COVID-19 Vaccine Safety Technical (VaST) 

Work Group 

Assessment 

Grace M. Lee, MD MPH (ACIP Chair) 

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

Advisory Committee on Immunization Practices 

August 30, 2021 
 

 

 

 

COVID-19 Vaccine Safety Technical (VaST) Work Group 

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 Work Group and 

the ACIP on COVID-19 vaccine safety 

2 
 

 

 

Dec 21, 2020 – present 

32 independent meetings to review vaccine safety data 

8 joint meetings with COVID-19 Vaccines Work Group focused on safety 

ACIP votes 

following Dec 12 Dec 19 Feb 28 May 12 Aug 13 

Dec Jan Feb Mar Apr May Jun Jul Aug 

Pfizer 

(16+) 

Janssen 

(18+) 

Apr 14 

CVST 

Moderna 

(18+) 

Pfizer 

(12-15) 

Jan 27 

Anaphylaxis 

Mar 1 

Anaphylaxis 

May 12 

TTS 

Jun 23 

Myocarditis 

EUA 

VaST 

assessments 

July 22 

GBS 

Additional mRNA 

vaccine doses 

 

VaST Activities 

at ACIP following updates; following updates updates following 

meetings or 

website 

mRNA 

vaccines 

Pregnancy 

vaccine safety 

data 

Janssen 

Apr 23 

TTS updates; 

May 17 & 24 

Myocarditis 

Janssen 

Janssen resumed 

CVST, cerebral venous sinus thrombosis; TTS, thrombosis with thrombocytopenia syndrome; GBS, Guillain-Barré syndrome 3 
U.S. Vaccine Safety Monitoring Systems and Timelines 

start 

of 

vax 

active surveillance, passive

surveillance, case consults 

4 
 

 

 

 

 

 

Monitoring and Responding to Safety Data 

Safety monitoring 

 mRNA COVID-19 vaccines 

– Anaphylaxis 

– Myocarditis 

 Janssen COVID-19 vaccine 

– TTS 

– GBS 

 Pre-specified AESI 

 Maternal immunization 

Incorporating safety data into decision-making 

 Dynamic benefit-risk balance 

 Risk mitigation strategies 

– Support informed discussions about 

benefits and risks of available vaccines 

– Clinical guidance to support early detection 

and appropriate management 

 Guidance for use of post-approval safety 

data in GRADE 

TTS, thrombosis with thrombocytopenia syndrome; GBS, Guillain-Barré syndrome 5 
 

 

 

VaST continues to review data on myocarditis, GBS 

and TTS from passive and active surveillance systems 

 Data from 

‒ U.S. systems including VAERS, VSD 

• Most updated data on myocarditis presented today 

– U.S. data from VA, DoD, FDA, and IHS 

‒ Israel, Canada, Global Advisory Committee on Vaccine Safety 

6 
 

 

 

Anaphylaxis following mRNA COVID-19 vaccination 

 Anaphylaxis following mRNA COVID-19 vaccination identified Dec 2020 

 Safety data and VaST assessment presented at January and March 2021 ACIP 

meetings* 

 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 

*https://www.cdc.gov/vaccines/acip/meetings/slides-2021-1-27-21.html; https://www.cdc.gov/vaccines/acip/meetings/slides2021-02-28-03-01.html 7 
8 
9 
 

 

 

 

Anaphylaxis: VaST Discussion and Interpretation 

 Initial data from VAERS 

– Rate for Pfizer-BioNTech: 11.1 per million doses admin (Dec 14-Dec 23)

https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm 

– Rate for Moderna vaccine: 2.5 per million doses admin (Dec 21-Jan 10)

https://www.cdc.gov/mmwr/volumes/70/wr/mm7004e1.htm 

 Most recent data from VSD among persons aged 12 and older* 

– 5.0 (95% CI 3.5, 6.9) (Pfizer-BioNTech) and 4.9 (95% CI 3.2, 7.2) (Moderna) 

per million doses administered 

– Most in females after first dose 

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

place 

*1-day risk interval 10 
 

 

 

 

 

 

 

Myocarditis following mRNA COVID-19 vaccination 

 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 

– Information on myocarditis/pericarditis in package insert3 

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 11 
12 
 

 

 

