AUDIENCE: Pediatrics, Pharmacy, Family Practice, Internal Medicine, Cardiology
ISSUE: FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA) manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines.
Specifically, FDA has required each manufacturer to update the warning about the risks of myocarditis and pericarditis to include information about
- the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines and
- the results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving an mRNA COVID-19 vaccine.
FDA also required 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.
The Fact Sheets for Healthcare Providers and for Recipients and Caregivers for Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19, which are authorized for emergency use in individuals 6 months through 11 years of age, have also been updated to include the new safety information in alignment with the Comirnaty and Spikevax Prescribing Information and Information for Recipients and Caregivers.
BACKGROUND: Information about myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) following vaccination with these mRNA COVID-19 vaccines has been included in the labeling since 2021. FDA closely monitors the safety of all vaccines, including the COVID-19 vaccines, during postmarket use.
RECOMMENDATION:
- Suspected adverse events may be reported to the Vaccine Adverse Event Reporting System (VAERS), which is co-managed by the FDA and the CDC.
[6/25/2025 - FDA Safety Communication - FDA]
