The FDA Will Add a Heart Inflammation Warning to Vaccine Fact Sheets
FDA plans to “move rapidly” to add a warning to fact sheets for Pfizer and Moderna’s Covid-19 vaccines about the rare risk of developing inflammatory heart conditions, an agency official said Wednesday.
“Based on the available data, a warning statement in the fact sheets for both health care providers and vaccine recipients and caregivers would be warranted in this situation,” Doran Fink, deputy director of FDA’s vaccines division, said during a CDC advisory committee meeting on Covid vaccines.
A CDC safety panel has determined there is a “likely association” between the Pfizer and Moderna shots, which both use mRNA technology, and cases of myocarditis and pericarditis in vaccine recipients, according to an analysis presented at the meeting Wednesday. Myocarditis is marked by inflammation of the heart muscle, while pericarditis involves inflammation of the membrane surrounding the heart.
