of non-Hispanic Black persons and a lower 

proportion of Hispanic persons. Additional data on type of HCP are collected. A small number of 

respiratory therapists have been hospitalized with COVID among whom 5% are physicians, 

24% nurses, and the remainder from the “other” category. It is a free text variable, but an

attempt was made to provide some additional detail to show the diversity of cases. Most were 

hospital-based patient care support, such as nursing assistants. But the cases also included

housekeeping or environmental services, home health workers, emergency personnel, 

pharmacy, food services, et cetera. Among hospitalized HCP, 87% had an underlying condition

(e.g., diabetes, hypertension, obesity, CKD, COPD, and/or asthma). For comparison, 91% of all 

hospitalized adults had an underlying medical condition. A higher proportion of HCP were obese 

and had asthma but had a lower proportion of other underlying medical conditions.

When the same data on underlying conditions were stratified by age, among adults 18-49 years 

and 50-64 years, HCP had a higher proportion of obesity and asthma, but a similar or lower 

proportion of other underlying conditions. Among adults 65 years of age and older, hospitalized 

HCP had a lower proportion of most underlying medical conditions. In terms of clinical 

outcomes, 3.7% of healthcare providers died, 13% required mechanical ventilation, and 26% 

required intensive care unit (ICU) admission. Overall, HCP had a lower proportion of severe 

clinical outcomes compared to all hospitalized adults. 

To summarize information from the past few studies, HCP with COVID-19 are demographically 

diverse, including geography, occupation, race and ethnicity, and underlying conditions. Many 

HCP report direct contact with COVID-19 patients through work. Among hospitalized HCP, there 

were similar proportions with underlying conditions, a higher prevalence of obesity and asthma, 

and a lower prevalence of other underlying conditions including diabetes, hypertension, and 

chronic kidney or lung disease.

Now to focus on a specific subset of HCP—staff at LTCFs. Many US states publicly report 

COVID-19 cases among staff of LTCF, including nursing homes and assisted living facilities. As 

of July 16th, there were nearly 70,000 confirmed or probable cases based on data reported from 

36 states. Of those, 342 confirmed or probable COVID-19 related deaths have been reported 

among staff at LTCF in 17 states. This series of maps demonstrates the number of skilled 

nursing facilities with at least 1 case among residents through the past 4 weeks. As the weeks 

progress, the states across the lower half of the country became progressively darker, 

representing a higher percent of facilities with at least one case: 

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This series of maps highlights COVID-19 cases among staff at skilled nursing facilities, which 

reflects a similar geographic pattern to the locations of staff and residents with COVID: 

 

In terms of counts and incidence of COVID 19 cases among staff at skilled nursing facilities, the 

incidence of cases per 1000 resident weeks has increased through late June and July. The 

incidence of death has remained relatively stable over that time. The LTCF workforce consists 

of a variety of occupations with different levels of direct patient contact. They are 

disproportionately lower-wage workers. Nearly 40% are 50 years of age and older, 82% are 

female, and a quarter are non-Hispanic Black persons. Both of those are higher than what is 

reported among the general workforce. In addition, staff can be shared among multiple facilities, 

and in many instances, COVID-19 activity increases among LTCF staff first, and then residents.

Moving to COVID-19 among workers in food processing and agriculture, through April and May, 

among 23 states reporting COVID-19 outbreaks in meat or poultry processing plants, there were 

over 16,000 cases in 239 facilities, including 86 deaths. However, testing strategies and 

methods varied by workplace. Symptom status was reported for around 10,000 cases. Of those, 

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88% were symptomatic. Among 14 states reporting total number of workers in affected meat 

and poultry processing plants, COVID was diagnosed in 9.1% of workers. This ranged from 3% 

to 25% per facility. Among cases with race and ethnicity reported, nearly 90% occurred among 

racial or ethnic minorities. Over half were Hispanic or Latino and 12% were Asian persons, 

suggesting that Hispanic and Asian workers might be disproportionally affected among meat 

and poultry processing facility outbreaks [MMWR July 10, 2020; https://www.cdc.gov/mmwr/

volumes/69/wr/mm6927e2.htm?s_cid=mm6927e2_w].

Outbreaks have been reported in other food production sectors, including food processing 

facilities and farms. Compared to all US salaried workers, individuals working in agriculture are 

more likely to be racial and ethnic minorities, lacking a high school diploma, and less likely to be 

born in the US. There are multiple factors that increase food processing and agriculture workers’ 

risk for exposure to SARS-CoV-2, including prolonged close workplace contact with coworkers, 

frequent community contact with fellow workers, mobility of the work force, shared 

transportation to and from the workplace, lack of paid sick leave, and congregate housing, 

which can include living in employer-furnished housing and shared living quarters or living in 

crowded and multigenerational housing.

Regarding COVID-19 among workers in correctional facilities, in terms of the number of 

infections per 100,000 in the prison population and the US population from April through early 

June, the COVID-19 case rate is 5.5 times higher among incarcerated persons, compared to the 

general US population. Overall, there have been 985 correctional or detention facilities with at 

least 1 COVID-19 case. COVID was diagnosed in over 77,000 incarcerated persons and 18,000 

staff, with 700 COVID related deaths among incarcerated persons and 56 among staff. 

However, actual case counts are likely higher than reported [UCLA COVID-19 Behind Bars Data 

Project; https://law.ucla.edu/academics/centers /criminal-justice-program/ucla-covid-19-behindbars-data-project].

