MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP) 

JUNE 23, 2021 

SUMMARY MINUTES 

TABLE OF CONTENTS

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

Wednesday: June 23, 2021........................................................................................................ 2

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

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

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

Overview of Myocarditis and Pericarditis............................................................................. 6

Update on COVID-19 Vaccine Safety, Including Myocarditis after mRNA Vaccines............ 8

VaST Assessment .............................................................................................................12

COVID-19 mRNA Vaccines in Adolescents and Young Adults: Benefit-Risk Discussion....15

Clinical Considerations and the COVID-19 WG Interpretation............................................19

Public Comment.................................................................................................................21

Data to Inform Recommendations for Additional Doses of COVID-19 Vaccines.................28

Certification...............................................................................................................................36

ACIP Membership Roster .........................................................................................................37

Acronyms used in the Document ..............................................................................................46
ACIP Meeting Summary June 23, 2021

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MEETING PURPOSE

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

Disease Control and Prevention (CDC) convened an emergency meeting of the Advisory 

Committee on Immunization Practices (ACIP) on June 23, 2021. The meeting took place

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

which focused on a variety of topics pertaining to COVID-19 vaccines, including an overview of 

myocarditis and pericarditis; an update on COVID-19 vaccine safety, including myocarditis after 

mRNA vaccines; a VaST WG assessment; benefit/risk of COVID-19 mRNA vaccines in 

adolescents and young adults; and an overview of data to inform recommendations for 

additional doses of COVID-19 vaccines.

WEDNESDAY: JUNE 23, 2021

WELCOME AND INTRODUCTIONS

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

everyone and thanked them for their attendance and the time they are dedicating to the COVID19 effort.

Dr. Amanda Cohn (ACIP Executive Secretary) thanked everyone for their flexibility in the 

rescheduling of the meeting from the previous Friday in honor of Juneteenth, which is now a 

federal holiday. She indicated that copies of the slides for the day were available on the ACIP 

website and were made available through a ShareLinkTM file for ACIP voting members, ex 

officios, and liaisons. She indicated that there would be an oral public comment session at 

approximately 2:30 PM Eastern Time (ET). Given that more individuals registered to make oral 

public comments than could be accommodated, selection was made randomly via a lottery.

Those individuals who were not selected and any other individuals wishing to make written 

public comments may submit them through https://www.regulations.gov using Docket Number 

CDC-2021-0034. Further information on the written public comment process can be found on 

the ACIP website.

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

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

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

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

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

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

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

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

the meeting. No votes were taken during this emergency meeting.

ACIP is accepting applications and nominations for new members to fill upcoming vacancies. 

Applications should be submitted by August 1, 2021 for the 4-year term beginning July 1, 2022.

The application and additional information can be found on the ACIP website at

https://www.cdc.gov/vaccines/acip/apply-for-membership/index.html.
ACIP Meeting Summary June 23, 2021

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Dr. Rochelle P. Walensky (CDC Director) verbatim: I just wanted to briefly come in and say 

thank you for being here today. I know you have a lot of work ahead of you over the next 3

days, but I just wanted to take a minute and stop by and share my true gratitude and 

appreciation. We appreciate the expertise and guidance you have given CDC through this 

pandemic. I know my tenure here has only been 5 months. Your tenures have been longer, way 

longer than that. I know you’ve devoted countless hours to grappling really tough questions with 

us on vaccination, and for that, we are deeply grateful. I am deeply grateful. We particularly 

appreciate that on top of the additional meetings to discuss COVID-19 vaccination efforts, you 

have continued to look at a broader vaccination program and continue to advise us on vaccine 

considerations. We need to all be thinking about coming out of this pandemic, such as catching 

up on vaccinations that might have been missed. So, thank you for sticking with us during this 

critical moment, for dedicating your insights, wisdom, and feedback throughout this last year 

and a half and for many of you much, much longer. I know you will be combining both of those 

agendas in the next several days.

I want to just take a moment to thank Dr. Jose Romero who is nearing the end of his 7-year 

term of the committee, with the last 3 as chair. While I have not personally had the pleasure of 

meeting Dr. Romero—this is one of those challenges of remoteness— his leadership of this 

committee will be long-lasting in the US immunization program. His mentorship truly, of both 

CDC staff and all of the ACIP members, will benefit the agency and truly our country for years to 

come.

I want to thank you for your commitment to vaccine safety. I regularly speak now publicly about 

our agency’s commitment, and my personal commitment, to ensuring that our vaccines are 

safe. I know that when I’m saying this that these are my words, but it is your actions that I’m 

relying on and that I’m referring to. So, I truly appreciate that you’re going to continue today, as 

you have always done, to help us keep this commitment to safety and looking objectively at the 

potential risks and the potential benefits of our COVID-19 vaccines and truly of all vaccines in all 

ages. I also want to thank you for looking into the issue of vaccine boosters, and we’ll very much 

be interested in your wisdom here. I’m particularly interested in hearing about your 

conversations on this topic and the critically important issue for the country as we move forward 

out of this pandemic. It would be helpful for me to know what data you think we might need to 

make an informed decision, guidance on how we might get there to receive those data, and 

what might be the thresholds of those data that would trigger the decision to boost. So, I really 

look forward to hearing this portion of your deliberations as with many others.

Lastly, I just want to take a moment to acknowledge that unbelievably, this is Dr. Anne 

Schuchat’s last meeting with the committee as Principal Deputy of CDC. I have always looked 

to Anne as the voice of calm. In standing with many dignitaries over my entire career, I have 

had the great pleasure and gift of getting to know Anne over the last 5 months. I have deeply 

appreciated her wisdom, guidance, and friendship to me during this transition into CDC, and she 

has promised me I can use her cell phone number if I continue to need it after she has left.

Anne has worked closely with many of you throughout the years through several past 

pandemics or epidemics, and I know you will feel it too when she transitions into retirement. We 

are all so sad to see her go. This week, we’re celebrating her years of service, her leadership,

and her incredible contributions to this agency, to the country, and truly to our overall health.

So, just to close, I want to thank you for being here today and for all you’re doing on behalf of 

the public’s health. I know we’ve asked a lot of you over the last many years, but particularly 

over the last year. So, I look forward to listening to your deliberations.
ACIP Meeting Summary June 23, 2021

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Dr. Amanda Cohn (ACIP Executive Secretary) verbatim: Dr. Schuchat, we also wanted to 

express, on behalf of ACIP, all of the committee’s gratitude to you over the years. Since 2006, 

you have either, and even before then, you have either been at the helm of the ACIP meetings, 

or looking down on us from your office since you have been Principal Deputy, or attending. We

are so grateful for your early recognition of the importance of an evidence-based 

recommendation process, which as all of you know has been so critical to us over the last 18 

months—to the impact you’ve had personally on vaccine preventable diseases in this country,

including your passion to increase pediatric and adult vaccination coverage with all of these new 

vaccines that have come to be used as tools over the last 15 years. Personally, I also want to 

express my gratitude for you. My early days of ACIP as a Meningococcal Work Group (WG)

lead, a member of ACIP at the time told me that I would always have professional challenges

because of three factors, and those factors were that I was female, I was short, and that I 

looked younger than my age. But I continued to be able to look at you, who have all three of 

those same characteristics as me, and see that, in fact, we are lucky enough to be living in a 

world where female, short, and young-looking women can be fierce, and kind, and empathetic 

leads. So, thank you on behalf of all of the ACIP. We will miss you greatly, but we look forward

to your continued input from your retirement over the years.

Dr. Romero (ACIP Chair) thanked Dr. Walensky on behalf of all of the members of the ACIP, 

the liaisons, and the ex officios and offered his personal thanks for the very, very kind words

that she offered regarding his tenure on the ACIP. He then conducted the roll call during which 

no conflicts 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.

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES

Introduction

Dr. Matthew Daley (ACIP, WG Chair) introduced the COVID-19 Vaccines WG session, first 

providing a brief overview of the COVID pandemic and vaccines. In December 2020, there were 

approximately 250,000 cases and 3000 deaths each day in the United States (US) from COVID19. In June 2021, there are approximately 13,000 cases and 300 deaths reported each day. 

There have been 3 vaccines against COVID-19 authorized under an Emergency Use 

Authorization (EUA) and recommended for use in the US. These vaccines have played a critical 

role in the extraordinary reduction in case counts and deaths occurring in the US. As of June 

21st, 318 million vaccine doses have been administered, with approximately 150 million people 

in the US fully vaccinated. This translates to approximately 53% of the population 12 years of 

age and older who are fully vaccinated. Upwards of 63% of all persons 12 years of age and 

older in the US have received at least 1 vaccine dose. The epidemiologic curve of case counts 

stands in stark contrast to the epidemiologic curves in many other parts of the world where 

vaccines are scarce and waves of COVID-19 cases and deaths have continued unabated.

In the time since the last ACIP meeting, the COVID-19 Vaccines WG has been meeting weekly. 

The topics covered in these weekly meetings have included review of vaccines with respect to 

SARS-CoV-2 variants; review of data to inform discussions around additional doses of COVID19 vaccines; review of a number of safety updates, including review of data regarding

myocarditis following vaccination; and extensive discussion about the overall benefit/risk 

balance for the use of COVID-19 vaccines in adolescents and young adults.
ACIP Meeting Summary June 23, 2021

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The plan for this emergency ACIP meeting was to discuss cases of myocarditis and pericarditis

that have been observed following receipt of mRNA COVID-19 vaccines. To frame the 

discussion about myocarditis, Dr. Daley highlighted several points related to vaccine safety. The

safety monitoring system put in place to monitor COVID-19 vaccines in the US is the most 

rigorous system ever implemented to monitor any vaccine in the country, and there is an 

extensive list of potential adverse events (AEs) being monitored. To date, the COVID-19 

vaccines authorized in the US have demonstrated a high degree of safety. However, nothing in 

life is absolutely risk free. It is known from decades of experience with other vaccines that rare 

and potentially serious adverse events (SAEs) can occur following vaccination. The extensive 

safety monitoring systems in the US should provide confidence that if a rare and potentially

serious adverse event occurs following vaccination, the systems in place will identify that risk.

Once a risk is identified, vaccine safety studies help to characterize and quantify the AE. Also, 

an understanding of risk factors helps to minimize AEs whenever possible. Finally, a critical 

aspect of vaccine safety is communication of vaccine risks, if identified, to the public, public 

health officials, and health care providers (HCP). In this circumstance, new knowledge about 

vaccine safety also is used in a reassessment of the benefit/risk balance of any vaccine in use.

Reassessment of the benefit/risk balance was part of the task during this session. The first 

reports of cases of myocarditis following vaccination with mRNA vaccines came from Israel. 

From December 2020-May of 2021 in Israel, 148 cases of myocarditis occurred around the time

of vaccination. Most of these reports, although not all, were in younger men 16-19 years of age. 

This typically occured after the second dose. While most of these cases were hospitalized, 95% 

were characterized as mild cases. Israel determined that there was a possible link between the 

second vaccine dose and the onset of myocarditis in young men aged 16-30 years, but 

determined that the risk of complications of Coronavirus disease outweighed the risk imposed 

by the vaccine side effects. They stated that myocarditis cases observed among teenagers 

aged 16-19 years occurred at low rates and in most cases passed with no complications.

Since April 2021, there also have been cases of myocarditis and pericarditis reported in the US

to the Vaccine Adverse Events Reporting System (VAERS). These reports and the reports from

Israel led to the posting of additional information on CDC’s website. In response to the report

that myocarditis and pericarditis following mRNA vaccines, the Vaccine Safety Technical WG 

(VaST), reviewed data from Israel. In addition, VaST reviewed data from the US Department of 

Defense (DoD) and from other CDC and FDA safety surveillance systems. The COVID-19 

Vaccines WG also reviewed these data and discussed the benefit/risk balance, which led to the 

convening of this June 23, 2021 public ACIP meeting to review these data and discuss a 

benefit-risk assessment.

After the discussion of myocarditis and pericarditis, the plan was for ACIP to begin discussion of 

the topic of booster doses of COVID-19 vaccines. The majority of Americans have received at 

least one dose of a COVID-19 vaccine. A great deal of planning is going to be required if

booster doses of COVID-19 vaccines are needed. Discussions around planning need to occur 

well in advance of future recommendations. Dr. Daley emphasized that planning discussions 

are not meant to imply that the decision has already been made that booster doses will 

definitely be recommended. Instead, the intent was to discuss what additional data would be 

needed to inform these future recommendations.
ACIP Meeting Summary June 23, 2021

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Overview of Myocarditis and Pericarditis

Dr. Matthew Oster (CDC/NCBDDD) provided an overview of myocarditis and pericarditis, 

explaining that myocarditis is inflammation of the myocardium or the heart muscle. This is not 

myocardial infarction (MI) or heart attack, which typically affects the coronary arteries. Instead, it 

is an inflammatory process that involves the actual muscle of the heart. Pericarditis is a similar

process, but instead of involving the heart muscle, it involves the pericardium, which is the lining 

around the heart. Often, these two entities can occur together and may have similar

mechanisms. When they occur together, they are known as myopericarditis.

Myocarditis is not a new disease, but there have been some updates in how to recognize it. For 

the purposes of surveillance, CDC has drafted a definition for “Probable” and “Confirmed”

cases. For the purpose of surveillance, both are counted. The following criteria are used to 

identify probable or confirmed cases:

Probable Confirmed

1. Symptoms

• Chest pain/pressure/discomfort

• Dyspnea/shortness of breath

• Palpitation

2. Abnormal testing

• Elevated troponin

• Electrocardiogram (ECG or EKG) findings

• Decreased function on echo or MRI

• MRI findings consistent with myocarditis

3. No other identified causes

1. Symptoms

• Chest pain/pressure/discomfort

• Dyspnea/shortness of breath

• Palpitations

2. Abnormal testing

• Biopsy

• Elevated Troponin AND MRI findings consistent with 

myocarditis

3. No other identified causes

There can be other symptoms, especially gastrointestinal (GI) symptoms or fatigue, especially in 

younger children. It is important to make sure there are no other identified causes, such as a 

structural abnormality or MI that is leading to abnormal testing values. There is a wellestablished definition for pericarditis that CDC has been using, that states that someone must 

have any 2 of 4 symptoms of chest pain (a certain type is associated with pericarditis), 

pericardial rub that is audible by stethoscope on the physical exam, abnormal ECG findings

(new ST-elevation or PR-depression), or pericardial effusion on ECG or magnetic resonance 

imaging (MRI). For the remainder of this talk, Dr. Oster focused primarily on myocarditis since it 

is the most concerning and most prominent that is occurring.

In children, the annual incidence of myocarditis on average is about 0.8 per 100,000. This has a 

a bimodal peak in that it tends to be seen a lot in infancy, there are some cases throughout 

childhood, and then there is an uptick in the number of cases as patients start reaching

adolescence. The annual incidence in a recent study was about 1.8 hospitalizations for 

myocarditis per 100,000 in 2015 and 2016.

1

In traditional myocarditis, there is a predominance 

of this affecting males more than females and a length of about 6 days that can range from mild 

to severe.2

1 Vasudeva et al. American J Cardiology. 2021

2 Kyto et al. Heart. 2013
ACIP Meeting Summary June 23, 2021

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Traditionally, there are many types of causes of myocarditis. Most typical myocarditis is often

from a viral trigger. A classic story would be someone who has mild viral symptoms for a few 

days, gets better, and then starts showing signs or symptoms of myocarditis a couple of weeks 

later as the immune system is ramped up. With traditional myocarditis, an exhaustive search is 

often undertaken to look for potential causes—especially viral causes. However, other causes 

can lead to myocarditis. For traditional myocarditis, supportive care has been the mainstay of 

therapy (e.g., oxygen, fluids) to support the body’s response. That also has been the first line

treatment for post-vaccine myocarditis, if needed. If there are effects on the heart (e.g.,

arrhythmias, decreased heart function, congestive heart failure), specific medicines or therapies 

can be implemented. A variety of anti-inflammatory medicines are often used and may vary by 

patient situation and age or by the hospital where they present. For post vaccine myocarditis,

many children have been responding to minimal treatment with anti-inflammatory medicine. In 

traditional myocarditis and severe cases, mechanical support or heart transplant can be 

considered. In traditional myocarditis, exercise restriction is typically recommended while the

heart recovers. The American Heart Association (AHA) and the American College of Cardiology

(ACC) recommend restriction from competitive sports for 3 to 6 months until a patient can show

documentation that the heart has recovered from this acute process. Many places are also 

implementing these same guidelines for post-vaccine myocarditis.

