MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP)

AUGUST 13, 2021

SUMMARY MINUTES

TABLE OF CONTENTS

MEETING PURPOSE ................................................................................................................ 2

Thursday: August 13, 2021 ........................................................................................................ 2

WELCOME AND INTRODUCTIONS ...................................................................................... 2

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES ..................................................... 3

FDA Announcement............................................................................................................ 3

Session Introduction ........................................................................................................... 3

EtR Framework: Additional Doses of mRNA COVID-19 Vaccines as Part of a Primary 

Series for Immunocompromised People ............................................................................. 4

Clinical Considerations for Use of an Additional Dose of mRNA COVID-19 Vaccines as .... 9

Part of a Primary Vaccine Series for Immunocompromised People..................................... 9

Public Comments...............................................................................................................15

Vote: Additional Doses of mRNA COVID-19 Vaccines as Part of a Primary Series for.......19

Immunocompromised People.............................................................................................19

Considerations for Booster Doses of COVID-19 Vaccines .................................................26

Certification...............................................................................................................................30

ACIP Membership Roster .........................................................................................................31

Acronyms Used in the Document..............................................................................................39
ACIP Meeting Summary August 13, 2021

2

MEETING PURPOSE

The United States (US) Department of Health and Human Services (HHS) and the Centers for 

Disease Control and Prevention (CDC) convened an emergency meeting of the Advisory 

Committee on Immunization Practices (ACIP) on August 13, 2021. The meeting took place

remotely via Zoom, teleconference, and live webcast. This document provides a summary of the 

meeting, which focused on additional doses of messenger ribonucleic acid (mRNA) COVID-19 

vaccines as part of a primary series among immunocompromised persons, emerging severe 

acute respiratory syndrome coronavirus-2 (SARS-CoV-2) variants and COVID-19 vaccines, and 

considerations for booster doses of COVID-19 vaccines for persons previously vaccinated with 

a primary series.

THURSDAY: AUGUST 13, 2021

WELCOME AND INTRODUCTIONS

Dr. Grace Lee (ACIP Chair) called to order and presided over her first meeting since assuming 

the role of ACIP Chair. She welcomed everyone to the 10th ACIP meeting for 2021 and the 20th

ACIP meeting since the beginning of the COVID-19 pandemic. She acknowledged outgoing 

members Dr. Hank Bernstein; Dr. Sharon Frey; and Dr. Jose Romero, ACIP former Chair and 

expressed gratitude for their service and dedication to the ACIP. In addition, Dr. Lee thanked 

the current ACIP members for continuing to support the United States (US) on decisions about 

the use of vaccines and their willingness to make decisions in the face of uncertainty and

constantly evolving data.

Dr. Amanda Cohn (ACIP Executive Secretary) added her welcome to those attending the 

August 13, 2021 virtual ACIP meeting. She indicated that copies of the slides for the day were 

available on the ACIP website and were made available through a ShareLinkTM file for voting 

ACIP Voting Members, Ex Officios, and Liaisons. She indicated that there would be an oral 

public comment session prior to the vote at approximately 12:30 PM Eastern Time (ET). Given 

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

selection was made randomly via a lottery. Those individuals who were not selected and any 

other individuals wishing to make written public comments may submit them through

https://www.regulations.gov using Docket Number CDC-2021-0084. Further information on the 

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

As noted in the ACIP Policies and Procedures manual, ACIP members agree to forgo 

participation in certain activities related to vaccines during their tenure on the committee. For 

certain other interests that potentially enhance a member’s expertise, CDC has issued limited 

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

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

vaccines, but are prohibited from participating in committee votes. Regarding other vaccines of 

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

abstains on all votes related to that company. ACIP members stated COIs at the beginning of 

the meeting.
ACIP Meeting Summary August 13, 2021

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Dr. Cohn announced that the anticipated dates for upcoming emergency ACIP meetings 

focused on COVID-19 vaccines would be August 24, 2021 and September 29-30, 2021, while 

the next regularly scheduled meeting focused on non-COVID vaccine related issues would be 

October 20-21, 2021. She emphasized that there could be additional COVID-19 vaccine 

meetings at any time, which would be updated on the ACIP website as soon as possible once

confirmed.

Dr. Lee (ACIP Chair) conducted a roll call, during which no COIs were declared and quorum 

was established. A list of Members, Ex Officios, and Liaison Representatives is included in the 

appendixes at the end of this summary document.

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES

FDA Announcement

Dr. Peter Marks (FDA/BCBER) reminded everyone that the immunocompromised is a 

heterogeneous group in their ability to respond to the available COVID-19 vaccines. While some 

have relatively modest immune repairment, others may either not respond or respond poorly to 

the existing COVID-19 vaccines such as those who have received solid organ transplants or 

who are on medications that are typically used for solid organ transplants. After reviewing recent 

studies, including one for the Pfizer-BioNTech vaccine and the other for the Moderna vaccine, 

the Food and Drug Administration (FDA) decided to amend the Emergency Use Authorization 

(EUA) to allow for a third dose of COVID-19 vaccine to be administered to individuals at least 12 

years of age for the Pfizer-BioNTech vaccine or at least 18 years of age for the Moderna 

vaccine who have undergone solid organ transplantation or who were diagnosed with conditions

that are considered to have an equivalent level of immunocompromise. That was caveated with 

the fact that the administration of these third doses appears to be only moderately effective in 

increasing antibody titers, so patients should be counseled to maintain physical precautions to 

help prevent COVID-19 and close contacts of immunocompromised persons should be 

vaccinated as appropriated for their health status. FDA will continue to evaluate data as they 

becomes available. 

Session Introduction

Dr. Matthew Daley (ACIP, WG Chair) introduced the COVID-19 Vaccines WG session, first 

noting that there had been a 700% increase in the 7-day moving average of COVID-19 cases in 

the US since July 1, 2021. He reported that for the last 2 months, the COVID-19 Vaccines Work 

Group (WG) had been meeting at least weekly during which they reviewed vaccines with 

respect to SARS-CoV-2 variants, reviewed and discussed updates on myocarditis following 

vaccination, reviewed in detail the Evidence to Recommendations (EtR) Framework for 

additional doses of mRNA COVID-19 vaccines for immunocompromised individuals, discussed 

a number of clinical considerations related to these individuals as well as other issues, and 

talked about considerations for booster doses of COVID-19 vaccines in the broader population. 

The goal for this ACIP meeting was to discuss and vote on additional doses of mRNA COVID19 vaccines as part of a primary series in immunocompromised individuals, discuss clinical

considerations for mRNA COVID-19 vaccines as part of a primary vaccine series for 

immunocompromised people, hear an update on emerging SARS-CoV-2 variants and COVID19 vaccines, and consider booster doses of COVID-19 vaccines in the general population.
ACIP Meeting Summary August 13, 2021

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EtR Framework: Additional Doses of mRNA COVID-19 Vaccines as Part of a Primary 

Series for Immunocompromised People

Dr. Kathleen Dooling (CDC/NCIRD) provided a summary of the EtR Framework on additional 

doses of mRNA COVID-19 vaccines as part of a primary series for immunocompromised 

people. Before getting into the EtR Framework, she referenced the regulatory allowance upon 

which they were proceeding during this meeting that was introduced by Dr. Marks. On the night 

of August 12, 2201, the FDA authorized an additional vaccine dose for certain 

immunocompromised individuals.1It should be noted that the amendment applies only to 

immunocompromised people. Other fully vaccinated individuals do not need an additional dose 

at this time. The amendment applies to Pfizer-BioNTech COVID-19 vaccine for individuals ≥12 

years of age and Moderna COVID-19 vaccine for individuals ≥18 years of age. Due to 

insufficient data, the EUA amendment for an additional dose does not apply to Janssen COVID19 vaccine or individuals who received Janssen COVID-19 as a primary series. CDC and FDA 

are actively engaged to ensure that immunocompromised recipients of Janssen COVID-19 

vaccine have optimal vaccine protection.

As sanctioned by the ACIP, the EtR Framework provides a structure to describe information 

considered in moving from evidence to ACIP vaccine recommendations and to provide 

transparency around the impact of additional factors on deliberations when considering a 

recommendation. The EtR policy question for this ACIP meeting was, “Should ACIP recommend

vaccination with an additional dose of either Pfizer-BioNTech or Moderna COVID-19 (mRNA

vaccines) following a primary series in immunocompromised people, under an Emergency Use 

Authorization?”

This discussion focused on the immunocompromised population, meaning people with medical 

conditions or people receiving treatments that are associated with moderate to severe immune

compromise.2 That includes active or recent treatment for a solid tumor or hematologic 

malignancies; receipt of solid organ or recent hematopoietic stem cell transplants (HSCT); 

severe primary immunodeficiency; advanced or untreated HIV infection; active treatment with

high-dose corticosteroids, alkylating agents, metabolites, tumor-necrosis (TNF) blockers, and

other biologic agents that are immunosuppressive or immunomodulatory; and chronic medical 

conditions such as asplenia and chronic renal disease that may be associated with varying

degrees of immune deficit.

The intervention of interest is an additional dose of Pfizer-BioNTech COVID-19 vaccine

(BNT162b2) or Moderna COVID-19 vaccine (mRNA-1273), both in people 18 years of age and 

older after an initial 2-dose primary series of mRNA COVID-19 vaccine in immunocompromised 

people. The WG interpretations that follow were based on consideration of people 18 years of 

age and older for both vaccines. However, the FDA EUA amendment provides allowance for the 

use of an additional dose of Pfizer-BioNTech vaccine in adolescents 12-17 years of age.

Attempts should be made to match the additional dose type of the mRNA primary series when 

1 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dosecertain-immunocompromised

2 Additional information about the level of immune suppression associated with a range of medical conditions and treatments can be 

found in general best practices for vaccination of people with altered immunocompetence, the CDC Yellow Book, and the 

Infectious Diseases Society of America policy statement, 2013 IDSA Clinical Practice Guideline for Vaccination of the 

Immunocompromised Host
ACIP Meeting Summary August 13, 2021

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possible. However, a heterologous additional dose is permitted when matching is not feasible. 

The additional dose of mRNA COVID-19 vaccine should be administered at least 28 days after 

completion of the primary mRNA COVID-19 vaccine series.

Before proceeding with the EtR, Dr. Dooling reiterated that any recommendation for an

additional dose would not supplant the importance of infection prevention measures.

Immunocompromised people should continue to wear a mask, stay 6 feet apart from others they 

do not live with, and avoid crowds and poorly ventilated indoor spaces until advised otherwise 

by their healthcare provider (HCP). Importantly, close contacts of immunocompromised people

are strongly encouraged to be vaccinated against COVID-19.3

As a reminder, the EtR domains include the Public Heath Problem, Benefits and Harms, Values, 

Acceptability, Feasibility, Resource Use, and Equity along with related questions for each. In 

this case, the public health problem refers to COVID-19 among immunocompromised people

and the intervention refers to an additional dose of mRNA COVID-19 vaccine in

immunocompromised people who already received a primary series of an mRNA COVID-19 

vaccine.

First, a description of the public health problem. COVID-19 cases have been increasing since 

early July. As of August 9th, there have been over 35 million COVID-19 cases reported to CDC

with the most recent 7-day average of over 100,000 cases per day.4 Hospitalization rates also 

have been increasing since early July.5 Deaths have been increasing as well. The current 7-day 

moving average is over 600 deaths per day from COVID-19.6

According to one national survey, immunocompromised people comprise approximately 2.7% of 

the US adult population or approximately 7 million adults. Immunocompromised people are 

more likely to get severely ill from COVID-19. They are at higher risk for prolonged SARS-CoV-2 

infection and shedding and viral evolution during the infection and treatment, particularly 

amongst hospitalized patients. They have lower antibody neutralization titers to SARS-CoV-2 

variants compared to non-immunocompromised people and they are more likely to transmit 

SARS-CoV-2 to household contacts. Immunocompromised people are more likely to have 

breakthrough infection. In small studies of hospitalized breakthrough cases, 40%-44% were 

deemed to be immunocompromised. Several observational studies have shown lower vaccine

effectiveness (VE) with VE estimates ranging from 59%-72% among immunocompromised

versus 90%-94% among non-immunocompromised people after 2 doses of mRNA vaccine.7

In terms of the percentage of antibody response after 2 mRNA vaccine doses by different types 

of immunocompromising conditions, studies among people with cancer showed that the

proportion with antibody response ranged from 45%-95%, with lower responses seen among 

people with hematologic cancers. Studies of people on hemodialysis ranged from 71%-98% 

response following 2 doses. Studies of people with solid organ transplant have the largest 

deficits in antibody response, ranging from 0%-79%. Studies of people treated for autoimmune

or inflammatory disorders ranged from 40%-94% response to an mRNA primary series. Healthy 

controls by comparison, where they were included in these studies, ranged from 95%-100% of 

vaccine response. Almost all studies that assessed response after the first and second doses 

3 https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html

4 https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases

5 https://gis.cdc.gov/grasp/covidnet/covid19_3.html August 9, 2021

6 https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases August 9, 2021

7 See references list for slides 15 and 16 at the end of Dr. Dooling’s slide set
ACIP Meeting Summary August 13, 2021

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demonstrated a less robust response after only one dose.8 Several countries, including France, 

the United Kingdom (UK), Israel, and Germany, are considering or have announced plans for 

the use of an additional dose in immunocompromised people.9 Based on review of this data, the 

WG felt that COVID-19 disease among immunocompromised people is of public health 

importance.

