MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP)

JUNE 17-18, 2022

EXECUTIVE SUMMARY

CONTENTS

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

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

Session Overview 6-17-22..................................................................................................... 2

Epidemiology of COVID-19 in Young Children ...................................................................... 3

Updates on VE of COVID-19 Vaccines in Children and Adolescents.................................... 4

Safety, Immunogenicity, and Efficacy of BNT162b2 (COVID-19 Vaccine, mRNA) in Children 

6 Months through 4 Years of Age .......................................................................................... 8

mRNA COVID-19 Vaccines in Young Children: Summary and WG Interpretation..............12

Session Overview 6-18-22...................................................................................................15

Implementation of Pediatric Vaccines..................................................................................16

EtR Framework: mRNA COVID-19 Vaccines in Young Children ........................................18

Clinical Considerations Update............................................................................................27

Vote: Moderna COVID-19 Vaccine in Children 6 Months Through 5 Years of Age.............30

Vote: Pfizer-BioNTech COVID-19 Vaccine in Children 6 Months Through 4 Years of Age . 30

ACIP MEMBERSHIP ROSTER...................................................................................................................32

ACRONYMS USED IN THIS DOCUMENT................................................................................................. 41
ACIP Meeting Summary June 17-18, 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 June 17-18, 2022. The meeting took place remotely via 

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

meeting, which focused on the epidemiology of COVID-19 in young children; vaccine

effectiveness (VE) of COVID-19 vaccines in children and adolescents; Moderna COVID-19 

vaccine mRNA-1273 safety, immunogenicity, and efficacy in children 6 months through 5 years 

of age; safety, immunogenicity, and efficacy of Pfizer-BioNTech BNT162b2 in children ages 6 

months through 4 years of age; implementation of pediatric vaccines; Evidence to 

Recommendations (EtR) Framework update on mRNA COVID-19 vaccines in young children; 

Clinical Considerations update; and votes on Moderna COVID-19 vaccine in children 6 months 

to 5 years of age and Pfizer-BioNTech COVID-19 vaccine in children 6 months to 4 years of 

age. 

EXECUTIVE SUMMARY

Session Overview 6-17-22

Dr. Matthew F. Daley (WG Chair) reported that there were 85,681,615 total COVID-19 cases

and 1,007,374 total deaths between January 23, 2020 – June 14, 2022. Based on cumulative 

total incidence, COVID-19 is the leading cause of death (COD) among infectious diseases for 

people ages 0-19. COVID-19 is the seventh most common of all COD for people 0-19 years of 

age. Among people 1-4 years of age, COVID-19 is the fifth most common of all COD. 

Unvaccinated people ages ≥5 years had 10 times the risk of dying from COVID-19 through 

March compared to people vaccinated with at least the primary series.

Among children 6 months to 4 years of age, seasonal influenzas vaccines have averted 4.3-

20.1 million illnesses, 2.9-15.5 million visits, 32,000-164,000 hospitalizations, and 130-2,350 

deaths. This was in the context of substantial disease burden with a seasonal incidence of 

about 5% to 20%, variable VE estimates ranging from 19% to 60% from 2010-2020, and 

consistent vaccine coverage of 63.6% to 75.2% influenza vaccine coverage among children 6 

months to 4 years of age from 2010-2020. 

There is no COVID-19 vaccine currently authorized for use in children less than 5 years of age. 

Only the Pfizer-BioNTech vaccine is currently authorized for use in children 5-17 years of age.

On June 14, 2022, the Food and Drug Administration’s (FDA’s) Vaccines and Related Biological 

Products Advisory Committee (VRBPAC) convened a meeting to review the request for 

Emergency Use Authorization (EUA) for the Moderna COVID-19 vaccine in children and 

adolescents 6-17 years of age. VRBPAC convened a meeting on June 15, 2022 to review 

requests for EUA for the Moderna COVID-19 vaccine in children 6 months through 5 years of 

age and the Pfizer-BioNTech COVID-19 vaccine in children 6 months through 4 years of age.
ACIP Meeting Summary June 17-18, 2022

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Between late May and early June 2022, the COVID-19 vaccine Work Group (WG) reviewed and 

discussed the following:











Vaccine safety, immunogenicity and efficacy data, including both immunobridging and 

laboratory-confirmed direct efficacy, for the Moderna COVID-19 vaccine for children and

adolescents 6 months through 5 years of age and 6 through 17 years of age

Vaccine safety, immunogenicity, and efficacy data, including both immunobridging and 

laboratory-confirmed direct efficacy, for the Pfizer-BioNTech COVID-19 vaccine for children 

and adolescents ages 6 months through 4 years of age

COVID-19 epidemiology and outcomes in children ages 6 months through 5 years of age

Post-authorization VE of COVID-19 vaccines in children and adolescents ages 5 through 17 

years of age

Grading of Recommendations, Assessment, and Evaluation (GRADE) and EtR Frameworks 

for both Moderna and Pfizer-BioNTech COVID-19 vaccines for children ages 6 months 

through 5 years of age

Epidemiology of COVID-19 in Young Children

Katherine Fleming-Dutra, MD (CDC/NCIRD) presented an update on COVID-19 epidemiology 

in children 6 months through 4 years of age in terms of COVID-19 incidence and burden, 

emergency department (ED) visits, hospitalization rates and severity, COVID-19-associated 

mortality, Multisystem Inflammatory Syndrome in Children (MIS-C), post-COVID conditions, and 

other impacts of the pandemic on children and families. Children 5-11 years of age and 

adolescents 12-17 years of age are currently eligible for COVID-19 vaccination.

As Dr. Daley reported, there were 85,681,615 total COVID-19 cases and 1,007,374 total deaths

among all ages between January 23, 2020 – June 14, 2022. COVID-19 is the leading COD

among infectious diseases for people ages 0-19. COVID-19 is the seventh most common of all 

COD for people 0-19 years of age. Among people 1-4 years of age, COVID-19 is the fifth most 

common of all COD. Unvaccinated people ages ≥5 years had 10 times the risk of dying from 

COVID-19 through March compared to people vaccinated with at least the primary series.

Among children 6 months through 4 years of age, from October 2020–September 2021, COVID19 hospitalization rates were lower than influenza hospitalization rates during the 2017–2018 

through 2019–2020 pre-pandemic influenza seasons. From October 2021–April 2022, COVID19 hospitalization rates were as high or higher than influenza hospitalization rates during the 

2017–2018 through 2021–2022 influenza seasons.

MIS-C causes severe illness in persons 0-20 years of age characterized by fever, multi-system 

organ involvement, laboratory evidence of inflammation, and SARS-CoV-2 infection with no 

alternative plausible diagnosis. Occurring 2-6 weeks after acute SARS-CoV-2 infection, 60% to 

70% of patients are admitted to intensive care and 1% to 2% die. A range of new, returning, or 

ongoing health problems have occurred 4 or more weeks after acute SARS-CoV-2 infection in 

adults and children <18 years of age. Children 0-5 years of with SARS-CoV-2 infection are more

likely than controls without known SARS-CoV-2 infection to experience symptoms lasting more 

than 4 weeks after acute infection of fatigue, loss of taste, and/or loss of smell. Evidence

regarding the prevalence and spectrum of post-COVID conditions among children, especially 

young children, is limited by the inability of younger children to verbalize symptoms, few studies 

including children, lack of control groups, and symptoms frequently occurring in children without 

known SARS-CoV-2 infection. 
ACIP Meeting Summary June 17-18, 2022

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Other indirect impacts of COVID-19 pandemic on children include worsening of mental or 

emotional health, widening of existing education gaps, decreased physical activity and

increased body mass index (BMI), decreased healthcare utilization, decreased routine 

immunizations, and increased adverse childhood experiences (ACEs). 

To summarize, as of June 12, 2022, COVID-19 has caused >570,000 cases among infants <1 

year of age and >1.9 million cases among children 1-4 years of age. The Omicron surge in the 

US led to the highest numbers of COVID-19 cases, ED, and hospitalization rates seen during 

the pandemic. Children 6 months through 4 years of are at risk of severe illness from COVID19. More than half of hospitalized children ages 6 months through 4 years had no 

underlying conditions. During Omicron predominance, COVID-19-associated hospitalizations 

among children ages 6 months through 4 years have similar or increased severity compared to 

older children and adolescents. The burden of COVID-19 hospitalization is similar to or exceeds 

that of other pediatric vaccine preventable diseases. The COVID-19 pandemic continues to 

have significant impact on families and increases disparities.

Updates on VE of COVID-19 Vaccines in Children and Adolescents

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

predominance. A booster dose in adolescents significantly improved VE initially, although there 

was waning. 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 both age groups, with some waning 

for hospitalization in adolescents. There was high VE in children and adolescents against 

hospitalizations and MIS-C. 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.

Moderna COVID-19 Vaccine (mRNA-1273): Safety, Immunogenicity, and Efficacy in 

Children 6 Months through 5 Years of Age

Rituparna Das, MD, PhD (Moderna) provided an update on the use of mRNA-1273 as a 2-

dose primary series for the prevention of COVID-19 caused by SARS-CoV-2 in young children 

2-5 years of age and infants and toddlers 6-23 months of age where the greatest increase has 

been seen in the burden of hospitalization with the Omicron surge. The proposed 2 doses at the 

25μg per dose level are to be administered 1 month apart. Moderna’s data in these age groups 

comes from Study 204 in which more than 6,500 infants, toddlers, and young children were 

enrolled and more than 5,000 received ≥1 25μg dose of mRNA-1273. Overall, this represents a 

substantial safety database for these groups. The median safety follow-up times in both age 

groups are more than 2 months. In the early cohorts, which is the dose-finding part of the study, 

there are children with 7 to 8 months of median safety follow-up.
ACIP Meeting Summary June 17-18, 2022

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Study 204 was conducted in 2 parts for each of the age strata. Part 1 was an open-label, doseescalation, age de-escalation study that was conducted to select a dose-level for further testing 

in Part 2, which was the placebo-controlled part of the trial. Both 25μg and 50μg were studied in 

the children 2-5 years of age. The 25μg dose was chosen for these older children. The 50μg

formulation was not investigated in the younger children. Overall, the 25μg dose was chosen for 

both age groups because it showed an acceptable tolerability profile and demonstrated a high 

likelihood of meeting the pre-specified immunogenicity success criteria for this study. After Part 

1 was completed, a Data and Safety Monitoring Board (DSMB) meeting was convened to 

ensure the committee’s concurrence with the selected dose. Part 2 was designed to randomize 

the children in a 3:1 ratio to receive either mRNA-1273 or saline placebo. The children will be 

followed for 12 months after receiving their last dose of vaccine. The data presented during this 

session focused on the randomized phase of the study. Overall, the demographics were wellbalanced between the vaccine and placebo cohorts in both age groups. The mean age was 

approximately 16 months in the youngest group and 3 years in the older age group. Gender, 

race, and ethnicity also were well-balanced.

The specific safety objectives included solicited, local, and systemic adverse events (AEs)

collected for 7 days post-vaccination. Unsolicited adverse events were captured for 28 days

after each vaccination. And serious AEs, medically attended AEs (MAAE), and AEs of special 

interest (AESI), including myocarditis, pericarditis, and MIS-C, were followed throughout the 

entire study. In children 2-5 years of age, pain was the most common event, with similar rates 

and severity following Dose 1 and Dose 2. Most local AEs, including pain, were Grade 1 or 

Grade 2, with few Grade 3 reactions. The median duration of local AEs in this age group was 2

to 3 days. In infants and toddlers 6-23 months of age, pain was the most common local AE,

although reports of pain in this youngest group were more similar to placebo both post-Dose 1

and post-Dose 2 compared to the older age group. Systemic adverse reactions were evaluated 

according to age. Young children’s events were fever, headaches, fatigue, myalgia, arthralgia, 

nausea, vomiting, and chills. For infants and toddlers, the events were fever, irritability, crying, 

sleepiness, and loss of appetite. Headache and fatigue were the most common systemic 

adverse reactions in the children 37 months to 5 years of age. Among the vaccine recipients,

systemic adverse reactions were more frequent post-Dose 2 compared to post-Dose 1,

although this difference was less pronounced than seen in older age groups. The duration was 

2-3 days, which is very consistent with other age groups. Reporting rates of systemic adverse 

reactions were similar between Dose 1 and Dose 2. Systemic events were reported at similar 

rates among vaccine and placebo recipients.

Fever is a particularly important event in the assessment of pediatric vaccines. In terms of 

fevers by increments among children 6 months through 5 years of age, fever after any dose 

occurred in about a quarter of the children. The distribution of temperatures was similar between 

the two age groups. Fevers of >40oC (>104oF) were rare. Fevers occurred more frequently 

following Dose 2 in children 2-5 years of age. It is important to note that most reports of fever 

were less than 39.0oC. Fevers in infants and toddlers also are reported more commonly postDose 2. The rates of fever greater than 39.0oC in this youngest group were similar to placebo.

