Briefing Document: Vaccines and Related Biological Products Advisory Committee Meeting 2021-10-26

“Post-EUA safety surveillance reports received by FDA and CDC identified increased risks of myocarditis and pericarditis, particularly within 7 days following administration of the second dose of the 2-dose primary series. Reporting rates for medical chart-confirmed myocarditis and pericarditis in VAERS have been higher among males under 40 years of age than among females and older males and have been highest in males 12 through 17 years of age (~71.5 cases per million second primary series doses among males age 16-17 years and 42.6 cases per million second primary series doses among males age 12-15 years as per CDC presentation to the ACIP on August 30, 2021). In an FDA analysis of the Optum healthcare claims database, the estimated excess risk of myocarditis/pericarditis approached 200 cases per million fully vaccinated males 16-17 years of age and 180 cases per million fully vaccinated males 12-15 years of age.”