The U.S. Food and Drug Administration has opened a wide-ranging inquiry into deaths that may be linked to COVID-19 vaccines, a spokesperson for Health Secretary Robert F. Kennedy Jr. confirmed on Tuesday. The move marks one of the most significant shifts in federal vaccine oversight since Kennedy—long known for his anti-vaccine views—joined the Trump administration.
According to Andrew Nixon, speaking on behalf of the Department of Health and Human Services, the FDA is “conducting a thorough investigation, across multiple age groups, of deaths potentially related to COVID vaccines.” Major U.S. outlets, including Bloomberg and The Washington Post, had earlier reported on the probe.
What began as a targeted review of potential child deaths has expanded into a nationwide examination following the leak of an internal memo in late November. The document, attributed to a senior FDA official, alleged that COVID-19 vaccines were tied to at least 10 infant deaths—claims the memo did not substantiate with data.
Global health authorities have consistently affirmed that COVID-19 vaccines are both effective and safe, noting that while rare adverse reactions can occur, the benefits far outweigh the risks for most people. The FDA has not disclosed the data sources, methodology, or expected timeline for completing the review.
The investigation has triggered strong reactions from medical experts, many of whom are alarmed by the FDA’s direction under Kennedy’s leadership. Kennedy has a history of promoting vaccine misinformation, including false claims in 2023 that COVID-19 vaccines were deadly and that the virus was genetically engineered to target specific ethnic groups.
For now, the agency’s review continues with little public clarity—raising questions within the medical community about how vaccine policy will evolve under the new administration.
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