DEPARTMENT OF HEALTH AND HUMAN SERVICES 

CENTERS FOR DISEASE CONTROL AND PREVENTION 

Advisory Committee on 

Immunization Practices (ACIP)

Summary Report

December 1, 2020 

Atlanta, Georgia 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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Table of Contents Page

Agenda 3 

Acronyms 4-6 

Welcome and Introductions 7-8 

Coronavirus Disease 2019 (COVID-19) Vaccines

 Introduction

 Allocation of Initial Supplies of COVID-19 Vaccine: Phase 1a

 Clinical Considerations for Populations Included in Phase 1a

 Post-Authorization Safety Monitoring Update

 Vote: Allocation of initial supplies of COVID-19 vaccine: Phase 1a

8-30

Certification 31

Membership Roster 32-41
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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Acronyms

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics

AAPA American Academy of Physician Assistants

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices

ACNM American College of Nurse Midwives 

ACOG American College of Obstetricians and Gynecologists

ACP American College of Physicians 

ADEs Adverse Drug Events 

ADL Activities of Daily Living 

AE Adverse Event

AECI Adverse Events of Clinical Interest 

AESI Adverse Events of Special Interest 

AGS American Geriatric Society 

AHIP America’s Health Insurance Plans

AIM Association of Immunization Managers 

ALF Assisted Living Facilities 

AMA American Medical Association

AMDA American Medical Directors Association 

AOA American Osteopathic Association 

APhA American Pharmacists Association 

ASTHO Association of State and Territorial Health Officers 

CBER Center for Biologics Evaluation and Research 

CDC Centers for Disease Control and Prevention

CISA Clinical Immunization Safety Assessment 

CISA Cybersecurity and Infrastructure Security Agency

CMS Center for Medicare and Medicaid Services

COI Conflict of Interest 

COU Clinical Operations Unit 

COVID-19 Coronavirus Disease 2019 

COVID-NET Coronavirus Disease 2019-Associated Hospitalization Surveillance Network

CoVPN COVID-19 Prevention Network 

CSTE Council of State and Territorial Epidemiologists 

DFO Designated Federal Official

DHA Defense Health Agency 

DoD Department of Defense

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs

ED Emergency Department

EMS Emergency Medical Services 

EtR Evidence to Recommendation 

EUA Emergency Use Authorization 

FDA Food and Drug Administration

GRADE Grading of Recommendation Assessment, Development and Evaluation 

HCoVs Human Coronaviruses 

HCP Healthcare Personnel / Providers
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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HCW Healthcare Workers 

HHS (Department of) Health and Human Services

HIPAA Health Insurance Portability and Accountability Act

HRSA Health Resources and Services Administration 

ICU Intensive Care Unit

IDSA Infectious Disease Society of America 

IHS Indian Health Service 

IIS Immunization Information Systems 

IRB Institutional Review Board

ISD Immunization Services Division 

ISO Immunization Safety Office

ISTM International Society for Travel Medicine 

LTCF Long-Term Care Facilities 

MedDRA Medical Dictionary for Regulatory Activities 

MERS Middle East Respiratory Syndrome

MMWR Morbidity and Mortality Weekly Report

mRNA Messenger Ribonucleic Acid 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada

NAM National Academy of Medicine 

NAPNAP National Association of Pediatric Nurse Practitioners 

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 

NFID National Foundation for Infectious Diseases 

NHSN National Healthcare Safety Network 

NIH National Institutes of Health

NMA National Medical Association 

NPI Non-Pharmaceutical Intervention

NVSN New Vaccine Surveillance Network 

NVAC National Vaccine Advisory Committee 

OID Office of Infectious Disease 

OIDP Office of Infectious Disease Policy and HIV/AIDS 

OWS Operation Warp Speed 

PCR Polymerase Chain Reaction 

PHAC Public Health Agency Canada 

PICO Population, Intervention, Comparison, Outcomes 

PIDS Pediatric Infectious Disease Society 

PPE Personal Protective Equipment 

QI Quality Improvement

RCA Rapid Cycle Analysis

RCT Randomized Controlled Trial

RNA Ribonucleic Acid 

rRT-PCR Real-Time Reverse Transcription Polymerase Chain Reaction 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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RT-PCR Reverse Transcriptase Polymerase Chain Reaction

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

SARS Severe Acute Respiratory Syndrome 

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

SHEA Society for Healthcare Epidemiology of America 

SLU Saint Louis University 

SME Subject Matter Expert

SNF Skilled Nursing Facilities

SVI Social Vulnerability Index 

US United States

USG US Government 

VA (US Department of) Veteran’s Affairs 

VA ADERS Veteran’s Affairs Adverse Drug Event Reporting System 

VAERD Vaccine-Associated Enhanced Respiratory Disease 

VAERS Vaccine Adverse Event Reporting System

VaST ACIP COVID-19 Vaccine Safety Technical Subgroup 

VE Vaccine Efficacy

VE Vaccine Effectiveness

VHA Veterans Health Administration 

VIS Vaccine Information Statement 

VRBPAC Vaccines and Related Biological Products Advisory Committee Meeting 

V-SAFE Vaccine Safety Assessment for Essential Workers 

VSD Vaccine Safety Datalink

WG Work Group
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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José Romero, MD, FAAP

ACIP Chair

Amanda Cohn, MD

Executive Secretary, ACIP / CDC

Dr. Romero called to order the December 1, 2020 emergency meeting of the Advisory 

Committee on Immunization Practices (ACIP), the primary purpose of which was to discuss and 

vote on allocation of initial supplies of Coronavirus Disease 2019 (COVID-19) Vaccine: Phase 

1a.

Dr. Cohn welcomed everyone and indicated that copies of the slides being presented during this 

meeting were available on the ACIP website and had been made available through a ShareFile 

link for ACIP Voting, Liaison, and Ex-Officio members; videos of the live webcast would be 

posted on the ACIP website approximately 1 week after the meeting; meeting minutes also 

would be posted on the ACIP website, generally within 90-120 days of the meeting; and that a 

brief summary from the previous week’s meeting had been posted to the ACIP website.

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

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

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

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

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

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

Zoom platform were instructed to disable their videos for the duration of the meeting, with the 

exception of the discussion and vote session during which time the voting ACIP members would 

turn on their videos.

The meeting’s oral and written public comment practices are designed to accommodate 

increased public interest in ACIP’s work, maximize opportunities for comments, make public 

comments more transparent and efficient, and create a fair process for assigning limited oral 

public comment time. More than 75 requests for public comment were made. Given that many 

more individuals registered to make oral public comments than could be accommodated, 

selection was made randomly via a lottery for 10 individuals to make public comment prior to the 

vote. Those individuals who were not selected and any other individuals wishing to make written 

public comments were instructed to submit them through https://www.regulations.gov using 

Docket Number CDC-2020-0121, which would be open through December 3, 2020. Those who 

submitted public comments to the ACIP mailbox or to individuals were instructed to submit 

those comments through the docket as well. Further information on the written public comment 

process can be found on the ACIP website. Dr. Cohn emphasized that public comments for this 

meeting should focus on the vote for allocation of initial supplies of COVID-19 Vaccine: Phase 

1a.

As a reminder, ACIP members agree to forgo participation in certain activities related to 

vaccines during their tenure on the committee. For certain other interests that potentially 

enhance a member’s expertise while serving on the committee, CDC has issued limited conflict 

Opening Session 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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of interest (COI) waivers. Members who conduct vaccine clinical trials or serve on data safety 

monitoring boards (DSMBs) may present to the committee on matters related to those vaccines, 

but are prohibited from participating in committee votes on issues related to those vaccines. 

Regarding other vaccines of the concerned company, a member may participate in discussions 

with the provision that he/she abstains on all votes related to that company. At the beginning of 

each meeting, ACIP members state any COIs. 

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, AstraZeneca, Janssen,

Novavax, and Sanofi. He has participated in the Moderna Phase 3 trial.

 Dr. Sharon Frey is employed by Saint Louis University (SLU), which has a Vaccine 

Treatment Evaluation Unit (VTU) that is part of the IDCRC. She is currently serving as the 

Site PI for the Moderna and Janssen Phase 3 COVID-19 vaccine clinical trials.

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

Pfizer to conduct a quality improvement (QI) project on pneumococcal vaccines.

Given that the recommendations under consideration were generalizable to all vaccine 

manufacturing companies and that no specific vaccine products were being recommended, all 

voting ACIP members were permitted to participate in the discussion and vote during this 

meeting. 

A list of Members, Ex Officio Members, and Liaison Representatives is included in the 

appendixes at the end of the full minutes for the December 1, 2020 ACIP meeting.

Introduction

Beth Bell, MD, MPH 

ACIP, COVID-19 Vaccine WG Chair

Clinical Professor, Department of Global Health

School of Public Health, University of Washington 

Dr. Bell introduced the COVID-19 Vaccines session. She began by taking a moment to 

recognize that this is a particularly difficult time with an average of one COVID-19 death per 

minute in the United States (US), meaning that 180 people would have died from COVID-19 by 

the end of the meeting—a somber reminder that that they were acting none too soon. ACIP is 

responding to the ongoing pandemic and accelerated vaccine development through the 

scheduling of additional meetings. As a reminder, ACIP convened an emergency meeting on 

November 23, 2020 during which the Evidence to Recommendations (EtR) framework was 

Coronavirus Disease 2019 (COVID-19) Vaccines
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discussed. When considering a recommendation, the EtR framework is used by ACIP as an 

explicit and transparent method for assessing the quality of the evidence related to benefits and 

harms and consideration of additional factors or domains. In this case, the domains included the 

Public Health Problem, Resource Use, Equity, Values, Acceptability, and Feasibility. In addition, 

the ACIP’s COVID-19 Work Group (WG) meets weekly.

