MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP) 

NOVEMBER 19, 2021 

SUMMARY MINUTES 

TABLE OF CONTENTS 

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

THURSDAY: NOVEMBER 19, 2021............................................................................................................. 2 

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

Call to Order/Roll Call ......................................................................................................... 2 

Announcements.................................................................................................................. 2 

Welcoming Remarks........................................................................................................... 3 

FDA Update........................................................................................................................ 3 

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES ..................................................... 4 

Session Introduction ........................................................................................................... 4 

Efficacy and Safety of BNT162b2 Booster Dose ................................................................. 6 

Update from Moderna ......................................................................................................... 8 

Discussion Summary: Perez & Das..................................................................................... 9 

Public Comment.................................................................................................................10 

COVID-19 Vaccine Booster Dose Safety ...........................................................................12 

VaST Summary..................................................................................................................16 

Discussion Summary: Shimabukuro & Talbot ....................................................................17 

Updates to the EtR Framework: Pfizer-BioNTech and Moderna COVID-19 Vaccine Booster 

Doses ................................................................................................................................18 

ASTHO Statement .............................................................................................................25 

Discussion Summary: Oliver ..............................................................................................25 

Votes: COVID-19 Booster Doses .......................................................................................27 

Discussion Summary: Vote ................................................................................................27 

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

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

Acronyms Used in This Document..............................................................................................................40 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ACIP Meeting Summary November 19, 2021 

MEETING PURPOSE 

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

Disease Control and Prevention (CDC) convened a meeting of the Advisory Committee on 

Immunization Practices (ACIP) on November 19, 2021. The meeting took place remotely via 

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

which focused on COVID-19 booster doses. 

THURSDAY: NOVEMBER 19, 2021 

WELCOME AND INTRODUCTIONS 

Call to Order/Roll Call 

Dr. Grace Lee (ACIP Chair) called to order and presided over the November 19, 2021 ACIP 

meeting. She pointed out that because this meeting was scheduled quickly, not all members 

could be in attendance due to responsibilities that could not be rescheduled at the last minute. 

She acknowledged and sincerely thanked all of the colleagues of the ACIP members who had 

often during the COVID-19 pandemic rescheduled their own days in order to provide coverage 

for many of the members, including caring for patients, so that they would be able to attend 

emergency ACIP meetings. ACIP recognizes that it is not only the ACIP members who are 

public servants, but also their colleagues, friends, and family members who enable them to 

serve in these roles. Dr. Lee conducted a roll call, which established that a quorum was present. 

Dr. Wilbur Chen reported the potential for a perception of a conflict of interest (COIs) in that his 

employer, the University of Maryland, receives a grant from Emergent BioSolutions, Inc. for the 

development of a shigella vaccine. No other COIs were declared. A list of Members, Ex Officios, 

and Liaison Representatives is included in the appendixes at the end of this summary 

document. 

Announcements 

Dr. Melinda Wharton (ACIP Executive Secretary, CDC) noted 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 1:00 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-2021-0125. 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 

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 

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ACIP Meeting Summary November 19, 2021 

all votes related to that company. ACIP members state any COIs at the beginning of each 

meeting. 

Welcoming Remarks 

Dr. Sam Posner (Acting Director, CDC/NCIRD) thanked the ACIP members for coming 

together so rapidly to deliberate the question of expanding the groups who may receive a 

COVID-19 vaccine booster dose. CDC greatly appreciates all of the work that the ACIP has 

done and continues to do for this response. ACIP is unable to expand groups for vaccination 

until the Food and Drug Administration (FDA) authorizes those persons in the Emergency Use 

Authorization (EUA). Although the ability to mix and match doses has made parts of the 

implementation process easier, it is clearly understood that the prior FDA groups were 

complicated to implement. Importantly, simplification of the booster dose recommendations will 

reduce confusion and will allow healthcare providers and the public health workforce to focus on 

high priority groups for boosters and continue to implement pediatric and primary series 

vaccination. He also took this opportunity to remind people of the importance of ensuring that 

people get the influenza vaccine this season. There already is increased circulation of both 

COVID-19 and influenza and there are vaccines to protect everyone from both. 

FDA Update 

Dr. Doran Fink (FDA/CBER) indicated the FDA EUA approved earlier in the morning expanded 

the populations eligible for a single COVID-19 vaccine booster dose to include all individuals 18 

years of age and older who have completed primary vaccination with an FDA-authorized or 

approved COVID-19 vaccine, regardless of the vaccine used for primary vaccination. These 

authorizations apply to homologous booster doses in which the same vaccine is used 

for both primary vaccination and booster doses, as well as heterologous booster doses in which 

one vaccine is used for primary vaccination and a different vaccine is used for the booster dose. 

The authorized interval between completion of primary vaccination and a booster dose remains 

tied to the vaccine used for primary vaccination, meaning that individuals who receive a primary 

series of Pfizer or Moderna COVID-19 vaccines are eligible for a booster dose beginning at 6 

months after completion of their primary series and individuals who receive primary vaccinations 

with the Janssen COVID-19 vaccine are eligible for a booster dose beginning at 2 months after 

their primary vaccination. 

FDA’s assessment of benefits versus risks for expanding booster dose eligibility following 

primary vaccination with Pfizer and Moderna COVID-19 vaccine relied primarily on clinical trial 

data previously reviewed when booster doses for these vaccines were first authorized for use, 

and real-world evidence regarding effectiveness of the Pfizer and Moderna COVID-19 vaccine 

primary series, preliminary safety information from use of Pfizer and Moderna COVID-19 

vaccine booster doses in the US, and relevant safety and effectiveness information from use of 

Pfizer mRNA COVID-19 vaccine booster doses in Israel. In considering the recently increasing 

incidence of COVID-19 in the US and abroad, including breakthrough cases in vaccinated 

individuals, and newer evidence providing reassuring information about the risks of myocarditis 

and pericarditis, following mRNA COVID vaccine booster doses, FDA determined that the 

known and potential benefits of expanding booster dose eligibility for these mRNA COVID-19 

vaccines now clearly outweigh the known and potential risks. 

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ACIP Meeting Summary November 19, 2021 

It is important to note that even with evidence of waning vaccine effectiveness (VE) among 

vaccinated individuals, the predominance of serious COVID-19 outcomes remains among 

unvaccinated individuals. Thus, FDA acknowledges that while the impact of expanding booster 

dose eligibility is expected to be most clear on the individual level (e.g., providing additional 

protection to vaccinated individuals against breakthrough cases of COVID-19 and potential 

serious consequences), the greatest impact on a population level is still dependent on 

increasing vaccine uptake among those who are eligible for primary vaccination but still 

unvaccinated, as well as maintaining scientifically proven non-pharmacologic measures for 

reducing transmission of the SAR-CoV-2 virus heading into the winter months. 

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES 

Session Introduction 

Dr. Matthew Daley (ACIP, WG Chair) provided the session introduction on behalf of the ACIP 

COVID-19 Vaccines Work Group (WG). There have been over 47 million cases of COVID-19 in 

the US since the start of the pandemic and there have been over 764,000 deaths from COVID19 in the US. Given the availability of vaccines that have a high degree of safety and real-world 

effectiveness, deaths from COVID-19 is, for most people living in the US, vaccine-preventable. 

The most recent wave of COVID-19 peaked in early September nationally. Unfortunately, case 

counts have been rising again for approximately the last 3 weeks. In some parts of the country, 

there is rapid rise in case counts. Colorado, for example, recently reinstituted crisis standards of 

care. 

In November 2021, the COVID-19 WG’s activities have been focused primarily on booster 

doses. In that context, the WG has heard Pfizer-BioNTech clinical trial data for booster doses; 

received safety updates regarding booster doses; reviewed the Grading of Recommendation 

Assessment, Development and Evaluation (GRADE); reviewed and discussed updates to the 

Evidence to Recommendations (EtR) Framework regarding booster doses; and had a very 

informative discussion about booster policy options. 

As Dr. Fink reported, the FDA expanded eligibility for COVID-19 vaccine boosters earlier in the 

day. As Dr. Fink described, this authorizes the use of a single booster dose for all individuals 18 

years of age and over at least 6 months after completion of primary vaccination with any FDAauthorized or approved COVID-19 vaccine. The EUA allows for the use of each available 

COVID-19 vaccine as heterologous (“mix and match”) booster dose in eligible individuals 

following completion of primary vaccination with a different COVID-19 vaccine. The dosing 

interval for the heterologous booster dose is the same as that authorized for a booster dose of 

the vaccine used for primary vaccination.1 

To provide an update about COVID-19 vaccination among children 5-11 years of age, almost 2 

million first doses have been administered to children in this age group through November 17, 

2021. This represents 6.2% of all children 5-11 years of age in the US who have received a first 

dose of Pfizer-BioNTech COVID-19 vaccine. In addition, the vaccine safety monitoring system 

that has been put in place to monitor the safety of COVID-19 vaccines is the most intensive ever 

for any vaccine. These systems include the Vaccine Adverse Event Reporting System 

(VAERS), Vaccine Safety Datalink (VSD), the Vaccine Safety Technical Work Group (VaST) 

1 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-covid-19-vaccineboosters 

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ACIP Meeting Summary November 19, 2021 

VEST system, and other systems. These systems are all very closely monitoring the real-world 

safety of COVID-19 vaccines in children 5-11 years of age. 

Though not the area of focus for this meeting, Dr. Daley went off script momentarily to say that 

he has been hearing from and talking to children about COVID-19 vaccination and has found 

that many children are very excited to get vaccinated—not about the poke, but about the 

promise. Their parents have been very worried about COVID infections and they think that 

getting vaccinated will allow them to return to some level of normalcy, both in school and 

outside of school. What has been striking to him is that children in this age range, especially the 

ones who are a little closer to 10 or 11 years old, also brought up their social responsibility. 

They have described wanting to protect their classmates, their parents, their grandparents, and 

their community. While acknowledging all of this, he also has heard from parents who have 

been offered but declined COVID-19 vaccination for their children. To those parents, he says 

that the door is always open and to please share their questions and/or concerns. 

Turning to data that were not yet publicly available on the CDC website, Dr. Daley reported that 

over the last 16 days there was a marked increase in the number of doses administered per 

day. Currently, an average of over 200,000 doses per day were being given to children 5-11 

years of age in the US. As background, CDC issued Emergency Use Instructions (EUI) on 

November 17, 2021 about use of the COVID-19 vaccine by Pfizer-BioNTech approved by the 

FDA to prevent COVID-19 in people ≥16 years of age. The EUI authority (e.g., 2013 Pandemic 

and All-Hazards Preparedness Reauthorization Act) allows CDC to create and issue EUI to 

permit emergency use of FDA-approved medical products. EUI are provided as fact sheets for 

healthcare providers and recipients that include information about such products’ approved, 

licensed, or cleared conditions of use. 

The EUI covers the use of Pfizer-BioNTech COVID-19 vaccine for those who have completed 

primary vaccination with a non-FDA-authorized or FDA-approved COVID-19 vaccine, such as 

certain people who are vaccinated outside of the US with a COVID-19 vaccine listed for 

emergency use by the World Health Organization (WHO). This also includes certain participants 

in COVID-19 vaccine clinical trials, either within or outside of the US. The EUI specifically 

provides information about use, including an additional primary dose in certain moderately or 

severely immunocompromised persons aged ≥12 years and a single booster dose among 

certain adults ≥18 years of age.

2 The EUI Fact Sheets for healthcare providers (HCP), 

recipients, and caregivers are available on the CDC website.3 

On the agenda for this session were presentations on the efficacy and safety of the BNT162b2 

booster dose, an update on boosters from the Moderna perspective, COVID-19 vaccine booster 

dose safety, a VaST summary and interpretation of the current evidence regarding booster dose 

safety, updates to the EtR Framework regarding Pfizer-BioNTech and Moderna COVID-19 

vaccine booster doses, and a vote. 

