MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP) 

NOVEMBER 2-3, 2021 

SUMMARY MINUTES 

TABLE OF CONTENTS 

MEETING PURPOSE ...................................................................................................................................3 

Tuesday: November 2, 2021.........................................................................................................................3 

WELCOME AND INTRODUCTIONS.........................................................................................3 

Call to Order/Roll Call ............................................................................................................3 

Announcements.....................................................................................................................3 

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES.......................................................5 

Session Introduction ..............................................................................................................5 

Pfizer-BNT162b2 Use in Children Aged 5-11 Years..............................................................6 

Public Comment: November 2, 2021.....................................................................................9 

SARS-CoV-2 Epidemiology in Children...............................................................................16 

Myocarditis in Adolescents and Young Adults.....................................................................22 

Vaccine Safety Surveillance in Children ..............................................................................28 

Implementation of COVID-19 Vaccine Pediatric Program ...................................................30 

Clinical Considerations for COVID-19 Vaccination in Children............................................32 

EtR Framework: Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5-11 Years ..........36 

Liaison Organization Statements.........................................................................................43 

Vote: Pfizer COVID-19 Vaccine Use in Children 5-11 Years of Age ...................................48 

Wednesday: November 3, 2021 .................................................................................................................50 

WELCOME AND INTRODUCTIONS.......................................................................................50 

Call to Order / Roll Call ........................................................................................................50 

HEPATITIS VACCINES...........................................................................................................50 

Session Introduction ............................................................................................................50 

Considerations for a Universal Adult HepB Recommendation ............................................51 

Vote: Hepatitis Vaccines......................................................................................................61 

IMMUNIZATION SCHEDULES ...............................................................................................64 

Session Introduction: Combined Immunization Schedule WG ............................................64 

Proposed Changes to 2022 Child and Adolescent Schedule ..............................................64 

Proposed Changes to 2022 Adult Immunization Schedule .................................................69 
ACIP Meeting Summary November 2-3, 2021 

Vote: Immunization Schedules ............................................................................................73 

ORTHOPOXVIRUSES VACCINES.........................................................................................74 

Session Introduction ............................................................................................................74 

Clinical Guidance for Use of JYNNEOS®.............................................................................74 

Summary of WG Considerations and Proposed Policy Options..........................................76 

Votes: Orthopoxviruses Vaccines........................................................................................85 

EBOLA VACCINE....................................................................................................................89 

Session Introduction ............................................................................................................89 

GRADE Review and Overview of State-Designated ETCs and LRNs ................................90 

EtR Framework....................................................................................................................95 

Proposed Policy Options ...................................................................................................100 

Votes: Ebola Vaccines.......................................................................................................101 

PUBLIC COMMENT: NOVEMBER 3, 2021...........................................................................103 

Certification ...............................................................................................................................................108 

ACIP Membership Roster .........................................................................................................................109 

Acronyms Used in This Document............................................................................................................118 

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ACIP Meeting Summary November 2-3, 2021 

MEETING PURPOSE

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

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

Immunization Practices (ACIP) on November 2-3, 2021. The meeting took place remotely via 

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

which focused COVID-19, hepatitis B, orthopoxvirus, and Ebola vaccines and immunization 

schedules. 

TUESDAY: NOVEMBER 2, 2021 

WELCOME AND INTRODUCTIONS 

Call to Order/Roll Call 

Dr. Grace Lee (ACIP Chair) called to order and presided over the first day of the November 2-

3, 2021 ACIP meeting. She conducted a roll call, which established that a quorum was present. 

Dr. Chen reported that his employer, the University of Maryland Baltimore, has a grant from 

Emergent BioSolutions that supports research he conducts on developing a Shigella vaccine. 

No other potential or perceived conflicts of interest (COIs) were identified or declared. A list of 

Members, Ex Officios, and Liaison Representatives is included in the appendixes at the end of 

this summary document. 

Announcements 

Dr. Melinda Wharton (ACIP Executive Secretary, ACIP/CDC) noted that copies of the slides 

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

file for voting ACIP Voting Members, Ex Officios, and Liaisons. She indicated that there would 

be an oral public comment session prior to the vote at approximately 12:10 PM Eastern Time 

(ET) on the first day and approximately 3:45 PM ET on the second day. 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-2021-0112. Further information on the 

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

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

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

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

COI waivers. Members who conduct vaccine clinical trials or serve on data safety monitoring 

boards (DSMBs) may present to the committee on matters related to those vaccines, but are 

prohibited from participating in committee votes. Regarding other vaccines of the concerned 

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

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

meeting. 

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ACIP Meeting Summary November 2-3, 2021 

CDC Update 

Dr. Rochelle Walensky (CDC Director) thanked Drs. Lee and Wharton for giving her the 

opportunity to speak with ACIP during this meeting, emphasizing that this was a monumental 

day in the course of this pandemic and one that many have been very eager to see. Ever since 

ACIP’s vote on December 12, 2020 recommending COVID-19 vaccination for those ≥16 years 

of age, everyone has been asking when it will be possible to expand this protection to younger 

children. In the nearly 12 months that have passed since that vote, a tremendous amount has 

been learned about COVID-19 disease and the vaccines to combat it. During this meeting, ACIP 

would have the opportunity to review those data, discuss the benefits of expanded vaccinations 

and consider the risks, and make a recommendation that likely would have tremendous impact. 

She pointed out that as ACIP reviewed the data throughout the day, it would be key to keep in 

mind the specific risk to children from this virus and this pandemic and to put that risk into the 

context of other vaccine-preventable diseases, such as varicella. In the 5 years prior to 

recommendation of varicella vaccination for children, each year there were between 4 to 31 

hospitalizations per 100,000 children less than 20 years of age. In those 5 years, 16 children 5-9 

years of age died from the virus. In the most recent Delta wave, pediatric admissions peaked 

higher than they had in any previous wave of a pandemic, reaching a rate of 25 hospitalizations 

per 100,000 per year in children between the ages of 5 to 11 years. There have been 745 

deaths in children less than 18 years of age and 94 deaths in children 5-11 years of age since 

the start of this pandemic. Fortunately these most severe outcomes are generally rare. 

The chance that a child will have severe COVID, require hospitalization, or develop a long-term 

complication like multisystem inflammatory syndrome in children (MIS-C) remains low. But still, 

the risk is too high and too devastating to children and far higher than for many other diseases 

for which children are vaccinated. There are now over 5200 children diagnosed with MIS-C and 

living with the complications of that disease. It is also known that beyond the clinical impact of 

COVID-19 on children, there have been detrimental social and mental health impacts that are 

just beginning to be fully understood. For almost 2 full years, school has been fundamentally 

changed. There are children in 2nd grade who have never experienced a normal school year. 

There are students in middle school who missed out on school sports and extracurricular 

activities. There are missed proms and homecoming dances and too many missed graduations. 

The education gaps that exists in this country have widened as this virus has disproportionately 

impacted racial and ethnic minority communities. Pediatric vaccinations have the power to help 

change all of that, move toward school as it was once known, and offer hope that it can be a 

safe and enriching environment for all children. Pediatric vaccination is just one important piece 

to this puzzle. It is important that as many adults as possible continue to be vaccinated to 

provide protection to children in the community, including those younger than 5 years of age 

who may not be eligible yet for vaccination. 

Looking at data from August-October 2021, Delta cases increased sharply across the country. 

There were stark differences in pediatric cases based on community vaccination level. In a 

stepwise fashion, as the percent of eligible populations fully vaccinated increased, the number 

of pediatric hospitalizations decreased. It is an ongoing responsibility to make sure as many 

people as possible are vaccinated and protected from COVID-19. Dr. Walensky recognized that 

ACIP had much to discuss throughout the day and emphasized that she looked forward to 

listening to the deliberations. As always, she said she was most interested in hearing how ACIP 

would interpret what is known and acknowledge areas of uncertainty. She stressed that she 

greatly appreciates ACIP’s dedication to getting this right, making sure that efforts continue to 

move forward to end this pandemic with science leading the charge, and for all that they are 

doing for everyone. 

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ACIP Meeting Summary November 2-3, 2021 

Dr. Lee (ACIP Chair) expressed ACIP’s appreciation for Dr. Walensky’s engagement in their 

work, and emphasized that ACIP looks forward to providing the advice and guidance that she 

needs to support decision-making for the country. 

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES 

Session Introduction 

Dr. Matthew Daley (ACIP, WG Chair) introduced this session on behalf of the ACIP COVID-19 

Vaccines’ Work Group (WG). In terms of daily trends and number of COVID-19 cases in the US 

for all ages from January 2020 through October 28, 2021, the US is in the midst of a second 

wave that is exceeded only by the wave experienced in December 2020. In the US, almost 46 

million cases of COVID-19 have been reported.1 To introduce the topic of the burden of COVID19 in children 5-11 years of age, 1.9 million cases have been reported in children in this age 

group. In addition, there have been more than 8000 hospitalizations in this age group. There 

have been 2316 MIS-C and 94 deaths reported among children 5-11 years of age in the US. It 

is important to highlight the fact that the burden of COVID-19 in children in this age group 

extends well beyond these case counts, including school being tremendously interrupted and 

lives entirely disrupted. 

During October 2021, the WG has been reviewing data regarding pediatric COVID-19 vaccines. 

Topics have included review of data on SARS-CoV-2 seropositivity in children, pediatric COVID19 epidemiology, ScenarioHub Modeling results of impact of pediatric vaccination on the 

pandemic, results of the Pfizer BioNTech clinical trial in children 5-11 years of age, GRADEing 

(Grading of Recommendation Assessment, Development and Evaluation) of the evidence, and 

the Evidence to Recommendations (EtR) Framework for the decisions before ACIP during this 

meeting. 

The Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) for 

Pfizer BioNTech COVID-19 vaccine to include children 5-11 years of age.2 To highlight a couple 

features of this, the pediatric formulation is a 10 μg dose give intramuscularly (IM). The vaccine 

is administered as a 2-dose series given 3 weeks apart. During this session, ACIP would hear 

extensive evidence on this. To highlight a few points, there were 4600 participants 5-11 years of 

age in a clinical trial that was randomized 2:1, with 3100 who received vaccine and 1538 who 

received placebo. In addition, knowledge and experience have been gained from administering 

more than 247 million doses to individuals 12 years of age and older in the US with PfizerBioNTech’s 30 μg formulation.3 This vaccine was fully licensed in people 16 years of age and 

older in August 2021, which was based on longer term follow-up data. 

1 https://covid.cdc.gov/covid-data-tracker/#trends_dailycases. Accessed October 29, 2021. 2 https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontechcovid-19-vaccine 3 https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed November 1, 2021 

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Pfizer-BNT162b2 Use in Children Aged 5-11 Years 

Dr. Alejandra Gurtman (Pfizer) presented the Pfizer-BioNTech clinical data that received EUA 

in individuals 5 to <12 years of age, focusing primarily on the clinical data that demonstrate 

clear and compelling vaccine safety and efficacy that supported EUA in this age group. A lower 

10 ug dose was selected as the optimum dose for this age group based to elicit robust immune 

responses with an acceptable safety profile. The indication is for immunization to prevent 

COVID-19 caused by SARS-CoV-2 in individuals 5 to <12 years of age administered as the 

primary series of 2 doses of 0.2 mL each 3 weeks apart. The vaccine met all safety data 

expectations and immunobridging criteria, with 90.7% efficacy observed. Plans have been 

established for active follow-up under the EUA. 

In terms of the clinical data, the goal of Phase 1 with 48 participants 5 to <12 years of age was 

to identify a preferred dose level based on immune response and a safety profile. As noted, the 

10 ug dose was chosen because it had the right balance between the immune response and 

safety profile. In Phase 2/3, the first group of safety information includes approximately 1500 

individuals who received the vaccine versus 750 placebo recipients. At the request of the FDA, 

an additional 1500 vaccine recipients and 750 placebo recipients were enrolled, most of whom 

who had at least 2 weeks of safety data after Dose 2. Non-inferior responses have been 

established to infer vaccine efficacy (VE) in children 5 to <12 years of age compared to 

individuals 16-25 years of age from the pivotal Phase 3 study. Although not required for EUA 

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

Similar to other populations in which the doses are administered 21 days apart, reactogenicity 

data were captured for 7 days. Non-serious adverse events (AEs) were captured for 1 month 

and serious AEs (SAEs) were captured for 6 months for participants 5 to <12 years of age. To 

enhance possible detection of myocarditis in adolescents and young adults should it occur, 

specific instructions were provided to investigators to be vigilant for symptoms and signs of this 

condition, including chest pain, and to perform a work-up in the event of suspected myocarditis. 

Blood draws for immunogenicity were done at Dose 1, 1 month, and 6 months. Surveillance 

continues to look for the potential to demonstrate efficacy. 

There were 2 datasets submitted to support the EUA. The first was the initial cohort of 2268 

participants for whom the median follow-up time was 2.3 months. In the latest submission, 

follow-up of this group was extended for additional follow-up time to 3.3 months. However, those 

data were not discussed during this presentation. An additional cohort of 2379 participants also 

were enrolled. In conjunction with the original cohort, this permitted evaluation of a total of 

approximately 3000 vaccine recipients for at least 2 weeks for most of the 3000 vaccine 

recipients, and 2 to 3 months for over 1500 vaccine recipients in the submission to the FDA. In 

terms of the demographics for children 5 to <12 years of age in the Phase 2/3 safety population 

initial enrollment group (N=2268), demographics for the vaccine and placebo groups were 

similar. There was good representation in terms of gender, race, and ethnicity and age at 

vaccination. More than 11% of the population had obesity as an underlying condition. 

Comorbidities, including obesity, were represented in approximately 20% of the population. 

Looking at local reactions by maximum severity within 7 days after each dose in persons 5 to 

<12 years of age and 16-25 years of age, there was some increase in mild to moderate redness 

and swelling after Dose 1 and Dose 2 in the 5 to <12 age group. Pain at the injection site was 

comparable between the two age groups. In general, local reactions met a satisfactory safety 

profile. In terms of systemic events by maximum severity within 7 days after Dose 2 in children 5 

to <12 years of age compared to persons 16-25 years of age, reactions were typically higher in 

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vaccine recipients. Dose 1 reactions tended to be less frequent and were not shown in this 

presentation. If anything, the incidence of fever was lower and mostly mild to moderate in 

individuals 5 to <12 years of age compared to the older age group. This was true for chills and 

across other systemic event parameters. This represented an acceptable systemic event profile 

for children 5 to <12 years of age. Moving to system events by maximum severity within 7 days 

after each dose in individuals 5 to <12 and 16-25 years of age, local reaction rates were very 

similar regardless of baseline status. There was a slight increase after Dose 1 in participants 

who were SARS-CoV-2 positive at baseline, which is similar to what has been observed in the 

adult studies. 

There were very few SAEs, no related SAEs, and no deaths after Dose 1 among children 5 to 

<12 years of age. There was 1 female participant withdrawn from the study due to a fever of 400 

C on Day 2 after the first dose, accompanied by neutropenia. The fever resolved in 1 day and 

she has been followed by a hematologist and recovered uneventfully. In terms of AEs occurring 

at an incidence of ≥1.0% by system organ class (SOC) for children 5 to <12 years of age from 

Dose 1 to the cutoff date in the safety expansion group (N= 2379), rates were comparable 

between vaccine recipients and placebo recipients for any AE. Lymphadenopathy has been 

infrequently observed in other populations after vaccine and was observed in fewer than 9% of 

recipients in this BNT162b2 enrollment group. For the safety expansion enrollment group of 

children 5 to <12 years of age, the rates of AEs were very similar between the vaccine and 

placebo recipients. In terms of overall AEs from Dose 1 to 1 month post-Dose 2 in children 5 to 

<12 years of age by baseline SARS-CoV-2 status the rates were very similar or a little lower in 

those who were positive compared to those who were negative prior to vaccination. 

Regarding SAEs from Dose 1 to the cutoff date in children 5 to <12 years of age in both safety 

groups, in the initial enrollment group all SAEs were unrelated to vaccine. One participant in the 

BNT162b2 group reported an SAE of an upper limb fracture and one participant in the placebo 

group reported an SAE of abdominal pain and an SAE of pancreatitis related to trauma. In the 

expansion safety group, one participant reported an infection 15 days after Dose 1 of infective 

arthritis, one reported an SAE of epiphyseal fracture, and one participant reported an SAE of 

ingestion of a foreign body. 

Participants also were followed for adverse events of special interest (AESI) as designated by 

either the FDA or the CDC. For the FDA AESIs, no cases were reported of anaphylaxis, 

myocarditis/pericarditis, Bell’s Palsy, or appendicitis. The CDC AESIs (e.g., hypersensitivity, 

arthritis, and vasculitis) were uncommonly observed in vaccine and placebo recipients and they 

were short-lived. Rashes tended to be more common after vaccine, but in general they were 

uncommon and were mild and short-lived overall. The case of arthritis was infective and was the 

one that already was described. One participant had a case of vasculitis that was reported as a 

mild case of Henoch-Schönlein Purpura (HSP) that was considered to be unrelated to vaccine 

that occurred 21 days after Dose 1. Follow-up of this child is ongoing. 

In terms of safety conclusions for children 5 to <12 years of age, reactogenicity was mostly mild 

to moderate and was short-lived. Observed mild to moderate local reactions such as redness 

and swelling captured by e-diary were more common and systemic reactions, including fever, 

were less common than those in persons 16-25 years of age. The observed AE profile in this 

study did not suggest any safety concerns for BNT162b2 vaccination in children 5 to <12 years 

of age. The database of approximately 3000 active vaccine recipients provides a high degree of 

confidence that rare AEs after vaccination such as myocarditis or anaphylaxis are unlikely to 

occur at the rate of 1 in 1000 or higher. 

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ACIP Meeting Summary November 2-3, 2021 

Turning now to the examination of the immune response to the vaccine, immunobridging criteria 

between persons 5 to <12 and 16-25 years of age were met for both geometric mean ratios 

(GMRs) and seroresponse. The observed GMR was above the pre-specified criterion of 0.8 and 

also above the GMR of 1.0 requested by the FDA. In addition, seroresponses were virtually 

identical in children 5 to <12 years of age compared to persons 16-25 years of age at 99.2% a 

piece. This criterion also met the lower end of the confidence interval of -2.0%, with 

immunobridging declared since the lower bound of the 95% confidence interval for the 

percentage difference was greater than the -10 required. 

Looking at geometric mean titers (GMTs) by baseline SARS-CoV-2 status among subjects 5 to 

<12 years of age, it is important to keep in mind that the number of positive participants in this 

analysis was relatively small. When looking at GMTs by age subgroup, titers were virtually 

identical across all ages. It was also important and requested by the FDA to assess the 

response to the Delta variant given its prominence as a cause of COVID -19. In an analysis of 

34 individuals at 1 month following receipt of the reference strain (USA-WA1/2020) or Delta 

strain (B.1.617.2), the comparable response predicts efficacy for children 5 to <12 years of age 

during the time that the Delta variant is prominent. High efficacy against COVID-19 was 

observed in children 5 to <12 years of age in a descriptive analysis of first COVID-19 

occurrence from 7 days after Dose 2. Remembering that this study had a 2:1 vaccine versus 

placebo randomization, the case split of 3 in the vaccine group versus 16 in the placebo group 

results in an efficacy of 90.7% (67.7, 98.3), with a high degree of confidence shown as well. No 

severe cases of COVID-19 or cases of MIS-C were reported in either group. Notably, the cases 

occurred in July to September when Delta was the most prominent variant in circulation. At this 

time, 14 of the 19 samples had been successfully sequenced and were all found to be the Delta 

variant, confirming high efficacy against this highly transmittable strain of SARS-CoV-2. In terms 

of the cumulative incidence of COVID-19 after Dose 1 among children 5 to <12 years of age, 

the mean length of follow-up time after Dose 2 was 3.3 months. Efficacy was suitable for this 

period of follow-up to date and surveillance is continuing. 

To summarize immunogenicity and efficacy, immunobridging success criteria were met for 

children 5 to <12 years of age compared to persons 16-25 years of age at the 10 μg dose level. 

BNT162b2-immune sera effectively neutralized both USA-WA1/2020 (reference strain) and the 

highly transmissible B.1.617.2 (Delta) variant of concern. BNT162b2 as a 2-dose series was 

highly protective against COVID-19 in children 5 to <12 years of age when the Delta variant was 

prominent. Pharmacovigilance activities are a critical component of activities to detect 

unexpected safety events rapidly. Pfizer continues to conduct robust pharmacovigilance 

activities, which include spontaneous report collection, active follow-up, and frequent signal 

detection and evaluation. Proactive risk mitigation activities (e.g., labeling, educational 

materials, and vial differentiation) will continue. In terms of pharmacoepidemiology studies, 5 

studies will include children ≥5 years of age to detect myocarditis occurrence and sequelae and 

other possible rare AEs. These include one study that will follow up identified US postvaccination myocarditis cases for 5 years within the Pediatric Heart Network (PHN). 

Discussion Summary 

• Referring to Slide 25 on GMTs for immunogenicity, Dr. Lee pointed out that a parallel slide 

on safety would be helpful for clinicians as well. 

• Dr. Caine pointed out that because there is such a high rate of obesity among African 

Americans, probably greater than 30%, people are asking if they should wait to get children 

who are African American and obese vaccinated at 12 years of age in order to receive the 

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ACIP Meeting Summary November 2-3, 2021 

larger dose. She noted that she would raise the issue again during the clinical 

considerations session. 

• Several members posed questions with regard to what the protocol should be for children 

who turn 12 years of age between doses. 

 Dr. Gurtman clarified that the children in the trial received the 10 μg formulation even 

if their age changed from 11 to 12 between doses. This was done knowing that some 

children would turn 12 during the study because they wanted to ensure that the 

protocol remained the same. 

 Dr. Fink indicated that the FDA authorized either the 10 μg formulation that is 

authorized for use in children 5-11 years of age or the 30 μg formulation that is 

authorized for use in ages 12 years and above can be used for either Dose 1 or 

Dose 2 in a scenario in which a child will be 11 years of age at the time of Dose 1 

and then turns 12 years of age before time to receive Dose 2. The most data-driven 

approach, the approach for which the data are actually available, would be for a 10 

μg dose be given to a child who is 11 years of age at the time the dose is 

administered and a 30 μg dose to be given to a child who is 12 at the time the dose 

is administered. However, FDA did recognize that there may be some situations in 

which there would be a need for flexibility and a totality of data to support this more 

flexible approach in which there would be a change in age occurring in between the 

2 doses. It is up to ACIP and CDC to make whatever they consider to be the most 

appropriate recommendations for implementation of the doses such as they are 

authorized. 

Public Comment: November 2, 2021 

The floor was opened for public comment on November 2, 2021 at 12:31 PM ET. Given that 

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

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–2021–0112. Visit 

http://www.regulations.gov for access to the docket or to submit comments or read background 

documents and comments received. 

Mrs. Christina Dietrich 

Delaware MOMs (Moms Oppose Mandates) 

I speak on behalf of Delaware MOM, Moms Opposed Mandates. Like most of us, I vaccinated 

my 4 children right on schedule. We trusted pediatricians, FDA, and the CDC. The response to 

COVID has shattered the trust that many Americans used to have. We’re confused and upset. 

We see FDA members resign facing political pressure to make approvals. We sounded the 

alarm on myocarditis long before you acknowledged it. We’re told not to trust our lying eyes with 

a barrage of talking points. There are “lies, damned lies, and statistics.” This week, Director 

Walensky said those unvaccinated with a recent infection were 5 times more likely to have 

COVID-19 than those recently fully vaccinated without prior infections. Sounds pretty definitive. 

But actually, among adults hospitalized for COVID-like illness, those with lab-confirmed COVID 

in the same hospital system within 3 to 6 months were more likely to test positive for COVID 19 

than those who had an mRNA vaccine within 3 to 6 months. Can you really extrapolate that to 

the general public? On the same day, the CDC website was updated to include a systematic 

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review and meta-analysis which found no significant difference in the level of protection 

provided by infections as compared to vaccinations. When the agency, politicians, and the press 

tout the hospital and MMWR and ignore the meta-analysis, parents wonder when else they 

promote or ignore in research in order to advance a narrative. Immunity is a very salient point in 

your deliberations today. We know that as of June the seroprevalence for these kids is 42%. 

What is it now in November? Parents are already being forced to vaccinate their children in 

order for them to participate in certain activities. Their risk is so low and many are immune. They 

don’t do it for the health reasons but for social consequences. I today propose a compromise. 

Doses are sent out. We know you will approve this. We beg you to say that kids 5 to 11 may 

receive the vaccine not that they should. Otherwise, your approval will be used to enact 

mandates unjustified by an EUA. They will mandate without evidence that it reduces severe 

disease or death in children when it doesn’t prevent transmission, the effectiveness wanes over 

time, the dosing schedule is sub-optimal, and a new buffer is being used—not the ones in the 

trial. When 40% of hospitalizations in these kids are incidental and the remaining 70% of kids 

have a comorbidity, you won’t even acknowledge that the risk benefit-ratio is different for 

healthy children versus those with risk factors. There are enough unknowns that parents should 

be able to wait for more data without suffering pressure and coercion. Mandela said that “There 

can be no keener revelation of a society’s soul than the way in which it treats its children.” Our 

children have given up so much. The benefits of this vaccine for kids are minimal. There are 

also risks. Protecting the community is not their job. We do not sacrifice the health of a single 

child to protect adults. That is counter to our nature. Please say that the children may receive 

the vaccine and not that they should. Words matter. Thank you so much for your attention and I 

appreciate the work you’re doing today. 

Ms. Patricia Neuenschwander, MSN, RN 

None 

Thank you for allowing me my public comment today. My name is Patricia Neuenschwander 

and I have been a nurse for 27 years. I am not sure if there’s anything I can say to you today to 

reach you, but I must try. Pfizer clinical trials did not detect any health benefit at all from their 

shots. They did not prevent a single hospitalization, ICU (intensive care unit) visit, MIS-C case, 

asymptomatic infection, nor death in the treatment group. There was a total of 19 mild infections 

out of 2300 children. The injection has not been shown to stop transmission or infection. In a 

meta-analysis combining from 11 countries, Stanford researchers found that children 0-19 

infected with COVID have a 99.9973 survival rate. This is a mild illness in the vast majority of 

children. The science being used for this are small studies using immuno-bridging, short followup time, vaccinating the control group as soon as possible, and excluding any 

immunocompromised or significantly ill children. It is estimated that over 40% of children have 

already been infected, but prior natural immunity is being ignored. We don’t know if giving the 

vaccine after the infection is safe or the consequences to the immune system post-infection. 

Does it destroy the natural antibodies that you created? Does boosting those antibodies impair 

the innate immune response to future or other infections? Pfizer’s clinical trial in kids was 

intentionally undersized to [not clear] . If the rate of a particular adverse outcome in kids is the 

result of the shot is 1 in 5000. The trial only enrolled 1500. Then you are unlikely to spot any 

particular harm. Supplemental data was obtained from an expansion group of another 1500, but 

that data was only followed up for 2 weeks. The follow-up period is intentionally too short. Two 

months of follow up will not provide information on the immediate or long-term safety of this 

experimental shot. Vaccine effectiveness was inferred by immuno-bridging data from 16-25 year 

olds, or junk science. You know, this injection will kill and maim some children—some 

immediately, some in the intermediate, and some in the long-term. You know that if you make 

this general recommendation for all children, it will be viewed as a mandate for all children ages 

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5 to 11. You can say “no.” The science does not support this as safe or effective in preventing 

serious complications or death. Please use your critical thinking, your wisdom, your experience, 

and be brave. Admit that the status does not support injecting perfectly healthy children. If you 

listen to the discussion from VRBPAC (Vaccine and Related Blood Products Advisory 

Committee) meeting last week, you heard several of the committee members had concerns. 

They were hesitant to recommend the full authorization of this. There is no amount of money, 

career advancement, or prestige that will make up with a crime against humanity of you 

recommending this experimental intervention on innocent healthy children. May God have 

mercy on the souls of the millions of children who receive this based on your recommendation. 

Please do not recommend this for children. Thank you. 

Andrea Kline-Tilford, PhD, CPNP, FAAN 

Pediatric Nurse Practitioner 

President, National Association of Pediatric Nurse Practitioners 

I am Andrea Kline-Tilford and I do not have any conflicts to report. I’m a Pediatric Nurse 

Practitioner (PNP) and the President of the National Association of Pediatric Nurse Practitioners 

(NAPNAP), a professional organization representing more than 8000 pediatric-focused nurse 

practitioners. We support the timely and complete immunization of all infants, children, and 

adults in an attempt to maximize the health and wellbeing of all people. The last 20 months 

have brought immense strain to the world, including our nation’s more than 20 million 5-11 year 

old children. Our children have been pivoting in all areas of life. Children can and do suffer 

acute illness, multi system inflammatory syndrome, and long-haul physical symptoms from 

SARS-CoV-2. Data shows children of marginalized racial and ethnic groups have suffered 

greater disparities. The strain has been immense and has resulted in mental health challenges 

that will undoubtedly have lasting impact on social, emotional, and mental health. In a poll 

conducted by researchers in Chicago, 71% of parents or caregivers believe the pandemic 

impacted their child’s mental health. Pediatric Nurse Practitioners are on the frontline in primary 

and acute care settings encountering these challenges in our children each and every day. 

There has been an alarming increase in child and adolescent anxiety, depression, and suicide. 

According to the CDC, mental health-related emergency department (ED) visits by adolescents 

increased 31% in 2020. At one point during the pandemic, emergency department visits for 

suicide attempts in girls 12-17 years of age was up 51% from 2019. Eating disorders, serious 

and sometimes deadly, have increased 62%, and more than 140,000 children have lost a parent 

or caregiver during the pandemic. Children have paid a significant toll associated with COVID19 and we have the ability to alter this trajectory. Right now we rely on masking, physical 

distancing, hand hygiene, and surrounding children with adolescents and adults who are 

vaccinated. Without other options, these strategies were acceptable, but are not a long-term 

solution and leave a tremendous gap in protection for our children. NAPNAP urges the ACIP to 

authorize the Pfizer BioNTech COVID-19 vaccine for all children 5-11 years and supports 

widespread equitable rollout to every eligible child in the US using all possible vaccination sites, 

including primary care offices, schools, pharmacies, pop-up sites, and mobile units. COVID-19 

vaccination is safe and effective. With the adjusted dosing for children 5-11, we can protect our 

school-aged children immediately to further shield them from short- and long-term physical and 

mental health consequences and to re-establish more ordinary daily activity. Let’s use the newly 

provided data on the Pfizer BioNTech COVID-19 vaccine to deliver comprehensive, equitable 

immunization to all children 5-11 years of age. NAPNAP offers provider- and family-focused 

resources about COVID-19 vaccination at napnap.org. 

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ACIP Meeting Summary November 2-3, 2021 

Mrs. Tia Severino 

Individual 

Yes, this is Tia Severino. I appreciate the opportunity to speak today. I requested to speak after 

watching the FDA VRBPAC meeting last week. I was heartbroken and outraged at the vote to 

recommend this vaccine despite legitimate concerns raised by voting members about unknown 

adverse events and known events such as myocarditis, which has already been observed in 12-

17-year-olds at startlingly high rates, especially for boys. One member even said, “We won’t 

know the rare events until we start giving the vaccine.” This is not okay. The adverse events 

which are under-reported are very disturbing. VAERS (Vaccine Adverse Event Reporting 

System) data as of October 22nd shows 17,619 deaths; 86,542 hospitalizations; 8,656 heart 

attacks; 2,712 miscarriages; 27,277 permanent disabilities; and 10,956 cases of 

myocarditis/pericarditis, and this is just scratching the surface. By recommending these 

vaccines, which are still under Emergency Use Authorization, you are paving the way for 

mandates in workplaces across the country and in schools. This is an illegal Emergency Use 

Authorization because there are effective alternative treatments for this virus, which has a 

greater than 99% recovery rate. I’m begging you to do something you’ve never done before. 

Vote “no” today. There is no reason to give this vaccine to children who are not at risk for severe 

COVID. We have already seen severe adverse events in the vaccine in the 12-17 age group. I 

will share one with you now. Maddie de Garay, a 12-year-old girl, was a participant in the Pfizer 

COVID trial. Previously healthy, energetic, and full of life—now she is confined to a wheelchair 

and has to be fed through a tube in her nose. She has been hospitalized numerous times. 

Maddie and her family have been ignored and dismissed by Pfizer and the CDC. Her voice 

matters. As the vaccine mandates roll out and people are losing their jobs over a personal 

medical choice that is their right, it appears you have found a way to get rid of the shaky front 

line of health care practitioners and soon there will only be compliant first responders, law 

enforcement, and military. At the same time, you are galvanizing those of us who are against 

the vaccines and creating greater vaccine hesitancy, including among those who previously 

believed in the vaccine program. Please, please, vote “no.” I cannot stress this enough. It is 

wrong to use our children as lab rats and it is equally wrong to use children as a shield with a 

failing vaccine. This vaccine is not preventing infection no matter how many you vaccinate or 

how many boosters you give. If you do vote “yes,” be prepared to face more distraught parents. 

Ms. Claire Hannan, MPH 

Executive Director, Association of Immunization Managers 

Good afternoon. I’m Claire Hannon, Executive Director of the Association of Immunization 

Managers (AIM). Thank you for the opportunity to provide comments on behalf of the state, 

territorial, and local public health immunization program managers. I’d like to take this 

opportunity to express the critical importance of vaccinating children against COVID, as well as 

draw attention to implementation challenges that continue to test public health’s response. First, 

I express strong support for universal recommendation for children aged 5-11 years old to 

receive COVID vaccination as authorized by the FDA. As of October 21, there have been 6.3 

million children who have tested positive for COVID-19 and of those, greater than 1.9 million 

aged 5-11. 8,300 cases have resulted in hospitalization and 745 children have died. I want to 

repeat that. There have been 745 deaths in children under 18 from COVID. Some say this 

illness is mild, but there is no acceptable number of deaths in children. Death is preventable 

with the vaccine, which is effective and safe. I look forward to the opportunity for children aged 

5-11 to receive protection through vaccination. Vaccinating kids minimizes disease spread in 

school settings and it’s the best way to keep our schools safe and open. Next, I want to draw 

attention to 2 ongoing implementation challenges. First, the logistical and IT challenges involved 

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with giving a half dose of Moderna vaccine as a booster. Jurisdictions and providers have been 

working diligently over the course of this pandemic, and previously through 27 years of the 

Vaccines for Children (VFC) program, to manage vaccine inventory and avoid waste. But now, a 

14-dose vial can yield up to 20 booster doses, or 14 regular doses, or anywhere in between and 

providers must manually track how many times they’ve drawn from the same vial. With the 

addition of the half dose Moderna booster and no change to the technology and coding tied to 

the 14-dose vials, there is no way to accurately track inventory and waste. A second 

implementation challenge is the need to provide electronic verification of vaccination and the 

lack of national standards to do so. There is no standard way for consumers to show digital 

proof of vaccination. Many states already provide consumer access to vaccination records 

through immunization information systems (IISs), but the lack of a nationally approved standard 

for QR codes and electronic verification has limited the ability of states to provide an electronic 

COVID vaccine record to consumers. I draw attention to these challenges so that efforts can 

continue to develop solutions and improve future pandemic response. Thank you. 

Martha Nolan, JD 

HealthyWomen 

Good afternoon. My name is Martha Nolan and I am speaking today on behalf of 

HealthyWomen, the nation’s leading nonprofit health information organization for women, 

providing consumers and healthcare providers accurate evidence-based information about 

diseases, conditions, and innovations and research changes in policy that impact the treatment 

and care women receive. HealthyWomen is also a convener of the COVID-19 Vaccine 

Education and Equity Project where we are joined by over 220 organizations representing 

patients, caregivers, families, diverse communities, health care workers, older Americans, 

veterans, frontline workers, and scientists—all who believe we have a responsibility to come 

together to provide information about the clinical trials process, regulatory review, and 

distribution and access to COVID-19 vaccines in a way that promotes equity and trust. Since the 

start of the COVID 19 pandemic, HealthyWomen has been diligent in working to understand the 

facts of COVID-19 and its related vaccines. COVID-19 vaccines have saved a significant 

number of lives. A National Institute on Aging-funded study published on August 18 in Health 

Affairs found that COVID-19 vaccines prevented more than 139,000 deaths during the first 5 

months they were available saving 2,285 lives per day. And the estimated economic value of 

preventing these deaths is close to a trillion dollars. But the value to families is priceless. 

Women are the predominant caretakers in our society and are often called upon to make critical 

decisions for the health and wellbeing of their families and communities. Since COVID-19 

vaccines were approved by the FDA for adults, women have led in the vaccination rates, with 

60% being fully vaccinated compared to men at 55%. But everyone eligible should be 

encouraged to get vaccinated as soon as possible if we’re going to stop the spread of the 

current COVID 19 Delta variant and more importantly, the development of new variants not 

covered by the COVID-19 current vaccines. We need to protect ourselves and more importantly, 

our kids and grandkids. Vaccinating our children is the best protection against serious infection, 

hospitalizations, and deaths from COVID-19. Rates of COVID-19 hospitalization among children 

and adolescents rose to the highest levels in August and September of 2021. Over 8,300 

children in the 5-11 age group have been hospitalized since the beginning of the pandemic. And 

sadly, the pandemic has taken a serious toll on our children’s emotional and mental wellbeing. 

Children need access to safe and effective COVID-19 vaccines to reestablish that safe 

environment where they can once again learn, play, and socialize without fear of serious illness. 

We adults started to feel that relief almost a year ago and finally, it’s our kids’ turn. The COVID19 Vaccine Education and Equity Project supports the robust regulatory review of the vaccines 

for children ages 5-11 and urgency to provide the American people with clear guidance on their 

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use. Thank you for the important work you are doing on behalf of Americans of all ages. We 

remain committed to partnering with you to ensure everyone understands the facts about this 

critical tool for protection. Thank you. 

Julie Boom, MD 

Baylor College of Medicine

Director, Texas Children’s Hospital Immunization Project 

On behalf of Texas Children’s Hospital, I would like to thank the CDC staff and ACIP members 

who have so diligently analyzed COVID-19 disease burden, vaccine safety, and efficacy data 

and then provided risk-benefit assessments based on this information. Using your in-depth 

analyses, my colleagues and I have been able to assure families about the safety and efficacy 

of COVID-19 vaccines in adolescents and adults. As a general pediatrician with 26 years of 

experience and Director of the Immunization Project at Texas Children’s Hospital, 

I know that vaccines are the best way to protect children from COVID-19. As you continue your 

discussion today, I urge you not to minimize the disease burden and risk of COVID-19 in 

children. To date, COVID-19 has proven to be more contagious and deadly than influenza, 

having killed almost 800 children ages 0-17 years, with 172 deaths in children 5-11 years. Even 

though the number of pediatric deaths pales in comparison to number of deaths among adults, 

especially the elderly, the risk to children shouldn’t be minimized. To frame the number of 

pediatric deaths, let me offer the following comparison. COVID-19 has killed more children than 

would fill 2 packed 747 airplanes. COVID-19 has killed more children than would fill 26 full 

classrooms or 16 full school buses sitting 2 children per seat. During any other years, these 

deaths would have made national headlines and created an outcry to mitigate the risks to these 

young persons. Unfortunately, pediatric deaths have been largely overshadowed and as a 

result, many have questioned the risk-benefit ratio of COVID-19 vaccination for children. In 

addition to the risk of death, we know that many children have experienced the long-term effects 

of COVID-19. Similar to adults, children are experiencing symptoms such as persistent chest 

pain, fatigue, and cognitive difficulties long after their acute COVID-19 infection. These 

debilitating symptoms have prevented their return to normal activity. In addition, over 5,000 

children have been diagnosed in the US with MIS-C, multi-system inflammatory syndrome in 

children. Most often these children present with symptoms severe enough to require 

hospitalization in an intensive care unit. Unfortunately, 46 children have died from the severe 

post-COVID inflammatory process. As mask requirements in schools and public places have 

been lifted in many parts of the country, recommendations for vaccinating children 5-11 years of 

age with COVID-19 vaccine cannot come soon enough. Children younger than 12 remain a 

vulnerable population among which COVID-19 can spread. Please give these factors your 

strongest consideration as you weigh the benefits and risks of COVID-19 vaccine. Thank you. 

Joan Edelstein, MS, MPH, DrPH 

Professor of Nursing, School Nurse Credential Program

California State University, Sacramento 

Thank you. I’m Joan Edelstein, professor in both nursing and faculty in the School Nurse 

Credential program at California State University Sacramento. As a pediatric nurse for over a 

half century, I’ve seen the devastating long-term effects of infectious diseases. I’ve personally 

cared for infants and children with rubella syndrome, polio, tuberculosis, and measles inclusionbody encephalitis (MIBE). We all know people who’ve had months of painful shingles due to 

having had chickenpox, and I have several friends who’ve had polio and now suffer the effects 

of post-polio syndrome decades later. As we try to address the highly unlikely long-term effects 

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of clearly safe and effective COVID vaccines, we do not yet know the long-term damage of 

having COVID in childhood. We do know that children suffer from long COVID as has been welldemonstrated by long COVID kids in the UK. We do know that COVID causes organ damage 

that may lead to long-term health problems. We do know organ damage can affect children with 

COVID as reflected in multi system inflammatory syndrome. We don’t know if organ damage will 

affect them weeks, months, years, or decades after having been infected with COVID-19 and 

we should not wait to find out. We ask that you provide Emergency Use Authorization for this 

clearly safe and effective vaccine now for children ages 5-11. Implementation purposes. As a 

credentialed school nurse, I’d also like to make a statement about the need for the CDC to 

support school nurses in vaccination administration that will impact the success of pediatric 

vaccine programs. Our pediatric public health population is right here in our schools, the ideal 

place to implement primary prevention measures such as vaccine. School nurses are 

responsible for the entire school health program and are the health experts in this nonhealthcare setting. Nonetheless, school nurses have been disregarded. We’ve been specifically 

excluded in planning for safe schools in my own state in spite of repeated requests to be at the 

table. In order to advocate for students and have effective mitigation programs and successful 

vaccine programs, school nurses nationwide are the public health experts in partnering for 

successful school-located vaccine clinics, in educating families, staff, and the community on the 

importance of vaccine. The CDC should include in all school-related recommendations that 

school nurses be actively included in assessment planning, policy, program development, 

implementation, and evaluation of both vaccine programs and mitigation efforts. Funding should 

be targeted to school nurse positions as they now have twice the work, uncompensated in time 

or money for inadequate pay. Rather than eliminating or ignoring school nurse positions in 

districts, the CDC should take the lead in recognizing the importance of including school nurses 

in all recommendations, and [inaudible] state, county, and city health departments to partner 

with school nurses at the district and school level to carry out this most critical task of getting our 

pediatric public health population vaccinated. Thank you. 

