FDA Chief Says No Plans to Put Boxed Warning on Covid Vaccines

December 15, 2025, 9:29 PM UTC

The US Food and Drug Administration has no plans to put a “black box” warning on Covid vaccines, the agency’s top official said, despite a recent report that US regulators were preparing to add a new caution to the immunizations.

CNN reported Friday that the FDA was preparing to change the safety information related to the shots to include its strongest level of warning. But on Monday, in an interview with Bloomberg TV, FDA Commissioner Marty Makary said that “we have no plans to put that on the Covid vaccine.”

WATCH: FDA Commissioner Dr. Marty Makary says the agency has no plans to put a black box warning on Covid-19 vaccines. Source: Bloomberg

Some agency officials had recommended putting ...

Learn more about Bloomberg Law or Log In to keep reading:

See Breaking News in Context

Bloomberg Law provides trusted coverage of current events enhanced with legal analysis.

Already a subscriber?

Log in to keep reading or access research tools and resources.