2 Refer to CDC’s Interim Clinical Considerations for additional information on moderately or severely immunocompromised persons 

recommended for an additional primary dose and populations recommended for a booster 

dosehttps://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html 3 https://www.cdc.gov/vaccines/covid-19/eui/index.html 

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ACIP Meeting Summary November 19, 2021 

Efficacy and Safety of BNT162b2 Booster Dose 

Dr. John Perez (Pfizer) presented on the safety and efficacy of a booster dose of BNT162b2 

from Study C4591031, which has recruited 10,000 individuals ≥16 years of age and older who 

completed a 2-dose primary series of BNT162 in Study C4591001. These subjects were 

randomized at a 1:1 ratio to receive either BNT162 30μg or a placebo dose at least 6 months 

after the second dose. Randomization was stratified by age, such that approximately 60% of the 

participants enrolled would be at least 16 years of age to 55 years of age and approximately 

40% would greater than 55 years of age. Assessments included safety evaluations of adverse 

events (AEs) and COVID-19 case surveillance for booster efficacy estimation after the booster 

dose. Reactogenicity data were not collected in this study, but booster reactogenicity was 

reported from Study C4591001 and was presented previous to ACIP. 

In terms of demographics, there was equal participation by males and females between the 

vaccine and placebo groups. About 79% of the subjects were White, about 15% were Latino, 

and about 86% were from the US. Roughly 55%-56% were between 16-55 years of age and the 

rest were greater than 55 years of age, with a median age in the study of 53 years. About 5.4% 

were positive for SARS-CoV-2 at baseline. Looking at when the booster was given after 

completing the 2-dose series, the median time to get that booster dose was about 10.8 months 

after completing the 2-dose series. The majority of booster doses were administered 10-12 

months after Dose 2. Recipients were followed for a median of 2.5 months after their booster 

dose. 

To review reactogenicity, this analysis was requested by CDC and these data were from Study 

C4591001. In terms of reactogenicity of a booster dose with at least a Grade 3 or higher 

severity, about 6.6% overall had a Grade 3 event or higher. All of the local reactions at Grade 3 

or higher were less than 1%. For systemic events, about 5.6% of participants reported a Grade 

3 reaction. The majority of these included 4.5% fatigue, 11.4% muscle pain, and 1% headache. 

Overall, low grades of Grade 3 or higher reactogenicity was reported. In terms of AEs 1 month 

after a booster dose, a higher rate of AEs and related AEs were reported for the vaccine group 

compared to the placebo group. This was seen previously in COVID-19 clinical trials. There was 

a very low rate of related serious adverse events (SAEs), withdrawals due to SAEs, or deaths 

reported in this group. 

Analyzing the AEs that are being reported at greater than 1% by System Organ Class (SOC) 

after the booster vaccination, a similar pattern is seen as what has been seen before. Namely, 

that AEs that are being reported in clinical trials are primarily AEs reflective of reactogenicity. 

The most common are general disorders and administration site conditions, which includes local 

injection site and systemic reactions of fever, fatigue, and chills. Next are in the musculoskeletal 

system, which includes myalgia and arthralgia. In the nervous system SOC are headache, blood 

and lymphatic system disorders, and lymphadenopathy. In this study, the rate of 

lymphadenopathy was 2.7%. And as reminder, that is comparative to 0.4% seen after the 

second dose in Study C4591001. 

Subjects were followed through the cutoff date of October 5, 2021. The same pattern was 

observed as at 1 month after the booster dose, with more AEs reported in the vaccine versus 

the placebo group. There were more AEs related to reactogenicity in the SOCs that were 

previously examined, with no new AEs or safety signals with the follow-up data. In terms of 

SAEs by SOC after the booster vaccination through the cutoff date, the rate of SAEs was higher 

in the placebo group than in the vaccine group. Specifically, there were 16 (0.3%) SAEs in the 

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vaccine group compared to 24 (0.5%) events in the placebo group. There was no imbalance 

seen in any of the SOC categories. 

There were 3 related SAEs from the booster vaccination in the vaccine group and two in the 

placebo group. Beginning with the vaccine group, the first was a young male with a past medical 

history of postural orthostatic tachycardia syndrome (POTS) and orthostatic hypotension, who 

developed tachycardia consistent with these medical diagnoses 8 days after booster vaccination 

that was moderate in nature and resolved 2 days later. The next case was an elderly female 

with Gilbert's syndrome, who developed moderate hepatic enzyme increase that occurred 5 

days after the booster vaccination that resolved over a month later. Importantly, she was taking 

TYLENOL® for diverticulitis that started 2 days before the booster dose. The next case was a 

young female who developed mild hepatic enzyme increase that occurred 49 days after the 

booster vaccination that was ongoing at the time of the cutoff. She saw her primary care 

physician (PCP) who thought that this was due to atorvastatin. In the placebo group, there was 

an elderly female who had multiple risk factors for cardiovascular disease (CVD), who 

developed an acute myocardial infarction (MI) 9 days after the placebo dose. It was lifethreatening, but resolved 4 days later. Finally, there was a young adult male with 

supraventricular tachycardia (SVT) who developed chest pain of unknown origin that occurred 6 

days after placebo that was severe in nature and resolved without treatment 1 day later. The 

subject was evaluated and troponin and electrocardiograms (ECGs) were normal. 

Looking at relative vaccine efficacy (VE) during the blinded follow-up period in subjects without 

evidence of infection prior to 7 days after Dose 2, subjects in the vaccine and in the placebo 

group both had 2 primary doses of vaccine roughly 21 days apart. They were randomized to 

receive either a booster dose or a saline injection. There were 6 cases in the vaccine group and 

123 cases in the placebo group who developed symptomatic COVID-19, which calculates to a 

relative VE of 95.3%. Regarding relative VE in subjects with or without evidence of infection 

prior to 7 days after the second dose now including people with evidence of infection, there 

were 7 subjects randomized to a booster dose who developed symptomatic COVID-19 

compared to 124 people in the placebo group. This calculates to a relative VE of 94.6%. In 

terms of the cumulative incidence curve with first COVID-19 occurrence after booster 

vaccination, the 2 curves diverge starting prior to 7 days after the booster dose, and then 

maintained separation with additional follow-up time. Looking at relative VE by subgroup with 

demographic characteristics, irrespective of age, sex, race, or ethnicity, relative VE was high, 

irrespective of demographic variable. When the data were further analyzed by country and by 

comorbidity, there were high rates of relative VE by country and also high rates of relative VE 

regardless of whether someone had a comorbidity. 

In conclusion, there was high relative VE in the boosted group compared to the un-boosted 

group from 7 days after the boost in those without evidence of infection was 95.6%. None of the 

protocol-defined cases of COVID-19 in the un-boosted placebo group resulted in hospitalization. 

Two cases of severe COVID-19 occurred in the placebo group based only on SpO2 <93%. 

Multiple subgroup analyses showed that efficacy was consistent irrespective of age, sex, race, 

ethnicity, and comorbid conditions. The AEs observed were consistent with those seen in 

previous studies with no safety signal identified. No cases of myocarditis or pericarditis were 

observed. Lymphadenopathy was higher after a booster dose at 2.7% compared to 0.4% seen 

in previous studies. Overall, these data strongly support that a booster dose of BNT162b2 

administered in individuals 18 years of age and older ≥6 months after the second dose improves 

protection against symptomatic COVID-19. 

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Update from Moderna 

Dr. Rituparna Das (Moderna) provided an update on a 50 μg booster dose of Moderna 

COVID-19 vaccine in individuals ≥18 years of age. The EUA that was granted earlier in the day 

was for a booster dose of the Moderna COVID-19 vaccine was for 0.25 mL. A single Moderna 

COVID-19 vaccine booster dose of 0.25 mL may be administered intramuscularly (IM) at least 6 

months after completing a primary series of the Moderna COVID-19 vaccine to individuals 18 

years of age or older. A single booster dose of the Moderna COVID-19 vaccine of 0.25 mL may 

be administered as a heterologous booster dose following completion of primary vaccination 

with another authorized or approved COVID-19 vaccine. The dosing interval for the 

heterologous booster dose is the same as that authorized for a booster dose of the vaccine 

used for primary vaccination. 

To review the data Moderna presented during the October 21, 2021 ACIP meeting, which was 

the data package was used for the original 50 μg booster dose under the EUA, an 

immunobridging approach was taken per the FDA guidelines for boosters and variant vaccines. 

In terms of safety, the rates of adverse reactions (ARs) following the 50 μg booster dose were 

comparable to that seen after Dose 2 of the primary series. The comparison was the primary 

series received in the pivotal study, Protocol 301 (COVE Efficacy Trial). Pain at the injection site 

was the most common solicited local AR. Headache, fatigue, and myalgia were the most 

common systemic ARs. The majority of ARs were mild to moderate in severity. Axillary swelling 

or tenderness was the only AR that was more frequently reported after the booster dose 

compared to Dose 2 in the primary series study. There were no vaccine-related SAEs or deaths 

in the booster study. 

Regarding the immunogenicity endpoints and analyses, the pre-specified co-primary 

hypotheses, the geometric mean ratio (GMR) and seroresponse rate (SRR) difference post 

booster compared to post-Dose 2 of the primary series, were met on the pooled dataset. The 50 

μg booster dose following the 100 μg primary series resulted in a higher antibody response to 

the original virus (D614G) than post-Dose 2 in Study 301 (GMR = 1.8) compared to post-Dose 2 

in the pivotal efficacy study. There was a 13-fold rise of antibodies compared to pre-boosters 

against the original virus. There was a 17-fold rise from pre-booster titers for the Delta variant. 

There were consistently high antibody titers in both age groups: 18-64 and ≥ 65 years of age. 

To summarize ongoing studies of the 50 μg booster dose, boosting began in Protocol 301 

(COVE Efficacy Trial) in September. To date, over 15,000 participants have received a booster 

dose 6-14 months after completion of their primary series. The safety and immunogenicity data 

from that cohort are being compiled. No unexpected signals have been reported. The safety and 

immunogenicity data will be brought forward as soon as they are available. Immunogenicity data 

are expected on subset of subjects in early 2022. In addition, sera are currently being tested to 

assess 6-month persistence of antibody (Study P201B) in approximately 300 subjects who were 

boosted with 50 μg. Moderna will update the COVID-19 Vaccines WG and the ACIP as soon as 

those data become available. 

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Discussion Summary: Perez & Das 

• Regarding an inquiry about the number of people in the group of adults 16-25 years of age 

in the Pfizer study, Dr. Perez indicated that there were 78 persons 16-17 years of age, 472 

persons 16-25 years of age, 933 persons 26-30 years of age, 855 persons 18-30 years of 

age, 1414 persons 31-40 years of age, and 2347 overall from 16-40 years of age. 

• Questions were posted regarding whether the lymphadenopathy cases in the Pfizer study 

were all axillary, what percentage occurred in women versus men, and about the painful 

swelling reported of the soft tissue rather than lymphadenopathy in younger individuals. Dr. 

Perez indicated that the lymphadenopathy was primarily ipsilateral to the injection site at 

about 8-9 days after the first dose and 3-4 days after the second dose. Sometimes 

lymphadenopathy occurs in the cervical regions. These were all palpable and soft lymph 

nodes could be easily noted on exam. There was no obvious sex difference in this analysis, 

although it appeared in a few analyses to be somewhat higher in females as opposed to 

males. Nevertheless, men also reported lymphadenopathy. There were a few reports of 

lymphadenitis. 

• Regarding the AEs reported in the Pfizer study, an inquiry was posed regarding whether any 

crowding of effects was observed depending upon the timing of the booster post-primary 

series. Dr. Perez indicated that while they did not look at it from that perspective, nothing 

stood out in the review of all AEs in the vaccinated group compared to the placebo group, 

other reactogenicity and lymphadenopathy. 

• In terms of whether there are any data on pregnancy and boosters in these cohorts, Dr. 

Perez indicated that none of the subjects who were boosted were pregnant. Dr. Das added 

that Moderna is following everybody for pregnancy. While she had not seen any reports 

come through on pregnancy at this point, Moderna will compile those data. 