A few reports have been published in the literature about myocarditis after mRNA COVID-19 

vaccines. In the US, a paper was published by Marshall et al3in Pediatrics that assessed 7 

males 14-19 years of age who were previously healthy who developed myocarditis within 4 days

of their second mRNA vaccine. All of these individuals had abnormal troponin levels, EKG 

findings, and MRI findings. Symptoms improved for 3 patients with nonsteroidal antiinflammatory agents (NSAIDs) alone, while 4 patients received intravenous immune globulin

(IVIG) and steroids. All of these patients were discharged to home after about 2 to 6 days in the 

hospital, with a median 4 days, and are currently being restricted from exercise.

Most recently, a paper was published by Rosner et al4in Circulation that looked primarily at 

adults. This paper reported 7 patients, 6 of whom received an mRNA vaccine. Among them 

were 5 males 19-39 years of who presented within 4 days of their second does and 1 male 24 

years of age who presented about a week after his first dose. All patients had abnormal troponin 

and MRI findings, and there were some varying EKG findings. Treatment included NSAIDs or 

colchicine in 4 patients, beta blockers in 2 patients to help support the heart, and steroids in 1 

patient. All patients were discharged home after 2 to 4 days in the hospital. One interesting 

finding for which the potential mechanisms are not yet known is that 1 patient who presented a 

week after the first dose had negative spike protein antibodies.

There also have been international reports of myocarditis after mRNA COVID-19 vaccine. 

Larson et al5 studied 8 males 22-56 years of age, 4 in the US and 4 in Italy. Among them, 7 

experienced onset within 4 days of their second dose and 1 had onset 2 days after his first 

dose. That patient had a history of prior SARS-CoV-2 infection. All of these patients also had 

abnormal troponin, EKGs, and MRIs. Of the 8, 7 had abnormal ECGs. Treatment included 

NSAIDs or colchicine in 4 patients, steroids in 2 patients, and no treatment in 3 patients. All 8 

individuals were discharged home with resolution of symptoms and preserved ejection fraction

(HFpEF). The Israeli Ministry of Health6reported 148 myocarditis cases occurring within 30 

3 Marshall et al. Pediatrics. 2021

4 Rosner et al. Circulation 2021; Rosner et al. also reported a 28 year old with myocarditis after Johnson & Johnson’s Janssen

COVID-19 vaccine

5 Larson et al. Circulation. 2021

6 https://www.gov.il/en/departments/news/01062021-03
ACIP Meeting Summary June 23, 2021

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days of mRNA vaccine, 27 of which occurred after 5.4 million first doses and 121 that occured 

after the first 5 million second doses. Most were in males 16-30 years of age, particularly 

adolescents 16-19 years of age. Most were in the hospital up to 4 days, with 95% of cases

considered to be mild.

To summarize, myocarditis is a rare disease though not new disease. Traditional triggers are 

thought to be viral, although there can be others. It appears that mRNA vaccine may be a new 

trigger for myocarditis, which has some different characteristics in presentation, particularly the 

course of how patients are doing. Treatment is largely supportive, which also has been the case

for myocarditis after mRNA vaccine. Myocarditis after mRNA vaccine most commonly occurs in 

males, which is also the case for traditional myocarditis. It remains to be determined whether 

myocarditis after mRNA vaccine is more pronounced. It has been seen predominantly in those 

less 30 years of age, with typical onset within a few days after the second dose. Early data of 

acute outcomes of myocarditis after mRNA vaccine have been good. There is typically quick 

resolution, though there are exceptions. Patients are being followed long-term, but no long-term 

data are available yet. Patients are receiving standard recommendations with regard to exercise

precautions.

Update on COVID-19 Vaccine Safety, Including Myocarditis after mRNA Vaccines 

Dr. Tom Shimabukuro (CDC/NCEZID) presented early safety data on Pfizer BioNTech 

vaccination in persons 12-15 years of age and myocarditis and pericarditis following mRNA 

COVID-19 vaccination. Beginning with vaccine safety of Pfizer BioNTech vaccination in persons 

12-15 years of age, v-safeSM is CDC’s smartphone-based active surveillance system that uses 

text messaging and web surveys to monitor for AEs.

7 Monitoring during the first week postvaccination is largely focused on local and systemic reactions with health impact assessment 

questions. On May 11, 2021, v-safeSM age limits were expanded to allow registration down to 12 

years of age at Dose 1. As of June 13, 2021 for persons 12-15 years of age after the Pfizer 

vaccination, there were just over 57,000 with at least 1 health check-in during Days 0-7 after 

Dose 1 and almost 16,000 with at least 1 health check-in during Days 0-7 after Dose 2. Many of 

these health check-ins may be done by a parent or a caregiver who is responsible for 

registering the patient.

A side-by-side comparison of the top solicited reactions during Days 0-7 in individuals 12-15 

years of age versus 16-25 years of age, the overall patterns were similar for Dose 1 versus

Dose 2 for pre-specified and self-reported reactions. Notably, the 16-25 year-old comparator 

group was chosen because that is same comparator group that was used in the clinical trials.

Injection site pain and certain systemic reactions are more common after Dose 2, at least for 

systemic reactions, than for Dose 1. If anything, there are slightly less self-reported solicited 

reactions in persons 12-15 years of age compared to persons 16-25 years of age.

In terms of the results of the health impact assessments, there are three categories: Unable to

Work, Unable to do Normal Daily Activities, and Required Medical Care. Notably, the responses 

for Unable to Work may be influenced by the actual question as most persons 12-15 years of 

age are not working. The plan is to modify this question to include school attendance to make it 

more comparable. The categories of Unable to do Normal Daily Activities and Required Medical 

Care were quite comparable for the two groups. Unable to do Normal Daily Activities was 

reported more frequently after Dose 2 for both age groups. Required Medical Care was reported 

7 http://cdc.gov/vsafe
ACIP Meeting Summary June 23, 2021

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slightly more frequently after Dose 2. For both Dose 1 and Dose 2, Required Medical Care had 

very low rates for both groups.

VAERS is the nation’s early warning system for vaccine safety, which is a spontaneous 

reporting or passive surveillance system that is comanaged by CDC and FDA. VAERS accepts 

all reports from everyone regardless of the plausibility of the vaccine causing the event or the 

clinical seriousness of the event. There are specific reporting requirements for the COVID-19 

vaccines under EUA. CDC encourages reporting of any clinically meaningful AE following 

immunization, although that does not necessarily mean that vaccination caused a health 

problem. The key strengths of VAERS are that it can rapidly detect potential safety problems 

and rare AEs. The key limitations are inconsistent data quality and completeness, reporting 

biases, and the general inability to determine cause and effect from VAERS data alone.

Regarding reports to VAERS after Pfizer COVID-19 vaccination in persons 12-15 years of age 

and using the same comparator of individuals 16-25 years of age, there were about 2500 

VAERS reports in the 12-15 years age group and over 12,000 reports in the 16-25 years age 

group as of June 11, 2021. The crude reporting rates were fairly comparable, with 422 per 

million in persons 12-15 years of age and 592 per million in persons 16-25 years of age. The 

percent of non-serious SAEs also were very similar at about 96% non-serious and about 6% 

serious for both age groups. That is similar to other vaccines routinely given in these age 

groups. It is important to note that this vaccine had been authorized for use for a much longer 

period of time in the older age group. Approximately 6.0 million doses had been administered to 

persons 12-15 years of age from May 10-June 11, 2021, while about 21.6 million doses had 

been administered to persons 16-25 years of age from December 14, 2020-June 11, 2021. The 

same age groups were compared for the most commonly reported AEs to VAERS after the 

Pfizer BioNTech vaccination through June 11, 2021. The most common AEs were similar in 

both age groups and were associated with vasovagal or pre-syncope/syncope-type reactions 

plus some systemic reactions. The overall safety profile for persons 12-15 years of age is 

consistent with that observed in the pre-authorization clinical trials among persons 16-25 years 

of age, and is similar for both groups in post-authorization safety monitoring.

Pertaining to myocarditis and pericarditis following mRNA COVID-19 vaccination in the US, 

CDC’s Clinical Immunization Safety Assessment (CISA) project participated in reviewing

individual cases of myocarditis and pericarditis and also provided expertise on the development 

of the CDC working case definitions for myocarditis and pericarditis. Preliminary reports of 

myocarditis and pericarditis are identified through the VAERS database using Medical 

Dictionary for Regulatory Activities (MedDRA) code searches and pre-screened VAERs reports 

with signs and symptoms that are suggestive of myocarditis or pericarditis, such as reports that 

are brought to CDC’s attention by HCPs. Follow-up, medical record review, application of CDC’s 

working case definition, and adjudication are ongoing or pending.

There were 791 reports after receipt of Pfizer-BioNTech (150 after Dose 1; 563 after Dose 2) 

and 435 reports after Moderna (117 after Dose 1; 264 after Dose 2) as of June 11, 2021 after 

about 300 million mRNA doses had been administered. In terms of the characteristics of the 

reports, the general pattern was that there were more reports after Dose 2 than after Dose 1.

There was a relatively small number of reports with an unknown dose. Moving forward, the plan 

is to focus on reports for which the dose number is available as that factors into the analysis. In 

the analysis of data through June 11, 2021, the median age of patients experiencing myocarditis

or pericarditis following mRNA COVID-19 vaccination was younger for Dose 2 at 24 years 

compared to 30 years for Dose 1. The median time to symptom onset after Dose 2 was 

somewhat shorter at 3 Days for Dose 2 compared to 4 days for Dose 1. There was a stronger 
ACIP Meeting Summary June 23, 2021

10

male to female predominance of reports at 79% male to 20% female after Dose 2 compared to 

66% male to 33% female after Dose 1.

Looking at vaccination by age and reports by age and dose number, the takeaway message is 

that most of the reports occurred in individuals in their late teens and early 20s, which were 

more pronounced for Dose 2 reports compared to Dose 1 reports. Looking at reports by dose 

number and time to symptom onset, there was a clear pattern of clustering for both doses in the 

several days after vaccination, with most of these occurring within a week of vaccination among 

individuals ≤ 29 years of age. Much of the analyses focused on the younger age groups

because this is where most of the reports have occurred, especially the recent reports. Looking 

more closely at the 484 preliminary myocarditis and pericarditis reports among individuals ≤ 29 

years of age through June 11, 2021, chest pain was the most common presenting symptom

(N=416). Dyspnea was also common (N117), though less common than chest pain. As far as 

diagnostics, ST or T-wave changes on ECG (N=295) and elevated troponins (N=310) were 

commonly documented in the reports. A substantial number of reports documented abnormal

echocardiography or imaging (N=81), which was often MRI noted in the reports.

Of these 484 reports in persons ≤ 29 years of age, 323 met the CDC working case definition of 

myocarditis, or pericarditis, or both. Of the total reports, 148 are under review. Notably, 

myocarditis and pericarditis are currently combined into the single category/outcome of 

myocarditis/pericarditis when they occur together. Of the 323 reports that met the case 

definition, 309 were hospitalized. Of those, 295 had been discharged and almost 80% of the 

295 (N=218) known to have recovered from symptoms at the time of time of this analysis. A 

relatively small number N=14) were not hospitalized, but were seen in an emergency

department (ED), urgent care facility, outpatient clinic, or unspecified setting.

Looking at myocarditis/pericarditis reports VAERS following Dose 2 with an observed or 

suspected analysis using a 7-day risk window, the expected was based on estimates generated 

from incidence rates in the published literature from an FDA/CDC literature review with an 

adjustment for male and female percentages. The takeaway message is that based on the 

reports received, myocarditis/pericarditis is occurring mainly in people in their teens and early 

20s and in more males compared to females. However, differences in the observed versus

expected in males versus females disappears in individuals 50 years of age and older. Looking 

at myocarditis/pericarditis reports per million mRNA vaccine doses administered by 

sex and dose number, with no restrictions on post-vaccination observation time, confirms these 

patterns.

The Vaccine Safety Datalink (VSD) system is CDC’s population-based large, linked data system 

that is used for active surveillance and research. It 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 has complete or near complete information from EHR

records to include immunizations, outpatient and clinic visits, ED visits, procedures, birth and 

death certificate and information, and demographics all linked by unique study identifiers (IDs). 

CDC has rapid access to charts and EHRs through the VSD that enables for review of cases.

The analysis done in the VSD is called Rapid Cycle Analysis (RCA), which is near real-time

sequential monitoring. As data become available, the system monitors a limited set of prespecified vaccine safety outcomes. This is a public health surveillance activity, which is not the 

same as an epidemiologic study. It is designed to detect statistically significant associations and 

statistical signals, which do not necessarily indicate a safety problem. When statistical signals 

are detected, they require further evaluation.
ACIP Meeting Summary June 23, 2021

11

Through June 12, 2021 in VSD, there were about 4.5 million total doses of Moderna and about 

5.8 million total doses of Pfizer. Broken down by age group, substantial doses were 

administered in persons 18-49 years of age because there were still a fairly limited number of 

doses administered among persons 12-15 years of age and 16-17 years of age. For the VSD

RCA overall analysis for outcome events in the 21-day risk interval after either dose of any 

mRNA vaccine compared with outcome events in vaccinated comparators, there were no 

signals for myocarditis/pericarditis as of June 12, 2021. The adjusted rate ratio was just over 1 

and has not yet statistically signaled. Given what was observed in VAERS, an age-stratified 

analysis was done in VSD for chart-confirmed events in persons 12-39 years of age in the 21-

day risk interval. As more data accumulate, that age groups can probably be sliced a little finer.

For any mRNA vaccination for both doses combined, the adjusted rate ratio was 3.5 and was 

statistically significant with a confidence interval of 1.1 to 15.0. The adjusted rate ratio was 

elevated for Dose 1, but was not statistically significant. It elevated for Dose 2 at 3.6 and was 

statistically significant. For the Pfizer BioNTech vaccine, the adjusted rate ratios were slightly 

elevated, but none of them reached statistical significance. The adjusted rate ratios were not 

estimable for the Moderna vaccine because at this point, there were no events in the control 

interval. The 95% confidence intervals for both doses and for Dose 2 were greater than 1. It is 

likely the Moderna findings are driving the overall analysis for any mRNA vaccine.

In the same analysis, the risk window was narrowed to 7 days because there is evidence to 

suggest that symptom onset occurs within that first week. There were similar findings in this 

combined analysis. The adjusted rate ratio for both doses for any vaccine was 10 and was 

statistically significant. It was elevated for Dose 1, but did not reach statistical significance. For 

Dose 2, the adjusted rate ratio was 10.8 and was statistically significant. For the Pfizer vaccine

for Dose 2, the adjusted rate ratio was elevated and statistically significant. The findings were 

similar for the Moderna vaccine, with no events in the control window to date.

Looking at chart-confirmed myocarditis/pericarditis cases in the VSD by day of symptom onset

since most recent vaccination in persons 12-39 years of age running a SaTScanTM analysis, the 

most likely clusters occurred in Days 0-5, 0-3, and 0-6. This offers clear evidence of onset for 

these vaccinated cases within the first week post-vaccination. This analysis includes cases on 

Day 0, while some of the other previous statistical testing did not. For straight-up rates among

chart-confirmed rates in VSD in the 21-day risk interval in persons 12-39 years of age, there are 

two important features. First, there is a dose effect and the rates were higher for both vaccines

after Dose 2 and in the combined analysis. However, this is still a rare event. For both vaccines 

combined, there were 12.6 cases per million doses administered. The highest rate was just 

under 20 per million doses administered for Dose 2 of the Moderna vaccine.