The topics considered by the WG since the November 23rd ACIP meeting included additional 

discussions pertaining to Phase 1a populations and clinical considerations for populations 

included in Phase 1a. Dr. Bell emphasized that two COVID-19 vaccine manufacturers recently 

announced their filings with the Food and Drug Administration (FDA) for Emergency Use 

Authorization (EAU): Pfizer/BioNTech on November 20, 2020 and Moderna on November 30, 

2020. Dr. Bell indicated that the agenda for the December 1, 2020 ACIP meeting would include 

presentations on the following topics: 

 Allocation of Initial Supplies of COVID-19 Vaccine: Phase 1a

 Clinical Considerations for Populations Included in Phase 1a 

 Post-Authorization Safety Monitoring Update

 Public Comment Focused on Phase 1a Allocation

 Vote: Allocation of Initial Supplies of COVID-19 Vaccine: Phase 1a

Allocation of Initial Supplies of COVID-19 Vaccine: Phase 1a 

Kathleen Dooling, MD MPH

Co-Lead ACIP COVID-19 Vaccine WG

Medical Officer, National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Dooling indicated that this session would revisit phased allocation of COVID-19 vaccine in 

order to answer the following policy question, “Should HCP and LTCF residents be offered 

COVID-19 vaccination in Phase 1a?” During the ACIP meeting on November 23rd, the WG 

reviewed evidence in three domains to inform allocation decisions. For the science pillar, the 

WG group examined COVID-19 disease burden, as well as the balance of benefits and harms in 

each group. Of course, details of the Phase III data will further inform this area when they 

become available. For implementation, the WG took into consideration the values, acceptability, 

and feasibility of implementation in each target group. Finally, the WG considered the ethical 

principles that apply to each group, which are to maximize benefits and minimize harms, 

promote justice, mitigate health inequities, and promote transparency throughout the policy 

process. The WG then used these three pillars to evaluate the proposed groups for Phase 1 

vaccination. ACIP discussed phased allocation with health care personnel (HCP) and long-term 

care facility (LTCF) residents in Phase 1a, essential workers who do not work in healthcare in 

Phase 1b, and adults with high-risk medical conditions and adults ≥ 65 in Phase 1c. In order to 

address the policy question before the ACIP for a vote during this meeting, the rest of this 

presentation focused on HCP and LTCF residents.

To review who these groups include, HCP are defined as “essential workers paid and unpaid 

serving in healthcare settings who have the potential for direct or indirect exposure to patients or 

infectious materials.” There are approximately 21 million HCP working in settings such as 

hospitals, LTCF, outpatient settings, home healthcare, pharmacies, Emergency Medical 

Services (EMS), public health, and others. The second group under consideration are residents 

of LTCF. About 3 million adults in the US live in LTCF, which provide a spectrum of medical and 

non-medical services, usually to frail or older adults unable to reside independently in the 
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community. There are several different categories of LTCF, including skilled nursing facilities 

(SNF). In general, SNF provide higher acuity care, including rehabilitation services. There are 

also assisted living facilities (ALF), where residents are provided help with activities of daily 

living (ADL) but may live in their own room or apartment within that facility. Other residential 

care facilities may provide specific services or cater to specific populations.

With respect to the science, as of November 30th, there have been at least 243,000 confirmed 

COVID-19 cases with 858 COVID deaths among HCP. LTCF modeling that was presented to 

ACIP in August predicts more cases and deaths averted at a facility by vaccinating staff 

compared to vaccinating residents. COVID-19 exposure, both inside and outside of the 

healthcare setting, results in absenteeism due to quarantine, infection, and illness. Vaccination 

has the potential to reduce HCP absenteeism. Older adults in congregate settings are 

disproportionately affected by COVID-19. LTCF facility residents and staff accounted for 6% of 

cases and 40% of deaths in the US, despite the fact that LTCF residents account for less than 

1% of the US population. The SNF population is approximately 1.3 million and as of November 

15th, had experienced almost half a million confirmed and probable cases and more than 

69,000 COVID-associated deaths. ALF are home to approximately 800,000 residents across the 

nation. Although surveillance is less systematic for these types of facilities, 27,965 confirmed 

and suspected cases were reported across 23 states and more than 5,469 deaths were 

reported across 20 states. Based on the Coronavirus Disease 2019 (COVID-19)-Associated 

Hospitalization Surveillance Network (COVID-NET) surveillance system, 31.4% of hospitalized 

patients aged 65 to 74 were admitted from a LTCF and 48.7% of hospitalized COVID patients 

75 and older were admitted from a LTCF.

Turning to implementation considerations, a Harris Poll was completed in August during which 

survey respondents were asked which groups should receive priority when a COVID-19 vaccine 

is available. Survey respondents most strongly supported early allocation of vaccine to 

healthcare workers and seniors. While not expected to exactly predict COVID-19 uptake, 

influenza vaccine among HCP may offer some indication of COVID-19 vaccine acceptance. 

Overall, influenza vaccine coverage is high among HCP, with the highest rates of uptake among 

hospital workers and lower rates among workers in a long-term care setting. Another early 

indication of LTCF acceptance of COVID-19 vaccination is the overwhelming response to the 

Pharmacy Partnership for Long-term Care (LTC) Program. The CDC is partnering with two 

national pharmacy chains to offer on-site COVID-19 vaccination services for residents and staff 

of SNF and ALF. To date, 99% of SNF nationwide have enrolled in this program. The program 

provides end-to-end management of the COVID-19 vaccination process, including cold-chain 

management, on-site vaccination, and fulfillment of reporting requirements. But even with the 

Pharmacy Partnership for LTC Program, COVID-19 vaccination implementation and achieving 

high levels of coverage in the long-term setting will still be challenging. Based on a simulation of 

1- and 2-dose coverage among SNF residents over time, even if acceptance is high and 3 

vaccination visits are made, because of the high turnover, the proportion of current residents 

who are vaccinated decreases over time. The situation will improve when vaccine is readily 

available in the community and adults can be vaccinated prior to admission.

Pertaining to ethics, vaccinating HCP supports the principle of maximizing benefits and 

minimizing harms for what the WG is calling the “multiplier effect.” In other words, protection of 

HCP leads to preservation of healthcare capacity and better health outcomes for all. Vaccinating 

health care workers promotes justice because HCP put themselves at risk and will be essential 

to carry out the vaccination program. Vaccinating HCP also has the potential to mitigate health 

inequities because the group includes a broad range of occupations inclusive of low wage 

earners and racial and ethnic minority groups. Vaccinating long-term care residents maximizes 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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benefits by directly preventing disease in a high-risk group and minimizes harms by potentially 

reducing the burden on hospitals. The federal Pharmacy Partnership for LTC Program can 

promote justice by facilitating equal access to vaccine across most LTCF. The program has the 

potential to mitigate health inequities by reaching LTCF across the socioeconomic spectrum. In 

summary, the WG felt that early vaccination of both HCP and LTCF residents was strongly 

supported by science, implementation, and ethical consideration.

There are several additional important considerations for Phase 1a. It is important to remember 

that the proposed recommendation represents interim guidance for Phase 1a. Allocation policy 

will need to be dynamic and adapted as new information such as vaccine performance and 

supply and demand become clear. To that end, gating criteria will be needed to move 

expeditiously from one phase to the next as demand saturates. It is important to keep in mind 

that following vaccination, measures to stop the spread of SARS-CoV-2, such as masks and 

social distancing, will still be needed. Ultimately, this interim allocation is a short-term measure. 

The US Government (USG) has stated its commitment to making COVID-19 vaccines available 

to all residents who want them as soon as possible. During the last ACIP meeting, a number of 

important issues were raised that the WG wanted to recap before the vote. For HCP, ACIP 

members and liaisons expressed a need for guidance on sub-prioritization of HCP when 

vaccine supply is very limited in the beginning, to address vaccination in pregnant or lactating 

HCP, and to consider how to approach expected reactogenicity following vaccination. For LTCF 

residents, ACIP members requested more information on consent and assent within the 

facilities and plans on interpretation of reactogenicity and safety monitoring in this specific 

population.

Discussion Points

Dr. Atmar pointed out that one of the arguments for performing vaccination in LTCFs during the 

prior meeting was that both HCP working in the unit or facility and the residents could be 

vaccinated at the same time. He asked whether the pharmacy partnership would vaccinate only 

HCP or would vaccinate the residents as well and what the potential advantages might be for 

vaccinating both simultaneously.

Dr. Dooling responded that the Pharmacy Partnership for LTC Program will vaccinate residents 

as well as staff in the facility.

Recalling a slide from earlier that looked at 1 and 2 doses of vaccine, Dr. Frey asked whether 

there is any evidence of efficacy after administration of a single dose of vaccine at this time.

Dr. Dooling replied that there is no evidence at this time, but this is one of the questions they will 

be asking of the Phase III data once these becomes available.

Dr. Atmar observed that it seemed that there might be a challenge in LTCFs with the declining 

population and wondered what the implementation plans would be to keep and complete 

vaccination in that setting.