• Regarding whether clinical efficacy was involved in the Moderna trial, Dr. Das indicated that 

this is not a placebo-controlled boosting trial. At the time they started the trial, they thought 

that they could no longer conduct placebo-controlled boosting. Case monitoring continues in 

the same way it always has been. During the last presentation to ACIP, the breakthrough 

case data were shown for early vaccinees versus late vaccinees to illustrate how early 

vaccinees seemed to be having more breakthrough cases. Anytime somebody has 

symptoms, they present for PCR testing and are followed to resolution. Moderna is also 

doing sequencing for all of the cases, so they will have incidence rates over time. 

• Asked to address thoughts about immunocompromised patients who received the J&J 

vaccine who are now recommended to receive a 50 μg booster dose of Moderna 2 or more 

months after their J&J vaccine and the fact that many clinicians want their 

immunocompromised patients to receive a full dose of Moderna vaccine after J&J, Dr. Das 

reported that Moderna has an immunocompromised study for those receiving a third dose. 

That study probably will be extended to a fourth dose as well. There is not a 

recommendation for a third dose for the J&J vaccine, so she did not have any data on this. 

• To summarize, ACIP members are very appreciative of the continued information on VE and 

safety by prior infection status and hope that will continue to be helpful going forward. They 

also are appreciative of further assessments on the impact of dosing intervals on efficacy 

and safety, and a continued focus on the age- and gender-specific safety data. In addition, 

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continued vaccine clinical trials are needed that are inclusive of children and pregnant 

women. Questions continue to arise about children and pregnant, including for booster 

doses, but data are typically on the general adult population. ACIP also appreciates 

continued input on duration of immunity. 

Public Comment 

The floor was opened for public comment during the December 16, 2021 ACIP meeting at 1:23 

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-2021-0125. Visit http://www.regulations.gov for access to the docket or to 

submit comments or read background documents and comments received. 

Ms. Mary Mahoney

Concerned Individual 

Good afternoon. My name is Mary Mahoney and I’m speaking on behalf of myself and my 

family. Thank you for this opportunity and for the hard work and commitment that the advisory 

committee has put forth during the pandemic. My family and I registered to received initial 

vaccines as soon as we were eligible to protect ourselves. We did this so to be able to resume 

important and meaningful aspects of our lives that had been on hold, such as going to school, 

attending church in person, and being around older adults that we love. It is important that we’re 

able to continue to enjoy these everyday experiences, which we now treasurer more than ever, 

especially having not been able to participate in them for almost 2 years. The opportunity for all 

adults to receive booster shots provides a much needed layer of protection, not only to each 

person who gets one, but all of those people with whom they interact. Every measure that cuts 

off potential avenues for this virus to invade, every step that keeps it from having places to 

replicate and possibly mutate, is a victory. I urge the committee to recommend that the booster 

shot be made available to every adult so that we continue to preserve and maximize the 

progress we’ve made toward ending its catastrophic impact on our lives, our traditions, our 

economy and our country. Thank you for your time. 

Mr. Edward Nirenberg

Science Communicator Focusing on Vaccines and COVID-19 

Hi, and thanks for this time again today. Before beginning I do want to take a moment to thank 

the ACIP team and professional collaborators for their extraordinary labors during this time. I 

think that this is more meetings than anyone wants to have for anything. I’m grateful as a citizen 

of this country that we have expert advisory committees that have worked to rise to the 

challenges of this crisis. As the subject of today’s discussion is boosters, I think it’s important to 

note that we are increasingly seeing recommendations for booster doses for adults, but there 

has been relatively limited guidance for those aged 12 to 18. And I think it would be helpful to 

have that data regarding whether or not appreciable declining effectiveness of the vaccine is 

being observed in that age cohort, as currently there seems to be something of a data vacuum 

and an absence of guidance. I’m sure that this data does exist, but it should be made publicly 

available. Additionally, on the subject of framing as a booster dose, I think Dr. Stanley Plotkin 

was the first to raise the suggestion that booster doses should not be considered booster doses, 

and rather should be thought of as part of the primary series. And I think that given the position 

we currently face and the substantial benefits we’re seeing with third doses that exceed the 

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ACIP Meeting Summary November 19, 2021 

protection allotted by second doses at their peak, he was likely correct. I think it would serve the 

US better to acknowledge this is intended as a 3-dose series for adults rather than 2 doses. 

Equity concerns surrounding the use of these vaccines are substantial, but each day we have 

doses going in the trash because they are expiring, and there’s presently no way to get these 

doses to the people that so desperately need them. First and second doses are always going to 

be far more important than third doses and if uptake in the US were better, we might not have 

such a significant need of third doses. But this counterfactual does not help our situation. It will 

always be better that a vaccine go into someone’s arm than into the trash, even if the owner 

of the arm has already received 2 doses. We are already seeing that there is a divergence in 

the Kaplan–Meier curve as was shown well before 7 days just in rapid recall kinetics and rapid 

onset of enhanced protection with Dose 3, as was seen with other vaccines. I also wish to make 

a gentle reminder regarding the importance of influenza vaccination, as underscored earlier in 

the meeting. Influenza has been a serious public health scare that we have adapted to with 

tools like vaccination. And while we’ve been extremely fortunate in the last year that NPI has 

managed to reduce incidence so dramatically, flu activity is rising throughout the US and the 

world. It’s a serious respiratory disease and super infectious with COVID-19 even more. So 

please, get your flu vaccines as soon as possible if you have not done so already. Thank you so 

much. 

Mrs. Melody Butler, RN, CIC

Nurses Who Vaccinate 

Good afternoon. My name is Melody Butler. I am a mother, a Registered Nurse (RN), and the 

Founder of Nurses Who Vaccinate (NWV). I’m also a dog owner, in case you hear that in the 

background. We are an organization committed to ensuring our patients have access to the 

most accurate evidence-based information from credible sources to support their decisions to 

vaccinate. We know vaccines save lives and we are grateful for the work of this committee to 

ensuring that before any vaccine is made available to the public, it is first and foremost safe and 

effective. The COVID-19 pandemic has been detrimental to the health of so many people, and 

not just due to the virus itself. It has kept people from routine exams, preventative care, and 

necessary vaccines. Much of our work is centered around ensuring our patients, colleagues, 

and communities understand the importance of keeping up with their routine vaccines, and 

doing their part to not only protect themselves, but society as a whole. We are disheartened by 

the misinformation campaigns that continually spread about the COVID-19 vaccine and 

treatments. While we as nurses are certainly no stranger to this anti-vaccine movement, the 

damage this can cause for those Americans who are simply looking for educated guidance for 

themselves and their families is unacceptable. What concerns us at Nurses Who Vaccinate is 

that sharing misinformation creates immense confusion, false hope, and in many cases 

encourages individuals to avoid appropriate medical care. This is why the work of this 

committee is so critical. Americans should be relying on the science-based assessments and 

recommendations by both the FDA and the CDC to guide their decision-making. The incredible 

advancements that have made in preventing and treating COVID-19 are something we as a 

nation should be proud of. And we strongly support the recommendation of a booster dose 

for all eligible Americans. We think this recommendation will provide much needed clarity for 

Americans who may be wondering if they are eligible for the booster and for whom that extra 

level of protection is needed. Vaccines represent our best tool in preventing serious illness and 

in reducing the overall threat of this deadly virus. We at Nurses Who Vaccinate appreciate this 

committee’s thoughtful consideration of a broader booster recommendation. We do ask that 

there’s further clarification and data about mixing boosters, and we will continue to do our part in 

educating our communities following your decision. Thank you very much. 

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Ms. Lisa Randall, JD, MPH 

Concerned Individual 

Hi. Good afternoon. Thanks for giving me the opportunity to make a public comment. And I send 

my enthusiastic thanks to the members and staff of ACIP for their hard work and good judgment 

in what has been a really long, stressful slog with COVID-19. I think it’s so valuable that these 

meetings are available for the public to watch and I wish more people would watch, because the 

fact of your transparency will help them understand that there’s nothing to be afraid of with 

recommended vaccines. I did have the experience recently of arranging a booster dose of 

COVID vaccine for someone in my family and I noticed that it was a little bit complicated by the 

need to ascertain that the person was eligible. When I tried to schedule online with the person’s 

primary provider, something had gone wrong with the logic of the questionnaire and it wouldn’t 

let me schedule. I only mention this to say that if the recommendation were simpler, this kind of 

thing would be less likely to inadvertently create a barrier. I’m happy to tell you I was able to 

straighten things out. But of course, the most important thing is to get doses to those who 

haven’t had any yet. And on that subject I’ll pass along one more anecdote, which is a 

conversation that my mom passed along to me with somebody who is her friend and not a bad 

person, but has fallen victim to misinformation about COVID. This person thought she could 

trust what she called “independent media,” whatever she thinks that is, that she distinguished 

them from what she called “corporate-owned media.” And she was just sure that what her 

sources were recorded was real science with studies backing it. The whole phenomenon of 

there being people who live in an alternate reality is not new, but it’s getting worse. And I can 

only encourage continued efforts and creative thinking about how to break through it, whether 

that’s through non-traditional partnerships, or media, or what have you. I appreciate everyone’s 

contribution to getting us through this experience. And thanks again for letting me comment. 

Ms. Karen Isabella Halabura 

Vaccine Advocate Who is Autistic 

Hi. I really appreciate how you’ve worked so hard to get these vaccines out. Vaccine advocates 

who are autistic have been fighting misinformation for many years. I actually seek out those 

sources because I kept getting told that vaccines cause autism, which is not true. I’m also a 

mom of an autistic child and we both are already immunocompromised. My autistic daughter 

has a tumor around pancreas which was diagnosed in April of last year and she’s fully 

vaccinated. We both had our flu shots this year. We’re doing great and it’s really nice that we 

have this option to be able to give her personal topics or personal information. It’s really hard to 

get through proper information online. All you find is people who are telling you that vaccines 

are going to end up hurting us in the long run. All I’ve ever had has been good information and 

I’ve never had a problem even when I got flu shots, and I’m allergic to eggs. So, I really want to 

say that I appreciate all the work you’ve done. Thank you very much. 

COVID-19 Vaccine Booster Dose Safety 

Dr. Tom Shimabukuro (CDC/NCEZID) presented on COVID-19 vaccine booster dose safety, 

first pointing out that for the purpose of this surveillance review, Pfizer-BioNTech vaccination 

doses administered beginning September 22, 2021 and Moderna and Janssen vaccination 

doses administered beginning October 20, 2021 are assumed to be booster doses. Some doses 

might be additional doses administered to immunocompromised individuals and therefore 

misclassified as boosters, but using these anchor points provide the cleanest analysis. COVID19 vaccines are being administered under the most intensive vaccine safety monitoring effort in 

US history. Strong, complementary systems are in place―both new and established. These 

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include v-safesm, VAERS, VSD, and the CISA Project. A full list of US COVID-19 vaccine safety 

monitoring systems is available on the CDC website.4 

As a reminder, v-safesm is a CDC smartphone-based monitoring program for COVID-19 vaccine 

safety in the US. It uses text messaging and web surveys to check in with vaccine recipients 

after vaccination. Patients can register at any time after the first, second, or third dose. 

However, questions can only be answered moving forward. It is not possible to go back in time 

after registration to answer questions about previous doses. Parents and guardians also can 

register on behalf of children. V-safesm solicits participants’ reports on how they feel after 

COVID-19 vaccination to include local injection site reactions (i.e., pain, redness, swelling), 

systemic reactions (i.e., fatigue, headache, muscle aches), and health impacts (unable to 

perform normal daily activities, missed school or work, or received medical care). 

In terms of patterns of vaccination for the 725,917 v-safesm participants who reported a booster 

dose as of November 14, 2021 looking at the primary series that an individual reported receiving 

and the booster dose that they reported receiving of Moderna, Pfizer, or Janssen, the takehome message was that for the mRNA vaccines, people overwhelmingly got boosted with the 

same vaccine they receive during the primary series. For Moderna or Pfizer, greater than 95% 

received a booster dose with the same vaccine for which they were vaccinated for the primary 

series. That was somewhat different for Janssen for which 16% received a Janssen booster, for 

which there could be multiple reasons. 

Looking at v-safesm data on reactions and health impact events reported at least once in the 

week after Pfizer BioNTech vaccination by dose, local reactogenicity, systemic reactogenicity, 

and health impact events were generally reported less following the booster dose compared 

to Dose 2. These were statistically significant, although the differences were not that great. 

