MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP) 

MAY 12, 2021 

SUMMARY MINUTES 

TABLE OF CONTENTS

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

Wednesday: May 12, 2021 ........................................................................................................ 2

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

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

Overview............................................................................................................................. 4

Introduction......................................................................................................................... 4

Safety, Immunogenicity, and Efficacy of BNT162b2 in Persons Aged 12-15 Years............. 5

GRADE: Pfizer-BioNTech COVID-19 Vaccine .................................................................... 9

EtR Framework: Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12-15 Years ..12

Clinical Considerations for Pfizer-BioNTech COVID-19 Vaccination in Adolescents ..........20

Public Comment.................................................................................................................25

Vote: Pfizer COVID-19 Vaccine for 12-15 Year Olds..........................................................31

Thrombosis with Thrombocytopenia Syndrome (TTS) Following COVID-19 Vaccination ...32

VaST Update .....................................................................................................................35

COVID-19 WG Interpretation of the TSS Updates..............................................................36

COVID-19 Vaccine Effectiveness Studies..........................................................................37

Update on Emerging SARS-CoV-2 Variants and Vaccine Considerations..........................41

Certification...............................................................................................................................45

ACIP Membership Roster .........................................................................................................46

Acronyms Used in the Document..............................................................................................55
ACIP Meeting Summary May 12, 2021

2

MEETING PURPOSE

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

Disease Control and Prevention (CDC) convened the regularly scheduled quarterly meeting of 

the Advisory Committee on Immunization Practices (ACIP) on May 12, 2021. The meeting took 

place remotely via Zoom and teleconference. This document provides a summary of the 

meeting, which focused on a variety of topics pertaining to COVID-19 vaccines, including the 

recent authorization of/vote on Pfizer-BioNTech COVID-19 vaccine in adolescents 12-15 years

of age, thrombosis with thrombocytopenia syndrome (TTS) following COVID-19 vaccination, 

safety and effectiveness updates, and an update on emerging SARS-CoV-2 variants and 

vaccine considerations.

WEDNESDAY: MAY 12, 2021

WELCOME AND INTRODUCTIONS

Dr. José R. Romero (ACIP Chair) called to order and presided over the meeting. He welcomed 

everyone and thanked them for their attendance and all of the time they are dedicating to the 

COVID-19 effort.

Dr. Amanda Cohn (ACIP Executive Secretary) welcomed everyone and noted that an agenda 

for the day soon would be posted to the ACIP website. She indicated that there would be an oral 

public comment session at approximately 2:00 PM Eastern Time (ET). Given that more 

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

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

individuals wishing to make written public comments may submit them through 

https://www.regulations.gov using Docket Number CDC-2021-0049. Further information on the 

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

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

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

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

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

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

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

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

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

the meeting. A vote was taken during this meeting on Pfizer COVID-19 Vaccine for adolescents 

12-15 years of age.

ACIP is accepting applications for new membership for the term beginning July 1, 2022. 

Applications are being sought from all fields of public health, internal medicine, obstetrics and 

gynecology (OB-GYN), pediatrics, infectious diseases, and consumer representation. 

Applications should be submitted by July 1, 2021. Further information and the application can 

be found on the ACIP website at https://www.cdc.gov/vaccines/acip/apply-formembership/index.html. Dr. Cohn then introduced Dr. Sam Posner, Acting Director of the 

National Center for Immunization and Respiratory Diseases (NCIRD), to say a few words to 

members of the committee and to the public.
ACIP Meeting Summary May 12, 2021

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Dr. Sam Posner (NCIRD Acting Director) welcomed attendees to this emergency meeting,

thanked them for their time and commitment to the ACIP, and took a few minutes to provide an 

update on some leadership transitions within the NCIRD. As many may already be aware, Dr. 

Messonnier has resigned from her position as Director of NCIRD effective Friday, May 14, 2021.

Dr. Posner will continue to serve as the Acting Director for NCIRD until a permanent placement 

has been hired. As seen over the past year, the ACIP plays an essential role in the collective

efforts to protect people from vaccine-preventable diseases. He thanked the members for their 

commitment to the scientific rigor and ethical and equitable health outcomes. Service on this 

committee has been extremely demanding during the COVID-19 pandemic, and CDC 

appreciates the members’ stewardship of this historic and influential group. He then took a few

minutes to recognize Dr. Messonnier and her amazing contributions to public health.

Many in the formal and informal ACIP community have worked with Dr. Messonnier for many 

years and are familiar with the outstanding contributions to public health she has made during 

her CDC career. Many members and their organizations have worked with her on some of these

accomplishments. Dr. Messonnier began her career at CDC over 25 years ago as an Epidemic 

Intelligence Service (EIS) Officer and became involved with emergency response early on as 

one of the staff involved in the 2001 intentional Anthrax release. She has built extensive

experience in prevention and control of bacterial meningitis and played a pivotal role in the

successful public-private partnership to develop and implement a low-cost vaccine to prevent 

epidemic meningococcal meningitis in Africa. As Director of NCIRD, Dr. Messonnier oversaw 

strategies to counterthreats like seasonal and pandemic influenza and has led the center

through the recent measles resurgence and the emergence and cyclical outbreaks of acute

flaccid myelitis (AFM). Since the beginning of the pandemic, in collaboration with the ACIP and 

CDC’s partners across public health and the state, tribal, and local, and territorial governments, 

Dr. Messonnier has led teams to achieve incredible things, including deploying multiple

vaccines in under one year and building the information infrastructure to provide real-time data

for vaccination coverage and vaccine safety data.

Dr. Messonnier is going to continue her work in public health as the Executive Director of

Pandemics and Health Systems for the Skoll Foundation. She has valued the singular purpose

and role of the ACIP and the varied perspectives that all of the members and the public bring to

the CDC and its national immunization program. On behalf of the entire center leadership team,

Dr. Posner thanked the entire ACIP for their continued service, with special thanks to Dr. Cohn 

and Dr. Romero for giving him a few minutes to provide this update.

Dr. Romero (ACIP Chair) said that on his behalf and on behalf of all the members of the ACIP, 

Dr. Messonnier would be greatly missed. She has been a role model for them and they 

appreciate all of her hard work during her tenure at the CDC. He then conducted the roll call 

during which one conflict of interest (COI) was declared by voting member Dr. Sharon Frey, who 

is the Site Principal Investigator (PI) at St. Louis University for the Moderna and Janssen SARSCoV-2 vaccine trials in adults. A list of Members, Ex Officios, and Liaison Representatives is 

included in the appendixes at the end of this summary document.
ACIP Meeting Summary May 12, 2021

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CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES

Overview

Dr. Doran Fink (FDA/DVRPA/CBER) explained that the purpose of this ACIP meeting was to 

consider the data that supported FDA authorization of the Pfizer-BioNTech COVID-19 vaccine 

for use in adolescents 12 through 15 years of age. These data were generated from a placebocontrolled study involving over 2200 participants, over 1100 of whom received the PfizerBioNTech COVID-19 vaccine and approximately 660 of whom had at least 2 months of followup after completion of the vaccination series. The evidence for vaccine effectiveness (VE) in this 

age group came from two sources of data, first an immunobridging analyses showing that 

neutralizing antibody responses elicited by the vaccine in adolescents 12 through 15 years of 

age were not inferior to those elicited by the vaccine in adults 18 through 25 years of age.

Additionally, the study evaluated protection against COVID-19 of any severity for the vaccine

versus the placebo control. There were zero cases of COVID-19 in vaccine recipients starting

from 7 days after completion of the vaccination series. The safety of the vaccine was evaluated

in all of the study participants and compared to the placebo control. It also was compared to the 

safety profile of the vaccine in study participants 18 through 25 years of age in the population 

that supported the original Emergency Use Authorization (EUA) of the vaccine in December

2020. Additionally, FDA evaluated longer-term safety data from all adult participants in the

clinical trial who were 18 through 55 years of age and included in the EUA safety population.

The safety evaluation did not raise any safety concerns for use of the vaccine in individuals 12 

through 15 years of age beyond reactogenicity events that had been described previously with 

older age groups.

Introduction

Dr. Keipp Talbot (ACIP, WG Member) introduced the COVID-19 Vaccines WG session, 

reporting that the WG continues to meet weekly. Recent topics covered have included the

clinical trial data for the Pfizer-BioNTech COVID-19 vaccine for adolescents, GRADE (Grading 

of Recommendations, Assessment, Development and Evaluations) and EtR (Evidence to 

Recommendations) Framework for the Pfizer-BioNTech COVID-19 vaccine for adolescents,

clinical considerations for the use of COVID-19 vaccines in this age group, and safety updates.

The major update is that the FDA an EUA on May 10, 2021 for use of the Pfizer-BioNTech 

COVID-19 vaccine for the prevention of COVID-19 Disease for individuals 12-15 years of age.

She indicated that this emergency ACIP meeting was convened to hear presentations on the 

related safety, immunogenicity, and efficacy of BNT162b2 in persons 12-15 years of age; 

GRADE of the Pfizer-BioNTech COVID-19 vaccine; the EtR Framework on the Pfizer-BioNTech 

COVID-19 vaccine in adolescents; clinical considerations; and public comments and for ACIP to 

vote on the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents 12-15 years of age. 

Following the vote, additional presentations would include an update from TTS following the 

Janssen COVID-19 vaccine, an update from the Vaccine Safety Technical (VaST) WG, an 

update on the COVID-19 VE studies, and an update on emerging SARS-CoV-2 variants and the 

implication for vaccines.
ACIP Meeting Summary May 12, 2021

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Dr. Talbot also took a moment to talk about the children in the US who have been part of this 

pandemic whether they have experienced infection, lost loved ones, lost parents, been out of 

school, and not been able to engage in their extracurricular activities. For many children, being 

out of school has resulted in lack of a safe place and/or food. Given all of that, she was happy 

that they were finally beginning to talk about the children and returning their lives to normal.

Safety, Immunogenicity, and Efficacy of BNT162b2 in Persons Aged 12-15 Years 

Dr. John Perez (Pfizer) presented the safety, immunogenicity, and efficacy of Pfizer’s COVID19 vaccines in subjects 12-15 years of age. Pivotal study C4591001 was initially an adult study. 

Once acceptable tolerance in adults was established within the original study, Pfizer amended 

the protocol to allow inclusion of subjects 16-17 years of age and subsequently 12-15 years of 

age. The same dose and schedule were used as had been used for adults, without further dosefinding, in order to generate data to understand whether people 12-15 years of age could be 

included in pandemic COVID-19 immunization programs. The data presented during this 

session were from Dose 1 to 1 month post-Dose 2 in persons 12-15 and 16-25 years of age,

and from Dose 1 to the data cut-off point of 13 March 2001 in persons 12-15 years of age. Data

from subjects 16-25 years of age were used for the safety comparisons and immunobridging 

purposes.

The Phase 2/3 safety study began on July 27, 2020. Two doses of vaccine were given 21 days 

apart and then active surveillance COVID-19 was undertaken. Anyone who had potential 

COVID-19 symptoms triggered a telehealth or in-person visit and a nasal swab was performed.

Reactogenicity was measured 7 days after each dose of vaccine using an electronic diary. This 

was done in a subset of individuals for 16 and above and for all participants 12-15 years of age.

Non-serious adverse events (SAEs) were measured through 1 month post-Dose 2, SAEs for 6 

months post-Dose 2, and deaths throughout the study for all participants. Overall, there were 

2260 persons 12-15 years of age and 1097 persons 16-25 years of age. Subjects with a history

of symptomatic COVID-19 or multisystem inflammatory syndrome in children (MIS-C) were 

excluded.

Looking at the demography, the vaccine and placebo groups were well-balanced with the

demographic variables of sex, race, ethnicity, and country. Roughly half the group was female, 

about 86% were white, 5% were Black or African American, 6% were Asian, and about 12% 

were Latino. All of the subjects in the 12-15 year old cohort were from the US. In the 16 to 25

year old group, about 71% were from the US and the rest were from a smattering of other 

countries included in the trial.

Regarding reactogenicity in the 12-15 year old and 16-25 year old groups, local reactions by 

maximum severity within 7 days after each dose in the two age cohorts for Dose 1 and Dose 2

are reported for redness, swelling, and pain at the injection site. Severity is measured from Mild 

to Grade 4. Within each reactogenicity, vaccine is compared to placebo for each of the two age 

cohorts. Pain at the injection site was the most frequent. Local reaction reported in the study 

was 86.2% in the 12-15 year-old group with the first dose and decreased to 78.9% with the 

second dose. Most of the reactions were reported to be mild to moderate in severity. There is

about 5% to 7% reporting of redness and swelling for Dose 1 and for Dose 2.
ACIP Meeting Summary May 12, 2021

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Turning to systemic events by maximum severity within 7 days after Dose 1, 10.1% of the 12-15

year old age group reported a fever compared to 7.3% in the 16-25 year old group. Fatigue, 

headache, and chills also were frequently reported in this age cohort. Vomiting and diarrhea 

were reported at similar frequencies to placebo. Muscle pain and joint pain were reported as 

well, but the frequency was slightly higher in the 16-25 year old group compared to the 12-15

year old group. For Dose 2, the frequency of fever increased from 10% with the first dose to

19.6% with the second dose. Similarly, fatigue, headache, and chills also increased with the 

second dose. For vomiting and diarrhea, there was really no increase. Muscle and joint pain

also increased with the second dose, but were higher in the 16-25 year old group compared to 

the 12-15 year old. This is precisely the same pattern seen in individuals 16 years of age and 

above in the entire study.

To summarize local and systemic events in Phase 3 within 7 days of each dose in the 12-15 

year old group (N=2254), pain at the injection site was the predominant local reaction and it was 

more prominent with the first dose. From a severity perspective, local reactions were mostly 

mild to moderate. Systemic events were predominantly fatigue, headache, chills, muscle pain, 

fever, and joint pain. These were more prominent after the second dose, but also were mostly 

mild to moderate in severity.

In terms of adverse events (AEs) reported in the Phase 3 study of 12-15 year olds from Dose 1

to one month post-Dose 2, 6% in the vaccine group reported AEs compared to 5.9% in the 

placebo group. In the 16-25 year old group, 10.8% recorded AEs compared to 8% in the 

placebo group. In both age groups, there were slightly more related AEs reported in the vaccine 

as compared to the placebo group. There were similar rates in both age groups for any SAE, 

related SAEs, and withdrawal due to AEs. There is a similar range of rates between the vaccine

and placebo, with low rates for all of these events. In terms of withdrawal due to AEs, there was 

one subject in the vaccine group in the 12-15 year old cohort who had no past medical history 

and developed a fever the day after vaccination of 104.7. The fever abated and resolved the 

next day after vaccination without sequala. The patient remains in the study and is being

followed for safety. No deaths have been reported in the study.

Continuing with the 12-15 year old subjects from Dose 1 to the cut-off date of 13 March 2021,

the pattern is the same as seen through one month post-Dose 2. In the vaccine group, 6.4% 

reported AEs compared to 6.3% in the placebo group. There were slightly more related AEs

in the vaccine group compared to the placebo group. There continued to be low rates of any 

SAEs, no related SAEs, no additional withdrawals, and no deaths. Digging a little deeper, 

reporting AEs by ≥1% by system organ class (SOC) in 12-15 year olds one month post-Dose 2, 

there 6% overall in the vaccine group compared to 5.9% in the placebo group. The difference 

between vaccine and placebo is driven by 3 SOC classifications, including general disorders,

gastrointestinal disorders, and nervous system disorders. These are the SOC classifications 

where reactogenicity AEs would be recorded. For example, the general disorders SOC is where 

injection-site reactions and system reactions of fever and fatigue would be reported. That is 

exactly what was observed in that SOC. The gastrointestinal disorders is nausea and diarrhea 

would be reported. Nervous system disorders is where headache is being reported.

The same pattern is observed looking at AEs ≥1% by SOC in the comparison group of 16-25

year olds, with 10.8% reporting an AE in the vaccine group compared to 8% in the placebo

group. That difference is being driven by similar organ class reactogenicity events being

reported as AEs. The new SOC with this age cohort is the musculoskeletal and connective 

tissue disorders SOC, which is where myalgias or arthralgias would be reported, with the same 

pattern between 12-15 and 16-25 year olds. Continuing to follow individuals to the cutoff date of 
ACIP Meeting Summary May 12, 2021

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the 13 March 2021, not much more is picked up than seen one month after the second dose.

Again, most of the AEs being recorded are in the general disorders, gastrointestinal, and 

nervous system disorders. The differences are being driven by injection-site reactions and some 

systemic reactions. No additional types of AEs were picked up with further follow-up.

One AE that was associated with the vaccine was lymphadenopathy in the 12-15 year olds.

Overall, there were 9 at 0.8% in the vaccine group and 2 cases in the placebo group at 0.2%.

Just focusing on those that were related to vaccination by the investigator, there were 7 cases 

or 0.6% compared to the placebo group of 0.1%. These were predominantly left axillary or left 

cervical lymphadenopathy. As a reminder, vaccination was given in the non-dominant arm,

which in most individuals would be the left arm. Onset was within 2 and 10 days after 

vaccination. The duration was 1 to 10 days, where it was reported. To compare adults 16-55 

years of age, 52 participants (0.4%) in the vaccine group compared to 2 participants in the 

placebo group had lymphadenopathy events reported up to the unblinding data and assessed

by the investigators as related to study intervention. The majority of these events occurred in the 

arm or the neck region. They were reported with 2 to 4 days after vaccination, typically after 

Dose 2 and typically resolving within 1 week of starting.

Turning to SAEs by SOC and preferred term from Dose 1 to the data cutoff date of the 13

March, overall there was a low rate of SAEs reported. In the vaccine group, there were 5 events 

reported giving a rate of 0.4%. In the placebo group, there were 2 events reported giving a rate 

of 0.1%. One thing to notice about these data is that many of the AEs were reported by a single 

individual. For example, abdominal pain, constipation, and neuralgia was reported by 1 

individual. This individual presented with abdominal pain and had multiple physical 

examinations and laboratory evaluations for these complaints. Ultimately, a diagnosis of 

functional abdominal pain was made. In the psychiatric disorders, there were reports of

depression, anxiety, and suicidal ideation. All of these individuals have a history of depression

and/or anxiety that was after the time of vaccination. The individuals in the depression and

suicidal ideation case had been on a selective serotonin reuptake inhibitor (SSRI) 1 to 2 months 

before vaccination. The subject with depression and anxiety had a history of depression, was 

being treated with SSRIs, and had an extensive history of multiple anxiety disorders. As a 

reminder, there were no deaths reported in the study.

Regarding efficacy and immunogenicity, in the follow-up time after Dose 2 in the 12-15 year

olds, total exposure from Dose 2 to the cut-off date was divided into <1 month, 1 to 2 months, 2 

to 3 months, and >3 months. Of the vaccine group, 54.1% had between 2 and 3 months of 

follow-up at the time of the analysis, with an additional 4.2% having greater than three months 

after the second dose at the time of this analysis. Overall, 98.3% of the subjects had at least 1

month of follow-up time in the study.