Beyond Day 2, fever rates in children receiving mRNA-1273 were similar to placebo. The 

median duration of fever in this age group was 1 day. It is important to note that this study was 

conducted during the winter months when respiratory tract infections are prevalent. This is 

evident by the relatively high rates of fever observed in the placebo group. A similar pattern was 

seen in infants and toddlers, with the peak of fever occurring on Days 1 and 2 after vaccination. 

On subsequent days, fevers looked similar across the vaccine and placebo groups. The higher 

background rate of fever is even more prominent in the infants and toddlers. There were 15 

children with fever >40oC (>104oF) in the mRNA group and 3 in the placebo group. The peak 
ACIP Meeting Summary June 17-18, 2022

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temperature of >40oC had a duration of less than 1 day. Of the 15 vaccine recipients, 5 of the 

children also had symptoms of concurrent viral infections. There was 1 febrile seizure that 

occurred proximal to vaccination and was considered related by the investigator. Febrile 

seizures can occur in up to 5% of young children. The child in this study also had a 

maculopapular rash onset 2 days after the seizure and went on to have a subsequent seizure 

associated with another fever approximately 6 weeks later. The child has remained in the study 

and received Dose 2 of the vaccine without events.

In terms of unsolicited AEs, this analysis presented events reported up to 28 days after any 

injection in children 2-5 years of age. The incidence of unsolicited AEs was similar among 

vaccine and placebo recipients. There were no SAEs considered to be related by the

investigator. Incidence of MAAEs were similar and there were no AEs that led to discontinuation

of the vaccine or from the study. After the data cutoff, one event of urticaria was reported on 

Day 1 post-vaccination that did lead to discontinuation. There were no events of death or AEs 

of MIS-C or myocarditis. Among the infants and toddlers, the incidence of unsolicited AEs 

overall and the MAAEs were similar among vaccine and placebo recipients. There was 1 SAE 

within 28 days that was considered related to vaccination as described in the fever discussion.

Since the data cut of Moderna’s submission in late February, the SAEs were pooled from the 

live database in early May to provide further reassurance of the long-term safety of mRNA1273. The updated analysis did not identify any new safety signals and there were no SAEs

considered by the investigator to be related to vaccination.

Turning to immunogenicity data, VE was successfully inferred by meeting the pre-defined coprimary immunogenicity objectives that were agreed to with the FDA. These included geometric 

mean concentration (GMC) and the difference in seroresponse. In each age group, immune 

responses were compared to the subset of persons 18-25 years of age in the immunogenicity 

subset from Study 301 in which primary efficacy of the vaccine against any and severe COVID19 disease was demonstrated. Immunogenicity for children 2-5 years of age compared to young 

adults was 1.01 (0.88, 1.17). The seroresponse rates were close to 100%, with a difference of 

-0.4% (-2.7,1.5). For infants and toddlers 6-23 months of age, both co-primary immunogenicity 

endpoints also were met. The ratio compared to young adults was 1.28 (1.12, 1.47). In addition, 

the seroresponse rate was 100%. The group difference was 0.7% (-1.0, 2.5). The immune

response to mRNA-1273 has been remarkably consistent across age cohorts despite

administering lower doses to young children. Across all age groups from young adults 18-25

years of age through the youngest children in the pediatric program of infants and toddlers 6-23 

months of age, the geometric mean ratio (GMR) ranged from 1.01 through 1.28, successfully 

meeting all primary immunogenicity hypotheses in all age groups. Additionally, support for VE 

was provided through assessments of efficacy in the study demonstrated that in all age groups, 

there was comparable effectiveness to adults when the variants were matched. Although no 

serious severe cases of COVID-19 were seen in the children at the time of data cutoff, this 

consistency led Moderna to believe that protection against severe disease will be comparable to 

adults, which will be evaluated in post-authorization effectiveness studies. To expand upon this, 

the studies were conducted as the SARS-CoV-2 in the pandemic was changing. This is 

important when interpreting the efficacy results in the 2 youngest age cohorts. The enrollment 

and efficacy follow-up in the youngest children was conducted when the Omicron variant was 

predominant. From December 2021 through March 2022, the US incidence of SARS-CoV-2 

infections rose from fewer than 200,000 per day to a peak of 1.4 million cases per day, which 

was when these youngest cohorts were followed.
ACIP Meeting Summary June 17-18, 2022

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While the study was not powered for assessment of efficacy, it was possible to get good efficacy 

estimates given the high rates of community SARS-CoV-2 transmission when these randomized 

cohorts were conducted. There were 2 case definitions for COVID-19 used, the CDC case 

definition that required at least 1 symptom and the Study 301 case definition that required 2 

systemic symptoms or 1 respiratory symptom. The CDC case definition was considered primary 

because children tended to have less severe symptoms of COVID-19 than adults. Of note, both 

definitions required a nasal swab positive by reverse transcriptase polymerase chain reaction 

(RT-PCR) for SARS-CoV-2 and a comprehensive approach was taken to capturing cases.

Efficacy estimates in the young children are based on 180 cases captured over 71 days postDose 2. Beginning with the children 2-5 years of age, there was a lower incidence of COVID-19 

by both definitions in children who received vaccines compared to those who received placebo. 

Statistically significant VE of 36.8% was observed using the CDC definition. With the Study 301 

case definition, number of cases was reduced, but efficacy of 46.4% was observed. This also 

was demonstrated by the cumulative incidence curve for COVID-19 by the CDC case definition. 

For infants and toddlers 6-23 months of age, efficacy estimates were based on 85 cases 

captured over 71 days post-Dose 2. There was statistically significant efficacy in this cohort of 

50.6% when the CDC definition is used. With the Study 301 definition, the point estimate was

directionally similar and the confidence intervals were wider due to the drop in the number of 

cases.

At the start of the Omicron wave, parents were reluctant to bring their youngest children into the

study site for illness visits. Instead, they were calling in results of positive home antigen tests.

Given that the home antigen test results also were captured, a sensitivity analysis was done that 

defined COVID-19 either by positive PCR or home antigen tests. With the increased number of 

cases captured, the confidence intervals narrowed and the point estimates for efficacy were 

53.5% and 43.7%, with the confidence intervals excluding zero. This also was demonstrated in 

the cumulative incidence curve for COVID-19 by the CDC case definition in the younger age 

groups. For context of the efficacy, real-world effectiveness in adults during the Omicron surge

was assessed to help interpret VE from the pediatric program. For real-world effectiveness data

against Omicron after a 2-dose primary series among adults, data were used from Moderna’s 

collaboration study with the Kaiser Permanente health system. VE of mRNA-1273 against

COVID-19 was 44% when the Omicron variant was predominant. In Study 304 in infants and 

young children, efficacy of mRNA-1273 was consistent with effectiveness observed in adults.

While VE against any infection was lower during Omicron, the benefits of mRNA-1273

continued to be seen against hospitalization. Two doses of mRNA-1273 were shown to be 84% 

effective against hospitalization during the Omicron period. This is important because the same 

level of protection would be expected in children, given the consistency of the immune response 

and the efficacy with adults. Study 204 is ongoing and safety follow-up will continue for all 

participants. All children will be offered a booster dose after their second dose, and they will be 

boosted either with mRNA-1273 or Moderna’s bivalent Omicron-containing vaccine.

In summary, mRNA-1273 was well-tolerated. Local and systemic reactions were seen less

frequently in the youngest age groups. Solicited adverse reactions were mostly Grade 1 or 2 

and slightly more common after Dose 2. Fever was reported in about a quarter of children and 

most commonly seen on Day 1 or 2 after each dose and resolved within 1 day. No deaths, 

myocarditis, pericarditis, or MIS-C were reported among vaccine recipients. There was 1 related 

SAE of febrile seizure within 28 days of any vaccination. The primary immunogenicity objectives

were met and demonstrated that 2 doses of mRNA-1273 were immunogenic. GMCs and

seroresponse rates were non-inferior to young adults. VE can, therefore, be successfully 

inferred based on immunogenicity. In both age groups, direct efficacy against COVID-19 was 

observed during the Omicron period. This is consistent with effectiveness observed in adults.
ACIP Meeting Summary June 17-18, 2022

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Based on the information shown during this session, Moderna has demonstrated that the 

benefit-risk profile for mRNA-1273 is strongly favorable in children 6 months through 5 years of 

age. 

Safety, Immunogenicity, and Efficacy of BNT162b2 (COVID-19 Vaccine, mRNA) in 

Children 6 Months through 4 Years of Age

William C. Gruber, MD, FAAP, FIDSA, FPIDS (Pfizer, Inc.) presented data supporting 

BNT162B2 (COVID-19 Vaccine, mRNA) in children 6 months through 4 years of age with a 

focus on Phase 2/3 clinical data on safety, immunogenicity, and efficacy and an assessment of 

benefit-risk. In terms of the clinical data that supports recommendations for this age group

beginning with children 5-11 years of age, nearly 19% of children 2 to <5 years of age who 

received 10μg developed fevers after the first and second doses. Of these fevers, 1/3 were 

severe. This could be poorly accepted by parents, reducing adherence to the primary 3-dose 

series. In contrast, the 3μg doses had a much better tolerability profile combined with

comparable to better immune responses to the SARS-CoV-2 reference strain. Therefore, the 

3μg doses level was advanced into Phase 2/3. 

To infer efficacy in the pediatric population in the pivotal study, immunological non-inferiority

to persons 16-25 years of age for whom efficacy was established was assessed in addition to 

safety to satisfy EUA immune response criteria and infer efficacy. Although not required for EUA 

approval, COVID-19 surveillance was conducted, permitting an early evaluation of VE. Children 

were administered 2 doses 21 days apart. A third dose was administered at least 60 days later.

Current follow-up includes 1-month post-Dose 3 serology and efficacy to the data cutoff of April

29, 2022. All safety data presented was from the blinded placebo-controlled follow-up period for 

children 2 to <5 years of age and then 6 months to <2 years of age. Demographics in the 2 to 

<5 age group were balanced between the vaccine and placebo groups in terms of gender, race, 

ethnicity, SARS-CoV-2 exposure, and comorbidities.

Local reactions captured by eDiary over 7 days were mostly mild to moderate in severity, 

somewhat higher in vaccine recipients compared to placebo recipients, and did not show an 

increase from Dose 2 to Dose 3. Local reactions were higher or similar in frequency and 

severity in those with evidence of prior SARS-CoV-2 infection at baseline and all were within a 

well-tolerated range. There were no Grade 4 local reactions. Systemic symptoms solicited by

eDiary were mostly mild to moderate and comparable after each dose. Fever, fatigue, or other 

symptom rates were remarkably similar to those seen in placebo recipients at each of the 3 

doses and much lower than those in older age groups immunized with a higher dose level.

Fever rates were comparable or lower than for other childhood vaccines. Only 3, or less than 

0.2%, of BNT162B2 participants recorded fever greater than >40.0°C after Dose 1 or 2 starting

on Day 2, Day 4, or Day 6. All returned to normal 6 to 7 days after the dose, one of whom had a 

presentation suggestive of a viral exanthem. None of these required hospitalization and all 

resolved quickly. Systemic symptoms were higher or similar in frequency and severity in those 

with evidence of prior SARS-CoV-2 infection at baseline and all were within a well-tolerate 

range. This highly favorable tolerability profile for the Pfizer-BioNTech vaccine should be 

reassuring to parents and care providers.

In children 2 to <5 years of age, blind and safety follow-up occurred from the time of Dose 2 to 

Dose 3 or cutoff date for a median of 4.0 months and for Dose 3 to the cutoff date for a median 

of 1.4 months. Overall, unsolicited AEs related to AEs, SAEs, withdrawals were infrequent and 

comparable between the vaccine and placebo groups. There were 3 (0.2%) subjects in the 

vaccine group who were withdrawn from the study due to AEs (e.g., pyrexia considered related, 
ACIP Meeting Summary June 17-18, 2022

9 

status epileptic considered unrelated, and urticaria considered unrelated). There was 1 

participant in the placebo group who was withdrawn due to facial swelling and rash that were 

considered related. There were no deaths reported in this age group. AEs, as defined by system 

organ class (SOC), were comparable between vaccine and placebo group.

Now looking at children 6 months to <2 years of age, the demographics were balanced between 

the vaccine and placebo groups related to gender, race, ethnicity, prior SARS-CoV-2 infection, 

and comorbidity. Local reactions in this age group, with and without prior SARS-CoV-2 infection, 

were mild to moderate with incidence somewhat higher in vaccine recipients. Local reactions

were somewhat higher or similar in frequency and severity in those with evidence of prior 

SARS-CoV-2 infection at baseline and all were within a well-tolerated range. There were no 

Grade 4 events and frequency remained relatively the same after each dose, which is 

consistent with a well-tolerated vaccine. Fever, decreased appetite, drowsiness, and irritability 

were mostly mild to moderate, similar to placebo rates, lower than those observed in older 

children and adults, and comparable to those after other childhood vaccines. Fever >40.0 °C

was recorded by only 3 vaccine recipients (<0.1%) for each dose starting on Day 1, Day 2, or 

Day 3. All returned to normal 5 to 6 days after Dose 2 among those who had a concurrent viral 

infection. One fever >40.0 °C was reported by a placebo recipient after the first dose. None of

these required hospitalization and all resolved quickly. Systemic symptoms were somewhat 

higher or similar in frequency in severity in those with evidence of prior SARS-CoV-2 infection at 

baseline and all were within a well-tolerated range. The overall incidence at low severity of

systemic symptoms speaks to a favorable tolerability profile, which should be reassuring to 

parents and care providers.

