MEETING OF THE ADVISORY 

COMMITTEE ON IMMUNIZATION 

PRACTICES (ACIP)

FEBRUARY 4, 2022

SUMMARY MINUTES

TABLE OF CONTENTS

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

Friday: February 4, 2022............................................................................................................................... 2

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

Call to Order/Roll Call ............................................................................................................ 2

CDC Announcements ............................................................................................................ 2

FDA Announcements............................................................................................................. 3

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

Session Introduction .............................................................................................................. 4

Public Comment .................................................................................................................... 9

Updates on Myocarditis and Pericarditis Following Moderna COVID-19 Vaccination.........15

Update on Myocarditis Outcomes: MOVING .......................................................................19

VaST Assessment ...............................................................................................................22

GRADE: Moderna COVID-19 Vaccine ................................................................................24

EtR Framework: Moderna COVID-19 Vaccine Primary Series in Adults ≥18 Years of Age 30

Discussion Summary ...........................................................................................................36

Vote: Moderna COVID-19 Vaccine for Individuals ≥18 Years of Age..................................37

Updates to Clinical Considerations......................................................................................38

Canadian Experience and Evidence with COVID-19 Vaccine Primary Series Extended 

Intervals ...............................................................................................................................42

VSD: Myocarditis after Moderna and Pfizer/BioNTech COVID-19 Vaccine ........................49

Myocarditis and COVID-19 Vaccine Intervals: International Data and Policies...................52

Summary and WG Interpretation: Extended Intervals for mRNA COVID-19 Vaccines .......56

CERTIFICATION.........................................................................................................................................62

ACIP MEMBERSHIP ROSTER...................................................................................................................63

ACRONYMS USED IN THIS DOCUMENT................................................................................................. 72
ACIP Meeting Summary February 4, 2022

2 

MEETING PURPOSE

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

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

Immunization Practices (ACIP) on February 4, 2022. The meeting took place remotely via 

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

which focused on COVID-19 vaccine safety and efficacy, myocarditis and pericarditis following 

Moderna COVID-19 vaccine, myocarditis after Moderna and Pfizer/BioNTech COVID-19 

vaccine, Moderna COVID-19 vaccine primary series for individuals ≥18 years of age, Canadian 

experience and evidence with COVID-19 vaccine primary series extended intervals, and

extended intervals for mRNA COVID-19 vaccines in the US. 

FRIDAY: FEBRUARY 4, 2022

WELCOME AND INTRODUCTIONS

Call to Order/Roll Call

Dr. Grace Lee (ACIP Chair) called to order and presided over the February 4, 2022 ACIP 

meeting. She conducted a roll call, which established that a quorum was present. No conflicts of 

interest (COIs) were declared. A list of Members, Ex Officios, and Liaison Representatives is 

included in the appendixes at the end of this summary document. The following conflict of 

interest (COI) was declared: Dr. Chen reported that his employing institution, the University of 

Maryland, received a grant from Emergent BioSolutions that supported work he conducted to 

develop a Shigella vaccine. 

CDC Announcements

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

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

voting ACIP Voting Members, Ex Officios, and Liaisons. She indicated that the ACIP is

at its heart a public body. Engagement with the public and transparency in the ACIP processes 

is vital to the committee’s work. She indicated that there would be an oral public comment 

session prior to the vote at approximately 11:10 AM Eastern Time (ET). To create a fair and 

more efficient process for requesting to make an oral comment, people interested

in making an oral comment are requested to submit a request online in advance of the meeting.

Priority is given to these advanced requests, and if more people request to speak than can be 

accommodated, a blind lottery is conducted to determine who the speakers will be. Speakers 

selected in the lottery for this meeting were notified in advance of the meeting. Members of the 

public also can submit public comments through https://www.regulations.gov using Docket 

Number CDC-2022-0022. Information on the written public comment process, as well as 

information on how to make a comment, can be found on the ACIP meeting website. As noted 

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

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

interests that potentially enhance a member’s expertise, CDC has issued limited COI waivers. 

Members who conduct vaccine clinical trials or serve on data safety monitoring boards (DSMBs) 

may present to the committee on matters related to those vaccines, but these members are 

prohibited from participating in committee votes on issues related to those vaccines. Regarding 
ACIP Meeting Summary February 4, 2022

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other vaccines of the concerned company, a member may participate in discussions with the 

provision that he or she abstains from all votes related to the vaccines of that company. ACIP 

members state any COIs at the beginning of each meeting.

FDA Announcements

Dr. Doran Fink (FDA) shared 2 announcements on behalf of FDA. First, FDA granted full 

approval on Monday, January 31, 2022 of Moderna’s COVID-19 vaccine, now known as 

Spikevax®, for use in people ≥18 years of age as a 2-dose primary series.1 Moderna COVID-19 

vaccine has been available under Emergency Use Authorization (EUA) for individuals ≥18 years 

of age since December 18, 2020. FDA’s approval was based on updated data and analyses 

from the same Phase 3 clinical trial involving approximately 30,000 participants that initially 

supported the EUA in December 2020. FDA’s approval also considered real-world experience

from post-authorization use of the vaccine in many millions of individuals. In the updated 

efficacy analyses, which included a median placebo-controlled blinded follow-up of 4 months, 

VE (VE) against any symptomatic COVID starting 14 days after Dose 2 was approximately 93% 

and VE against severe COVID was approximately 98%. The review of safety data from 

additional follow-up conducted in the clinical trial, as well as data from the post-authorization 

experience, did not raise any new safety concerns compared to the safety profile that the FDA

labeled in the EUA Fact Sheet. Important but very uncommon adverse reactions continue to be 

anaphylaxis and myocarditis and pericarditis, particularly following Dose 2 and among males 

less than 40 years of age. The approved US prescribing information for Spikevax® includes 

warnings about these adverse reactions, which will continue to be followed through postmarketing surveillance. FDA recognizes that approval of the Biologics License Application (BLA) 

Spikevax® represents an important step in building and maintaining the armamentarium of 

countermeasures against COVID-19, as well as an important regulatory step for this particular 

vaccine. It certainly will not be the last step. There are other uses of this vaccine, such as 

booster doses that are currently available under the EUA. Work is ongoing to eventually 

transition some of these products over to licensure. FDA anticipates that in the future, there will 

be supplements to the license or amendments to the EUA to address other needs as they arise.

Second, FDA announced publicly earlier in the week that the Vaccines and Related Biological 

Products Advisory Committee (VRBPAC) would meet on February 15, 2022. In mid-December, 

Pfizer/BioNTech announced initial safety and immunogenicity results from infants and children 6 

months to 4 years of age enrolled in their ongoing clinical trial of the Pfizer/BioNTech COVID-19 

vaccine. Pfizer/BioNTech also announced their plans to amend the trial to evaluate a third dose

of the vaccine in this age group. As reports of pediatric hospitalizations increase in association

with the Omicron variant surge in late December 2021, FDA requested Pfizer to provide more 

detailed data for review as the information became available. At the same time, FDA has 

received many inquiries from healthcare providers, advocacy groups, and the general public 

expressing intense interest in the details of the data and prospects for EUA of the vaccine

for use in this age group. During its ongoing review, FDA recognized that additional 

immunogenicity and efficacy data have become available to better inform vaccine benefits. In 

the meantime, the Omicron surge is now receding in some parts of the nation but is certainly not 

over. Furthermore, it is imperative not only to react to the present situation but also to be 

prepared when confronted with the next unexpected twist. The decision to hold this VRBPAC 

was motivated not only by the need for transparency on the newly available data, but also on 

the declining unpredictability of the pandemic. FDA intends to conduct an open, transparent,

1 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-action-approving-secondcovid-19-vaccine 
ACIP Meeting Summary February 4, 2022

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and thorough discussion of the available data; to listen carefully to the assessment of its expert 

committee members, and to end the meeting better prepared to build upon FDA’s response to 

COVID-19 whether this follows from a clear recommendation for an authorization or from

recommendations for additional data that could support an expedient authorization in the near 

future.

CORONAVIRUS DISEASE 2019 (COVID-19) VACCINES

Session Introduction

Dr. Matthew Daley (ACIP, WG Chair) provided the session introduction on behalf of the ACIP 

COVID-19 Vaccines Work Group (WG). Through January 30, 2022, there have been over 75

million cases of COVID-19 in the US since the start of the pandemic. the case range had 

reached approximately 497,000 per day.2 Although case counts have been declining in the last 

several weeks, the US is still averaging hundreds of thousands of cases of COVID-19 every 

day. During the pandemic, more than 880,000 individuals in the US have died from COVID-19. 

Based on the most recent 7-day moving average, more than 200,000 individuals will die today 

from COVID-19. Achieving disease prevention requires not only an effective vaccine, but also

an effective vaccination program. There also need to be adequate vaccine supplies, the people

and processes to administer vaccines, and public acceptance of vaccines. More than threequarters of US adults across every age group have received at least 1 dose of a COVID-19 

vaccine. While these are perhaps lower vaccination than hoped, this is still and important 

accomplishment.3 Several recent studies have tried to estimate COVID-19-associated 

hospitalizations and deaths prevented by COVID-19 vaccination in the US. Based on these new 

studies, it has been estimated that up to 10.3 million hospitalizations had been averted through 

November of 2021 through vaccination,4 and an estimated 1.1 million deaths have been averted

through November 2021 by vaccination.5 

In terms of the FDA updates Dr. Fink announced, it is important to note that the Moderna 

COVID-19 vaccine remains under EUA for the following indications:

 Third primary series doses for individuals 18 years of age and older who have been 

determined to have certain kinds of immunocompromise

 Single booster dose for individuals 18 year of age and older at least 5 months after 

completing a primary series

During January and February 2022, the COVID-19 Vaccines WG has reviewed data on the 

safety and efficacy of Modern COVID-19 vaccine from the Phase 3 clinical trials; a metaanalysis for global real-world effectiveness data from Moderna COVID-19 vaccine; safety

updates for Modern COVID-19 vaccine specifically and for mRNA COVID-19 vaccines in 

general; addition, GRADE (Grading of Recommendation Assessment, Development and 

Evaluation) and the Evidence to Recommendations (EtR) Framework data for Moderna COVID2 https://covid.cdc.gov/covid-data-tracker/#trends_dailycases Accessed February 1, 2022 3 https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends Accessed February 01, 2022 4 Moghadas SM, Sah P, Fitzpatrick MC, et al. COVID-19 deaths and hospitalizations averted by rapid vaccination rollout in the 

United States. medRxiv. Published online July 8, 2021:2021.07.07.21260156; doi:10.1101/2021.07.07.21260156; and Eric C. 

Schneider, Arnav Shah, Pratha Sah, Seyed M. Moghadas, Thomas Vilches, Alison Galvani. The U.S. COVID-19 Vaccination 

Program at One Year: How Many Deaths and Hospitalizations Were Averted.

5 Moghadas SM, Sah P, Fitzpatrick MC, et al. COVID-19 deaths and hospitalizations averted by rapid vaccination rollout in the 

United States. medRxiv. Published online July 8, 2021:2021.07.07.21260156; doi:10.1101/2021.07.07.21260156; and Gupta S, 

Cantor J, Simon KI, Bento AI, Wing C, Whaley CM. Vaccinations Against COVID-19 May Have Averted Up To 140,000 Deaths In 

The United States. Health Aff (Millwood). 2021;40(9):1465-1472. 
ACIP Meeting Summary February 4, 2022

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19 vaccine primary series; global data for myocarditis after mRNA COVID-19 vaccines; and 

emerging data about safety/effectiveness of longer inter-dose intervals for mRNA COVID-19 

vaccines. The agenda for this meeting included the following presentations:

 mRNA 1273 COVID-19 vaccine BLA safety and efficacy data (followed by Public Comment)

 Updates on myocarditis and pericarditis following Moderna COVID-19 vaccination

 Updates on myocarditis outcomes from the MOVING study, which is looking at longer-term 

outcomes following vaccine-associated myocarditis

 Vaccine Safety Technical Subgroup (VaST) assessment of the current state of knowledge 

around COVID-19 vaccine safety specifically focused on Moderna COVID-19 vaccination 

 GRADE: Moderna COVID-19 vaccine

 EtR Framework regarding the use of Moderna COVID-19 vaccine for a primary series in 

individuals ≥18 years of age

 Vote on the routine use of Moderna COVID-19 vaccine for individuals ≥18 years of age

 Updates to Clinical Course

 Canadian experience and evidence with COVID-19 vaccine primary series extended 

intervals

 Vaccine Safety Datalink (VSD): Myocarditis after Moderna and Pfizer/BioNTech COVID-19 

vaccines

 Myocarditis and COVID-19 vaccine intervals: International data and policies

 Summary and Work Group Interpretation: Extended intervals for mRNA COVID-19 vaccines

Overview of BLA for Use of Moderna’s COVID-19 Vaccine (Spikevax®) in Individuals ≥18 

Years of Age

Rituparna Das, MD, PhD (Moderna) present an overview of the BLA for the Moderna COVID19 vaccine or Spikevax®, which was approved at the beginning of the week. She discussed the 

contents of the BLA and Phase 3 safety and efficacy data. The follow-up time included 5.3 

months post-vaccination for the blinded study and 7.6 months for the blinded and open-label 

phases of the study together. The BLA does not include the authorized indication for a third 100 

μg dose for immunocompromised populations (EUA approved August 13, 2021), an indication 

for the 50 μg booster dose (EUA approved October 18, 2021), or data for the Omicron variant. 

Therefore, these were not covered in this presentation. Spikevax® is indicated for immunization

to prevent COVID-19 caused by SARS-CoV-2 in individuals ≥18 years of age. It is administered 

as an intramuscular injection in a series of 2 doses 0.5 mL in volume 1 month apart. 

Protocol 301, the Coronavirus Efficacy (COVE) trial, is the pivotal safety and efficacy study. This 

study enrolled 30,400 people who were randomized 1:1 to receive the vaccine mRNA-1273 or a

saline placebo, with about 15,200 in each group. The study started in July 2020 and completed 

enrollment by October 2020. The initial efficacy readout came from the interim analysis, which 

was at the end of November 2020. That led to the approval of the EUA on December 18, 2020. 

Thereafter, participants were offered unblinding and placebo recipients were allowed to be 

vaccinated. All participants then continued to be followed in an open-label manner according

to the original schedule of events. At baseline, all participants had a nasopharyngeal (NP) swab

and a blood sample to assess their SARS-CoV-2 status. After vaccination, everybody was given 

an e-diary to monitor solicited adverse events (AEs) for 7 days. Unsolicited AEs were monitored 

via weekly phone calls for 28 days. The same protocol was repeated after Dose 2. Serious

adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events 

leading to discontinuation were to be monitored for the duration of the study, which was planned 

to be 2 years. Throughout the study, case monitoring was conducted through weekly eDiary 

prompts and monthly phone calls. If the participants met the criteria for a clinic visit, went to the
ACIP Meeting Summary February 4, 2022

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site, had a sample collected for central laboratory testing, and were followed daily through 

telemedicine contact for 14 days or until the resolution of symptoms, whichever was longer.

Additional clinic visits were planned for 3, 6, 12, and 24 months after vaccination. 

Regarding demographics, the mean age of the population in the study was about 52 years. The 

goal of the study was to reach the populations most affected by severe COVID-19. Accordingly, 

25% of participants were ≥65 years of age. About 1,500 participants were ≥75 years of age and 

another 17% were 18-64 years of age with comorbid conditions including chronic lung disease 

or moderate to severe asthma, significant cardiac disease, obesity, diabetes, liver disease, or 

stable human immunodeficiency viruses (HIV) infection. The HIV group had about 90 

participants in the vaccine and placebo groups. Baseline SARS-CoV-2 status was assessed. 

Approximately 2% of participants had baseline evidence of prior SARS-CoV-2 infections. The 

racial and ethnic distribution of the study was generally similar to the US population, and this 

was a key objective in the recruitment of the study. There were 10% Black or African American 

participants and 20% Hispanic or Latino participants.

In terms of safety, solicited injection site reactions were more common among vaccine 

recipients compared to placebo recipients. Following Dose 1, injection site pain among 

participants 18-64 years and ≥65 years was the most common reaction and local reactions were 

very similar between these age groups. Solicited local reactions after Dose 2 were very similar

and were primarily Grade 1 or 2. Overall, local reactions also were of short duration and 

generally resolved in 1 to 3 days. Delayed local reactions with an onset after 7 days were seen

but were relatively rare, occurring in 2.4% of vaccine recipients and 1.45% of placebo recipients.

The solicited system reaction, most of which were Grade 1 or 2, were observed more frequently 

in vaccine compared to placebo recipients. Fatigue and headache were the most common 

reaction. Solicited reactions were more common following Dose 2 compared to Dose 1. 

Participants ≥65 years had a numerically lower reactogenicity compared to their younger 

counterparts. The duration of solicited systemic AEs also were short, ranging from 1 to 3 days.

Unsolicited events occurring within 28 days of vaccination were similar among vaccine and 

placebo groups. MAAEs, SAEs, and deaths also were similar. Broken down by System Organ 

Class (SOC), SAEs were generally balanced. The same was noted for MAAEs. 

Looking specifically at myocarditis and pericarditis, there were no myocarditis events during the 

blinded or the open label periods of the study. In the blinded phase, there were 2 pericarditis

events in the vaccine group and 2 in the placebo group. The first event that was considered 

related was in a female 59 years of age with non-serious chest pain, dyspnea, and fatigue 4 

days after Dose 2 that resolved within 2 days. She then experienced chest pain and syncope 68 

days after Dose 2. When pericarditis and effusion were diagnosed, this was considered by the 

investigator to be vaccine-related. The second case was a post-myocardial infarction pericarditis

73 days after Dose 2 that resolved the following day and was considered by the investigator to 

be unrelated. Again, no myocarditis was observed in the open label study. There was 1 

pericarditis event in a 23-year-old male who had COVID-19 about 2 months prior to vaccination. 

Subsequent to vaccination, he developed bradycardia and was diagnosed with a pericardial 

effusion. This also was classified as a vaccine-related event. All of the events of pericarditis that 

occurred in either the blinded phase or the open label phase of the study results.
ACIP Meeting Summary February 4, 2022

7 

Now turning to efficacy. As a reminder, 30,000 participants were randomized to receive vaccine 

or placebo. The first read on efficacy was at the interim analysis conducted in November 2020,

which showed 94.1% efficacy.6 For the BLA, a final blinded analysis was performed with 5.3

months of follow-up that was calculated post-Dose 1 through March 2021. Subsequently, the

study entered the open label phase during which placebo recipients were offered vaccine.

Effectiveness has been followed since then in an open label manner. Additionally, boosting of 

study participants started in September 2021 and is ongoing. In the final analysis of efficacy,7

the results were very similar to the initial interim analysis. There were 744 cases of COVID-19 

infection in the placebo group compared to 55 cases in the vaccine group, for an efficacy of 

93.2%. The median duration of follow-up was 5.3 months. Since the blinded period of the study 

was conducted between July 2020 and March 2021, the predominant SARS-CoV-2 variant 

identified in the majority of the COVID-19 cases were the original variant. Some additional 

variants that were identified (Epsilon, Gamma, and Zeta). The case numbers for the other 

variants were small, but there was no indication that efficacy against other variants was

impacted. There was no Delta or Omicron circulation during that timeframe. Efficacy was 

consistent and durable over the observation period. High efficacy started after vaccination and 

was maintained consistently through >4 months after vaccination. VE to prevent severe COVID19 also was consistent with 106 cases in the placebo group and 2 cases in the vaccine group, 

for an efficacy of 98.2%.

Looking at efficacy by primary and secondary endpoints, even asymptomatic infection was 

prevented by vaccination with an efficacy point estimate of 63%. Efficacy was consistent 

regardless of baseline serostatus. However, the group sizes and the number of cases became 

too small for an analysis of baseline SARS-CoV-2 seropositive only. Demographically, efficacy

was consistent across age groups. Persons ≥65 of age and persons ≥75 years of age had very 

high and consistent efficacy, although the case number had become small at this point. Efficacy 

also was consistent across race and ethnic groups. Efficacy also was similar and consistent

across the co-morbid conditions targeted to be recruited in the trial.

In summary, mRNA-1273 was well-tolerated in individuals ≥18 years of age. Pain was the most 

commonly reported local reaction. Fatigue, headache, myalgia, and arthralgia were the most 

commonly reported systemic reactions. Systemic reactions were more common after Dose 2 

than after Dose 1. There was no difference in AEs for persons 18 to 64 years of age versus

those ≥than 65 years of age. After a median of 5.3 months following Dose 1 of efficacy followup, there was 93.2% efficacy against COVID-19 starting 14 days post-Dose 2. Efficacy was 

98.2% against severe COVID-19 starting 14 days post-Dose 2. There was an 82% reduction of 

infection regardless of symptoms and a 63% reduction in asymptomatic infection starting 14 

days post-Dose 2. Efficacy was consistent regardless of risk factors, age, gender, race, or 

ethnicity. 

Discussion Points

Dr. Poehling asked whether Moderna has had a chance to assess VE for persons with and 

without co-morbid conditions. 

Dr. Das indicated that they have assessed all of the co-morbid conditions identified for the study 

(e.g.,chronic lung disease or moderate to severe asthma, significant cardiac disease, obesity, 

6 Baden et al NEJM, 2020

7 El Sahly, NEJM, 2021
ACIP Meeting Summary February 4, 2022

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diabetes, liver disease, or stable HIV infection). Efficacy was consistently above 80% for all of 

these comorbid conditions.

Referring to Slide 8, Dr. Loehr wondered how the asymptomatic data were assessed. He did not 

see anything about this in terms of blood tests. Referring to Slide 26, he noted that the curve 

flattened for the placebo group and it was not clear why that would occur if they were still getting 

more cases.

Dr. Das indicated that there was no weekly or bi-weekly screening for asymptomatic infection.

The numbers came from the nucleic protein assays. Participants also had NP swabs each time

they had a blood draw, entered the study, and/or presented for a clinic visit. All of the positive

participants were checked for symptom. All of the participants who were positive but did not 

have any symptoms contributed to the asymptomatic infection analysis. In terms of the flattening 

curve, they still were subject to the ebbs and flows of the overall trajectory of the pandemic.

Their COVID-19 infection curve does the same.

Dr. Sanchez observed that on Slide 18, there were 16 deaths in the vaccine group and 16 in the 

placebo group. Only the COVID-related deaths were analyzed, but he inquired as to the cause 

of the other deaths in the vaccine group. In addition, he asked whether they were able to assess 

the development of diabetes during the study.

Dr. Das clarified that the deaths on Slide 18 are total deaths. The COVID-related deaths 

analysis included 3 deaths in the placebo group and no deaths in the vaccine group. None of 

the deaths were considered to be related to the vaccine and are reflective of the type of 

population enrolled (e.g., persons with multiple comorbid conditions). The database was locked 

on May 4th and all of the data are through the March timepoint.

Dr. Das did not recall whether there was a signal for new diabetes and will check with her 

colleagues to determine whether there was a specific analysis performed for new diabetes.

Dr. Poehling asked whether Dr. Das could share more information about the results for 

anaphylaxis in the trial.

Dr. Das indicated that anaphylaxis was balanced between the vaccine and placebo groups. In 

the placebo group, anaphylaxis was reported in 2 participants on Day 10 and Day 11 after the 

first injection. Anaphylaxis also was reported in 2 participants in the vaccine group. The 

anaphylaxis events in the vaccine group were reported almost 2 months after the second dose

and neither was considered to be related. Although an imbalance of anaphylaxis was not seen 

in the trial, anaphylaxis is listed in the label as a possible side effect.

Dr. Sanchez requested information about the severity of the previous COVID-19 infection in the 

23-year-old male patient in the placebo group who developed pericardial effusion after receiving 

the second dose of the vaccine. The question is often raised about how long after having 

COVID-19 someone should wait to be vaccinated.

Dr. Das indicated that this individual was not hospitalized or meet the criteria for severe COVID19 because he was one of the cases in the in the blinded phase of the analysis. His COVID-19 

case was mild. The information Moderna has is that 43 days after Dose 2, he was diagnosed 

with bradycardia and a pericardial effusion. There was some kind of bradycardia prior to that,

which was not associated with any chest pain. The second dose was administered 2 months 

after the first dose. 
ACIP Meeting Summary February 4, 2022

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Public Comment

The floor was opened for public comment during the February 4, 2022 ACIP meeting at 11:10

AM ET. All speakers submitted a request in advance of the meeting and the final list of public 

commenters was determined via a lottery. Everyone was reminded that the ACIP appreciates 

diverse viewpoints that are respectful in nature and issue-focused. The comments made during 

the meeting are included in this document. Members of the public also were invited to submit 

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

CDC-2022-0022. Visit http://www.regulations.gov for access to the docket or to submit 

comments or read background documents and comments received.

Milena Berhane

National Consumers League

My name is Milena Berhane. Today I'm representing the National Consumers League (NCL). 

Since NCL's founding in 1899 by social reformer Florence Kelley, we have advocated for the 

critical role immunizations play in the preservation and improvement of public health. We extend 

our gratitude to this committee for the opportunity to present public comment. An estimated 

890,000 Americans have died from COVID-19 during this pandemic that has persisted in the US 

for the past 2 years. The COVID-19 virus continues to threaten the health and safety of many, 

especially vulnerable populations such as the elderly and immunocompromised groups. The 

currently available COVID-19 vaccines have worked to save lives and avoid preventable illness,

hospitalizations, and deaths in our communities. The National Consumers League commends 

the FDA and CDC on the approval of the Moderna COVID-19 vaccine, which will continue to be 

a key tool in the public health response to this pandemic. This vaccine has been and will

continue to be a safe and effective measure for protecting Americans 18 years of age and older.

America's families are hopeful that the Pfizer COVID-19 vaccine will be granted emergency use

approval for children under 5 years of age. Hospitalization of children under 5 years of age has 

soared—further evidence of the need for expanding vaccine access to children in this age 

group. Vaccinating children under the age of 5 will protect them from illness but also protect 

their families, caretakers, and teachers from contracting COVID-19 as well. We are also

concerned about the widespread drop in routine childhood immunization rates during the 

pandemic. According to CDC data released last May, over 11.7 million children have missed 

doses of their recommended vaccines. We are particularly worried that our nation's most 

vulnerable children, those who qualify for the Vaccines for Children (VFC) program are getting 

caught up at a much slower rate than children with commercial insurance. The National 

Consumers League recognizes the extreme importance of immunizations and protecting the 

health and safety of all Americans and will continue with efforts to increase vaccine confidence 

and uptake across lifespan. We look forward to the upcoming recommendations by this 

committee regarding these COVID-19 vaccines.

