A senior vaccine official at the Food and Drug Administration has ignited a national debate after claiming in an internal memo that 10 children’s deaths were linked to the COVID-19 vaccine — without releasing the data behind the assessment.
The memo, written Friday by Dr. Vinay Prasad, said FDA staff found the deaths to have a “likely, probable, or possible” connection to vaccination. But the agency has not explained how those conclusions were reached, and the findings have not been made public or reviewed by outside experts.
The document was first reported by a PBS NewsHour correspondent and later obtained by the Washington Post.
FDA Under Pressure to Explain Its Methods
FDA Commissioner Marty Makary told Fox News over the weekend that the agency intends to release information about the cases — material he says the Biden administration did not previously share.
“It makes a mockery of science if we’re just going to rubber-stamp things with no data,” Makary said, while also noting that the COVID vaccine “was amazing for people at risk and for older people.”
The memo surfaced days after the CDC dropped its universal COVID vaccine recommendation, shifting toward a more targeted approach.
Experts Say FDA Must Produce Evidence
Public health experts across the U.S. expressed alarm at the lack of supporting data.
Dorit Reiss, a professor at UC Law San Francisco who studies federal regulatory processes, criticized Prasad for proposing changes to vaccine review protocols based on an unpublished and unvetted internal review.
“Dr. Prasad is not suggesting a deliberative process to assess next steps, as was FDA’s usual practice,” she wrote. “It’s more problematic given that Dr. Prasad’s expertise is not in vaccines.”
Dr. Amesh Adalja of the Johns Hopkins Center for Health Security said the memo contains “no actual medical data” that could justify linking the children’s deaths to vaccination.
“To make such a claim, one would need to know basic things such as age, vaccine type, underlying conditions, and what analysis was done to establish causality,” Adalja told ABC News.
He warned the statement could fuel misinformation: “It will only serve to increase anti-vaccine sentiment and further politicize an issue that should not be politicized.”
Questions Loom as Agencies Stay Silent
ABC News contacted both the FDA and the Department of Health and Human Services for comment. Neither has released additional details about the children’s deaths or the internal review cited in the memo.
With no publicly available data, the episode has intensified tension around U.S. vaccine oversight, raising concerns from both vaccine experts seeking transparency and parents looking for reliable guidance.
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