Testing of staff at correction and detention facilities does not always occur with larger 

investigations and may be self-reported. In an analysis of 16 US prisons and jails, 56% 

identified their first case of COVID-19 among staff members as opposed to incarcerated or 

detained persons1

. This indicates that staff members can introduce the virus into correction and 

detention settings through their daily movements between the facility and the community

[

1

Hagan et al. MMWR – projected publication date August 7. Results of Mass Testing for SARSCoV-2 in 16 Prisons and Jails—Six U.S. Jurisdictions, April–May 2020].

Turning to the epidemiology among military personnel, there have been over 36,000 cases and 

56 deaths among DoD personnel. Among those, a total of 960 were hospitalized; 15,122 

recovered; and 56 died. The number of cases by branch of service include Army: 8623, Marine 

Corps 3003, Navy 6340, Air Force 3964, National Guard 3398, and DoD Agencies 262 

[https://www.defense.gov/Explore/Spotlight/Coronavirus/].

Challenges that can be faced among military personnel are highlighted in the MMWR reporting 

an outbreak aboard the USS Theodore Roosevelt in April. During this time, approximately 1000 

service members were determined to be infected with SARS-CoV-2. A portion of those 

associated with the ship provided specimens and answered questionnaires. In terms of the 

results, 37% had positive PCR results at the time of testing, 60% had positive antibodies to 

SARS-CoV-2 spike protein, and nearly 20% of those with previous or current infection were 

asymptomatic. Risk factors among military personnel faced here include congregate living 

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quarters and close working environments [Payne DC et al. June 12, 2020 MMWR; 

https://www.cdc.gov/mmwr/ volumes/69/wr/mm6923e4.htm?s_cid=mm6923e4_w].

In summary, there have been over 4 million cases of COVID-19 diagnosed in the US through 

July. Information on occupation for COVID-19 cases has not been systematically collected and 

reported for all cases. However, through available data, many occupations appear to have 

increased risk for COVID-19, including HCP and staff at LTCF, correctional and detention 

facilities, and food/agricultural settings. Surveillance and additional projects are ongoing to 

identify risk factors for COVID-19, including risk factors associated with occupations. 

Discussion Points

Dr. Frey requested additional information, based on the knowledge that continues to accrue 

about bad outcomes and people regardless of whether they were ventilated or in the ICU, about 

people who end up with worsening lung disease or heart disease 3 to 6 months later. She 

wondered if at this point, it would be possible to look at statistics or data as it relates to those 

types of core clinical outcomes as opposed to just looking at death, mechanical ventilation, and 

ICU admissions.

Dr. Oliver indicated that they are collecting data on some longitudinal cohorts so that they will be 

able to follow up with individuals and look at potential readmissions for COVID-19 cases. 

Dr. Hall added that they are standing up multiple longitudinal cohort studies that will attempt to 

address the issue of longer-term outcomes, sequelae, and functional status (including things 

like lung function). Essentially, cohorts will be established of infected individuals who will be 

followed prospectively. These are still in the early stages of award and implementation, so it will 

be some time before there are data from those studies. Some of the other studies that Dr. Oliver 

alluded to are looking at readmission from some of CDC’s surveillance networks and some 

community cohorts that can follow people regardless of infections status prospectively through 

integrated healthcare systems and also affords an opportunity to look at the admission or

subsequent follow-up for related conditions. These natural history studies are following 

infections prospectively and are specifically designed to look for functional outcomes and 

longer-term sequelae. There are no data yet, but there are plans in place to address this.

In terms of population sizes, Dr. Szilagyi asked whether the HCW are all part of the 12 million 

that are listed in the next presentation for critical healthcare and other workers and if Dr. Oliver 

could provide a sense of the population size of workers in LTCF, correctional facilities, et cetera.

Dr. Oliver said that in the upcoming presentations, they would be talking more about population 

size so she did not include all of those numbers in this presentation. 

Dr. Poehling asked whether data would be forthcoming from the EIP, COVID-NET, and other 

ongoing studies about other people who may be considered essential workers such as teachers

and other populations.

Dr. Oliver said that the short answer is that they are working on collecting occupation status, not 

necessarily just through COVID-NET and EIP, but across projects that are looking more at 

occupational status. The EIP-specific projects were set up more around HCW, but there is a 

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definite effort to collect more occupational status information moving forward. That is a part of 

the case-based surveillance data recently.

In terms of other populations, Dr. Finley (AIM) asked whether there are plans to look at college 

dorms and military barracks. 

Dr. Oliver indicated that consideration is being given to what types of risk factors they will 

assess for future ACIP meetings. Individuals residing in congregate settings is an area of focus 

for upcoming ACIP meetings. 

COVID-19 Vaccine Prioritization: Work Group Considerations 

Sarah Mbaeyi, MD MPH

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Mbaeyi reviewed the COVID-19 Vaccine WG’s considerations for COVID-19 vaccine 

prioritization. Identifying priority groups for COVID-19 vaccination is essential to support vaccine 

implementation planning, such as the strengthening of vaccine distribution networks, creating 

communication strategies to reach the target population, developing state and local vaccine 

microplans, and implementing safety and effectiveness evaluations. To avoid delays once 

vaccine is available, it is important to start this prioritization and implementation planning now,

as Dr. Messonnier mentioned earlier, despite the challenges due to incomplete information on

vaccine safety and efficacy in population subgroups and vaccine dose availability. A 

prioritization framework for COVID-19 vaccines is being adapted from the 2018 pandemic 

influenza vaccine guidance. At the June 24th ACIP meeting, the WG proposed priority 

vaccination of essential workers, including HCP and high-risk populations. 

