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

 

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.”

https://www.bloomberg.com/news/articles/2025-12-15/fda-chief-says-no-plans-to-put-boxed-warning-on-covid-vaccines