The benefits and harms domain focused on the primary questions regarding how substantial the 

anticipated desirable and undesirable effects are for each main outcome, as well as whether the 

desirable effects outweigh the undesirable effects. Earlier in the week, the first randomized trial 

of third dose of mRNA vaccine in transplant recipients was published. This study randomized 

120 vaccinated people to either a third dose of Moderna vaccine or placebo. The primary 

outcome was a receptor binding domain (RBD) antibody level of at least 100 U/mL at 1 month 

post-Dose 3. Antibodies were higher in recipients of the third dose of Moderna vaccine, with 

55% of the vaccine group achieving the endpoint versus only 18% of the placebo group.

Encouraging improvements in immune response also were observed for neutralizing antibodies 

and T-cell function.10

Looking at 5 observational studies looking at seropositivity after a second dose of mRNA, 2 in 

recipients of solid organ transplants and 3 in patients on hemodialysis, seropositivity after a 

second dose of mRNA ranged from 20%-89%. A third dose of mRNA was administered among 

those who had no detectable antibody response to the initial mRNA vaccine primary series, with 

33%-50% developing an antibody response to a third dose.11 In the Kamar et al. study12 of solid 

organ transplant patients, the proportion of the group who were seropositive increased after 

each dose at 40% post-Dose 2 and 68% 1 month post-Dose 3. In addition, the average antibody 

titer increased after each dose. Even those who were already seropositive experienced 

increases in their antibody levels. In this study of 99 transplant patients, no serious adverse 

events (SAEs) were reported after administration of the third dose and no acute rejection 

episodes occurred. The Epsi et al. study13 showed the reactogenicity of a third mRNA vaccine 

in a cohort of patients on hemodialysis. No patients developed side effects that required 

hospitalization. Symptoms reported were consistent with the previous doses and the intensity of 

the symptoms was mostly mild or moderate.

To summarize the available evidence regarding possible benefits, emerging experimental and 

observational data in adults suggests that an additional mRNA COVID vaccine in 

immunocompromised people enhances antibody response and increases the proportion who 

respond to COVID-19 vaccine. No efficacy or effectiveness studies of COVID-19 prevention 

following a third dose exist. With respect to potential harms, in small studies of an additional 

dose of mRNA vaccine, no SAEs were observed and reactogenicity of a third dose of mRNA 

was similar to prior doses. It should be noted that mRNA COVID-19 vaccines are associated

with rare but serious adverse events, including anaphylaxis, myocarditis, and pericarditis in 

young adults. The impact of immunocompromising conditions on these rare events is unknown.

There are no safety studies published on additional mRNA doses in immunocompromised

8 See references list for slide 17 at the end of Dr. Dooling’s slide set

9 1) dgs_urgent_n43_vaccination_modalites_d_administration_des_rappels.pdf (solidarites-sante.gouv.fr); 2) 

https://govextra.gov.il/media/30095/meeting-summary-15122020.pdf; 3) 

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1009174/COVID19_vaccination_programme_guidance_for_healthcare_workers_6_August_2021_v3.10.pdf; 4) 

https://www.reuters.com/world/europe/french-president-macron-third-covid-vaccine-doses-likely-elderly-vulnerable-2021-08-05/

10 Hall et al. (2021) NEJM. Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients. DOI: 

10.1056/NEJMc2111462

11 See list of references for slide 26 at the end of Dr. Dooling’s presentation

12 Kamar et al. (2021) NEJM Three Doses of an mRNA Covid-19 Vaccine in Solid-Organ Transplant Recipients (nejm.org)

13 Epsi et al. (2021) medRxiv doi: https://doi.org/10.1101/2021.07.02.21259913
ACIP Meeting Summary August 13, 2021

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adolescents. The WG felt that the desirable anticipated effects were large, the undesirable 

anticipated effects were minimal, and that the balance favored the intervention of the use of an 

additional dose of mRNA COVID vaccine in immunocompromised people.

The domain of values and acceptability addresses how the target population feels about the 

balance of desirable and undesirable effects, if there is variability in how people value the 

outcomes, and whether an additional dose of mRNA COVID-19 vaccines is acceptable to 

stakeholders. The use of additional doses of COVID-19 vaccines in the general US population is 

not currently recommended by ACIP. Approximately 140 million individuals have completed a 2-

dose primary series of either Moderna or Pfizer-BioNTech COVID-19 vaccine. Approximately 

1.14 million people (<1%) received one or more additional COVID-19 doses. Approximately 12 

million individuals received a 1-dose primary series of Janssen COVID-19 vaccine, with a little 

over 90,000 (~1%) people in this population receiving one or more additional doses of COVID19 vaccines.

To focus in on the immunocompromised population under consideration, a large study was 

conducted among individuals with cancer, autoimmune disease, and other conditions early in 

the COVID vaccine rollout. At that time, 81% already were vaccinated or intended to become 

vaccinated and 19% either said that they were unsure, probably would not, or definitely would

not receive a COVID-19 vaccine. This was a higher intent to vaccinate than the general adult 

population. Factors associated with hesitancy among recipients were younger age, female 

gender, Black, Pacific Island or Native American race or ethnicity, less formal education, antivaccine sentiment, and distrust of the media.14 While the stated reasons for vaccine refusal 

among immunocompromised people are many and varied, across studies concerns about 

safety, possible side effects, discomfort, and distrust of vaccines were common.15

Professional bodies strongly support COVID-19 vaccination and use of an additional dose in 

immunocompromised populations. In the many letters received from professional associations,16

two main points emerged. They encouraged study of safety and efficacy/effectiveness of an 

additional dose of COVID-19 vaccine in immunocompromised people, and they supported swift 

action on the part of ACIP to recommend use of an additional dose of COVID-19 vaccine in 

immunocompromised people. The Pediatric Infectious Diseases Society (PIDS) and Children’s 

Oncology Group (COG) supported use of an additional dose in immunocompromised 

adolescents. Patient advocacy bodies also expressed strong support of COVID-19 vaccination 

and study of an additional dose. Specifically, the Leukemia & Lymphoma Society (LLS) supports 

providing access to doses of COVID-19 vaccine for supplemental vaccination in 

immunocompromised patients and urges that these patients have the opportunity to be among 

the first to receive these additional doses.

In summary of the available evidence for values overall, the initial intent to vaccinate is high 

among immunocompromised populations. Concerns about safety and possible side effects are 

the main reasons for vaccine hesitancy. Younger age, female gender, racial/ethnic minorities,

and less formal education are factors associated with vaccine hesitancy. Strong support for an 

additional dose was expressed by immunocompromised patients via written and oral comments 

14 COVID-19 vaccine hesitancy among individuals with cancer, autoimmune diseases, and other serious comorbid conditions 

(medrxiv.org) 

15 1) COVID-19 vaccine hesitancy among individuals with cancer, autoimmune diseases, and other serious comorbid conditions 

(medrxiv.org); 2) SARS-CoV-2 Vaccine Acceptability in Patients on Hemodialysis: A Nationwide Survey | American Society of 

Nephrology (asnjournals.org)

16 Infectious Diseases Society of America, American College of Rheumatology, American Society of Transplantation, American 

Society of Transplant Surgeons, International Society for Heart and Lung Transplantation, Pediatric Infectious Diseases Society, 

Children’s Oncology Group
ACIP Meeting Summary August 13, 2021

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to ACIP meeting on July 22, 2021. With regard to acceptability, professionals who provide 

healthcare to immunocompromised people recognize that their patients are at high risk for 

severe outcomes from COVID-19 and strongly support a recommendation for an additional dose 

of COVID-19 vaccine. Societies that advocate for access to the best quality care for patients

with immunocompromising conditions support access to an additional dose of COVID-19 

vaccine to increase the chances of vaccine protection. The WG concluded that the target group 

felt the desirable effects were large compared to the undesirable effects and that there was 

probably no important uncertainty or variability. The WG felt that an additional dose of mRNA 

COVID vaccine for immunocompromised people was acceptable to key stakeholders.

The primary question regarding the domain of feasibility pertained to whether an additional dose 

of mRNA COVID vaccine would be feasible to implement among immunocompromised people. 

In general, there are high levels of interaction between immunocompromised populations and 

the healthcare system that provide opportunities for an additional dose following the primary 

series. mRNA COVID-19 vaccine supply in the US is sufficient to make an additional dose for

immunocompromised people feasible. Testing for antibodies following vaccination is not

recommended, thus reducing the complexity of a recommendation for an additional dose.

Therefore, the WG felt that an additional dose of mRNA vaccine would be feasible to implement 

among immunocompromised people.

The primary question regarding the domain of resource use pertained to whether an additional 

dose of mRNA vaccine given to immunocompromised people would be a reasonable and 

efficient allocation of resources. The US Government (USG) purchased 600 million doses of 

mRNA vaccines,17 which is available at no cost to the recipient. No studies have evaluated costeffectiveness regarding the use of COVID-19 vaccines among immunocompromised or a third 

dose. Immunocompromised patients experience high medical costs at baseline and are at high

risk of hospitalization. The cost of an additional dose of COVID-19 vaccine is small relative to

these costs. As a reminder, the WG previously concluded that cost-effectiveness may not be the

primary driver for decision-making during a pandemic and for vaccines under an EUA. The WG

felt that an additional dose of mRNA vaccine given to immunocompromised people would be a 

reasonable and efficient allocation of resources.

The primary question regarding equity regarded what the impact on health equity would be of an 

additional dose of mRNA COVID-19 vaccine given to immunocompromised people. As a 

reminder, health equity is when everyone has the opportunity to be as healthy as possible and 

no one is disadvantaged from achieving this potential because of a social position or other 

socially determined circumstances. There are a number of immunocompromised groups in the 

US who could be disadvantaged with respect to an additional mRNA COVID vaccine dose, such 

those who may experience limited access to vaccines because of their place of residence, 

race/ethnicity, socioeconomic status (SES), personal characteristics associated with 

discrimination, and/or those who belong to a group for whom vaccine hesitancy is high. In 

addition, for the time being, those who receive Janssen COVID-19 vaccine will not be eligible for 

an additional dose of mRNA vaccine.

17 https://www.hhs.gov/about/news/2021/02/11/biden-administration-purchases-additional-doses-covid-19-vaccines-from-pfizer-andmoderna.html
ACIP Meeting Summary August 13, 2021

9

In the general US population, great strides have been made toward equitable uptake of COVID19 vaccines. However, there is still room for improvement.18 Similar patterns may be seen with 

uptake among immunocompromised people. Equitable application of this intervention can be 

bolstered by a multi-pronged approach to ensure access, making sure that mRNA vaccines are 

available at primary care provider (PCP) and specialist clinics serving immunocompromised 

patients, Federally Qualified Health Centers (FQHCs), rural health clinics, community health 

centers, hospitals, and pharmacies. The WG felt that an additional dose of mRNA COVID-19 

vaccine given to immunocompromised people probably would have no impact on health equity.

In summary of the EtR domains, the WG concluded that COVID-19 disease in 

immunocompromised people is an important public health problem. The anticipated desirable 

effects of an additional dose of mRNA vaccine are large and undesirable effects are expected to 

be minimal, favoring the intervention. The certainty of the evidence was not formally graded.