The WG assumes that vaccination will occur through phased implementation. Initially, a limited 

number of doses will be available for vaccination of HCP and other essential workers, and other 

high-risk populations, such as LTCF residents. Subsequently, a large number of doses will 

become available. At this point, the objectives of the vaccination program will be targeting of 

specific populations at increased risk for severe COVID-19, as well as HCP and essential 

workers to ensure high uptake in these groups, as well as widespread access to achieve high 

coverage across the population.

Thus, the WG has been reviewing considerations for priority vaccination of essential workers 

and high-risk populations. This session focused on considerations for vaccination of essential 

workers, including HCP. During the August ACIP meeting, the WG will review considerations for 

other high-risk populations. The CDC definition of HCP that the WG used in its deliberations is 

as follows:

Healthcare personnel are defined as all paid and unpaid persons serving in healthcare 

settings who have the potential for direct or indirect exposure to patients or infectious 

materials. This includes persons not directly involved in patient care, but who are 

potentially exposed to infectious agents while working in a healthcare setting, including 

clerical, dietary, environmental services, laundry, security, maintenance, engineering 

and facilities management, administrative, billing, and volunteer personnel

[https://www.cdc.gov/infectioncontrol/pdf/guidelines/infection-control-HCP-H.pdf].

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From the WG’s perspective, the goals of including essential workers, including HCP, in the 

earliest priority group for vaccination is to minimize the impact of COVID-19 on the healthcare 

infrastructure and societal functions, protect individuals who risk their health and safety to take 

care of others, and reduce the risk of transmission to vulnerable populations, such as LTCF 

residents. Considerations for prioritizing this group include the risk of exposure, infection, and 

severe disease; the risk of transmitting disease to vulnerable populations; disparities and equity; 

feasibility of implementation; and values of the target group and the public.

The overarching policy question is, “When COVID-19 vaccines become available, should 

essential workers (including healthcare personnel) be among the initial priority group?” To help 

answer this question, the WG reviewed elements of the Evidence to Recommendations (EtR)

framework, which is the framework used by ACIP to make evidence-based, transparent policy 

decisions. The WG reviewed the following EtR criteria:

 Is the problem of public health importance?

 Does the target group, in this case healthcare personnel and other essential workers, feel 

that the desirable effects of vaccination are large relative to the undesirable effects?

 Is there important uncertainty about or variability in how much people value the main 

outcomes from vaccination?

 Is the intervention, in this case vaccination, acceptable to key stakeholders?

 Is vaccination feasible to implement?

Starting with the public health problem, occupational groups as defined by the Bureau of Labor 

Statistics (BLS) who are at greatest risk for exposure to infectious diseases include those in the 

healthcare support (e.g., home health aides, nursing assistants, massage therapists, dental 

assistants, medical assistants); healthcare practitioner (e.g., physicians, dentists, nurses, 

pharmacists, physical therapists, respiratory therapists); protective services (e.g., police officers, 

firefighters, correctional officers, security guards, transportation screeners); personal care and 

service (e.g., childcare workers, barbers, manicurists, fitness trainers, skincare specialists, 

gaming service workers); community support (e.g., social workers, therapists, counselors, 

probation officers, health educators); and education, training, and library categories (e.g., 

teachers (K-12), teaching assistants, librarians) according to a recent study [Baker MG, et al. 

PLoS One. 2020. 15(4), e0232452]. 

In addition, there are socioeconomic and racial disparities in worker risk to infectious disease 

exposures. People with lower income occupations are generally less likely to be able to work 

from home1 and thus have a greater risk of exposure. In addition, racial and ethnic minorities 

are more likely to work in occupations deemed essential or with increased risk of infectious 

disease exposure. These include workers in the healthcare and social assistance, animal 

slaughtering and processing, and transportation industries2

 [Hawkins D. American Journal of 

Industrial Medicine. 2020 Jun 15].

These occupational groups at risk of infectious disease exposure are consistent with those 

observed to have an increased burden of COVID-19 disease. As discussed in the last 

presentation, over 110,000 cases of COVID-19 have been reported in HCP to date. This 

includes a substantial proportion of HCP who are at increased risk of severe COVID-19 disease, 

including those with high-risk conditions or those who belong to a racial or ethnic minority group.

Outbreaks and increased incidence also have been reported in workers of congregate settings, 

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often among lower-wage workers or workers belonging to racial/ethnic minority groups, 

including LTCF, meat and poultry processing facilities, and correctional facilities.

Examining HCP in greater detail, 39% have a high-risk condition or are aged ≥65 years. Those 

in support roles (such as medical assistants or home health aides) or licensed practical nurses

(LPNs), emergency medical technicians (EMTs), or others with less than a Bachelor’s degree, 

have the highest rates of underlying conditions. These groups in general also have a higher 

proportion of workers who are African-American, Latinx, uninsured, or have an income of less 

than 200% of the federal poverty level. Thus, vaccination of HCP will help to reach populations 

who are otherwise at increased risk of severe COVID-19 disease, and help to address health 

equity concerns [Gibson D, J Gen Int Med, 2020].

Occupational setting is also an important consideration for vaccination of HCP, as the 

composition of the healthcare workforce varies widely by setting. For example, nursing care 

facilities have a greater proportion of healthcare support staff such as nursing assistants and 

personal care aides, as well as non-clinical staff such as cooks and housekeepers, than 

hospitals. It is important to make sure that prioritization deliberations take into account these 

differences [https://datausa.io/profile/naics/hospitals https://datausa.io/profile/naics/nursingcare-facilities].

