A senior Food and Drug Administration official has revealed that at least 10 children's deaths have been linked to COVID-19 vaccination, according to an internal memorandum dated Friday and obtained by The Washington Post.
FDA Investigation Uncovers Vaccine-Related Deaths
Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, stated in the memo that "these deaths are related to vaccination" with staff attributing them as likely, probable, or possible outcomes. He emphasized that "that number is certainly an underestimate due to underreporting, and inherent bias in attribution."
The investigation was initiated over the summer by FDA senior advisor Tracy Beth Høeg, a known COVID-19 vaccine critic, who examined child deaths reported to the federal Vaccine Adverse Event Reporting System (VAERS). The FDA analysis focused on 96 deaths reported between 2021 and 2024, concluding that no fewer than 10 were connected to COVID-19 vaccination.
Proposed Vaccine Policy Overhaul
Prasad described the findings as "a profound revelation," noting this marks the first time the US FDA will acknowledge that COVID-19 vaccines have caused fatalities among American children. He criticized vaccination mandates, stating that "healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death."
The FDA official outlined a comprehensive plan to redirect vaccine regulation toward evidence-based medicine. Key components include examining whether Americans should receive multiple vaccines simultaneously and revising what he called the "evidence-based catastrophe" of the annual flu vaccine framework, which he criticized for "low quality evidence, poor surrogate assays, and uncertain vaccine effectiveness."
Stricter Requirements and Expert Criticism
The proposed reforms include more stringent authorization requirements for vaccines intended for pregnant women. Additionally, pneumonia vaccine manufacturers will need to demonstrate that their products actually reduce pneumonia rates rather than merely generating antibodies.
However, the claims faced immediate pushback from medical experts. Dr. Paul Offit, a pediatrician and director of the Vaccine Education Center at Children's Hospital of Philadelphia, told NPR that Prasad provided no evidence supporting the conclusion that COVID-19 vaccines caused 10 child fatalities. Offit warned that "all this will do is scare people unnecessarily" and called for Prasad to release all evidence for expert review.
The memo also addressed concerns about leaks to media, with Prasad describing such behavior as "unethical, illegal, and factually incorrect." The Department of Health and Human Services, which oversees the FDA, has not yet responded to requests for comment regarding these developments.