In terms of the immune response and the geometric mean titers (GMTs) of the SARS-CoV-2 

neutralization assay (NT50) and subjects from the two age cohorts, in this particular assay, 

values of 20 and above would be measurable and valid assay results. Before vaccination

and in the placebo group, there was essentially no measurable neutralization results. However, 

1 month after the second dose, in the 12-15 year olds, GMT increased to 1283, and in the 16-25

year olds, the GMT increased to 730.8. Therefore, the vaccine was able to generate potent 

neutralization responses in both groups.
ACIP Meeting Summary May 12, 2021

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Non-inferiority between 12-15 and 16-25 years of age was met. This was the primary endpoint 

to evaluate immunobridging between the two age cohorts. The neutralization titer in the 12-15

year-olds one month after the second dose was 1239.5. This analysis only included people who 

had no signs of infection prior to or during the study, so in that group, 1239.5 was the GMT.

That compared to a GMT of 705.1 in the 16-25 year olds. Divide 1239 by 705, the geometric 

ratio is 1.76 with a confidence interval of 1.47 to 2.10. Non-inferiority is declared at the lower 

bound at the 95% confidence interval at >0.67; 0.67 is the natural log of 1.5, which is the noninferiority margin used for this analysis. That 1.47 is much greater than 0.67, and hence the predefined non-inferiority margin in this study was met. Because the lower limit of the 95%

confidence interval to GMR is >1, that indicates a statistically greater response in the 12-15 year 

old group compared to the 16-25 year old group.

Efficacy was assessed from a descriptive perspective looking at subjects without evidence of 

infection prior to 7 days after the second dose. In the vaccine group, there were no cases of 

COVID-19 in individuals vaccinated with BNT162b2. In the placebo group, 16 individuals

developed COVID-19. That calculates out to a vaccine efficacy of 100%, with a 95% confidence 

interval of 75.3% to 100%. In this study, there were no severe COVID-19 cases. Looking at 

individuals with or without evidence of infection prior to 7 days after Dose 2, an additional 2 

cases were picked up in the placebo group for a total of 18 cases in the placebo group and zero 

cases in the vaccine group. This calculates out to a vaccine efficacy of 100%, with a tighter 95% 

confidence interval. There were no severe COVID-19 cases in this analysis.

Overall, from a safety perspective, reactogenicity was found to be well-tolerated in subjects 12-

15 years of age and showed a very similar pattern to what was seen in the 16-25 year olds.

Pain at the injection site, fatigue, headaches, chills, joint pain, and muscle pain were the most 

predominant as well as fever. Increased systemic events after dose 2 was similar to that seen 

with 16-25 year olds. AEs overall were relatively few. The highest incidence was in the SOC of 

General Disorders and Administration Site Conditions, reflecting local and systemic 

reactogenicity events. Lymphadenopathy was identified as related to vaccination and there were 

no related SAEs and no deaths reported in the study.

In terms of immunogenicity and efficacy, the immune response in the Pfizer-BioNTech COVID19 vaccine in terms of our SARS-CoV-2 50% neutralization titers in adolescents was noninferior to and, in fact, exceeded the immune response in young adults 16-25 years of age, 

which provides immunobridging between adolescents in this pivotal study. In the adolescent 

group, efficacy analyses based on the cases reported from at least 7 days after Dose 2 through

the data cutoff date, the observed VE was 100% for individuals without evidence of prior SARSCoV-2 infection, and 100% of those with or without evidence of prior SARS-CoV-2 infection 

before their vaccination regimen. There were no severe cases reported in the 12-15 year old 

age cohort as of the data cutoff date. Overall, these immunogenicity and efficacy data strongly 

support the vaccine use in adolescents 12-15 years of age.

Summary of Discussion

• ACIP expressed an interest in hearing more safety and immunogenicity by race and 

ethnicity, which Pfizer has not performed.

• The number of children with psychiatric diagnoses raised concerns for ACIP members. CDC 

called upon Dr. Fink, FDA, to speak further to these. He indicated that FDA noted the 

numerical imbalance in SAEs related to worsening of depression that was ongoing at the 

time of study enrollment and evaluated the narratives of these cases provided by the 
ACIP Meeting Summary May 12, 2021

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vaccine manufacturer. FDA also noted the proportion of the study population that entered 

the study with active psychiatric diagnoses, including most commonly attentiondeficit/hyperactivity disorder (ADHD), but also a fair number of subjects (~4%) had a history 

of ongoing depression. FDA also noted that in 3 of the SAEs that were reported in vaccine 

recipients, an SSRI medication had been initiated approximately 1 to 2 months prior to study 

enrollment, which Dr. Perez mentioned in the Pfizer presentation just given. These SSRIs 

do carry a boxed warning in the FDA package inserts that they may worsen depression and 

cause suicidal ideation in adolescents specifically, so FDA recognizes these exposures to 

SSRIs and potentially contributing factors that offer the reasonable explanation for the 

events. The other SAEs that occurred in a subject who was not taking an SSRI, according to 

careful review of the narrative, revealed other psychosocial factors that were described by

the participant that FDA felt constituted a reasonable explanation for the event. Taken 

together, although there was a small numerical imbalance with zero cases in the placebo 

group, the FDA did not see evidence to support a causative role of the vaccine in these 

events.

• ACIP expressed an interest in whether Pfizer would be assessing co-administration with 

other vaccines in this age group. Pfizer indicated that they have no plans to do so currently, 

but plans frequently change with their COVID-19 program.

GRADE: Pfizer-BioNTech COVID-19 Vaccine

Dr. Megan Wallace (CDC/NCIRD) presented GRADE for the Pfizer-BioNTech COVID-19 

vaccine. The policy question under consideration for this analysis was, “Should vaccination with 

Pfizer-BioNTech COVID-19 vaccine be recommended for persons 12-15 years of age under an 

Emergency Use Authorization?” In terms of the components of the PICO question, the 

population under consideration is persons 12-15 years of age. The intervention is 2 doses of the 

Pfizer-BioNTech COVID-19 vaccine 21 days apart. The comparison is no vaccine. The WG

identified 7 outcomes as the most important for the policy question: Symptomatic lab-confirmed 

COVID-19, hospitalization due to COVID-19, MIS-C, SARS-CoV-2 seroconversion to a nonspike protein, asymptomatic SARS-CoV-2 infection, SAEs, and reactogenicity.

The WG felt that the outcomes that needed to be considered for policy should be modified when 

considering COVID-19 vaccines for adolescent and pediatric populations. Symptomatic 

laboratory-confirmed COVID-19 remains a critical benefit. Given that the size of pediatric trials is 

smaller, direct efficacy data may not be robust. These studies were designed to assess 

immunobridging, which can be considered in support of efficacy. Hospitalization due to COVID19, which is less common in children, remains an outcome but is important instead of critical.

Death, which is rare in children, has been replaced with MIS-C, but deaths will still be monitored 

as part SAEs. For harms, SAEs remain a critical outcome and reactogenicity remains an

important outcome.

Of note, in the case of vaccine trials, hospitalization due to COVID-19 and MIS-C are less 

common. The Phase 3 trials may not be designed or powered to evaluate differences between 

treatment groups. The WG does not necessarily expect to have direct evidence for these 

outcomes at this point, and to some degree, can infer that decreases in symptomatic COVID-19 

would also translate into decreases in hospitalizations and MIS-C. There were no COVID-19 

hospitalizations or cases of MIS-C among vaccinated or placebo participants in the available 

body of evidence, so these outcomes were not included in the evidence profile Dr. Wallace 

presented. Additionally for the outcomes of seroconversion and asymptomatic infection, no data 

are currently available, so these outcomes also were not included in the evidence profile.
ACIP Meeting Summary May 12, 2021

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A systematic review was conducted to identify evidence related to the policy question.

Published articles were identified published using a variety of databases and search terms to 

identify data on vaccination with a specific vaccine formulation under consideration that involved 

human subjects, reported primary data, included persons at risk for SARS-CoV-2 infection,

included data relevant to the efficacy and safety outcomes being measured, and included data

on the dose and timing under consideration. Additional sources were sought, including obtaining 

unpublished data from vaccine manufacturers. Over 5300 records were identified through

database searching, and one record was obtained directly from the sponsor of the Phase 2/3

trial. Ultimately, one resource was included in the evidence synthesis.

GRADE evidence type assesses the certainty of estimates from the available data. The highest 

level of certainty is Type 1 (high certainty), which means the WG is very confident the true effect 

lies close to that of the estimate. Type 2 (moderate certainty) means that the WG is moderately 

confident in the effect estimate, but there is a possibility the true effect could be substantially 

different. Type 3 (low certainty) means that the WG’s confidence in the effect estimate is limited. 

Type 4 (very low certainty), means that the WG has little confidence in the effect estimate. The 

evidence type is not measuring the quality of individual studies, but rather how much certainty

the WG had in the quantitative estimates of effect across each outcome.

Initial evidence type is determined by the study design. A body of evidence from randomized 

control trials (RCTs) starts with an initial evidence Type of 1, indicating high certainty. A body of 

evidence from observational studies starts with an evidence Type of 3, indicating low certainty.

The evidence type could be downgraded due to risk of bias, inconsistency, indirectness, or

imprecision. Other considerations could downgrade or upgrade the evidence type.

To review the evidence of benefits, for the critical outcome of symptomatic COVID-19, one 

study provided data. This was the Pfizer-BioNTech Phase 2/3 RCT trial, and the data were

attained directly from the sponsor. The data cutoff date was March 13, 2021. Primary analyses 

were performed for an evaluable efficacy population defined as all eligible randomized

participants who received all vaccinations as randomized within the predefined window and 

have no other important protocol deviations as determined by the investigator, and who do not 

have evidence of prior SARS-CoV-2 infection. For these analyses, there were over 1900

persons, about 1000 per arm, who contributed 300 person years of observation, about 150 per 

arm. Secondary analyses included persons with prior infection. Analyses also were done for an 

all-available efficacy population, which includes all randomized participants who received at 

least 1 dose with outcomes counting any time after that. It may be helpful to think of the

evaluable efficacy as similar to protocol analysis and all-available efficacy as similar to an

intention-to-treat (ITT) analysis.

Using the evaluable efficacy population for all persons aged 12-15 years, there were zero cases 

among 1001 persons in the vaccine arm and 16 cases among 972 persons in the placebo arm,

which resulted in a VE estimate of 100%. This is the outcome used for GRADE. Varying timing

of outcome assessments and with inclusion of persons who had evidence of prior infection had 

little influence on the efficacy estimates. The Phase 2/3 trial was designed and powered to use 

immunobridging to evaluate efficacy. Immunobridging studies compare immunogenicity in a

group of interest, for example, those age 12-15 years, with a comparison group in which efficacy 

has been demonstrated in clinical trials. For example, those aged 16-25 years. For the 

immunogenicity analyses, 209 participants aged 12-15 years and 186 participants aged 16-25

years were randomly selected from the vaccine and placebo arms of the trial for comparison.

The immune response to vaccine was evaluated using the geometric mean ratio of neutralizing 

antibody titers comparing adolescents to young adults. Non-inferiority criteria are met when the 
ACIP Meeting Summary May 12, 2021

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lower bound of the 95% confidence interval for the geometric mean ratio is not less than a 

preset value, which for this study was 0.67. The immune response to vaccine in adolescents

aged 12-15 years was non-inferior to that observed in young adults aged 16-25 years, with a 

geometric mean ratio of 1.76 based on SARS-CoV-2 neutralizing titers at 1 month after Dose 2

in participants without prior evidence of SARS-CoV-2 infection. In fact, antibody levels were 

significantly higher among adolescents aged 12-15 years than young adults aged 16-25 years.

For the sake of transparency, the WG also wanted to mention additional analyses from the

study that compared seroresponse in adolescents and young adults. These analyses are 

considered exploratory because there is not yet an established immunological correlate of

protection. Among participants without prior evidence of SARS-CoV-2 infection, 97.9% had at 

least a 4-fold rise in SARS-CoV-2 neutralizing titers from the vaccination to 1 month after Dose 

2. There was a difference in proportions of participants who had at least a 4-fold rise because 

adolescents and young adults was 2.1%, but the difference was not significant.

Looking at the GRADE evidence table for the outcome symptomatic COVID-19, because the 

data were from an RCT, the evidence type started at 1. Regarding risk of bias, there was some 

concern related to blinding. Participants and study staff were blinded to assignments, but they 

may have inferred receipt of vaccine or placebo assignment based on reactogenicity. This was 

deemed unlikely to overestimate the efficacy results. Therefore, the WG considered the risk of 

bias to be not serious. Because there was only one study, there were no serious concerns of 

inconsistency. Some concern for indirectness was noted due to the short duration of

observation and the available body of evidence. The VE efficacy observed at a median 2-month 

follow-up may be different from the efficacy observed with ongoing follow-up. However, in 

consideration with the strength of association, it is unlikely that the efficacy estimate for 

symptomatic COIVD-19, which changed substantially enough to fall below the FDA-defined 

efficacy threshold for licensure under an EUA to less than 50% efficacy. The WG also noted that 

longer-term efficacy from the adult RCT suggests that short-term efficacy will translate to longerterm efficacy. Further, the immunobridging data indicates that the immune response in 

adolescents is at least as strong as that observed in adults. This resulted in a final certainty of 

Type 1.

Regarding the data on GRADE for harm, the Phase 2/3 trial was the only study to provide data

on SAEs. In terms of the raw data on a critical outcome of SAEs, in the Phase 2/3 trial, there 

were 5 events among the vaccine group and 2 among the placebo group. None of the events 

were considered to be associated with vaccination. Looking at the GRADE evidence table

SAEs, the relative risk of SAEs between vaccinated and placebo was 2.5 a 95% confidence 

interval of 0.49 to 12.84. The certainty assessment was reduced one point due to serious 

concern of indirectness because the body of evidence does not provide certainty that rare SAEs

were captured due to the short follow-up and sample size. There was also very serious concern 

for imprecision due to the confidence interval crossing the line with no effect and the width of the 

confidence interval containing estimates for which different policy decisions may be considered. 

This left the WG with a final certainty of Type 4.

Reactogenicity was evaluated using the same Phase 2/3 study. The local reaction solicited for 

the 7 days following vaccination were injection site pain, redness, and swelling. The systemic 

events solicited were fever, vomiting, diarrhea, headache, fatigue, chills, new or worsening 

muscle pain, and new or worsening joint pain. In the Phase 2/3 study, Grade 3 local reactions or 

systemic events were reported in 10.7% of persons in the vaccine arm and 1.9% of persons in 

the placebo arm. Most of these events were Grade 3, with one Grade 4 event of pyrexia 

reported in a vaccine recipient. The relative risk for any Grade 3 or 4 event was 5.49 with a 95% 
ACIP Meeting Summary May 12, 2021

12

confidence interval from 3.51 to 8.58. There was no serious concern for risk of bias, 

inconsistency, indirectness, or imprecision. The final certainty was Type 1.

To summarize the WG’s GRADE assessment for the Pfizer-BioNTech COVID-19 vaccine in 

adolescents, in terms of benefits, the available data indicate that the vaccine is effective for 

preventing symptomatic COVID-19 with direct efficacy data and supplemental immunobridging

data with an evidence Type of 1. No data were available to assess the other potential benefits.

In terms of harms, a total of 5 SAEs were observed in the vaccine arm and 2 in the placebo

arm. There was concern for indirectness, and the wide confidence interval included both

benefits and harms, so the evidence type was 4, indicating very low certainty. No SAEs were 

judged to be related to vaccination. Regarding reactogenicity, severe reactions were more 

common in vaccinated persons and 10.7% of vaccine recipients versus 1.9% of placebo

recipients reported Grade 3 or 4 reactions. The evidence type for reactogenicity was Type 1.

In conclusion, the Phase 2/3 RCT of the Pfizer COVID-19 vaccine was conducted among

persons aged 12-15 years in the US. The VE estimate for the Pfizer-BioNTech COVID-19 

vaccine in adolescents was 100% for symptomatic laboratory-confirmed COVID-19. SAEs were 

more common among vaccine than placebo participants, but there was very low certainty in the 

estimates. No SAEs were judged to be related to vaccination. Grades 3 or 4 local or systemic 

reactions were more common among vaccine than placebo recipients and were reported by 

about 11% of vaccinated subjects. The certainty and estimates for critical benefits was Type 1, 

high. The certainty in the estimates for critical harms was Type 4, very low.

EtR Framework: Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12-15 Years

Dr. Sara Oliver (CDC/NCIRD) presented the EtR Framework findings for Pfizer-BioNTech 

COVID-19 vaccine in adolescents aged 12-15 years. As a reminder, the EtR Framework allows

the WG to describe the evidence to inform ACIP recommendations in a transparent manner.

The policy question under consideration was, “Should vaccination with Pfizer-BioNTech COVID19 vaccine (2-doses, IM) be recommended for persons 12-15 years of age under an Emergency 

Use Authorization?” As was just shown in GRADE, the PICO questions were updated with 

outcomes for adolescents. As a reminder, the EtR domains as questions about each of 7 

domains: Public Health Problem, Benefits and Harms, Values, Acceptability, Feasibility, 

Resource Use, and Equity. The intervention was updated with the Pfizer-BioNTech COVID 

vaccine given to adolescents aged 12-15 years and the problem as COVID-19 among 

adolescents aged 12 to 15 years.

For the public health problem question regarding whether COVID-19 among adolescents aged

12-15 years is of public health importance, the WG reviewed evidence on COVID incidence and 

burden estimates, COVID-associated hospitalization rates, COVID-associated mortality, MIS-C,

and transmission. Based on the overall epi curve of the pandemic, there have been over 32 

million cases of COVID reported to CDC, with the most recent 7-day moving average of 38,000 

cases per day. Cases declined in recent weeks after a slight uptick in late March and early 

April.1In terms of trends among the adolescent population, much of the surveillance data in the 

US uses a 12-17 year age group, so much of the epi data will be presented with this age cutoff.