Myocarditis/Pericarditis – 0-7 day risk interval 

VAERS reporting rates per million 

doses administered 

VSD excess cases per million doses 

based on chart confirmed data 

Ages 

(yrs) 

Pfizer 

Dose 1 

Pfizer 

Dose 2 

Moderna 

Dose 1 

Moderna 

Dose 2 

Pfizer 

Dose 1 

Pfizer 

Dose 2 

Moderna 

Dose 1 

Moderna 

Dose 2 

12–15 2.6 20.9 

16–17 2.5 34.0 

18–24 1.1 18.5 2.7 20.2 0.7 14.4 4.9 19.7 

25–29 1.0 7.2 1.7 10.3 

30–39 0.8 3.4 1.0 4.2 

Data presented at Aug 30, 2021 ACIP Meeting 13 
 

 

 

 

Myocarditis following vaccination – Clinical course 

 VAERS reports for individuals <30 years of age (N=845 cases reviewed) 

– 88% of reviewed cases met CDC case definition 

– 77% were known to have recovered from symptoms at time of VAERS 

report 

 VSD cases among individuals 12-39 years of age (N=98 cases reviewed) 

–

–

–

–

56% of cases met chart confirmation criteria for myocarditis within 0-21 

days of vaccination 

100% with chest pain/pressure/discomfort 

Elevated troponin, abnormal EKG findings, abnormal MRI common 

76% discharged within 0-2 days; 100% discharged to home 

14 
 

Myocarditis: VaST Discussion and Interpretation 

 Data available to date suggest association of myocarditis with 

mRNA vaccination in adolescents and young adults 

 Further data are being compiled to understand potential risk 

factors, optimal management strategies, and long-term 

outcomes 

– 

– 

Patient survey on functional status, clinical symptoms, 

quality of life and ongoing need for medication or treatment 

Provider survey on cardiac health and functional status 

15 
16 
 

 

 

 

 

 

 

 

Myocarditis: FDA Post-Marketing Requirements for

Pfizer-BioNTech COVID-19 mRNA vaccine 

 Non-Interventional Post-Approval Safety Study to evaluate occurrence of 

myocarditis and pericarditis in the U.S. 

 Post Conditional Approval Active Surveillance Study to evaluate occurrence 

of myocarditis and pericarditis in Europe 

– Sub-study to describe the natural history of myocarditis and pericarditis 

 Prospective cohort study ≥5 years for potential long-term sequelae of 

myocarditis after vaccination (in collaboration with Pediatric Heart Network) 

 Sub-studies of clinical trials to prospectively assess the incidence of 

subclinical myocarditis following 2nd dose in subset of participants aged 5-15 

years and 16-30 years 

https://www.fda.gov/media/151710/download 17 
 In a 42-day risk window for 

myocarditis: 

– Risk ratio 3.2 after 

vaccination vs. 18.3 after 

SARS-CoV-2 infection 

– Risk difference of 2.7 per 

100,000 persons after 

vaccination vs. 11.0 events 

per 100,000 persons after 

SARS-CoV-2 infection 

 Adverse events substantially 

increased after infection 

 Protective effects of 

vaccination observed 

Barda et al., NEJM 2021 
 

 

 

Safety Monitoring and VaST Next Steps 

 Continue near real-time monitoring of vaccine safety in the U.S. 

– Collaboration across U.S. federal agencies 

 Continue collaboration with global vaccine safety colleagues on 

key issues that impact benefit-risk balance 

– Myocarditis 

– Booster doses 

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

Workgroup and the ACIP at future meetings 

19 
20

 

 

VaST Members 

VaST Members 

Grace Lee (ACIP) 

Robert Hopkins (NVAC) 

Matt Daley 

Veronica McNally 

Keipp Talbot 

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) 

Judith Steinberg (OIDP) 

Jeffrey Kelman (CMS) 

Matthew Clark (IHS) 

Mary Rubin (HRSA) 

Fran Cunningham (VA) 

Limone Collins (DoD) 

Administrative Support 

Jared Woo 

20 
 

 

 

 

Reporting rates of myopericarditis (per million doses administered), by 

manufacturer, sex, and dose number, 7-day risk period* (as of Aug 18, 2021) 

* Reports with time to symptom onset within 7 days of vaccination

† Reports among persons 12–29 years of age were verified by provider interview of medical record review

21