FDA Adds Warning to mRNA Vaccine Fact Sheets

FDA announced on June 25, 2021, the addition of warnings about myocarditis and pericarditis to the fact sheets for healthcare providers administering messenger RNA-based vaccines from Moderna and Pfizer-BioNTech; fact sheets for patients also were revised to provide information about potential reactions and when to seek medical attention.

The Centers for Disease Control and Prevention (CDC) reported on June 23, 2021, that more than 1000 cases of myocarditis and pericarditis in patients receiving the mRNA vaccine had been reported to the Vaccine Adverse Event Reporting System. The cases primarily involved male adolescents and young adults after receiving a second dose of the vaccine. CDC calls the reports to be rare and patients typically recover quickly. More than 300 million doses of mRNA vaccines have been administered.

The vaccine fact sheet revisions were implemented following review of data presented at a meeting of CDC’s Advisory Committee on Immunization Practices. FDA said the agency and CDC will continue to monitor reports, gather information, and assess longer-term outcomes.

Source: FDA