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Dec 12, 2025 4:00 PM

FDA Weighs Black Box Warning For COVID Vaccines, Experts Push Back

The U.S. Food and Drug Administration (FDA) is reportedly considering adding a boxed warning, the agency's highest-level safety alert, to Covid-19 vaccines, a move that has drawn immediate criticism from outside experts who say there is no evidence to support such a step.

The effort represents the latest internal push by members of President Donald Trump's health team to revisit a product widely viewed as a major success of his first term.

A boxed warning appears prominently at the top of a medicine's prescribing label and is typically reserved for the most serious risks.

Also Read: Debate On Vaccine Safety Reaches Policy Stage – FDA Broadens Review Into Covid-19 Shot Risks In Adults

FDA's Warning Proposal

Similar warnings currently appear ...