FDA approves required updated warning in COVID-19 vaccine labeling

The US Food and Drug Administration (FDA) has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer (NYSE: PFE) and Spikevax (COVID-19 Vaccine, mRNA) manufactured Moderna (Nasdaq: MRNA) to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines.

Specifically, the FDA has required each manufacturer to update the warning about the risks of myocarditis and pericarditis to include information about the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines and the results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving an mRNA COVID-19 vaccine.

The FDA also required each manufacturer to describe the new safety information in the Adverse Reactions section of the Prescribing Information and in the Information for Recipients and Caregivers.   
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