RELEASE
ARTICLE
The FDA has required the manufacturers of the mRNA COVID-19 vaccines Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) to revise their labels to include updated information about the risks of myocarditis/pericarditis. The FDA requested that the manufacturers submit the proposed labeling changes or contest the agency’s requirement for the safety update by May 17, 2025. As of June 4th, to our knowledge, the labels of Comirnaty and Spikevax have not been updated and neither manufacturer has submitted a rebuttal.
The current Comirnaty label states that the observed risks of myocarditis and pericarditis, particularly within the first week following vaccination, are highest in males 12-17 years old and the current Spikevax label states the risks are highest in males 18-24 years old.
The new label wording proposed by the FDA for both vaccines reads: "Following administration of the 2023-2024 formula of mRNA COVID-19 vaccines, the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age."
The FDA has also proposed the addition of new cardiovascular safety information based on the estimated incidence of post-vaccination myocarditis and/or pericarditis and one longitudinal retrospective study in hospitalized patients 5-29 years old who were diagnosed with myocarditis following vaccination.
Based on health insurance claims data, the estimated incidence of myocarditis and/or pericarditis 1-7 days post-vaccination with the 2023-2024 formulations of the COVID-19 vaccines in persons 6 months to 64 years old was 8 cases/1 million doses; the incidence was highest in males 16-25 years old (38 cases/1 million doses).1,2
In the longitudinal retrospective study, at a median of about 5 months post-vaccination with either mRNA COVID-19 vaccine, persistence of abnormal cardiac MRI findings was common, but the clinical significance of these f ndings is unknown.3
- FDA. Notification safety labeling change. April 17, 2025. Available at: https://bit.ly/4jll53z. Accessed June 2, 2025.
- FDA. Notification safety labeling change. April 17, 2025. Available at: https://bit.ly/3SnQ1Fv. Accessed June 2, 2025.
- SS Jain et al. Cardiac manifestations and outcomes of COVID-19 vaccine-associated myocarditis in the young in the USA: longitudinal results from the Myocarditis After COVID Vaccination (MACiV) multicenter study. EClinicalMedicine 2024; 76:102809. doi:10.1016/j.eclinm.2024.102809