Safety follow-up in children 6 months to <2 years of age included blinded follow-up from the 

time of Dose 2 to Dose 3 or the cutoff date for a median of 6.3 months and from Dose 3 to the 

cutoff date for a median of 1.3 months. Any AEs, related AEs, SAEs, and withdrawals were

infrequent and comparable between the vaccine and placebo groups. Three participants (0.3%) 

in the BNT162B2 group were withdrawn from the study due to AEs that all were related. Of 

these, 2 were due to fever >40.0 °C and had a viral exanthem that was unrelated. One

participant was withdrawn due to a generalized rash on the face and trunk. There were no 

deaths reported in this age group. AEs defined by SOC were comparable between vaccine and 

placebo recipients.

Few AESIs were recorded among children 6 to <5 years of age. Predominant categories with 

potential angioedema and hypersensitivity comprising mainly urticarias and rashes were

balanced between groups. No CDC-defined AESIs were observed. The carefully selected dose 

level of 3μg for the BNT162B2 vaccine was shown to have a favorable safety profile and was 

well-tolerated in infants, toddlers, and very young children. Vaccine reactions were mostly mild 

to moderate and were short-lived with systemic reactions comparable to placebo. Reactions

were comparable after Doses 1, 2, and 3. The unsolicited AE profile mostly reflected

reactogenicity or common childhood illness. Favorable safety profiles should encourage vaccine 

adherence for each of the 3 doses.

Demonstration of non-inferior immune response in children <5 years of age compared to

immune response in persons 16-25 years of age after 2 doses was judged by the FDA to be 

sufficient to meet immunologic success criteria for EUA. The immunobridging criteria for 

children 2 to <5 years of age were not met for GMR, but were met for seroresponse after Dose

2. GMR children 2 to <5 years of age compared to those in persons 16-25 years of age after

Dose 2 was 0.61(0.53, 0.70), which failed to meet the immunobriding criteria. However, the 

difference in seroresponse in these groups of -0.9 (-4.3, 2.3) the lower bound of the 95% 
ACIP Meeting Summary June 17-18, 2022

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confidence interval for the percentage difference is greater than -10. Success was not declared 

due to not meeting the GMR criterion. However, in consultation with the FDA, a similar 

comparison was made between GMTs in children 2 to <5 compared to persons ≥65 year of age 

in the pivotal efficacy trial. In this case, the GMR was 1.92 at the lower bound of 1.56, which 

was well above the 0.679 inferior criterion. Although this was a post-hoc analysis, VE in persons

≥65 years of age was 94.5%, so the non-inferior immune response seen in children 2 to <5 

years of age is likely to predict efficacy. Notably, 45.9% efficacy was observed in children 2 to 

<5 years of age after the second dose. Despite the likely benefit of a level of 35.9% efficacy

after Dose 2, based on the growing importance of Omicron, Pfizer judged the 3-dose series as 

important to provide improved protection just as is required for every other age group. The 

immunobridging criteria for children 6 months to <2 years of age compared to persons 16-25

years of age were both met. Immunobridging criteria were met for both the GMR at 1.03 (0.90, 

1.19) and a difference in seroresponse at 1.7% (-1.4, 5.2). Based on observed efficacy data, 

Pfizer judged that in an Omicron-predominant environment, a 3-dose series would prove 

necessary for a high level of protection.

Immunobridging criteria in children 2 to <5 years of age were met for both GMR and 

seroresponse comparing post-Dose 3 responses to post-Dose 2 responses in persons 16-25

years of age, which infers VE after Dose 3 in this age group. The median dosing time between 

Dose 2 and Dose 3 was 10.7 weeks. The GMR observed was 1.30 with a lower bound

of 1.13, which was well above the 0.67 success criteria. Likewise, the difference in 

seroresponse was 1.2% with a lower bound of -1.5%, which was well above the -10% noninferiority success criteria. Among children 6 months to <2 years of age, immunobridging criteria 

were met for both GMR and seroresponse, which infers VE in this age group. Median dosing 

time between Dose 2 and Dose 3 was 12.9 weeks. GMR was 1.19 with a lower bound of 1.00, 

well above the 0.67 required success criteria. The difference in seroresponse was 1.2% with a 

lower bound of -3.4, which was well above the -10% required success criteria. For both the 

younger children and older children, immunobridging criteria were met, inferring VE. 

Given that most current COVID-19 cases are caused by Omicron, Pfizer also evaluated the 

ability of 2- and 3-dose immune sera in children 6 months to <5 years of age to neutralize 

Omicron compared to sera from adults 24-74 years of age in the sentinel cohorts from the 

licensing trial. Immune responses to Omicron were compared to those of the reference vaccine 

strain using a plaque reduction neutralization test (PRNT). There were comparable immune 

responses across all 3 age groups to the reference strain and Omicron. However, as reported 

by several groups, Omicron responses after only 2 doses were uniformly low across the

pediatric and adult age groups. Low Omicron neutralization titers after 2 doses seems to

correlate with lower efficacy against 2 vaccine doses of Omicron. However, this changes when 

serum samples after 3 doses are being evaluated. In this dataset, an adult comparative group 

was used who received the third dose at a similar time interval after the second dose in the 

pediatric group at about 11 to 13 weeks. The neutralizing antibody responses were measured 

using a fluorescent focused neutralization assay. For children 6 months to less <2 years of age 

and children 2 years to <5 years of age, the Omicron-specific neutralization titers after 3 doses 

were far higher than those after 2 doses. The Omicron-specific titers were very similar across 

age groups. Most importantly, the pediatric group titers were essentially the same as in the adult 

group, predicting that similar efficacy could likely be observed for children 6 months of age to <5 

years of age after Dose 3. 
ACIP Meeting Summary June 17-18, 2022

11

Regarding the immunogenicity conclusion in children 6 months to <5 years of age, 

immunobridging criteria were partially met after Dose 2. All immunobridging criteria post-Dose 3 

in young children required for an EUA were met for both age groups, inferring effectiveness.

Omicron neutralization titers were low after 2 doses for pediatric and adult cohorts, but 

increased substantially after a third dose in children 6 months to <5 years of age similar to the 

levels observed in adults. 

In terms of what has been learned from the adult and pediatric experiences about potential VE 

against COVID-19, the Delta surge ended prior to the third dose so no children were exposed to 

Delta after the third dose. Observed efficacy against Delta post-Dose 2 is favorable across all 

age groups post-Dose 2. The emergence of Omicron presented a new challenge. For children 6 

months to <5 years of age post-Dose 2, efficacy was 21.8% (-1.7, 39.7). This is consistent with 

the antibody response after the second dose. Cases post-Dose 3 in this clinical study were 

confirmed to be Omicron. Efficacy rose to 80.3% overall and was correspondingly high for the 

respective age groups. This is consistent with the higher antibody response seen after the third 

dose against Omicron, like that of older children and adults, and is consistent with 

corresponding higher efficacy in older children and adults after a third dose against Omicron.

Overall, VE observed over the period of blinded observation after Dose 2 in children 2 to <5 

years of age was 35.9% in those without prior evidence of SARS-CoV-2 infection and 34.3% in 

those with or without prior evidence of SARS-CoV-2 infection. For children 2 to <5 years of age, 

there appeared to be increasing efficacy over 210 days. The interval is important in terms of 

observation after Dose 1 and is largely driven by the efficacy after the second dose since cases 

after the third dose represent a small minority of total cases. This supports a likely benefit after 

the second dose in this age group. The potential benefit of the second dose is not as readily 

apparent in children 6 months to <2 years of age. Some VE after Dose 2 is likely to be inferred 

by the observed 35% efficacy in at least children 2 years to <5 years of age. However, the 

immune response data shared during this session and the descriptive efficacy show that 3 

doses of the BNT162B2 vaccine are in the best interest of children to provide a high level of 

protection against Omicron, observed to be 80.3% with lower bound of 95% confidence interval 

of 13.9 in children 6 months to <5 years of age.

With regard to what can be concluded about efficacy for children 6 months to <5 years of age, 

as demonstrated in other pediatric and adult age groups, 2 doses of BNT162b2 are protective 

against variants of concern such as Delta, but do not provide adequate protection against 

Omicron. As demonstrated in other pediatric and adult age groups, a third dose is necessary to 

provide high protection against Omicron. Ongoing pharmacoepidemiology, including 5 pediatric 

studies, and proactive risk mitigation and pharmacovigilance will be extended to this younger 

age group. The potential benefits of vaccinating children 6 months to <5 years of age outweigh 

the known potential risk. This age group is currently unprotected. Protection against COVID-19 

is critical, particularly given the unpredictability of potential new waves and emergence of new 

variants of concern. Available safety, immunogenicity, and efficacy information support a highly 

favorable benefit risk profile for administration of 3 doses of BNT162B2 at 3μg to children 6 

months to <5 years of age. 
ACIP Meeting Summary June 17-18, 2022

12

mRNA COVID-19 Vaccines in Young Children: Summary and WG Interpretation

Sara Oliver, MD, MSPH (CDC/NCIRD) briefly summarized the COVID-19 Vaccine WG’s 

interpretation of the data presented from Moderna and Pfizer on mRNA COVID-19 vaccines in 

young children. As a reminder, the Moderna trial among children 6 months through 5 years of 

age was conducted from December 2021 through February of 2022, with case accrual after a 

second dose at the height of the Omicron surge. Children 6 months through 5 years of age in 

the US and were randomized 3:1 vaccine to saline placebo. The analyses were performed 

separately for children 6-23 months of age and 2-5 years of age. The results were pooled for a 

combined estimate of children 6 months through 5 years of age. The Moderna schedule is 2 

doses of 25μg separated by 28 days. The median follow-up time post-Dose 2 was 2.5 months.

For the overall population, there were over 6,000 children included in the efficacy and safety 

analyses who were randomized 3:1. A subset of nearly 500 children were included in the 

immunogenicity analysis. For the efficacy endpoint among subjects with or without evidence of 

prior infection, VE was 50.9% (21.4-68.6%) for children 6-23 months of age and 36.5% (12.5-

54.0%) for children 2-5 years of age. The overall VE for children 6 months to 5 years of age was 

41.5% (23.8–55.0%). There is higher confidence in this estimate based on 181 COVID cases in 

the vaccine group and 97 cases in the placebo group. In addition, efficacy in this trial is 

consistent with a post-authorization VE for the Moderna vaccine in adults 18-64 years of age 

during Omicron for whom VE against infection 2 months after Dose 2 was 35% (24%-45%). 

Regarding immunogenicity data, the antibody levels were measured 28 days after the second 

dose for participants without prior infection. The antibody responses after 2 doses at 25μg each 

in children 6 months to 5 years of age compared to 2 doses at 100μg each in individuals 18-25 

years of age met inferiority criteria with a ratio of 1.28 (1.12–1.47) in children 6-23 months of 

age and a ratio of 1.01 (0.90–1.17) in children 2-5 years of age. Regarding safety data, no 

deaths were reported in any trial participants. SAEs were rare overall, occurring in 0.5% of 

vaccine recipients and 0.2% of placebo recipients. One vaccine recipient had 2 SAEs, a fever 

and febrile seizure, that were deemed possibly related to the vaccine by FDA. No cases of 

myocarditis or anaphylaxis were noted in any trial participants.

Local reactions, such as pain at the injection site, were common. Systemic reactions also 

occurred in the children 2-5 years of age. Fatigue and headache were the most common. In the 

younger children 6-23 months of age, irritability and sleepiness were most common. Symptoms 

typically started 1 to 2 days post-vaccine and resolved after 2 to 3 days. Fevers were more 

common after vaccine in the placebo group and were more common after Dose 2 than Dose 1. 

Most fevers were reported in the first few days after vaccine and lasted for around 1 day. Fevers 

after the second dose were 16%. However, fevers for other routine vaccines given at this age, 

such as the pneumococcal vaccine, can be around 30%. There was 1 febrile seizure that was 

possibly related to the vaccine.

The WG also noted imbalances with some respiratory infections, such as respiratory syncytial 

virus (RSV). However, in the context of all respiratory infections, including COVID, no

imbalances were noted. The events were rare in less than 1% of trial participants. In addition, 

there was no patterning or clustering of the cases. The clinical characteristics were typical and 

consistent with seasonal respiratory infections. In addition, testing was not performed

systematically for all patients and was at the discretion of the clinician evaluating the patient.