In terms of the care and status of the chart-confirmed myocarditis/pericarditis cases in the VSD, 

including cases with onset on the day of vaccination, there were 29 cases. Most of these cases 

were hospitalized either inpatient or in an intensive care unit (ICU). The median length of 

hospital stay was 1 day, with a range of 0 to 13. All were discharged home at the time of chart 

review, and a follow-up visit was noted in 27 of the 29 cases in the VSD in the 21 days following 

vaccination. As far as a qualitative summary, nearly all follow-up visit notes indicated resolution 

of symptoms at the time of follow-up. Of those who had a follow-up ECG /echo or other 

laboratory testing, most had returned to normal or baseline. As far as treatment plan, most 

follow-up visit notes indicated tapering of some medications, as well as maintenance of 

colchicine and activity limitations for 3 to 6 months.
ACIP Meeting Summary June 23, 2021

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Looking at all myocarditis/pericarditis rates based on ICD-10 coded cases, not just chartconfirmed cases, in the 21 days for persons 12-39 years of age, Dr. Shimabukuro focused on 

two findings here. In the overall analysis after Dose 2, the rate in the 21 days after vaccination

was 4.7 cases per million doses administered for females and 32 per million for males. Again, 

there is a dose effect with Dose 2 rates being higher than Dose 1 rates. Returning to the 

VAERS reporting rates, the female reporting rates in the younger age groups were as high as 9

up to 25 years of age for Dose 2 and 1.8 for ages 30-39 years. Smoothing that out and thinking 

about the VSD rates, 4.7 is within the range seen in VAERS. For males, the VSD rate was 32.

In VAERS that goes from 66.7 down to 10 for Dose 2 among males 12-39 years. Smoothing 

that out with the total age groups, it is probably within that range or reasonable estimate. These 

rates are thought to be comparable in terms of automated cases in VAERS or ICD-10 coded 

cases in VSD, which to CDC is indirect evidence that the capture of these cases in VAERS is 

probably pretty good. Therefore, the reporting efficiency of post-vaccination 

myocarditis/pericarditis to VAERS is probably pretty high, meaning that there is good capture of 

these cases by reporting primarily by HCPs.

In summary, the initial safety findings of the Pfizer BioNTech COVID-19 vaccination of persons 

12-15 years of age from v-safeSM and VAERS are consistent with the results from preauthorization clinical trials. Analysis of VAERS preliminary reports is in progress, including 

follow-up. Applying the CDC working case definition and adjudicating cases, the preliminary 

findings suggest that the median age of reported patients is younger for reports after Dose 2

versus Dose 1. Symptom onset clusters within a week following vaccination. There is a 

predominance of male patients in younger age groups, especially after Dose 2. The observed 

reported cases exceed expected cases, especially after Dose 2 in younger age groups. The 

early VSD data in persons 12-39 years of age also suggests that there are more cases after 

mRNA COVID-19 vaccination with Dose 2 versus to Dose 1. There is a rate of 12.6 cases per 

million second-doses of any mRNA vaccination in the 21 days following vaccination. These 

rates appear to be higher in males and females. There is clustering of myocarditis/pericarditis

within the week following vaccination, most likely within 0 to 5 days. Reassuringly, the available 

outcome data indicate that patients generally recover from symptoms and do well.

In terms of next steps, CDC will continue monitoring in VAERS. Follow-up will be done to obtain 

medical records, conduct case reviews, apply the CDC working case definition, and adjudicate 

case reports. A surveillance review focused on myocarditis and myopericarditis to describe the 

epidemiology and characterize clinical features of cases is in progress. Monitoring and 

assessment also will continue in the VSD to quantify risk and characterize the clinical features

of cases. There are plans to conduct follow up on vaccine-associated cases to assess the 

longer-term outcomes of 3 to 6 months.

VaST Assessment

Dr. Grace Lee (ACIP, VaST Co-Chair) reminded everyone that the objectives of the VaST WG 

are to: 1) review, evaluate, and interpret post-authorization/approval COVID-19 vaccine safety 

data; 2) serve as the central hub for technical subject matter expertise from federal agencies 

conducting post-authorization/approval safety monitoring; 3) advise on analyses, interpretation, 

and data presentation; and 4) provide updates to the ACIP COVID-19 Vaccines WG and the 

ACIP on COVID-19 vaccine safety. Since December 21, 2020, VaST has had 25 independent 

meetings to review vaccine safety data and 5 joint meetings with the COVID-19 Vaccines WG 

focused on safety issues.
ACIP Meeting Summary June 23, 2021

13

As a reminder, ACIP votes since December 2020 have included recommendations for use of 

Pfizer BioNTech vaccines in those 16 years of age and older on December 12, 2020; use of 

Moderna vaccines for adults 18 years of age and older on December 19, 2020; use of the 

Janssen vaccine for those 18 years of age and older on February 28, 2021, and use of the 

Pfizer vaccine for adolescents 12-15 years of age on May 12, 2021. As vaccine safety data

have become available in real-time, VaST also has communicated their assessments in realtime through presentations during ACIP meetings or via the ACIP website. As a reminder, on 

January 27, 2021, VaST discussed anaphylaxis following mRNA vaccines. On March 1, 2020, 

VaST had updates on anaphylaxis and also reviewed pregnancy safety data, which were 

reassuring. On April 14, 2021, data on cases of cerebral venous sinus thrombosis (CVST)

following the Janssen vaccine were shared. On April 23, 2021, updates on safety data regarding 

thrombosis with thrombocytopenia syndrome (TSS), including CVST, were shared to support 

decision-making by the ACIP and the Johnson vaccine was resumed with a warning. During the 

May 12, 2021 ACIP meeting, updates on TTS were again shared. Since the last ACIP meeting, 

VaST shared some early information about cases of myocarditis via the website in order to 

support early recognition and reporting of cases into VAERS. They just heard an extremely 

comprehensive review and update of the data on myocarditis following mRNA vaccination from 

Dr. Shimabukuro. This timeline of activities should ensure that there can be confidence in the 

systems that are in place and the processes, and that there is continuous and ongoing 

monitoring of vaccine safety for all vaccinations in the US.

To review the issue of myocarditis, the VaST WG met on May 17, 2021 at which time there 

were relatively few reports of myocarditis. However, they noted that the reports were 

predominantly in adolescents and young adults, more often in males than females, more often 

following Dose 2 than Dose 1, and typically within one week after vaccination. The majority of 

patients appeared to have transient symptoms, rapid resolution of laboratory abnormalities, and 

brief hospitalizations. Follow-up data were limited at that time. During the May 24th VaST 

meeting, the VaST WG reviewed updated data and noted a higher number of observed versus 

expected myocarditis/pericarditis cases in persons 16-24 years of age following Dose 2 of 

mRNA vaccines in VAERS using a 30-day window. During that meeting, VaST WG members 

discussed: 1) the need for continued vaccine safety monitoring through multiple surveillance

systems; 2) the need for multidisciplinary collaboration as the vaccination rate started to 

increase in younger age groups to provide clinical guidance about early recognition, differential 

diagnosis to ensure that there are no other causes, diagnostic testing, and appropriate

management of persons who develop myocarditis or pericarditis; and 3) the need for long-term 

follow-up of patients to understand the clinical course of these cases and the timing of resolution 

following both COVID-19 infection and COVID-19 vaccination. A few days later, CDC posted 

additional information about myocarditis and pericarditis following mRNA vaccines8in order to 

communicate transparently about what was known and what was not known on this topic. In 

addition, CDC posted clinical considerations for HCP to ensure that cases are reported in 

VAERS, which is critical to ensure robust monitoring of vaccine safety in the US and to ensure 

early detection, evaluation, and timely management of potential cases.

Moving onto the data just presented by Dr. Shimabukuro, the v-safeSM data indicate comparable 

local and systemic reactogenicity rates among persons 12-15 years of age and 16-25 years of 

age. Dizziness and syncope are the most common AEs reported among persons 12-15 years of 

age in VAERS. Partnerships and ongoing communication with clinician communities have

enhanced vaccine safety efforts through their early recognition of potential AEs such as 

myocarditis. Based on the continued review of data, the risk of myocarditis/pericarditis following 

8 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html
ACIP Meeting Summary June 23, 2021

14

mRNA vaccination in adolescents and young adults aged 12-39 years remains higher after 

Dose 2 and in males. To summarize the cases of myopericarditis per million vaccine doses 

administered in the VSD and VAERS on chart-confirmed cases, the overall estimated rate of 

myocarditis/ pericarditis is 4.4 per million first doses administered and 12.6 per million second

doses administered. For context, published estimated background rates of myocarditis ranging 

from 1 to 10 cases per 100,000 persons annually. The rates following Dose 2 are noticeably 

higher for males, with estimates of 32 cases per million doses in VSD following Dose 2 using 

ICD-10 codes, compared to females at 4.7 cases per million post-Dose 2. The findings from 

VAERS are similar in nature to the findings from VSD by gender and across age groups within 

persons 12-39 years of age, which offers more confidence in these findings.

In summary, the VaST WG feels that the available data to date suggests a likely association of 

myocarditis/pericarditis with mRNA vaccination in adolescents and young adults. The clinical 

presentation of these myocarditis cases following vaccination have been distinct, occurring most 

often within one week after Dose 2 and with chest pain as the most common presentation.

Further data are being compiled to understand potential risk factors, optimal management 

strategies, and long-term outcomes, which will continue to be needed to support ongoing 

decision-making. The VaST WG will continue to review data on myocarditis/pericarditis from 

available surveillance systems and ongoing safety evaluations; review and assess all safety 

data on all outcomes from these safety surveillance systems; and update the ACIP COVID-19 

Vaccines WG, the ACIP Secretariat, and the ACIP on a regular basis.

Summary of Discussion (Oster, Shimabukuro, & Lee)

• ACIP members applauded CDC for the transparency regarding the vaccine safety 

surveillance process, for putting clinicians on alert about reports of myocarditis, and for 

highlighting that anyone can submit a report to VAERS—not just HCP. This is an excellent 

illustration of the commitment to safety.

• The importance of using terms carefully, such as “rare” and “very rare” was emphasized. 

There is a difference in the definitions that clinicians might use in practice, versus the 

definitions that the general public may use in understanding risks, versus the definitions 

used when reviewing the overall safety of products that are used in medical practice and in 

making medical and public policy. 

• ACIP members expressed interest in further information on the following topics related to 

myocarditis following COVID-19 vaccination with mRNA vaccines:

➢ Breakdown of mild, moderate, and severe cases

➢ Long-term prognosis and outcomes

➢ Similarities between the pathophysiology of myocarditis after Dose 2 and the cardiac 

findings associated with Multisystem Inflammatory Syndrome in Children (MIS-C)

➢ Myocarditis related to COVID-19 infection

➢ Mechanisms for testing negative for spike protein and antibodies in patients who 

develop myocarditis after vaccine

➢ Factors driving male predominance

➢ Effort to proactively look for asymptomatic markers such elevated troponin levels or 

abnormal EKG findings in people who have been vaccinated but do not present for 

clinical care

➢ Potential link between myocarditis/pericarditis and vigorous exercise or sports
ACIP Meeting Summary June 23, 2021

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➢ Possible geographic clustering of cases, if any, and whether there might be a 

biological or behavioral link 

➢ Relationship of race and ethnicity on the potential for myocarditis/pericarditis

➢ Deeper information on understanding the burden of disease, the benefit-risk balance, 

symptomatic versus asymptomatic disease, et cetera in pediatrics, as vaccine trials 

continue in younger age groups and ACIP moves toward decision-making on 

children

COVID-19 mRNA Vaccines in Adolescents and Young Adults: Benefit-Risk Discussion

Dr. Megan Wallace (CDC/NCIRD) reminded everyone that the current COVID-19 mRNA 

vaccine policy is that COVID-19 vaccines are recommended for persons 12 years of age and 

older in the US under FDA’s EUA. This presentation focused on the risks as well as the benefits 

after COVID-19 mRNA vaccines in adolescents and young adults. To frame this benefit-risk 

discussion, data were first presented on the public health problem, including COVID-19 

infections and complications in adolescents and young adults, with a focus on epidemiology in 

adolescents and young adults 12-29 years of age; post-COVID conditions, including MIS-C and 

MIS-A, and myocarditis. This was followed by a benefit-risk assessment, including benefits of 

mRNA vaccines and risk of myocarditis after mRNA vaccines, and the WG’s interpretation.

Since January 22, 2020, more than 33 million cases of COVID-19 have been reported to CDC.

Overall, COVID-19 cases in the US have been declining since January 2021.9 Based on 

projections of incident COVID-19 cases from the Scenario Modeling Hub depicting projections

with models assuming 83% vaccination coverage and 68% vaccination coverage, cases may 

increase substantially in the setting of low vaccination rates and high variant transmissibility.

10

NOWCAST projections of the proportions of circulating SARS-CoV-2 variants from CDC’s 

COVID Data Tracker provide timely estimates while accounting for limited sequence data 

availability. Based on recent NOWCAST data, variants of concern (VOC) are an increasing 

proportion of SARS-CoV-2 lineages circulating in the US. For the projections for the two weeks 

ending June 19th. B.1.1.7 (Alpha) remained the most frequent lineage, with a projected 

prevalence of 52%. P.1 (Gamma) increased to 16%, and B.1.617.2 (Delta) increased to 21%.11

Based on data showing cumulative COVID-19 incident rates by age and sex from April 1-June 

11, 2021, adolescents and young adults have the highest COVID-19 incidence rates.

Since the beginning of the pandemic, at least 7.7 million COVID-19 cases have been reported 

among persons aged 12-29 years. Therefore, the remainder of the presentation focused on this 

group.12 In terms of the proportion of total COVID-19 cases by age group over time, as more 

older adults are vaccinated, adolescents and young adults make up a greater proportion of total 

cases. In May, 33% of cases reported were in persons aged 12-29 years compared with 28% 

last December.13 Despite other age groups experiencing recent decreases in hospitalization 

rates, COVID-19-associated hospitalization rates have remained stable in adolescents and 

young adults.14 In terms of cumulative COVID-19 mortality rates by age group and sex from 

April 1-June 11, 2021, looking at recent months when incident cases have been lower, COVID19-associated deaths continue to occur in adolescents and young adults. Since the beginning of 

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

10 COVID-19 Scenario Modeling Hub Round 5: https://covid19scenariomodelinghub.org/viz.html 

11 CDC COVID DATA TRACKER AS OF 6/14/21

12 https://covid.cdc.gov/covid-data-tracker/#demographics

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

14 https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html
ACIP Meeting Summary June 23, 2021

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the pandemic, 2767 COVID-19 deaths have been reported among persons aged 12-29 years;

316 have been reported since April 1, 2021.

Post-COVID conditions also can occur after COVID-19. There is no standardized definition, but 

it is generally understood to be new or persisting symptoms from acute infection or exacerbation

of a chronic condition 4 weeks or more after SARS-CoV-2 infection. Post-COVID conditions 

have been reported after infections ranging from asymptomatic to severe. There are currently 

limited data in adolescents and young adults,15,

16 but recent cross-sectional studies have shown 

evidence of new or persisting COVID symptoms in this age group. In these studies, up to the 

one half of study participants had symptoms one month post-diagnosis. The symptoms reported 

included fatigue, insomnia, rhinorrhea, muscle pain, headache, lack of concentration, exercise

intolerance, dyspnea, and chest pain.

MIS-C is a post-COVID condition. It is a severe hyperinflammatory syndrome occurring 2 to 6 

weeks after acute SARS-CoV-2 infection among persons less than 21 years old, resulting in a 

wide range of manifestations and complications. Approximately 60% to 70% of patients are

admitted to intensive care and 1% to 2% die.

17

,

18 There have been over 4018 MIS-C cases 

reported as of June 2, 2021.19 The estimated incidence of MIS-C cases is 1 per 3200 SARSCoV-2 infections20; 36% of reported MIS-C cases occurred in persons aged 12-20 years; and 

62% of reported cases have occurred in children who are Hispanic, Latino, or black/nonHispanic. Lagging by a couple of weeks, MIS-C cases track with COVID-19 incidence. If 

COVID-19 cases were to increase, an increase also could be anticipated in MIS-C.21

MIS has also been reported in adults, though cases are less common. A single center 

retrospective cohort study22 identified adults at risk of MIS-A from those hospitalized with a 

positive SARS-CoV-2 test result in which 15 (1.7%) hospitalized patients were diagnosed with 

MIS-A. Patients with MIS-A were younger and more likely to have evidence of SARS-CoV-2 

infection documented by serologic testing compared to acute COVID-19 patients. Other 

demographic characteristics and comorbidities did not differ between MIS-A patients and acute 

COVID-19 patients. Of the 15 MIS-A patients, 8 had cardiovascular involvement. In a case 

series of 27 MIS-A patients,23 antibody testing was required to identify SARS-CoV-2 infection in 

approximately 1/3 of cases. Patient ages ranged from 21-50 years, 96% of patients belonged to 

racial or ethnic minority groups, and 3 patients died.