Dr. Dooling agreed that it would be a challenge, but indicated that the pharmacies that have 

signed up for this program have agreed to make 3 separate visits to the facility in order to 

vaccinate all persons who wish to be vaccinated. This will be less of a challenge when vaccine 

is more available in the community.
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Dr. Goldman (ACP) thanked the committee and staff for all their hard work and consideration on 

this difficult issue. Concerning Phase 1 prioritization, especially healthcare workers and 

guidance on sub-prioritization, with the outpatient community physician and small private 

practice truly being the backbone of the healthcare system, he is pleased to see it is considered 

in healthcare in the first phase. However, it is important to look at the outpatient offices as being 

most at risk. A recent study out of the University of Pennsylvania showed small community and 

outpatient physicians may be at a higher risk of death than the inpatient. While Intensive Care 

Unit (ICU) physicians might see sicker patients, they also may have greater access to personal 

protective equipment (PPE) compared to small offices. Dr. Goldman expressed great concern 

about the ability for small and private practices to acquire vaccination doses, especially from 

large healthcare systems. Additionally, the office staff are critical to running small practices, 

almost as much as the physician. They truly are the frontline workers. He expressed hope that 

the committee would consider this in the guidance and sub-prioritization, especially in terms of 

vaccine distribution for those offices whose physicians are not employed by hospitals and not 

associated with large healthcare systems, to ensure that the vaccines are truly getting to the 

people on the frontlines who need it the most—more specifically, the small private independent 

community primary care physicians. 

Dr. O’Leary (PIDS) agreed with Dr. Goldman’s point about outpatient providers and added that 

consideration also should be given to other people who work outside of hospitals like home 

health aides and Emergency Medical Services (EMS), and that plans should be made for those 

providers as well. 

Dr. Sanchez agreed that with sub-prioritization, a lot of which will likely be left to jurisdictions, 

the availability of PPE will be critical in terms of what sub-specialties and what practices they 

should be allocated to first. 

Dr. Fryhofer (AMA) emphasized the importance of making sure that small community practices 

have access to COVID-19 vaccines.

Dr. Romero pointed out that there would be some data in Dr. Oliver’s next presentation that 

would deal with this. 

In terms of science, Dr. Duchin added that the transmission dynamics of COVID-19 also 

suggests that those providers who care for patients earlier in their course of illness may be at 

higher risk, including outpatient HCP. This also is supported by information CDC recently 

published.

Regarding sub-prioritization, Dr. Bernstein asked whether it was envisioned that HCP in LTCFs 

would receive vaccine if supply is constrained before giving it to the residents or if there was 

another prioritization scheme.

Dr. Cohn said she would assume that most planning around LTCFs would have LTCFs 

vaccinate both residents and HCP working in these facilities at the same time, but some 

jurisdictions will likely start with HCP and then vaccinate residents. This will be dependent on 

supply and local context.

Ms. Bahta said she had similar concerns about making sure that the staff at LTCFs are being 

vaccinated. They too are often less equipped in terms of PPE and certainly have experienced a 

major burden of disease. 
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Ms. Léger (AAPA) recalled that in previous discussions, there was mention of high turnover of 

the residents of LTCFs, usually within a 30-day time period. This raised a question about 

implementation and follow-up of those residents for their second dose and the challenge that 

may result.

Dr. Cohn said this highlighted one of the many challenges with ensuring high coverage in 

LTCFs among residents and staff. The turnover among LTCF residents tends to represent a 

portion of resident turnover, with the additional residents being more long-term. There will need 

to be additional visits to the LTCFs. There are data systems in place to support those individuals 

who leave the facility in getting a second dose. That still will be a challenge, particularly in the 

first couple of months of vaccination when locations where people can be vaccinated will be 

more limited.

Dr. Gluckman (AHIP) endorsed the efficiency that could be gained by co-administering residents 

and HCP at the same site at the same time. Given the relatively small number, it will not likely 

have a meaningful impact on delaying vaccination for other populations such as essential health 

workers or others who would be phased in at a later place. The logistics can be overcome with 

thoughtful planning. For instance, it seems that the SNFs could schedule people for one of the 

subsequent second or third days that the pharmacy is coming on-site again, and then it would 

just be a transportation issue. 

Dr. Szilagyi agreed that it would be efficient to vaccinate the residents and the HCP 

simultaneously. He asked what was known about the number of COVID deaths between those 

who cycle through quickly versus those who stay longer-term in LTCFs. 

Dr. Cohn responded that they did not have these data readily available, but would acquire them 

and report back to the committee.

Dr. Gluckman (AHIP) pointed out that some of the patients in LTCFs are there for acute medical 

illnesses for which they need short-term help. From a health education point of view, many 

patients need short-term help with conditions such as sepsis, post-pneumonia care, congestive 

heart failure. People who have joint replacements are not in LTCFs as much as they used to be. 

He thought perhaps short-term residents would not be at most risk. 

Dr. Frey pointed out that if people in LTCFs, particularly the elderly, are going to be batch 

vaccinated, a lot of guidance will be needed post-vaccination to evaluate symptoms, adverse 

events, or side effects. If the elderly suffer from fatigue or even a little fever, people worry about 

them having underlying infections. If there are more than just a few people suffering from those 

side effects, it perhaps could cause issues in a facility. Dr. Dooling indicated that the next 

presentation would address specific guidelines around managing symptoms.

Dr. O’Leary (PIDS) requested clarification regarding whether the recommendation would pertain 

to only adult LTCFs or if pediatric facilities would be involves as well since the Pfizer vaccine 

may go down to 16 years of age.

Dr. Dooling indicated that the recommendation on which they would be voting during this 

meeting pertained to adults. The specifics of the age cutoff will be determined once a specific 

vaccine has been authorized.
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Considerations for Populations Included in Phase 1a 

Sara Oliver MD, MSPH 

Co-Lead ACIP COVID-19 Vaccine WG

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Oliver presented clinical consideration for populations discussed for the potential inclusion in 

Phase 1a, HCP and LTCF residents. This included sub-prioritization, reactogenicity, and 

considerations for implementation. One or more COVID-19 vaccines may be authorized by the 

FDA for use in December. However, the initial doses of any COVID-19 vaccine will be limited. 

There is expected to be a constrained supply environment for some months, which will require 

the best use of available vaccine. By the end of December, the number of doses available will 

be approximately 40 million, enough to vaccinate around 20 million people. However, that will 

not all be available at the same time. Approximately 5 to 10 million doses per week are 

anticipated post-authorization, which could lead to a need for sub-prioritization of the initial 

populations, at least for the first several weeks.

Where sub-prioritization of HCP is needed, individuals with direct patient contact who are 

unable to telework should be considered. This includes personnel who provide services to 

patients or patients’ family members and persons who handle infectious materials. This can also 

include both inpatient and outpatient settings. Consideration also should be given to personnel 

working in residential or LTCFs and personnel without known infection in the prior 90 days. 

Reinfection appears uncommon during the initial 90 days after symptom onset preceding 

infection. However, serologic testing is not recommended prior to vaccination. For pregnant or 

breastfeeding women, as has been discussed over the last several ACIP meetings, 75% of the 

healthcare workforce are female and there are approximately 330,000 HCP who are pregnant or 

recently postpartum at the time of vaccine implementation. Data demonstrate potentially 

increased risk for severe maternal illness and preterm birth due to COVID-19 disease. However, 

this must be balanced with the fact that there are no data on the use of mRNA vaccines in 

pregnant or breastfeeding women. The WG is awaiting Phase 3 data and FDA assessment and 

the EUA conditions of use. Once reviewed, further guidance is anticipated around the use of 

COVID-19 vaccines in pregnant or breastfeeding Phase 1a populations.

Reactogenicity post-vaccination will be a concern among vaccinated HCP. There will be 

additional data soon from the Phase III trials. Current data from the Phase I/II trials with vaccine 

doses used in the Phase III trials indicated that systemic symptoms are more common after the 

second dose. It is important to note that the numbers are quite small. There are several 

considerations for implementation among HCP. Healthcare systems and public health should 

work together to ensure vaccine access for HCP who are not affiliated with hospitals, which 

could include home health, community services, or broad practice types. Next, consideration 

should be given to staggering vaccination of personnel from similar units or positions. In 

addition, consideration should be given to planning for personnel to have time away from clinical 

care if HCP experience systemic symptoms post-vaccination. On that issue, there is additional 

CDC guidance forthcoming that describes the approach to systemic symptoms in HCP after 

COVID-19 vaccination. This will provide detailed information on how to handle these systemic 

symptoms and HCP. This guidance will be available on the CDC website before any vaccine 

doses are administered. Regarding clinical consideration for LTCF residents, as mentioned 

before, LTCFs provide a spectrum of medical and non-medical services to frail and older adults 

unable to reside independently in the community. SNF and ALF are both considered types of 

LTCF. SNF are engaged primarily in providing skilled nursing care and rehabilitation services for 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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residents who require care because of injury, disability, or illness. ALF provide help with ADL; 

however, residents often live in their own room or apartment within buildings or groups of 

buildings.

Regarding COVID-19 disease among the LTCF, as of November 26th, there have been around 

730,000 COVID-19 cases and 100,240 deaths among LTCF residents and staff. As of midNovember, SNFs reported nearly 500,000 cases and 70,000 deaths through the Centers for 

Medicare & Medicaid Services (CMS). Reporting varies for ALF, but through October 15th, 23 

states reported nearly 28,000 cases and 20 states report around 5500 deaths. Therefore, where 

sub-prioritization of LTCF is needed, consideration should be given to SNF which care for the 

most medically vulnerable residents. Then after SNF, consideration could be given to 

broadening to other facility types, including ALF, residential or intermediate care facilities, or 

state Veterans Homes.