Because of this, testing for additional respiratory pathogens may have varied by the results of 

COVID-19 testing. Lymphadenopathy was a solicited AE. Lymphadenopathy, either in the 
ACIP Meeting Summary June 17-18, 2022

13

axillary region or the groin, was noted in 9% of vaccine recipients compared to 2% of placebo 

recipients.

In conclusion, the efficacy seen after 2 doses of the Moderna COVID-19 vaccine in children 6 

months through 5 years of age is consistent with real-world VE in other ages during Omicron 

predominance. The antibody levels after 2 doses in children 6 months through 5 years of age 

produces similar antibody levels seen after 2 doses in individuals 18-24 years of age. 

Reactogenicity post-vaccine is consistent with other recommended vaccines in this age group.

Moving now to the Pfizer-BioNTech COVID-19 vaccine in children 6 months to 4 years of age, 

the clinical trial was conducted from June 2021 through April 2022. Children 6 months to 4 years 

of age in the US were randomized 2:1 vaccine to a saline placebo. The analyses were

performed separately for the 2 age groups and were then pooled for a combined analysis. This 

series is 3 of 3μg each, with Dose 1 and Dose 2 separated by 21 days and Dose 2 and Dose 3 

separated by at least 8 weeks. Note that the interval between Dose 2 and Dose 3 in the trial 

was longer than the authorized interval. Among children 6-23 months of age, the interval was 16 

weeks with a range of 8-32 weeks. For children 2-4 years of age, the interval was 11 weeks with 

a range of 8-34 weeks. In addition, the median follow-up time post-Dose 3 was 1.3 months.

In terms of timing in the Pfizer trial, children 2-4 years of age began receiving their first doses in 

June and second doses in July. However, per protocol, the investigators began unblinding 

participants 6 months after the second dose around December 2021 and into January and 

February 2022. Based on analyses after the second dose, the protocol was amended in 

February 2022 and third doses were given. However, by then, many of the initial cohort from the 

trial were unblinded and placebo crossover had already occurred. After FDA’s request to

expand the size of the trial, expanded safety enrollment began. This cohort began receiving 

doses in October and November, with third doses starting in February and March. Blindedperson time contributing to the Dose 3 efficacy and safety evaluation was from February 

through April, which was when the cases began declining after the Omicron surge. For children 

6-23 months of age, the same phenomenon occurred in which participants were unblinded 6 

months after the second dose. In terms of the impact unblinding had on the total number of 

participants who contributed blinded-person time to the efficacy and safety evaluations, there 

were about 2,700 children 2-4 years of age and about 1,700 children 6-23 months of age. By 

Dose 3, much of the population had been unblinded, with 32% of the overall eligible population 

contributing blinded-person time to the efficacy and safety evaluations.

Efficacy estimates after the third dose in subjects with or without evidence of prior infection were 

75.5% (-370.1–99.6%) among children 6-23 months, 82.3% (-8.0–98.3%) among children 2-4 

years of age, and 80.3% (13.9–96.7%) overall among children 6 months through 4 years of age.

However, the confidence intervals were wide. There is lower confidence in these estimates 

based on 3 COVID-19 cases in the vaccine group and 7 COVID-19 cases in the placebo group. 

For comparison and context, post-authorization VE against infection for the Pfizer COVID-19 

vaccine in adolescents 12-15 years of age during Omicron was 29% 2 months after Dose 2

and 43% 2 months after Dose 3. Overall, the WG felt that the post-Dose 3 efficacy data are

difficult to interpret. There were a limited number of cases during the blinded follow-up. In 

addition, the protocol specified a need for 21 cases prior to the formal efficacy analysis and only 

10 were included in the interim descriptive analysis. Importantly, the dosing intervals between 

Dose 2 and Dose 3 varied and are longer than the authorized interval. The median blinded 

follow-up time is limited, with the median time of 35 days for children 6-23 months of age and 40 

days for children 2-4 years of age.
ACIP Meeting Summary June 17-18, 2022

14

Antibody levels were measured 1-month post-Dose 3 for participants without prior infection.

Antibody responses after three 3μg doses in children 6 months to 4 years of age compared to 

two 30μg doses in individuals 16-25 years of age met the non-inferiority criteria. The ratio for 

children 6-23 months of age was 1.19 (1.00–1.43), the ratio for children 2-4 years of age was 

1.30 (1.13–1.50), and the overall ratio for children 6 months through 5 years of age was 1.26 

(1.13–1.40). The immunogenicity population was comprised of 82 children 6-23 months of age 

and 143 children 2-5 years of age for a total of 225 children. For comparison and context, the 

WG reviewed the results that were seen after Dose 2. For children 6-23 months of age, VE was 

minimal VE 14.5% (-24.9–41.0%). However, the non-inferiority criteria were met. Some 

protection was noted for children 2-4 years of age with a VE of 33% (9.1–51.3%), but the noninferiority criteria were not met. 

From a safety standpoint, no deaths were reported in any trial participants. SAEs were rare 

overall and occurred in 1% of vaccine recipients and 1.5% of placebo recipients. One vaccine 

recipient had 2 SAEs, fever and pain in an extremity requiring hospitalization that were possibly 

related to the vaccine. However, the FDA felt the symptoms were potentially consistent with viral 

myositis. No cases of myocarditis or anaphylaxis were noted in trial participants. Local reaction, 

such as pain or tenderness at the injection site, occurred within 7 days and were common.

Fatigue was the most common systemic symptom in children 2-4 years of age. Irritability and 

drowsiness were more common in children 6-23 months of age. Overall, the reactions were 

comparable after Doses 1, 2, and 3. Most symptoms were mild and resolved after 1 to 2 days. 

Fevers were reported with similar frequency after both vaccine and placebo and after Doses 1, 

2, and 3. Most fevers were reported on Days 1 and 2 after any dose and lasted for a median of 

1 day. 

In conclusion, antibody levels after the 3 doses of Pfizer-BioNTech COVID-19 vaccine in 

children ages 6 months through 4 years of age produce similar antibody levels after 2 doses in 

individuals 16-24 years of age. Reactogenicity post-vaccine was similar after each of the 3 

vaccine doses and similar to reactions seen in placebo recipients. However, the efficacy

estimates after 3 doses are difficult to interpret given the small numbers and limited follow-up 

time. The WG noted that the impact of the longer intervals in the trial between Dose 2 and Dose 

3 on efficacy, reactogenicity, and safety are unknown.

Regarding the WG’s interpretation in total, the mRNA COVID-19 vaccine clinical trials in young 

children were both conducted during Omicron predominance but at different months and 

incidence levels. In addition to differences in the number of participants in the efficacy analyses 

and differences in follow-up time, these incidence levels impacted COVID-19 case accrual

and certainty in the efficacy estimates. Because of this, the efficacy estimates for these 2 mRNA 

vaccines cannot be directly compared. However, both vaccines met the non-inferiority criteria

from neutralizing antibody levels. Notably, the current data are for either a 2-dose or 3-dose 

primary series. To achieve the criteria set by FDA for authorization, 2 doses for Moderna or 3 

doses of the Pfizer vaccine were required. For individuals 5 years of age and older, 2 doses

achieved the preset efficacy requirements or the required antibody levels for immunobridging. A 

booster was then provided to optimize the immune response and address waning of antibody 

titers detected after completion of the primary series. Post-authorization effectiveness studies 

can help determine the subsequent timing and need for boosters after a 2-dose series with 

Moderna or a 3-dose series with Pfizer. That booster would then be a third dose for the

Moderna vaccine and a fourth dose for the Pfizer vaccine in this age group. However, it is 

known that in other age groups during Omicron, mRNA COVID-19 vaccine post-authorization 

VE was lower against infection, but higher protection was noted against severe disease. While 

the clinical trials were not powered to detect efficacy against severe disease in this young
ACIP Meeting Summary June 17-18, 2022

15

population, similar patterns in this age group are expected to what is seen in everyone 5 years 

of age and over.

In terms of next steps, Dr. Oliver noted that the EtR framework, including the GRADE summary

of the data, would be presented the next day at which time the WG would be discussing 2 

separate policy questions: 

“Should vaccination with Moderna COVID-19 vaccine (2-doses, 25μg, IM) be 

recommended for children 6 months – 5 years of age, under an Emergency Use 

Authorization?”

“Should vaccination with Pfizer-BioNTech COVID-19 vaccine (3-doses, 3μg, IM) be 

recommended for children 6 months – 4 years of age, under an Emergency Use 

Authorization?”

These 2 vaccines will not be compared. Instead, the comparison would be of each vaccine to no 

vaccine.

Session Overview 6-18-22

Dr. Matthew F. Daley (WG Chair) reminded everyone that on June 16, 2022, FDA granted 

EUA for the following: 











2-dose Moderna COVID-19 vaccine primary series for administration to individuals ages 6 

months through 5 years

3rd primary series dose to individuals ages 6 months through 5 years with certain kinds of 

immunocompromise

3-dose Pfizer-BioNTech COVID-19 vaccine primary series for administration to individuals 

ages 6 months through 4 years

2-dose Moderna COVID-19 vaccine primary series for administration to individuals ages 6 

through 17 years

3rd primary series dose to individuals ages 6 through 17 years with certain kinds of 

immunocompromise

On June 17, 2022, the ACIP heard presentations on the epidemiology of COVID-19 in young 

children; COVID-19 VE in children and adolescents; safety and immunogenicity of the Moderna 

COVID-19 vaccine 2-dose primary series in children 6 months through 5 years of age; safety 

and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine 3-dose primary series in children 

6 months through 4 years of age; and an ACIP COVID-19 Vaccine WG interpretation of safety, 

immunogenicity, and efficacy of Moderna and Pfizer-BioNTech COVID-19 vaccine primary 

series data.

The agenda for the second day of the meeting included presentations on implementation of 

pediatric COVID-19 vaccines; the EtR Framework on mRNA COVID-19 vaccines in young 

children; an update on Clinical Considerations; and votes on Moderna COVID-19 vaccine in 

children 6 months through 5 years of age and Pfizer-BioNTech COVID-19 vaccine in children 6 

months to 4 years of age.
ACIP Meeting Summary June 17-18, 2022

16

Implementation of Pediatric Vaccines

Kevin Chatham-Stephens, MD, MPH, FAAP (CDC/NCBDDD) discussed pediatric COVID-19 

vaccine planning for children 6 Months through 4 years of age, explaining that this very 

important vaccine rollout for children <5 years of age mimics the overarching goal in children 5-

11 years of age and the adolescent vaccine programs to ensure that all children have access to 

the vaccine. Similar to the vaccine rollout for children 5-11 years of age, the plan is to ensure 

that vaccine is widely available in different locations throughout communities through primary 

care providers (PCPs), urgent care facilities, hospitals, Federally Qualified Health Centers 

(FQHCs), Rural Health Centers (RHCs), commercial pharmacies, federal entities (e.g., DoD, 

IHS), public health programs in jurisdictions, and Head Start and other Early Care and 

Education (ECE) systems.

However, there also will be some key differences between the rollout for children 5-11 years of 

age and the rollout for children <5 years of age. For example, approximately a third of children 

5-11 years of age were vaccinated in pharmacies and just under 10% were vaccinated in 

school-located vaccination clinics. Those settings are anticipated to be less prominent in the

vaccine program for children <5 years of age in that pediatricians and family practice doctors in 

the medical home (e.g., private pediatric clinics, FQHCs, local health departments, et cetera) 

will play a larger role, especially for the younger children in this age group. Pharmacies are still 

anticipated to play a critical role in having the vaccine available at nights, on weekends,

and on holidays when clinics may be closed. In local health departments, especially in rural 

areas, federal partners such as Indian Health Service (IHS), and Health Resources and 

Services Administration (HRSA) FQHCs, and RHC will continue to serve critical roles in 

contributing to vaccine equity. ECE programs like Head Start and other support programs such 

as Women, Infants, and Children (WIC) will play more prominent roles in this vaccine program 

given their roles as trusted messengers to families of children in this age group.

To estimate how well a network of likely pediatric vaccine providers would cover children <5 

years of age, a mapping analysis was conducted to assess the proportion of children <5 years 

of age who reside within 5 miles of a likely vaccine provider. There are approximately 18,000 

non-pharmacy providers that have administered vaccines to children <5 years of age and about 

4,000 pharmacies that have expressed interest in offering vaccines to children <5 years of age. 

The mapping analysis found that when these 2 sets of providers are combined, approximately 

85% of children <5 years of age reside within 5 miles of likely vaccine providers and 94% live 

with 10 miles.

It is known that vaccinating in the medical home is incredibly important, as the medical home 

provides comprehensive primary care that facilitates partnerships between children’s families 

and clinicians, and routine immunizations typically occur in the medical home. For instance, 

approximately 80% of children 6 months through 4 years of age received influenza vaccine for 

the 2020-2021 influenza season in their doctor’s office. This is compared to the very low 

percentages of children this age group who are vaccinated at a pharmacy, including less than 

1% of children 6-23 months of age and approximately 4% of children 2-4 years of age. In 

addition to vaccination, the medical home is a location in which children also receive 

recommended screenings for a variety of issues (e.g., such as development, autism, vision, iron 

deficiency, lead poisoning) and are provided guidance that helps them thrive in a healthy and 

safe environment (e.g., nutrition, injury prevention, and chronic disease management).
ACIP Meeting Summary June 17-18, 2022

17

To better understand COVID-19 vaccine practices and intention to vaccinate children <5 years 

of age, CDC surveyed thousands of Vaccines for Children (VFC) providers in March 2020. Dr. 

