Dec 12 (Reuters) – The US Food and Drug Administration intends to put a ‘black box’ warning on COVID-19 vaccines, CNN reported on Friday, citing two people familiar with the agency’s plans.
The ‘black box’ is the most serious type of warning, which highlights major risks such as serious side effects and restrictions.
The plan to install the warnings for COVID shots is being orchestrated by Vinay Prasad, the FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, the report added.
Vaccine makers Moderna, Pfizer and Novavax, as well as the U.S. Department of Health and Human Services, did not immediately respond to Reuters’ requests for comments.
The plan has not been finalized and may still change, CNN reported.
It was not immediately clear whether the plans for the warnings, expected to be unveiled by the end of the year, would be applied only to mRNA vaccines or all COVID vaccines, or whether they would apply to all age groups, the report added.
Vaccines from Pfizer and Moderna use messenger RNA technology, while Novavax is a more traditional protein-based vaccine.
(Reporting by Sriparna Roy in Bengaluru; Editing by Arun Koyyur and Shinjini Ganguli)
