FDA adds 'black box' warning to Covid-19 vaccines

On December 12, 2025, the U.S. Food and Drug Administration (FDA) announced that it will add a “black box” warning to Covid-19 vaccines. This warning is the strongest type used by the agency to highlight significant risks associated with medications and vaccines.

The FDA"s decision comes amid ongoing discussions about the safety and efficacy of Covid-19 vaccines. The black box warning is intended to inform healthcare providers and patients about potential serious side effects.

This development follows a trend of increasing scrutiny regarding vaccine safety, as reported in earlier coverage of related health issues. The FDA"s action underscores the agency"s commitment to ensuring that the public is adequately informed about the risks associated with medical products.

For more information on recent developments in government policy, see recent developments regarding AI regulation.

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