FDA Expands Warning For Pfizer, Moderna COVID-19 Vaccines About Heart Side Effect Risk In Adolescent And Young Adult Males

CBS News (5/21, Tin, Cohen) reports the FDA has told Pfizer and Moderna “to expand the warning labels on their COVID-19 vaccines about the risk of a possible heart injury side effect linked to the mRNA shots, primarily in teen boys and young men, citing findings from a study published last year and new agency data.” The agency’s orders to expand the warnings were posted Wednesday “in letters dated April 17 to Pfizer and BioNTech about their Comirnaty vaccine and Moderna about its Spikevax vaccine.” Both vaccines “previously carried warnings about how the risk of the heart side effects...looked to be higher in young men, generally within the first week after vaccination.” The new warnings state the “highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age,” with a rate of 38 cases per million.