FDA Vaccine Chief Claims COVID Shots Linked to 'At Least 10' Child Deaths but Offers No Data

An internal memo written by the US Food and Drug Administration's top vaccine official has triggered fierce public backlash after directly claiming that COVID-19 vaccines were linked to the deaths of at least ten children while presenting no evidence to support the assertion.

The document, dated 16 May 2025, was authored by Dr Vinay Prasad, Director of the FDA's Center for Biologics Evaluation and Research (CBER).

Although written more than six months ago, it only became public earlier this week after being leaked to The New York Times, sparking immediate controversy across the medical community and social media.

In the memo, Prasad states that an internal review 'found that at least 10 children have died after and because of receiving COVID-19 vaccination.'

The document offers no accompanying data or case summaries to substantiate the grave allegation. It includes no information on the children's ages, medical histories, pre-existing conditions, or timelines between vaccination and death, nor does it explain how a causal link was determined rather than a temporal association.

Prasad attributes the alleged deaths to myocarditis, an inflammation of the heart muscle that has been recorded as a rare side effect of certain COVID-19 vaccines.

However, large clinical studies cited previously by medical authorities show that myocarditis occurs far more frequently following COVID-19 infection itself than after vaccination, and that cases linked to vaccination generally have milder outcomes and higher recovery rates.

None of the findings referenced in the memo have been published in any peer-reviewed medical journal, and the FDA has not released any surveillance data or coroner reports validating the memorandum's conclusions.

Leading vaccine experts quickly condemned the move, warning that introducing unverified mortality claims could fuel misinformation.

Dr Paul Offit of the Children's Hospital of Philadelphia described the memo as an example of 'science by press release', saying that scientific claims without evidence risk undermining public trust.

Shift in Federal Vaccine Policy

Prasad's memo emerged just months after he signed off on a significant restriction affecting one of the nation's remaining COVID vaccine options.

On the same date, 16 May 2025, Prasad issued a separate decisional memorandum approving a sharply narrowed license for Novavax's COVID-19 vaccine, NUVAXOVID. The decision limited use to adults 65 and older and individuals aged 12 to 64 with high-risk medical conditions, reversing earlier blanket eligibility recommendations.

In that official approval memo, Prasad wrote that the benefit-risk calculation for low-risk populations had changed due to declining COVID death rates and uncertainties about vaccine efficacy derived primarily from observational studies.

He warned of 'overreliance on potentially confounded observational data' and cited concerns about the so-called 'healthy vaccinee bias', arguing that available safety data made continued broad usage difficult to justify.

Prasad also acknowledged myocarditis as a 'known risk' associated with the Novavax vaccine and cited imbalances in neurological, cardiac and thrombotic adverse events reported during post-marketing surveillance.

The FDA nevertheless approved the vaccine for high-risk populations, requiring Novavax to conduct a new randomised placebo-controlled trial involving adults aged 50 to 64 to reassess the true benefit and safety of ongoing COVID boosters.

Medical Community Pushback

Despite Prasad's cautionary approach, mainstream medical organisations continue to recommend vaccination for children.

The FDA has previously stated that myocarditis rates connected to COVID vaccination average around eight cases per million doses among individuals under 65. Warning labels were expanded in April 2025 to include males aged 16 to 25, the demographic most affected by vaccine-associated myocarditis.

The American Academy of Pediatrics maintains its recommendation that children between six months and two years receive COVID vaccines, while the Infectious Diseases Society of America recommends vaccination for everyone aged six months and older.

CBS News health contributor Dr Céline Gounder cautioned parents amid the renewed debate: 'There is a lot of noise out there. Families should stick the course and talk to their doctors about keeping children up to date on their vaccinations.'

Fallout Continues

The leak of Prasad's memo has intensified scrutiny over political influence on vaccine policy under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr., who is openly sceptical of vaccination programs.

As pressure grows for public disclosure of the FDA's alleged evidentiary basis, critics argue that the memo's unsupported claim of child deaths risks amplifying vaccine fear at a time when health authorities are battling declining public confidence.

For now, however, the FDA has not released any data corroborating the statement that COVID vaccines directly caused the deaths of children.