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

Discussion and Interpretation 
Vaccine Safety Surveillance in the United States

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Well-established vaccine safety surveillance systems remain the 

cornerstone for monitoring the safety of approved COVID-19 vaccines in 

the United States

Enhanced approaches to surveillance have enriched our understanding of 

COVID-19 vaccine safety in the early phases of vaccine deployment

VaST continues to meet weekly to review all available data and to ensure a 

coordinated approach across multiple safety surveillance systems

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VaST Discussion and Interpretation

▪ Local and systemic reactions continue to be most commonly reported 

following vaccination in v-safe, VAERS and VA-ADERS

▪ Anaphylaxis reporting rate ranges from 2.5 to 4.7 cases per million doses 

administered

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Most common reason for CISA consultation

Allergy/immunology specialists provide expert input on clinical 

considerations

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VaST Discussion and Interpretation

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VSD Rapid Cycle Analysis

Multiple methods for surveillance are being used, depending on phase 

of the vaccination program

Pre-specified outcomes are actively monitored

No statistical signals detected to date

▪ CMS Rapid Cycle Analysis 

Descriptive analyses reviewed; sequential analyses to begin soon

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VaST Discussion and Interpretation

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A large number of pregnant women have chosen to receive COVID-19 

vaccines in the United States

A novel pregnancy registry in v-safe was established to monitor pregnancy 

and birth outcomes

Similar to non-pregnant adults, pregnant women commonly report 

local and systemic reactogenicity (e.g. pain, fatigue, headache)

Pregnancy and birth outcomes following COVID-19 vaccination appear 

similar to rates reported in the literature

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Vaccine Safety Updates

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Vaccine Safety Updates

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https://www.cdc.gov/coronavirus/2019-

ncov/vaccines/safety.html

https://www.fda.gov/vaccines-blood-biologics/safetyavailability-biologics/covid-19-vaccine-safety-surveillance
VaST Plans

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Statistical signals should be expected in a robust monitoring program

Timely investigations will be conducted once signals are identified

Only 1 in 10 statistical signals have been true associations

Maternal vaccine safety data from multiple sources will be regularly 

reviewed in collaboration with pregnancy experts

Future vaccine safety surveillance activities will include the newly 

approved Janssen COVID-19 vaccine

VaST will continue to update the ACIP COVID-19 vaccines workgroup, ACIP 

secretariat and ACIP on a regular basis

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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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