CNN: FDA Considers Strongest Warning for COVID Vaccines

A major shift in how COVID-19 vaccines are presented to the public may be on the horizon, as the U.S. Food and Drug Administration is preparing to add a stringent “black box” warning to the shots, according to a CNN report citing individuals familiar with the internal discussions. A black box warning is the FDA’s strongest caution, reserved for highlighting potentially serious risks or important limitations on use.

CNN reported that the effort to implement the enhanced warnings is being directed by Vinay Prasad, who serves as the FDA’s chief medical and scientific officer as well as director of the Center for Biologics Evaluation and Research. His office is reportedly coordinating the review and the proposed language of the label changes.

Pharmaceutical manufacturers Moderna, Pfizer, and Novavax, along with the U.S. Department of Health and Human Services, did not immediately respond to Reuters when asked for comment about the developing plan.

According to CNN, the proposal remains fluid. Officials have not yet finalized the policy, and the contours of the warning could still be revised before anything is made public.

The report said it is still uncertain whether the warning—expected to be announced before the end of the year—would apply only to mRNA-based vaccines or to all COVID vaccines on the market. It also remains unclear whether the warning would be uniform across all age groups.

Moderna and Pfizer both rely on messenger RNA technology for their shots, while Novavax offers a protein-based vaccine built on a more traditional platform.