The WG felt that the target population valued the intervention and that the intervention was 

acceptable to stakeholders, feasible to implement, and a reasonable use of resources. The WG

thought an additional dose of mRNA vaccine for immunocompromised people probably would

not impact health equity. Overall, most WG members felt that the desirable consequences

clearly outweighed undesirable consequences in most settings. After reviewing the totality of 

information presented in the EtR Framework, the WG discussed the type of recommendation to 

propose to ACIP. Most WG members supported recommending the intervention.

To begin the discussion, the WG posed the following questions for ACIP to consider and 

deliberate:

1. Does ACIP support the intervention of an additional dose of mRNA COVID-19 vaccine 

following a primary series in immunocompromised people?

2. Balancing potential benefits and potential harms, what is the optimal lower age threshold for 

the additional dose intervention in immunocompromised people?

Clinical Considerations for Use of an Additional Dose of mRNA COVID-19 Vaccines as 

Part of a Primary Vaccine Series for Immunocompromised People

Dr. Neela Goswami (CDC/NCHHSTP) shared the proposed clinical considerations for use of 

an additional mRNA COVID-19 vaccine dose following a primary COVID-19 vaccine series for 

immunocompromised people. To respond to a request that was raised during the last ACIP WG 

meeting regarding COVID vaccines and pregnancy, language strengthening the

recommendation for COVID vaccine among child-bearing women and pregnant people was 

updated and posted by CDC earlier in the week. In summary, COVID-19 vaccination is 

recommended for all people aged 12 years and older, including people who are pregnant, 

lactating, trying to get pregnant, or who might become pregnant in the future. It is important to 

know that CDC and ACIP have never pointed to pregnancy as a contraindication to COVID 

vaccine, but additional real-world evidence about the safety and effectiveness of COVID-19 

vaccination during pregnancy further demonstrates that the benefits of receiving a COVID-19 

vaccine outweigh any known or potential risks. This is particularly important given that COVID19 disease itself increases the risk of severe illness and pregnancy complications.

18 CDC. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic as of August 8, 2021, and US Census Bureau National 

Population Estimates
ACIP Meeting Summary August 13, 2021

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The updated language was posted on August 11, 2021 to the Clinical Considerations site.

19

There is no evidence that any of the COVID-19 vaccines affect current or future fertility. COVID19 vaccines do not cause infection in the pregnant person or the fetus. There are no safety 

signals in animal studies. There are reassuring early safety data on mRNA COVID-19 vaccines 

during pregnancy. Early data suggest mRNA COVID-19 vaccines during pregnancy are

effective.

Now moving to the topic at hand. As a reminder, the first step in the process for the

consideration of an additional dose of COVID-19 vaccine in immunocompromised people is data 

review to assess the safety, immunogenicity, and implementation features related to the use of 

an additional dose of COVID-19 vaccine in this population, which Dr. Dooling just presented.

Then there is regulatory allowance by the FDA. At this point, FDA has issued an EUA for both 

Pfizer-BioNTech and Moderna COVID-19 vaccine that allows ACIP to make recommendations 

under an EUA. Once there is regulatory allowance, CDC or ACIP can have a clinical update

with clinical considerations or recommendations for use. The purpose of this presentation was 

to review the proposed interim clinical considerations for use of an additional dose of mRNA 

COVID-19 vaccine in immunocompromised people.

It is important to keep in mind that there are two distinct potential ways an additional vaccine 

dose can be used. The first way is after but in association with a primary vaccine series.

Administration of this additional dose is needed when the initial immune response following a

primary vaccine series is likely to be insufficient. In contrast, a booster dose is a dose of vaccine 

administered when the initial sufficient immune response to a primary vaccine series is likely to

have waned over time. The need for and timing of a COVID-19 booster dose have not been

established. The focus of the proposed clinical considerations is for people with moderate to 

severe immunocompromise due to a medical condition or immunosuppressive treatment the 

potential to increase immune response coupled with an acceptable safety profile support 

consideration for an additional dose of mRNA COVID-19 vaccine following an initial two-dose 

primary mRNA COVID-19 vaccine series in this population.

The proposed categories for “moderate” and “severe” immunocompromised people were 

developed from a combination of resources, including the ACIP General Best Practice 

Guidelines for Immunization, CDC Yellow Book, and the 2013 IDSA Clinical Practice Guideline

for Vaccination of the Immunocompromised Host. The list proposed for inclusion on the CDC 

Clinical Considerations page includes immunocompromised people who have experienced the 

following:

• Active treatment for solid tumor and hematologic malignancies

• Receipt of a solid organ transplant and are taking immunosuppressive therapy

• Receipt of chimeric antigen receptor T-cell (CAR-T-cell) or HSCT transplant within 2 years of 

transplantation or taking immunosuppressive therapy

• Moderate or severe primary immunodeficiency (e.g., DiGeorge, Wiskott-Aldrich syndromes)

• Advanced or untreated HIV infection

• Active treatment with high-dose corticosteroids (i.e., ≥20mg prednisone or equivalent per 

day), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs,

cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis 

factor (TNF) blockers, and other biologic agents that are immunosuppressive or 

immunomodulatory

19 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#pregnant
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The following additional considerations would be listed:

• There are chronic medical conditions that may be associated with varying degrees of 

immune deficit.

• The patient’s clinical team is best able to assess the degree of altered immunocompetence

and optimal timing of vaccination, with specific attention paid to current or planned 

immunosuppressive therapies.

• Whenever possible, mRNA COVID-19 vaccination doses (including the primary series and 

additional dose) should be given at least 2 weeks before initiation of immunosuppressive 

therapies.

• Factors to consider in assessing the general level of immune competence of patients with 

chronic diseases include disease severity, duration, clinical stability, complications, 

comorbidities, and any potentially immune-suppressing treatment.

• The utility of serologic testing or cellular immune testing to assess immune response to 

vaccination and guide clinical care (e.g., need for an additional dose) has not been 

established and is not recommended at this time.

The following implementation considerations would be listed:

• The additional dose should be the same mRNA vaccine as the primary series.

• An alternate mRNA product can be used if the primary series product is not available.

• Until more data are available, the additional dose would be administered at least 28 days

after completion of the initial primary series.

• Currently there are not data to support the use of an additional mRNA COVID-19 vaccine 

dose after a primary Janssen COVID-19 vaccine in immunocompromised people. FDA and 

CDC are actively working to provide guidance on this issue.

In response to ACIP feedback, there are plans to emphasize the importance of infection

prevention measures, recognizing this additional layer of protection. Here immunocompromised 

people, including those who receive an additional mRNA dose, should be counseled about their 

continued potential for reduced immune response to COVID-19 vaccination and their need to 

follow prevention measures,20 including wearing a mask, staying 6 feet apart from others they

do not live with, and avoiding crowds and poorly ventilated indoor spaces until advised 

otherwise by their HCP. Close contacts of immunocompromised people also should be strongly

encouraged to be vaccinated against COVID-19. There also will be updates to the CDC clinical 

resources regarding administration of the additional dose associated with the primary vaccine

series for some immunocompromised patients that will be available on the CDC vaccines 

website.21

Summary of Discussion (Dooling & Goswami)

• Regarding an inquiry pertaining to whether human immunodeficiency viruses (HIV)-positive 

populations were considered in the 63 studies identified on Slide 14, Dr. Dooling indicated 

that there was not sufficient information specifically on HIV-positive populations to present 

the data as a body of evidence.

20 https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html

21 Updates will be posted at: https://www.cdc.gov/vaccines/covid-19/info-by-product/index.html
ACIP Meeting Summary August 13, 2021

12

• Children 12-17 years of age have moderate to severe immunocompromised conditions that 

reflect the full spectrum that occur in adults, leukemia and lymphoma are common cancers 

in children, and the mechanism creating the immunocompromising conditions are similar for 

both children and adults:

➢

➢

➢

➢

➢

➢

Given that the response to the Pfizer mRNA vaccine, which is the only one with an 

EUA for children, was similar for children and young adults and that there are data to 

suggests that breakthrough disease occurs in 40%-44% in persons with 

immunocompromising conditions, numerous ACIP members felt that it would be very 

important for children 12-17 years of age to have access to an additional dose. Not 

only will this be important for health equity, but also some of these children will be in 

schools making the additional dose of paramount importance.

Some ACIP members expressed concern about potential harm for children 12-17 

years of age, particularly those who had a robust response to the first 2 doses and 

potentially would receive a third dose 1 month after the second dose. This could 

increase the potential for myopericarditis and/or other immune or inflammatory 

responses. Moreover, there are limited data regarding a rare AE such as myocarditis 

and giving a third dose. Nevertheless, their risk of severe disease and death also are 

higher. This raised a request for additional information about the WG’s discussions 

on age and why some members had a dissenting opinion about persons 12-17 years 

of age.

Dr. Cohn noted that when the WG discussed this recommendation, they did not

know the specific age indication that would be in the expanded EUA. Therefore, they 

focused on individuals 18 years of age and older.

Dr. O’Leary (PIDS) pointed out that pediatric cardiologists have been integral to the 

WG’s discussions pertaining to myocarditis and pericarditis issues. PIDS also would 

support the inclusion of children 12-17 years of age.

Dr. Maldonado (AAP) commented that the President of the AAP provided an open 

letter to the FDA underscoring the myopericarditis issue, children 12-17 years of age, 

and that there needs to be a focus on children under 12 years of age as well. While 

there is justifiable concern about reported cases of myocarditis, these are extremely 

rare and the severity of the infections and events seen with vaccines have not shown 

any evidence of adverse immunologic responses clinically or in laboratory studies. 

The AAP stands behind any efforts to provide vaccines for children when they are 

indicated, and the indication for immunocompromised adults would hold true for the 

pediatric population as well to provide them additional options—of course, with 

appropriate counseling from their providers and subspecialty providers pertaining to 

benefits, harms, and potential risks.

Dr. Zahn (NACCHO) emphasized that from a public health standpoint, the surge in 

Delta cases throughout the country is difficult to address in a number of settings. 

There is probably no setting more difficult than schools. Given the commitment to 

getting children back in schools and learning, it is especially imperative to protect 

immunocompromised children in those settings. Therefore, he echoed support for 

consideration of children 12-17 years of age.
ACIP Meeting Summary August 13, 2021

13

➢ Given the potential for harm, ACIP members supported the notion that enhanced 

surveillance in this group would be beneficial. Communication about any expansion 

of the recommendation should emphasize to providers the importance of having their 

patients enroll in v-safeSM when they get the vaccine in order to accumulate more 

robust safety data on these issues of concern.

➢ Dr. Cohn confirmed that CDC absolutely will be enhancing v-safeSM to capture the 

third dose, and will ensure that other surveillance methods are monitoring the safety 

of a third dose.

• Some ACIP members felt that at least some equity issues would be improved with the 

additional dose among immunocompromised persons, including pediatric patients. Many 

people already have managed to obtain a third dose, though not under physician guidance. 

However, this tends to be people who are highly educated, medically savvy, and reside in 

suburban versus rural areas. Those who may not know how to advocate for their health and 

live rurally are not equitably receiving an additional dose, which this recommendation is 

likely to help improve.

• ACIP members expressed concern about the potential consequences for people who 

received the J&J vaccine as their primary series, who would not be eligible to receive an 

additional dose under this recommendation:

➢ Concern was expressed by some ACIP members that from a health equity 

standpoint, many African American and Latino populations received the J&J vaccine 

and immunocompromised persons tend to be higher among these populations. If 

they are going to make a big push for an additional dose in immunocompromised 

persons, it would be helpful to be able to recommend that those who received the 

J&J vaccine could receive an mRNA vaccine as their additional dose since it is 

unclear how long it will be before J&J data will be available. This seems particularly 

imperative given the contagiousness of the Delta variant and its rapidly increasing 

transmission.

➢ Dr. Cohn emphasized that while this is recognized as a very important issue, 

immunocompromised people who received the J&J vaccine as their primary series 

are not included in the FDA EUA that Dr. Marks announced at the beginning of this 

session. There were not sufficient data to support that population in the EUA and 

ACIP and CDC need to keep their recommendations boundaries aligned with the 

considerations of use to ensure that vaccines are being implemented appropriately 

under the EUA. Fewer doses of the J&J vaccine have been administered overall, so 

there is likely to be a very small number of those would fall into the severely 

immunocompromised based on the timing of when that vaccine became available.