Through the end of April, there have been over 1.5 million cases among adolescents 12-17 

years of age.2

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

2 https://covid.cdc.gov/covid-data-tracker/#demographicsovertime
ACIP Meeting Summary May 12, 2021

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In terms of the proportion of total COVID cases by age group throughout the pandemic, early in 

the pandemic, the older adults represented a larger proportion of cases. However, that 

proportion decreased in recent weeks. As more adults are vaccinated, adolescents aged 12-17 

years make up a greater proportion of total cases. In April, 9% of cases were aged 12-17 years,

which represents a larger proportion of total cases than adults 65 years of age and over.3

However, it is known that diagnosed and reported cases are an underestimate. To better reflect 

the burden of COVID-19 the full impact of disease, CDC provides estimates of COVID-19 

infections, symptomatic illness, and hospitalizations using a statistical model to adjust for cases 

that national surveillance networks are unable to capture for a number of reasons. For children 

and adolescents 5-17 years of age, there have been estimated 22 million SARS-CoV-2

infections, making up around 19% of all estimated SARS-CoV-2 infections.4

Looking at estimated rates of SARS-CoV-2 infections, symptomatic illness, and hospitalization

rates per 100,000 population by age group, children and adolescents 5-17 years of age have 

the highest rates of infection and symptomatic illness. However, the proportion of symptomatic 

patients who are hospitalized are lower among children.5 Moving to cumulative rates of COVIDassociated hospitalizes for children and young adults from March 2020 through the end of 

March 2021 from COVID-NET, COVID-NET is a population-based surveillance system that 

collects data on laboratory-confirmed COVID-associated hospitalizations among children and 

adults through a network of over 250 acute care hospitals in 14 states. The rate for persons 

aged 12-17 years was 51 per 100,000 population. Rates for this age group have consistently 

been higher than those in persons aged 5-11 for most of the pandemic.6

To highlight recent hospitalization rates in this pediatric and adolescent population looking at the 

3-week moving average rate of hospitalizations among children and adolescents, over the past 

2 months, there has been a gradual increase in the hospitalization rate among adolescents 12-

17 years of age. To provide some additional context to these hospitalization rates, cumulative 

COVID-19-associated hospitalization rates among adolescents 12-17 years by MMWR week

were compared to the cumulative influenza-associated hospitalization rates during the H1N1 

pandemic year from 2009 to 2010 from historic FluSurv-NET. Cumulative hospitalization rates 

for adolescents aged 12-17 years is 51.3 per 100,000 population and 23.9 per 100,000 

population for H1N1 influenza. Then the last several influenza-associated hospitalization rates

were added in for three of the most recent influenza seasons (2017-2018, 2018-2019, 2019-

2020), ranging from 12 to 15 per 100,000. Of note, the influenza season starts at MMWR Week 

40, so these accumulate over a shorter period of time.

To continue with COVID-NET, results from an investigation of 722 hospitalized adolescents, 

over half of whom were Hispanic or non-Hispanic Black, 31% had severe disease defined as 

requiring intensive care unit (ICU) admission or invasive mechanical ventilation during 

hospitalization. In addition, 61% of children had at least one underlying condition. The most 

common underlying conditions were obesity, asthma, developmental delay, and diabetes.

3 https://covid.cdc.gov/covid-data-tracker/#demographicsovertime

4 Sources: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burden.html; US Census Bureau, Population Division, 2020 

Demographic Analysis (December 2020 release)

5 https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burden.html

6 https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html
ACIP Meeting Summary May 12, 2021

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Moving COVID-related deaths, there have been nearly 580,000 deaths in the US, with the most

recent 7-day moving average of 604 deaths per day. Between January 1, 2020 and April 30,

2021, there were 127 COVID-19 deaths among adolescents 12-17 years of age, which 

accounted for 1.3% of all deaths among adolescents during the same time period. While this 

sounds low, it is worth noting that this would still be in the top 10 causes of death among 

children in 2019, which is the last year that there are top 10 causes of death for comparison.7

Moving MIS-C, this is a severe hyperinflammatory syndrome occurring 2 to 6 weeks after acute 

SARS-CoV-2 infection and resulting in a wide range of manifestations and complications. 

Approximately 60% to 70% of patients with MIS-C are admitted to intensive care, and 1% to 2% 

die.8,

9 There have been 3742 MIS-C cases reported to national surveillance as of early May.

The median age was 9 years, with 21% of cases occurring in adolescents 12-17 years of age

and 63% of cases occurred in children who were Hispanic or non-Hispanic Black. MIS-C has an 

estimated incidence of 1 to 8.5 MIS-C cases per million person-months.10 While adolescents 

may have a slightly lower incidence of MIS-C compared with younger children, they generally

present with more severe MIS-C compared with MIS-C patients aged 0-5 years. Both ICU 

admission and decreased cardiac function were more likely in patients 13-20 years hospitalized 

with MIS-C.11

Regarding adolescents in transmissions, some studies observed similar infection rates between

children and adults, while others found lower infection rates among children compared to 

adults.12,

13 Adolescents may be more likely to be infected than younger children. This is 

supported by data from several different methods, including contact tracing, test positivity, and 

population-based seroprevalence data.14 Secondary transmission from adolescents can and 

does occur. While SARS-CoV-2 transmission among students is relatively rare, several studies 

suggest transmission is more likely within high school settings than in elementary school

settings.15,

16

7 https://data.cdc.gov/NCHS/Provisional-COVID-19-Death-Counts-by-Age-in-Years-/3apk-4u4f/data

8 Characteristics and Outcomes of US Children and Adolescents With Multisystem Inflammatory Syndrome in Children (MIS-C) 

Compared With Severe Acute COVID-19. JAMA. 2021;325(11):1074-1087. doi:10.1001/jama.2021.2091

9 Belay ED, Abrams J, Oster ME, et al. Trends in Geographic and Temporal Distribution of US Children With Multisystem 

Inflammatory Syndrome During the COVID-19 Pandemic [published online ahead of print, 2021 Apr 6]. JAMA Pediatr. 

2021;e210630. doi:10.1001/jamapediatrics.2021.0630 

10 Health Department-Reported Cases of Multisystem Inflammatory Syndrome in Children (MIS-C) in the United States. 

https://www.cdc.gov/mis-c/cases/index.html

11 Abrams JY, Oster ME, Godfred-Cato SE, et al. Factors linked to severe outcomes in multisystem inflammatory syndrome in 

children (MIS-C) in the USA: a retrospective surveillance study. Lancet Child Adolesc Health. 2021;5(5):323-331.

doi:10.1016/S2352-4642(21)00050-X

12 Bi Q et al. Lancet Infect Dis. 2020;20(8):911-919 

13 CDC Science Brief: Transmission of SARS-CoV-2 in K-12 schools. https://www.cdc.gov/coronavirus/2019-ncov/science/sciencebriefs/transmission_k_12_schools.html

14 Goldstein E et al. On the Effect of Age on the Transmission of SARS-CoV-2 in Households, Schools, and the Community. J Infect 

Dis. 2021 Feb 13;223(3):362-369.

15 Larosa E et al. Secondary transmission of COVID-19 in preschool and school settings in northern Italy after their reopening in 

September 2020. Euro Surveill. 2020;25(49):2001911.
ACIP Meeting Summary May 12, 2021

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Multiple outbreaks and contact tracing investigations have demonstrated efficient transmission 

among children, adolescents, and young adults, including transmission to older more vulnerable 

household members.17,

18 A recent publication in Science described results from a survey of over 

1.5 million adults, including over 500,000 who are living with at least one child in school. The 

survey found that after adjusting for county-level incidence and other factors, but not necessarily 

school-based mitigation measures, living in a household with a child engaged in full-time inperson school was associated with a substantial increase in the odds of reporting a COVID-like 

illness, loss of taste or smell, or a positive SARS-CoV-2 test within the previous 14 days

compared to those with children not attending in-person school. The association between

COVID outcomes and reporting a child in the household was attenuated somewhat when that 

child was attending part-time schooling.

19

In summary, adolescents 12-17 years of age are at risk of severe illness from COVID-19. There 

have been over 1.5 million reported cases and over 13,000 hospitalizations to date among

adolescents 12-17 years. Overall, the hospitalization rate for COVID in this population is higher

than the influenza-associated hospitalization rate for the same group during the 2009 H1N1

influenza pandemic. The clinical presentation of MIS-C is more severe in adolescents than in 

younger children. In addition, COVID in adolescents may also indirectly impact others’ health.

Adolescents contribute to transmission in households and communities, including older, 

vulnerable populations. Finally, adolescents represent an increasing proportion of recent COVID 

cases. Based on the review of these data, the WG felt that COVID disease among adolescents 

is of public health importance.

Moving to benefits and harms, the WG answered the questions, 1) How substantial are the 

desirable anticipated effects?, 2) How substantial are the anticipated undesirable effects?, and 

3) Do the desirable effects outweigh the undesirable effects? To summarize the available 

evidence for benefits, overall efficacy of the vaccine was supported by both immunobridging 

data and clinical efficacy. The clinical trial for the Pfizer-BioNTech COVID-19 vaccine 

demonstrated efficacy against symptomatic, laboratory-confirmed COVID-19 of 100% with a 

high certainty of evidence as just detailed in the GRADE presentation given by Dr. Wallace. 

Regarding the immunobridging data, the geometric mean ratio for antibodies in the 12-15 year

olds compared to the 16-25 year olds was 1.76, which met the non-inferiority criteria. No 

hospitalizations due to COVID or MIS-C were reported by any trial participants.

In terms of potential harms, SAEs were reported in a higher proportion of recipients of vaccine 

versus placebo based on 5 SAEs in the vaccine group and 2 in the placebo group. This was 

graded at a very low certainty of evidence. Severe reactions were more common in the vaccine 

recipients, where a Grade 3 or higher reaction was reported by 10.7% of vaccinated versus 

1.9% of the placebo group. This also was graded with a high certainty of evidence. No deaths 

were reported among any of the trial participants. Local reactions within 7 days were common,

occurring in 91% of vaccine recipients, with pain at the injection site as the most common.

Systemic reactions were common as well, with fatigue and headache as the most common. 

Most symptoms resolved within 1 to 2 days. Regarding other events of interest following the 

mRNA vaccines, no cases of anaphylaxis were reported in study participants 12-15 years of 

age. No cases of Bell’s Palsy or facial paralysis were reported in adolescents. Among the 

study participants 12-15 years of age, 7 in the vaccine group that had lymphadenopathy 

compared to 1 (0.1%) participant in the placebo group. Most lymphadenopathy was local in the 

17 Lopez A et al. MMWR Morb Mortal Wkly Rep 2020;69:1319–1323 

18 Schwartz N et al. MMWR Morb Mortal Wkly Rep 2020;69:1457–1459

19 Lessler J et al. Household COVID-19 risk and in-person schooling [published online ahead of print, 2021 Apr 29]. Science. 

2021;eabh2939. doi:10.1126/science.abh2939 
ACIP Meeting Summary May 12, 2021

16

arm or neck region, occurred on the same side as vaccination, and was reported within 2 to 10 

days after receiving the vaccine.

To summarize benefits and harms, the WG felt that the desirable anticipated effects were large, 

the undesirable effects were small, and that the balance favored the intervention, use of the 

Pfizer BioNTech COVID vaccine.

The questions assessed with regard to the values domain were: 1) Does the target population 

feel that the desirable effects are large relative to undesirable effects?; and 2) Is there important 

uncertainty about, or variability in, how much people value the main outcomes? The WG 

continues to review the scientific literature, news media, and reports. However, limited surveys 

have been conducted since authorization of the COVID vaccines. In terms of the overall 

proportion reporting positive vaccine intentions by month of data collection, surveys were 

conducted among adults asking about their intent to receive the vaccine for themselves. There 

has been a steady increase and intent to be vaccinated among adults. Surveys evaluating 

parents regarding their intent to have their children vaccinated have found that 46% to 60% of 

parents surveyed said they planned to get their children vaccinated.20,

21

,

22

,

23 The most common 

reasons for not planning to vaccinate their children included not being sure it is safe, the vaccine 

was developed too quickly, that they do not trust information being published about the 

vaccines, or they do not have enough information.2 Generally, parents reported a similar or 

slightly lower intent to vaccinate their children compared with the intent to vaccinate 

themselves.3,4

It was found that the intents to vaccinate children differed by parents’ gender, age, and income 

status. Fathers were more willing to vaccinate their children than mothers. Older mothers were 

more willing to vaccinate their children than younger mothers. Higher-income households were 

more likely to report an intent to vaccinate, where lower-income households were twice as likely

to say they were not sure about vaccinating their children compared to these higher-income 

households. When evaluating parents’ intent for children to receive their vaccine, intent varied 

by race and ethnicity, which is similar to the overall intent to get vaccinated among adults. When 

adolescents were asked about their intent to get vaccinated, 51% reported that they would

definitely or probably get vaccinated. Parents in this same survey, although not necessarily 

paired parents to the adolescents’ interviewed, reported that 55% would definitely or probably 

get their adolescent vaccinated. Then parents were asked how concerned they were about their 

adolescent getting COVID-19 and asked if they were concerned about their adolescent having 

any side effects from the COVID-19 vaccines. Adolescents were asked these questions about 

themselves. In both samples, respondents reported moderate levels of concern about 

adolescents getting COVID and adolescents having side effects from COVID vaccination.

Values for concern about the COVID vaccine side effects were slightly but significantly higher 

than values for concern about COVID disease in both populations.24

20 Axios/Ipsos April 2-5; Axios/Ipsos April 16-19; Calarco and Anderson preprint; WebMD March 2021

21 National Parents Union Survey January 2021

22 Simonson M, Baum M, Lazer D, et al. The COVID States Project #45: Vaccine hesitancy and resistance among parents. OSF 

Preprints, 19 Mar. 2021. https://doi.org/10.31219/osf.io/e95bc

23 Parents Together March 2021 Survey

24 CDC/U Iowa Survey of Parents and Adolescents, April 2021
ACIP Meeting Summary May 12, 2021

17

To summarize values, about half of parents say they are likely to get their adolescent

vaccinated. The intent to vaccinate adolescents differed by parents’ gender, race, and income.

The intent to vaccinate adolescents were similar or slightly lower than parental intent to get 

vaccinated themselves. There was overall limited information on adolescent intent to get 

vaccinated themselves. However, one study did find that nearly 40% of adolescents said they 

would let their parents or caregivers decide if they would get the vaccine. When the WG asked if 

the target population felt that the desirable effects were large relative to undesirable effects,

answers varied. Many felt that they were moderate to large but ultimately, most said that it 

varies. Not surprisingly, when asked if there was variability in how people value the outcomes,

they felt that there was probably important or uncertainty or variability.

Moving to acceptability, the WG was asked, “Is the Pfizer/BioNTech COVID-19 vaccine

acceptable to key stakeholders? A pulse survey was conducted of the jurisdictions in mid-April 

for their implementation planning for adolescents. Overall, most jurisdictions were taking a multipronged approach using existing provider networks, pediatric providers, and school-based

clinics.25 In addition, there was a survey late last year about physicians’ willingness to 

administer the COVID vaccine in their practices. Overall, 97% of providers were willing to 

administer COVID vaccine. The largest perceived barrier to vaccination was parent or patient 

concern about the safety of COVID vaccines.26 The CDC/Iowa survey of parents and

adolescents mentioned earlier asked the location where parents would be the most comfortable 

receiving a COVID vaccine. Parents were the most comfortable being vaccinated at their regular 

doctor’s office, with the local pharmacy as next.

To summarize acceptability, most jurisdictions are utilizing a variety of implementation strategies 

to vaccinate adolescents. Nearly all primary care providers surveyed are willing to provide 

COVID vaccines to their patients, and adolescents and their parents report their greatest 

comfort with receiving COVID vaccines at their primary care provider’s office. The WG felt that 

yes, the Pfizer vaccine was acceptable to key stakeholders.

The primary question regarding feasibility was, “Is the Pfizer/BioNTech COVID-19 vaccine

feasible to implement among adolescents aged 12-15 years? The objective of adolescent 

vaccination is to promote adolescent vaccination as quickly and equitably as possible, which will 

require a multi-pronged approach. Jurisdictions and providers already are vaccinating

adolescents 16-17 years of age. Current implementation plans to expand this down to 12 years 

of age include leveraging current COVID vaccine infrastructure and adapting over time. This 

would include an early Summer sprint in May-June, followed by increasing access in June and 

July, and a back-to-school campaign later in the Summer at the start of the school year. This will 

require a stepwise approach to increasing vaccine access for adolescents. Phase 1 involves 

augmenting the existing public health infrastructure for vaccination, which includes all current 

COVID vaccine providers opening up to allow vaccination for children 12 years of age and over.

Phase 2 involves strategically adding providers serving adolescents, including larger provider 

groups in children’s hospitals as well as smaller providers needed to increase access, such as

those in areas with high social vulnerability and rural areas. Phase 3 includes utilizing schoolbased vaccination programs in partnership with public health, pharmacies, and third parties, as 

well as through Health Resources and Services Administration (HRSA) sites.

25 Source: Jurisdiction data call survey – 05/03/21-05/06/21. n=46

26 Kempe A, et al. Primary Care Physicians’ Willingness and Capacity to Contribute to COVID-19 Vaccine Delivery. Unpublished.
ACIP Meeting Summary May 12, 2021

18

Increasing access to primary care providers serving adolescents has the benefits of utilizing 

trusted providers for providing information and education about COVID vaccines, as well as 

vaccinating against COVID and managing routine vaccinations, particularly as students return to 

school in the fall. Pharmacies and HRSA sites have a broad footprint across the nation and can 

rapidly expand to provide COVID vaccines for adolescents. School-based vaccinations have the 

benefit of reaching adolescents in their own communities, as well as being trusted sources of 

information for communities. Schools can partner with Federally Qualified Health Center

(FQHCs), pharmacies, and/or public health to hold targeted programs to improve coverage,

particularly as students return.

There are a few additional implementation considerations. First, current cold-chain storage

requirements and package sizes may limit the availability of COVID vaccines, particularly to 

smaller primary care providers. There are recent updates to both cold-chain and package size 

requirements that could improve this, however. Second, for the short-term, Pfizer could be the 

only vaccine available for this population. And jurisdictions and vaccine providers may need to 

determine a process for allocation of this product of this age group. Third, there are no federal 

legal requirements for caregiver consent of COVID-19 vaccine or any other vaccine. However, 

COVID vaccine must be administered according to applicable state and territorial vaccination 

laws, including those related to a consent. Sites administering vaccines should follow the 

current state and jurisdictional policies and practices other routine immunizations in this age 

group. The WG felt that overall, the Pfizer vaccine is feasible to implement among adolescents.

The primary question related to resource use was, “Is the Pfizer/BioNTech COVID-19 vaccine, 

given to adolescents aged 12-15 years, a reasonable and efficient allocation of resources?

The US government has purchased 600 million doses of mRNA vaccines, with 300 million

doses of the Pfizer vaccines. These vaccines will be available at no cost.27 There are no studies 

that evaluate the cost-effectiveness around the use of COVID vaccines among adolescents.

However, vaccinating adolescents may allow for a greater confidence and a safe return to

schools. Vaccination could lead to reduced work and school absenteeism related to COVID 

quarantine and isolation. There was one study that estimated that over time, school closures 

could have a total economic loss as high as $15 trillion over a lifetime.28

The WG concluded that cost-effectiveness may not be a primary driver for decision-making 

during a pandemic and for a vaccine used under EUA. However, it will need to be reassessed

for future recommendations. The use of COVID vaccines in as many populations as possible,

including adolescents, will be important to returning to pre-pandemic activities. This return to 

pre-pandemic activities is likely to have an overall positive economic impact. The WG felt that, 

yes, during the pandemic the use of the Pfizer vaccine among adolescents is a reasonable and 

efficient allocation of resources.