Dr. David Wiseman 

Synechion, Inc. 

Good morning. Thank you, Dr. Lee. Please refer to our previous submissions for disclosures. 

Former FDA medical officer, Dr. David Gardner, just wrote that FDA failed in its duty to ensure 

vaccine safety for children. After criticizing the UK for rushing to approve Pfizer’s vaccine, Dr. 

Fauci called FDA the “gold standard” of regulation. With extensive medical industry experience, 

I say this is the “gold standard” of regulatory dereliction. FDA touted its children’s vaccine review 

as thorough and transparent. Far from it. For safety, 1,500 patients were followed less than 3 

months and another 1,500 only two and a half weeks. A small immuno-bridging study against 

Wuhan, still with no immune correlation of protection. A similar study against Delta was marked, 

“Assay not validated. Analysis not verified by FDA.” Where is FDA? The efficacy study yielded 

only 16 placebo and pre-vaccine outcome events, with a large imbalance of mysteriously 

excluded vaccinated subjects, bias in this observer-blinded but not double-blinded study could 

drop the 90% efficacy to zero. See today’s BMJ for allegations of trial unblinding. Where is 

FDA? Why was the efficacy analysis not verified by FDA? Where were FDA? Where is Pfizer’s 

sub-study on troponin levels in subclinical myocarditis? Where is FDA? FDA’s risk-benefit 

analysis failed to consider a 42% serum prevalence. Non-myocarditis serious AE reports as 

many as for myocarditis, an improperly model wave and waning efficacy. When properly 

accounted for, we find risks outweigh benefits by nearly 2:1 before under-reporting. The one 

thing FDA got right was revealing an almost 5-fold rate of under-reporting at least and a 

database more reliable than theirs that CDC didn’t know about. Pfizer has changed to a buffer 

that could change the particle charge, but there has been no assessment of particle distribution 

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in animals. No safety. No efficacy studies. Where was FDA? With no cancer or immunogenicity 

studies, especially in young animals, FDA has not assuaged the concern for radiation-like 

toxicity of this gene therapy product. With CDC’s study on all-cause mortality and vaccination, 

we find correlations between vaccine coverage and mortality. Adults benefit from 4 to 26 weeks 

outside of which there are detriments. In non-vaccinated children, all-cause deaths correlate 

with adult vaccine coverage. Vaccination already appears to harm non-vaccinated children. Will 

ACIP request our analysis? No emergency, unblinding, unverified efficacy data, missing, 

unlimited safety data, faulty risk benefit analysis—you have nothing to work with and FDA has 

shunted the work of defining risk groups onto you. We’re never going to learn how safe this 

vaccine is until we start giving it. FDA has abandoned their responsibility to our children. Will 

you? 

SARS-CoV-2 Epidemiology in Children 

Dr. Jefferson Jones (CDC/NCIRD) presented an overview of the epidemiology of COVID-19 in 

children 5-11 years of age covering incidence and seroprevalence estimates, COVID-19- 

associated hospitalization rates and mortality, MIS-C, additional post-COVID conditions, and 

transmission. 

In terms of incidence and seroprevalence, over 45 million cases of COVID-19 have been 

reported in the US as of October 22, 2021. The majority of these have been in adults, who have 

experienced the most hospitalizations and deaths due to COVID-19 illness. However, children 

have been greatly impacted by the pandemic. In total, there have been over 1.9 million cases of 

COVID-19 reported among children 5-11 years of age. Starting in July and August of 2021, 

there was a sharp increase in cases in this age group. Over the past few months, children 5-11 

years of age have been making up a greater proportion of total cases. This age group has 

represented 10.6% of all cases reported to CDC as of the week of October 10, 2021, while 

making up 8.7% of the total US population in the 2020 Census. These data are for cases 

reported to CDC; however, many infections are asymptomatic or result in mild illness and are 

not tested and reported.4 

To estimate all infections, CDC conducts an ongoing nationwide seroprevalence study in 

collaboration with commercial laboratories. Every 2 weeks, approximately 50,000 de-identified 

residual sera specimens collected by commercial laboratories or preventive or acute clinical 

care for routine screening and are tested for SARS-CoV-2 antibodies. However, many 

jurisdictions have limited availability of pediatric specimens. People presenting for acute clinical 

care or screening and having their blood drawn by commercial laboratories might not represent 

the general population, particularly in children who do not frequently require blood tests. The 

most common reasons for the clinical visits among children, as documented by International 

Classification of Diseases (ICD)-10 codes, include general examination (e.g., cholesterol as all 

children are recommended to have cholesterol screens between 9-11 years of age), obesity, 

long-term drug monitoring, and fatigue.5 

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

5 https://covid.cdc.gov/covid-data-tracker/#national-lab; https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/geographicseroprevalence-surveys.html; Couture et al. Methods for Estimation of SARS-CoV-2 Seroprevalence and Reported COVID-19 

Cases in U.S. Children, August 2020—May 2021. medRxiv. https://doi.org/10.1101/2021.09.26.2126375; Bajema et al. Estimated 

SARS-CoV-2 Seroprevalence in the US as of September 2020. JAMA Intern Med. 2021;181(4):450–460. 

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Looking at weighted infection-induced antibody seroprevalence estimates by age groups for 

September 2021 for 47 US jurisdictions, seroprevalence in children 5-11 years of age was 

estimated to be 38%. This is higher than seroprevalence estimates among adults and similar 

to estimates in children 12-17 years of age. Notably, these results are preliminary and are 

subject to change. Seroprevalence varies greatly by state and jurisdiction. Among 23 

jurisdictions with at least 75 specimens collected from this age group during September, the 

state or jurisdiction-level estimates ranged from 11% to 61%. This seroprevalence estimate is 

different than the estimates presented at the FDA VRBPAC meeting, as it includes 47 

jurisdictions for September as opposed to 15 jurisdictions from May to June. Using 

seroprevalence to estimate the cumulative number of infections, the number of infections per 

reported case by age was calculated. For the general population, including adults, the 

jurisdiction-level infection-to-case ratio had a median of 2.4 with a range of 2.0 to 3.9. For 

children, the infection-to-case ratio was substantially higher with a median of 6.2 and a range of 

4.7 to 8.9. 

Numerous children 5-11 years of age have previously been infected, but what does this mean 

for vaccination? Based on data in adults, infected individuals have a low risk of infection for at 

least 6 months, but protection is not 100% and is likely lower against the Delta variant. Of note, 

the antibody response after infection is lower and less consistent, meaning there is a wide range 

of antibody titers in response to infection compared with mRNA vaccine-induced antibody 

response, which produces higher and more consistent antibody titers. Additionally, antibody 

titers generated after infection are lower in people with mild or no symptoms. Infections resulting 

in mild or no symptoms appeared to be much more common in children with SARS-CoV-2 

infection than in adults. Data among children are lacking and data in adults might not apply to 

children. Substantial immunologic evidence and a growing body of epidemiologic evidence 

indicate that vaccine after infection significantly enhances protection and further reduces risk of 

reinfection. Among those eligible, CDC recommends vaccination regardless of a history of 

infection, and serologic testing to assess for prior infection is not recommended for the purpose 

of vaccine decision-making.6 

Seroprevalence data suggest that infections in children are less likely to be reported compared 

with adults. Seroprevalence estimates in children 5-11 years of age were approximately 38% in 

September 2021. Seroprevalence indicates that children are at least as likely as adults to be 

infected with SARS-CoV-2. Note that residual sera specimens collect by commercial 

laboratories may not be representative of the general pediatric population. Antibody tests cannot 

determine whether a person is protected from infection. The assay used for the analysis, a total 

antibody test that maintains a high sensitivity for at least 6 months after infection, is good for 

detecting previous infection but is unlikely to correlate with protection from infection. 

Now to review pediatric hospitalization data from the COVID-19-Associated Hospitalization 

Surveillance Network (COVID-NET). COVID-NET is a population-based surveillance system 

that collects data on laboratory-confirmed COVID-19-associated hospitalizations among 

children and adults through a network of over 250 acute care hospitals in 14 states. Data are 

preliminary and subject to change. Cases are identified in COVID-NET if they test positive for 

SARS-CoV-2 through a test ordered by a health care provider (HCP) and are hospitalized within 

14 days of the positive test. In terms of weekly rates of COVID-19-associated hospitalizations by 

age group, the cumulative hospitalization rate was 32.3 per 100,000 population for children 5-11 

6

 CDC. Science Brief: SARS-CoV-2 Infection-induced and Vaccine-induced Immunity. https://www.cdc.gov/coronavirus/2019-

ncov/science/science-briefs/vaccine-induced-immunity.html; CDC. Interim Clinical Considerations for Use of COVID-19 Vaccines 

Currently Approved or Authorized in the United States: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-

vaccines-us.htm 

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years of age as of October 23, 2021. Rates for this age group have been consistently lower than 

other age groups. However, population-based hospitalization rates for children 5-11 years of 

age were higher in September 2021 than in any other previous point during the pandemic. 

Variations in hospitalization rates by race and ethnicity are seen with American Indian and 

Alaskan Native (AI/AN), Hispanic, and non-Hispanic Black children having cumulative 

hospitalization rates that were 3 times as high as the hospitalization rates in non-Hispanic White 

or non-Hispanic Asian children. This disparate impact of the pandemic, including high rates 

of hospitalizations on these groups, is similar to disparities seen in other age groups.7 

To further put the burden of COVID-19 illness in context, COVID-19 and influenza-associated 

hospitalization rates were compared among children aged 5 to 11 years using data from 

COVID-NET and data from the Influenza Hospitalization Surveillance Network (FluSurv-NET). 

FluSurv-NET, a longstanding platform that was leveraged to create COVID-NET, conducts 

population-based surveillance from October 1 through April 30 each year. This is roughly 

Morbidity and Mortality Weekly Report (MMWR) Weeks 40 to 18. This timeframe is the typical 

US influenza season. Influenza-associated hospitalizations occur seasonally, with very low 

influenza detection during May through September, suggesting that few influenza-associated 

hospitalizations are missed outside the October through April surveillance window. Therefore, 

FluSurv-NET rates from October through April were used to approximate the annual influenza 

hospitalization rate. FluSurv-NET has a similar catchment area to that of COVID-NET and uses 

similar methods for case ascertainment and data abstraction. 

The influenza 2020-2021 rate was added to influenza seasons 2017-2018, 2018-2019, and 

2019-2020. The hospitalization rate was extremely low with only 9 influenza hospitalizations 

being reported across all pediatric age groups. This is likely because during 2020-2021 

influenza season, mitigation measures (e.g., school closures, mask wearing, et cetera) were in 

place and decreased influenza transmission. During the same time frame, the COVID-19-

associated hospitalization rate was added. It was calculated for a 1-year period from October 1-

September 30, 2021 because COVID-19 transmission has been occurring throughout the year. 

The 2020-2021 annual COVID-19-associated hospitalization rate was similar to influenzaassociation hospitalization rates for the 2017-2018 and 2018-2019 seasons, and the COVID-19 

rate was lower than the rate for the 2019-2020 season for influenza. The low influenza 

hospitalization rate for the 2020-2021 season suggests that the annual rate of COVID-19 

hospitalizations might have been much higher, including higher than influenza hospitalization 

rates during typical influenza seasons had these COVID-19 mitigation measures not been in 

place. 

Outcomes and interventions in children 5-11 years of age hospitalized with COVID-19 were 

compared with influenza, combining three pre-pandemic influenza seasons from 2017 to 2020. 

The median length of stay among children hospitalized with influenza was 2 days versus 3 days 

for children with COVID-19. Twenty-one percent of children with influenza versus 32% of 

children with COVID-19 required ICU admission, and 4.6% of children with influenza versus 

7.2% of children with COVID-19 required invasive mechanical ventilation. A similar proportion of 

children with influenza versus COVID-19 died in the hospital at approximately 0.6%. Of 562 

children 5-11 years of age who were hospitalized with COVID-19 during March 2020 to August 

2021, 68% were Hispanic or non-Hispanic Black, which make up one-third of the general 

population. Thirty-two percent of hospitalized children had no underlying conditions, and the 

most common underlying conditions were chronic lung disease, primarily asthma, and obesity. 

7 https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html 

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As of October 22, 2021, over 730,000 COVID-19 deaths have been reported in the US—the 

vast majority of whom were adults. However, deaths in children have been reported. Between 

January 1, 2020 and October 16, 2021, there were 94 COVID-19 deaths reported among 

children 5-11 years of age. Among deaths in this age group, COVID-19-associated deaths 

account for 1.7% of all deaths during the same time period. Notably, there was a lag in death 

reporting. To put this into context, the top 10 causes of death for children 5-11 years of age for 

the year 2019, the most recent year with complete National Center of Health Statistics (NCHS) 

mortality data, were accidents (unintentional injuries); malignant neoplasms; congenital 

malformations, deformations, and chromosomal abnormalities; assault (homicide); diseases of 

the heart; chronic lower respiratory diseases; influenza and pneumonia; intentional self-harm 

(suicide); cerebrovascular diseases; and septicemia.8 

Restricting this to the 12-month period of October 3, 2020 through October 2, 2021, there were 

66 COVID-19-associated deaths reported for this age group. This would be equal to the 8th 

leading cause of death for 2019. In contrast to COVID-19, during the 2020-2021 influenza 

season, only 1 death from influenza was reported in all age groups for children. This is likely 

because of reduced transmission due to COVID-19 mitigation measures. During 2019, 84 

influenza pneumonia-associated deaths occurred among children 5-11 years of age—the 7th 

most common cause of death. This suggests that similar to COVID-19 hospitalizations, more 

COVID-19-associated deaths would likely have occurred had these mitigation measures not 

been implemented. 

Now to discuss MIS-C followed by additional post-COVID conditions, MIS-C is a severe 

hyperinflammatory syndrome typically occurring 2 to 6 weeks after acute SARS-CoV-2 infection 

resulting in a wide range of clinical manifestations and complications. Incidence is estimated as 

1 MIS-C case in approximately 3200 SARS-CoV-2 infections. This varies by race, ethnicity, age, 

and region. Approximately 60% to 70% of patients with MIS-C are admitted to intensive care 

and 1 to 2% die.9 Nationally, 5217 MIS-C cases have been reported with date of onset between 

February 19, 2020 through September 23, 2021. Children 5-11 years of age are most frequently 

affected by MIS-C. The median age of cases is 9 years and 2,316 (44%) of all reported MIS-C 

cases have occurred in children in this age group. A disproportionate 61% of children with MISC are Hispanic/Latino or non-Hispanic black. Again, these populations comprise only one-third 

of the overall population of persons 0-20 years of age. Among children 5-11 years of age, 9 

MIS-C associated deaths have been reported, which is 20% of all MIS-C deaths.10 

Beyond MIS-C, additional post-COVID conditions occur in children. These encompass a wide 

range of new, returning, or ongoing health problems, including physical and mental health 

consequences, experienced by patients 4 or more weeks after initial infection with SARS-CoV2. Few data exist on post-COVID conditions in children. It appears that post-COVID conditions 

in children is less common than among adults. In published reports, frequencies of occurrence 

8

 CDC NCHS WONDER Online Database. Accessed at http://wonder.cdc.gov/ucd-icd10.html on May 6, 2021 9

 Bowen, et al. Demographic and Clinical Factors Associated With Death Among Persons <21 Years Old With Multisystem 

Inflammatory Syndrome in Children—United States, February 2020–March 2021, Open Forum Infectious Diseases, Volume 8, 

Issue 8, August 2021,, https://doi.org/10.1093/ofid/ofab388; • Payne AB, et al. Incidence of Multisystem Inflammatory Syndrome in 

Children Among US Persons Infected With SARS-CoV-2. JAMA Netw Open. 2021;4(6):e2116420. Published 2021 Jun 1. 

doi:10.1001/jamanetworkopen.2021.16420; • Feldstein LR, et al. 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; • Belay ED, 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; • https://covid.cdc.gov/covid-data-tracker/#mis-nationalsurveillance. 

10 Bowen, et al. Demographic and Clinical Factors Associated With Death Among Persons <21 Years Old With Multisystem 

Inflammatory Syndrome in Children—United States, February 2020–March 2021, Open Forum Infectious Diseases, Volume 8, 

Issue 8, August 2021, https://doi.org/10.1093/ofid/ofab388 https://covid.cdc.gov/covid-data-tracker/#mis-national-surveillance 

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ACIP Meeting Summary November 2-3, 2021 

have varied depending on the characteristics of the children studied and other factors. Further 

investigation is needed to better characterize post-COVID conditions in children. However, a 

national survey in the United Kingdom (UK) found that 7% to 8% of children with COVID-19 

reported continued symptoms >12 weeks after their initial diagnosis.11 Post-COVID conditions in 

children may appear after mild or severe infections or after MIS-C. Symptoms are similar to 

those seen in adults and include fatigue, cough, muscle and joint pain, headache, insomnia, and 

trouble concentrating.12 

Now to review SARS-CoV-2 transmission among children. Multiple factors impact the 

transmission of SARS-CoV-2 virus, including presence and type of symptoms of the index case, 

type and timing of the exposure, viral load, and variant. Some studies have reported similar 

rates of transmission from infected children as from infected adults, while others have found 

lower rates of transmission from infected children compared with rates from infected 

adults.13,14,15 Some data from earlier studies likely underestimated infections in children; 

however, it is clear that secondary transmission from children both to other children and to 

adults can and does occur and has been reported in both household and school settings.16 

Studies have shown that vaccination decreases transmission.17 

Multiple household studies and outbreak and contact tracing investigations have demonstrated 

efficient transmission among children and adults in multiple settings. A recent MMWR article 

describing Delta variant transmission within a classroom setting in an elementary school 

showed an attack rate of 50% among students too young to be vaccinated. Some students were 

linked to transmission to other students, siblings, and their parents.18 

In summary, children 5-11 years of age are at least as likely to be infected with SARS-CoV-2 as 

adults, with over 1.9 million cases reported. Seroprevalence is estimated to be approximately 

38% through September 2021 using the dataset previously described. Seroprevalence data 

suggest that infections in children are less likely to be reported as cases than infection in adults. 

Children 5-11 years of age are at risk of severe illness from COVID-19. Over 8300 

hospitalizations have occurred to date. Hospitalization rates were 3 times higher for nonHispanic Black, non-Hispanic AI/AN, and Hispanic children compared with non-Hispanic white 

children. Hospitalization rates are similar to pre-pandemic influenza-associated hospitalization 

rates. Severity was comparable among children hospitalized with influenza and COVID-19. 

11 Office for National Statistics United Kingdom. (2021) Prevalence of ongoing symptoms following coronavirus (COVID-19) infection 

in the UK. Retrieved on September 17, 2021 from Office for National Statistics’ website. 

https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/prevalenceofongoin 

gsymptomsfollowingcoronavirus covid19infectionintheuk/1april2021 12 Buonsenso D, Munblit D, De Rose C, et al. Preliminary evidence on long COVID in children. Acta Paediatr. 2021;110(7):2208-

2211. doi:10.1111/apa.15870. 3Molteni E, Sudre CH, Canas LS, et al. Illness duration and symptom profile in symptomatic UK 

school-aged children tested for SARS-CoV-2. Lancet Child Adolesc Health 2021; 5: 708–18. 

https://www.thelancet.com/action/showPdf?pii=S2352-4642%2821%2900198-X 13 Bi Q et al. Lancet Infect Dis. 2020;20(8):911-919 

14 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.htm 15 McLean, et al. Household Transmission and Clinical Features of SARS-CoV-2 Infections by Age in 2 US Communities. medRxiv. 

https://doi.org/10.1101/2021.08.16.21262121 16 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; McLean, et al. Household Transmission and Clinical Features of SARS-CoV-2 Infections 

by Age in 2 US Communities. medRxiv. https://doi.org/10.1101/2021.08.16.21262121; Chu VT, Yousaf AR, Chang K, et al. 

Household Transmission of SARS-CoV-2 from Children and Adolescents. N Engl J Med. 2021;NEJMc2031915; 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; and 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. 17 CDC Science Brief. COVID-19 Vaccines and Vaccination. https://www.cdc.gov/coronavirus/2019-ncov/science/sciencebriefs/fully-vaccinated-people.html 18 Lam-Hine et al. MMWR Morb Mortal Wkly Rep ePub: 27 August 2021. 

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ACIP Meeting Summary November 2-3, 2021 

Approximately one-third of hospitalized children 5-11 years of age require ICU admission. At 

least 94 COVID-19-associated deaths occurred in children 5-11 years of age. MIS-C was most 

frequent among children 5-11 years of age. Post-COVID conditions have been reported in 

children. All of these adverse outcomes likely would have been more numerous had pandemic 

mitigation measures not been implemented. Finally, secondary transmission from school-aged 

children occurs in household and school settings. 

Discussion Summary 

• Dr. Poehling asked whether there are any data on MIS-C in children 12-17 years of age in 

terms of how the frequency has changed since vaccine has been approved for children in 

that age group. 

 Dr. Campbell indicated that these data are not available yet, noting that there is a lag 

to the MIS-C national surveillance system reporting. The cases were low through the 

summer. Now that vaccination has become more common in children 12 years of 

age and older, that may make a difference in the current wave of cases being 

reported to CDC. In a few weeks, they hope to have enough cases to look 

specifically at vaccine effectiveness (VE) against MIS-C in hospitalized children. 

• Dr. Daley observed that based on the numbers, COVID-19 severity in children appeared to 

be at least as great, or perhaps more severe, than influenza in children. 

• Regarding seroprevalence, it seemed to Dr. Daley that children who have blood drawn may 

differ from children who do not. For example, a child having blood drawn due to fatigue 

would suggest that an asymptomatic case of COVID may have led to that blood draw. 

Perhaps there is more likely an overestimate of seroprevalence in the general population. 

Ms. Bahta asked how the infection-to-case ratio was determined. 

 Dr. Jones confirmed that the seroprevalence comes from a unique group of children 

having their blood drawn. Serum samples for children having blood drawn 

specifically for COVID-19 are excluded from the study. There could be other reasons 

for a blood draw without an ICD-10 code mentioned for COVID-19. However, there 

are not many randomized household-based studies to which a comparison can be 

made. These results are somewhat similar to other seroprevalence studies in 

children, but most of those studies used a similar approach of using a convenience 

sample from laboratory-sampled children. 

 In terms of the infection-to-case ratio, Dr. Jones explained that for the 6 or 7 

jurisdictions that had complete age data (e.g., >90%), the cumulative number of 

reported cases in children were compared to the projected number of cumulative 

infections in children using the seroprevalence data. If 5% of the population reported 

cases and 20% would be projected to be infected for seroprevalence, that would be 

a 4:1 ratio. 

• Dr. Sanchez inquired as to whether children in COVID-NET who were identified as 

having an infection, but perhaps presented for a trauma and then tested positive for 

COVID-19 as opposed to being hospitalized for COVID-19, were included or excluded 

from the analysis. 

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ACIP Meeting Summary November 2-3, 2021 

 Dr. Jones indicated that the COVID-19 team reviews medical records for all children. 

Approximately 79% to 80% of children were confirmed to be hospitalized for COVID19, with other cases being somewhat more difficult to determine. He did not believe 

they were excluded from the analysis. 

 Dr. Garg added that among the 79% to 80% of children 5-11 years of age who were 

admitted specifically related to COVID-19, about 87% had at least 1 of the symptoms 

on which data are collected. These children were not excluded from either the rates 

or from the analysis comparing severity among those with COVID-19 versus those 

with influenza. 

• Dr. Poehling asked whether any disparities were observed among children who died 

from COVID-19. Dr. Lee remarked on the stark disparities that continue to exist in adult 

and pediatric population in terms of severe disease and hospitalization. It is recognized 

that disparities in health are a consequence of decades of compounding inequities that 

impact both the health and education of these children. There is much to do not only 

through ACIP recommendations, but also through implementation to address those 

disparities. Thus far in the pandemic, data continue to show disparities in the outcomes 

for children and adults. 

 Dr. Jones indicated that he was unaware of any analyses of COVID 19 deaths by 

race and ethnicity that were available at this time. Since infections, 

hospitalizations, and MIS-C have all followed similar patterns as those occurring 

among adults, disparities would be expected to follow similar patterns among 

children as well. 

 Dr. Campbell added that in terms of deaths associated with MIS-C, a paper led 

by Bowen published in Open Forum Infectious Diseases (OFID) showed an 

increased odds ratio in Blacks, Black non-Hispanics, and Hispanics relative to 

Whites. While the numbers were not large enough for adjusted analyses for 

AI/AN and Native Hawaiians or Pacific Islanders, the crude ratios for those 

populations were very elevated relative to the white population. 

Myocarditis in Adolescents and Young Adults 

Dr. Matthew Oster (CDC/NCBDDD) presented on mRNA COVID-19 vaccine-associated 

myocarditis following COVID-19 vaccination, primarily in adolescents and young adults, 

comparing types of myocarditis and 3- to 6-month outcomes. As a reminder, the reporting rates 

of myocarditis within 7 days after vaccination exceeded background incidence19 for males 12-24 

years of age after the first dose and males 12-49 years of age after the second dose. Among 

females, an increased risk or reporting rates was not seen after Dose 1. A slight increase was 

observed among females 12-24 years of age after Dose 2, with a peak in females 16-17 years 

of age. 

19 An estimated 1–10 cases of myocarditis per 100,000 person years occurs among people in the United States, regardless of 

vaccination status; adjusted for the 7-day risk period, this estimated background is 0.2 to 1.9 per 1 million person 7-day risk 

period. 

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ACIP Meeting Summary November 2-3, 2021 

Of the cases reported to VAERS, further investigation was performed to obtain more clinical 

information and to verify cases. Of the total 1640 reports, 877 met the case definition of 

myocarditis and 637 reports are still under review and need more information. Of the 877 

meeting the case definition,20 829 were known to have been hospitalized. At the time of the 

report, 789 patients had been discharged. Of those, 607 (77%) were known to have recovered 

from their symptoms at the time of the report. A small number (34) were not hospitalized (e.g., 

were seen in the ED, urgent care, outpatient clinic, not specified). About 312 of the 877 received 

cardiac MRIs, with 223 of the 312 (72%) having an abnormal MRI. 

Now to address deaths reported to VAERS with concern for myocarditis in persons <30 years of 

age among about 86 million doses from about 47 million individuals. When CDC receives 

reports of deaths through VAERS or other means, an extensive process is undertaken that 

includes reading reports submitted to CDC, reaching out to the reporter to acquire additional 

information, obtaining extensive medical records and autopsy reports if available, having 

discussions/meetings with the state health departments and the Medical Examiner (ME) for 

each death, and offering to review pathology samples at CDC to try to answer any questions 

that may be pertaining to the case in terms of diagnosis or potential causes. CDC is aware of 9 

cases with concern for myocarditis for which information was available for 8 cases. The case for 

which there was no information available was in an adult 27 years of age with Trisomy-21. This 

case has been published in the literature and is available online. This case was reported as 

fulminant myocarditis, but it was not possible to confirm this as a myocarditis case because the 

individual did not have an MRI and an autopsy was not available. Therefore, a full investigation 

to look for other potential causes could not be undertaken by CDC. 

Among the 8 individuals for whom information was available, 2 have an ongoing evaluation. Of 

the 6 individuals for whom evaluations have been completed, 3 were determined to have 

myocarditis and 3 were found not to have myocarditis on the review of pathology samples. 

These are felt to be other cardiac causes of sudden death for which there is a background rate 

as well, with no evidence of being due to myocarditis. For the cases with myocarditis, further 

investigation was completed looking for other potential infectious causes with classic 

myocarditis. There are bacterial, infectious, and other causes that can lead to myocarditis. A 

potential infectious cause of myocarditis was identified in each of the 3 cases found not to be 

COVID-19 vaccine-related myocarditis. 

The term “myocarditis” technically means inflammation of the heart muscle, but types of 

myocarditis can differ in how it presents, is treated, and what the short- and long-term outcomes 

are. “Classic myocarditis” refers to myocarditis in a pre-COVID era. Within the COVID-19 era, 3 

types of myocarditis have been observed: myocarditis related to COVID-19 infection, 

myocarditis related MIS-C, and COVID-19 vaccine-related myocarditis. Classic myocarditis 

could have a number of infectious etiologies (e.g., common viral, parasitic, bacterial, fungal, and 

protozoal agents), as well as non-infectious etiologies (e.g., toxins, hypersensitivity to 

medications, and immunologic syndromes). The incidence of classic myocarditis among 

children and infants is about 0.8 per 100,000 per year. Incidence among persons 15-18 years of 

age was 1.8 per 100,000 in 2015-2016. There is an early peak before 1 year of age, which is 

thought to be due primarily to genetic causes, but that rises again in adolescents. About 66% of 

cases are male and there has been significant mortality (4% to 7%) and morbidity (e.g., 4% to 

20 Definition available from Gargano JW, Wallace M, Hadler SC, et al. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis 

Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021. 

MMWR Morb Mortal Wkly Rep 2021;70:977–982. https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7027e2-H.pdf 

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9% transplant), especially in the pre-COVID era.21 There is a peak seen in adolescents and 

young adults, especially amongst males, that generally decreases over time. The percentage for 

females was static over time, with a slight peak in adults 50-60 years of age.22 

For MIS-C myocarditis, a paper was published earlier in 2021 regarding the first 1700 symptoms 

or cases of MIS-C reported to CDC. Myocarditis was listed on the case report form in about 300 

cases (17%).23 Data from COVID-NET showed that more than just myocarditis pertains to heart 

involvement in MIS-C. Of the first reported cases, 80% had cardiovascular involvement. 

Approximately 50% had elevated troponin, 73% had elevated brain natriuretic peptide (BNP), 

and 40% had decreased ejection fraction.24 There have been some reports of myocarditis due 

to COVID-19 infection, which seems to be more of a problem in adults than in children. Based 

on aggregate data from Epic CosmosTM and from the Children’s Hospital Association Pediatric 

Health Information System® (PHIS®) database, most clinical myocarditis seen in pediatric 

patients is due to MIS-C. However, subclinical myocarditis would not be captured by clinical 

databases.25 

A medRxiv study published online26 compared MIS-C-related myocarditis, classic viral 

myocarditis, and COVID-19 vaccine-related myocarditis. It did not include COVID-19 

myocarditis, because there were insufficient cases defined that way. This study found that at 

least on presentation, cases of vaccine-related myocarditis looked very similar to classic 

myocarditis or pre-COVID myocarditis in terms of troponin, BNP, lymphocytes, white blood cells, 

C-reactive protein, and platelets. Looking at their cardiac function as measured by ejection 

fraction by echocardiogram, the picture was different. On initial presentation, about two-thirds 

each of the classic myocarditis group and MIS-C myocarditis group had a decrease in their 

ejection fraction. Just over 30% had a normal ejection fraction at presentation. In the vaccinerelated myocarditis group, 7 of the 9 had a normal ejection fraction at presentation. It took a 

while for a number of the individuals in the classic myocarditis group to reach normal function, 

with about a third of them not reaching normal function by 2 weeks. Contrast that with the MIS-C 

myocarditis group in which almost all individuals regained normal function by 10 days after 

presentation. All individuals in the vaccine-related myocarditis group regained normal function. 

The 2 who had decreased function both regained normal function within a couple of days. 

Regarding long-term outcomes, a study published early in 202127 looked at the outcomes in 

pre-COVID myocarditis and identified the characteristic variables that could be associated with 

good or poor long-term outcomes. Like the pre-COVID myocarditis group, the classic 

myocarditis with vaccine-related myocarditis tend to have chest pain at clinical presentation with 

little to no heart failure symptoms identified in the New York Heart Association (NYHA) 

Functional Classification. Patients tend to have a good outcome if their electrocardiogram (ECG 

or EKG) shows abnormalities that tend to be ST-elevation with a pericarditis pattern, their 

biomarkers show early rise and fast decline in troponin, and they have preserved ejection 

fraction at onset with early improvement or normalization. One variable associated with poor 

outcomes is that 72% of those who had an MRI had abnormalities and the presence of late 

21 Vasudeva et al. American J Cardiology. 2021; Kyto et al. Heart. 2013; Ghelani et al. Circ Cardiovasc Qual Outcomes. 2012; Butts 

et al. Pediatric Cardiology. 2017; Sachdeva et al. Am J Cardiol.2015. 22 Kyto et al. Heart. 2013. 

23 Belay et al. 2021, Trends in Geographic and Temporal distribution of US Children With Multisystem Inflammatory Syndrome 

During the COVID-19 Pandemic. JAMA Pediatrics. 24 Feldstein et al. 2020, Multisystem Inflammatory Syndrome in US Children and Adolescents. NEJM. 

25 https://www.epic.com/software#Cosmos and https://www.childrenshospitals.org/phis 26 Patel et al. 2021 

27 Piccirillo F, Watanabe M, Di Sciascio G. Diagnosis, treatment and predictors of prognosis of myocarditis. A narrative review. 

Cardiovasc Pathol. 2021 Sep-Oct;54:107362. doi: 10.1016/j.carpath.2021.107362. Epub 2021 Jun 27. PMID: 34192559. 

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ACIP Meeting Summary November 2-3, 2021 

gadolinium enhancement (LGE). What exactly this means for this particular group remains 

unclear. 

Because of pre-COVID classic myocarditis and some of the long-term outcomes, the concern 

has been sudden cardiac event. The American Heart Association (AHA) and the American 

College of Cardiology (ACC) published guidelines28 in 2015 recommending that before persons 

diagnosed with myocarditis return to competitive sports, they should undergo extensive cardiac 

testing including 24-hour Holter monitoring and exercise ECG no less than 3 to 6 months after 

the initial illness. The 2015 guidelines left the issue of whether resolution of myocarditis-related 

LGE should be required for return to competitive sports. Importantly, the recommendation at the 

time was independent of age, gender, and function. Given the lack of data in the current era 

while still learning about vaccine-related myocarditis, these guidelines often have been applied 

to those with vaccine-related myocarditis as well. 

A 3-month follow-up review of cases with at least 1 follow-up visit since the initial episode was 

conducted using data from Vaccine Safety Datalink (VSD), which includes medical records data 

from a large network of health systems. The 3-month chart review assessed the status of cases 

in 4 areas: 1) recovered, no medication, without exercise restrictions or symptoms; 2) still 

symptomatic; 3) still on medication (primarily NSAIDS, colchicine); and 4) still on exercise 

and/or physical activity restrictions. About 30% of persons 12-17 years of age and about 40% to 

50% of persons 18-39 years of age were recovered with no medication, exercise restrictions, or 

symptoms. About 25% of persons 12-17 years of age were still symptomatic according to their 

charts, 13% were still on medications, and 44% were still on exercise/physical activity 

restrictions. 

In addition to the chart reviews, CDC launched an investigation of patients reported to VAERS 

to assess the long-term effects of myocarditis that involves conducting surveys of the patients 

(or their parents or guardians) and their HCPs to obtain information about myocarditis after 

mRNA COVID-19 vaccination.29 CDC has reached just under 250 patients thus far and has 

asked for a self-report of whether the patients had particular symptoms (e.g., fatigue, 

palpitations, shortness of breath, chest pain) within the prior 2 weeks of the phone calls. The 

calls were made approximately 3 months after their initial myocarditis diagnosis. Each of the 4 

symptoms was reported in about a quarter of patients at any point in the prior 2 weeks—not just 

at the time of the call. About half of patients reported no symptoms and about half reported at 

least 1 symptom within the prior 2 weeks. To date, the data are limited on cardiac testing. About 

83% of electrocardiograms that were performed were normal and about 14% were borderline. 

About 88 of echocardiograms were normal. Only 15 cardiac MRIs were done among the study 

patients, with about 67% normal and 33% abnormal. When checked (N=25 cases), troponin 

was normal at 96%. Among cardiologists and other HCPs, 91% indicated that the patient was 

fully or probably recovered. Of the 91%, 74% said the patient had fully recovered and 17% said 

the patient was probably recovered, but they were awaiting additional information from further 

testing/MRI. 

28 Maron et al. JACC. 2015; Burns et al. J Peds X. 2020 

29 Vaccination https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myo-outcomes.html 

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ACIP Meeting Summary November 2-3, 2021 

Discussion Summary 

• Dr. Lee asked whether any differences in severity have been observed in distinguishing 

features in terms of the phenotype and outcomes between males and females and, if not, 

whether that might be worth studying moving forward. 

 Dr. Oster indicated that while they have not noticed a big difference, it certainly 

would be worth assessing moving forward for males and females. Overall, the 

epidemiology is classic myocarditis. What has been seen in vaccine-related 

myocarditis thus far is that it seems vary in terms of peaking in adolescents, though 

not as high in the older population. The post-vaccine side effects follow what has 

been seen for classic myocarditis in the younger age group, which is not expected to 

be as prevalent in adolescents. 

• Dr. Poehling asked whether any disparities have been observed by race and ethnicity in 

hospitalizations or in COVID-related myocarditis. 

 Dr. Oster responded that at least in the younger population, little hospitalization is 

seen with COVID infection-related myocarditis. With MIS-C myocarditis, as is seen 

with MIS-C in general, hospitalization is definitely higher in African Americans. That 

is not fully explainable by their baseline COVID infection rates. It is higher in 

Hispanics, which is partially explained by the baseline COVID infection rates in the 

population. For other populations, there are not enough data to make strong 

determinations. For most of the cases for which race and ethnicity are known, 

myocarditis after vaccination tends to occur more often in whites, but with 2 caveats. 

First, race and ethnicity are not always listed on the VAERS report form. Second, it 

has not been possible to assess the percentages compared to the underlying 

vaccination rates. There are disparities in who is getting vaccinated, making it difficult 

to interpret the disparities in who is experiencing vaccine AEs. 

• Dr. Brooks inquired as to whether there was increased incidence of myocarditis in VAERS 

reporting among persons under 30 years of age with underlying cardiac disease. 

 Dr. Oster indicated that for those on whom full investigations have been done, no 

strong patterns or major upticks have been seen so far in terms of co-morbidities and 

underlying diseases. Among the 877 cases reported to VAERS of persons ≤30 years 

of age, there were 9 or 10 deaths out of 86 million doses. Vaccine-related 

myocarditis could not be identified as the cause of death in any of those cases. 

 Along the same lines, Dr. Hogue asked whether there were any data about the risks 

among individuals with congenital cardiac defects/abnormalities of experiencing 

myocarditis resulting from receipt of Pfizer vaccine. 

 Dr. Oster reported that an increased risk for myocarditis has not been observed in 

those with congenital heart disease, either through his work with CDC or through his 

work as a pediatric cardiologist taking care of these patients. One study has been 

published and another was going through channels to be published that focus on 

children with congenital heart disease who have had severe COVID-19 that required 

hospitalization. These studies showed that once children were hospitalized, they 

were more likely to have critical outcomes requiring ICU-level support or more. His 

advice to families is that he is much more worried about what would happen to a 

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ACIP Meeting Summary November 2-3, 2021 

patient with congenital heart disease if they got COVID-19 versus getting the 

vaccine. 

• Dr. Duchin requested further comment on myocarditis with COVID-19 being approximately 3 

times more common than that associated with vaccination found in the Israeli study, and 

about vaccine-related myocarditis among children 5 to 11 years of age. 

 Dr. Oster pointed out that so far, the epidemiology for vaccine-related myocarditis by 

age and sex appears to be following the pattern that has been seen with classic 

myocarditis. There is no reason to suspect that this would differ in children under 12 

years of age. There are a number of pathophysiological mechanisms and rationales 

for why that is. One of the most common thoughts is that testosterone plays a role, 

which fits the profile over time by sex and age. 

 Dr. Long added that she has managed a couple of manuscripts on patients who had 

myocarditis for other reasons. One was a typical viral-type myocarditis who was 

recovering who got the vaccine, 2 days later had chest pain, and had a recurrence of 

their myocarditis with vaccine-associated pericarditis. The other was a young man 

who 20 days after his first dose of vaccine had typical vaccine-associated 

myopericarditis. Then 2 to 3 weeks later after Dose 2, he had typical 2-day 

myopericarditis. Therefore, one could be thought to have had typical myocarditis who 

still could have vaccine-associated myopericarditis. Therefore, it is possible someone 

could have underlying typical viral myopericarditis that was exacerbated by the 

vaccine. 

 Dr. Oster acknowledged that people can be walking around for weeks or months with 

myocarditis and then have something push them over the edge, such as an 

infectious stressor or something else. It is possible that vaccine could be the 

stressor. While this will be a difficult question to answer without knowing someone’s 

baseline, it is certainly worth considering and trying to capture when possible. 

 To help parents better weigh the risk of vaccinating their children 5-11 years of age 

in terms of myocarditis, Dr. Shah suggested further quantifying the relative risk 

reduction or the differences in risk from vaccine-associated myocarditis versus 

COVID-19-associated. In effect, this would translate the information on Slide 10 into 

a rate and incident and have that on a bar graph alongside what is shown on Slide 4 

on the risk of vaccine-associated myocarditis to demonstrate the risk for each of 

those. This would be extremely helpful from a communications perspective. 

• Ms. McNally requested that Dr. Oster discuss the current management approach for 

myocarditis in the adolescent age group and whether imaging is part of the work-up for 

these patients and asked whether it is less likely that children 5-11 years of age will have 

vaccine-related myocarditis than adolescents based on the epidemiology, and if the benefits 

of vaccination in children 5-11 years of age outweigh the potential risk of vaccine-related 

myocarditis in his professional opinion and to a reasonable degree of medical certainty with 

the information currently available. 

 Dr. Oster indicated that primary management is symptom-based in terms of 

assessing how the person is presenting. For instance, chest pain is a prominent 

feature so treating with pain medicine is going to be a first-line treatment. Many 

children with vaccine-related myocarditis have received non-steroidal anti27 
 

 

 

 

 

 

 

 

 

 

 

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inflammatory drugs (NSAIDs) like ibuprofen. If there are cardiac problems, such as 

poor heart function or other cardiac manifestations, cardiac medications are 

considered (e.g., diuretics, rhythm-monitoring agents). For those who are critically ill, 

critical measures are instituted as needed. While cardiac manifestations or critical 

illness are common features of classic myocarditis, this has not been seen much in 

vaccine-related myocarditis in children. In terms of imaging, the first step is to look at 

cardiac manifestations. EKG and ECG are very common, along with looking for 

biomarkers such as troponin and BNP. MRIs can be institution-dependent. Some 

institutions will do an MRI if the diagnosis is unclear or for monitoring purposes in the 

acute or long-term phase to look for evidence of inflammation in the heart. 

 In terms of whether it is less likely that children 5-11 years of age will have vaccinerelated myocarditis than adolescents, Dr. Oster did not think the pediatric trials were 

sufficiently powered to determine this. 

 Dr. Oster indicated that in his professional opinion, the benefits of vaccination in 

children 5-11 years of age outweigh the risk of vaccine-related myocarditis. 

Vaccine Safety Surveillance in Children 

Dr. Tom Shimabukuro (CDC/NCEZID) discussed surveillance systems and processes for 

monitoring vaccine safety among children, emphasizing that COVID-19 vaccines are being 

administered under the most intensive vaccine safety monitoring effort in history. CDC’s strong 

and complementary systems include v-safesm, VAERS, VSD, and the Clinical Immunization 

Safety Assessment (CISA) Project. A full list of US COVID-19 vaccine safety monitoring 

systems is available on the CDC website.30 

v-safesm is CDC’s smartphone-based active safety monitoring system that was developed for 

COVID-19.31 It uses text messaging and secure web-based surveys. It is now available to enroll 

children and for third-dose reporting. Participants can register themselves and their dependents 

through a voluntary self-registration process after Dose 1, 2, or 3. Dependents can be added 

even if the primary smartphone account is not a v-safesm participant. The parent or guardian 

must create a profile and then add the dependent. The text messaging is directed to the parent 

or guarding. The v-safesm check-in schedule is the same for all ages: Once a day (days 0–7), 

once a week (weeks 2–6), and once a month (months 3, 6, and 12). The schedule restarts after 

each dose received. v-safesm will aggregate data from health surveys completed on Days 0-7 

after vaccination for children 5-11 years of age. The analytic plan for this age group will be to 

describe the data based on demographics (e.g., sex, median age, race/ethnicity), local and 

systemic reactions, and health impacts by dose received. The reactogenicity profile for children 

5-11 years of age will be compared to adolescents 12-17 years of age. Reports to VAERS 

solicited by active telephone follow-up of v-safesm participants are included in VAERS analyses. 

VAERS is a jointly operated spontaneous reporting or passive surveillance system operated by 

CDC and FDA.32 VAERS accepts reports from anyone regardless of the plausibility of the 

vaccine causing the event or the clinical seriousness of the event. Its key strengths are that it 

can rapidly detect potential safety problems and can detect rare AEs. The key limitations of 

VAERS are that it is a passive surveillance system that has inconsistent quality and 

completeness of information, reporting biases, and generally cannot be utilized alone to 

30 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html 31 http://cdc.gov/vsafe 32 http://vaers.hhs.gov 

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determine cause and effect. The VAERS pre-specified AESIs as of October 27th include: death; 

acute myocardial infarction; anaphylaxis; coagulopathy (e.g., thrombocytopenia, deep venous 

thrombosis or pulmonary embolism, or disseminated intravascular coagulopathy); Guillain-Barré 

Syndrome (GBS); Kawasaki disease; MIS-C; myocarditis, myopericarditis, and pericarditis; 

narcolepsy/cataplexy; seizure; stroke; thrombosis with thrombocytopenia syndrome 

(TTS); and transverse myelitis. The assessment of these AESIs includes a clinician review of 

the VAERS report, follow-up to obtain/review medical records, application of case definitions, 

and adjudication to classify the report with respect to the case definition. 

There will be a specific focus on myocarditis/pericarditis reports in children 5-11 years of age. 

Potential reports are identified by Medical Dictionary for Regulatory Activities (MedDRA) 

standardized codes assigned to reports that could indicate a potential myocarditis or pericarditis 

case. Clinical abstraction includes a review of the initial report, outreach to the healthcare 

provider involved in the report of a patient’s care, request and review of medical records, and 

comparison of abstracted data elements against the CDC case definitions for myocarditis and 

pericarditis. CDC will conduct periodic analyses of case counts and reporting rates and 

comparison of reporting rates to background. 

The VSD is an electronic health record (EHR)-based system that includes 9 participating 

integrated health care organizations with data on over 12 million persons per year. The VSD 

conducts rapid cycle analyses (RCA). The aims are to monitor the safety of COVID-19 vaccines 

weekly using pre-specified outcomes of interest and to describe the uptake of COVID-19 

vaccines over time. Surveillance in the VSD began in December 2020. The VSD analytics 

strategy statistical analysis will be similar to what has been done for other age groups but will 

include stratified analysis on children 5-11 years of age. For the primary analysis, the number of 

outcomes observed in a risk interval after vaccination will be compared to the number expected. 

The risk intervals are 0-7 days for myocarditis/pericarditis and seizures and 1-21 days for other 

outcomes. The expected is derived from “vaccinated concurrent comparators” who are in a 

comparison interval of 22-42 days after COVID-19 vaccination. On each day that an outcome 

occurs, vaccinees who were in their risk interval are compared with similar vaccinees who were 

concurrently in their comparison interval. Comparisons will be adjusted for by single year of age, 

sex, race/ethnicity, VSD site, and calendar date. 

For children 5-11 years of age, VSD will continue to review medical records and adjudicate any 

potential cases of myocarditis/pericarditis identified within 1-98 days following any COVID-19 

vaccination. In addition, VSD will conduct chart review of all identified cases of GBS, Acute 

disseminated encephalomyelitis (ADEM), transverse myelitis, anaphylaxis, and cerebral venous 

sinus thrombosis (CVST) within 1-98 days following any COVID-19 vaccination. VSD is able to 

capture information on simultaneous vaccinations. 

The CISA Project is a collaboration between CDC and 7 participating medical research centers. 

CISA COVID-19 vaccine core activities include clinical case reviews and clinical consults on 

complex cases of vaccine AEs; technical consultation on clinical guidance and clinical 

considerations for use of COVID-19 vaccines; contributions to enhance surveillance for AEs; 

and clinical research, including in pediatric populations. More information about clinical consults 

is available on the CDC website.33 

33 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html 

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In terms of other federal programs, FDA’s COVID-19 surveillance programs include the Center 

for Biologics Evaluation and Research (CBER) active surveillance program and the Biologics 

Effectiveness and Safety (BEST) system and collaborations with federal partners. The Indian 

Health Service (IHS) vaccine safety monitoring systems include passive surveillance with 

VAERS through a collaboration with CDC and the IHS Safety Tracking and Response System. 

IHS also conducts active surveillance through the IHS Sentinel Survey. The Department of 

Defense (DoD) also monitors DoD VAERS reports through a collaboration with CDC. They have 

a system known as the Vaccine Adverse Event Clinical System (VAECS), the DoD Electronic 

Health Record and Defense Medical Surveillance System (AHLTA/MHS GENESIS), and the 

Joint Trauma System/COVID 19 Vaccine Breakthrough Metrics. The DoD detected the initial 

safety signal for myocarditis through monitoring in their active duty population, and they are a 

key partner in safety monitoring. 

The COVID-19 Vaccine Safety Technical (VaST) WG serves as the central hub for technical 

subject matter expertise from federal agencies conducting post-authorization and post-approval 

safety monitoring. They meet weekly or biweekly to review data on AESIs. They share learning, 

including all members, federal partners, and subject matter experts (SMEs). They review, 

evaluate, and interpret post-authorization safety data and advise the federal agencies on 

monitoring, analyses, and interpretation of data. There also is independent discussion of 

findings by the VaST WG members. The VaST WG’s plans for children 5-11 years of age are to 

review safety in this age group as soon as available, continue close review of myocarditis data, 

and provide updates to the ACIP COVID-19 Vaccines WG and ACIP on COVID-19 vaccine 

safety. 

In closing, Dr. Shimabukuro made a plea to health care and public health partners and to the 

public, especially parents/guardians of children and those getting booster doses, to participate 

in vaccine safety. Participation matters. Everyone can help CDC by getting involved in terms of 

reporting AEs following vaccination to VAERS, even if not sure whether the vaccination caused 

the AE, and by enrolling in v-safesm. HCP can encourage their patients to enroll in v-safesm and 

parents/guardians can enroll their children in v-safesm. 

Discussion Summary 

• ACIP members emphasized that since December 2020, these multiple surveillance systems 

have demonstrated the ability to detect rare AEs following vaccination. They are designed to 

assess the situation rapidly and the findings are communicated transparently to the public 

and policymakers at FDA and CDC. There have been instances of the data from these 

systems being deliberately misrepresented, which can cause concern/confusion among the 

public. However, these large and distinct systems are reassuring and are constantly 

evaluating the safety of COVID-19 vaccines, including for new groups. With over 420 million 

doses administered in the US, there is an extensive amount of data to date. 

Implementation of COVID-19 Vaccine Pediatric Program 

Dr. Kevin Chatham-Stevens (CDC/NCIRD) described some of CDC’s work in preparation for 

vaccination among children 5-11 years of age. High-level implementation goals are to: 1) enable 

access to and availability of vaccine providers where populations are most likely to seek 

vaccination in order to reach the most families and children possible; 2) establish programming 

to ensure vaccine access for vulnerable, underserved, and hard-to-reach pediatric populations; 

3) minimize delays between FDA authorization of pediatric vaccines and initial rollout of 

pediatric administration; and 4) disseminate timely clinical guidance to jurisdictions and 

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providers. To achieve each of these goals, CDC is harnessing the existing robust pediatric 

vaccination network in the US, complementing that network with additional sites and building on 

successes and lessons learned from the adult and adolescent vaccine programs. 

Regarding the approach to reaching children through a variety of settings, utilization of providers 

serving children 5-11 years of age is the optimal location for many children to be vaccinated. 

This includes clinical settings such as primary care clinics, Federally Qualified Health Centers 

(FQHCs), rural health clinics (RHCs), health departments, IHS clinics, and others who can help 

ensure vaccine equity and broad coverage. Given that not every child 5-11 years of age has a 

medical home, the medical home will be complemented by other vaccine providers. For 

instance, pharmacies will be leveraged to administer a vaccine to children who may not seek or 

have access to care in a pediatric practice. In addition, schools can partner with vaccine 

providers such as health departments, pediatric clinics, FQHCs, and pharmacies to host schoollocated vaccination clinics. School-located vaccination clinics can provide a convenient option 

for parents and caregivers who may experience challenges taking their child to a clinic. As 

announced by the White House recently as part of several key initiatives, more than 100 

children’s hospitals will set up vaccination sites. This will be a critical part of efforts to provide 

vaccine access for children, especially those with underlying medical conditions. 

Jurisdictions also may use temporary community clinics, leveraging the experience with these 

clinics from the adult and adolescent vaccine programs. To assess jurisdictions’ plans to use 

various COVID-19 vaccination providers for children 5-11 years of age, CDC surveyed 64 state 

and local health departments in late September. Of the 64 jurisdictions, 58 responded to the 

question regarding which providers they plan to use to deliver the vaccine. It is important to note 

that these options were not mutually exclusive. Jurisdictions seem to be using an “all of the 

above” approach, with most jurisdictions planning to use large pediatric providers, VFC 

providers, pharmacies, temporary community vaccine clinics, and temporary school-located 

vaccine clinics. In a follow-up survey, jurisdictions were asked to rank the settings in which they 

anticipated that most children 5-11 years of age would be vaccinated. Pediatric providers were 

the most highly ranked, followed by FQHCs/RHCs, health departments, and pharmacists. 

A parental survey was conducted by CDC, RAND, and the University in late September/early 

October among just over 1000 parents of children 5-11 years of age. Almost two-thirds of 

parents felt comfortable having their child vaccinated in their regular doctor’s office or clinic, 

followed by the pharmacy or in another doctor’s office or clinic. Approximately a quarter of 

parents felt comfortable having their child vaccinated at school with the parent present and 

about 15% felt comfortable without the parent present. Thus, surveys of both jurisdictions and 

parents indicate that children 5-11 years of age likely will be vaccinated across a variety of 

settings. 

Data from the 2 jurisdictional surveys have helped to guide CDC’s outreach and planning and 

identify key issues. In addition, the agency has disseminated an Operational Planning Guide34 

and preliminary information about the Pfizer BioNTech vaccine.35 The Operational Planning 

Guide includes key information about the vaccine, assumptions to inform planning, and 

strategies for jurisdictions to consider implementing. For example, a checklist in the document 

includes various tasks such as jurisdictions routinely evaluating the adequacy of the provider 

network, identifying gaps, and determining whether additional vaccination locations (e.g., 

FQHCs, pharmacies, school-located vaccination clinics, or RHCs) may be needed to further 

34 https://www.cdc.gov/vaccines/covid-19/downloads/Pediatric-Planning-Guide.pdf; https://www.cdc.gov/vaccines/covid19/planning/children.html 35 https://www.cdc.gov/vaccines/covid-19/downloads/Pfizer-Pediatric-Reference-Planning.pdf 

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increase equitable access and ensure vaccine equity. The document about the Pfizer BioNTech 

vaccine includes a side-by-side comparison of the adult/adolescent formulation and the 

formulation for children 5-11 years of age. CDC also is working to provide guidance on, and 

support of, school districts partnering with pharmacies to conduct school-located vaccine clinics. 

Resources for schools are available on the CDC website.36 CDC also has conducted numerous 

listening sessions with a variety of public health, clinical, and other partners to hear about 

potential challenges in the rollout of the vaccine and what resources CDC or others could 

provide to help facilitate the rollout. 

Discussion Summary 

• Dr. Daley requested information about communication plans for providers and the public, 

given that considerations pertaining to myocarditis may be the focal point of many parents’ 

decision to vaccinate. 

• Dr. Chatham-Stevens indicated that CDC’s communications experts have done a fantastic 

job of laying out a plan to make sure the agency is communicating to key populations such 

as parents, providers, and partners (e.g., health departments and academic professional 

societies) so that they can amplify the messages. This includes the key points that have 

been eloquently laid out previously that COVID-19 presents a risk to children and that the 

risk must be balanced with the potential side effects. Communications materials will be 

disseminated in the coming days on this topic. 

• Dr. Poehling inquired about the extent to which input was acquired from historically 

marginalized populations to inform the implementation planning process. 

• Dr. Chatham-Stevens stressed that vaccine equity is definitely top of mind for CDC and 

state, territorial, local, and tribal health departments. This is an opportunity to build on the 

lessons learned and successes from the adult and adolescent rollout. The agency has 

numerous resources online, including various toolkits, that are aimed at various partners to 

help ensure that equity work is being incorporated across the vaccine program. Each of the 

settings he described can contribute to this. For instance, the VFC program has done a 

great job historically of providing vaccine to children whose families may not be able to 

afford the vaccine otherwise. FQHCs, RHCs, school-located vaccine clinics, and travel 

health care partner providers also can help to ensure that vaccine is available for their 

particular populations. Due to transportation and other challenges, some families cannot 

make it to a clinic during regular business hours. Vaccine availability at pharmacies and 

school-located vaccine clinics can help to ensure that the vaccine is widely available to 

various populations. 

Clinical Considerations for COVID-19 Vaccination in Children 

Dr. Kate Woodworth (CDC/NCEZID) explained that the interim clinical considerations provide 

additional information to healthcare professionals and public health officials on the use of 

COVID-19 vaccines and are informed by ACIP/CDC recommendations; data submitted to the 

FDA; and other data sources, such as general best practice guidelines for immunization and 

expert opinion. This presentation included a review of the Pfizer-BioNTech COVID-19 vaccine 

formulation and dosing for children 5-11 years of age; proposed considerations for vaccine 

recipients (e.g., those with underlying medical conditions, prior SARS-CoV-2 infection, and/or a 

36 https://www.cdc.gov/vaccines/covid-19/planning/school-located-clinics/how-schools-can-support.html 

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history of MIS-C); patient and parent/guardian counseling; and vaccine administration, including 

co-administration and administration errors. 

The Pfizer-BioNTech COVID-19 vaccine for children 5-11 years of age is a new and different 

formulation from the current formulation for persons 12 years of age and older. The formulation 

for children 5-11 years of age comes in an orange capped vial as opposed to the purple vial for 

those 12 years of age and older. The dose will be 10 ug, a third of the concentration of the 

mRNA vaccines in the purple capped and older formulation for those 12 years of age and older. 

The formulation for children 5-11 years of age requires a different injection volume and amount 

of diluent, will contain 10 doses per vial, is stable at ultra-low temperatures (-90°C to -60°C) for 

up to 6 months, and can be stored at routine refrigerator temperatures (2°C to 8°C) for 10 

weeks. 

Similar to the formulation for those 12 years of age and older, children 5-11 years of age would 

receive 2 doses spaced 3 weeks apart. Currently, children 5-11 years of age with moderate and 

severe immunocompromise are not recommended to receive an additional, or third, primary 

dose. ACIP and CDC will continue to evaluate the data to update these recommendations if 

needed. Booster doses are not recommended for anyone under 18 years of age. Children 

should receive the age-appropriate vaccine formulation regardless of their size or weight. As 

opposed to many medications, vaccine dosages are based on age, not weight or body size. In 

general, the formulation and dosage should be based on the child’s age on the day of 

vaccination. However, if a child turns 11 to 12 years of age in between their first and second 

doses and receives the 5–11 years 10 μg (orange cap) for their second dose, they do not need 

to repeat the dose and this is not considered an error per the EUA. 

Children with underlying medical conditions may be at increased risk for severe illness from 

COVID-19.37 However, severe COVID-19 can occur in children with and without underlying 

medical conditions. As the policy question for ACIP currently stands, COVID-19 vaccination 

would be recommended for everyone 5 years of age and older regardless of underlying medical 

conditions. People with known current SARS-CoV-2 infection should defer vaccination, at least 

until the person has recovered from their acute illness, if the person has symptoms and they 

have met criteria for discontinuing isolation.38 Serologic testing to assess for prior infection is not 

recommended for the purpose of vaccine decision-making.39 As the policy question for ACIP 

currently stands, COVID-19 vaccination would be recommended for everyone 5 years of age 

and older, regardless of a history of symptomatic or asymptomatic SARS-CoV-2 infection or 

seropositivity. More than 7 million adolescents 12-15 years of age have been fully vaccinated 

with a Pfizer-BioNTech COVID-19 vaccine in the US.40 

In the general population, there have been no safety concerns associated with vaccination of 

those who have had prior infection. Additionally, data from clinical trials in children 5-11 years of 

age indicate that the Pfizer-BioNTech COVID-19 vaccine can be safely given to those of 

evidence of prior SARS-CoV-2 infection. Current evidence suggests that protection from 

reinfection is high after initial infection but decreases with time due to waning immunity. 

Substantial heterogeneity exists in the individual immune responses to infection. In adults, 

asymptomatic infection leads to lower antibody levels. Growing epidemiologic evidence from 

adults and adolescents indicates that vaccination following infection increases protection from 

37 https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html#ChildrenAndTeens 38 https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html 39 https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html 40 https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic 

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subsequent infection, including in the setting of more infectious variants.41 There are numerous 

limitations to antibody testing. Antibody tests cannot determine when a person was infected. 

Antibody tests vary greatly in their sensitivity, particularly more than 3 months after infection. 

People can test positive on commercial antibody tests even after other markers of immunologic 

response, such as neutralizing antibodies, have waned. At this time, there is no FDA-authorized 

or approved test that providers or the public can use to reliably determine whether a person is 

protected from infection. 

For children with a history MIS-C, the benefits of COVID-19 vaccination are likely to outweigh 

any theoretical risk of a MIS-like illness or the known risks of COVID-19 vaccination if they meet 

all the following criteria: 1) clinical recovery has been achieved, including return to normal 

cardiac function; 2) it has been ≥90 days since their diagnosis of MIS-C; 3) they are in an area 

of high or substantial community transmission of SARS-CoV-2, or otherwise have an increased 

risk for SARS-CoV-2 exposure and transmission; and 4) onset of MIS-C occurred before any 

COVID-19 vaccination. COVID-19 vaccination may also be considered for children with a history 

of MIS-C who do not meet all the prior criteria. However, experts view clinical recovery, 

including return to normal cardiac function, as an important factor when considering COVID-19 

vaccination. Additional factors when considering individual benefits and risks may include an 

increased personal risk of severe COVID-19 (e.g., age, underlying conditions) and timing of 

immunomodulatory therapies. If a child develops MIS-C or a similar clinical illness after 

receiving a COVID-19 vaccine, referrals to a specialist should be considered. Because MIS-C is 

a condition known to occur with SARS-CoV-2 infection, these individual should be assessed for 

laboratory evidence of current or prior SARS-CoV-2 infection. Any cases should be reported 

VAERS.42 Consultation is available to healthcare providers and health departments from the 

CISA Project.43 

With respect to counseling patients and parents/guardians on expected side effects from PfizerBioNTech COVID-19 vaccine, children may experience fewer side effects than adolescents or 

young adults based on the clinical trial data presented earlier in the day. Children with evidence 

of prior infection may have fewer side effects than those without evidence of prior infection.44 

The expected side effects are similar to those seen in adolescents and include local reactions 

(e.g., pain, swelling, erythema at the injection site) and/or systemic reactions (e.g., fever, 

fatigue, headache, chills, myalgias, arthralgia, lymphadenopathy). While preemptive medication 

prior to vaccination is not routinely recommended, routine antipyretic or analgesic medications 

can be taken for the treatment of post-vaccination local or systemic reactions if medically 

appropriate. In general, aspirin is not recommended for use in children and adolescents ≤18 

years due to risk of Reye’s syndrome. 

Myocarditis and/pericarditis have occurred rarely in some people following receipt of mRNA 

COVID-19 vaccines, typically within a few days following receipt of the second dose. What is 

known about this risk comes from post-marketing data available from adolescents and adults. 

The highest risk observed has been in males 12-29 years of age.45 The risk of myocarditis or 

41 Dan 2021, Science: https://doi.org/10.1126/science.abf4063; Cavanaugh 2021, MMWR; 70(32):1081-3. Lumley 2021; Clin Infect 

Dis; doi: 10.1093/cid/ciab608. Gazit 2021, medRxiv; https://doi.org/10.1101/2021.08.24.21262415. Shenai 2021, medRxiv; 

https://doi.org/10.1101/2021.09.12.21263461. 42 https://vaers.hhs.gov/reportevent.html 43 http://www.cdc.gov/vaccinesafety/Activities/CISA.html 44 https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontechcovid-19-vaccine 45 Gargano JW, Wallace M, Hadler SC, et al. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine 

Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021. MMWR Morb Mortal 

Wkly Rep 2021;70:977–982. DOI: http://dx.doi.org/10.15585/mmwr.mm7027e2 

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pericarditis after receipt of an mRNA COVID-19 vaccine in adolescents and adults is lower than 

the risk of myocarditis associated with SARS-CoV-2 infection in adolescents and adults.46 No 

cases of myocarditis or pericarditis were reported in the clinical trial for children 5-11 years of 

age, which included 3,082 children followed for at least 1 week after Dose 2. However, the study 

was not powered to assess the risk of myocarditis.47 As discussed earlier, the baseline risk of 

myocarditis prior to the COVID-19 pandemic was much higher in adolescents 12-17 years of 

age compared to children 5-11 years of age. 

The FDA has authorized the Pfizer-BioNTech COVID-19 vaccine in children 5-11 based on the 

determination that the benefits of COVID-19 vaccination outweigh the risk in this population. 

People receiving mRNA COVID-19 vaccine, especially males less than 30 years of age, should 

be made aware of the possibility of myocarditis or pericarditis following receipt of mRNA 

COVID-19 vaccines and informed to seek care for symptoms of chest pain; shortness of breath; 

or feelings of having a fast beating, fluttering, or pounding heart. Any cases of myocarditis or 

pericarditis after vaccination should be reported to VAERS.48 

COVID-19 vaccines may be administered without regard to timing of other vaccines. This 

includes simultaneous administration of COVID-19 vaccine and other vaccines on the same 

day. This is all the more important as influenza season begins in order to ensure that children 

are protected against both influenza and COVID-19. If multiple vaccines are administered at a 

single visit, they should be administered at different injection sites separated by 1 inch or more 

and according to recommendations by age.49 If more than 2 vaccines are injected into a single 

limb in younger children 5-10 years of age, the vastus lateralis muscle of the anterolateral thigh 

is preferred site because of greater muscle mass. For children ≥11 years of age, the deltoid 

muscle can be used. In terms of vaccinating before someone’s eligible birthday, the 4-day grace 

period that is in place for other vaccines would apply to this population as well. 

With a new formulation for children 5-11 years of age, it is important to highlight a couple 

possible administration errors. Importantly, the formulation of the Pfizer-BioNTech COVID-19 

vaccines are not interchangeable. If a child 5-11 years of age inadvertently receives a PfizerBioNTech purple capped 30 μg dose for their first dose, they should receive a single ageappropriate 10 μg dose for their second dose 21 days later and should be considered as having 

completed a primary series. If a child 5-11 years of age inadvertently receives a 30 μg dose for 

their second dose, they should be considered as having a completed primary series. 

Administration errors should be reported to VAERS. The Clinical Considerations website 

provides a much longer table with additional possible administration errors, as well as actions to 

take after an error has occurred.50 CDC is updating many current tools to help providers with the 

information they need to provide these vaccines safely. All of the information discussed during 

this presentation be found on the CDC website page with the Interim Clinical Consideration for 

Use of COVID-19 Vaccines, which will be updated to include information on children 5-11 years 

of age in the coming days. 

46 Boehmer TK, Kompaniyets L, Lavery AM, et al. Association Between COVID-19 and Myocarditis Using Hospital-Based 

Administrative Data — United States, March 2020–January 2021. MMWR Morb Mortal Wkly Rep 2021;70:1228–1232. DOI: 

http://dx.doi.org/10.15585/mmwr.mm7035e5 47 https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontechcovid-19-vaccine 48 https://vaers.hhs.gov/reportevent.html 49 https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html 50 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html; Updates will be posted at: 

https://www.cdc.gov/vaccines/covid-19/info-by-product/index.html 

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ACIP Meeting Summary November 2-3, 2021 

Discussion Summary 

• Dr. Amanda Cohn (CDC) noted that this presentation was given prior to the EtR Framework 

presentation because there are so many clinical considerations, which ACIP members 

already raised throughout the day. She emphasized that the clinical considerations would be 

predicated on ACIP voting to recommend vaccination for children 5-11 years of age. 

• Questions were raised regarding whether parents or guardians would be given an EUA Fact 

Sheet or Vaccine Information Statement (VIS), what information would be included 

regarding myocarditis in this age group, what information would be provided about the 

protocol in a scenario in which someone experiences myocarditis/pericarditis after their first 

dose, and whether vaccine injuries among children 5-11 years of age would go through the 

Countermeasures Injury Compensation Program (CICP). 

 Dr. Cohn indicated that CDC is working on other parent education materials that 

distill the provider fact sheet into the key messages that would be important for 

parents to understand prior to vaccination. CDC will ensure that its communication 

materials include information about the potential AE of myocarditis for parents of 

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

 Dr. Fink (FDA) added that the EUA Fact Sheet for Vaccination Providers and the 

EUA Fact Sheet for Vaccine Recipients/Caregivers for the new lower dose 

formulation for use in children 5-11 years of age includes the same language 

regarding the risk of myocarditis as currently appears in the Fact Sheet for the 30 μg 

formulation that is authorized for use in persons 12 years of age and above. To 

summarize, the Warning Statement notes that a risk of myocarditis in the week 

following Dose 2 has been observed and appears to be greatest in males under 40 

years of age. It also states that in most cases, symptoms have resolved with 

conservative management but that longer-term follow-up is needed. 

 Dr. Woodworth indicated that the existing Clinical Considerations address a scenario 

in which a vaccine recipient experiences myocarditis after their first dose of an 

mRNA vaccine. While this will be updated somewhat, the same scenario would apply 

for adults as well as children who develop myocarditis after their first dose. It is 

possible that the preference would be to defer the second dose, but this would be 

discussed with a clinical team to decide whether a second dose should be 

administered and under what scenario. 

 It was confirmed that vaccine injuries among children 5-11 years of age would go 

through the CICP. 

EtR Framework: Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5-11 Years 

Dr. Sara Oliver (CDC/NCBDDD) presented the EtR Framework for the policy question, “Should 

vaccination with Pfizer-BioNTech COVID-19 vaccine (2-doses, 10μg, IM) be recommended for 

children 5-11 years of age, under an Emergency Use Authorization?” For the PICO question, 

the population is children aged 5-11 years; the intervention is Pfizer-BioNTech COVID-19 

vaccine (BNT162b2, 2-doses, 10μg, IM); the comparison is no vaccine; and the outcomes are: 

symptomatic laboratory-confirmed COVID-19, hospitalization due to COVID-19, MIS-C, 

asymptomatic SARS-CoV-2 infection, SAEs, and reactogenicity of Grade ≥3. As a reminder, the 

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ACIP Meeting Summary November 2-3, 2021 

EtR domains include the Public Health Problem, Benefits and Harms, Values, Acceptability, 

Feasibility, Resource Use, and Equity. 

Regarding the public health problem, over 45 million COVID-19 cases were reported in the US 

between January 22, 2020 and October 29, 2021. The current 7-day moving average is 

approximately 70,000 cases per day.51 To summarize the epidemiology of SARS-CoV-2, over 

1.9 million cases have been reported in children 5-11 years of age. Infections in children are 

less likely to be reported as cases than infections in adults. Children 5-11 years of age are at 

risk for severe illness from COVID. The cumulative hospitalization rate for COVID is similar to 

pre-pandemic influenza seasons. Severity is comparable among children hospitalized with 

influenza and COVID-19, with approximately 1/3 of hospitalized children 5-11 years of age 

requiring ICU admission. In addition, MIS-C is most frequently reported among children in this 

age group. Post-COVID conditions have been reported in children. Secondary transmission 

from these young school-aged children can and does occur in household and in school settings. 

To put this epidemiology into other contexts, additional hospitalizations per year prior to the 

recommended pediatric vaccines varied by disease. COVID-19 just in children 5-11 years of 

age is in line with many of the diseases for which vaccination is routinely recommend.52 

Average deaths per year prior to recommended pediatric vaccines also varied by disease. In 

just children 5-11 years of age, COVID-19 is among the highest deaths across these now 

vaccine-preventable diseases.53 Through collaborations with the CDC Modeling Team and the 

COVID-19 Scenario Modeling Hub Consortium, multi-model projections were created to 

evaluate the impact of vaccination of children 5-11 years of age on COVID-19 cases and 

hospitalizations in this population.54 They assumed vaccination started November 1, 2021 and 

would have similar uptake rates as adolescents 12-17 years of age. Scenarios projected cases 

prevented in the presence or absence of pediatric vaccination and in the presence or absence 

of a new, more transmissible variant. Their pooled projections showed that vaccination among 

children 5-11 years of age is expected to accelerate the decline in cases currently being 

experienced, reducing the cumulative incidence nationally by an expected 8% (~600,000 cases) 

from November of 2021 through March of 2022. The emergence of a more transmissible variant 

could impact future COVID-19 epidemiology and projected impact. The models estimate that 

vaccination of children 5-11 years of age would dampen but not prevent a resulting resurgence. 

In addition to the severe outcomes of hospitalization, ICU admission, and death, missed school 

is another potential adverse outcome of COVID-19 illness and exposure among children. 

Numerous reports have described the negative impact on the social, emotional, and physical 

health of children, with disproportionate impacts on children of color. The School Dismissal 

Monitoring System performs daily systematic searches of Google, Google News, and Google 

Alerts to assess information on unplanned school closures, including the number of districts, 

individual schools, students, and teachers impacted. In this school year to date, over 2,000 

schools had unplanned closures impacting nearly 1.2 million students. For the 2020-2021 

51 https://covid.cdc.gov/covid-data-tracker/#trends_dailytrendscases 52 https://www.cdc.gov/mmwr/preview/mmwrhtml/ss5603a1.htm (Hepatitis A); Meyer PA, Seward JF, Jumaan AO, Wharton M. 

Varicella mortality: trends before vaccine licensure in the United States, 1970-1994. J Infect Dis. 2000;182(2):383-390 (Varicella) 

doi:10.1086/315714; and https://www.cdc.gov/flu/weekly/weeklyarchives2007-2008/07-08summary.htm (Influenza) 53 Vogt TM , Wise ME, Bell BP, Finelli L. Declining hepatitis A mortality in the United States during the era of hepatitis A vaccination. 

J Infect Dis2008; 197:1282–8; National Notifiable Diseases Surveillance System with additional serogroup and outcome data from 

Enhanced Meningococcal Disease Surveillance for 2015-2019; Meyer PA, Seward JF, Jumaan AO, Wharton M. Varicella 

mortality: trends before vaccine licensure in the United States, 1970-1994. J Infect Dis. 2000;182(2):383-390. 

doi:10.1086/315714; Roush SW, Murphy TV; Historical comparisons of morbidity and mortality for vaccine-preventable diseases 

in the United States. JAMA 2007; 298:2155–63; and Glass RI, Kilgore PE, Holman RC, et al. The epidemiology of rotavirus 

diarrhea in the United States: surveillance and estimates of disease burden. J Infect Dis. 1996 Sep;174 Suppl 1:S5-1 54 https://covid19scenariomodelinghub.org/ 

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school year, at least 19,000 school closures occurred in all 50 US states affecting at least 12 

million students.55 A larger and growing body of literature describes the numeric indirect impacts 

from the COVID-19 pandemic on children. A few of these include worsening of mental or 

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

increasing body mass index (BMI), decreasing healthcare utilization, decreasing routine 

immunizations, increasing Adverse Childhood Experiences (ACEs), and/or loss of caregivers. 

An estimated 140,000 children have lost a caregiver to COVID-19. This is by no means an 

exhaustive list. For all of the indirect impacts, children of color have been disproportionately 

impacted. 

To summarize the public health problem, children 5-11 years of age are at increased risk of 

severe illness from COVID. This includes hospitalization as well as MIS-C. Other post-COVID 

conditions have been seen in children. COVID in children leads to missed school for themselves 

and their communities. Wide use of an effective vaccine would reduce the public health burden 

of COVID in children 5-11 years of age. The WG felt that COVID-19 disease among children in 

this age group is an important public health problem. 

For the domain of benefits and harms, Dr. Oliver provided an overview of GRADE outcomes, 

potential benefits and harms in seropositive children, and potential risk of myocarditis. A 

systematic review was conducted to identify evidence related to the policy question, which 

identified 1 clinical trial for inclusion. There also were data from the trial described earlier for the 

critical outcome of the prevention of laboratory-confirmed symptomatic COVID-19. There was a 

2:1 randomization of vaccine to placebo and a median follow-up time of 3.3 months. The 

primary efficacy endpoint selected was the estimate among children with or without prior 

evidence of SARS-CoV-2 infection as it best reflects what may be seen as a real-world 

estimate. There were 3 COVID cases occurring at least 7 days post-Dose 2 among 

approximately 1,400 children in the vaccine arm and 16 cases among approximately 700 

children in the placebo arm, which resulted in a VE estimate of 90.9%. The Phase 2/3 trial was 

designed and powered to use immunobridging to evaluate efficacy. Immunobridging studies 

compare immunogenicity in a group of interest (e.g., children 5-11 years of age) with a 

comparison group in which efficacy has been demonstrated in clinical trials (e.g., persons 16-

through 25 years of age. The immune response to vaccine in children 5-11 years of age was at 

least as strong as the immune response in young adults 16-25 years of age based on SARSCoV-2 neutralization titers measured one month after Dose 2 in participants without prior 

evidence of SARS-CoV-2 infection. 

In terms of the GRADE evidence table for the outcome of symptomatic laboratory-confirmed 

COVID-19, indirectness was noted due to the short duration of observation. The VE observed 

with a 3-month follow-up may differ from efficacy with ongoing follow-up. However, for GRADE 

specifically under an EUA, this was deemed not serious. This resulted in a final certainty of 

Type 1. 

Data on SAEs from the initial enrollment group were reviewed for all randomized participants 

who received at least one dose of vaccine. SAEs on a safety expansion group also was 

included with an additional 1,500 children in the vaccine arm and 700 children in the placebo 

arm. The median follow-up time for the safety expansion group was 2.4 weeks. Due to the short 

follow-up time in the safety expansion group, SAEs in this population were noted and described 

55 Data from the Unplanned School Closure Monitoring Project (DGMQ/CDC), ongoing research that uses systematic daily media 

searches (methods explained in https://doi.org/10.1371/journal.pone.0248925). 

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ACIP Meeting Summary November 2-3, 2021 

but not pooled for GRADE purposes. In the initial enrollment group, there was 1 SAE of limb 

fracture in 1 child in the vaccine arm and 2 SAEs of pancreatitis and abdominal pain related to 

injury in 1 child in the placebo arm. In the safety expansion group, there were 3 SAEs of 

infective arthritis, foreign body ingestion of a penny, and an epiphyseal fracture in 3 children in 

the vaccine arm. There were no SAEs in the placebo arm within the safety expansion group. No 

SAEs were assessed by the investigator to be related to the study intervention, and no deaths 

were reported in any trial participants. Regarding the GRADE table for SAEs, the relative risk for 

SAEs between the vaccinated and placebo groups was 0.49. Serious concern for indirectness 

was noted due to short follow-up time and sample size. There also was very serious concern for 

imprecision due to the wide confidence intervals, resulting in a final certainty of Type 4. 

Local and systemic events were solicited from participants or their parent or legal guardian via 

an electronic diary for 7 days following each dose. Grade 3 or higher local reactions or systemic 

events were reported in 2.7% of children in the vaccine arm and 1.1% of children in the placebo 

arm. Most of these events were Grade 3, with 1 Grade 4 event of pyrexia reported in a vaccine 

recipient. Events were more common after Dose 2. Pain at the injection site, fatigue, and 

headache were the most common events. The relative risk for any Grade 3 or 4 event was 2.5. 

There was serious concern for imprecision given the wide 95% confidence interval, which 

cannot exclude the possibility of no difference between vaccine and placebo. The final certainty 

was Type 2. 

The conclusion for GRADE is the Phase 2/3 randomized controlled trial (RCT) for the Pfizer 

COVID-19 vaccine was conducted among persons 5-11 years of age. Over 3,000 children were 

vaccinated with BNT162B2. The efficacy estimate against symptomatic laboratory-confirmed 

COVID-19 for children with and without prior infection with SARS-CoV-2 was 90.9%. The 

certainty for this critical benefit was high. SAEs were rare, but the certainty estimate was low for 

this evidence. No SAEs were judged to be related to vaccination and there were no deaths. 

Grade 3 or 4 local or systemic reactions were reported by 2.7% of children who were 

vaccinated. The certainty estimate for this important harm was moderate. 

Moving to potential benefits and harms in seropositive children in the trial, geometric mean titers 

(GMTs) were higher in those with prior infection. Although, the GMTs pre-vaccination among 

seropositive individual were substantially lower than GMTs seen post-vaccination in either 

population. The fold rise was less in the seropositive population, which is likely due to the 

slightly higher GMTs initially. To summarize what is known about COVID-19 vaccines and 

seropositivity with the focus on children, data from the Phase 3 three clinical trial show that 

about 9% of children in the trial were baseline SARS-CoV-2 seropositive. Post-vaccination 

antibodies were higher in children who were seropositive. Rates of local and systemic reactions 

and AEs were lower in children who were seropositive. Based on broader US studies, 

approximately 38% of children 5-11 years of age have evidence of prior infection based on 

seroprevalence estimates from residual commercial laboratory sera. Prior infection can result in 

some protection against infection, but not 100% and likely decreases over time. Children have a 

greater proportion of asymptomatic infection relative to adults, and asymptomatic infection can 

result in lower antibody levels compared to severe disease.56 

56 Viner RM, Ward JL, Hudson LD, et al. [published online ahead of print, 2020 Dec 17]. Arch Dis Child. 2020;archdischild-2020-

320972; Irfan O, Muttalib F, Tang K, Jiang L, Lassi ZS, Bhutta Z. [published online ahead of print, 2021 Feb 16]. Arch Dis Child. 

2021;106(5):440-448; Dawood FS, Porucznik CA, Veguilla V, et al. [published online ahead of print, 2021 Oct 8]. JAMA Pediatr. 

2021;10.1001/jamapediatrics.2021.4217. doi:10.1001/jamapediatrics.2021.4217; and Poline J, Gaschignard J, Leblanc C, et al.. 

Clin Infect Dis. 2021;72(12):2215-2217. doi:10.1093/cid/ciaa1044. 

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Considering the balance of benefits and risks by seropositive status, Delta wave surges 

of pediatric COVID hospitalizations occurred even with the known seroprevalence, suggesting 

that this alone is not sufficient to provide broad protection for children. There are limited data on 

rates of reinfection in children. Protection against asymptomatic or mild infection is still an 

important outcome in children. MIS-C typically occurs after asymptomatic or mild infection. 

Additional post-COVID conditions also can occur after mild infection. Over 400 million doses of 

COVID-19 vaccines have been administered to persons 12 years of age and over. No concerns 

have been identified in post-authorization safety surveillance with seropositive adolescents and 

adults. Individuals 12-64 years have seropositivity of over 30%. Vaccine recommendations that 

require serologic testing place unnecessary barriers to vaccination and would be difficult to 

implement. While there may be limited data to estimate the direct impact of vaccination on 

seropositive children, the risks are minimal. Based on that, the balance of benefits and risks is 

favorable for vaccination of all children 5-11 years of age. 

Concerning vaccine-associated myocarditis, identified rates of myocarditis are based on data 

from adolescents and adults receiving a 30 μg dose of Pfizer-BioNTech COVID-19 vaccine, 

which is different from the dose proposed for this age group. Myocarditis is a rare event that is 

most common in males 12-29 years of age. No cases of myocarditis occurred during the clinical 

trials in this pediatric population of children 5-11 years of age. A formal benefit-risk assessment 

was conducted in this population. In terms of the estimated benefits for every million Pfizer 

vaccinations given in children 5-11 years of age using recent incidence projecting out over 6 

months and using epidemiologic data from mid-September, over 50,000 cases, hundreds of 

hospitalizations, and 130 MIS-C cases, and 60 ICU cases would be prevented in children. Given 

that recent epidemiology estimates were from close to the peak of the recent Delta surge, other 

epidemiology estimates were made for context. Looking back at the pandemic average and 

smoothing out all the previous peaks and troughs to determine a pandemic average, the 

prediction would be that nearly 20,000 cases of COVID-19, 80 hospitalizations, and 40 MIS-C 

cases would be prevented. 

