FDA May Slap Covid Vaccines With Black Box Warning

Dec 15th 2025 2:00am EST

Black box warnings, also called “boxed” warnings, are the FDA’s most serious warning label, used to indicate that a drug is associated with a serious hazard, often including death or life-threatening reactions. COVID-19 vaccine critics told The Defender the warning comes too late, and that the shots should be pulled from the market.

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