Overview

• The FDA now requires expanded warnings on Pfizer and Moderna COVID-19 vaccines, citing rare myocarditis and pericarditis risks for males aged 16 to 25.
• FDA data indicates an incidence rate of 38 cases per million doses among young males, though such cases are described as rare and often mild.
• A GOP-led Senate subcommittee report accuses federal health agencies of delaying public warnings about myocarditis risks in 2021 to avoid causing alarm.
• CDC initially opted for less formal communication through clinical considerations rather than issuing a Health Alert Network warning in May 2021.
• The Senate investigation raises concerns about underreporting of myocarditis cases in early vaccine safety monitoring systems.