FDA Directs COVID-19 Vaccine Makers to Expand Heart Inflammation Warning

The new warning will advise that those at highest risk are males aged 16 to 25.

A health care worker prepares a COVID-19 vaccine in New York City, in this file photograph. Michael Santiago/Getty Images

The Food and Drug Administration (FDA) has directed COVID-19 vaccine manufacturers to expand the warning for two forms of inflammation, according to letters made public on May 21.

The FDA told BioNTech, which produces a vaccine with Pfizer, and Moderna to update warnings regarding myocarditis—or heart inflammation—and the related condition pericarditis.