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 on opioid medications to highlight the dangers of addiction, overdose, and death.

The acne drug Accutane includes a warning related to severe birth defects if taken during pregnancy. ACAM2000, a vaccine used against smallpox and mpox, carries warnings for risks including myocarditis and encephalitis.

Citing people familiar with the matter, CNN reported the FDA plan is being driven by Dr. Vinay Prasad, the agency's chief medical and scientific officer and head of its Center for Biologics Evaluation and Research.

What Could This Mean For Vaccine Perception?

These individuals said the proposal has not been finalized and remains subject to change.

Key details also remain uncertain, including whether the warning would apply to all COVID-19 vaccines or only those built on mRNA technology. In the U.S., three Covid-19 vaccines currently hold full FDA approval, two of which — from Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (NASDAQ:BNTX), and Moderna Inc. (NASDAQ:MRNA) — use mRNA platforms that have been a central focus of the administration's review.

The timing and scope of the potential warnings, expected to be unveiled by the end of the year, also remain unclear, including whether they would apply to all age groups.

U.S. Department of Health and Human Services spokesperson Andrew Nixon told CNN on Thursday that any assertions about pending FDA actions are "pure speculation" unless the agency announces them directly.

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