For the domain of health equity, the primary question posed was, “What would be the impact of 

the Pfizer-BioNTech COVID-19 vaccine, given to adolescents aged 12-15 years, on health

equity?” Health equity is when everyone has the opportunity to be as healthy as possible, and 

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

determined circumstances. The WG identified groups who might be disadvantaged in relation to 

COVID-19 disease burden or receipt of a COVID vaccine using the PROGRESS-Plus 

Framework (Place of residence, race or ethnicity, gender or sex, socioeconomic 

27 https://www.hhs.gov/about/news/2021/02/11/biden-administration-purchases-additional-doses-covid-19-vaccines-from-pfizer-andmoderna.html

28 https://www.oecd.org/education/the-impact-of-covid-19-on-education-insights-education-at-a-glance-2020.pdf;

https://www.cnbc.com/2020/09/08/school-disruption-could-cost-the-us-economy-15point3-trillion-oecd.html
ACIP Meeting Summary May 12, 2021

19

status, disability).

29 This process has been used previously for other EtRs. Evidence related to 

this group was gathered through a review of scientific and GRADE literature, as well as the 

CDC COVID-19 response data and resources. Groups have been identified as being

disadvantaged in relation to COVID-19 disease burden or receipt of the Pfizer BioNTech COVID 

vaccine. Dr. Oliver shared a list (slide 81) and a grid (slide 82) demonstrating where published 

peer-reviewed literature is available describing either disproportionate COVID-19 morbidity and 

mortality among adolescents or among adults, which can be inferred may apply to adolescents.

Additionally, grid includes where data are available demonstrating general barriers to healthcare 

in each of these populations. It is important to point out that there is diversity within each of 

these groups, as well as significant intersections between these groups. For example, Black and 

indigenous adolescents and adolescents who are LGBTQ+ (lesbian, gay, bisexual, transgender, 

questioning, and others) are considered overrepresented among the homeless youth 

populations.

As of May 4th, a lower percentage of Black and Hispanic or Latino adults were fully vaccinated 

compared with the percentage of these groups in the overall population. While these data are 

specific to adults, similar patterns may be seen in adolescents.30 Again, there are two

characteristics of the Pfizer BioNTech COVID vaccine that have the potential to impact health 

equity, cold-chain storage handling31 and administration requirements and the need for a 2-dose 

series.32 New data recently submitted to FDA on stability may reduce the need for ultra-cold

storage, thereby increasing access, particularly in smaller providers. Additional support to 

efficiently utilize doses, as well as smaller tray size, also will improve access. The requirements 

for a 2-dose series will make follow-up challenging for some disadvantaged groups, such as 

those who are homeless, live in rural locations, and have limited to no access to healthcare.

Among adults early in the vaccination program, only a small proportion did not receive the 

second dose of a 2-dose series. However, differences were seen by jurisdiction, race, ethnicity, 

and age. Overall, the multi-pronged approach described earlier to implementation can improve 

access and overall can improve equity. The WG felt that the impact of the Pfizer vaccine would 

probably increase health equity.

After reviewing the data, the WG provides a judgment on the balance of consequences. The 

WG felt that the desirable consequences clearly outweigh undesirable consequences in most 

settings. In addition, after reviewing the totality of information presented in the EtR framework, 

the WG discussed the type of recommendation proposed to ACIP. Based on the totality of data 

presented, the WG proposed to recommend the intervention to ACIP.

29 PROGRESS-Plus is an acronym to identify factors associated with unfair differences in disease burden and the potential for 

interventions to reduce these differential effects. See O'Neill J, Tabish H, Welch V, et al. Applying an equity lens to interventions: 

using PROGRESS ensures consideration of socially stratifying factors to illuminate inequities in health. J Clin Epi. 2014;67: 56-

64; Welch VA, Akl EA, Guyatt G, et al. GRADE equity guidelines 1: considering health equity in GRADE guideline development: 

introduction and rationale. J Clin Epidemiol. 2017;90:59-67.

30 CDC. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic as of May 4, 2021, and US Census Bureau National 

Population Estimates

31 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-more-flexible-storagetransportation-conditions-pfizer

32 Kriss JL, Reynolds LE, Wang A, et al. COVID-19 Vaccine Second-Dose Completion and Interval Between First and Second 

Doses Among Vaccinated Persons — United States, December 14, 2020−February 14, 2021. MMWR Morb Mortal Wkly Rep 

2021;70:389–395.
ACIP Meeting Summary May 12, 2021

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Summary of Discussion

• ACIP members expressed an interest in hearing additional information in the future about 

the following topic areas:

➢ MIS-C and cardiac outcomes and long-term outcomes among MIS-C survivors

➢ The impact on if/how the loss of a family member to COVID-19 has influenced a 

family’s intent to get vaccinated

➢ More details on the cold-chain and packaging changes as soon as possible

➢ Additional information on if/how English as a primary or secondary language impacts 

whether parents are willing to vaccinate their children with COVID-19 vaccine

• AAP emphasized that while there are some gaps in the information that needs to be 

collected, this should not be considered barriers to moving forward. This is an urgent 

problem. Mortality rates in children are demonstrating that this is one of the top 10 causes of 

death in children under 18 years of age. While there have not been the same tens of 

thousands of deaths that have occurred among adults, children do not die at the same rates 

overall. Several datasets have shown that pandemic has caused deaths in children that are 

unprecedented. This is a critical need, and AAP supports the findings that the WG has 

assembled and presented.

Clinical Considerations for Pfizer-BioNTech COVID-19 Vaccination in Adolescents

Dr. Kate Woodworth (CDC/NCBDDD) noted that interim clinical considerations for COVID-19 

vaccines are available on CDC’s website and apply to the use of the Pfizer/BioNTech, Moderna, 

and Janssen/Johnson & Johnson COVID-19 vaccines under the FDA’s EUA.33 These clinical 

considerations are being updated for adolescents and to include recommendations regarding 

vaccine co-administration and vaccination after MIS-C or MIS-A. She highlighted some of the 

considerations during this presentation.

In terms of administration, the Pfizer-BioNTech COVID-19 vaccine is currently the only COVID 

vaccine authorized by FDA for use under EUA for adolescents aged 12-17 years. The dosing 

and administration schedule is the same as for adults. Syncope or fainting may occur in

association with any injectable vaccine, especially in adolescents. Procedures should be in 

place to prevent falling injuries and manage syncopal reactions following COVID-19 vaccination.

All people are recommended to be observed following COVID vaccination for at least 15 

minutes, and patients should be seated or lying down during the observation period to decrease 

their risk for injury should they faint. If syncope develops, patients should be observed until their 

symptoms resolve.

Regarding issues related to consent, the federal government does not have specific

requirements for medical consent for vaccination, including COVID-19 vaccines. However, 

states and jurisdictions have medical consent laws that address the circumstances requiring

and the processes for obtaining consent. It is important to note that these laws vary across

jurisdictions. Providers also may be subject to policy requirements for consent within their own 

organizations. All sites administering vaccines should follow current state or jurisdictional 

policies and practices for other routine immunizations in this age group.

33 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/index.html
ACIP Meeting Summary May 12, 2021

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With respect to co-administration of vaccines, due to the novelty of the COVID-19 vaccines, the 

previous recommendation was to administer COVID-19 vaccines alone with a minimum interval

of 14 days before or after administration of any other vaccine to better understand any AEs.

However, substantial data have now been collected regarding the safety of COVID-19 vaccines 

currently authorized by FDA for use under EUA. Extensive experience with non-COVID-19 

vaccines has demonstrated that immunogenicity and AE event profiles are generally similar

when vaccines are administered simultaneously as when they are administered alone. For 

these reasons, the clinical considerations regarding co-administration are being updated to state 

that, “COVID-19 and other vaccines may now be administered without regard to timing. This 

includes simultaneous administration of COVID-19 with other vaccines on the same day, as well

as co-administration within 14 days.

To the question raised earlier about routine adolescent immunizations, it is important to note

that these updated co-administration recommendations may facilitate catch-up vaccination of

adolescents. Early in the pandemic, VFC provider orders of routine immunizations fell 

substantially. While overall VFC provider orders have rebounded from lows seen earlier in the 

pandemic, there is still a substantial deficit for 2020 and 2021, with overall orders other than

influenza down by 1.7 million doses. The largest gaps are seen with vaccines primarily given to 

adolescents, including Tdap, HPV, and meningococcal conjugate vaccines. Many school-aged

children missed recommended vaccines over the last year due to disruptions associated with 

COVID-19, and schools may not have focused on compliance with school vaccination

requirements during the 2020-2021 school year. The need for catch-up vaccination and

coordination with COVID-19 vaccination is urgent in planning for safe return to in-person school.

Moving to clinical considerations for people with a history of MIS-C or MIS-A, which are severe 

hyperinflammatory syndromes occurring 2 to 6 weeks after acute SARS-CoV-2 infection and 

result in a wide range of manifestations and complications, the mechanisms of MIS-C or MIS-A 

are not well understood but include a dysregulated immune response to SARS-CoV-2. Children 

with a history of MIS-C have high antibody titers to SARS-CoV-2. However, it is unknown if this 

correlates with protection against reinfection and for how long protective antibodies persist. It is 

unclear if people with a history of MIS-C or MIS-A are at risk for reoccurrence of the same

dysregulated immune response following reinfection with SARS-CoV-2 or in response to a

COVID-19 vaccine.

People with a history of MIS-C or MIS-A may choose to be vaccinated. Considerations for 

vaccination may include clinical recovery from MIS-C or MIS-A, including return to normal 

cardiac function; personal risk of severe acute COVID-19, such as age or underlying conditions; 

level of COVID-19 community transmission and personal risk of reinfection; lack of safety data

of COVID-19 vaccines following these illnesses; and timing of any immunomodulatory therapies.

Current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after 

initial infection, but may increase with time due to waning immunity. Thus, people with a history 

of MIS-C or MIS-A should consider delaying vaccination until they have recovered from illness

and for 90 days after the date of diagnosis of MIS-C or MIS-A, recognizing that the risk of 

reinfection and, therefore, the benefit from vaccination might increase with time following initial 

infection. HCP or health departments can request a consultation from the Clinical Immunization 

Safety Assessment (CISA) COVIDvax project if they have complex COVID-19 vaccine safety

questions that are not addressed by CDC guidance.34

34 https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/cisa/index.html
ACIP Meeting Summary May 12, 2021

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Regarding contraindications and precautions, anaphylactic reactions have rarely been reported 

following receipt of COVID-19 vaccines. Information is available on the CDC website regarding 

preparing for the potential management of anaphylaxis at COVID-19 vaccine sites.35 The 

following are considered to be contraindications to vaccination with COVID-19 vaccines:

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of 

the COVID-19 vaccine

• Immediate allergic reaction of any severity to a previous dose or known (diagnosed) 

allergy to a component of the vaccine

• Known polysorbate allergy is no longer a contraindication to mRNA vaccination but is a 

contraindication to Janssen COVID-19 vaccine and thus, a precaution to mRNA COVID19 vaccination.

CDC recommends that vaccine providers observe all persons for 30 minutes after vaccination

who have a history of immediate allergic reaction (any severity) to a vaccine or injectable 

therapy, contraindication to a different type of COVID-19 vaccine, and/or a history of 

anaphylaxis (due to any cause). All other persons should be observed for at least 15 minutes

following vaccination.

CDC has developed some additional resources pertaining to COVID-19 vaccines that will be 

relevant for vaccine providers, parents, and teens. CDC has developed additional tools that 

providers can use at the vaccination site to help identify persons with contraindications or 

precautions to vaccination, including a pre-vaccination checklist. There are numerous resources 

available regarding COVID-19 vaccine administration, storage, reporting, patient education, and 

more on the CDC’s website at the following links:

COVID-19 Vaccination:

https://www.cdc.gov/vaccines/covid-19/index.html

For Healthcare Professionals:

https://www.cdc.gov/vaccines/covid-19/hcp/index.html

Engaging in Effective COVID-19 Vaccine Conversations:

https://www.cdc.gov/vaccines/covid-19/hcp/engaging-patients.htm 

Toolkit for Medical Centers, Clinics, and Clinicians:

https://www.cdc.gov/vaccines/covid-19/health-systems-communication-toolkit.html

In closing, Dr. Woodworth posed the following questions for ACIP’s consideration and 

discussion:

1. Does ACIP agree with the proposed clinical considerations related to vaccination?

2. Are there any sections of the clinical considerations that ACIP would like to discuss?

35 https://www.cdc.gov/vaccines/covid-19/downloads/IntermConsid-Anaphylaxis-covid19-vaccine-sites.pdf
ACIP Meeting Summary May 12, 2021

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Summary of Discussion

• Concern was expressed about the relaxation of timing between vaccines, decrease in 

immunization rates, and insufficient immunogenicity and safety data when COVID-19 

vaccine is co-administered with other vaccines. ACIP members inquired as to whether there 

is a way to encourage sponsors to study co-administration with routinely administered 

adolescent vaccines and what education tools will be available related to co-administration:

➢ Dr. Oliver indicated that CDC agrees that having solid data would be helpful and is 

pursuing multiple avenues for ways to obtain additional data. This information can be 

brought to ACIP during future meetings.

➢ Dr. Fink responded that FDA absolutely encourages vaccine manufacturers to study 

concomitant administration when concomitant administration would be anticipated to 

occur in practice with use of the vaccine. The studies to generate data on 

concomitant administration in terms of both safety and immunogenicity can become 

very complex based on the number of vaccines and number of antigens being 

evaluated. The added benefit of these data do need to be balanced in some way

with the primary goal of generating safety and effectiveness data to support use of 

the COVID vaccines in certain age groups. FDA’s regulatory precedent has not been

to require concomitant administration studies as a condition of authorization or

licensure, though such studies are certainly encouraged.

➢ Dr. Cohn pointed out that no data will be available before the summertime to 

consider for co-administration. There are a couple of small studies for which there is 

hope of having some safety data before influenza season. Given the concerns 

around childhood and adolescent back-to-school vaccinations, this language in the 

clinical guidance is being proposed in the absence of additional data that specifically 

looks at co-administration because of the known safety profile of COVID vaccines 

along with many years of experience with co-administration with inactivated 

vaccines. CDC is working on multiple educational tools for providers and parents 

regarding co-administration, timing of administration, et cetera.

➢ ACIP members remained concerned about some vaccines for which coadministration might have more anticipated AEs, such as the recombinant zoster 

vaccine. It is known that at baseline, adults who get that vaccine have been 

surprised by how significant impact it has in terms of reactogenicity. Given that both 

vaccines have significant reactogenicity profiles, it might be worth making individuals 

aware that co-administration is some cases might have a greater impact than 

anticipated. Members felt that the clinical guidance should be better fleshed out, 

given that many vaccination sites adhere so strictly to the guidelines without 

understanding the reasoning behind them to the point that they do not change 

quickly to modifications in the recommendation and may be limiting the ability for 

people to get necessary vaccines. In addition, patients are very concerned and may 

not understand or appreciate why there was a change unless it is clearly explained to 

them that it was not for any safety concern but rather was out of an abundance of 

caution. There is a tremendous amount of safety data on other vaccines and coadministration, as well as expert opinion. However, perhaps adult co-administration 

should be separate from pediatric co-administration due to the overwhelming 

concern for the pediatric population.
ACIP Meeting Summary May 12, 2021

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• Dr. Maldonado, AAP Liaison Representative to ACIP, stated that the AAP put together a 

policy statement that was embargoed until after the end of this ACIP meeting and to be read 

at this point. This statement was developed in consultation with a variety of groups and has 

received full approval from the AAP Board, as well as the Committee on Infectious Diseases

(CID). This policy statement is organizational principles to guide and define the child 

healthcare system and/or improve the health of all children around COVID-19 vaccines

children and adolescents and reads:

“Vaccines are safe and effective in protecting individuals and populations against infectious diseases. New vaccines are 

evaluated by a longstanding, rigorous, and transparent process through the US Food and Drug Administration and the 

Centers for Disease Control and Prevention by which safety and efficacy data are reviewed prior to authorization

recommendations. The American Academy of Pediatrics recommends the following related to COVID-19 vaccine and 

children and adolescents: 1) The AAP recommends COVID-19 vaccination for all children and adolescents 12 years of 

age and older who do not have contraindications using a COVID-19 vaccine authorized for use for their age; 2) Any 

COVID-19 vaccine authorized through Emergency Use Authorization by the FDA recommended by the CDC and 

appropriate by age and health status can be used for COVID-19 vaccination in children and adolescents; and 3) Given the 

importance of routine vaccinations and the need for rapid update of COVID-19 vaccine, the AAP supports coadministration of routine childhood and adolescent immunizations with COVID-19 vaccines or vaccinations in the days 

before or after for children and adolescents who are behind on or due for immunizations based on the CDC/AAP 

Recommended Child and Adolescent Immunization Schedule who are at increased risk from vaccine-preventable 

diseases.”

• Dr. Schaffner, NFID Liaison Representative to ACIP, indicated that NFID welcomes the new 

recommendations and clinical guidance from the CDC and the AAP regarding coadministration and emphasized especially that there will be the usual influenza vaccination 

campaigns that go on in the Fall and essentially all adolescents are recommended to 

receive influenza vaccine. NFID certainly will welcome data on the subject of coadministration as they become available. The same permissiveness for co-administration

now extends to adults as well.

• Dr. Fryhofer, AMA Liaison Representative to ACIP speaking as a practicing physician, 

offered kudos to CDC for its proposed guidance on co-administration and said she was very 

reassured by the AAP statement of support. She was very excited that it was confirmed that 

co-administration also applies to adults. However, she shared the concerns expressed 

about co-administration with vaccines that have adjuvants in terms of the potential impact on 

reactogenic side effects. As a practicing physician, she would welcome more specific 

guidance about co-administration with certain vaccines. While people may get vaccinated 

elsewhere, she is the one they will call when they experience side effects.

• ACIP expressed an interest in hearing about any discussions concerning booster doses. Dr. 

Oliver indicated that CDC the WG are continuing to follow studies for this and will bring 

information to ACIP as soon as they have information on duration of immunity and/or 

booster doses.

• Dr. Howell, AIM AMA Liaison Representative to ACIP, indicated that AIM represents the 64

awardees who are implementing COVID vaccine and other vaccines around the country. 

