FDA Set to Give COVID Vaccines Serious ‘Black Box’ Designation: Report

The U.S. Food and Drug Administration is reportedly preparing to place a serious “black box” warning on COVID-19 vaccines, according to a CNN report citing people familiar with the agency’s plans.

A black box warning is the most serious safety designation the FDA can require — appearing in bold at the top of a drug or vaccine’s prescribing information to alert doctors and patients to potentially serious risks.

According to CNN, the FDA’s proposed action would highlight major risks such as serious side effects and usage restrictions that should be weighed against benefits before administering the shots.

The FDA is finalizing plans to put a “black box” warning on Covid-19 vaccines, sources tell CNN, its most serious alert meant to warn about drug risks.https://t.co/toYYb357fN

— CNN (@CNN) December 12, 2025

The report says two people familiar with the agency’s internal planning confirmed the intention to add the warning, though the plan has not yet been finalized and could change before it is publicly announced.

Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and head of the Center for Biologics Evaluation and Research, is said to be leading the review of the COVID vaccine warning label.

CNN’s account indicates that officials are still determining whether the black box warning would apply to all COVID vaccines, only mRNA-based shots from manufacturers like Pfizer and Moderna, or specific age groups.

The warning is expected to be unveiled before the end of 2025, though agency officials have not publicly confirmed plans.

Black box warnings are typically reserved for medicines with evidence of serious or potentially life-threatening adverse reactions that must be clearly communicated to providers and patients.

In describing the proposal, CNN’s sources noted that risks such as myocarditis or other serious effects — and possibly even deaths in rare cases — are part of what the agency is evaluating internally, though those claims have not been made public in detail.

The new black box designation, if finalized, would be a significantly stronger warning than existing vaccine labels, and is expected to prompt debate among medical professionals and the public — as most thing COVID-19 entail.

Critics of the move warn that placing the highest-level warning on widely used vaccines could fuel public distrust and hesitancy, especially among those already wary of vaccine safety.

Supporters of the idea argue that transparency about potential risks — even rare ones — is essential to informed consent and respects patients’ right to understand safety concerns.

Some observers have noted that earlier public skepticism about vaccine risks, once dismissed by many as misinformation, may now merit reconsideration in light of the FDA’s apparent warnings.

Public health experts emphasize that a black box label does not mean vaccines are unsafe overall, but that doctors and patients should carefully assess benefits and risks before vaccination.

Manufacturers of COVID vaccines, including Moderna and Pfizer, and the U.S. Department of Health and Human Services have not publicly commented on the reported warning plans.

The FDA’s deliberations come amid ongoing efforts to balance vaccine safety monitoring with public health goals as COVID-19 continues to circulate seasonally.

Even as the proposal unfolds, many will watch closely to see whether a black box warning influences vaccination decisions, regulatory policy, and broader conversations about drug safety in the United States.

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