FDA's Vaccine Chief Prasad Links Pediatric Deaths to COVID-19 Shots, Proposes Stricter Regulatory Framework

The FDA's top vaccine regulator has claimed that an internal agency review linked at least 10 pediatric deaths to COVID-19 vaccination, using the findings to justify sweeping changes in how the agency evaluates and approves immunizations.

In a memo sent to staff at the Center for Biologics Evaluation and Research (CBER) on Friday, Director Vinay Prasad, MD, MPH, wrote that the deaths emerged from an analysis of 96 fatalities reported between 2021 and 2024. "For the first time, the US. FDA will acknowledge that COVID-19 vaccines have killed American children," Prasad stated in the communication obtained by The New York Times¹ and NBC News.²

The memo, which has not been made public by the agency, provided no details on the children's ages, underlying medical conditions, temporal relationships between vaccination and death, or vaccine manufacturers involved,^1-3 nor have the findings been published in a peer-reviewed medical journal. Prasad suggested the deaths were related to vaccine-associated myocarditis but offered no supporting data for this attribution.¹

Proposed Regulatory Changes

Prasad indicated the analysis would drive fundamental shifts in vaccine oversight. "Vaccines are like any other medical product," he wrote, stating that immunizations would now "be treated like all other medication classes—no better or worse than AAV vectors, monoclonal antibodies or anti-sense oligonucleotides."³

The proposed changes include requiring premarket randomized controlled trials with clinical endpoints for most new vaccine products, particularly for use in pregnant women, rather than relying on surrogate endpoints. Pneumococcal vaccine developers would need to demonstrate reductions in pneumonia cases, at least in post-marketing studies, vs solely showing antibody response.^1,3

Prasad also criticized the annual influenza vaccine framework as "an evidence-based catastrophe of low quality evidence, poor surrogate assays and uncertain vaccine effectiveness," pledging to revise the process.^2,3 He stated further that larger studies would be required before vaccines could be promoted as safe for co-administration, such as flu and COVID-19 shots given together.¹

"Science by Press Release"

The memo is based on data from the government's Vaccine Adverse Event Reporting System (VAERS) and as such has drawn sharp criticism from vaccine experts. VAERS is an unverified passive surveillance system that accepts reports from anyone, and its own website warns submissions may contain "inaccurate, incomplete or biased information."²

"This is sort of science by press release" is both "irresponsible" and "dangerous," Paul Offit, MD, director of the Vaccine Education Center at Children's Hospital of Philadelphia, said.^1,2 He noted that vaccine-related myocarditis cases in children typically resolve quickly, while viral myocarditis from COVID-19 infection "was quite severe and caused admissions to the intensive care unit."^1,2

Peter Marks, MD, Prasad's CBER predecessor who was removed by Health Secretary Robert F. Kennedy Jr. earlier this year, said the agency appeared to be "re-examining older" VAERS reports and reclassifying them as vaccine-related. "This memo conveys a very troubling mixture of misrepresentation and lies," Marks told NBC News, adding that the claims follow the "anti-vaccine playbook."²

Michael Osterholm, PhD, MD, an infectious disease expert and regents professor at the University of Minnesota, suggested the memo's release ahead of next week's CDC vaccine advisory committee meeting (December 4-5) was deliberate. "This is an irresponsible way to deal with a very critical public health issue like vaccination and adverse events," he said.¹

More of the Same

The memo represents the latest action on vaccines under Kennedy's leadership of the Department of Health and Human Services. The CDC removed COVID-19 vaccines from its recommended immunization schedule for healthy children and pregnant women in May, and further restricted seasonal formulation approvals in children in August.⁴ Current recommendations limit COVID-19 vaccination to those 65 and older and younger individuals with high-risk medical conditions.⁵

According to the American Academy of Pediatrics, approximately 2,100 children have died from COVID-19 since the pandemic began.¹ A 2023 analysis published in JAMA Pediatrics that covered more than 10 million children aged 5-11 found that vaccinated children had lower rates of infection and hospitalization compared to unvaccinated peers.²

The proposed regulatory changes would likely increase development costs for vaccine manufacturers and could affect timelines for bringing new vaccines to market, according to experts.¹