➢ Dr. Marks stressed that FDA understands the challenges and will continue to work 

diligently to try to have solutions. They had to make decisions based on the data they 

had in hand, which will offer a solution for the large majority of immunocompromised

individuals. FDA anticipates having additional data and a solution for the remainder 

of those individuals in the not too distant future.
ACIP Meeting Summary August 13, 2021

14

• ACIP members requested additional information regarding why antibody testing was not

included as an option in the proposed recommendation:

➢ Dr. Dooling indicated that there were two primary reasons why the WG agreed with 

not including an antibody test into a proposed recommendation for a third dose in 

immunocompromised persons. First, there is insufficient information on a correlative 

protection. There are many different types of antibody tests (e.g., binding antibody 

tests, neutralizing antibody tests) and the interpretation of these would be extremely 

difficult on an individual level, certainly with variability among commercially available 

tests and between laboratories. Second, no tests are FDA-approved for the purpose 

of testing antibody levels post-vaccination due to this variability among commercial 

tests and laboratories. Interpretation would be very difficult and not particularly useful 

in a population recommendation. While antibody testing is used in studies in various 

forms to try to characterize the immune response, variability between assays is 

noted as a limitation of the data.

➢ ACIP members pointed out that in Dr. Goswami’s presentation, chronic medical 

conditions and immunocompromised were both mentioned in terms of considering 

Doses 1, 2, and 3 and that these are different situations. Some members felt that in 

relation to this, there may be instances in which antibody testing would be prudent. 

For instance, someone being prepared for/receiving a transplant is likely not to 

respond adequately to vaccine, especially after receipt of anti-rejection medication. 

This seems like a case in which antibody testing should be used when considering a 

third dose. 

• From an immunological standpoint, ACIP members suggested that perhaps clinical 

guidance should be considered in terms of the timing of a third dose for an optimal 

response. For instance, other vaccine vaccination time periods have been Day 0, 1 Month, 

and 6 Months:

➢ Dr. Dooling pointed out that the EUA was written for at least 1 month after the 

primary series, though the WG would be happy to hear additional considerations. 

Some of these individuals will have had time elapse since completing their primary 

series as individuals with underlying medical conditions, including 

immunosuppression, were included in the earlier phase of the vaccine rollout. There 

is concern that these individuals and those who have not responded to the first two 

doses would be left unprotected if the recommendation was to wait at least 6 months 

since the second dose before receiving an additional dose.

➢ Dr. Kotton, who is a practicing physician caring for immunocompromised patients, 

confirmed that someone who has not responded adequately to the first 2 doses may 

not respond to a third dose. Given that this is a heterogeneous population, in the 

absence of data and presence of an intense worldwide pandemic, she would be 

reluctant to recommend a Day 0, 1 Month, and 6 month schedule that would require 

vulnerable patients to wait a long period of time before receiving an additional dose. 

With that in mind, she supported flexible timing of at least 1 month following 

completion of the primary series.
ACIP Meeting Summary August 13, 2021

15

➢ Given that this is a heterogeneous group with very complicated medical needs that 

will vary by condition and individual, Dr. Dooling emphasized that the WG wanted the 

clinical considerations to serve as a starting point and understood that the clinical 

teams caring for such patients would need to adapt the considerations accordingly. 

The 28 days is intended to serve as a minimum and will need to be adjusted based 

on individual considerations. Many of the studies presented provided a third dose at 

an interval of 1, 2, or 3 months beyond completion of the primary series. Perhaps the 

third bullet stating, “ whenever possible, vaccination should be given at least 2 weeks 

before initiation of immunosuppressive therapies” could be revised to “at least 2 

weeks before initiation or resumption of immunosuppressive therapies.”

➢ From a clinical standpoint, ACIP members encouraged practitioners to think about 

patients as individuals in terms of helping them understand the risk/benefit balance 

as this is highly individualized among immunocompromised patients of all ages.

• Dr. Cohn emphasized that the comments made during this session would be taken into 

consideration and incorporated into the clinical consideration language before 

dissemination. She also reminded everyone that ACIP would be voting on whether to make 

the recommendation as proposed, but would not be voting on the clinical considerations 

language. The purpose of the clinical considerations was to assist providers who are 

seeking guidance about their patients.

• Dr. Dooling stressed that the WG was not recommending that any kind of medical sign-off 

be required to prove immunocompromised eligibility. This is self-attestation that will not 

require a prescription or physician letter. New patients presenting for a primary series will 

have to weigh the options of receiving the J&J vaccine or an mRNA vaccine with the vaccine 

provider to determine which may be the best option depending upon their individual 

situation.

Public Comments

The floor was opened for public comment during the August 13, 2021 ACIP meeting at 12:30 

PM ET. Given that many more individuals registered to make oral public comments than could 

be accommodated during this meeting, selection was made randomly via a lottery. The 

comments made during the meeting are included here. Members of the public also were invited 

to submit written public comments to ACIP through the Federal eRulemaking Portal under 

Docket No. CDC–2021–0084. Visit http://www.regulations.gov for access to the docket or to 

submit comments or read background documents and comments received.

Ms. Hanna Kaufman

Immunocompromised Individual

Hello. My name is Hannah Kaufman and I am immunocompromised. I live with ankylosing 

spondylitis and Behcet’s disease. I currently take three different immunosuppressant

medications, including an anti-metabolite, a biologic, and corticosteroids. I was hospitalized 

twice in June for a bad flare of my autoimmune disease, triggered by a relatively mild, nonCOVID infection. I’m speaking to you today from the infusion center where I am currently being 

treated with Remicade®. My doctors are waiting on clearer guidance from you before they can 

recommend moving forward with any kind of third vaccine dose recommendation for me. My 

plea is that the guidance that you come up with and vote on today defines 

“immunocompromised” as broadly as possible. I implore you to leave as much to the discretion
ACIP Meeting Summary August 13, 2021

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of patients and healthcare providers working collaboratively to determine individual risk/benefit 

of third doses on a case-by-case basis. I want to stress the importance of recommending the

third doses for people in all categories of immunocompromised and immunosuppression. It is 

horrifying to know that vaccinated solid-organ transplant recipients are 485 times more likely to

be hospitalized or die than their healthy, vaccinated peers. Still, many of us don’t know our risk

level. I haven’t had a transplant. Am I 300 times more likely to die? Am I only twice as likely to 

die, which is still horrifying? What is the threshold where I can get a third dose? Quite honestly, 

death is not the only thing I fear and not even the thing I fear most. What truly scares me is the 

possibility of developing long-term COVID complications that will further degrade my quality of

life. Something I don’t even know the likelihood of because you aren’t keeping track of it. I need 

to do all I can to avoid infection in the first place. The world has become much less safe for

people like me since people took their masks off in May. I was unable to even pick up my

immunosuppressant medications from the pharmacy yesterday, because there were unmasked 

people bumping into me from all sides in a ZIP Code that is only 39% vaccinated. For

immunocompromised people with less-effective vaccinations, the recommendation has been to

build a shield around us of others who are vaccinated and others who wear masks. These are 

wonderful observations, but not at all in our personal control. Please give all of us who are

immunocompromised a fighting chance to protect ourselves in a world where we have to rely on 

others to make the right choices, and many refuse to do so. Please define 

“immunocompromised” as broad as possible. Don’t just do it for people like me. Do it for the 

caregivers who are exposed to us. Do it for the children we live with who are too young to be 

vaccinated and are being thrown back into schools without masks. Do it for the population as a 

whole. I don’t want to be the one who instigates the next variant of concern. Thank you.

Ms. Elizabeth Fashing

Parent of Young Children Too Young for Vaccine

Executive Director, Colorado Immunization Advocates

Hello, my name is Elizabeth Fashing. I’m from Erie, Colorado and I am proud to be the 

Executive Director of Colorado Immunization Advocates. Today, though, I’m speaking as a 

parent with two children who are not old enough to receive a COVID vaccination and to urge the 

approval of the vaccine for those under 12 as quickly as possible. When my children were 

infants, and too young to receive all of the standard childhood immunizations, I felt some 

trepidation. I knew there were some members of our community who chose not to vaccinate

children and have put my children at risk, but I at least had a light at the end of the tunnel. I 

knew exactly when each of my children would be fully vaccinated, and once they were, I could 

breathe a sigh of relief. Today, that trepidation is much different. There is no light at the end of 

the tunnel. I have no idea when my children will be able to get vaccinated against COVID.

Instead of the highly localized outbreaks of vaccine-preventable diseases that are easier to 

avoid a few years ago, COVID is everywhere and my options to protect my kids from it are

limited. They don’t come to the store with me. We haven’t traveled with them on airplanes or 

visited the public spaces we used to enjoy like the museum. My husband and I got vaccinated 

as soon as we could. We wear masks everywhere. Next week, my kids go back to school. I am 

more worried this year than last year because of the contagiousness of the Delta variant and the 

number of children currently infected and hospitalized. Although we are fortunate to live in a

county which has mandated masking for all students and staff in schools, I still know that the 

best way to protect my children is to get them vaccinated. Other friends live in districts which 

don’t have mask mandates. Some of my friends have children who are immunocompromised.

Only one district in our state is requiring teachers and staff to be vaccinated. We need to get our 

kids access to the vaccine. Please, on behalf of all parents who are facing such an uncertain 
ACIP Meeting Summary August 13, 2021

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school year and who want to do everything we can to protect our children from COVID, please 

approve the COVID vaccine for children as soon as possible.

Ms. Braaten Heather

Ovarian Cancer Survivor

Thank you for allowing me to speak today. I wrote different versions of my public comments,

because I did not know which groups would qualify for additional vaccine doses. It seems that 

this is still being clarified, but that I will most likely qualify. I am a 44-year-old ovarian cancer

survivor. Although I’m grateful to have received my Pfizer vaccination this winter between cycles 

of chemotherapy, I was also worried because I knew chemotherapy blunts the effects of 

vaccines. I regretted that I could not wait until after treatment to get my shots. Over the past few 

months, I have become somewhat obsessive with reading news articles and medical studies. I 

have become so anxious because research shows that cancer patients like myself, who have 

solid tumors, only develop a fraction of antibody titers, T-cells and B-cells of healthy controls. I 

have felt distraught over the situation. My prognosis is poor. I most likely have about two to

three years left to live, so everyday counts. My life ambitions are humble. I want to be able to 

the visit with vaccinated friends and family and not have to worry if I’ll become a breakthrough

case just because we took off our masks or got too close to each other or dared to actually 

spend some time inside. I’d like to go grocery shopping again and not panic and leave the store 

after five minutes. I’d like to travel because that’s what people with a diagnosis like mine usually 

do before our health deteriorates. But this year, catching COVID and knowing that I could 

become seriously ill and that approximately 10% to 30% of cases become COVID long-haulers,

has kept me from being so bold. I don’t think I could cope with both the side effects of cancer 

treatments and debilitating post-COVID symptoms. I’d like to thank the committee for including

cancer patients like myself who have recently undergone chemotherapy for solid tumors to 

potentially receive additional doses of COVID vaccine. I’m not afraid of potential side effects of

the third dose. While I understand I will still need to be cautious, I am hopeful for the peace of 

mind and greater freedom a third shot can provide. Thank you for listening.