The rates of myocarditis after vaccination among children 5-11 years of age are unknown. No 

cases occurred during clinical trials. While the underlying epidemiology of viral myocarditis 

varies greatly between children 5-11 years of age and adolescents 12-17 years of age, 

myocarditis after vaccination is substantially lower in children 5-11 years of age than 

adolescents 12-15 years of age. The dose used in children 5-11 years of age is a third 

of the one used in adolescents. A formal risk-benefit assessment cannot be conducted in those 

5-11 years of age due to these factors. However, estimated rates of myocarditis after 

vaccination in adolescents 12-15 years of age per million second doses total 21.5 in VAERS 

and 60.2 in VSD. The outcomes for vaccine-associated myocarditis are reassuring, making it 

possible to think through the benefit-risk balance. The benefits include prevention of COVID-19 

cases, hospitalizations, MIS-C, deaths, and additional post-COVID conditions. There also could 

be possible prevention of transmission and a greater confidence in safer return to school and 

social interactions. Risks include possible myocarditis or other rare AEs after mRNA 

vaccination; however, short-term reactogenicity data are reassuring in terms of the possible risk 

of myocarditis or other rare events after receipt of mRNA vaccines. 

Regarding the number of children 5-11 years of age needed to vaccinate to prevent a case 

of COVID-19, COVID-associated hospitalization, or an MIS-C case, the absolute numbers 

depend on the epidemiology. Using the current epidemiology, less than 10 children 5-11 years 

of age would need to be vaccinated to prevent a case of COVID-19. 

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ACIP Meeting Summary November 2-3, 2021 

To summarize benefits and harms, the clinical trial demonstrated that the Pfizer-BioNTech 

COVID-19 vaccine is safe, immunogenic, and efficacious in children 5-11 years of age. The trial 

was not powered to assess the rate of rare AEs, but no cases of myocarditis were identified in 

over 3,000 vaccinated children. The balance of benefits and risks varies by COVID incidence as 

with all previous analyses, with the largest benefits in higher incidence settings. The balance of 

benefits and risks is favorable regardless of seropositivity rates. While many children 5-11 years 

may be seropositive, duration of protection is unknown for asymptomatic infection in children. 

Safety data are reassuring in the seropositive population. The WG felt that the desirable 

anticipated effects are large and the undesirable anticipated effects are small. Therefore, the 

balance favors the intervention. 

Moving to the values domain, there have been several parental surveys to assess intent to have 

children vaccinated. Among parents surveyed 34% to 57% plan to get their children vaccinated. 

Parental intent varies by several factors, with 90% of parents who are very worried their child 

would get COVID-19 reporting an intent to vaccinate their child compared to 7% of parents who 

are not worried at all. In addition, 82% of fully vaccinated parents report an intent to vaccinate 

their child compared to 1% of parents who are unvaccinated and do not plan to get vaccinated. 

Recommendations from a child’s healthcare provider is important. Among parents of teens who 

discussed vaccination with their pediatrician, 3/4 of those whose pediatrician recommended 

vaccination say their child received at least one dose.57 Those intending to vaccinate their child 

vary by age of the child as well as by race and ethnicity.58 Based on data from a survey of 1,000 

US parents of children 5-11 years of age in September 2021, 57% of parents stated that they 

definitely or probably would get their child vaccinated. Parents frequently reported concerns for 

long- or short-term side effects (e.g., fever, anaphylaxis, or myocarditis), lack of trust for the 

vaccine, or that their child does not need the vaccine as reasons not to get the vaccine. Among 

the parents surveyed, 37% reported side effects as a reason for not wanting a COVID-19 

vaccine for their child. The WG determined that the target population felt that the desirable 

effects are moderate compared to the undesirable effects and that there is probably important 

uncertainty or variability in how people value these outcomes. 

Moving to the acceptability domain, over 70% of VFC providers were enrolled as COVID-19 

vaccine providers as of October 15, 2021. These providers represent over 80% of VFC vaccines 

distributed in 2019 for influenza and MMR. As an American Academy of Pediatrics (AAP) survey 

demonstrated, 75% of primary care pediatricians reported that their main work setting is 

enrolled as a COVID-19 vaccine provider and 70% are already giving vaccine to those 12 years 

of age and older in their practice. To summarize acceptability, most jurisdictions plan to utilize a 

variety of implementation strategies to vaccinate children 5-11 years of age. Parents report the 

greatest comfort with receiving a COVID vaccine at their primary care provider’s office. 

Jurisdictions anticipate that most children will be vaccinated at these providers. Over 70% of 

VFC providers are already enrolled as COVID providers. The WG group felt that the Pfizer 

vaccine is acceptable to key stakeholders for children. 

57 Szilagyi PG, et al. Parents' Intentions and Perceptions About COVID-19 Vaccination for Their Children: Results From a National 

Survey [published online ahead of print, 2021 Aug 3]. Pediatrics. 2021;e2021052335; Ruggiero KM, et al. Parents' Intentions to 

Vaccinate Their Children Against COVID-19 [published online ahead of print, 2021 Jun 30]. J Pediatr Health Care; Brenan M. In 

U.S., 55% Would Get COVID-19 Vaccine for Young Child. Gallup. September 28, 2021. Available at: 

https://news.gallup.com/poll/354998/covid-vaccine-young-child.aspx . Accessed October 1, 2021; Unpublished data from the 

CDC, the University of Iowa, and RAND Corporation Survey of Parents, September 2021; Gallup Panel Poll. Available at 

https://news.gallup.com/poll/354998/covid-vaccine-young-child.aspx. Accessed September 29, 2021; and Lopes L, et al. KFF 

COVID-19 Vaccine Monitor: Available at: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitortrends-among-children-school/ Accessed: October 1, 2021. 58 Szilagyi PG, et al. Parents' Intentions and Perceptions About COVID-19 Vaccination for Their Children: Results From a National 

Survey [published online ahead of print, 2021 Aug 3]. Pediatrics. 2021;e2021052335 

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Regarding the feasibility domain, implementation goals were described earlier to reach the most 

children, including those who are hard-to-reach. There are approximately 28 million children 5-

11 years of age in the US.59 There are some feasibility concerns with regard to the formulation 

for the vaccine for children 5-11 years of age, given that it may lead to administration errors. 

Provider education regarding this must be ongoing. In addition, this new formulation can be 

stored at refrigerator temperatures for up to 10 weeks prior to use and has a 100-dose minimum 

order size. The WG felt that the vaccine is feasible to implement among children 5-11 years of 

age. 

For the resource use domain, the US government has purchased enough vaccine to support 

vaccination of the pediatric population. The vaccine will be available at no cost. Costeffectiveness may not be a driver in the pandemic, but will be reassessed in the future. The use 

of COVID-19 vaccines in as many populations as possible likely will have a positive economic 

impact in terms of returning to pre-pandemic activities. The WG felt that the vaccine is a 

reasonable and efficient allocation of resources. 

With respect to the equity domain, some children may be disproportionately affected by COVID19 and/or access to healthcare due to place of residence, race/ethnic, gender/sexual identity, 

socioeconomic status, personal characteristics associated with discrimination, and/or features of 

relationships such as family stability or not being enrolled in school. There are disparities among 

adolescents in terms of COVID-19 vaccine coverage based on the National Immunization 

Survey (NIS)-Teen survey conducted in September 2021. The proportion of those who are 

vaccinated already or who definitely/probably will get vaccinated varies by sex, age, and race. 

This unrealized intent is also quite high for those living below poverty and those living in rural 

areas. While there are no data on inequities with the vaccine in children 5-11 years of age, 

lessons learned from the adolescent population can be considered. Nearly 5 months after the 

adolescent vaccine rollout, there remains unrealized intent for adolescent COVID-19 vaccine. 

This is largest for adolescents living in poverty and rural areas. It is critical for CDC and public 

health partners to redouble efforts for equitable access to COVID-19 vaccines. This can include 

novel strategies, such as school-located vaccinations. There are a variety of other opportunities 

to increase the equitable access, including utilizing trusted providers in the medical home, 

partnering with school-located clinics to reach those without a medical home, and utilizing the 

broad reach of pharmacies. As with previous EtR Framework presentations, the WG struggled 

with the impact of a Pfizer vaccine among children on equity. Broad prevention of disease, 

especially disease that has disproportionately impacted communities of color and lower income 

communities, can provide equity only if every effort is made to ensure that the intervention is 

accessible to all. 

To summarize the conclusions for each of the WG judgements, the WG discussed that vaccine 

policy decisions are made on the balance of known benefits and risks to the individual. Other 

benefits (e.g., prevention of transmission, greater confidence in return to school or social 

interactions, and risks such as extrapolation of myocarditis risks from other ages) are part of a 

broader picture. There is experience with over 400 million doses of mRNA vaccines 

administered to people 12 years of age and over with a reassuring safety profile. Overall, the 

benefits outweigh the risk regardless of seropositivity rates. Thinking about the direct impact of 

vaccination of children 5-11 years of age, there is over 90% efficacy in the prevention of COVID19 cases. There also is likely prevention of COVID-19-related post-COVID conditions, MIS-C, 

hospitalizations, ICU admissions, and deaths and the possibility for more social interactions and 

uninterrupted school. Children are also part of a family. Vaccination of children possibly could 

59 US Census Bureau, Population Division, 2020 Demographic Analysis 

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prevent transmission to vulnerable family members. If a family’s children are not getting sick, 

parental participation in a workforce may be more stable and predictable. Children also live 

within a community. Vaccination of children could result in lower transmission within schools in a 

community and could result in a more confident return to in-person learning. 

As with all ages and vaccines, next steps would include ongoing close monitoring and postauthorization safety surveillance. As was done for Pfizer vaccine recommendations in those 16 

years of age and over, the vaccine recommendations made under EUA are interim and will be 

reviewed at the time of Biologics License Application (BLA) submission. At that time, there will 

be longer-term follow-up data for children enrolled in the clinical trials. The benefit-risk analysis 

can be updated with additional data from the clinical trials, as well as post-authorization safety 

surveillance. Evaluation will continue of ways to mitigate risk of rare events after vaccination. 

Plans are already in place for post-authorization monitoring VE, so it is possible that estimates 

will be available as early as 90 days after authorization. As always, this will depend upon 

vaccine coverage and rates of disease. 

Since the beginning of the COVID-19 pandemic, there have been 1.9 million cases of COVID-19 

disease among US children 5-11 years of age. There also have been 8,300 hospitalizations, 

over 2,000 MIS-C cases, and at least 94 deaths in this age group. COVID-19 is vaccinepreventable, meaning that there is now an ability to prevent the burden of disease, future 

hospitalizations, and deaths from COVID-19 in children 5-11 years of age. Considering the 

totality of the data, the WG felt that the desirable consequences clearly outweigh the 

undesirable consequences in most settings and proposed to recommend the intervention. 

Liaison Organization Statements 

Dr. Bonnie Maldonado 

American Academy of Pediatrics 

I’d like to read a statement on behalf of the American Academy of Pediatrics in my role as Chair 

and representing the Committee on Infectious Diseases for the Academy. This is our stand on 

COVID-19 vaccines in children and adolescents. Vaccines are safe and effective in protecting 

individuals in 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 before authorization recommendations. The American Academy of Pediatrics 

recommends the following related coronavirus disease 2019 or COVID-19 vaccine in children 

and adolescents. The AAP recommends COVID-19 vaccinations for all children and 

adolescents 5 years of age and older who do not have contraindications using a COVID-19 

vaccine authorized for use for their age. Any COVID-19 vaccine authorized through Emergency 

Use Authorization or approved through a Biologic License Application by the US Food and Drug 

Administration, recommended by the CDC, and appropriate by age and health status can be 

used for COVID-19 vaccination primary series, additional doses, or booster doses according to 

CDC guidelines for children and adolescents. Children with prior infection or disease with 

SARS-CoV-2 should receive COVID-19 vaccination according to CDC guidelines. Given the 

importance of routine vaccination and the need for rapid uptake of COVID-19 vaccines, the AAP 

supports co-administration of routine childhood and adolescent immunizations of COVID-19 

vaccines or vaccination the day before or after for children and adolescents who are behind on 

or due for immunizations based on the CDC/AAP recommended children and adolescent 

immunization schedule and/or at increased risk for vaccine-preventable diseases. Pediatricians 

are encouraged to promote vaccinations through ongoing proactive messaging. For example, 

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reminder recall, vaccine appointments, and clinics as well as to use existing patient visits as an 

opportunity to promote and provide COVID-19 vaccines. Pediatricians’ role in promoting 

vaccination among their patient population and in their community is critical, especially among 

those of highest risk for severe illness, hospitalization, and death from COVID-19, as well as 

their household contacts. Parents, caregivers, and patients might have questions that need to 

be addressed related to the vaccine. Pediatricians play an essential role in helping answer 

these questions, as well as in reducing existing disparities in addressing any barriers to 

accessing COVID-19 vaccine in the community. For additional guidance on the administration 

of COVID-19 vaccine, storage, handling, reporting, and patient education for each specific visit, 

please visit the appropriate CDC and AAP websites at AAP.org. 

Pamela Rockwell 

American Academy of Family Physicians 

Hi, this is Pamela Rockwell, liaison to the American Academy of Family Physicians. The AAFP 

strongly supports COVID-19 vaccination in all eligible children 5-11 years of age as authorized 

by the FDA. Vaccination will provide children protection from the very real and significant harms 

of COVID-19 infection. In speaking as a family physician with 30 years of clinical experience 

treating both children and adults in my practice, I have seen the devastating effects of COVID19 infection, not only in my patients who have died from the disease, but also in those who have 

survived and now suffer from long-term effects of COVID-19. They suffer physical, mental, and 

emotional effects of long-haul COVID. And as we have seen in the presentations today, longhaul COVID also occurs in children and data are still emerging. Vaccination of children ages 5-

11 years will not only help prevent COVID-19 infection and serious consequences of infection in 

this age group, but it will also help children emotionally and socially to improve their 

development. It will help reduce inequities in the impact of COVID-19 on our population, reduce 

the need for future school closures, disruptions, and obligatory times of quarantine, allowing 

sports after school and other school-based and social activities to occur without risk and 

anxiety, and help improve our children’s quality of life, not just prevent COVID-19 illness and 

death in children and all the adults around them. 

Ms. Patsy Stinchfield

National Association of Pediatric Nurse Practitioners 

As the ACIP liaison representative for America’s Pediatric Nurse Practitioners, I want to offer 

our strong support of the use of Pfizer-BioNTech pediatric formulation equitably distributed to all 

children 5-11 years of age, as you heard during our public comment from our NAPNAP 

president. We cannot reliably predict which child will have severe disease, with 1/3 of those 

children admitted to hospitals not having any underlying condition. We have heard the national 

data today, which includes the nearly 800 deaths of children, which is 4 times that of the annual 

influenza deaths, 94 children in the 5-11-year-old age group. For parents and clinicians, there is 

an urgency to act. To look at this at a local level, at just one of the United States’ 250 children’s 

hospitals, last week alone, as an example, Children’s Minnesota tested 107 children positive for 

COVID. Eighteen of those children were admitted to the hospital. Half of them went to the ICU. 

None of them were vaccinated and half of them were not age eligible for vaccines. We must 

protect our kids directly, which, in turn, protects families and the community at large against 

both direct and indirect harms from COVID disease. Having been called to the PICU over my 34 

years as a pediatric nurse practitioner in infectious disease to talk to parents of children on life 

support for vaccine-preventable diseases, such as HIB, measles, and influenza, the common 

sentiment parents in that situation expressed is regret. Their question is, “Why didn’t we 

vaccinate? We didn’t know that children could get this sick.” While hospitalization and death in 

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ACIP Meeting Summary November 2-3, 2021 

children from COVID-19 is rare, even one child and family loss is one too many when we have a 

safe and efficacious vaccine. We urge the committee to vote to recommend COVID vaccine for 

all children and encourage all families to enroll your child in the v-safesm program. We must 

remove all barriers and not put up more new ones. We encourage all clinicians to report 

anything unusual to VAERS. All things considered, this is ultimately a risk-benefit decision for 

ACIP, parents, and clinicians. And we agree, all measures point to COVID vaccine in 5-11-yearolds is a greater benefit than the real risk of children being unvaccinated. Pediatric nurse 

practitioners will be strongly recommending vaccination to our patients. Thank you for your 

commitment. 

Dr. Shawn O’Leary

Pediatric Infectious Diseases Society 

Thank you, Dr. Lee, and thanks to all of the great presenters today. This is on behalf of the 

Pediatric Infectious Diseases Society. The Pediatric Infectious Diseases Society, the world’s 

largest organization of pediatric infectious diseases specialists, strongly supports a universal 

recommendation for COVID-19 vaccination of children 5-11 years of age as authorized by the 

FDA. PIDS also strongly encourages efforts to ensure equitable access to pediatric COVID-19 

vaccine. More than 28 million children will be eligible for vaccination against COVID-19 with this 

recommendation. To date, over 6 million children have been diagnosed with COVID-19. 

Vaccination will provide children with critical protection against serious disease and long-term 

complications of COVID-19 and will help bolster overall immunity in the community. Vaccinating 

school-aged children has other benefits, such as limiting disruptions in school attendance, which 

allows children to participate in learning and other activities that are crucial to mental health and 

development. PIDS is encouraged that the federal government has developed a vaccine 

implementation plan that includes pre-purchasing vaccine dosage for children and outlining a 

multi-pronged distribution strategy. The federal government and state and local partners should 

collaborate with trusted community-based organizations to ensure equitable vaccine access and 

uptake. This is a good time for parents to ensure that children are also up-to-date on all of the 

other recommended vaccines of childhood, including seasonal influenza. Don’t procrastinate. 

Vaccinate. Thank you. 

Dr. Michael Hogue

American Pharmacists Association 

The American Pharmacists Association is very supportive of routine immunization of children 5-

11 with COVID-19 vaccine. We strongly believe that the benefits outweigh the risks. There were 

great presentations that we saw today. I do want to remind consumers who may be listening to 

this presentation that vaccinations are a part of a child’s well-development. There are many 

things that pediatricians want to visit with you as a parent and your children about when you 

have a healthcare encounter. We would encourage you to have conversations with your 

pediatricians, to follow-up on well-child visits that may have been missed during the pandemic, 

and to catch up on the vaccines that you need by working with your pediatric office. That said, 

community pharmacies are accessible in local communities and rural areas and sometimes in 

places where it may be inconvenient and not possible to get to your primary care provider’s 

office. Pharmacists are more than willing to help ensure that vaccine is available and to 

administer those vaccine doses. We do want to advise parents, however, that you should 

expect to have to make an appointment at a pharmacy to get vaccinated and you should expect 

that there may be a longer than normal waiting time. We are experiencing staffing shortages in 

pharmacies, much like the rest of the workforce is experiencing shortages of personnel. We just 

want to set an expectation with consumers on being able to get vaccinated. 

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ACIP Meeting Summary November 2-3, 2021 

Dr. Patricia Whitley-Williams

National Medical Association 

Thank you for this great presentation. While equitable access to this vaccine was mentioned, 

and particularly at appropriate facilities (e.g., pharmacies, community health centers, and 

children’s hospitals, physician’s offices), there are lessons that we learned through our 

experience with the rollout of the adult COVID-19 immunizations. It taught us valuable lessons 

and if we really look at our experience, community health centers and community-based 

vaccination sites made access more equitable, particularly in communities of color. Not all 

communities of color have the larger pharmacies based right in their community. At the top 10 

children’s hospitals, most of which are located in major cities and serve diverse populations of 

children, if they were to be a major player and successful in outreach, that would be extremely 

supported. I think what is not taken into account, and that is that parents or guardians of 

children, especially in communities of color, may be working and having a necessity to work. We 

do not have the buy-in from all employers to protect the employment of those individuals or loss 

of wages of those parents to take time off and to take their child or children to get vaccinated. I 

think it is critical for us to continue to monitor the equitable access issue. I think the other 

consideration is the need for children to be in school because some of the children who are at 

highest risk depend on their schools as a safe haven as well as a source of 2 meals a day, 5 

days a week. To get the 5-11-year-old school-age children vaccinated will provide protection, 

especially when they are in school. And hopefully, they will continue to stay in school. The 

National Medical Association will continue to provide education to its membership, many of 

whom practice in communities of color and continue to conduct educational outreach programs 

to persons and communities of color. We certainly support the vaccination and rollout to 

continue to protect the public, particularly those who are most vulnerable. Thank you. 

Discussion Summary 

• While it is impressive that the new formulation can be stored at refrigerator temperatures for 

up to 10 weeks, it is important to emphasize to pediatric offices and pharmacies that the 

vaccine must be used within 6 hours once opened. CDC noted that they have 

communicated this message to health departments and clinical partners to ensure that this 

aspect of the vaccine is being incorporated into implementation plans. 

• For future meetings, it would be beneficial to have the number needed to vaccinate (NNV) to 

prevent 1 case of COVID-19 among adults. 

• Sentiment was expressed that this recommendation needs to stand on its own merit, 

meaning that the benefits of vaccinating an individual child strongly outweigh the vaccination 

risks for that very same child. Children in this age group in the US are dying from COVID-19. 

This includes children who were healthy and did not have any underlying chronic medical 

conditions. Real-world in adults demonstrates that deaths from COVID-19 are vaccinepreventable. In any context, it should be considered a tremendous medical breakthrough 

that death can be prevented through vaccination. The available safety evidence comes not 

only from the clinical trial in this age group, but also from the safety knowledge that has 

been gained from vaccinating several hundred million adults and adolescents with this 

vaccine. 

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ACIP Meeting Summary November 2-3, 2021 

• Regarding an inquiry about whether the vaccine rollout for the formulation for children 5-11 

years of age would be similar to the Pfizer adult formulation, Dr. Chatham-Stevens indicated 

that the approach to this vaccine rollout would be somewhat different in that a large initial 

bolus of vaccine will be distributed to jurisdictions, pharmacies, and some federal entities. 

After that initial bolus, there will be a more titrated approach with weekly doses going out as 

well. CDC has been encouraging jurisdictions, pharmacies, and providers who are getting 

vaccine to take into account how they will manage their second doses to ensure that 

everyone is aware and planning for that contingency. 

• It was observed that one of the most dramatic numbers in the presentations during this 

session was that the number of deaths per year prevented with COVID-19 vaccine was 3 

times the number of those prevented with other standard childhood vaccines routinely given 

to children. Vaccinating children also helps prevent spread to other children and to adults in 

the community, especially those who would be less well-protected by vaccination. Too many 

children have either lost a parent or become orphaned in this pandemic, which is incredibly 

tragic. 

• Regarding an inquiry about whether the majority of the WG supported the proposed 

recommendation for this age group, Dr. Oliver indicated that the WG reviewed and 

discussed the data and felt strongly that the vaccine should be recommended for this 

population. 

• For members of the public listening to the meeting, it was emphasized that the WG is 

comprised of several ACIP liaison members and additional consultants from the healthcare 

setting. As seen earlier with their public statements, many organizations (AAP, AAFP, PIDS, 

APhA) emphasized the importance of this vaccine to their members and their patients. 

• Numerous ACIP members stressed that in addition to being practicing professionals (e.g., 

pediatricians, adult practitioners, infectious disease specialists, immunologists, pharmacists, 

et cetera) they are parents and grandparents who fully support recommendation of Pfizer 

COVID-19 vaccine use in children 5-11 years of age—including in their own children and 

grandchildren. 

• With regard to an inquiry about COVID-19 vaccine and fertility, Dr. Reddy (ACOG) indicated 

that a lot of data have been reviewed regarding COVID-19 vaccine safety in pregnant 

women, women who want to get pregnant, and women who were recently pregnant and are 

now breastfeeding. All of the evidence supports the recommendation to vaccinate women in 

all of those categories. 

• ACIP members recognized the importance of dissenting voices, emphasized that they heard 

loud and clear that some parents remain concerned about COVID-19 vaccination, and 

stressed that it is understandable to have questions and concerns. Given that there seems 

to be a deliberate campaign of disinformation, parents were encouraged to talk to their 

child’s pediatrician or family physician to express concerns and ask questions. Pediatricians 

and family physicians know the family, child, and medical history and can help to walk 

through the information with them. 

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ACIP Meeting Summary November 2-3, 2021 

Vote: Pfizer COVID-19 Vaccine Use in Children 5-11 Years of Age 

Dr. Oliver (CDC/NCBDDD) reminded everyone that based on the available data, the WG 

interpreted that the desirable consequences clearly outweigh the undesirable consequences in 

most settings and that they proposed to recommend the intervention. The proposed vote 

language read as follows: 

The Pfizer-BioNTech COVID-19 vaccine (2-doses, 10μg, IM) is recommended for 

children 5-11 years of age under the FDA’s Emergency Use Authorization. 

Motion/Vote: Pfizer COVID-19 Vaccine Use in Children 5-11 Years of Age 

Dr. Kotton made a motion for ACIP to adopt an interim recommendation stating that “The PfizerBioNTech COVID-19 vaccine (2-doses, 10μg, IM) is recommended for children 5-11 years of 

age under the FDA’s Emergency Use Authorization.” Ms. Bahta seconded the motion. Dr. Chen 

reminded everyone that his employer, the University of Maryland Baltimore, has a grant from 

Emergent BioSolutions that supports research he conducts on developing a Shigella vaccine. 

With 14 affirmative votes, 0 negative votes, and 0 abstentions, the motion carried. The 

disposition of the vote was as follows: 

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

Poehling, Sanchez, Talbot

 0 Opposed: N/A 

0 Abstained: N/A 

Member Statements 

Subsequent to the votes, Dr. Lee invited ACIP members to make a statement about the 

rationale for their vote and/or to share any additional general comments. 

Dr. Daley indicated that the reason he voted for this individual protection was because he 

values preventing infection in children and thought it could have a huge positive impact on their 

health, social and emotional well-being, educational outcomes, and long-term trajectory. While 

other ways are available to prevent infection such as masking, it is known that there is 

substantial variability in the use of masks in school settings, transmission can occur, and 

vaccines are the only consistent and reliable way that protection can be provided to these 

children other than cocooning them at home to minimize their risk. This deprives them of many 

other important aspects of their childhood. He also emphasized the importance of continuing to 

invest resources and effort in understanding the broader health and non-health impacts of 

COVID-19 infections in the pediatric population and in children in general. He expressed his 

hope that this recommendation would take them one step further along in that journey. He also 

highlighted what Dr. Whitley-Williams mentioned about disparities continuing to exist and the 

need to make additional efforts, in partnership with communities, where the need is the greatest. 

This seems to him to be an incredibly important investment in their efforts, in addition to making 

sure that children are able to seek care in their medical homes. 

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ACIP Meeting Summary November 2-3, 2021 

Dr. Talbot stressed that while there seemed to be an impression that ACIP members are not 

parents or people, many of them spoke up as parents throughout the day. She has reviewed the 

data and has vaccinated her children because feels like it is safe. She would not recommend 

something if she did not feel that way. Therefore, she thought it was very important to reiterate 

what many of them said, “We are parents and we have given this to our children because we 

have seen the devastation of this disease and the destruction in our kids’ lives and are looking 

forward to moving forward.” 

Ms. McNally indicated that she also has a child in this age group and was going to take that 

child to get this vaccine. She has gotten her other children vaccinated as they are in the older 

age group. She is doing this to prevent the 95th death. Some 94 parents have had to bury their 

child, 8300 children have been hospitalized,1.9 million lives have been disrupted by cases, and 

2300 families have experienced a child with multiple organ failure. To say that this disease is 

not impacting children is not an accurate statement. She expressed hope that people would 

understand that. She also took a moment to talk to providers caring for children in this age 

group to emphasize the importance of recommending this vaccine and the significance on 

families if not. She expressed her confidence in the US’s vaccine safety monitoring system and 

stressed that she felt very comfortable as a parent and as the consumer representative 

recommending that children 5-11 years of age be vaccinated. 

Dr. Brooks emphasized to the public at large that the vote ACIP took was based on the data that 

brought them to this conclusion and recommendation. For those who may be conflicted due to 

misinformation, he clarified that ACIP members have nothing to do with employment termination 

regarding mandates or what happens once this recommendation is made. 

Dr. Bell stated that all of the ACIP members have a lot of enthusiasm for this vaccine in this age 

group, but also understand that parents have legitimate concerns and legitimate questions. 

ACIP’s vote is a way of telling the American public that, based on their expertise and the 

information that they have, they are very enthusiastic. Many members talked about getting their 

children and grandchildren vaccinated. Another point to be made to the American public is that 

ACIP members do understand that people have legitimate concerns and a lot of questions and 

encourage them to ask their providers, visit the CDC website, talk their friends, talk to other 

parents, and do what they need to do to feel comfortable with their decision. 

Dr. Loehr said that like his colleagues, he feels that this is a safe and effective vaccine with 

more benefits than risks. 

Dr. Lee thanked the committee members for their incredible and ongoing service to the country. 

She also expressed gratitude to all of the speakers of the day for their outstanding presentations 

and all of their federal colleagues and liaisons for supporting ACIP with the robust discussion 

throughout the day. 

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ACIP Meeting Summary November 2-3, 2021 

WEDNESDAY: NOVEMBER 3, 2021 

WELCOME AND INTRODUCTIONS 

Call to Order / Roll Call 

Dr. Grace Lee (ACIP Chair) called to order and presided over the meeting. She conducted the 

roll call during which no new COIs were identified or declared. A list of Members, Ex Officios, 

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

document. 

HEPATITIS VACCINES 

Session Introduction 

Dr. Kevin Ault (ACIP, WG Chair) provided the session introduction on behalf of the Hepatitis 

Vaccines WG. He indicated that Dr. Wang would present the WG’s considerations for universal 

adult hepatitis B vaccination recommendations and would review how the risk-based strategy 

has been given over a decade to prove itself. The risk-based strategy has not panned out 

because of the complex list of risk factors, many of which do not lend themselves to well-defined 

identifiable populations who regularly access care in dedicated locations or the structure of 

current clinical practice. The guiding principles for these considerations are to decrease new 

hepatitis B infections, prevent ongoing transmission, and reduce health disparities. HHS has 

called for the elimination of viral hepatitis as a public health threat by 2030.60 The National 

Academies of Science, Engineering, and Medicine (NASEM) has provided a roadmap to 

achieve viral hepatitis elimination. Their report emphasized the role of vaccination and called for 

expansion and simplification of adult hepatitis B immunization recommendations.61 

Looking at the rates of reported hepatitis B in the US over the past 15 years stratified by age 

group, the success achieved over the past 20 to 30 years in the US is a result of the 

implementation of universal adult and infant hepatitis B vaccination. The rate of new infections 

among persons 20-29 years of age dropped from 3.5 in 2014 to 0.5 in 2019. There also have 

been extremely low infection rates among persons 0-19 years of age over the past decade. 

Unfortunately, the level of success achieved among children, adolescents, and young adults 

less than 29 years of age has not been achieved among adults 30 years of age and older. 

There has been a slow rate of decline among adults 30-39 years of age and increasing rates 

among adults 40 years of age and older. It is important to note that this is about half of all 

people with acute hepatitis B when the available risk factor data do not report any identifiable 

risks.62 

60 https://www.hhs.gov/sites/default/files/Viral-Hepatitis-National-Strategic-Plan-2021-2025.pdf 61 https://www.nationalacademies.org/our-work/a-national-strategy-for-the-elimination-of-hepatitis-b-and-c 62 https://www.cdc.gov/hepatitis/statistics/2019surveillance/index.htm 

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ACIP Meeting Summary November 2-3, 2021 

The current risk-based hepatitis B vaccination strategy has taken public health as far as it can 

and falls short of the goal of elimination. In the past 10 years, the total number of hepatitis B 

cases has plateaued at more than 20,000 estimated new infections every year. Furthermore, 

rates of new cases are highest among adults 30 years of age and older and have been 

increasing among adults 40 years of age and older. Despite 16 different categories of risk (e.g., 

blood and sexual exposure, diabetes, household contact, living with someone with hepatitis B, 

et cetera), determining risk for vaccination across all those categories is not easily incorporated 

into clinical practice/provider screening. The risk-based strategy also assumes patient 

recognition and disclosure of risk and exacerbates health disparities, favoring patients with a 

higher degree of health literacy and engagement in care. 

The Hepatitis Vaccine WG has been deliberating universal hepatitis B vaccinations for several 

years and is unanimous in proposing the universal hepatitis B vaccination recommendation. 

During the fall 2016 ACIP meeting, the topic of universal hepatitis B adult vaccination was 

initially suggested to the ACIP as the next step toward hepatitis B elimination. In 2016, 2017, 

and 2018, the WG focused on evaluation of HEPLISAV-B vaccine and updates to the hepatitis 

A policy. Since 2019, the WG has focused its review and discussion in 15 WG calls on a 

universal hepatitis B protocol. This brought them to the in-depth presentation and economic 

model during the February 2021 ACIP meeting, during which ACIP members advised the WG 

to move forward with a universal hepatitis B immunization recommendation. Based on that 

advice, the WG presented the EtR Framework and GRADE analysis during the September 2021 

ACIP meeting. 

In the context of all evidence presented and considered over the past 2 years with the SMEs 

comprising ACIP’s Hepatitis Vaccines WG, the WG unanimously agreed that the current riskbased recommendations need revision, with the majority preferring a universal adult hepatitis B 

strategy with no upper age limit. There was no WG support for retaining the current risk-based 

recommendations. Two scenarios were presented for ACIP consideration: 

WG Preferred 

All adults previously unvaccinated for hepatitis B 

should receive hepatitis B vaccination. 

WG Alternative 

Adults aged ≤59 years and previously

unvaccinated for hepatitis B should receive 

hepatitis B vaccination. 

Note: Adults >59 years would continue to follow 

existing risk-based recommendations. 

Considerations for a Universal Adult HepB Recommendation 

LCDR Mark Weng, MD, MSc, FAAP (CDC/NCHHSTP) presented considerations for universal 

adult hepatitis B vaccinations on behalf of the Hepatitis Vaccines WG. There are 20,700 

estimated acute hepatitis B infections annually in the US.63 Over $1 billion is spent on hepatitis 

B-related hospitalizations each year, not including indirect costs. Almost 2 million people are 

estimated to be living with chronic hepatitis B in the US,64 among whom there is a 15% to 25% 

risk of premature death from sclerosis or liver cancer.65 The WG’s goal is to examine hepatitis B 

vaccine policy and propose strategies that are most effective at preventing new infections 

63 https://www.cdc.gov/hepatitis/statistics/2019surveillance/HepB.htm 64 Wong et al. Am J Med. 2021 

65 https://www.cdc.gov/std/treatment-guidelines/hbv.htm 

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ACIP Meeting Summary November 2-3, 2021 

and hepatitis B-related cancer and death. It is in this context that the WG was proposing that the 

existing risk-based hepatitis B vaccination strategy be expanded among adults and simplified to 

a universal recommendation. As noted by Dr. Ault, the risk-based recommendations among 

adults are complex and include 15 specific behavioral and non-behavioral risks in 3 categories 

(e.g., sexual exposure, percutaneous or mucosal exposure to blood, and others such as travel 

or having chronic liver disease). Moving through a universal vaccine recommendation among 

adults would serve as a natural extension of existing routine childhood vaccination 

redocumentations. It also would serve to collapse the numerous existing adult risk groups into a 

single recommendation in that all adults previously unvaccinated for hepatitis B would be 

recommended to receive hepatitis B vaccination. Dr. Weng distilled prior WG discussions on the 

evidence and experience of patient, provider, and practice factors underpinning this universal 

proposal. 

The hepatitis B immunization strategy has evolved over the last 4 decades. Risk-based 

strategies were first introduced among adults and prenatally exposed infants in the early 1980s. 

Then universal infant vaccination was introduced in 1991, with catch-up vaccination 

recommendations for all adolescence in 1999, followed by the introduction of a universal birth 

dose among all newborns in 2005. All of these steps toward routine hepatitis B vaccination 

resulted in large declines in new hepatitis B infections among children and adolescents. 

However, hepatitis B incidence has plateaued over the past 10 years with more than 20,000 

new infections estimated to occur each year. The past decade has illustrated that risk-based 

screening among adults has achieved as much as it can. Initial decreases in new infections 

have stagnated. Rates of acute infections are now high among adults 30-59 years of age and 

rates have increased among adults 40 years of age and older, indicating that ground is being 

lost. It will not be possible to eliminate hepatitis B in the US without a new approach. 

There was limited hepatitis B vaccine coverage among adults in 2018. Overall, coverage was 

30% for adults 19 years of age and older. Reported vaccine coverage rates were likewise low 

across risk groups, including travelers, people with chronic liver conditions, and people with 

diabetes. Rates were particularly low among older people with diabetes. Surprisingly, hepatitis B 

vaccination coverage was only about 67% among HCP—far short of this group’s Healthy 

People 2020 target of 90%.66 Hepatitis B vaccination coverage in adults with identified risk 

factors is suboptimal across all age groups and is lower among older adults. The youngest adult 

age groups might have received protection under the universal childhood hepatitis B 

recommendations in 1991, with a catch-up recommendation in 1999. However, as the age 

groups get older, coverage rates steadily drop. Less than 20% of older adults with identified risk 

report having been vaccinated.67 

It is important to recall that only one-third of people with reported acute hepatitis B reported any 

risk factors. For the remaining two-thirds of reported acute infections, the current risk-based 

vaccination strategy among adults provides no advantages in identifying and vaccinating people 

who were missing risk data or reported no identified risk.68 Multiple health disparities could be 

improved with a universal hepatitis B recommendation. Among children and adolescents, acute 

hepatitis B infection rates in all races and ethnicities converged to a lower rate when a universal 

vaccination strategy was implemented for children ≤ 18 years of age.69 Current acute infection 

66 National Health Interview Survey (NHIS) – US, 2018; Lu et al. Vaccination Coverage Among Adults in the United States, National 

Health Interview Survey, 2018. 2021 May 14;70(3):1-26. Surveillance of Vaccination; Coverage Among Adult Populations -United 

States, 2018 - PubMed (nih.gov) 67 Lu et al. National Health Interview Survey, 2018. Unpublished 2021. 

68 https://www.cdc.gov/hepatitis/statistics/2019surveillance/index.htm 69 https://www.cdc.gov/hepatitis/stati stics/2019surveillance/HepB.htm; Wasley et al. MMWR. 2008 

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ACIP Meeting Summary November 2-3, 2021 

rates among black American adults are up to 3 times the rates of Asian/Pacific Islanders and 

Hispanic groups.70 Racial and ethnic disparities remain in terms of who gets infected with 

hepatitis B virus. The WG recognizes that the risk for acquiring hepatitis B is dynamic 

throughout one’s lifetime, meaning that a person might move in and out of risk categories. 

Exposure, whether recognized or not, might change over time. The current risk-based hepatitis 

B vaccination recommendations favor patients with access to healthcare over their lifetime, trust 

to disclose potentially stigmatizing risk factors to the provider, awareness of risk, and a high 

degree of health literacy. 

Hepatitis B vaccination provides lifelong protection whether someone develops diabetes, enters 

an assisted living facility, shares a home with a person with hepatitis B, and/or chooses to 

travel. The WG reasoned that it would be better to be vaccinated before people get exposed 

and that the universal adult vaccination recommendation would promote health equity. The WG 

distilled ACIP feedback from the February and September 2021 sessions into 3 overarching 

questions to help drive the decision-making during this session: 1) Can universal 

recommendations increase vaccine uptake among people with risk factors?; 2) Is a universal 

hepatitis B vaccination recommendation an effective use of resources?; and 3) Should the 

proposed hepatitis B recommendation include adults of all ages or revisit adding an upper age 

limit of 59 years, compared with adding an upper age limit at ≤59 years and resuming 

the existing risk-based recommendation for persons >59 years? Notably, the cutoff of 59 years 

of age was selected to align with the hepatitis B diabetes recommendations. 

To address the first question regarding whether universal recommendations increase vaccine 

uptake among people with risk factors, the WG recognized that while there is no perfect parallel, 

several vaccine-preventable diseases provide useful comparison points, common themes, and 

rationales that ACIP has discussed in the past. In 2010, influenza vaccine coverage of adults 

with high-risk conditions was 28.6%. Universal influenza recommendations were then 

promulgated that year. By the 2020-2021 season, influenza vaccine coverage has nearly 

doubled to 51% for people with high-risk conditions.71 Pneumococcal vaccines provided a 

different type of example where in 2018 there was a risk-based cohort among persons 19-64 

years of age at the same time as a universal cohort among adults 65 years and older. Under 

risk-based recommendations, just under a quarter of persons 19-64 years of age who had 

increased risks were vaccinated, while adults 65 years of age and older under the universal 

recommendation were vaccinated at nearly triple the vaccination coverage.72 To bring it back to 

hepatitis B, the WG looked at birth dose recommendations. Shifting from a risk-based to a 

universal vaccine in 1991 resulted in increased coverage among all newborns. Birth dose 

coverage went from half of newborns in 200573 to almost 80% in 2018—just shy of the Healthy 

People 2020 target of 85%.74 The WG felt strongly that these and other examples provide 

compelling examples of how universal recommendations increased vaccine uptake among 

people with risk factors and therefore answered “yes” to this question. 

70 Harris et al. MMWR. 2016 

71 CDC FluVaxView 

72 NHIS 2018. NHIS captures “any” pneumococcal vaccination; risk-based recommendation includes groups with different 

pneumococcal recommendations 73 Allred, NJ et al CDC MMWR 2008. Birth Dose, to 3 days from birth 74 CDC ChildVaxView, HepB Birth Dose by Age 0-3 Days 

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ACIP Meeting Summary November 2-3, 2021 

The WG summarized limitations and advantages of universal recommendations to increase 

hepatitis B vaccine uptake. The limitation is that future increased vaccine uptake is unknown. 

However, that magnitude can be inferred from public health experience with other vaccinepreventable diseases. The advantages for patient groups with high-risk behaviors might be 

concerned with stigma, which reduces the motivation to get hepatitis B vaccines. A universal 

recommendation would facilitate patients’ access to routine standard of care by not requiring 

patients to recognize and disclose risk. Even though current indications allow for vaccination 

among anyone who requests it, it already has been demonstrated that only one-third of people 

who reported acute hepatitis B in the US report any risk factors. About two-thirds of the people 

in the US with chronic hepatitis B infection are estimated to be unaware of their own infection, 

precluding them getting treatment for their own health or informing their contacts of possible 

transmission risk. For providers, a simplified recommendation facilitates implementation and 

empowers clinicians to offer vaccination. It shifts the onus to vaccinate from patients to 

providers and at the same time, makes it easier for providers to help their patients. 

