MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP)

MAY 19, 2022

EXECUTIVE SUMMARY

CONTENTS

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

EXECUTIVE SUMMARY .............................................................................................................................. 2

Session Overview.................................................................................................................. 2

Updates on VE of COVID-19 Vaccines in Children 5-11 Years of Age ................................. 2

Updates on Safety of COVID-19 Vaccines in Children 5-11 Years of Age............................ 3

VaST Assessment ................................................................................................................. 4

Safety and Immunogenicity of BNT162b2 Booster (Third) 10 μg Dose in Children 5-11 

Years of Age.......................................................................................................................... 5

Updates to the EtR Framework: COVID-19 Vaccine Booster Doses in Children 5 to 11 

Years of Age.......................................................................................................................... 8

Vote: COVID-19 Vaccine Booster Doses in Children 5-11 Years of Age ............................10

ACIP MEMBERSHIP ROSTER...................................................................................................................12

ACRONYMS USED IN THIS DOCUMENT................................................................................................. 21
ACIP Meeting Summary May 19, 2022 

2 

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 May 19, 2022. The meeting took place remotely via Zoom, 

teleconference, and live webcast. This document provides an Executive Summary of the 

meeting, which focused on COVID-19 vaccines among children 5-11 years of age in terms of 

vaccine effectiveness (VE) and safety, a Vaccine Safety Technical Subgroup (VaST) 

assessment, safety and immunogenicity of booster doses, Evidence to Recommendations (EtR) 

Framework on booster doses, and a vote on booster doses in this age group.

EXECUTIVE SUMMARY

Session Overview

Dr. Matthew F. Daley (WG Chair) reported that there were 82,522,948 total COVID-19 cases

and 997,215 total deaths between January 23, 2020 – May 16, 2022. Unvaccinated people ≥5 

years of age had 10 times the risk of dying from COVID-19 in February compared to people 

vaccinated with at least the primary series. Unvaccinated people ≥12 years of age had 20 times

the risk of dying from COVID-19 in February compared to people vaccinated with a primary 

series and booster dose. A new analysis predicts that vaccines could have prevented at least

318,000 COVID-19 deaths between January 2021 and April 2022. 

On May 17, 2022, the Food and Drug Administration (FDA) expanded eligibility for a PfizerBioNTech COVID-19 vaccine booster dose to children 5-11 years of age. FDA amended the 

Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, authorizing 

the use of a single booster dose for administration to individuals 5 through 11 years of age at 

least 5 months after completion of a primary series with the Pfizer-BioNTech COVID-19 vaccine. 

The current recommendations for COVID-19 vaccines in children 5-11 years of age should 

receive 2 doses of Pfizer-BioNTech vaccine 3 weeks apart. Children 5-11 years of age who are 

moderately to severely immunocompromised should receive 2 doses 3 weeks apart followed by 

a third dose 4 weeks after the second dose.

Between April-May 2022, the COVID-19 Vaccine WG has reviewed the following: vaccine 

response by type of immunocompromise in adults, seroprevalence of infection-induced SARSCoV-2 antibodies, COVID-19 epidemiology in children 5-11 years of age, safety and

immunogenicity for a Pfizer-BioNTech COVID-19 vaccine booster dose in children ages 5-11 

years, VE data for COVID-19 vaccines in children 5-11 years of age, safety data for COVID-19 

vaccines in children 5-11 years of age, and policy around booster doses for children 5-11 years 

of age.

Updates on VE of COVID-19 Vaccines in Children 5-11 Years of Age

Ruth Link-Gelles, PhD, MPH (CDC/NCIRD) presented on COVID-19 VE during Omicron for

children and adolescents. She described data from the Pediatric Research Observing Trends 

and Exposures in COVID-19 Timelines (PROTECT), Increasing Community Access to Testing 

(ICATT) Partnership, the VISION Network, and unpublished preliminary data from CDC. To 

summarize some of the findings, in terms of infection, 2-dose VE declined quickly in children 

and adolescents, following a similar pattern that occurred among adults during Omicron. A 
ACIP Meeting Summary May 19, 2022 

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booster dose in adolescents significantly improved VE at least 6 weeks to 3 months after the 

third dose. With regard to emergency department/urgent care (ED/UC) visits, 2-dose VE was 

higher for ED/UC visits compared to infection but declined 60 days after the second dose for 

adolescents. A booster dose in persons 12-15 years of age significantly improved VE. 