Finally, health-related workplace absenteeism also has been observed in several essential 

workforce sectors. While overall there has been a relatively minor impact of COVID-19 on 

absenteeism at a national level, increased absenteeism was observed in the personal care and 

service, healthcare support, and production sectors [Groenewold MR, et. al. MMWR Morb 

Mortal Wkly Rep 2020;69:853–858]. 

Turning to values and acceptability of vaccinating essential workers, including HCP, from June 

to July, CDC-sponsored focus groups were conducted to explore attitudes and beliefs about 

COVID-19 vaccines, including who should be among the first to get the vaccine once available. 

Virtual focus groups were led by trained qualitative moderators, with 33 of 49 planned sessions 

completed to date. Quota sampling was conducted through a professional recruitment company. 

The focus groups included participants from 12 audience segments: adults older than 60 years 

of age in both the low and median socioeconomic ranges, parents of children less than 18 years 

of age, adults 20-30 years of age without children, non-medical essential workers, and nurses.

Focus groups for each of the segments were conducted among the general population, as well 

as specifically among African-Americans. The focus group participants overwhelmingly 

supported prioritization of healthcare and frontline personnel, essential workers, and high-risk 

populations for vaccination. These beliefs were similar across audience segments. The primary 

reasons stated by the participants are that these groups are most likely to be exposed to 

COVID-19, have higher rates of infection, and perform important public services. Additional 

analyses are ongoing to evaluate overall public attitudes, beliefs, and intended practices 

towards COVID-19 vaccines [CDC unpublished data]. 

Consistent with the focus group findings, stakeholders and the public consistently name HCP as 

a priority group for vaccination during pandemics. For COVID-19, the WHO has included HCP 

as a priority group in its Global Allocation Framework. Similarly, the United Kingdom’s (UK’s)

vaccine policy body, the Joint Committee on Vaccination and Immunisation (JCVI), recently 

issued a report advising priority vaccination of frontline health and social care workers. For 

pandemic influenza, participants in a series of public and stakeholder meetings to identify 

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priority vaccination groups in the event of a pandemic identified healthcare personnel as a 

priority group. When the 2009 H1N1 pandemic occurred, ACIP recommended that HCP be 

included in the highest priority group for vaccination [https://apps.who.int/gb/COVID19/pdf_files/18_06/Global%20Allocation%20Framework.pdf; https://www.gov.uk/government/ 

publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi/interimadvice-on-priority-groups-for-covid-19-vaccination; University of Nebraska. Evaluation of the 

Public Engagement Project on Pandemic Influenza Vaccine Prioritization. February 7, 2008; 

https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5810a1.htm].

In terms of the general public’s views towards COVID-19 vaccination, 49% to 72% of consumer 

survey respondents in May and June expressed vaccine intention. Differences in methodology 

and framing of the question likely account for some of the variation. However, there is likely 

substantial variation in the population views towards vaccination. As seen in the figure below, 

vaccination intention was substantially higher in persons aged 60 years and older compared to 

younger adults, and higher among White compared to Black and Hispanic participants, in one 

recent survey: 

“If a coronavirus vaccine becomes available, do you plan to get vaccinated?”

Source: AP/NORC, survey among 1,056 people (May 14-18, 2020)

There is currently limited information on views and intentions towards COVID-19 vaccines 

among healthcare and other essential workers. However, coverage of influenza vaccination 

among HCP can help shed some insight into potential acceptance of COVID-19 vaccines.

During the 2017-2018 influenza season, 78% of HCP received influenza vaccination, which is 

more than double that observed in the general adult population. However, one potential factor is 

workplace vaccination requirements, which is the greatest predictor of coverage among HCP. 

Coverage also varied by setting, with the highest coverage among hospital personnel and 

lowest among long-term care facility personnel [Black CL, et. al. MMWR Morb Mortal Wkly Rep 

2018;67:1050–1054; https://www.cdc.gov/flu/fluvaxview/coverage-1819estimates.htm].

Healthcare providers are consistently rated as the most trusted source of information not only 

on vaccines, but also for COVID-19. Evidence shows that healthcare providers who are 

confident in vaccines and are themselves vaccinated are more likely to recommend vaccination 

to patients. This is important, given that provider recommendation is the strongest predictor of 

vaccine uptake. Thus, early acceptance of COVID-19 vaccines among HCP is likely to be 

important in building public trust in the vaccination program [Freed GL, et al. Pediatrics 2011; 

127 Suppl 1: S107-12; Gust DA, et al. Pediatrics 2008; 122(4): 718-25; Paterson P, et al. 

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Vaccine 2016; 34(52): 6700-6; AP-NORC Center. https://apnews.com/ 

1ca088a559803242579630f88b99b681]. 

Turning to feasibility considerations, a recent assessment of immunization programs showed 

that the majority have plans for vaccination of the critical workforce, but other than for HCP, 

implementation has not been fully tested during a pandemic. Several vaccine candidates require 

a 2-dose series. Series completion may be a challenge, given the experience with other multidose adult vaccines, such as zoster and meningococcal B. Furthermore, there may be multiple 

non-interchangeable products available which could add additional complexities. In addition, 

some vaccines may have different storage and administration requirements. These barriers 

apply to all target groups, but may be more manageable in targeted occupational groups than in

the general population [CDC, Program Annual Progress Assessment of Immunization 

Awardees, January 1, 2018 – June 30, 2019; CDC unpublished data].

