New York [US], December 17: The U.S. 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 the most serious warning on the shots, but agency leaders, including top vaccine regulator Vinay Prasad, did not think it was necessary, FDA commissioner Makary told Bloomberg News in an interview.
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 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.
Health Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic, has sharply changed government policy on COVID vaccines, limiting access to people aged 65 and above as well as those with underlying conditions.
Moderna (MRNA.O), opens new tab did not immediately respond to a Reuters request for comment but has previously said that there were no new or undisclosed safety concerns in children or in pregnant women related to its mRNA-based COVID shot, Spikevax.
Pfizer (PFE.N), opens new tab, which markets another mRNA-based COVID shot with partner BioNTech SE (22UAy.DE), opens new tab, reaffirmed its safety and efficacy.
Source: Fijian Broadcasting Corporation