These are large data and that can impact the ability to find statistically significant findings. There 

was slightly more medical care received after the booster dose compared to Dose 2, but the 

differences were very small. This general pattern held true for Moderna as well for injection site 

reactions, systemic reactions, and health impact events generally. There was less reported 

reactogenicity or health impacts following the booster dose when compared to Dose 2, although 

the differences were fairly small in some cases. 

For heterologous versus homologous prime boost combinations, the general was that 

regardless of the primary series on received, there was more reported local reactogenicity 

if boosted with the Moderna compared to getting boosted with the Pfizer. The Janssen booster 

was the least reactogenic for individuals who received the Janssen primary series. The general 

trends persisted in reported systemic reactions at least once in the week after vaccination. 

Individuals who were boosted with Moderna, regardless of the primary series, reported more 

systemic reactions compared with Pfizer and with Janssen for those who received the Janssen 

primary series. The differences were fairly small in the case of the Moderna primary and the 

Janssen primary series. For health impact events, the trends generally persisted such that there 

were more self-reported health impact events the week after booster for individuals getting the 

Moderna boost compared to the Pfizer boost, regardless of the primary series that they 

received. 

4 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html 

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ACIP Meeting Summary November 19, 2021 

In summary, after over 725,000 v-safesm registrants reported a booster dose, most reported a 

primary mRNA vaccine series followed by booster dose from the same manufacturer. 

Consistent with findings on reactogenicity following a primary series, generally Moderna 

boosters appeared to be more reactogenic than the Pfizer-BioNTech booster, regardless of the 

primary series manufacturer. For Pfizer and Moderna, local and systemic reactions and health 

impacts were reported less frequently following a booster dose than Dose 2 of the primary 

series. 

Now moving on to data from VAERS. As a reminder, VAERS is the national spontaneous 

reporting or passive surveillance system that is co-managed by the CDC and the FDA. VAERS 

accepts reports from anyone, regardless of the plausibility of the vaccine causing the event or 

the clinical seriousness of the event. The key strengths of VAERS are its ability to rapidly detect 

potential safety problems and to detect rare AEs. As a passive surveillance system, VAERS has 

inconsistent quality and completeness of information and it is subject to reporting biases. 

Because of these limitations, it generally cannot be determined whether a vaccine caused an 

AE based on VAERS data alone. 

In terms of reports to VAERS following COVID-19 booster dose vaccination, regardless of 

manufacturer, ≥93% of reports were non-serious. This is consistent with what is seen for the 

primary series for these vaccines and consistent with what is observed for other vaccines in 

general. Looking at crude reporting rates to VAERS for COVID-19 booster dose vaccination per 

million doses administered, the number of reports is divided by the doses administered and then 

multiplied by 1 million to get the reporting rate per million doses administered. For Janssen, it 

was necessary to do some extrapolation because there were less than 1 million doses. Using 

this formula allows for a standardized comparison for the 3 vaccines. For all 3 vaccines, the 

reporting rates for all reports and serious reports were comparable and were fairly similar to 

what has been observed with the primary series for these vaccines. 

With regard to the patient characteristics for these booster dose reports to VAERS, most of 

these reports are in individuals ≥50 years of age. The median age was 62 years. The 

interquartile range was 45-71 years of age. Two-thirds of the reports were in females. The maleto-female ratio for reporting was consistent with what has been seen for the primary series for 

these vaccines, and also was consistent with what has been observed for VAERS reporting in 

general. There were more reports in females compared to males. VAERS also captures reports 

on race and ethnicity. Most reports were in persons of white, non-Hispanic race and ethnicity or 

unknown race and ethnicity, meaning that section of the form was not completed. 

The most frequently reported non-serious AEs reported to VAERS following a COVID-19 

vaccination were headache, fever, fatigue, pain, and chills. The most frequently reported SAEs 

were dyspnoea, death, fever, chest pain, and asthenia. There have been 82 reports of deaths 

submitted to VAERS. To put that in context, that is after 26.3 million booster doses administered 

in the US. Among the 82 initial reports of deaths following booster doses, 60 received Pfizer and 

22 received Moderna. There were no Janssen reports. The median age in these reports was 79 

years and the interquartile range was 69-90 years. 

In terms of the preliminary impression of the cause of death (COD), when sufficient information 

was available to make that determination, included: Acute Leukemia, Cardiomyopathy, 

Congestive Heart Failure, COVID-19 Disease, General Decompensation (end stage disease), 

Glioblastoma, Myocardial Infarction, Pneumonia and Sepsis, Pulmonary Embolism, Renal 

Failure (end stage renal disease), Respiratory and/or Cardiac Arrest, and Stroke. This is based 

on CDC physician review of initial VAERS report and available documentation, including death 

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certificates. Based on an analysis conducted by CDC,

5 it was estimated that 236.5 coincidental 

all-cause deaths would be expected in 10 million vaccinated people within 1 day of vaccination; 

1,655.5 coincident all-cause deaths in 10 million people within 7 days of vaccination; and 

9,932.8 coincident all-cause deaths in 10 million vaccinated people within 42 days of 

vaccination. The reports after booster doses, given the amount of booster doses administered 

so far, put that below the background that would be expected. 

Myocarditis and myopericarditis cases have been reported following booster doses. There have 

been 54 preliminary reports of myocarditis and myopericarditis, all after Pfizer-BioNTech or 

Moderna vaccination. The median age in these cases was 51 years, with an interquartile range 

of 38-67 years. Median time to onset was 3 days, with an interquartile range of 1-7 days. These 

reports were in 29 males, 24 females, 1 person for whom sex was not reported. The crude 

unadjudicated reporting rate was 2.1 cases per million mRNA COVID-19 vaccine doses 

administered. The characteristics of reports appear to reflect the population for booster dose 

recommendations, mainly older adults. Of the 54 cases, 38 are still under review, 4 did not meet 

case definition, and 12 have met case definition. For some additional information on these 12 

cases that were concluded to have met the CDC case definition, the median age was 46 years, 

the median symptom onset was 4 days, 9 were male and 3 were female, and most were nonHispanic White. There were 8 Pfizer reports and 4 Moderna reports, with 10 of these 12 were 

known to have been hospitalized. All 10 were discharged home. The recovery status was known 

for 8 of those, 6 (75%) of whom were known to have recovered from symptoms at the time of 

the report. 

To summarize the VAERS findings, during the period from September 22, 2021 through 

November 5, 2021, there were 25.9 million mRNA and 334,000 Janssen vaccine booster doses 

administered. Most reports, 93% or more, were non-serious. This is similar to what is observed 

for the primary series for these vaccines. Almost half of the reports were among persons 65 

years of age and older and two-thirds were in females. The most frequently reported nonserious AEs were known and well-characterized AEs associated with COVID-19 vaccination. 

There were no unusual or unexpected patterns observed with respect to reports of deaths 

following COVID-19 booster vaccination. There were 54 preliminary reports of myocarditis and 

myopericarditis identified. Of these, 12 reports met the CDC case definition, while others are 

under review or have been ruled out. The characteristics of these reports appear to reflect the 

population for booster dose recommendations. 

V-safesm is available for booster dose registration and for surveys. Those who are already 

registered can access their account, enter the vaccine information, and proceed. Those who are 

not registered will need to register as a new user and then proceed. CDC is aware that there 

have been some questions about registering dependents in v-safesm. Parents or caregivers 

need to register children 5-15 years of age, which must be done through a parent or caregiver 

account. If a parent or caregiver is already registered, they can simply access their current 

account. Once on the landing screen, they can click “Add a Dependent” to register one of their 

dependents. Those who do not have an account can create a new account and then register 

their dependent. This will allow parents and caregivers to respond on behalf of their minor 

children. 

5 Abra et al. Expected Rates of Select Adverse Events following Immunization for COVID-19 Vaccine Safety Monitoring. medRxiv. 

doi: https://doi.org/10.1101/2021.08.31.21262919 

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ACIP Meeting Summary November 19, 2021 

VaST Summary 

Dr. Keipp Talbot (VaST Chair) provided a summary from the VaST WG. As a reminder, the 

objectives of the VaST WG are to: 1) review, evaluate, and interpret post-authorization/approval 

COVID-19 vaccination safety data; 2) serve as the central hub for technical subject matter 

expertise from federal agencies conducting post-authorization/approval safety monitoring; 3) 

advise on analyses, interpretation, and presentation of vaccine safety data; and 4) provide 

updates to the ACIP COVID-19 Vaccines WG and the entire ACIP on COVID-19 vaccine safety. 

VaST continues to review COVID-19 vaccination safety data from passive and active 

surveillance systems. US safety monitoring systems include VAERS, VSD, FDA’s Biologics 

Effectiveness and Safety (BEST) System, Department of Veterans Affairs (VA), Indian Health 

Service (IHS), and Department of Defense (DoD). In addition, there are the Israeli and 

Canadian data and data from the Global Advisory Committee on Vaccine Safety (GACVS). 

Special evaluations are underway on myocarditis case follow-up. 

VaST has presented assessments during ACIP meetings almost monthly at this point. From 

December 21, 2020 to the present, VaST has had 41 independent meetings to review vaccine 

safety data and 11 joint meetings with the COVID-19 Vaccines WG focused on safety. VaST 

previously reviewed US safety for the September 22, 2021 ACIP vote on boosters. At that time, 

the data available for third doses were mainly for those provided under recommendations for 

persons with immunocompromising conditions. Since that time, VaST has been able to accrue 

more safety data. The data that were reviewed include data from VAERS, v-safesm, and Israel 

Ministry of Health data. 

The booster vaccination data that come from VAERS include information from almost 26 million 

doses of mRNA and 334,000 Janssen vaccine doses. Among the almost 12,000 VAERS 

reports, nearly 93% were non-serious and almost half were in persons 65 years of age and 

older. The most frequently reported non-serious AEs were similar to AEs reported after earlier 

doses of COVID-19 vaccine, similar to the reactogenicity previously seen. There are 54 

preliminary reports of myocarditis following mRNA vaccination. Of these, 12 have been verified 

as meeting the CDC case definition and 38 are pending investigation. The age distribution 

reflects the booster dose recommendations. 

Safety data after booster doses have been reported by over 700,000 v-safesm participants. Most 

reported a primary mRNA vaccine series followed by a booster from the same manufacturer. 

For both mRNA vaccinations, local and systemic reactions and health impacts were reported 

less frequently following a booster dose than following Dose 2 of the primary series. The 

Moderna booster appears to be more reactogenic than the Pfizer-BioNTech booster, regardless 

of the type of mRNA vaccine given previously. 

In addition, VaST has been shown data from Israel for a third dose.6 In Israel, booster doses 

of Pfizer-BioNTech vaccine were phased in first for persons ≥60 years of age. Since the end of 

August, everyone ≥12 years of age has been eligible for a third dose. Approximately 4 million 

third doses have been administered to persons ≥12 years of age through November 15, 2021. 

Rates of reported systemic, local, neurologic, allergic, and other reactions were lower after Dose 

3 than after either Dose 1 or Dose 2. The reported rates of myocarditis have been lower than 

after Dose 2. 

6 Updated from: https://www.fda.gov/media/153086/download 

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ACIP Meeting Summary November 19, 2021 

The VaST WG assessment of COVID-19 booster vaccination safety data is that data regarding 

booster doses to date are reassuring. Reactogenicity and adverse events of special interest 

(AESI) are similar to or lower than those seen after the primary series. Myocarditis risk after a 

Pfizer booster dose appears lower than after Dose 2. However, there are limited data available 

to assess myocarditis risk after Moderna booster. As a reminder, Moderna booster dose is a 

lower dose (50μg) than the primary series dose (100μg). Deaths reported to VAERS after a 

primary series or a booster dose do not suggest any concerning patterns and reported rates are 

below background rates. VaST will continue to review further safety regarding booster doses as 

data become available, collaborate with global vaccine safety colleagues on key issues, and 

provide updates to the ACIP COVID-19 Vaccines WG and ACIP during future meetings. 

