Name: FDA may add its strongest warning labels to mRNA COVID-19 vaccines
Uploaded: 2025-12-12T18:27:11.502Z
Duration: 27 s
Description: The FDA plans possible black box warning for COVID-19 shots amid rare heart risk reports; studies say the virus carries a higher threat.

The FDA plans possible black box warning for COVID-19 shots amid rare heart risk reports; studies say the virus carries a higher threat.

Washington

The U.S. Food and Drug Administration has announced plans to add a black box warning, its most serious warning label, to mRNA COVID-19 vaccines. This warning is designed to alert healthcare providers and patients to serious risks, including death or life-threatening reactions.

The FDA's plan for the black box warning is not yet finalized and may still change. The agency expects to unveil the final decision by the end of the year.

FDA may add its strongest warning labels to mRNA COVID-19 vaccines

The U.S. Food and Drug Administration intends to put a black box warning on COVID-19 vaccines. Black box warnings appear at the top of prescribing information for medicines and it's the FDA's most serious warning. It's intended to warn about serious risks such as death or life-threatening reactions. The plan has not been finalized. It may still change. It's expected to be unveiled by the end of the year.

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