Regarding severe disease, 2-doses provided protection for children and adolescents against 

hospitalizations and multisystem inflammatory syndrome in children (MIS-C). However, there 

some waning evident for hospitalization in adolescents. There were not enough data to assess 

waning in children 5-11 years of age or the impact of a booster dose in persons 12-15 years of 

age.

Updates on Safety of COVID-19 Vaccines in Children 5-11 Years of Age

Tom Shimabukuro, MD, MPH, MBA (CDC/NCEZID) provided an update from postauthorization safety monitoring for the primary series of Pfizer-BioNTech (COMIRNATY) 

COVID-19 vaccination in children 5–11 years of age from the Vaccine Adverse Event Reporting 

System (VAERS), v-safeSM, and the Vaccine Safety Datalink (VSD).

To summarize the VAERS findings, since authorization, 18.1 million doses of Pfizer-BioNTech 

vaccine have been administered to children 5-11 years of age in the United States (US). Most 

VAERS reports (8750/9001, 97%) were non-serious. The most frequently reported adverse 

events (AEs) for non-serious reports were known and well-characterized AEs associated with 

Pfizer-BioNTech vaccination, including potential allergic reactions. The most frequently reported 

AEs for serious reports were consistent with MIS-C. There were 20 reports of myocarditis 

verified to meet the CDC case definition among children 5-11 years of age. There was male 

predominance of myocarditis reports that occurred mostly after Dose 2. This is similar to older 

age groups. There was one death in a male with symptom onset 12 days after Dose 1. The 

clinical course was rapid and there was histopathologic evidence of myocarditis on autopsy. The 

reporting rates for males 5-11 years of age are lower than for males 12-15 and 16-17 years of 

age, especially after Dose 2. Reporting rates for males after Dose 1 and for females after either 

Dose 1 or Dose 2 are within background rates using the 0–7-day risk interval. CDC will continue 

monitoring COVID-19 vaccine safety among this age group and is following up on VAERS case 

reports of myocarditis to assess functional status and clinical outcomes at least 90 days after 

the onset of myocarditis symptoms.

As a reminder, v-safeSM is a voluntary CDC smart phone-based monitoring program 

for COVID-19 vaccine safety in the US that uses text messaging and web surveys to check in 

with vaccine recipients after vaccination. It solicits participants’ reports on how they feel after 

COVID-19 vaccination in terms of local injection site reactions (e.g., pain, redness, swelling), 

systemic reactions (e.g., fatigue, headache, joint pain), and health impacts (unable to perform 

normal daily activities, missed school or work, or received care). To summarize the findings 

from v-safeSM reports after Pfizer-BioNTech vaccination among children 5-11 years of age, there 

have been a total of 49,396 v-safeSM among children 5-11 years of age. Reactions were 

generally mild to moderate and were most frequently reported the day after vaccination. 

Generally, reactions were more frequently reported after Dose 2 than Dose 1. Patterns are 

generally similar to those observed in people ≥12 years of age.

To summarize the VSD Rapid Cycle Analysis (RCA) analyses for children 5-11 years of age as 

of April 23, 2022, there are approximately 877,855 children ages 5-11 years in the VSD and 

786,202 total doses of Pfizer-BioNTech vaccine have been administered in this age group. 

About 41% of children 5-11 years of age have completed the primary series. No statistical 

signals have been identified to data for any outcomes. There were 10 potential cases of
ACIP Meeting Summary May 19, 2022 

4 

myocarditis or pericarditis identified in the 98 days post-vaccination, 6 (60%) of which were 

verified through chart review and included the following: 

• Male age 7 years with acute myocarditis 16 days after dose 1

• Male age 11 years with acute pericarditis 19 days after dose 1

• Female age 9 years with acute pericarditis 14 days after dose 1

• Male age 8 years with acute myocarditis 3 days after dose 2

• Male age 9 years with acute myocarditis the day of vaccination after dose 2

• Male age 10 years with acute myocarditis 2 days after dose 2

Of the 10 cases reported, 4 were determined not to be cases. There were 2 cases with a history 

of myocarditis, 1 with a congenital heart defect, and 1 with chest pain but normal troponin and 

electrocardiogram (ECG). There were 3 verified anaphylaxis cases identified on Days 0-1 after 

vaccination. Anaphylaxis rates in children ages 5-11 years are consistent with rates observed in 

people ≥12 years of age.