Moving to epidemiology, myocarditis is inflammation of the heart muscle and pericarditis is 

inflammation of the outer lining of the heart as mentioned earlier. Myocarditis and pericarditis 

generally occur more frequently in young adults, men, and persons with certain underlying 

medical conditions or who have had recent medical procedures. They also can occur after 

SARS-CoV-2 infection, but data to estimate the frequency after COVID-19 are limited. There is 

a spectrum of disease, but for the purpose of the benefit-risk discussion, both myocarditis and 

pericarditis are referred to as myocarditis in this presentation.

15 Buonsenso et al, Acta Paediatrica (2021) 

16 Walsh-Messinger et al, medRXiv (2020)

17 Feldstein LR, Tenforde MW, Friedman KG, 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 

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

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

2021;e210630. doi:10.1001/jamapediatrics.2021.0630

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

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

20 Payne et al, JAMA Netw Open. 2021;4(6):e2116420. doi:10.1001/jamanetworkopen.2021.16420

21 https://www.cdc.gov/mis-c/cases/index.html; accessed 06/08/2021

22 Davogustto et al, JAMA Netw Open. 2021;4(5):e2110323. doi:10.1001/jamanetworkopen.2021.10323

23 Morris SB et al, MMWR Morb Mortal Wkly Rep 2020;69:1450–1456. DOI:http://dx.doi.org/10.15585/mmwr.mm6940e
ACIP Meeting Summary June 23, 2021

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In a recent cohort study of 1597 collegiate athletes with recent SARS-CoV-2 infections who had 

cardiac MRI, 37 (2.3%) had abnormal MRI findings. However, 65% of the 37 had normal 

laboratory findings and no symptoms.24 Another study suggested that some MRI findings may 

be related to remodeling from athletic training.25 Studies also have highlighted differences

between myocarditis related and unrelated to SARS-CoV-2. In a retrospective study that 

identified children with acute myocarditis treated at a single center from 2018-2020, 27 children 

18 years of age and younger were identified.26 Of the cases, 7 had evidence of prior SARSCoV-2 infection or exposure and 6 were ultimately diagnosed with MIS-C. Individuals with 

myocarditis, or MIS-C-related to SARS-CoV-2 had a better clinical course than those with 

myocarditis due to other causes. None were diagnosed with acute fulminant myocarditis. There 

was a shorter duration of ionotropic drug support and ICU stay, and they did not require

mechanical respiratory support.

As is discussed in presentations earlier in the day by Drs. Oster and Shimabukuro, there also 

have been cases of myocarditis after mRNA vaccines reported. These reports have been most 

commonly in males less than 30 years of age. Symptom onset clusters in the week following 

vaccination, and early data of acute outcomes have been good. Many of the cases have been 

hospitalized, but usually for a short duration. No long-term data are available yet, but continued 

monitoring is ongoing.27

In summary, COVID-19 incidence, hospitalization, and mortality rates are decreasing overall.

However, variants continue to spread and scenarios exist in which cases increase in the fall.

Adolescents are a growing proportion of cases, given vaccine coverage among adults. PostCOVID-19 conditions also impact adolescents and young adults. There have been 4018 MIS-C 

cases reported to national surveillance. Myocarditis is a disease marked by inflammation of the 

heart muscle, and risk factors include younger age and male sex. Myocarditis can be related to 

SARS-CoV-2 infection. Myocarditis after mRNA vaccines has been noted, with highest 

frequency in males aged 12-29 years following the second dose. Early outcomes have been 

encouraging, but no long-term data are available yet.

Moving on to benefits, the Phase 3 clinical trial data for the Pfizer-BioNTech COVID-19 vaccine 

demonstrated efficacy against thematic laboratory-confirmed illness among individuals 16 years 

of age and older, with an overall efficacy estimate of 95%. The VE against COVID-19-

associated hospitalization was 100%. The Pfizer-BioNTech COVID-19 vaccine also 

demonstrated high efficacy against symptomatic laboratory-confirmed COVID-19 and 

adolescents aged 12-17 years. Overall efficacy was 100% and immunogenicity was non-inferior

to persons 16-25 year of age. The Phase 3 clinical trial data for the Moderna COVID-19 vaccine 

demonstrated efficacy against symptomatic laboratory-confirmed COVID-19 among individuals 

18 years of age and older. The overall efficacy estimate was 94%. The VE against COVID-19-

associated hospitalization was 89%. Additionally, multiple real-world effectiveness studies from 

the US and other countries demonstrate that a 2-dose mRNA COVID-19 vaccination series in 

the age groups for which the vaccine is recommended is effective against SARS-CoV-2

infection, with an estimated range of 64% to 99%. It also is effective against COVID-19-

associated hospitalization, with an estimated range of 87 to 97%. In terms of harms, there have 

been 133 million vaccine second doses administered, and 636 reported myocarditis cases as of 

24 Daniels CJ, et al. JAMA Cardiol. Pub online May 27, 2021. doi:10.1001/jamacardio.2021.2065

25 Clark DE, et al. Circulation; 2021:143(6)

26 Vukomanovic et al. PIDJ;2021:40(5):e173-e1782

27 Marshall et al. Symptomatic acute myocarditis in seven adolescents following Pfizer-BioNTech COVID- 19 vaccination. Pediatrics. 

2021; Larson et al. Myocarditis after BNT162b2 and mRNA-1273 Vaccination; Mouch et al. Myocarditis following COVID-19 

mRNA vaccination. Vaccine. 2021 May 28;S0264-410X(21)00682-4
ACIP Meeting Summary June 23, 2021

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June 11, 2021. An individual-level benefit-risk analysis to evaluate the direct benefits and risks 

per million mRNA COVID-19 vaccine doses, which was used to examine the sex and age

difference in risks and benefits. These calculations are based on recent COVID-19 case and 

hospitalization incidents, mRNA vaccine efficacy, number of mRNA vaccinations to date,

number of persons already vaccinated, myocarditis risk within 7 days after Dose 2, and using a 

120-day risk period. Benefits of vaccination are also described at the population level. Based on 

age-specific hospitalization rates as of May 22, 2021 and calculated over a 120-day risk 

window, when comparing COVID-19 hospitalizations prevented to risk of myocarditis, the 

benefits clearly outweigh the risk in the older populations, so the focus was on persons 12-29

years age.

For females aged 12-17 years, it is estimated that for every 1 million doses of mRNA given to 

complete the 2-dose series, 8500 COVID-19 cases, 183 hospitalizations, 38 ICU admissions,

and 1 death would be prevented and that there would be an estimated 8-10 cases of

myocarditis. For males aged 12-years, it is estimated that per-million second dose vaccinations,

5700 COVID-19 cases, 215 hospitalizations, 71 ICU admissions, and 2 deaths would be

prevented and there might be 56-69 myocarditis cases. In persons aged 18-24 years, the 

benefit-risk balance is more favorable. For males, aged 18-24, for whom the risk is higher than 

females, it would be expected that 12,000 cases, 530 hospitalizations, 127 ICU admissions, and 

3 deaths would be prevented and there might be 45-56 myocarditis cases. In persons aged 24 

to 29 years, the benefit-risk balance is even more favorable and this trajectory continues with 

increased age. There are additional considerations for direct benefits that were not captured in 

the benefit-risk assessment, such as prevention of MIS-C, prevention of prolonged symptoms,

and protection against variants.

For population-level considerations, there are no alternatives to mRNA vaccines for the 

foreseeable future in adolescents. Vaccination of students offers an additional layer of 

protection against COVID-19 and can be an important tool to return to normal. Higher levels of 

vaccination coverage can lead to less community transmission, which can protect against 

development and circulation of emerging variants. Racial and ethnic minority groups have 

higher rates of COVID-19 and severe disease. Potential changes in vaccine policy or anything

that would impact vaccination coverage for adolescents and young adults may 

disproportionately impact those groups with the highest rates of poor COVID-19 outcomes.

The direct benefit-risk assessment shows a positive balance for all age and sex groups. It 

considers individual benefits of vaccination versus individual risks. The benefits presented are 

likely an underestimate because the analysis was performed using reported rates of cases and 

hospitalizations, which likely represent only a fraction of the true cases that have occurred in the 

population. There is still uncertainty in the rates of myocarditis after mRNA vaccines. Not all 

cases are verified, and the crude rates were used. The balance of risks and benefits varies by 

age and sex, and the balance could change with increasing or decreasing incidence. There is 

limited data currently on risk of myocarditis in persons 12-15 years of age due to the timing of 

recommendations and limited number of second doses given.
ACIP Meeting Summary June 23, 2021

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Clinical Considerations and the COVID-19 WG Interpretation

Dr. Sara Oliver (CDC/NCIRD) briefly described the draft clinical considerations around 

myocarditis and pericarditis and the WG interpretation, which are shown in the following table:

Vaccine Considerations in People with a History of Myocarditis or Pericarditis

Scenario Recommendation

Pericarditis prior to COVID-19 vaccination Receive any FDA-authorized COVID-19 vaccine.

Pericarditis after 1st dose of an mRNA COVID-19 

vaccine but prior to 2nd dose

Proceed with a 2nd dose of mRNA COVID-19 

vaccine after resolution of symptoms. Discuss 

with patient, guardian, and clinical team.

Myocarditis after 1st dose of an mRNA 

COVID-19 vaccine but prior to 2nd dose

Defer 2nd dose of mRNA COVID-19 vaccine until 

more information is known. However, if heart has 

recovered, could consider proceeding with 2nd

dose under certain circumstances. Discuss with 

patient, guardian, and clinical team.

The clinical considerations website will be updated with additional language for each of these 

recommendations, but the WG wanted to share a brief summary.

The WG reviewed the data presented during this meeting on COVID-19 mRNA vaccines in 

adolescents and young adults and discussed the benefit-risk balance. Overall, they felt that the 

initial presentations are reassuring. However, continued monitoring of cases, the clinical course,

and long-term outcomes of myocarditis after mRNA vaccines will be important. The WG also felt 

the need to follow the benefit-risk balance as more is learned around myocarditis, as well as 

updates to epidemiology (e.g., cases, variants, etc.). However, they felt that currently, the 

benefits still clearly outweigh the risks for COVID vaccination in adolescents and young adults.

As a reminder, the current vaccine policy for COVID vaccines is that: “COVID-19 vaccines are 

recommended for persons 12 years of age and older in the United States under FDA’s 

Emergency Use Authorization.”

In closing, the following questions were posed for ACIP consideration and deliberation:

1. What does ACIP think about the benefit-risk balance of COVID-19 vaccines in adolescents 

and young adults, in the setting of the reports of myocarditis?

2. What additional information or analyses could inform these discussions as we continue to 

closely monitor the situation?

Summary of Discussion (Wallace & Oliver)

• The safety monitoring systems continue to be reassuring and the transparent 

communication is greatly appreciated. It was clear to ACIP members that based on current 

information, the benefits of vaccine clearly outweigh the risks related to the incidence of 

myocarditis.
ACIP Meeting Summary June 23, 2021

20

• ACIP members emphasized the importance of being very upfront with parents and patients

in terms of mentioning myocarditis/pericarditis as a potential risk of COVID messenger-RNA 

vaccinations and in updating the EUA fact sheets:

➢ Dr. Fink, FDA, reported that the FDA has been working very closely with its partners 

at CDC in assessing the evolving data on this issue and interpreting the results. FDA 

and CDC are very much aligned with the information that was presented throughout 

the day and do agree that based on the available data, a warning statement in the 

fact sheets for both HCP, vaccine recipients, and caregivers. FDA thought it would 

be important to hear the discussion from the ACIP team meeting before finalizing the 

language on these anticipated warnings. The warning statements would likely 

include information stating that these events have occurred in some vaccine 

recipients, particularly following Dose 2 of the mRNA vaccines; onset of symptoms 

typically has been several days to a week following vaccination; based on limited 

follow-up, most cases appear to have been associated with resolution of symptoms;

limited information is available about potential long-term sequelae; and symptoms 

suggestive of myocarditis or pericarditis should result in vaccine recipients seeking 

medical attention. Also anticipated is that warning statements would refer to CDC 

clinical guidance on use of mRNA COVID vaccines in individuals with a history of 

myocarditis or pericarditis, and that FDA would move rapidly to update the facts 

sheets with this information.

➢ Dr. Cohn, CDC, indicated that CDC would coordinate closely with FDA after the 

language has been finalized and will update all CDC fact sheets and parent

information sheets to reflect the same language, although potentially at the 

appropriate reading level for the documents.

• Regarding Slide 39 pertaining to vaccine consideration of people with a history of 

myocarditis or pericarditis, concern was expressed with the language in the fourth line 

reading, “myocarditis after the first dose prior to second.” It is not clear how easily 

interpretable or user-friendly that language might be because one can have myocarditis with 

pericarditis at the same time and it is not always easy to differentiate in the clinic setting. 

Perhaps the language could be revised to reduce the potential for confusion.

• In terms of consideration for people with a history of myocarditis and pericarditis, Dr. Long 

indicated that she is an Associate Editor of the Journal of Pediatrics and that they received a 

single case that did get through to publication and is now on the journal’s website. The first 

author’s last name is Minocha. This is a case from Manhattan that she accepted because it 

was so beautifully proven. This was a 17-year-old boy who had traditional myocarditis in 

January 2012, with a lot of investigation, including SARS PCR and antibody, both of which 

were negative in January. He recovered and had normal findings in cardiac follow-up within 

a month of discharge. In April, he received Pfizer Dose 1 without difficulty. Two days after 

Pfizer Dose 2 given at the appropriate interval, he had sudden onset of severe chest pain 

going to his left shoulder, and again was investigated very thoroughly. He had all of the 

findings that would confirm myocarditis, including a cardiac MRI. He had no PCR positivity,

but IgM antibody at the time he presented with the myocarditis. While this is a single case, it 

is well-documented and raised some uncertainty about what a clinician should do with a 

patient in front of them.
ACIP Meeting Summary June 23, 2021

21

• Dr. Oster indicated that he quickly reviewed the Minocha paper that Dr. Long described and 

had some comments with regard to the guidance that was given. First, a timeline of about 3 

months from myocarditis to vaccine will be included with the clinical considerations. This 

gets at long-term follow-up in that they want to see resolution of the myocarditis and full 

heart recovery. As Dr. Oliver mentioned, there is other verbiage that will be in this content. A 

lot of it is taken from the guidance of the AHA and ACC, which recommend about 3- to 6-

month window for allowing the heart to recover. Second, it is especially important to followup on abnormal findings. He was struck that in the Minocha paper, the distribution of 

inflammation in the follow-up myocarditis was identical to the MRI in the acute phase of the 

earlier myocarditis. It does not appear that there was an intervening MRI to show that that 

had resolved. While Dr. Long’s thoughts are very well-taken, it is important to emphasize

that people who have ongoing concerns and ongoing considerations are still followed. It was 

meant more for those who have a remote history of myocarditis that have essentially

recovered, are off of cardiac medications, and have been discharged from cardiology care.

Public Comment

The floor was opened for public comment during the June 23, 2021 ACIP meeting at 2:30 PM 

ET. Given that many more individuals registered to make oral public comments than could be 

accommodated during this meeting, selection was made randomly via a lottery. The comments 

made during the meeting are included here. Members of the public also were invited to submit 

written public comments to ACIP through the Federal eRulemaking Portal under Docket No. 

CDC–2021–0034. Visit http://www.regulations.gov for access to the docket or to submit 

comments or read background documents and comments received.

Ms. Susie Olsen Corgan

Concerned Individual

Thank you for the opportunity to speak today. Today, as I listened to the committee discuss the 

cases of myocarditis and pericarditis following COVID-19 vaccinations in adolescents and 

young adults, I was alarmed. As we all know and has been documented, adolescents and 

young adults have zero relative risk of dying from COVID-19 infection and very low risk of 

having severe adverse events. But as we have heard today and have seen from the Vaccine 

Adverse Event Reporting System, there have been several severe adverse events reported

after receiving COVID-19 injections. As of June 11, looking at myocarditis and pericarditis alone, 

there have been 197 reports in 30-39-year-olds, 392 reports in 19 to 29-year-olds, and 279 

reports in 18 years and younger. Looking at the Harvard Pilgrim study, which states that less

than 1% of adverse events were reported to VAERS, it is reasonable to assume that these

numbers are much higher than are being reported. From the meeting here today, we heard that 

there have been more than 1200 cases of myocarditis or pericarditis, mostly in people under 30.