Laura Burns

TRAIPAG

Good morning. My name is Laura Burns and I represent TRAIPAG, the Transplant and 

Immunocompromised Patient Advocacy Group. There are about 2,000 of us linked by a 

Facebook group. About half of us are participants in the Johns Hopkins VE studies for 

transplant patients and the immunocompromised. TRAIPAG strongly supports approval of the 

BLA for the Moderna vaccine, but we wish that the approval could take the straitjacket off our 

doctors and give them the ability to individualize our care. I'd like to quote something Dr. Dorry 
ACIP Meeting Summary February 4, 2022

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Segev, the head of the Johns Hopkins studies, said in an interview a couple of weeks ago, "So, 

for example, if one of my patients got 3 doses, and they ended up with a relatively low

but still positive antibody, I would want to give them a fourth dose to boost them up so that it'll 

be much higher. But I can't do that today. The only fourth dose that people can get is if they had 

3 doses 6 months ago. Now they can get a fourth dose as a booster, but not to complete the 

primary series." Our group is very active on Facebook and we are all discussing our individual 

dilemmas. For example, a number of people get infusions twice a year. Many find their 5-month 

booster falls at the same time as their infusion, but they know from their doctors that the infusion 

will negate the VE. What to do? We're seeing the same thing with EvusheldTM. People know 

they should get boosted before EvusheldTM and wouldn't it be better to get the booster now, 4 

months after their third dose, and then EvusheldTM rather

than waiting a month for the booster and then another 2 weeks for EvusheldTM. Six weeks!

Likewise, many of our doctors tell us they wish we could get a full dose of Modern for our 

booster. They think it makes more sense for the immunocompromised, especially if we had a 

weak response to the primary series. I'll close with another quote from Dr. Segev's interview. As 

doctors, I'm sure you'll be able to appreciate it, "Look, this really needs to be individualized. We 

can't keep going to the CDC/FDA guidelines can't be this really complex decision tree of, ‘Well, 

did you have 3 doses and was your antibody level less than 250? And if it was, are you taking

MMF, and if you are, then you should get a fourth dose, but it should be at 2 months whereas 

this other person should get it a the 4.’ I mean, that's just way too complicated for a big 

government agency to be doing. But that is what doctors do. That's like what medical providers 

do. They individualize care for their patient. The difference is for any other medication I give my 

patient, I have the permission to do so. For vaccines, we don't have permission to do so."

Committee members, thank you so much for your attention and for all that you're doing to keep 

us safe. Again, we fully support the BLA for Moderna.

Leila Sahni, PhD, MPH

Texas Children’s Hospital

Good morning. My name is Leila Sahni. On behalf of Texas Children's Hospital, I would like to 

thank the CDC employees and ACIP members who have diligently analyzed COVID-19

epidemiology and vaccine safety and efficacy data and adeptly provided risk/benefit

assessments based on this information. Using your in-depth analyses, my colleagues and I 

have been able to assure families of the safety and effectiveness of COVID-19 vaccines. As an 

epidemiologist with more than a decade of experience conducting pediatric infectious disease 

research, I know that vaccines are the best way to protect people from COVID-19 and are our 

best hope for ending the pandemic. As you continue your discussions today and in the future,

I urge you not to minimize the risk of COVID-19 to our youngest children under 5 years of age.

To date, almost 10 million children have been diagnosed with COVID-19, with almost 2 million 

cases and almost 400 deaths occurring in children younger than 5. Early in the pandemic, 

compared to the elderly, children were thought to be relatively unaffected by COVID-19 and 

pediatric hospitalizations and deaths have been largely overshadowed, causing many 

requesting the need for COVID-19 vaccine for children. However, with the arrival of the Omicron 

variant, children's hospitals across the nation have reported dramatic increases in COVID-19 

hospitalizations. As we continue to vaccinate persons 5 years of age and older, we drive 

COVID-19 into the unprotected group of our youngest children. As a result, hospitalization rates 

in children younger than 5 years are the highest they've been at any point in the pandemic,

peaking in January at almost 5 times higher than they were last year. Children younger than 5 

are typically unable to wear masks for extended periods of time and don't understand the 

concept of social distancing. At the same time, we know that interaction with other children and 

early childhood education are essential for child development. Parents of young children have 
ACIP Meeting Summary February 4, 2022

11

no good choices. They must either accept the risk of infection as a consequence of social 

interactions in preschool attendance in communities with high levels of COVID-19 and minimal 

mitigation measures, or they must forgo the important benefits these activities confer. They

deserve better options. Although the immunogenicity of 2-dose primary series of COVID-19 

vaccines for children under the age of 5 produced a less than best immune response than 

desired, there is every reason to believe that it provides some protection. The safety profile of 

this vaccine is reassuring, and the third dose currently being studied is expected to provide 

comparable protection in COVID-19 vaccines given to older children and adults. For these

reasons, ACIP must act expeditiously to recommend COVID-19 vaccines for children younger 

than 5 years of age as soon as emergency use authorization is granted. As we approach the 2-

year mark of the COVID-19 pandemic, we must do everything we can to minimize further

detrimental effects to young children, many of whom cannot remember life before the pandemic.

COVID-19 vaccines are safe and effective for children of all ages, and I urge you to give these 

factors your every consideration. Thank you for your time.

Mr. Kermit Kubitz

Individual

Good morning. My name is Kermit Kubitz, and I support the comments before me of the 

National Consumers League and the transplant group. The success and positive benefit-risk 

of COVID-19 vaccines is clear, and the most important slide that I saw in the presentations this 

morning was the success in vaccination of preventing more than 10 million hospitalizations and 

more than 1.1 million deaths. That is, without the COVID-19 vaccines, we could have had 2 

million deaths from COVID-19 in the United States instead of the 890,000 so far, and further 

vaccination will allow a return to normalcy. So, I support the COVID-19 vaccine BLA for

Moderna. Increased vaccination will allow a return to normalcy. Denmark, for example, has 

recently lifted COVID restrictions because of its high vaccination rate of more than 80%

compared to the US of about 64% fully vaccinated. If we want a return to normalcy, if we want a 

return to schools without masks, if we want a return to dining in restaurants, if we want a return 

to meeting in groups—we must have vaccinations to the level that reduces the pandemic

to an endemic, if that is the future. I also support rapid development and approval of lower-cost 

vaccines like Biological E's CorbevaxTM, which is capable of promoting more widespread

worldwide vaccination. The development of variants around the world threatens all of us. No

one is protected until everyone in the world is protected. We must support global vaccine equity

and increased vaccination of the 70% of the world, which has not received the same vaccination 

levels in the United States. And I want to thank all the doctors and nurses around the country 

struggling with the pandemic and the result of the pandemic of the unvaccinated causing

hospitals to be overwhelmed. Thank you CDC, and FDA, and ACIP members for all you do.

Aaron Prosser, MD, MSc

McMaster University

I want to thank the committee for the opportunity to provide comments. My name is Dr. Aaron 

Prosser, Medical Resident at McMaster University in Canada. COVID-19 vaccines have been a 

vital tool for reducing the burden of this disease on healthcare systems. My comments pertain to 

COVID-19 vaccine mandates. This is because policy set by the CDC influences whether 

COVID-19 vaccination will, for example, be a condition of employment or education. In addition 

to increasing vaccination levels, mandates isolate those who remain unvaccinated from

accessing various settings. The hope is isolation will reduce transmission from the 

unvaccinated. This is based on the idea that unvaccinated people are at high absolute risk of 

transmission in non-household settings. These risks are thought to be high enough to justify 
ACIP Meeting Summary February 4, 2022

12

excluding the unvaccinated. However, these absolute risks have not been quantified. The 

arithmetic is simple and the data is publicly available. These absolute risks are the combined 

probabilities that an unvaccinated person gets infected and transmits COVID-19 in a given type 

of setting. My colleagues and I have quantified these absolute risks in a recent paper for which

a preprint is timely. Dividing one by these absolute risks gives the metric similar to the number 

needed to treat, which we call the number needed to isolate. In the United States, once a wave 

of infections subsides, we found that on any given day the absolute risk of a transmission event 

in healthcare or educational settings is between 1 in 1,000 and 1 in 3,000. In other words, on 

any given day, we would have to exclude between 1,000 and 3,000 unvaccinated people from 

working in healthcare or accessing education to prevent one transmission event. Please know, 

this is to prevent usually mild, sometimes asymptomatic infections, especially given the high 

levels of immunity already present in the population, particularly the most vulnerable. And so, 

my comment is one of proportionality and compassion. COVID-19 has been devastating.

COVID-19 vaccines are beneficial, especially for preventing severe illness, but our policy 

responses towards the unvaccinated people needs to be proportionate to the risks,

compassionate to the harms of these policies, and open to accommodation. In medicine, there 

is a clinical intuition that if one has to apply an intervention to hundreds or thousands of people

to extract one benefit, a careful weighing of harms and benefits is needed. We may disagree 

with the viewpoints of people who remain unvaccinated, but we must consider the harms of 

exclusion through mandates, which includes making people unemployed, unemployable, and 

unable to access education. My one request is that you clarify your position on COVID-19 

vaccine mandates. Since your decision today on this question will echo throughout the United 

States and beyond, I think it is important that this be part of the public record. Thank you very 

much for your time.

Mr. Steven Kirsch

Executive Director

Vaccine Safety Research Foundation

My name is Steven Kirsch. I'm the Executive Director of the Vaccine Safety Research

Foundation. I have no conflicts. My remarks, as well as all the supporting data, are posted on 

my website at stevekirsch.substack.com. There are 4 compelling reasons why you should not 

approve the Moderna vaccine. Reason number one, after 90 days, the Moderna vaccine has 

negative efficacy against Omicron. You cannot possibly approve a vaccine which after just 90 

days shows negative efficacy against the predominant variant. This was very clearly shown for 

the Moderna vaccine in the Denmark study and subsequently confirmed by data from the 

German government. There are now over 13 studies including the famous Harvard study that 

clearly shows that the infection rate is highest in those countries with the greatest vaccination 

rate. If the vaccines worked as claimed, how do you explain these studies? Reason number 

two, the Moderna vaccine kills more people than it's likely to save. A conservative estimate of 

the number of deaths using the VAERS data and the CDC's own methodology shows the 

Moderna vaccine has killed at least 64,000 people. The Moderna trial data shows that over 

13,000 lives may have been saved, but that is optimistic because the dominant variant has 

shifted. In short, the Moderna vaccine will kill at least 4.8 people from all-cause mortality for 

every life we might save from COVID. It simply makes no sense. Reason number three, the 

vaccine fails on an absolute safety basis. The Moderna vaccine kills at least 643 people per 

million, as I just pointed out. That makes these vaccines nearly 1,000 times deadlier than the 

smallpox vaccine, which previously was the most deadly vaccine in human history and is 

considered too unsafe to use by experts. Reasons number four, you should not approve the 

vaccine until you see all the safety signals. Although the Phase 3 trials claim no safety concerns 

were identified, there are hundreds of very serious adverse events that are being ignored. For 
ACIP Meeting Summary February 4, 2022

13

example, according the VAERS US data, the average rate of pulmonary embolism reports is

just 3 per year. With Moderna, we have 1,245 events—415 times normal. How can that not be 

flagged as an adverse event? The only way that can happen is if the people who are in charge

of monitoring the safety signals are either blind or corrupt. The public is not being informed of 

hundreds of safety signals like this. Some people believe that the reports in VAERS are

unreliable. There's no evidence of this. In fact, the individual doctors report seeing adverse 

event rates that are 20,000 times higher than any other vaccine. These doctors are afraid to 

speak out due to threats and intimidation by state medical boards and others. There were 

Facebook vaccine injury support groups with 250,000 people that were deleted by Facebook.

Both of these anecdotes are impossible to explain if the COVID vaccines are truly safe and 

effective as claimed. Again, all of the supporting data is posted to my substack at

stevekirsch.substack.com. Thank you. 

Dr. David Wiseman, PhD

Synechion

FDA has repeated the regulatory misdirection used for collinearity by BLA-approving a nonavailable Spikevax® and maintaining an EUA for a legally distinct Moderna product with "certain 

differences that do not impact safety or effectiveness." This nonsense, somewhat repeated in a 

presentation later today, was rationalized at the August 30th ACIP by the suggestion

that full approval of one quasi vaccine would motivate 31% of vaccine-hesitants to take any of 

the 3 vaccines. This product is obsolete. Its pre-Omicron efficacy is irrelevant to this discussion,

and no Omicron data have been presented today. The Spikevax® indication is prevention of

COVID, but it fails to meet FDA's guidance VE target of 50% with a lower confidence boundary 

of 30%. Not shown in the GRADE presentation later today is a Danish study with an initial 37% 

Omicron VE waning to negative 39% by 3 months. Neither is the Canadian Buchan study with 

VE starting around zero, dropping to minus 40%. The February 3rd UK report shows Omicron 

VE waning to around 50% by 5 weeks and below 30% by 15 weeks before the 5-month

authorized boost interval. None of these support the indication of COVID prevention within FDA 

guidance. Whatever VE can be mangled out of Spikevax® with boosting with a risk of immune 

erosion would only have been relevant had 3 doses, not 2, been included in the BLA. With 

almost no benefit, we are left with risk. There has now been enough time to collect data, but the 

labels said there are insufficient data to inform risks in pregnancy, something similar to lactation 

as well. Yet CDC still recommends vaccination in pregnancy and lactation. The label and CDC 

statement compete regarding immunocompromised, who may have a diminished immune 

response to Spikevax®. The effects of Spikevax® on immunogenicity and male fertility have still 

not been evaluated. I have already written comments documenting 10 safety signals of death, 

coagulopathy, and thrombotic events. For myocarditis, FDA and Pfizer have ignored underreporting by 4.8 times. A recent MMWR paper revealed VAERS has 6.5 times under-reporting 

for hospitalization in children. Though Spikevax® is not regulated as a gene therapy product, as 

Moderna said in a 2020 FCC filing, “We still lack the full sequence of this nucleoside modified 

mRNA.” Moderna's founders previously wrote that their first application will likely not be a 

vaccine because the tolerance of side effects is very low in healthy individuals. The use of 

booster doses was considered the last “whack-a-mole” according to Dr. Long at the last ACIP 

meeting, using an obsolete product that ventures into negative VE territory before the

authorized boosting interval must surely put us way beyond the last whack-a-mole. Thank you. 
ACIP Meeting Summary February 4, 2022

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Ms. Elizabeth Ditz

Vaccinate California

Good morning, Dr. Lee and committee members, and thanks for your tireless work in this

pandemic. My name is Liz Ditz and I'm speaking for myself as a citizen and as a grandmother. I 

strongly support the BLA for the Moderna vaccine and moving with all due speed to approve

vaccines for under 5. The effects of the pandemic are universal. They're also hyperlocal and

vaccine access and other NPIs are noticeable. I live in San Mateo County, California. Because 

of the strong public health leadership in my county and state, we have been doing relatively 

well. Eight-six percent of county residents 5 years and older have been vaccinated. Omicron 

testing trends are going in the right direction, dropping from 16% positive at the beginning of 

January to a 7% rate on January 31st. But we are failing to reach some of our most vulnerable 

populations. The Pacific Island population, the Black/African American community, and the 

Hispanic population are all less than 63% fully vaccinated. The February 1 report from the 

Kaiser Family Foundation is for me hard to put a shine on as 8 in 10 parents have unvaccinated 

kids and say that Omicron doesn't make a difference, and 1/4 of the parents stated they will 

definitely not get their 12 to 17-year-olds vaccinated for COVID-19. Why the resistance? On 

February 3rd, Brandy Zadrozny and other anti-vaccine national groups have enjoyed a pandemic 

windfall. She reported that Del Bigtree’s Informed Consent Action Network reported $5.5 million 

in revenue in 2020, a 60% increase over 2019. Robert Kennedy's organization, Children's 

Health Defense, more than doubled its revenue in 2020. By contrast, 2 pro-public health groups, 

Voices for Vaccines' budget was $600,000 and Vaccinate Your Family noted that they had $1.6 

million in revenue. Pro-public health groups are woefully losing the funding and so these bad 

ideas spread. I'd like to point your attention to the Urgency of Normal group that has developed 

a platform for parents to convince school boards to give up NPIs and throw it open. I have no 

solutions other than to push back against these ideas. The right to health is a fundamental 

right—even for the smallest children. None of us in safe until all of us are safe. Thank you for 

this opportunity to share my concerns with you.

Evelyn Pineiro

Parent

Good morning. As an informed member of the public, a teacher, a mother of small children, I am 

in complete support of the BLA for the Moderna vaccine. I also belong to a group of parents and 

physicians called Protecting the Future, and we specifically implore you to expedite the

authorization of this vaccine for children under 5 once it's deemed safe and effective. This is the 

only segment of the population who does not have access to a vaccine. Pediatric

hospitalizations surged during the Omicron wave, and a full half of them in New York were from 

the 0-5 age group. At a time when districts are repealing their masking mandates and going 

back to normal, which mine just did last night, we still have no normal. I have no protection for 

my preschooler in school now, and parents of children under 5 note the same thing to me. While 

myocarditis has been a side effect under discussion, physicians note that this doesn't seem to 

be an issue in prepubescent children. If the committee feels they must limit usage to certain age 

groups due to this risk, we ask you to humbly bypass the age de-escalation barriers that would 

prevent the vaccine from being used in the younger age groups. We do have the upcoming 

possibility of a Pfizer vaccine, but especially in the 2 to 4-year-old population, this will be the 

subject of much debate. We desperately need access to the Moderna vaccine for the under 5 

age group. In addition, I also implore you to allow off-label use for our children, especially those 

at high risk. Once Moderna is deemed safe and effective in the under-5 age group, please do 

everything in your power to expedite its EUA, including bypassing age de-escalation barriers. 
ACIP Meeting Summary February 4, 2022

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Updates on Myocarditis and Pericarditis Following Moderna COVID-19 Vaccination

Tom Shimabukuro, MD, MPH, MBA (Vaccine Safety Team, CDC COVID-19 Vaccine Task 

Force) provided an update on myocarditis and pericarditis following Moderna COVID-19 

vaccination in terms of the reporting rates of myocarditis following Moderna COVID-19 primary

series vaccination and the Vaccine Adverse Event Reporting System (VAERS) among persons 

ages 18 years and older; care and outcomes of persons ≥18 years of age with myocarditis

after Moderna primary series vaccination reported to VAERS; and a Vaccine Safety Datalink

(VSD) subgroup analysis of confirmed myocarditis and pericarditis cases after primary series 

Moderna vaccination among persons aged 18-39 years.

VAERS is the nation's early warning system for vaccine safety. It is a spontaneous reporting or 

passive surveillance system that is comanaged by CDC and FDA and has been in effect since 

1990. As a passive surveillance system, VAERS accepts reports from everyone regardless of 

the plausibility of the vaccine causing the event or the clinical seriousness of the event. The key 

strength for VAERS is that it can rapidly detect potential safety problems and rare AEs. Key 

limitations of VAERS is that it is a passive surveillance system with spontaneous reporting that 

is subject to include inconsistent quality and completeness of information; there are reporting 

biases; and generally, cause-and-effect cannot be determined from VAERS data alone. Reports 

to VAERS do not necessarily mean that the vaccine caused the AE. 

Beginning with reporting rates per 1 million doses administered of myocarditis among males 

after Moderna COVID-19 vaccination in Days 0-7 after vaccination, Day 0 was the day of 

vaccination. Through January 13, 2022, there had been 76.6 million total doses of Moderna 

COVID-19 vaccine administered to males. This includes both Dose 1 and Dose 2. Through that 

time, there have been 283 myocarditis case reports in Days 0-7 after vaccination that met the 

CDC case definition. These reports were followed-up for medical records or interviews the 

providers to confirm that the case report met the CDC case definition. After Dose 1 in the age 

groups 18- 24, 25-29, and 30-29, the reporting rate exceeded the background incidents a 5.8 

per million, 2.9 per million, and 3.3 per million, respectively. After Dose 2, the reporting rates 

exceeded background incidence in the 18-24, 25-29, 30-39, and 40-49 age groups. Reporting 

rates were consistently higher after Dose 2 versus Dose 1. However, reporting rates do not 

exceed incidence in the 50-64 and 65+ groups and there is not much difference between Dose 

1 and Dose 2 as might be expected. Roughly 85.7 million total doses of Moderna administered 

to females during this same time period. During this analytic period, there were 76 myocarditis 

case reports in Days 0-7 that met the CDC case definition. The reporting rates exceeded 

background incidence after Dose 2 in the age groups 18-24 and 25-29. The reporting rates 

exceeded background incidence in more age groups for males for Dose 1 and Dose 2 and the 

overall reporting rates were higher.

In terms of the care and outcomes of myocarditis cases reported to VAERS after the Moderna 

primary series among persons aged 18 years and older in the 0-7 days after vaccination, of the 

359 case reports meeting the case definition, 337 were hospitalized, 335 were discharged,

230 (69%) were known to have recovered from symptoms at the time of the report, 2 had 

disposition under review, and 22 were not hospitalized—they were seen in an emergency 

department (ED), urgent care, outpatient clinic, or it was not specified.
ACIP Meeting Summary February 4, 2022

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The Vaccine Safety Datalink (VSD) is a collaborative project between CDC and 9 integrated 

healthcare organizations across the country. This is an electronic health record-based system

that was established in 1990. Rapid Cycle Analysis (RCA) is conducted in the VSD to monitor 

the safety of COVID-19 vaccines weekly, using prespecified outcomes of interest among the 

VSD member population and to describe uptake of COVID-19 vaccines over time among 

eligible VSD members overall and by strata of age, sex, race, and ethnicity. Monitoring began in 

December 2020 when the vaccines became available. The VSD COVID-19 vaccine RCA 

prespecified surveillance outcomes and settings in which they are monitored are shown in this 

table:

In terms of the analytic strategy for the primary analysis, the number of outcomes observed in 

the risk interval after vaccination were compared to the number expected. The expected counts 

were derived from vaccinated concurrent comparators who were in a comparison interval after 

COVID-19 vaccination. On each day that an outcome occurred, vaccinees who were in their risk 

interval were compared with similar vaccinees who were concurrently in their comparison

interval. The comparisons were adjusted for age group, sex, race/ethnicity, VSD site, and 

calendar date. The myocarditis and pericarditis electronic case identification follows a pathway. 

Cases are initially identified using the following International Classification of Disease (ICD)-10 

codes: 

 B33.22 Viral myocarditis

 B33.23 Viral pericarditis

 I30.* Acute pericarditis

 I40.* Acute myocarditis

 I51.4 Myocarditis, unspecified

 I31.9 Disease of the pericardium, unspecified 

This is followed by chart review and adjudication of these cases by clinical subject matter 

experts (SMEs) using the CDC case definition.
ACIP Meeting Summary February 4, 2022

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Through the analytic period, there were about 923,000 Moderna Dose 1 and about 901,000 

Moderna Dose 2. This table shows confirmed myocarditis and pericarditis cases identified in the

Day 0-7 risk interval among persons 18-39 years of age compared with outcome events

in vaccinated comparators on the same calendar days from Moderna COVID-19 vaccination

through January 15, 2022: 

For Dose 1, the adjusted rate ratio is 3.46 and is statistically significant. That equates to an 

excess in cases of 6.9 per million doses administered. For Dose 2, the adjusted rate ratio is

18.75 and is highly statistically significant with a confidence interval from about 6.7 up to 65. 

This equates to 31.2 excess cases in the risk interval per million doses administered. The 2 

bottom rows are subsets of Dose 2 looking at males and females separately. The adjusted rate 

ratio in males is 16.96 with a confidence interval of 6 up to about 59, with excess cases of 61.8 

per million doses administered. For Dose 2, females had a small number of events. The 

adjusted rate ratio was not estimable because there were no events in the comparison interval. 

It was possible to calculate a lower bound of the 95% confidence interval, which was 6.2 excess 

case in the risk interval per million doses administered. 

Discussion Summary

Related to a public comment made earlier, Dr. Poehling asked Dr. Shimabukuro to help explain

the difference in the reported cases of myocarditis and those that met the CDC definition and 

why that is so important.

Dr. Shimabukuro indicated that the VAERS data are based on spontaneous reports that anyone 

can submit (patient, parent, healthcare provider, caregiver). These reports come into CDC in

different states of completeness. When reports are received that are suspicious for myocarditis, 

CDC tries to contact the healthcare provider or the healthcare facility to obtain medical records

in order to review them for missing information in the report, confirm information in the report, or 

correct information that may be erroneous in the report. They sometimes speak to the

healthcare provider over the phone and are able to gather enough information to be confident in 

applying the CDC case definitions for myocarditis and pericarditis, which are published in the 

MMWR. This adjudication is done by clinicians who are trained in doing this. The reports are 

classified by those that meet the CDC case definition, those that do not have enough 

information to evaluate, and those that for which the information that is provided leads CDC to 

believe that this is not a true case of myocarditis. The reporting rate analyses in the evaluation

of these reports is based on reports that have been reviewed and adjudicated to meet the CDC 

case definition.
ACIP Meeting Summary February 4, 2022

18

Dr. Loehr asked whether the Day 8 to 21 window was assessed for comparison. For instance, 

he wondered what would happen with a report of someone having chest pain and elevated 

troponin on Day 10 after the vaccine. 

Dr. Shimabukuro indicated that they also do that analysis and follow-up on these in the 

enhanced surveillance. Follow-up in done on all cases that meet the CDC case definition for 

myocarditis. It is known from VAERS, VSD, and data that have been generated from

international partners that these cases cluster in Days 2, 3, and 4 after vaccination. In order to 

focus the analysis for this particular presentation, the decision was made to concentrate on 

cases that present or have symptom onset within the week of vaccination. They have performed 

analyses that assess other intervals, mainly up to 21 days. 

Dr. Brooks asked whether the rate in the Day 22 to 42 window was equivalent to what is 

expected based on the background. Of the 359 cases in the VAERS data, he asked whether 

there were any additional data on the 2 under review and if there were any deaths.

Dr. Shimabukuro indicated that he did not have the VSD data for the 22-42 days postvaccination. In terms of the interval question, the VSD has assessed the Days 0-7 and 0-21 

windows and have noticed that most reports are concentrated in Days 0-7. Therefore, they are 

confident that the vaccine-associated cases tend to cluster fairly closely after vaccination.

