WASHINGTON — The U.S. Food and Drug Administration is preparing to put a "black box" warning on COVID-19 vaccines, CNN reported Friday , citing two people familiar with the agency's plans.

It wasn't immediately clear whether the warning for COVID vaccines would be applied only to MRNA vaccines or to all COVID shots or if it would apply to all age groups.

Black box warnings appear at the top of prescribing information for medicines.

It's the FDA's most serious warning - intended to warn about risks, such as death or life-threatening disabling reactions that should be weighed against the benefits.

A Department of Health and Human Services spokesperson told CNN that unless the agency announces a change, any reports about what it might do is "pure speculation."

The plan, which is expe

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