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FDA Weighs Black Box Warning for COVID Vaccines
12 Dec, 2025
Summary
- FDA is considering a 'black box' warning for COVID-19 vaccines.
- This warning highlights major risks and serious side effects.
- The plan is not finalized and may change before year-end.
The U.S. Food and Drug Administration (FDA) is considering the implementation of a 'black box' warning for COVID-19 vaccines. This critical warning signifies the most serious category, intended to alert the public about major risks, including severe side effects and usage restrictions. The initiative is reportedly being led by Vinay Prasad, the FDA's chief medical and scientific officer.
This potential warning underscores a heightened focus on vaccine safety and transparency. The specific details, such as whether the warning would encompass all COVID vaccines or be limited to mRNA types like those from Pfizer and Moderna, are still being determined. Additionally, the age groups to be covered by this alert remain undecided.
The agency has not finalized this plan, indicating that it may still undergo modifications before its expected unveiling by the end of the year. Major vaccine manufacturers and the Department of Health and Human Services have not yet commented on the developing situation.