The WG drew parallels with opt out public health policies that have shown success in lowering 

barriers to care, such as universal hepatitis C and HIV screening among adults and routine HIV, 

hepatitis B, hepatitis C, and syphilis screening during pregnancy. Simpler clinical 

implementation likely would result in increased vaccinations for healthy adults and adults with 

the risk factors who have not yet been vaccinated. The WG showed data during the September 

2021 ACIP meeting published by Dr. Daley and colleagues suggesting that even providers have 

trouble processing that long list of risk factors during a busy clinical session. For public health 

and clinical practice, universal hepatitis B recommendations would contribute to larger efforts to 

eliminate hepatitis B nationally and globally. Underlying all these advantages is that it facilitates 

health equity goals in terms of reducing disparities and inequities in accessing hepatitis B 

vaccination. Based on all of the points just discussed and the EtR Framework provided in 

September 2021, in a straw poll, 100% of WG members said that universal hepatitis B 

recommendations would increase vaccine uptake among people with risk factors. 

In terms of the second question regarding whether a universal hepatitis B vaccination 

recommendation is an effective use of resources, the incremental cost-effectiveness ratio 

(ICER) was calculated at $153,000 per quality-adjusted life-year (QALY) gained.75 The ICER 

decreases as coverage improves in groups at higher risk. For example, with 20% additional 

coverage in people with increased risks, the cost per QALY decreases to $135,000, illustrating 

the benefits of an increased access. The economic model presented to ACIP in February 2021 

was used to estimate the health improvements of a universal adult hepatitis B vaccination, 

which would reduce acute infections by 24% and deaths by 23%. The WG had selected a 

conservative base-case in the economic model. After the February presentation, several 

committee members considered the model assumptions to be too conservative because the 

base-case did not assume any increase in additional vaccination among people with risk 

factors. The WG agreed with the committee that higher hepatitis B coverage likely could be 

assumed in this population, which then would lead to a lower cost estimate than the 

conservative base-case cost and would increase access at the same time. The results of the 

analysis presented in February are available for these assumptions of increased coverage. In a 

straw poll, 70% of the WG agreed that universal hepatitis B vaccination is an effective use of 

resources. The remaining 30% said that it probably would be an effective use of resources. 

75 Hall et al, ACIP Presentation, Feb 2021. Assumptions: 3-dose vaccine; base case summary input of~30% coverage (based on 

35.8% protected, with varying age-group specific coverages among people with risk factors; 50% vaccination coverage in general 

population) 

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ACIP Meeting Summary November 2-3, 2021 

With regard to the third question pertaining to whether the recommendation should include all 

ages or if it should include an upper age limit of 59 years of age, a sub-analysis of the Hall 

economic model included the upper age limit. The ICER, NNV, and dose are lower for the upper 

age limit. There is a similar reduction in infections. Despite the cost, the WG saw many 

advantages of the universal recommendation for all ages. The upper age limit did initially 

receive some support of the WG, but when presented to ACIP as an option in February, the 

committee discussion seemed to support universal recommendation without an upper age limit. 

Based on the committee’s subsequent September feedback, the WG revived the age limit 

scenario for consideration for this meeting. In terms of the limitations on including adults of all 

ages as discussed by the WG, there is a relatively lower incidence among persons over 59 

years of age that yielded a higher ICER to protect older populations.76 With an upper age limit, 

specificity would be improved by clearly defining an age group of interest. The WG also 

reasoned that the trade-off is that a complex risk-based recommendation still would be required 

for adults over 59 years of age with all of its inherent flaws as just discussed. A key unknown is 

the exact impact on vaccine uptake. The WG believes that based on the supporting evidence 

just shown, it is likely that uptake would increase though it is hard to say exactly how much. As 

a committee member observed in February, opportunities would be missed to vaccinate older 

adults by maintaining barriers to access at a time in their lives when older adults might 

otherwise be going in to see their providers. 

Regarding the main advantages of a recommendation to include adults of all ages, hepatitis B 

still causes significant disease in older adults, so individuals over the age of 59 still deserve 

protection. Many adults will age into one of the risk groups like diabetes, kidney disease, or 

certain lifestyle changes. Therefore, it is better to vaccinate them early. If a large portion of 

adults already have or will eventually develop one or more risk factors, why wait until they 

become sick with comorbidities—comorbidities that might actually lower their response to 

vaccines just when they need it most? Implementation will be less complicated without the 

additional age cutoff, so the WG preferred a recommendation that is more likely to be followed 

by patients and providers. Again, improved health equity is sought across the ages in this case. 

In a WG straw poll, 56% favored a universal adult recommendation to include adults of all ages. 

They felt that a one-time completion of a hepatitis B vaccination would provide lifetime 

protection. For many adults, the absence of a risk factor now does not mean that they will be 

without risk for the rest of their lives and that people respond better to vaccination at younger 

ages before comorbidities or risk factors develop. Therefore, why not vaccinate people before 

they acquire that risk factor and can transmit the virus if infected? 

To recap, no one on the WG supported staying with the current risk-based recommendations 

and 100% of the WG preferred a universal adult hepatitis B recommendation, with the majority 

supporting inclusion of all ages. To summarize in the context of the calls from HHS and NASEM 

to eliminate viral hepatitis, there are multiple examples and evidence supporting where universal 

recommendations are preferred over risk-based vaccination approaches. This is in line with 

public health principles and practice. The WG reviewed these examples along with the 

previously shown hepatitis B infection rates, dynamic risks of hepatitis B over everyone’s 

lifetime, and health equity observations. The WG concluded that by relying on the current riskbased recommendations focusing only on the slow bottom-up approach of vaccinating all 

children who will then take their immunity with them when they reach adulthood would be a 

disservice to a large portion of the US population. Plus, the current risk-based policy creates 

obstacles for the provider to identify risk and for the patient to self-advocate, which is a 

76 Assumptions: 3-dose vaccine, base case: 50% vaccination coverage in general population; ~30% coverage (summary input 

based on 35.8% protected, with varying age-group specific coverages ) among people with risk factors 

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ACIP Meeting Summary November 2-3, 2021 

particularly challenging barrier for people in vulnerable and medically underserved communities. 

In terms of what else is different this time compared to 1982 when risk-based hepatitis B 

recommendations were first introduced, there is now a growing toolbox and new access points 

for vaccination to eliminate this potentially fatal virus. There are now 2 single antigen 3-dose 

vaccines available that are safe, effective, and with long-term immunogenicity. There is one 2-

dose vaccine that is safe and effective. There also is 1 combination vaccine and 1 vaccine 

in the pipeline. The WG concluded that the universal recommendation would allow the US to 

leverage this growing toolbox for public health and equity goals. With an eye toward 

implementation, this universal recommendation dovetails with recent developments—the 

ongoing expansion of viral hepatitis surveillance, a renewed focus on vaccination delivery, 

improved integration of services, and expanded immunization venues. By late 2022, CDC 

recommendations are anticipated for 1-time hepatitis B screening guidelines for all adults. 

Hepatitis B is vaccine-preventable. Safe, effective, cancer-preventing vaccines have been 

available for over 40 years. However, the current risk-based hepatitis B vaccine policy has 

clearly become a barrier to public health objectives. For these reasons, the WG believes a 

universal hepatitis B vaccination recommendation among adults would provide the best chance 

of achieving hepatitis B elimination goals in the US. This is the language of the proposed 

recommendation for the ACIP consideration: 

All adults previously unvaccinated for hepatitis B should receive hepatitis B vaccination. 

Discussion Summary 

Key discussion points from ACIP voting members: 

• Dr. Chen inquired as to how the screening mentioned would dovetail with the vaccination 

program and the frequency of testing. 

 Dr. Nelson indicated that CDC testing/screening recommendations have been 

drafted. This is a separate process following the CDC evidence review. The draft will 

go to peer review and public comment. What has been proposed in the draft is 1-

time testing/screening using hepatitis B surface antibody (HBsAb), hepatitis B 

surface antigen (HBsAg), and hepatitis B core antibody (HBcAb) tests for all adults 

over 18 years of age. This is anticipated to be recommended later in 2022. Additional 

intermittent testing may be warranted for persons with ongoing risk, though that may 

be based on provider guidance and frequency has not been determined. 

 It was noted that additional screening was not incorporated as part of the universal 

vaccination recommendation. Dr. Nelson indicated that cost analyses were 

performed for the screening, but they were not prepared to present these data in the 

ACIP forum at this time. 

• Dr. Long observed that the NNV seemed low among persons over 60 years of age, pointing 

out that they probably will not live long enough to get sclerosis and cancer from hepatitis B. 

She requested clarification about why the NNV to avert an acute infection was relatively 

similar and low for the age group that seems to have such a low incidence. 

 Dr. Weng indicated that in that age group, the WG was focused on the concept of 

dynamic risk and the heterogeneity of the nature of behavioral and non-behavioral 

risk factors in this group rather than being able to predict how long someone might 

live. 

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ACIP Meeting Summary November 2-3, 2021 

 Dr. Hall added that in terms of how the NNV was calculated within this model 

involved a couple of key elements. The first was that the analytic horizon of this 

model was the lifetime of the initial cohort of individuals vaccinated. The NNV also 

applied to a static cohort of adults in time moving forward, which was discussed 

previously. Second, the NNV within this current cohort of adults was calculated going 

forward in order to prevent an acute infection. This is simply the difference in the 

number of people protected by vaccination divided by the difference in number of 

infections between the 2 strategies. In this setting, it pretty much has a direct tie to 

the incidence of acute infection within the different age groups. That is slightly 

different from other types of vaccination modeling studies that incorporate a dynamic 

risk of infection so there are herd immunity type effects, such that the NNV can 

change as a higher proportion of people are vaccinated and prevalence of disease 

goes down in the population. 

 While Dr. Loehr agreed that the risk-based strategy had achieved as much as 

possible and that the proposed universal strategy was appropriate, he had concerns 

about a recommendation for adults over 60 years of age for several reasons. There 

is diminishing return in that vaccinating only people under 59 years of age would 

result in giving 298 million doses versus 352 million doses if given to all adults. That 

is an additional 54 million doses. Although this would increase the percent of people 

who are protected by 28%, it would reduce acute infections by only 1%. The 

$153,000 base-case for all adults is reasonable, the ICER would be over $500,000 if 

persons over 60 years of age are included. He was not comfortable supporting that. 

The reason the past recommendation for hepatis B vaccination for diabetics over 60 

years of age was not a routine recommendation in 2011 was because it did not 

appear to be cost-effective. He agreed with Dr. Long that if an adult 70 to 80 years of 

age got an acute infection, only about a 5% to 10% of them would have a chronic 

infection and it would take 20 years before that chronic infection would affect their 

health with cirrhosis or cancer. Therefore, a recommendation for all adults would not 

be a good use of resources. 

 Conversely, Dr. Talbot emphasized that this is a disease with a lot of disability and 

mortality, adults 60 years of age and older are very good vectors. One example is 

that people who need hemodialysis are very unlikely to respond by the time they are 

identified. If they could be identified prior to renal failure and vaccinated as adults, 

this would reduce the risk of outbreaks occurring in these facilities. Another example 

occurs in facilities such as hospitals and nursing homes where there are many 

documented outbreaks of hepatitis B due to sharing of glucometers. In addition to the 

potential for spread, the public health cost in time, money, and human resources to 

investigate outbreaks must be considered. 

 Dr. Bell expressed concern about the potential for vaccinating a lot of people who are 

not at risk and do not need it, with the possibility of still not seeing an impact on 

disease incidence due to not vaccinating the right people. The success of this 

program may hinge on implementation to the right populations. 

 Dr. Kotton emphasized how shocked she was at the number of at-risk people who 

are not vaccinated against hepatitis B. 

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ACIP Meeting Summary November 2-3, 2021 

 As a busy PCP, Dr. Cineas emphasized that simplification of the recommendations 

would help reach more individuals at risk and would offer a great opportunity to 

promote health equity among disproportionally affected groups. In addition, adults 60 

years of age represent a very heterogenous group. Some may have more risks than 

others, with some older adults engaging in higher risk activities. For these reasons, 

she supported a universal hepatitis B recommendation without an age cutoff. 

 Ms. McNally indicated that she was leaning in favor of a universal recommendation 

due to concerns about health literacy. This is a complicated disease to understand 

and for which to self-identify risk factors. It can present without symptoms and 

develop into chronic and debilitating diseases. In addition, this disease 

disproportionally impacts minority populations. 

• Dr. Poehling pointed out that one of the reasons behind the success of childhood 

vaccination was due to having a universal registry. She wondered what the plans were for a 

universal registry for adults. 

 Dr. Posner pointed out that considerable progress had been made in the ability to 

document adult vaccinations in the context of the COVID-19 pandemic. CDC is 

working to increase the ability to document other adult vaccines as well and to have 

a more comprehensive adult immunization program, which also will support reporting 

to the registries. 

 Dr. Coyle (AIRA) added that the same IISs that are capturing childhood and COVID19 vaccines are lifetime registries that are capturing all vaccines being administered 

birth to death. Prior to 2020 when adults were starting to be vaccinated with COVID19 vaccine, 60% of all adult vaccinations were captured in an IIS. It is anticipated 

that that has increased dramatically and that a lot of the adults who potentially would 

receive hepatitis B vaccines already would be in the system. Not all providers who 

are vaccinating adults are reporting to an IIS, but there have been significant strides 

in closing that gap over the past year—particularly with COVID vaccines. 

Pharmacies are great reporters of vaccination data to immunization registries, and 

more adult providers are now aware of and reporting to these registries. 

• Dr. Bell pointed out that in order to achieve the elimination for which everyone is clamoring, 

there also needs to be funding. This has not occurred for hepatitis in general or hepatitis B 

in particular. 

 Dr. Nelson agreed with the importance of making sure that efforts are not detracted 

away from making sure that outreach is made to specific risk-based groups, and that 

it was important for ACIP to recognize that they were seeing this recommendation as 

one part of a many pronged strategy to try to address hepatitis B incidence rates. It is 

sometimes easier to revert to a universal recommendation as the default and not 

always have the funding or effort to continue to make sure that outreach is enhanced 

to difficult-to-reach communities. While the way to tackle this has not yet been 

figured out, it is important to ensure that funding and effort are being allocated to 

outreach in areas where implementation will be the most impactful even though they 

are the most difficult to reach. CDC recognizes the benefit of a complementary 

program that also would enhance the ability to capture these populations. 

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• Ms. McNally asked whether there are any other countries with a universal recommendation 

for hepatitis B vaccination. 

 Dr. Weng indicated that this was of interest to the WG as well. When the GRADE 

and EtR Framework were presented in September, no evidence was found of other 

countries pursuing this universal policy. Short of having evidence from other 

countries, they relied on assessment of a subset of well-defined patient groups such 

as those in the dialysis setting, which is a well-defined group that regularly accesses 

care in designated locations. They also drew from other vaccine-preventable 

diseases. 

Key discussion points from ACIP liaison members: 

• Dr. Schaffner (NFID) pointed out that the US began a strategy to eliminate hepatitis B virus 

transmission through immunization in 1991. Since then, hepatitis B infections have declined 

substantially. However, infections have persisted and even increased in parts of the adult 

population due to low adult vaccination rates and the opioid crisis. While most of the 

discussion has focused on individuals, universal coverage also would eliminate complicated 

discussions that doctors have to have with patients. Retiring the risk-based approach would 

eliminate cost barriers and increase equity. He urged everyone to think big in the use of 

these safe and effective vaccines in a universal manner, which has the potential to achieve 

the goal to eliminate hepatitis B virus transmission in the entire population. This aspirational 

goal is why the NFID supports universal hepatitis B vaccination. 

• Dr. Hogue (APhA) observed that there seemed to be a strong case for persons less than 59 

years of age and strongly supported a universal recommendation in that group. However, he 

was not convinced of the marginal benefits among persons 60 years of age and older. 

Arguably the risk in persons over 85 years of age seemed to be very small. For many years, 

the Centers for Medicare and Medicaid (CMS) have covered hepatitis B vaccine under Part 

B for patients on dialysis. Subsequently, that was expanded to some extent. He requested 

input regarding coverage if a universal recommendation was adopted by ACIP for people 

over 65 years of age who are Medicare-eligible, and on whether private insurance providers 

would be required to provide first-dollar coverage under the Affordable Care Act (ACA). 

Given that a large segment of people at highest risk are uninsured and there is not a 

program in the US that provides free vaccines to uninsured adults like the VFC program 

does for uninsured children, he wondered if there are any plans to ensure that vaccine is 

available for uninsured adults. 

 Ms. Hance (CMS) indicated that Medicare Part B currently covers hepatitis B 

vaccines for those who are at medium or high risk. Instances are identified that 

place individuals at increased risk (e.g., hemophilia, end stage renal disease, 

diabetes, hepatitis B, HCP with frequent contact with blood or bodily fluids, and 

others). Being a specialist on the Medicaid side, she did not feel comfortable 

speaking definitively for CMS regarding whether a universal recommendation 

would be covered under part B. Therefore, she reached out to Medicare 

colleagues to get a response to address that question. 

 Dr. Wharton added that CDC concurs regarding the importance of vaccine 

coverage for the uninsured, which will be a policy decision in the future. 

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ACIP Meeting Summary November 2-3, 2021 

• Dr. Zahn (NACCHO) indicated that NACCHO supports the recommendation for universal 

vaccination of all adults based on local public experience. When jurisdictions follow-up on 

cases of acute hepatitis B, they often find that the field person had no previously identified 

risk factors and had not previously been offered hepatitis B vaccine despite contact with the 

healthcare system months or years previously. Follow-up with cases also has confirmed that 

there is reluctance to report risk factors due to the associated social stigma. Cases certainly 

are identified in persons 60 years of age and older, long-term care facilities (LTCF), and 

dialysis clinics. Even a single case in a facility requires a large facility and public health 

response, so it is not a trivial issue. NACCHO strongly supports the need for continued and 

increased support for outreach to at-risk populations, and believes that local public health 

should continue to play a role in leading outreach efforts to high-risk populations on multiple 

fronts. 

• Dr. Goldman (ACP) said that as a practicing physician, he strongly favored a universal 

recommendation. He teaches colleagues nationally how to implement vaccine programs and 

has heard from them that the biggest barrier to implementation is how confusing and 

detailed the current hepatitis B recommendations are. Making a simple universal 

recommendation is key to increasing uptake. PCPs must manage chronic illnesses, blood 

pressure, diabetes, hypertension, recommending screening for colonoscopies and 

mammograms, et cetera in addition to learning vaccine schedules. He emphasized that the 

presumption of risk decreasing after 60-65 years of age is not necessarily accurate. There 

are many areas in Florida where sexually transmitted disease (STD) outbreaks are 

increasing persons over 65 years of age. A database of Florida’s reportable diseases 

showed that over 25% of the acute hepatitis B reported cases were in persons over 60 

years of age in 2021 alone. A universal vaccine recommendation would help to decrease 

the incidence of hepatitis B. Dr. Goldman suggested a revision to the proposed language to 

state, “all previously unvaccinated adults without evidence of immunity.” 

• Ms. Howell (AIM) pointed out that one gap in having adult immunizations in IISs is not 

receiving reporting from federal systems such as IHS, VA, and DoD, which will be critical for 

compiling complete adult immunization records. Another gap is due to adults being highly 

mobile, so interstate data exchange between IISs is critical to ensure that adults have a 

single central record of their immunizations to inform future vaccines needed. Many 

awardees use Section 317 vaccines that provide access to vaccines to uninsured adults. 

Section 317 vaccine funding is limited such that state awardees may or may not be able to 

include hepatitis B vaccines in their formulary for all uninsured adults unless there is an 

increase in that funding. 

• Dr. Schmader (AGS) indicated for the record that AGS supports universal hepatitis B 

vaccination with no upper age limit for all of the advantages presented on Slide 19. He 

pointed out that what will happen in practice is that very old persons or those with limited life 

expectancy and their caregivers and clinicians will make their own common sense decisions. 

• Dr. Fryhofer (AMA) said that speaking as a practicing internal medicine physician, she 

supported universal recommendation of hepatitis B vaccinations. When she was a third year 

medical student, she rotated through a hepatitis unit. These were some of the sickest and 

most miserable patients she had ever seen and she knew she never wanted to feel that 

way. That was before a hepatitis vaccine was available. As soon as a vaccine was available, 

she signed up for it. No one should endure the suffering she witnessed before vaccine was 

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available from something that is now totally vaccine-preventable, so she hoped that ACIP 

would recommend universal vaccination for all adults—including older adults. 

• Dr. Baker (IDSA) said that speaking as a former member and Chair of ACIP, it is the 

mandate of the ACIP to make good evidenced-based health policy. A lot of the comments 

made throughout the day were very true and she personally strongly support the comments 

that funding is needed for all vaccine programs. As the representative for the IDSA, which is 

comprised of leaders in a variety of areas (e.g., public health, vaccine research, clinical 

practice, advising, community education, policy-making, et cetera), she conveyed that the 

IDSA supports universal hepatitis B vaccination for many of the reasons mentioned. This 

includes improving health equity. The evidence is overwhelming that a risk-based 

recommendation is a failed policy. 

• Dr. Zimmerman (APTR) indicated that he actively treats hepatitis B in his clinical practice. 

He works in an FQHC that reports adult immunization to the state registry. A universal nonrisk-based recommendation would be very helpful in his inner-city practice, particularly for 

those less than 60 years of age due to the number of persons who have been infected with 

hepatitis B who have risk factors such as diabetes. Many of his patients do not have risk 

factors to his knowledge or have been vaccinated because they have been in a dialysis 

program. There is notably a diminishing return in adults 60 years of age and older. He could 

see some advantages to phasing in a universal recommendation starting with the younger 

age group and then perhaps extending that in a number of years. 

Vote: Hepatitis Vaccines 

Dr. Mark Weng (CDC/NCHHSTP) indicated that based on the discussions and in order to allow 

for deliberation of screening considerations separately, the WG revised the proposed 

recommendation language to read: 

All adults are recommended to receive hepatitis B vaccination. 

Discussion Summary 

• Dr. Talbot made a motion for ACIP to adopt an interim recommendation stating that “All 

adults are recommended to receive hepatitis B vaccination.” Ms. Bahta seconded the 

motion. 

• Dr. Loehr made a motion for ACIP to adopt an amended interim recommendation stating 

that “All adults ≤59 years of age are recommended to receive hepatitis B vaccination. Adults 

>60 years of age would continue to follow existing risk-based recommendations.” Dr. Long 

seconded the motion. 

• Dr. Lee indicated that per Roberts Rules of Order, they would need to vote on the 

amendment proposed by Dr. Loehr first. If the amendment passed, the initial motion would 

be amended and voted on accordingly. If the amendment failed, they would vote on the 

initial motion made by Dr. Talbot. 

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Motion/Vote to Amend the Proposed Recommendation Language: Hepatitis B Vaccines 

Dr. Loehr made a motion for ACIP to adopt an amended interim recommendation stating that 

“All adults ≤59 years of age are recommended to receive hepatitis B vaccination. Adults >60 

years of age would continue to follow existing risk-based recommendations.” Dr. Long seconded 

the motion. No COIs were declared. The motion carried with 8 affirmative votes, 7 negative 

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

8 Favored: Bell, Brooks, Daley, Lee, Loehr, Long, Poehling, Sanchez, 

7 Opposed: Ault, Bahta, Chen, Cineas, Kotton, McNally, Talbot 

0 Abstained: N/A 

0 Absent: N/A 

As the amendment motion passed, the initial motion was amended to include the following 

language: 

Vote: Hepatitis B Vaccines 

The Advisory Committee on Immunization Practices (ACIP) recommends the following groups 

should receive hepatitis B vaccines: 

-Adults 19 through 59 years 

-Adults 60 years and older with risk factors for hepatitis B infection 

The ACIP recommends the following groups may receive hepatitis B vaccines: 

-Adults 60 years and older without known risk factors for hepatitis B infection 

The motion carried with 15 affirmative votes, 0 negative votes, and 0 abstentions. The 

disposition of the vote was as follows: 

15 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, 

McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

0 Absent: N/A 

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ACIP Meeting Summary November 2-3, 2021 

Member Statements 

Subsequent to the vote, Dr. Lee invited ACIP members to make a statement about the rationale 

for their votes and/or to share any additional general comments: 

• Regarding hepatitis vaccine and ages, Dr. Talbot pointed out that for so long, the focus of 

the immunization programs has been on the pediatric population. That is rightly so as this 

work has led to a strong infrastructure to implement widespread and efficient vaccination 

processes integrated into the routine care at pediatricians’ offices. This has dramatically 

reduced the morbidity from vaccine-preventable diseases among children, which is a 

blessing because one of her favorite sayings is that “vaccines cause adults.” The discussion 

throughout the day and other discussions that ACIP recently has had illustrate that there 

needs to be re-examination of the approach to adult and older adult immunizations. Now 

that there are more immunization options for adults, especially older adults, ACIP needs to 

re-examine the approach to immunizations in this population in a way that takes into 

account the unique aspects of adult primary care practices, the presence of multiple 

comorbidities, and immune senescence. As a reminder, adults are not big kids. To this end, 

she would like to advocate for and will personally commit to work with ACIP leadership to 

strategically assess how the goal to improve the adult immunization program can be 

achieved. Even if it was half as successful as the child and pediatric program, she would be 

ecstatic. 

• Dr. Chen emphasized that they must acknowledge that the projection is 300 million chronic 

hepatitis B cases all throughout the world and 1.5 million new or acute infections per year. 

This is a global health problem. ACIP is being asked to address global health, about which 

he is passionate. 

• Dr. Loehr said he would have been content if the hepatitis B recommendation had not had 

an age restriction, but felt that it was better policy to have an age restriction. The discussion 

regarding this recommended showed that the ACIP can be a very transparent and open 

body on which he looked forward to working over the next 4 years. 

• Dr. Lee said she was swayed by the resource use domain in particular, realizing that 

immunization efforts are underfunded in many ways. She felt like it came down to values to 

a certain extent at the end of the day, which was the value of preventing an acute infection 

versus the value of preventing chronic liver disease or death due to hepatitis B infection. For 

her, the older age population was tougher. However, she also was reassured by the fact that 

anyone who wishes to get a vaccine can receive that vaccine. She expressed her hope that 

they would continue to focus efforts on this and believes expansion may be possible. She 

absolutely believes that ACIP’s decision-making is dynamic and not fixed in time, so they 

always need to reevaluate what makes sense for the US population. 

• Dr. Long pointed out that because of the way the “may” and “should” accompanied the age 

recommendations for hepatitis B, it certainly would be within the purview of the practitioner 

who has a patient population above 60 years of age with risks that are out of proportion to 

others to be strong advocates for their patients. That certainly would be within the spirit of 

the recommendation. She inquired as to whether anyone disagreed with that interpretation 

of the recommendation, which no one did. 

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IMMUNIZATION SCHEDULES 

Session Introduction: Combined Immunization Schedule WG 

Dr. Kevin Ault (ACIP, WG Chair) provided the session introduction. He acknowledged Dr. 

Henry Bernstein, who Co-Chaired the committee until he rotated off the ACIP earlier in the year, 

and welcomed new member, Dr. Sybil Cineas, who joined the WG in July 2021. 

As a reminder, the Combined Immunization WG updates the Child and Adolescent and Adult 

Immunization Schedules annually. The Child and Adolescent Immunization Schedule 

summarize ACIP’s vaccination recommendations for persons 18 years of age or younger, while 

the Adult Immunization Schedule summarizes ACIP’s vaccination recommendations for persons 

19 years of age or older. The goal of the Combined Immunizations Schedule WG is to better 

harmonize the Child and Adolescent and Adult Immunization Schedules. It is important to note 

that the use of vaccine trade names is for identification purposes only and does not imply 

endorsement by the CDC. The 2022 schedules presented during this session are drafts and are 

therefore subject to change based on ACIP’s discussion and vote. New policies are not 

established in the proposed schedules. Annual schedules reflect recommendations already 

approved by ACIP. 

The Child and Adolescent and Adult Immunization Schedules are presented to ACIP for votes 

every fall. The ACIP’s approval is necessary prior to publication of the schedule in the Morbidity 

and Mortality Weekly Report (MMWR) in January of the following year. In addition, ACIP 

approval is necessary before partners from the following professional societies review and 

approve the schedules prior to publications: 

 American Academy of Pediatrics (AAP): only child/adolescent schedule 

 American College of Physicians (ACP): only adult schedule 

 American Academy of Family Physicians (AAFP) 

 American College of Obstetricians and Gynecologists (ACOG) 

 American College of Nurse-Midwives (ACNM) 

 National Association of Pediatric Nurse Practitioners (NAPNAP): only child/adolescent 

schedule 

 American Academy of Physician Assistants (AAPA) 

 Society for Healthcare Epidemiology of America (SHEA): only adult schedule 

This session included presentations on harmonization between the Child and Adolescent and 

Adult Schedules; edits to all tables that have occurred since October 2020; content changes of 

the notes; the new appendix listing contraindications and precautions; and discussion and votes 

for each schedule. 

Proposed Changes to 2022 Child and Adolescent Schedule 

Dr. Patricia Wodi (CDC/NCIRD) presented the proposed edits for the 2022 Child and 

Adolescent Immunization Schedule. ACIP votes since October 2020 have included a vote in 

June 2021 on the use of dengue vaccination in children and adolescents 9-16 years of age in 

endemic areas. Influenza vaccination votes in June 2021 included 2021-2022 influenza vaccine 

recommendations, minimum age for cell culture-based inactivated influenza vaccine (IIV), and 

contraindications and precautions for influenza vaccines. In addition, edits were made to 

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ACIP Meeting Summary November 2-3, 2021 

sections of the tables and notes of other vaccines to improve readability of the schedule. An 

appendix was added listing contraindications and precautions for each vaccine type. 

Changes to the tables included the cover page and Tables 1, 2, and 3. To harmonize with the 

cover page of the adult schedule, a section was included with information on how vaccine 

providers can contact CDC with questions and comments about the schedule. In addition, a link 

was included to the webpage for vaccine information. A QR code was placed on the right lower 

corner of the cover page that when scanned will take providers directly to the online version of 

the Child and Adolescent Schedule. In the box describing how to use the schedule, a fifth step 

was added instructing providers to review the newly added appendix of contraindications 

and precautions for each vaccine type. A row was added to the cover page to identify vaccine 

abbreviations and trade names. 

The proposed edits to Table 1, which is the graphical representation of the immunization 

schedule, now includes a row for dengue vaccine with a column for persons 9-16 years of age 

shaded in yellow to indicate the recommended age for vaccinations. In addition, overlying text 

was included stating, “Seropositive in endemic areas only (See Notes).” In the human 

papillomavirus (HPV) row, the WG made a change to the column for children 9-10 years of age 

because the descriptive text in the blue box within the table signifies “recommended based on 

shared clinical decision-making.” Some providers found this confusing, so the WG decided to 

replace the blue color to a new checkered yellow color that signifies, “Recommended 

vaccination can begin in this age group.” The blue box within the legend was revised. The Tdap 

row for children 11-12 years of age was changed to “1 dose.” The emphasis on the color was 

removed for ages 4-6 years, 11-12 years, and 16 years by changing the color from green to 

black to match the other columns in this table. Emphasizing these columns was not a part of an 

ACIP recommendation and providers should review vaccination status at every encounter. 

However, some WG members indicated a preference for continuing emphasizing this age 

column as a way for providers to check vaccination status. 

Table 2 outlines the catch-up immunization schedule for children and adolescents who started 

immunizations late or are more than one month behind. A row has been added to Table 2 for 

dengue vaccine showing the minimum age for Dose 1 and the minimum intervals between Dose 

1 to Dose 2 and Dose 2 to Dose 3. In the Haemophilus influenzae (HIB) row, the text in the 

minimum interval between Dose 2 to Dose 3 was updated to include a 4-week interval and to 

delete COMVAX® from the 8-week interval as COMVAX® was discontinued in 2014. 

Table 3 is the graphical representation of the recommended child and adolescent schedule by 

medical indication. The sub-header for HIV infection CD4+ count was changed to <15% or total 

CD4 cell count of </mm. This change was made to be consistent with ACIP’s General Best 

Practice Guidelines for Immunization. For clarity, the descriptive text in the red box within the 

legend was changed from “not recommended/contraindicated” to “contraindicated or not 

recommended.” In addition, the checked yellow box was revised to read, “Vaccination is 

recommended, and additional doses may be necessary based on medical condition or vaccine. 

See notes.” A row was added for dengue vaccine indicating that the vaccine is contraindicated 

in persons with an immunocompromising condition, including those with severe 

immunosuppression due to human immunodeficiency virus (HIV) infection. In the columns for 

pregnancy and persons with HIV infection who do not have immunosuppression, the orange 

color was used to point out that the vaccine might be indicated if the benefits of protection 

outweighs the risk of adverse reaction. 

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ACIP Meeting Summary November 2-3, 2021 

Now moving to changes made to the notes sections. For COVID-19 vaccination, additions were 

made to Additional Information as highlighted here, “COVID-19 vaccines are recommended for 

use within the scope of the Emergency Use Authorization or Biologics License Application for 

the particular vaccine, or as otherwise recommended by ACIP and adopted by the CDC 

director. ACIP recommendations for the use of COVID-19 vaccines can be found at 

www.cdc.gov/vaccines/hcp/acip-recs/index.html. CDC’s interim clinical considerations for use of 

COVID-19 vaccines can be found at www.cdc.gov/vaccines/covid-19/clinicalconsiderations/covid-19-vaccines-us.html. 

Dengue vaccination was added to the notes section to summarize the recommendations for 

routine vaccinations and provide guidance on geographical areas where Dengue is endemic. 

This reads as follows: 

Routine vaccination 

• Age 9–16 years living in dengue endemic areas AND have laboratory confirmation of 

previous dengue infection 

- 3-dose series administered at 0, 6, and 12 months 

• Endemic areas include Puerto Rico, American Samoa, US Virgin Islands, Federated States 

of Micronesia, Republic of Marshall Islands, and the Republic of Palau. For updated 

guidance on dengue endemic areas and pre-vaccination laboratory testing see [weblink 

pending]. 

The routine catch-up vaccinations section has been updated to include a revised bullet in which 

a notation was added about Vaxelis as highlighted in yellow, “For other catch-up guidance, see 

Table 2. Vaxelis can be used for catch -up vaccination in children less than age 5 years. Follow 

the catch -up schedule even if Vaxelis is used for one or more doses. For detailed information 

on use of Vaxelis see www.cdc.gov/mmwr/volumes/69/wr/mm6905a5.htm 

A minor edit was made for clarity within the hepatitis A vaccination routine recommendations to 

read, “2-dose series (minimum interval: 6 months) at age 12-23 months.” Within the Hepatitis B 

notes, the introductory sentence in the Special Situation section regarding recommendations 

for the vaccination was updated to include post-vaccination serology such that it now begins 

with, “Post-vaccination serology testing and re-vaccination (if anti-HBs < 10mlU/mL) . . .” 

Within the HPV notes, the final bullet in the routine vaccination section was edited for clarity to 

read as follows, with changes highlighted: 

Routine and catch-up vaccination

Revised bullet: No additional dose recommended when any HPV vaccine series has been 

completed using the recommended dosing intervals. 

Special situations 

• Revised bullet: Immunocompromising conditions, including HIV infection: 3-dose series 

regardless of age at initial vaccination 

• Revised bullet: Pregnancy: Pregnancy testing not needed before vaccination; HPV 

vaccination not recommended until after pregnancy; no intervention needed if vaccinated 

while pregnant 

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ACIP Meeting Summary November 2-3, 2021 

For influenza vaccine, the Special Situation section included revised and deleted bullets as 

shown here: 

Special situations

Revised bullets: 

• Egg allergy with symptoms other than hives (e.g., angioedema, respiratory distress) or 

required epinephrine or another emergency medical intervention: see Appendix listing 

contraindications and precautions 

• Severe allergic reaction (e.g., anaphylaxis) to a vaccine component or a previous dose of 

any influenza vaccine: see Appendix listing contraindications and precautions 

Deleted bullets: 

• Severe allergic reactions to vaccines can occur even in the absence of a history of previous 

allergic reaction. All vaccination providers should be familiar with the office emergency plan 

and certified in cardiopulmonary resuscitation. 

• LAIV4 should not be used in persons with the following conditions or situations: 

Within the MMR section, the Routine Vaccinations section was updated to include the use of 

MMRV. In addition, language was included stating, “*Note: For dose 1 in children aged 12-47 

months, it is recommended to administer MMR and varicella vaccines separately. MMRV may 

be used if parents or caregivers express a preference.” Under the Catch-Up Vaccination 

section, a bullet was added reading, “Minimum interval between MMRV doses: 3 months.” 

Under the Special Situations section for meningococcal serogroup A,C,W,Y vaccination, the 

Menactra note was revised to read, “Menactra should be administered either before or at the 

same time as DTaP. MenACWY vaccines may be administered simultaneously with MenB 

vaccines if indicated, but at a different anatomic site, if feasible.” 

For the varicella vaccine section, the following additions or revisions were made to various 

bullets: 

Routine vaccination 

• Added bullet: VAR or MMRV may be administered* 

• Added: *Note: For dose 1 in children aged 12-47 months, it is recommended to administer 

MMR and varicella vaccines separately. MMRV may be used if parents or caregivers 

express a preference. 

• Revised bullet: Dose 2 may be administered as early as 3 months after dose 1 (a dose 

inadvertently administered after at least 4 weeks may be counted as valid) 

Catch -up vaccination 

• Revised bullet: Age 7-12 years: routine interval: 3 months (a dose inadvertently 

administered after at least 4 weeks may be counted as valid) 

Changes to the appendix include the addition of the following to the top of the page: 

Guide to Contraindications and Precautions to Commonly Used Vaccines 

Adapted from Table 4 in Advisory Committee on Immunization Practice (ACIP) General Best 

Practice Guidelines for Immunization: Contraindication and Precautions available at 

www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html and ACIP’s 

Recommendations for the Prevention and Control of 2021-22 seasonal influenza with Vaccines 

available at www.cdc.gov/mmwr/volumes/70/rr/rr7005a1.html 

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ACIP Meeting Summary November 2-3, 2021 

Interim clinical considerations for use of COVID-19 vaccines including contraindications 

and precautions can be found at www.cdc.gov/vaccines/covid-19/clinicalconsiderations/covid19-vaccines-us.html 

Discussion Summary 

• The schedule may become so complex with so many colors, it may become difficult to 

display visually. Every time a new color is added, it becomes harder to interpret. This is 

especially true for those who are colorblind. 

 Dr. Wodi indicated that the schedule can be accessed online and printed. There is a 

color version and a grayscale version. They are working with the graphics team to 

ensure that it can be used by people who have colorblindness. 

• The link to download the CDC Vaccine Schedules app for providers included on the cover 

pages of the schedules was observed to be extremely beneficial. 

• An inquiry was posed regarding approval of the immunization schedule recommendations 

by the societies listed earlier in terms of whether this always has been the case, the 

protocol/timeframe for their approval, and what occurs should any of the societies disagree 

with the recommendations (e.g., would the recommendations go back to ACIP?). 

 Dr. Ault indicated that as part of the ACOG committee that reviews these 

recommendations, after the ACIP votes, ACOG distributes them to others in the 

organization and then ACOG endorses the recommendations. He did not recall a 

society not endorsing a schedule in the past, likely because liaisons spend so much 

time attending committee meetings. 

 Dr. Goldman reported that the way that ACP handles this is that once a vaccine 

schedule is approved by CDC, he takes it back to ACP’s vaccine committee, which 

then votes and brings it up to the Board of Regents. When the Board of Regents 

approves the policy, it is published in the Annals of Internal Medicine. ACP is usually 

in concert with and supports ACIP/CDC guidelines, but sometimes does not agree. 

When that happens, ACP would publish the policy differently in the Annals of Internal 

Medicine. 

 Dr. Wharton pointed out that because of the involvement of the listed groups in the 

WG, the schedule is developed collaboratively. If there are late changes, they are 

worked through by the group as a whole. Although there are formal processes for 

approval, they tend to work seamlessly. 

• A key feature of IISs is that they can evaluate what vaccines/doses someone has received 

in the past and compare these to the ACIP recommendations to forecast what that person is 

likely recommended to receive, which can aid the provider and patient in decision-making. 

• Concern was expressed about inclusion of the process language “or as otherwise 

recommended by ACIP and adopted by the CDC director” for COVID-19 vaccination when it 

is not included for other vaccines and given that the process does not always flow in that 

direction. 

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ACIP Meeting Summary November 2-3, 2021 

 Dr. Wodi indicated that they worked with CDC’s Office of General Counsel (OGC) to 

help write the language. 

 Dr. Lee requested that a representative from CDC confer with the CDC team to 

clarify this. This is part of the charter and should not be included in every 

recommendation, nor is it unique to this particular recommendation. 

Proposed Changes to 2022 Adult Immunization Schedule 

LCDR Neil Murthy (CDC/NCIRD) presented proposed substantive changes to the 2022 Adult 

Immunization Schedule, noting that minor grammatical or formatting edits meant to improve 

clarity of the language would not be presented. He discussed proposed edits to the tables, 

proposed vaccine-specific changes in the notes section, and the addition of a new appendix 

with contraindications and precautions for each vaccine. 

There were 4 main changes on the cover page. The first was in the how to use the adult 

immunization schedule box, where a Step 4 was included instructing providers to review the 

newly added appendix that lists the contraindications and precautions for all the vaccines listed 

in the adult immunization schedule. The second edit was in the box in the upper right-hand 

corner of the cover page, where SHEA was added as a partner organization approving the adult 

schedule. The third edit was the list of adult vaccines, where PCV13 was removed and the 2 

new pneumococcal conjugate vaccines, PCV15 and PCV-20, were added to the list. The final 

edit was the addition of a QR code at the bottom right-hand corner of the cover page that when 

scanned takes the user to a CDC website with the adult immunization schedule, which can be 

viewed from a mobile device if preferred. 

Table 1 had 4 proposed edits. The first edit was to the Zoster vaccine row, where 2 doses of 

recombinant zoster vaccine (RZV) are now recommended for adults 19-49 years of age who 

have immunocompromising conditions. This change reflects the new ACIP recommendations. 

The second edit was to the pneumococcal vaccine row. To reflect the new ACIP 

recommendations, the new pneumococcal conjugate vaccine and the polysaccharide vaccine 

were collapsed into one row. Guidance for which vaccines are indicated for certain age groups 

was displayed by the corresponding colors and overlying text. The final edit to Table 1 was to 

the hepatitis B row, which was changed to yellow in anticipation of ACIP’s recommendation for 

universal Hepatitis B vaccination for adults up to and including 59 years of age. Those 60 years 

of age and older will continue to have risk-based recommendations, which is indicated by the 

purple bar. 

