The Food and Drug Administration (FDA) has revealed that at least 10 American children died following vaccination against COVID-19. This disclosure comes from a memorandum issued by Dr. Vinay Prasad, the director of the FDA’s vaccine division, which was first reported by PBS. In the extensive 3,000-word document, Prasad stated that these conclusions were drawn from a multi-month analysis of data reported to the Vaccine Adverse Event Reporting System (VAERS). The findings indicate a troubling association between the vaccines and pediatric fatalities.
In his memo, Prasad described the acknowledgment as a “profound revelation,” marking the first official recognition by the FDA that COVID-19 vaccines may have contributed to deaths among children. He asserted that the figure of “no fewer” than 10 deaths was likely an underestimation, suggesting that the true number could be higher. According to his analysis, the review focused on 96 deaths reported between 2021 and 2024.
Prasad criticized coercive vaccination policies implemented during the pandemic, which required children to receive the vaccine despite their low risk of severe illness from COVID-19. He stated, “Healthy young children who faced tremendously low risk of death were coerced…to receive a vaccine that could result in death.” He expressed concern that the regulatory actions taken by the FDA might have inadvertently caused more harm than good to this vulnerable population.
Prasad’s memo also highlighted the procedural challenges associated with VAERS, noting that the reporting system is often underutilized. He pointed out that many deaths potentially linked to vaccines may not be reported due to the complex submission process, which requires significant motivation from healthcare providers.
To address these safety concerns, the FDA plans to implement stronger regulations regarding vaccine testing, including a demand for pre-market randomized trials assessing clinical outcomes for new vaccines. Prasad emphasized the need for a shift in the FDA’s approach to evaluating vaccines, particularly regarding their administration to children.
The announcement comes just ahead of a scheduled meeting for the Centers for Disease Control and Prevention (CDC) vaccine committee on December 4-5, 2025. The agenda includes discussions on the immunization schedule for children and the administration of various vaccines, including hepatitis B for newborns. These meetings will be open to the public via live webcasts.
Prasad concluded his memo by encouraging staff who disagree with the new direction to resign. He expressed a willingness to engage in open discussions about the changes, inviting a culture of debate on vaccine policies within the agency.
The memorandum has sparked significant discussion within public health circles. Critics of the COVID-19 vaccination policy, such as Dr. Robert Malone, have hailed Prasad’s statements as a crucial turning point in vaccine policy, emphasizing the need for transparency and rigorous evaluation of vaccine safety.
As the FDA prepares to overhaul its evaluation processes, the implications of Prasad’s revelations will likely reverberate through public health policy and vaccine administration practices. The agency’s commitment to reassessing its approach underscores the ongoing complexities surrounding COVID-19 vaccinations and their impact on child health.