Ms. Elizabeth Ann Ditz

Founder Member

Vaccinate California

Good morning. My name is Liz Ditz. Greetings committee members and workgroup members. I 

am grateful for your tireless work over the last 18 months and in the time before COVID-19 so 

much. I have been advocating for high vaccine uptake in my community in San Mateo County 

for over 20 years. I’m a founding member of Vaccinate California, a grassroots volunteer 

advocacy group. I’m a longtime supporter of Voices of Vaccines, a national parent-led 

organization advocating for vaccine uptake. I’m a frequent contributor to a Facebook group 

called Vaccine Talks, an evidence-based discussion forum which has over 67,000 members 

worldwide. Over the last four-plus years, this group has helped 443 people move from being 

vaccine-resistant to vaccine-accepting. That’s about 1 every 3.5 days. Fact-based social media 

is having a positive impact. I’m also over 65 with several risk factors for severe COVID if 

infected. I’ve been fully vaccinated for 153 days. Eventually, I might be in a group considered for

a booster dose. I want to make three points: 1) overreliance on vaccines is a way to end this 

pandemic; 2) global perspective on vaccine access; and 3) health equity in the US. First, I know 

you are all not the Advisory Committee on Non-Pharmaceutical Interventions for COVID 

Prevention, but I must say that the US’s hyper focus on immunization over NPIs has harmed our 

country’s response to this crisis. As a nation, we must adopt all the tools at hand to tame this

virus. Second, Gavin Yamey, MD tweeted, “For the love of all that is good and holy, we need to 
ACIP Meeting Summary August 13, 2021

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recognize that we are a global community. There’s a moral and ethical urgency to ensure that 

everyone worldwide has the same chance to benefit from the fruits of scientific progress, not 

just rich people.” Finally, here in San Mateo County, we have a very high vaccination rate, with 

noticeable holes. Many of our agricultural and hospitality-industry workers are not yet

vaccinated. When one friend learned, she was bringing in vaccine advocates who are native 

Spanish speakers. It turns out most of her employees, although from Mexico or Central 

American nations, were not native Spanish speakers and didn’t really have health vocabulary in 

Spanish. They were native Mixtec or other indigenous languages without health vocabulary in 

Spanish. So, we need to fine-tune our efforts to increase vaccine uptake. Thank you very much.

Ms. Pam Dixon

Executive Director

World Privacy Forum

Yes, thank you, Chair Lee and members of the committee. Thank you for the opportunity to 

participate in the ACIP meeting today. I’m Pam Dixon, Executive Director of the World Privacy 

Forum, a public-interest research group focused on privacy and data governance, including in 

the health sector. I have two brief points today. First, we support the CDC’s prohibition on the 

use of vaccine-recipient data for commercial and marketing purposes. The CDC’s Vaccination 

Program Provider Requirements published in May of this year specifically prohibits the 

commercial marketing use of COVID-19 vaccination registration information and the vaccine 

administration data. These prohibitions were warranted and are important for ensuring patient 

trust in the public health data ecosystem. I note that standard HIPAA rules already prohibit

providers from using patient data for commercial purposes. There is now, after many years of 

HIPAA implementation, a reasonable expectation of some of the same levels of privacy in 

COVID-19 data ecosystems. Very few individuals understand the rules regarding HIPAAcovered ecosystems and public health ecosystems. Second, we urge the committee to ensure

that the same prohibitions that have already been put in place for commercial marketing uses of 

vaccine-recipient data will also be required when this data is utilized in vaccine-credentialing

systems or proof of vaccination systems. We see significant potential risks for the commercial

use of patient registration and patient vaccination data due to the sheer number of credentialing 

systems in development across complex public-private pathways. In conclusion, we support the 

work that the ACIP committee is doing to protect privacy interests and the integrity of public

health data. We can all say a lot about how credential systems should operate, but this the 

committee has the ability to make the most important statement of all about this ecosystem, 

which is to ensure that this data of those who have been vaccinated is fully protected in 

credentialing systems as well. Thank you very much for the opportunity to participate today.

Mr. Edward Nirenberg

Concerned Individual

Hello, and thank you for this time today. I’d like to call attention to several issues. To begin with, 

I do think it’s important to offer consideration to heterologous-boosting strategies in the data 

suggested inferior responses from the combination of adenovirus vectors and mRNA vaccines,

and preliminary effectiveness data suggests non-inferiority. Given how the study has just found 

71% effectiveness of the Janssen vaccine against hospitalization, I would request that mRNA 

boosters be offered for recipients of Janssen, a vaccine that may have been favored in the first 

place by more vulnerable groups for whom access to vaccination may be an issue. Additionally, 

immunocompromised patients’ infections are especially concerning for their public health

implications, because of propensity for antibody escape variants as far as CoV-2. It may be 

worthwhile to consider prophylactic dosing of monoclonal antibody cocktails for those who have 
ACIP Meeting Summary August 13, 2021

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substantial humoral immunodeficiencies. Pregnancy is also an important, high-risk state for

COVID-19. Given that some individuals are becoming pregnant relatively far from their initial 

immunization, it may be worth considering additional doses during pregnancy, both to bolster 

their protection and to provide a pathway of immunity to their future children through transfer of

antibodies. It remains critical to our mind, everyone, that we have a pretty grave situation with 

COVID-19 in the pediatric world. Since the beginning of the pandemic, in spite of aggressive 

mitigation measures in the US, approximately 500 children have died. Hundreds and thousands 

have been hospitalized, millions have been affected, and hundreds of thousands are 

additionally likely suffering. Furthermore, as was mentioned during the meeting, the AAP 

described in a recent letter to the FDA there has been a substantial rise in hospitalization 

among children recently, and I would urge everyone listening to do everything in their power to 

vaccinate their children against COVID-19 as quickly as possible. The call for a larger sample 

size by the FDA in clinical trials for children offers only marginal gains in the way of our

pharmacovigilance, but access to vaccination would be substantially delayed and is a limit to the 

significant surge. The late sequelae of COVID-19 in children are currently unknowable. Many of 

those cause deaths months to years after initial infection as a complication is both fatal and 

lacks treatment options. If COVID-19 causes anything analogous, we will not know for some 

time. A circumspect approach is dominant here, given the substantial cost incurred to address 

child safety and well-being at the public health scale. Lastly, I would request more frequent 

updates from v-safeSM and the Vaccine Safety Data link, if possible, because I think that having 

these references of vaccine safety for the public is extremely valuable. I would additionally like 

for stronger language regarding recommendations to vaccinate recovering patients now, as the 

clinical benefits of doing so have been ascertained, in addition to immunological ones.

Vote: Additional Doses of mRNA COVID-19 Vaccines as Part of a Primary Series for 

Immunocompromised People

Dr. Kathleen Dooling (CDC/NCIRD) presented the following proposed recommendation for an 

ACIP vote:

An additional dose of Pfizer-BioNTech COVID-19 vaccine (≥12 years) or Moderna 

COVID-19 vaccine (≥18 years) is recommended following a primary series in 

immunocompromised people under the FDA’s Emergency Use Authorization.

Summary of Discussion

• In response to an observation that Moderna has submitted data to the FDA for expansion to 

an adolescent indication and the potential to have to quickly revisit this recommendation, Dr. 

Dooling indicated that the intent for this ACIP meeting was to proceed with the maximum 

specificity possible under the EUA as it stood at this point. Dr. Cohn added that when there 

is an FDA authorization for Moderna vaccine down to a different age group, a WG and then 

ACIP meeting will be convened to review the data and vote on a revised recommendation at 

that time. It is important to be very careful in voting for each change to ensure that ACIP 

recommendations are being made in accordance with the EUA as authorized.

• ACIP members expressed how grateful they are for the expanded EUA for persons who are 

immunocompromised so that more protection can be provided to them, and emphasized the 

importance of clear communication about who this is for and why it is an additional dose 

versus a booster dose.
ACIP Meeting Summary August 13, 2021

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• Regarding an ACIP inquiry about the language in the clinical considerations regarding not 

including the J&J vaccine in this recommendation, Dr. Cohn indicated that the language 

would be clear that there are no data at this time to support the use of an additional dose of 

mRNA vaccine after the J&J vaccine. Efforts are in place to address this as soon as possible 

and it is anticipated that data will soon be available on this matter. CDC also will have a 

communications package for HCP and the public to ensure that people understand who 

needs an additional dose at this time and who does not.

• ACIP members commended the CDC for their incredible efforts to develop and prioritize 

education and communications materials in the midst of ever-evolving contexts and data.

• Regarding an ACIP inquiry about whether CDC has any guidance for dealing with persons 

who are obtaining additional doses of their own accord in a variety of places, CDC is 

working on clinical guidance about this matter based on the feedback provided by ACIP that 

was anticipated to be published later in the day. In addition, CDC anticipated having a 

COCA call with partners early the next week and already had been working over the last 24 

to 48 hours with pharmacy groups and jurisdictions to prepare for implementation of this 

anticipated recommendation. While pharmacy groups ask some questions about potential 

contraindications and/or compromising conditions, there will be no requirement for a 

prescription or other proof from a person’s HCP.

• Regarding whether v-safeSM will be updated to include a third dose, Dr. Broder from CDC’s 

Immunization Safety Office (ISO) indicated that v-safeSM is being updated to capture third 

dose information for new registrants and those who have entered previous doses.

• ACIP members emphasized the importance of the clinical guidance being as specific as 

possible from clinicians in the field in terms of coded diagnoses, specific drugs, medication 

names, et cetera in electronic health records (EHR). “Immunosuppressive therapies” and 

“severe primary immune deficiencies” are too broad to be used in EHRs. It is important to 

ensure that people who have been diagnosed with conditions that are considered to have an 

equivalent level of immunocompromise be permitted to receive a third dose. The proposed 

recommendation seemed like too broad a swath of what appeared to be all persons who are 

immunocompromised. With that in mind, it was suggested that the language be amended to 

reflect something to the effect of “an additional dose following a primary series in those who 

have moderate or severe immunocompromise” to avoid confusion.

• Dr. Coyle, American Immunization Registry Association, pointed out that there is a 

technological component in terms of clinical support capabilities for EHRs and immunization 

registries. For immunization registries, it will be important to note that 

“immunocompromised” is a very broad category as most Immunization Information Systems 

(IISs) will not have the ability to identify individuals who would fall into this category due to 

the types of risk factors. EHRs and IISs will have to work together on this. It may be 

challenging with booster doses when systems reflect that a series is complete at 2 or 3 

doses.

• In response to several comments, Dr. Dooling emphasized that this recommendation is for 

moderately and severely immunocompromised people. This is very clearly spelled out with 

specific reference to conditions that would constitute that category in the clinical 

considerations document that will be posted on the CDC website as soon after the vote as is 

humanly possible. She fully supported all of the statements made about registries’ ability to 
ACIP Meeting Summary August 13, 2021

21

collect a third dose. The more that EHRs and IISs can link and add specificity around 

immunocompromised and a third dose, the better.

• Regarding concerns expressed about the potential for confusion with regard to mandates 

and whether immunocompromised persons will be considered fully vaccinated with 2 or 3 

doses, Dr. Dooling stressed that for the purpose of meeting the definition of “fully 

vaccinated,” it is 2 doses of mRNA or 1 dose of Janssen. That has not changed and will be 

spelled out explicitly in the clinical considerations.

Motion/Vote: Additional Doses of mRNA COVID-19 Vaccines

as Part of a Primary Series for Immunocompromised People

Dr. Ault made a motion and Dr. Poehling seconded to approve the recommended language for 

additional doses of mRNA COVID-19 vaccines as part of a primary series for 

immunocompromised people as presented. The motion carried with 11 affirmative votes, 0 

negative votes, and 0 abstentions. The disposition of the vote was as follows:

11 Favored: Ault, Bahta, Chen, Daley, Kotton, Lee, Long, McNally, Poehling, Sanchez, 

Talbot

 0 Opposed: N/A

 0 Abstained: N/A

Following the vote, ACIP members were invited to make a statement on the rationale for their 

vote or provide additional comments:

Dr. Talbot: I just wanted to say how much I appreciated how ACIP, and the WG and the CDC 

have really delineated the idea of a third dose in a series, for a primary series versus a booster.

I think that’s incredibly important. I think we’re looking at a very specific population of the US 

that was not able to mount an appropriate immune response to the normal two doses. This is a 

very specific population and it’s not meant for the entire US population. We are all very worried 

about the Delta variant, but that may be the least of our problems if COVID-19 continues to 

circulate across the US and the world. So, I think it’s incredibly important that we remember that 

we need to begin sharing more and more vaccines across the world and encouraging those

pockets of low vaccination rates to immunize, or the Delta variant may be the least of our 

concerns.

Dr. Poehling: I do want to express my sincere thanks to everybody at the ACIP, the WG, and 

the FDA for making this data available so we could have this vote. I voted “yes” for an additional 

dose of mRNA vaccine for all children and adults over 12 years of age with moderate and 

severe immunocompromising conditions to maximize their chance of protection from vaccines.