While there are no data from LTCF residents specifically on reactogenicity for the older adult 

populations, there are data from the Phase I/II trials among community-dwelling older adults ≥71 

years of age in the Moderna trials and 65-85 years of age in the Pfizer trials. Systemic 

symptoms are generally lower among the older adult population. The one severe reaction postdose 2 in the Moderna trial was a report of Grade 3 fatigue. There are considerations for 

implementation among LTCF residents. Federal pharmacy partners supporting the LTCF 

program will be required to adhere to all EUA conditions of use, including providing fact sheets 

to recipients. In addition to the fact sheets for staff and residents getting vaccinated, they will be 

provided to families and medical proxies as applicable. CDC also will provide language 

clarifying that while there are available data on safety and efficacy among adults 65 and older, 

there are no data on individuals in LTCF. Importantly, consent or assent will be obtained from 

residents or families or medical proxies and documented in the patient’s chart as is standard 

practice for other vaccines.

In summary, sub-prioritization may be required with an initial limited supply of vaccine. 

Implementation of vaccination programs for HCP will need to consider reactogenicity postvaccination and additional guidance is forthcoming from CDC. Reactogenicity appears lower in 

the older adult population for mRNA vaccine, but there are no reactogenicity data in LTCF 

residents specifically. Safety monitoring, which will be described in detail in our next 

presentation, will be critical post-authorization for all populations in Phase 1a, especially LTCF 

residents.

Discussion Points

Dr. Atmar offered a cautionary comment about comparing the community-dwelling older adults 

to younger adults living in the community, pointing out that 2 out of 12 verses 1 out of 12 is 

hardly reassuring. He did not think any conclusions could be drawn about the relative 

frequencies of side effects based on this limited dataset. While the data from the Phase III trial 

should provide a lot more information, it is much too early to draw conclusions about the relative 

reactogenicity of the vaccine in these two different age groups.

Dr. Hunter commended the notion of not vaccinating everybody who works on a particular unit 

at the same time. The convenience of vaccination unit-by-unit would be pretty high within a 

healthcare system, but that could wipe out that unit for an entire day 2 to 3 days later when 

people have their reactogenicity. That level of detail will be highly valuable for those who are 

going to be administering vaccinations.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

16

Dr. Hunter added that this also applies to emergency personnel as mass vaccination could 

result in a shortage of EMTs in a community.

Dr. Sanchez suggested separating lactating mothers from pregnant woman. Although there may 

not be safety or transmission data on lactation, it is known that women with COVID-19 can 

breastfeed safely. HCP working on the frontline who recently gave birth and are at risk should 

be vaccinated and continue breastfeeding as well.

Dr. Maldonado found it helpful to think about how to allocate vaccine across healthcare 

systems. In thinking about the science, implementation, and ethics, sub-allocation comes into 

play in much more granular ways when looking at the tiered approach to these smaller 

allocations of vaccine. She requested guidance on how and when to weigh age greater than 65 

years, versus risk of exposure, versus racial and ethnic disparities, versus risk for community 

transmission at home among HCP. She wondered whether the bottom line was to prevent 

transmission in the hospital setting, among HCP specifically, and/or community transmission. 

These are very entangled concepts to which people would look to CDC and ACIP for further 

guidance.

Dr. Szilagyi added that he is on multiple groups trying to sub-prioritize within healthcare systems 

and everybody is looking for guidance from ACIP or CDC. He emphasized the importance of 

guidance and the balance between being specific enough to help health systems, but allowing, 

suggesting, and encouraging some flexibility because health systems know their own 

populations the best. He asked whether there be a discussion about coordination with SHEA or 

other groups that are also in this space working on guidance for healthcare facilities and subprioritization. 

Dr. Cohn indicated that about 40 million doses are anticipated initially. That would be enough to 

cover approximately 15 and 20 million individuals and would cover a large portion of healthcare 

workers by the end of December. Approximately 5 to 10 million doses are anticipated each 

week thereafter. In essence, sub-prioritization is likely to be needed for a limited period of time 

in this population.

Dr. Oliver added some context around WG discussions about this. Protection for HCP is related 

to both direct protection for that individual as well as for the health care system as a whole. 

Each individual health care system is going to need to figure out whether they need additional 

sub-prioritization based on the doses and staff that they have, as well as weighing privacy and 

protection for the individual HCP.

Dr. Hunter asked for clarification regarding whether it was anticipated that 20 million people 

could be vaccinated with the 40 million doses by the end of December or that the doses would 

be available to be distributed by the end of December. 

Dr. Cohn clarified that if jurisdictions and providers place orders, they will be available and it is 

anticipated that most of those doses will be distributed. This relates to the storage and handling 

requirements, but jurisdictions have very detailed plans about how to ensure maximizing doses 

in clinics. That being said, it will not be 40 million doses equals 20 million people vaccinated 

because there will be some dose mismatching in some areas.

Dr. Messonnier added that in discussions with the jurisdiction, most believe that they can 

vaccinate all of their healthcare workers within 3 weeks. That is certainly dependent upon the 

workforce and the hope that there will be support for the vaccine among them. From an 
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17

operational standpoint, most jurisdictions are planning far less than 3 weeks. The goal is to 

vaccinate health care workers quickly.

Dr. Drees (SHEA) indicated that SHEA is very interested in working with CDC with regard to 

healthcare worker sub-prioritization and managing the reactogenicity of the vaccines in this 

population, and that work has started already. Because of the characteristics of the vaccine, a 

high throughput, centralized vaccine distribution system would be ideal. However, this is at odds 

with staggering vaccine across different units and departments, as well as requesting that 

people schedule their vaccine before they have a day off already scheduled. Those things are 

going to be very challenging to manage logistically. From a large healthcare system

perspective, she will not be able to manage which people in which units get vaccines on which 

days. They are going to have to manage that at the unit level as much as possible. She thinks 

the smaller hospitals are going to have a really hard time. For instance, a 100-bed hospital will 

have to order enough vaccine to vaccinate their entire staff within a day or two. Given that this 

may not be feasible with smaller staffs, there is going to be a need for a lot of partnerships 

between local and state health departments and smaller hospitals to distribute the vaccine in a 

way that makes sense and allows them to stagger it over time.

Dr. Poehling commented that the reactogenicity data available from two trials was particularly 

helpful as everybody is looking to identify how best to move these forward. It does highlight the 

importance of staggering, which is not going to be easy.

Ms. McNally asked how the EUA fact sheet for recipients differs from a Vaccine Information 

Statement (VIS), how often the EUA fact sheets will be updated with the accumulation of new 

data, and whether the EUA fact sheet has a public comment session like a VIS.

Dr. Cohn indicated that the EUA fact sheet will be very similar to a VIS in terms of overlapping 

content, though it will be formatted differently. VISs are also reviewed and coordinated with the 

FDA. There is not a public comment period for an EUA fact sheet. It is developed as part of the 

EUA authorization between FDA and the manufacturer. The EUA fact sheet is given to all 

vaccine recipients, not just those working within LTCFs. There are fact sheets for providers and 

the individuals receiving the vaccine. Another difference between the VIS statements and the 

EUA fact sheets is that each product will have an individual EUA fact sheet. The VIS is specific 

to the types of the disease a vaccine prevents or the type of vaccine. An individual will receive 

the EUA fact sheet for the vaccine product that they receive, which is part of the EUA package. 

Providers will be trained rapidly on how to provide vaccines under an EUA, including ensuring 

that patients have the fact sheet.

Dr. Fink added that the EUA fact sheet will be updated with any new information the FDA 

considers important to allow vaccine recipients to understand the benefits, risks, and options 

related to use of the vaccine under the EUA. The timeframe for updates will depend on when 

information is received by the FDA that warrants a change.

Dr. Lee asked whether there would be differences in the benefit/risk counseling that is intended 

with the EUA fact sheet and whether it would be reasonable to have one that is tailored to 

LTCFs that would be different from generic fact sheets specific to a healthier population.

Dr. Cohn indicated that the EUA fact sheets that are FDA-authorized and sent by the 

manufacturer will be the same for every individual. However, CDC is developing specialized 

toolkits for communications materials that will provide additional information and context around 

COVID vaccination specific to each product that should be available soon. The first one to roll 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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out will be specifically for healthcare systems vaccinating HCP. The second one will be the 

LTCF toolkit, which will have information about what vaccination means for LTCF residents and

their family members.

Dr. Lee expressed gratitude to CDC for the development of the implementation toolkits. She 

recognized how challenging it is to develop these communications in the absence of having the 

Phase III clinical trial data in hand. She also recognized that providers and healthcare delivery 

systems need to partner with CDC, states, and jurisdictions in order to support these 

communications. This will be an iterative process in part because everything is happening on 

such a compressed timeline. 

Dr. Atmar asked whether there any Institutional Review Board (IRB) reporting requirements if 

there are AEs. Dr. Fink indicated that the EUA, if issued, would lay out requirements for AE 

reporting.

Ms. Stinchfield, (NAPNAP) commented on some of the practical considerations of subprioritization, which she is already working on in her healthcare institution. The total employee 

population at Children’s Minnesota is 5300, with 3300 direct care providers. While they have 

employees’ month and day of birth, the year is not included in their files for age discrimination 

reasons. They also may not have race and ethnicity. Because they do not have employee 

medical records and personal medical histories in the occupational health setting, they can only 

go down so far in terms of sub-prioritization among mostly direct and indirect patient care 

providers. In thinking about asking the other 2000 employees to hold, it was helpful to know that 

they were talking about weeks rather than months in terms of giving people the guidance on 

when to expect their doses. There is a lot of enthusiasm and understanding the timeframe is 

really helpful.