Discussion Summary: Shimabukuro & Talbot 

• In response to an inquiry regarding the total number of people who died of COVID infection 

after receiving the booster and which primary series of vaccine they received, Dr. 

Shimabukuro indicated that he did not have that information on hand and would have to go 

back to the physician reviewers and the database to obtain it. He indicated that of the 82 

individuals who died, some died of COVID-19. However, he emphasized that these are 

preliminary reports and that CDC is in the process of following up on these reports to obtain 

medical records, death certificates, and autopsy reports. That process can take a while. The 

conclusions were based on a physician review and an initial impression made based on the 

reports submitted, some of which had limited information. Therefore, additional follow-up 

must be done before any harder conclusions about the CODs can be made and whether 

these individuals actually had COVID-19 can be confirmed. Dr. Shimabukuro said that he 

would get this specific information to provide to ACIP. 

• Regarding a request for further information about the size, scope, and relationship v-safesm 

has to VAERS, Dr. Shimabukuro reminded everyone that v-safesm is a voluntary selfenrollment program. Anyone who receives a vaccination can register and enroll in v-safesm 

and start sending information to CDC. It is anticipated that a lot of people who got early 

booster doses probably were existing v-safesm participants and essentially were early 

adopters. CDC was pleasantly surprised about the participation for the booster doses, and 

those numbers continue to grow by the day. VAERS is a spontaneous reporting system that 

receives reports that patients or HCP choose to submit. It is anticipated that the database on 

booster dose safety in VAERS will continue to grow as more doses are administered. If an 

individual reports that they received medical care during one of their health check-in surveys 

in v-safesm, that case is referred to a follow up group which contacts the person to take a 

VAERS report if appropriate, or helps facilitate the patient to report the AE to VAERS. The 

VSD also is monitoring booster dose safety, which is a very robust electronic health recordbased system that has complete or near complete information on about 12 million persons 

per year. Booster dose information will accumulate over time. Dr. Shimabukuro said that 

they would be happy to present again to ACIP at a later date to provide an update on the 

safety findings from the VSD. 

• In terms of a question regarding myocarditis being rarer after a booster than a second dose, 

Dr. Shimabukuro said he thought it was early to draw conclusions about a booster dose and 

myocarditis. There have been a relatively small number of reports of myocarditis and 

myopericarditis relative to the number of booster doses that have been given, but it is 

difficult to compare what is being observed with a booster dose compared to what is being 

seen with the primary series at this point. Because of the recommendations, most of the 

individuals getting booster doses tended to be older. The demographics of the reports 

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received so far after booster doses are representative of the population getting vaccinated, 

which is different than for the primary series where this risk has been seen primarily in 

adolescents and young adults. 

• Asked whether the VaST WG had any insight on the data from Israel that included younger 

children, Dr. Talbot indicated that the WG did not receive an extensive briefing beyond what 

was given during the Vaccine and Related Blood Products Advisory Committee (VRBPAC) 

meeting. There was not much information specifically looking at the young adults. Israel has 

looked prospectively for myocarditis and did not observe any increasing rates. While they 

did have cases following booster doses, there were less than seen after second doses. 

• Regarding a question about whether it is possible to ascertain if individuals reporting AEs to 

v-safesm following booster doses experienced similar events with their primary series, Dr. 

Shimabukuro indicated that CDC is exploring how they may be able to address that question 

in v-safesm. They do have individual level data and should be able to look at that. He 

cautioned that depending upon what happens with a second dose may impact people’s 

decision regarding whether to get a booster dose, which could complicate any analyses. 

Updates to the EtR Framework: Pfizer-BioNTech and Moderna COVID-19 Vaccine Booster

Doses 

Dr. Sara Oliver (CDC/NCIRD) provided updates to the EtR Framework on Pfizer and Moderna 

COVID-19 vaccine booster doses, first reminding everyone that a slightly modified EtR 

Framework was used to discuss recommendations pertaining to COVID-19 boosters. Previous 

presentations and discussions for booster doses of COVID-19 vaccines occurred on September 

23, 2021 during which there was a benefit/risk discussion regarding COVID-19 vaccine booster 

doses and the EtR Framework was presented on booster doses of Pfizer-BioNTech COVID-19 

vaccine. There was a vote at that time for Pfizer-BioNTech COVID-19 booster doses.7 On 

October 21, 2021, there was a presentation on a National Institutes of Health (NIH) mix and 

match booster study and an EtR Framework presentation on booster doses of Moderna and 

Janssen COVID-19 vaccines. In addition, there was a vote for Moderna and Janssen COVID-19 

booster doses, including heterologous boosting.8 

The current recommendations for a COVID-19 vaccine booster dose in persons who received a 

Janssen COVID-19 vaccine primary series are, for which no updates were discussed during this 

session: 

All persons ≥18 years should receive primary vaccination with Janssen COVID-19

vaccine should receive a single COVID-19 vaccine booster dose at least 2 months later.

And any FDA-approved or authorized COVID-19 vaccine (Pfizer-BioNTech, Moderna, or

Janssen) can be used for a booster dose, regardless of the vaccine received for the 

primary series.

7 https://www.cdc.gov/vaccines/acip/meetings/slides-2021-09-22-23.html 8 https://www.cdc.gov/vaccines/acip/meetings/slides-2021-10-20-21.html 

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The current recommendations for a COVID-19 vaccine booster dose in those who completed an 

mRNA vaccine primary series are: 

Persons who should receive a COVID-19 booster dose include those who are: 

- Aged ≥65 years

- Aged ≥18 years and reside in long-term care settings

- Aged 50-64 years with certain underlying medical conditions

Persons who may receive a booster dose, based on individual benefit risk, include those

who are:

- Aged 18-49 years with certain underlying medical conditions (includes pregnant

people)

- Aged 18-64 years at increased risk for SARS-CoV-2 exposure and transmission 

because of occupational or institutional setting

The mRNA booster dose is recommended at least 6 months after completion of the primary 

series. Any FDA-authorized or approved vaccine may be used. 

The focus of this session’s discussion was on the “may” recommendations. The relevant policy 

question brought before the ACIP was, “Do the balance of benefits and risk and facilitation of 

implementation warrant an update to COVID vaccine policy?” The proposed update would 

clarify that all other persons ≥18 years of age may receive a COVID-19 booster dose ≥6 months

after completion of the mRNA primary series under the current EUA. 

Moving to the public health problem, over 47 million cases of COVID-19 had been reported to 

CDC as of November 16, 2021. In late October, the recent wave had declined to a point at 

which the 7-day moving average was just over 60,000 cases per day. There have been 

increases over recent weeks, with the 7-day moving average back up to over 80,000 cases per 

day. Trends in COVID hospitalization are being monitored closely as well. Hospitalizations can 

lag behind increases in COVID cases. While substantial increases have not been seen in 

hospitalizations to date, this will be watched closely moving into the next few weeks and 

months.9 In a country as large as the US, it is known that the pandemic can evolve differently 

in various regions of the country. While parts of the country had an earlier Delta surge, many 

areas of the country are seeing higher case rates now than they had in recent weeks to 

months.10 Over 195 million people are fully vaccinated in the US, representing 69% of the 

population 12 years of age and over.11 As a reminder, As you know, early in the vaccine 

distribution, much of the older population was vaccinated. Vaccination moved into younger age 

groups as time progressed.12 

In terms of VE data for the primary series, data from the Increasing Community Access 

to Testing (ICAT) platform gathers pharmacy testing data and assesses VE against 

symptomatic infection. Because the data set is so large, it provides the unique opportunity to 

look at waning both before and during Delta. Similar trends have been observed across age 

groups, with some waning during the pre-Delta period and additional waning in the Delta period. 

Looking at 4 studies13 that assessed waning of Pfizer-BioNTech vaccine by time since second 

9 CDC: https://covid.cdc.gov/covid-data-tracker/#new-hospital-admissions Accessed November 17, 2021 10 CDC: https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days Accessed November 18, 2021 11 CDC. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-onedose-pop-12yr. Accessed November 18, 2021 12 Source: Immunization Data Lake. 13 Lin, North Carolina surveillance, Alpha & Delta, symptomatic disease, ≥12 years; Tartof, Kaiser Southern CA, Delta, any infection, 

≥16 years and all variants, severe disease, ≥16 years; Lin, North Carolina surveillance, Alpha & Delta, ≥12 years; Tenforde, IVY,

Alpha & Delta, hospitalization, ≥18 years (Feikin et al. in press at The Lancet and Tenforde et al in preparation)

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ACIP Meeting Summary November 19, 2021 

dose, outcome, and age, 2 studies (Lin, Tartof) included estimates against both of these 

outcomes. Lin et al showed a steep decline in the VE between 2 and 7 months from the second 

dose against symptomatic disease, but saw much smaller declines against more severe 

endpoints. Tardiff et al showed similar warning against infection, but not against severe disease. 

Looking at similar data for Moderna, overall waning was slightly less pronounced. However, the 

pattern was similar with declines again shown for VE against infection and minimal declines 

against severe disease. 

In summary, over 195 million people are fully vaccinated in the US. COVID-19 cases are 

increasing in some jurisdictions recently. VE after the primary series is waning for infection. 

Overall, protection remains high for severe disease and hospitalization, and waning appears to 

be less pronounced for the Moderna vaccine compared to the Pfizer vaccine. 

Moving to the benefits and harms domain and the PICO questions, the population is persons 

aged ≥18 years who completed a COVID-19 vaccine primary series ≥6 months ago. The

intervention varies by vaccine: Pfizer-BioNTech COVID-19 Vaccine booster dose (BNT162b2, 

30 μg, IM) and Moderna COVID-19 Vaccine booster dose (mRNA-1273, 50 μg, IM). The 

comparison is no booster dose. The outcomes are symptomatic laboratory-confirmed COVID-19 

(critical), hospitalization due to COVID-19 (critical), death due to COVID-19, transmission of 

SARS-CoV-2 infection, serious adverse events (critical), and reactogenicity. These have not 

changed from previous presentations. 

They heard from Pfizer earlier in the day about the data from the Phase 3 trial of around 10,000 

participants.14 All received a 2-dose primary series of the Pfizer-BioNTech vaccine, and then 

were randomized to receive either a booster dose or placebo with median follow-up of around 

2.5 months. For the outcome of symptomatic laboratory-confirmed SARS-CoV-2 infection, the 

primary outcome evaluated was symptomatic COVID among persons with no evidence of prior 

infections, with events counting from 7 days post-booster dose. The outcome showed a relative 

vaccine efficacy of 95.2%, with a confidence interval of 89.3%, 97.9%. 

The secondary VE outcomes, including those with prior infection and the all-available efficacy 

group, showed similarly high relative VE efficacy results. For the other beneficial outcomes, no 

hospitalizations due to COVID-19 occurred in either the booster (3-dose) group or placebo (2-

dose) group. No deaths due to COVID-19 occurred in the booster or placebo groups. There 

were no data to assess the outcome of transmission of a SARS-CoV-2 infection. SAEs occurred 

in 0.3% of the booster recipients compared to 2.5% of placebo recipients. There were 3 AEs 

deemed by the investigator to be potentially associated with the vaccine that were described 

earlier by Pfizer, including the tachycardia and some elevations in hepatic enzymes. 

Looking more broadly at AEs of clinical interest, there were no cases of anaphylaxis, 

hypersensitivity, myocarditis, or pericarditis reported in the trial. However, given the rarity of 

these events, it would not necessarily be expected to capture them in a trial of this size. 

Lymphadenopathy was more common after the third dose (2.7%) than in the primary series 

(0.4%). Lymphadenopathy following a booster dose was typically mild to moderate and located 

in the axilla or cervical nodes. Most occurred 1 to 3 days post-booster and resolved within 1 to 3 

days after onset. The frequency of lymphadenopathy was slightly higher in younger participants 

and female participants. There was no updated reactogenicity from the Phase 3 booster trial. 

