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….