Dr. Duchin indicated that as a member of the COVID-19 Vaccine WG, he wanted to make sure 

that the ACIP voting members were clear about whether they thought the level of substratification guidance was adequate given what is expected in terms of supply. With all due 

respect, it is never possible to predict the future. Supply issues may go on longer than 

anticipated. In case supply is insufficient to meet demand, consideration should be given to 

whether ACIP feels that the sub-stratification guidelines are adequate or if there should be 

further guidance around equity or other considerations in determining who receives vaccine first. 

For example, should more facilities be given fewer doses or should fewer facilities be given 

more doses?

Dr. Lee said she certainly believed that the WG’s goal in Phase 1a with regard to HCP is to 

preserve the workforce and health care capacity regardless of where exposure occurs. She

feels strongly that this includes those who need to be in the workplace interacting with patients, 

families, and staff for their job function. This includes clinical support services such as nursing 

assistants, medical aids, environmental services, food services, frontline staff who all are critical 

to the delivery of healthcare. She is very mindful of the equity considerations and the 

importance of making sure it reflects the distribution of the workforce early on in terms of those 

who must attend work in person to function in their jobs. Medical conditions of health care 

workers and age are clearly going to be important in Phase 1c. Her concern about the equity 

issue is that if people are asked to self-disclose, it may inherently create some unintended 

inequities in that some healthcare workers are more easily able to self-advocate and feel 

comfortable in their position in being able to declare medical conditions. She worries that

creating that as a construct might unintentionally create more inequity in that if lower-wage 

workers do not feel comfortable self-disclosing medical conditions, they may effectively not be 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

19

put in the front of the line as they should be. At least in some institutions and in the national 

data, lower-wage workers are faced with higher rates of infection in the community or the 

workplace. If there are supply issue for a longer period of time, it will be important to make sure 

there is a focus on Phases 1b and 1c. The workforce who cannot stay home and shelter in 

place until the spring or summer, certainly as they meet 1c conditions, should be vaccinated in 

that phase. However, there is a portion of the workforce who can work from home without going 

into the workplace until spring or summer who she would have a hard time personally allocating

to early on when she knows that there are so many individuals who are in need.

Dr. Hunter said he was thinking of a process related to venues and gathering people who are 

making the decisions at the venue level; that is, the unit of the healthcare delivery itself. 

Perhaps those people could be brought together in some type of forum every week or so to 

discuss the issues they are facing with allocation on a state, federal, and/or national 

organizational level and consider how to interpret the general guidelines that the ACIP votes on. 

This could address how to have enough specificity in ACIP recommendations while at the same 

time having enough flexibility to implement them.

Dr. Goldman (ACP) emphasized the need for guidance, oversight, and detailed gating criteria

for large hospital systems receiving huge amounts of vaccine to distribute vaccine to the small 

and community practices. It would be a shame for a large system to vaccinate everyone 

including those not necessarily at risk, such as those working in the IT department who are not 

in patient care but are employed by a hospital, versus getting vaccine out to small/community

practices where it is needed. In rural areas, there may be many physicians, practices, providers, 

et cetera who do not even know where to go to get the vaccines or who is distributing them if it 

is only being localized to large healthcare systems. 

Dr. Fryhofer (AMA) asked whether there is a place on the EUA forms for patients to sign. She is 

concerned about ensuring that the frail elderly really understand what they are getting and what 

the side effects might be. If these patients are not able to sign on their own, she wondered 

whether there would be outreach to family members, or whomever has their power of attorney,

to sign for them. She emphasized Dr. Goldman’s concerns about the importance of community 

outreach to HCP who might not work in the hospital to ensure that they get vaccines.

Dr. Messonnier said that CDC agreed to the concern about ensuring that the frail elderly and 

their families understand the vaccine that they are getting. There is a special provision in the 

LTCF program to ensure that this occurs. There was a detailed presentation during a previous 

meeting, for which CDC can resend the slides. This is a space where CDC has been very 

concerned. Part of the issue is that everybody must be pulling together and working together to 

ensure that messages are harmonious. As Dr. Cohn said, a big effort for CDC in the next two 

weeks is to get out as much communication material as possible. The plan is to ensure that 

ACIP is fully briefed on CDC’s efforts so that they can then brief their counterparts.

Regarding sub-prioritization, Dr. Sanchez pointed out that importance of including 

recommendations for individuals who are receiving biologics.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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COVID-19 Vaccine Post-Authorization Safety Monitoring Update

Dr. Tom Shimabukuro

CDC COVID-19 Vaccine Task Force, Vaccine Safety Team

National Center for Emerging and Zoonotic Infectious Diseases 

Centers for Disease Control and Prevention

Dr. Shimabukuro presented a COVID-19 vaccine post-authorization safety monitoring update in 

the context of the various safety monitoring systems that are available, which he described in 

detail and with respect to HCP and LTCF residents specifically. The systems are listed in this 

table depicting the populations they include and level of coverage for HCP and LTCF residents: 

To be more specific on safety monitoring in LTCF residents, the Vaccine Adverse Event 

Reporting System (VAERS) is the nation’s early warning system for vaccine safety and will be 

the system that captures information on LTCF residents the quickest and provides the quickest 

data for CDC and FDA on safety in this particular demographic. VAERS includes all 320 million 

US residents as a covered population. This includes all ages, races, occupations (including 

healthcare workers) states/jurisdictions, healthy people, those with chronic health problems, 

long-term care facility residents, older adults living in the community, et cetera. 

The Veteran’s Affairs Adverse Drug Event Reporting System (VA ADERS) is the VA’s 

spontaneous reporting system. Although VA healthcare workers may not be enrolled as VA 

patients, many of them are vaccinated in occupational health at the VA and will be eligible to be 

captured by the VA ADERS. It also includes the 8,000 residents per day in VA LTCFs. A 

Veterans Health Administration (VHA) directive from 2020 established a national policy for 

reporting, monitoring, and surveillance of adverse drug events (ADEs). By policy, vaccine AE 

reports captured in the VA ADERS are reported to VAERS.

The National Healthcare Safety Network (NHSN) captures a weekly count of doses 

administered by product type. There are roughly 17,000 LTCFs in NHSN. It includes aggregate 

voluntary reporting of vaccine doses administered and counts of non-specific AEs. Importantly,

NHSN includes guidance on reporting AEs to VAERS with a link to the VAERS website where 

reporting can be done electronically. Instructions are included to enter the NHSN organization 

identification (orgID) number in box 26 of the VAERS form. Coding NHSN reports by site allows 

CDC to make queries and identify those reports that originated from NHSN sites.
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Through the Pharmacy Partnership Program for LTCF vaccination, pharmacy partners may 

vaccinate in a substantial percentage of LTCFs/ This can provide early denominator information 

in LTCF residents, which can improve the accuracy of reporting rate estimates. Outreach to 

pharmacy partners on VAERS reporting is planned.

FDA’s Rapid Cycle Analysis (RCA) in the Center for Medicare and Medicaid Services (CMS) 

data includes about 92% of the US elderly including approximately 650,000 LTCF residents. 

The data will be refreshed weekly with weekly sequential analyses. Because the data are 

refreshed and the analyses are done, that is a separate issue from the data actually 

accumulating. For CMS fee-for-service, the average data lag is around 4 weeks. The average 

data lag can be up to 5 to 6 weeks for hospitalizations. In the VA electronic health record data 

warehouse, historically 60% of VA patients who receive influenza vaccinations are 65 years and 

older. That translates into about 1.56 million older adults vaccinated for influenza annually in 

recent years. There are also 8,000 LTCF residents per day captured in the VA EHR data 

warehouse. The data will be refreshed weekly with weekly sequential analysis. For the VA, 

there is an approximate 1-week average data lag and up to about 4 weeks for hospitalization.

For CDC RCA in the VSD, there are about 1.8 million older adults in 9 integrated healthcare 

systems that comprise the VSD. Again, the data refresh weekly with weekly sequential 

analyses. There is an approximate 1 to 2 week average data lag and up to around 6 weeks for 

hospitalization. The data lag for hospitalization for these systems is primarily due to the hospital 

stay. These are average lags as some hospitalizations are longer than others. Once the patient 

is discharged, the processing of the data and entering that into the database for these systems 

is fairly rapid.

There are plans to do case evaluations of AEs. Some of the planned activities include rapid 

processing and review of reports to VAERS classified as “serious” and adverse events of 

special interest (AESI). FDA reviews all reports that are classified as “serious” and CDC will be 

reviewing a selected list of AESIs for which the reports and accompanying medical records will 

be reviewed. The processing times for COVID-19 will be 1 day for death reports, 3 days for 

serious reports, and 5 days for non-serious reports. There also will be an investigation of 

clusters of adverse events of clinical Interest (AECI) by a multidisciplinary CDC team if 

necessary and clinical case reviews by the CDC Clinical Immunization Safety Assessment 

(CISA) project.

In terms of coordination, communication, and implementation, the Vaccine Safety Technical 

Sub-Group (VaST) was built off lessons learned from H1N1. The terms of reference and 

composition are finalized and the VaST is ready to begin reviewing data once implementation 

commences. It is co-chaired by an ACIP member and a National Vaccine Advisory Committee 

(NVAC) member. It has ACIP and NVAC representation, includes independent expert 

consultants, federal agency ex officio members, and liaisons from the VA and Department of 

Defense (DoD). The post-implementation objectives of VaST are to review, evaluate, and 

interpret post-authorization/ approval COVID-19 vaccine safety data; service as the central hub 

for technical subject matter experts (SMEs) from federal agencies conducting safety monitoring 

to share safety surveillance data; advise on analyses, interpretation, and data presentation; and 

to liaise with the ACIP COVID-19 Vaccines WG on issues of safety data presentations to the 

ACIP and application of safety data to policy decisions. It is important to understand that safety 

monitoring does not stop with tracking alone. 
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CDC is ramping up communications efforts in anticipation that vaccine soon will be distributed, 

available, and administered in priority groups. These efforts include distributing communication 

materials to state health officials, HCP, and health care systems; providing up-to-date 

information on the website; and conducting ongoing partner outreach and engagement to raise 

awareness of V-SAFE and the VAERS requirements to include healthcare provider professional 

organizations, public health partners, healthcare organizations and other private sector partners, 

long-term care partners, and pharmacy partners.