From a programmatic perspective, AIM would be supportive of co-administration. Over the 

summer months, there would be a lot of missed opportunities with high school activity, 

physicals, and other back-to-school immunizations if COVID vaccine is not given at the 

same time as other vaccines. In the third bullet in the clinical guidelines regarding coadministration, something else to consider would be school requirements and deciding 

whether to co-administer with COVID vaccines, given that many states have school 

requirements for different adolescent vaccines.
ACIP Meeting Summary May 12, 2021

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During the break, the co-administration language was revised to address some of the concerns 

raised by members to read as follows:

Coadministration

• COVID-19 vaccines were previously recommended to be administered alone, with a 

minimum interval of 14 days before or after administration of any other vaccines. This was 

out of an abundance of caution and not due to any known safety or immunogenicity 

concerns.

• However, substantial data have now been collected regarding the safety of COVID-19 

vaccines currently authorized by FDA for use under EUA. Although data are not available for 

COVID-19 vaccines administered simultaneously with other vaccines, extensive experience 

with non-COVID vaccines has demonstrated that immunogenicity and adverse event profiles 

are generally similar when vaccines are administered simultaneously as when they are 

administered alone.

• COVID-19 vaccines and other vaccines may now be administered without regard to 

timing. This includes simultaneous administration of COVID-19 vaccines and other vaccines 

on the same day, as well as co-administration within 14 days.

• It is unknown whether reactogenicity is increased with co-administration, including with other 

vaccines known to be more reactogenic, such as adjuvanted vaccines.

• When deciding whether to co-administer with COVID-19 vaccines, providers could consider 

whether the patient is behind or at risk of becoming behind on recommended vaccines and 

the reactogenicity profile of the vaccines.

Public Comment

The floor was opened for public comment during the May 12, 2021 ACIP meeting at 2:00 PM 

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

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

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

written public comments to ACIP through the Federal eRulemaking Portal under Docket No. 

CDC–2021–0049. Visit http://www.regulations.gov for access to the docket or to submit 

comments or read background documents and comments received.

Mrs. Alycia Finch

Parents Protecting Education

Good afternoon members of the Advisory Committee on Immunization. My name is Alycia 

Finch. I represent Parents Protecting Education (PPE). Thank you for selecting me to reiterate 

concerns from colleagues and parents in my community. Before I begin, I’d like to thank the 

Centers for Disease Control and Prevention for diligently working to resolve the pandemic’s 

devastating consequences on our global community. Your steadfast scientific work is essential

to promoting a lasting solution to the challenges the US and other governments face to building 

a healthy community. Today, I speak on behalf of the parents who are skeptical of resolving this 

challenge by mandating a vaccine. While we are aware there are large numbers of communities

who desire this vaccination, there’s also a large community who desires the ability to choose a 

sound medical decision based on each child’s medical needs. The CDC’s recommendation has 
ACIP Meeting Summary May 12, 2021

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a great influence on our local, state, and federal government’s decisions to mandate

vaccinations for our nation’s children. I plead for the consideration as a mother responsible for 

the well-being of my children. My husband and I are committed to raising our children using a 

mindful and educated decision-based approach to health. The benefits of this vaccine may be 

great for one family and not for others with medical conditions. The facts are that these

vaccinations, despite their positive intent, are too new to understand the lasting effects on our 

communities’ children at large. Clinical trials have not had the time to gauge the long-term 

effects on the development and the growth of our children, and for this reason alone, we ask 

you to recognize in your decision-making that communities with significant medical challenges 

need and should be able to require a choice as far as the mandating or the requirements of this 

vaccine goal in our communities. I thank you so much for your time and consideration today.

Mrs. Savannah Starkey White

Representing Son, Baby Remy

My name is Savannah Starky. I am representing my son, Baby Remy. I’m an individual. Thank 

you for the opportunity to speak today. In February of 2020, I stood in front of you and I spoke

on behalf of my son, Baby Remy. I’d like to honor my son today by speaking about the topic at 

hand. Baby Remy passed away approximately 12 hours after his CDC recommended schedule

at his 2-month appointment. His autopsy came back anaphylactic adverse reaction to the

multiple vaccinations received the day prior. The current schedule had been approved for 

decades and we still have thousands of infants, children, and adults dying and suffering as a 

result of them. I can’t emphasize enough how important it is to truly know all of the adverse 

effects of a vaccine no matter how small you might consider it. To you, my son was just one 

baby, but to my children, my husband, and myself—he was our world and it is forever shattered.

Pfizer is filing for the full FDA approval of their COVID vaccine this month. It’s no secret that the 

vaccine comes with significant immediate reactions. The list of adverse reactions is growing and 

the number of complaints are tripling daily. We do not know enough about the long-term effects

of this vaccine to approve it for full FDA approval. Based on the limited study that you all 

conducted yourselves, 77.4% reported at least 1 systematic reaction. Lymphadenopathy, Bell’s 

palsy, appendicitis, acute myocardial infarction, cerebral vascular accidents were all reported

and considered adverse reactions just from your studies alone. There have been thousands of 

additional reports to VAERS for serious adverse reactions, blood clots, nerve pain, rashes,

hives, multiple deaths, and dozens of others are trickling in. Concerns of infertility are rippling 

through social media and flooding doctors with concerned patients. We do not know the longterm effects of this vaccine. We will not know this for 5, 10, or even 20 years. This information is 

critical and it must be known before the FDA approves it, especially for our children. Our 

children are our future. We have to protect them by not jumping the gun. America is looking up 

to you to do the right thing. I challenge you to advise the FDA to deny the full approval of the 

Pfizer vaccine as it stands right now. Thank you.

Janelle Sullivan 

Heartline Foundation

Hi. I’m Janelle Sullivan from Heartline Foundation. I have a son who is recovered from severe 

autism. I spoke in front of this panel in the past about how I’ve recovered him. “Autism, Beyond 

Despair” was a book that was very helpful. It actually has a chapter as a rebuttal to Paul Offit’s 

book, “Autism’s False Prophets.” I recovered him doing what Paul Offit says not to do. This 

panel likes to pretend the anti-vaccine families are child abusers to autistic kids. Your CDC 

schedule caused my son to bang his head on cement and to have absence seizures. It is guilty 

of the worst child abuse on this planet and I seriously fear what your recommendations are
ACIP Meeting Summary May 12, 2021

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going to cause. You have the power today to say “no.” You have the power. It is so much easier 

for you to do this now than it will be later. You will not be able to take this decision back. It’s 

going to affect so many lives. These children are not affected from COVID. They are affected 

from your lockdown measures. They are affected from masking, from social distancing, and 

from not receiving the contact and the love and the hugs and the high-fives that were meant to 

be given and received. Our hearts are not meant to be kept separate. They are meant to come 

together and do great things, and they're also meant to heal, and they don’t need you putting all

of these poisons in our body. We need to have the ability to say “no.” Your recommendations, 

your schooling, has encouraged doctors to say things like, “You can’t breathe around the 

unvaccinated.” My father-in-law was told that and he stayed away from me for three and a half 

years. My child had a seizure following his last vaccines and people request that he not be

invited to parties. People that my husband was in their wedding parties of keep their children 

away from us. You guys are doing to us just what the Germans did to the Jews. They said that 

they were guilty of spreading diseases. I see you. I see what you’re doing and I’m telling you

because of what you’re doing, more people are listening to me than ever before. More people 

are coming to our side. Please stop this now. Thank you.

Susie Olsen Corgan

Concerned Individual

Hello. My name is Susie Olsen Corden. Thank you for the opportunity to speak once again 

today. I realize we have a limited timeframe, so I’m just going to highlight a few points really 

quickly. One of three of my main issues with this COVID-19 vaccine is the fact that implications

of fertility impairment have not been studied, so how can we recommend a vaccine to 12 to 15-

year-olds that could potentially cause impairment in their fertility? Why weren’t these studies 

done prior to recommending these vaccines? These studies need to be done now and parents 

need to be given informed consent. Prior to administration of these vaccines they need to be 

told that these studies were not done. Combining vaccines. One of the primary questions today 

was in regard to safety data and co-administration of the mRNA vaccine simultaneously with 

routinely recommended adolescent vaccines. After listening to the ACIP meeting today, it is 

clear that these studies have not been done. Yet I keep hearing that in the absence of data, you 

will still recommend administration of the mRNA COVID-19 vaccines along with routinely 

recommended vaccines. Adolescents are going through things that adults are not. Hormonal 

changes during puberty and brain development should be closely looked at in studies prior to 

any administration of these vaccines. In the absence of data, ACIP should not be 

recommending this vaccine. Today I heard about deaths. We heard that 127 deaths were 

attributed to COVID-19 disease 12 to 17-year-olds; however, since we are discussing the 

interim recommendation of COVID-19 vaccination for 12 to 15-year-olds, I’m highlighting just 

that data which is needed to make this decision today. Thus by age, according to CDC, it says 

that we have had a total of 17 deaths in 12-year-olds, 13 in 13-year-olds, 15 in 14-year-olds, 

and 24 in 15-year-olds. That is a total of 69 deaths that have been attributed to COVID-19 in 12 

to 15-year-olds. While the loss of any life is tragic, especially in children, we have to look at this 

and declare there is no emergency for children in this age range. How can you, the members of 

ACIP, who are entrusted with making these decisions, recommend this vaccine based off this 

data?
ACIP Meeting Summary May 12, 2021

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Lindsay Maher, BS, MS

Informed Choice Iowa

My name is Lindsay Mayer with Informed Choice Iowa. I’m here today also from a virology 

perspective. My background is in virology and I studied at the University of Iowa. It has been 

well-documented and demonstrated that kids are at extremely low risk of serious illness from 

COVID-19. In comparison, around 600 children died in the influenza season of 2017 and 18, 

which you reflected earlier in your hospitalizations, in comparison to 282 deaths in children 

related to COVID. This despite already having a widespread influenza vaccination campaign in 

America. Quite frankly, it does not matter how efficacious this vaccine is in stopping illness in 

children, considering healthy children are never actually seriously impacted and considering a 

primary concern that risk transmission was not even evaluated in this trial. So, why are we not 

practicing these base medicines? Will we be doing more harm than good considering that 

children have a 99.99% survival rate from COVID and have demonstrated that they are not a 

primary source of transmission in this pandemic. The Pfizer vaccine has already been

associated with 1719 deaths according to the passive reporting system, VAERS, which we 

know grossly underestimates the true numbers, given that both the FDA and Department of 

Health and Human Services have published studies on this. Yet here we are today discussing 

data that hasn’t been seen or analyzed by the public, hasn’t looked at asymptomatic 

transmissions, lacks data in those with underlying health conditions, or data on coadministration of this vaccine with others on the schedule. And still, this body plans to vote on 

emergency approval for which there isn’t even an emergency in children. Finally, Pfizer has 

again failed to test this product in a cohort that truly represents the US population of children. A 

2011 study found 54% of our nation’s children have a diagnosed chronic illness. In the adult 

trial, only 10% of the total 46,000 participants who received the vaccine had a chronic illness,

with no autoimmune conditions represented in that group at all, and the rest fall under the

definition of small numbers as does this trial. It failed to enroll representative numbers of those

with underlying conditions, yet this group plans to roll it out so all 12-15 year olds regardless of 

what their health is like. How can you confidently say that it isn’t going to significantly harm them 

more so than benefit them? How can you say this is safe when you do not know what the 

chances are for them developing a new onset chronic disease, cancer, fertility issues,

hospitalizations, disability, or death as a result of taking this experimental vaccine that was only 

tested in 2620 participants. It’s clear that children’s well-being is not the priority in approving this 

authorization. Irrational recommendations will do no good, will certainly cause harm, and will 

further discredit our federal health agencies. You do not gain public trust through quickly 

approving experimental vaccines that will eventually be forced on millions of American children

in order to attend schools. You will only increase those who distrust the entire public health

industry, as well as the entire recommended schedule. So, go ahead, vote “yes” if you want to 

increase vaccine hesitancy for an unnecessary product for a situation that isn’t a true

emergency. Or vote “no” and get your questions actually answered. Thank you.
ACIP Meeting Summary May 12, 2021

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Ms. Allison Winnike, JD

President and CEO

The Immunization Partnership

Good Afternoon Chairman Romero and members of the committee. My name is Allison Winnike

and I am President and CEO of The Immunization Partnership. Our non-profit mission is to 

eradicate vaccine-preventable diseases by educating in the community, advocating for 

evidence-based public policy, and supporting immunization best practices. Thank you to the 

committee and to the COVID-19 Vaccine Work Group for your tremendous work during this 

pandemic reviewing scientific data and developing vaccine recommendations to keep all 

Americans safe and healthy. Your scientific recommendations are an important tool that states 

use to carry out their constitutional duty to protect the public’s health. As we move into 

vaccinating adolescent populations against COVID-19, we are observing that hesitancy among 

parents has been amplified even as compared with those parents’ own comfort in receiving their 

adult COVID-19 vaccine. And it’s understandable that parents may have additional questions or 

fears regarding COVID-19 vaccines for their children. We have observed many questions and 

concerns regarding these vaccines’ impact on hormonal changes, reproductive issues, allergies,

and potential long-term effects when administered to adolescents. And so it is critical that 

trusted messengers proactively share medically accurate and culturally appropriate information

with these parents to address these issues before they fall victim to misinformation and 

disinformation spread online. We can build trust and comfort through dialogue, listening to 

concerns, explaining this peer-reviewed data, and meeting them where they are whether 

physically or emotionally. As presented today, a recent survey indicated that 74% of parents 

would feel comfortable with their child receiving a COVID-19 vaccine in their regular provider’s 

office as opposed to other venues such as pharmacies or vaccine clinics. So, we should take 

heed of these parental preferences and states should rapidly enroll pediatricians and other 

adolescent healthcare providers as accessible COVID-19 vaccine providers. At the same time, 

we need to promote health equity and continue to offer accessible vaccine administration sites

for those who lack a regular medical home and those who continue to experience barriers to 

access. It is imperative that we increase our lackluster immunization rates by increasing 

demand for these life-saving vaccines. As we expand our COVID-19 vaccination experts into 

the adolescent population, I recommend a multi-prong approach proactively addressing parental 

questions, incorporating parental feedback and best practices to increase confidence, and

continuing to expand access to trusted vaccination locations. Thank you so much for your 

important work and the opportunity to share our comments.

Mr. Richard Robbins

Parent of 13- and 15-Year-Old Daughters

Hi. Thank you very much to the committee. My name is Richard Robbins. I’m speaking today as 

a parent of 13- and 15-year-old daughters and thus have a vested interest in your decision.

After the FDA gave its authorization for 12-15 year olds on Monday, I went to the ACIP website

to see how quickly my daughters would be able to get vaccinated and saw that there was an 

opportunity for public comments prior to today’s vote. I thank you for this opportunity on behalf 

of my daughters who are eagerly awaiting the opportunity to get their vaccines and return

to some approximation of normal life. I strongly recommend that you vote in favor approving the 

vaccine for 12-15 year olds today. I recognize that there is irony in my recommending that you 

listen only to scientists, as I am not a scientist, but the overall recommendation of doctors and 

scientists that the vaccine is safe and effective. Pfizer’s trial results are nothing short of

miraculous. As you know, the Phase 3 trial demonstrated 100% efficacy and robust antibody 

responses among the half of the 2260 adolescents who received the vaccine versus 18 cases in 
ACIP Meeting Summary May 12, 2021

30

the placebo group. Further, the trial found that the vaccine was well tolerated with limited side 

effects. On the other hand, even if the risk of COVID is lower for adolescents than for the 

elderly, it is still a serious and risky disease. A recent article by Dr. Kristin Moffitt, Pediatric 

Infectious Diseases Doctor and Researcher at the Boston Children’s Hospital and Assistant 

Professor Pediatrics at Harvard Medical School, reported that over 400 children have died from 

the COVID infection. More than the number of childhood deaths during the deadliest flu season

in the past two decades. Further, in the NewScientist’s Helen Thompson wrote of the first study 

of long COVID in children. It’s found that nearly half of children with both symptomatic and 

asymptomatic COVID-19 are experiencing long-term effects many months after the initial

infection. More than half of children aged between 6- and 16-years-old who contracted the virus 

have at least one symptom lasting more than 120 days, with 42.6% impaired by these 

symptoms during daily activities. As my daughters can attest, young people have endured many 

hardships this past year. This meeting is a good example of how Zoom is an imperfect

replacement for live in-person interactions, especially for school children. It is important that 

children are able to safely resume going to school, seeing friends, and having some

approximation of normal life as soon as possible. It is even more important that in doing so, they 

do not risk transmitting the virus to older family members who are even more at risk. We need to 

do everything we can to get as many Americans vaccinated as soon as possible. This is an 

important step. Thank you for all the work you are doing. I look forward to your vote and

assuming you approve, look forward to taking my daughters to get vaccinated tomorrow, but 

nowhere near as much as my daughters look forward to getting their shots.

Mrs. Mya Olson

Representing Herself/Other Parents

Good afternoon and thank you for your time. My name is Mya Olsen and I’m from South Dakota.

I’m commenting today for myself along with the millions of parents who are protected by the

Nuremberg Code which states, “The experiment should be such as to yield fruitful results for the 

good of society unprocurable by other methods or means of study and not random and

unnecessary in nature.” Right now, we know that there are other methods of treatment for 

COVID-19 that are successful without death as an adverse event. The Nuremberg also states, 

“No experiment should be conducted where there is a priori reason where death or disabling

injury will occur,” which we also know is tragically not the case as your very own reporting

system has reported 11 deaths associated with the COVID-19 vaccine since granting 

emergency use authorization for 16- to 18-year-olds a little over a month ago. Your own Paul

Offitt stated in an interview that it would be a mistake to put out to the American public a vaccine 

that was only tested in a few thousand people, which is what we’re doing right now. Your trial for 

this age group had very small enrollment population and a very short timeframe, and there were 

severe injuries within the trial. Just this past week, a 15-year-old in Colorado died after receiving 

the vaccine. You are currently charged with approving the vaccine for the children with no longterm studies, with over 1700 deaths associated with this vaccine as per your own reporting 

system. Allowing this vaccine to stay on the market is unprecedented, as the FDA pulled the

rotavirus after far fewer deaths. Not only that but Pfizer has pled guilty to a felony violation of the 

FDA for misbranding with the intent to defraud or mislead. What is to say that isn’t happening 

again? The children aren’t at risk for this disease. Per the CDC, there were 69 deaths for this 

age group. Why is it that you are asking them to carry the burden of a society on their

shoulders? I ask that you do not approve this vaccine without further long-term studies. I 

mentioned the quote from Paul Offitt earlier. I will now quote from the governor of my life, Luke 

17:2, “It were better for him that a milk stone were hung around his neck and he cast into the 

sea than he should offend one of these little ones.” Please don’t vote to pass this.
ACIP Meeting Summary May 12, 2021

31

Vote: Pfizer COVID-19 Vaccine for 12-15 Year Olds

Dr. Sara Oliver (CDC/NCIRD) presented the following proposed recommendation for an ACIP 

vote:

Pfizer-BioNTech COVID-19 vaccine (2-doses, IM) is recommended for persons 12-15

years of age in the US population under the FDA’s under an Emergency Use 

Authorization.

