FDA plans to put ‘black box’ warning on Covid vaccines: Report

The US Food and Drug Administration intends to put a “black box” warning—the most serious type, which highlights major risks such as severe side effects and restrictions—on COVID-19 vaccines, said a CNN report on Friday, citing two people familiar with the agency’s plans. The plan to include the warnings for COVID shots is being coordinated by Vinay Prasad, the FDA’s chief medical and scientific officer and director of the agency’s Centre for Biologics Evaluation and Research. “Unless the FDA announces it, any claim about what it will do is pure speculation,” said US Department of Health and Human Services spokesperson Andrew Nixon about the plans to include the warning.

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After the report, vaccine-maker Moderna pointed to its statement issued in September about the safety of its COVID shot. Pfizer also reiterated a statement that its vaccine continues to demonstrate a favourable safety and efficacy profile supported by extensive real-world evidence.

Prasad told staffers last month in a memo that COVID shots probably contributed to the deaths of at least 10 children who died of heart inflammation.

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The FDA is investigating deaths potentially related to COVID-19 vaccines across multiple age groups as part of a safety review, a HHS spokesperson said on Tuesday.

FDA Commissioner Marty Makary has previously said the agency was looking at such deaths in young people.

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Health Secretary Robert F. Kennedy Jr., a vaccine sceptic, has sharply changed government policy on COVID vaccines, limiting access to people aged 65 and above, as well as those with underlying conditions.

The plan to add the warning has not been finalised and may still change, the CNN report said.

It was not immediately clear whether the plans for the warnings would be applied only to mRNA vaccines or all COVID vaccines, and if they would apply to all age groups.

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Vaccines from Pfizer and partner BioNTech and Moderna use messenger RNA technology, while the Novavax shot is a more traditional protein-based one.