Regarding follow-up on the reports after receipt of the primary series of Moderna vaccination,

there are reports of deaths in which there was histopathologic or clinical evidence of myocarditis 

following vaccination, and CDC has thoroughly reviewed those cases and has not been able to 

conclude definitively that the vaccine was in the causal pathway for the deaths. Looking at all 

deaths, not just those among Moderna vaccine recipients, there have been death reports to 

VAERS among persons under 30 years of age with myocarditis after a primary series mRNA 

vaccination. There were 13 death reports with concern for myocarditis identified through 

January. Of these, 3 did not have adequate information available to assess. For instance, there 

may have been clinical evidence of myocarditis but additional tests and/or an autopsy were not 

performed. This left 10 with available information. Of those 10, 2 are ongoing and evaluation 

has been completed for the other 8 cases. Of those, 3 were not myocarditis and 5 were 

myocarditis. All 5 deemed to be myocarditis had other potential etiologies identified, which left 

no deaths related to the vaccine.

Dr. Sanchez observed that in the randomized study, it would be important to know whether 

cases that occurred later at around 43 days after Dose 2 were related to vaccine administration.

He also recalled that there was an increase in males in 40-49 years of age, but that was not part 

of the analysis.

Referring to Slide 5, Dr. Shimabukuro indicated that the VAERS analysis identified an increased 

reporting rate above what would be expected based on the baseline rates in males aged 40-49 

years after Dose 2. That age group is being monitored for myocarditis the VSD, as are all ages. 

When CDC performed their analysis, it was restricted to the 18-39 age group for Moderna. That 

was largely a numbers issue as the more it is extended, the less numbers there are relative to 

doses administered. Therefore, the analysis was based largely on the number of cases.
ACIP Meeting Summary February 4, 2022

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Update on Myocarditis Outcomes: MOVING

Ian Kracalik PhD MPH (Vaccine Safety Team, CDC COVID-19 Vaccine Task Force)

provided an update on myocarditis outcomes following mRNA COVID-19 vaccination. There is 

evidence from safety monitoring systems in multiple countries that supports the finding of an

increased but small risk of myocarditis following mRNA COVID-19 vaccination.8 This risk of

vaccine-associated myocarditis appears to be highest in adolescent and young adults, males

compared to females, and following Dose 2 compared to Dose 1. Onset is typically within a few 

days of vaccination, with most presenting within the week following vaccination. The severity of 

cases varies. Most who presented to medical care have responded well to medications and rest. 

Assessment of myocarditis health effects after COVID-19 vaccination are in progress.

CDC initiated enhanced surveillance for myocarditis outcomes after mRNA COVID-19 

vaccination in VAERS case reports. The purpose of this enhanced surveillance was to assess 

functional status and clinical outcomes among individuals reported to have developed

myocarditis after receiving and mRNA COVID-19 vaccination. This enhanced surveillance 

involved a 2-component survey conducted at least 90 days after the onset of myocarditis

symptoms. The first component was a patient survey focused on persons 12-29 years of age to 

ascertain functional status, clinical symptoms, quality of life measures, and the need for 

medication or other medical treatment. The second component was a healthcare provider 

survey, the objective of which was to gather data on cardiac health and functional status. The 

timeline for data collection was approximately August 2021 through January 2022.

First, preliminary data from surveys of patients 12-29 years of age at least 90 days postmyocarditis diagnosis. As of November 2021, VAERS had received approximately 989 reports 

of myocarditis or myopericarditis after COVID-19 vaccination that met the CDC case definition. 

Of these, approximately 850 patients aged 12-29 years had reached 90 days post-myocarditis 

diagnosis. Of the approximately 850 patients 90 days post diagnosis, 81% had a phone number 

listed. Of the 648 who were called, 56% completed the survey, 42% were unreachable, and 3% 

declined to participate. For the 360 patients interviewed, the time from myocarditis onset to 

interview was 143 days, with an interquartile range of 131 to 162 days. 

In terms of some of the demographic characteristics, most patients diagnosed with myocarditis 

were young males. The median patient age was 18 years, with an interquartile range of 15 to 22 

years. Of the 360 patients 90 days post-myocarditis diagnosis, 86% or 308 were males. Most 

patients were White, non-Hispanic. Hispanic of any race made up 20% of patients. Asian nonHispanic comprised 5%. Black, non-Hispanic and multi-racial, non-Hispanic made up 4% each. 

Other, non-Hispanic were 3% and American Indian or Alaskan Native (AI/AN), non-Hispanic

comprised less than 1%.

Prior to myocarditis diagnosis, 87% of patients reported having received 2 doses of a COVID-19 

vaccine. Of those who received 2 doses, 98% reported receiving both doses before they were 

diagnosed with myocarditis and 9% had evidence of COVID-19 with a positive COVID-19 test 

before their myocarditis diagnosis. Looking at some of the self-reported previous medical history 

among these patients with myocarditis after mRNA COVID-19 vaccination, 17% reported having 

any condition, 3% reported having an arrhythmia. 2% each had congenital heart disease or a 

history of myocarditis, less than 1% had Kawasaki disease or a history of previous heart failure, 

9% had a history of asthma, 2% had an autoimmune disorder, 1% each had a genetic or 

chromosomal condition or were immunosuppressed, and then less than 1% each had a history 

8 https://www.who.int/news/item/09-07-2021-gacvs-guidance-myocarditis-pericarditis-covid-19-mrna-vaccines 
ACIP Meeting Summary February 4, 2022

20

of leukemia or Type I diabetes. Most patients with myocarditis after receiving COVID-19 

vaccination reported being hospitalized at the time of their diagnosis. Of the patients with 

myocarditis post-vaccination, 92% were hospitalized and 4% were readmitted following 

myocarditis. Of those who were readmitted, 62% were readmitted because of the concern with 

the heart and 20% had been prescribed medication for their heart at their last appointment with 

their provider. Looking at absenteeism related to missed school or work within the 2 weeks prior 

to the date of the interview reported among patients, 8% reported missing school. Of these, 

37% believed it was due to their myocarditis. Of the 5% who reported missing work, 37%

believed it was due to their myocarditis.

Self-reported symptoms within 2 weeks prior to the date of the interview among myocarditis 

patients included chest pain, shortness of breath, palpitations, and/or fatigue. About a third were 

experiencing chest pain and about a quarter each were experiencing shortness of breath, 

palpitations, and fatigue. In terms of any symptom reported across all patients, 49% reported

experiencing at least one of these symptoms in the prior 2 weeks of the interview. 

The EuroQoL 5-dimension, 5-level (EuroQol-5D-5L) severity measurement of health status 

among patients who developed myocarditis after vaccination was used to assess the patients’ 

quality of life in terms of their ability for self-care, their mobility, their ability to perform usual 

activities, whether they were experiencing any pain or discomfort, and whether they were 

experiencing any anxiousness or depression. The 5 levels of severity measurements can range

from experiencing no problems to experiencing extreme problems. Most patients reported

experiencing no problems with self-care, mobility, usual activities, or pain or discomfort.

However, almost half experienced anxiousness or depression.

Next, preliminary data from completed cardiologist or other healthcare provider (HCP) surveys. 

Outreach to cardiologists or other HCP involved interviews with 360 of the 648 patients. About 

346 of these patients listed contact information for a cardiologist or other HCP. Of the 346 

providers for whom contact information was provided, 229 completed the survey. An additional 

151 providers completed the surveys they had submitted for multiple patients in VAERS or

provided contact information via the VAERS report. CDC was unable to reach 268 providers.

In total, 380 providers completed the survey with a median of 191 days and interquartile range 

of 170 to 216 days from a patient’s myocarditis onset to the date of the provider’s survey. A 

proportion of myocarditis patients cleared for physical activity by their cardiologist or healthcare 

provider had increased. At the time of myocarditis diagnosis, 83% of patients had restrictions

on their physical activity. At the time of the provider's survey at least 90 days post-diagnosis,

only 39% had restrictions on physical activity.

Based on the cardiologist or other healthcare provider assessment, most patients appeared to 

have fully or probably fully recovered from their myocarditis. In total, 81% of cardiologists or 

healthcare providers indicated that the patient was fully or probably recovered and more than 

90% showed some improvement. Looking at the proportion of myocarditis patients deemed to 

be fully or probably fully recovered by their HCP, about 80% of patients were fully or probably 

fully recovered at about Week 38. Regarding results from the most recent cardiac function test 

or biomarker test among 6 specific tests (e.g., troponin, cardiac MRI, echocardiogram, 

electrocardiogram, exercise stress test, and ambulatory rhythm monitoring), the most the recent 

cardiac function tests were normal with the exception of cardiac MRIs, which were abnormal.
ACIP Meeting Summary February 4, 2022

21

Looking more closely at abnormal findings from the most recently cardiac function tests, 

for a cardiac MRI, the most common abnormal finding on cardiac MRI was late gadolinium 

enhancement. On the electrocardiogram, the most common abnormal finding was T wave 

abnormalities. For the exercise stress test, there other cardiac concerns were identified. During 

ambulatory rhythm monitoring, the most common abnormality found was an arrhythmia.

Overlapping the abnormal findings among the most recent cardiac function tests, 51% of 

abnormal MRI findings also had an elevated troponin, 25% of abnormal MRIs also had an 

abnormal EKG, 3% of abnormal MRIs also had an abnormal ambulatory rhythm

monitoring finding, and 1% of abnormal MRIs also had an abnormal exercise stress test finding.

There was a low percentage of abnormal findings for the most part in the overlap of abnormal

echocardiogram findings and abnormal findings among the other tests.

Comparing cardiac function tests at the time of diagnosis and the time of follow-up, many

patients did not have an initial cardiac MRI performed. Those with an initial cardiac MRI that 

was abnormal (79%) also did not have a follow-up cardiac MRI. Most patients had an initial 

echocardiogram that was normal and a follow-up echocardiogram that was normal. There were 

17 patients who had a follow-up echocardiogram that was abnormal. Most patients who had an 

initial troponin that was elevated did not receive a follow-up test or the test was not available. 

One follow-up, 20 patients had an elevated troponin level. Looking at the cardiac assessment 

and symptoms among patients deemed to be recovered and not recovered in their myocarditis, 

few patients among those deemed to be fully or probably fully recovered had a complete normal 

baseline function or absence of symptoms across this subset of tests and clinical assessments.

Some also had normal baseline function, but were missing cardiac MRI results. Even among 

patients deemed not recovered, some had normal or baseline function or absence of symptoms 

across all of the subsets of tests and clinical assessments, which suggests that there is some

heterogeneity in the way patients are deemed recovered and there is likely a lot of HCP 

judgment in the assessment of these patients.

In summary, at least 90 days after myocarditis diagnosis, most patients reported no impact on 

their quality of life and most did not report missing school or work. A few were readmitted to the 

hospital. Most HCP indicated the patient probably or fully recovered. However, there did not 

appear to be a single test that was indicative of recovery. To CDC’s knowledge, there were no 

vaccine-associated myocarditis deaths in this group of patients they interviewed. Currently, 

there are ongoing efforts to continue patient follow-up and contact of myocarditis patients who 

were not yet recovered at the time of the survey. Additional surveys are being modified for

children 5-11 years of age for whom follow-up will begin in February 2022.

Discussion Summary

Dr. Poehling noted that these analyses focused individuals 12-29 years of age in the VAERS 

database and that some of the numbers looked different from what Dr. Shimabukuro presented 

earlier. She inquired whether she was correct to assume that the data just presented included 

Pfizer or Moderna vaccines and this was why the numbers differed.

Dr. Kracalik confirmed that the data he presented were for both the Pfizer and Moderna 

vaccines. 

Ms. Bahta asked whether the surveys assessed social or behavioral impact and if so, whether 

those types of impact from the myocarditis have been resolving. Looking at Slide 19, it 

appeared to her that 50% recovery happened shortly after 16 weeks. That is a long time for a 

person with limited activity or who may not be able to work or attend school. She emphasized 
ACIP Meeting Summary February 4, 2022

22

the importance of assessing no only the physiology, but also the whole impact on a person who 

ended up with myocarditis after getting vaccinated.

Dr. Kracalik indicated that they attempted to get at this using the EuroQol-5D-5L, which does 

assess measures such as anxiousness, depression and the ability to perform usual activities. 

While most appeared to be able to perform usual activities, about half were experiencing some 

level of anxiousness or depression that could have been extreme.

Dr. Lee expressed gratitude to the teams involved in this study. The ACIP recognizes that the 

study went above and beyond to respond to the pandemic and ensure that the committee

and the public had the information needed about the long-term follow-up of these cases. The 

medical information from long-term cardiology follow-up continues to reflect disease that is mild 

and consistent with what has been seen previously. What she found remarkable and telling was 

that some of the patient- and family-centered measures, such as the EuroQol-5D-5L measures, 

showed that there is substantial impact on individuals. They also must acknowledge that these 

data likely reflect the experience that many people are having living through this pandemic,

regardless of whether they have been infected or vaccinated. She is hopeful that other ongoing 

studies supported by the CDC, NIH, and FDA will continue to shed light on the impact of this 

pandemic on children and young adults.

Dr. Kotton emphasized that these data, while clearly robust, interesting, and helpful to see, do 

not allow them to understand what this means in isolation. Most of time in the medical world, 

they do not look at data without a control population or other populations to compare to. She 

encouraged CDC to assess people who had myocarditis from true infections, which has been 

devastating and has a much bigger impact. For the epidemiology, it would be helpful to have 

controlled populations. Without good comparison populations, there is some danger in focusing

on vaccines and myocarditis when the “elephant in the room” is true disease and true infection

from COVID-19 and the potentially devastating, even life-threatening myocarditis, occurring in 

that context. 

In terms of the data on those fully recovered versus not fully recovered, Dr. Brooks observed 

that the top 4 (shortness of breath, chest pain, daily medication, and physical activity) were the 

ones the patient would feel, while the bottom 4 (troponin, ECHO, EKG, cMRI) were abnormal 

findings not found in the fully recovered. Troponin was elevated, but these patients recovered 

on quality of life relative to the physical findings, which is reassuring. For the public, it is 

important to do this dissection of myocarditis in order to have a more full picture of what is 

occurring. 

VaST Assessment

H. Keipp Talbot, MD, MPH (VaST Chair) provided the VaST’s assessment of the data

that was just presented and some other that have been reviewed. The objectives of VaST are 

to: 1) review, evaluate, and interpret post-authorization and approval of COVID-19 vaccination 

safety data; 2) serve as a central hub for technical subject matter expertise from federal 

agencies conducting post-authorization and approval safety monitoring; 3) advise on analysis, 

interpretation, and presentation of vaccine safety data; and 4) provide updates to the ACIP 

COVID-19 Vaccines WG and the entire ACIP on COVID-19 vaccine safety.9

9 https://www.cdc.gov/vaccines/acip/workgroups.html 
ACIP Meeting Summary February 4, 2022

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VaST continues to review COVID-19 vaccination safety data from passive and active 

surveillance systems. US safety monitoring systems include VAERS, VSD, the FDA Biologics 

Effectiveness and Safety (BEST) System,10 the Department of Veterans Affairs (VA), Indian 

Health Service (IHS), and the Department of Defense (DoD). VaST also continues to work with 

international partners, including the Public Health Agency of Canada (PHAC) and the Global 

Advisory Committee on Vaccine Safety (GACVS). VaST also reviews special evaluations, such 

as the myocarditis case follow-up studies just presented. 

From December 21, 2020 through February 4, 2022, VaST has had 45 independent meetings to 

review vaccine safety data. There also have been 12 joint meetings with ACIP COVID-19 

Vaccines WG and 15 ACIP meeting presentations or reports with VaST assessments. VaST 

reviews of the Moderna COVID-19 vaccine post-authorization data have included CDC safety 

monitoring systems (VAERS, V-Safe, and VSD), other US monitoring systems, and systems of 

international partners.

Previously, VaST monitored anaphylaxis following mRNA COVID-19 vaccinations. Anaphylaxis 

following mRNA COVID-19 vaccines was identified in December of 2020. Safety data and VaST 

assessments were presented to ACIP in January and March 2021.11 CDC and FDA

recommended risk mitigation strategies, including screening for risk prior to vaccination,

monitoring for symptoms post-vaccination, early recognition and management of anaphylaxis 

on-site, and provider and patient education by CDC and partners. Anaphylaxis following

vaccination was reviewed again in August 2021 for the Pfizer BLA.12 There has been no

substantial change in the benefit-risk balance with risk mitigation strategies.

Myocarditis following mRNA COVID-19 vaccination was identified in May 2021.13 CDC issued 

clinical guidance for myocarditis/pericarditis following mRNA vaccines in May 2021. Data were 

presented to the FDA VRBPAC on June 10, 2021. Data and a VaST assessment were 

presented during ACIP meetings on June 23, 202114 and an MMWR was published. EUA Fact 

Sheets were revised with a warning added June 25, 2021. FDA approval of the Pfizer/BioNTech 

COVID-19 vaccine on August 23, 2021, with information included on myocarditis/pericarditis in 

the package insert.15 The FDA approved Moderna COVID-19 vaccine on January 31, 2021, with 

information on myocarditis/pericarditis in the package insert.16

Data from VAERS, which is a collaboration between CDC and FDA, reporting rates per 1 million 

doses administered of myocarditis in the window of 0-7 days after Moderna vaccination, showed 

that reporting rates exceeded background incidence in males after Dose 1 for males 18-39

years of age and especially after Dose 2 in males 18-49 years of age. In females, reporting

rates exceeded background incidence after Dose 2 in those 18-29 years of age.17

10 https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-biologics-effectiveness-and-safety-best-system 11 https://www.cdc.gov/vaccines/acip/meetings/slides-2021-1-27-21.html; https://www.cdc.gov/vaccines/acip/meetings/slides-2021-

02-28-03-01.html 12 https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/05-COVID-Lee-508.pdf 13 https://www.cdc.gov/vaccines/acip/work-groups-vast/index.html 14 https://www.cdc.gov/vaccines/acip/meetings/slides-2021-06.htm 15 https://www.fda.gov/media/151707/download 16 https://www.fda.gov/media/155675/download 17Source: Shimabukuro, Feb 4, 2022 ACIP presentation
ACIP Meeting Summary February 4, 2022

24

In VAERS for all mRNA vaccines, 359 reports met the CDC case definition among adults ≥18 

years in the 0-7 days post-vaccination. Among those identified, 94% were hospitalized and 

almost 70% had recovered from symptoms at time of the VAERS report. In follow-up surveys of 

myocarditis cases in VAERS, 360 patients were interviewed with ≥ 90 days of follow-up. Of 

these, 92% were hospitalized. Among the 380 providers contacted, 81% indicated that the 

patient was fully or probably fully recovered. VSD information for Moderna vaccination alone 

identified 38 chart-confirmed cases among individuals 18-39 years of age, of whom 79% were 

hospitalized. Of the hospitalized patients, 75% were hospitalized for 2 days or less and 100% 

had been discharged to home.18

The VaST assessment is as follows. Data available to date show association of myocarditis with 

Moderna mRNA COVID-19 vaccination in adolescents and young adults. Risk is low overall, but 

highest in adolescent and young adult males—especially following Dose 2. Data continue to 

show that most cases of post-COVID-19 vaccination myocarditis appear to be clinically mild.

More data are being accumulated and analyzed to further define myocarditis clinical course and 

risk. Presently, data do not suggest new safety concerns regarding Moderna vaccination among 

persons aged 18 years or older beyond those that have been previously identified and 

discussed.

VaST’s work is not finished. In terms of next steps, VaST will continue to: 1) review data on 

myocarditis from national safety monitoring systems and manufacturer post-marketing 

requirements; 2) review real-time monitoring of vaccine safety as vaccination efforts expand to 

younger age groups, booster doses, and new vaccines; 3) collaborate across US federal 

agencies evaluating vaccine safety; 4) collaborate with global vaccine safety colleagues on key 

issues that impact benefit/risk; and 5) provide updates to the ACIP COVID-19 Vaccines WG and 

ACIP during future meetings.

Discussion Summary

Dr. Daley noted that as Dr. Talbot went through her presentation, he was struck by how she 

balanced what has been learned so far with the idea that there is still work to do. This work is 

going to extend across new indications and across learning more about the outcomes for the

individuals with vaccination-associated myocarditis.

GRADE: Moderna COVID-19 Vaccine

Megan Wallace, DrPH, MPH (CDC/NCIRD) presented the GRADE assessment for Moderna 

COVID-19 vaccination for which the policy question was, “Should vaccination with Moderna 

COVID-19 vaccine be recommended for persons aged 18 years of age and older?” For the 

PICO question, the population under consideration is persons ages 18 years and older, the 

intervention is 2 doses of the Moderna COVID-19 vaccine, and the comparison is no vaccine.

The WG identified these 6 outcomes their level of importance for the policy as: Symptomatic 

Laboratory-Confirmed COVID-19 (Critical), Hospitalization Due to COVID-19 (Critical), Death 

Due to COVID-19 (Important), Asymptomatic SARS-CoV-2 Infection (Important), SAEs 

(Critical), and Reactogenicity (Important). For all outcomes, data from randomized controlled 

trials (RCTs) were evaluated. For all benefits, observational studies of VE were evaluated. For

SAEs, safety surveillance data were reviewed for specific outcomes.

18 Sources: Shimabukuro, Feb 4, 2022 ACIP presentation; Kracalik, Feb 4, 2022 ACIP presentation; Klein, Feb 4, 2022 ACIP 

presentation 
ACIP Meeting Summary February 4, 2022

25

To identify relevant RCTs, the WG relied on clinicaltrials.gov as the source. Phase 1, 2, or 3 

trials of Moderna COVID-19 vaccine were included that fit the PICO question. Additional 

resources were sought as well, including obtaining unpublished data from the vaccine 

manufacturer. To identify relevant VE studies, the WG used an ongoing, publicly available 

systematic review conducted by the International Vaccine Access Center (IVAC) and the World 

Health Organization (WHO) using studies identified through December 10, 2021. From this

database, studies were selected that provided VE estimates for at least 1 of the benefits in the 

PICO question. Of note, only studies that specifically evaluated VE against symptomatic or 

asymptomatic infection were included. Studies that reported on VE against any infection were 

not included. Only studies that had estimates of VE specifically for the Moderna COVID-19 

vaccine were include and not those that included estimates for mRNA vaccines as a group. The 

WG reviewed studies of the general population and of special populations as long as they

included persons aged at least 18 years. For observational data on vaccine safety, in

consultation with VaST, the WG included data from safety surveillance systems that have been 

presented to ACIP.

In terms of the evidence retrieval for all records included in the evidence synthesis, 127 records 

were identified from the IVAC systematic review and 7 were identified through other sources, 

including 5 records from clinical trials and 2 CDC safety surveillance systems. A total of 38 full 

text articles or other resources were assessed for eligibility and 33 were included in the

evidence synthesis. A total of 26 records of observational studies were identified that met 

inclusion criteria and addressed one or more of the PICO outcomes. The WG conducted a risk 

of bias assessment using the Newcastle-Ottawa scale, which assigns up to 9 points based on 

specific criteria related to selection of cohorts, comparability of cohorts, and assessment of 

outcome or ascertainment of exposure. Studies with Newcastle-Ottawa scores less

than 7 were considered to have serious study limitations.

For each outcome, the WG assessed the body of evidence for suitability for pooling. Given that 

the WG was working with the fluid evidence base that includes data that had not been peerreviewed, they excluded estimates with serious limitations from the pooled estimates used for

GRADE. If multiple studies were conducted in the same population, the most representative

study was selected. Meta-analyses were conducted using the remaining studies. Initial 

estimates were evaluated for heterogeneity using I

2. Sensitivity analyses were conducted

to assess the influence of study characteristics (e.g., special population vs. full population, 

preprint vs. peer-reviewed, standard/extended dosing interval, study design, circulating 

variants). The pooled estimates were developed to summarize the estimates across several 

studies succinctly for GRADE and described the best available real-world data for this policy 

question at this time. However, the WG acknowledges that the included studies represent

different populations and times and that the science in this area is developing quickly. This 

GRADE analysis did not aim to parse out effects of time since vaccination or circulating variants 

in the VE studies.

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

evidence type is determined by the study design. A body of evidence from an RCT starts

with an initial evidence type of 1, indicating high certainty. A body of evidence from

observational study starts with an evidence type of 3, indicating low certainty. The evidence type 

can then be downgraded due to risk of bias, inconsistency in directness, or imprecision and 

other considerations could downgrade or upgrade the evidence type. The final evidence type 

may range from type 1 (high certainty), which indicates we are very confident the true effect lies 

close to that of the estimate, to type 4 (very low certainty), meaning the WG has little confidence 

in the effect estimate. The evidence type is not measuring the quality of individual studies, but 
ACIP Meeting Summary February 4, 2022

26

rather how much certainty there is in the quantitative estimates of effect across each outcome.

For each outcome, Dr. Wallace reviewed data from RCTs and from observational studies and 

the GRADE assessment for both.

For the critical outcome of symptomatic COVID-19, 1 randomized study provided data. This was 

the Moderna Phase 3 RCT that was conducted in the US and enrolled over 30,000 

participants.19 The data were published and additional data were obtained directly from the 

sponsor. The WG used data through the unblinding date with a data cut-off date of May 4, 2021.

Unblinded safety follow-up continues in trial participants. To consistently apply GRADE in a 

rapidly evolving pandemic, the WG considered the data for benefits in the context of the

pandemic during the study time. Using the available efficacy population for all persons aged 18 

years and older, there were 55 cases among 14,287 persons in the vaccine arm and 744 cases 

among 14,164 persons in the placebo arm, which resulted in a VE estimate of 92.7% and a 95% 

confidence interval of 90.4% to 94.4%. This is the primary outcome of the study and the 

outcome used for GRADE. VE also was over 90% in a number of key subgroups, including 

those aged 65 and older, 75 and older, those at risk due to the presence of a comorbidity, those 

aged 65 years and older and at risk, and those with evidence of prior infection. In terms of 

timing, VE remained above 90% through unblinding.

Moving on to the observational studies for symptomatic laboratory-confirmed COVID-19, Dr. 

Wallace briefly summarized the 14 VE studies reviewed that evaluated this outcome. The most 

common study design was test-negative design followed by retrospective and prospective 

cohort studies. Study locations were predominantly in North America. The pre-print study 

captured a more recent time period than the peer-reviewed studies. Among these 14 studies, 11 

were included in the final pooled analysis for this outcome. The pooled VE estimate from the 

observational studies for the outcome of symptomatic laboratory-confirmed COVID-19 was 

89.2%. For the GRADE assessment for the outcome of symptomatic laboratory-confirmed

COVID-19, the WG evaluated data from 1 RCT for which the evidence type started at 1. The 

relative risk of 0.07 and 95% confidence interval strongly favored vaccination and there were no 

serious concerns in the certainty estimate. The final evidence certainty was Type 1 (high 

certainty) for this critical outcome. The WG evaluated 11 observational studies for this outcome. 

