COVID-19 VaST Work Group Report – May 24, 2021

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The Advisory Committee on Immunization Practices (ACIP) COVID-19 Vaccine Safety Technical (VaST) Work Group has reviewed post-authorization COVID-19 vaccine safety data weekly since the start of the U.S. vaccination program in December 2020. Updates of VaST activities and VaST assessments of safety data were presented at ACIP meetings on January 27, March 1, April 14, April 23, and May 12, 2021; ACIP meetings are open to the public. In lieu of presentations at ACIP meetings, reports from VaST meetings on March 29 and May 17, 2021 have been posted on the ACIP website.

During the VaST session on May 24, 2021, members reviewed updated data on myocarditis and pericarditis after COVID-19 vaccination, including presentations from the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), along with a brief update from the Department of Veteran Affairs (VA) about further plans for investigation.

  • Data from VAERS show that in the 30-day window following dose 2 mRNA COVID-19 vaccination, there was a higher number of observed than expected myocarditis/pericarditis cases in 16–24-year-olds.
  • Data from VSD do not show that rates of myocarditis/pericarditis reports in the window following COVID-19 vaccination differ from expected at this time; however, analyses suggest that these data need to be carefully followed as more persons in younger age groups are vaccinated. VSD found no concerns among the over 20 other adverse events of special interest being monitored.

VaST members discussed the following key points:

  • Information should be provided to clinicians to enhance early recognition and appropriate management of persons who develop myocarditis or pericarditis following vaccination.
  • Further information on potential myocarditis or pericarditis cases should continue to be collected through medical record review of cases reported into VAERS and observed in VSD.
  • Data from vaccine safety monitoring systems for potential cases should continue to be obtained as vaccination rates increase in younger age groups.
  • Collaboration between cardiology, infectious diseases, and rheumatology specialists is needed to provide clinical guidance about early recognition, differential diagnosis, diagnostic testing, and appropriate management of persons who develop myocarditis or pericarditis.
  • Long-term follow up of patients with myocarditis or pericarditis is needed to understand clinical course and natural history following both COVID-19 infection and COVID-19 vaccination.