The FDA has approved required updates to the labeling of Pfizer’s Comirnaty and Moderna’s Spikevax COVID-19 vaccines to include revised warnings about the risk of myocarditis and pericarditis following vaccination.
The updates reflect new data, including estimated unadjusted incidence rates of myocarditis and/or pericarditis following the 2023-2024 vaccine formulations. The updated warning also reflects results from a study using cardiac MRI in individuals who develop myocarditis after receiving the mRNA COVID-19 vaccine, according to a June 25 news release from the agency.
The action follows letters issued by the FDA April 17, which directed manufacturers to revise their vaccine warnings based on new safety data. In the letters, the FDA instructed both Pfizer and Moderna to replace existing warning language with the following: “Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated incidence of myocarditis and/or pericarditis during the period one through seven days following administration of the 2023-2024 formula of mRNA COVID-19 vaccines in individuals 6 months through 64 years of age was approximately eight cases per 1 million doses. The highest estimated incidence was in males 16 through 25 years of age (approximately 38 cases per 1 million doses).”
The FDA is requiring both companies to revise the prescribing information, adverse reactions section and fact sheets for providers and caregivers including those for vaccines still under emergency-use authorization for children ages 6 months to 11 years old.