Limiting vaccine allocation to other essential workers during a period of limited initial supply may 

help to facilitate implementation. First, this would allow for coordinated vaccine distribution and 

tracking through occupational health services. It also would facilitate streamlined vaccine 

microplanning at the state and local levels, as well as efficient post-approval routine vaccination 

monitoring. 

In summary, the WG feels that protection of the healthcare infrastructure is an important 

consideration in vaccine prioritization. Vaccination of healthcare and other essential workers is 

consistent with the principles of ensuring health equity in vaccine prioritization, as a high 

proportion of minority, lower income, or medically high-risk populations comprise the workforce 

of some sectors. In addition, there is likely broad public support for the prioritization of these 

groups for COVID-19 vaccine. Finally, although implementation will likely have challenges, 

vaccination of these occupational groups is likely more feasible than the general population. 

The WG feels that the prevention of COVID-19 in healthcare and other essential workers is a 

problem of public health importance, that the target population probably feels that the desirable 

effects of vaccination are large relative to undesirable effects, that there is important uncertainty 

about or variability in how much people value the main outcome, that vaccination is probably 

acceptable to key stakeholders, and that vaccination is probably feasible to implement. Thus, 

the overall WG interpretation is that the initial priority group for COVID-19 vaccination should 

include healthcare and other essential workers. 

In terms of how to prioritize vaccination in the setting of initial limited supply, the WG consensus 

is that both essential workers (including healthcare personnel) and high-risk populations are 

important priority groups. However, the WG acknowledges that sub-prioritization will be 

necessary given the initial anticipated supply, and that not all groups that are deemed a priority 

will be able to be vaccinated at once. There was also discomfort among some members of the 

WG about limiting the priority group to only HCP and other essential workers. As the WG and 

ACIP are largely comprised of HCP, and there was concern about appearing bias toward this 

group. There is also recognition that those at highest risk of death would not be included.

However, given all the factors discussed during this presentation, the WG was in agreement 

that essential workers, including HCP, should be included as one of the priority groups for initial 

doses.

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As not all healthcare and essential workers can be vaccinated at once during a period of initial 

limited supply, sub-prioritization among essential workers, which can be categorized as HCP, 

homeland and national security personnel, and other essential workers, likely will be necessary.

The WG proposes the following criteria for which healthcare and other essential workers to 

include in the priority group:

 Risk of exposure, infection, and severe disease, including the risks that occur both in the 

occupational as well as community setting, as both have an impact on healthcare and 

societal functions.

 Other criteria, including protection of these healthcare and societal functions.

 Reducing the risk of transmission to vulnerable populations, such as LTCF residents.

 Equity and implementation considerations.

In terms of next steps, during the August ACIP meeting, the WG anticipates reviewing 

considerations for prioritization of high-risk populations, including persons:

 Who are older (e.g., ≥65 years)

 With high-risk medical conditions

 Residing in LTCF and other congregate settings

 Belonging to certain racial and ethnic minority groups

 Residing in geographic hot spots

During future ACIP meetings, the WG will continue to review evidence and considerations to 

develop an overall vaccine prioritization scheme.

To set the stage for the discussion period, the WG requested ACIP’s feedback on the following 

questions:

 Does ACIP agree with the WG’s assessment to include essential workers, including HCP, in 

the initial priority group for vaccination?

 Does ACIP agree with the proposed criteria for sub-prioritization of essential workers?

 What additional evidence would ACIP like to review?

Discussion Points

Dr. Bernstein asked whether epidemiology thresholds are established a priori for the various 

subpopulations that will help with prioritization, and whether prioritization includes compliance 

with important mitigation practices.

Dr. Mbaeyi said she thought that would be challenging given some of the limitations in knowing 

the occupation of all of the cases, so they have not focused on developing thresholds. There are 

a number of other considerations other than the epidemiology that will be guiding those 

decisions as well. It is an all-encompassing effort to take all of the factors into consideration, 

including the epidemiology. The WG feels that vaccination and other mitigation measures are 

complementary in helping to control this disease. It is known that in certain settings, there are 

periodic shortages of PPE. On a national level in terms of trying to develop national policy, it is 

somewhat challenging to prioritize based on other mitigation factors. However, the WG has 

certainly discussed some other mitigation measures and how they are complementary to 

vaccine and how that might relate to prioritization.

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Dr. Szilagyi supports the prioritization of HCP and pointed out that vaccination of HCP in skilled 

nursing facilities would be an excellent way to protect the group that is at the most high-risk from 

death, even though the residents would not be prioritized. In Los Angeles County, 47% of 

deaths from COVID-19 were individuals in skilled nursing facilities. In earlier studies for 

influenza vaccination demonstrated that high rates of vaccination in these kinds of facilities, 

among the staff, significantly reduced influenza disease throughout these facilities.

Dr. Mbaeyi indicated that the WG has discussed vaccination of HCP in skilled nursing facilities 

and completely agrees.

Regarding the data Dr. Szilagyi mentioned, Dr. Poehling pointed out that there clearly was a 

difference in vaccine uptake in LTCFs than some of the others for HCP and said she is excited 

that they are talking about this. This also highlighted what Dr. Messonnier mentioned earlier 

about making sure they communicate about and really work on that component, because it will 

be a very important strategy. She requested further clarification about the definition of “essential 

workers.”

Dr. Mbaeyi indicated that they reviewed a couple of sources, one of which was an independent 

influenza guidance in which essential workers are listed out. CISA and the Department of 

Homeland Security (DHS) also have some groupings. While the WG began with those, they 

also looked at some categories that traditionally have not been included as essential workers in 

some of the previous iterations such as teachers and other educators. They have tried to think 

through other groups who are essential to society and where those impacts on society may 

occur. This certainly has been seen with school closures.

