FDA Expands Existing Warning On Two COVID-19 Vaccines About Rare Heart Side Effect

June 26, 2025

The AP (6/25, Perrone) reports that the FDA “said Wednesday it has expanded existing warnings on” Pfizer and Moderna “COVID-19 vaccines about a rare heart side effect mainly seen in young men.” This “new warning lists the risk of myocarditis as 8 cases per 1 million people who got the 2023-2024 COVID shots between the ages of 6 months and 64 years old.” Additionally, “the label...notes that the problem has been most common among males ages 12 to 24. The previous label said the problem mostly occurs in 12- to 17-year-olds.”