The relative risk of 0.11 strongly favored vaccination, with a 95% confidence interval of 0.06 to 

0.18. There were no serious concerns in the certainty assessment and certainty increased due 

to strong association. For the observational studies, the final certainty was Type 2 (moderate).

The second outcome for consideration was hospitalization for COVID-19. The protocol included 

a definition of severe COVID-19 with at least 1 of the following: clinical signs at rest indicative of 

severe systemic illness; respiratory failure; evidence of shock; significant acute renal, hepatic, or 

neurologic dysfunction; admission to an intensive care unit; or death. This did not necessarily 

require hospitalization. The WG obtained data on hospitalization due to COVID-19 from the

sponsor as an ad hoc analysis. The 2 VE estimates from the RCT were severe COVID-19 and 

severe COVID-19 with hospitalization. VE against severe COVID-19, a secondary endpoint 

defined in the Phase 3 protocol, was 98.1%. For VE against severe COVID-19 requiring

hospitalization, which was the PICO outcome and the outcome used for GRADE, the VE 

estimate was 95.9%. To summarize the 19 observational studies that evaluated VE against 

hospitalization due to COVID-19, the most common study design was test-negative design and 

study locations were predominantly in North America. Among the 19 observational studies, 

which provided 20 VE estimates, 14 studies providing 15 estimates were included in the final 

19 A) Baden et al., New England Journal of Medicine; additional unpublished data obtained from authors; b) El Sahly et al., New 

England Journal of Medicine; additional unpublished data obtained from authors
ACIP Meeting Summary February 4, 2022

27

pooled analysis. For the outcome of hospitalization due to COVID-19, the pooled VE estimate 

was 94.8%.

For the GRADE assessment for the outcome of hospitalization due to COVID-19, the WG 

evaluated 1 RCT for which the evidence type started at 1. The relative risk of 0.04 (95% CI: 

0.01–0.31) strongly favored vaccination but there were serious concerns of imprecision due to 

the small number of events observed from a single RCT. The final certainty estimate for

hospitalization for COVID-19 based on RCT data was Type 2 (moderate certainty). The WG 

evaluated 14 observational studies which provided 15 VE estimates for this outcome

for a pooled relative risk of 0.05 (95% CI: 0.04–0.07). There were no serious concerns in the 

certainty assessment and the certainty was increased due to a strong association. The final 

certainty estimate based on the observational data was Type 2 (moderate).

The next outcome was death due to COVID-19. This was a secondary efficacy endpoint

in the trial protocol defined as “any participant who died during the study with a cause directly 

attributed to a complication of COVID-19.” There were a total of 3 deaths due to COVID-19

among trial participants, all among placebo recipients. The available data indicate a VE of 

100%. A total of 5 observational studies provided VE estimates for the outcome of death due to 

COVID-19. These were all cohort studies and the study locations were predominantly in North 

America. The pooled VE estimate from these studies was 93.8%. For the GRADE assessment 

for the outcome of death due to COVID-19, the WG evaluated 1 RCT. The relative risk of 0.14 

(95% CI: 0.01 to 2.79) favored vaccination, but the very wide 95% confidence interval did not 

rule out harms, leading to very serious concern for imprecision due to the small number of 

events observed in a single RCT. The final evidence certainty was Type 3 (low certainty). The 

body of evidence from observational studies started with an evidence type of 3. There were no 

serious concerns in the certainty assessment. In light of the strong association, the certainty 

was raised one level to Type 2 (moderate certainty).

The next outcome of interest was asymptomatic SARS-CoV-2 infection, which was a secondary 

endpoint in the Phase 3 RCT. Asymptomatic SARS-CoV-2 infection was defined as having a 

“Negative SARS-CoV-2 status with both negative RT-PCR and negative binding antibody levels 

against SARS-CoV-2 at baseline prior to Dose 1; AND positive RP-PCR at the participantdecision visit; OR seroconversion due to infection assessed by binding antibody levels against 

SARS-CoV-2 at day 57 (28 days after Dose 2); AND absence of COVID-19 symptoms, including 

both symptoms for the primary endpoint of COVID-19 and the CDC definition of COVID-19.” 

Using the per protocol population for all persons aged 18 years and older, the VE for 

asymptomatic infection was 57.4 (50.1, 63.6).

To summarize the 3 observational studies that examined VE against asymptomatic SARS-CoV2 infection and met the inclusion criteria, all were peer-reviewed and 2 used a test-negative 

study design. The most recent data were from September 2021. Notably, there was substantial 

heterogeneity in the effect estimates. The pooled VE from these studies was 69.8% (95% CI: 

60.9% to 76.7%). In the GRADE assessment of the outcome of asymptomatic infection, one 

RCT provided data. The relative risk of 0.43 (95% CI: 0.36–0.50) favored vaccination and there 

were no serious concerns in the certainty assessment. The final evidence certainty was Type 

(high certainty). The WG evaluated 3 observational studies that had a pooled relative risk of 

0.30 (95% CI: 0.23–0.39). There was serious concern for inconsistency because the magnitude 

of relative risk from the 3 studies and the body of evidence varied widely. The final evidence

certainty was Type 4 (very low).
ACIP Meeting Summary February 4, 2022

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In terms of the data for the GRADE evaluation of harms, 4 randomized studies provided data. 

These included the Phase 3 trial (Baden 2021, El Sahly 2021), the Phase 2 trial (Chu 2021), 

and 2 published articles on the Phase 1 trials that did not have an unvaccinated comparator

(Jackson 2020; Anderson 2020). The Phase 3 study included data on persons aged 18 years 

and older in the US. The data evaluated had a final analysis cutoff date of May 4, 2021 and 

consisted of roughly 30,000 participants. The Phase 2 dose confirmation RCT enrolled healthy 

adults aged 18 years and older in the US. The WG evaluated data on the 200 participants who 

received the 100 μg dose and the 200 participants who received placebo. The primary

outcomes for the Phase 2 trial for safety including reactogenicity and SAEs. From the Phase 2 

trial, there were no SAEs in either treatment group. In the Phase 3 trial, SAEs were balanced 

across treatment groups, with 1.8% of vaccine recipients and 1.9% of placebo recipients 

reporting an SAE. There were 12 participants who reported 15 SAEs, which were deemed

by blinded investigators to be related to vaccination.

The WG also assessed specific SAEs that have been identified in safety surveillance during the 

period of the EUA, which previously have been described to ACIP. An RCA from the VSD 

evaluated chart-reviewed cases of myocarditis occurring among persons aged 18-39 years

following Dose 2. Based on events occurring in the 7-day risk interval after vaccination versus a 

comparison interval in vaccinated individuals, the adjusted rate ratio was 18.75 (6.73 – 64.94). 

Data from VAERS showed an elevated ratio of observed to expected chart-confirmed

myocarditis cases in the 7-day interval following vaccination among females aged 18-29 years 

and among males aged 18-49 years, with higher observed to expected ratios in males and 

females. Although VAERS data are subject to the limitations of a passive surveillance system, 

the elevated risk of myocarditis following Moderna vaccination is consistent with that observed 

in VSD. Regarding anaphylaxis, an RCA of data from VSD evaluated chart-reviewed cases of 

anaphylaxis among all vaccinated persons aged 18 years and older. Based on events occurring 

in a 0-1 day risk interval after vaccination, the estimated incidence of confirmed anaphylaxis

was 5.1 (95% CI 3.3–7.6) per million doses.20

The GRADE assessment for SAEs was based on 2 RCTs. The pooled relative risk indicated a 

balance of SAEs between vaccinated and placebo groups with a relative risk of RR 0.92 (95% 

CI: 0.78–1.08). The certainty assessment was reduced 1 point due to serious concern of 

imprecision because the confidence interval indicates that both reduced and increased risk of

SAEs are possible. The final evidence certainty was Type 2 (moderate certainty). The 

observational data concerning the specific SAEs of myocarditis and anaphylaxis included the 

description of the quantitative data described earlier. The WG started with Type 3 data from 

observational surveillance systems and did not decrease or increase the certainty. The final 

certainty was Type 3 (low certainty). 

For the outcome of severe reactogenicity, the Phase 2 and 3 RCTs solicited events through 

electronic diaries for the 7 days following each dose. Both randomized studies used the same 

events and grading scales shown here: 

 Grade 3: pain at injection site or axillary swelling/tenderness that prevents daily activity; 

redness >10 cm; and swelling >10 cm

 Grade 4: emergency room visit or hospitalization for severe pain at the injection site or 

axillary swelling/tenderness, necrosis (redness and swelling categories) or exfoliative 

dermatitis (redness category only)

20 Klein et al. Surveillance for Adverse Events After COVID-19 mRNA Vaccination. JAMA. 2021;326(14):1390-1399 
ACIP Meeting Summary February 4, 2022

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The local reaction solicited were injection site pain, redness, swelling, and axillary swelling and 

tenderness. The systemic events listed were fever, nausea and vomiting, headache, fatigue, 

chills, muscle pain, and joint pain. The events and grading scales are shown here: 

 Grade 3: fever >38.9°C to 40.0°C, vomiting that requires IV hydration; fatigue, headache, 

muscle pain, or joint pain that prevents daily activity

 Grade 4: fever >40.0°C, fatigue, headache, muscle pain, joint pain, or vomiting that require 

emergency room visit or hospitalization

In the Phase 2 study, Grade 3 or 4 systemic events were reported in 16% of persons in the 

vaccine arm and 3% of persons in the placebo arm. In the Phase 3 study, Grade 3 or 4 

reactions were reported by 22.6% of persons in the vaccine arm and 4.5% of persons in the 

placebo arm. Pooling the data from these 2 trials, the estimated relative risk for any Grade 3 or 

4 event was 5.03 (95% CI: 4.65–5.45). There were no serious concerns in the certainty 

assessment. The final evidence certainty was Type 1 (high certainty). 

To summarize the GRADE assessment for the Moderna COVID-19 vaccine, the data available 

for benefits indicate that the vaccine is effective for preventing symptomatic COVID-19 with high 

evidence certainty. For hospitalization and death, the available evidence favors the intervention

and certainty was moderate. For asymptomatic SARS-CoV-2 infection, the available data favors 

the intervention with high evidence certainty. In terms of harms in the RCTs, SAEs were 

balanced between the vaccine and placebo arms. In post-authorization safety monitoring,

myocarditis and anaphylaxis were rare but more common following vaccination. SAEs had 

moderate evidence certainty. In terms of reactogenicity, severe reactions were more common in 

vaccinated persons. In 21.3% of vaccine recipients versus 4.5% of placebo, recipients reported 

Grade 3 or 4 reactions. The evidence type for reactogenicity was high.

There are important limitations that should be acknowledged. In this rapidly evolving pandemic, 

the available body of evidence often does not represent the most recent epidemiology, including 

the impact of a new dominant variant on VE. The evidence available for inclusion in this GRADE

analysis does not capture the impact of the Omicron variant on VE. The VE estimates presented 

represent the best estimates within the context of the pandemic during the time of the study, but 

may not be representative of VE in different phases of the pandemic or with different circulating 

variants. The evidence available for inclusion in this GRADE evaluation is predominantly from 

the time periods in which Alpha and Delta were the dominant circulating variants.

In conclusion, the GRADE evaluation focuses on recommendations following licensure

of the Moderna COVID-19 vaccine that has been in use for a year under an EUA. Evidence for 

benefits are supported by a body of evidence comprised of 1 large Phase 3 RCT and numerous 

observational studies conducted worldwide. The RCT evidence demonstrated efficacy

for all beneficial outcomes, including the 2 critical outcomes of symptomatic disease and 

hospitalization. Efficacy data were further supported by a body of evidence from observational 

studies. Regarding harms, Grade 3 reactions were more common in vaccine than placebo 

recipients. RCT evidence showed that SAEs occurred at a similar frequency in vaccine and 

placebo groups overall. However, 2 specific rare but serious AEs have been associated with 

vaccination as identified through safety surveillance systems. 
ACIP Meeting Summary February 4, 2022

30

Discussion Summary

Dr. Poehling offered very special thanks to the COVID-19 Vaccines WG for the tremendous 

amount of work they did in pooling these data and recognized how reassuring it was that the 

RCTs and the observational studies showed the same patterns. 

Dr. Daley emphasized that these data are all very important and that Dr. Wallace presented

them in a clear and consistent way. He noted that he was sitting at his desk, but would give her 

a standing ovation if he could. 

EtR Framework: Moderna COVID-19 Vaccine Primary Series in Adults ≥18 Years of Age

Sara Oliver, MD, MSPH (CDC/NCIRD) provided updates to the EtR Framework on the 

Moderna COVID-19 vaccine, Spikevax®. She reminded everyone that the policy question they 

would vote on later in the day was, “Should vaccination with the Moderna COVID-19 vaccine

(Spikevax®, 2-dose primary series) be recommended for persons 18 years of age and over?” 

The WG presented this previously with the Pfizer BLA, but as a reminder with the FDA 

authorization of an EUA, ACIP has made interim recommendations. As the vaccine receives full 

FDA approval under the BLA, ACIP reviews the totality of the data available and votes to make 

a standard recommendation. In addition, for regulatory action GRADE (e.g., the EtR framework, 

and the ACIP vote) Moderna COVID-19 vaccine was considered compared to no vaccine.

Additional questions for discussion later in the session would focus on implementation,

myocarditis, and intervals. Those discussions would be open to discussion of data for both the 

Moderna and Pfizer COVID-19 vaccines. 

This PICO question used for the EtR framework included a population of people aged 18 years 

and older, and intervention of Moderna COVID-19 vaccine mRNA-1273 (100μg, 2 doses IM, 28 

days apart), a comparison of no vaccine, and the following outcomes: symptomatic laboratory 

confirmed COVID-19, hospitalization due to COVID-19, death due to COVID-19, asymptomatic 

SARS-CoV-2 infection, SAEs, and reactogenicity. As a reminder, the EtR framework assess 

questions with the 7 domains of the public health problem, benefits and harms, values, 

acceptability, feasibility, resource use, and equity.

Beginning with the public health problem, there have been over 75 million COVID-19 cases 

reported to CDC from January 23, 2020 – February 1, 2022. The US recently experienced a 

substantial surge that peaked mid-January with a 7-day moving average of over 800,000 cases 

per day. Since mid-January, cases have been declining and the current 7-day moving average 

is now just over 400,000 cases.21 As of February 1, over 888,000 deaths due to COVID-19 had 

been reported in the US.22 In terms of rates of COVID-19 cases by vaccination status, 

unvaccinated people in all age groups had higher case rates than fully vaccinated people in the 

same age groups. Notably in November 2021, unvaccinated adults aged 18 years and over had 

a 4 times greater risk of testing positive for COVID compared to fully vaccinated adults.23

Importantly, vaccines continue to provide substantial protection against severe disease and 

death. Unvaccinated adults 18 years of age and over had a 15 times greater risk of dying

from COVID compared to fully vaccinated adults. Furthermore, people who were fully 

vaccinated and had received an additional or booster dose had an even further lower risk of 

testing positive and dying from COVID compared to people who were unvaccinated. The largest 

gap was between those who are unvaccinated and those who are fully vaccinated.

21 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailycases Accessed February 3, 2022 22 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#trends_dailydeaths Accessed February 3, 2022 23 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status Accessed January 24, 2022 
ACIP Meeting Summary February 4, 2022

31

In terms of weekly trends in COVID-associated hospitalization rates in the US, there is a 

reporting delay in recent weeks. However, hospitalizations have increased in recent weeks

across all ages.24 While COVID hospitalization rates have been increasing, it is important to 

evaluate the hospitalization rates by vaccination status. In terms of the rates of COVIDassociated hospitalization by vaccination status in adults 18-49 years of age between January 

and December 2021, compared to fully vaccinated adults 18-49 years of age the monthly rates 

of COVID-associated hospitalizations were 12 times higher in unvaccinated adults 18 to 49 

years in December. Additionally, compared to fully vaccinated adults 50-64 years of age, the 

monthly rates of COVID-associated hospitalizations were 18 times higher in unvaccinated adults 

in the same age range. In those adults 65 years of age and over, COVID-associated 

hospitalizations were 18 times higher in unvaccinated adults 65 years of age and over

compared to fully vaccinated adults in that same age range.25 Hospitalizations can take a toll on 

the health care system. As of February 3, over half of states where at 80% ICU capacity or 

greater.26 Omicron is now the dominant circulating SARS-CoV-2 variant in the US.27

Now to look at the daily count of total doses administered and reported to CDC by date 

administered in the US. As of February 1, the 7-day moving average for doses administered 

was over 464,000 per day.28 It is known that approximately 25% of people aged 18 years and 

over are not fully vaccinated. Looking at COVID vaccine administration by vaccine type, over 

540 million COVID vaccines have been administered in the US and over 204 million of those 

were the Moderna COVID-19 vaccine. Over 212 million people are fully vaccinated in the US 

and over 74 million of these received the Moderna 2-dose series.29 In terms of the percent of 

COVID-19 vaccination coverage by age and date administered, the highest coverage with at 

least one dose is 95% among the oldest groups aged 65-74 years and 75+ years. The lowest 

coverage is 75% with at least one dose among those 18-24 years of age.30 Focusing on those 

fully vaccinated with Moderna by week and age group, similar patterns have been observed in 

which more doses were administered earlier in the rollout and older adults received their 

vaccines earlier.31 Those who are fully vaccinated varies by geographic location as well.32

To summarize the public health problem, the Omicron variant is the dominant circulating variant

of SARS-CoV-2 in the US. In January, COVID-19 cases, hospitalizations, and deaths increased, 

although cases have been declining in recent weeks. In November 2021, unvaccinated adults

18 years of age and over had 4 times the risk of testing positive and 15 times the risk of dying 

from COVID compared to fully vaccinated adults. Increasing cases are taxing health care

resources, with many states facing ICU bed shortages again. While over 200 million people are 

fully vaccinated in the US, vaccination coverage varies by age and geography. The WG agreed

that COVID-19 disease among adults continues to be of public health importance.

24 CDC COVID-NET. https://gis.cdc.gov/grasp/covidnet/covid19_3.html Accessed February 3, 2022 25 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalizations-vaccination Accessed January 31, 

2022 26 HHS Protect Public Data Hub. https://protect-public.hhs.gov/pages/hospital-utilization Accessed February 3, 2022 27 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#variant-proportions Accessed February 3, 2022 28 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-trends Accessed February 3, 2022 29 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed February 

3, 2022 

30 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends Accessed February 3, 

2022 31 CDC Data Analytics and Visualization Task Force; Data included through the end of January 2022 32 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-people-fully-percent-pop18 Accessed 

February 3, 2022
ACIP Meeting Summary February 4, 2022

32

Moving now to the benefits and harms domain. Based on the GRADE evaluation, the clinical 

trial demonstrated efficacy against symptomatic laboratory-confirmed COVID, which was further 

supported by observational data. Overall efficacy was 92.7%, with high certainty. The clinical 

trial also demonstrated efficacy against hospitalization and was further supported by 

observational data. The overall efficacy was 95.9%, with moderate certainty of evidence.

Thought deaths were uncommon in the clinical trial, observational data demonstrated 

effectiveness against death due to COVID-19. The pooled VE was 93.8%, with moderate 

certainty of evidence. The clinical trial demonstrated efficacy against asymptomatic SARS-CoV2 infection. Overall efficacy was 57.4%, with high certainty. In terms of harms, SAEs were 

reported in a similar proportion among recipients of vaccine and placebo. There have been 2

specific rare SAEs identified as being associated with vaccination through safety surveillance. 

There was moderate certainty of evidence for these SAEs. Serious reactions were more 

common in vaccine recipients and any Grade 3 or more reaction was reported by 21% of 

vaccinated versus 4.5% of placebo groups. The reactogenicity had a high evidence certainty.

To summarize the benefits and harms domain, the GRADE evaluation focused on

recommendations following licensure of the Moderna COVID-19 vaccine that has been used for 

a year under the EUA. Evidence for benefits is supported by a body of evidence comprised of 1

large Phase 3 RCT and numerous observational studies conducted worldwide. The RCT

evidence demonstrated efficacy for beneficial outcomes, including the 2 critical outcomes of 

symptomatic disease and hospitalization. Efficacy data were further supported by the body of 

evidence from observational studies. Regarding harm, Grade 3 events were more common in 

vaccine than placebo recipients, but overall RCT evidence showed that SAEs occurred at a 

similar frequency in vaccine and placebo groups overall. However, these 2 specific but rare AEs 

have been associated with vaccination as identified through US safety surveillance systems.

In summary of the potential benefit and harm balance, VAERS has demonstrated reporting 

rates of myocarditis greater than the background rates for males 18-49 years of age and 

females 18-29 years of age after Dose 2. At least 90 days after myocarditis diagnosis, most 

patients reported no impact on their quality of life and most did not report missing school or 

work. Most HCP (81%) indicated that the patient was probably or fully recovered. For 

assessment of this benefit risk balance, the benefits were calculated per 1 million people

who are fully vaccinated. The age group of 18-39 years was selected for this assessment 

because this age group has the highest rates of myocarditis and lowest hospitalization rates 

among adults and would therefore have the closest benefit-risk margin. Age- and sex-specific 

hospitalization rates were used from COVID-NET and VE estimates came from the COVIDNet 

and COVID Data Tracker platforms. The benefits were calculated over a 150-day or 5-month 

period. Harms were calculated as per 1 million persons who are fully vaccinated. The vaccinespecific myocarditis rates were used from the VSD. The vaccine-specific estimates of

effectiveness against COVID hospitalization from both the Ivy Network and VISION were pooled 

to create a final VE estimate of 92%, which is the VE estimate used in the model. Looking at 

rates of myocarditis following the Moderna COVID-19 vaccine per million second doses 

administered among persons aged 18-39 from the VSD, myocarditis was most common in 

males who had a rate of 67.5 myocarditis cases per million second doses in the 7-day risk 

period. In terms of COVID-associated hospitalizations prevented by the Moderna vaccine 

compared with myocarditis cases expected per million fully vaccinated persons 18-39 years of 

age, many more COVID-19 hospitalizations would be prevented than myocarditis cases 

expected over the course of 5 months. Among males 18-39 years who have the highest rates

of myocarditis overall, many more COVID-19 hospitalizations would be expected to be 

prevented than myocarditis cases expected.
ACIP Meeting Summary February 4, 2022

33

For the benefit-risk balance there are a few limitations that should be noted. The benefit-risk 

analysis considered direct benefits and risks over the 150-day period comparing vaccine to no 

vaccine. The VE assumptions used in the model do not yet include Omicron specific VE 

estimates. The model assumes a static hospitalization rate over 5 months. The benefit-risk 

profile would change as hospitalization rates change. The model does not account for booster 

doses or prior infection. To summarize the benefits and harms, the clinical trial and

observational studies demonstrated that the Moderna vaccine is effective in the prevention of 

COVID-19 in persons 18 years of age and over. The risk of myocarditis or pericarditis is noted

after the mRNA vaccines and the highest risk was seen after the second doses in younger 

males. However, the benefits for the Moderna COVID-19 vaccine far outweigh any possible 

vaccine-associated risk. Therefore, the WG felt that the desirable anticipated effects were large, 

undesirable anticipated effects were small, and the balance favors the intervention.

In terms of the values domain, surveys were conducted among adults asking about their intent 

to receive the COVID-19 vaccine. Overall, intent has consistently increased since 2020 when 

the vaccines were authorized. In a survey of vaccination status and intent among adults 18 

years of age and over in the US, almost 85% of adults reported that they are vaccinated

or definitely will get vaccinated, 4% reported they probably would get vaccinated or are unsure,

and 10% reported they would probably or definitely not get vaccinated.33 A survey of the

American general population was conducted among individuals 18 years of age and over 

between January 7-10, 2022. Unvaccinated survey respondents were asked, “Does the 

discovery of the Omicron variant make you more or less likely to get the COVID vaccine?” The 

majority (72%) of respondents expressed that it makes no difference, while a smaller proportion 

said that they would be less or more likely to receive the vaccine at 13% each.34 When 

unvaccinated adults were asked, “What, if anything, would convince you to receive a COVID-19

vaccine?” half of unvaccinated adults said that nothing would convince them to get a COVID-19 

vaccine. 12% said that more research or transparency would convince them, fewer said that 

they would get it if it was required for work or was mandatory (6%), if they received a large 

monetary incentive (5%), if their doctor recommended it (3%), or if the vaccine prevented 100% 

of infections (3%).35

Following FDA's full approval of the Pfizer vaccine in the US, initial data indicated that there was 

a slight uptick of 17% in the average number of Americans getting their first COVID-19 vaccine 

dose in the days immediately following approval. In the week prior to full approval, an average 

of about 404,000 Americans were initiating vaccination each day. Following approval,

approximately 473,000 Americans were getting their first dose each day. Although not a rapid 

surge in vaccinations in the days immediately following approval, full approval may have been 

enough to convince some to finally get immunized.36

Another ongoing survey was designed by CDC and the University of Iowa to assess vaccine 

intent of unvaccinated Americans in response to this FDA BLA for the Moderna vaccine. Data

were collected from January 27-31, 2022. The current sample size is around 500 respondents.

When asked about reasons surrounding vaccine hesitancy, concerns about vaccine side effects

33 CDC COVID Data Tracker. Trends in COVID-19 Vaccine Confidence in the US. https://covid.cdc.gov/covid-data-tracker/#vaccineconfidence. Accessed January 21, 2022

34 Axios/Ipsos Poll. January 2022. https://www.ipsos.com/en-us/news-polls/axios-ipsos-coronavirus-index Accessed January 19, 

2022

35 KFF COVID-19 Vaccine Monitor: Early Omicron Update (Dec 15 – 20, 2021). https://www.kff.org/coronavirus-covid-19/pollfinding/kff-covid-19-vaccine-monitor-early-omicron-update/. Accessed January 19, 2022 36 Rise in COVID-19 vaccinations following full FDA approval

ABC news. August 31, 2021. More Americans getting vaccinated following full FDA approval of Pfizer COVID vaccine. 

https://abcnews.go.com/Health/americans-vaccinated-full-fda-approval-pfizer-covid-vaccine/story?id=79750505
ACIP Meeting Summary February 4, 2022

34

and general mistrust of COVID-19 vaccines were the top reasons for remaining unvaccinated.