The numbers are growing quickly. This should ring the alarm for all of you. It certainly does for 

me. With information on myocarditis or pericarditis being just two of the effects being reported 

and no long-term safety data on these vaccines, how can you, the ACIP committee who were 

entrusted by the citizens of this country to provide the safest recommendations, continue to 

recommend any COVID-19 vaccines for adolescents or young adult populations? Furthermore, 

since we know that many of the deaths stated to be caused by COVID-19 infection in

adolescents and young adults have underlying health conditions such as obesity and diabetes, 

why aren’t we talking about how to live a healthy lifestyle? Simple guidance on eating a

diversified whole foods diet, getting outside and exercising regularly—how much could we 

reduce negative outcomes in the entire population with just these few simple recommendations?

A report came out several months ago saying that 90% of COVID-19 deaths could have been
ACIP Meeting Summary June 23, 2021

22

prevented if the individual had adequate levels of vitamin D. Why is this not being discussed

further? Why is the vaccine the only option being given when we do not yet know what the longterm effects are going to be on our children? Why aren’t you, our public health regulatory

agency, looking at other options that carry zero risk for most individuals? I brought several 

concerns up to you many months ago prior to the emergency use authorization of any COVID19 vaccines. I warned you that if this rush through of COVID vaccines continued, the supply of 

that vaccine would not be your primary issue, but that demand would be. We are seeing that 

now. Even with the many courses of tax incentives given millions in lotteries, free beer, joints, 

donuts, scholarships, etc., hesitancy is still growing. The only way that you may begin to regain 

any confidence from the public is to completely stop administration of the COVID-19 vaccines in 

adolescent young adult populations until the safety studies have been done. Please take these 

comments into consideration. Thank you for your time.

Mr. William Huston

Terra Vigilate (Earth Watch)

My name is William Huston. I'm associated with Terra Vigilate, a public interest research 

organization focused on public health and safety. Thank you to the committee for letting me 

speak today. I just want to start by saying that technical experts with a lot more credentials and 

knowledge than I were denied a right to speak today, and I was denied the ability to cede my 

time to the technical experts. So, if the ACIP is truly wanting to engage the public and have a 

robust conversation about the safety and efficacy of these vaccines, I would suggest an

additional public comment session that’s open to anyone and it should be taken as long as 

needed to get everybody heard. These COVID-19 vaccine trials must be halted immediately and 

the emergency use authorization withdrawn, because it’s causing massive, massive injuries and

deaths. These vaccines are unnecessary for a purported infectious disease with a case fatality

rate comparable with a common flu. The EUA was issued using scientific and medical fraud due

to violations of the criteria for issuance of authorization, including that the infectious agent is

serious. It’s not. The benefits of the product must outweigh the risk, and that’s highly

questionable, and that there's no adequate alternative, yet existing prophylactics and

therapeutics known to be effective against coronavirus infections were banned for off-label use 

by the FDA. The testing and surveillance program is an unmitigated disaster. All testing 

including PCR and antigen and antibody are non-specific to the SARS-CoV-2 virus, which is 

purported to be the pathogen which causes COVID-19, yet that simple fact is unproven. RTPCR is utterly unsuitable for the diagnosis of clinical disease, and that comes from Kary Mullis.

He’s the guy that won a Nobel Prize for inventing the thing. The FDA recalled 255 test kits, tens 

of millions, due to contamination at a cost of billions. The VAERS database is known to be

underreported by a factor of between 10x and 100x. This is according to the Harvard study.

There’s also what I call the VAERS data lag, and other people are calling it the backloading of

data. The CDC is apparently withholding and delaying submitted adverse event reports from the 

published data by a factor of at least 3x and could be as high as 14x. And when you combine 

these two factors together, we can say that the number of deaths in the US is not 6000, but it 

could be 180,000, and the upper bound might be 6 million. So, you know, this is the 20th

anniversary of 9/11 when 3000 people died. So this vaccine program is like two 9/11s . . . [time 

expired].
ACIP Meeting Summary June 23, 2021

23

Thomas Perry, MD

Phoenix Allies for Community Health

My name is Thomas Perry. I’m a retired cardiologist from Phoenix. Thank you for inviting me to 

speak. My written comment is much more detailed and with references. There is a large sector 

of the population which does not trust the scientific integrity of the vaccine program. This was 

especially notable before the mask requirement for fully vaccinated people was removed. I 

believe in universal vaccination based on scientific proof that vaccines are 20 times stronger

than placebo to prevent COVID. No such finding is available for recovered COVID patients. The 

WHO states that 11 billion vaccines will be needed. Perhaps 2 billion have already been 

distributed. The CDC continues to target recovered COVID victims who are already immune. If 

large numbers of vaccine are wasted on the already immune population, the overall vaccine

strategy is slowed down, allowing more time for the evolution of variants. Scientific assessment 

of the durability of COVID immunity is a key to the formation and reformation of vaccination 

policy. This includes boosters and second generation vaccine development. The results of 4837

COVID-recovered victims randomized in the Moderna and J&J trials, Phase 3, are pending. The 

available scientific studies on vaccine durability warrant more critical scrutiny. In my written

comment, I examine four excellent studies on reinfection of already infected people. These 

show 180,000 patient years with a reinfection rate of less than 1 per 100-person years,

hospitalization rate less than 0.15, and mortality rate of 0. Natural immunity shows itself to be

good and durable. By contrast, there are studies which claim that the reinfection rate is high so 

that transient immunity should be the working hypothesis. Most commonly, such claims are 

based on waning IgG levels in neglect of T and B cell immunity, which may be more important.

Others omit antibody data using only PCR swab results. A report in Lancet from Denmark uses

twisted tables of PCR results to claim only 82% immune protection in the first year of recovery,

and an extremely low 47% for the 65-year-old and over group. The serious flaws in this study

includes omission of all data on clinical severity. Vaccine resistors have a sharp eye on the

logical and scientific integrity . . . [time expired].

Ms. Sarah Barry

Ms. Independent Pro-Vaccine Advocate

Hello, ACIP. My name is Sarah Barry. I am an independent pro-vaccine advocate from Ohio,

and I thank you for the continued transparent and thorough discussions of the safety data. I 

have previously given comment before about the rampant abuse of autistic children within the 

anti-vax community and how anti-vax lobbyists in Ohio made efforts to censor my testimony in a 

government committee. I also wanted to give testimony these past few weeks on Ohio House

Bill 248, which would make it illegal for hospitals, nursing homes, and any business or school to 

require any vaccine—not just the COVID vaccine. However, the testimony protocol was

changed and the anti-vax Chair of the Health Committee did not select me to give testimony. So 

today I will use this time to give it to you all now: Chairman Lipps, Vice Chair Holmes, Ranking 

Member Liston, and Members of the Ohio House Health Committee, thank you for the

opportunity to give opponent testimony for House Bill 248. We all saw Sherri Tenpenny come 

before this committee and turn Ohio into a national embarrassment. Tenpenny is, in fact, one of 

the founding members of Ohio Advocates For Medical Freedom who are the anti-vax lobbyists

that worked with the sponsor to write the bill. Health Freedom Ohio, the anti-vax lobbyist group

that previously tried to censor my testimony in this building, is responsible for the amendments.

That makes this bill an anti-vax bill. You cannot continue to hide behind the rhetoric of freedom

as cute as the attempt is. You can call this a “freedom bill” if you want, but everybody knows it is 

a freedom to be anti-vax bill. If you have cancer and you want to go to get your normal checkup,

you have to worry that the people who are treating you might not be vaccinated against 

measles. Sherri Tenpenny, in addition, is a grifter who not only is embarrassing for the 
ACIP Meeting Summary June 23, 2021

24

statements she made in front of this committee, but made statements about mental illness and 

vaccines and implied that vaccines caused the Sandy Hook shooting. She also, her clinic that 

she runs in Ohio, offers homeoprophylaxis. Homeoprophylaxis is a non-FDA approved

alternative to a vaccine. It is absolutely disgusting to me that these are the experts that you

would listen to and these are the groups that you would listen to in the construction of this bill. I 

am ashamed to be an Ohioan when I think of the corruption that is going on behind closed

doors. I question the testimony protocol changes that have been made, and I urge a “no” vote 

on House Bill 248 as it is an anti-vax bill. Thank you for your time, ACIP, and thank you for the 

time of the Ohio House Health Committee that did not select my testimony.

Ms. Cathy Margolin

Acupuncturist and Herbalist

My name is Kathy Margolin. I’m a nationally licensed acupuncturist and herbalist and myself,

along with my colleagues of East Asian medicine, have suddenly noticed a startling difference in 

our new patient population. As a small piece of background, I communicate directly with 

thousands of traditional Chinese medicine practitioners from all over the world in various online

Meetup bulletin boards, social, and university groups. We are all experiencing a trend we've

never seen before. New patients are arriving with complaints that they attribute to the

vaccinations. Some of these pathologies happen within days. Others within a few weeks. But 

the common theme is patients never had these symptoms and they have all received

vaccinations. Acupuncturists like myself are having some very good success with menstrual 

disorders, Bell’s palsy, respiratory issues, palpitations, generalized malaise, a wide variety of GI 

disorders, shingles, and now more common than ever, skin and eye disorders, along with 

extreme anxiety and depression. We can and are treating all of them. But one of the most 

frightening symptoms acupuncturists worldwide are experiencing with their patients are

immediate changes in patients’ radial artery wrist pulses after vaccination. Pulse analysis is a 

major assessment of health in TCM. This has never been seen before, certainly not in the 

volume where we are seeing. Clearly, heart mechanics are being affected by these 

vaccinations. Two days ago, the World Health Organization revised the recommendations, as 

you know, for children 18 and younger—no COVID vaccinations for this group. I commend them 

for this action and would go further to say pause all vaccinations in the US until the current 

reports from the government’s VAERS website are thoroughly investigated, tracked, and 

reviewed. Pause until we know for sure that vaccinations are safe for all. As a health 

practitioner, I’m alarmed at what I’m seeing. As a mom, I’m scared for the next generation. I 

have a pediatric focus in my TCM practice, and this last year, I’ve seen a colossal amount of 

depression, anxiety, and suicidal thoughts in the under 18 age group, in fact, for all age groups.

China has been treating COVID with herbal formulations since the onset of the epidemic. The 

acupuncture community in the US has been able to learn these treatment protocols since

February 2020. We have learned from some of the very first Chinese medicine doctors in 

Wuhan what botanical combinations work best for COVID-19 patients. We, the acupuncture

community here, have been treating COVID patients successfully for more than a year without 

long-term side effects. We have adapted to virtual consultations and mailing herbal formulas, 

keeping people out of the hospitals, and now we are being perversely rewarded with patients

who have taken the vaccine. I implore you, review the risks of these vaccinations for all ages.

Benefits should never . . . [time expired]. Isn’t the rule of medicine and the oath I took “first do no 

harm?”
ACIP Meeting Summary June 23, 2021

25

Mrs. Barbara Loeppke

Loeppke Professional Services

Hi. My name is Barbara Loeppki. I’m a parent and a parent advocate. After attending a February 

2019 ACIP meeting, I’ve had concerns about the rigor of the ACIP recommendations. My 

takeaway from that meeting was hearing the phrase numerous times, “don’t let the lack of data 

keep you from voting.” My takeaway from today’s meeting is that this will still occur. How can 

you look people in the eye and say that you voted without all the data? We’re told that the 

mechanism of the cardiac problems isn’t known and that there is no data about the long-term 

effects. We’re told that the prior current COVID infection is being looked at, but the presence of 

the vaccine spike protein is not. We’re told the background rate for myocarditis has been used

for 12- to 15-year-olds from 2015-2016, but that’s 5- to 6-year-old data. Why is that year’s entire 

numbers being compared to the vaccine numbers when these kids have only had it for 32 days?

In fact, the background rate used in every meeting is very vague. This does not show 

transparency, nor does it build trust. Why are the different reporting systems using different age

group ranges? The discussion is that myo- and pericarditis is mostly occurring in young 

participants, yet the VSD presentation diluted the results by using data from ages up to 39

years. Parents are very concerned about VAERS data. Medical professionals have stated that 

the forms are time consuming, cumbersome, and often they are penalized by their healthcare 

systems for reporting. What are you doing to make sure that all vaccine reactions are being 

reported? Parents are watching. Parents are relying on you to get the correct info before their 

children are injured for life. The events are not mild to them. Parents feel minimalized. How do 

you even begin to think you’ll be able to address vaccine hesitancy when you do this? The very 

fact that the ACIP scheduled an emergency meeting to address heart problems and then 

postponed it to take a holiday speaks volumes. In December, the Committee met numerous 

times on the weekend when the manufacturers wanted approval. An emergency, yet you 

postponed for 5 days. This brings up three possible scenarios. Either you thought it wasn’t really 

an emergency; or you really don’t care about children, which I don’t think is the case; or most 

likely answer, which the public believes is the outcome, was already determined before the 

meeting was going to be held. Vaccine hesitancy is not about having a needle poke the skin. It’s 

about the lack of trust in you, the ones who are responsible for the recommendations. Will you 

do the right thing? Thank you for your time.

Leslie Moore, MD

Mother & Physician

My name is Leslie Moore. I am a mother and a physician. I’m not a virologist, but I can read 

data, and I cannot fathom why this mass vaccination program has not been halted yet and why 

the consideration to extend it to younger ages because the data is atrocious and frightening.

First, let’s acknowledge that these experimental vaccine products are still investigational. Yet, 

there is no comprehensive monitoring and data collection. People get shot up and left to deal

with the consequences on their own. All we have is the VAERS system, which is voluntary selfreporting. We know VAERS only captures 1% to 10% of all adverse events. Adverse events are 

grossly underreported for a variety of reasons. I looked at OpenVAERS this morning. These 

products have amassed 6,000 deaths and 20,000 hospitalizations in the US alone, which is 

more than the other 70 vaccines for the last 30 years combined. That is with gross underreporting and a 2-month backlog. Let’s face it. These vaccine products are not safe. Now let’s 

consider these products for children. What is the risk-benefit analysis? Children are at a 

statistically insignificant risk from COVID-19, so there is no benefit to vaccination. And you can’t 

vaccinate them to protect others. These shots don’t work that way. They don’t prevent infection 

or transmission. Your shot at best protects you from severe symptoms. No one else. Children 
ACIP Meeting Summary June 23, 2021

26

have no benefit, only risk from these products. Any child injured or killed by the shot likely would 

have done fine with the virus and received broad and lasting natural immunity. Natural immunity 

is always better than vaccine immunity. Anyone who says otherwise needs to go back to

medical school. Finally, these risks and injuries are all short-term data. We have no long-term 

data. But one extremely concerning signal is the biodistribution study from Japan that showed

that the lipid nanoparticle did not stay in the shoulder as intended but traveled throughout the

body and then concentrated in the ovary. That should set off alarm bells that more study is

needed before we inject our youth. In conclusion, I believe available data and common sense 

justifies a halt to the mass vaccination of our children. Thank you.