There were 12 potential cases of MIS-C identified after vaccination. Of these, 8 were verified as 

meeting the CDC case definition (7 Brighton Collaboration Level 1, 1 Brighton Collaboration 

Level 4) and 4 were ruled out. Of the verified cases, 5 (63%) were in males and 6 (75%) 

occurred following Dose 1. All 8 cases were admitted to the hospital, with 5 (63%) admitted to 

the intensive care unit (ICU). The median length of stay was 3 days (range 1-7 days). The 

median time from vaccination to symptom onset was 19.5 days. Of the 8 cases, 6 had both 

documented COVID-19 infection and COVID-19 vaccination before diagnosis, 3 had infection

<12 weeks prior to vaccination followed by vaccination and then MIS-C, 1 had vaccination

followed by infection and then MIS-C, 2 had unclear timing but with infection and vaccination 

prior to MIS-C diagnosis, and 2 had vaccination followed by a known exposure to COVID-19

and then MIS-C. 

In terms of the overall summary of safety following the primary series of Pfizer-BioNTech 

COVID-19 vaccination in children 5-11 years of age, findings from post-authorization safety 

monitoring of Pfizer-BioNTech primary series vaccination are generally consistent with those 

from the clinical trials. Systemic and local reactions are relatively common, with more systemic 

reactions after Dose 2. The reporting rate for myocarditis in VAERS in males after Dose 2 is 

slightly elevated when compared to background incidence; otherwise, reporting rates are below 

background incidence. No statistical signal for myocarditis has been observed in VSD RCA. 

Anaphylaxis rates in children 5-11 years of age following Pfizer-BioNTech COVID-19 

vaccination are comparable to rates in people ≥12 years of age. MIS-C cases detected in the 

VSD following vaccination had a history of COVID-19 infection or a known exposure to COVID19 prior to their MIS-C diagnosis. Enhanced safety monitoring continues, including following up 

on recovery status and longer-term outcomes in myocarditis case reports. 

VaST Assessment

H. Keipp Talbot, MD MPH (VaST Chair) reminded everyone the objectives of VaST 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 has convened 57

meetings to review vaccine safety data from December 21, 2020 to the present. 
ACIP Meeting Summary May 19, 2022 

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VaST reviewed the most recent data from 3 US safety monitoring systems to assess safety after 

the primary vaccination series in children 5-11 years of age and after booster doses in 

adolescents 12-15 years of age. Adolescents 12-15 years of age are the youngest group for 

which boosters were previously authorized. A total of 18.1 million doses of Pfizer-BioNTech 

vaccine have been administered to children aged 5-11 years of age in the US. In VAERS, the 

reporting rate for myocarditis among males was lower among children 5-11 years of age versus 

adolescents 12-15 years of age. In the VSD RCA, no statistical safety signals have occurred 

after more than 778,000 doses Pfizer-BioNTech vaccine in children 5-11 years of age. Data do 

not suggest potential safety concerns regarding a Pfizer-BioNTech COVID-19 vaccine booster 

dose for children 5-11 years of age beyond those previously identified in older age groups. 

In terms of a VaST assessment of mortality following COVID-19 vaccination in the US, the CDC 

Immunization Safety Office (ISO) and FDA have standard and systematic methods for following 

up on all reported deaths following vaccination. Because of the importance of mortality as a 

potential AE following vaccination, VaST has reviewed mortality data as they have become 

available from several systems. Population-based studies conducted to date have not identified 

increased risk of death following COVID-19 vaccination. Spontaneous reporting to VAERS has 

not identified any unusual reporting or patterns of causes of death (CODs). In a cohort of 6.4 

million COVID-19 vaccinees and 4.6 million demographically similar unvaccinated persons, no 

increased risk was identified of mortality among COVID-19 vaccine recipients. Among over 

20,000 nursing home residents in 284 facilities, no increases were identified in 7-day mortality 

following COVID-19 vaccination. Among deaths reported to VAERS following COVID-19 

vaccination, Bayesian data mining identified no signals other than mortality due to COVID-19 

disease following the Ad26.COV2.S vaccine in adults. No unusual clustering of CODs has been

associated with US-authorized COVID-19 vaccines.

