Heart Inflammation Warning to Be Added to mRNA Vaccine Fact Sheet: FDA

Authorities say no change in vaccine policy but risks should be disclosed

A sign is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters

The Food and Drug Administration (FDA) said on Wednesday that it will add a warning of heart inflammation to the fact sheet for the Pfizer and Moderna mRNA COVID-19 vaccines that are given to patients prior to vaccination.

At a meeting of the Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP), Dr. Doran Fink, deputy director of the FDA’s vaccines division told the committee that the FDA will “move rapidly to update the fact sheets” to ensure transparency surrounding identified risks, no matter how rare.