Mrs. Christina Dietrich

Delaware Medical Freedom Alliance

My name is Christina Dietrich and I represent Delaware Medical Freedom Alliance. I have 4 

children, including 14-year-old twins. I live in a low-income majority-minority neighborhood in 

Middletown, Delaware. I also work in home healthcare. I’ve had a patient for 9 years who has a 

neuromuscular disease and a tracheotomy and is obviously at very high risk for COVID

complications. My family, therefore, took extreme precautions to avoid me bringing the infection 

to work, including homeschooling. I even made my husband, an Amazon worker, shave his 

beloved beard. My parents were both hospitalized with COVID in April 2020. The high 

effectiveness rate of the vaccines seemed very exciting. After the vulnerable people in my life 

had been vaccinated, I allowed my children back to normal life. As their mom, I decided the 

socioemotional benefits clearly outweigh the incredibly low morbidity and mortality from COVID19 in healthy kids. As I began to consider vaccinating my children, I called the CDC mid-May to 

inquire about myocarditis and other adverse events. I asked if an emergency ACIP meeting 

might be called before children 12 to 15 started getting their second doses. Why can we not wait 

for a BLA. As Dr. Cody Meisner pointed out at the SBA meeting on June 10, the current COVID 

pediatric hospitalization rate of 4 per million certainly does not constitute an emergency. Nearly 

half these children had a positive test that was only incidental to their hospitalization, and 7 in 10 

hospitalized for COVID had at least one comorbidity. Your own charter states that you will 

advise on population groups and/or circumstances in which a vaccine is recommended. Healthy 

children are not the same as kids with risk factors. I fear that your risk-benefit balance fails to 

take this into account. I’m also not compelled by the argument that we need to use kids to

constrain community spread. It is unconscionable to ask a child to risk his health in order to 

protect adults. Human beings hold the welfare of our children and the health of human future 

generations paramount. The WHO, UK, Germany and others have all declined to recommend 

this vaccine for all children. I thought the USA was the standard bearer for safety and evidencebased medicine. The prevalence for COVID-19 antibodies in children is 27%. Why ignore 

natural immunity? How can universities mandate a vaccine under EUA when the federal 

government is barred from such a mandate? Would young people be as willing to use this 

product if they knew, for example, the odds of winning a serious adverse event exceeded the 

odds of winning a state-won lottery prize? Is it ethical for the CDC Director to use out-of-date

and improperly contextualized hospitalization data to frighten parents into vaccinating their

children? “Primum non nocere. First, do no harm.” In other words, don’t just do something—

stand there. Recommendations should not be based on conjecture, nor should they be political,

made to protect pharmaceutical companies, or to manipulate public opinion. Trust in our public 

health apparatus has declined precipitously. Any risk has been downplayed by government 

officials with the slogan of “safe and effective,” which violates the spirit of informed consent, if 

not the letter . . . [time expired] Updating your guidance in light of the adverse events in mRNA 

vaccines in young Americans will go a long way towards increasing trust in the future. Thank 

you very much for the opportunity to speak.
ACIP Meeting Summary June 23, 2021

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Kelly Moore, MD

Deputy Director

Immunization Action Coalition

I’m Dr. Kelly Moore, Deputy Director of the Immunization Action Coalition (IAC), the nation’s 

leading non-profit focused on supporting frontline immunization providers. Thank you to the 

committee for your ongoing work. I want to add my personal thanks to Drs. Ann Schuchat,

Nancy Messonnier, and Jose Romero for their years of leadership of CDC and ACIP, especially 

the past 18 months. With my time, I’d like to recognize another person who’s been essential to 

the work of ACIP. Next week, Dr. Deborah Wexler retires as the Founder and Executive Director 

of IAC. Although not a voting member of the ACIP, she served on several working groups and 

has been a constant presence at meetings and the public comment microphone for many years.

In the late 1980s, Dr. Wexler first began helping clinicians understand and implement ACIP 

recommendations. She started out writing a local hepatitis B vaccination newsletter in St. Paul,

Minnesota, then went national, creating 3 major print publications: Needle Tips, Vaccinate 

Adults, and Vaccinate Women mailed free of charge to the offices of thousands of healthcare 

providers. In 1993, Deborah founded IAC and created one of the first websites dedicated to 

immunization, our online home, immunize.org. In 1997, Deborah founded IAC Express, a free 

weekly e-newsletter featuring the latest CDC immunization news. This morning, the 1574th

edition went out to nearly 53,000 subscribers. Twenty-five years ago, Deborah and her CDC 

collaborators created Ask the Experts, now an online repository of more than 1100 up-to-date 

answers to common questions from immunization providers about how to apply ACIP’s 

recommendations in specific situations. Deborah has inspired many other vaccine champions.

In 2005, she conceived of Voices For Vaccines, the first national immunization advocacy group 

for parents, recruiting and mentoring its leader Karen Ernst. In 2012, she founded the National 

Network of Immunization Coalitions to facilitate ongoing collaboration among over 100 state and 

local immunization coalitions. IAC also is the home of the National Adult and Influenza 

Immunization Summit, Co-Chaired by IAC’s Dr. LJ Tan, in partnership with CDC and HHS.

Thanks to the tireless educational efforts of Dr. Deborah Wexler, the recommendations of the 

ACIP have been implemented more effectively by thousands of immunization providers,

preventing untold suffering. Thank you for the opportunity to acknowledge her vital contributions 

to the work of the ACIP today on the occasion of her well-earned retirement.

Mrs. Heidi Johnson-Sandall

Mother & Grandmother

I am a mother of 5, I am a grandmother to 8 little ones, and I am very concerned with the 

adverse events reporting worldwide with these vaccines. They include bleeding, clotting issues, 

immune system issues, neurological problems, loss of sight, hearing, speech, smell, pregnancy 

loss, heart inflammation, and the list keeps going on. It is one thing for the ACIP, and the NIH,

and our government to target adults with these vaccines, but to target children when there is 

such a very low risk of complications with this virus, it makes my heart hurt. I’m literally shaking 

right now. I feel like the ACIP and all the government regulatory agencies are not taking into 

consideration natural infection—the rates of infection for children. I would implore this agency to 

look at this a little bit more carefully since there are no long-term studies whatsoever with any of 

this. We have no idea what this is going to look like in a year—what kind of illnesses this is 

going to create for our children and our next generation. Please, I implore you.
ACIP Meeting Summary June 23, 2021

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Data to Inform Recommendations for Additional Doses of COVID-19 Vaccines

Dr. Oliver (CDC/NCIRD) presented a COVID-19 WG overview of the data to inform 

recommendations for booster doses of COVID-19 vaccine. This will include data currently 

available, as well as data needed before recommendations can be made. The main policy 

question and other questions to be addressed include the following:

Are booster doses of COVID-19 vaccines needed for those previously vaccinated with a 

primary series?

- Are booster doses needed for all persons or only in specific populations?

- What is the optimal timing of booster doses after a primary series?

- Can these be given as a “mixed dose” or do they need to be matched to a primary 

series?

Note that decisions around strains for vaccine productions are likely to be made separately. The 

focus of this session was on data to inform the overall decisions around the use for boosters.

Policy on booster doses will need to be coordinated with the FDA for possible amendments to 

the EUA and ACIP for recommendations around use in specific populations. Both FDA and 

ACIP will require data on safety, immunogenicity, and the public health need. By definition, the 

term “booster dose” refers to vaccine doses after a primary series, which could be 1 or 2 doses

in the case of COVID vaccines, that are needed to increase immunity after waning of the initial 

immune response. However, it is important to note that if there was a specific subset of 

individuals who may not have mounted a sufficient immune response after an initial 1- or 2-dose 

primary series and could need an additional dose to reach protective immunity, this would not 

meet the technical definition of a booster dose. However, for the purposes of this presentation,

they were all referred to as “booster doses.”

To inform recommendations on the initial doses of COVID-19 vaccine, ACIP used the ethical 

framework as well as data on the risk of COVID-19 complications and risk of COVID-19

exposure. Balancing these two risks led to the populations recommended for allocation of initial 

supplies of COVID vaccine for LTCF residents, HCP, persons 65 years of age and older, 

persons 16-64 years of age with high-risk medical conditions, frontline essential workers, and 

other essential workers. However, data to inform recommendations for booster doses will 

require even more information. To inform recommendations around booster doses of COVID-19 

vaccine, information will be needed on the risk of COVID complications, risk of exposure, risk of 

waning immunity, and risk of COVID variants.

As was done previously, COVID-19 epidemiology will be closely monitored in terms of cases; 

hospitalizations; and deaths by age, settings, and medical conditions. The risk of waning 

immunity after the primary series also will have to be factored in. The ability to boost after 

additional doses also will have to be assessed. VE studies will have to be monitored and 

vaccine breakthrough cases will have to be assessed. Data will need to be monitored by time 

since vaccination, age, settings, and medical conditions. Information on correlates of protection 

would be very important to interpret data around the risk of waning immunity. Risk of COVID 

variants, variant proportions, antibody response, and effectiveness for each variant and vaccine 

will have to be monitored as well.
ACIP Meeting Summary June 23, 2021

29

To inform these discussions on booster doses, it is important to understand what is currently 

known. Booster doses would apply only to those individuals who already have received a 

primary series. As of June 21, there have been over 318 million doses of COVID vaccines 

administered, which means that at least 62% of those 12 years of age and over, 65% of those 

18 years of age and over, and 87% of those 65 years of age and over have received at least 

one dose.28 For data around immunogenicity and antibody response, first, to discuss what is 

known around a correlate of protection. A correlate of protection is the immune response that 

allows prediction of the degree of protection against infection or disease. This work is ongoing

and no official correlate has been established yet. Available information will be reviewed on 

duration of protection, including the kinetics, of the antibody responses and efficacy from early 

phase clinical trials. In addition, preliminary information on antibody responses to variant 

vaccines will be reviewed.

While there have not yet been established correlates of protection, two studies have 

demonstrated robust correlations between vaccine efficacy and mean neutralizing antibody 

titers across vaccines. The study by Khoury et al29 estimated 54 IU/ml as a correlate of 

protection against detectable SARS-CoV-2 infection, which was estimated to be around 20% of 

the mean convalescent titers and noted this threshold for protection against severe disease may 

be lower and less likely to be affected by vaccine differences. For variants where declines have 

been in neutralization titer, the authors estimate that a 5-fold lower neutralization titer was

predicted to reduce efficacy from 95% to 77% in a high efficacy vaccine or from 70% to 32% for 

a vaccine that starts out with lower efficacy. The same paper illustrates that initial efficacy may 

be useful in predicting time until boosting may be needed. For example, a vaccine starting with 

an initial efficacy of 95% is expected to maintain 77% efficacy by 250 days or 8 months. An 

initial efficacy of 70% may be predicted to drop to 33% efficacy within the same period.

However, it is important to note in interpretation of all of this information that this model 

assumes that neutralization is the only major mechanism of protection. These numbers may be 

an underestimate where neutralization and cell-mediated immunity (CMI) both play a role in 

protection.

Another important consideration is the duration of protection against severe disease. Studies of 

antibody responses to many vaccines shows that after an initial period of rapid exponential 

decline, antibody levels generally stabilize into a slow linear decline with half-lives of over 10 

years. Depending on when this transition occurs, this model predicts that even without immune 

boosting, a significant proportion of individuals may maintain long-term protection from severe 

infection by an antigenically similar strain, even though they may become susceptible to mild 

infection. In terms of what is known around duration of immunity, antibody persistence has been 

demonstrated up to 8 months after COVID infection and up to 6 months after the second mRNA 

vaccine dose so far. Two studies were conducted around 6 months after receiving the Moderna 

vaccine. These studies showed lower neutralization titers and higher proportions with

undetectable titers against a B.1.351 and P.1 variant compared with an ancestral strain.

However, many studies have shown larger decreases in variant neutralization for convalescent 

sera than for post-vaccine sera.30

28 https://covid.cdc.gov/covid-data-tracker

29 https://www.nature.com/articles/s41591-021-01377-8

30 Gaebler, C. et al. Evolution of antibody immunity to SARS-CoV-2. Nature 591, 639–644 (2021); Dan, J. M. et al. Immunological memory to SARSCoV-2 assessed for up to 8 months after infection. Science 371, eabf4063 (2021); Choe et al. Antibody Responses 8 Months after Asymptomatic or 

Mild SARS-CoV-2 Infection. Emerg Infect Dis. 2021;27(3):928-931; Doria-Rose et al. Antibody Persistence through 6 Months after the Second Dose 

of mRNA-1273 Vaccine for Covid-19. N Engl J Med 2021; 384:2259-226; https://www.pfizer.com/news/press-release/press-release-detail/pfizerand-biontech-confirm-high-efficacy-and-no-serious; Khoury et al. Nat Med (2021). https://doi.org/10.1038/s41591-021-01377-8 ; Pegu et al. bioRxiv 

preprint (May 16 2021): https://doi.org/10.1101/2021.05.13.444010; Wu et al. medRxiv preprint (2021): 

https://doi.org/10.1101/2021.05.05.21256716; Luo, Hu, Letterio, medRxiv preprint (4 2021): medRxiv preprint doi: 

https://doi.org/10.1101/2021.05.04.21256537
ACIP Meeting Summary June 23, 2021

30

Preliminary data were published by preprint evaluating the safety and immunogenicity of a 

SARS-CoV-2 variant vaccine booster after a 50 μg booster dose of mRNA-1273 vaccine and a 

B.1.351 specific booster. Two weeks after booster vaccination, titers against the wild-type 

original strain, D614G, as well as titers against the B.1.351 and P.1 variants all increased to 

level similar to or higher than peak titers after the primary series. Overall, both vaccines 

demonstrated broad antibody boosting across all variants detected. There may be a slight 

advantage for B.1.351 with a B.1.351 specific boost, but the preliminary study documented that 

both vaccines demonstrated broad boosting for a variety of variants.31

Turning to what is known around VE in terms of overall real-world VE in the general population,

efficacy and effectiveness against the variants and effectiveness in specific populations are 

illustrated by several published studies.

32 In a real-world VE in a fully vaccinated adult 

population, studies looking at symptomatic infections had a range of 82% to 97% VE compared 

to infection, which had greater variation with a range of 65% to 95%. Overall, a higher VE is 

generally observed for symptomatic disease where assessed. Many variants showed reduced 

antibody neutralization activity relative to the wild-type or ancestral strain. The largest fold 

reductions have been in the B.1.351 or beta variants, among others.

The best way to get specific impact of a vaccine and only a single variant is through laboratorybased neutralization studies. However, VE in specific geographic locations can be assessed to 

determine the dominant strain or strains at the time a study was conducted. Overall, VE remains 

fairly high, even where the dominant strain has been a VOC. VE is slightly lower for the B.1.351 

or beta variants. But even for this variant of concern, VE is higher for the prevention of severe 

disease.33

To highlight what is known around the newest variant of concern, Delta or B.1.617.2 variant, 

there are 3 studies.34 A study from Scotland, which highlights the Delta-specific VE for PCRconfirmed infections, estimates 79%. A study from England shows that VE is higher for 

symptomatic infection at 88% and 96% for hospitalization. This increase in VE for symptomatic 

disease and severe disease has been observed in both the clinical trials and for other variants.

There are 4 antibody neutralization studies35 in which 2 doses of a Pfizer vaccine lead to 

somewhere between a 1.4- and 5.8-fold reduction compared to a wild-type virus. A recent study 

from the UK36 showed a resurgence driven by a replacement of a B.1.1.7 with B.1.617.2, which 

has a higher transmission rate and infections driven by younger unvaccinated people.

Boosters may be required for a broad population. However, it could also be that the need for 

boosters of COVID vaccines may only be demonstrated in some populations. Populations to 

monitor include residents of LTCF, adults 65 years of age and older, HCP, and 

immunocompromised persons.

31 https://www.medrxiv.org/content/10.1101/2021.05.05.21256716v1

32 See reference list at end of slide presentation

33 CDC Science Brief : https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html; Abu-Radad 

and Butt. NEJM (2021); Sandoff et al. NEJM (2021); Chung et al. medRxiv preprint (May 28 2021); Yassi et al. medRxiv preprint 

(May 25 2021))

34 Sheikh et al. Lancet (2021): https://doi.org/10.1016/S0140-6736(21)01358-1; Lopez Bernal et al. medRxiv preprint (May 26 2001); 

https://doi.org/10.1101/2021.05.22.21257658

35 Stowe et al. PHE preprint: https://khub.net/web/phe-national/public-library/-/document_library/v2WsRK3ZlEig/view/479607266 ; 

Planas et al. bioRxiv preprint (May 27 2021); https://doi.org/10.1101/2021.05.26.445838 ; Wall et al. Lancet (2021).

https://doi.org/10.1016/ S0140-6736(21)01290-3: Liu et al. Cell (2021). https://doi.org/10.1016/j.cell.2021.06.020

36 Riley et al. medRxiv (June 21 2021): https://doi.org/10.1101/2021.06.17.21259103 ; Liu et al. Nature (2021); 

https://doi.org/10.1038/s41586-021-03693-y
ACIP Meeting Summary June 23, 2021

31

Looking at 2-dose mRNA VE for SARS-CoV-2 infections in older adults 60 years of age and 

older and adults in LTCFs,37 VE initially has been high, although with some variability among 

studies and populations. The range among residents of LTCFs was 64% to 92%. For adults 60 

years of age and older, VE ranged from 70 to 95%.38 Given that HCP were a group prioritized

for initial vaccination, there are several studies39 evaluating VEs specifically in this population.

