The FDA has included increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination on the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccine.
According to the agency, the update follows an extensive review of information and the discussion by CDC’s Advisory Committee on Immunization Practices meeting on Wednesday. The data presented at this meeting reinforced the FDA’s decision to revise the fact sheets and further informed the specific revisions.
The FDA noted reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly following the second dose and with onset of symptoms within a few days after vaccination. The FDA and CDC are monitoring the reports, collecting more information, and will follow-up to assess longer-term outcomes over several months.