These persons have increased risk of hospitalization, breakthrough disease, and death from

COVID-19. In addition, the VE among immunocompromised is lower than those without 

immunocompromising conditions. Recent studies demonstrate that 33%-50% of persons with 

immunocompromising conditions who did not initially respond, did respond with a third dose in 

the primary series. This vote enables all persons 12 and older to obtain a third dose in the

primary care series to increase their protection from the vaccine. It is critical to highlight to 

persons with immunocompromising conditions and their families the importance of wearing

masks, maintaining social distance, avoiding crowded locations indoors, and cocooning by 

having close contacts vaccinated. It’s equally important to share and highlight the importance
ACIP Meeting Summary August 13, 2021

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that all schools create plans so that all children, including those with moderate-to-severe

immunocompromising conditions can safely attend school.

Update on Emerging SARS-CoV-2 Variants and COVID-19 Vaccines

Dr. Heather Scobie (CDC/CGH) first shared an example one of the new ways that CDC is 

visualizing the impact of COVID vaccination in the COVID Data Tracker website. The graphs 

display weekly trends by age group for the cumulative percent of people fully vaccinated and the 

average rate of new cases per 100,000 population. In the three age groups greater than 50 

years of age, there were higher coverage rates and lower case rates compared with the 

younger age groups between December 28, 2020—August 11, 2021.

22 The county-level map 

from Data Tracker shows that counties with low vaccination coverage have had high coverage

rates. Counties with greater than 50% coverage and high incidence were relatively few and 

reflected the recent increases in Delta variant transmission occurring largely among 

unvaccinated persons.23

A lot of public concern has been raised about the Delta variant and breakthrough transmission, 

which Dr. Scobie contextualized with 2 example state scenarios each with 1 million population 

and different coverage levels. State A had 70% coverage and State B had 30% coverage. The 

COVID data used for this example are actual data from the COVID Data Tracker website for 

states with similar coverage levels. In State A, 130 cases were occurring per week compared to 

over 5000 cases occurring weekly in State B. Using VE estimates from the UK, the number and 

proportion of unvaccinated cases and vaccinated cases. Proportionally, there were more 

vaccinated cases in State A at 22% of cases vaccinated, compared with just 5% vaccinated in 

State B. This is expected because the proportion of cases vaccinated increases with increasing 

vaccination coverage. At the extreme of 100% vaccination coverage, all cases would be 

vaccinated because no vaccine is 100% effective. Similar trends were observed with 

hospitalizations. Just 1.4 hospitalizations would occur weekly in State A compared to 18.8 

hospitalizations in State B. In both states, the majority of cases and hospitalizations would occur 

among unvaccinated people.

In terms of what is currently known about emerging SARS-CoV-2 variants and vaccines, 4 

variants are considered Variants of Concern (VOCs): Alpha (B.1.1.7) first detected in the UK, 

Beta (B.1.351) first detected in South Africa, Gamma (P.1) first detected in Brazil and Japan, 

and Delta (B.1.617.2) first detected in India. Of note, all of the VOCs have mutations in the 

receptor binding domain that have variably impacted VE, with the cluster of mutation shared by 

Beta and Gamma having the largest known impact. Another class of variants under monitoring 

are the Variants of Interest (VOIs), which have similar mutations but less current evidence of 

public health impact.24

Regarding the latest national NOWCAST projections25 of the proportions of circulating SARSCoV-2 variants from CDC’s COVID Data Tracker for the 2 weeks ending July 31, 2021, Alpha 

decreased to a projected prevalence of 2%, Gamma decreased to 1%, and Beta remained at 

0%. However, the Delta variant increased to 94%. The Delta sub-lineage AY.3 increased to 

13%. This lineage does not contain the so-called Delta plus mutation, formally known as AY.4.2.

22 https://covid.cdc.gov/covid-data-tracker/#vaccinations-cases-trends

23 https://covid.cdc.gov/covid-data-tracker/#vaccination-case-rate

24 https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html

25 https://covid.cdc.gov/covid-data-tracker/#variant-proportions as of 8/10/21
ACIP Meeting Summary August 13, 2021

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CDC monitors several types of evidence to assess the impact of variants on vaccines, including 

antibody neutralization generated in the laboratory.26 Though a correlative protection has not yet 

been established, good correlation has been observed between VE and neutralizing antibody

levels from different vaccines. This likely will be the first type of evidence obtained on the impact 

of new variants on vaccines. CDC also monitors VE data from clinical trials and real-world VE.

Notably, greater protection is usually observed against severe disease and symptomatic illness

and confirmed infection, which includes asymptomatic cases. This is because protection against 

severe disease requires lower antibody levels and is less affected by differences in efficacy 

across vaccines. In addition, CDC monitors breakthrough infection.

A review was conducted of available studies on vaccines authorized or intending to be 

authorized in the US (mRNA, AstraZeneca, Novavax, Janssen) and containing data on the 

ability of post-vaccination sera to neutralize SARS-CoV-2 variants. Beta had the largest median 

reduction at 7.5-fold, Delta had a median reduction of 2.8-fold, Gamma was reduced 3.1-fold, 

and Alpha was reduced 1.9-fold. While an alpha variant with an E484K change, which has been 

detected in the UK, US, and other countries, had a further reduction in neutralization compared 

to Alpha alone.27

In terms of what is known about duration of immunity to date, available data demonstrate

antibody persistence for at least 8 months after COVID infection and at least 6 months after the 

second mRNA vaccine dose, with some evidence at 8 months for the Janssen vaccine. Studies 

suggest that individuals may maintain long-term protection from severe illness caused by

antigenically similar strains, even if they become susceptible to mild infection. Two studies have 

shown a combined impact of waning antibody levels and reduced neutralization of variants. At 6

months after receiving the Moderna vaccine, neutralizing antibody levels were reduced but

sufficient to protect against the ancestral strain, while about 50% of people had undetectable

neutralizing titers against the Beta and Gamma variants. A small study at 8 months after receipt

of the Janssen vaccine observed minimal decline in neutralizing titers and improved protection

against Beta, Gamma, and Delta variants compared with 1 month after vaccination, which was 

suggested to be related to antibody maturation. It is unclear if there are differences in the

kinetics of antibody response by vaccine platform and more data are needed.28

Pfizer recently published their 6-month clinical efficacy data.29 VE against infection out to 6 

months was 91%. They performed an additional analysis looking at different time intervals after 

receiving the second vaccine dose and observed a gradual decline in VE against infection of 6 

percentage points every 2 months. The confidence intervals around the estimates were

overlapping. At 4 to 6 months post-vaccination, VE was 84% compared with 96% at less than 2

months after vaccination. VE against severe illness during the period was 97%. Moderna30 has 

not yet published their extended efficacy results, but announced in a press release that VE was 

93% for up to 6 months.

26 https://www.nature.com/articles/s41591-021-01377-8

27 See references for Slide 11 at the end of Dr. Scobie’s slide set

28 Gaebler, C. et al. Nature 591, 639–644 (2021); Dan, J. M. et al. Science 371, (2021); Choe et al. Emerg Infect Dis. 

2021;27(3):928-931.;Doria-Rose et al. N Engl J Med 2021; 384:2259-226; Khoury et al. Nat Med (2021).; Pegu et al. bioRxiv 

preprint; Wu et al. medRxiv preprint (2021): Luo, Hu, Letterio, medRxiv preprint (2021): Barouch et al. medRxiv preprint (2021): 

Thomas et al. medRxiv preprint

29 Thomas et al. medRxiv preprint https://doi.org/10.1101/2021.07.28.21261159

30 Moderna. https://investors.modernatx.com/news-releases/news-release-details/moderna-reports-second-quarter-fiscal-year-2021-

financial
ACIP Meeting Summary August 13, 2021

24

In terms of VE against the variants,31 for the Alpha (B.1.1.7) variant, mRNA vaccines have been

shown to have greater than 85% real-world VE against confirmed infection in the US and 

multiple countries. For Gamma (P.1), mRNA vaccines have 84% to 88% real-world VE against 

symptomatic infection and 79% VE against confirmed infection when Gamma was widely 

circulating in Canada. For Beta (B.1.351), Moderna vaccine had 96% real-world VE and Pfizer 

vaccine had 75% VE against confirmed infection in a study from Qatar, while Janssen vaccine 

had 52% VE against moderate or severe disease in their clinical trial in South Africa.

Importantly, all studies observed high VE against severe disease.

Regarding what is known about the Delta variant,32 it is nearly twice as contagious as previous 

variants. There is some evidence of increased illness severity compared with previous strains 

and unvaccinated persons. The greatest risk of transmission is still among unvaccinated people,

and fully vaccinated people with Delta breakthrough infections can spread virus to others.

However, vaccinated people with Delta may be infectious for shorter periods than unvaccinated 

persons with Delta.

VE studies33 have been published from several countries for the Delta variant, mostly for the 

Pfizer vaccine. In England and Scotland, reduced Pfizer VE was observed at 70% for infection 

and 88% for illness, compared to 92% and 93% for the Alpha variant. Protection against 

hospitalization from Delta was 96%, which was similar to that observed with Alpha. In Canada, 

Delta VE estimates were similar to the UK, but with smaller differences in VE for Alpha and 

Delta. Israel has observed a progressive decline in VE during the period after Delta

predominance, with the most recent VE estimates of around 40% against infection and illness,

while VE against severe disease has remained above 90%. Qatar was the only country that

assessed Delta VE for both Pfizer and Moderna. VE against symptomatic illness was 54% for 

Pfizer compared with 85% for the Moderna vaccine. While VE against severe illness was above 

90% for both, it is important to note that the comparison shown for the Alpha and Delta VE in 

Israel and Qatar are for different studies that were separated by 2 to 5 months during the time 

periods when Alpha and Delta circulated. Other methodologic differences may explain some of 

the variation observed in the study results across countries.

Other potential differences in VE results relate to differences in the vaccine programs by 

country.34 The US uses the Pfizer, Moderna, and Janssen vaccines, which have followed the 

manufacturers’ recommended intervals of 3 and 4 weeks between mRNA doses. Israel has

used Pfizer vaccine only, though they also authorized Moderna, and follow the 3-week interval 

between doses. Israel also had a very tight cohort with more than 50% of the country vaccinated 

in the first 3 to 4 months. Qatar is the most similar country to the US in terms of using both 

31 CDC Science Brief : https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html Abu-Radad 

and Butt. NEJM (2021); Andrejko et al. medRxiv preprint (Apr 10 2021); Chemaitellyet al. Nature Med (2021):

https://doi.org/10.1038/s41591-021-01446-y; Sandoff et al. NEJM (2021); Chung et al. medRxiv preprint (May 28 2021); Yassi et 

al. medRxiv preprint (May 25 2021)); Nasreen et al.medRxivpreprint: https://doi.org/10.1101/2021.06.28.21259420

32 https://www.cdc.gov/coronavirus/2019-ncov/variants/delta-variant.html; Fisman & Tuite. medRxiv; Ong et al. SSRN Journal. 2021; 

Sheikh et al. Lancet (2021); Dagpunar J. medRxiv.; Li et al. medRxiv; Lopez Bernal et al. NEJM (2021); Stowe et al. PHE preprint; 

Riley et al.; medRxiv : Micochova et al. Research Square preprint ; Musser et al medRxiv; Brown et al. MMWR (2021); Riemersma 

et al. medRxiv; Chia et al. medRxiv

33 Sheikh et al. Lancet (2021): https://doi.org/10.1016/S0140-6736(21)01358-1; Lopez Bernal et al. medRxiv preprint;

https://doi.org/10.1101/2021.05.22.21257658; Stowe et al. PHE preprint: https://khub.net/web/phe-national/public-library/-

/document_library/v2WsRK3ZlEig/view/479607266; Nasreen et al.medRxiv preprint: 

https://doi.org/10.1101/2021.06.28.21259420; Haas et al Lancet (2021): https://doi.org/10.1016/S0140-6736(21)00947-8 ; Israel 

MOH: https://www.gov.il/BlobFolder/reports/vaccine-efficacy-safety-follow-up-committee/he/files_publications_corona_two-dosevaccination-data.pdf; Abu-Radad and Butt. NEJM (2021); Chemaitelly et al. Nature Med (2021): Tang et al medRxiv

34 Parry et al. https://www.medrxiv.org/content/10.1101/2021.05.15.21257017v1; Flaxman et al. Lancet (2021); 

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3873839; Amirthalingam et al.

https://www.medrxiv.org/content/10.1101/2021.07.26.21261140v1; Carazo et al. : https://doi.org/10.1101/2021.07.19.21260445
ACIP Meeting Summary August 13, 2021

25

Moderna and Pfizer at the same dosing intervals. Finally, the UK and Canada are the most 

similar to each other in that they both use mRNA and the AstraZeneca (AZ) vaccines. As part of 

a dose-sparing strategy, they also adopted extended dose intervals of up to 12-16 weeks, which 

were later shown to improve immunogenicity and VE compared with standard intervals,

including for ages greater than 80 years. The countries also support mixing and matching

between vaccines, which has been shown to increase VE. The Pfizer vaccine has a lower 

mRNA dosage and accelerated schedule of 3 weeks compared to 4 weeks for Moderna, which 

has the potential to impact the robustness and duration of immunity, as has been generally 

observed for other vaccines.

