FDA Approves New Warnings on Covid mRNA Vaccines

FDA has required and approved updates to the prescribing information for Pfizer’s Comirnaty Covid-19 mRNA vaccine and Moderna’s Spikevax Covid-19 mRNA vaccine to include new safety information about the risks of myocarditis and pericarditis following their administration. The warning on myocarditis and pericarditis in the vaccines’ prescribing information has been updated to explain that the observed risk has been highest in males 12 through 24 years of age.

A new safety communication says the update warns about (1) the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023-2024 Formula of mRNA Covid-19 vaccines and (2) the results of a study that collected information on cardiac magnetic resonance imaging in people who developed myocarditis after receiving a vaccine. The agency is also requiring each manufacturer to describe the new safety information in the adverse reactions section of the prescribing information and in the information for recipients and caregivers.