Chatham-Stephens presented some of the preliminary unpublished results for all providers, as 

well as results by urban or rural location. Of note, these results were limited to those who were 

enrolled in the COVID-19 vaccination program. Most VFC (85%) providers have administered a

COVID-19 vaccine to children 5-17 years of age and almost three quarters (73%) of all 

providers intend to offer COVID-19 vaccination to children <5 years of age. This percentage is 

higher for urban providers at 76% compared with rural providers at 67%. Since not all clinics will 

have the vaccine and not all children have a medical home, CDC also asked whether the

practice intends to offer COVID-19 vaccination to children who are not currently patients of the 

practice. Approximately half of all providers said they would offer COVID-19 vaccination to 

children who are not currently patients of their practice. The percentage is higher for rural 

providers at 58% compared with urban providers at 49%.

In terms of some of the select activities CDC has conducted to support health departments, 

clinicians, and others, the agency disseminated an Operational Planning Guide over the past 

several months that includes characteristics of the vaccines, key planning assumptions, and a 

planning checklist. They also are We are also working on a “Dear Colleague” letter for VFC 

providers that emphasizes the importance of their role in this vaccination program and provides 

various tips and resources. CDC also has engaged in a variety of vaccine confidence 

bootcamps, which are great interactive trainings to provide partners and participants with 

strategies for building vaccine confidence in their communities. Examples that are particularly 

relevant in this discussion include bootcamps with the National Association of School Nurses

(NASN), early care and education partners, and YMCA. The agency also has shared 

jurisdiction-specific maps of likely vaccine providers for children <5 years of age. Jurisdictions 

have been able to use these maps to identify and then address gaps in provider availability. 

CDC’s communications experts continue to release resources to promote COVID-19 vaccine for 

children and teens, including social media graphics, videos, and customizable materials in 

various web pages available at https://www.cdc.gov/vaccines/covid-19/planning/children/ 

resources-promote.htm. 

The vaccines.gov site enables the public to identify nearby providers with vaccine in stock and

make an appointment, and it enables providers to report their COVID-19 vaccine inventory. To 

prepare for the rollout of vaccines for children <5 years of age, a new function will be added that 

enables the minimum age that can be vaccinated at a location in months and years to be

displayed. Providers can report these data now. The CDC will be monitoring inventory as the 

vaccines are delivered to clinics, pharmacies, and other clinical settings starting on Monday, 

June 20, 2022. In addition to vaccines.gov, parents and caregivers can reach out to their child’s 

pediatrician or family practice doctor, local health department, pharmacy, et cetera to ask if they 

have the vaccine. It is important to understand that not every clinic or pharmacy will receive their 

vaccine on June 20, 2022. Some vaccine providers were waiting for the EUAs and CDC’s 

recommendations before ordering the vaccine. They wanted to see the data to help them decide 

which of the 2 vaccines to order. CDC expects the vaccine provider network to expand as these 

providers order their vaccine post-EUA or post-ACIP voting.
ACIP Meeting Summary June 17-18, 2022

18

EtR Framework: mRNA COVID-19 Vaccines in Young Children

Sara Oliver, MD, MSPH (CDC/NCIRD) provided a combined EtR Framework presentation on

both Moderna COVID-19 vaccine in children 6 months through 5 years of age and PfizerBioNTech COVID-19 vaccine in children 6 months through 4 years of age in order to offer a 

comprehensive review of the entire program for both vaccines in this age group, given that they 

will rollout at the same time—something that has not occurred in the COVID-19 program to 

date. As a reminder, the EtR Framework is a structure to describe information considered in 

moving from evidence to an ACIP vaccine recommendation. This process provides 

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

recommendation. These 2 policy questions for this EtR framework were as follows:

“Should vaccination with Moderna COVID-19 vaccine (2-doses, 25μg, IM) be

recommended for children 6 months–5 years of age, under an Emergency Use 

Authorization?”

“Should vaccination with Pfizer-BioNTech COVID-19 vaccine (3-doses, 3μg, IM) be 

recommended for children 6 months–4 years of age, under an Emergency Use 

Authorization?”

In terms of the overall PICO (population, intervention, comparison, outcomes) for this analysis, 

the population was young children 6 months through 5 years of age or children 6 months 

through 5 years of age depending upon the vaccine focus. The comparison group for both

vaccines was to no vaccine. These 2 vaccines were not compared to each other. The outcomes 

of interest included symptomatic laboratory confirmed COVID-19, hospitalization due to COVID19, MIS-C, asymptomatic SARS-CoV-2 infection, SAEs, and/or reactogenicity of Grade ≥3.

For the public health problem domain, as of June 14, 2002, there were more than 85 million 

total recorded cases of COVID-19 in the US. Since April 2022, there has been an increasing 

number of cases, although perhaps with a slight decrease at the end of May 2022. At this point, 

the 7-day moving average was just over 100,000 cases. During the pandemic, over 570,000 

cases have occurred among infants and more than 1.9 million cases have occurred among 

children 1-4 years of age. Regarding COVID-19-associated hospitalization rates per 100,000 

population among children and adolescents 6 months through 17 years of age from CDC’s 

COVID-NET surveillance system, as with COVID-19 cases and ED visits, hospitalization rates 

increased during the Omicron surge to the highest rates seen during the pandemic. During

2022, the hospitalization rates were the highest among children 6 months through 4 years of 

age followed by children 5-11 years of age and adolescents 12-17 years of age. 

Cumulative COVID-19-associated hospitalizations in the same age groups further illustrate this 

point. During the Omicron surge among children 6 months through 4 years of age, the slope of 

the cumulative hospitalization rate increased more than it did for older children and adolescents. 

By March 2022, it was higher among this age group than among adolescents. During the 

Omicron surge, both children 5-11 years of age and 12 to 17 years of age were eligible for 

vaccination. Data from the National Center for Health Statistics (NCHS) showing the number of 

COVID-19 deaths in children from January 1, 2020 through May 11, 2022 are based on death 

certificate reporting. Among children 6 months through 4 years of age, there were 202 COVIDrelated deaths, which made up 1.7% of all deaths among children in this age group. COVID-19 

is the leading cause of death among children <1 year of age and 1-4 years of age and 

adolescents 5-19 years of age. The cumulative COVID-19 deaths rank among the top 5 causes 
ACIP Meeting Summary June 17-18, 2022

19

of death in children <1 year of age and 1-4 years of age and is the only infectious cause of 

death throughout the March 1, 2020 through April 30, 2022 timeframe.

Not all COVID-19 cases are captured using traditional surveillance methods because some 

cases are asymptomatic, not diagnosed, or not reported. Tracking the proportion of the

population with SARS-CoV-2 antibodies (e.g., seroprevalence) can improve understanding of 

the population level incidence of COVID-19. Data from national commercial laboratory 

surveillance from September 2021 through February 2022 show that seroprevalence from 

infection-induced SARS-CoV-2 antibodies increased substantially during Omicron. The largest 

increase was among children 6 months through 4 years of age who have not been eligible for 

vaccination to date. There are now 2 additional months of data that show a less steep rise in 

seroprevalence between February and the combined March and April timepoint. 

Seroprevalence in this age group is now estimated at 71%.

Then look further at what is known about infection in children and adults who are seropositive, a 

study among Quebec residents from December 2021 through March 2022 in persons ≥12 years 

of age showed that those with prior infection who were not vaccinated had the lowest 

effectiveness or protection against reinfection. Similar data were found for effectiveness of 

vaccination from mRNA vaccine against COVID-19 hospitalization among adults previously 

infected. Antibodies produced by previous SARS-CoV-2 infection in the pediatric population 

may not neutralize the currently circulating Omicron variant, leaving them potentially susceptible 

to reinfection with Omicron. In a study by Tang and colleagues among children, COVID-19 

vaccines were shown to induce a broader neutralizing antibody response against variants of 

concern (Alpha, Beta, Gamma, Delta, and Omicron) compared with natural immunity induced 

following the SARS-CoV-2 infection. This study highlights the importance of vaccinating children 

with prior infection to prevent both severe disease and future infections.

To summarize the public health problem, COVID-19 has caused over 2 million cases among

children 6 months through 4 years of age. Children in this age group are at risk of severe illness 

from COVID-19. More than half of hospitalized children in this age group had no underlying

medical conditions, can have similar increased severity compared to older children and 

adolescents, and the burden of COVID-associated death is similar to or exceeds that of other 

pediatric vaccine-preventable diseases. Prior infection may not provide broad protection against 

newer SARS-CoV-2 variants, and the COVID-19 pandemic continues to have significant impact 

on families. Overall, the WG felt that COVID-19 among children 6 through 4 or 5 years of age is 

a public health problem.

Now moving to the domain of benefits and harms. As a reminder from the presentation the 

previous day, data from the Moderna COVID-19 vaccine comes from 1 Phase 2/3 randomized 

controlled trial (RCT) conducted in the US. Participants were randomized 3:1 vaccine to saline 

placebo. Per protocol, the 2 co-primary endpoints for immunobridging were GMR and 

seroresponse. Efficacy data also were provided for symptomatic infection. Relative risks were 

calculated from cases in the study population, and VE for GRADE was calculated based on 

these relative risks. In addition, a sensitivity analysis of VE was performed to include COVID-19 

cases that were identified using home testing but RT-PCR confirmation. First looking at the 

prevention of symptomatic laboratory-confirmed COVID-19 with pooled results among children 6 

months through 5 years if age, using the CDC case definition VE was 40.3% among those who 

were seronegative at baseline and 37.8% when those who were seropositive at baseline were 

included. In a sensitivity analysis, including home tests, the VE was 36.6%. The VE of 37.8 

using the CDC case definition among seropositive or seronegative is the outcome that was used 

in GRADE.
ACIP Meeting Summary June 17-18, 2022

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The Phase 2/3 trial also was designed to use immunobridging to evaluate efficacy. 

Immunobridging studies are used to compare immunogenicity for a group of interest, here 

children 6-23 months and children 2-5 years of age, with a comparison group in which efficacy 

has been demonstrated in clinical trials. In this case, the comparison group was adults 18-25 

years. The immune response to vaccine was evaluated using a GMR of adults to young children 

to young adults. Non-inferiority criteria are met when the lower bound of the 95% confidence 

interval for the ratio comparing the geometric mean neutralizing antibody titers for the 2 groups 

is not less than a preset value, which for this evaluation was 0.67. In both age groups, children 

6-23 months and children 2-5 years of age, the immune response to vaccine was non-inferior to 

that observed in those aged 18-25 years of age, with a GMR of 1.28 in the younger age groups 

and 1.01 in children 2-5 years of age. 

The GRADE assessment for the outcome of symptomatic laboratory-confirmed COVID-19

using the direct efficacy, the relative risk was 0.62 (0.49, 0.79). There were no serious concerns 

in the certainty estimate and the final evidence certainty was Type I (high). GRADE also was 

performed for symptomatic laboratory-confirmed COVID-19 using immunobridging. Among both 

age groups (6–23 months and 2–5 years), the non-inferiority criteria were met. There were 

serious concerns of indirectness because immunogenicity is a surrogate marker of efficacy, so 

the final evidence certainty was Type 2 (moderate). 

The next outcome of interest was asymptomatic SARS-CoV-2 infection. For this trial, it was 

identified by absence of symptoms and at least 1 of the following: 1) binding antibodies against 

SARS-CoV-2 nucleocapsid protein negative at Day 1 that became positive post-baseline; or 2) a 

positive PCR test post-baseline at a scheduled or unscheduled visit. Participants who were

PCR-positive at baseline were excluded. Among children 6 months through 5 years of age, the 

VE against asymptomatic infection was 16% (-18.5%, 40.5%). This is the outcome that was 

used for GRADE. In addition, when home antigen tests were included, the VE estimate was 

21% (4.5 to 35). For the GRADE assessment of this outcome, the relative risk was 0.84 (0.60, 

1.19). There were serious concerns of indirectness because asymptomatic SARS-CoV-2 PCR 

testing on the full cohort occurred only once, and serology was not done on all participants.

There also were serious concerns of imprecision due to the wide confidence interval. The final 

evidence certainty was Type III (low). 

For the critical outcome of SAEs, 24 participants in the Phase 2/3 trial among both age groups

experienced 28 events among the 4,800 children in the vaccine group and 3 participants

experienced 4 events out of 1,600 in the placebo group for a comparison of 0.50% to 0.19%. 

One participant experienced 2 SAEs of fever and febrile seizure that were considered possibly 

related by FDA. No deaths were reported. For GRADE for SAEs, there was serious concern 

of indirectness due to the short duration of follow-up of 2 months after Dose 2. There also were

very serious concerns for study size and the width of the confidence interval. The final evidence 

certainty was Type IV (very low). 