14 Clinical trial data requested by CDC 

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ACIP Meeting Summary November 19, 2021 

Now to summarizes the GRADE assessment for the Pfizer BioNTech COVID-19 vaccine for 

persons 18 years of age and over who completed a COVID primary series ≥6 months after the 

primary series. In terms of benefits, the newly available data indicate that the Pfizer-BioNTech 

COVID-19 booster dose is effective in preventing symptomatic laboratory-confirmed COVID-19 

with a high evidence of certainty. No new data were submitted for the outcomes of 

hospitalization due to COVID-19, death due to COVID-19, or transmission of SARS-CoV-2 

infection. The GRADE assessments for these outcomes did not change. In terms of harms, the 

available data showed no increase in SAEs for the booster group. The evidence certainty was 

low, and no new evidence was available for the outcome of reactogenicity. 

Looking at the data is from the Israeli Ministry of Health reported during the last VRBPAC 

meeting, myocarditis rates reported after the Pfizer-BioNTech COVID-19 vaccine booster dose 

in Israel suggests that the rates of myocarditis after a third dose fall between the rates seen 

after Dose 1 and Dose 2.15 In terms of the benefit/risk assessment of booster doses previously 

presented to ACIP,

16 the risk of myocarditis is now equivalent to the risk after the first and 

second dose averaged, as indicated by the Israeli data. All other inputs remained the same. 

Over the next 6 months, per million booster doses given, many more hospitalizations would be 

prevented than myocarditis expected for all age groups, even when considering a differential 

myocarditis risk by sex. 

In summary, the Phase 3 randomized controlled clinical trial (RCT) booster efficacy data 

demonstrate that this booster dose provides additional protection and is safe. There were no 

hospitalized cases of COVID-19 even after the 2-dose primary series and even in those who did 

not receive the booster. Based on data from Israel, the myocarditis risk after the booster dose of 

Pfizer appears to fall between the rates seen after Dose 1 and Dose 2. 

No Moderna booster vaccine efficacy/effectiveness studies were identified. One Moderna 

booster study was previously presented to ACIP.17 In this study, participants already had 

received a Moderna primary series and were recruited to receive a booster dose in the open 

label study. This was immunobridging with a pre-specified non-inferiority analysis comparing the 

immune response 28 days after a booster versus 28 days after Dose 2 of the primary series. 

For the outcome of symptomatic laboratory-confirmed COVID-19, the GMTs of the 149 booster 

recipients were compared to over 1,000 primary series recipients. The GMR was 1.76, which 

met the non-inferiority criteria. No SAEs occurred among the participants receiving the 50 ug 

booster dose in that open label study within 28 days. Severe reactogenicity occurred among 

10% of participants receiving a booster dose in the open label study. 

To summarize the GRADE assessment for the Moderna vaccine for persons 18 years of age 

and over who completed the COVID-19 vaccine primary series ≥6 months or more before 

receiving a booster dose, there were no updates to previous discussions. In terms of benefits, 

the available data indicate that the Moderna booster dose induced an immune response that 

was non-inferior to those following Dose 2. The evidence certainty was very low. No data were 

available for the outcomes of observational data that suggested a protective effect against any 

SARS-CoV-2 infection. The evidence Type 4. For hospitalization due to COVID-19, 

observational data suggested an increased protective effect against severe COVID-19. The 

evidence was Type 4. No data were available on important outcomes of deaths due to COVID15 As reported by Israel at FDA’s VRBPAC meeting. Slides here: https://www.fda.gov/media/153086/download 16 Scobie et al., COVID-NET, VISION, IVY Network; COVID-NET hospitalization rates from the week of August 21, 2021; 

Myocarditis rates from VAERS data through August 18, 2021 17 Unpublished data obtained from the study sponsor: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-10-20-

21/02-COVID-Miller-508.pdf 

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ACIP Meeting Summary November 19, 2021 

19 or transmission. In terms of harms, available data identified no SAEs attributable to the 

booster dose, and this was Type 4. Grade 3 reactogenicity was reported by 6% of booster dose 

participants, which also was Type 4. This was the same as presented previously for GRADE. 

In summary, there were no Phase 3 RCT booster efficacy data available from Moderna, but the 

immunogenicity study demonstrated the ability to boost antibody levels. Effectiveness after a 

primary series appears to have waned less in Moderna than in Pfizer. Myocarditis risks after a 

booster dose are unknown. Accumulating evidence from multiple sources suggests a higher risk 

for myocarditis following the Moderna compared to the Pfizer primary series vaccination, but 

note that the Moderna booster dose is lower at 50 μg than in the primary series at 100 μg. 

Therefore, the ability to extrapolate what was seen after the primary series to the booster dose 

is unknown. 

When considering the number needed to vaccinate (NNV) with a booster dose to prevent 1 

hospitalization over 6 months, the fewest doses are needed in those 65 years of age and over. 

When considering the NNV with a booster dose to prevent 1 infection over 6 months, the 

numbers are substantially lower with fewer doses needed to prevent infection in the younger 

age groups. 

To summarize the safety surveillance findings presented earlier by Dr. Shimabukuro, local and 

systemic reactions were less frequent overall following a booster dose than after Dose 2. The 

Moderna booster appeared to be more reactogenic than Pfizer. For VAERS, most reports were 

non-serious. Rare cases of myocarditis have been reported after a booster dose, and 

investigations are ongoing to review and confirm these cases. 

To highlight what is known around the impact of booster dose on transmission,

18 after a primary 

mRNA COVID-19 vaccine series, protection against asymptomatic infection and presumably 

transmission was found for a time perioda,b. The largest impact was seen in the first 2 months 

post-vaccination,b and likely an impact of very high antibody titers. There are limited data of the 

impact of boosters on asymptomatic infection or transmission. However, one study from Israel 

found lower viral loads in patients with breakthrough infections after booster doses, similar to 

the viral load seen within 2 months after the primary series.b Early VE against SARS-CoV-2 

infection after a booster dose demonstrates an increase in VE, including asymptomatic 

infection.c,d While it is known that protection against asymptomatic infection may not be 

permanent, even temporary protection may factor into the benefit/risk balance, especially 

approaching the winter and holidays with increased traveling and indoor gatherings. 

In summary, booster doses of the Pfizer vaccine were effective in preventing laboratoryconfirmed symptomatic SARS-CoV-2. Data from the Moderna trial does not provide efficacy 

data but demonstrates the ability to boost the immune response. Individual benefit/risk balance 

for boosters varies by age, with the largest benefit seen in older adults. Among other ages, 

there is likely variation within the balance of benefits and risks given exposure, medical 

condition, and sex. However, the myocarditis data after booster doses is reassuring to date. It 

also was not possible account for other benefits, including the possible impact on rates of 

community transmission. 

18 a) CDC Science Brief https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html; b) LevineTiefenbrun et al. Nature Medicine 2021 https://www.nature.com/articles/s41591-021-01575-4; c) Saciuk et al. Journal of Infectious 

Diseases https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiab556/6415586; d) Andrews et al. Effectiveness of 

BNT162b2 (Comirnaty, Pfizer-BioNTech) COVID-19 booster vaccine against covid-19 related symptoms in England: test negative 

case-control study | medRxiv 

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ACIP Meeting Summary November 19, 2021 

Moving now to values and acceptability. A survey19 was conducted recently that showed that 

there appears to be uncertainty among fully vaccinated adults around eligibility for a booster 

dose, with 4 in 10 fully vaccinated adults stating that they were unsure whether they were 

eligible for a booster dose. Among fully vaccinated adults 65 years of age and over, 21% said 

that they already received a booster dose and another 52% said they believed they were 

eligible. Young adults were more uncertain, with two-thirds of fully vaccinated adults 18-29 

years of age saying that they were unsure if they were eligible for a vaccine. It is known overall 

that the booster dose discussion seems to have increased rather than decreased public 

confidence in COVID-19 vaccines, although the opposite may be true for those who remain 

unvaccinated. More than 6 in 10 adults overall said the news that some people might need 

boosters show that scientists are continuing to find ways to make vaccines more effective, while 

one-third say that the vaccines may not be working as well as promised. 

Now to consider feasibility and implementation. It is known that in general, booster doses are 

feasible to implement overall. Over 31 million people have received a booster dose. For the 

mRNA vaccines, people have mostly received a homologous boost. There is more variation for 

those who have received a J&J primary dose.20 In terms of the daily number of booster doses 

by vaccine type over time, doses of Pfizer increased after the initial recommendations and then 

that expanded to all authorized vaccines with the updated recommendations.21 Overall, at least 

31 million individuals in the US have received a booster dose. To date, about 17 million of those 

are individuals 65 years of age and over. Some states are currently broadening booster 

eligibility criteria. For considerations around implementation, vaccine recommendations that are 

based on risk or exposure are more difficult to implement than age-based recommendations. 

ACIP recommendations that are consistent with an FDA EUA are easier to communicate and 

implement. If recommendations for booster doses varied across the mRNA vaccines, meaning if 

they were different for Pfizer and Moderna, this would be quite difficult to communicate and 

implement. 

For the equity domain, the percentage of people who received at least 1 dose of the COVID-19 

vaccine was assessed by race and ethnicity over time. These data were shown to ACIP 

previously, and were updated with additional time and data. American Indian and Alaskan 

Native (AI/AN) populations have consistently had the highest percentage among those who 

have received at least 1 dose, and some equity gaps have improved over time.22 Looking at 

initial booster data in those 18 years of age and over by race and ethnicity, the highest uptake of 

booster doses in this population was in the non-Hispanic white population.23 To summarize the 

equity domain, some disparities in primary series delivery have improved over time. However, 

early data on the COVID-19 booster doses demonstrate disparities by race and ethnicity. 

Recommendations that are complex, difficult to communicate, or difficult to implement may 

worsen disparities in booster vaccination rates. 

19 KFF COVID-19 Vaccine Monitor (October 14-24, 2021) KFF COVID-19 Vaccine Monitor: October 2021 | KFF 20 CDC. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-onedose-pop-12yr. Accessed November 18, 2021 21 Source: Immunization Data Lake. Data as of November 16, 2021, 0600 AM. 22 CDC. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends as of November 16, 2021, and US Census 

Bureau National Population Estimates 23 Source: Immunization Data Lake. Data as of November 16, 2021, 0600 AM. 

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ACIP Meeting Summary November 19, 2021 

To summarize the WG interpretation, the WG reviewed and discussed the data as well as the 

policy option. They continue to emphasize that the top priority and largest impact will come from 

vaccination of the primary series in the unvaccinated population. It is known that the balance of 

benefits and risks varies by age. Older adults have the clearest benefits and risks. The 

myocarditis data are reassuring to date and will continue to be monitored closely. Increases in 

COVID-19 cases may also impact this benefit/risk balance. Previously, the goals of the overall 

COVID vaccination program have been discussed. The primary goal remains prevention of 

severe disease. The WG has discussed the importance of the secondary goals of maintaining 

the workforce and healthcare capacity, as well as the goal to reduce infection and transmission. 

The impact of a COVID-19 vaccine booster dose on prevention of transmission remains 

unknown. However, even a reduction in transmission may be important around this winter and 

holidays. 

As a reminder, the types of ACIP recommendations that can be made have been presented 

previously with these booster discussions, including: 

 We do not recommend the intervention, which is used when the risks clearly outweigh the 

benefits. 

 We recommend the intervention for individuals based on an assessment of benefits and 

risk, which is used when there is a diversity of the benefits and risks to allow flexibility across 

a population. (May receive a booster) 

 We recommend the intervention, which is used when the benefits clearly outweigh the risks 

in a population. (Should receive a booster) 

The language currently in the clinical considerations to illustrate the factors that may go into this 

benefit/risk discussion already exists and will continue to be in the clinical considerations.24 

These are as follows: 

 Potential benefits of booster dose 

- Reduced risk of SARS-CoV-2 infection, severe disease 

- May reduce transmission of SARS-CoV-2 to others 

 Potential risks of booster dose 

- Rare risks of serious adverse events (e.g., myocarditis, pericarditis, TTS, GBS, 

anaphylaxis) 

- Common risks of transient local and systemic symptoms 

 Individual risk factors for SARS-CoV-2 infection 

- Risk of exposure (occupational and institutional settings, e.g., healthcare workers, 

long term care settings) 

- Risk for infection (time since completion of primary series) 

 Individual impacts of SARS-CoV-2 infection 

- Risk for severe infection (related to underlying conditions) 

- Risk associated with a person’s circumstances (living with/caring for at-risk 

individuals or consequences of inability to meet obligations due to infection) 

24 CDC https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html 

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ACIP Meeting Summary November 19, 2021 

In the future, the WG will present updates to ACIP on data from the Moderna booster dose; 

rates of myocarditis after a third dose; updated data for the overall safety profile of a booster 

dose; and continued evaluations for VE, including VE for the primary series and booster doses. 

