The U.S. Food and Drug Administration is reportedly considering placing a “black box” warning on COVID-19 vaccines, the agency’s most serious type of alert. Black box warnings, which appear at the top of prescribing information, are intended to highlight risks such as death or life-threatening reactions that should be carefully weighed against potential benefits.
It remains unclear whether the warning would apply only to mRNA vaccines, all COVID shots, or specific age groups. A Department of Health and Human Services spokesperson emphasized that any reports about the FDA’s plans are speculative until an official announcement is made. The proposed warning is expected to be unveiled before the end of the year, though the plan has not been finalized and may still change.
The potential change is reportedly being led by Vinay Prasad, the FDA’s top vaccine regulator. Earlier this month, a group of a dozen former FDA leaders criticized new agency assertions that questioned COVID-19 vaccine safety following the leak of an internal memo by Prasad. The memo claimed — without presenting supporting evidence — that COVID-19 vaccines had caused 10 child deaths and outlined proposed changes in how the FDA handles certain vaccines. It also suggested that staff who disagreed with the plan should resign.
Among Prasad’s proposals are revisions to the annual flu vaccine updates and a stronger focus on the risks and benefits of administering multiple vaccines at the same time. While vaccine skeptics have argued that too many shots could overwhelm children’s immune systems or that ingredients may accumulate to cause harm, scientific studies have consistently found no evidence supporting these claims. The former FDA leaders stressed that reports cited in Prasad’s memo came from a surveillance system lacking medical records or sufficient information to establish a causal link, and that substantial evidence shows COVID-19 vaccines effectively reduce severe disease and hospitalization in children.