There were 5 changes proposed for Table 2, the medical indications table. The first change was 

to the CD4 percentages and counts header to harmonize with the way this information is 

presented in the Child and Adolescent Schedule. The second edit was to the legend at the 

bottom of the table where the description was reworded for the color red in the legends. Red 

now indicates the vaccine is contraindicated or not recommended. The third edit was to the 

zoster vaccine row, where 2 doses of RZV are now recommended to adults ≥19 years of age 

who have immunocompromising conditions, including HIV infection. This change reflects the 

new ACIP recommendation. The fourth edit was to the pneumococcal vaccine row. As in Table 

1, all the pneumococcal vaccines were collapsed into one row with colors and overlying text 

indicating which groups need which vaccines. The fifth edit was to the Hepatitis B row, which 

was changed entirely to yellow indicating that the vaccine is recommended for various riskbased groups. 

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ACIP Meeting Summary November 2-3, 2021 

Now turning to the changes proposed in the notes section of the adult schedule, beginning with 

the COVID-19 vaccination box on the first page of the notes section. In addition to stating that 

COVID-19 vaccines are recommended within the scope of the Emergency Use Authorization 

or Biologic License Application for this particular vaccine, a phrase was added reading, “or as 

otherwise recommended by ACIP and adopted by the CDC director.” Because it was felt that 

clinicians would benefit from having this information readily available, the hyperlink to CDC’s 

Interim Clinical Considerations for the use of COVID-19 Vaccines was added. 

Moving to the hepatitis B section, In this section, clarification was added for the 2-, 3-, and 4-

dose hepatitis B vaccine series. Based on the hepatitis B discussions from earlier in the day, 

language will be included about risk-based recommendations for adults 60 years of age and 

older. 

In terms of the HPV vaccine, the wording was changed in the final bullet of the Routine 

Vaccination section to increase clarity. This bullet now reads, “No additional dose 

recommended when any HPV vaccine series has been completed using the recommended 

dosing intervals.” In the Special Situation section, wording was added to the 

immunocompromising conditions bullet for clarity, which now reads, “Immunocompromising 

conditions, including HIV infection: 3-dose series as above, when initiating vaccination at 

age 9-45 years. Recommendations for routine and shared clinical decision-making similar to 

those for persons without immunocompromising conditions.” Finally, the wording was 

rearranged for the pregnancy bullets in the Special Situations section, which now reads, 

“Pregnancy testing is not needed before vaccination; HPV vaccination is not recommended until 

after pregnancy; no intervention needed if inadvertently vaccinated while pregnant.” 

On the first page of the influenza section, the language in the first bullet under routine 

vaccination was changed to read, “Age 19 years or older: 1 dose any influenza vaccine 

appropriate for age and health status annually.” The hyperlink to the 2021-2022 Influenza 

Vaccine Recommendations was added, along with a bullet for the 2022-23 influenza season 

recommendations. On the second page of the notes section, much of the special situations with 

different influenza vaccinations has been condensed and refers HCP to the Appendix to learn 

about contraindications and precautions. 

Under the Special situations Section for MMR vaccination, CD4 percentages were added in 

addition to CD4 counts for HIV infection to harmonize the language with child/adolescent 

schedule for the HIV infection bullets. 

For meningococcal vaccination, a note was added at the end that states, “Meningococcal B 

vaccines may be administered simultaneously with MenACWY vaccines if indicated, but a 

different anatomic site, if feasible.” 

The pneumococcal vaccination section was modified substantially to reflect the new ACIP 

recommendations. The first bullet now states that adults, “Age 65 years or older who have not 

previously received a pneumococcal conjugate vaccine or whose previous vaccination history is 

unknown: 1 dose PCV15 or 1 dose PCV20. If PCV15 is used, this should be followed by a dose 

of PPSV23.” Once details about the dosing intervals between PCV15and PPSV23 are finalized, 

a link will be added to that guidance. A link also will be included for providers to reference the 

guidance for patients who previously received PCV13 or PPSV23 in the past. The Special 

Situation section was changed and now has a bullet stating, “Age 19-64 years with certain 

underlying medical conditions or other risk factors who have not previously received a 

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ACIP Meeting Summary November 2-3, 2021 

pneumococcal conjugate vaccine or whose previous vaccination history is unknown: 1 dose 

PCV15 or 1 dose PCV20. If PCV15 is used, this should be followed by a dose of PPSV23.” 

Again, once details about the dosing intervals between PCV15 and PPSV23 are finalized, a link 

to that guidance would be added here. Similarly, a link would be included for providers to 

reference the guidance for patients who have previously received PCV13 or PPSV23. A note 

was added at the end of the pneumococcal section stating, “Underlying medical conditions or 

other risk factors include alcoholism, chronic heart/liver/lung disease, cigarette smoking, 

diabetes mellitus, chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic 

immunosuppression, generalized malignancy, HIV, Hodgkin disease, leukemia, lymphoma, 

multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease or 

other hemoglobinopathies, CSF leak, or cochlear implant.” 

For the varicella section, CD4 percentages have been added in addition to CD4 counts in the 

HIV infection bullet to harmonize the language with the child and adolescent schedule. In the 

Special Situation section, the language was revised for the pregnancy bullet. This now reads, 

“There is currently no ACIP recommendation for RZV use in pregnancy. Consider delaying RZV 

until after pregnancy.” To reflect the new ACIP recommendations for persons with 

immunocompromising conditions, this bullet now states, “Immunocompromising conditions 

(including HIV): RZV recommended for use in persons aged 19 years or older who are or will 

be immunodeficient or immunosuppressed due to disease or therapy.” 

The newest addition to the adult immunization schedule is the appendix that lists all of the 

contraindications and precautions to each of the adult vaccines. At the top of the appendix, the 

same items were added that were added to the child/adolescent schedule: 

Guide to Contraindications and Precautions to Commonly Used Vaccines 

Adapted from Table 4-1 in Advisory Committee on Immunization Practice (ACIP) General Best 

Practice Guidelines for Immunization: Contraindication and Precautions available at 

www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html and ACIP’s 

Recommendations for the Prevention and Control of 2021-22 seasonal influenza with Vaccines 

available at www.cdc.gov/mmwr/volumes/70/rr/rr7005a1.html 

Interim clinical considerations for use of COVID-19 vaccines including contraindications 

and precautions can be found at www.cdc.gov/vaccines/covid-19/clinicalconsiderations/covid19-vaccines-us.html 

The first page of the appendix lists the contraindications and precautions for all of influenza 

vaccines approved for adults. The second page of the appendix lists the contraindications and 

precautions for all of the other non-influenza vaccines. 

Discussion Summary 

• Concern was expressed that cochlear implants were included on Table 2 in the 

child/adolescent schedule but not on the adult schedule. Physicians want to be alerted to 

cochlear implants being an indication for a special situation if it impacts their vaccination 

schedule, which is not captured by this schedule. 

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ACIP Meeting Summary November 2-3, 2021 

 Dr. Murthy indicated that because there were so many nuances with the 

contraindications and precautions to the influenza vaccination recommendations, the 

WG decided to have a separate section for the contraindications and precautions in 

the appendix. The cochlear implant is listed as a contraindication for the live 

attenuated influenza vaccine (LAIV). The goal is to direct HCP to glean this 

information from the new appendix. In the pneumococcal vaccination section, there 

is a special note that mentions that persons 19-54 years of age with cochlear 

implants should receive vaccinations. However, an analogous appendix is not 

included per se based on those very specific risk factors. Table 2 does not have 

cochlear implant, but does have other risk factors that would indicate certain 

vaccines. 

 There was support for including a few words in the pneumococcal statement in 

addition to referring people to information located elsewhere. For instance, it could 

read, “PCV15 or PCV20 may be administered. If PCV15 is used, it should be 

followed by PPSV23.” Then 2 weeks to 12 months and the URL could be included. 

Perhaps a few more words could express the urgency of attaining full coverage as 

quickly as possible rather than waiting 12 months in persons with a cochlear implant 

or who just had their spleen removed for instance. 

 Dr. Murthy indicated that the team would work closely with pneumococcal vaccine 

colleagues to consider how this could be presented succinctly in the final version that 

will be published in February 2022. 

• The HPV recommendation in the Special Situation section that references routine and 

shared clinical decision-making in the context of immunocompromising conditions is 

confusing. Though the goal was to add clarity, it was not clear what this was trying to covey. 

Part of the confusion may be due to the sentience prior to this stating 9-45 years of age. 

Perhaps adding clarifying information about the age-based recommendations for persons 9-

45 years of age would make this clearer. This needs to be very direct about needing a 3-

dose series even if the first dose is given before 15 years of age. 

 Dr. Murthy said that because people were misinterpreting last year’s schedule, the 

proposed language was developed with input from their HPV colleagues, who 

pointed out that the recommendations for routine and shared clinical decision-making 

are similar for persons with or without immunocompromising conditions. Essentially, 

the point was to state that people still would need to fall within the recommended 

timeframe and age range. They will work with the HPV SMEs to further clarify this. 

• The red box in Table 2 is “contraindicated or not recommended.” All of the red boxes have 

overlaying text of “not recommended,” but sometimes a vaccine is contraindicated as distinct 

from not being recommended. Providers may find this confusing, so it was suggested that 

either all of the overlying text be removed or “contraindicated” be placed where appropriate. 

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ACIP Meeting Summary November 2-3, 2021 

Vote: Immunization Schedules 

Dr. Wharton (ACIP, Executive Secretary) indicated that the ACIP procedural language that 

was included in the schedules was removed and other comments throughout the discussion 

from the committee were incorporated and revised schedules were developed. The language for 

the vote read as follows: 

The ACIP approves the recommended Child and Adolescent Immunization Schedule, 

United States, 2022 and the recommended Adult Immunization Schedule, United, States 

2022. 

Vote: Child and Adolescent and Adult Immunization Schedules 

Dr. Ault made a motion to accept the language stating that, “The ACIP approves the 

recommended Child and Adolescent Immunization Schedule, United States, 2022 and the 

recommended Adult Immunization Schedule, United, States 2022.” Ms. Bahta second the 

motion. No COIs were declared. The motion carried with 15 affirmative votes, 0 negative votes, 

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

15 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, 

McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

0 Absent: N/A 

Member Statements 

Subsequent to the votes, Dr. Lee invited ACIP members to make a statement about the 

rationale for their votes and/or to share any additional general comments: 

• Dr. Chen recognized that the orchestration of the vaccination schedules and development of 

these tools in a way that makes sense for providers to be able to use clearly takes a 

tremendous amount of work, for which he expressed gratitude to the WG. 

• Dr. Poehling emphasized that the immunization schedule for adults is complicated, which is 

good in that it signifies that there are a lot of adult vaccines available. Now is the time to 

create a universal vaccine registry for adults because this will be an essential component of 

determining which vaccines people have had. She strongly encouraged the development of 

a universal vaccine registry for adults, combined across states. Consideration must be given 

to how to move forward on this. 

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ACIP Meeting Summary November 2-3, 2021 

ORTHOPOXVIRUSES VACCINES 

Session Introduction 

Dr. Pablo Sanchez (ACIP Chair) provide an introduction and overview of the orthopoxviruses 

vaccines session. As a reminder, the WG provided background information important to 

understanding the EtR Framework and presented EtRs for 5 policy questions for JYNNEOS® 

during the ACIP meeting on September 29, 2021. WG discussions since that ACIP meeting 

have focused on clinical guidance for the use of JYNNEOS®, including contraindications and 

precautions/warnings, and wording of proposed recommendations. Topics during this session 

included presentations on clinical guidance for the use of JYNNEOS®, a summary of WG 

considerations and proposed policy options, and orthopoxviruses vaccine votes. Publication of 

the recommendations in the MMWR is anticipated in early to mid-2022. 

Clinical Guidance for Use of JYNNEOS® 

Dr. Brett Petersen (NCEZID/ CDC) presented clinical guidance for the use of JYNNEOS® 

vaccine in terms of contraindications and precautions/warnings, guidance for minimizing the risk 

of occupational exposure, and titers and starting work in laboratories. The vaccines under 

discussion during this session were ACAM2000 and JYNNEOS®. The major difference between 

these vaccines is that ACAM2000 is a replication-competent vaccinia virus vaccine while 

JYNNEOS® is replication deficient. With ACAM2000, a vaccine site lesion or a “take” occurs that 

is not seen with JYNNEOS®. Consequently, there is a risk of an inadvertent inoculation and 

autoinoculation with ACAM2000 that does not exist with JYNNEOS®. Other SAEs occur with 

ACAM2000, which are expected to appear less frequently with JYNNEOS®. 

Both of these vaccines are licensed by the FDA, and their effectiveness was evaluated by 

comparing the immunologic responses of these vaccines with their predecessor previously 

licensed vaccines. The proposed recommendations for these vaccines are for persons at 

occupation risk of exposure to orthopoxviruses. This includes research laboratory personnel, 

diagnostic laboratorians, and response team members. This vaccine also would be offered 

under shared clinical decision-making to persons who administer ACAM2000 or care for 

patients with infections or after vaccination with replication-competent virus vaccines. The 

vaccines would also be recommended as a booster for persons who are at continued or 

sustained risk for exposures to orthopoxviruses. For those working with smallpox and 

monkeypox, booster doses would be every 3 years for ACAM2000 and every 2 years for 

JYNNEOS®. Booster doses would be every 10 years for either vaccine for those working with 

less virulent orthopoxviruses. 

Severe vaccinia virus complications can occur following vaccination with replication-competent 

vaccinia virus vaccines or after occupational exposures and infections with orthopoxviruses, 

such as progressive vaccinia or eczema vaccinatum, which can occur in individuals with 

immunocompromise or atopic dermatitis, respectively. These complications are due to 

uncontrolled viral replication. There also can be severe vaccinia virus complications related to 

inadvertent transmission. For example, fetal vaccinia can occur following vertical transmission 

to the fetus or autoinoculation and inadvertent inoculation can occur as well. These can be 

serious when they affect anatomic areas of particular sensitivity like the eyes. Severe vaccinia 

virus complications of uncertain etiology can occur as well, such as post-vaccinal encephalitis 

and myopericarditis. No confirmed cases of any of these severe vaccinia virus complications 

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ACIP Meeting Summary November 2-3, 2021 

have been reported in any of the clinical trials with JYNNEOS® to date. There does remain a 

theoretical risk that severe vaccinia virus complications of uncertain etiology could occur based 

on the hypothesis that there may be an immune-mediated phenomenon rather than direct viral 

infection, which is dependent on the replication status of the vaccine. 

Regarding the proposed ACIP contraindications for ACAM2000 and JYNNEOS®, the 

contraindications for ACAM2000 are unchanged from previous ACIP recommendations as there 

are no significant new safety data to suggest a need for a change. For JYNNEOS®, the WG 

recommended a contraindication for persons who have a serious vaccine component allergy. 

This recommendation was made in recognition of the currently available safety data and the 

population that is the subject of these recommendations. Precautions and warnings are 

provided in the footnotes for household contacts, atopic dermatitis/eczema and other active 

exfoliative skin conditions, conditions associated with immunosuppression, pregnancy, children 

<1 year of age, breastfeeding, and three or more known major cardiac risk factors. 

For household contacts, a bullet was added to note that “JYNNEOS® is a replication-deficient 

vaccine and therefore should not present a risk of transmission to household contacts.” For 

persons with atopic dermatitis/eczema and other active exfoliative skin conditions, a bullet was 

added to indicate that “Studies evaluating JYNNEOS® in persons with atopic dermatitis have 

demonstrated immunogenicity in eliciting a neutralizing antibody response and did not reveal 

any significant safety concerns.” Individuals with immunosuppression are contraindicated for 

receipt of ACAM2000, but a bullet was added to indicate that “Immunocompromised persons, 

including those receiving immunosuppressive therapy, may have a diminished immune 

response to JYNNEOS® because of their immunocompromised status.” While pregnant women 

are contraindicated to receive ACAM2000, bullets were added to indicate that “Available human 

data on JYNNEOS® administered to pregnant women are insufficient to inform vaccineassociated risks in pregnancy. However, animal models, including rats and rabbits, have shown 

no evidence of harm to a developing fetus.” 

Infants aged less than one year are contraindicated for receipt of ACAM2000. Notes have been 

added that “That JYNNEOS® is not licensed for persons <18 years and has not been rigorously 

evaluated in this population” and that for that reason “Caution should be used when considering 

the administration of ACAM2000 or JYNNEOS® to children and adolescents aged <18 years.” 

Breastfeeding women are contraindicated for receipt of ACAM2000. Information was added to 

the footnote to indicate that “The safety and efficacy of JYNNEOS® has not been evaluated 

in breastfeeding women.” Therefore, “It is not known whether JYNNEOS® is excreted in human 

milk and data are not available to assess the impact of JYNNEOS® on milk production or the 

safety of JYNNEOS® in breastfed infants.” “However, JYNNEOS® vaccine is replication deficient 

and therefore should not present a risk of transmission to breastfeeding infants.” Nevertheless, 

“Caution should be used when considering the administration of JYNNEOS® to breastfeeding 

women.” Individuals who have an underlying cardiac disease or three or more known major 

cardiac risk factors are contraindicated for primary vaccination with ACAM2000. However, 

bullets were added to indicate that “Clinical studies have not detected an increased risk of 

myopericarditis in recipients of JYNNEOS®” and that “Persons with underlying heart disease or 

≥3 major cardiac risk factors should be counseled on the theoretical risk of myopericarditis given 

the uncertain etiology of myopericarditis associated with replication-competent smallpox 

vaccines.” 

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The WG also proposed to include guidance on minimizing risk of occupational exposure, titer 

testing, and starting work in laboratories as follows: 

Guidance for Minimizing the Risk of Occupational Exposure 

 Many persons with contraindications to vaccination with ACAM2000 (e.g., atopic dermatitis, 

immunocompromising conditions, breastfeeding, or pregnancy) may receive vaccination with 

JYNNEOS®. 

 However, such persons may be at increased risk for severe disease if an occupational 

infection occurs despite vaccination. 

 Persons with immunocompromising conditions may be less likely to mount an effective 

response after any vaccination, including after JYNNEOS® even though JYNNEOS® can be 

safely administered to such persons. 

 Persons who are pregnant, immunocompromised, with atopic dermatitis, or breastfeeding 

may receive JYNNEOS® when it is considered imperative to provide protection against 

orthopoxvirus infections and after careful consideration of the risk/benefit ratio. 

 To find more information about the risk for severe outcomes if orthopoxvirus infections are 

acquired, please see [Smallpox Vaccination and Adverse Reactions: Guidance for 

Clinicians, 2003. MMWR 2003, 52(RR04);1-28]. 

Titer Testing 

 As a replication-deficient vaccine, JYNNEOS® does not produce a vaccine site lesion (also 

known as a “take”) that can be used as a marker of successful vaccination. 

 Routine titer testing is not recommended following vaccination with JYNNEOS® to confirm 

successful administration of vaccine given that high rates of seroconversion were 

demonstrated in clinical trials. 

 However, titer testing could be considered on a case-by-case basis after consultation with 

public health authorities for select persons with immunocompromising conditions or those 

working with more virulent orthopoxviruses (e.g., variola virus and monkeypox virus) to 

confirm an immune response has been achieved. 

 A correlate of protection has not been established and there is no known antibody titer level 

that will ensure protection. 

 Titer results should be interpreted with caution in such cases to avoid providing a false 

sense of security. 

Starting Work in Laboratories 

 A person can be considered fully immunized 2 weeks following administration of the second 

dose of JYNNEOS® when clinical studies have demonstrated maximal antibody titers. 

Summary of WG Considerations and Proposed Policy Options 

Dr. Agam Rao (NCEZID / CDC) reminded everyone that there are 5 PICO questions. The first 

and the second pertain to primary vaccination with JYNNEOS® for 2 at-risk populations. The 

third and fourth questions regard the frequency of booster doses after the primary vaccination 

series with JYNNEOS® and persons with continued occupational risk. The fifth relates to one of 

the most frequent questions received, which concerns changing from boosters with ACAM2000 

to boosters with JYNNEOS® for those who received the ACAM2000 primary series. Because 

there are 5 PICOs, there are 5 EtR frameworks. Dr. Rao noted that she would go over the first 

one in detail, but would move quickly through the other 4 because many of the WG sentiments 

were the same. 

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Beginning with the EtR for the first 2 PICO questions pertaining to primary vaccination with 

JYNNEOS®, orthopoxvirus infections cause morbidity and mortality. Several populations are at 

occupational risk. The first are research laboratory personnel, who are defined as those who 

directly handle 1) cultures or 2) animals contaminated or infected with replication-competent 

vaccinia virus, recombinant vaccinia viruses derived from replication-competent vaccinia strains 

(i.e., those that are capable of causing clinical infection and producing infectious virus in 

humans), or other orthopoxviruses that infect humans (e.g., monkeypox, cowpox, and variola). 

The second are clinical laboratory personnel performing diagnostic testing for orthopoxviruses. 

The third are response team members designated by public health authorities to receive the 

vaccine for preparedness purposes. The fourth population are select HCP who administer 

ACAM2000 or care for patients infected with replication-competent orthopoxviruses, such 

patients enrolled in clinical trials. 

ACAM2000 is currently recommended by the ACIP for persons at occupational risk. If 

JYNNEOS® were to also be recommended, there would be benefits to having more than one 

effective vaccine available. Additionally, having more than one vaccine provides options. Some 

people may prefer receiving one of these vaccines over the other. The first PICO question is, 

“Should JYNNEOS® be recommended for research laboratory personnel, clinical laboratory 

personnel performing diagnostic testing for orthopoxviruses, and designated response team 

members at risk for occupational exposure to orthopoxviruses?” The intervention is vaccination 

with JYNNEOS® and the comparison is ACAM2000, which is the standard of care for persons at 

risk for occupational exposure. The outcomes listed for this question are the same as for the 

other 4 PICOs to be presented: prevention of disease, severity of disease, SAEs, myo-/pericarditis. The outcomes of prevention of disease, SAEs, and myo-/peri- carditis were deemed 

critical by the WG. These are the outcomes that will be evaluated in the Evidence Tables. 

Regarding the first EtR domain of benefits and harms, JYNNEOS® is not a replicating virus so 

there is not potential spread to others. FDA found JYNNEOS® to be non-inferior to ACAM2000 

for immunogenicity. Most importantly, the evidence table for outcome A suggests that there is 

as small benefit of JYNNEOS® compared to ACAM2000 for prevention of disease. For this 

reason, the WG concluded that the desirable anticipated effects are small. Looking at the 

evidence table, GMTs and seroconversion rates are the 2 indirect measures of prevention of 

disease evaluated. Regarding prevention of disease assessed with GMT, the mean difference in 

titer units between those who received JYNNEOS® compared to those who received a live 

replicating vaccinia vaccine with either ACAM2000 or Dryvax®, was 1.62 titer units higher. The 

95% confidence interval ranged from 1.32 to 1.99 titer units higher. 

In terms of harms and how substantial the undesirable anticipated effects are, JYNNEOS® is a 

non-replicating vaccinia virus, so there were fewer contraindications to JYNNEOS® compared to 

ACAM2000. The RCTs and pooled observational data and the evidence tables indicate fewer 

AEs with JYNNEOS®. The WG decided that the answer to this question was “minimal” based on 

the data considered for this question. The absolute effect from the RCT data was 3 fewer SAEs 

per 1000 with JYNNEOS® compared to ACAM2000. The observational data support the RCT 

data. Because it is relevant to later aspects of the EtR, many more people were included in the 

observational data than the RCT data. Similarly, there were fewer myocarditis events 

associated with JYNNEOS® compared to ACAM2000. The observational data supported the 

same conclusion, offered a lot more data, and showed that there are minimal harms from 

JYNNEOS®. 

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The benefits were determined to be small and harms minimal, so the desirable effects were 

determined to outweigh the undesirable effects. Therefore, the WG favored the intervention. 

The overall certainty in the benefits was moderate based on the evidence table for prevention of 

disease. After considering GMT and SCR data together, there is moderate certainty that there 

was a small increase in disease prevention provided by JYNNEOS® compared to ACAM2000. 

The certainty level was determined by an assessment of the RCTs for study design, risk of bias, 

inconsistency, indirectness, and imprecision. GMT is an indirect measure of prevention of 

disease, which is what has led to a Level 2 or moderate-level certainty for the effect estimate. 

The WG estimated that there were fewer SAEs in myocarditis cases after a JYNNEOS® primary 

series compared to ACAM2000 vaccination, but there was low certainty in these conclusions. 

For SAEs, RCT data were downgraded due to the sample size being small and therefore not 

meeting the optimal size to assess this rare outcome. Also, the 95% confidence interval 

includes the potential for meaningful harm. The observational data included many more subjects 

(over 5000) in the JYNNEOS® arm and showed no harm. This was reassuring for the WG and is 

the reason that both the RCT data and observational data were presented. Similarly, for 

myo/pericarditis, there were too few subjects enrolled in the RCTs to assess for this rare event. 

Therefore, there was very serious concern for imprecision. While the observational data 

included many more subjects, the certainty level for observation studies is low to start with at 

Level 3. It was downgraded here because of serious concerns for risk of bias because of 

selection bias and for indirectness because this was an indirect comparison of pooled singlearm studies compared to a historical control. 

Moving to the values domain, the WG concluded that the target population probably feels that 

the desirable effects are large relative to the undesirable effects. In 2015, CDC surveyed 275 

HCP in the Democratic Republic of Congo (DRC) to evaluate the target population’s values. 

Among the respondents, 99% reported having seen a monkeypox case, over 75% were not 

interested in ACAM2000 after they heard what it was, and 98% were interested in JYNNEOS®. 

The US target population has made multiple requests for JYNNEOS® vaccine, although the US 

does not have similar data. The WG determined that while no research has been identified, 

stakeholders are expected to value immunity. FDA deemed the JYNNEOS® primary vaccination 

series to be non-inferior to that for ACAM2000. It will take longer from the first vaccination 

before a person given JYNNEOS® is considered fully vaccinated compared to a person given 

ACAM2000, given that 2-doses of JYNNEOS® administered over 28 days are required 

compared to 1 vaccination for ACAM2000. The WG concluded that there is probably no 

important uncertainty or variability. 

For the acceptability domain, there is ease in finding a provider and it is known that some 

vaccinees have difficulty finding an ACAM2000 provider because it is administered by a 

technique with which many physicians may not be familiar. It involves the bifurcated needle and 

multiple punctures. Because JYNNEOS® is a non-replicating virus vaccine, there is no risk of 

transmission to others, particularly to those who are immunocompromised or who have skin 

conditions like eczema. AEs also are expected to be rarer with JYNNEOS® compared to 

ACAM2000. For all of these reasons, the WG thought that the intervention would be acceptable 

to key stakeholders. 

Now moving to the resource use and equity domains. JYNNEOS®, like ACAM2000, would be 

provided from HHS’s Strategic National Stockpile (SNS) free of cost. Even in cases where 

employers do not cover the cost of clinic appointments, there may be similar clinic costs 

associated with JYNNEOS® as with ACAM2000 vaccinations because in some clinics, patients 

return for in-person clinic appointments on multiple days after ACAM2000 vaccination on Days 

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3, 7, and sometimes several times after that to perform dressing changes and assess the “take” 

sites and evaluate for symptoms or complaints consistent with myocarditis. Therefore, the WG 

felt that JYNNEOS® would be a reasonable and efficient allocation of resources. Because there 

are fewer costs and challenges associated with identifying a provider, equity would be 

increased. 

For the domain of feasibility, there likely would be the same number of clinic visits or possibly 

even fewer with JYNNEOS®. Also, there would be less difficulty getting on a vaccine schedule 

because more providers would be willing to administer subcutaneous injections. People would 

not necessarily have to go to military sites to receive the vaccine. JYNNEOS®, once thawed and 

refrigerated, is good for 6 months. According to recent approvals made by FDA, thawed 

ACAM2000 is good for longer at about 18 months, but the shipping conditions are the same for 

both. Therefore, the 6-month window allows for ample time for providers to schedule 

vaccinations. CDC Drug Service would be sending out the vaccine and they foresee no issues 

with feasibility. Therefore, the WG deemed the intervention feasible to implement. 

To summarize the EtR Framework for the first PICO question in terms of the balance of 

consequences, the WG felt the desirable consequences probably outweigh undesirable 

consequences in most settings. Therefore, the WG proposed the following language for the first 

recommendation: 

Proposed Recommendation 1 

The ACIP recommends JYNNEOS® as an alternative to ACAM2000 for research laboratory 

personnel*, clinical laboratory personnel performing diagnostic testing for orthopoxviruses†, and 

for designated response team members at risk for occupational exposure to orthopoxviruses§ 

*Research laboratory personnel are those who directly handle 1) cultures or 2) animals contaminated or infected with replicationcompetent vaccinia virus, recombinant vaccinia viruses derived from replication-competent vaccinia strains (i.e., those that are 

capable of causing clinical infection and producing infectious virus in humans), or other orthopoxviruses that infect humans (e.g., 

monkeypox, cowpox, and variola). †Clinical laboratory personnel who perform routine chemistry, hematology, and urinalysis testing, 

including for suspect or confirmed patients with Orthopoxvirus infections, are not included in this recommendation as their risk for 

exposure is very low §Public health authorities, at their own discretion, may approve a cohort of healthcare and/or public health 

personnel to receive primary vaccination against Orthopoxviruses for preparedness purposes (e.g., first responders who might 

participate in a smallpox or monkeypox outbreak). 

Moving to the second PICO question regarding whether JYNNEOS® should be recommended 

for HCP who administer ACAM2000 or care for patients infected with replication-competent 

orthopoxviruses, many of the responses were the same as for the first PICO question. In terms 

of benefits and harms, the same evidence tables were used for this PICO. There were 

differences in the values domain. There is no research data to evaluate whether the target 

population feels that the desirable effects are large relative to undesirable effects, but it is 

believed that some members of this population will be interested in vaccination or at least would 

like the option of being vaccinated, even though it is not indicated for the entire population. In 

the past, when patients were admitted with AEs from replicating orthopoxvirus vaccines, some 

HCP were anxious. Allowing for these persons to be vaccinated is consistent with the ACIP 

recommendations for ACAM2000 and is something that the WG wanted to do. The ACAM2000 

language for this particular population is that it “can be offered.” Because of the low risk for such 

persons who already are wearing personal protective equipment (PPE), many may opt to not 

get vaccinated. The WG concluded that there is possibly important uncertainty or variability in 

this recommendation, potentially indicating that it could be recommended by shared clinical 

decision-making. 

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The WG responses for all of the remaining domains were the same as presented for the first 

EtR, and they determined that the desirable consequences probably outweigh the undesirable 

consequences in most settings. With that in mind, the WG proposed the following language for 

the second recommendation: 

Proposed Recommendation #2

The ACIP recommends JYNNEOS®, based on shared clinical decision-making, as an alternative 

to ACAM2000 for health care personnel who administer ACAM2000 or care for patients infected 

with replication-competent orthopoxviruses.* 

* For example, those caring for patients enrolled in clinical trials for replication-competent orthopoxvirus vaccines and those caring 

for persons with suspected or confirmed orthopoxvirus infections (e.g., clinicians and environmental services personnel) 

The third and fourth EtRs regard the frequency of JYNNEOS® booster doses after the 

JYNNEOS® primary series. The problem here is virulent orthopoxviruses (e.g., variola virus and 

monkeypox virus). An increasing number of laboratories are working with monkeypox viruses 

(e.g., primate laboratories). Work with these typically requires PPE and other safeguards, but 

ensuring long-term immunogenicity through a booster provides an additional level of protection 

if unintentional breaches occur. For less virulent orthopoxviruses (e.g., vaccinia virus, cowpox 

virus, and Alaskapox virus), morbidity may be prevented. For example, a mild case of vaccinia 

infection occurred in a laboratorian in the US who had not received a booster >10 years after his 

primary ACAM2000 vaccination. These cases could potentially be prevented with the 

recommended booster. The stakes are higher to individuals and public health if virulent 

orthopoxvirus infections are acquired. Monkeypox or smallpox in a laboratorian would be a very 

large problem for public health. An individual getting infected with vaccinia virus is of concern to 

that individual, but is not a concern on a population level. For this reason, boosters historically 

have been given more frequently for those working with virulent orthopoxviruses compared to 

those working with less virulent orthopoxviruses. 

The third PICO focuses on whether persons who are at continued risk for occupational 

exposure to more virulent orthopoxviruses such as variola virus or monkeypox virus should 

receive a booster dose of JYNNEOS® every 2 years after the primary JYNNEOS® series, the 

comparison is no vaccine booster after the JYNNEOS® primary series. The fourth PICO 

question focuses on whether persons who are at continued risk for occupational exposure to 

less virulent replication-competent orthopoxviruses like vaccinia virus or cowpox virus should 

receive a booster dose of JYNNEOS® at least every 10 years after the primary JYNNEOS 

series. The outcomes are the same for both (e.g., prevention of disease, SAEs, and 

myocarditis/pericarditis). 

In terms of benefits and harms domain, the WG felt that the desirable anticipated effects are 

small for the third and fourth policy questions. The evidence tables showed a small increase in 

disease prevention after the JYNNEOS® booster to the JYNNEOS® primary series. 

Nevertheless, boosters may provide reassurance of continued protection from inadvertent 

exposures. Harms. The WG felt that the undesirable anticipated effects are minimal. No SAEs 

or myopericarditis/pericarditis were reported among those who received a JYNNEOS® booster 

dose 2 years after the primary series. Because of the benefits being small and the harms being 

minimal, the benefits-to-harm ratio favors the intervention. The overall certainty of the evidence 

for the critical outcomes was very low for both the fourth and fifth policy questions because of 

the limited data available about booster doses. This means that the WG estimated that there is 

a small increase in disease prevention after a JYNNEOS® booster following the JYNNEOS® 

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primary series versus the JYNNEOS® primary series with no booster. However, the WG had 

very low certainty in that estimate. 

The reason that the answer was “serious” for PICO #3 and “very serious” for PICO #4 was 

because there are data for the 2-year timepoint for a booster dose, but there are no data 

beyond the 2-year time point. Therefore, indirect data inform the 10-year booster 

recommendation. This was somewhat arbitrarily chosen by the WG, but the WG felt strongly 

that there had to be a recommendation about when people working with the less virulent 

orthopoxviruses should get a booster dose or otherwise it would be forgotten. The 10 years was 

chosen because 2 years clearly was too often and 10 years is the same as what is 

recommended for ACAM2000. Despite the answer being different for PICOs #3 and #4 for 

indirectness, the certainty level was not impacted and was determined to be Level 4 or very low 

for both. 

For harm, SAEs and myopericarditis were considered. There were no cases of SAEs after the 

JYNNEOS® booster. The effect estimate for the RCT and observational data were not estimable 

because there were no recorded events of vaccine-related SAEs after the booster. The 

denominators were too small to have identified an SAE known to be a rare occurrence event for 

ACAM2000, so the certainty in that estimate is very low. There also were no reported cases of 

myopericarditis, but the number of enrolled subjects was extremely low for both arms. With the 

available data, the effect of JYNNEOS® plus a booster compared to just the JYNNEOS® primary 

series cannot be estimated. Therefore, the certainty level was very low for this conclusion. For 

the remainder of the EtR domains for PICOs #3 and #4, all of the WG’s responses were 

positive. 

For the value domain, the WG felt that the target population probably feels that the desirable 

effects are large. The booster may be desirable to those who want to ensure long-term 

immunogenicity. The WG thought there probably is not important uncertainty about or variability 

in values. Stakeholders are expected to value persistent immunity. The WG felt that the 

intervention is likely to be acceptable to stakeholders because it is easy to find caregivers 

to administer the vaccine. The WG thought that the intervention would be a reasonable and 

efficient allocation of resources for PICO #3 and probably would be for PICO #4. There could be 

costs associated with clinic visits, but the WG thought that this still likely would be acceptable. 

The WG thought that there probably would be no impact on health equity since many employers 

absorb the costs. The WG thought that it probably would be feasible to implement the 

intervention as well. People would need to get a booster dose, but many clinicians can provide 

that subcutaneous injection. In terms of the balance of consequences, the WG thought that 

desirable consequences probably outweigh undesirable consequences in most settings. 

Therefore, the WG proposed the following recommendations for PICOs #3 and #4: 

Proposed Recommendation #3 

The ACIP recommends persons who are at continued risk* for occupational exposure to more 

virulent orthopoxviruses like variola virus or monkeypox virus receive booster doses of 

JYNNEOS every 2 years after the primary JYNNEOS series. 

*Continued risk refers to persistent risk due to occupational work performed. Designated public health and healthcare worker 

response teams approved by public health authorities are not at “continued risk” because they are vaccinated for the purposes of 

preparedness 

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Proposed Recommendation #4 

The ACIP recommends persons who are at continued risk* for occupational exposure to 

replication competent orthopoxviruses like vaccinia or cowpox receive booster doses of 

JYNNEOS® after the primary JYNNEOS® series at least every 10 years. 

*Continued risk refers to persistent risk due to occupational work performed 

EtR #5 regards changing from ACAM2000 boosters to JYNNEOS® boosters for those who 

received the ACAM2000 primary series. In terms of the problem, the health authorities and the 

JYNNEOS® sponsor are routinely being asked when this vaccine will be available. Some 

laboratory directors have indicated that many of those who receive ACAM2000 boosters would 

like to change to JYNNEOS® if the ACIP recommendations explicitly allow for this. This is due to 

the ease of identifying a clinician who can administer JYNNEOS®, no risk for infection spread to 

others, no dressings to manage, and fewer relative contraindications. The unpublished data 

from the DRC indicates that JYNNEOS® is preferred to ACAM2000. Therefore, the fifth PICO 

question regards whether persons who are at continued risk for occupational exposure to 

orthopoxviruses and who received an ACAM2000 primary vaccination should receive a booster 

does of JYNNEOS® as an option to a booster dose of ACAM2000. The intervention is a booster 

with JYNNEOS® and the comparison is a booster with ACAM2000. The outcomes are the same 

as previously described (e.g., prevention of disease, SAEs, myocarditis/pericarditis). 

Regarding the benefits and harms domain, the WG did not know how substantial the desired 

anticipated effects would be since there are only observational data for this outcome. There 

were no available comparison data for that, so it is unknown from the evidence table how 

substantial the desirable anticipated effects would be if a JYNNEOS® booster is given to those 

individuals who were previously getting ACAM2000 boosters. The WG determined the be 

undesirable anticipated effects to be minimal. No SAEs or myopericarditis cases were identified. 

The benefit/harm ratio is unclear because the benefits are unknown in terms of administering 

JYNNEOS® boosters compared to ACAM2000 boosters. The WG determined the overall 

certainty of the evidence for the critical outcomes to be very low for effectiveness and safety. 

For the outcome of prevention of disease, the RCTs showed serious concerns about risk of 

bias, indirectness, and imprecision. For the outcome of SAEs, serious concerns about risk of 

bias and very serious concerns about imprecision contributed to the very low rating. There were 

no myopericarditis events regardless of whether a JYNNEOS® booster or ACAM2000 booster 

was given to persons previously vaccinated with ACAM2000; however, the WG had very low 

certainty in this estimate. Because of the very small number of subjects included in the analysis, 

this was not evaluated. 

In terms of the remaining domains, the WG found that the target population feels the desirable 

effects are large. Target populations have made multiple requests for this vaccine. Unpublished 

data from the DRC indicates strong interest in JYNNEOS®. The WG thought that there probably 

was not any important uncertainty about or variability in values. Anecdotally, it is known that 

some laboratory directors anticipate many of their staff to change to JYNNEOS® boosters if the 

ACIP explicitly indicates that it is acceptable. The WG thought that the intervention would be 

acceptable to stakeholders due to ease of finding a provider, no risk of transmission to others, 

no work absences due to travel to get the vaccine, and fewer contraindications with JYNNEOS® 

compared to ACAM2000. The WG thought this would be a reasonable and efficient allocation of 

resources, given that it would be the same as for the ACAM2000 booster. The vaccine is 

provided free of cost by the SNS. The WG felt that health equity probably would be increased 

because there is no cost with travel to find a provider. The WG felt that it would be feasible for 

CDC’s Drug Service to ship and for the product to be used within the 6-month time interval after 

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that. The WG concluded that the desirable consequences probably outweigh the undesirable 

consequences in most settings. The WG proposed the following language for Recommendation 

#5: 

Proposed Recommendation #5

The ACIP recommends person who are at continued risk* for occupational exposure to 

orthopoxviruses, and who received an ACAM2000 primary vaccination, receive a booster dose 

of JYNNEOS® as an option to a booster dose of ACAM2000. 

* Continued risk refers to persistent risk due to occupational work performed. Designated public health and healthcare worker 

response teams approved by public health authorities are not at “continued risk” because they are vaccinated for the purposes of 

preparedness 

The 5 proposed recommendations are not preferential for JYNNEOS® and are intended to be an 

option. In terms of the proposed clinical guidance, the WG felt that if recipients change from 

ACAM2000 to JYNNEOS®, they should receive subsequent boosters with JYNNEOS® 

according to the JYNNEOS® vaccination booster schedule. That would be every 2 years instead 

of every 3 years, which is the ACAM2000 recommendation. The reasons the WG chose this is 

because there are actual data about 2 years, but there are no data beyond that. While the WG 

assumed that boosting would be possible, the decision was made to be conservative since 

there are only data up to the 2-year time period. Given that people changing from JYNNEOS® to 

ACAM2000 is anticipated to occur much less frequently, the WG thought that these individuals 

could be handled on a case-by-case basis. 

Discussion Summary 

• Concern was expressed about the timing of myopericarditis in relation to the vaccine and in 

terms of concomitant vaccine use, particularly with COVID-19 vaccine. 

 Dr. Petersen indicated that concomitant administration of other vaccines is a 

concern. Myopericarditis generally occurs within a 10-day timeframe, similar to what 

is seen with other vaccines. The DoD has raised that as a potential issue since their 

population receives multiple vaccines simultaneously, including smallpox vaccine. 

They are planning a separate study to evaluate this to better understand the risk of 

concomitant administration JYNNEOS® specifically with the other vaccines that they 

administer. 

 It was noted that the DoD has a waiting period to receive ACAM2000 following 

COVID-19 vaccine, which should be included in the clarifying statement. CDC will 

ensure that this is part of the guidance pertaining to this vaccine and will convey the 

information to the COVID-19 clinical guidance team as well. 

 Some concern was expressed about adding it to the COVID-19 clinical guidance, 

given that it is so complicated already and likely will just confuse people. Perhaps it 

should be targeted to the people receiving orthopoxviruses vaccine to inform them 

that they might want to consider separation until additional information is available. 

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ACIP Meeting Summary November 2-3, 2021 

• Dr. Rao was requested to provide an overview of considerations around a preferential 

recommendation versus a neutral recommendation between JYNNEOS® and ACAM2000. 

