The U.S. Food and Drug Administration (FDA) is planning to put a “black box” warning on COVID-19 vaccines, CNN reported Friday, citing two sources familiar with the agency’s plans. This type of warning is considered the most serious and highlights major risks, including serious side effects and restrictions on use.
According to the report, planning to include this warning for vaccines is being led by Vinay Prasad, the FDA's chief medical and scientific officer and director of the Center for Biologics Evaluation and Research.
"Until the FDA makes an official announcement, any claims about what will happen are purely speculative," said Andrew Nixon, a spokesman for the US Department of Health and Human Services.
Following CNN's report, Moderna referred to a statement released in September about the safety of its COVID-19 vaccine. Pfizer also reiterated that its vaccine continues to demonstrate a favorable safety and efficacy profile, supported by extensive real-world trials.
Last month, Prasad told employees in a memo that COVID vaccines may have contributed to the deaths of at least 10 children who died from heart inflammation. The FDA is investigating possible deaths linked to COVID vaccines in several age groups as part of a safety review. FDA Commissioner Marty Makary has previously said the agency is looking into such cases in young people.
Health Secretary Robert F. Kennedy Jr., a longtime vaccine critic, has changed government policy on COVID vaccination, limiting it only to people over 65 and those with pre-existing conditions.
The plan for implementing the warning has not yet been finalized and is subject to change. It is not clear whether the warning will apply only to mRNA vaccines or to all COVID vaccines, or whether it will include all age groups.
The Pfizer/BioNTech and Moderna vaccines use messenger RNA (mRNA) technology, while the Novavax vaccine is more traditional, protein-based.
