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

June 30, 2025
The FDA has approved updated safety data for Pfizer's Comirnaty and Moderna's Spikevax COVID-19 vaccines, including new information on myocarditis and pericarditis risks.

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.

About the Author

Janette Wider | Editor-in-Chief

Janette Wider is Editor-in-Chief for Healthcare Purchasing News.

ID 366090882 © Zhanna Hapanovich | Dreamstime.com
dreamstime_xl_366090882
ID 179810040 © Josepalbert13 | Dreamstime.com
cdc_3
ID 150983874 © Adonis1969 | Dreamstime.com
dreamstime_xl_150983874
ID 241576013 © Josepalbert13 | Dreamstime.com
cms_2