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 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.
Hellbound and Down 