COVID-19 Vaccine Safety Technical (VaST) 

Work Group 

Safety Assessment 

H. Keipp Talbot, MD MPH (VaST Chair)

Robert H. Hopkins, Jr., MD (NVAC Chair)

Advisory Committee on Immunization Practices

February 4, 2022
COVID-19 Vaccine Safety Technical (VaST) Work Group

Objectives

 Review, evaluate, and interpret post-authorization/approval COVID-19 

vaccination safety data

 Serve as the central hub for technical subject matter expertise from federal 

agencies conducting post-authorization/approval safety monitoring

 Advise on analyses, interpretation, and presentation of vaccine safety data

 Provide updates to the ACIP COVID-19 Vaccines Work Group and the entire 

ACIP on COVID-19 vaccine safety

https://www.cdc.gov/vaccines/acip/workgroups.html 2
VaST continues to review COVID-19 vaccination safety 

data from passive and active surveillance systems

 U.S. safety monitoring systems including Vaccine Adverse Events 

Reporting System (VAERS), Vaccine Safety Datalink (VSD), FDA BEST 

System,1 Department of Veterans Affairs (VA), Indian Health Service (IHS), 

Department of Defense (DoD)

 International partners, including Public Health Agency of Canada, Global 

Advisory Committee on Vaccine Safety

 Special evaluations, including myocarditis case follow-up studies

1https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/cber-biologics-effectiveness-and-safety-best-system 3
VaST activities

 From December 21, 2020 through February 4, 2022

– 45 independent meetings to review vaccine safety data

– 12 joint meetings with ACIP COVID-19 Vaccines Work Group

– 15 ACIP meeting presentations or reports with VaST assessments

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VaST review, Moderna COVID-19 vaccine 

post-authorization safety data

 VaST has continued to review data from 

– CDC safety monitoring systems*

– Other U.S. monitoring systems

– International partners

*VAERS (a joint CDC/FDA effort), v-safe, VSD 5
Anaphylaxis following mRNA COVID-19 vaccination 

 Anaphylaxis following mRNA COVID-19 vaccination identified Dec 2020

 Safety data and VaST assessments presented at January & March 2021 ACIP1

 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 

• Provider and patient education by CDC and partners

 Anaphylaxis following vaccination reviewed again August 2021 for Pfizer BLA2

 No substantial change in benefit-risk balance with risk mitigation strategies

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1https://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

2https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/05-COVID-Lee-508.pdf
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 Myocarditis following mRNA COVID-19 vaccination identified in May 20211

 CDC issued clinical guidance for myocarditis/pericarditis following mRNA 

vaccines, May 2021

 Data presented at the Vaccines and Related Biologics Products Advisory 

Committee (VRBPAC), June 10

 Data and VaST assessment presented at ACIP meeting on June 232 and 

MMWR published

 EUA fact sheets revised with warning added, June 25

 FDA approval of Pfizer BioNTech COVID-19 vaccine on August 23, 2021

• Information on myocarditis/pericarditis in package insert3

• FDA approval of Moderna COVID-19 vaccine on January 31, 2022

• Information on myocarditis/pericarditis in package insert4

1https://www.cdc.gov/vaccines/acip/work-groups-vast/index.html; 2https://www.cdc.gov/vaccines/acip/meetings/slides-2021-06.htm;

3https://www.fda.gov/media/151707/download; 4 https://www.fda.gov/media/155675/download