 Dr. Rao explained that there is no preferential recommendation, which means that 

people can choose either one. Even though several of the PICO questions were set 

up such that the intervention was JYNNEOS® and the comparison was ACAM2000, 

the actual recommendations themselves are not saying that people should stop 

receiving ACAM2000 and only get JYNNEOS® or vice versa. The intent is to allow 

people to have the option of choosing one or the other. The reason the WG set up 

the PICO questions this way was because ACAM2000 is currently the standard of 

care for people at occupational risk for the pox viruses, so the two questions had to 

have ACAM2000 as the comparator. There is insufficient evidence to make a 

preferential recommendation. 

• A question was raised regarding whether the duration of protection may be shorter for 

JYNNEOS® since this is a newer vaccine that uses a non-replicating virus instead of the 

traditional replicating virus, and what the plan would be to follow those who are on a 10-year 

cycle to ensure that they have adequate protection throughout that timeframe. 

 Dr. Petersen reported that in the clinical trials that have been performed, antibody 

titers have been observed to drop off with time, so the persistence of antibodies is 

shorter with JYNNEOS® compared to ACAM2000. However, the memory immune 

response does persist to the 2-year timepoint for which there are data. Individuals do 

boost with a robust antibody titer following a booster dose. In terms of how this will 

be followed, there are some discussions of performing additional vaccine studies to 

evaluate how far out this immune memory response persists. In particular in the DRC 

vaccine study, there is a plan to conduct a follow-on booster study at timepoints 

beyond 5 years to evaluate whether individuals who have received primary 

vaccination with JYNNEOS® retain the memory immune response at those later 

timepoints. CDC engages in consultations for exposures that occur in the laboratory 

as well as infections and tracks those, and would perform routine surveillance to 

evaluate whether there are any real-world effectiveness data that would be relevant 

in this population receiving JYNNEOS®. 

• It was noted that patient counseling information is particularly important for informing 

recipients about the potential benefits and risks of vaccination with JYNNEOS® and to 

emphasize the importance of completing the 2-dose series. 

 Dr. Peterson noted that it is routine practice that individuals receiving ACAM2000 are 

counseled about risks and benefits prior to beginning the occupational work. 

Regarding the importance of the 2-dose regimen, it would be reasonable to include 

information to ensure that individuals are receiving both of those doses so that they 

do achieve that maximal immune response and the equivalent antibody titers to what 

was seen with the previous vaccine, ACAM2000. 

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ACIP Meeting Summary November 2-3, 2021 

• Regarding Recommendation #5, an inquiry was posed regarding why the word “option” was 

used and suggested changing it to “alternative” to a booster dose. 

 Dr. Rao read the following revised version, “The ACIP recommends persons who are 

at continued risk* for occupational exposure to orthopoxviruses, and who received an 

ACAM2000 primary vaccination, receive a booster dose of JYNNEOS®. 

Votes: Orthopoxviruses Vaccines 

Dr. Agam Rao (NCEZID / CDC) posted Proposed Recommendations for review before the 

votes: 

Proposed Recommendation #1 

The ACIP recommends JYNNEOS® as an alternative to ACAM2000 for research laboratory 

personnel*, clinical laboratory personnel performing diagnostic testing for orthopoxviruses†, and 

for designated response team members at risk for occupational exposure to orthopoxviruses§ 

*Research laboratory personnel are those who directly handle 1) cultures or 2) animals contaminated or infected with replicationcompetent vaccinia virus, recombinant vaccinia viruses derived from replication-competent vaccinia strains (i.e., those that are 

capable of causing clinical infection and producing infectious virus in humans), or other orthopoxviruses that infect humans (e.g., 

monkeypox, cowpox, and variola). †Clinical laboratory personnel who perform routine chemistry, hematology, and urinalysis testing, 

including for suspect or confirmed patients with Orthopoxvirus infections, are not included in this recommendation as their risk for 

exposure is very low §Public health authorities, at their own discretion, may approve a cohort of healthcare and/or public health 

personnel to receive primary vaccination against Orthopoxviruses for preparedness purposes (e.g., first responders who might 

participate in a smallpox or monkeypox outbreak). 

Proposed Recommendation #2

The ACIP recommends JYNNEOS®, based on shared clinical decision-making, as an alternative 

to ACAM2000 for health care personnel who administer ACAM2000 or care for patients infected 

with replication-competent orthopoxviruses.* 

* For example, those caring for patients enrolled in clinical trials for replication-competent orthopoxvirus vaccines and those caring 

for persons with suspected or confirmed orthopoxvirus infections (e.g., clinicians and environmental services personnel) 

Proposed Recommendation #3

The ACIP recommends persons who are at continued risk* for occupational exposure to more 

virulent orthopoxviruses like variola virus or monkeypox virus receive booster doses of 

JYNNEOS® every 2 years after the primary JYNNEOS® series. 

* Continued risk refers to persistent risk due to occupational work performed. Designated public health and healthcare worker 

response teams approved by public health authorities are not at “continued risk” because they are vaccinated for the purposes of 

preparedness 

Proposed Recommendation #4

The ACIP recommends persons who are at continued risk* for occupational exposure to 

replication competent orthopoxviruses like vaccinia or cowpox receive booster doses of 

JYNNEOS® at least every 10 years after the primary JYNNEOS® series. 

*Continued risk refers to persistent risk due to occupational work performed 

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ACIP Meeting Summary November 2-3, 2021 

Proposed Recommendation #5

The ACIP recommends persons who are at continued risk* for occupational exposure to 

orthopoxviruses, and who received an ACAM2000 primary vaccination, receive a booster dose 

of JYNNEOS® as an option to a booster dose of ACAM2000. 

* Continued risk refers to persistent risk due to occupational work performed. Designated public health and healthcare worker 

response teams approved by public health authorities are not at “continued risk” because they are vaccinated for the purposes of 

preparedness 

Vote #1: Orthopoxviruses Vaccines 

Dr. Sanchez made a motion to approve the first recommendation reading, “The ACIP 

recommends JYNNEOS® as an alternative to ACAM2000 for research laboratory personnel*, 

clinical laboratory personnel performing diagnostic testing for orthopoxviruses†, and for 

designated response team members at risk for occupational exposure to orthopoxiviruses§.” 

*Research laboratory personnel are those who directly handle 1) cultures or 2) animals contaminated or infected with replicationcompetent vaccinia virus, recombinant vaccinia viruses derived from replication-competent vaccinia strains (i.e., those that are 

capable of causing clinical infection and producing infectious virus in humans), or other orthopoxviruses that infect humans (e.g., 

monkeypox, cowpox, and variola). †Clinical laboratory personnel who perform routine chemistry, hematology, and urinalysis 

testing, including for suspect or confirmed patients with Orthopoxvirus infections, are not included in this recommendation as their 

risk for exposure is very low. §Public health authorities, at their own discretion, may approve a cohort of healthcare and/or public 

health personnel to receive primary vaccination against Orthopoxviruses for preparedness purposes (e.g., first responders who 

might participate in a smallpox or monkeypox outbreak) 

Dr. Poehling seconded the motion. No COIs were declared. The motion carried with 15 

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

follows: 

15 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, 

McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

0 Absent: N/A 

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ACIP Meeting Summary November 2-3, 2021 

Vote #2: Orthopoxviruses Vaccines 

Ms. Bahta made a motion to approve the second recommendation reading, “The ACIP 

recommends JYNNEOS®, based on shared clinical decision-making, as an alternative to 

ACAM2000 for healthcare personnel who administer ACAM2000 or care for patients infected 

with replication competent orthopoxviruses.”* 

* For example, those caring for patients enrolled in clinical trials for replication-competent orthopoxvirus vaccines and those caring 

for persons with suspected or confirmed orthopoxvirus infections (e.g., clinicians and environmental services personnel) 

Dr. Ault seconded the motion. No COIs were declared. The motion carried with 15 affirmative 

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

15 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, 

McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

0 Absent: N/A 

Vote #3: Orthopoxviruses Vaccines 

Dr. Daley made a motion to approve the third recommendation reading, “The ACIP 

recommends persons who are at continued risk* for occupational exposure to more virulent 

orthopoxviruses like variola virus or monkeypox virus receive booster doses of JYNNEOS® 

every 2 years after the primary JYNNEOS® series.” 

* Continued risk refers to persistent risk due to occupational work performed. Designated public health and healthcare worker 

response teams approved by public health authorities are not at “continued risk” because they are vaccinated for the purposes of 

preparedness 

Dr. Long seconded the motion. No COIs were declared. The motion carried with 15 affirmative 

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

15 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, 

McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

0 Absent: N/A 

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ACIP Meeting Summary November 2-3, 2021 

Vote #4: Orthopoxviruses Vaccines 

Dr. Kotton made a motion to approve the fourth recommendation reading, “The ACIP 

recommends persons who are at continued risk* for occupational exposure to replication 

competent orthopoxviruses like vaccinia or cowpox receive booster doses of JYNNEOS® at 

least every 10 years after the primary JYNNEOS® series.” 

*Continued risk refers to persistent risk due to occupational work performed 

Dr. Sanchez seconded the motion. No COIs were declared. The motion carried with 15 

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

follows: 

15 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, 

McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

0 Absent: N/A 

Vote #5: Orthopoxviruses Vaccines 

Dr. Sanchez made a motion to approve the fifth recommendation reading, “The ACIP 

recommends persons who are at continued risk* for occupational exposure to orthopoxviruses, 

and who received an ACAM2000 primary vaccination, receive a booster dose of JYNNEOS®.” 

* Continued risk refers to persistent risk due to occupational work performed. Designated public health and healthcare worker 

response teams approved by public health authorities are not at “continued risk” because they are vaccinated for the purposes of 

preparedness. 

Dr. Chen seconded the motion. No COIs were declared. The motion carried with 15 affirmative 

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

15 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Long, 

McNally, Poehling, Sanchez, Talbot 

0 Opposed: N/A 

0 Abstained: N/A 

0 Absent: N/A 

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ACIP Meeting Summary November 2-3, 2021 

EBOLA VACCINE 

Session Introduction 

Dr. Wilbur Chen (ACIP WG Chair) reminded everyone that the FDA approved Ervebo® on 

December 19, 2019. Ervebo® is a replication-competent, live-attenuated recombinant vesicular 

stomatitis virus (VSV) vaccine in which the glycoprotein of Ebola Zaire virus is expressed. The 

ACIP recommended pre-exposure vaccination with Ervebo® for adults aged ≥18 years in the US

population who are at highest risk for potential occupational exposure to Ebola virus species 

Zaire ebolavirus because they are: 1) responding to an outbreak of Ebola Virus Disease (EVD); 

or 2) work as health care personnel at federally designated Ebola Treatment Centers (ETCs) in 

the US, or 3) work as laboratorians or other staff at biosafety level-4 (BSL-4) facilities in the US. 

During the February 2021 ACIP meeting, 2 additional US populations were described who are 

at risk for potential occupational exposure to Ebola virus (species Zaire ebolavirus). This 

includes HCP at state designated ETCs involved in the care and transport of confirmed EVD 

patients and individuals who work as laboratorians and support staff at Laboratory Research 

Network (LRN) facilities that handle replication competent Ebola virus (species Zaire 

ebolavirus). During that meeting, the WG presented the results of vaccine accessibility surveys 

for both of these populations. 

Although COVID-19 continues to occupy the minds of most of the world, Ebola does continue 

to be a major global health problem. In February 2021, Ebola broke out in Guinea in West Africa 

causing 23 cases and 12 deaths (52%). The DRC in Central Africa experienced an outbreak of 

12 cases and 6 deaths (50%). Another outbreak was declared on October 8, 2021 that is 

currently ongoing. An update from the previous day reported that 8 cases have been identified, 

6 of which have resulted in deaths. 

The WG has continued to solicit input from CSTE to define, enumerate, and better understand 

state-designated ETCs. The WG also has discussed the risks of exposure to Ebola virus for 

both of these identified occupational risk groups, and has engaged in ongoing discussions on 

proposed policy options. Presentations during this session included a review of GRADE and an 

overview of state-designated ETCs and the LRN, the EtR Framework, and a summary of WG 

considerations and proposed policy options. As a reminder, HCP have been carefully defined as 

follows: 

Healthcare personnel (HCP) refers to all paid and unpaid persons serving in healthcare settings who have the potential for 

direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific 

body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or 

contaminated air. These HCP include, but are not limited to, emergency medical service personnel, nurses, nursing 

assistants, physicians, technicians, clinical laboratory personnel, autopsy personnel, therapists, phlebotomists, 

pharmacists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly 

involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting 

(e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, 

billing, and volunteer personnel).77 

77 Adapted from https://www.cdc.gov/infectioncontrol/guidelines/healthcare-personnel/index.htm 

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ACIP Meeting Summary November 2-3, 2021 

GRADE Review and Overview of State-Designated ETCs and LRNs 

Ms. Amy Whitesell (CDC/NCEZID) presented a review of GRADE and an overview of statedesignated ETCs and LRN facilities. For the purpose of this presentation, the rVSVΔG-ZEBOVGP Ebola vaccine is referred to as rVSV vaccine. As a reminder, these data were presented 

during a previous ACIP meeting in February 2020. 

First, a review of the critical outcomes for the rVSV vaccine evaluated by the GRADE approach. 

Per the February 2020 ACIP recommendation, the ACIP Ebola Vaccine WG determined the 

PICO (population, intervention, comparison, and outcome) to be as follows. The population of 

interest at that time was adults 18 years of age or older in the US population who were at risk of 

occupational exposure to Ebola virus within 3 subgroups: 1) individuals responding to an 

outbreak of Ebola virus disease due to Ebola virus (species Zaire ebolavirus); 2) HCP involved 

in the care and transport of confirmed EVD patients at federally-designated ETCs in the US; and 

3) laboratorians and support staff working at BSL-4 laboratories that handle a) cultures, or b) 

animals infected with replication-competent Ebola virus, or c) diagnostic or clinical specimens 

containing replication-competent Ebola virus. 

The intervention of interest was pre-exposure intramuscular immunization with a single licensed 

dose of the rVSV Ebola vaccine, and the comparison was no vaccine. The outcomes the WG 

considered to be critical and important included the following: 

Critical 

 Development of Ebola-related symptomatic illness 

 Vaccine-related joint pain or swelling (arthritis or arthralgia) 

 Vaccine-related adverse pregnancy outcomes for women inadvertently vaccinated while 

pregnant and women who become pregnant within in 2 months of vaccination 

 Transmissibility of rVSV vaccine virus: Surrogate assessed with viral dissemination/ 

shedding of the rVSV vaccine virus 

 Serious adverse events related to the vaccination 

Important 

 Incidence and severity of oral or skin lesions 

 Interaction or cross-reactivity with monoclonal antibody-based therapeutics or other VSVbackboned vaccines 

Data for the important outcomes have not been analyzed to date and were not included in the 

GRADE evaluations presented in February 2020. The focus for this session was on the critical 

outcomes that were subject to analysis. To assess these outcomes, a literature search was 

executed that resulted in the identification of 18 articles that presented data from 11 unique 

studies which were included in a qualitative synthesis. Of these articles, 9 were presented and 

data from 8 studies also were included in a quantitative synthesis or meta-analysis. The 

outcomes of incidence of arthralgia, severity of arthralgia: events of grade 3 (severe) arthralgia, 

incidence of arthritis, and vaccine-related adverse pregnancy outcomes for women inadvertently 

vaccinated while pregnant and women who become pregnant within in 2 months of vaccination 

were included in a meta-analysis. The outcomes of detection of rVSV vaccine virus in blood or 

plasma (viremia), saliva (viral shedding), and urine (viral shedding) and SAEs related to 

vaccination were included for descriptive analyses only. 

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ACIP Meeting Summary November 2-3, 2021 

To summarize an overview of the benefit outcome of Ebola-related symptomatic illness, there 

was one published study with an unvaccinated comparator that was included in the body of 

evidence for this outcome from Henao-Restrepo, 2017. This publication was associated with the 

2-part Phase III cluster-randomized open-label, ring vaccination trial in the beginning. This initial 

study involved contacts and contacts of contacts of confirmed EVD, or EVD cases that were 

randomized to either immediate or delayed vaccination. Delayed vaccination was defined as 

vaccination that occurred 21 days after randomization. A follow-up study included additional 

data about clusters who were offered immediate vaccination following cessation of the 

randomized trial. The primary outcome was the incidence of EVD with an onset of 10 days or 

more following randomization. The 10 days accounts for the average incubation period of Ebola. 

In this study across 51 clusters randomized to receive immediate vaccination, which includes 

2108 participants, no cases of EVD occurred 10 days or more after randomization. In contrast, 

across 47 clusters that were randomized to delayed vaccination, which include 3000 sets of 75 

participants, 16 cases within 7 clusters developed EVD 10 days or more after randomization. 

These randomized cluster data presented in the study equated to a calculated VE of 100% 

(95% CI: 68.9 – 100, p=0.0045), with the confidence interval listed here. The calculated relative 

risks using participant-level data from the randomized clusters was 0.04 (95% CI: 0.0001 – 

0.74), which corresponds to a 96% relative risk reduction. The absolute risk was 5 fewer events 

of Ebola-related symptomatic illness per 1000 people. 

Now to provide a summary of the safety outcomes that were presented during the February 

2020 ACIP meeting. The first safety outcome was incidence of arthralgia. Incidence of arthralgia 

was assessed for the incidence of arthralgia or joint pain that was elicited within 0-42 days. For 

this outcome, 8 studies with unvaccinated comparators elicited arthralgia within 0-days and 

were evaluated by GRADE. It is important to note that across these studies, variable definitions 

for arthralgia were used, including joint pain with or without joint swelling or fusion. In some 

cases, a definition was not provided. Additionally, length and time of follow-up and dose varied 

between studies. Across 6 RCTs, arthralgia was reported in 316/1874 (16.9%) of vaccinated 

participants compared to 42/891 (4.7%) of non-vaccinated participants. Taken together, the 

calculated risk from the 6 RCTs is 2.55 (95% CI: 0.94-6.91) and the absolute risk is 73 more 

events of arthralgia per 1000 people. 

The next safety outcome is the severity of arthralgia. The severity of arthralgia was assessed 

with the incidence of severe or Grade 3 arthralgia elicited between 0-42 days and defined as 

significant, slight pain or discomfort, or prevents daily activity. For background, arthralgia is 

described on a Grade 1-4 scale, with Grade 1 being mild, no interference with activity; Grade 2 

being moderate, some interference with activity; Grade 3 being significant, prevents daily 

activity; and Grade 4 being potentially life threatening, medical consultation and/or 

hospitalization. There were no reports of Grade 4 arthralgia across the body of evidence. There 

were 6 studies in which unvaccinated comparators reported arthralgia severity within 0-42 days. 

It is important to note that across these studies, variable definitions for arthralgia were used and 

the time of follow-ups and dose of vaccine used varied between studies. Across 4 RCTs 

included in the body of evidence, 2/333 (0.6%) of vaccinated participants reported Grade 3 

arthralgia compared to 0/264 non-vaccinated participants. The calculated risk ratio from the 4 

RCTs included in GRADE was 6.4 (95% CI: 0.0001-27950.69). The absolute risk was 0 more 

events of severe arthralgia per 1000 people. 

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ACIP Meeting Summary November 2-3, 2021 

The next safety outcome is the incidence of arthritis, which was assessed with an event of 

arthritis reported within 5-56 days of follow-up. The 6 studies with unvaccinated comparators 

elicited arthritis within 5-56 days. It is important to note that much like the arthralgia outcome, 

each of these studies defined and diagnosed arthritis with considerable variability. 

Additionally, time of follow-up and dose of vaccine used varied between studies. Among the 4 

RCTs, arthritis was reported in 39/1776(2.2%) of vaccinated participants compared to 16/858 

(1.8%) of non-vaccinated participants. The calculated risk ratio across RCTs was 1.8 (95% CI: 

0.21-15.13). The absolute risk was 23 more events of arthritis per 1000 people. Additionally, 3 

published studies reported on the detection of vaccine virus in synovial fluid. Across this body of 

evidence, vaccine virus has been detected by reverse transcriptase polymerase chain reaction 

(rRT-PCR) in 4/7 vaccinated participants that had synovial fluid tests. Viral isolation was 

attempted on 1 synovial fluid specimen and was negative. 

The next safety outcome was vaccine-related adverse pregnancy outcomes for women 

inadvertently vaccinated while pregnant, and women who become pregnant within 2 months of 

vaccination. This was assessed with incidence of pregnancy loss defined as spontaneous 

abortion and stillbirth. There was 1 study included in the body of evidence for this outcome, 

which was a non-randomized sub-study of the Sierra Leone Trial to Introduce a Vaccine against 

Ebola. In this study, 14/31 (45%) of immediately vaccinated pregnant women experienced 

pregnancy loss compared to 11/33 (33%) of unvaccinated pregnant women. The calculated risk 

ratio was 1.35 (95% CI 0.73-2.52) and the calculated absolute risk was 117 more events of 

pregnancy loss per 1000 people. The study concluded that overall, the rate of pregnancy loss 

among pregnant women who received immediate vaccination is not significantly higher than the 

rate of pregnancy loss among unvaccinated women. Additionally, among live births, no external 

congenital anomalies were detected among either group. Further studies with larger sample 

sizes would be needed to rule out meaningful difference in the percentage of pregnancy loss 

against pregnancy complications or birth defects. 

The next safety outcome is the transmissibility of vaccine virus. There were no available data 

that reported on transmissibility; therefore, detection of vaccine virus RNA in a vaccine 

recipient’s blood, saliva, and urine by rRT-PCR was used as a surrogate for the theoretical 

possibility of vaccine virus transmission. Data from 8 studies were included for the body of 

evidence for detection of rVSV in blood or plasma. Across these 8 studies, the longest recorded 

rRT-PCR positive blood sample was collected 14 days post-vaccination, and 1/501 samples 

tested positive. Additionally, 1 study performed viral isolation on solicited blood specimens and 

all were negative. Data from 4 studies were included for the body of evidence for detection of 

rVSV in urine and saliva. The longest recorded rRT-PCR positive saliva sample was collected 

14 days post-vaccination and 1/98 samples tested positive. The longest recorded rRT-PCR 

positive urine sample was 7 days post-vaccination when 2/246 samples tested positive. Viral 

isolation was not attempted on saliva or urine samples. 

As previously mentioned, data related to oral and skin lesions, including the detection of rVSV 

and skin vesicles, was not included in the February 2020 GRADE presentation since the WG 

termed it to be an important but not critical outcome. The WG limited its assessment of the 

transmissibility outcomes to detection of vaccine virus in blood, saliva and urine. However, for 

this presentation, the data were included from the FDA package insert related to skin vesicles 

for additional background. The longest recorded rRT-PCR positive skin vesicle sample was 

collected 20 days post-vaccination. In one study among 3 participants with rash, all were 

positives by rRT-PCR up to 17 days post-vaccination. Virus isolation was positive in 1 specimen 

with a highest RNA level at 9 days post-vaccination. It is important to note with these data 

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ACIP Meeting Summary November 2-3, 2021 

that the true estimate of duration of shedding is unknown because daily collection was not 

performed. Additionally, rRT-PCR positivity is not synonymous with infectivity. 

The final safety outcome was SAEs. There were 12 clinical trials and 2 additional publications 

that described vaccine-related SAEs. Across this body of evidence, 3/17,119 (0.02%) people 

who received the vaccine experienced SAEs judged to be related to or possibly related to the 

vaccine. Of these, 2 were related to vaccination and included febrile reaction and anaphylaxis, 

both of which resolved without sequelae. One was judged to be possibly related to the vaccine, 

an influenza-like illness, which also resolved without sequelae. Additional data that were not 

included in the initial GRADE analysis included another case of anaphylaxis that was identified 

in data provided to the FDA and resolved without sequelae. In summary, the majority of studies 

did not record any vaccine-related SAE. 

Now turning to the GRADE summary for the rVSV Ebola vaccine compared to placebo or no 

vaccine in adults aged 18 and older. The overall evidence type for each outcome is determined 

by taking the lowest certainty value across RCTs and observational studies for each outcome. 

As a reminder, this is not measuring how well the individual studies were conducted, but rather 

how much confidence there is in the estimates of effects in the body of evidence across each 

outcome. In summary, the WG’s findings were that the rVSV Ebola vaccine is effective at 

preventing EVD. The randomized cluster-level data for this outcome was assessed to be 

evidence Type 3 (low certainty evidence), while the participant-level data for this outcome was 

assessed to be evidence Type 2 (moderate certainty evidence). For the safety outcome of 

incidence of arthralgia, the findings were that arthralgia is more commonly reported among 

vaccine recipients compared to placebo. This outcome was assessed to be evidence Type 4 

(very low certainty evidence). 

For the safety outcome of severity of arthralgia, the findings were that severe or Grade 3 

arthralgia is more commonly reported among vaccine recipients compared to placebo or 

unvaccinated, but it is overall uncommon. This outcome was assessed to be evidence Type 4 

(very low certainty evidence). For the safety outcome of incidence of arthritis, the findings were 

that arthritis was more commonly reported among vaccine recipients compared to placebo. This 

outcome was assessed to be evidence Type 4 (very low certainty evidence). For the safety 

outcome of pregnancy-related AEs due to vaccination, the findings were that the rate of 

pregnancy loss among pregnant women who received immediate vaccination was not 

significantly higher than the rate of pregnancy loss among unvaccinated pregnant women. This 

outcome was assessed to be evidence Type 4 (very low certainty evidence). 

For the safety outcome of transmissibility of vaccine virus, the findings were that the vaccine 

virus has been detected in blood or plasma up to 14 days, in saliva up to 14 days, and in urine 

up to 7 days post-vaccination. However, true duration of shedding and potential for 

transmissibility is uncertain. This outcome was assessed to be evidence Type 4 (very low 

certainty evidence). For the safety outcome of vaccine-related SAEs, the findings were that the 

vaccine-related SAEs are an uncommon occurrence with 3 events in 17,119 vaccine recipients 

across 12 studies. This outcome was assessed to be evidence Type 3 (low certainty evidence). 

To provide an overview of the population, the evidence will be discussed in the context of the 

EtR Framework. After the February 2020 recommendations were made, the ACIP Ebola 

Vaccine WG identified 2 additional populations at potential risk for occupational exposure to 

Ebola virus. The first is HCP at state-designated ETCs who are involved in the care and 

transport of suspect or confirmed EVD patients. Following the importation of Ebola virus 

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ACIP Meeting Summary November 2-3, 2021 

to the US in 2014, certain hospitals were designated by states to serve as state-designated 

ETCs based on requirements set by the regional Ebola Treatment Network. This group has 

evolved over time and different terminology has been used to describe them, particularly as a 

result of the COVID-19 pandemic. This population needs to be described in a way that would be 

evergreen and not subject to framework changes in the future. Since these facilities are 

designated by the state, the WG reached out to the CSTE to determine the preferred 

terminology for these facilities and to define them moving forward. This resulted in CSTE 

convening a WG who determined that the preferred terminology for these facilities should be 

changed to Special Pathogen Treatment Centers (SPTCs). 

For the purposes of ACIP recommendations for the rVSV Ebola vaccine, these SPTCs have 

been defined as, “Healthcare facilities that intend to receive and are able to provide care for a 

suspect or confirmed patient with Ebola virus disease (EVD) for the duration of their illness, as 

assessed by their state health department. In addition to EVD, these facilities may also be 

designated by the states to treat other high consequence pathogens.”78 At this time, 55 SPTCs 

have been identified and it is estimated that each has a staff of 100 to 150 HCP. Thus, there are 

approximately 5500 to 8250 individuals at potential risk of occupational exposure to Ebola virus 

across the SPTCs who potentially could benefit from pre-exposure vaccination with the rVSV 

Ebola vaccine. 

At the time the vaccine acceptability survey was conducted, 51 SPTCs had been identified and 

an invitation to participate in the survey was sent to 49 of these. A total of 364 survey responses 

were received. Of these, 56 were incomplete and were excluded. Therefore, a total of 298 

responses from SPTC personnel were included in the analysis. Nurses and doctors made up 

the majority (81%) professional groups among the 298 survey respondents. The response rates 

were lower from other professional groups of respiratory therapists, emergency medical 

technicians (EMTs), advanced practice providers (including nurse practitioners and physician 

assistants), laboratory technicians, managers and safety officers, and environmental services. 

When asked if they were eligible for vaccinations and offered the rVSV Ebola vaccine at that 

time would they choose to be vaccinated, 54% of the survey respondents expressed interest in 

receiving the vaccine. It is important to note their responses to this question were recorded 

between October 2020 and January 2021. During this time, the Ebola outbreak in Equateur 

Province, DRC was declared over in November 2020. Therefore, responses were given as EVD 

cases were waning or when there was no active EVD outbreak in the world. When survey 

respondents were given the option of choosing when to get vaccinated, such as when an EVD 

case was imported into the US or into their state, the interest in receiving the vaccine increased 

from 54% to 81%, while 19% of respondents would not choose to be vaccinated. When asked if 

they thought that ACIP should recommend the vaccines to HCP at their facility, 53% thought 

ACIP should recommend the vaccine, 9% thought ACIP should not recommend the vaccine, 

and 38% were unsure. Notably, the option of shared clinical decision-making was not included. 

The second population that the ACIP Ebola Vaccine WG identified as having potential risks for 

occupational exposure to Ebola virus was individuals who work as laboratorians and support 

staff at LRN facilities who handle replication-competent Ebola virus. The LRNs comprise the 

large network of laboratories that aim to respond quickly to biological and chemical threats and 

other public health emergencies. The Laboratory Response Network for Biological Threats 

(LRN-B) has 3 tiers that include thousands of sentinel laboratories that are situated largely in 

hospitals, clinical institutions, and commercial diagnostic laboratories that perform rule-out 

78 Definition adapted from: https://www.cdc.gov/vhf/ebola/healthcare-us/preparing/treatment-centers.htm 

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ACIP Meeting Summary November 2-3, 2021 

testing. The next tier consists of roughly 130 reference laboratories that are situated in state and 

local health departments and at various military, veterinary, agricultural, and water-testing 

facilities that can do additional testing. The top tier is comprised of national laboratories, 

including those operated by CDC, the US Army Medical Research Institute for Infectious 

Diseases (USAMRIID), and the Naval Medical Research Center (NMRC). These laboratories 

are responsible for specialized characterization of organisms, bioforensics, select agent activity, 

and handling highly infectious biological agents. Thus, a potential recommendation would 

involve an estimated 580 to 870 individuals. 

The structure of the vaccine acceptability survey for LRN facilities was the same as the one 

administered to the SPTCs. Survey invitations were sent out to facilities that had capacity for 

Ebola testing, which at the time was 62 possible laboratories. A total of 96 responses were 

received from these facilities, of which 26 were incomplete and were excluded. Therefore, 70 

total responses were included in the analysis. The majority of respondents (64%) self-identified 

as laboratory scientists, 30% identified as management, and 4 (6%) identified as other 

occupations of either director or laboratory director. 

When asked if eligible for vaccine and offered the rVSV Ebola vaccine that day, 59% of the 

respondents expressed interest in receiving the vaccine. It should be noted that this survey was 

administered from December 2020 to January 2021, so there was no active Ebola outbreak at 

the time of these responses. Similar to the SPTC participants, when LRN survey respondents 

were given the option about when to get vaccinated either immediately when an EVD case was 

imported into the US or when the EVD case was imported into their state, interest in receiving 

the vaccine increased to 86%. Among the LRN population, 59% said that they thought ACIP 

should recommend the vaccine, 9% thought that ACIP should not recommend the vaccine, and 

33% were unsure. 

In summary, 54% of the SPTC study population was interested in receiving the vaccine at the 

time survey was administered. When given the option to get vaccinated at a later time, such as 

when there is an EVD case in the US or in their state, interest in receiving the vaccine increased 

to 81%. When asked which AE they were most concerned about, concern for a SAEs and 

transmission of the vaccine virus to others were most common among the study population. 

Among the LRN study population, 59% of respondents said they would be interested in 

receiving the vaccine at the time of survey administration. This increased to 86% when they 

could choose when to be vaccinated. When asked which AEs they would be most concerned 

about, most responded with an increased risk of arthritis, which differed from the SPTC 

participants for an increased risk of transmission of the vaccine virus to others. 

EtR Framework 

Dr. Jason Malenfant (CDC/NCEZID) presented the EtR Framework specifically for expansion 

of the recommendations for vaccination with rVSV for the categories of SPTC and LRN facilities 

in the US. The WG developed 2 policy questions for this purpose: 

Policy Question 1

Should pre-exposure vaccination with the rVSVΔG-ZEBOV-GP vaccine be recommended for 

healthcare personnel* involved in the care and transport of suspect or confirmed Ebola virus 

disease patients at Special Pathogens Treatment Centers? 

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Policy Question 2

Should pre-exposure vaccination with the rVSVΔG-ZEBOV-GP vaccine be recommended for 

laboratorians and support staff at Laboratory Response Network (LRN) facilities that handle 

specimens that may contain replication-competent Ebola virus (species Zaire ebolavirus) in the 

United States? 

Notably, the species Zaire ebolavirus was selected because it is the most lethal of the 4 viruses 

that cause Ebola virus disease in humans. It is highly transmissible and is found in all of the 

body fluids of an infected individual. It causes severe disease, with rapid death usually occurring 

7-10 days after symptom onset. In survivors, the virus has been known to persist in immunoprivileged sites and in some instances has resulted in continued disease transmission and 

disease recrudescence. The virus is known to be a large international public health threat. Ebola 

Virus (species Zaire ebolavirus) is responsible for the majority of reported EVD outbreaks, 

including the 2014 West Africa outbreak—the largest EVD outbreak in history. This virus has 

infected over 31,000 persons and resulted in greater than 12,000 deaths. This does not include 

the ongoing 2018 DRC outbreak. The virus also is a US public health threat, with 11 individuals 

infected with Ebola virus (species Zaire ebolavirus) having been treated in the US. All were 

associated with the 2014 West Africa outbreak. Of the people infected, 9 were infected in West 

Africa and 2 were infected in the US while caring for a returned traveler. Additional persons 

were repatriated to the US following high-risk exposures to confirmed EVD, but none developed 

EVD. The WG concluded that EVD due to Ebola virus (species Zaire ebolavirus) is an important 

public health problem. 

Now turning to the benefits and harms domain. In terms how substantial the desirable 

anticipated effects of vaccination are, there was 1 study evaluated using GRADE that provided 

evidence on VE. At the participant level, this study demonstrated a protective effect with 96% 

risk reduction in vaccinated individuals against acquiring EVD. Given this, the WG felt that the 

desirable anticipated effects are large. With regard to how substantial the undesirable 

anticipated effects are, data on AEs showed that arthralgia is more commonly reported among 

vaccine recipients. Severe arthralgia also is more commonly reported among vaccine recipients, 

but is overall uncommon. Arthritis is more commonly reported among vaccine recipients as well. 

Pregnancy loss in vaccinated women was not significantly higher than in non-vaccinated 

women. rVSV vaccine virus has been detected post-vaccination in blood, saliva, urine, and 

synovial fluid. Vaccine-related SAEs are uncommon. The WG concluded that the undesirable 

anticipated effects are moderate. 

Regarding whether the desirable effects outweigh the undesirable effects, the WG considered 

that there is documented protective efficacy of the vaccine; the virus causes high severity of 

illness; the virus is highly transmissible; Ebola virus has been shown to persist in survivors, with 

documented instances of continued disease transmission and disease recrudescence; and 

vaccine-related SAEs are uncommon. Based on these considerations, the WG felt that the 

desirable effects outweigh the undesirable effects and favor intervention. In terms of the 

effectiveness of the intervention, the WG again considered the 1 study evaluated using the 

GRADE process that demonstrated a protective effect from vaccination. At the participant level 

in that study, the overall certainty in the evidence for effectiveness is moderate (Type 2). At the 

cluster level, the overall certainty in the evidence for effectiveness is low (Type 3). Taking these 

into consideration, the WG felt that the overall certainty of evidence for the effectiveness of the 

intervention is moderate (Type 2). With regard to the safety of the intervention, the majority of 

the AEs were deemed to be Type 4 (very low certainty), with the exception of SAEs for which 

was Type 3 (low certainty). The WG determined that the overall certainty of evidence with 

regard to safety was Type 4 (very low). 

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The WG next considered whether the target population of HCP at SPTCs think that the 

desirable effects are large relative to the undesirable effects. Based on the surveys presented 

earlier, 54% of the study population expressed interest in receiving the vaccine if eligible and 

offered the vaccine at the time they were surveyed. When people were given the choice to get 

vaccinated at different time points, such as when there was an EVD case in the US or in their 

state, interest in the vaccine increased to 81%. Of the surveyed population, 53% thought that 

ACIP should vote to recommend a vaccine for HCP at SPTCs. Therefore, the WG thought that 

the target population probably feels that the desirable effects are large relative to the 

undesirable effects. While there were mixed responses to vaccination among HCP at SPTCs in 

terms of how much people value the main outcome, interest in the vaccine increased markedly 

with perceived risk. Given the potential and variability, the WG thought that there is possibly 

important uncertainty or variability in how much people value the main outcomes. Because 53% 

of the survey population thought that ACIP should vote to recommend the vaccine to HCP at 

SPTCs, the WG thought that key stakeholders probably would find the intervention to be 

acceptable. 

Now moving to the second target population, staff at LRN facilities. In terms of whether the 

target population feels that the desirable effects are large relative to the undesirable effects, the 

survey responses from staff at LRN facilities were similar to responses received from HCP at 

SPTCs. Among staff at LRN facilities, 59% of respondents expressed interest in receiving the 

vaccine if eligible and offered the vaccine at the time of the survey. When people were given the 

choice to get vaccinated, such as an EVD case in the US or their state, interest in the vaccine 

increased to 86%. Of the LRN survey population, 59% thought that ACIP should vote to 

recommend the vaccine to staff in LRN facilities. With that in mind, the WG thought that the 

target population probably feels that the desirable effects are large relative to undesirable 

effects. 

In terms of whether there is important uncertainty about or variability in how much people value 

the main outcome, similar to the HCP at SPTCs, there were mixed responses from staff at LRN 

facilities. When asked if they would get the vaccine at the time of the survey, 59% of LRN staff 

surveyed expressed interest. When they were given the option of choosing when to get 

vaccinated, either immediately or when an EVD case was imported to the US or their state, the 

interest in receiving the vaccine increased to 86%. When the perceived risks seemed to 

increase and there was flexibility in when to get the vaccine, acceptability also increased. Given 

the potential and variability seen, the WG thought that there is possibly important uncertainty or 

variability in how much people value the main outcomes. In terms of whether the intervention is 

acceptable to key stakeholders, 59% of the LRN survey population thought that ACIP should 

vote to recommend the vaccine to staff at LRN facilities. Therefore, the WG thought that key 

stakeholders probably would find the intervention to be acceptable. 

Turning to the domain of resource allocation, the WG considered whether the intervention is a 

reasonable and efficient allocation of resources. A cost-effectiveness analysis was not 

performed for this vaccine as it is intended for use in preparedness scenarios in limited 

populations and not as a routine vaccination in the general population. At this time, the vaccine 

will be stored and made available through the USG. The WG thought that the intervention would 

be a reasonable and efficient allocation of resources. 

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Regarding the domain of equity and what the impact of the intervention might be on health 

equity, the WG did not have a good sense of this since the only demographic characteristics in 

surveys that were distributed to the facilities included age, sex, and profession of the individual. 

No race or ethnicity data were collected. Therefore, the WG determined that the impact on 

health equity is not known. In terms of the feasibility domain and whether the intervention is 

feasible to implement, licensed doses are currently available through the SNS. Therefore, the 

WG concluded that the intervention is feasible to implement. 

In regard to the balance of consequences, the WG thought that the desirable consequences 

probably outweigh the undesirable consequences in most settings based on all of the 

considerations. To make a determination about whether there was there sufficient information to 

move forward with a recommendation, the WG considered that the efficacy data available from 

outbreak settings show high efficacy. Safety data also are available for the over 17,000 persons 

who have been vaccinated in the US, Europe, and Africa that the WG evaluated using the 

GRADE process. Data also are available from the vaccine acceptability surveys for both target 

populations under consideration. Therefore, the WG concluded that there is sufficient 

information to move forward with a recommendation. 

Discussion Summary 

• ACIP members requested clarity regarding why the rVSV vaccine was being discussed 

rather than the less reactogenic vector vaccine and whether a goal was to encourage the 

manufacturer to submit this vaccine to the FDA for licensure and then if FDA-approved, the 

ACIP would make recommendations on it. Or, if the goal was to use the vaccine in 

outbreaks under an EUA. 

 Dr. Choi indicated that the rVSV Merck vaccine is the only licensed Ebola vaccine. 

Other vaccines are in development, one of which is the Johnson & Johnson (J&J) 

vaccine. The J&J vaccine also has been used overseas in the setting of outbreaks, 

but it should be noted there are several differences between these 2 vaccines. First, 

the licensed rVSV vaccine under discussion during this session is a 1-dose vaccine 

after which people are considered to be protected against infection with Zaire 

ebolavirus after a period of time. The J&J MVA adenovirus vaccine is a 2-dose 

vaccine, with the 2 doses administered 54 days apart. The Merck vaccine is more 

amenable to outbreak response in that it is a 1-dose vaccine. The approval 

processes are continuing for the other vaccines. 

 Dr. Fink added that there are regulatory mechanisms that could allow for access to 

investigational Ebola vaccines, including for pre-exposure vaccination, which include 

use under an Investigational New Drug (IND) determination, including extended 

access. 

 Dr. Lee clarified that the purpose of this session was not discussion of outbreak 

responses, but was instead on pre-exposure use among the 2 additional populations 

described during the presentations. 

 Commenting from a local public health perspective, Dr. Zahn (NACCHO) pointed out 

that in 2014-2015, there was a large West African outbreak of Ebola in Orange 

County in Southern California. There were a few Ebola treatment facilities where 

patients with symptoms consistent with Ebola or with confirmed disease would be 

admitted. Because there were so many travelers at the time, some hospitals were 

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willing to accept patients with Ebola with symptoms for initial assessment. Patients 

determined to be at risk would go on to a treatment facility. However, assessment 

facility conversations were always difficult because nobody wanted to see patients 

returning from West Africa due to the infection control risk associated with that. If a 

situation such as this occurred again, there would be difficult conversations about 

why ETC staff get the vaccine and others do not. This seems important to consider in 

terms of messaging. 