Dr. Oliver shared a figure developed to represent the current recommendations and another that 

was adapted for the proposed updates, if the recommendation was expanded to reflect that 

those 18-49 years of age and 50-64 years of age with no risk factors would be eligible in the 

may category. The proposed policy question had no edits to the should population and would 

consolidate the may population to “all other persons aged ≥18 years.” 

ASTHO Statement 

Dr. Nirav Shah (Director, State of Maine CDC; President, ASTHO; ACIP Liaison

Representative for ASTHO) made the following statement: Thank you very much, Dr. Lee. 

Good afternoon, everyone. I’m Nirav Shah, the Director of the State of Maine CDC and I also 

have the privilege of serving as the President of ASTHO, the Association of State 

and Territorial Health Officials. Since I’m addressing the committee, I wanted to note that I have 

no conflicts. Dr. Lee, thank you for the opportunity to address the committee on this important 

issue. I would like to provide some context and perspective to the committee from the point of 

view of state health officials, specifically on the operational and implementational contours of the 

issue under discussion today. Last night, on our All-State Health Official Call, we actually 

discussed this precise topic in detail. States were strongly in support of expanding, clarifying 

and simplifying the eligibility guidance in the manner that’s been discussed and proposed. 

Indeed, I’ll take it a click further. There was not a single state that voiced opposition to this 

move. Our summary and rationale was that the current guidelines, so well-intentioned and 

thoughtful, generate an obstacle to uptake of boosters. In pursuit of precision, they create 

confusion. This is what we see happening in our jurisdictions. Individuals who right now are 

absolutely eligible for boosters are not able to parse the guidelines to come to that conclusion 

on their own. This is in part an inherent limitation of the approach that we’ve used here, wherein 

individuals make their own eligibility determination. But this is why states believe that a move of 

the sort under discussion today would remove confusion and replace it with clarity. Our concern 

is that eligible individuals are not receiving boosters right now because of this confusion, and as 

a result, not enjoying the various benefits that have been discussed today. We urge you to 

move in the direction of expanded, simplified eligibility. In that world, instead of wondering if 

individuals are eligible, anyone 18 and over simply needs to find a clinic and get a booster. 

Operationally, such a move has the benefit of easing pressure on state health department 

immunization program staff, who are now fielding a high volume of booster eligibility questions. 

Simplifying eligibility will allow staff across the states, territories, and local health departments to 

focus on making vaccination, primary vaccination series, as easy and accessible as possible. 

Thank you very much, Dr. Lee. 

Discussion Summary: Oliver 

• There was broad agreement that the recommendations need to be as clear as possible, 

particularly given the statement from ASTHO about states, practitioners, and individuals 

being unsure about eligibility for boosters. This is especially important with respect to equity. 

• It is important to be clear about the meaning of “fully vaccinated.” The current primary series 

has been shown to be effective in terms of preventing serious disease, hospitalization, and 

death. 

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ACIP Meeting Summary November 19, 2021 

• It seems reasonable at this time to facilitate individuals being able to make a decision 

themselves based on benefits/risks. 

• Consideration needs to be given to what the criteria would be for moving from a “may” to 

“should” recommendation for younger age groups. It seems that the goalposts have been 

moved to some extent, but the recommendations need to be broadened for the sake of 

equity. 

• It is important to remember that these are all interim recommendations that will need to be 

re-evaluated continuously, including for younger populations. This will be impacted by 

incidence and what is known about the safety of boosters, particularly in terms of the risk of 

myocarditis. 

• There was support for expanding the “should” recommendation to “Aged ≥50 years” due to 

the substantial number of individuals 50-64 years of age with risk factors: 

 Concern was expressed that this could create a barrier inadvertently when no 

barrier was intended, given the long list of possible underlying medical 

conditions. 

 Referring to Slide 61 with the proposed recommendations and revised table, Dr. 

Oliver reviewed the pros and cons of a “should” recommendation for those ≥50 

years of age. As mentioned previously, age-based recommendations are easier 

to communicate and it is known that easy-to-communicate recommendations can 

facilitate equitable distribution. There is a very inclusive list of underlying medical 

conditions, which means that about 75% of persons 50-64 years of age would be 

covered. The remaining persons in that age group who would not meet a criterion 

on that list is relatively small. Moreover, having to check this inclusive list of 

underlying medical conditions can be difficult for providers to identify those who 

are at risk each time. This age group has the lowest risk of myocarditis after 

mRNA vaccines in this age group, which would impact that balance of benefits 

and risk. Adults 50-64 years of age, even those without medical conditions, may 

be at increased risk of severe COVID just due to a slightly older age. In thinking 

through the potential cons, there are limited VE data to specifically compare this 

exact age group with/without underlying medical conditions. Therefore, it is not 

possible to have detailed waning data. There is a risk of rare AEs, but 

myocarditis is low in this age group. However, it is also known that the risk of 

Guillain-Barré Syndrome (GBS) is a concern. GBS risk after a J&J vaccine has 

been seen in this age group. 

 Concern was expressed that it seemed dangerous in the last five minutes for 

ACIP to make a substantial change move without having spent an hour reviewing 

hospitalizations and outcomes of persons 50-64. The NNV is quite large and it is 

unlikely that there would be harm, but it is important to remember that a “should” 

recommendation from ACIP is taken by others to be a mandate. 

 Dr. Oliver emphasized that there may not be substantially more data forthcoming 

specifically related to persons 50-64 years of age without medical conditions, 

even with additional time. This was one of the reasons for the proposed 

recommendations presented during this session. 

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ACIP Meeting Summary November 19, 2021 

 There continued to be support for the stronger recommendation of “should” for 

persons ≥50 years of age, particularly heading into the holiday season and winter 

and given the equity issues. 

 It was noted that time and again, risk-based recommendations have not worked. 

Persons 50-64 years of age represent a subgroup of whom the vast majority 

meet the criteria. 

 The observation was made that immunosenescence begins before 65 years of 

age, and would seem to become more relevant around 50 years of age and 

favoring the concept of a “should” recommendation for persons ≥50 years of age. 

 Practicing physicians emphasized simplicity as a sound rationale for a “should” 

recommendation for persons ≥50 years of age.

Votes: COVID-19 Booster Doses 

Dr. Sara Oliver (CDC/NCIRD) showed the proposed recommendations table for booster doses 

of COVID-19 vaccine, which reflected the following: 

Persons who should receive a COVID-19 booster dose include those who are: 

- Aged ≥65 years

- Aged ≥18 years and reside in long-term care settings

- Aged ≥18 years who received the Janssen COVID-19 vaccine primary series

- Aged 50-64 years with certain underlying medical conditions

Persons who may receive a booster dose, based on individual benefit risk, include those

who are:

- Aged 18-49 years with certain underlying medical conditions (includes pregnant

people)

- Aged 18-64 years with no risk factors

The proposed policy question had no edits to the should population and consolidated the may

population to “all other persons aged ≥18 years.”

Discussion Summary: Vote 

• Based on the key discussion points following Dr. Oliver’s presentation, Ms. Bahta made a 

motion for ACIP to recommend that “COVID-19 vaccine boosters may be given to all other 

persons ≥18 years of age and that COVID-19 boosters should be given to persons ≥50 

years of age.” 

• Dr. Cohn suggested that given the discussion, perhaps taking two votes would be the best 

option. 

• Ms. Bahta withdrew her previous motion. She then made a motion to for ACIP to approve an 

interim recommendation stating that “A single COVID-19 vaccine booster dose is 

recommended for all persons aged ≥18 years* who received an mRNA vaccine primary 

series based on individual benefit and risk, at least 6 months after the primary series, 

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ACIP Meeting Summary November 19, 2021 

under the FDA’s Emergency Use Authorization.” *Individuals not otherwise recommended to 

receive a COVID-19 vaccine. Dr. Kotton seconded the motion. 

• Dr. Loehr made a motion for ACIP to approve an interim recommendation that “A single 

COVID-19 vaccine booster dose is recommended for persons ≥50 years who received an 

mRNA COVID-19 vaccine, at least 6 months after the primary series, under the FDA’s 

Emergency Use Authorization.” Dr. Poehling seconded the motion. 

Motion/Vote #1: COVID-19 Vaccine Booster Doses in Persons ≥18 Years of Age 

Ms. Bahta made a motion for ACIP to approve an interim recommendation stating that “A single 

COVID-19 vaccine booster dose is recommended for all persons aged ≥18 years* who received 

an mRNA vaccine primary series based on individual benefit and risk, at least 6 months after 

the primary series, under the FDA’s Emergency Use Authorization.” 

*Individuals not otherwise recommended to receive a COVID-19 vaccine. 

Dr. Kotton seconded the motion. No COIs were declared. 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, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Poehling, 

Sanchez 

0 Opposed: N/A 

0 Abstained: N/A 

0 Absent: N/A 

Motion/Vote #2: COVID-19 Vaccine Booster Doses in Persons ≥50 Years of Age 

Dr. Loehr made a motion for ACIP to approve an interim recommendation that “A single COVID19 vaccine booster dose is recommended for persons ≥50 years who received an mRNA 

COVID-19 vaccine, at least 6 months after the primary series, under the FDA’s EUA.” Dr. 

Poehling seconded the motion. No COIs were declared. 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, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Poehling, 

Sanchez 

0 Opposed: N/A 

0 Abstained: N/A 

0 Absent: N/A 

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ACIP Meeting Summary November 19, 2021 

Discussion Points 

Subsequent to the vote, Dr. Lee invited ACIP members to make a statement about the rationale 

for their vote and/or to share any additional general comments: 

Dr. Kotton said that as a clinician deep in the clinical trenches, she was really glad that there 

was now clarity and streamlining of the recommendations so that all Americans can understand 

the vaccines that are recommended for them at this time. She said that she was proud of the 

work they had done during this meeting. 

Dr. Loehr thanked Dr. Oliver for portraying all of the excellent reasons for having this 

recommendation. He thought it would be especially important going into the holiday season and 

the winter season. He looks forward to having more data in the future about whether this is 

actually a booster dose or whether it is a third dose in the primary series, recognizing that it 

would take months, if not years, to figure that out. 

Dr. Lee thanked ACIP’s colleagues for the discussions throughout the day. She felt that it was 

important for them to acknowledge the “elephant in the room” in that there are many voices the 

public hears regarding the best way to use vaccines to handle this pandemic. ACIP recognizes 

that this pandemic has created a situation where absolutely nothing is normal. Everything 

moves quickly, data are constantly evolving, and local context can drive differences and the 

urgency and the need for these boosters and vaccines in general. She emphasized that diverse 

opinions at every level are always valued. However, it does create communication challenges 

and can often lead to more confusion not only for the public, but also even amongst the provider 

community. ACIP has been in place since 1964 and became a federal advisory committee in 

1972, nearly 50 years ago. A priority for the ACIP always has been to ensure that they apply a 

consistent process for reviewing data and that this is done in public view so that there is 

transparency regarding the rationale for ACIP recommendations. During a pandemic, both 

speed and process are incredibly important. Ensuring that the public can understand the 

rationale behind any recommendation is critical for ongoing public trust. Because of this, Dr. Lee 

took a moment to thank Dr. Rochelle Walensky for being consistent, unwavering, and ensuring 

that ACIP continues to have a process that allows the members to transparently review the data 

and the science that are available in these open public meetings. ACIP is often criticized for not 

being fast enough, but this is the 22nd open meeting that ACIP has convened dedicated to the 

topic of COVID-19 vaccines, not to mention the hundreds of meetings that are occurring before 

and after each of these open meetings. Their commitment as ACIP members is to the public. 

She expressed her hope that they would continue to rely on the ACIP process, because she 

believes that public deliberation is an important part the pandemic response. 

