FDA Approves Updated Safety Data for Pfizer and Moderna COVID-19 Vaccines

On June 25, the U.S. Food and Drug Administration has approved updated Prescribing Information for Pfizer’s Comirnaty and Moderna’s Spikevax COVID-19 vaccines to include new safety data regarding myocarditis and pericarditis risks.

According to the FDA, the updates include “the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023–2024 Formula” and findings from “a study that collected information on cardiac MRI in people who developed myocarditis after receiving an mRNA COVID-19 vaccine.”

The changes apply to both the full Prescribing Information and the Fact Sheets for healthcare providers, recipients, and caregivers—including those for the emergency use-authorized vaccines in children aged 6 months to 11 years. Myocarditis and pericarditis warnings have been part of labeling since 2021, and the FDA continues to monitor postmarket vaccine safety closely.

Suspected adverse events should be reported to the Vaccine Adverse Event Reporting System (VAERS), co-managed by the FDA and CDC.