The headquarters of the US Food and Drug Administration (FDA)
Credit: Reuters Photo
The US Food and Drug Administration has no plans to put a "black box" warning on Covid-19 vaccines, Bloomberg News reported on Monday, citing the agency's top official Marty Makary.
Some agency officials had recommended putting its most serious warning on the shots, the report said, citing an interview with FDA Commissioner Makary, adding that agency leaders, including top vaccine regulator Vinay Prasad, did not think it was necessary.
The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for comment.
CNN reported last week that the agency was planning to put a boxed warning on these vaccines, and that it was being orchestrated by Prasad, the FDA's chief medical and scientific officer.
Giving two doses of the vaccine just three months apart was linked to higher rates of side effects, such as myocarditis in young people, Makary said in the Bloomberg interview, adding that the prevalence may not be the same with annual dosing.
Last month, Prasad told staffers in a memo that Covid shots probably contributed to the deaths of at least 10 children who died of heart inflammation.
The FDA is investigating deaths potentially related to Covid-19 vaccines across multiple age groups as part of a safety review.