VaST will continue to review vaccine safety data from multiple US safety systems, in specific 

age groups, and after primary series and booster doses; collaborate with global vaccine safety 

colleagues on key issues; and provide updates to the ACIP COVID-19 Vaccines WG and ACIP 

during future meetings. 

Safety and Immunogenicity of BNT162b2 Booster (Third) 10 μg Dose in Children 5-11

Years of Age 

Charu Sabharwal, MD, MPH (Pfizer) reviewed the safety and immunogenicity of a 10μg

booster dose of BNT162b2 in children 5 to <12 years of age in terms of the data that was 

agreed upon with the FDA for safety and tolerability in 401 participants with follow-up from Dose 

3 to 1 month post-Dose 3; a subset of the first 130 participants to complete 1 month post-dose 3 

by March 15, 2022 who contributed to the overall descriptive immunogenicity assessment

against the SARS-CoV-2 wild-type; an 67 participants from a 2-dose series population to 

conduct a robust 1 month post-Dose 2 comparison; and 30 of the 130 participants at 1 month 

post-Dose 3 to analyze their immune response against the Omicron variant.

In terms of the study design and timeline, this originally was a placebo-controlled observerblinded study evaluating a 2-dose primary series. On June 7, 2021, the Phase 2/3 2-dose series

was initiated. Enrollment was completed on September 10, 2021, with approximately 4,500 

participants randomized in a 2:1 ratio to achieve a safety database of 3,000 actively vaccinated

participants. On October 29, 2021, the EUA authorization was expanded to include this group 

based on immunogenicity, safety, and descriptive efficacy. The immunogenicity criteria for the 

primary immunogenicity objective were to immunobridge the immune response elicited by

participants in this age group to that of the participants 16-25 years of age in the landmark
ACIP Meeting Summary May 19, 2022 

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efficacy trial up to 1 month after the second dose. Only 450 of the randomly selected

participants in the trial had a 1-month post-Dose 2 blood draw. With the EUA authorization,

participants in this age group became eligible for unblinding. On January 4, 2022, the protocol 

was amended to include a third dose for all participants to maximize protection against variants 

of concern, including Delta and Omicron. On January 31, 2022, booster doses were initiated

in this age group among existing participants. The data cutoff period was March 22, 2022.

Of the 401 participants to receive the booster dose at the 10μg dose, the overall demographics 

were representative of participants in the trial. Slightly more than 50% were male, 70% were 

White, 7% were African American or black, 12% were multi-racial, and 22% were Hispanic. The 

mean age was 8 years at the time of Dose 1. While none of the participants reported a history of 

COVID-19 at that time, 5.5% had a baseline positive test for SARS-CoV-2. In terms of the 

follow-up time for the booster dose, 86.8% occurred approximately 8 to 9 months after Dose 2. 

The range was from approximately 5 to 9 months.

In terms of the Dose 3 mean follow-up time of 1.3 months in the 5 to <12 years of age safety 

population, pain at the injection site was the most commonly reported local reaction. Most local 

reactions were mild or moderate in severity. Severe reactions were infrequent and occurred at 

<1%. The median onset for all local reactions after any dose of BNT162b2 10μg was 1 to 2 

days. All events resolved with a median duration of 1 to 2 days after onset. Most systemic 

events were mild to moderate. Fatigue and headache were the most commonly reported across 

the 3 doses. Overall, the rates of fever were low and there were no fevers >40.0 °C. In addition, 

chills also remained low. There were no Grade 4 systemic events at Dose 3 and severe

reactions remained infrequent and occurred at less .2%. The overall number of AEs were small, 

with 9% percent of participants reporting an AE. Of these, 4.7% were reported to be related to 

the vaccine. Most of these were related to reactogenicity events. There were no related serious 

adverse events (SAEs), withdrawals due to AEs, or deaths. This was consistent with the 2-dose 

series data.

In terms of the breakdown of the 9% AEs that occurred from Dose 3 to 1 month after Dose 3 

that occurred in ≥1.0% of participants by system organ class, these events were consistent with 

reactogenicity events and included general disorders (2.2%), blood and Lymphatic system

disorders (2.0%), respiratory/thoracic/mediastinal disorders (1.5%), gastrointestinal disorders

(1/5%), nervous system disorders (1.0%), and infections and infestations (1%). There were few 

AEs of clinical interest corresponding to those requested by the FDA or CDC in terms of the list 

of AEs of special interest (AESIs). No events of anaphylaxis, myocarditis/pericarditis, Bell’s 

palsy (or facial paralysis/paresis), or appendicitis were reported in BNT162b2 recipients up to 

the data cutoff point. From Dose 3 to cutoff, there was 1 event of mild facial rash that was

considered to be unrelated to vaccine by the investigator that was attributable to wearing a face 

mask. The onset was 11 days post-Dose 3 and resolved 4 days later.

