A senior US Food and Drug Administration official has claimed in an internal memo that at least ten American children died as a direct result of receiving COVID-19 vaccines, triggering a major controversy within the medical community and raising questions about vaccine safety protocols.
The Controversial FDA Memo
Dr Vinay Prasad, Director of the FDA's Center for Biologics Evaluation and Research, authored a comprehensive 3,000-word memo obtained by NBC News that has sent shockwaves through public health circles. The document claims that agency staff identified "no fewer than 10" child deaths among 96 reported to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024 that were directly linked to COVID-19 vaccination.
In his communication to FDA staff, Dr Prasad made the dramatic assertion that "For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children." He further added that "Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it," suggesting systemic issues within the agency's monitoring processes.
Scientific Community Pushes Back
The memo has drawn sharp criticism from numerous public health experts who question its methodology and conclusions. Dr Paul Offit, a respected paediatrician and director of the Vaccine Education Center at the Children's Hospital of Philadelphia, characterized the approach as "sort of science by press release," labeling the memo both "irresponsible" and "dangerous."
Former FDA vaccine chief Dr Peter Marks expressed particular concern about the document's "clearly political tone" and noted that the claims appeared drawn from what he described as the "anti-vaccine playbook." He emphasized the complexity of establishing causation in child deaths and clarified that VAERS is designed to detect early safety signals rather than confirm vaccine-related fatalities.
Dr Kathryn Edwards, professor emeritus at Vanderbilt University, stressed that determining whether a vaccine caused death requires thorough investigations including autopsies and careful review of alternative causes. She highlighted a crucial context often missing from the discussion: COVID-19 itself has caused significantly more child deaths than those cited in Dr Prasad's memo.
Broader Implications for Vaccine Policy
The controversial document extends beyond COVID-19 vaccines to propose sweeping changes to the FDA's entire vaccine evaluation framework. Dr Prasad's recommendations include:
- Revisiting flu shot assessments and requirements
- Demanding post-market proof of pneumonia vaccine effectiveness
- Reconsidering the co-administration of multiple vaccines
Medical experts warn that implementing these changes could significantly slow vaccine approval processes, delay product launches, and disrupt established immunization schedules that have protected children from numerous diseases for decades.
Context and Supporting Evidence
The memo emerges against the backdrop of recent FDA and CDC decisions to limit COVID vaccine eligibility this winter primarily to adults over 65 and those with underlying medical conditions.
Notably, the internal document lacks critical details about the cases it references, including the children's ages, medical histories, specific timelines, or vaccine manufacturers. The findings have not undergone peer review, a standard process for scientific validation.
Meanwhile, substantial research continues to support vaccine safety. A 2023 JAMA Pediatrics study examining over 10 million children aged 5-11 found vaccination significantly reduced both infection and hospitalization risks. Similarly, a 2024 Nature Communications study reported no increase in serious adverse events, noting only a minimal myocarditis risk confined primarily to teenage boys.
As the debate continues, the medical community remains divided on how to interpret the VAERS data and what implications it should have for future vaccine policies and public health communication strategies.