During the data collection period, 29% of the unvaccinated respondents said that they thought 

the Moderna COVID-19 vaccine already had full approval from the FDA. In relation to vaccine 

intentions in response to the Moderna BLA, 5% of unvaccinated respondents said that they 

would get a vaccine as soon as they could if the Moderna vaccine received full approval from 

the FDA. Among unvaccinated respondents, 20% said they would continue waiting to see if 

COVID-19 vaccines were safe, 52% said they would definitely not get vaccinated

or would only do so if it was required, 11% said that they would wait a few more weeks to get a 

COVID vaccine after the Moderna vaccine received full approval but were open or unsure about 

getting the vaccine, and 11% said they would wait more than a year to get a COVID vaccine

after the Moderna vaccine received full approval. 

The WG felt that the overall population felt the desirable effects were large relative to 

undesirable effects. However, there was probably important uncertainty or variability in how 

people value the outcome.

Moving to the domain of acceptability, over 200 million doses of the Moderna vaccine had 

already been administered and implemented as of February 2, 2022 in a wide variety of 

settings, including state and local health departments, mass vaccination clinics, long-term care 

facilities (LTCF), and retail pharmacies.37 Vaccination with the Moderna COVID vaccine already

was highly acceptable to stakeholders under FDA's EUA and ACIP interim recommendations.

Vaccination may be more acceptable under full FDA approval and standard ACIP

recommendations. The WG felt that the Moderna vaccine is acceptable to key stakeholders.

Moving to the domain of feasibility, possible barriers to implementation that have been 

mentioned in previous EtRs complexity of recommendations, vaccine storage and handling 

requirements, financial barriers, and supply barriers. The Moderna vaccine will be the second

vaccine with the BLA. The BLA has only been issued for some indications, which could add 

complexity. The BLA is issued for the primary series in those 18 years of age and over, while 

the EUA recommendations remain for the additional dose and booster dose recommendations.

Recommendations made under COVID-19 Vaccine Emergency Use Instructions (EUI) only 

allow for vaccines with a BLA. The BLA will allow these recommendations to be extended to 

include the Moderna vaccine. There have been a variety of updates and improvements to the 

vaccine storage and handling requirements since the initial EUA.38 Now, the vaccine can be 

stored frozen and refrigerated for up to 30 days prior to the first use. As throughout the

pandemic, all COVID vaccines are provided to the US free of charge. However, health systems 

or health departments can incur costs for vaccine implementations, clinics, and outreach.

Financial hardships may arise if vaccine recipients need to take time off of work or could 

experience post-vaccination reactogenicity that would keep them from working. Supply barriers 

are not anticipated. Vaccine supply in the US is sufficient for implementation of the intervention.

As of February 2, over 200 million doses have been administered in the US, demonstrating that 

the vaccine is feasible to implement broadly.39 In terms of the feasibility domain, the WG felt that 

the vaccine is feasible to implement.

37 CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed February 

3, 2022. 38 Moderna. Storage & Handling. Storage & Handling | Moderna COVID-19 Vaccine (EUA) (modernatx.com). Accessed January 18, 

2022 39CDC COVID Data Tracker. https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total Accessed February 

3, 2022.
ACIP Meeting Summary February 4, 2022

35

Moving to the resource use domain, a KFF analysis estimated the cost of preventable COVID19 hospitalizations among unvaccinated adults in the US.40 From June - November 2021, 

preventable COVID hospitalizations among unvaccinated adults were estimated to cost over 

$13 billion. Vaccine doses purchased with US taxpayer funds will be given to people living in the 

US at no cost.41 Several published modeling studies have found that COVID vaccines are likely 

to be of reasonable economic value and may also be cost-saving under many circumstances.42

While not a primary driver of decision-making in the pandemic, the WG still felt that the Moderna 

vaccine was a reasonable and efficient allocation of resources.

For the domain of equity, the cumulative COVID-19-associated hospitalizations in the US by 

race and ethnicity for March 7, 2020 through March 22, 2022 showed that AI/AN, Black, and 

Hispanic populations have consistently had the highest rates of COVID-19-associated

hospitalizations in the US.43 In terms of the percentage of people 18 years of age and over who 

have received at least one dose of COVID-19 vaccine by race and ethnicity over time, AI/AN 

populations have consistently had the highest percentage of those receiving at least one dose 

of COVID-19 vaccine.44 Looking at COVID-19 vaccination coverage by geography, only 20% of 

US counties report 70% or more of the population 18 years of age and over who are fully

vaccinated.45 Vaccine uptake lags in adults living in rural and suburban areas compared to 

urban areas. As of November 2021, 8 in 10 urban residents said that they have received at least 

one dose of a COVID vaccine, compared to 7 in 10 suburban adults and 67% of rural adults. Of 

those living in rural areas, 1 in 5 say they will “definitely not” get a COVID-19 vaccine and 1 in 6

of those living in suburban areas say they will “definitely not” get a COVID vaccine. This is at 

least twice the share of urban residents who say the same.46

An MMWR published earlier in the week assessed COVID-19 vaccination coverage among 

LGBT adults 18 years of age and older by sexual orientation. Gay or lesbian adults reported 

higher vaccination coverage overall than heterosexual adults. There were no significant 

differences in vaccination coverage among persons based on gender identity. Vaccination 

coverage was lowest among non-Hispanic Black LGBT persons across all categories

of sexual orientation and gender identity.47 While there was considerable variability in the

interpretation of the equity domain, overall the WG felt that the approval of the Moderna vaccine 

probably would have no impact on health equity.

40 Peterson-KFF Health System Tracker. https://www.healthsystemtracker.org/brief/unvaccinated-covid-patients-cost-the-u-s-healthsystem-billions-of-dollars/ Accessed January 25, 2022 41 CDC COVID-19. COVID-19 Vaccines Are Free to the Public. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/no-cost.html 42 a) Padula et al. 2021. J Med Econ; b) Bartsch et al. 2021 J Inf Dis; c) Gupta et al. 2021 Health Aff; d) Kohli et al 2021 Vaccine 43 CDC. https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network Accessed February 3, 2022 44 CDC. https://covid.cdc.gov/covid-data-tracker/#vaccination-demographics-trends as of February 2, 2022, and US Census Bureau 

National Population Estimates 

45 CDC COVID-19 County Integrated County View. https://covid.cdc.gov/covid-data-tracker/#vaccinations-county-view Accessed 

January 20, 2022 

46 KFF COVID-19 Vaccine Monitor: Differences in Vaccine Attitudes Between Rural, Suburban and Urban Areas. 

https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-vaccine-attitudes-rural-suburban-urban/

Accessed January 18, 2022

47 McNaghten A, Brewer NT, Hung M, et al. COVID-19 Vaccination Coverage and Vaccine Confidence by Sexual Orientation and 

Gender Identity — United States, August 29–October 30, 2021. MMWR Morb Mortal Wkly Rep 2022;71:171–176. DOI: 

http://dx.doi.org/10.15585/mmwr.mm7105a3
ACIP Meeting Summary February 4, 2022

36

This table summarizes the WG’s judgments for each of the EtR domains: 

For both of the primary series and additional booster doses and for all 3 COVID vaccines used 

in the US, there are EUAs in place. The primary series for Pfizer in those 16 and over and the 

primary series for Moderna in those 18 and over have full FDA approval with the BLA. Dr. Oliver 

emphasized that the authorization in any vote by the ACIP during this session would not 

override any existing recommendations for the EUAs. The ACIP will continue to review data as 

additional vaccines and indications move from EUA to BLA. The WG’s interpretation is that 

overall, COVID-19 vaccines have been a critical tool in this pandemic, preventing millions of 

COVID-19-associated hospitalizations and deaths. To date, hundreds of millions of doses of the 

Moderna COVID-19 vaccine have been given with over a year of incredibly closely monitored 

real-world safety and effectiveness data. Vaccinating the unvaccinated with a primary series 

continues to be important. Additional protection from all recommended COVID-19 vaccine 

doses is important over the course of an evolving pandemic. In summary of the WG’s 

interpretations with the balance of consequences, the WG felt that the desirable consequences 

clearly outweigh undesirable consequences in most settings. In terms of the type of 

recommendation, the WG recommended the intervention. 

Discussion Summary

Dr. Hahn (CSTE) said she came to fully understand something in the last week or so that she 

wanted to bring forward. CSTE continues to get questions about case rates, particularly for 

hospitalization rates among people who are partially vaccinated. CSTE has responded that they 

continue to consider these individuals to be unvaccinated because that is where they show up in 

the data. It was not until recent conversations with continued queries from members of the 

public that she realized that the perception, rumor, or theory is that partially vaccinated people

who had a single dose or have just gotten their second dose make up a large percentage of the

group being identified as “unvaccinated” in hospitals and hospitals are filling up with people who 

got a dose of the vaccine and that maybe that somehow gave them COVID-19 from the vaccine 

itself or from some sort of immune suppression after the vaccine. CSTE has begun to produce 

data showing this as a separate group. Perhaps ACIP should show this group separately in the 

data. CSTE was able to demonstrate that a very small percentage of people in the hospital 

currently had a single dose or had recently been vaccinated.
ACIP Meeting Summary February 4, 2022

37

Regarding the resource use allocation, Dr. Lee recognized that the mandate of ACIP is the 

health of the US population. However, she also highlighted that the estimated impact or 

economic burden does not reflect the true cost of the pandemic in the US society. It is not just

the cost of the hospitalizations. It is the cost of the work missed, businesses closed, wages lost, 

and the worsening of the already existing educational disparities in the in this country which also 

have long-term economic consequences on this generation of children directly impacted by the 

pandemic. While she recognized that it is nearly impossible to capture all of that in the resource

assessment, it is important to acknowledge in some way because this goes well beyond the way 

ACIP vaccine deliberations are typically thought of. 

Dr. Poehling expressed gratitude to Dr. Oliver for a fantastic presentation that was very clear. 

She asked for additional input about whether there was much diversity in the opinion of the WG

in voting for this recommendation?

Dr. Oliver indicated that there was not. The WG overwhelmingly agreed that they would 

recommend the intervention of the 2-dose Moderna primary series among those ≥18 years of 

age.

Vote: Moderna COVID-19 Vaccine for Individuals ≥18 Years of Age

Dr. Sara Oliver (CDC/NCIRD) presented the proposed recommendations for Moderna COVID19 vaccine for individuals ≥18 years of age, which follows: 

“The Moderna COVID-19 BLA-approved vaccine (Spikevax®, 2-dose primary series) is 

recommended for persons 18 years of age and older.”

Though not included in the vote language, Dr. Oliver clarified that the ACIP recommendations

addressing the EUA uses of the Moderna vaccine will remain in effect. This is the only change 

that would move the recommendation for the 2-dose primary series from the interim

recommendation under EUA to a full recommendation. The other EUA votes would remain in 

effect.

Motion/Vote: COVID-19 Vaccine Booster Doses for Individuals ≥18 Years of Age

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

“The Moderna COVID-19 BLA approved vaccine (Spikevax®, 2-dose primary series) is 

recommended for persons 18 years of age and older.” Dr. Ault seconded the motion. No COIs 

were declared. The motion carried with 13 affirmative votes, 0 negative votes, and 0 

abstentions. The disposition of the vote was as follows:

13 Favored: Ault, Bahta, Bell, Brooks, Chen, Cineas, Daley, Kotton, Lee, Loehr, Poehling, 

Sanchez 

 0 Opposed: N/A

 0 Abstained: N/A

 0 Absent: Long, McNally
ACIP Meeting Summary February 4, 2022

38

Discussion Summary

Subsequent to the vote, Dr. Lee invited ACIP members to make a statement about the rationale 

for their vote and/or to share any additional general comments: 

Dr. Daley expressed his sense of wonder at what had been accomplished, along with his deep 

sense of gratitude. There are now 2 vaccines against COVID-19 that are fully licensed in the 

US. These vaccines were authorized and then licensed along a rapid timeline while still

following all of the well-established regulatory processes in place before the pandemic. As he 

mentioned earlier in the day, an estimated 1.1 million deaths have been averted through

vaccination in the US and countless more globally. This cannot be taken for granted and it 

should not be assumed that this was an inevitable outcome. To put this in a more personal 

context, everyone has individuals in their lives—parents, grandparents, children, friends—who 

may have gotten sick and/or died from COVID who did not because of vaccination. For that, he 

is very grateful. That said, he acknowledged that many have lost their lives to COVID-19 and 

everyone is still vulnerable, particularly the very young, the very old, the unvaccinated, and 

those with immunocompromise. While he realizes that there is still a lot of work to do and a lot

of challenges ahead with respect to the pandemic and the role that vaccines play, on this day he 

was just very appreciative of all that has been accomplished.

Dr. Lee thanked Dr. Daley and expressed everyone’s appreciation of his leadership of the 

COVID-19 Vaccines WG, which has been quite busy.

Dr. Bell commented on a corollary to what Dr. Daley said. One of the things that the ACIP

values the most is transparency. Therefore, one of the things she thought they could see from 

the process throughout the day was the broad context of evaluating risks and benefits using 

scientific evidence that has been accumulated over a long period of time with millions of people 

vaccinated. It is possible to see the power and the value of vaccination. Given that the biggest 

risk continues to be to individuals not getting vaccinated, she hoped that this transparent 

process would encourage at least some people who are still thinking about whether they should 

get vaccinated to do the most important thing that they can do to protect themselves and their 

family, which is to get a vaccine.

Dr. Duchin (NACCHO) said he wanted to reinforce the importance of the booster dose. While 

they had rightly been talking about the primary series, there are many people in many 

communities throughout the country who have received the primary series who are eligible but

yet have not received a booster dose. It is critical to understand how necessary that booster 

dose is in terms of receiving the full protection that these vaccines can offer against serious 

disease, hospitalizations, and deaths. For people who wonder whether an Omicron-specific 

vaccine will be needed, perhaps one of the one of the experts could talk about what is on the 

horizon with respect to the potential need and development of such a vaccine. 

Updates to Clinical Considerations

Elisha Hall, PhD (CDC/NCIRD) presented on anticipated updates to the Interim Clinical 

Considerations for use of COVID-19 Vaccines. Anticipated updates will include clarification

and updates on guidance for people who are moderately or severely immunocompromised, 

updates to recommendations on passive antibody products, and reduction in reorganization for 

ease of use.
ACIP Meeting Summary February 4, 2022

39

Beginning with the guidance for people who are moderately or severely immunocompromised, 

all guidance in this section will apply only to this population. As a reminder, recommendations

for people who are immunocompromised at the time of vaccination are already different than 

recommendations for most people. This is because this group is at increased risk for severe 

COVID-19 and more likely to have serious breakthrough infections. They may not mount a 

protective immune response after a 2-dose primary series, in general have lower VE than 

people who are not immunocompromised, and have waning protection over time. In terms of the 

current COVID-19 vaccination schedule for people who are moderately or severely 

immunocompromised, similar to the recommendation for the general population, mRNA COVID19 vaccines are preferred for all doses over Janssen COVID-19 vaccine. For those in this 

population who choose an mRNA COVID-19 vaccine 2-dose primary series,

1 additional dose and 1 booster dose are recommended for people aged 12 years and older

for a total of 4 doses. This is not indicated for people who are immunocompetent. For those who 

choose Janssen, this includes 1 primary dose and 1 booster dose.

There has been recent confusion about the recommendations for this population, including 

reports of people who choose mRNA COVID-19 vaccines being denied their fourth dose. In 

addition to communication efforts, more clarification is being added in the clinical considerations

to emphasize that this population should receive 3 doses for a primary series and 1 booster

dose if they are aged 12 years and older. There are no changes in the number of doses. It is 

simply clarification to address the challenges being reported. 

The next few changes are possible through use of EUI. EUI are allowed under the Pandemic 

and All Hazards Preparedness Reauthorization Act (PAHPRA). EUI provides information about 

emergency use of FDA-approved medical products that may not be included or may differ from

the information provided in the FDA approved labeling package insert. Since EUI are only for 

FDA-approved products, this only applies to the 2 approved COVID-19 vaccines Spikevax®

(Moderna) for which guidance would apply to people 18 years and older, and Comirnity® (PfizerBioNTech), for which guidance would apply to people 12 years and older. EUI materials include 

fact sheets for HCP, fact sheets for recipients and caregivers, and FAQs and can be found

on the CDC website.48 Revisions utilizing the EUI mechanism for people who are moderately or 

severely immunocompromised include a shorter booster interval after an mRNA COVID-19 

vaccine primary series, an additional dose after a Janssen COVID-19 vaccine primary series, 

and case-by-case clinical decision-making.

Currently, people who are moderately or severely immunocompromised who received an mRNA 

COVID-19 vaccine primary series are recommended to receive a booster dose at least 5 

months after completion of the series. This 5-month booster interval will be revised to at least 3 

months after completion of the mRNA primary series. The rationale for this decision was out of 

an abundance of caution to help this population who may not be as well-protected get their 

booster dose sooner, particularly with concerns about initial immune response, loss of 

protection over time, and high community transmission due to the Omicron variant. To support 

this change, small studies demonstrate immunogenicity of a fourth dose when administered 1 to 

3 months after the third dose. Among participants with seronegative or low positive responses 

after 3 doses, 42% to 66% were seropositive after 4 doses. Additionally, multiple studies 

demonstrate immunogenicity of a booster dose as early as 3 months in the general population 

following a 2-dose primary series. Multiple countries have implemented booster doses as early 

as 3 months in the general population following a 2-dose primary series. To support this 

change, small studies demonstrate immunogenicity of a fourth dose when administered 1 to 3 

48 https://www.cdc.gov/vaccines/covid-19/eui/index.html 
ACIP Meeting Summary February 4, 2022

40

months after the third dose. Among participants with seronegative or low positive responses 

after 3 doses, 42% to 66% were seropositive after 4 doses. Additionally, multiple studies 

demonstrate immunogenicity of a booster dose as early as 3 months in the general population 

following a 2-dose primary series. Multiple countries have implemented booster doses as early 

as 3 months in the general population following a 2-dose primary series.49

Guidance will be added on the schedule for people who are moderately or severely

immunocompromised who received a Janssen COVID-19 vaccine primary series. These people 

are currently recommended to receive 1 booster dose at least 2 months after completion of the 

primary dose. An mRNA COVID-19 vaccine is preferred for the booster dose, but Janssen

COVID-19 vaccine can be used provided that the patient is educated on the risks and

symptoms of thrombosis with thrombocytopenia syndrome (TTS), the need to seek medical care 

should such symptoms develop, and the availability of mRNA COVID-19 vaccines. The revised 

guidance will add an additional dose to this schedule. People who are moderately or severely

immunocompromised would be recommended to receive 1 additional dose at least 28 days after 

the primary Janssen COVID-19 vaccine dose, and 1 booster dose at least 2 months after

completion of the additional dose for a total of 3 doses. Recognizing that many people may

already have received 2 doses—their primary dose and booster dose. The guidance will 

address what to do if someone already has received a booster dose. There is not guidance for 

more than 3 doses.

Language will be added that on a case-by-case basis, providers who care for moderately or 

severely immunocompromised patients may administer mRNA COVID-19 vaccines outside of 

the FDA and CDC dosing intervals based on clinical judgment when the benefits of vaccination 

with a different schedule or dosage are deemed to outweigh the potential and unknown risks.

However, providers should not routinely administer additional doses of COVID-19 vaccine

beyond those recommended in this guidance. Additionally, antibody testing is not currently

recommended to assess the need for vaccination or assess immunity following vaccination.

Passive antibody products guidance applies to everyone, not just those who are

immunocompromised. Currently, for people who have received passive antibody products for 

COVID-19, there is a recommended deferral period before vaccination. People should defer

vaccination for 30 days if the product was used for post-exposure prophylaxis (PEP) and 90 

days if it was used for treatment. With the revised guidance, people who previously received

antibody products such as anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma as 

part of COVID-19 treatment PEP or pre-exposure prophylaxis (PrEP) can be vaccinated at any 

time. There is no longer a recommended deferral period for COVID-19 vaccination following 

receipt of anti-SARS-CoV-2 antibody product. In people who previously received a COVID-19

vaccine, EVUSHELDTM for PrEP should be deferred for at least 2 weeks after vaccination per 

the product EUA.

49 a) Kamar, N., Abravanel, F., Martion, O. (2021). Assessment of 4 Doses of SARS-CoV-2 Messenger RNA–Based Vaccine in 

Recipients of a Solid Organ Transplant. Infectious Diseases, 4(11), e2136030; b) Benotmane, I., Bruel, T., Planas, D., et al. 

(2021). A fourth dose of the mRNA-1273 SARS-CoV-2 vaccine improves serum neutralization against the delta variant in kidney 

transplant recipients. medRxiv. Preprint. doi.org/10.1101/2021.11.25.21266704; c) Alejo, J.L., Mitchell, J., Chiang, T., et al. 

(2021). Antibody Response to a Fourth Dose of a SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients: A Case Series. 

Transplantation, 105(12), e280-281; d) Munro, A., Janani, L., Cornelius, V. (2021). Safety and immunogenicity of seven COVID19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a 

blinded, multicentre, randomised, controlled, phase 2 trial. Lancet, 398, 2258-76; and e) Atmar, R.L., Lyke, K.E., Deming, M.E. 

(2021). Heterologous SARS-CoV-2 booster vaccinations-preliminary report. medRxiv. Preprint. doi: 

10.1101/2021.10.10.21264827
ACIP Meeting Summary February 4, 2022

41

The reason for removing the deferral period is based on a balance of benefits and risks. A study 

among nursing home residents and staff demonstrated that recipients of the monoclonal 

antibody bamlanivimab mounted a robust immune response to mRNA vaccination regardless of 

age, risk category, or vaccine type. This suggests that an interval dose does not need to be

tailored to particular subgroups. Although antibody response was numerically lower in people 

who received monoclonal antibodies, it was still considered to be high and the clinical

significance of the reduction is unknown. Most notably, there was no correlation between 

interval to COVID-19 vaccination and neutralizing titers. Programmatically, there can be

challenges to current intervals between receipt of monoclonal antibodies and COVID-19 

vaccination, which may reduce the likelihood of getting vaccinated. In the current setting of the 

COVID-19 pandemic, getting people vaccinated, including booster vaccination, is a priority and 

the benefits likely outweigh any potential risks for immune interference for monoclonal 

antibodies.50

CDC is in the process of streamlining the content and layout of the Interim Clinical 

Considerations for increased usability. The Interim Clinical Considerations can be found on the 

CDC website.51

Discussion Summary

Dr. Lee noted that the changes were very much welcome for those of who are providing care or 

recommendations on the frontline. This is helpful, practical implementation information that 

should make a huge difference to many patients.

Dr. Kotton agreed that the updates will dramatically help immunocompromised patients. In the 

past 2 months, she has seen many of these immunocompromised patients who followed all of 

the rules still have significant breakthrough infections.

Dr. Brooks observed that the J&J guideline for immunocompromised showed that for the second 

dose, only an mRNA vaccine should be used but that for the booster, any vaccine could be 

used. He asked for further explanation for that difference in the recommendation. 

Dr. Hall acknowledged that it is confusing and explained that the main reason for this is due to 

legal limitations. The recommendations that have been added for moderately or severely 

immunocompromised, including this recommendation, are possible through the EUI that can 

only be used for licensed vaccines. The additional dose added on must be Pfizer or Moderna

because those are the only vaccines allowed through the EUI. The booster continues to be

preferred for Moderna and Pfizer due to the risk for TTS with the J&J vaccine. 

Dr. Sanchez emphasized that the datasets are strong in that it has to be at least 2 months and 

the other one has to be 3 months, especially if the second dose is a Pfizer or Moderna. He 

asked whether this could be harmonized to say that all booster doses are to be given 3 months 

or later rather than grappling with 21, 28, 1 month, 2 months.

Dr. Hall acknowledged that it is confusing to have different intervals. She clarified that the 2

months is currently allowed under the EUA for the booster and consideration has not been given 

to extending that interval for the mRNA. They want people to get it sooner. The Janssen vaccine 

50 Benschop, et al. (2021). The effect of anti-SARS-CoV-2 monoclonal antibody, bamlanivimab, on endogenous immune response 

to COVID-19 vaccination. medRxiv. Preprint. doi: https://doi.org/10.1101/2021.12.15.21267605 51 https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#CoV-19-vaccination 
ACIP Meeting Summary February 4, 2022

42

is already sitting with that 2-month interval, so consideration would have to be given to whether 

it would be possible to actually extend that. However, they would not necessarily want anyone

to get the booster later.

Given that the ACIP just voted to expand the BLA for the primary series for Moderna, it seemed 

to Dr. Loehr that the clinical considerations were going past that to make suggestions that still 

fall into the EUA. It was not clear to him whether it was appropriate to do that. His sense in the 

past had been the EUA was a strict guideline and those rules should not be bent at all.

Dr. Hall stressed that this is being done through an EUI not an EUA. CDC is allowed to issue

EUIs that go outside of what is indicated in the package insert. That is the reason they were 

able to do that and still be covered.

Dr. Fryhofer (AMA) noted that Slide 7 said that this applied only to use of Spikevax® that is 

approved for persons 18 years of age and older and Comirnaty® for persons 12 years of age

and older. She thought that the Comirnaty® vaccine was FDA-approved with the BLA for 

persons 16 years of age and older.

Dr. Hall confirmed that Comirnaty® is licensed for the 2-dose primary series for persons 16 

years of age and older. Essentially, the EUI allows for use of approved vaccines. Comirnaty®

has gray cap and purple cap vials, which means that they would be called BLA-compliant vials. 

Anything in the EUI can apply to those vials. Since they can be used for ages 12 years and 

older, that is why the EUI can apply down to that age. However, it cannot go down to 5-11 years 

of age. 

Dr. Mbaeyi added that EUI are a new pathway that many people are hearing about for the first

time. CDC is using these in close coordination with FDA, not going outside of FDA, to determine 

the best way forward that legally would allow CDC to make some necessary changes to the 

clinical considerations. It is through mutual consultation that CDC has sometimes made the 

decision that it is more appropriate to use an EUI for certain guidance versus other regulatory 

mechanisms. 