Myocarditis following mRNA COVID-19 vaccination 
VAERS: Reporting rates (per 1 million doses administered) of 

myocarditis, days 0–7 after Moderna mRNA COVID-19 vaccination

 Reporting rates exceed 

background incidence

Males

– After dose 1: 18–39 years 

– After dose 2: 18–49 years

Females

– After dose 2: 18–29 years

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Males Females

Ages 

(years) Dose 1 Dose 2 Dose 1 Dose 2

18-24 5.8 40.0 0.5 5.5

25-29 2.9 18.3 0.3 5.8

30-39 3.3 8.4 0.6 0.6

40-49 0.5 3.5 0.8 1.6

50-64 0.7 0.9 0.8 0.4

65+ 0.2 0.6 0.1 0.5

Males, N = 283; Females, N = 76; Data through January 13, 2022

Source: Shimabukuro, Feb 4, 2022 ACIP presentation 
VSD: Confirmed myocarditis/pericarditis in 0–7-day risk interval 

among 18–39-year-olds compared with events in vaccinated 

comparators, Moderna vaccination

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1Adjusted for VSD site, 5-year age group, sex, race/ethnicity, and calendar date

2NE = not estimable

Source: Shimabukuro, Feb 4, 2022 ACIP presentation; data through Jan 15, 2022

Moderna

COVID-19

vaccine

Adjusted 

rate ratio1

(95% CI)

2-sided

P-value

Excess cases in

risk interval

(per million doses)

Both doses 9.18 (4.12 – 22.89 ) <0.001 18.8

Dose 1 3.46 (1.12 – 11.07) 0.031 6.9

Dose 2 18.75 (6.73 – 64.94) <0.001 31.2

Dose 2 males 16.96 (6.02 – 59.17) <0.001 61.8

Dose 2 females NE2 (0.93 – ∞) 0.056 6.2
Myocarditis outcomes following mRNA COVID-19 vaccination

 VAERS 

– 359 reports meeting case definition among individuals ≥18 years in 0–7 days 

post-vaccination

– 94% hospitalized

– 69% recovered from symptoms at time of VAERS report

 Follow-up surveys of myocarditis cases in VAERS

– 360 patients interviewed with ≥ 90 days of follow-up 

– 92% hospitalized

– 380 providers contacted, 81% indicated patient fully or probably fully recovered

 VSD (following Moderna vaccination) 

– 38 chart confirmed cases among individuals aged 18-39 years

– 79% hospitalized; 75% for 2 days or less

– 100% discharged to home

Sources: Shimabukuro, Feb 4, 2022 ACIP presentation; Kracalik, Feb 4, 2022 ACIP presentation; Klein, Feb 4, 2022 ACIP presentation 10
VaST Assessment

 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, 

following dose 2

 Data continue to show that most cases of post-COVID-19 vaccination 

myocarditis appear clinically mild 

 More data are being accumulated and analyzed to further define 

myocarditis clinical course and risk

 At the present time, data do not suggest new safety concerns 

regarding Moderna vaccination among persons aged 18 years or 

older, beyond those previously identified

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VaST Next Steps

 Continue to review data on myocarditis from national safety 

monitoring systems and manufacturer post-marketing requirements

 Continue to review real-time monitoring of vaccine safety as 

vaccination efforts expand to younger age groups, boosters doses, and 

new vaccines 

 Collaboration across U.S. federal agencies evaluating vaccine safety

 Collaboration with global vaccine safety colleagues on key issues that 

impact benefit-risk balance

 Continue to provide updates to the ACIP COVID-19 Vaccines 

Workgroup and the ACIP at future meetings

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VaST Members

VaST Members

Keipp Talbot (ACIP)

Robert Hopkins (NVAC)

Matt Daley

Grace Lee

Veronica McNally

Kathy Edwards

Lisa Jackson

Jennifer Nelson

Laura Riley

Robert Schechter

Patricia Whitley-Williams

CDC Co-Leads

Lauri Markowitz

Melinda Wharton

Ex Officio and Liaison Representatives 

Tatiana Beresnev (NIH)

Karen Farizo; Hui Lee Wong (FDA)

Valerie Marshall (OIDP)

Jeffrey Kelman (CMS)

Matthew Clark (IHS)

Mary Rubin (HRSA)

Fran Cunningham (VA)

Limone Collins (DoD)

Administrative Support

Jared Woo

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