Motion/Vote: Pfizer COVID-19 Vaccine for 12-15 Year Olds

Dr. Poehling made a motion and Ms. Bahta seconded to approve the recommended language 

for Pfizer COVID-19 Vaccine for 12-15 Year Olds as presented. The motion carried with 14

affirmative votes, 0 negative votes, and 1 abstention due to a conflict of interest (COI). The 

disposition of the vote was as follows:

15 Favored: Ault, Bahta, Bell, Bernstein, Chen, Daley, Kotton, Lee, Long, McNally, 

Poehling, Romero, Sanchez, Talbot

 0 Opposed: N/A

 1 Abstained: Frey

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

vote or provide additional comments:

Dr. Talbot: I just want to say how excited I am. This will mean that the rest of my family can be 

vaccinated. That’s a little selfish because I know we have less than 12 years of age to go, but 

just to set an example, my husband and I are vaccinated, my 16-year old is vaccinated, and 

now my 12- and 15-year olds will be in line, and I’m ever so thankful.

Dr. Kotton: Similarly, I’m very excited to have this vaccine approved for this age group. This is a 

really important issue for the summer. It’s also a very good way to provide better community

immunity, especially for immunocompromised patients who have these teenagers in their 

families, and this is another way to get closer to ending this horrible pandemic.

Dr. Lee: I just wanted to make a comment because I think sometimes we lose the importance of 

children and adolescents in the midst of a pandemic. There’s been such a focus on older adults 

in particular. I think that the childhood experience that our kids have gone through will have 

long-lasting consequences that may extend across generations to be honest. We don’t really 

fully yet understand the total mental health, physical health, and educational impact of the 

pandemic on our kids. We know that there are already disparities in hospitalizations and 

disparities in MIS-C. I anticipate that with disparities in infection as well, the consequences 

could be far more severe than we anticipate. I strongly advocate for taking a life-course 

approach to thinking about COVID and the impact of COVID for our generation and for 

generations to come.

Dr. Daley: Yes, thanks so much. Two brief comments. One is the US focus and the other is 

global. In terms of the US focus, I think one thing we haven’t talked about a ton, a little bit but 

not a ton, is that there really have been 130 million doses of Pfizer vaccine given and to date,

the safety profile of that vaccine in use has been really positive. So, I think I want to remind 

everyone that the intensive safety scrutiny of this vaccine will continue after the authorization.
ACIP Meeting Summary May 12, 2021

32

We’re just going to get more data about the 12-15 year olds. The global comment is that I think 

if we look at what’s happening elsewhere in the world, that’s evidence of what happens if you 

don’t have adequate supplies of safe and effective vaccines. That is what happens and so we’re

in this very privileged position where we can see declining deaths and declining case rates

because of these vaccines, and so this is just another group that will be vaccinated and it will 

continue those downward trends.

Dr. Bernstein: I just wanted to reiterate what everyone else is saying that benefits far outweigh 

the risks. I think this will provide protection for 12-15 year olds. It will decrease transmission 

within their families, it will contribute to community immunity, and it will allow kids to more safely 

go back to camps this summer and back to in-person school. So I’m excited for the idea that 12-

15 year olds are eligible for vaccine.

Dr. Poehling: I want to reiterate the importance of this vaccine for the teenage children 

themselves. COVID-19 hospitalizations are increasing in children, with over 13,000

hospitalizations. April 2021, children comprised 9% of all cases and that’s even higher than 

those 65 years of age and older. Children can have severe disease from COVID-19 infection 

themselves, as well as from MIS-C. Long-term implications of COVID-19 can be very significant.

For example, we had a teenager who presented with a heart attack with their COVID-19

ailments and fortunately did survive, but that will have long-lasting impact. While deaths are 

uncommon in children, COVID-19 deaths are one of the top 10 causes of death for children.

Many children have underlying conditions putting them at increased risk. COVID-19 vaccine is 

both safe and effective. Many parents and adolescents want to be protected by being 

vaccinated, and I’m so glad we have the vote to enable them to do that today.

Dr. Romero: Let me just say that this is one more step closer to gaining immunity and bringing 

the pandemic closer to the end. We still have the younger age group to deal with, and we are 

dealing with that, and we still need to vaccinate the rest of the world. But, we have made

significant steps and are on the road. As usual, I want to think all of you (voting members,

liaisons, and ex officios) for all of the time and work that you spent and dedicated to this effort.

This is now our 15th meeting this year. That translates to roughly 5 years of work in a single

year. So again, thank you. It does not go unnoticed and unappreciated. So thank you very, very 

much and good work to all of you.

Thrombosis with Thrombocytopenia Syndrome (TTS) Following COVID-19 Vaccination

Dr. Tom Shimabukuro (CDC/NCEZID) recapped the background of the TTS situation, 

described updated data for TTS following COVID-19 vaccination, and summarized the most 

recent data. He explained that thrombosis occurs when blood clots block blood vessels. 

Thromboses can be venous our arterial and complications can include heart attack, stroke, and 

other infarctions. Causes and risk factors include trauma, immobility, inherited disorders, 

autoimmune diseases, obesity, hormone therapy or birth control pills, pregnancy, smoking, 

cancer, and older age and sometimes may include pain and swelling in extremities, chest pain, 

numbness or weakness on one side of the body, and a sudden change in mental status. They

are diagnosed primarily through imaging studies and blood tests. Platelets, also called 

thrombocytes, are colorless blood cells that help blood clot. A normal platelet count is 150,000-

450,000 per microliter. That is usually shorthanded to 150-450. Platelets stop bleeding by 

clumping and forming plugs in blood vessel injuries. Thrombocytopenia is a condition in which 

one has a low platelet count of below 150. Dangerous internal bleeding can occur when platelet 

counts fall below 10,000 per microliter. Though rare, severe thrombocytopenia can cause

bleeding into the brain, which can be fatal.
ACIP Meeting Summary May 12, 2021

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A Health Alert Network (HAN) notification went out on April 13, 2021 summarizing cases of 

cerebral venous sinus thrombosis with thrombocytopenia (CVST) after the Janssen vaccine and 

announcing that CDC and FDA had initiated a pause and would convene an emergency 

meeting to review the data. The emergency meeting was convened on April 14, 2021. About 10 

days later, there was a follow-up meeting on April 23rd during which updated results were 

presented. Following that, meeting the CDC issued an MMWR recommending resuming

vaccine. The reason CDC was following this condition closely in its post-authorization 

surveillance was due to reports of CVST or unusual clotting in the presence of 

thrombocytopenia following the AstraZeneca (AZ) vaccine in Europe. Updated 

recommendations of ACIP which were issued April 27, 2021 after the April 23rd meeting.

36 At 

that time, ACIP concluded that the benefits of resuming vaccination with Janssen outweighed 

the risks and reaffirmed the interim recommendations under FDA’ EUA, which included the new 

warning.

Most of the data on TTS comes from the Vaccine Adverse Event Reporting System (VAERS), 

which is the nation’s early warning system for vaccine safety. It is a spontaneous reporting 

system or passive surveillance system that is co-managed by CDC and FDA. This systems 

relies on individuals to report events into VAERS. As a passive surveillance system, it has the 

limitations of passive surveillance in general. It is not designed to assess causality. However, it 

has a large population under surveillance and is, therefore, able to detect rare AEs and

unexpected patterns for these rare events, which it did with TTS. CDC’s Clinical Immunization

Safety Assessment (CISA) Project was instrumental in conducted a detailed clinical review of 

these cases in consultation with its consultants and hematologists, neurology experts, and other 

vaccinology experts at CISA sites.

Case finding for TTS following COVID-19 vaccines occurs in a variety of ways. One way is 

that HCP contact CDC directly about potential TTS cases by phone or by email by astute HCP 

who recognize a TTS case or potential TTS case, often to inform CDC that they have 

simultaneously reported to VAERS. CDC may initiate an investigation along with the HCP and 

facilitate the report into VAERS. Also, FDA physicians screen incoming VAERS reports daily to 

identify potential TTS cases. In addition, CDC searches the VAERS database of process reports 

daily for possible TTS cases. Medical records are requested for all potential TTS case reports to 

confirm thrombosis with laboratory evidence of thrombocytopenia using a working case 

definition. CDC and FDA medical officers review TTS case reports and available medical 

records. CISA experts, including hematologists, are consulted as necessary. There is an interim 

Brighton collaboration case definition for TTS. Some of the criteria are new onset of 

thrombocytopenia, no known recent exposure to heparin, and the presence of venous or arterial 

thrombosis. In addition to rare thromboses (e.g., CVST), it currently includes more common 

thromboses like deep vein thrombosis (DVT), pulmonary thromboembolism (PE), ischemic 

stroke, and myocardial infarction. CDC has adopted a modified version of this interim Brighton 

collaboration case definition, which is divided into two tiers to organize searches and clinical 

reviews. In consultation with specialists at CISA, CDC has reviewed its criteria for identifying 

cases and decided that for specificity and to avoid including a lot of non-cases into the Tier 2

category and then into the overall TTS case count, requiring a positive heparin PF4 ELISA HIT 

antibody test adds specificity and is appropriate.

36 https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7017e4-H.pdf
ACIP Meeting Summary May 12, 2021

34

Taking a high-level look at US COVID-19 vaccine administration by product type and TTS 

reports to VAERS for the 3 authorized vaccines, after 135 million doses of Pfizer-BioNTech 

vaccine, there have been no confirmed TTS reports to VAERS. After 110 million doses 

administered of Moderna vaccine, there have been no confirmed TTS reports to VAERS. After 

8.7 million doses administered of the Janssen vaccine, there are 28 confirmed TTS reports to 

VAERS. There was one CVST with thrombocytopenia case observed in the Janssen preauthorization clinical trials in a male 25 years of age. This case is not included in the VAERS or 

post-authorization confirmed case count. Some of the basic characteristics of the 28 cases are 

that 25 were Tier 1, 3 were Tier 2, the median age was 40, median time from vaccination to 

symptom onset was 9 days, all had received the Janssen COVID-19 vaccine before the pause 

on April 13th, there were 22 females, 6 males, 19 of the 28 TTS cases had CVST, there were no 

pregnant or postpartum case patients, and 5 had a past SARS-CoV-2 infection. In terms of the 

risk factors, it is important to note that there were no cases with a known or documented 

coagulation disorder. Most of the TTS cases, are occurring in the 30-49 year old age group.

There have been increases in some of these age groups, which seem to be most pronounced in 

the 40-49 year old age group.

In terms of the treatment outcomes among the 28 TTS cases, 12 individuals received heparin.

Of those 12 cases, 9 of 11 admitted before the HAN were treated with heparin and only 3/17

admitted after the HAN were treated with Heparin. Twenty-six were ultimately treated with nonHeparin anticoagulants and 18 received intravenous immune globulin (IVIG). There were 3 

deaths, which is unchanged from the first presentation of the initial 6 CVST cases. Four remain 

hospitalized, 1 in intensive care, 2 have been discharged to post-acute care facilities, and 19 

have been discharged home. None of the patients who died received heparin.

VSD is CDC’s large, linked database for active surveillance and research. It includes 9 

participating integrated healthcare organizations with data on over 12 million persons per year.

A substantial number of doses administered of mRNA vaccines are in the VSD (3.3 million 

Pfizer-BioNTech, 3 million Moderna) as of April 24th. After the 6.3 million doses total, 11 total 

ICD-10 coded CVST diagnoses have been identified following mRNA vaccination (3 PfizerBioNTech and 8 Moderna). Of the 11 cases, 5 were ruled out for incident cases and 6 were 

considered potential CVST incident cases. All were without thrombocytopenia. There have been 

no confirmed cases of incident CVST with thrombocytopenia after 6.3 million doses of mRNA 

COVID-19 vaccines administered in the VSD. Just under 160,000 Janssen COVID-19 vaccine 

doses administered are in VSD through April 24th. There have been no statistical signals for any 

pre-specified rapid cycle analysis (RCA) outcomes and no CVST cases identified. There are 32 

venous thromboembolism (VTE) and/or PE embolism cases identified in the 1-42 days following 

vaccination. That includes 3 cases that had both VTE and PE. Of the 32 VTE/PE cases, 29 

have been quick reviewed and 3 are in progress. Of the 29 cases that have been quick 

reviewed, 6 were ruled out as not being VTE or PE and 23 were confirmed as VTE or PE cases.

Of the 22 confirmed cases, 4 were determined to have symptom onset prior to vaccination,1 

had indeterminate symptom onset, and 18 were potential VTE or PE cases with incidence 

following vaccination. Among the 18 cases of potential incident VTE/PE cases, 10 were female, 

8 were male, ages ranged from 30-79 years, none had a history of COVID-19 infection and

none had thrombocytopenia noted at the time of the VTE or PE. A fairly small number of 

Janssen COVID-19 vaccines administered are in the VSD, but no potential cases of TTS have 

been identified to date.
ACIP Meeting Summary May 12, 2021

35

In summary, TTS is a rare, clinically serious, and potentially life-threatening condition. Current 

evidence suggests a plausible causal association with the Janssen COVID-19 vaccine.

Symptom onset appears to occur from several days after vaccination up to 2 weeks, with most 

cases having symptom onset around 1-2 weeks. Most cases are in women, with most aged 18-

49 years old. The clinical features of TTS following Janssen COVID-19 vaccination appear to be 

similar to what is being observed following AZ COVID-19 vaccination in Europe. It is important 

to recognize TTS early and initiate appropriate treatment, but cases of thrombosis with 

thrombocytopenia should not be treated with heparin unless heparin-PF4 ELISA HIT antibody 

testing is negative. TTS does not appear to be associated with mRNA COVID-19 vaccines. The 

US vaccine safety monitoring system is able to rapidly detect rare AEs following vaccination and 

quickly assess safety signals. CDC is committed to open and transparent communication of 

vaccine safety information. In terms of next steps, CDC will continue enhanced monitoring in 

VAERS, conduct surveillance in other vaccine safety systems, and update ACIP and the public 

as additional information becomes available. CDC’s healthcare provider partners on the front 

lines are reminded to submit AE reports to VAERS. There are specific EUA reporting

requirements and CDC encourages the reporting of any clinically significant AEs VAERS.

In the spirit the vote earlier in the day, v-safeTM is CDC’s smartphone-based active safety 

monitoring system. It is a post-vaccination health checker that is a voluntary self-enrollment 

program that sends text messages with embedded web links from CDC to take respondents to

secure, web-based surveys in which they can report to CDC about the post-vaccination

experiences. Now that adolescent vaccination has been recommended, CDC encourages 

parents and guardians to enroll their vaccinated adolescents into v-safeTM. Parents and 

guardians can complete health surveys on behalf of their adolescents, describing symptoms

and health events after vaccination. CDC encourages completing the health surveys even if the 

vaccinated persons are feeling well and have no side effects. All of this information is important

and helpful to CDC in terms of continued monitoring of the safety of COVID-19 vaccines as use 

is expanded into younger populations. CDC thinks that taking advantage of the post-vaccination 

observation period to counsel patients on v-safeTM and encourage patients and parents on 

behalf of their adolescents would be a good use of the waiting time during the post-vaccination 

observation period.

VaST Update 

Dr. Grace Lee (ACIP, VaST Chair) reminded everyone that the objectives of the Vaccine Safety 

Technical (VaST) WG are to : 1) review, evaluate, and interpret post-authorization/approval 

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

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

analyses, interpretation, and data presentation; and 4) provide updates to the ACIP COVID-19 

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

At this point in the US vaccination program, a tremendous amount of safety data has been 

accumulated to date. There have been 262 million doses administered in the US, including 140 

million Pfizer-BioNTech doses administered and 153 million individuals who have received at 

least one dose. v-safeTM has been incredibly helpful for confirming the reactogenicity profile

observed in clinical trials. It includes over 110,000 individuals who self-identify as pregnant who 

are now being recruited for a specific pregnancy registry. This is a great example of innovation 

and the ability to capture enhanced data for a population where more data are needed. VAERS 

has been critical in the early detection of both anaphylaxis and TTS, and the CISA consultation 

service for COVID-19 vaccines has added tremendous value for challenging clinical questions.
ACIP Meeting Summary May 12, 2021

36

Having moved further along in the vaccine program timeline, the focus is shifting to data from 

large link databases such as the VSD, VA, and DMSS.

Dr. Lee reviewed the timing of various ACIP recommendations, emphasizing that it has been a 

busy 5 months of service for the VaST members and for the vaccine safety teams who are 

presenting at all of these meetings. VaST on April 12-14, 2021 to address the TTS signal and 

the CVST cases with thrombocytopenia following the Janssen vaccine. VaST requested 

additional information to support evidence-based decision-making about the use of this vaccine

and met numerous times before and after the April 23, 2021 ACIP meeting during which the 

recommendations for use of the Janssen COVID-19 vaccine was updated. ACIP concluded the 

benefits of resuming vaccination among persons 18 years and older outweighed the risks of the 

population level and reaffirmed its interim recommendation under the FDA’s EUA with a new 

warning put into place for rare clotting events among women aged 18-49.

Since the last public ACIP meeting, VaST met 3 times to review the findings from enhanced

monitoring efforts and the tiered CDC case ascertainment approach for TTS cases in VAERS.

VaST also reviewed available data from the VSD RCA. An advantage of both of these vaccine 

safety systems is that they can implement broad electronic algorithms to capture potential CVST 

or TTS events, followed by a rapid review of electronic medical records (EMRs) for confirmation.

This illustrates the robust system that allowed this to be done in real-time. VaST appreciates

that its CDC colleagues have published what information they had available expeditiously and 

transparently. Dr. Lee also thanked their CDC colleagues for making the information available to 

providers and patients about the benefit/risk balance of using the Janssen vaccine that is easier 

to understand at a better health diversity level.

To summarize the VaST assessment, there are no confirmed TTS cases following mRNA 

vaccines. The risk of TTS following the Janssen vaccine is rare, yet remains highest in females 

less than 50 years of age. Risk mitigation strategies appear to be effective and should continue, 

including educating patients about the benefits and risks of available vaccines and ensuring that 

patients and providers are aware of the importance of early recognition and timely management 

of TTS. For example, in the data reviewed earlier in the day, recent TTS cases seem to be 

detected slightly earlier in the course of illness and fewer cases of TTS were treated with

heparin after the HAN was released. VaST will continue to monitor TTS, thromboembolic 

disease, and thrombocytopenia in all available vaccine safety surveillance systems. VaST will 

update the ACIP COVID-19 Vaccines WG, the ACIP Secretariat, and the ACIP on a regular 

basis.