In summary, early data on COVID-19 vaccine safety in healthcare workers will be available 

primarily through V-SAFE, VAERS, and systems that report into VAERS. Early data on safety in 

LTCF residents will be mainly available through VAERS and systems that report into VAERS. 

VAERS is a long-standing established safety monitoring system that is critical to monitoring new 

vaccines during the early uptake period. It is also critical to monitoring influenza vaccine every 

season when a 150 million doses or so are administered in a very compressed time window of 

several months. Large-linked database monitoring systems, such as CDC’s Vaccine Safety 

Datalink (VSD), will provide safety data when vaccines become more widely available in priority 

groups and in the general population. Efforts are ongoing to increase awareness and provide 

information needed to CDC’s partners for safety monitoring.

ACIP, public health and health care providers, and the public should feel assured that the 

systems are in place to collect safety data. There are validated methods to rapidly analyze the 

data, processes in place to respond to safety signals when detected, and trusted partnerships 

are well-established. To strengthen vaccine safety efforts, Dr. Shimabukuro specifically called 

upon: 1) CDC’s public health partners to promote participation in V-SAFE, promote reporting to 

VAERS, and communicate with partners on vaccine safety; and 2) healthcare providers to 

inform patients about V-SAFE and encourage them to participate, report AEs to VAERS, and 

communicate with patients about vaccine safety. He shared the following links: 

Discussion Points

Dr. Messonnier reiterated the importance that CDC places on the safety of vaccines. FDA will 

not authorize a vaccine and ACIP will not recommend a vaccine unless they are convinced, 

based on the Phase III clinical trials, that the vaccines are very safe. But everyone knows that 

vaccine safety does not stop there, especially for these vaccines. CDC is going to hold itself to 

an exceedingly high standard for safety monitoring after a vaccine is authorized and when it is 

rolled out more broadly. Dr. Shimabukuro, his team, and a vast array of scientists across the 

USG and among CDC’s partners have done an incredible job of enhancing existing vaccine 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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safety systems to meet this challenge. They have done a great job of trying to anticipate gaps in 

the system and fill them. But as Dr. Shimabukuro pointed out, vaccine safety systems are partly 

dependent on the stakeholders in the health systems, public health departments, and the public 

reporting AEs. Especially in this initial phase, she implored everybody in the community to work 

together to help ensure the safety of these vaccines. It may mean extra work for some groups 

that have to report through other systems as well as through these systems, but these early 

phase are crucial.

Dr. Ault asked what has been proposed to encourage people to be involved in the V-SAFE 

program since that seems to be the quickest way to get safety data.

Dr. Shimabukuro indicated that CDC is ramping up communications efforts to get the message 

out to its public health partners, the provider community, and pharmacy partners, and other 

about the importance of V-SAFE in capturing early information on vaccine safety. They soon will 

push this out strongly and will try to get the message out as broadly as possible to those who 

are vaccinating or those who partner with CDC who vaccinate. This mostly involves reaching 

out to partner organizations, professional societies, public health partners, pharmacy partners, 

and others who are going to be directly involved in vaccination.

Dr. Cohn added that the health system and health care provider communication toolkit will 

include information about how to enroll patients in V-SAFE and information about the program 

and tips for encouraging patients to enroll.

Dr. Poehling thanked Dr. Shimabukuro for this really important conversation highlighting the 

importance of the initial assessment of safety, as well as following the safety of all vaccines that 

are administered. She requested additional information about V-SAFE in terms of how that data 

will be monitored and the confidentiality of reporting through this system.

Dr. Shimabukuro indicated that operationally, an information sheet will be available in different 

formats, including a URL and scannable QR code. The individual patient enrolls themselves by 

either typing in the URL or scanning this QR code. It takes them to a registration sites and there 

is a limited amount of information a person puts in to register. There is a confirmation step and 

place to enter the vaccine. Once someone is registered, CDC sends messages with a weblink 

that takes them to an electronic survey. For the first week of vaccination, CDC does daily checkins where recipients are asked about local and systemic reactogenicity and some health impact 

questions. The local and systemic reactogenicity questions and some other questions are fed 

into a database that has all of the federal IT security and privacy protections. That information is 

available to the CDC staff who are doing the safety monitoring. For those who have a health 

impact question, CDC is going to use the cell phone numbers from the registration to reach out 

to them and take a VAERS report. That report will actually go into VAERS, the spontaneous 

reporting system that is subject to all of the security requirements and Health Insurance 

Portability and Accountability Act (HIPAA) as well. Vaccinated individuals should be confident 

that private information will be protected and that it will be used for safety monitoring purposes 

only. That will be reviewed and presented to the VaST regularly and analyzed in the context of 

signal detection.

Dr. Zahn (NACCHO) said that as a local public health person, he will be extremely enthusiastic 

to get out information about the need to report. The general message needs to be, “If something 

happens to you or your patients, report it.” However, the need to have a smartphone in order to 

use V-SAFE complicates the message. In terms of messaging, providers are going to hear 

about V-SAFE and they going to hear about VAERS. Clarifying which system to use for which 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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situations and what to tell patients to report seems very important. While CDC will be conducting 

outreach to pharmacies and pharmacists regarding AEs in the reporting in the context of 

vaccinating in LTCF, they are going to take the responsibility to vaccinate. However, the people 

who are caring for them at their facility or their primary providers are the ones who are going to 

be identifying and reporting those issues. Therefore, it seems really important to communicate 

to SNF or LTCF staff about how they are supposed to report these events. Obviously, NHSN is 

one resource.

Dr. Shimabukuro agreed that this raised a good point that needs clarification and probably a 

better explanation in CDC’s communication material. V-SAFE is really an interaction between 

the patient and CDC through which patients are reporting information to CDC. Beyond the first 

week of looking at local and systemic reactogenicity, the patient will be answering health impact 

questions that pertain to three things: Did you miss work? Were you unable to do certain daily 

activities? Did you seek or receive health care? Checking any one of those triggers an active 

telephone follow-up with that patient during which CDC would perform an assessment. If the 

patient or the patient’s provider has not already submitted a VAERS report, that also would be 

completed over the phone. He agreed that CDC’s message to providers should be to encourage 

reporting of any clinically significant adverse health events in addition to the EUA reporting 

requirements, even if they are not sure if the vaccine caused it. That would be irrespective of 

whether the person is enrolled in V-SAFE. If it happens that two reports are made, CDC has 

ways of identifying and consolidating the reports.

Dr. Foster (APhA) expressed gratitude for the enormous effort that has gone into the planning, 

and asked whether a mechanism has been built in for reporting at LTCFs and whether the 

facilities would be reporting back to the pharmacists or would be making reports themselves.

Dr. Shimabukuro said that based on the comments from Drs. Zahn and Foster, CDC would 

probably need to revise that. Maybe this would include awareness for providers and pharmacy 

partners, and specific guidance on AE reporting targeted to the HCP who are going to be 

interacting with these patients on a daily basis following immunization.

Dr. Maldonado requested further information about where VaST fits within the workflow of all of 

the various systems.

Dr. Shimabukuro explained that VaST is a group of external experts and that this forum is the 

central hub for the federal agencies that are doing the monitoring in the systems. Information 

from the systems will be provided to VaST for feedback on data interpretation, analyses, and 

maybe even further signal assessment. For example, RCA is done in the VSD. If an RCA signal 

is detected, it would be further assessed in the VSD and CDC would possibly even engage with 

FDA colleagues to determine if further signal assessment could be done in the CMS data. CDC 

will be meeting regularly with the VaST group to present data from these systems on signal 

detection and signal assessment and so that they can provide feedback to CDC. If a signal is 

detected, it is likely that the VaST, ACIP COVID-19 WG, and ACIP would be involved in the 

process in terms of receipt and discussion of this information. There potentially may be some 

type of policy decision, which might involve public health or regulatory action if necessary. That 

is a separate process. What the VaST is going to do is intimately linked. During an upcoming 

ACIP meeting, CDC can further delineate the step-by-step process of what will be done if there 

is a signal. It is anticipated that there will be signals that will need to be assessed because of 

the various populations, which may or may not be related to the vaccine. There will be many 

more signals than there will be actual AEs that need to be assessed.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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Dr. Lee added that she and Bob Hopkins are Co-Chairs of the VaST sub-group. The goal is to 

review the data from all of these systems as it is coming in. She thought Dr. Shimabukuro 

outlined nicely that the timing of the availability of the data will likely be staggered. However, the 

plan is for those data to be reviewed on a regular basis at least weekly at this point pending the 

availability of data. It is anticipated that the VaST sub-group, which reports to the ACIP COVID19 Vaccines WG, will do so on a regular basis and that this information, through the COVID-19 

Vaccines WG, will be brought forth to ACIP. She agreed that it would be helpful to present the 

processes that are in place for the framework for evaluating signals, which is signal detection, 

signal refinement, and signal evaluation. They can definitely bring that forward next time. Similar 

to what was done during H1N1, this is anticipated to be a robust process. There are a lot of 

safety systems available, but the way she is thinking about this right now from a healthcare 

provider perspective is that V-SAFE focuses on individual patients. The role of care providers is 

to support and facilitate vaccinees to enroll in V-SAFE so that they can self-report what is going 

on post-vaccination. This is a patient-directed system. In addition, the goal is to ensure that all 

HCP are aware of how to report any potential AEs that may occur into VAERS. VAERS is comanaged by CDC and FDA, but that would be specific to providers and asking them to take 

action. The third layer that is important to highlight is the NHSN, which is a national safety 

surveillance network that has been in place for decades. Over 4700 acute care facilities and 

17,000 LTCF in the US are NHSN users. It is going to be important to encourage facility-level 

reporting, different from patient-level and provider-level reporting, that encourages acute care 

facilities and LTCFs to support efforts to report not only doses administered, but also any 

clinically significant safety events that occur. That would address some of the questions and 

issues that were raised earlier regarding the connection between LTCFs and pharmacies, 

recognizing that those systems are coming online for the acute care facilities sooner compared 

to the LTCFs. Sharing this aggregate information with NHSN and linking it to VAERS will be 

incredibly helpful for the safety monitoring system overall.

