FDA

FDA updates mRNA COVID-19 vaccine labels to highlight rare myocarditis risk

June 27, 2025

FDA approved updated safety labeling for Pfizer’s Comirnaty and Moderna’s Spikevax COVID-19 vaccines, requiring clearer warnings about the risk of myocarditis and pericarditis. The revised labels now include new data from health insurance claims and cardiac MRI studies, highlighting that the highest risk group is males aged 12 to 24, with an estimated 27 cases of heart inflammation per million doses administered. For the broader population aged 6 months to 64 years, the rate is approximately 8 cases per million. These updates apply to the 2023–2024 vaccine formulations and are reflected in both the Prescribing Information and Fact Sheets for healthcare providers and caregivers. FDA emphasizes continued post-market safety monitoring and encourages reporting of adverse events through the Vaccine Adverse Event Reporting System (VAERS).

Source:

(2025, June 25). FDA. FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-approves-required-updated-warning-labeling-mrna-covid-19-vaccines-regarding-myocarditis-and