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ACIP Meeting Summary November 19, 2021 

CERTIFICATION 

Upon reviewing the foregoing version of the November 19, 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. 

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ACIP Meeting Summary November 19, 2021 

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 

BROOKS, Oliver, MD, FAAP 

Chief Medical Officer 

Watts HealthCare Corporation 

Los Angeles, CA 

Past President, National Medical Association 

Term: 7/26/2021 – 6/30/2025 

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ACIP Meeting Summary November 19, 2021 

CHEN, Wilbur H, MD, MS, FACP, FIDSA 

Professor of Medicine 

Center for Vaccine Development and Global Health 

University of Maryland School of Medicine 

Baltimore, MD 

Term: 12/23/2020 – 6/30/2024 

CINEAS, Sybil, MD, FAAP, FACP 

Associate Professor of Medicine, Pediatrics, and Medical Science (Clinical) 

The Warren Alpert Medical School of Brown University 

Associate Program Director 

Brown Combined Residency in Internal Medicine and Pediatrics 

Providence, RI 

Term: 7/28/2021 – 6/30/2025 

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 

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ACIP Meeting Summary November 19, 2021 

POEHLING, Katherine A, MD, MPH 

Professor of Pediatrics and Epidemiology and Prevention 

Director, Pediatric Population Health 

Department of Pediatrics 

Wake Forest School of Medicine 

Winston-Salem, NC 

Term: 7/1/2019 – 6/30/2023 

SÁNCHEZ, Pablo J, MD 

Professor of Pediatrics 

The Ohio State University – Nationwide Children’s Hospital 

Divisions of Neonatal-Perinatal Medicine and Pediatric Infectious Diseases 

Director, Clinical & Translational Research (Neonatology) 

Center for Perinatal Research 

The Research Institute at Nationwide Children's Hospital Columbus, Ohio 

Term: 7/1/2019 – 6/30/2023 

TALBOT, Helen Keipp, MD 

Associate Professor of Medicine 

Vanderbilt University 

Nashville, TN 

Term: 10/29/2018 – 6/30/2022 

EX OFFICIO MEMBERS 

Centers for Medicare and Medicaid Services (CMS)

HANCE, Mary Beth 

Senior Policy Advisor 

Division of Quality, Evaluations and Health Outcomes 

Children and Adults Health Programs Group 

Center for Medicaid, CHIP and Survey & Certification Centers 

for Medicare and Medicaid Services 

Baltimore, MD 

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 

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ACIP Meeting Summary November 19, 2021 

Indian Health Service (IHS)

WEISER, Thomas, MD, MPH 

Medical Epidemiologist 

Portland Area Indian Health Service 

Portland, OR 

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

KIM, David, MD, MA 

Director, Division of Vaccines, OIDP 

Office of the Assistant Secretary for Health 

Department of Health and Human Services 

Washington, DC 

National Institutes of Health (NIH)

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) 

Bethesda, MD 

LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP)

ROCKWELL, Pamela G, DO 

Associate Professor, Department of Family Medicine, University of 

Michigan Medical School 

Medical Director, Dominos Farms Family Medicine 

Ann Arbor, MI 

American Academy of Pediatrics (AAP)

MALDONADO, Yvonne, MD 

Senior Associate Dean for Faculty Development and Diversity 

Professor of Pediatrics and Health Research and Policy 

Chief, Division of Pediatric Infectious Diseases 

Stanford University School of Medicine 

Stanford, CA 

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 

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ACIP Meeting Summary November 19, 2021 

American College Health Association (ACHA)

CHAI, Thevy S., MD 

Director of Medical Services 

Campus Health Services 

University of North Carolina at Chapel Hill Chapel Hill, 

NC 

American College Health Association (ACHA) (alternate) 

MCMULLEN, Sharon, RN, MPH, FACHA 

Assistant Vice President of Student & Campus Life for Health and Wellbeing Cornell Health 

Ithaca, NY 

American College of Nurse Midwives (ACNM)

HAYES, Carol E., CNM, MN, MPH 

Lead Clinician 

Clinical Quality Compliance and Management 

Planned Parenthood Southeast Atlanta, GA 

American College of Nurse Midwives (ACNM) (alternate) 

MEHARRY, Pamela M., PHD, CNM 

Midwifery Educator, Human Resources for Health 

In partnership with University of Rwanda and University of Illinois, Chicago 

American College of Obstetricians and Gynecologists (ACOG)

ECKERT, Linda O, MD, FACOG 

Professor, Department of Obstetrics & Gynecology 

Adjunct Professor, Department of Global Health 

University of Washington 

Seattle, WA 

American College of Physicians (ACP)

GOLDMAN, Jason M, MD, FACP 

Affiliate Assistant Professor of Clinical Biomedical Science, Florida Atlantic University, Boca 

Raton, Florida 

Private Practice 

Coral Springs, FL 

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 

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ACIP Meeting Summary November 19, 2021 

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA Washington, DC 

American Medical Association (AMA)

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine Emory 

University School of Medicine 

Atlanta, GA 

American Nurses Association (ANA)

RITTLE, Charles (Chad), DNP, MPH, RN Assistant 

Professor, Nursing Faculty 

Chatham University, School of Health Sciences 

Pittsburgh, PA 

American Osteopathic Association (AOA)

GROGG, Stanley E, DO 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA)

FOSTER, Stephan L, PharmD CAPT 

(Ret) USPHS 

Professor, College of Pharmacy 

University of Tennessee Health Sciences Center 

Memphis, TN 

Association of Immunization Managers (AIM)

HOWELL, Molly, MPH 

Immunization Program Manager 

North Dakota Department of Health 

Bismarck, ND 

Association for Prevention Teaching and Research (APTR) 

McKINNEY, W Paul, MD 

Professor and Associate Dean 

University of Louisville School of Public Health and Information Sciences 

Louisville, KY 

Association of State and Territorial Health Officials (ASTHO)

SHAH, Nirav D, MD, JD 

Director 

Maine Center for Disease Control and Prevention 

Augusta, ME 

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ACIP Meeting Summary November 19, 2021 

Biotechnology Industry Organization (BIO)

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 

Council of State and Territorial Epidemiologists (CSTE)

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

Council of State and Territorial Epidemiologists (CSTE) (alternate) 

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 

Canadian National Advisory Committee on Immunization (NACI)

QUACH, Caroline, MD, MSc 

Pediatric Infectious Disease Specialist and Medical Microbiologist 

Medical Lead, Infection Prevention and Control Unit 

Medical Co-director – Laboratory Medicine, Optilab 

Montreal-CHUM 

Montreal, Québec, Canada 

Infectious Diseases Society of America (IDSA)

BAKER, Carol J., MD 

Professor of Pediatrics 

Molecular Virology and Microbiology 

Baylor College of Medicine 

Houston, TX 

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 

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ACIP Meeting Summary November 19, 2021 

National Association of County and City Health Officials (NACCHO) (alternate) 

DUCHIN, Jeffrey, MD 

Health Officer and Chief, Communicable Disease 

Epidemiology and Immunization Section 

Public Health - Seattle and King County 

Professor in Medicine 

Division of Allergy and Infectious Diseases 

University of Washington School of Medicine and School of Public Health 

Seattle, WA 

National Association of Pediatric Nurse Practitioners (NAPNAP) 

STINCHFIELD, Patricia A, RN, MS, CPNP 

Director 

Infectious Disease/Immunology/Infection Control 

Children's Hospitals and Clinics of Minnesota 

St. Paul, MN 

National Foundation for Infectious Diseases (NFID)

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 

National Foundation for Infectious Diseases (NFID) (alternate) 

DALTON, Marla, PE, CAE 

Executive Director & CEO 

National Foundation for Infectious Diseases (NFID) 

Bethesda, MD 

National Medical Association (NMA) 

WHITLEY-WILLIAMS, Patricia, MD Professor and Chair 

University of Medicine and Dentistry of New Jersey Robert Wood 

Johnson Medical School 

New Brunswick, NJ 

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 

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ACIP Meeting Summary November 19, 2021 

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 

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ACIP Meeting Summary November 19, 2021 

ACRONYMS USED IN THIS DOCUMENT 

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics 

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices 

ACOG American College of Obstetricians and Gynecologists 

ACP American College of Physicians 

AE Adverse Event 

AESI Adverse Events of Special Interest 

AHIP America’s Health Insurance Plans 

AI/AN American Indian/Alaskan Native 

AIM Association of Immunization Managers 

AIRA American Immunization Registry Association 

AMA American Medical Association 

AOA American Osteopathic Association 

APhA American Pharmacists Association 

AR Adverse Reaction 

ASTHO Association of State and Territorial Health Officers 

BEST System Biologics Effectiveness and Safety System 

CBER Center for Biologics Evaluation and Research 

CDC Centers for Disease Control and Prevention 

CICP Countermeasures Injury Compensation Program 

CISA Clinical Immunization Safety Assessment 

CMS Center for Medicare and Medicaid Services 

COD Cause of Death 

COI Conflict of Interest 

COVID-NET COVID-19-Associated Hospitalization Surveillance Network 

CSTE Council of State and Territorial Epidemiologists 

CVD Cardiovascular Disease 

DFO Designated Federal Official 

DoD Department of Defense 

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs 

ECG Electrocardiogram 

EMR Electronic Medical Record 

ET Eastern Time 

EtR Evidence to Recommendation 

EU European Union 

EUA Emergency Use Authorization 

EUI Emergency Use Instructions 

FDA Food and Drug Administration 

FQHC Federally Qualified Health Center 

GACVS Global Advisory Committee on Vaccine Safety 

GBS Guillain-Barré Syndrome 

GMR Geometric Mean Ratio 

GMT Geometric Mean Titers 

GRADE Grading of Recommendation Assessment, Development and Evaluation 

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ACIP Meeting Summary November 19, 2021 

HCP Healthcare Personnel / Providers 

HHS (Department of) Health and Human Services 

HRSA Health Resources and Services Administration 

IDSA Infectious Disease Society of America 

IHS Indian Health Service 

IM Intramuscular 

ISD Immunization Services Division 

ISO Immunization Safety Office 

J&J Johnson & Johnson 

LTCF Long-Term Care Facilities 

MASO Management Analysis and Services Office 

MMWR Morbidity and Mortality Weekly Report

MI Myocardial Infarction 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada 

NAPNAP National Association of Pediatric Nurse Practitioners 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

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

NCHS National Center of Health Statistics 

NCIRD National Center for Immunization and Respiratory Diseases 

NEJM New England Journal of Medicine

NFID National Foundation for Infectious Diseases 

NHSN National Healthcare Safety Network 

NIH National Institutes of Health 

NMA National Medical Association 

NNV Number Needed to Vaccinate 

NWV Nurses Who Vaccinate 

OID Office of Infectious Disease 

OIDP Office of Infectious Disease Policy and HIV/AIDS 

PCP Primary Care Provider/Practitioner 

PCR Polymerase Chain Reaction 

PHAC Public Health Agency Canada 

PICO Population, Intervention, Comparison, Outcomes 

PIDS Pediatric Infectious Disease Society 

POTS Postural Orthostatic Tachycardia Syndrome 

RCT Randomized Controlled Trial 

RN Registered Nurse 

RNA Ribonucleic Acid 

RR Relative Risk 

SAE Serious Adverse Event 

SAGE Strategic Advisory Group of Experts on Immunization (WHO) 

SAHM Society for Adolescent Health and Medicine 

SHEA Society for Healthcare Epidemiology of America 

SME Subject Matter Expert 

SOC System Organ Class 

SRR Seroresponse Rate 

SVT Supraventricular Tachycardia 

TTS Thrombotic Thrombocytopenia Syndrome 

UK United Kingdom 

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ACIP Meeting Summary November 19, 2021 

US United States 

USG United States Government 

VA (US Department of) Veteran’s Affairs 

VAERS Vaccine Adverse Event Reporting System 

VaST WG Vaccine Safety Technical Work Group 

VE Vaccine Efficacy 

VE Vaccine Effectiveness 

VRBPAC Vaccine and Related Blood Products Advisory Committee 

VSD Vaccine Safety Datalink 

WG Work Group 

WHO World Health Organization 

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