COVID-19 Vaccine Safety Technical (VaST) 

Work Group 

VaST assessment

H. Keipp Talbot, MD MPH (VaST Chair)

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

Advisory Committee on Immunization Practices

May 19, 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

VaST meetings 

 December 21, 2020 – present: 57 meetings to review vaccine safety data

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VaST assessment – Pfizer-BioNTech COVID-19 vaccine 

booster dose in 5–11-year-olds

 VaST reviewed the most recent data from three U.S. safety monitoring systems*

• Safety after the primary vaccination series in 5–11-year-olds

• Safety after booster doses in 12–15-year-olds (the youngest age group for which boosters 

were previously authorized

 18.1 million doses of Pfizer-BioNTech vaccine administered to children aged 5–11 years 

in the United States

• In VAERS, reporting rate for myocarditis among males lower in ages 5–11 vs. 12–15 years

• In VSD Rapid Cycle Analysis, no statistical safety signals after > 778,000 doses in 5–11-year-olds

 Data do not suggest potential safety concerns regarding a Pfizer-BioNTech COVID-19 

vaccine booster dose for 5–11-year-olds, beyond those previously identified in older age 

groups

*Vaccine Adverse Event Reporting System, v-safe, Vaccine Safety Datalink 3
VaST assessment – Mortality following COVID-19 

vaccination in the United States

 CDC Immunization Safety Office and FDA have standard and systematic methods for 

following up on all reported deaths following vaccination

 Because of the importance of mortality as a potential adverse event following 

vaccination, VaST has reviewed mortality data, as available, from several systems

 Population-based studies conducted to date have not identified increased risk of 

death following COVID-19 vaccination 

 Spontaneous reporting to VAERS has not identified any unusual reporting or patterns 

of causes of death

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VaST assessment – Mortality following COVID-19 

vaccination in the United States (continued)

 In a cohort of 6.4M COVID-19 vaccinees and 4.6M demographically similar unvaccinated 

persons, no increased risk of mortality among COVID-19 vaccine recipients1

 Among >20,000 nursing home residents in 284 facilities, no increase in 7-day mortality 

following COVID-19 vaccination2

 Among deaths reported to VAERS following COVID-19 vaccination

• Bayesian data mining identified no signals other than mortality due to COVID-19 disease 

(vaccine failure) following the Ad26.COV2.S vaccine (in adults)3

• No unusual clustering of causes of death associated with U.S. authorized COVID-19 vaccines3,4

1COVID-19 Vaccination and Non-COVID-19 Mortality Risk - Seven Integrated Health Care Organizations, United States, December 14, 2020-July 31, 2021 MMWR Morb Mortal Wkly Rep 2021;29;70:1520-4

2Adverse events following mRNA SARS-CoV-2 vaccination among U.S. nursing home residents. Vaccine 2021;39:3844-51.

3Reporting Rates for VAERS Death Reports Following COVID-19 Vaccination, December 14, 2020-November 17, 2021 https://www.medrxiv.org/content/10.1101/2022.05.05.22274695v1

4Safety of mRNA vaccines administered during the initial 6 months of the US COVID-19 vaccination programme: an observational study of reports to the Vaccine Adverse Event Reporting System and v-safe. 

Lancet ID 2022 3099(22):00054-8. Epub March 7, 2022. doi: https://doi.org/10.1016/S1473-3099(22)00054-8. 5
 VaST will continue to 

 Review vaccine safety data from multiple U.S. safety systems, in specific age 

groups, and after primary series and booster doses

 Collaborate with global vaccine safety colleagues on key issues

 Provide updates to the ACIP Work Group and ACIP at future meetings

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VaST plans
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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