The FDA now requires certain COVID-19 vaccines to include safety information about the risks of myocarditis and pericarditis following administration.


RT’s Three Key Takeaways:

  1. Updated safety warnings: The FDA has required Pfizer and Moderna to update Prescribing Information for their mRNA COVID-19 vaccines to include new data on the risks of myocarditis and pericarditis.
  2. Inclusion of incidence data: The updates now include estimated unadjusted incidence rates of myocarditis/pericarditis following the 2023–2024 vaccine formulas and findings from cardiac MRI studies.
  3. Broader communication: These safety updates have also been added to Fact Sheets for healthcare providers and caregivers, including for vaccines authorized under emergency use for children ages 6 months to 11 years.


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

  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 (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.