Dr. Hunter pointed out that there is a best case scenario in which the supply ramps up quickly. It 

would be extremely important to change messaging quickly to make it clear that the initial 

prioritization categories no longer apply to avoid people not getting the vaccine because they 

think they are not in a priority category.

Dr. Ault wondered what guidance ACIP might offer about pregnant HCW, given that it did not 

seem there would be pregnancy data from the planned Phase 3 trials.

Dr. Mbaeyi called upon Dr. Bell to comment on this based on the WG discussions pertaining to 

pregnancy.

Dr. Bell acknowledged the importance of addressing pregnancy among HCP in terms of 

vaccination, which the WG is mindful of. There are some liaisons on the WG who have thought 

very deeply about this issue. While the WG has not finished discussing this, they have taken 

into consideration issues of personal choice, informed consent, and so forth. The WG has not 

reached any conclusions, but is committed to thinking about it further.

Dr. Bernstein asked whether, once the prioritization plans are crystalized, if there will be 

discussion about this being a universal recommendation for those particular groups or if it would 

be shared clinical decision-making. They have seen that influenza vaccination rates are highest 

in hospitals where influenza vaccines are mandated, which certainly could have quite an impact 

in terms of COVID-19 transmission.

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Dr. Mbaeyi indicated that while the WG has not reached the specific phase of reviewing 

proposed recommendations, they would anticipate that this would be a regular recommendation 

rather than a shared clinical decision-making recommendation.

Dr. Sanchez emphasized that while it is easy to say “all essential HCW” a lot of prioritization 

occurs within that category. With that in mind, he wondered whether ultimately this would have 

to be decided on a local basis to determine which of the groups have the highest contact with 

COVID-19 patients. Another important consideration is HCW who are breastfeeding, which 

perhaps should be considered to be a contraindication.

Dr. Mbaeyi said that in the presentation they tried to lay out the WG criteria that might be 

thought of in terms of how to sub-prioritize essential workers. This harkens back to Dr. 

Messonnier’s point about how important state and local microplanning will be so that decisions 

can be made appropriately at the local level.

Dr. Hunter observed that someone who is a middle-aged, older, African American, female, 

medical assistant with diabetes and hypertension would be at the top of the list to get a vaccine. 

He wondered whether any outreach had been done to the professional society for medical 

assistants.

Dr. Mbaeyi indicated that they have not spoken specifically with them yet, but they are planning 

additional stakeholder engagement as Dr. Messonnier mentioned. There is very robust 

representation on the WG of other professional societies, such as the American Nurses 

Association (ANA) and others. The professional society for medical assistants is a great

suggestion for further stakeholder engagement.

Dr. Lee pointed out that as the WG deliberations continue to take their course, one of the 

challenges is not knowing which populations will be under the potential EUA. Who those 

populations are will need to be included in the WG’s decision-making process. A lot of this is 

also about risk/benefit assessment in the various subpopulations and making sure that the 

vaccine gets to the areas where the benefit/risk balance is known to be the greatest. 

Dr. Arthur (BIO) asked whether in the future there would be some data on how the population 

that has had the most cases is transmitting into the community, which would be interesting data 

to examine as they consider the role of HCP in their workplace as well as at home in their 

communities.

Dr. Mbaeyi indicated that they would look into these data and would bring that back to ACIP. 

There are plans for future meetings to have some presentations on some modeling that will look 

at transmission factors.

Dr. Romero added that careful assessment of transmission outward into the community via 

essential workers, such as those who work in meat packing and poultry industry, will be 

particularly important. In a recent outbreak in Arkansas, there was extensive transmission 

outside of that group of individuals into the community.

Dr. Atmar added that transmission into healthcare facilities is also important, as highlighted by 

the data from LTCFs. One thing they have seen locally in Texas as they investigate HCP who 

become infected is that their significant exposures or contacts did not occur in the work setting 

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where they had PPE. Instead, it occurred in community settings including home and other 

contacts outside the workplace.

Dr. Duchin (NACCHO) indicated that they too are seeing that a significant amount of community 

transmission is occurring locally in Seattle and that many of the HCW infections are communityacquired and not healthcare facility-acquired.

COVID-19 Vaccine WG Considerations: EtR Framework

Kathleen Dooling, MD, MPH

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Dooling reminded everyone what the WG considers the objectives of the COVID-19 Vaccine 

Program to be: 1) ensuring the safety and effectiveness of COVID-19 vaccines; 2) reducing

transmission, morbidity, and mortality of COVID-19 disease; 3) helping minimize disruption to 

society and the economy, including maintaining healthcare capacity; and 4) ensuring equity and 

vaccine allocation and distribution.

In order to realize those program objectives, the ACIP WG will rely on a transparent pathway for 

evidence-based decision-making. Evidence from published in gray literature is systematically 

collected and rigorously assessed and GRADE’d (Grading of Recommendation Assessment, 

Development, and Evaluation). Next that evidence is evaluated within the EtR framework, which 

contains domains critical to the success of any vaccine program. These include assessment of 

the magnitude of the public health problem; balancing of expected benefits against any possible 

harms; understanding the values of the target population as they relate to the vaccine; 

understanding whether the target population will accept a proposed vaccine; the feasibility of a 

vaccine program, including allocation and distribution plans; and the resources needed for 

success. This compilation of evidence, as well as the understanding of the uncertainty therein, 

forms the foundation upon which ACIP recommendations may be rendered. An ACIP

recommendation may come in one of three forms: 1) a recommendation for a given population 

to receive a vaccine; 2) a recommendation for individuals within a certain group to receive a 

vaccine based on shared clinical decision-making with their healthcare provider; or a decision 

not to recommend the vaccine. This schematic diagram represents some of the more granular 

details: 

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The WG has begun the process of systematic review of the evidence by formulating the policy 

question in a format that can facilitate systematic review of the evidence and transparent 

GRADE’ing of the quality of that evidence. 