In terms of the outcome of severe reactogenicity of Grade 3 or 4, the overall main criteria for 

Grade ≥3 or higher is typically a symptom that prevents daily activity. Overall, 7.7% of vaccine 

recipients and 4.1% of placebo recipients reported a local or systemic reaction of Grade ≥3. The 

majority of these events were Grade ≥3. There were 15 fevers of >40.0 °C in the vaccine group 

and 3 in the placebo group. The GRADE assessment for reactogenicity relative risk was 1.87

(1.44 to 2.42). There were no serious concerns in the certainty assessment, so the final 

evidence certainty was Type 1 (high). 
ACIP Meeting Summary June 17-18, 2022

21

In conclusion, efficacy seen after 2 doses of the Moderna vaccine in children 6 months through 

5 years of age in the trial is consistent with the real-world VE of other ages in Omicron. The 

comparison of antibody levels met the immunobridging criteria, and the reactogenicity postvaccine is consistent with other recommended vaccines in this age group.

Moving now to the GRADE evaluation for the Pfizer vaccine among children 6 months through 4 

years of age, the Pfizer Phase 2/3 trial was conducted in the US, Finland, Poland, and Spain.

Participants were randomized 2:1 vaccine to saline placebo. The interval between Dose 1 and 

Dose 2 was 21 days and the interval between Dose 2 and Dose 3 varied, with a median of 11 to 

16 weeks. Direct efficacy and immunobridging, the per protocol primary endpoints, were

evaluated. The median follow-up after Dose 3 was 1.3 months. VE from relative risk also was 

calculated. While most of the randomized participants received the first 2 doses, only 32.9% of 

the vaccine arm and 30.7% of the placebo arm went on to receive a blinded third dose as the 

protocol specified unblinding at 6 months after the second dose.

The 3-dose VE estimate for symptomatic laboratory-confirmed COVID-19 among participants 6-

23 months was 76% (-161.2, 97.8). For participants 2-4 years of age, the3-dose VE was 81%

(5.3, 96.4). The combined efficacy estimate was 80% (22.8, 94.8). The immune response to 

vaccine in children 6-23 months of age and those 2-4 four years of age was non-inferior to that 

observed in young adults 16-25 years of age, with a GMR of 1.19 (1.00, 1.43) in children 6-23 

months of age and 1.3 (1.13, 1.50) in children 2-4 years of age. For context, the trial was 

originally designed to be evaluated as a 2-dose primary series. The 2-dose VE for participants 

6-23 months of age was 15% (-19.4, 40.0) and non-inferiority criteria for immunobridging were 

met. The VE for children 2-4 years of age was 32% (10.0, 49.6). However, non-inferiority criteria

for immunobridging were not met for this age group. 

The GRADE assessment for the outcome of symptomatic laboratory-confirmed COVID-19 was 

assessed using direct efficacy. There was serious concern for indirectness due to the short 

duration of follow-up of 1.3 months and very serious concern for imprecision due to the study 

size. The final evidence certainty was Type 4 (very low). In addition to direct efficacy, a GRADE 

assessment was conducted for the outcome of symptomatic laboratory-confirmed COVID-19 

assessed using immuno-bridging. There were serious concerns for indirectness because

immunogenicity is a surrogate measure of efficacy. The final evidence certainty for this outcome 

was Type 2 (moderate). 

For the evaluation of SAEs, the safety population included all randomized participants who

received at least 1 dose of vaccine. This included approximately 1700 children 6-23 months of 

age and approximately 2700 children 2-4 years of age. The median follow-up after Dose 3 was 

1.3 months for children 6-23 months of age and 1.4 months for children 2-4 years of age. The 

pooled SAEs among all participants aged 6 months through 4 years of age included 29 events 

out of 3,000 participants in the vaccine arm and 22 events out of 1,500 participants in the 

placebo arm for comparison of 1% to 1.5%. One vaccine participant had 2 SAEs, fever and pain 

in an extremity that required hospitalization that were considered possibly related by the

investigator. FDA considered the events potentially consistent with symptoms due to an

unspecified viral myositis. No deaths were reported in trial participants.

Regarding the GRADE assessment for SAEs, there was very serious concern for indirectness 

due to the short duration of follow-up 1-month post-Dose 3 and because only 32% of trial 

participants received Dose 3 in the blinded follow-up, which limited the ability to detect SAEs 

that could occur at a higher rate after Dose 3. There were also serious concerns of imprecision 

due to study size. The final evidence certainty was Type 4 (very low). For reactogenicity of 
ACIP Meeting Summary June 17-18, 2022

22

Grade ≥3 symptoms that interfered with daily life, among participants 6 months through 4 years

of age, GRADE ≥3 local reactions or systemic events after any dose was reported in 4.3% of 

participants in the vaccine arm and 3.6% of participants in the placebo arm. The majority of 

these events were GRADE 3. There were 6 fevers of >40.0 °C among vaccine recipients and 1 

among placebo recipients. For GRADE, there was a relative risk of 1.2 (0.88, 1.64). Serious 

concern for indirectness was noted because only 31% of trial participants received Dose 3, 

limiting the ability to detect severe reactogenicity that would occur specifically after Dose 3. The 

final evidence certainty was Type 2 (moderate). 

In summary for Pfizer, the conclusions from the trial were that the antibody levels seen after 3 

doses in children 6 months to 4 years of age produce similar antibody levels after 2 doses in 

individuals 16-24 years of age. Reactogenicity post-vaccine was similar for each of the 3 

vaccine doses and similar to the reaction seen in the placebo recipients. Efficacy estimates are 

difficult to interpret given the small numbers and limited follow-up time and because the impact 

of the longer interval in the trial between Dose 2 and Dose 3 on efficacy, reactogenicity, or 

safety are unknown.

Other considerations for benefits and harms of mRNA vaccines in young children include 

COVID-19 vaccines and seropositivity, myocarditis in young children, cardiac complications 

after SARS-CoV-2 infections, vaccine-associated myocarditis in children and adolescents, and 

the numbers needed to vaccinate (NNV) analysis. In terms of COVID-19 vaccines and 

seropositivity, Omicron wave-surges of pediatric COVID-19 hospitalization occurred even with 

high seroprevalence, suggesting that this alone is not sufficient to provide broad protection.

Many millions of seropositive individuals have been vaccinated without safety concerns.

Vaccination remains the safest strategy for preventing complications from SARS-CoV-2 

infection and offers additional protection against reinfection. Prior infection may not provide

broad protection against newer SARS-CoV-2 variants. However, the Clinical Consideration state 

that people who recently had a SARS-CoV-2 infection may consider delaying their COVID 

vaccine by 3 months from symptom onset or a positive test. An increased time between 

infection and vaccination may result in an improved immune response to vaccination. A low risk 

of reinfection has been observed in the weeks following infection.

Then thinking through myocarditis in young children, before the COVID-19 pandemic, peaks in 

myocarditis hospitalizations were seen in infants and in adolescents. In adolescents,

myocarditis is typically viral in etiology and male predominance is observed. In infants, many 

cases can represent cardiomyopathy with a congenital or genetic component. It also is possible 

to infer what is known regarding cardiac complications due to SARS-CoV-2 infection in young 

children. Cardiac complications in the setting of acute SARS-CoV-2 infection in young children 

are uncommon. Most cardiac complications post-SARS-CoV-2 infection in infants are related to 

MIS-C, of which about 1.8% cases are children 6-11 months of age. However, infants <1 year of 

age with MIS-C have severe cardiovascular involvement in about 55% to 65% of cases. This is 

contrasted to around 80% in the adolescent populations.

As Dr. Shimabukuro showed during the last ACIP meeting, reporting rate to the Vaccine 

Adverse Event Reporting System (VAERS) for myocarditis following the Pfizer vaccine in male 

children 5-11 years of age after Dose 2 of the primary series is slightly elevated when compared 

to the background incidence. Otherwise, reporting rates are within the background incidence. In 

addition, to date myocarditis and pericarditis have not statistically signaled in Vaccine Safety 

Datalink (VSD) surveillance in children 5-11 years of age. Overall, the risk of myocarditis after 

mRNA COVID-19 vaccination, if any, in young children is unknown. No cases occurred during 

the clinical trials and there were almost 8,000 who had at least 7 days of follow-up. However, 
ACIP Meeting Summary June 17-18, 2022

23

the trials were not powered to detect rare AEs. Based on the epidemiology of classic 

myocarditis and what is known from safety monitoring in children 5-11 years of age, myocarditis 

after mRNA COVID-19 vaccination in young children is anticipated to be rare. This is likely due 

to multiple factors, including the underlying epidemiology of myocarditis fundamentally being 

different in infants. In addition, the dose used in young children is even lower than the dose 

used in children 5-11 years of age. 

During the previous day, Dr. Link-Gelles summarized that in older children and adolescents, 

there are real-world VE data to show that 2 doses can provide good protection against severe 

disease and against MIS-C. The NNV was calculated using the following methods. Benefits 

were calculated per 1 million fully vaccinated with an mRNA vaccine, focusing on the age group 

6 months through 4 years of age and using pandemic average age-specific incidence rates with 

hospitalization rates from COVID-NET and case rates from case-based surveillance. VE against 

hospitalization was assumed to range from 42% to 84% and VE against symptomatic infection

was assumed to range from 30% to 60%. A120-day time horizon was used. Among children 6 

months through 4 years, 600 to 1,300 vaccinations are needed to prevent 1 case, and 6,100 to 

12,000 vaccinations are needed to prevent 1 hospitalization over a 120-day period.

To put these numbers into context, the NNV to prevent 1 hospitalization for COVID-19 were

compared to influenza. To make the methods comparable, COVID-19 rates were used from the 

influenza season from October 1 through April 29 and the time horizon was extended out to 6 

months. The VE assumptions remained the same as for the COVID-19 calculation. Making this 

set of assumptions comparable between COVID-19 and influenza, the NNV to prevent 1 

COVID-19 hospitalization ranged from 1,600 to 3,300 in comparison and the NNV to prevent 1 

influenza hospitalization in this similar age group ranged from 1,000 to 6,800.

In summary for the known and potential benefits, the clinical trials provide data for protection

against symptomatic infection. The clinical trials were not powered to detect efficacy against 

severe disease in young children, but similar patterns are expected those seen in everyone 5 

years of age and older, with higher protection against severe disease. Emerging data in adults 

suggest that post-COVID conditions may be less likely to occur in vaccinated individuals, and 

vaccination in this age group also may provide parents with increased confidence to return to 

pre-pandemic activities, improving social interactions for young children.

To summarize the known and potential harms, the clinical trial data provided safety data in 

nearly 8,000 vaccinated young children. This is a larger safety database than any of the prior 

pediatric age groups for COVID-19 vaccines. There are also post-authorization safety data after 

almost 600 million doses of COVID-19 vaccines given in the US. Post-authorization safety data 

for children ages 5-11 years of age are very reassuring. The reporting rates of myocarditis in 

males are only slightly elevated compared to the background incidence, which is likely related to 

both underlying epidemiology of myocarditis and dose de-escalation.

To summarize benefits and harms, these are the first COVID-19 vaccine clinical trials conducted 

exclusively during the Omicron predominance. Post-authorization VE studies have shown a 

lower effectiveness during Omicron compared to the previous SARS-CoV-2 variants. Both 

mRNA COVID-19 vaccines for young children met the non-inferiority criteria for neutralizing 

antibody levels. Differences have been noted in the certainty of efficacy estimates for each of 

the mRNA vaccines, and their efficacy estimates cannot be directly compared. Importantly,

receipt of a primary COVID-19 vaccine series can provide protection against COVID-19 disease 

and severe outcomes. Therefore, reviewing the totality of this data, the benefits of the COVID 

vaccines in young children outweigh possible risks. The WG felt that the desired anticipated 
ACIP Meeting Summary June 17-18, 2022

24

effects were moderate to large risk, reflecting some uncertainty with regard to the efficacy 

estimates, and that the undesirable anticipated effects were minimal to small. In terms of the 

judgment for Moderna, the WG felt that the desirable effects outweigh the undesirable effects.

For the Pfizer vaccine, the WG felt that the desirable effects outweighed undesirable effects. 

Moving now to the domain of values, a survey was designed by CDC, the University of Iowa, 

and RAND Corporation to assess parental beliefs and attitudes toward pediatric COVID-19 

vaccines among children 6 months through 4 years of age that was administered February 2-10, 

2022. At that time, around half of parents of children 6 months through 4 years of age said that 

they would definitely or probably vaccinate their child once they become eligible. A third of 

parents of children 6 months through 4 years of age said they definitely or probably would not 

vaccinate their child once eligible. Only a fifth of respondents said that they would get their child 

vaccinated within 3 months after becoming eligible, but additional respondents said that they 

would vaccinate with subsequent time. Parents also were asked about preference for a 2-dose 

or a 3-dose series, with some uncertainty around the timing availability. There was a slight 

preference for a 2-dose series, but with no data on VE or timing of when these vaccines would 

be available, there was no strong preference either way at the time of the survey. The 

percentage of parents of children 6 months through 4 years of age who definitely or probably 

would vaccinate their child when eligible varied by gender of the parent, race, ethnicity, and

education.

