June 25, 2025 at 07:36PM FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination

FDA has required and approved updates to the Prescribing Information for Comirnaty manufactured by Pfizer Inc. and Spikevax manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines.

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