Dr. Dooling reported on WG progress toward formulating the policy, or PICO question. PICO 

stands for: Population, Intervention, Comparison, and Outcomes. The WG envisions the entire 

US population as the population of interest. Understanding the evidence may be generated at 

different times for different groups. For example, the Phase 3 trials sub-populations will be 

defined moving forward. With respect to the intervention, the WG agreed that the 

recommendations should be specific to an individual vaccine, not by class or group, and that 

evidence be directly comparable regarding the number of doses, routes of administration, and

the schedule used in the studies. There are several comparison groups against which vaccine 

performance could be measured. Placebo groups might include saline or a non-COVID-19 

vaccine; no vaccine, including community comparisons that may be informative in some 

circumstances; and in the future, if a COVID-19 vaccine is approved, it may be possible to use 

that vaccine to compare against other COVID-19 vaccines in non-inferiority type study designs.

Next, the WG considered outcomes of interest. The outcomes discussed included both potential 

benefits as well as possible harms of a vaccine. Additionally, WG members selected outcomes 

that are important or critical to vaccine policy deliberations.

Following WG discussion and a modified Delphi process, important and critical outcomes to be 

considered by the WG for inclusion in the GRADE process were determined. The critical 

outcomes that ACIP considers to be essential for making a recommendation are prevention of 

symptomatic COVID-19 disease and possible severe adverse events (SAEs), including vaccine 

enhanced disease. Important outcomes include reactogenicity, prevention of SARS-CoV-2 

seroconversion, COVID-19 hospitalization, mechanical ventilation, and death. The WG looks 

forward to ACIP’s feedback on these outcomes.

The evidence pertaining to each selected outcome will be GRADE’d, and the resulting 

assessment of the quality of evidence will be considered in the EtR framework to adjudicate the 

domains of “Balance of Benefits” and “Risks.” Ultimately, COVID-19 recommendations may be 

thought of in two broad categories. The first is the specific vaccine recommendations, which are 

generally stable, usually applicable to broad populations, and for which the purpose is a to set a 

standard of clinical practice. In the case of COVID-19, the specific vaccine recommendation 

also could inform prioritization recommendations. This recommendation would be much more 

dynamic and expand as vaccines are approved for different populations and as supply and 

demand change over time. The purpose of the prioritization recommendation is primarily to 

facilitate implementation. 

Dr. Dooling next reviewed WG considerations of equity. Dr. Mbaeyi introduced this concept on 

the last ACIP meeting, but the WG was considering the pandemic influenza framework as a 

starting point for COVID adaptation and also the EtR recommendation framework. In addition to 

this, the WG considered it important to employ ethics and equity principles to accomplish 

program goals, especially reducing disproportionate burden on members of groups with existing 

disparities. This desire is featured prominently in the WG’s “Proposed Guiding Principles” as a 

cross-cutting theme for the COVID-19 Vaccine Program and is highlighted in the need for 

inclusive clinical trials and equitable distribution of approved vaccine.

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As described earlier in the day, NASEM has struck a committee on Equitable Allocation of 

Vaccine for the Novel Coronavirus. The purpose of this committee is to develop a framework for 

planning for equitable allocation of vaccines, which can inform decisions by ACIP. The 

committee has certainly proposed questions of mutual interest to ACIP, including the following:

 What criteria should be used in setting priorities for equitable allocation of vaccine?

 How should the criteria be applied in determining the first tier of vaccine recipients?

 How can communities of color be assured access to vaccination? 

ACIP looks forward to working with NESEM’s committee in the shared goal of equity in 

allocation and distribution of COVID-19 vaccines.

There is certainly a lot of work ahead for the WG. The WG’s next steps with regard to vaccine 

recommendation are to: 1) complete the definition of the policy question for inclusion in the EtR 

framework; 2) review clinical trial data for candidate vaccines as they become available; 3) build 

the understanding of AE reporting and surveillance systems in clinical studies and post-approval 

use—identifying gaps and strengthen systems; and 4) further refine the Tier Groups for 

allocation of early vaccine, including persons at high risk, by reviewing proposed vaccine 

implementation to understand the needs at the state and local levels; reviewing modeling 

analyses of vaccine implementation strategies; and reviewing results of focus groups and other 

public engagement as they become available.

Discussion Points

Dr. Atmar noted that as he was listening to Dr. Dooling’s presentation, one of the things that 

occurred to him was that some of the groups potentially being targeted for initial allocation of

vaccine could include individuals who are not part of the persons participating in the Phase 3 

efficacy trials, such that the groups who are participating in the Phase 3 efficacy trials may not 

be initially prioritized for vaccine allocation or use once there is an EUA or vaccine is licensed. It 

raises in his mind the question of equity that the individuals who are assuming the risk

participating in trials may not be some of the initial groups who have or will be targeted for 

vaccination. This gets at the definition of essential personnel, such as people working in the 

grocery store. He had not heard a discussion about that kind of equity in terms of rolling out the 

vaccine and was wondering if that had been discussed by the WG. 

Dr. Dooling indicated that representation and inclusive clinical trials has certainly been 

discussed by the WG in that everyone they think is at risk for COVID-19 should be represented 

in clinical trials to maximize their generalizability. She was encouraged to hear Dr. 

Ledgerwood’s presentation earlier in the day about the lengths to which the recruiting entities 

have gone and are committed to going to make sure that these Phase three clinical trials are 

truly representative of all communities. In terms of ensuring equity across essential workers, 

including all of those people whose duties have demanded that they go into public settings and 

put themselves at risk to do their jobs (people in the food system, grocery store workers, et 

cetera), that is absolutely front of mind in the WG considerations. They hope to move the 

prioritization work forward so that mechanisms to reach those populations can be developed in 

a timely way so that people who need to be at the front of the line can be.

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Dr. Fryhofer (AMA) said that speaking as a primary care physician and on behalf of the AMA, 

they greatly appreciate the WG’s considerations for vaccine prioritization. The AMA Ethics 

Committee is also assessing these issues. The AMA and its Center on Health Equity strongly 

support attention to equity and diversity in this process, and they want to reinforce the 

importance of safety and transparency and also the spirit of health equity. It is so important to 

make sure that these Phase 3 trials that are looking at safety and efficacy include ethnic and 

racial diversity; are representative of the US population; and take into account age, individuals 

with comorbidities, and vulnerable populations.

Dr. Lee said that as they are thinking about the benefits and risks of vaccine balanced against 

the benefits and risks of disease, they recognize the benefit/risk balance of the populations who 

are incorporated in the clinical trials. That will be better known at the end of the Phase 3 clinical 

trials. The benefit/risk balance of vaccine and populations not included in trials, such as 

pregnant women, will continue to be a challenge. With that in mind, her thinking on this is that 

there are still risks of having disease and those still need to be considered. Even though the 

benefits and risks of the vaccine may be less well-known, the risk of disease can be substantial 

in certain populations. She does not think it is necessarily a contraindication, but rather further 

discussion is needed and it is very important that access is not limited to populations who might 

need it. She continues to hope that those clinical trials will be as inclusive as possible.

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Certification

Upon reviewing the foregoing version of the July 29, 2020 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. 

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ACIP Membership Roster

Department of Health and Human Services 

Centers for Disease Control and Prevention 

Advisory Committee on Immunization Practices 

July 1, 2019 – June 30, 2020 

 

CHAIR 

ROMERO, José R., MD, FAAP 

Professor of Pediatrics 

Horace C. Cabe Endowed Chair in Infectious Diseases Director, Pediatric Infectious Diseases 

Section 

University of Arkansas for Medical Sciences and Arkansas Children's Hospital 

Director, Clinical Trials Research 

Arkansas Children's Hospital Research Institute 

Little Rock, AR 

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 

ATMAR, Robert L., MD 

John S. Dunn Clinical Research Professor in Infectious Diseases 

Departments of Medicine and Molecular Virology & Microbiology 

Baylor College of Medicine 

Chief, Infectious Diseases Service 

Ben Taub General Hospital, Harris Health System

Houston, TX 

Term: 7/1/2016 – 6/30/2020 

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 

 

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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 

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 

 

FREY, Sharon E., M.D. 

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 

 

HUNTER, Paul, MD 

Associate Professor of Family Medicine and Community Health 

University of Wisconsin School of Medicine and Public Health 

Associate Medical Director 

City of Milwaukee Health Department 

Milwaukee, WI 

Term: 7/1/2016 – 6/30/2020 

 

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 – 6/30/2020 

 

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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., M.D.

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 

 

SZILAGYI, Peter, MD, MPH 

Professor of Pediatrics 

Executive Vice-Chair and Vice-Chair for Research 

Department of Pediatrics 

University of California, Los Angeles (UCLA) 

Los Angeles, California 

Term: 7/1/2016 – 6/30/2020 

 

TALBOT, Helen Keipp, MD 

Associate Professor of Medicine Vanderbilt University

Nashville, TN 

Term: 10/29/2018 – 6/30/2022 

 

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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 

Department of Defense (DoD) 

SCHUMACHER, Bryan, MD

Department of Defense Liaison

Centers for Disease Control and Prevention

Atlanta, GA

Department of Veterans Affairs (DVA) 

KIM, Jane A., MD, MPH 

Deputy Chief Consultant for Preventive Medicine 

Office of Patient Care Services 

National Center for Health Promotion and Disease Prevention 

Durham, North Carolina 

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 

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Office of Infectious Disease and HIV/AIDS Policy (OIDP) 

KIM, David, MD CAPT, 

US Public Health Service Director Division of Vaccines 

Washington, DC 

National Institutes of Health (NIH) 

BEIGEL, John, M.D. 

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 

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

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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 

American Geriatrics Society (AGS) 

SCHMADER, Kenneth, MD 

Professor of Medicine-Geriatrics 

Geriatrics Division Chief 

Duke University and Durham VA Medical Centers

Durham, NC 

America’s Health Insurance Plans (AHIP) 

Vacant

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA

Washington, DC 

 

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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) 

U.S.P.H.S. 

Professor, College of Pharmacy 

University of Tennessee Health Sciences Center 

Memphis, TN 

Association of Immunization Managers (AIM) 

FINLEY, Christine, RN, MPH 

Immunization Program Manager 

Vermont Department of Health 

Burlington, VT 

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

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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 

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

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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 

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 

 

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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

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