In public data from Israel,35 the Ministry of Health (MoH) has observed higher breakthrough 

rates and lower Pfizer VE against infection for persons vaccinated during January to February.

Then in more recent months for persons 16-59 years of age and 60 years of age and older and 

older. Two retrospective cohort studies of persons vaccinated with Pfizer in large healthcare 

systems observed increasing breakthrough infections among persons vaccinated in January

versus April, and higher breakthrough infection rates among those who received the second 

mRNA dose more than 5 months ago compared with less than 5 months ago. All age groups 

were impacted, but one study observed higher magnitude of differences with increasing age.

Delta only rose to predominance in the US at the end of June. This week, the first study 

assessing potential VE changes in July was posted from the Mayo Clinic Healthcare System.36

For patients in Minnesota, the authors observed that VE against infection was significantly lower

for both Moderna and Pfizer vaccines in July when the Delta variant was more than 70% 

prevalent compared with previous months and insignificantly lower for Pfizer at 42% compared 

with Moderna at 76%. Importantly, the effectiveness of both vaccines against COVID-associated 

hospitalization remained consistently high during the same timeframe. More information is 

needed in this area and will be forthcoming.

Despite high efficacy, vaccine breakthrough cases are still expected to occur, including those

caused by circulating variants. CDC conducts nationwide monitoring of vaccine breakthrough

cases resulting in hospitalization or death. As of August 2nd among more than 164 million fully 

vaccinated in the US, there have been 7101 hospitalizations and 1507 deaths with vaccine 

breakthrough cases reported through national passive surveillance. Among hospitalized or fatal 

breakthrough cases, 75% were 65 years of age or older. In addition to national passive 

surveillance, CDC has a number of other ways to monitor breakthrough infection, including a 

population-based service surveillance system called COVID-NET, which represents 10% of the 

US population. The most recent COVID-NET data on COVID-associated hospitalizations among 

adults estimated that 32% of all vaccinated cases are immunocompromised versus 11% of 

unvaccinated cases.37

To summarize, Alpha, Beta, and Gamma variants have low prevalence in the US. Alpha has 

minimal impact on VE, while Beta and Gamma have moderate impact and the vaccines appear 

likely to protect against severe disease. Delta has high prevalence in the US and has moderate 

impact on VE. The vaccines are likely to still provide protection against severe disease. More 

35 Correlation of SARS-CoV-2 Breakthrough Infections to Time-from-vaccine; Preliminary Study | medRxiv; Elapsed time since 

BNT162b2 vaccine and risk of SARS-CoV-2 infection in a large cohort | medRxiv; https://www.gov.il/BlobFolder/reports/vaccineefficacy-safety-follow-up-committee/he/files_publications_corona_two-dose-vaccination-data.pdf

36 Puranik et al. medRxiv: https://www.medrxiv.org/content/10.1101/2021.08.06.21261707v2

37 CDC website as of 8/5/21; 1,816 hospitalizations and 316 fatal cases reported as asymptomatic or not related to COVID-19; CDC. 

MMWR (2021); COVID-NET: https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html
ACIP Meeting Summary August 13, 2021

26

data are needed on the impact of Delta, especially for the Janssen vaccine and the potential for 

waning immunity.

Manufacturers are conducting booster studies of current vaccines and or second-generation 

vaccines against the Beta variant. Moderna has posted preliminary results of the Phase 2 trial of 

a single booster dose of the previously authorized and a Beta variant-specific vaccine. Both 

vaccines had acceptable safety and boosted immunity to the wild-type strain, as well as to the 

Beta and Gamma variants. Pfizer has also submitted preliminary data on a booster of their 

original vaccine to the FDA. No Delta-specific booster vaccine studies have been shared to 

date.38

In summary, the currently authorized vaccines work against known variants. Given the 

increased risk related to the Delta variant, it is important to increase vaccine uptake in all eligible 

populations. CDC is closely monitoring real-world VE and breakthrough infections using multiple

methods, populations, and outcomes. CDC continues to monitor emerging variants, including 

the prevalence and impact on disease incidence, severity, and vaccine breakthrough. The ACIP 

will review evidence submitted for boosters and any next generation vaccines to address the

evidence of diminished VE related to the variants or waning immunity. Finally, this is a changing 

landscape and the CDC will continue to communicate promptly about emerging evidence.

Summary of Discussion

• Referring to Slide 3 from the COVID Data Tracker, a breakdown of vaccine breakthrough 

cases by race and ethnicity would be beneficial. In terms of understanding the overlapping 

pockets of unvaccinated persons, the age category is just one part of the problem. 

Understanding how race and ethnicity are affecting both vaccination levels and case counts

would be extremely helpful.

• It would be beneficial to have additional information on the duration of immunity for those 

who had the vaccine and COVID-19 infection in terms of how long their immunity antibody 

persistence lasted.

Considerations for Booster Doses of COVID-19 Vaccines

Dr. Sara Oliver (CDC/NCIRD) presented considerations for COVID-19 vaccine booster doses. 

In thinking through recommendations for booster doses of COVID-19 vaccines, the primary 

policy question is, “Are booster doses needed for those previously vaccinated with the primary 

series?” Policies on boosters will be coordinated with FDA for regulatory allowance and ACIP 

for recommendations around use in specific populations. There are two distinct potential uses 

for an additional dose of COVID-19 vaccine: 1) An additional COVID-19 dose after receipt of a 

primary series is one way to provide protection for those who may not have mounted an

appropriate immune response to the initially recommended series. This is not considered a 

booster dose and is what was described for the first part of the meeting; and 2) An actual 

booster dose, which is a dose administered when the initial sufficient immune response to a 

primary series may have waned over time. This presentation focused on booster doses.

38 Wu et al. medRxiv preprint (May 6, 2021): https://doi.org/10.1101/2021.05.05.21256716; https://investors.modernatx.com/newsreleases/news-release-details/moderna-announces-positive-initial-booster-data-against-sars-cov/

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-study-part-broad-development

https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-06/06-COVID-Oliver-508.pdf
ACIP Meeting Summary August 13, 2021

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Recommendations for booster doses would apply only to those who have completed a primary 

series. To date, over 350 million vaccine doses have been administered in the US. Over 60% of 

those 18 years of age and over are fully vaccinated. This increases to over 80% among those 

65 years of age and over. The timing of when individuals became fully vaccinated is important to 

this discussion as well. Looking at the daily count of fully vaccinated people, the COVID 

vaccination program began in December of 2020. As only 2-dose series were available at that 

time, individuals began to become fully vaccinated in January 2021. Through Spring vaccination 

rates increased such that between 1 to 2 million individuals were fully vaccinated each day.

Through the past month, approximately 200,000 fully vaccinated individuals have been added 

each day. However, it is known that due to the way the vaccine was recommended and rolled 

out initially, age groups are not evenly distributed across the last 8 months. Looking at the 

weekly count of fully vaccinated people in the US by age group, those 65 years of age and over

were among the earliest vaccinated. In the Spring, vaccination moved into larger populations of 

those 18-39 years of age and 40-64 years of age. Since vaccination was recommended recently 

for adolescents, persons 12-17 years of age were added. This varying age distribution will be 

important in thinking through recommendations for boosters in a variety of populations and 

ages.39

The plan for how ACIP will approach booster doses over the next several weeks will involve 

thinking through the key considerations for decision-making, evaluating what data are available 

for decision-making, and addressing whether ACIP recommends booster doses for COVID-19 

vaccines in any populations. This presentation focused on key considerations for decisionmaking. During the June ACIP meeting, the data were laid out that would be needed to inform 

recommendations for booster doses in terms of the risk of COVID complications, exposures,

risk of waning immunity, and risk of COVID variants.

Moving into preparations for a possible vote in the future, the WG restructured the questions 

slightly into two main questions that need to be addressed in terms of whether they are needed 

(public health problem) and whether they work (benefits and harms). The WG can use these 

questions to think through aspects of the EtR Framework. In terms of the public health problem, 

the WG will need to specifically address whether VE is waning over time, if VE is reduced for 

the Delta variant, and whether the data vary by sub-population. Regarding benefits and harms, 

the WG will need to consider whether booster doses of COVID-19 vaccines are safe and 

immunogenic; will reduce COVID-19 incidence, hospitalization, and mortality; and if they 

improve VE against the Delta variant. Dr. Oliver walked through each of these questions in more 

detail, outlining the data that will be collected to address these overall questions.

Regarding whether VE is waning over time in terms of the public health problem, VE will need to 

be assessed at 6 and 8 months similar to what was noted at 2 months after vaccination that 

ACIP reviewed at the time of the EUA. Consideration will have to be given to how these data 

vary by severity of disease. It may be that VE wanes for asymptomatic or mild disease, but 

remains high for severe disease, hospitalization, and death. In addition, the WG would need to 

consider what data on waning VE would identify a need for booster doses of COVID-19

vaccines. Consideration would have to be given to whether VE is reduced for the Delta variant, 

how this varies by severity of disease, how this information would impact VE for future variants. 

The final question for the public health problem pertains to whether the data vary by subpopulation. During previous ACIP meetings, the WG discussed that boosters may be

recommended for the entire population or they could only be needed among specific subpopulations. Groups identified as needing close monitoring and additional data collection 

39 https://covid.cdc.gov/covid-data-tracker/#datatracker-home
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28

include residents of long-term care facilities (LTCF), adults 65 years of age and over, and HCP.

Persons in LTCF and older adults were vaccinated in the earlier phases of the COVID-19 

vaccine rollout. In addition, this is a population that has needed special considerations for other 

vaccines, including additional boosters or higher dose vaccines. In addition, HCP were 

vaccinated in the early phase of the vaccine rollout. They will have continued exposure to 

SARS-CoV-2. Another point that clearly could be an issue in the future is that there could be a 

need for additional considerations for HCP to include the continuity of healthcare systems, given 

that there may be a very specific need to prevent asymptomatic or mild infections in HCP if 

there are COVID-19 surges straining the healthcare infrastructure.

Moving to the benefits and harms, it will be important to address whether booster doses of 

COVID-19 vaccines are safe and immunogenic. Assuring COVID-19 vaccine safety has been a 

critical element of the entire COVID-19 vaccine program and will continue into this phase as 

well. It is important to know if COVID-19 vaccines provide a boost in neutralizing antibody

response. While it is likely that this information will be available, it also will be necessary to 

address how neutralizing antibodies correlate to clinical protection from COVID-19. It will be 

necessary to evaluate if booster doses of COVID-19 vaccines will reduce COVID-19 incidence,

hospitalization, and mortality. There are not to be data from long-term efficacy studies with 

booster doses, but thought must be given to other ways to address whether booster doses will 

reduce COVID-19 morbidity and mortality. Additionally, consideration will have to be given to 

whether booster doses improve VE against the Delta variant and other VOCs. While Delta is the 

current VOC, it is unlikely to be the only variant that will have to be addressed in the future.

Now moving to the WG’s interpretation of these considerations and the framework around 

booster doses. In terms of the public health problem, receipt of a COVID-19 vaccine primary 

series will continue to have the largest public health impact. Decisions for boosters need to 

focus on prevention of severe disease, hospitalization, and death. It is known that the vast 

majority of cases, especially cases requiring medical attention now, are among unvaccinated 

individuals. The WG emphasized the importance of ensuring global vaccine availability, given 

that new variants could emerge from regions with low vaccine coverage and high community 

transmission. One of the best ways to protect the US population from the next variant threat is 

to ensure that the remainder of the global population has access to a safe and effective COVID19 vaccines.

