FDA Plans to Put Black Box Warning on Covid-19 Vaccines: CNN

December 12, 2025, 10:53 AM UTC

The US Food and Drug Administration is preparing to put a “black box” warning on Covid-19 vaccines, CNN reported Friday, citing people familiar with the agency’s plans.

Vinay Prasad, the FDA’s top vaccine regulator, is leading the potential change to the safety information related to Covid-19 vaccines, CNN said, citing one person it didn’t identify.

A black box warning is the strongest caution for prescription drugs and is usually reserved for alerting patients to possible adverse reactions that could lead to death or serious injury. The warning usually appears in a black bordered box on the packaging of ...

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