The Food and Drug Administration has directed COVID-19 vaccine manufacturers to expand the warning for two forms of inflammation, according to letters made public on May 21.
The FDA told BioNTech, which produces a vaccine with Pfizer, and Moderna to update warnings regarding myocarditis—or heart inflammation—and the related condition pericarditis.
Richard Forshee, acting director of the FDA’s Office of Biostatistics and Pharmacovigilance, said that new information has emerged, including a 2024 FDA study that found some myocarditis patients had signs of heart scarring months after vaccination.
The companies must update labels to state that following administration of the 2023–24 versions, “the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age,” Forshee said. The highest estimated incidence of the post-vaccination inflammation is about 38 cases per million doses for both vaccines, according to the proposed update.
The current warnings say the highest observed risk after Moderna vaccination is in males aged 18 to 24, and after Pfizer-BioNTech vaccination is in males aged 12 to 17.
The companies were also directed to add new information summarizing the FDA study, including that “at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common.”
The updates should also state that “it is not known if these heart MRI findings might predict long-term heart effects of myocarditis,” according to the letters.
The FDA first added warnings to the labels for the vaccines in June 2021, several months after officials learned of post-vaccination myocarditis cases.
The letters are dated April 17. It’s not clear why they were not released until May 21. The FDA did not respond to a request for comment.
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