Lymphadenopathy post-Dose 3 occurred in 10 (2.4%) of BNT162b2 participants compared to 

0.9% in post-Dose 2 recipients and 5.2% of post-Dose 3 adults who received a 30μg dose. 

Lymphadenopathy occurring in participants 5 to <12 years of age was mild overall and 

considered to be related to the vaccine by the investigator. Overall, these events were mild and 

occurred primarily in the axillary or cervical nodes. Onset was within 2 days of receipt of a 

booster vaccination, and they were reported as resolved within 1 week of onset.
ACIP Meeting Summary May 19, 2022 

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In terms of overall safety conclusions, the safety data from 401 participants who received a 

booster (3rd) dose of BNT162b2 at the 10μg dose did not identify any new safety concerns.

Reactogenicity was mostly mild to moderate and short-lived after the third dose and was 

generally comparable to that observed after the second dose. AESIs were limited to the 1 case 

of rash.

With regard to the descriptive immunogenicity analysis that compared the immune responses at 

1-month post-Dose 3 to 1-month post-Dose 2, not all participants in the trial had a blood draw at 

1-month post-Dose 2. As mentioned, 130 participants did complete 1-month post-Dose 3 by 

March 15, 2022. Of those, 123 received the 10μg dose. These participants were with and 

without evidence of infection. Of those participants, 30 were part of the 1-month post-Dose 2 

immunobridging subset. Of the 103 participants who completed 1-month post-Dose 3, 67 did not 

have evidence of infection. Of the 30, 29 did not have evidence of infection. This contributed to 

the Omicron analysis. In addition, the 2-dose set included an additional 67 participants without 

evidence of infection who were randomly selected from the 1-month post-Dose 2 evaluable 

population.

Among participants without evidence of infection, using the combined 2-dose and 3-dose 

datasets, there were substantial increases in the SARS-CoV-2 neutralizing titers against wildtype SARS-CoV-2 after Dose 3 compared to after Dose 2. The geometric mean ratio (GMR)

comparing 1-month post-Dose 3 to 1-month post-Dose 2 was 2.17 (1.76, 2.68). In addition, the 

overall geometric mean titers (GMTs) and GMRs were similar to this in participants when those 

with and without evidence of infection were included. There also were high seroresponses 

against SARS-CoV-2 wild-type after Dose 3 at 98.5%. Seroresponses were high in participants 

with and without evidence of infection as well at 99.1%. 

Regarding the supportive analysis that was conducted using participants from the 3-dose set to 

assess responses to Omicron, robust neutralizing titers were elicited after Dose 3 at 614.4

(410.7, 919.2) compared to Dose 2 at 27.6 (22.1, 34.5) for a GMR of 22. In terms of the wildtype reference, similarly improved GMTs occurred after Dose 3 compared to Dose 2, with a

GMR of 5. Among the evaluable population with and without evidence of infection in this 

supportive analysis, an increase in GMTs was noted 1 month after the third dose. They were 

higher than the previous 992.7 (675.9, 1458.1) compared to Dose two at 27.3 (22.0, 33.9), for a 

GMR of 36. Similarly, an increase was seen in the wild-type reference strain with a GMR of 6. 

The immunogenicity conclusions are that among participants with and without evidence of prior

infection, administration of a booster (3rd) dose of BNT162b2 10μg elicited robust neutralization

titers against SARS-CoV-2 wild-type. In addition, a booster (3rd) dose of BNT162b2 10μg

elicited neutralizing titers against SARS-CoV-2 Omicron in participants with and without 

evidence of infection. Overall, the immune response associated with a booster (3rd) dose of 

BNT162b2 10μg given at least 6 months after the second dose is expected to confer protection 

against COVID-19, including that due to Omicron. 
ACIP Meeting Summary May 19, 2022 

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Updates to the EtR Framework: COVID-19 Vaccine Booster Doses in Children 5 to 11 

Years of Age

Sara Oliver, MD, MSPH (CDC/NCIRD) provided updates to the EtR Framework on PfizerBioNTech COVID-19 boosters in children aged 5-11 years. The policy question for this analysis 

was, should individuals ages 5-11 years receive a Pfizer-BioNTech COVID-19 vaccine booster 

dose at least 5 months after completion of the primary series, based on the balance of benefits 

and risks?” 