To date, VE has been high for both SARS-CoV-2 infection and symptomatic COVID in this 

population.

Moving to people with clinically or therapeutically suppressed immunity, the 

immunocompromised population represents around 2.7% of US adults and includes a broad 

variation of conditions. It is known that immunocompromised adults are more likely to get 

severely ill from COVID and may be at higher risk for prolonged infection, viral evolution, and 

may be more susceptible to infection from variants. This variety of conditions for 

immunocompromised populations may also impact how they respond to a vaccine.40 Among 

populations identified as immunocompromised, there are additional factors that can impact that 

response, including host factors such as older age, decreased kidney function and degree of 

immunocompromise as well as type of immunosuppressive medications.

Information is beginning to become available around VE among these immunocompromised 

populations. One study found that 2 doses of an mRNA vaccine was 71% effective compared to 

90% overall, but the VE was slightly higher for symptomatic infection. There was also lower 

protection with increasing age group.41 Another study estimated 2 doses of mRNA vaccines 

were 80% effective against SARS-CoV-2 infection among people with inflammatory bowel 

disease on various immunosuppressive medications. The VE after the first dose was low, 

highlighting the need to complete the recommended series in this population. No differences

were noted in effectiveness between the two mRNA vaccines.42

Looking at percent antibody response after two mRNA vaccine doses by different types of 

immunocompromising conditions. Studies of people with cancers ranged from 45 to 95%, with 

larger impact seen among the people with hematologic cancers. Studies of people on dialysis

ranged from 45% to 88%. Studies of people with solid organ transplant had the largest effects

and antibody response, ranging from 3% to 58%. Studies of people being treated for 

autoimmune or inflammatory disorders ranged from 40% to 87%. For reference, the healthy

controls included in all of these studies ranged from 95% to 100%. Almost all studies that 

assessed response after the first and second doses demonstrated poor response of people who 

are immunosuppressed to a single mRNA vaccine dose.43 For antibody titers observed in 

different studies of immunocompromised groups, shown as full reduction of healthy controls, the 

largest full decreases were observed among some of the hematologic cancers, but some 

studies of people with cancer, on hemodialysis, or with solid organ transplants observed more

than a 5-fold reduction in antibody titers compared to healthy controls. However, an important 

question to address is if the situation regards whether immunocompromised persons would 

mount a sufficient immune response if given a booster or third dose if they did not mount one 

after the first two doses.44

37 Cabezas et al, Emorg et al, Canvanaugh et al, Mousten-Helms

38 Dagan et al, PHE (5.20.21), Lopez-Bernal et al, Aran, Mason et al

39 https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html

40 See list of references on slide 29

41 Chodick et al. Clinical Infectious Diseases, ciab438, https://doi.org/10.1093/cid/ciab438

42 Khan et al. Gastroenterology (2021). https://www.gastrojournal.org/article/S0016-5085(21)03066-3/pdf

43 See references at the end of the slide set

44 See references at the end of the slide set
ACIP Meeting Summary June 23, 2021

32

There is evidence on providing a third COVID-19 vaccine dose to immunosuppressed people 

with suboptimal response. One study45 looked at solid organ transplant recipients who had 

suboptimal responses to standard vaccination and subsequently received a third dose. Among 

these individuals, 80% had negative antibody titers and 20% had low positive titers after a 

primary series. These individuals received a third dose, a median of 67 days after their second 

dose. After this third dose, over half of those individuals remained antibody negative. Another 

study46 assessed persons on hemodialysis vaccinated with up to three doses among whom 

83% seroconverted after a second dose. Of those who were negative after the second dose,

nearly 60% remained negative after a third dose. As there is no correlate of protection, it is not 

clear how these antibody test results relate to clinical protection for disease, so additional 

studies are needed. There is at least one trial looking at additional doses in transplant

recipients.

To recap, there are plans to monitor data across all populations. However, the WG has 

highlighted the populations to monitor closely: LTCF residents, adults ≥65 years of age, HCP, 

and immunocompromised persons. For LTCF residents and ≥65 years of age, the 

VE is encouraging. However, these individuals were vaccinated in the early phase of COVID 

vaccine rollout. In addition, this is a population that in the past has needed special

considerations for other vaccines, including additional booster doses or higher dose vaccine.

HCP also were vaccinated in the early phase of the COVID vaccine rollout. They also will have 

continued exposure to SARS-CoV-2, even as community transmission rates improve. For 

immunocompromised persons, emerging literature is suggesting a reduced antibody response 

after a primary series. In addition, by definition, this is a population with an impaired immune 

response. Because of the concern regarding the ability of this population to mount an immune 

response after additional vaccine doses, consideration will have to be given to whether this is a 

population that needs additional vaccine doses or a population that may need other prevention 

measures, such as monoclonal antibodies.

The WG also highlighted the issue of mix-and-match, or more formally, a heterologous primary 

series and booster vaccine. Recent studies from Europe47 have assessed heterologous primary

series with a Pfizer and AstraZeneca (AZ) vaccine with reassuring results. Information can 

definitely be learned from these studies. Evidence also is needed regarding the ability to use 

different vaccines as a booster than what was used in the primary series, including studies 

specific to US-authorized vaccine.

To highlight additional data that may be forthcoming,

48 there will be data from the Phase 1, 2,

and 3 clinical trials. This will include kinetics and duration of the antibody response, as well as 

efficacy from the early phase clinical trials. In addition, the Biologics License Application (BLA)

submissions should include efficacy for approximately 6 months. To inform the heterologous 

boost, defined as a primary series followed by a different boost vaccine, there is an NIHsponsored study that is looking to address this, with the results expected late Summer 2021. In 

terms of the booster-specific studies, Moderna published preliminary results in May that were 

45 Werbel et al. Annals of Internal Medicine. https://www.acpjournals.org/doi/pdf/10.7326/L21-0282

46 Longlune et al.. Nephrology Dialysis Transplantation, gfab193, https://doi.org/10.1093/ndt/gfab193

https://clinicaltrials.gov/ct2/show/NCT04885907

47 Borobia et. Al Reactogenicity and Immunogenicity of BNT162b2 in Subjects Having Received a First Dose of ChAdOx1s: Initial 

Results of a Randomized, Adaptive, Phase 2 Trial (CombiVacS). Available at SSRN: https://ssrn.com/abstract=3854768; Shaw 

et. al Heterologous prime-boost COVID-19 vaccination: initial reactogenicity data, ISSN 0140-6736, 

https://doi.org/10.1016/S0140-6736(21)01115-6; Hillus D, Schwarz T, Tober-Lau P, et al. Safety, reactogenicity, and 

immunogenicity of homologous and heterologous prime-boost immunization with ChAdOx1-nCoV19 and BNT162b2: a 

prospective cohort study. medRxiv; 2021. DOI: 10.1101/2021.05.19.21257334.Schmidt et al. medRxiv preprint (June 15 2021): 

https://doi.org/10.1101/2021.06.13.21258859

48 https://www.nih.gov/news-events/news-releases/nih-clinical-trial-evaluating-mixed-covid-19-vaccine-schedules-begins
ACIP Meeting Summary June 23, 2021

33

described earlier in this presentation. Additional data on mRNA-1273 vaccine and other variant 

vaccines as boosters is expected late Summer or early Fall of 2021. Pfizer’s data on their 

BNT162b2 (30μg) vaccine and variant booster studies is expected during the same timeframe 

as well.

To highlight data from CDC, vaccine breakthrough cases will be tracked and severity of disease

and genomic sequences specifically to monitor for variants of concern will continue to be 

monitored. VE studies over time will continue to be monitored to stratify by age, time since 

vaccination, setting, and medical conditions. It is important to note that the ability to track

waning VE could be impacted by the declining incidence and changes in variant prevalence. In

addition, over time, individuals who are vaccinated may become increasingly less comparable to 

the unvaccinated population. This will need to be considered in terms of both study design and 

study interpretation.

There are many studies ongoing to assess the VE and vaccine breakthrough cases, three of 

which Dr. Oliver highlighted. The Healthcare, Emergency Response, and Other Essential 

Workers Surveillance Study-Research on the Epidemiology of SARS-CoV-2 in Essential 

Response Personnel (HEROES-RECOVER) study is following around 5000 essential workers 

with weekly SARS-CoV-2 testing and quarterly serology. To date, they have fully vaccinated 

populations that have been followed for around 4 months post-vaccination, and they plan to 

assess neutralizing antibodies at 6 months post-vaccination to inform duration of protection. The 

VISION VE Network is a multi-state network of 8 integrated care systems and research centers.

They assess COVID disease by confirmed molecular assays and vaccination documented by 

EHRs and registries. The network plans to assess waning effectiveness using a test-negative 

VE design. The Influenza and Other Viruses in the Acutely Ill Network (IVY VE Network) is a 

collaboration of hospital-based investigators through 18 tertiary academic medical centers in 16 

states. They plan to assess duration of protection by adapting prior methods used for influenza.

This is not a comprehensive list of studies, but highlights some of the larger studies as a 

representation of upcoming data that are expected.

Attempting to put everything together, later this Summer and early Fall, CDC expects to receive 

manufacturer data on safety and immunogenicity of booster doses, longer-term trial follow-up,

and results from the mix-and-match studies. In early Fall, COVID epidemiology will be 

monitored closely for any possible increase in cases, COVID variants, VE studies, and 

assessment of vaccine breakthrough cases. There will continue to be ACIP meetings during 

which updates will be provided on all of these data as they become available. A vote to 

recommend boosters in any population could occur whenever data support updating policy.

These data were reviewed with the workgroup as well. Their interpretation was that

recommendations for booster doses would occur only: 1) After evidence of declining protection 

against illness, such as declines in VE, not only waning antibody response; and/or 2) An escape 

variant, VOC, is substantially impacting vaccine protection. There are not sufficient data to 

support recommendations for booster doses currently, but this will continue to be closely 

monitored. The WG felt that global vaccine availability should be considered in these 

discussions as well.

The following questions were posed for ACIP consideration and deliberation:

1. What does ACIP feel would be needed to move forward with booster recommendations?

2. Is the risk of disease enough to warrant a recommendation for boosters, before additional

data may be available, or would ACIP need to see the data around waning VE and 

breakthrough cases prior to a recommendation for boosters?
ACIP Meeting Summary June 23, 2021

34

Summary of Discussion

• Dr. Fink commented that in the past when the FDA has contemplated the addition of a 

booster dose to a vaccine that has been previously authorized for use as a primary series, 

they have assessed the safety profile of the primary series, including in clinical trials and 

post-authorization use. In addition, they have assessed the safety profile of the booster dose 

as studied in clinical trials. The overall safety database from clinical trials that have 

supported approval of a booster dose typically has not been nearly as large as the size of 

the safety database that would be expected to support initial approval as the primary series 

for a number of reasons. The primary reason is because they are relying on and leveraging 

the vast experience that they typically would have available with post-authorization use of 

the primary series. Unless there is a reason to suspect or be concerned about a specific 

safety issue with an additional dose, the FDA typically would characterize reactogenicity to

the booster dose. Given that evaluation for much less common adverse reactions would be 

outside the realm of what is feasible, the FDA would need to look carefully at the safety 

profiles from clinical trials and post-authorization use for COVID vaccines and the 

reactogenicity profile from clinical trials that typically could be characterized with several 

hundred or slightly more booster dose recipients. If there are specific safety concerns that 

could feasibly be evaluated with a somewhat larger safety database, they would take that 

under consideration as well.

• ACIP members raised some concerns and expressed interest in further information on a 

variety of topics related to data needed to move forward with booster recommendations for 

COVID-19 vaccines and/or whether to recommend boosters, before additional data may be 

available:

➢ Boosters should not become a distraction for the US. Many parts of the US have 

incredibly low vaccination rates, which poses a risk for homegrown variants that may 

spread rapidly across the US when introduced. Before focusing efforts on giving 

everyone boosters, improvement is needed in the overall vaccination rate—

especially for those who continue to be at risk.

➢ Extensive vaccine education continues to be needed for families, friends, coworkers, and religious attendees to emphasize that they must be vaccinated 

themselves to protect those who are immunocompromised, frail, and or live in 

nursing homes/LTCFs. It is critical for people to have their questions answered, to 

have geographic access to vaccines, and to clearly understand that even though 

they are immunized they may still be vulnerable and should consider continuing 

other countermeasures (e.g., masks, social distancing, sanitizer).

➢ It is important to communicate and share with the world. While ACIP is a US-focused 

committee, the world is very small world thanks to air travel and other luxuries. 

Variants are surging and causing large numbers of deaths across the world. To 

prevent further evolution of these variants, the US should provide vaccines to these 

countries. While there has been discussion about sending doses to the rest of the 

world, that is not enough. More needs to be done and there is extra vaccine in this 

country that needs to be distributed to help stop the suffering and the evolution of 

more variants.
ACIP Meeting Summary June 23, 2021

35

➢ The relatively heterogeneous immunocompromised populations represent a common 

theme, given the devastating number of breakthrough infections seen even in fully 

vaccinated individuals. While additional information would be beneficial, this 

population should be offered a booster dose as soon as there is good science on 

which to base a decision to recommend.

➢ As Dr. Fink highlighted, the safety profile should be one of the considerations for 

boosters.

➢ The basic research laboratory data are needed from long-term memory B cell and T 

cell studies and CMI studies.

➢ In the absence of sufficient data to make a recommendation for booster or third 

doses, perhaps a cue that might trigger ACIP to move quickly to make a 

recommendation would be if an uptick is observed in reinfections or new infections 

among people who are considered to be fully vaccinated with the primary series. An 

exception may be making a recommendation for a booster vaccine against a variant 

for which a booster vaccine is not available, though ACIP should be able to make a 

recommendation for a booster of the primary vaccines that were given against wildtype virus.

➢ There are years of experience on the safety and epidemiology of influenza vaccine, 

but the US does not wait until disease is full-blown or there is an outbreak before 

beginning a new vaccine with a different combination of vaccine viruses. Much has 

been learned from the Delta variant that certainly will inform ACIP on whether to 

begin considering a decision on the use of a booster ahead of outbreaks throughout 

the US or the world. This consideration should begin before there is evidence of 

disease from variants if this continues to be an ongoing virus with periodic 

recirculation. While they certainly want to mitigate the risk of severe breakthrough 

disease, breakthrough cases appear to be milder at this time. Perhaps consideration 

should be given to a trigger threshold for a booster dose.

➢ It may be a mistake to administer a booster dose in someone who is elderly or 

immunocompromised without additional safety data, especially given that there have 

been issues with the second dose of mRNA vaccines.