Canadian Experience and Evidence with COVID-19 Vaccine Primary Series Extended 

Intervals

Dr. Matthew Tunis (Public Health Agency of Canada) presented on the Canadian program 

context and highlighted some of the evidence that has informed Canadian recommendations in 

terms of 1-dose effectiveness and duration between doses, immunogenicity with longer 

intervals, effectiveness with longer intervals, and safety with the longer intervals. Canada's 

National Advisory Committee on Immunization (NACI) has been providing advice on the 

COVID-19 vaccine intervals since 2020. It is important to note some of the structural differences 

throughout the pandemic between the Canadian and US context. Under the Terms of 

Reference, even under a regulatory Interim Order (roughly comparable to an EUA) through 

most of the pandemic, NACI was permitted to issue off-label advice on COVID-19 vaccines as 

per usual. There have been a number of off-label recommendations from the beginning of 

COVID-19 vaccines, for which there have been no issues. NACI has provided several updates 

on extended intervals for the primary series as evidence has evolved.
ACIP Meeting Summary February 4, 2022

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There has been an evolving story in Canada around intervals. From the beginning with the 

COVID-19 vaccines in December 2020, NACI recommended an alternate interval of 28 days for 

Pfizer-BioNTech versus the 21-day authorized interval. In early in December 2020, Quebec's 

Provincial Immunization Committee (CIQ), which has a strong linkage with NACI, recommended 

first doses to all priority groups before second doses. On December 30, 2020, the Joint 

Committee on Vaccination and Immunisation (JCVI) in the United Kingdom (UK) recommended 

a 3-12 interval for Pfizer-BioNTech and a 4-12 week interval for AstraZeneca to maximize firstdose priority groups. An alternate interval was recommended by NACI in January 2021 moving 

to six 6 or 42 days for mRNA vaccines based on the clinical trial data and the efficacy estimates

that included up to 42 days. The purpose of that alternate interval was to maximize first doses to 

priority groups. The big shift in Canada occurred in March 2021 when NACI recommended up to 

a 4-month interval for all COVID-19 vaccines. There was a full statement with all of the evidence

and rationale in April 2021. In October 2021, the interval was refined further to an optimal 

interval of 8 weeks for adolescents and adults. In November 2022 when the pediatric program 

for children 5-11 years of age came through, NACI recommended an interval of at least 8 

weeks. Notably in January 2022, WHO and its Strategic Advisory Group of Experts on 

Immunization (SAGE) recommended an interval of 4–8 weeks, with a preferential 8-week 

interval. The settling place does seem to be around 8 weeks.

The core principles that have informed NACI interval recommendations have been fairly diverse.

The extended interval recommendation for up to 16 weeks in March 2021 was initially informed 

by a trigger for limited supply. There were early VE assessments of strong 1-dose protection

from mRNA clinical trials and from Israel, and later from Canada and UK research and

surveillance. AstraZeneca 2-dose clinical trials showed that longer intervals yield better vaccine 

efficacy. There was modeling to optimize program impact in the context of limited supply. In 

addition, there were immunology and vaccinology principles and ethics, equity, feasibility, and 

acceptability. The subsequent move in the fall toward an 8-week interval was additionally

informed by Canadian and UK VE data demonstrating increased protection with longer intervals, 

which plateaued around 8 weeks; immunological data on the breadth and duration of immune 

response with longer intervals; Canadian safety surveillance showing lower rates of myocarditis 

with a longer interval; and ethics, equity, feasibility, and acceptability. While safety and 

myocarditis have been an emerging part of the story, it actually is a latecomer to the Canadian 

interval story that originally was driven more by other vaccine principles. Now safety and 

myocarditis rates also have additionally augmented and informed the interval story.

To recap some immunological principles regarding longer intervals, it is known that affinity

maturation can be improved. The longer interval between primary and secondary antigen 

exposures will allow immune memory cells more cycles of affinity maturation to develop higher 

affinity. This may increase the breadth and/or neutralizing activity of the response. There also is 

less potential for immune interference also with longer intervals. Circulating antibodies may 

interfere with the immune responses of the subsequent exposures due to: 1) epitope masking in 

which circulating antibodies may occupy antigen binding sites on the surface of the vaccine 

antigen; and 2) reduced antigen availability in which antibodies can form immune complexes 

and be cleared through the liver and spleen to reduce the pool of available antigen if the antigen 

is reintroduced too soon.
ACIP Meeting Summary February 4, 2022

44

Dr. Bryna Warshawsky (Public Health Agency of Canada) indicated that the first area 

explored when Canada considered an extended interval was VE with regard to 1 dose. NACI 

reviewed the literature that was available at the time and published a statement on April 7, 2021

that summarized the literature to that point.52 Based on that summary, 1 dose of mRNA vaccine 

was shown to be effective against symptomatic disease and infection at about 60% to 80%.

That was somewhat lower than expected based on the 1-dose efficacy from the clinical trial, 

which was 92% and lower than the effectiveness and efficacy with 2 doses. Very reassuringly, 

1-dose protection against serious outcomes was higher than against symptomatic disease and 

infection at around 80% or more. Regarding the question of how long the protection would be 

from that 1 dose, NACI turned to its colleagues from the UK who already had started the 

extended interval. JCVI presented to NACI on a regular basis. A summary of the data that JCVI 

has on VE following the first dose over time53 shows that for adults 50-64 years of age who 

have had 1 dose of the Pfizer-BioNTech vaccine, VE is about 60%. About 8 weeks after the first 

dose, VE decreases to 40% to 50%. This was similar for persons 65-79 years of age at about

60% out to 10 weeks, followed by a decrease. 

Knowing that there is VE after 1 dose and that it lasts 8-10 weeks, NACI also was interested in 

the principle from immunology that the longer the interval between the first and second dose, 

the higher the immune response that might be expected after a second dose. This was borne 

out in trials from the UK. These data come from the CONSENSUS Trial in the UK that followed 

a cohort of 750 people ≥50 years of age who had periodic serological testing. Based on the

interval between their first and second doses, the geometric mean titers (GMTs) achieved after 

the second dose were lower when the interval was shorter. As the interval was increased 

between the first and second dose, the GMTs were higher after the second dose. There also 

were subsequent studies from the UK group showing that extending the interval between the 

second dose and the booster dose also results in higher titers. This immunologic information

suggests that this may translate as well into VE. 

Data from the UK also examined VE after the second dose of the Pfizer-BioNTech vaccine. 

Among persons 65-79 years of age, when the interval was shorter at 19-29 days between the 

first and second dose, VE was around 75%. With longer intervals between doses of 6 weeks or 

more, VE became higher at up to 90%. This was observed in other age groups as well. Notably, 

those who had a shorter interval also were likely to have a longer period of time from their 

second dose to when the study was completed. The longer interval between the second dose 

and the time of the study also affected VE. Those 2 concepts, the interval between first and

second dose and the time from second dose to the study end can be conflated. 

Studies from Canada helped to tease those 2 concepts apart. A study by Skowronski and Arel 

from Canada54 examined mRNA VE in British Columbia and Quebec against infection and 

hospitalization by interval. Looking at Quebec, when the interval was short at 3-4 weeks, there 

was 79% VE against infection. When the interval was longer at 7-8 weeks between the first and 

second dose, VE after the second dose was 89% or about a 10% difference with the longer and 

the shorter interval. This was similar with hospitalizations. With an interval of 3-4 week, VE 

against hospitalization was 87%. With a longer interval, VE against hospitalization increased to 

97% to 98%. Again, there was about a 10% VE difference moving from a shorter interval to a 

52 https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/extended-doseintervals-covid-19-vaccines-early-rollout-population-protection.html 53 Amirthalingam et al. Serological responses and vaccine effectiveness for extended COVID-19 vaccine schedules in England | 

Nature Communications 54 Skowronski et al, 2021 (Preprint) Two-dose SARS-CoV-2 vaccine effectiveness with mixed schedules and extended dosing 

intervals: test-negative design studies from British Columbia and Quebec, Canada

https://www.medrxiv.org/content/10.1101/2021.10.26.21265397v1
ACIP Meeting Summary February 4, 2022

45

longer interval. The findings were similar in British Columbia, thought the difference was about

6% difference between the shorter interval and the longer interval. The investigators also 

assessed this over time. In Quebec, the lower VE with the shorter intervals and the higher VE 

with the longer intervals persisted over time. A study from Kwong and colleagues55 examined 

VE over time in Ontario during various parts of the outbreak. In the Delta wave, they examined a 

longer interval of ≥8 weeks, an intermediate interval of 5 to <8 weeks, and a shorter interval of 2 

to <5 weeks. Again in this study, VE was lower if the interval was shorter and higher if the 

interval was longer. Though the difference was not as large in this study, it was still 5% and that 

persisted over time.

To summarize this portion of the Canadian journey through the extended interval, 1-dose

provides good protection against symptomatic disease and infection at about 60% to 70% that 

lasts between 8-10 weeks. The protection for serious infection is higher at about 80% or more 

compared to protection against infection. One a second dose has been received, the longer

interval in the primary series results in a higher antibody response. That higher antibody

response also translates to somewhat higher VE.

Canada has some varying intervals over the time. Based on data on fully vaccinated people to 

mid-August 2021, about 52% of the Canadian population who have been fully vaccinated had 

an interval between 50-77 days. Only 4% had a shorter interval of 28 days or less. This varies

somewhat depending on provinces and territories. Particularly notable are 3 territories that are 

smaller and Northern that received higher allocations of doses originally and used a shorter 

interval between the first and second dose. The rest of the provinces had a range of intervals for 

their populations over time.

What Canada did not expect was that there also would be a benefit from prolonged intervals 

based on safety that emerged. When the safety signal for myocarditis and pericarditis with the

mRNA vaccines was first identified, colleagues in Ontario and nationally began to assess 

whether the difference in the interval might impact the rate of myocarditis and pericarditis. A 

study by Buchan and colleagues56 conducted in Ontario looked at myocarditis and pericarditis 

rates based on vaccine product, schedule, and interval using a 7-day risk period between 

vaccination and the onset of myocarditis and pericarditis and a Brighton Collaboration level of 1-

3. This study showed that the reported rates of myocarditis and pericarditis were higher after the 

second dose of an mRNA vaccine than after the first, which has been seen in a number of other 

studies. This was particularly for individuals who received Moderna as their second dose. The 

highest reporting rate was for myocarditis and pericarditis in males 18-24 years of age following 

Moderna as their second dose. Males 18-24 years of age had a 5 times higher rate of

myocarditis and pericarditis compared to Pfizer after the second dose. An interesting finding of 

this study was that for both vaccines, the longer interval resulted in lower myocarditis rates and 

the shorter interval had higher myocarditis and pericarditis rates. The study also showed that 

among individuals who received a heterologous schedule with Pfizer as their first dose and

Moderna as their second dose, the rates of myocarditis and pericarditis were higher than those

who received a homologous schedule of either Pfizer-Pfizer or Moderna-Moderna. In 

conclusion, this study supports the identified age and sex risks for myocarditis and pericarditis

and shows that vaccine product, schedule, and interval also may have an impact on the rates of 

myocarditis and pericarditis.

55 Kwong et al. Effectiveness of COVID-19 vaccines over time in Ontario. Presentation January 24, 2022 56 Buchan et al, Epidemiology of myocarditis and pericarditis following mRNA vaccines in Ontario, Canada: by vaccine product, 

schedule and interval | medRxiv
ACIP Meeting Summary February 4, 2022

46

Ongoing analyses of national passive surveillance from the Canadian Adverse Event Following 

Immunization Surveillance System (CAEFISS), which includes the Ontario dataset and 

information from other provinces and territories, supports the same interval trend. The CAEFISS 

analysis found that the interval makes a difference with regard to myocarditis and pericarditis 

rates, with shorter interval/higher rates and longer intervals/lower rates of myocarditis and 

pericarditis. To explore the Buchan et al study further by vaccine product, schedule, interval, 7-

day risk period, there were 297 cases of myocarditis and pericarditis. In a sub-analysis of 202 

cases from June onwards who received 2 doses, those with a heterologous schedule of Pfizer 

followed by Moderna had a higher rate of myocarditis than the other schedules. Also notable 

was the difference in myocarditis rates between the shorter interval and the longer interval. For 

both the homologous Moderna schedule and the homologous Pfizer schedule, comparing a 

shorter interval of 30 days or less to a longer interval of 56 days or more, there was a 5-fold or

greater rate of myocarditis with the shorter interval compared to the longer interval.

To summarize the myocarditis/pericarditis story, Canada is seeing the same risk profile with 

regard to younger males being at greater risk after the second dose. Myocarditis is higher

after Moderna for the second dose, particularly with the heterologous schedule. The shorter 

interval seems to result in a higher rate of myocarditis and pericarditis compared to a lower rate

with a longer interval.

Discussion Summary

Dr. Lee commented that a silver lining of this pandemic has been that it has strengthened the 

US’s collaboration with its international partners such as Canada, Israel, and others. That has 

created a focus on what countries can share and learn together to improve the health of their 

respective populations. She expressed appreciation for Canada sharing this information with

ACIP. 

Dr. Poehling asked whether Canada has learned anything about the resolution of myocarditis in 

terms of shorter intervals versus longer intervals. 

Dr. Tunis said that to his knowledge, they have not yet been able to ascertain any differences in 

severity or resolution based on intervals. 

Ms. Ogunnaike-Cooke from the surveillance group at PHAC added that this is an area of active 

interest and they are working with external partners to put in place some outcome monitoring 

studies that will help to look in more detail. They data they get with this surveillance does not 

have that ongoing monitoring components to give them that richness of information at this time.

Dr. Daley asked whether they have any sense about whether the individuals who got a shorter 

interval were different in any of systematic way from the individuals who received doses at a 

longer interval. 

Dr. Tunis said that in broad strokes, they did see a difference in terms of territorial populations

where there was more complete allocation pushed to those territories early on that allowed 

shorter intervals before the preference toward extended intervals was implemented.

Ms. Ogunnaike-Cooke added that this is an interesting and tough question. This analysis is 

complicated because the interval does have some kind of age component to it, because that is 

because the vaccine rollout plan used an age-based component. The surveillance data do not 

necessarily have that depth of clinical information to be able to dig deep into the clinical
ACIP Meeting Summary February 4, 2022

47

presentations by age. While there was a shorter interval than the territories, the populations are 

so small that there were not enough cases to assess and differentiate between what the pattern 

of myocarditis was for that group compared to the other populations.

Dr. Sanchez observed that the Canadian data had some important implications that may impact 

ACIP’s ultimate recommendations. It is interesting that the Moderna booster after the Pfizer was 

associated with more myocarditis. This would suggest that perhaps ACIP should recommend a 

preference to Pfizer versus Moderna, at least in the highest risk group of younger males. The 

data also speak to pathogenesis, because the longer interval was associated with higher GMTs

but less myocarditis. Moderna is a higher dose than the Pfizer, so maybe it is not all related to 

an immune antibody-mediated process.

Ms. Stinchfield (NAPNAP) asked whether Canada was seeing data for people who have not 

completed the series as the intervals are lengthened or if they have any concerns about that.

Dr. Tunis said he had not seen anything in the data to be able to tease apart those who are 

receiving incomplete series in terms of whether there was a temporal association between them 

not being able to receive the second dose for a number of months like early in the rollout and 

then giving up.

Dr. Warshawsky added that she also was not aware of any data regarding the interval impacting 

people getting their second dose or a booster. She thought this may be driven more by the 

context of the outbreak. If the outbreak is settling down, people may be less enthusiastic about 

their vaccines. But as the outbreak ramps up, they become more so.

Ms. Ogunnaike-Cooke added that Canada has been very fortunate to have high coverage 

overall. The latest information shows that almost 83% of the population is fully vaccinated. She 

thinks Omicron had a lot to do with that in terms of motivating stragglers to get their primary 

series, complete their schedules, and/or get their boosters.

Dr. Lee commented that the data presented were convincing that an extended interval is not 

only potentially safer from a myocarditis standpoint, but also potentially more effective. She 

asked whether it is also more durable or if they have noticed that in provinces that had shorter 

vaccination intervals the need for a booster is greater than in areas where there are extended 

vaccination intervals. There is not only the immediate question around this series, but also the 

potential question about the need for future boosters in terms of whether the need for ongoing 

boosters can be mitigated. Every time there is a booster, it carries both benefits and risks. The 

cumulative benefit-risk profile over time does change.

Dr. Tunis indicated that Canada has been very preoccupied with this excellent point as well. 

Various countries have been trying to compare notes with other countries throughout the 

pandemic. Canada has been closely watching what happens in Israel, understanding that Israel 

has been using the authorized interval. Everything has been short and quick as things rolled out 

there, which he supposed is often the case in the US. There is a sense that the booster

programs in Canada were held off somewhat longer than in other countries. Part of their 

understanding is that that was due to the longer intervals. However, that is somewhat 

confounded because those who got longer intervals over the summer also had a shorter time

since their second dose. If worried about time since second dose, Canada was at an advantage 

in that respect going into the fall compared to some other countries. That was perhaps 

compounded also by the longer intervals that afforded more durable immunity. There has been 

some research around the breadth of response and the longer time between exposures in terms 
ACIP Meeting Summary February 4, 2022

48

of whether vaccine or viral exposures could allow affinity maturation to improve the breadth of 

response against variants. Part of the rationale that NACI is articulating in some of their 

statements regards durability, higher effectiveness, and possibly the breadth against variants 

that has been of interest to the committee. Not only has this been seen with the primary series,

but also NACI continues to recommend a 6-month interval for boosters, although many

jurisdictions have gone a little bit shorter that that.

Dr. Warshawsky added that Canada was still seeing high VE against infection and severe 

disease as they headed into the Delta period, which she thinks is because their interval was 

longer. There were some populations for which a shorter interval was used, particularly at the 

beginning of the outbreak when they were vaccinating older adults in LTCF. In that population,

there was a more rapid decline in VE. In the general population, a sustained higher level of 

protection was observed against both infection and severe disease into the Delta period. They 

did not need the booster as quickly because they were still seeing sustained protection in the 

Canadian data. The other population is healthcare workers (HCW) who dominantly received a 

short interval, except in the province of Quebec where a longer interval was used. HCW had a 

short interval because they were prioritized early for boosters due to concern about potential 

waning of protection occurring earlier.

Dr. Sanchez asked what vaccines are being used in Canada and whether they have any 

preferential recommendations for use of one versus the other based on their data, especially as 

it relates to the myocarditis.

Dr. Tunis indicated that the program in Canada has used predominantly mRNA vaccine.

AstraZeneca viral vector vaccine was also used in the Winter/Spring of 2021, but it accounts for 

a very small proportion at about 4% viral vector, and then the vast majority has been mRNA.

Janssen vaccine supply was made available to some Canadian provinces and territories

in the past few months, but it has been a relatively small amount. The program has used over 

90% mRNA. Since Spring/Winter of 2021, NACI has been preferentially recommending mRNA 

over viral vector vaccines. As TTS emerged, that strengthened the preferential position even 

further for the committee. Similar to ACIP who have now also preferentially recommended

mRNA over viral vector vaccines, that position has been longstanding in Canada and he thought 

was part of what pushed toward the predominantly mRNA program. Based on the myocarditis

signals that have been observed within the mRNA category, NACI has preferentially

recommended Pfizer over Moderna for persons 12-29 years of age for both primary series and 

booster doses.

Dr. Warshawsky added that Canada has had some mixed schedules in which people who

started with AstraZeneca vaccine finished with an mRNA vaccine. Most of the heterologous

vaccination is Pfizer as the first dose and Moderna as the second dose. About 12% of people 

have received either heterologous AstraZeneca with an mRNA or heterologous mRNA

schedules.

Dr. Tunis pointed out that a theme Canada has been trying to communicate is that the strength 

of this surveillance system and the research that has been conducted has allowed Canada

iterate and refine the program to improve the safety of already safe vaccines. That has been a 

nice lesson learned in a pandemic. It can be a challenging communication message at times as 

things evolve, but Canada is quite pleased that they have been able to evolve in a positive 

direction to iterate on over time.
ACIP Meeting Summary February 4, 2022

49

VSD: Myocarditis after Moderna and Pfizer/BioNTech COVID-19 Vaccine

Nicola Klein, MD, PhD (KPNC) presented the results of a myocarditis analysis monitoring 

COVID-19 vaccine safety conducted by the VSD and head-to-head product comparisons, with a 

focus was on myocarditis and pericarditis during the Day 0-7 window after mRNA vaccination in 

terms of the risk among competitors who were 22-42 days after vaccination and direct head-tohead comparisons of Moderna vaccine versus Pfizer vaccine. As a reminder, the aims of the 

VSD RCA are to: 1) monitor the safety of COVID-19 vaccines weekly using pre-specified 

outcomes of interest among VSD members; and 2) describe the uptake of COVID-19 vaccines 

over time among eligible VSD members overall and in strata by age, site, and race/ethnicity.

Myocarditis/pericarditis in the first 60 days after vaccine is one of the pre-specific RCA 

outcomes. Surveillance began in December 2020 and the pre-specified outcomes are monitored

weekly.

The codes in the left column in the following table initially were used for early surveillance, but 

based on some feedback and discussions internally with the VSD investigators, the ICD code 

list was expanded within the past few months to include the ICD codes listed in the right column. 

All of the data and analyses Dr. Klein shared were based on the codes in the right column: 

As of January 15, 2022 in the VSD, nearly 15 million total doses of COVID-19 vaccines had 

been administered and 73% of the age-eligible population was fully vaccinated. The vast

majority of vaccines that have been administered through the VSD are mRNA vaccines, with 

somewhat more Pfizer-BioNTech than Moderna vaccine. Substantial numbers of each mRNA 

vaccine have been administered compared to Janssen vaccines.

For the analytic strategy, the number of outcomes observed in the risk interval (1-21 days) after 

COVID-19 vaccine were compared to the number expected. The expected number was derived 

from “vaccinated concurrent comparators” who were in a comparison interval (Days 22-42) after 

COVID-19 vaccination. On each day that an outcome occurred, vaccinees who were in their risk 

interval were compared with similar vaccinees who were concurrently in their comparison 

interval. Comparisons were adjusted for age group, sex, race/ethnicity, VSD site, and calendar 

date. 

This presentation focused on a subgroup of persons 18-39 years of age who were verified to be 

myocarditis/pericarditis patients after mRNA vaccine through January 15, 2022. At this time, the 

total number of doses administered to data included the following: Moderna Dose 1: 923,711; 

Moderna Dose 2: 901,393; Pfizer Dose 1: 1,479,596; Pfizer Dose 2: 1,432.447. In terms of 

dates and intervals between Dose 1 and Dose 2 in this age group, all most all Pfizer doses were 

given 21 days between Dose 1 and Dose 2. There was some variation on either side of Day 21, 

but not much. For Moderna, nearly all doses were given on Day 28, with some doses given a 

couple of days later or earlier than that.
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50

For myocarditis and pericarditis, chart reviews are performed for all cases identified. Chart 

review has been completed for 297 cases since January 15, 2022. There are 19 charts pending 

review for persons under 18 years of age. Cases amongst individuals 5-39 years of age are 

identified anytime post-vaccination. After initial chart review, they are adjudicated either by an 

infectious disease clinician and/or cardiologist to confirm that the case is an incident following 

vaccination, that the case meets the CDC case definition (myocarditis, pericarditis, or 

myopericarditis), and to evaluate the level of certainty for myocarditis. Adjudication has verified 

213/297 (71%) of myocarditis and pericarditis cases. Of those, 79 (16 after Dose 1 and 63 after 

Dose 2) have been verified amongst persons 18-39 years of age, all of whom experienced 

onset in the Day 0-7 risk interval—the risk interval of focus for the rest of analyses, the selection 

of which was based on earlier findings of significant clustering of cases in the first week after 

vaccination.

In the vaccinated concurrent analyses comparing myocarditis and pericarditis in the Day 0-7 risk 

interval among persons 18-39 years of age by product and dose, all adjusted rate ratios were 

elevated for all vaccinees after both doses. Focusing on Dose 2, the adjusted rate ratio for 

Pfizer was 14.3 with 22.4 excess cases. The adjusted rate ratio for Moderna was 18.75 with 

31.2 excess cases. This suggests indirectly that the rate ratio after Moderna appears to be 

higher than after Pfizer, but that they are both very elevated. The excess cases in the risk period

are roughly 31.2 versus 22.4. Notably, these are indirect calculations and indirect comparisons.

This table shows what was in the charts for verified myocarditis/pericarditis cases in the 0-7 

days after any dose of either mRNA vaccine:

Based on the chart review of cases only, there do not appear to be any obvious differences in 

the clinical cases of myocarditis/pericarditis between persons 18-39 years of age for Pfizer or 

Moderna.
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51

In terms of whether there is any difference in the risk of myocarditis and pericarditis between 

mRNA vaccines, analyses with vaccinated concurrent comparators indicate that both Pfizer 

and Moderna are associated with increased risk of myocarditis/pericarditis in persons 18-39

years of age. Analyses with vaccinated concurrent comparators indirectly suggest that Moderna 

may be associated with more risk of myocarditis/pericarditis than Pfizer. To directly test whether 

the risk of myocarditis/pericarditis after Moderna differs from that after Pfizer, a head-to-head 

comparison was conducted among persons 18-39 years of age.

Based on data through January 15, 2022, the interval between Dose 1 and Dose 2 was fairly 

consistent between Pfizer and Moderna vaccines and with what was seen in the overall 

population at about 21 days for Pfizer and about 28 days for Moderna. In terms of symptom 

onset of verified cases, there was very strong clustering of cases after both vaccines in the first 

week after vaccination. Temporal clustering scan statistics show that the clustering is highly 

statistically significant in the first 3-5 days after Moderna vaccine and 0-4 days after Pfizer

vaccine. In the head-to-head comparison, the Moderna and Pfizer vaccinees were directly 

compared during the risk interval within groups. The groups were comprised of individuals 

inside the risk interval (Days 0-7 post-vaccination); individuals of the same age group, sex, and 

race/ethnicity and from the same VSD site; and on a calendar day when an mRNA vaccinee 

had myocarditis/pericarditis. The rate ratios were estimated with 95% confidence intervals (rate 

post-Moderna / rate post-Pfizer). The null hypothesis was tested that the rate of myocarditis and 

pericarditis after vaccination does not differ between Moderna and Pfizer. 

Following either dose in both sexes, there was an elevated rate ratio of 1.61 that was

statistically significant, and excess cases of 8 per 1 million doses. The other analyses trended 

similarly, although none of them met statistical significance. Looking at Dose 2 comparing 

Moderna versus Pfizer, there were excess case of 10.7. In the analysis with pericarditis

excluded, the adjusted rate ratios were similar in terms of the level of the increased point 

estimates, although none of these analyses meet statistical significance. 

In summary, among persons 18-39 years of age, both mRNA vaccines were associated with 

increased risk of myocarditis and pericarditis in the 0-7 days post-vaccination, particularly after 

Dose 2. There were an estimated 22.4 excess cases per million second doses after Pfizer and 

31.2 excess cases per million second doses after Moderna. Among persons 18-39 years of age, 

there were no noticeable clinical differences between cases after Moderna and those after 

Pfizer. Most had a hospital length of stay of 0-1 days and none were admitted to the ICU. Direct 

head-to-head comparisons provided evidence that the risk of myocarditis and pericarditis may 

be higher after Moderna than after Pfizer. Comparing Moderna versus Pfizer, it was estimated 

that Moderna was associated with an additional 10.7 cases of myocarditis and pericarditis per 

million second doses. Both mRNA vaccines were associated with increased risk of myocarditis 

and pericarditis for individuals aged 18-39 years. 

