CNN first reported, FDA may add black box warning to Covid-19 vaccines

The U.S. Food and Drug Administration is considering adding a “black box” warning to Covid-19 vaccines, according to a CNN report published Friday.

The potential change to safety information is being led by Vinay Prasad, the FDA’s top vaccine regulator, CNN reported, citing an unidentified person familiar with the agency’s plans.

Black box warnings represent the strongest caution for prescription drugs and are typically reserved for alerting patients to possible adverse reactions that could lead to death or serious injury. These warnings usually appear in a black bordered box on medication packaging.

The FDA is currently conducting a safety review that includes investigating whether Covid-19 vaccines caused deaths in adults. Bloomberg first reported on Tuesday that this investigation appears to have expanded beyond an earlier focus that seemed limited to children.