FDA to add most serious warning to COVID

WASHINGTON (CNN) - The U.S. Food and Drug Administration said it intends to put a “black box” warning on COVID-19 vaccines.

That’s according to two people familiar with the agency’s plans.

Black box warnings appear at the top of prescribing information for medicines. It is the FDA’s most serious warning intended to warn about risks, such as death or life-threatening or disabling reactions, that should be weighed against the benefits.

It wasn’t immediately clear whether the warning for COVID-19 vaccines would be applied only to MRNA vaccines or to all COVID-19 vaccines, or to certain age groups.

The agency’s plan has not been finalized but is expected to be unveiled by the end of the year.