Dr. Talbot pointed out that while their pediatric colleagues are very well-versed in VAERS, their 

adult colleagues are not. Family practice physicians are included because they expand the gap, 

but internists and geriatricians rarely have any knowledge about VAERS. What concerns her is 

that the people who work at LTCFs are not actually represented around the circle. The 

American Geriatrics Society (AGS) is there, but not the American Medical Directors Association 

(AMDA). She asked what has been done to reach out to other groups beyond ACIP liaisons and 

how many VAERS reports have actually been entered from LTCFs in the last year.

Dr. Shimabukuro said that CDC’s communications folks are planning substantial outreach to 

partners, including long-term care partners, geriatric care partners, OB/GYNS, and other 

vaccinators. They certainly recognize the need to get the word out as rapidly and as broadly as 

possible on the availability and importance of VAERS and VAERS reporting. As far as how 

many reports have come from LTCFs, that is captured on the VAERS form though he did not 

have the total number of reports on hand. The category is more combined, so it could be LTCFs 

and community living facilities for older adults and it may not be possible to split these apart. 

CDC will look at this and will report back to ACIP, and will attempt to assess this by vaccine type 

as well.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

26

Dr. Dooling added that many of the important constituents who will need to be plugged into 

VAERS to ensure its success for this program are represented as liaisons on the ACIP COVID19 WG. CDC will continue to inform them and have them inform their liaison constituents.

Dr. Bernstein wondered whether CDC could work with cell phone carriers to have V-SAFE 

offered for download now the way updates are made for software and then practice teaching 

examples could be created so that vaccine recipients in the near future can begin to learn about 

V-SAFE and hit the ground running for their own individual safety monitoring after being 

vaccinated.

Dr. Shimabukuro said he would take this question back to CDC’s technical experts at V-SAFE to 

see what they think about that. 

Dr. Romero pointed out that in educating the public regarding these vaccines safety systems, it 

is going to be a very important to provide culturally and linguistically appropriate information to 

the general public so that they understand what this is all about and they enter data as 

appropriate. This is critical going forward in order to capture all signals that could arise from the 

use of these vaccines.

Dr. Hayes (ACNM) said she would submit suggestions for organizations that are not ACIP 

liaisons to ensure they are communicated with. She asked whether the app and consent forms 

are being translating into multiple languages other than just English and if so, how many 

languages.

Dr. Shimabukuro clarified that the V-SAFE program is not an app like on a cell phone. It is 

actually a text messaging program that includes a link to a survey. There are plans to translate 

the messages and survey into a variety of languages, with the first being Spanish.

Dr. Cohn added that V-SAFE and the survey, among other CDC products, will be translated into 

5 languages. She emphasized that in addition to the 30 ACIP liaison organizations, CDC has 

hundreds of partners that they need to engage, listen to, educate, and talk to about all of this. 

They have very strong partnerships across the healthcare sector that have been solidified over 

the past year with the pandemic and they will ensure that extensive outreach is done beyond 

the ACIP community. She assured everyone that they absolutely take the advice and 

understand the importance of ensuring that CDC’s outreach materials speak to HCP and others 

recommended to be vaccinated, to ensure that the communication materials are culturally 

appropriate and at a reading level that is accessible across the educational background of the 

health care community.

Interim Recommendation: Proposed Language for Phase 1a Allocation

Kathleen Dooling, MD MPH

Co-Lead ACIP COVID-19 Vaccine WG

Medical Officer, National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Dooling observed that they had seen the evidence and engaged in some very detailed 

discussions pertaining to critical considerations and safety in the rollout of future COVID 

vaccines. She asked the ACIP members to take a step back and look once again at the policy 

question at hand, “Should HCP and residents of LTCF be offered COVID-19 vaccination in 

Phase 1a?” and posed the following interim recommendation language:
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

27

When a COVID-19 vaccine is authorized by FDA and recommended by ACIP, health care 

personnel§ and residents of long-term care facilities¶ should be offered vaccination in the initial 

phase of the COVID-19 vaccination program (Phase 1a) §Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials

¶ Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live 

independently.

Discussion Points

Dr. Poehling made a motion, which Dr. Ault seconded, to approve the proposed language.

Dr. Kimberlin (AAP Red Book) reminded everything that he asked at the November 23rd ACIP 

meeting for confirmation that people who work in LTCFs are considered HCP and was told that 

they are. He requested at least a verbal confirmation of that if not actually putting them in one of 

the little sub-bullets to explain that more directly.

Dr. Dooling confirmed that LTCF staff are included as HCP under the definition displayed and 

the details, including that group, will be included in a future MMWR. Other groups, such as 

EMS, community health, et cetera will be discussed in greater detail as well. The long-term care 

definition that they are going by, which is listed, refers to facilities that are providing medical and 

personal care. Occasionally, those are provided within a corrections facility and those would be 

included. 

Dr. Atmar said that while he had no issue with the HCP, he remained somewhat concerned 

about including residents of LTCF in the Phase 1a group because of the lack of both safety and 

efficacy data in that patient population. He was somewhat persuaded by the support of the AGS 

and others and the information provided about the ease of administration at the same time to 

the resident population as vaccinations are being provided to the HCP working in that area. He 

was somewhat concerned about the issue that Dr. Talbot raised about the safety reporting.

While plans are in place to do the monitoring, there is a potential for a lag of information arriving. 

It will be particularly important that as planned, the LTCFs be asked to participate vigorously in 

the VAERS program. Staffing to do that may be an issue and he is still worried about this group, 

although he was leaning toward including it.

Dr. Hunter said he was very strongly supportive of the interim recommendation as written, 

assuming that the sub-prioritization discussed earlier would be captured in guidance that is 

written as part of the publication of this vote in the MMWR. He asked how soon that might be 

available, especially to healthcare systems that are going to be needing that to do the 

prioritizations.

Dr. Oliver indicated that the clinical considerations, including sub-prioritizations that were 

discussed earlier in the day, would be summarized and posted on the CDC website, the ACIP 

website, and under the recommendation, including the HCP and LTCF information.

Ms. Howell (AIM) indicated that AIM surveyed 64 of its members regarding whether they would 

like LTCF residents included in Phase 1a with HCP. The turnaround was short, so there were 

only 19 responses. However, 14 responded that they would like long-term care residents 

included in Phase 1a, mostly for logistical reasons and concerns about uptake with vaccination 

among staff in long-term care. The one question or clarification that would be helpful is 

regarding the definition of LTCF. Ms. Howell thinks that many have been planning for skilled and 

assisted living. After today’s meeting, Ms. Howell stated that she was getting the impression that 

it also may include group homes and then it was just mentioned that it might also include 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

28

corrections. Now she is also wondering about homeless shelters. If additional clarification could 

be provided on the definition of long-term care, that would be helpful.

Dr. Dooling clarified that LTCFs are primarily focusing on SNF and assisted living with an 

implied priority for SNF first and moving on to assisted living as vaccine supply dictates. It is 

understood that gating criteria will be needed to move from one phase to the next. As shown 

previously, it possible that they may be working on assisted living while moving into other 

phases.

Dr. Sanchez pointed out that as worded “HCP and residents of long-term facilities” would say 

that is the HCP of the long-term facilities. He suggested those two be separated as: 1) HCP; 

and 2) Residents of LTCF.

Dr. Szilagyi expressed strong support for this interim recommendation, including both HCP and 

residents of LTCF. There is incredibly high-risk among residents of LTCFs. While there is some 

concern over the modeling studies suggesting that vaccinating the HCP around the residents is 

more effective, if more protection could be added by vaccinating the residents, that swayed him. 

He was very impressed with the safety monitoring systems being designed and emphasized 

that the transparency with consent and assent in the LTCFs will be really important. That also 

swayed him to express strong support for this recommendation. 

Ms. Bahta added her support if this interim recommendation and thanked the two CDC leads for

such a well-thought-out process that they took to get to this point.

Dr. Hahn (CSTE) observed that most LTCF residents and potentially workers would be 

vaccinated through the pharmacy contract. His understanding for his immunization program is 

that it takes 2 weeks for the state request process to start and be turned on. Vaccine is not on 

their doorstep at this point, but there is a possibility that states will be hamstrung by the delay in 

getting vaccination started and will struggle to implement this recommendation. He wondered 

whether somebody could address that from a practical standpoint of trying to be fair in getting 

this started so that health care workers and long-term care residents are being offered 

vaccinations at the same time. 

