FDA Eyes Black Box Warning on COVID Vaccine
FDA considers adding “black box” warning to COVID-19 shots as internal disputes and former leaders’ criticisms surface amid safety review
The U.S. Food and Drug Administration (FDA) is preparing to place its strongest safety alert—a “black box” warning—on COVID-19 vaccines, according to current and former government sources, CNN is reporting.
A black box warning is the most serious label the FDA can issue. It signals that a drug or vaccine may carry significant risks and that clinicians and patients should be aware of them before use.
According to people familiar with the matter, the effort is being led by Dr. Vinay Prasad, the FDA’s Chief Medical and Scientific Officer and Director of the Agency’s Center for Biologics Evaluation and Research.
Last month, Prasad wrote in an internal memo that COVID-19 vaccines “probably contributed to the deaths of at least 10 children who died of heart inflammation.”
That memo—which has not been publicly released—ties myocarditis to several deaths. Myocarditis, an inflammation of the heart muscle, is associated with the COVID vaccine. Previous FDA updates already expanded warning labels about rare heart risks associated with COVID shots.
While “Experts” caution that reports of adverse events do not prove causation—possibly the same “Experts” who insisted the vaccines were “safe and effective”—a number of physicians, including many in Alabama, have long questioned the marked increase in myocarditis, sudden death and other significant adverse reactions and conditions temporally correlated with COVID vaccine administration.
A Department of Health and Human Services spokesperson told Reuters that “unless the FDA announces it, any claim about what it will do is pure speculation.”
In addition to the internal push for a black box warning, a dozen former FDA leaders—appointed by both Republican and Democratic administrations—issued a strong rebuke of the Agency’s approach in a commentary published this month. They wrote that new internal directives would “disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections.”
In the piece, the former officials criticized the memo’s assertion that COVID vaccines caused the alleged child deaths and warned that sweeping changes to vaccine policy could undercut scientific standards and public trust.
Notably, Conflict of Interest statements—specifically, those related to pharmaceutical industry funding—have not been made readily available for the authors of this “rebuke.”
The FDA has also been reviewing COVID-19 vaccine safety across age groups. FDA Commissioner Dr. Marty Makary previously said the agency is looking into reports of deaths among younger people, though detailed findings have not been released.
At the same time, Health Secretary Robert F. Kennedy Jr., a long-time critic of vaccine mandates, has sharply limited COVID-19 vaccine access, focusing eligibility on older adults and people with medical conditions that put them at higher risk from COVID.
Officials say the warning is still under development and could change before any formal announcement by the end of the year. It is also unclear whether the warning would apply to all COVID-19 vaccines—including mRNA shots from Pfizer/BioNTech and Moderna or the protein-based vaccine from Novavax—or be targeted to specific age groups or products.