Based on data from the National Immunization Survey-Child COVID Module (NIS-CCM) from 

December 2021 – May 2022, over time the population that reported that they would definitely 

get their child vaccinated had declined to 33% in May. This could be due to a variety of factors, 

including a declining sense of urgency with the pandemic. In May, 17% of parents reported that 

they definitely would not get their child vaccinated. Looking at this by age subgroups, a smaller 

percent of parents of children 6-23 months tended to have their child vaccinated compared to 

parents of children 2-4 years of age. A Kaiser Family Foundation (KFF) survey showed that 1 in 

5 parents of children <5 years of age were eager to vaccinate their child and would do so right 

away once a COVID-19 vaccine was authorized. Almost 4 in 10 parents said they wanted to 

wait and see before getting their child vaccinated. Another 4 in 10 said they were reluctant to 

get their child vaccinated, with 11% saying they would only do it if they were required and 27% 

saying they would definitely not get their child vaccinated. Lack of information may be a factor in 

parents’ reluctance to have their younger children vaccinated right away. A majority of parents 

of children <5 years of age at the time of the KFF survey said that they did not have enough

information about the safety and effectiveness of COVID-19 vaccines. Notably, this survey was 

conducted in April, which was prior to having information on the safety and efficacy of COVID19 vaccines in young children.

In summary of the available evidence for the values domain, half of parents of children 6 months

through 4 years of age definitely or probably would get their child vaccinated once eligible and 1

in 5 parents of children in this age group are eager to vaccinate and plan to do so right away 

once the vaccine is available. However, nearly a third of parents of children 6 months through 4 

years of age definitely or probably would not vaccinate their child once eligible. In a survey 

conducted prior to available data, parents of children under 5 years of age said they did not 

have enough information. This highlights the importance of communicating these data broadly 

to parents. The WG felt that whether the target population feels the desirable effects are large 

relative to the undesirable effects varies, and that there is important or probably important 

uncertainty or variability. 
ACIP Meeting Summary June 17-18, 2022

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Regarding the domain of acceptability, a child’s pediatrician or HCP remains the top trusted 

source for vaccine information for parents. The involvement of the VFC program, with many of 

the VFC providers being enrolled as COVID-19 providers, will be especially important for the 

population of young children. A variety of other programs also will be important to engage in 

order to reach children in this young age group, including the IHS, Tribal and Urban Indian 

Health Programs, and HRSA programs. The goal is an efficient rollout resulting in equitable 

vaccine access for young children in the initial weeks when demand is likely to be higher. Also 

head earlier was the goal of over 85% of children living within 5 miles of a vaccine provider. In 

summary of the acceptability domain, the child’s HCP continues to be the top trusted source of 

information, with a variety of programs to facilitate this rollout and acceptability among 

providers. The WG felt that the mRNA COVID-19 vaccines would be acceptable to

stakeholders. 

For the domain of feasibility, the Moderna vaccine product for children 6 months through 5 years 

of age ships at -20°C and has a different color border (magenta). It is a different concentration 

than the adult primary series. It will have a new National Drug Code (NDC) code, and it does not 

require a diluent. The Pfizer vaccine for children 6 months through 4 years of age ships at -80°C

and has a different color cap (maroon). It has a different amount of diluent added and a new 

NDC code. The product configurations for both products currently are 10-dose vials in cartons

of 10 vials each for a total of 100 doses total. The minimum order quantity is 100 doses per 

product. Ancillary supplies will be provided for both vaccine products, including pediatric-specific 

needles. Diluent will be provided with the Pfizer orders.

To summarize the feasibility domain, the Pfizer vaccine for children 6 months through 4 years of 

age has a similar product configuration to other Pfizer pediatric products. The maroon cap may 

be more familiar to pediatric HCP. The long-term storage requires an ultra-low temperature 

freezer and requires diluent. The Moderna vaccine for children 6 months through 5 years of age

may be less familiar to pediatric HCP. The product is able to be stored at traditional freezer 

temperatures and does not require diluent. Overall, the WG felt the Moderna vaccine would be 

feasible to implement. The WG also felt that the Pfizer vaccine would be feasible to implement. 

However, discussions among the WG highlighted that the lack of diluent and other storage 

issues may make the Moderna vaccine more feasible to implement, especially for new providers 

to the COVID vaccine program.

In terms of the resource domain, no studies were found that evaluated cost-effectiveness of 

COVID-19 vaccination among children. Studies in adults have shown that COVID-19 vaccinerelated healthcare costs could be billions or trillions of dollars. Given this, COVID vaccines 

overall are likely cost-saving. In a study conducted by Pfizer, it was estimated that the Pfizer 

vaccine use in individuals 12 years of age and over in 2021 may have averted 9 million cases, 

almost 700,000 hospitalizations, and over 100,000 deaths. This would have resulted in $30 

billion of direct healthcare cost savings. At this time, a vaccine will be available at no cost to the 

recipient, so cost-effectiveness is not a primary driver for decision-making during the pandemic 

but will continue to be reassessed in the future. The WG felt that mRNA COVID vaccines in 

young children are a reasonable and efficient allocation of resources.

Regarding the equity domain, there was an increase in COVID-19 cases among all children

during the Omicron surge. However, there were considerable increase among American Indian 

and Alaskan Native (AI/AN) children. Based on NIS-CCM data, parental intent varied by race, 

ethnicity, household income, and metropolitan area. There was lower intent among rural

individuals and much higher intent among those who have previously received their influenza 

vaccine. HHS focus groups were conducted, some of which focused on race and ethnicity
ACIP Meeting Summary June 17-18, 2022

26

specifically and another that focused on the overall population without a specific race and 

ethnicity focus. There were 18 focus groups with 4-6 participants in each group. Some groups 

were composed of parents who were ready to vaccinate, while others were waiting to vaccinate.

Participants in the focus groups shared their thoughts and opinions about the COVID-19 

pandemic regarding their child, vaccination intent, and getting their child a COVID-19 vaccine 

when it is authorized and available.

Black parents of children 6 months through <2 years of age noted that their child’s pediatrician 

did not have a strong stance on receiving a COVID-19 vaccine, despite having a strong 

stance on vaccines in general. This made them second guess whether the COVID-19 vaccine is 

necessary for children. Young children cannot talk/say what is going on or how they feel, which 

contributed to their concerns about vaccinating childing. The only thing that will make them trust 

is time. COVID is such a new virus, they are still learning about it. Long-term side effects are the 

big concern. A child will be living a long time, and they want to know that they are safe. One 

person admitted that they made an intentional choice to not pay attention to the news or get 

information on COVID-19 because it will make them worry too much. Hispanic/Latino parents 

want to wait a couple of months perhaps but want the pediatrician to specifically advise it. Some 

parents have talked to their doctor about the options and did not get a strong recommendation. 

If things get worse (e.g., high cases, worse scenarios), that will motivate them to vaccinate their 

child. One parent felt like COVID is so new that the information medical professionals have 

might not be totally right. One parent would get their young child vaccinated right away based 

on the experience from themselves and their other child. A smaller dose makes them more 

comfortable. One parent would rather not get it for their child unless they had to.

In terms of what actions can be taken to improve equity regarding COVID-19 vaccines, it is 

known that CDC and HCP are trusted sources of information for parents. Parents want to 

discuss both the pros and the cons of vaccination. Advertisements need to include

representative images, including diversity in racial and ethnic groups, gender, and parents (e.g., 

moms and dads should be shown). Public health and clinical trial research must be inclusive

of all populations from before research initiation through completion and dissemination. There 

are ways that communities can help improve equity as well. Pediatricians and VFC providers 

can provide vaccines, but they will not be the only providers of these vaccines. In many areas, 

pharmacies, community or rural health clinics, school providers, faith-based organizations, and 

others could partner with others or serve as community vaccination sites. In summary, the WG 

interpretation was that mRNA COVID-19 vaccines in young children probably would have no 

impact on health equity.

In summary, the WG discussed each mRNA COVID vaccine primary series compared to no 

vaccine. Both mRNA COVID-19 primary series in young children met the non-inferiority 

endpoints, provide protection against symptomatic disease, and are expected to provide higher 

protection against severe disease. Two vaccine options in this population may allow parents 

and providers a choice, which could increase uptake and acceptability. The WG felt that for the 

2 doses of 25μg of the Moderna vaccine, the desirable consequences clearly outweigh the 

undesirable consequences and proposed to ACIP to recommend the intervention. For the 3 

doses of 3μg of the Pfizer-BioNTech COVID-19 vaccine, the WG felt that the desirable

consequences clearly outweigh the undesirable consequences. While the WG noted that there 

was more uncertainty with this outcome, they still proposed to ACIP to recommend the

intervention.
ACIP Meeting Summary June 17-18, 2022

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Since the beginning of the COVID pandemic, among US children 6 months through 4 years of 

age, there have been over 2 million cases, over 20,000 hospitalizations, and over 200 deaths.

COVID-19 can cause severe disease and death among children, including children without

underlying medical conditions. Future surges will continue to impact children, with unvaccinated 

children remaining at higher risk of severe outcomes. As with all other age groups, the priority is 

vaccination of unvaccinated individuals. Expansion of vaccine recommendations down to

children 6 months of age would allow an additional 18.7 million children to receive a primary 

COVID-19 vaccine series. The current data are for a 2-dose Moderna or a 3-dose Pfizer primary 

series. Post-authorization VE studies will be monitored closely to help determine subsequent 

timing and the need for boosters, with the acknowledgement that immunocompromised children 

may also need additional doses for optimal protection.

Clinical Considerations Update

Sara Oliver, MD, MSPH (CDC/NCIRD) presented an update on the Interim Clinical 

Considerations for Pediatric COVID-19 vaccines on behalf of Dr. Hall, who had developed 

laryngitis. In terms of the vaccine schedules, the age ranges differ in that Moderna’s age group 

is 6 months through 5 years of age and Pfizer’s is 6 months through 4 years of age. It is 

important to note that “through” means “up to and including.” That means the upper age ranges 

includes that year through the last day before their birthdate. This applies to all age ranges

discussed throughout the meeting.

According to the pediatric schedule for the Moderna vaccine for people who are not moderate or 

severely immunocompromised, all children 6 months through 5 years of age would receive a 2-

dose primary series separated by 4 to 8 weeks. Based on the schedule for people who are 

moderate or severely immunocompromised, all children who are 6 months through 5 years

should receive a 3-dose primary series separated by 4 weeks. Just like when the other COVID19 vaccines were first authorized by age group, only primary series doses are authorized at this 

time. There are not boosters currently authorized, but there may be recommendations for those 

in the future.

Based on the pediatric schedule for the Pfizer vaccine for children 6 months through 4 years of 

age, a 3-dose primary series is recommended for those who are moderate to severely 

immunocompromised and those who are not. For those who are not immunocompromised, 

Dose 1 and Dose 2 can be separated by 3 to 8 weeks and Dose 2 and Dose 3 are separated by 

8 weeks. For those who are immunocompromised, Dose 1 and Dose 2 are separated by 3 

weeks and Dose 2 and Dose 3 are separated by at least 8 weeks. Booster doses are not

authorized to this age group, but there may be recommendations for those in the future.

In terms of the 3- to 8-week interval between Dose 1 and Dose 2 and when it may be 

appropriate to use the shorter authorized interval of 3 to 4 weeks or when it would be 

appropriate to use the longer 8-week interval, this can be used in anyone 6 months through 64 

years of age. The benefits and risks can be weighed with individual patients based on their 

characteristics and situations. The shorter interval is more appropriate when the protection 

needs to be achieved the soonest. These situations could include being immunocompromised 

or living with an underlying medical condition that would put somebody at higher risk for severe 

disease, living with a household member who has an increased risk for severe disease who 

cannot be vaccinated due to contraindication or living, and/or going to school in or traveling to 

an area with high COVID-19 community levels. The longer interval may be more important

in some situations when the priority is to reduce the myocarditis risk. Some studies in

adolescents and adults have shown that the small risk of myocarditis associated with the mRNA 
ACIP Meeting Summary June 17-18, 2022

28

COVID-19 vaccines may be reduced with the longer interval. The use of this longer interval 

would be especially important in adolescents and young adult males where the highest risk is 

seen. Another instance would be to optimize VE, which may be increased with a longer interval, 

keeping in mind that this is balanced with a risk of remaining not fully protected for a longer 

period of time. Extending the interval to beyond 8 weeks has not been shown to provide

additional benefit.