COVID-19 WG Interpretation of the TSS Updates

Dr. Oliver (CDC/NCIRD) presented a COVID-19 WG Interpretation of the TTS updates. As 

mentioned several times in this session, an MMWR was published after the vote where ACIP 

reaffirmed its recommendations for all persons 18 years of age and older under the EUA that 

now includes the warning about clotting events and highlights the fact that patient and provider 

education about the risk for TTS with the Janssen vaccine, especially among women less than 

50 is important, as well as the availability of alternative COVID vaccines. This information is 

required to guide vaccine decision-making and ensure early recognition and clinical 

management of TTS. Educational materials that are now on CDC’s website.
ACIP Meeting Summary May 12, 2021

37

In terms of how doses of Janssen COVID-19 vaccine have been used since the pause, nearly 8 

million doses were used prior to the pause April 13, 2021. There was a fairly even split between 

males and females. Since the pause, 1.2 million doses of the Janssen COVID-19 vaccine have 

been administered. Doses are still being utilized for females, but in a smaller proportion since 

before the pause, especially in the population identified as the highest risk (females 18-49 years 

of age).

The risk/benefit analysis has been updated with the incidence of TTS that Dr. Shimabukuro just 

presented. This reviewed by the COVID-19 Vaccines WG. The WG’s interpretation at this time 

is that the benefits still outweigh the risk and that no updates to vaccine policy are needed. The 

WG will continue to review TTS updates, as well as updates to the risk/benefit analysis. The 

WG will continue its discussions if or when the WG’s assessment is that updates to 

recommendations for the use of the Janssen COVID-19 vaccine should be considered. The full 

risk/benefit analysis will be presented to ACIP again, along with potential updated policy 

considerations. Dr. Oliver emphasized that just because they are not bringing information 

forward to ACIP at every meeting, everyone can be reassured that the WG and others are 

continuing to look at the data and will bring it forward if and when needed.

Summary of Discussion (Shimabakuro, Lee, Oliver)

• Concern remained among ACIP members regarding the Janssen vaccine. While the 

warning that has been tied to the vaccine recommendation has been 18-49 years old and 

predominantly female, there are quite a few confirmed cases in the 50-59. With that in mind, 

it was suggested that perhaps the warning age range should be 18-60 years of age.

• ACIP members emphasized the importance of strong educational materials and continuing 

to seek better ways to ensure that everybody is being educated about all vaccines and 

vaccine recommendations, particularly pregnant women.

• The dynamic benefit/risk assessment is critically important in terms of understanding the 

status of the pandemic. ACIP praised the modeling team for a phenomenal job during the 

last meeting in putting numbers to the qualitative sense that everyone had.

COVID-19 Vaccine Effectiveness Studies 

Dr. Katherine Fleming-Dutra (CDC/NCIRD) presented on why post-authorization vaccine

effectiveness (VE) estimates are needed. It is known that real-world performance of vaccines 

can vary from that seen in the controlled trial setting due to implementation differences that can 

occur in widespread vaccination programs in terms of adherence to cold-chain requirements; a

broader population that is eligible to receive the vaccine, such as persons with certain 

underlying health conditions who may not have been included in the trials; and the potential for 

the timing and coverage of the second dose of a 2-dose series to vary from what was studied or 

even from what is recommended. Post-authorization VE studies build on evidence from clinical

trials to better understand VE in groups experiencing disproportionate impacts of COVID-19, 

especially since in the trials the number of individuals from various groups may have been 

limited; to understand the VE against severe disease for SARS-CoV-2 infection and 

transmission; and to better understand the duration of protection.
ACIP Meeting Summary May 12, 2021

38

This team’s priorities have been developed based on the results of internal and external input to 

focus on the information that will be most useful for guiding policy. The most immediate priority 

after introduction of COVID-19 vaccines has been to answer the question, “Does vaccine 

protect against symptomatic diseases as expected from the clinical trials?” Subsequent priorities 

include: 1) estimating VE against the key outcomes of severe disease, non-severe disease, and 

infection and transmission; 2) estimating VE in groups experiencing disproportionate impact of 

COVID-19 (e.g., adults ≥65 years, those living in LTCF, people with key underlying health 

conditions, and racial and ethnic minority groups experiencing disproportionate impact of 

COVID-19; 3) estimating the VE for regimen-related questions for 2-dose products; 4) 

understanding viral evolution and whether genome changes impact VE; 5) understanding 

duration of protection; and 6) comparison of VE across products.

In terms of the overall landscape of the COVID-19 mRNA VE literature globally, Dr. FlemingDutra focused on mRNA vaccines. Because the of the products that are currently in use in the 

US, the vast majority of real-world literature is from mRNA vaccines. It is very important to

address the caveats of the literature. The literature is rapidly evolving and growing exponentially 

by the day. A wide variety of methods, populations, and definitions are being used. Most of the 

VE literature is currently in pre-press form and there are few peer-reviewed publications. The 

quality of the literature varies widely among studies. Meta-analyses and formal comparisons are 

not appropriate at this time due to these caveats. Dr. Fleming-Dutra shared a graph (slide 6) to 

illustrate the complexity of the literature examining the VE of the 2-doses of the Pfizer-BioNTech 

vaccine.37 To summarize the literature, there is very high and relatively consistent VE across all

of these studies and even across the outcomes, with the possible exception of asymptomatic 

infections. These consistent results are very reassuring. The VE literature for two doses of 

mRNA vaccines comes from populations that were using both the Moderna and Pfizer products. 

There were fewer studies in this category, all of which were from the US. Again, there is 

reassuringly high and relatively consistent VE across these studies.

Turning to the CDC VE studies, Dr. Britton and colleagues from CDC, Connecticut Department 

of Health, and Yale School of Medicine, published an MMWR on March 15, 2021 on the

effectiveness of the Pfizer-BioNTech vaccine among residents of two skilled nursing facilities

(SNF). These facilities were experiencing COVID-19 outbreaks that began just after the vaccine

was introduced in these facilities. This offered an early opportunity to assess VE in this

population. During this investigation, the researchers found that a partial regimen of the PfizerBioNTech vaccine from 14 or more days after the first dose and 7 days after the second dose

provided significant protection against infection, with a VE of 63% (33%-79%). They conducted 

a couple of sensitivity analyses that excluded residents with prior SARS-CoV-2 infection and 

examined time windows of 14 more days after Dose 1 up to the receipt of Dose 2 and from 14 

or more days after Dose 1 through 14 days following Dose 2. The sensitivity analyses yielded 

very similar VE results. These findings are comparable to other first dose VE findings among the 

broader adult population, community-dwelling older adults, and adults with multiple 

comorbidities.38

37 Figure courtesy of Dr. Minal Patel, World Health Organization, Individual studies results only

38 https://www.cdc.gov/mmwr/volumes/70/wr/mm7011e3.htm?s_cid=mm7011e3_w
ACIP Meeting Summary May 12, 2021

39

On March 29, 2021, Dr. Thompson and colleagues published an MMWR with the interim 

estimates of VE of the Pfizer-BioNTech and Moderna mRNA vaccines in preventing SARS-CoV2 infection and among HCP, first responders, and other essential and front line workers in 8 US

sites. This is an ongoing cohort study. This interim analysis found the adjusted VE against 

infection for partial immunization status, meaning 14 days after the first dose through receipt, to 

be 80% (59%-90%). VE against infection for full immunization, starting 14 days after the second 

dose, was 90% (68%-97%).

39

On April 28, 2021, Dr. Tenforde and colleagues published an MMWR on the effectiveness of the 

Pfizer-BioNTech and Moderna vaccines against COVID-19 among hospitalized adults aged 65 

years or older in multiple sites across the US. This is also an ongoing study. This interim 

analysis used a test-negative design by enrolling hospitalized adults aged 65 years or older. 

Those who tested positive for COVID-19 by PCR were cases and those who tested negative 

were controls. In these interim results, VE against hospitalization of full vaccination was 94%

(44%-99%). Additionally, the investigators looked at any vaccination. Partial or full vaccination 

status had a VE of 71% (44%–85%) and partial vaccination status alone had a VE of 64%

(28%-82%).

40

On April 30, 2021, Dr. Cavanaugh and colleagues from Kentucky published another MMWR that 

included VE during a COVID-19 outbreak associated with a SARS-CoV-2 R.1 lineage variant in 

a SNF. During this outbreak investigation, it was estimated that VE against symptomatic

disease was 87%(66%-95%) among residents who were fully vaccinated. Among HCP in the 

facility who were fully vaccinated, VE was basically the same at 87% (46%-97%).

41

Dr. Fleming-Dutra shared a summary table previewing the work that is still ongoing, including 

the VE priority, prospective data collection, and type of analyses (slides 18). Work has been 

done to harmonize and coordinate across various platforms, the COVID-19 response, and 

across the US government. Because this meeting was focused primarily on the pediatric

population, she highlighted the ongoing work that will include adolescents and children (slide 

19).

The OVERCOMING2 platform will focus specifically on adolescents and children. This is the VE 

arm of the OVERCOMING COVID-19 surveillance system. OVERCOMING2 will be assessing 

VE against COVID-19 and MIS-C among hospitalized children less than 19 years of age. This 

platform is based on an ICU network assessing influenza VE against critical illness in pediatric 

patients. During 2020, OVERCOMING2 enrolled all MIS-C patients and ICU patients with

COVID-19 at about 57 US pediatric hospitals. The primary objectives for the VE portion of this 

network will be to: 1) assess the VE against any hospitalized COVID-19 in MIS-C among two 

control groups (test-negative acute respiratory illness and non-acute respiratory illness

hospitalizations); and 2) assess the VE by several subgroups (variant, vaccine type, age, 

race/ethnicity, sex, time since vaccination, partial vaccination).

Another critical question that CDC is assessing is, “Do viral genome changes impact VE?” 

Selected prospective platforms will be collecting specimens from cases where possible for 

whole genome sequencing (WGS). It is important to note that this will not be performed in realtime and may not be powered for variant-specific VE assessment. The Vaccine Evaluation Unit

(VEU) also has a team assessing vaccine breakthrough cases with hospitalization or death, and 

also is collaboration with the Emerging Infections Program (EIP) to compare the frequency of 

39 https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e3.htm?s_cid=mm7013e3_w

40 https://www.cdc.gov/mmwr/volumes/70/wr/mm7018e1.htm?s_cid=mm7018e1_w

41 https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e2.htm?s_cid=mm7017e2_w
ACIP Meeting Summary May 12, 2021

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variants among vaccinated and unvaccinated persons that may help shed light on this question.

This work is part of the broader CDC efforts to monitor the impact of SARS-CoV-2 variants. Dr. 

Fleming-Dutra shared a summary table delineating current VE assessments for genomic 

characterization (slide 22).

Another important VE priority is to understand the duration of protection provided by COVID-19 

vaccines. This will help inform the question about the potential need for a booster or booster 

doses. To better understand duration of protection, it is important to take into account into 

account changes in the circulating variants over time. The work to assess the duration of 

protection will leverage platforms that can be used on an ongoing basis to assess VE with 

increasing time since vaccination. Dr. Fleming-Dutra shared a summary table previewing VE 

assessments including duration of protection (slide 24).

In terms of the VE estimates that were calculated from the COVID-19 outbreaks in Connecticut 

and Kentucky and published in the MMWR, COVID-19 outbreaks in defined populations may 

provide opportunities to estimate VE around important questions. The Vaccine Effectiveness 

team is currently working with state and local health departments and other federal partners to 

conduct VE assessments in outbreak settings among residents of long-term care facilities

(LTCF) and among incarcerated and detained persons and staff in corrections facilities. They 

are actively looking for COVID-19 outbreaks in congregate settings, but the investigations for 

these outbreaks can be leveraged to assess variant-specific effectiveness, VE for Johnson & 

Johnson’s Janssen vaccine, and the VE of among adolescents and children when children are 

eligible for vaccine.

In conclusion, the initial COVID-19 VE estimates from recently published reports are

demonstrating remarkably consistent results across studies with a variety of methods and 

populations, which is very reassuring. There is an urgent need for VE data to guide vaccine 

policy. A broad approach including a diversity of projects, methods, bias control, populations,

and sample sizes strengthens the understanding of the true real-world performance of these 

vaccines.

Summary of Discussion

• ACIP members suggested a number of additional studies they hoped might be underway or 

could be considered, including the following:

➢ Some of the large datasets probably have enough pregnant women to examine 

efficacy in this population

➢ More data are needed on the immunocompromised population (~4% of the US

population) in terms of overall efficacy and timing of vaccination, particularly given 

the relatively devastating data over the past few weeks about cellular immune 

response in these populations and the inability to give a booster under the current 

EUA

➢ Perhaps consideration could be given to more severe forms of the illness rather than 

just mildly symptomatic infection and other important factors that will stress medical 

systems

➢ Consider modeling certain locations with varying levels of uptake of vaccination to

determine the indirect protective effects in localized communities with higher uptake

➢ With regard to the analysis of completing the vaccination schedule as planned, one 

suggestion would be to assess how many subjects had a prior COVID infection and 
ACIP Meeting Summary May 12, 2021

41

1 versus 2 doses with respect to VE, given that 1 dose in people with prior COVID 

infection may result in a sufficient antibody response

➢ Duration of protection and VE against variants are critically important to better 

understand, particularly in terms of immunocompromised populations

Update on Emerging SARS-CoV-2 Variants and Vaccine Considerations

Dr. Heather Scobie (CDC/CGH) provided an update on emerging SARS-CoV-2 variants and 

vaccine considerations. There are multiple SARS-CoV-2 variants circulating globally. Viruses 

constantly change through mutation, so new variants are to be expected. After emerging, some 

disappear and other persist. CDC and others are studying these variants to understand whether 

they spread more easily, cause milder or more severe disease, are detected by available 

diagnostic tests, respond to current therapeutics, or change the effectiveness of COVID-19 

vaccines.42

A SARS-CoV-2 Interagency Group (SIG) has established definitions for classifying variants into 

three categories for public health action, which are described below:

❑ Variant of Interest (VOI): Genetic markers associated with changes to receptor binding, 

reduced antibody neutralization, reduced efficacy of treatments, potential diagnostic impact, 

or predicted increase in transmissibility or disease severity

❑ Variant of Concern (VOC): Evidence of increased transmissibility, more severe disease, 

significant reduction in neutralization by antibodies, reduced effectiveness of treatments or 

vaccines, or diagnostic detection failures

❑ Variant of High Consequence (VOHC): Clear evidence that prevention measures or 

medical countermeasures have significantly reduced effectiveness [None yet]

US classifications may differ from those of the WHO since the importance of variants may differ 

by location. Currently, there are 8 VOIs. B.1.526 and B.1.526.1 were first detected in New York. 

B.1.525 was first detected in the United Kingdom (UK) and Nigeria and P.2 was first detected in 

Brazil. The previous week, 4 VOIs were detected. B.1.617 was first detected in India and

B.1.617.1, 2, and 3 also were added as variants of interesting in India. The variants have 

independently evolved shared mutations in the receptor binding domain of the spike protein, 

which can reduce the efficacy of antibody therapies and vaccines.

Three variants have global consensus as VOCs. These include B.1.1.7 first detected in the UK, 

B.1.351 first detected in South Africa, and P.1 first detected in Brazil and Japan. Both B.1.1.7 

and B.1.351 are estimated to be 50% more transmissible and have become the dominant 

strains in some areas. The Brazil and South Africa strains share a cluster of three mutations in 

the receptor binding domain that have the largest known impact on VE, with the E484K mutation 

being the most problematic. More recently, the US classified the California variants B.1.427 and 

B.1.429 as VOCs. These variants appear to be 20% more transmissible.

42 https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant.html
ACIP Meeting Summary May 12, 2021

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Turning to genomic surveillance and the epidemiology of the variants, US SARS-CoV-2

sequences are submitted in two public repositories, the National Center for Biotechnology 

Information (NCBI) and GISAID starting in January 2020 to the present. As a result of efforts by 

CDC and partners to improve genomic surveillance, the number of published sequences has 

substantially increased during 2021. Overall, 6%-9% of SARS-CoV-2 positive cases were

sequenced weekly.

National estimates of the proportions of circulating SARS-CoV-2 variants are available from 

CDC’s COVID data tracker. To provide more accurate estimates, proportions are adjusted with 

weights to correct for non-random sampling. The previous week, CDC started producing 

NOWCAST projections and prediction intervals that account for a limited data availability during 

the 3-4 week lag between sample collection and sequencing results. This allows estimation for a 

more recent time period. For the 2 weeks ending May 8th, B.1.1.7 remained the most frequent

lineage, with a projected prevalence of 72%. B.1.427 and B.1.429 were projected to have 

decreased 1% combined. B.1.351 decreased to less than 1%, while P.1 increased to 6%. The 

VOIs B.1.526 and B.1.526.1 were relatively steady at 7% and 3%, and B.1.617.2 increased to 

3%. Other VOIs were less than 1%. In terms of the NOWCAST projected variant proportions in 

each of the 10 designated HHS services regions for the 2 weeks ending May 8th, while B.1.1.7 

predominated in each region, the distribution of other lineages varied. For example, B.1.526 and 

B.1.526.1 were highest in the Northeast, while B.1.427 and B.1.429 were highest on the West 

Coast. P.1 was projected to have increased in all regions, but was highest at around 10% in 

regions 1, 5, and 9. B.1.617.2 was greater than 10% in regions 2 and 8.

Regarding the impact of variants on VE, while cellular immunity likely plays a role in protecting

against SARS-CoV-2, a robust correlation has been observed between VE versus neutralizing

or binding antibody titers. Current vaccines produce neutralizing antibody levels falling within a 

protective margin, but a precise threshold or correlative protection has not yet been determined.

New vaccines may be needed for E484K and future escape mutations, which may reduce 

protection to near below the threshold resulting in lowered VE, increased breakthrough 

infections, and shortened duration of immunity.

CDC conducted a review of available studies on vaccines authorized or intending to be 

authorized in the US and containing data on the ability of post-vaccination sera to neutralize 

SARS-CoV-2 variants. In terms of the reduction in neutralization and variants relative to the 

wildtype or dominant strain used in each study, B.1.1.7 had a median 2-fold reduction in 

neutralization, B.1.351 had the largest median reduction at 7.6-fold, and P.1 had an

intermediate reduction of 3.7-fold. One study assessed the other Brazil variant, P.2, and 

observed a similar effect to P.1. Two studies assessed a B.1.1.7 variant with an E484K change,

which has been detected in the UK and the US, and found that neutralization was reduced 

compared to B.1.1.7 alone. The India B.1.617, California B.1.429, and New York B.1.526 

variants had modest reductions of less than 3-fold, while one study of B.1.617.1 and a B.1.526 

variant with an additional 484K mutation have larger reductions.

In summary, the largest impacts on neutralization were observed for B.1.351, followed by P.1. It 

is difficult to estimate how these results might translate into clinical protection. Some of the 

variation in the results presented may be explained by differences in experimental conditions.