Discussion Summary

Dr. Zimmerman (APRT) asked whether there are any data from this study on the background

rates from COVID disease-induced myocarditis. 

Dr. Klein indicated that this was not part of this study.

Dr. Duchin (NACCHO) inquired as to whether any analyses were performed for the risk window 

through 21 days and whether cases in that window were adjudicated to determine whether they 

might be vaccine-associated.
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52

Dr. Klein indicated that all cases of myocarditis/pericarditis after vaccination are adjudicated. 

Referring to Slide 36 showing the results of the primary analysis of the 21-day risk interval, the 

adjusted rate ratios were numerically lower than for the Day 0-7 interval, which is remarkable. 

The excess cases following Dose 2 after both Pfizer and Moderna was 22.6 and 31.3, 

respectively. That suggests that all of the excess risk is in the Day 0-7 risk window because it is 

the same as seen in the 21-day risk interval.

Myocarditis and COVID-19 Vaccine Intervals: International Data and Policies

Danielle Moulia, MPH (CDC/NCIRD) presented an examination of international data

and policies on preferential recommendations of an mRNA vaccine product or extended primary 

series interval as they relate to myocarditis and/or pericarditis. This included a review of data on 

the risk of myocarditis by mRNA vaccine product, focusing on the highest risk group: younger 

males post second dose; a review of data on an extended primary series interval, specifically 

how that relates to myocarditis risk and VE; and presentation of international policies related

to preferential recommendations or extended primary series intervals. Throughout this

presentation, myocarditis and/or pericarditis were generally referred to as myocarditis unless a 

specific study was being referenced. As a reminder, in the VAERS data among males aged 18-

24 years, the observed myocarditis reporting rate within a 7-day risk interval after a second 

dose of Moderna was 40 per million doses. In the VSD data among males 18-39 years of age, 

the rate for myocarditis in the 7 days after a Moderna vaccine was 1.5 times the rate for the 7 

days after Pfizer vaccine. However, the adjusted rate ratio of 1.5 was not statistically significant.

To review key findings from Canada heard earlier in the day,57 in a study of passive and 

enhanced surveillance, the myocarditis and/or pericarditis reporting rate among males 18-29 

years of age in the 7 days after a second dose of Moderna vaccine was 140 per million

doses, which was almost 5 times higher than the Pfizer reporting rate of 25 per million doses.

In Ontario during the period of enhanced passive surveillance, among males 18-24 years of 

age, the myocarditis and/or pericarditis reporting rate after a second dose of Moderna was

over 5 times the Pfizer reporting rate. The reporting rates included all reports during the length

of the study.

The UK's Yellow Card reporting scheme is a national passive and active surveillance system.

Among all persons aged 18-29 years of age, the myocarditis and pericarditis reporting rate after 

a second dose of Moderna was 71 per million doses, roughly 2.5 times higher than the Pfizer 

reporting rate of 24 per million doses. In a self-controlled case series of myocarditis

hospitalizations in the UK, among males younger than 40 years of age after a second dose of 

Moderna, there were 101 additional events of myocarditis per million doses compared to 12 

additional events of myocarditis per million doses of Pfizer.58

The Nordic Collaboration (includes Denmark, Finland, Norway, and Sweden) presented the 

results of their study of all 23 million residents aged 12 years and older to VaST on January 10, 

2022. While these data are not publicly available, within a 7-day risk period, the rate ratio for 

myocarditis after either dose of Moderna vaccine versus an unvaccinated comparator was

higher than Pfizer. The highest rate ratios observed were among those receiving a second dose 

57 Sources: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3988612 Accessed 1/23/2022; and 

https://www.medrxiv.org/content/10.1101/2021.12.02.21267156v1.article-metrics Accessed 1/23/2022 58 Sources: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccinesummary-of-yellow-card-reporting#yellow-card-reports Accessed 1/22/2022; and Patone M. 2021 MedRxiv preprint. 

https://www.medrxiv.org/content/10.1101/2021.12.23.21268276v1.full.pdf Accessed 1/22/2022
ACIP Meeting Summary February 4, 2022

53

of Moderna in a heterologous mRNA primary series.59 A retrospective cohort of all 5 million 

residents of Denmark ages 12 years and older60 had a case definition of hospital diagnosis of 

myocarditis or pericarditis, increased troponin levels, and the hospital state lasting more than 24 

hours within 28-day risk period. Analysis was done using a Cox proportional hazard model with 

covariates for age, sex, vaccine priority group, season, and clinical comorbidities. The absolute 

rate of myocarditis was per 100,000 doses and the adjusted hazard ratio with an unvaccinated 

comparator for those aged 12-39 years. By gender after any dose, the rates were about 3-fold 

to 4-fold higher for those vaccinated with Moderna compared to Pfizer. In a post-hoc analysis of 

males ages 12-39 years, the rate of myocarditis was 9.4 per 100,000 or 94 per million postDose 2 of Moderna. Using an unvaccinated comparator, the adjusted hazard ratio of myocarditis 

was 9.8 for Moderna and 1.5 for Pfizer.

Looking to France and Germany, in both national AE surveillance systems, the highest reporting 

rates of myocarditis were among young males. In Germany, among males ages 18-29 years,

the myocarditis and pericarditis reporting rate after any dose of Moderna was 117 per million 

doses, roughly 2.5 times higher than that of Pfizer. In France, among males ages 18-24 years,

the myocarditis reporting rate after a second dose of Moderna was 139 per million doses,

roughly 3 times higher than that of Pfizer.61 

Summarizing the myocarditis rate ratios comparing Moderna to Pfizer by country,

subpopulation, and dose number looking across the studies, there is a 1.5-fold to 5-fold 

increase in myocarditis after a second dose of Moderna vaccine compared to a second dose

of Pfizer among younger males. Direct comparisons of rate ratio should be interpreted

with caution due to differences in subpopulation, study design, modeling, national setting, and 

implementation factors.62

In summary of the findings for myocarditis risk by mRNA product, global data suggests that the 

risk of myocarditis may be higher for Moderna than Pfizer vaccine. There are limitations to this 

review. Absolute rates are not readily comparable due to differences in case definition and risk 

period, subpopulation, case ascertainment, calendar time, and vaccine implementation factors 

including extended primary series intervals. A limited number of geographic locations are 

administering both Moderna and Pfizer and had data available.

Turning now to the risk of myocarditis by primary series interval or the time between the first and 

second doses, this assessment returned to the work of Bouken and colleagues out of Ontario, 

examining rates of myocarditis by dosing intervals of less than 4 weeks, 5-7 weeks, and greater 

than 8 weeks among adults ages 18 years and older. Across the three schedules of primary 

series, rates of myocarditis decreased as the intervals between Dose 1 and Dose 2 lengthened.

Within each vaccine schedule, the lowest rates of myocarditis were observed among those

with the longest time between Dose 1 and Dose 2. The highest rate was observed among 

persons who received Pfizer for their first dose and Moderna for their second dose within the 

59 Source: Hovi et al., Slides not publicly available 60 Source: Husby et al., SARS-CoV-2 vaccination and myocarditis or myopericarditis: population-based cohort study BMJ 2021; 

 375 :e068665 doi:10.1136/bmj-2021-068665 61 Sources: https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2021/Ausgaben/46_21.pdf. Accessed 1/23/2022; 

https://www.omedit-auvergne-rhone-alpes.ars.sante.fr/index.php/system/files/2021-

10/ANSM_Rapport_CRPV_Moderna_22102021.pdf Accessed 1/23/2022; https://ansm.sante.fr/uploads/2021/10/22/20211021-

covid-19-vaccins-pfizer-focus-1-2.pdf Accessed 1/23/2022 62 Sources: Husby et al., SARS-CoV-2 vaccination and myocarditis or myopericarditis: population-based cohort study. BMJ 2021; 

375:e068665 doi:10.1136/bmj-2021-068665 https://ansm.sante.fr/uploads/2021/10/22/20211021-covid-19-vaccins-pfizer-focus-1-

2.pdf Accessed 1/23/2022; Klein, N. Myocarditis Analyses in the Vaccine Safety Datalink: Rapid Cycle Analyses and “Head-toHead” Product Comparisons. Slides. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3988612 Accessed 1/23/2022 

https://www.medrxiv.org/content/10.1101/2021.12.02.21267156v1.article-metrics Accessed 1/23/2022
ACIP Meeting Summary February 4, 2022

54

shortest interval of 4 weeks or less between doses. In summary, limited data suggest the rates 

of myocarditis may be lower with an extended interval between Dose 1 and Dose 2 of a primary 

series. These observed rates were observed both with Moderna and Pfizer vaccine.

Looking now to data on VE with an extended primary series interval, results from a test-negative 

case control study from May to October 2021 among 1.2 million community-dwelling adults 

aged 18 years and older in British Columbia and Quebec, adjusted VE estimates against SARSCoV-2 infection and hospitalization was 5% to 10% higher with an extended interval of 7 to 8

weeks compared to a standard interval of 3 to 4 weeks. Increases in VE can be observed to 

level off at around the 7- to 8-week interval. The overall VE against hospitalization and infection 

for a 2-dose mRNA series with an extending dosing interval of 7 weeks or greater was 94% to 

97% for hospitalization and 89% to 91% for infection.63

Turning to England, there was a test-negative case control study of VE from October 2020 to 

June 2021 among adults aged 50 and older attending community testing, across all age groups 

starting at age 50, estimated Pfizer VE against SARS-CoV-2 infection was higher with extended 

intervals of greater than 6 weeks compared to the standard 3- to 4-week interval.64 Looking at

immunogenicity with an extended primary series interval in a study by Payne and colleagues out 

of the UK that examined SARS-CoV-2 infection-naïve persons. Serological responses were

higher after an extending dosing interval of 6 to 14 weeks compared to a standard interval

of 3 to 4 weeks. Among persons with an extended interval, there were higher antibody and B 

cell responses, as well as sustained B and T cell responses compared to a standard interval. An 

extended interval may promote efficient T cell expansion and long-term memory cell

persistence.65 Three additional studies found that neutralizing antibody titers were higher 

following an extended dosing interval of 6 to 14 weeks with an mRNA vaccine compared to a 

standard interval of 3 to 4 weeks.66

In summary, global data suggest that an extended primary series interval may improve

immunogenicity and VE. Neutralizing antibody titers were higher following an extended dosing 

interval of 6 to 14 weeks with an mRNA vaccine compared to a standard interval of 3 to 4 

weeks. VE against infection and hospitalization was higher with an extended interval of 7 to 8 

weeks compared to a standard interval of 3 to 4 weeks. One limitation to note is that these 

studies were conducted prior to the Omicron surge, during which the absolute VE may be lower.

Turning finally to global policies, Canada's NACI67 strongly recommends a complete mRNA

series for all persons aged 12 years and older. Among persons 12-29 years of age, Pfizer is 

preferred for the primary series. For all mRNA primary series, the optimal interval is 8 weeks. In 

the UK, there is a preferential recommendation for the use of Pfizer over Moderna in persons 

aged 12-17 years. The UK’s JCVI68 has advises a minimum interval of 8 weeks between first 

and second doses for all persons over 18 years of age. For children and adolescents aged 12-

17 years who are at higher risk of COVID due to underlying conditions, living accommodations, 

or who are contacts of immunocompromised persons, the recommended interval is 8 weeks.

63 Skowronski DM. 2021, MedRxiv preprint 64 Amirthalingam G. 2021, Nat Commun 65 Payne R. 2021, Cell 66 Amirthalingam G. 2021, Nat Commun.; Parry H. 2022, Npj Vaccines.; Grunau B. 2022, Clin Inf Dis 67 Sources: National Advisory Committee on Immunization: Updated Guidance on the use of COVID-19 Vaccines (slides) 

https://www.canada.ca/en/public-health/services/diseases/coronavirus-disease-covid-19/vaccines/safety-sideeffects.html#myocarditis-and-pericarditis Accessed 1/23/2022; https://www.canada.ca/en/publichealth/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-26-covid-19-

vaccine.html#a5.4. Accessed 2/1/2022. 68Source: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1045852/Greenbookchapter-14a-11Jan22.pdf. Accessed 1/22/2022
ACIP Meeting Summary February 4, 2022

55

However, for children and adolescents who do not fall into these high-risk groups, a 12-week 

interval is preferred. The guidance does go on to note that in periods of high incidence or 

concern over a new variant, the interval can be shortened to eight weeks.

Looking now to the Nordic countries. In Sweden, Pfizer is recommended over Moderna for

persons aged 12-30 years. The recommended interval for both vaccines is 3 to 4 weeks. In 

Norway, Pfizer should be offered to persons aged 12-30 years. Children and adolescents aged 

5-15 years without severe underlying conditions may receive 1 or 2 doses based on their 

parents' decision. Persons aged 16 years and older should receive 2 doses. The recommended 

interval for persons aged 18 years and older is 3-12 weeks. For adolescents aged 16-18 years,

the recommended interval is 8-12 weeks. For children and adolescents aged 5-15 years with 

severe underlying conditions, the recommended interval is 8-12 weeks. However, this can be 

adapted down to 3 weeks based on medical assessment. In Finland, boys and men aged 12-30 

years are only offered Pfizer. Girls and women aged 12 years and older are offered Moderna or 

Pfizer. The recommended interval is 6 to 12 weeks for all persons aged 5 years and older. In 

Denmark, both Moderna and Pfizer vaccine are approved for persons aged 12 years and older.

The primary series interval is 3 to 6 weeks, and studies have shown that the median interval 

between Dose 1 and Dose 2 is 5 weeks.69

In Singapore, children and adolescents ages 18 years and younger should receive Pfizer

vaccine. The recommended interval is at least 21 days. Guidance notes myocarditis risk may 

decrease with a longer interval, but encourages a second dose at 21 days due to Omicron. In 

Taiwan, both Pfizer and Moderna vaccines are approved for persons aged12 and older, and the 

recommended interval between first and second dose is at least 12 weeks.70 In Australia, the 

recommended interval is at least 3 weeks for Pfizer or 4 weeks for Moderna. Among children 

aged 5-11 years, the recommended interval is 8 weeks. Guidance notes that the interval can be 

shortened in special circumstances to a minimum of 3 weeks, such as in an outbreak response 

prior to the initiation of significant immunosuppression or international travel.71 In France, Haute 

Autorité de Santé (HAS) recommends persons under the age of 30 be given Pfizer over

Moderna when available. The recommended interval is 6 weeks. And in Germany, the 

recommendation is for persons under the age of 30 to be given Pfizer over Moderna. The 

recommended interval is 3 to 6 weeks.72

This review has a number of limitations. It was not a systematic review and the studies

presented are biased toward findings that influence national vaccine policy. Caution should be 

used when comparing myocarditis rates across studies as surveillance systems, case 

definitions, risk intervals, subpopulation, age ranges, and vaccine implementation differ 

substantially. National vaccines policies are constantly evolving. Some policies extending the 

primary series interval evolved from implementation strategies to reach the most people with a 

first dose.

69 Source: https://www.fhi.no/en/id/vaccines/coronavirus-immunisation-programme/coronavirus-vaccine/#vaccination-of-childrenand-adolescents. Accessed 1/22/2022 https://www.lakemedelsverket.se/en/coronavirus/covid-19-vaccine. Accessed 1/23/2022

https://thl.fi/en/web/infectious-diseases-and-vaccinations/what-s-new/coronavirus-covid-19-latest-updates/vaccines-andcoronavirus/getting-vaccinated-against-covid-19-how-why-and-whenhttps://www.sst.dk/en/English/Corona-eng/Vaccinationagainst-covid-19/COVID-19-vaccines-in-Denmark 70 Source: https://www.cdc.gov.tw/En/Bulletin/Detail/YPIDZwC4HjqBMtGi4jynHQ?typeid=158. Accessed 1/31/22; 

https://www.moh.gov.sg/covid-19/vaccination/faqs---children-related-vaccination-matters. Accessed 1/31/22 71 Source: https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/advice-for-providers/clinical-guidance/doses-and 

administration. Accessed 1/30/2022; https://www.health.gov.au/sites/default/files/documents/2021/12/atagi-recommendations-onpfizer-covid-19-vaccine-use-in-children-aged-5-to-11-years_0.pdf Accessed 1/30/2022 72 Source: https://www.nitag-resource.org/sites/default/files/2021-12/48_21.pdf. Accessed 1/23/2022; 

https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2021/46/Art_03.htm Accessed 1/23/2022; 

https://www.reuters.com/business/healthcare-pharmaceuticals/french-health-authority-advises-against-moderna-covid-19-

vaccine-under-30s-2021-11-09/ Accessed 1/23/2022
ACIP Meeting Summary February 4, 2022

56

In conclusion, observational data suggests that myocarditis may be associated with receipt

of Moderna mRNA vaccine in persons aged 18-29 years, especially males and with shorter 

primary series intervals. Extended primary series intervals may improve VE and several 

countries have implemented policies or recommendations to lengthen the interval between 

doses in the primary series, which may improve VE and mitigate myocarditis risk. Some have 

preferentially recommended use of Pfizer among males and/or persons aged 30 years

or younger, which may mitigate the risk of myocarditis.

Discussion Summary

Dr. Lee expressed gratitude for the comprehensive overview of the various policies. Much of the 

tension over the course of the past year for ACIP has been to try to simplify the message to 

make it more straightforward for implementation. From a global perspective, she recognizes 

how confusing this must be going from country-to-country but also recognizing that everyone is 

trying to do the right thing—optimize health and mitigate risk.

Ms. Bahta noted that in the summary of US findings, the reporting rate after a second dose

of Moderna was 42 million, but there was not a rate for the second dose of Pfizer.

Dr. Shimabukura clarified that the reporting rates for Moderna in males after Dose 2 in 0-7 days 

was 40 per million. The corresponding rate for Pfizer was 37 per million. For persons 25-29

years of age, Moderna after Dose 2 in 0-7 days was 18.3 per million and Pfizer was 11.7 per 

million. After those ages, there is not much of a difference between these vaccines.

Dr. Sanchez noted that these presentations raised a lot of questions and issues in his mind as 

ACIP tries to refine vaccine policy, recommendations, and the pursuit of safety and efficacy. It 

seemed to him that it was not just a matter of saying that Pfizer is recommended over Moderna. 

Based on the data, Pfizer has been associated with lower myocarditis. However, to try to

minimize myopericarditis occurrence, ACIP also will have to deal with the intervals. Perhaps a 

preferential recommendation should be for the vaccine and the interval, which has a lot of 

implications for boosters as well.

Summary and WG Interpretation: Extended Intervals for mRNA COVID-19 Vaccines

Sara Oliver, MD, MSPH (CDC/NCIRD) provided a summary and WG interpretation of the data 

on extended intervals for mRNA COVID-19 vaccines. As a reminder, the policy question for the 

ACIP voted was, “Should vaccination with the Moderna COVID-19 vaccine (Spikevax®, 2-dose 

primary series) be recommended for persons 18 years of age and older?” comparing the

Moderna vaccine to no vaccine. This presentation focused on an additional question for

discussion based on new and emerging data heard throughout the afternoon, “Based on new 

and emerging data, should CDC consider guidance around the interval between Dose 1 and 2 

for mRNA COVID-19 vaccines?” This discussion addressed both Moderna and the Pfizer 

COVID-19 vaccines.

VaST reviewed the most recent data from 3 US safety monitoring systems, as well as data

from international partners. Reported rates of myocarditis following the mRNA vaccines are 

higher than background, highest after Dose 2, and higher in adolescent young adult males. In 

most safety monitoring systems, myocarditis risk is somewhat higher after Dose 2 of Moderna

vaccine than Dose 2 of Pfizer vaccine. The data are limited but emerging around myocarditis 

risk following different Dose 1 and Dose 2 intervals.
ACIP Meeting Summary February 4, 2022

57

Summarizing the international data around myocarditis after the mRNA vaccines, the risk of 

myocarditis was higher for Moderna than Pfizer and highest after the second dose among 

younger males. However, the rates of myocarditis were lower with an extended interval between 

the first and second doses of the mRNA vaccine primary series.

To summarize the extended primary series interval data around immunogenicity and VE, an 

extended primary series interval may improve immunogenicity and VE. Antibody responses

were higher following an extended interval between the first and second doses of the mRNA 

vaccines compared to a standard interval. VE against infection and hospitalization were higher 

with an extended interval compared to a standard interval.

Considering the benefit-risk balance for mRNA COVID-19 vaccines looking specifically in adults 

18-39 years of age but comparing vaccine-specific benefits to vaccine-specific harms with the 

mRNA vaccines, the benefit-risk assessment used the same methods as those previously 

described, but now includes vaccine-specific VE and myocarditis inputs for both the Moderna 

and Pfizer vaccines. In terms of vaccine-specific estimates for effectiveness against COVID-19 

hospitalization from both IVY and VISION, the pooled VE estimate was 92% for Moderna and 

87% for Pfizer. In terms of vaccine-specific rates of myocarditis per million second doses

administered among persons 18-39 years from VSD, the rates were the highest in males at 67.5 

per million second doses for Moderna and 46.8 per million second doses for Pfizer.

Regarding COVID-associated hospitalizations prevented compared with myocarditis cases 

expected from the vaccine, over the course of 5 months, the benefits of receiving either mRNA 

vaccine far outweigh the risks. More myocarditis cases would be expected among the Moderna 

COVID-19 vaccine recipients than Pfizer, but more COVID hospitalizations would be prevented 

among the Moderna recipients compared to Pfizer as well. For males aged 18-39 years for 

whom the myocarditis rates are the highest, the benefits for the mRNA vaccines still far 

outweigh the potential risk. Again, more myocarditis cases would be expected among the

Moderna vaccine recipients compared to Pfizer. But again, more COVID hospitalizations would 

be prevented among the Moderna recipients than the Pfizer recipients.

To highlight the limitations, the benefit-risk analysis focuses on individuals 18-39 years of age,

considers direct benefits and risk over a 150-day period, and compares vaccine vs. no vaccine. 

VE assumptions used in the model do not yet include Omicron-specific VE estimates. The 

model assumes static hospitalization rate over 5 months. The benefit-risk profile might change 

as hospitalization rates change. The model does not account for booster doses or prior 

infection.

To summarize the benefit-risk balance for mRNA COVID-19 vaccines, COVID hospitalizations 

averted by the Moderna COVID-19 vaccine are greater than for the Pfizer BioNTech COVID-19 

vaccine. On the risk side, myocarditis after the Moderna COVID-19 vaccine are likely greater 

than for the Pfizer BioNTech COVID-19 vaccine. The benefits for both mRNA vaccines far 

outweigh the risk of myocarditis compared to no vaccine. When compared to the benefit risk 

balance for Pfizer, Moderna prevents more hospitalization, but more myocarditis cases would 

be expected. Rates of myocarditis were lower with extended intervals between the first and 

second dose of the mRNA vaccine, and the extended vaccine primary series may improve 

immunogenicity and VE.
ACIP Meeting Summary February 4, 2022

58

In terms of the additional question regarding the possibility of an extended interval, 

consideration must be given to how such a recommendation would be applied. Overall, there 

are around 33 million unvaccinated individuals. If there is a focus on those aged 12-39 years, 

the population with no vaccine at all is lower in the older age groups. Then there are several 

considerations regarding extended intervals between the first and second doses of mRNA 

vaccines. Thinking through the possible benefits specifically for safety, the extended interval

appears to reduce the risk of myocarditis, with the lowest rates of myocarditis with an interval at 

least 8 weeks. Extending the interval also appears to increase the VE for the primary series, 

although this benefit may level out at about 8 weeks. For implementation, it is possible that

uptake of the COVID-19 vaccine primary series could increase if individuals or parents desire an 

action that they could take that would lower their risk for myocarditis. Thinking through possible 

risk with regard to effectiveness, there will be a longer duration of time where individuals would 

only have the benefit of a single dose of an mRNA vaccine. Regarding implementation, for 

aspects that require being fully vaccinated (e.g., quarantine, travel, or restaurants), extending an 

interval would extend the time before somebody would be considered fully vaccinated.

Overall, the WG had several thoughts about an extended interval. An individual's risk of getting 

COVID-19 likely increases the longer they are only partially vaccinated with a single dose. That 

risk needs to be balanced with the benefits of lowering rates of myocarditis and optimizing the 

long-term VE. This balance is influenced by the trajectory of the pandemic and recent 

epidemiology of COVID-19, which can change over time. Early in the pandemic, the priority was 

for individuals to have optimum protection from the primary series as quickly as possible.

However, guidance around COVID vaccines can be updated as new data become available, 

and the focus expands to also look to the future of the COVID-19 vaccine program. The WG 

emphasized that clear communication for COVID-19 vaccines and preferred intervals is 

important. Being specific for what interval is desired and for whom will be critical for those and is 

needed to implement any updated guidance. Also, there may be populations for whom the

benefits of the earlier interval at 3 or 4 weeks would outweigh any possible risks of myocarditis.

The licensed interval of 3 weeks for Pfizer or 4 weeks for Moderna would continue to be

recommended, especially in circumstances where early protection is desired. Overall, after 

having discussions, the WG supported a preferred interval of 8 weeks between the first and 

second doses of an mRNA COVID-19 vaccine primary series.

Discussion Summary

Dr. Poehling expressed appreciation to everybody on the ACIP for putting together these 

presentations and pulling information from around the world. She found the data presented

from their Canadian colleagues and from around the world very persuasive that an extended 

interval, particularly in younger persons at increased risk of myocarditis, would be particularly

beneficial. She also appreciated the caveat the WG included because it appeared that the US 

was beyond the peak of Omicron. When the pandemic is receding is a particularly good time to 

do a prolonged interval, but there may be cases and circumstances in which a shorter interval 

would be recommended. She liked the extended interval of 8 weeks, which seems ideal

according to Canadian data.

Dr. Daley said he was in favor of extending intervals as doing so would provide benefits to the 

recipients of Pfizer vaccine or Moderna vaccine. He also appreciated the desire for clear 

communication, which is why he would prefer an 8-week interval, but with flexibility for those 

who need to achieve protection sooner.
ACIP Meeting Summary February 4, 2022

59

Thinking from the frontline and the knowledge that extended time seems to provide a better 

immune response, Ms. Bahta would support the proposed extension.