Dr. Cohn clarified that the intent of the vote for this meeting was to provide guidance and 

recommendations for health departments to place their orders for COVID-19 vaccine and 

determine how they want to implement this guidance at state and local levels. It is anticipated 

that if a state chooses to turn on a pharmacy program for LTCF residents in the first few days or 

week of the program, there would be enough time between the end of this week and vaccine 

availability. Substantial delays in that program are not anticipated, but it will be determined at 

the jurisdiction level how orders are placed. 

Dr. Frey weigh in in favor of group 1a as it was currently categorized with healthcare workers 

and people living in LTCF. She thinks it is crucial to maintain health care capacity for 

vaccinating health care workers, but it also is important to prevent severe disease and death in 

the group that is at highest risk for those complications, and that includes the people in the 

LTCF. She was less concerned about risk early on in those in LTCFs because typically lesser 

immune responses are seen in this group in general. But this is an unknown platform that is 

being testing in thousands of people, and there is not a lot of good safety data at this time postsecond vaccination. She remains concerned about vaccinating this group, but still thinks it is the 

appropriate thing to move forward and vaccinate the healthcare workers and folks in the LTCF 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

29

simultaneously in order to get the job done more quickly, keeping in mind oversight of safety at 

the same time.

Vote: Allocation of Initial Supplies of COVID-19 Vaccine: Phase 1a

Kathleen Dooling, MD MPH

Co-Lead ACIP COVID-19 Vaccine WG

Medical Officer, National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Dr. Dooling posted reworded language in accordance with feedback received during the 

previous session, explaining the rewording clarified the intent of the interim recommendation. 

Because the change was minor, a new motion and second were deemed unnecessary.

Motion/Vote: Interim COVID-10 Vaccine Recommendation Phase 1a 

Dr. Poehling made a motion and Dr. Ault seconded to approve the revised language reading, 

“When a COVID-19 vaccine is authorized by FDA and recommended by ACIP, vaccination in 

the initial phase of the COVID-19 vaccination program (Phase 1a) should be offered to both 1) 

health care personnel§ and 2) residents of long-term care facilities¶.”

§Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials.

¶ Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently.

. 

No COIs were declared. The motion carried with 13 affirmative votes, 1 negative votes, and 0 

abstentions. The disposition of the vote was as follows:

13 Favored: Atmar, Ault, Bahta, Bell, Bernstein, Frey, Hunter, Lee, McNally, Poehling, 

Romero, Sanchez, Szilagyi 

 1 Opposed: Talbot

 0 Abstained: N/A

Following the vote, Dr. Romero invited ACIP members who wished to do to reflect on the 

rationale for their votes: 

Dr. Bernstein said that his decision to include the HCP in Phase 1a was straightforward. In 

contrast, the decision to include LTCF residents was initially a challenging one for him, 

especially when vaccine supply is initially constrained. Coupled with controlling resident direct 

contact with outside visitors and use of appropriate mitigation, he was thinking that vaccinating 

only staff was likely to notably minimize coronavirus exposure to LTCF residents. However, 

reflecting further on the data that has been presented over the last several months moved him 

to change his thinking on LTCF residents. In particular, LTCF residents and staff account for 6% 

of COVID cases and 40% of the deaths in the US. A majority of the COVID-related 

hospitalizations in those 75 years and older have been from LTCF. The systemic reactogenicity 

of the vaccine in a relatively small number of older adults appeared lower among the older age 

population in Phase I and Phase II trials, although LTCF populations were not included. While 

vaccination should be strongly encouraged, it is likely that vaccine uptake among LTCF staff will 

vary considerably, which is not ideal for limiting resident exposure. Lastly, there are federal 

pharmacy partners in place to help implement LTCF programs for residents. For all these 

reasons, he was in support of this policy question.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

30

Dr. Talbot emphasized that she has struggled with this recommendation throughout these 

meetings. She has spent her career studying vaccines in older adults. Vaccines have 

traditionally been tested in a young, healthy population with the hope that they would work in 

frail older adults. Entering this realm of hoping it works and hoping it is safe concerns her on 

many levels, particularly for this vaccine. One concern is that there is less reactogenicity, which

also means there is less immunogenicity. She also does not feel that the safety network for 

LTCF is strong enough and that work remains to be done. If time is going to be spent educating 

anyone, HCP are going to be incredibly important to vaccinate. It is known with influenza that 

there is a little impact on vaccinating residents, but major impact on vaccinating health care 

workers. She emphasized that she was still struggling with this and that it was not an easy vote. 

She expressed her hope that this would highlight that LTCF residents are a population who 

needs many vaccines, not just COVID-19. It is important to find ways of developing and testing 

vaccines to prolong the quality of life of LTCF residents. She stressed that she has no 

reservations for HCP taking this vaccine. There are amazing data about a respiratory vaccine 

that have never been seen before. It is incredibly exciting and she wants HCP to know that she 

has no reservations about them taking the vaccine whatsoever. She thanked ACIP for letting 

her serve and said she was very glad it is a village and not one person.

Dr. Bell reflected on the weight of the decision made during this meeting and the process upon 

which they are embarking. While they all would like to know more, they go through a process, 

evaluate carefully every bit of information available to them, and then comes a time when they 

need to act. She found the consistency with which all of her colleagues on the ACIP essentially 

had the same way of looking at the evidence that was available to them and settling on the 

same conclusions was testament not only to the fidelity of the process, but also to the 

soundness of the thinking for this moment. She thanked her colleagues for continuing to work 

through this to reach this point.

Dr. Romero reminded everyone that the WG and ACIP have spent 8 months discussing and 

evaluating the data. Whatever they have asked for has been presented to them and has been 

clearly discussed, both in the WG and in a public setting. Their discussions have been 

transparent and their motives clear. As stated previously, they are using the principles of 

maximizing benefits and minimizing harms, promoting justice, and mitigating health inequities. 

Those who are in the area of public health at this time see the growing number of cases that are 

coming before them. They see the growing number of HCP who have become infected, some of 

whom have unfortunately passed away. They see that individuals living in LTCF are at 

exceptional risk for morbidity and mortality due to this virus and disease. He believes that his 

vote reflects maximum benefit, minimum harm, promoting justice, and mitigating the health 

inequalities that exist with regard to distribution of this vaccine. It is because of that that he 

voted in favor of this recommendation. He expressed gratitude to the WG leads, Chair, and 

members of CDC from whom the WG and ACIP receive support. He stressed what an incredible 

honor it is has been to serve and how humbled he feels to lead ACIP.

Dr. Messonnier thanked the public and everyone listening to this incredibly important meeting. 

For all those who are anxiously awaiting a vaccine, she expressed her hope that this vote would 

get them one step closer to the day they can all feel safe again and the pandemic is over. In 

conclusion of the meeting, she thanked Dr. Romero for presiding over this meeting and for his 

work over the past year guiding the ACIP.
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

31

 

Upon reviewing the foregoing version of the December 1, 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.

Certification
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

32

Department of Health and Human Services 

Centers for Disease Control and Prevention 

Advisory Committee on Immunization Practices 

July 1, 2019 – December 31, 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 

 

ACIP Membership Roster
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

33

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 

 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

34

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 

 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

35

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 

Food and Drug Administration (FDA) 

FINK, Doran, MD, PhD 

Deputy Director, Clinical, Division of Vaccines and Related Products Applications Office of 

Vaccines Research and Review 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

Silver Spring, MD

 

Health Resources and Services Administration (HRSA) 

RUBIN, Mary, MD 

Chief Medical Officer 

Division of Injury Compensation Programs 

Rockville, MD 

Indian Health Service (IHS) 

WEISER, Thomas, MD, MPH 

Medical Epidemiologist 

Portland Area Indian Health Service 

Portland, OR 

 

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

KIM, David, MD 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 

 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

36

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

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 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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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) 

GLUCKMAN, Robert A., MD, MACP 

Chief Medical Officer, Providence Health Plans 

Beaverton, OR

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA

Washington, DC 

American Medical Association (AMA) 

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine 

Emory University School of Medicine

Atlanta, GA 

 

American Nurses Association (ANA) 

RITTLE, Charles (Chad), DNP, MPH, RN 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

38

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) 

HOWELL, Molly, MPH Immunization Program Manager 

North Dakota Department of Health 

Bismarck, ND

 

Association for Prevention Teaching and Research (APTR) 

McKINNEY, W. Paul, MD 

Professor and Associate Dean 

University of Louisville School of Public Health and Information Sciences

Louisville, KY 

Association of State and Territorial Health Officials (ASTHO) 

SHAH, Nirav D, MD, JD

Director 

Maine Center for Disease Control and Prevention

Augusta, ME

Biotechnology Industry Organization (BIO) 

ARTHUR, Phyllis A., MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD State 

Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare

Boise, ID 

 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

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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 

International Society for Travel Medicine (ISTM)

BARNETT, Elizabeth D, MD

Professor of Pediatrics

Boston University School of Medicine

Boston, MA

National Association of County and City Health Officials (NACCHO) 

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 

 

National Association of County and City Health Officials (NACCHO) (alternate) 

DUCHIN, Jeffrey, MD 

Health Officer and Chief, Communicable Disease Epidemiology and Immunization Section 

Public Health - Seattle and King County 

Professor in Medicine, Division of Allergy and Infectious Diseases 

University of Washington School of Medicine and School of Public Health

Seattle, WA

National Association of Pediatric Nurse Practitioners (NAPNAP) 

STINCHFIELD, Patricia A., RN, MS, CPNP 

Director, Infectious Disease/Immunology/Infection Control 

Children's Hospitals and Clinics of Minnesota

St. Paul, MN 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

40

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 

 

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 
Advisory Committee on Immunization Practices (ACIP) Summary Report December 1, 2020

41

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