 Dr. Choi indicated that the issue of access to vaccine by assessment hospitals has 

been raised within the WG. In terms of the priorities for the WG, the focus has been 

on individuals perceived to have the highest occupational risk, which is why the initial 

recommendations were for the federally-designated SPTC and LRN facilities. Given 

that the conversation about assessment hospitals has been raised several times 

within the WG, it is likely to be the topic of future agendas. 

• Inquiries were posed by ACIP members about why the proposed recommendation did not 

(but perhaps should) include language about optimal timing and/or shared clinical decisionmaking, particularly given that when survey respondents intending to care for Ebola-infected 

patients indicated that they would get the vaccine increased from 54%-59% to 81% in a 

situation in which there was an EVD case in the US or in their state. 

 Dr. Choi emphasized that when respondents were asked about whether they would 

be willing to take the vaccine “today,” the word “today” was important because it had 

to do with perceived risk. At the time the survey was administered, there essentially 

were no Ebola cases occurring in the world. Short of occupational exposure, they 

would not get a case. However, they might get arthralgia or other AEs from the 

vaccine. Therefore, timing and the balance of the consequences tends to swing back 

and forth. The WG robustly discussed shared clinical decision-making versus 

recommendation. To her, the gestalt of that discussion was that the WG felt in 

general that the focus was on the 2 additional populations at risk and whether a 

vaccine would protect them. The WG felt that the vaccine would protect these 

populations who are at risk due to their jobs and VE is clear, which compelled the 

WG to lean toward recommendation. 

 Dr. Chen agreed and added that the WG revisited this question numerous times. 

There was concern that this could be perceived as a vaccine mandate by the 

facilities, regardless of whether it was shared decision-making versus a 

recommendation. Therefore, the WG concentrated on making decisions based on 

the strength of whether they thought vaccination would be protective to a population 

who would be at risk because of their occupations versus the general population. 

The WG fully recognized that this vaccine would be implemented at the local 

jurisdictional level and would be occupational in nature. Therefore, the employer and 

employee would be having this conversation. There will be discussion of the 

precautions and contraindications to help people decide whether a particular person 

could or perhaps should not be vaccinated. 

 Dr. Lee emphasized that procedurally, regardless of whether this might be a full 

recommendation or shared clinical decision-making, fear of mandates should not be 

driving ACIP’s decisions. In addition, she thought it would be beneficial to include 

timing rationales in the clinical considerations such as when there is an Ebola 

outbreak, when there are X number of cases, anticipation of an influx of patients who 

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are traveling in from a location with an outbreak, or some other threshold to give 

people a sense of risk. 

 Regarding shared clinical decision-making, Dr. Poehling expressed concern about 

the many women working in laboratories who may become pregnant within 2 months 

of being vaccinated because not all pregnancies are planned. 

 Dr. Choi indicated that they reached out to several ETCs and LRNs to get a sense of 

whether these facilities would be likely to mandate the vaccine, and they said they 

would not. 

 Given that the risk is variable and the definition of HCP is broad and the vaccine is 

not without side-effects, there was sentiment among some ACIP members that 

shared clinical decision-making or some other way of conveying “may” rather than 

“should” ought to be considered. 

 It was suggested that perhaps CDC could offer more detailed guidance around 

thresholds for concern, and perhaps institute a threat level of red, orange, yellow, 

green as has been done for COVID-19. 

 In terms of the potential for vaccine injury, Dr. Rubin (HRSA) confirmed that use of 

Ebola vaccine would be covered under the CICP. 

 Given the potential for if people have to miss work, just as was done for COVID 

vaccines, it was suggested that perhaps guidance could be provided to facilities so 

that they are covering individuals who received the vaccine. This seems particularly 

important in terms of preventing potential transmission of vaccine virus. 

Proposed Policy Options 

Dr. Caitlin Cossaboom (CDC/NCEZID) presented the policy options for the use of rVSV Ebola 

vaccine among personnel working in SPTCs or LRN facilities, noting that the proposed 

recommendation language could be revised as needed based on the discussion. As noted by 

Dr. Chen, the ACIP Ebola Vaccines WG had robust discussions on the potential implications of 

an ACIP recommendation. And as with any other employee health-related vaccine, it is the 

WG’s expectation that this recommendation will be implemented based on institutional 

occupational health policy. The majority of voting WG members were in favor of the following 

proposed recommendation language: 

Proposed Vote #1: SPTC HCP 

Pre-exposure vaccination with rVSVΔG-ZEBOV-GP vaccine is recommended for healthcare 

personnel* involved in the care and transport of suspect or confirmed Ebola virus disease 

patients at Special Pathogens Treatment Centers. 

* Healthcare personnel (HCP) refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct 

or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); 

contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. These HCP 

include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, technicians, clinical 

laboratory personnel, autopsy personnel, therapists, phlebotomists, pharmacists, students and trainees, contractual staff not 

employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents 

that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and 

facilities management, administrative, billing, and volunteer personnel). 

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Proposed Vote #2: LRN Staff

Pre-exposure vaccination with rVSVΔG-ZEBOV-GP vaccine is recommended for laboratorians 

and support staff at Laboratory Response Network (LRN) facilities that handle specimens that 

may contain replication-competent Ebola virus (species Zaire ebolavirus) in the United States. 

Discussion Summary 

• Dr. Poehling proposed an amendment to the language of the two proposed 

recommendations to include “shared clinical decision-making.” 

• Dr. Lee suggested that the two proposed recommendations be taken to a full vote and if the 

two votes did not pass, the WG could be asked to reconsider the language for a different 

vote that incorporates “shared clinical decision-making.” 

Votes: Ebola Vaccines 

Vote #1: Ebola Vaccines for SPTC HCP 

Dr. Loehr made a motion to approve the first Ebola recommendation stating, “The ACIP 

recommends pre-exposure vaccination with rVSVΔG-ZEBOV-GP vaccine for healthcare 

personnel* involved in the care and transport of suspect or confirmed Ebola virus disease 

patients at Special Pathogens Treatment Centers.” 

*Healthcare personnel (HCP) refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or 

indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); 

contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. These HCP 

include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, technicians, clinical 

laboratory personnel, autopsy personnel, therapists, phlebotomists, pharmacists, students and trainees, contractual staff not 

employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents 

that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and 

facilities management, administrative, billing, and volunteer personnel). Adapted from 

https://www.cdc.gov/infectioncontrol/guidelines/healthcare-personnel/index.htm 

Dr. Ault seconded the motion. No COIs were declared. The motion carried with 11 affirmative 

votes, 4 negative votes, and 0 abstentions. The disposition of the vote was as follows: 

11 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Loehr, Long, Sanchez, 

4 Opposed: Lee, McNally, Poehling, Talbot 

0 Abstained: N/A 

0 Absent: N/A 

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Vote #2: Ebola Vaccines for HRN Staff 

Dr. Loehr made a motion to approve the first Ebola recommendation stating, “The ACIP 

recommends pre-exposure vaccination with rVSVΔG-ZEBOV-GP vaccine for laboratorians and 

support staff at Laboratory Response Network (LRN) facilities that handle specimens that may 

contain replication-competent Ebola virus (species Zaire ebolavirus) in the United States.” 

Dr. Ault seconded the motion. No COIs were declared. The motion carried with 11 affirmative 

votes, 4 negative votes, and 0 abstentions. The disposition of the vote was as follows: 

11 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Loehr, Long, Sanchez, 

4 Opposed: Lee, McNally, Poehling, Talbot 

0 Abstained: N/A 

0 Absent: N/A 

Member Statements 

Subsequent to the votes, Dr. Lee invited ACIP members to make a statement about the 

rationale for their votes and/or to share any additional general comments: 

• Dr. Talbot commented that she felt like people should have the option of receiving the Ebola 

vaccine. She voted “no” not because she did not feel like they should, but because she felt 

like it should be shared clinical decision-making. 

• Dr. Chen observed that it has become increasingly necessary to address global health 

pathogens. When Ebola and smallpox are discussed, people do not believe that they are 

really in the US. However, they are global health pathogens from history to the present that 

will continue to threaten mankind. 

• Dr. Poehling recognized that while Ebola is an important pathogen globally, she voted “no” 

for the Ebola recommendations because she felt strongly that people should have a choice 

and that shared clinical decision-making would be the best approach. 

• Ms. McNally commented that she agreed with the Ebola vaccination recommendation but 

hoped it would be under shared clinical-decision making. She thanked the CDC and 

providers who vaccinate for their continued effort on patient education, given that it is 

critically important for patients to understand the risks and the benefits. 

• Dr. Kotton thanked all of the hardworking people at the CDC who did so much work to get 

the ACIP to this point. It was a very exciting several weeks of meetings. As a clinician in the 

field who has seen a tremendous amount of hepatitis B, zoster, pneumococcal disease, et 

cetera, it was very exciting to see these expanded indications for vaccines. She hopes to 

see a lot less hepatitis B, pneumococcal disease, and zoster and never to see diseases 

such as smallpox or Ebola that could be vaccine-prevented. This is a very exciting time, 

especially for adults. 

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PUBLIC COMMENT: NOVEMBER 3, 2021 

The floor was opened for public comment on November 3, 2021 at 4:47 PM ET. Given that 

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

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–2021–0112. Visit 

http://www.regulations.gov for access to the docket or to submit comments or read background 

documents and comments received. The public comment session was conducted prior to the 

votes. However, the votes were included with their respective sessions for ease of reading. 

Ms. Sarah Barry 

Independent Pro-Vaccine Advocate 

Hello, my name is Sarah Berry. I am an independent pro-vaccine advocate. I thank the ACIP 

members not only for the opportunity to speak today, but also for continuing to have these 

critical discussions. I would also like to thank ACIP specifically for their vote to recommend the 

COVID-19 vaccine for children. My main goal as a pro-vaccine advocate has been to educate 

anybody who will give me their time about the extensive abuse of autistic children at the hands 

of the anti-vaccine community, and I do this because I truly believe that vaccine hesitancy will 

not go away until as many people as possible will become aware of the fact. If you don’t believe 

me, then you should at least believe the anti-vaxxers who are afraid of me and my message. As 

I shared last time I gave public comment, my advocacy has resulted in online harassment from 

extremists and also what I worry were intentional efforts to intimidate me at my home in the form 

of multiple protests across the street from where I live. I’ve also shared how I worked with Angie 

Nassar from Al Jazeera Plus to expose anti-vax lobbyists who wanted to and tried to censor my 

testimony at the Ohio State House, and you can find the video evidence of that on the Al 

Jazeera + YouTube channel. I truly believe that the only reason anti-vaxxers might try to harass 

and censor me is because they know that what I say is true, and they are terrified of me. When I 

did my first research on vaccine controversies, I started by reading anti-vaccine articles that 

were being propped up as evidence that vaccines could cause harm, and anti-vax family 

members started me on my journey by sending me a PDF of study summaries created by the 

anti-vax group, Focus for Health, which is run by Brian Hooker. The second study on that PDF 

was done by Mark Geier, and I believe, as I’ve shared before, it took me one five-second 

Google search to discover that he lost his medical license for chemically castrating autistic 

children. Think of all the times anti-vaxxers accused ACIP of unethical behavior, even to the 

point of implying that you deserve to go on trial. Where is that same energy for Mark Geier and 

others like him? Geier literally experimented on autistic children without telling parents the full 

risks, but Robert F. Kennedy Jr. complained that corrupt medical professionals have 

systematically disgraced and silenced him. In fact, if you go on the anti-vax nonprofit website 

run by Robert F. Kennedy Jr., you will find dozens upon dozens upon dozens of examples of 

Mark Geier’s work being propped up as legitimate evidence of vaccine harm. The vaccine 

hesitancy conversation should be about so much more than just vaccines. To truly win against 

the misinformation, you have to expose the ridiculous double standards that allow charlatans 

like Mark Geier to profit off of desperate, anti-vax families. It was not difficult for somebody as 

average as myself to research this information, and as much as I disagree with them, the antivaccine community deserves to know that the leaders they look up to have utterly betrayed 

them. I again thank the ACIP for continuing to have these important conversations, and if 

anybody listening has any questions, you can find me on Twitter at @42believer. 

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Mrs. Colleen Thomas 

Hoosiers Vaccinate 

My name is Colleen Thomas. I work with Hoosiers Vaccinate, a volunteer-led vaccine advocacy 

group in Indiana. I became a vaccine advocate because my 9-year-old son has a primary 

immunodeficiency, meaning he was born missing part of his immune system. He also has 

severe asthma. Since birth, he has suffered from recurrent severe respiratory infections, often 

taking weeks to recover from multiple rounds of antibiotics, sometimes oral steroids. He 

depends on herd immunity to avoid exposure to preventable diseases in our community. The 

more people around him that are vaccinated, the less likely he is to encounter a severe disease 

that he would struggle to fight off. Having a child with this condition was always a challenge, but 

the past 20 months, living through a global pandemic has been the biggest challenge we’ve 

ever faced. Our family has isolated since March 2020. My son has not been in school. We have 

missed all holidays. He rarely plays with friends. His education has suffered. The social isolation 

had a major impact on my son’s emotional and mental health. Finally, a vaccine is available and 

it will allow him to return to school, play sports, and be with friends and family. I’m speaking 

today to thank you, the ACIP members, who have invested time in reviewing the vaccine studies 

and recommending this pediatric vaccine. You had an integral part in ending this nightmare for 

our family. In truth, my son doesn’t always mount an immune response to all vaccines. He may 

not develop as many antibodies as a healthy child once he gets the vaccine. He’ll probably wear 

a mask in school and out in public longer than his peers. But even so, his life is about to 

improve greatly. I understand there are vaccine-hesitant parents, and they get a lot of press, 

and I have empathy for all parents through this whole ordeal. But I’m all too keenly aware of risk 

versus benefit analysis when it comes to my little boy’s health. And this vaccine for us is a nobrainer. As I speak, my son is at the health department with his dad. Actually, he’s home now 

because this went long, but he got his first dose of COVID vaccine today. I took the first 

available appointment and it happened to be right now. I didn’t go so I could stay here and make 

this comment, but I’ll for sure be at his second appointment. There are over 300 types of 

primary immunodeficiencies and they affect thousands of children in the US, many of whom can 

safely receive the vaccine and who no doubt have parents who have been anxiously waiting for 

this vaccine just as we have been. Vaccinations have protected children from severe disease 

for decades and are safe and effective. They protect the most vulnerable in our society. My final 

comment is I would like to see a better system in place for verifying vaccination status, as the 

CDC COVID cards have been all too easy for people to falsify. Not all states have electronic 

verification systems. The US needs a central verification database that’s more tamper-proof 

going forward. I thank you for your time for allowing my comments today and especially for the 

work you do. 

Susie Olson Corgan 

Citizen 

My name is Susie Olson Corrigan. Thank you for the opportunity to speak today. My comments 

are in direct response to your recommendation to add the Pfizer-BioNTech COVID-19 biological 

products to the adolescent immunization schedule for 5-11-year-olds. During the Food and Drug 

Administration’s Vaccine and Related Biological Products Advisory Committee meeting last 

week, Pfizer was asked several questions regarding safety and potential adverse events in 

children receiving their COVID-19 jab. Answers included the following, “We do not know we 

don’t have that data. We will find out as more children receive them.” Hearing, “we do not know” 

should have been the end of this discussion, yet VRBPAC went ahead and recommended the 

EUA application to be approved, and the FDA obliged with answers like “we do not know.” How 

could you, ACIP, our public health regulatory agency in good conscience while maintaining your 

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duty to protect the public add this product to the recommended adolescent schedule? Did you 

listen to this meeting? Did you ask questions? Did you read all the reports and presentations? 

Did you do your due diligence before your vote took place yesterday? During these meetings, 

once again, it was made clear that our children are the safety study. There is nothing definitive 

showing that children—giving them this jab is justified when looking at the risk-benefit of 

adverse events from the jab versus potential risk of natural infection. There’s no definitive data 

showing that children are receiving the COVID-19 jab will protect adults. And since when have 

we as adults been okay with sacrificing our kids and their health to potentially protect us? When 

did this become a data point we even considered? There is nothing definitive showing that these 

biological products will stop transmission, hospitalizations, or deaths in adolescents. However, 

myocarditis, pericarditis, Bell’s palsy, death, all adolescent adverse events that have been 

reported to the Vaccine Adverse Event Reporting System after having received a COVID-19 jab, 

are these AEs not a concern to you? They surely are to me. As for me and the thousands of 

parents I’ve spoken to across the country, we will not give our children any version of the 

COVID-19 jab no matter how often you participate in, create, or fund social media campaigns 

trying to convince us otherwise. No matter how many billions of dollars you put into public 

relations campaigns, we will not give our children this experimental product. No matter how 

many times you, the ACIP, the FDA, public health officials, politicians, or celebrities tell us that 

we have to for the greater good. My child is my responsibility and mine alone. I will not give my 

child this jab despite how many products, services, access to restaurants, bars, or events we 

are unjustifiably barred from. There’s absolutely nothing you can do to convince me that giving 

this to my child is worth the risk. It is all risk. For any parent listening to this meeting, I beg you 

please do your own research, read the report submitted to the vaccine manufacturers by the 

vaccine manufacturers to the FDA for EUA. Make sure that you know the actual risks versus 

benefit. Public health won’t tell you, and after listening to regulatory agency meetings, I will tell 

you they do not care. 

Michaela Jackson 

Prevention Policy Manger

Hepatitis B Foundation 

Good afternoon. My name is Michaela Jackson. I am the Prevention Policy Manger for the 

Hepatitis B Foundation. During the September discussion on a recommendation for universal 

adult hepatitis B vaccination, committee members question the true need for such a 

recommendation. For the past two years, we have submitted comments filled with statistics and 

data on the need for all adults to be vaccinated. Today, we would like to answer the question 

posed during the September meeting with the responses of brave individuals who shared their 

moving stories with us. So why do we need universal hep B vaccination for all adults? We need 

universal hep B vaccinations for the daughter who did not know that she should have been 

vaccinated. Her mother passed away from hepatitis C-related liver cancer, and now she lives in 

fear that she might develop it too. We need this recommendation for the mother who lost her 

son to hepatitis C after he was accidentally pricked by a needle in medical school. Hepatitis B 

vaccination for adults was not common when he was exposed. Just this year, a 56-year-old 

woman became infected by hep C and she does not know how she was exposed. The woman 

says, “I want everyone to be vaccinated for hepatitis B. I didn’t believe I was at risk.” A universal 

recommendation is needed for the niece who worried about losing her aunt to liver cancer and 

the emotional toll it took on her family. She asked ACIP to pass the recommendation to help 

inform the public about the vaccines they need and to prevent others from going through the 

pain that her family felt. We need universal vaccination for the man who became an advocate 

after learning he had hepatitis C and hepatitis B co-infection. He now wants everyone to know 

that this vaccine can prevent two serious severe infections. Another man pays $2,700 a month 

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for chronic hepatitis B treatment. Many people are unaware that this vaccine exists. “I have 

been dealing with hep B for 16 years, and I was never told about the vaccine,” he says. “If I 

would have known about it, I would have gotten it without question.” We need the universal 

recommendation for primary care providers who find it burdensome to ask about 18 different 

risk factors and for people who want to be vaccinated but are afraid to discuss the true risk with 

their doctor. And finally, we need it for the dozens of people who commented, “I wish I knew 

about the vaccine before I contracted hep B.” Simply put, the public health community believes 

as one person wrote that an anti-cancer vaccine should be universally available. The stories told 

today demonstrate the clear lack of awareness and education from both a patient and provider 

perspective, in addition to highlighting the need for an inclusive recommendation. They also 

represent the numerous lives that have been irrevocably changed by a failure to close wellknown gaps and access to hepatitis B vaccination. Sadly, stories like the one for today are 

common, but they do not have to be. The recommendations by ACIP have real-life implications 

that reach every single American. It is time to eliminate burdensome stigmatizing risk-based 

guidelines and replace them with effective policies that would help eliminate viral hepatitis. 

Thank you for this opportunity. 

Ms. Beatrice Zovich 

Public Health Program Coordinator 

Hepatitis B Foundation 

Good afternoon. My name is Beatrice Zovich. I am a Public Health Program Coordinator 

for the Hepatitis B Foundation. While we wait in great anticipation of the vote for universal adult 

hepatitis B vaccination this afternoon, we must express disappointment with the committee’s 

decision to exclude adults aged 60 and older in the proposed recommendation. No one should 

be subjected to the stress and mental anguish of being diagnosed with a preventable illness, 

and prevention is always more cost-effective than treatment. As a patient advocacy 

organization, we receive thousands of calls annually from people who have questions or 

concerns about hepatitis B. And each year, nearly 10% of calls are from people aged 60 and 

older. We’ve also received countless inquiries from people aged 60 and older who have tried to 

get vaccinated but were denied by their primary care providers. Many insurance programs 

provide coverage for ACIP recommended vaccines, but will only cover those who are at highrisk for infection. We cannot claim that everyone has equal access when people are regularly 

refused the vaccine because of the current guidelines. The reality is that risk-based guidelines 

for any adult ignore the role of the social determinants of health. Hep B and its risk factors are 

heavily stigmatized, especially among immigrants who already face health care challenges, 

including those relating to language and culture. As many as 60% of individuals living with 

hepatitis B in the United States were born in a different country. The stigma and discrimination 

faced by those living with hep B and many parts of the world is tremendous. Misperceptions that 

the disease primarily affects those who engage in certain behaviors run rampant, and it is not 

uncommon for people to face barriers to obtaining education and employment. Given prevailing 

cultural attitudes, as well as limited English proficiency and the discomfort and confusion that 

surround navigation of the health care system in the United States, the burden of requesting 

hep B vaccination needs to be removed from vulnerable communities. Additionally, the 

responsibility of questioning each patient about their country of origin in order to determine 

whether or not they should receive a vaccine, information that is not generally collected by most 

physicians in standard health surveys, should not be placed on busy physicians either. By 

making this recommendation universal and creating a standing order for it, all confusion and 

shame will be removed from the equation, and adults will be able to receive this important 

vaccine in a way that is as routine as the offering of a flu shot or a blood test for cholesterol. 

The hep B vaccine prevents not only hepatitis B but also hepatitis Delta, the most severe form 

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ACIP Meeting Summary November 2-3, 2021 

of viral hepatitis that can only occur in people living with hep b. With no treatments approved in 

the US, people who contract this dangerous co-infection have a nearly 70% chance of 

developing significant liver damage, including liver cancer. One couple who shared their story 

with us talked about the heartbreaking ordeal they endured when doctors did not conduct proper 

monitoring of the husband’s infection and did not test for hepatitis Delta until significant liver 

damage and cancer had developed. No one should have to invest years of their life and 

countless emotional and financial resources for a vaccine-preventable illness. Vaccinating all 

adults is a very safe and highly effective way to move swiftly toward the goal of hep B 

elimination and in as equitable fashion as possible. Thank you for your time. 

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ACIP Meeting Summary November 2-3, 2021 

CERTIFICATION 

Upon reviewing the foregoing version of the November 2-3, 2021 ACIP meeting minutes, Dr. 

Grace Lee, ACIP Chair, certified that to the best of her knowledge, they are accurate and 

complete. Her original, signed certification is on file with the Management Analysis and Services 

Office (MASO) of CDC. 

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ACIP Meeting Summary November 2-3, 2021 

ACIP MEMBERSHIP ROSTER 

CHAIR 

LEE, Grace M, MD, MPH 

Associate Chief Medical Officer for Practice Innovation 

Lucile Packard Children’s Hospital 

Professor of Pediatrics, Stanford University School of Medicine 

Stanford, CA 

Term: 8/4/2021 – 6/30/2023 

EXECUTIVE SECRETARY 

WHARTON, Melinda, MD, MPH 

National Center for Immunization and Respiratory Diseases 

Centers for Disease Control and Prevention 

Atlanta, GA 

MEMBERS 

AULT, Kevin A, MD, FACOG, FIDSA 

Professor and Division Director 

Department of Obstetrics and Gynecology University of 

Kansas Medical Center 

Kansas City, KS 

Term: 10/26/2018 – 6/30/2022 

BAHTA, Lynn, RN, MPH, CPH 

Immunization Program Clinical Consultant 

Infectious Disease, Epidemiology, Prevention & Control Division 

Minnesota Department of Health 

Saint Paul, Minnesota 

Term: 7/1/2019 – 6/30/2023 

BELL, Beth P, MD, MPH 

Clinical Professor 

Department of Global Health, School of Public Health 

University of Washington 

Seattle, WA 

Term: 7/1/2019 – 6/30/2023 

BROOKS, Oliver, MD, FAAP 

Chief Medical Officer 

Watts HealthCare Corporation 

Los Angeles, CA 

Past President, National Medical Association 

Term: 7/26/2021 – 6/30/2025 

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ACIP Meeting Summary November 2-3, 2021 

CHEN, Wilbur H, MD, MS, FACP, FIDSA 

Professor of Medicine 

Center for Vaccine Development and Global Health 

University of Maryland School of Medicine 

Baltimore, MD 

Term: 12/23/2020 – 6/30/2024 

CINEAS, Sybil, MD, FAAP, FACP 

Associate Professor of Medicine, Pediatrics, and Medical Science (Clinical) 

The Warren Alpert Medical School of Brown University 

Associate Program Director 

Brown Combined Residency in Internal Medicine and Pediatrics 

Providence, RI 

Term: 7/28/2021 – 6/30/2025 

DALEY, Matthew F, MD 

Senior Investigator 

Institute for Health Research, Kaiser Permanente Colorado 

Associate Professor of Pediatrics 

University of Colorado School of Medicine 

Aurora, CO 

Term: 1/4/2021 – 6/30/2024 

KOTTON, Camille Nelson, MD, FIDSA, FAST 

Clinical Director, Transplant and Immunocompromised Host Infectious Diseases 

Infectious Diseases Division, Massachusetts General Hospital 

Associate Professor of Medicine, Harvard Medical School 

Boston, MA 

Term: 12/23/2020 – 6/30/2024 

LOEHR, Jamie, MD, FAAFP 

Owner, Cayuga Family Medicine 

Ithaca, New York 

Term: 7/26/2021 – 6/30/2025 

LONG, Sarah S, MD 

Professor of Pediatrics 

Drexel University College of Medicine 

Section of Infectious Diseases 

St. Christopher’s Hospital for Children 

Philadelphia, Pennsylvania 

Term: 12/24/2020 – 6/30/2024 

MCNALLY, Veronica V, JD 

President and CEO Franny 

Strong Foundation 

West Bloomfield, Michigan 

Term: 10/31/2018 – 6/30/2022 

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ACIP Meeting Summary November 2-3, 2021 

POEHLING, Katherine A, MD, MPH 

Professor of Pediatrics and Epidemiology and Prevention 

Director, Pediatric Population Health 

Department of Pediatrics 

Wake Forest School of Medicine 

Winston-Salem, NC 

Term: 7/1/2019 – 6/30/2023 

SÁNCHEZ, Pablo J, MD 

Professor of Pediatrics 

The Ohio State University – Nationwide Children’s Hospital 

Divisions of Neonatal-Perinatal Medicine and Pediatric Infectious Diseases 

Director, Clinical & Translational Research (Neonatology) 

Center for Perinatal Research 

The Research Institute at Nationwide Children's Hospital Columbus, Ohio 

Term: 7/1/2019 – 6/30/2023 

TALBOT, Helen Keipp, MD 

Associate Professor of Medicine 

Vanderbilt University 

Nashville, TN 

Term: 10/29/2018 – 6/30/2022 

EX OFFICIO MEMBERS 

Centers for Medicare and Medicaid Services (CMS)

HANCE, Mary Beth 

Senior Policy Advisor 

Division of Quality, Evaluations and Health Outcomes 

Children and Adults Health Programs Group 

Center for Medicaid, CHIP and Survey & Certification Centers 

for Medicare and Medicaid Services 

Baltimore, MD 

Food and Drug Administration (FDA)

FINK, Doran, MD, PhD 

Deputy Director, Clinical, Division of Vaccines and Related Products Applications 

Office of Vaccines Research and Review 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

Silver Spring, MD 

Health Resources and Services Administration (HRSA)

RUBIN, Mary, MD 

Chief Medical Officer 

Division of Injury Compensation Programs 

Rockville, MD 

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ACIP Meeting Summary November 2-3, 2021 

Indian Health Service (IHS)

CLARK, Matthew, MD, FAAP, FACP 

Physician 

Chair, IHS National Pharmacy & Therapeutics Committee 

Durango, CO 

Office of Infectious Disease and HIV/AIDS Policy (OIDP)

KIM, David, MD, MA 

Director, Division of Vaccines, OIDP 

Office of the Assistant Secretary for Health 

Department of Health and Human Services 

Washington, DC 

National Institutes of Health (NIH)

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) 

Bethesda, MD 

LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP)

ROCKWELL, Pamela G, DO 

Associate Professor, Department of Family Medicine, University of 

Michigan Medical School 

Medical Director, Dominos Farms Family Medicine 

Ann Arbor, MI 

American Academy of Pediatrics (AAP)

MALDONADO, Yvonne, MD 

Senior Associate Dean for Faculty Development and Diversity 

Professor of Pediatrics and Health Research and Policy 

Chief, Division of Pediatric Infectious Diseases 

Stanford University School of Medicine 

Stanford, CA 

American Academy of Pediatrics (AAP) 

Red Book Editor 

KIMBERLIN, David, MD 

Professor of Pediatrics 

Division of Pediatric Infectious Diseases 

The University of Alabama at Birmingham School of Medicine 

Birmingham, AL 

American Academy of Physician Assistants (AAPA)

LÉGER, Marie-Michèle, MPH, PA-C 

Senior Director, Clinical and Health Affairs 

American Academy of Physician Assistants 

Alexandria, VA 

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ACIP Meeting Summary November 2-3, 2021 

American College Health Association (ACHA)

CHAI, Thevy S., MD 

Director of Medical Services 

Campus Health Services 

University of North Carolina at Chapel Hill Chapel Hill, 

NC 

American College Health Association (ACHA) (alternate) 

MCMULLEN, Sharon, RN, MPH, FACHA 

Assistant Vice President of Student & Campus Life for Health and Wellbeing Cornell Health 

Ithaca, NY 

American College of Nurse Midwives (ACNM)

HAYES, Carol E., CNM, MN, MPH 

Lead Clinician 

Clinical Quality Compliance and Management 

Planned Parenthood Southeast Atlanta, GA 

American College of Nurse Midwives (ACNM) (alternate) 

MEHARRY, Pamela M., PHD, CNM 

Midwifery Educator, Human Resources for Health 

In partnership with University of Rwanda and University of Illinois, Chicago 

American College of Obstetricians and Gynecologists (ACOG)

ECKERT, Linda O, MD, FACOG 

Professor, Department of Obstetrics & Gynecology 

Adjunct Professor, Department of Global Health 

University of Washington 

Seattle, WA 

American College of Physicians (ACP)

GOLDMAN, Jason M, MD, FACP 

Affiliate Assistant Professor of Clinical Biomedical Science, Florida Atlantic University, Boca 

Raton, Florida 

Private Practice 

Coral Springs, FL 

American Geriatrics Society (AGS) 

SCHMADER, Kenneth, MD 

Professor of Medicine-Geriatrics Geriatrics 

Division Chief 

Duke University and Durham VA Medical Centers 

Durham, NC 

America’s Health Insurance Plans (AHIP)

GLUCKMAN, Robert A, MD, MACP 

Chief Medical Officer, Providence Health Plans 

Beaverton, OR 

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ACIP Meeting Summary November 2-3, 2021 

American Immunization Registry Association (AIRA)

COYLE, Rebecca, MSEd 

Executive Director, AIRA 

Washington, DC 

American Medical Association (AMA)

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine Emory 

University School of Medicine 

Atlanta, GA 

American Nurses Association (ANA)

RITTLE, Charles (Chad), DNP, MPH, RN Assistant 

Professor, Nursing Faculty 

Chatham University, School of Health Sciences 

Pittsburgh, PA 

American Osteopathic Association (AOA)

GROGG, Stanley E, DO 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA)

HOGUE, Michael D., PharmD, FAPhA, FNAP 

Dean and Professor of Loma Linda University School of Pharmacy 

Director, Center for Interprofessional Education & Practice 

Loma Linda, CA 

Association of Immunization Managers (AIM)

HOWELL, Molly, MPH 

Immunization Program Manager 

North Dakota Department of Health 

Bismarck, ND 

Association for Prevention Teaching and Research (APTR) 

ZIMMERMAN, Richard, MD, MPH 

Professor 

University of Pittsburgh School of Medicine 

Department of Family Medicine and Clinical Epidemiology 

Pittsburgh, PA 

Association of State and Territorial Health Officials (ASTHO)

SHAH, Nirav D, MD, JD 

Director 

Maine Center for Disease Control and Prevention 

Augusta, ME 

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Biotechnology Industry Organization (BIO)

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 

Council of State and Territorial Epidemiologists (CSTE)

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

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

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 

Canadian National Advisory Committee on Immunization (NACI)

DEEKS, Shelley, MD, MHSc, FRCPC, FAFPHM 

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

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

Chair, National Advisory Committee on Immunization 

Halifax, Nova Scotia 

Infectious Diseases Society of America (IDSA)

BAKER, Carol J., MD 

Professor of Pediatrics 

Molecular Virology and Microbiology 

Baylor College of Medicine 

Houston, TX 

International Society for Travel Medicine (ISTM)

BARNETT, Elizabeth D, MD Professor of 

Pediatrics 

Boston University School of Medicine 

Boston, MA 

National Association of County and City Health Officials (NACCHO)

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 

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ACIP Meeting Summary November 2-3, 2021 

National Association of County and City Health Officials (NACCHO) (alternate) 

DUCHIN, Jeffrey, MD 

Health Officer and Chief, Communicable Disease 

Epidemiology and Immunization Section 

Public Health - Seattle and King County 

Professor in Medicine 

Division of Allergy and Infectious Diseases 

University of Washington School of Medicine and School of Public Health 

Seattle, WA 

National Association of Pediatric Nurse Practitioners (NAPNAP)

STINCHFIELD, Patricia A, RN, MS, CPNP 

Director 

Infectious Disease/Immunology/Infection Control 

Children's Hospitals and Clinics of Minnesota 

St. Paul, MN 

National Foundation for Infectious Diseases (NFID)

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 

National Foundation for Infectious Diseases (NFID) (alternate) 

DALTON, Marla, PE, CAE 

Executive Director & CEO 

National Foundation for Infectious Diseases (NFID) 

Bethesda, MD 

National Medical Association (NMA) 

WHITLEY-WILLIAMS, Patricia, MD Professor and Chair 

University of Medicine and Dentistry of New Jersey Robert Wood 

Johnson Medical School 

New Brunswick, NJ 

Pediatric Infectious Diseases Society (PIDS) 

O’LEARY, Sean, MD, MPH 

Associate Professor of Pediatrics 

Pediatric Infectious Diseases 

General Academic Pediatrics 

Children’s Hospital Colorado 

University of Colorado School of Medicine 

Pediatric Infectious Diseases Society (PIDS) (alternate) 

SAWYER, Mark H, MD 

Professor of Clinical Pediatrics 

University of California, San Diego School of Medicine 

San Diego, CA 

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ACIP Meeting Summary November 2-3, 2021 

Pharmaceutical Research and Manufacturers of America (PhRMA) 

ROBERTSON, Corey, MD, MPH 

Senior Director, US Medical, Sanofi Pasteur 

Swiftwater, PA 

Society for Adolescent Health and Medicine (SAHM)

MIDDLEMAN, Amy B, MD, MSEd, MPH 

Professor of Pediatrics 

Chief, Section of Adolescent Medicine 

University of Oklahoma Health Sciences Center 

Oklahoma City, OK 

Society for Healthcare Epidemiology of America (SHEA)

DREES, Marci, MD, MS 

Chief Infection Prevention Officer & Hospital Epidemiologist 

ChristianaCare 

Wilmington, DE 

Associate Professor of Medicine 

Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA 

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ACIP Meeting Summary November 2-3, 2021 

ACRONYMS USED IN THIS DOCUMENT 

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics 

AAPA American Academy of Physician Assistants 

ACA Affordable Care Act 

ACC American College of Cardiology 

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices 

ACNM American College of Nurse-Midwives 

ACOG American College of Obstetricians and Gynecologists 

ACP American College of Physicians 

ADEM Acute disseminated encephalomyelitis 

AE Adverse Event 

AESI Adverse Events of Special Interest 

AGS American Geriatrics Society 

AHA American Heart Association 

AHIP America’s Health Insurance Plans 

AI/AN American Indian/Alaska Native 

AIM Association of Immunization Managers 

AIRA American Immunization Registry Association 

AJPM American Journal of Preventive Medicine 

AMA American Medical Association 

AOA American Osteopathic Association 

APhA American Pharmacists Association 

APRN Advanced Practice Registered Nurse 

APTR Association for Prevention, Teaching, and Research 

ASTHO Association of State and Territorial Health Officers 

BLA Biologics License Application 

BNP Brain Natriuretic Peptide 

BSL-4 Biosafety Level-4 

CDC Centers for Disease Control and Prevention 

CICP Countermeasures Injury Compensation Program 

CISA Project Clinical Immunization Safety Assessment Project 

CMC Chronic Medical Condition 

CMI Cell-Mediated Immunity 

CMS Center for Medicare and Medicaid Services 

CNS Central Nervous System 

COI Conflict of Interest 

CSTE Council of State and Territorial Epidemiologists 

CVST Cerebral Venous Sinus Thrombosis 

DFO Designated Federal Official 

DIC Disseminated Intravascular Coagulation 

DoD Department of Defense 

DRC Democratic Republic of Congo 

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs 

DVD Division of Viral Diseases 

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ACIP Meeting Summary November 2-3, 2021 

DVT Deep Venous Thrombosis 

ED Emergency Department 

EHR Electronic Health Record 

ECG or EKG Electrocardiograms 

EMR Electronic Medical Record 

EMTs Emergency Medical Technicians 

ET Eastern Time 

ETC Ebola Treatment Center 

EtR Evidence to Recommendation 

EUA Emergency Use Authorization 

FDA Food and Drug Administration 

FluSurv-NET Influenza Hospitalization Surveillance Network 

FP Family Physician 

FQHC Federally Qualified Health Center 

GBS Guillain-Barré Syndrome 

GI Gastrointestinal 

GMR Geometric Mean Ratios 

GMT Geometric Mean Titers 

GRADE Grading of Recommendation Assessment, Development and Evaluation 

GSK GlaxoSmithKline 

HBcAb Hepatitis B Core Antibody 

HBsAb Hepatitis B Surface Antibody 

HBsAg Hepatitis B Surface Antigen 

HCP Healthcare Personnel / Providers 

HCW Healthcare Workers 

HepB Hepatitis B 

HHS (Department of) Health and Human Services 

HIB Haemophilus Influenzae 

HIV Human Immunodeficiency Virus 

HM Hematologic Malignancies 

HRSA Health Resources and Services Administration 

HSCT Hematopoietic Stem Cell Transplant 

IBD Inflammatory Bowel Disease 

ICD International Classification of Diseases 

ICD-10-CM International Classification of Diseases 10 Clinical Modification 

ICER Incremental Cost-Effectiveness Ratio 

ICU Intensive Care Unit 

IDSA Infectious Disease Society of America 

IDU Injection Drug Use 

IHS Indian Health Service 

IIS Immunization Information System 

IIV Inactivated Influenza Vaccine 

IND Investigational New Drug 

IPD Invasive Pneumococcal Disease 

ISD Immunization Services Division 

ISO Immunization Safety Office 

LAIV Live Attenuated Influenza Vaccine 

LGE Late Gadolinium Enhancement 

LRN Laboratory Research Network 

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ACIP Meeting Summary November 2-3, 2021 

LRN-B Laboratory Response Network for Biological Threats 

LTCF Long-Term Care Facilities 

MIBE Measles Inclusion-Body Encephalitis 

MIS-C Multisystem Inflammatory Syndrome in Children 

MMWR Morbidity and Mortality Weekly Report 

MPH Masters of Public Health 

MRI Magnetic Resonance Imaging 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada 

NAPNAP National Association of Pediatric Nurse Practitioners 

NASEM National Academies of Science, Engineering, and Medicine 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

NCHHSTP National Center for HIV, Viral Hepatitis, STD, and TB Prevention 

NCHS National Center of Health Statistics 

NCIRD National Center for Immunization and Respiratory Diseases 

NEJM New England Journal of Medicine 

NFID National Foundation for Infectious Diseases 

NHIS National Health Interview Survey 

NIH National Institutes of Health 

NMA National Medical Association 

NNDSS National Notifiable Diseases Surveillance System 

NNV Number Needed to Vaccinate 

NSAIDs Non-Steroidal Anti-Inflammatory Drugs 

NYHA New York Heart Association Functional Classification 

NVPO National Vaccine Program Office 

OFID Open Forum Infectious Diseases 

OGC Office of General Counsel 

OID Office of Infectious Disease 

OIDP Office of Infectious Disease Policy and HIV/AIDS 

PCP Primary Care Practitioner 

PE Pulmonary Embolism 

PHAC Public Health Agency Canada 

PHN Pediatric Heart Network 

PhRMA® Pharmaceutical Research and Manufacturers of America® 

PICO Population, Intervention, Comparison, Outcomes 

PIDS Pediatric Infectious Disease Society 

PNP Pediatric Nurse Practitioner 

PPE Personal Protective Equipment 

QALY Quality-Adjusted Life-Year 

RCA Rapid Cycle Analysis 

RCT Randomized Controlled Trial 

RHCs Rural Health Clinics 

RT-PCR Reverse Transcriptase Polymerase Chain Reaction 

RZV Recombinant Zoster Vaccine 

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

SDOH Social Determinants of Health 

SHEA Society for Healthcare Epidemiology of America 

SME Subject Matter Expert 

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ACIP Meeting Summary November 2-3, 2021 

SNS Strategic National Stockpile 

SOC System Organ Class 

SOT Solid Organ Transplant 

SPTC Special Pathogen Treatment Centers 

ST3 Serotype 3 

STD Sextually Transmitted Disease 

STM Solid Tumor Malignancies 

TBE Tick-Borne Encephalitis 

TTS Thrombosis with Thrombocytopenia Syndrome 

UK United Kingdom 

US United States 

USAMRIID United States Army Medical Research Institute for Infectious Diseases 

USG United States Government 

VA (US Department of) Veteran’s Affairs 

VAERS Vaccine Adverse Event Reporting System 

VaST WG Vaccine Safety Technical Work Group 

VE Vaccine Efficacy 

VE Vaccine Effectiveness 

VFC Vaccines for Children 

VIS Vaccine Information Statement 

VRBPAC Vaccine and Related Blood Products Advisory Committee 

VSD Vaccine Safety Datalink 

WG Work Group 

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