To summarize the evidence relevant to the public health problem, children ages 5-11 years are 

at risk of severe illness from COVID-19. There have been over 4.8 million reported cases and 

>15,000 hospitalizations to date. In 2020, COVID-19 was a leading COD in children ages 5-11 

years. Children who have received a COVID-19 vaccine primary series have better outcomes 

than children who are unvaccinated, particularly against severe illness. A total of 28.8% of 

children ages 5-11 years have completed their primary series.

In summary of the benefits and harms evidence, waning of antibody levels have been observed 

after completion of the 2-dose primary series. Booster doses achieve antibody levels higher 

than after the primary series. Reactogenicity reported after a booster dose is similar to what was 

reported after the primary series. Rates of myocarditis after the primary series in children ages 

5-11 years is considerably lower than rates in adolescents. Rates after booster doses are likely 

even lower. Receipt of a primary series of COVID-19 vaccines remains important and continues 

to provide protection against severe COVID-19 outcomes. Based on information from other age 

groups, providing booster doses can increase protection against both COVID-19 infection and 

severe disease. 

In terms of values and acceptability based on surveys regarding booster doses, about half of 

parents are worried about rare and serious side effects of the COVID-19 vaccines, but many 

also are worried about how new variants will affect children. Slow COVID-19 vaccine uptake can 

be expected in children 5-11 years of age as about 4 in 10 (41%) parents plan to “wait and see.” 

Ultimately, 63% of parents of children 5-11 years of age intend to vaccinate their children at 

some point. Most parents trust their children’s healthcare provider (HCP) as a source of 

information about COVID-19 vaccines.

Regarding the evidence supporting feasibility, 35.4% of children 5-11 years of age have 

received at least 1 dose of the COVID-19 pediatric vaccine. Nearly 10 million first doses have 

been administered since November 3, 2021. Medical facilities and pharmacies were the highest 

reported place of vaccination among children ages 5-11 years. Efforts to strengthen the provider 

network and mitigate barriers to provider participation is crucial to improving pediatric COVID-19 

vaccination coverage. Booster dose coverage is lower among adolescent and young adult 

populations.

With respect to equity, there are noted disparities in vaccination coverage and parental intent for 

children ages 5-11 years by race and ethnicity, income, and geographic location. Addressing 

barriers to vaccination in rural areas is critical to achieving vaccine equity, reducing disparities, 

and decreasing COVID-19-related illness and death in the US. Additional outreach is critical to 

improve vaccine confidence and increase coverage rates among children ages 5-11 years, 

especially in high Social Vulnerability Index (SVI) areas. Disseminating culturally and

linguistically appropriate messaging through trusted channels is pertinent to reaching parents

and caregivers who reside in areas with low vaccination coverage among children. 
ACIP Meeting Summary May 19, 2022 

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Regarding the COVID-19 Vaccine WG’s conclusions, prior to COVID-19 vaccine authorization 

for children in this group, among US children ages 5-11 years, there were 1.9 million cases

8,300 hospitalizations, 3,070 MIS-C cases, 94 deaths related to COVID-19. Since authorization 

of COVID-19 vaccines for children ages 5-11 years of age, there have been 2.9 million cases, 

6,700 hospitalizations, 739 MIS-C cases, and 95 deaths. This is in the context of approximately 

90% of the children hospitalized overall being unvaccinated and 93% of MIS-C cases being 

unvaccinated.

Receipt of a primary series provides protection against COVID-19, especially against severe 

disease. Myocarditis after COVID-19 vaccines in children ages 5-11 years is rare. Given that 

only 29% of children ages 5-11 years are fully vaccinated with a primary series, future surges 

will continue to impact children and unvaccinated children will remain at higher risk of severe 

outcomes. The benefits of COVID-19 vaccines continue to outweigh the risks. Receipt of a 

COVID-19 vaccine primary series continues to be important. 