With regard to the new formulations, children should receive the age-appropriate vaccine

formulation and follow the schedule based on their age on the day of vaccination regardless

of their size or weight. If a person moves from a younger age group to an older age group 

during the primary series or between the primary series and receipt of a booster dose, they 

should receive the vaccine dosage for the older age group for all subsequent doses. However, 

FDA authorizations do allow for some different dosing for certain age transitions. There will be 

an upcoming clinician education call that will address a variety of scenarios for aging up into the 

next age group. Additional slides will be posted on the ACIP website that will walk through all

of these possible options. Dr. Oliver reviewed the formulations and labels for the Moderna and

Pfizer-BioNTech COVID-19 formulations for children. COVID-19 vaccines are not

interchangeable. The same mRNA vaccine product should be used for all doses of the primary 

series. In exceptional situations in which the mRNA vaccine product administered for a previous 

dose(s) of the primary series cannot be determined or is not available, either age-appropriate 

available mRNA COVID-19 vaccine product may be administered at a minimum interval of 28 

days between doses to complete the mRNA COVID-19 primary vaccination series.

As is currently the recommendation, the guidance will continue that COVID-19 vaccines may be 

administered without regard to timing of other vaccines. This includes both simultaneous 

administration of COVID-19 vaccine and other vaccines on the same day or at any time before 

or after another vaccine. Extensive experience with non-COVID-19 vaccines has demonstrated

that immunogenicity and AE profiles are generally similar when vaccines are administered 

simultaneously as when they are administered alone. However, data assessing the outcomes of 

simultaneous administration of COVID-19 with other vaccines are limited currently, including 

any potential to increase reactogenicity when COVID-19 and other vaccines are administered at 

the same basis. Therefore, providers can make decisions about co-administration on a case-bycase basis. In accordance with general best practices, routine administration for all ageappropriate doses of vaccines simultaneously is recommended for children for whom no specific 

contraindications exist at the time of the healthcare visit.

When deciding whether to co-administer another vaccine with the COVID-19 vaccine, providers 

and guardians may consider whether a child is behind or at risk of becoming behind on their 

recommended vaccines, the likelihood of the child returning for another vaccination visit, their 

risk of vaccine-preventable diseases, and the reactogenicity profile of the vaccines. Best 

practices for multiple injections include labeling each syringe with the name and dosage of the 

vaccine with the lot number and initials of the preparer and the exact beyond use time, if 

applicable. Each injection should be administered in a different injection site, with injection sites 

separated by 1 inch or more if possible. COVID-19 vaccines and vaccines that may be more 

likely to cause a local reaction can be administered in different limbs, if possible. Additionally, 

vaccines that may be known to be more painful also could be administered after the other 

vaccine(s). 
ACIP Meeting Summary June 17-18, 2022

29

It also is important to take a closer look at the importance of catch-up vaccination and avoiding 

missed opportunities to vaccinate. In terms of what is known about vaccination coverage since 

the pandemic began, vaccination coverage among kindergarteners nationwide was lower during 

the 2020-to 2021 school year compared with the 2019-2020 school year. There was 94%

coverage for MMR, DTaP, and varicella at a level just below the Healthy People target of 95%.

Coverage for all 3 vaccines decreased in the majority of states. During the 2020-2021 school

year, 10% of school principals reported that fewer students were fully vaccinated, 27% of school 

nurses reported that fewer students were vaccinated in that school year, and 46% of school 

nurses reported that school vaccination requirements were a much lower priority compared to 

recent years. An assessment of VFC orders for influenza vaccine components through May 

showed that overall, there was a dramatic decrease in orders from the 2019 baseline. Orders 

decreased in 2020 and 2021. To date in 2022, there has been some catch-up. However, orders

are still about 4% lower than the same time in 2019 pre-pandemic. This emphasizes the gap 

that need to be made up with routine vaccination and the importance of opportunities with 

COVID-19 vaccines that could play a role in that catch-up.

In terms of patient and patent/guardian counseling on side effects, in clinical trials have shown

that young children tend to experience similar but maybe fewer side effects than adolescents or 

young adults. Providers should counsel parents and guardians on the potential side effects. 

Local side effects may include pain, swelling, and redness at the injection site and/or axillary or 

inguinal lymphadenopathy. Systemic side effects may include fever, fatigue, headache, chills, 

myalgia, and arthralgia. In younger children and infants, there may be irritability, crying,

sleepiness, and loss of appetite. Febrile seizures were rare in the COVID-19 clinical trials for 

young children. In most cases, simultaneous vaccine does not lead to higher rates of febrile 

seizures, although administering more than one vaccine at the same clinic visit has been 

associated with an increased risk of febrile seizures for some specific vaccines in young 

children. The impact of co-administration with COVID-19 on the risk of febrile seizures has not 

been specifically studied to date. Febrile seizures are not uncommon generally and can occur

in infants and young children with any condition that causes a fever. Up to 5% of children

younger than 5 years of age will have at least one febrile seizure. These can occur with

vaccination but are uncommon. Nearly all children who have a febrile seizure recover quickly 

and do not have any permanent neurologic damage. CDC and FDA are going to closely monitor 

COVID-19 vaccines to identify any safety signals.

To wrap up the end of EtR Framework, as with all ages, post-authorization safety and

effectiveness monitoring will be critical. Platforms are in place to monitor VE and the results will 

be communicated publicly as soon as possible. As heard to the previous day, timing of these 

results will depend on vaccine uptake and COVID-19 incidence. COVID-19 vaccines are being 

administered under the most intensive vaccine safety effort in US history. For these young 

children, parents can complete the surveys in v-safeSM, the CDC smartphone-based monitoring 

program. Doing so will provide critical information in the post-authorization monitoring.

Healthcare providers also can help by promoting v-safeSM in their practices through information 

sheets, posters, and QR codes. All of this information and tools are available on the CDC 

website. 
ACIP Meeting Summary June 17-18, 2022

30

Vote: Moderna COVID-19 Vaccine in Children 6 Months Through 5 Years of Age

Sara Oliver, MD, MSPH (CDC/NCIRD) presented the proposed recommendations for a 

Moderna vaccine series for children 6 months through 5 years of age, which read as follows:

“A two-dose Moderna COVID-19 vaccine series (25μg each) is recommended for 

children ages 6 months through 5 years under the EUA issued by FDA.” 

Motion/Vote: Moderna COVID-19 Vaccine in Children 6 Months Through 5 Years of Age

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

“A two-dose Moderna COVID-19 vaccine series (25μg each) is recommended for children ages 

6 months through 5 years under the EUA issued by FDA.” Ms. Bahta seconded the motion. No 

conflicts of interest (COIs) were declared. The motion carried with 12 affirmative votes, 0 

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

12 Favored: Bahta, Bell, Brooks, Chen, Daley, Lee, Loehr, Long, McNally, Poehling, 

Sanchez, Talbot

 0 Opposed: N/A

 0 Abstained: N/A 

Vote: Pfizer-BioNTech COVID-19 Vaccine in Children 6 Months Through 4 Years of Age

Sara Oliver, MD, MSPH (CDC/NCIRD) presented the proposed recommendations for a PfizerBioNTech COVID-19 vaccine booster dose for children 6 months through 4 years of age, which

read as follows:

“A three-dose Pfizer-BioNTech COVID-19 vaccine series (3μg each) is recommended 

for children ages 6 months through 4 years of age under the EUA issued by FDA.” 

Motion/Vote: Pfizer-BioNTech COVID-19 Vaccine in 

Children 6 Months Through 4 Years of Age

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

three-dose Pfizer-BioNTech COVID-19 vaccine series (3μg each) is recommended for children 

ages 6 months through 4 years of age under the EUA issued by FDA.” Dr. Sanchez seconded 

the motion. No COIs were declared. The motion carried with 12 affirmative votes, 0 negative 

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

12 Favored: Bahta, Bell, Brooks, Chen, Daley, Lee, Loehr, Long, McNally, Poehling, 

Sanchez, Talbot

 0 Opposed: N/A

 0 Abstained: N/A
ACIP Meeting Summary June 17-18, 2022

31

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. Bell emphasized that as oftentimes is the case about balancing benefits and harms, this is 

an opportunity that one does not get very often to participate in preventing the death of young 

children. Any deaths are a tragedy. A death in a young child is an incredible tragedy and this 

disease is killing children. On the harm side, all the information so far is good. There is more 

information than there often is for other vaccines. Anyone making an important decision about 

anything, especially for their children, wants to consider that balance. While they do not know 

everything there is to be known about this and the data may change, the bottom line is that this 

infection kills children and there is an opportunity to prevent that. Every parent will want to

consider that calculus as well. ACIP members take their responsibility extremely

Seriously and this is an opportunity to prevent a known risk. She thought they made a big step 

forward with these votes.

Dr. Brooks stressed that the ACIP just authorized 18.7 million children to get vaccinated. There 

have been over 2 million cases in these children and 200 plus deaths. While it is unknown what 

is coming in terms of future variants, he felt comfortable in saying that vaccinating will be a net 

benefit. ACIP made a decision that will help children in that they will achieve a certain level of 

efficacy and going forward, that will be a benefit over the next months and years. He agreed that 

ACIP had taken a major step forward.

Dr. Daley reminded everyone that they heard pleas to approve these vaccines through public 

commentary during the first day of the meeting and in the written comments submitted through 

the docket. They also heard pleas not to approve these vaccines. He said he wanted to

explicitly state that ACIP heard those who disagreed with the decisions made during this 

meeting. Some people emphasized that they do not think these vaccines are effective. Data 

were presented showing that they are effective. Some commenters emphasized concerns that 

the vaccines are not safe. The safety data indicate that they have a high degree of safety. ACIP 

took all comments and data into consideration and made the votes that they did for the reasons 

articulated by Dr. Brooks and Dr. Bell—that ACIP feels like this is an opportunity to prevent 

severe disease and death in this in this age group. He also reiterated that the work continues

and that ACIP will continue to communicate this as best they can to the public.

Dr. Lee said that she was fully confident that vaccines should be recommended. They clearly

can prevent hospitalizations and deaths. She also believes they have the potential to prevent 

long-term complications of infections that are not yet understood. She is very concerned that the 

long-term implications of infection over time will be the next big public health burden that they 

face, particularly among children. Her hope is that these votes will allow for one step forward in 

the right direction and that progress will continue over time. She thanked all of her fellow 

committee members. 

Dr. Romero thanked the ACIP voting members, liaisons, and ex-officios and all of the members 

of CDC who put time into making this decision. As someone who once sat where they all sat 

during this meeting, he understands how much effort goes into this and how much effort has 

gone forward since the end of his tenure. On behalf of NCIRD, he thanked everyone very much

for doing such an incredible job of protecting the nation’s children. He wished everyone a muchdeserved rest this weekend and a Happy Father’s Day to the fathers in the group. 
ACIP Meeting Summary June 17-18, 2022

32

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 June 17-18, 2022

33

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 June 17-18, 2022

34

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 June 17-18, 2022

35

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 June 17-18, 2022

36

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 June 17-18, 2022

37

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 June 17-18, 2022

38

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 June 17-18, 2022

39

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 June 17-18, 2022

40

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 June 17-18, 2022

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ACRONYMS USED IN THIS DOCUMENT

ACEs Adverse Childhood Experiences 

ACIP Advisory Committee on Immunization Practices

AE Adverse Event

AESI Adverse Events of Special Interest

AI/AN American Indian and Alaskan Native 

CDC Centers for Disease Control and Prevention

COD Causes of Death

COI Conflicts of Interest 

DSMB Data and Safety Monitoring Board 

ECE Early Care and Education 

ED Emergency Department

ET Eastern Time

EtR Evidence to Recommendation 

EUA Emergency Use Authorization 

FDA Food and Drug Administration

FQHC Federally Qualified Health Center 

GMC Geometric Mean Concentration

GMR Geometric Mean Ratio 

GMT Geometric Mean Titers 

GRADE Grading of Recommendations, Assessment, and Evaluation 

HCP Healthcare Personnel / Provider

HHS (Department of) Health and Human Services

HRSA Health Resources and Services Administration 

ICATT Increasing Community Access to Testing Partnership

ICU Intensive Care Unit 

IHS Indian Health Service 

MAAE Medically Attended Adverse Events

MIS-C Multisystem Inflammatory Syndrome in Children 

NASN National Association of School Nurses 

NDC National Drug Code 

NIS-CCM National Immunization Survey-Child COVID Module 

PCP Primary Care Providers 

PCR Polymerase Chain Reaction 

PICO Population, Intervention, Comparison, Outcomes

PRNT Plaque Reduction Neutralization Test 

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

RCA Rapid Cycle Analysis

RCT Randomized Controlled Trial 

RHC Rural Health Center 

RSV Respiratory Syncytial Virus

RT-PCR Reverse Transcriptase Polymerase Chain Reaction

SAE Serious Adverse Event 

SOC System Organ Class

UC Urgent Care 

US United States
ACIP Meeting Summary June 17-18, 2022

42

VAERS Vaccine Adverse Event Reporting System

VE Vaccine Efficacy

VE Vaccine Effectiveness

VFC Vaccines for Children 

VRBPAC Vaccines and Related Biological Products Advisory Committee 

VSD Vaccine Safety Datalink

WG Work Group

WIC Women, Infants, and Children