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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
February 24, 2023
COVID -19 Vaccine Safety Technical (VaST) Work Group
Objectives
Review, evaluate, and interpret post -a uthorization/approval COVID -19
vaccination safety data
Serve as the central hub for technical subject matter expertise from
fe
deral 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
2
Activities
From December 21, 2020 through February 24, 2023
–
––71 independent meetings to review vaccine safety data17 joint meetings with ACIP COVID-19 Vaccines Work Group22 ACIP meeting presentations or reports with VaST assessments
3COVID -19 Vaccine Safety Technical (VaST) Work Group
VaST assessment
Statistical signal for ischemic stroke in the Vaccine Safety Datalink
fo
llowing bivalent COVID -19 booster vaccination
Myocarditis/pericarditis following mRNA COVID-19 vaccination
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The statistical signal among persons aged ≥ 65 years for ischemic stroke/transient
is
chemic attack (TIA) following bivalent Pfizer-BioNTech COVID -19 booster vaccination
in VSD is based on limited data and has been attenuating over time.
A signal has not been observed in two other U.S. active vaccine safety monitoring sy
stems1, nor in data from other countries2.
–The U.S. systems differ from each other; the VSD and VA analyses included TIA w
ith ischemic stroke, while FDA CMS analysis did not.
–VSD is the only U.S. system that uses concurrent comparator groups .
–The VA and FDA CMS analyses have not evaluated simultaneous administration w
ith influenza vaccination.
5VaST assessment –statistical signal for ischemic
stroke/TIA in the Vaccine Safety Datalink (VSD)
1FDA analysis of Centers for Medicare and Medicaid Services (CMS) data, and Department of Veterans Affairs (VA) rapid cycle an alyses
2Israel and European countries
No increased rate ratio for ischemic stroke/TIA following bivalent Moderna COVID -19
booster vaccination .
Previous surveillance in VSD and other U.S. systems found no evidence of increased
risk of ischemic stroke/TIA after the primary series or monovalent COVID -19 booster
vaccination for either Pfizer- BioNTech or Moderna products.
6VaST assessment –statistical signal for ischemic
stroke/TIA in the Vaccine Safety Datalink (VSD)
The cause of the increased rate ratio is unclear; potential contributing factors include
s
imultaneous administration of bivalent COVID -19 booster and influenza vaccines* or
unmeasured confounding or bias.
VaST would like to review additional data on simultaneous administration of bivalent C
OVID -19 booster and influenza vaccination.
VaST highlighted several areas for further exploration:
–
–Assess the impact of recent respiratory viral illness (e.g., COVID -1 9, influenza) on
risk of ischemic stroke/TIA.
Analyses in VSD h ighlighted potential reasons for the lower rate of ischemic
stroke/TIA in the vaccinated comparator group, which could be contributing to the
increased rate ratio. These should be explored further.
7VaST assessment –statistical signal for ischemic
stroke/TIA in the Vaccine Safety Datalink (VSD)
*Most VSD participants aged≥ 65 years received high- dose influenza vaccine in 2022 -23 season
VaST has reviewed data on myocarditis/pericarditis following COVID -1 9 vaccination
since April 2021 and provided several assessments at ACIP meetings.
–
–
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–Rates a fter the monovalent primary series, monovalent booster doses and
bivalent booster doses have been assessed.
Rates h ighest in adolescent and young adult males following primary series
dose 2 and first monovalent booster dose.
Outcomes after the monovalent primary series and monovalent booster doses
h
ave also been assessed.
Data on rates after bivalent COVID- 1 9 booster vaccination are limited.
Current data in VSD do not raise additional concerns about myocarditis f
ollowing bivalent COVID -19 booster vaccination.
8VaST assessment –myocarditis/pericarditis following
mRNA COVID-19 vaccination
The ACIP COVID -19 Vaccines Work Group will continue to review safety data
VaST is preparing to transition review of vaccine safety data to the ACIP COVID -19
Vaccines Work Group
9VaST –future plans
VaST Members
VaST Members
Keipp Talbot (ACIP)
Robert Hopkins (NVAC)
Matt Daley
Grace Lee
Veronica McNallyKathy EdwardsLisa JacksonJennifer NelsonLaura Riley
Robert Schechte r
Patricia Whitley -Williams
CDC Co -Leads
Lauri Markowitz
Melinda WhartonEx Officio and Liaison Representatives
Tatiana Beresnev (NIH)Karen Farizo; Hui Lee Wong (FDA)
Valerie Marshall (OIDP)
Jeffrey Kelman (CMS)Matthew Clark (IHS)Timothy Styles (HRSA)Fran Cunningham (VA)
Margaret Ryan (DoD)
Administrative Support
Jared Woo
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