➢ It is important to note that people are already requesting and receiving booster doses 

even though there is not a recommendation.
ACIP Meeting Summary June 23, 2021

36

CERTIFICATION

Upon reviewing the foregoing version of the June 23, 2021 ACIP meeting minutes, Dr. Jose 

Romero, ACIP Chair, certified that to the best of his knowledge, they are accurate and 

complete. His original, signed certification is on file with the Management Analysis and Services 

Office (MASO) of CDC.
ACIP Meeting Summary June 23, 2021

37

ACIP MEMBERSHIP ROSTER

CHAIR

ROMERO, José R, MD, FAAP 

Arkansas Secretary of Health 

Director, Arkansas Department of Health 

Professor of Pediatrics, Pediatric Infectious Diseases 

University of Arkansas for Medical Sciences 

Little Rock, Arkansas 

Term: 10/30/2018-06/30/2021 

EXECUTIVE SECRETARY

COHN, Amanda, MD 

Senior Advisor for Vaccines 

National Center for Immunization and Respiratory Diseases 

Centers for Disease Control and Prevention 

Atlanta, GA 

MEMBERS

AULT, Kevin A, MD, FACOG, FIDSA 

Professor and Division Director 

Department of Obstetrics and Gynecology University of 

Kansas Medical Center 

Kansas City, KS 

Term: 10/26/2018 – 6/30/2022 

BAHTA, Lynn, RN, MPH, CPH 

Immunization Program Clinical Consultant 

Infectious Disease, Epidemiology, Prevention & Control Division 

Minnesota Department of Health 

Saint Paul, Minnesota 

Term: 7/1/2019 – 6/30/2023

BELL, Beth P, MD, MPH 

Clinical Professor 

Department of Global Health, School of Public Health 

University of Washington 

Seattle, WA 

Term: 7/1/2019 – 6/30/2023 
ACIP Meeting Summary June 23, 2021

38

BERNSTEIN, Henry, DO, MHCM, FAAP 

Professor of Pediatrics 

Zucker School of Medicine at Hofstra/Northwell 

Cohen Children’s Medical Center 

New Hyde Park, NY 

Term: 11/27/2017-06/30/2021 

CHEN, Wilbur H, MD, MS, FACP, FIDSA 

Professor of Medicine 

Center for Vaccine Development and Global Health 

University of Maryland School of Medicine 

Baltimore, MD 

Term: 12/23/2020 – 6/30/2024 

DALEY, Matthew F, MD 

Senior Investigator 

Institute for Health Research, Kaiser Permanente Colorado 

Associate Professor of Pediatrics 

University of Colorado School of Medicine 

Aurora, CO 

Term: 1/4/2021 – 6/30/2024 

FREY, Sharon E, MD 

Professor and Associate Director of Clinical Research 

Clinical Director, Center for Vaccine Development 

Division of Infectious Diseases, Allergy and Immunology 

Saint Louis University Medical School 

Saint Louis, MO 

Term: 11/27/2017-06/30/2021 

KOTTON, Camille Nelson, MD, FIDSA, FAST 

Clinical Director, Transplant and Immunocompromised Host Infectious Diseases 

Infectious Diseases Division, Massachusetts General Hospital 

Associate Professor of Medicine, Harvard Medical School 

Boston, MA 

Term: 12/23/2020 – 6/30/2024 

LEE, Grace M, MD, MPH 

Associate Chief Medical Officer for Practice Innovation 

Lucile Packard Children’s Hospital 

Professor of Pediatrics, Stanford University School of Medicine 

Stanford, CA 

Term: 7/1/2016 – 6/30/2021 
ACIP Meeting Summary June 23, 2021

39

LONG, Sarah S, MD 

Professor of Pediatrics 

Drexel University College of Medicine 

Section of Infectious Diseases 

St. Christopher’s Hospital for Children 

Philadelphia, Pennsylvania 

Term: 12/24/2020 – 6/30/2024 

MCNALLY, Veronica V, JD 

President and CEO Franny 

Strong Foundation 

West Bloomfield, Michigan 

Term: 10/31/2018 – 6/30/2022 

POEHLING, Katherine A, MD, MPH 

Professor of Pediatrics and Epidemiology and Prevention 

Director, Pediatric Population Health 

Department of Pediatrics 

Wake Forest School of Medicine

Winston-Salem, NC 

Term: 7/1/2019 – 6/30/2023 

SÁNCHEZ, Pablo J, MD 

Professor of Pediatrics 

The Ohio State University – Nationwide Children’s Hospital 

Divisions of Neonatal-Perinatal Medicine and Pediatric Infectious Diseases 

Director, Clinical & Translational Research (Neonatology) 

Center for Perinatal Research 

The Research Institute at Nationwide Children's Hospital Columbus, Ohio 

Term: 7/1/2019 – 6/30/2023 

TALBOT, Helen Keipp, MD 

Associate Professor of Medicine 

Vanderbilt University 

Nashville, TN 

Term: 10/29/2018 – 6/30/2022 

EX OFFICIO MEMBERS 

Centers for Medicare and Medicaid Services (CMS)

HANCE, Mary Beth 

Senior Policy Advisor 

Division of Quality, Evaluations and Health Outcomes 

Children and Adults Health Programs Group 

Center for Medicaid, CHIP and Survey & Certification Centers 

for Medicare and Medicaid Services Baltimore, MD 
ACIP Meeting Summary June 23, 2021

40

Food and Drug Administration (FDA) 

FINK, Doran, MD, PhD 

Deputy Director, Clinical, Division of Vaccines and Related Products Applications 

Office of Vaccines Research and Review 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

Silver Spring, MD 

Health Resources and Services Administration (HRSA) 

RUBIN, Mary, MD 

Chief Medical Officer 

Division of Injury Compensation Programs 

Rockville, MD 

Indian Health Service (IHS) 

WEISER, Thomas, MD, MPH 

Medical Epidemiologist 

Portland Area Indian Health Service 

Portland, OR 

Office of Infectious Disease and HIV/AIDS Policy (OIDP)

KIM, David, MD, MA 

Director, Division of Vaccines, OIDP 

Office of the Assistant Secretary for Health 

Department of Health and Human Services 

Washington, DC 

National Institutes of Health (NIH) 

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) Bethesda, MD 

LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP)

ROCKWELL, Pamela G, DO 

Associate Professor, Department of Family Medicine, University of 

Michigan Medical School 

Medical Director, Dominos Farms Family Medicine 

Ann Arbor, MI 

American Academy of Pediatrics (AAP) 

MALDONADO, Yvonne, MD 

Senior Associate Dean for Faculty Development and Diversity 

Professor of Pediatrics and Health Research and Policy 

Chief, Division of Pediatric Infectious Diseases 

Stanford University School of Medicine Stanford, CA 
ACIP Meeting Summary June 23, 2021

41

American Academy of Pediatrics (AAP) 

Red Book Editor

KIMBERLIN, David, MD 

Professor of Pediatrics 

Division of Pediatric Infectious Diseases 

The University of Alabama at Birmingham School of Medicine Birmingham, AL 

American Academy of Physician Assistants (AAPA) 

LÉGER, Marie-Michèle, MPH, PA-C 

Senior Director, Clinical and Health Affairs 

American Academy of Physician Assistants Alexandria, VA 

American College Health Association (ACHA) 

CHAI, Thevy S., MD 

Director of Medical Services 

Campus Health Services 

University of North Carolina at Chapel Hill Chapel Hill, 

NC 

American College Health Association (ACHA) (alternate) 

MCMULLEN, Sharon, RN, MPH, FACHA 

Assistant Vice President of Student & Campus Life for Health and Wellbeing Cornell Health 

Ithaca, NY 

American College of Nurse Midwives (ACNM) 

HAYES, Carol E., CNM, MN, MPH 

Lead Clinician 

Clinical Quality Compliance and Management 

Planned Parenthood Southeast Atlanta, GA 

American College of Nurse Midwives (ACNM) (alternate) 

MEHARRY, Pamela M., PHD, CNM 

Midwifery Educator, Human Resources for Health 

In partnership with University of Rwanda and University of Illinois, Chicago 

American College of Obstetricians and Gynecologists (ACOG) 

ECKERT, Linda O, MD, FACOG 

Professor, Department of Obstetrics & Gynecology 

Adjunct Professor, Department of Global Health 

University of Washington 

Seattle, WA

American College of Physicians (ACP) 

GOLDMAN, Jason M, MD, FACP 

Affiliate Assistant Professor of Clinical Biomedical Science, Florida Atlantic University, Boca 

Raton, Florida 

Private Practice 

Coral Springs, FL 
ACIP Meeting Summary June 23, 2021

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American Geriatrics Society (AGS) 

SCHMADER, Kenneth, MD 

Professor of Medicine-Geriatrics Geriatrics 

Division Chief 

Duke University and Durham VA Medical Centers 

Durham, NC 

America’s Health Insurance Plans (AHIP) 

GLUCKMAN, Robert A, MD, MACP 

Chief Medical Officer, Providence Health Plans 

Beaverton, OR 

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA Washington, DC 

American Medical Association (AMA)

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine Emory 

University School of Medicine 

Atlanta, GA 

American Nurses Association (ANA) 

RITTLE, Charles (Chad), DNP, MPH, RN Assistant 

Professor, Nursing Faculty 

Chatham University, School of Health Sciences 

Pittsburgh, PA 

American Osteopathic Association (AOA) 

GROGG, Stanley E, DO 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA) 

FOSTER, Stephan L, PharmD CAPT 

(Ret) USPHS 

Professor, College of Pharmacy 

University of Tennessee Health Sciences Center 

Memphis, TN 

Association of Immunization Managers (AIM) 

HOWELL, Molly, MPH 

Immunization Program Manager 

North Dakota Department of Health

Bismarck, ND 
ACIP Meeting Summary June 23, 2021

43

Association for Prevention Teaching and Research (APTR) 

McKINNEY, W Paul, MD 

Professor and Associate Dean 

University of Louisville School of Public Health and Information Sciences

Louisville, KY 

Association of State and Territorial Health Officials (ASTHO) 

SHAH, Nirav D, MD, JD 

Director

Maine Center for Disease Control and Prevention

Augusta, ME 

Biotechnology Industry Organization (BIO) 

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy 

Washington, DC 

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

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

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 

Canadian National Advisory Committee on Immunization (NACI) 

QUACH, Caroline, MD, MSc 

Pediatric Infectious Disease Specialist and Medical Microbiologist 

Medical Lead, Infection Prevention and Control Unit 

Medical Co-director – Laboratory Medicine, Optilab 

Montreal-CHUM 

Montreal, Québec, Canada 

Infectious Diseases Society of America (IDSA) 

BAKER, Carol J., MD 

Professor of Pediatrics 

Molecular Virology and Microbiology 

Baylor College of Medicine 

Houston, TX 
ACIP Meeting Summary June 23, 2021

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International Society for Travel Medicine (ISTM) 

BARNETT, Elizabeth D, MD Professor of 

Pediatrics 

Boston University School of Medicine 

Boston, MA 

National Association of County and City Health Officials (NACCHO)

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 

National Association of County and City Health Officials (NACCHO) (alternate)

DUCHIN, Jeffrey, MD 

Health Officer and Chief, Communicable Disease

Epidemiology and Immunization Section 

Public Health - Seattle and King County 

Professor in Medicine 

Division of Allergy and Infectious Diseases 

University of Washington School of Medicine and School of Public Health

Seattle, WA 

National Association of Pediatric Nurse Practitioners (NAPNAP) 

STINCHFIELD, Patricia A, RN, MS, CPNP 

Director 

Infectious Disease/Immunology/Infection Control

Children's Hospitals and Clinics of Minnesota 

St. Paul, MN 

National Foundation for Infectious Diseases (NFID) 

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 

National Foundation for Infectious Diseases (NFID) (alternate)

DALTON, Marla, PE, CAE 

Executive Director & CEO 

National Foundation for Infectious Diseases (NFID) 

Bethesda, MD 

National Medical Association (NMA) 

WHITLEY-WILLIAMS, Patricia, MD Professor and Chair 

University of Medicine and Dentistry of New Jersey Robert Wood 

Johnson Medical School 

New Brunswick, NJ 
ACIP Meeting Summary June 23, 2021

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Pediatric Infectious Diseases Society (PIDS) 

O’LEARY, Sean, MD, MPH 

Associate Professor of Pediatrics 

Pediatric Infectious Diseases 

General Academic Pediatrics 

Children’s Hospital Colorado 

University of Colorado School of Medicine 

Pediatric Infectious Diseases Society (PIDS) (alternate)

SAWYER, Mark H, MD 

Professor of Clinical Pediatrics 

University of California, San Diego School of Medicine 

San Diego, CA 

Pharmaceutical Research and Manufacturers of America (PhRMA) 

ROBERTSON, Corey, MD, MPH 

Senior Director, US Medical, Sanofi Pasteur 

Swiftwater, PA 

Society for Adolescent Health and Medicine (SAHM) 

MIDDLEMAN, Amy B, MD, MSEd, MPH 

Professor of Pediatrics 

Chief, Section of Adolescent Medicine 

University of Oklahoma Health Sciences Center

Oklahoma City, OK 

Society for Healthcare Epidemiology of America (SHEA)

DREES, Marci, MD, MS 

Chief Infection Prevention Officer & Hospital Epidemiologist 

ChristianaCare 

Wilmington, DE 

Associate Professor of Medicine 

Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA 
ACIP Meeting Summary June 23, 2021

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ACRONYMS USED IN THE DOCUMENT

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics

ACC American College of Cardiology 

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices

ACOG American College of Obstetricians and Gynecologists

ACP American College of Physicians 

AE Adverse Event

AGS American Geriatric Society 

AHA American Heart Association 

AHIP America’s Health Insurance Plans

AIM Association of Immunization Managers 

AMA American Medical Association

AOA American Osteopathic Association 

APhA American Pharmacists Association 

APTR Association for Prevention Teaching and Research

ASTHO Association of State and Territorial Health Officers 

AZ AstraZeneca

BLA Biologics License Application

CBER Center for Biologics Evaluation and Research 

CDC Centers for Disease Control and Prevention

CISA Clinical Immunization Safety Assessment 

CMI Cell-Mediated Immunity 

CMS Center for Medicare and Medicaid Services

COD Cause of Death

COI Conflict of Interest 

COVID-19 Coronavirus Disease 2019 

CSTE Council of State and Territorial Epidemiologists 

CVST Cerebral Venous Sinus Thrombosis 

DoD Department of Defense

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs

DVRPA Division of Vaccines and Related Product Applications 

DVT Deep Vein Thrombosis 

ECG/EKG Electrocardiogram 

ED Emergency Department 

EHR Electronic Health Record 

EIS Epidemic Intelligence Service 

EIP Emerging Infections Program 

ELISA Enzyme-Linked Immunosorbent 

EMA European Medicines Agency 

EtR 

Framework

Evidence to Recommendations Framework

EUA Emergency Use Authorization 

FDA Food and Drug Administration

FQHCs Federally Qualified Health Center 
ACIP Meeting Summary June 23, 2021

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GRADE Grading of Recommendations, Assessment, Development and Evaluations

HAN Health Alert Network 

HCP Health Care Personnel / Provider / Professional 

HCW Health Care Workers 

HEROESRECOVERHealthcare, Emergency Response, and Other Essential Workers Surveillance 

Study-Research on the Epidemiology of SARS-CoV-2 in Essential Response 

Personnel

HFpEF Ejection Fraction 

HHS (Department of) Health and Human Services

HIPAA Health Insurance Portability and Accountability Act 

HIT Heparin-Induced Thrombocytopenia 

HRSA Health Resources and Services Administration 

IAC Immunization Action Coalition

ICU Intensive Care Unit 

ID Identifier 

IDSA Infectious Disease Society of America 

IHS Indian Health Service 

IM Intramuscular 

ISO Immunization Safety Office

ISTM International Society for Travel Medicine 

IVIG Intravenous Immune Globulin 

IVY VE 

Network

Influenza and Other Viruses in the Acutely Ill Network 

J&J Johnson & Johnson 

MASO Management Analysis and Services Office 

MedDRA Medical Dictionary for Regulatory Activities 

MIS-C Multisystem Inflammatory Syndrome in Children 

MMWR Morbidity and Mortality Weekly Report

MRI Magnetic Resonance Imaging 

mRNA Messenger Ribonucleic Acid 

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada

NAPNAP National Association of Pediatric Nurse Practitioners 

NCEZID National Center for Emerging and Zoonotic Infectious Diseases 

NCHHSTP National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention 

NCIRD National Center for Immunization and Respiratory Diseases 

NEJM New England Journal of Medicine 

NFID National Foundation for Infectious Diseases 

NIH National Institutes of Health

NMA National Medical Association 

NSAIDS Nonsteroidal Anti-Inflammatory Agents

OB-GYN Obstetrics and Gynecology 

PE Pulmonary Embolism 

PF4 Platelet Factor 4 

PHAC Public Health Agency Canada 

PhRMA® Pharmaceutical Research and Manufacturers of America®

PI Principal Investigator

PIDS Pediatric Infectious Disease Society 

RCA Rapid Cycle Analysis 
ACIP Meeting Summary June 23, 2021

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RCT Randomized Controlled Trial

RR Relative Risk

RT-PCR Reverse Transcriptase Polymerase Chain Reaction

SAE Serious Adverse Event 

SAHM Society for Adolescent Health and Medicine 

SARS Severe Acute Respiratory Syndrome 

SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus-2 

SHEA Society for Healthcare Epidemiology of America 

SMEs Subject Matter Experts

TCM Traditional Chinese Medicine 

TTS Thrombosis with Thrombocytopenia Syndrome 

UK United Kingdom

US United States

VA (US Department of) Veteran’s Affairs 

VAERS Vaccine Adverse Event Reporting System

VaST ACIP COVID-19 Vaccine Safety Technical Work Group 

VOC Variant of Concern 

VOHC Variant of High Consequence 

VOI Variant of Interest 

VSD Vaccine Safety Datalink

VTE Venous Thromboembolism 

WG Work Group

WGS Whole Genome Sequencing 

WHO World Health Organization