Exhibit 119 ยท Regulatory action
FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis
the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age.
FDA required Pfizer and Moderna to update the myocarditis and pericarditis warning in the Comirnaty and Spikevax labels. The warning now states that risk has been highest in males 12 through 24 and gives estimated incidences of about 8 cases per million doses in people aged 6 months to 64 years and about 27 per million in males 12 through 24. FDA cited a study it funded, published in September 2024, in which abnormal cardiac MRI findings commonly persisted at about five months. FDA states that myocarditis information has been in the labeling since 2021.
- Source
- U.S. Food and Drug Administration
- Date
- 25 June 2025
- Quoted from
- FDA Safety Communication, 25 June 2025, 'Updated Warning for Myocarditis and Pericarditis', labeling text paragraph
- Grade
- Primary record
- Document
- https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-approves-required-updated-warning-labeling-mrna-covid-19-vaccines-regarding-myocarditis-and
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit