USFDA preparing to issue 'black box' warning on Covid-19 vaccines

By Ashleigh Furlong

 

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 a medicine. 

 

An FDA spokesperson told CNN that unless the agency announces a change, any claim about what it will do is “pure speculation.” The agency did not immediately respond to a request for comment from Bloomberg. 

 

The FDA is currently investigating whether Covid-19 vaccines caused deaths in adults, as part of a safety review that earlier appeared to just be focused on children, Bloomberg first reported on Tuesday. 

 

US Health and Human Services Secretary Robert F. Kennedy Jr. is upending longstanding guidance for a wide range of vaccines. Kennedy has repeatedly called the safety and efficacy of the shots into question despite numerous studies showing that Covid vaccines are safe. 

 

--With assistance from Naomi Kresge.

 

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