Limitations for all studies were small sample sizes and a lack of generalizability. Almost half of 

the studies have yet to be peer-reviewed.
ACIP Meeting Summary May 12, 2021

43

With regard to VE point estimates related to the variants (slides 21, 22), a Pfizer vaccine study 

published the previous week from Qatar showed a high real-world VE of 90% against infection 

with B.1.1.7 and 75% against B.1.351. A growing number of Pfizer studies from the UK and 

Israel also have demonstrated high real-world VE while B.1.1.7 was prevalent. For the Janssen 

vaccine clinical trial, a variation in VE was observed across countries that may have been 

related to the high prevalence of circulating variants in Brazil and South Africa. Importantly, both 

the Qatar Pfizer study and Janssen clinical trial demonstrated high VE against severe critical 

disease regardless of circulating variants. In the Novavax and AZ vaccine clinical trials, slightly 

lower VEs were observed for B.1.1.7 than non-B.1.1.7 strains and more substantial reductions 

were observed for B.1.351. The AZ vaccine clinical trial in South Africa observed a VE of only 

10% against B.1.351, but study investigators noted that only mild or moderate cases were 

observed in the trial.

Despite high vaccine efficacy, vaccine breakthrough cases are still expected to occur, including 

those caused by circulating variance. As of April 26th, among 95 million people who were fully 

vaccinated in the US, 9245 breakthrough infections were reported through national passive 

surveillance. CDC works with state health departments on case investigations and sequencing 

to identify variants. Starting soon, a CDC project was the emerging infections program sites 

should allow estimation of the frequency of SARS-CoV-2 variants among vaccinated and 

unvaccinated people in the US.43

One study from Israel assessed variants of concern and infections among Pfizer vaccinated 

people versus unvaccinated matched controls during a time when B.1.1.7 was predominant and 

B.1.351 was found in less than 1% of specimens. Investigators found that people testing 

positive for SARS-CoV-2 at least a week after the second vaccine dose had significantly higher 

odds of infection with B.1.351, while partially vaccinated persons between 2 weeks after the first 

dose and 1 week after the second dose had significantly higher odds of having B.1.1.7

compared with unvaccinated people. The authors concluded that breakthrough infection was 

more frequent for VOCs.

44 For perspective, CDC also notes that other studies from Israel have 

documented high VE and a dramatic decline in COVID cases despite B.1.1.7 predominance.

In summary, the B.1.1.7 variant is exponentially increasing in prevalence in the US but has 

minimal impact of VE. However, variants with additional substitutions in their receptor binding 

domain, like E484K, deserve special attention. The B.1.351 variant is at low prevalence in the

US, but has moderate impact on the effectiveness of some vaccines, though they may still 

provide protection against severe disease. P.1 has increasing prevalence in the US and has the 

same triple mutation in the receptor binding domain as B.1.351, which is worth watching closely.

Additional data are still needed on the potential impact on VE.

Vaccine manufacturers have announced booster studies of current vaccines and their 

development of second generation vaccines against B.1.351. The previous week, Moderna 

posted preliminary results of a Phase 2 clinical trial of a single 50 μg booster dose of the 

previously authorized and new variant specific vaccines. At 6-8 months after the primary series,

study participants had low or undetectable neutralizing antibodies for B.1.351 and P.1, while 

titers against wild-type virus were still likely to be productive. Both variant vaccines had 

acceptable safety and boosted immunity levels roughly equivalent to those after primary

vaccination for all viruses tested. The variant booster was more effective than the original 

43 Tehran et al. https://www.cdc.gov/mmwr/volumes/70/wr/mm7017e1.htm

44 Kustin et al. MedRxiv preprint (16 April 2021): https://www.medrxiv.org/content/10.1101/2021.04.06.21254882v2
ACIP Meeting Summary May 12, 2021

44

vaccine at neutralizing B.1.351. Still in progress is a clinical trial for bivalent vaccine with a 1:1 

mix of the original and variant vaccines.45

Periodic update of SARS-CoV-2 vaccines is likely to be needed. The FDA has defined the data

needed to support an EUA amendment for a vaccine addressing emerging SARS-CoV-2

variants, which includes an immunogenicity study designed as a non-inferiority comparison. The 

SIG is developing an evaluation and risk assessment framework that defines the evidence

needed to recommend whether a modified vaccine is needed. WHO will have a role in global 

coordination.

It is important to emphasize that the current prevention measures and authorized vaccines offer 

good protection against SARS-CoV-2 variants and efforts are needed to increase uptake. CDC

will continue to monitor evidence on the emergence and spread of SARS-CoV-2 variants, VE, 

breakthrough infections in vaccinated or previously infected persons, and the ability of postvaccinations serum to neutralize emerging variant viruses. ACIP will review evidence submitted 

for booster doses and any next generation vaccines if it becomes clear that they are needed to 

address the variants.

45 Wu et al. medRxiv preprint (May 6, 2021): https://doi.org/10.1101/2021.05.05.21256716 https://investors.modernatx.com/newsreleases/news-release-details/moderna-announces-positive-initial-booster-data-against-sars-cov/

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-study-part-broad-development
ACIP Meeting Summary May 12, 2021

45

CERTIFICATION

Upon reviewing the foregoing version of the May 12, 2021 ACIP meeting minutes, Dr. Jose 

Romero, ACIP Chair, certified that to the best of his knowledge, they are accurate and 

complete. His original, signed certification is on file with the Management Analysis and Services 

Office (MASO) of CDC.
ACIP Meeting Summary May 12, 2021

46

ACIP MEMBERSHIP ROSTER

CHAIR

ROMERO, José R, MD, FAAP 

Arkansas Secretary of Health 

Director, Arkansas Department of Health 

Professor of Pediatrics, Pediatric Infectious Diseases 

University of Arkansas for Medical Sciences 

Little Rock, Arkansas 

Term: 10/30/2018-06/30/2021 

EXECUTIVE SECRETARY

COHN, Amanda, MD 

Senior Advisor for Vaccines 

National Center for Immunization and Respiratory Diseases 

Centers for Disease Control and Prevention 

Atlanta, GA 

MEMBERS

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 
ACIP Meeting Summary May 12, 2021

47

BERNSTEIN, Henry, DO, MHCM, FAAP 

Professor of Pediatrics 

Zucker School of Medicine at Hofstra/Northwell 

Cohen Children’s Medical Center 

New Hyde Park, NY 

Term: 11/27/2017-06/30/2021 

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 

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 

FREY, Sharon E, MD 

Professor and Associate Director of Clinical Research 

Clinical Director, Center for Vaccine Development 

Division of Infectious Diseases, Allergy and Immunology 

Saint Louis University Medical School 

Saint Louis, MO 

Term: 11/27/2017-06/30/2021 

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 

LEE, Grace M, MD, MPH 

Associate Chief Medical Officer for Practice Innovation 

Lucile Packard Children’s Hospital 

Professor of Pediatrics, Stanford University School of Medicine 

Stanford, CA 

Term: 7/1/2016 – 6/30/2021 
ACIP Meeting Summary May 12, 2021

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LONG, Sarah S, MD 

Professor of Pediatrics 

Drexel University College of Medicine 

Section of Infectious Diseases 

St. Christopher’s Hospital for Children 

Philadelphia, Pennsylvania 

Term: 12/24/2020 – 6/30/2024 

MCNALLY, Veronica V, JD 

President and CEO Franny 

Strong Foundation 

West Bloomfield, Michigan 

Term: 10/31/2018 – 6/30/2022 

POEHLING, Katherine A, MD, MPH 

Professor of Pediatrics and Epidemiology and Prevention 

Director, Pediatric Population Health 

Department of Pediatrics 

Wake Forest School of Medicine 

Winston-Salem, NC 

Term: 7/1/2019 – 6/30/2023 

SÁNCHEZ, Pablo J, MD 

Professor of Pediatrics 

The Ohio State University – Nationwide Children’s Hospital 

Divisions of Neonatal-Perinatal Medicine and Pediatric Infectious Diseases 

Director, Clinical & Translational Research (Neonatology) 

Center for Perinatal Research 

The Research Institute at Nationwide Children's Hospital Columbus, Ohio 

Term: 7/1/2019 – 6/30/2023 

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 
ACIP Meeting Summary May 12, 2021

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Food and Drug Administration (FDA) 

FINK, Doran, MD, PhD 

Deputy Director, Clinical, Division of Vaccines and Related Products Applications 

Office of Vaccines Research and Review 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

Silver Spring, MD 

Health Resources and Services Administration (HRSA) 

RUBIN, Mary, MD 

Chief Medical Officer 

Division of Injury Compensation Programs 

Rockville, MD 

Indian Health Service (IHS) 

WEISER, Thomas, MD, MPH 

Medical Epidemiologist 

Portland Area Indian Health Service 

Portland, OR 

Office of Infectious Disease and HIV/AIDS Policy (OIDP)

KIM, David, MD, MA 

Director, Division of Vaccines, OIDP 

Office of the Assistant Secretary for Health 

Department of Health and Human Services 

Washington, DC 

National Institutes of Health (NIH) 

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) Bethesda, MD 

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 
ACIP Meeting Summary May 12, 2021

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American Academy of Pediatrics (AAP) 

Red Book Editor

KIMBERLIN, David, MD 

Professor of Pediatrics 

Division of Pediatric Infectious Diseases 

The University of Alabama at Birmingham School of Medicine Birmingham, AL 

American Academy of Physician Assistants (AAPA) 

LÉGER, Marie-Michèle, MPH, PA-C 

Senior Director, Clinical and Health Affairs 

American Academy of Physician Assistants Alexandria, VA 

American College Health Association (ACHA) 

CHAI, Thevy S., MD 

Director of Medical Services 

Campus Health Services 

University of North Carolina at Chapel Hill Chapel Hill, 

NC 

American College Health Association (ACHA) (alternate) 

MCMULLEN, Sharon, RN, MPH, FACHA 

Assistant Vice President of Student & Campus Life for Health and Wellbeing Cornell Health 

Ithaca, NY 

American College of Nurse Midwives (ACNM) 

HAYES, Carol E., CNM, MN, MPH 

Lead Clinician 

Clinical Quality Compliance and Management 

Planned Parenthood Southeast Atlanta, GA 

American College of Nurse Midwives (ACNM) (alternate) 

MEHARRY, Pamela M., PHD, CNM 

Midwifery Educator, Human Resources for Health 

In partnership with University of Rwanda and University of Illinois, Chicago 

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 
ACIP Meeting Summary May 12, 2021

51

American Geriatrics Society (AGS) 

SCHMADER, Kenneth, MD 

Professor of Medicine-Geriatrics Geriatrics 

Division Chief 

Duke University and Durham VA Medical Centers 

Durham, NC 

America’s Health Insurance Plans (AHIP) 

GLUCKMAN, Robert A, MD, MACP 

Chief Medical Officer, Providence Health Plans 

Beaverton, OR 

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA Washington, DC 

American Medical Association (AMA)

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine Emory 

University School of Medicine 

Atlanta, GA 

American Nurses Association (ANA) 

RITTLE, Charles (Chad), DNP, MPH, RN Assistant 

Professor, Nursing Faculty 

Chatham University, School of Health Sciences 

Pittsburgh, PA 

American Osteopathic Association (AOA) 

GROGG, Stanley E, DO 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA) 

FOSTER, Stephan L, PharmD CAPT 

(Ret) USPHS 

Professor, College of Pharmacy 

University of Tennessee Health Sciences Center 

Memphis, TN 

Association of Immunization Managers (AIM) 

HOWELL, Molly, MPH 

Immunization Program Manager 

North Dakota Department of Health

Bismarck, ND 
ACIP Meeting Summary May 12, 2021

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Association for Prevention Teaching and Research (APTR) 

McKINNEY, W Paul, MD 

Professor and Associate Dean 

University of Louisville School of Public Health and Information Sciences

Louisville, KY 

Association of State and Territorial Health Officials (ASTHO) 

SHAH, Nirav D, MD, JD 

Director

Maine Center for Disease Control and Prevention

Augusta, ME 

Biotechnology Industry Organization (BIO) 

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

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

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 

Canadian National Advisory Committee on Immunization (NACI) 

QUACH, Caroline, MD, MSc 

Pediatric Infectious Disease Specialist and Medical Microbiologist 

Medical Lead, Infection Prevention and Control Unit 

Medical Co-director – Laboratory Medicine, Optilab 

Montreal-CHUM 

Montreal, Québec, Canada 

Infectious Diseases Society of America (IDSA) 

BAKER, Carol J., MD 

Professor of Pediatrics 

Molecular Virology and Microbiology 

Baylor College of Medicine 

Houston, TX 
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International Society for Travel Medicine (ISTM) 

BARNETT, Elizabeth D, MD Professor of 

Pediatrics 

Boston University School of Medicine 

Boston, MA 

National Association of County and City Health Officials (NACCHO)

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 

National Association of County and City Health Officials (NACCHO) (alternate)

DUCHIN, Jeffrey, MD 

Health Officer and Chief, Communicable Disease

Epidemiology and Immunization Section 

Public Health - Seattle and King County 

Professor in Medicine 

Division of Allergy and Infectious Diseases 

University of Washington School of Medicine and School of Public Health

Seattle, WA 

National Association of Pediatric Nurse Practitioners (NAPNAP) 

STINCHFIELD, Patricia A, RN, MS, CPNP 

Director 

Infectious Disease/Immunology/Infection Control

Children's Hospitals and Clinics of Minnesota 

St. Paul, MN 

National Foundation for Infectious Diseases (NFID) 

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 

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 
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Pediatric Infectious Diseases Society (PIDS) 

O’LEARY, Sean, MD, MPH 

Associate Professor of Pediatrics 

Pediatric Infectious Diseases 

General Academic Pediatrics 

Children’s Hospital Colorado 

University of Colorado School of Medicine 

Pediatric Infectious Diseases Society (PIDS) (alternate)

SAWYER, Mark H, MD 

Professor of Clinical Pediatrics 

University of California, San Diego School of Medicine 

San Diego, CA

Pharmaceutical Research and Manufacturers of America (PhRMA) 

ROBERTSON, Corey, MD, MPH 

Senior Director, US Medical, Sanofi Pasteur 

Swiftwater, PA 

Society for Adolescent Health and Medicine (SAHM) 

MIDDLEMAN, Amy B, MD, MSEd, MPH 

Professor of Pediatrics 

Chief, Section of Adolescent Medicine 

University of Oklahoma Health Sciences Center

Oklahoma City, OK 

Society for Healthcare Epidemiology of America (SHEA)

DREES, Marci, MD, MS 

Chief Infection Prevention Officer & Hospital Epidemiologist 

ChristianaCare 

Wilmington, DE 

Associate Professor of Medicine 

Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA 
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ACRONYMS USED IN THE DOCUMENT

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices

ACOG American College of Obstetricians and Gynecologists

ACP American College of Physicians 

ADHD Attention-Deficit/Hyperactivity Disorder 

AE Adverse Event

AFM Acute Flaccid Myelitis 

AGS American Geriatric Society 

AHIP America’s Health Insurance Plans

AIM Association of Immunization Managers 

AMA American Medical Association

AOA American Osteopathic Association 

APhA American Pharmacists Association 

APTR Association for Prevention Teaching and Research

ASTHO Association of State and Territorial Health Officers 

AZ AstraZeneca

CBER Center for Biologics Evaluation and Research 

CDC Centers for Disease Control and Prevention

CISA Clinical Immunization Safety Assessment 

CMS Center for Medicare and Medicaid Services

COD Cause of Death

COI Conflict of Interest 

COVID-19 Coronavirus Disease 2019 

CSTE Council of State and Territorial Epidemiologists 

CVST Cerebral Venous Sinus Thrombosis 

DoD Department of Defense

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs

DVRPA Division of Vaccines and Related Product Applications 

DVT Deep Vein Thrombosis 

ED Emergency Department 

EHR Electronic Health Record 

EIS Epidemic Intelligence Service 

EIP Emerging Infections Program 

ELISA Enzyme-Linked Immunosorbent 

EMA European Medicines Agency 

EtR Framework Evidence to Recommendations Framework

EUA Emergency Use Authorization 

FDA Food and Drug Administration

FQHCs Federally Qualified Health Center 

GRADE Grading of Recommendations, Assessment, Development and Evaluations

HAN Health Alert Network 

HCP Health Care Personnel / Provider / Professional 

HCW Health Care Workers 
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HHS (Department of) Health and Human Services

HIPAA Health Insurance Portability and Accountability Act 

HIT Heparin-Induced Thrombocytopenia 

HRSA Health Resources and Services Administration 

ICU Intensive Care Unit 

IDSA Infectious Disease Society of America 

IHS Indian Health Service 

IM Intramuscular 

ISO Immunization Safety Office

ISTM International Society for Travel Medicine 

ITP Immune Thrombocytopenia 

ITT Immune Thrombotic Thrombocytopenia 

ITT Intention-To-Treat 

IVIG Intravenous Immune Globulin 

J&J Johnson & Johnson 

LGBTQ+ Lesbian, Gay, Bisexual, Transgender, Questioning, and Others

MIS-C Multisystem Inflammatory Syndrome in Children 

MMWR Morbidity and Mortality Weekly Report

mRNA Messenger Ribonucleic Acid 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada

NAPNAP National Association of Pediatric Nurse Practitioners 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

NCHHSTP National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention 

NCIRD National Center for Immunization and Respiratory Diseases 

NEJM New England Journal of Medicine 

NFID National Foundation for Infectious Diseases 

NIH National Institutes of Health

NMA National Medical Association 

OB-GYN Obstetrics and Gynecology 

PE Pulmonary Embolism 

PF4 Platelet Factor 4 

PHAC Public Health Agency Canada 

PhRMA® Pharmaceutical Research and Manufacturers of America®

PI Principal Investigator

PIDS Pediatric Infectious Disease Society 

RCA Rapid Cycle Analysis 

RCT Randomized Controlled Trial

RR Relative Risk

RT-PCR Reverse Transcriptase Polymerase Chain Reaction

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

SARS Severe Acute Respiratory Syndrome 

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

SHEA Society for Healthcare Epidemiology of America 

SIG SARS-CoV-2 Interagency Group 

SMEs Subject Matter Experts

SOC System Organ Class 

SSRI Selective Serotonin Reuptake Inhibitor 
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TTS Thrombosis with Thrombocytopenia Syndrome 

UK United Kingdom

US United States

VA (US Department of) Veteran’s Affairs 

VAERS Vaccine Adverse Event Reporting System

VaST ACIP COVID-19 Vaccine Safety Technical Work Group

VITT Vaccine-Induced Immune Thrombotic Thrombocytopenia 

VOC Variant of Concern 

VOHC Variant of High Consequence 

VOI Variant of Interest 

VSD Vaccine Safety Datalink

VTE Venous Thromboembolism 

WG Work Group

WGS Whole Genome Sequencing 

WHO World Health Organization