COVID-19 vaccine booster doses have been shown to increase protection against all outcomes 

in those ages 12 years and over. Waning of protection over time after 2 doses has been noted 

for those 12 years of age and over. Notably, there has been limited time to detect waning in 

children 5-11 years. For each age, myocarditis after booster doses of COVID-19 vaccines is 

lower than after Dose 2 in the primary series. It is likely that children ages 5-11 years would 

benefit from a COVID-19 vaccine booster dose.

The WG discussed vaccine policy in which children ages 5-11 years “may receive” or “should 

receive” a COVID-19 vaccine booster dose, with the pros and cons considered shown in this 

table:

Overall, the WG supported the current recommendation that children ages 5-11 years “may 

receive” a COVID-19 vaccine booster dose. This would allow flexibility to adjust to a stronger 

recommendation in the Fall if the epidemiology warrants this or if newer vaccines become 

available. This was not unanimous. Both viewpoints were represented on the WG.
ACIP Meeting Summary May 19, 2022 

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Vote: COVID-19 Vaccine Booster Doses in Children 5-11 Years of Age

Sara Oliver, MD, MSPH (CDC/NCIRD) presented the proposed recommendations for a PfizerBioNTech COVID-19 vaccine booster dose for individuals 5-11 years of age, which read as 

follows:

“A single Pfizer-BioNTech COVID-19 vaccine booster dose is recommended for persons

ages 5-11 years at least 5 months after the primary series under the FDA’s Emergency 

Use Authorization.” 

Motion/Vote: COVID-19 Vaccine Booster Doses for Individuals 5-11 Years of Age

Dr. Loehr made a motion for ACIP to adopt the verbiage of the recommendation stating that, “A 

single Pfizer-BioNTech COVID-19 vaccine booster dose is recommended for persons ages 5-11

years at least 5 months after the primary series under the FDA’s Emergency Use Authorization.”

Dr. Brooks seconded the motion. No conflicts of interest (COIs) were declared. The motion 

carried with 11 affirmative votes, 1 negative vote, and 1 abstention. The disposition of the vote 

was as follows:

11 Favored: Bahta, Bell, Brooks, Cineas, Daley, Kotton, Lee, Loehr, Long, McNally,

Poehling

 1 Opposed: Talbot

 1 Abstained: Ault 

Discussion Summary

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. Talbot emphasized that she wants children to be vaccinated. However, if only 30% of 

children have received only 1 dose, there is a need to spend time and effort on educating the 

70% who have not been vaccinated. Boosters are great, but everyone getting their primary 

series in this age group first needs to be a priority.

Dr. Loehr said that while he supported this recommendation, he wanted to add his voice to the 

public comments provided during the meeting and the written public comments posted to the 

docket by requesting that FDA expedite the review of the EUA application for immunizations

for children less than 5 years of age. He thinks this is an important priority, especially given that 

many parents and many of his personal patients are asking for that.

Dr. Kotton emphasized the importance of making sure that immunocompromised children and 

adult receive all of their vaccines. The vast majority of immunocompromised patients she is 

seeing are not fully protected. She encouraged everyone to take the opportunity to be as wellprotected as possible and encouraged the CDC to provide as much advertising and clarity on 

this topic as possible so that people can be as well-protected as possible against this horrible 

infection.
ACIP Meeting Summary May 19, 2022 

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Ms. McNally said she felt very strongly that this recommendation should send a clear message 

regarding the importance of this vaccine. She voted for a “should” recommendation for the 

reasons stated in Dr. Oliver’s presentations pertaining to the available evidence on benefits and 

harms. She encouraged parents with questions about this vaccine and the booster to review the 

information on waning immunity, reactogenicity, rates of myocarditis being considerably lower 

with the booster dose, and the fact that the booster will offer increased protection.

Dr. Poehling agreed that the pros of a booster dose in this age group are strong and that 

benefits are seen for many outcomes, which is why she voted yes for a “should” 

recommendation. She stressed that only 28% of 5-11 years of age are fully vaccinated and that 

it is very important to enhance protection of all children by making sure that all who are eligible

receive their primary series and booster—both are equally important.

Dr. Daley emphasized the importance of communicating to parents. In addition to encouraging 

parents to review the data Ms. McNally suggested, he also would encourage them to talk to 

their child’s HCP as a trusted advisor. These are complicated decisions and providers need to 

meet families where they are in terms of their questions and concerns. While HCP will not have 

all of the answers, they can share their thoughtful opinions based on knowing their patients. 

