COVID-19 Vaccine Safety Technical (VaST) 

Subgroup

Grace M. Lee, MD MPH & Robert Hopkins, MD

VaST Co-Chairs

Advisory Committee on Immunization Practices

March 1, 2021

Introduction 
COVID-19 Vaccine Safety Technical (VaST) Subgroup

Objectives

▪ Review, evaluate, and interpret post-authorization/approval 

COVID-19 vaccine 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 data presentation

▪ Provide updates to the ACIP COVID-19 Vaccines Working Group 

and the ACIP on COVID-19 vaccine safety

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VaST Activities

Pre-authorization

Jun-Dec 2020

• 14 meetings to 

prepare for vaccine 

safety surveillance 

in the U.S.

ACIP 

Recommendations

• Dec 12 –

Pfizer/BioNTech

• Dec 14 – 1

st dose 

administered in 

U.S.

• Dec 19 – Moderna

• Feb 28 – Janssen

Post-authorization

Dec 21-present

• 10 meetings to 

review vaccine 

safety data
start 

of vax

safety monitoring timeline

active surveillance, passive 

surveillance, case consults

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VaST Procedures 

▪ Data – Weekly review of available data on vaccine administration 

and adverse events of special interest (AESI)

▪ Shared learning – All members, federal partners, and subject matter 

experts are present for presentation of data

▪ Independence – VaST members discuss findings independently

▪ Reports – Summary and interpretation of aggregate data provided 

to the ACIP Secretariat on a regular basis 

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VaST Topics Covered 

▪ Reviewed routine data from VAERS, v-safe, VA ADERS, VSD and CMS

▪ Reviewed special topics including 

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Background rates for AESI 

Maternal immunization

Thrombocytopenia

Multisystem Inflammatory Syndrome (MIS)

Vaccination of persons with prior infection 

▪ Initiated monthly sessions with additional experts to review data on 

vaccine safety in pregnancy 
Outline of Today’s Session

▪ COVID-19 vaccine safety update

– Maternal immunization

▪ COVID-19 Vaccine Safety Technical (VaST) Subgroup discussion and 

interpretation

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VaST Members 

Co-Chairs

Grace Lee (ACIP)

Robert Hopkins (NVAC)

ACIP Members

Beth Bell

Matt Daley

Veronica McNally

Keipp Talbot

Expert Consultants

Kathy Edwards

Lisa Jackson

Martin Kulldorff

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)

Judith Steinberg (OIDP)

Jeffrey Kelman (CMS)

Matthew Clark (IHS)

Mary Rubin (HRSA)

Fran Cunningham (VA)

Limone Collins (DoD)

Administrative Support

Susan Hiers

Jared Woo

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Acknowledgments

▪ CISA 

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Karen Broder

▪ FDA

Rich Forshee

Steve Anderson

Narayan Nair

▪ Genesis

Barbara Bardenheier

▪ VAERS

John Su

▪ v-safe

Tanya Myers

Shin Kim

▪ VSD

Nicola Klein

Ned Lewis

Eric Weintraub

Michael McNeil

▪ Vaccine in pregnancy 

Richard Beigi

Brenna Hughes

Denise Jamieson

Dana Meaney Delman

Titilope Oduyebo 

Lakshmi 

Panagiotakopoulos

▪ CDC Vaccine Evaluation Unit

Tom Shimabukuro

Julianne Gee

David Shay

Tom Clark

Stacey Martin

▪ Other CDC and ISO

Frank Destefano

Rita Helfand

Jessica MacNeil

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