The US Food and Drug Administration (FDA) has expanded its probe into whether coronavirus vaccines may be linked to deaths among adults, following internal claims that at least 10 children โdied after and because ofโ receiving COVID-19 shots โ a statement that has drawn sharp criticism from public health experts.
Andrew Nixon, spokesperson for the Department of Health and Human Services (HHS), confirmed Tuesday, December 10, that the FDA is conducting โa thorough investigation, across multiple age groups,โ into reports of deaths potentially tied to coronavirus vaccines. Nixon said the public can expect documents soon that will detail the agencyโs framework and the data behind its review.
The probe into adult fatalities was first reported by Bloomberg.
A leaked email, a brewing policy shift
The controversy stems from a leaked internal email by Vinay Prasad, head of the FDA division overseeing vaccine approvals. In the memo, reported by The Washington Post, Prasad claimed the agency had found at least 10 children died โafter and because ofโ COVID-19 vaccination โ without providing evidence or methodological details.
He also said the FDA would raise the bar for approving future vaccines, requiring proof that shots prevent disease after they are on the market, rather than merely demonstrating immune response levels.
This potential shift immediately set off alarm bells among vaccine scientists. Twelve former FDA commissioners warned in a New England Journal of Medicine commentary last week that such changes could slow the development of new vaccines, weaken the US response to infectious diseases, and endanger vulnerable communities.
Analysts also noted that Prasadโs email was neither officially announced nor cleared by HHS Secretary Robert F. Kennedy Jr., who leads the department and has long been associated with anti-vaccine activism. HHS later said Prasad sent the message without consulting the secretary.
Public health community demands transparency
The FDA has long maintained that coronavirus vaccines have a strong safety record, backed by multiple studies. Public health experts are now pressing the agency to explain the basis of Prasadโs claims about childrenโs deaths, including how the review was conducted and whether the findings will influence regulatory policy.
Under Kennedyโs leadership, HHS has taken an increasingly skeptical stance on mRNA vaccines, issuing statements that cast their use as risky โ a tone that experts say may undermine public confidence and fuel misinformation.
RSV treatments also under review
In a separate development, the FDA has reached out to drugmakers about potential safety concerns involving preventive therapies for respiratory syncytial virus (RSV), Reuters earlier reported.
Merck confirmed meeting briefly with FDA officials last week regarding Enflonsia, its monoclonal antibody for infants. The company said it welcomes regulatory scrutiny and remains โconfident in the safety profileโ of the product.
Sanofi and AstraZeneca, partners in the widely used infant RSV therapy Beyfortus, also reiterated their treatmentsโ safety and efficacy, citing clinical data from more than 400,000 infants.
What comes next
As scrutiny intensifies, the FDA faces mounting pressure to release data underpinning the alleged vaccine-linked deaths and to clarify whether Prasadโs proposed regulatory overhaul will materialize.
The findings โ and how the agency communicates them โ could have sweeping implications for public trust, vaccine development, and the nationโs preparedness for future outbreaks.
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