This hopefully will go a long way toward improving vaccination coverage among the large 

proportion of families who have not yet vaccinated their children.
ACIP Meeting Summary May 19, 2022 

12

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 

WHARTON, Melinda, MD, MPH

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
ACIP Meeting Summary May 19, 2022 

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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 

LOEHR, Jamie, MD, FAAFP

Owner, Cayuga Family Medicine

Ithaca, New York

Term: 7/26/2021 – 6/30/2025

 

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 
ACIP Meeting Summary May 19, 2022 

14

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 

 
ACIP Meeting Summary May 19, 2022 

15

Indian Health Service (IHS) 

CLARK, Matthew, MD, FAAP, FACP

Physician

Chair, IHS National Pharmacy & Therapeutics Committee

Durango, CO

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 
ACIP Meeting Summary May 19, 2022 

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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 

 
ACIP Meeting Summary May 19, 2022 

17

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) 

HOGUE, Michael D., PharmD, FAPhA, FNAP 

Dean and Professor of Loma Linda University School of Pharmacy

Director, Center for Interprofessional Education & Practice

Loma Linda, CA

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) 

ZIMMERMAN, Richard, MD, MPH

Professor

University of Pittsburgh School of Medicine

Department of Family Medicine and Clinical Epidemiology

Pittsburgh, PA

Association of State and Territorial Health Officials (ASTHO) 

SHAH, Nirav D, MD, JD 

Director

Maine Center for Disease Control and Prevention

Augusta, ME 

 
ACIP Meeting Summary May 19, 2022 

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Biotechnology Industry Organization (BIO) 

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 

 

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

 

Council of State and Territorial Epidemiologists (CSTE) (alternate) 

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 

Canadian National Advisory Committee on Immunization (NACI) 

DEEKS, Shelley, MD, MHSc, FRCPC, FAFPHM

Deputy Chief Medical Officer of Health, Department of Health and Wellness, Nova Scotia

Associate Professor, Dalla Lana School of Public Health, University of Toronto

Chair, National Advisory Committee on Immunization

Halifax, Nova Scotia

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 

 
ACIP Meeting Summary May 19, 2022 

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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 

 
ACIP Meeting Summary May 19, 2022 

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Pharmaceutical Research and Manufacturers of America (PhRMA) 

ROBERTSON, Corey, MD, MPH 

Senior Director, US Medical, Sanofi Pasteur 

Swiftwater, PA 

 

Society for Adolescent Health and Medicine (SAHM) 

MIDDLEMAN, Amy B, MD, MSEd, MPH 

Professor of Pediatrics 

Chief, Section of Adolescent Medicine 

University of Oklahoma Health Sciences Center

Oklahoma City, OK 

Society for Healthcare Epidemiology of America (SHEA)

DREES, Marci, MD, MS 

Chief Infection Prevention Officer & Hospital Epidemiologist 

ChristianaCare 

Wilmington, DE 

Associate Professor of Medicine 

Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA
ACIP Meeting Summary May 19, 2022 

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ACRONYMS USED IN THIS DOCUMENT

ACIP Advisory Committee on Immunization Practices

AE Adverse Event

AESI Adverse Events of Special Interest

CDC Centers for Disease Control and Prevention

COD Causes of Death

ED Emergency Department

ET Eastern Time

EtR Evidence to Recommendation 

EUA Emergency Use Authorization 

FDA Food and Drug Administration

GMR Geometric Mean Ratio 

GMT Geometric Mean Titers 

HCP Healthcare Personnel / Provider

HHS (Department of) Health and Human Services

ICATT Increasing Community Access to Testing Partnership

ICU Intensive Care Unit 

J&J Johnson & Johnson

MIS-C Multisystem Inflammatory Syndrome in Children 

PROTECT Pediatric Research Observing Trends and Exposures in COVID-19 Timelines 

RCA Rapid Cycle Analysis

SAE Serious Adverse Event 

SVI Social Vulnerability Index 

UC Urgent Care 

US United States

VAERS Vaccine Adverse Event Reporting System

VaST Vaccine Safety Technical Subgroup 

VE Vaccine Efficacy

VE Vaccine Effectiveness

VSD Vaccine Safety Datalink

WG Work Group