Dr. Sanchez agreed and would favor an extended interval, especially among the younger male 

individuals because of the association with myocarditis. This is an age group that in general 

does not have severe infection, but still should be protected. Trying to optimize vaccine safety

in that group is important. He would support a recommendation for an extended interval in that 

group. In the extended interval, the difference in occurrence of myocarditis between the Pfizer 

versus the Moderna vaccine seem less significant. With respect to making a recommendation

for one versus the other product, particularly in those who are at highest risk for myocarditis, 

with a shorter interval it should be the Pfizer product if needed and somebody wants quicker 

protection. Certainly, he would favor the longer duration of 8 weeks.

Dr. Oliver noted that especially around that kind of clear communication, the thought was that 

any recommendations around an extended interval would be best to be applied to both mRNA 

vaccines. There would not be an extended interval for one or the other. Based on the data from 

other countries regarding myocarditis concerns, it seems that the extended interval could be a 

potential mitigation measure for myocarditis concerns. Looking at the totality of the benefit-risk

in terms of VE and myocarditis, it was felt that the extended interval may lower the risk of 

myocarditis, which hopefully would negate the need for a preferential recommendation.

Certainly, individual clinicians could make a choice around which vaccine they thought would be 

best in any specific circumstance. As a nationwide public health policy, the extended interval 

would be a good way to mitigate the myocarditis risk.

Dr. Sanchez clarified that he did not mean to imply or suggest that there should be a different 

interval between the two vaccines, but they may need to harmonize it. His understanding of the 

Canadian data was that with the extended interval, the differences in myocarditis with Moderna 

versus Pfizer was not so significant. If that was not the correct interpretation, then they would 

want a preferential product.

Dr. Kotton requested information on the thoughts of the WG about the people to whom this 

would apply who are still unvaccinated in terms of how a change in the interval might impact 

their desire or ability to get vaccinated.

Dr. Daley agreed that people who are not currently vaccinated have some reluctance for which 

there may be multiple reasons. Vaccine safety is a concern that has been raised repeatedly. As 

always, these are complicated issues that are nuanced and hard to communicate. 

Communication that there are highly effective vaccines that have a high degree of safety, but

there is a way to make them even safer and the risk of myocarditis, could convince some who 

are reluctant to get vaccinated.

Dr. Loehr agreed with the proposed extended interval and supported the 8-week 

recommendations.

Ms. Hayes (ACNM) requested a reminder of the original clinical trials for the mRNA vaccines the 

number of times the frequency between the 2 doses was studied. She recalled that multiple 

schedules were tested.
ACIP Meeting Summary February 4, 2022

60

Dr. Oliver emphasized that early in the pandemic, the goal was to get optimum protection

as quickly as possible, so the early clinical trials for both mRNA vaccines had 3- or 4-week 

intervals.

Dr. Das added that by and large, the participants in the Moderna vaccine trial were extremely 

compliant with a 4-week interval. But they have data out to 6-week intervals showing the same 

level of efficacy.

Dr. Lee said she thought an extended interval would be a win-win in terms of the reduction of 

AEs and improvement in immunogenicity. As they approach new variants, the higher the 

antibodies and the more diverse these antibodies are, the better protected people will be.

As a member of the WG, Dr. Bell noted that she had the opportunity to have a very robust 

discussion about this already, which Dr. Oliver reflected very accurately. She was very taken 

with the consistency of the WG members feelings about this issue of the extended interval and 

the overwhelming agreement that an extended interval makes sense for both safety and efficacy 

reasons. She certainly supported this and thought at the end of the day, picking an8-week 

interval, but recognizing the need for flexibility would be the best way to keep things as simple 

as possible.

Dr. Ault pointed out that one of the potential problems during the 8-week gap would be that 

people will be vulnerable to getting infected, which would be important to address in the Clinical 

Considerations. Going back through his copy of the slides to see if that was specifically 

addressed, it appeared to be addressed tangentially.

Dr. Daley indicated that the WG did discuss that. It is a risk to be sure, but as Dr. Poehling said,

if this is implemented at a timeframe when case counts are falling, that is a benefit. It is still a 

fairly short period of time of a 4-week or 5-week difference. The WG felt comfortable with the 

idea that there would be some protection from a first dose, even if the second dose was delayed

somewhat. He emphasized that how this is communicated will be very important. Since many 

parents express concern about vaccine safety of often bring up myocarditis, perhaps they would 

be best service to start with that.

Dr. Brooks said that the benefit of greater immunogenicity and decrease in the rates of

myocarditis made it clear to him that this would be a good recommendation. Based on the 

Canadian study, the level of coverage did not drop off appreciably. Concern about lowering 

immunity over time by only one dose is not a major worry of his. He thinks it affords a level of 

safety and also demonstrates to the public that ACIP is very focused on doing this in the right 

way and making these adjustments that are overall beneficial.

Dr. Duchin (NACCHO) agreed with the rationales around improving vaccine safety and 

improving VE. The type of graphics that were shown earlier may be very helpful in

communicating to the public around any changes that may be made in the vaccine schedule. He 

asked whether someone could comment on any implications for timing of booster doses if an 

extended primary series interval is adopted.

Dr. Oliver indicated that booster recommendations are based on timing since completion of the 

primary series, so that recommendation would stay the same and the clock would start counting 

after the second dose. It would be 5 months after someone is fully vaccinated, and that would 

not change. If they have learned anything throughout the pandemic, it is that their crystal balls 

are not always great at predicting what the future will be. They are aware that there are studies 
ACIP Meeting Summary February 4, 2022

61

ongoing for Omicron-specific vaccines. As they learn what is going on with the pandemic, as the 

pandemic evolves, and as additional data become available, the WG will review the information 

and will bring it to ACIP.

Dr. Lee said that recognizing that the current authorization either sits at 21 or 28 days, she 

appreciated the flexibility. In terms of whether a full recommendation is needed versus clinical 

guidance, this felt to her like a good opportunity to use the Clinical Guidance from a timeliness 

perspective and because they have an opportunity to optimize the immune response in young 

children, many of whom remain unvaccinated. The hope is that this will continue to improve 

vaccination rates over time. She recognize that there seemed to be generally supportive 

comments in favor of an extended interval, and now they needed to understand the regulatory 

allowance for these comments to be incorporated into the Clinical Guidance. Regarding the 

question of Moderna versus Pfizer, and also recognizing and acknowledging the variable 

vaccination policies that are occurring in different countries, she was not yet personally sure that 

there was sufficient evidence to make a preferential recommendation for two reasons. First,

some people decide that they would like Moderna, such as people who have a suboptimal 

immune response. Allowing flexibility to be available to individual patients and clinicians to think

about the benefit-risk balance for the individual would be important to reflect. That may be more 

difficult with a preferential recommendation. Second, the Moderna vaccine is now fully approved 

for persons 18 years of age and older.

Dr. Sanchez said that as much as he agreed with that statement, if there is a higher risk of 

myocarditis in the highest risk group of males and now one of the vaccines is associated with 

lower risk, he thought there should be a preferential recommendation for that vaccine in that age 

group in males. His current preference was that somebody in the highest risk group for 

myocarditis who received either Moderna or Pfizer as the first dose should get the Pfizer

vaccine for their second dose.

Dr. Daley pointed out that the ACIP COVID-19 Vaccines WG discussed all of the issues that

had been discussed throughout the day and they felt like an extended interval was a strategy

to increase safety and decrease myocarditis risk for both mRNA COVID-19 vaccines, and did 

not find that there was compelling evidence at this time to have a preferential recommendation 

for one mRNA vaccine over another.

Dr. Fryhofer (AMA) said that speaking as a practicing physician, she greatly appreciated all of 

the data that had been presented throughout the day about ways to make the vaccines work 

better and make them safer. She also greatly appreciated what Dr. Lee mentioned about 

increasing flexibility for the doctors who care for these patients to help patients make decisions. 

By adding some flexibility there, physicians know what the points are that patients are

concerned about and what might make them go ahead and get a vaccine now or wait. In 

previous conversations, they heard that Moderna seemed to be more durable. Now on the

downward curve of Omicron, the myocarditis concern was a big one. She liked the concept

of giving guidance, but also giving some flexibility. She also looks forward to more details

in the Clinical Guidance about immunocompromised patients and expanding who that group of 

patients is for those new booster recommendations.

Dr. Loehr emphasized that one thing which came out in the presentations was that there is a 

higher risk of myocarditis from Moderna, but there also is a benefit in terms of hospitalization. 

He did not want that to get lost. In terms of a preferential recommendation, he thought they 

needed to look at the whole picture. Hospitalizations might be just as important as the 

myocarditis.
ACIP Meeting Summary February 4, 2022

62

CERTIFICATION

Upon reviewing the foregoing version of the February 4, 2022 ACIP meeting minutes, Dr. Grace 

Lee, ACIP Chair, certified that to the best of her knowledge, they are accurate and complete.

Her original, signed certification is on file with the Management Analysis and Services Office 

(MASO) of CDC.
ACIP Meeting Summary February 4, 2022

63

ACIP MEMBERSHIP ROSTER 

CHAIR 

LEE, Grace M, MD, MPH 

Associate Chief Medical Officer for Practice Innovation 

Lucile Packard Children’s Hospital 

Professor of Pediatrics, Stanford University School of Medicine 

Stanford, CA 

Term: 8/4/2021 – 6/30/2023

EXECUTIVE SECRETARY 

WHARTON, Melinda, MD, MPH

National Center for Immunization and Respiratory Diseases

Centers for Disease Control and Prevention

Atlanta, GA

MEMBERS 

AULT, Kevin A, MD, FACOG, FIDSA 

Professor and Division Director 

Department of Obstetrics and Gynecology University of 

Kansas Medical Center 

Kansas City, KS 

Term: 10/26/2018 – 6/30/2022 

 

BAHTA, Lynn, RN, MPH, CPH 

Immunization Program Clinical Consultant 

Infectious Disease, Epidemiology, Prevention & Control Division 

Minnesota Department of Health 

Saint Paul, Minnesota 

Term: 7/1/2019 – 6/30/2023

 

BELL, Beth P, MD, MPH 

Clinical Professor 

Department of Global Health, School of Public Health 

University of Washington 

Seattle, WA 

Term: 7/1/2019 – 6/30/2023 

BROOKS, Oliver, MD, FAAP

Chief Medical Officer

Watts HealthCare Corporation

Los Angeles, CA

Past President, National Medical Association

Term: 7/26/2021 – 6/30/2025
ACIP Meeting Summary February 4, 2022

64

CHEN, Wilbur H, MD, MS, FACP, FIDSA 

Professor of Medicine 

Center for Vaccine Development and Global Health 

University of Maryland School of Medicine 

Baltimore, MD 

Term: 12/23/2020 – 6/30/2024 

CINEAS, Sybil, MD, FAAP, FACP

Associate Professor of Medicine, Pediatrics, and Medical Science (Clinical)

The Warren Alpert Medical School of Brown University

Associate Program Director

Brown Combined Residency in Internal Medicine and Pediatrics

Providence, RI

Term: 7/28/2021 – 6/30/2025

DALEY, Matthew F, MD 

Senior Investigator 

Institute for Health Research, Kaiser Permanente Colorado 

Associate Professor of Pediatrics 

University of Colorado School of Medicine 

Aurora, CO 

Term: 1/4/2021 – 6/30/2024 

KOTTON, Camille Nelson, MD, FIDSA, FAST 

Clinical Director, Transplant and Immunocompromised Host Infectious Diseases 

Infectious Diseases Division, Massachusetts General Hospital 

Associate Professor of Medicine, Harvard Medical School 

Boston, MA 

Term: 12/23/2020 – 6/30/2024 

LOEHR, Jamie, MD, FAAFP

Owner, Cayuga Family Medicine

Ithaca, New York

Term: 7/26/2021 – 6/30/2025

LONG, Sarah S, MD 

Professor of Pediatrics 

Drexel University College of Medicine 

Section of Infectious Diseases 

St. Christopher’s Hospital for Children 

Philadelphia, Pennsylvania 

Term: 12/24/2020 – 6/30/2024 

MCNALLY, Veronica V, JD 

President and CEO Franny 

Strong Foundation 

West Bloomfield, Michigan 

Term: 10/31/2018 – 6/30/2022 
ACIP Meeting Summary February 4, 2022

65

POEHLING, Katherine A, MD, MPH 

Professor of Pediatrics and Epidemiology and Prevention 

Director, Pediatric Population Health 

Department of Pediatrics 

Wake Forest School of Medicine 

Winston-Salem, NC 

Term: 7/1/2019 – 6/30/2023 

 

SÁNCHEZ, Pablo J, MD 

Professor of Pediatrics 

The Ohio State University – Nationwide Children’s Hospital 

Divisions of Neonatal-Perinatal Medicine and Pediatric Infectious Diseases 

Director, Clinical & Translational Research (Neonatology) 

Center for Perinatal Research 

The Research Institute at Nationwide Children's Hospital Columbus, Ohio 

Term: 7/1/2019 – 6/30/2023 

TALBOT, Helen Keipp, MD 

Associate Professor of Medicine 

Vanderbilt University 

Nashville, TN 

Term: 10/29/2018 – 6/30/2022 

EX OFFICIO MEMBERS 

 

Centers for Medicare and Medicaid Services (CMS) 

HANCE, Mary Beth 

Senior Policy Advisor 

Division of Quality, Evaluations and Health Outcomes 

Children and Adults Health Programs Group 

Center for Medicaid, CHIP and Survey & Certification Centers 

for Medicare and Medicaid Services 

Baltimore, MD 

Food and Drug Administration (FDA) 

FINK, Doran, MD, PhD 

Deputy Director, Clinical, Division of Vaccines and Related Products Applications 

Office of Vaccines Research and Review 

Center for Biologics Evaluation and Research 

Food and Drug Administration 

Silver Spring, MD 

 

Health Resources and Services Administration (HRSA) 

RUBIN, Mary, MD 

Chief Medical Officer 

Division of Injury Compensation Programs 

Rockville, MD 

 
ACIP Meeting Summary February 4, 2022

66

Indian Health Service (IHS) 

CLARK, Matthew, MD, FAAP, FACP

Physician

Chair, IHS National Pharmacy & Therapeutics Committee

Durango, CO

 

Office of Infectious Disease and HIV/AIDS Policy (OIDP) 

KIM, David, MD, MA 

Director, Division of Vaccines, OIDP 

Office of the Assistant Secretary for Health 

Department of Health and Human Services 

Washington, DC 

 

National Institutes of Health (NIH) 

BEIGEL, John, MD 

Associate Director for Clinical Research 

Division of Microbiology and Infectious Diseases 

National Institute of Allergy and Infectious Diseases (NIAID) 

Bethesda, MD 

LIAISON REPRESENTATIVES 

American Academy of Family Physicians (AAFP)

ROCKWELL, Pamela G, DO 

Associate Professor, Department of Family Medicine, University of 

Michigan Medical School 

Medical Director, Dominos Farms Family Medicine 

Ann Arbor, MI 

 

American Academy of Pediatrics (AAP) 

MALDONADO, Yvonne, MD 

Senior Associate Dean for Faculty Development and Diversity 

Professor of Pediatrics and Health Research and Policy 

Chief, Division of Pediatric Infectious Diseases 

Stanford University School of Medicine 

Stanford, CA 

American Academy of Pediatrics (AAP) 

Red Book Editor

KIMBERLIN, David, MD 

Professor of Pediatrics 

Division of Pediatric Infectious Diseases 

The University of Alabama at Birmingham School of Medicine

Birmingham, AL 

 

American Academy of Physician Assistants (AAPA) 

LÉGER, Marie-Michèle, MPH, PA-C 

Senior Director, Clinical and Health Affairs 

American Academy of Physician Assistants 

Alexandria, VA 
ACIP Meeting Summary February 4, 2022

67

American College Health Association (ACHA) 

CHAI, Thevy S., MD 

Director of Medical Services 

Campus Health Services 

University of North Carolina at Chapel Hill Chapel Hill, 

NC 

American College Health Association (ACHA) (alternate) 

MCMULLEN, Sharon, RN, MPH, FACHA 

Assistant Vice President of Student & Campus Life for Health and Wellbeing Cornell Health 

Ithaca, NY 

American College of Nurse Midwives (ACNM) 

HAYES, Carol E., CNM, MN, MPH 

Lead Clinician 

Clinical Quality Compliance and Management 

Planned Parenthood Southeast Atlanta, GA 

American College of Nurse Midwives (ACNM) (alternate) 

MEHARRY, Pamela M., PHD, CNM 

Midwifery Educator, Human Resources for Health 

In partnership with University of Rwanda and University of Illinois, Chicago 

American College of Obstetricians and Gynecologists (ACOG) 

ECKERT, Linda O, MD, FACOG 

Professor, Department of Obstetrics & Gynecology 

Adjunct Professor, Department of Global Health 

University of Washington 

Seattle, WA

American College of Physicians (ACP) 

GOLDMAN, Jason M, MD, FACP 

Affiliate Assistant Professor of Clinical Biomedical Science, Florida Atlantic University, Boca 

Raton, Florida 

Private Practice 

Coral Springs, FL 

American Geriatrics Society (AGS) 

SCHMADER, Kenneth, MD 

Professor of Medicine-Geriatrics Geriatrics 

Division Chief 

Duke University and Durham VA Medical Centers 

Durham, NC 

America’s Health Insurance Plans (AHIP) 

GLUCKMAN, Robert A, MD, MACP 

Chief Medical Officer, Providence Health Plans 

Beaverton, OR 
ACIP Meeting Summary February 4, 2022

68

American Immunization Registry Association (AIRA) 

COYLE, Rebecca, MSEd 

Executive Director, AIRA

Washington, DC 

American Medical Association (AMA)

FRYHOFER, Sandra Adamson, MD 

Adjunct Associate Professor of Medicine Emory 

University School of Medicine 

Atlanta, GA 

American Nurses Association (ANA) 

RITTLE, Charles (Chad), DNP, MPH, RN Assistant 

Professor, Nursing Faculty 

Chatham University, School of Health Sciences 

Pittsburgh, PA 

American Osteopathic Association (AOA) 

GROGG, Stanley E, DO 

Associate Dean/Professor of Pediatrics 

Oklahoma State University-Center for Health Sciences 

Tulsa, OK 

American Pharmacists Association (APhA) 

HOGUE, Michael D., PharmD, FAPhA, FNAP

Dean and Professor of Loma Linda University School of Pharmacy

Director, Center for Interprofessional Education & Practice

Loma Linda, CA

Association of Immunization Managers (AIM) 

HOWELL, Molly, MPH 

Immunization Program Manager 

North Dakota Department of Health

Bismarck, ND 

Association for Prevention Teaching and Research (APTR) 

ZIMMERMAN, Richard, MD, MPH

Professor

University of Pittsburgh School of Medicine

Department of Family Medicine and Clinical Epidemiology

Pittsburgh, PA

Association of State and Territorial Health Officials (ASTHO) 

SHAH, Nirav D, MD, JD 

Director

Maine Center for Disease Control and Prevention

Augusta, ME 
ACIP Meeting Summary February 4, 2022

69

Biotechnology Industry Organization (BIO) 

ARTHUR, Phyllis A, MBA 

Senior Director, Vaccines, Immunotherapeutics and Diagnostics Policy

Washington, DC 

Council of State and Territorial Epidemiologists (CSTE) 

HAHN, Christine, MD 

State Epidemiologist 

Office of Epidemiology, Food Protection and Immunization Idaho 

Department of Health and Welfare 

Boise, ID 

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

LETT, Susan, MD, MPH 

Medical Director, Immunization Program 

Division of Epidemiology and Immunization 

Massachusetts Department of Public Health 

Boston, MA 

Canadian National Advisory Committee on Immunization (NACI) 

DEEKS, Shelley, MD, MHSc, FRCPC, FAFPHM

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

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

Chair, National Advisory Committee on Immunization

Halifax, Nova Scotia

Infectious Diseases Society of America (IDSA) 

BAKER, Carol J., MD 

Professor of Pediatrics 

Molecular Virology and Microbiology 

Baylor College of Medicine 

Houston, TX 

International Society for Travel Medicine (ISTM) 

BARNETT, Elizabeth D, MD Professor of 

Pediatrics 

Boston University School of Medicine 

Boston, MA 

National Association of County and City Health Officials (NACCHO)

ZAHN, Matthew, MD 

Medical Director, Epidemiology 

Orange County Health Care Agency 

Santa Ana, CA 
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National Association of County and City Health Officials (NACCHO) (alternate)

DUCHIN, Jeffrey, MD 

Health Officer and Chief, Communicable Disease

Epidemiology and Immunization Section 

Public Health - Seattle and King County 

Professor in Medicine 

Division of Allergy and Infectious Diseases 

University of Washington School of Medicine and School of Public Health

Seattle, WA 

National Association of Pediatric Nurse Practitioners (NAPNAP) 

STINCHFIELD, Patricia A, RN, MS, CPNP 

Director 

Infectious Disease/Immunology/Infection Control

Children's Hospitals and Clinics of Minnesota 

St. Paul, MN 

National Foundation for Infectious Diseases (NFID) 

SCHAFFNER, William, MD 

Chairman, Department of Preventive Medicine 

Vanderbilt University School of Medicine 

Nashville, TN 

National Foundation for Infectious Diseases (NFID) (alternate)

DALTON, Marla, PE, CAE 

Executive Director & CEO 

National Foundation for Infectious Diseases (NFID) 

Bethesda, MD 

National Medical Association (NMA) 

WHITLEY-WILLIAMS, Patricia, MD Professor and Chair 

University of Medicine and Dentistry of New Jersey Robert Wood 

Johnson Medical School 

New Brunswick, NJ 

Pediatric Infectious Diseases Society (PIDS) 

O’LEARY, Sean, MD, MPH 

Associate Professor of Pediatrics 

Pediatric Infectious Diseases 

General Academic Pediatrics 

Children’s Hospital Colorado 

University of Colorado School of Medicine 

Pediatric Infectious Diseases Society (PIDS) (alternate)

SAWYER, Mark H, MD 

Professor of Clinical Pediatrics 

University of California, San Diego School of Medicine 

San Diego, CA 
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Pharmaceutical Research and Manufacturers of America (PhRMA) 

ROBERTSON, Corey, MD, MPH 

Senior Director, US Medical, Sanofi Pasteur 

Swiftwater, PA 

Society for Adolescent Health and Medicine (SAHM) 

MIDDLEMAN, Amy B, MD, MSEd, MPH 

Professor of Pediatrics 

Chief, Section of Adolescent Medicine 

University of Oklahoma Health Sciences Center

Oklahoma City, OK 

Society for Healthcare Epidemiology of America (SHEA)

DREES, Marci, MD, MS 

Chief Infection Prevention Officer & Hospital Epidemiologist 

ChristianaCare 

Wilmington, DE 

Associate Professor of Medicine 

Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA
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ACRONYMS USED IN THIS DOCUMENT

 

AAFP American Academy of Family Physicians 

AAP American Academy of Pediatrics

ACHA American College Health Association 

ACIP Advisory Committee on Immunization Practices

ACOG American College of Obstetricians and Gynecologists

ACP American College of Physicians 

AE Adverse Event

AHIP America’s Health Insurance Plans

AI/AN American Indian/Alaskan Native 

AIM Association of Immunization Managers 

AIRA American Immunization Registry Association 

AMA American Medical Association

AOA American Osteopathic Association 

APhA American Pharmacists Association 

AR Adverse Reaction 

ASTHO Association of State and Territorial Health Officers 

BEST Biologics Effectiveness and Safety System

BLA Biologics License Application 

CAEFISS Canadian Adverse Event Following Immunization Surveillance System 

CDC Centers for Disease Control and Prevention

CIQ Quebec's Provincial Immunization Committee 

CMS Center for Medicare and Medicaid Services

COD Cause of Death

COI Conflict of Interest 

COVE Trial Coronavirus Efficacy Trial

CSTE Council of State and Territorial Epidemiologists 

CVD Cardiovascular Disease 

DFO Designated Federal Official

DoD Department of Defense

DSMB Data Safety Monitoring Board 

DVA Department of Veterans Affairs

ECG/EKG Electrocardiogram

ED Emergency Department

EMR Electronic Medical Record 

ET Eastern Time

EtR Evidence to Recommendation 

EUA Emergency Use Authorization 

EUI COVID-19 Vaccine Emergency Use Instructions 

FDA Food and Drug Administration

GACVS Global Advisory Committee on Vaccine Safety

GMT Geometric Mean Titers 

GRADE Grading of Recommendation Assessment, Development and Evaluation 

HCP Healthcare Personnel / Providers

HCW Healthcare Workers
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HHS (Department of) Health and Human Services

HIV Human Immunodeficiency Virus 

HRSA Health Resources and Services Administration 

ICD International Classification of Disease 

ICU Intensive Care Unit

IDSA Infectious Disease Society of America 

IHS Indian Health Service 

IVAC International Vaccine Access Center 

J&J Johnson & Johnson

JCVI Joint Committee on Vaccination and Immunisation 

KFF Kaiser Family Foundation 

LTCF Long-Term Care Facilities 

MAAE Medically Attended Adverse Events 

MMF Mycophenolate Mofetil 

MMWR Morbidity and Mortality Weekly Report

NACCHO National Association of County and City Health Officials 

NACI National Advisory Committee on Immunization Canada

NAPNAP National Association of Pediatric Nurse Practitioners 

NCIRD National Center for Immunization and Respiratory Diseases 

NCL National Consumers League 

NFID National Foundation for Infectious Diseases 

NIH National Institutes of Health

NMA National Medical Association 

NP Nasopharyngeal 

PAHPRA Pandemic and All Hazards Preparedness Reauthorization Act 

PCP Primary Care Provider/Practitioner

PEP Post-Exposure Prophylaxis 

PHAC Public Health Agency Canada 

PIDS Pediatric Infectious Disease Society 

RCA Rapid Cycle Analysis

RCT Randomized Controlled Trial

RR Relative Risk

SAE Serious Adverse Event 

SAGE Strategic Advisory Group of Experts on Immunization 

SAHM Society for Adolescent Health and Medicine 

SHEA Society for Healthcare Epidemiology of America 

SME Subject Matter Expert

SOC System Organ Class 

TRAIPAG Transplant and Immunocompromised Patient Advocacy Group

TTS Thrombotic Thrombocytopenia Syndrome 

UK United Kingdom

US United States

USG United States Government

VA (US Department of) Veteran’s Affairs 

VAERS Vaccine Adverse Event Reporting System

VaST Vaccine Safety Technical Subgroup

VE Vaccine Efficacy

VE Vaccine Effectiveness

VFC Vaccines for Children 
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VRBPAC Vaccine and Related Blood Products Advisory Committee 

VSD Vaccine Safety Datalink

WG Work Group

WHO World Health Organization