Turning to the WG’s interpretation of the benefits and harms, neutralizing antibody data will be 

important for booster dose discussions, but may not represent the entire immune response to 

COVID-19 vaccines. Decisions around boosters cannot be based solely on detectable 

neutralizing antibodies. The cellular immune response can be difficult to measure in a broad 

population, but is important in the ability to fight COVID-19. Commercial antibody testing is not 

authorized or recommended to evaluate post-vaccination immune response. Based on the 

available data and the timing of vaccine rollout, the initial booster vaccine policy will be focused

on the at-risk adult population. Adolescents are only just now receiving their primary series. The 

at-risk individuals on whom the WG will focus will include adults 65 years of age and over, LTCF

residents, and HCP as mentioned earlier.

Returning to the roadmap for booster doses, key considerations for decision-making were just 

addressed. The plan moving forward is to have another ACIP meeting in the next several weeks 

to fill in this framework and identify what data are available for decision-making. Once the 

available data have been evaluated and there is regulatory allowance for booster doses, the 

WG can address whether the ACIP recommends booster doses of COVID-19 vaccines in any 

populations. There will be some questions for which the amount of data desired may not be 
ACIP Meeting Summary August 13, 2021

29

available as the ACIP moves into these decisions. For instance, there may not be detailed 

information around how VE varies for each specific COVID-19 vaccine in each specific subpopulation; what the VE is for booster doses of COVID-19 vaccines and how that varies by subpopulation; and or how the need for booster doses of COVID-19 vaccines may evolve as the 

pandemic evolves. By continuing to present and discuss the available data during public ACIP 

meetings, the WG can highlight what is known and not known and how that information can 

inform possible future recommendations.

The following questions were posed for ACIP consideration and deliberation:

1. Does ACIP agree with the framework laid out to address booster dose recommendations

and the WG’s interpretations?

2. Are there other questions that would be important for ACIP to address?

Summary of Discussion

• ACIP members suggested the following topic areas of interest related to booster doses:

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➢

➢

Identification of areas in the US with low vaccination rates

Assessment of whether giving a third dose to people already willing to take it and to 

mask will help to overcome the large pockets of unvaccinated individuals

Effectiveness of booster doses and duration, particularly with regard to whether this 

varies depending on race/ethnicity and type of chronic underlying medical conditions

such as diabetes and HIV, which are higher among some populations (e.g., African 

Americans, Latinx, Native Americans)

Identification of a better correlative of immunity

A better understanding of the gaps in data and what is being pursued by the CDC, 

the FDA, and/or the National Institutes of Health (NIH)

More information about individuals living in congregate settings

At well beyond a year since the clinical trials started and many thousands of 

individuals volunteered for them and provided blood samples and extensive detailed 

follow-up information, the vaccine companies owe it to the public health infrastructure 

of the US and elsewhere to share those data

Plan ahead relative to children and do not wait to finish one set of studies before 

starting studies among children pertaining to booster doses

The overwhelming driver of current disease, particularly severe disease, is people 

who are unvaccinated—an important distinction that needs to be communicated to 

the general public and providers
ACIP Meeting Summary August 13, 2021

30

CERTIFICATION

Upon reviewing the foregoing version of the August 13, 2021 ACIP meeting minutes, Dr. Grace 

Lee, ACIP Chair, certified that to the best of her knowledge, they are accurate and complete.

Her original, signed certification is on file with the Management Analysis and Services Office 

(MASO) of CDC.
ACIP Meeting Summary August 13, 2021

31

ACIP MEMBERSHIP ROSTER

CHAIR

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: 8/4/2021 – 6/30/2023

EXECUTIVE SECRETARY

COHN, Amanda, MD 

Senior Advisor for Vaccines 

National Center for Immunization and Respiratory Diseases 

Centers for Disease Control and Prevention 

Atlanta, GA 

MEMBERS

AULT, Kevin A, MD, FACOG, FIDSA 

Professor and Division Director 

Department of Obstetrics and Gynecology University of 

Kansas Medical Center 

Kansas City, KS 

Term: 10/26/2018 – 6/30/2022 

BAHTA, Lynn, RN, MPH, CPH 

Immunization Program Clinical Consultant 

Infectious Disease, Epidemiology, Prevention & Control Division 

Minnesota Department of Health 

Saint Paul, Minnesota 

Term: 7/1/2019 – 6/30/2023

BELL, Beth P, MD, MPH 

Clinical Professor 

Department of Global Health, School of Public Health 

University of Washington 

Seattle, WA 

Term: 7/1/2019 – 6/30/2023 

CHEN, Wilbur H, MD, MS, FACP, FIDSA 

Professor of Medicine 

Center for Vaccine Development and Global Health 

University of Maryland School of Medicine 

Baltimore, MD 

Term: 12/23/2020 – 6/30/2024 
ACIP Meeting Summary August 13, 2021

32

DALEY, Matthew F, MD 

Senior Investigator 

Institute for Health Research, Kaiser Permanente Colorado 

Associate Professor of Pediatrics 

University of Colorado School of Medicine 

Aurora, CO 

Term: 1/4/2021 – 6/30/2024 

KOTTON, Camille Nelson, MD, FIDSA, FAST 

Clinical Director, Transplant and Immunocompromised Host Infectious Diseases 

Infectious Diseases Division, Massachusetts General Hospital 

Associate Professor of Medicine, Harvard Medical School 

Boston, MA 

Term: 12/23/2020 – 6/30/2024 

LONG, Sarah S, MD 

Professor of Pediatrics 

Drexel University College of Medicine 

Section of Infectious Diseases 

St. Christopher’s Hospital for Children 

Philadelphia, Pennsylvania 

Term: 12/24/2020 – 6/30/2024 

MCNALLY, Veronica V, JD 

President and CEO Franny 

Strong Foundation 

West Bloomfield, Michigan 

Term: 10/31/2018 – 6/30/2022 

POEHLING, Katherine A, MD, MPH 

Professor of Pediatrics and Epidemiology and Prevention 

Director, Pediatric Population Health 

Department of Pediatrics 

Wake Forest School of Medicine

Winston-Salem, NC 

Term: 7/1/2019 – 6/30/2023 

SÁNCHEZ, Pablo J, MD 

Professor of Pediatrics 

The Ohio State University – Nationwide Children’s Hospital 

Divisions of Neonatal-Perinatal Medicine and Pediatric Infectious Diseases 

Director, Clinical & Translational Research (Neonatology) 

Center for Perinatal Research 

The Research Institute at Nationwide Children's Hospital Columbus, Ohio 

Term: 7/1/2019 – 6/30/2023 
ACIP Meeting Summary August 13, 2021

33

TALBOT, Helen Keipp, MD 

Associate Professor of Medicine 

Vanderbilt University 

Nashville, TN 

Term: 10/29/2018 – 6/30/2022 

EX OFFICIO MEMBERS 

Centers for Medicare and Medicaid Services (CMS)

HANCE, Mary Beth 

Senior Policy Advisor 

Division of Quality, Evaluations and Health Outcomes 

Children and Adults Health Programs Group 

Center for Medicaid, CHIP and Survey & Certification Centers 

for Medicare and Medicaid Services Baltimore, MD 

Food and Drug Administration (FDA) 

FINK, Doran, MD, PhD 

Deputy Director, Clinical, Division of Vaccines and Related Products Applications 

Office of Vaccines Research and Review 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

Silver Spring, MD 

Health Resources and Services Administration (HRSA) 

RUBIN, Mary, MD 

Chief Medical Officer 

Division of Injury Compensation Programs 

Rockville, MD 

Indian Health Service (IHS) 

WEISER, Thomas, MD, MPH 

Medical Epidemiologist 

Portland Area Indian Health Service 

Portland, OR 

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

KIM, David, MD, MA 

Director, Division of Vaccines, OIDP 

Office of the Assistant Secretary for Health 

Department of Health and Human Services 

Washington, DC 

National Institutes of Health (NIH) 

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) Bethesda, MD 
ACIP Meeting Summary August 13, 2021

34

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 

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 
ACIP Meeting Summary August 13, 2021

35

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 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 
ACIP Meeting Summary August 13, 2021

36

American Pharmacists Association (APhA) 

FOSTER, Stephan L, PharmD CAPT 

(Ret) USPHS 

Professor, College of Pharmacy 

University of Tennessee Health Sciences Center 

Memphis, TN 

Association of Immunization Managers (AIM) 

HOWELL, Molly, MPH 

Immunization Program Manager 

North Dakota Department of Health

Bismarck, ND 

Association for Prevention Teaching and Research (APTR) 

McKINNEY, W Paul, MD 

Professor and Associate Dean 

University of Louisville School of Public Health and Information Sciences

Louisville, KY 

Association of State and Territorial Health Officials (ASTHO) 

SHAH, Nirav D, MD, JD 

Director

Maine Center for Disease Control and Prevention

Augusta, ME 

Biotechnology Industry Organization (BIO) 

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

Council of State and Territorial Epidemiologists (CSTE) (alternate) 

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 
ACIP Meeting Summary August 13, 2021

37

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 

National Foundation for Infectious Diseases (NFID) 

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 
ACIP Meeting Summary August 13, 2021

38

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 

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 
ACIP Meeting Summary August 13, 2021

39

ACRONYMS USED IN THE DOCUMENT

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics

ACC American College of Cardiology 

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices

ACOG American College of Obstetricians and Gynecologists

ACP American College of Physicians 

AE Adverse Event

AESI Adverse Events of Special Interest 

AGS American Geriatric Society 

AHA American Heart Association 

AHIP America’s Health Insurance Plans

AIM Association of Immunization Managers 

AMA American Medical Association

AOA American Osteopathic Association 

APhA American Pharmacists Association 

APTR Association for Prevention Teaching and Research

ASTHO Association of State and Territorial Health Officers 

AZ AstraZeneca

BEST Biologics Effectiveness and Safety System 

BLA Biologics License Application

CAR-T Chimeric Antigen Receptor T-Cell Therapy

CBER Center for Biologics Evaluation and Research 

CDC Centers for Disease Control and Prevention

CISA Clinical Immunization Safety Assessment 

CMS Center for Medicare and Medicaid Services

COG Children’s Oncology Group 

COI Conflict of Interest 

COVID-19 Coronavirus Disease 2019 

CSTE Council of State and Territorial Epidemiologists 

DoD Department of Defense

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs

DVRPA Division of Vaccines and Related Product Applications 

EHR Electronic Health Record 

EIS Epidemic Intelligence Service 

EIP Emerging Infections Program 

EMA European Medicines Agency 

EtR Framework Evidence to Recommendations Framework

EUA Emergency Use Authorization 

FDA Food and Drug Administration

FQHCs Federally Qualified Health Center 

HCP Health Care Personnel / Provider / Professional 

HHS (Department of) Health and Human Services

HIPAA Health Insurance Portability and Accountability Act 

HIV Human Immunodeficiency Viruses 

HRSA Health Resources and Services Administration 

HSCT Hematopoietic Stem Cell Transplantation 

IAC Immunization Action Coalition

ID Identifier 

IDSA Infectious Disease Society of America 
ACIP Meeting Summary August 13, 2021

40

IHS Indian Health Service 

IM Intramuscular 

ISO Immunization Safety Office

ISTM International Society for Travel Medicine 

J&J Johnson & Johnson 

LLS Leukemia & Lymphoma Society 

LTFC Long-Term Care Facilities 

MASO Management Analysis and Services Office 

MMWR Morbidity and Mortality Weekly Report

MoH Ministry of Health 

mRNA Messenger Ribonucleic Acid 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada

NAPNAP National Association of Pediatric Nurse Practitioners 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

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

NCIRD National Center for Immunization and Respiratory Diseases 

NEJM New England Journal of Medicine 

NFID National Foundation for Infectious Diseases 

NIH National Institutes of Health

NMA National Medical Association 

PCP Primary Care Provider 

PHAC Public Health Agency Canada 

PhRMA® Pharmaceutical Research and Manufacturers of America®

PIDS Pediatric Infectious Disease Society 

RBD Receptor Binding Domain 

RCT Randomized Controlled Trial

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 

TNF Tumor-Necrosis Factor Blockers

UK United Kingdom

US United States

USG United States Government 

VA (US Department of) Veteran’s Affairs 

VAERS Vaccine Adverse Event Reporting System

VaST ACIP COVID-19 Vaccine Safety Technical Work Group 

VE Vaccine Effectiveness

VOC Variant of Concern 

VOI Variant of Interest 

VSD Vaccine Safety Datalink

WG Work Group