by James Lyons-Weiler, PhD, Popular Rationalism, ©2025
(Dec. 1, 2025) — Key Takeaways
The FDA now acknowledges that at least ten U.S. children died because of COVID-19 vaccination, admitting that regulators failed to identify these fatalities in real time. An internal memo by vaccine chief Vinay Prasad details years of methodological and cultural failure inside the agency, including reliance on unstable observational designs and surrogate immune markers in place of direct clinical evidence. Under the new standards, pediatric and pregnancy-related vaccine approvals must be supported by randomized data demonstrating meaningful clinical benefit, and longstanding practices — from immunobridging to annual flu-shot immunogenicity — can no longer justify authorization. The “Kennedy Bar” now governs all indications, a shift already reflected in the termination of multiple mRNA programs and the cancellation of a major BARDA contract for inadequate evidence. The FDA frames this pivot as essential to restoring credibility: vaccines will be regulated with the same rigor as any high-risk medical product, and assumptions will no longer substitute for proof.
WASHINGTON — In a decisive break from years of inertia, the Food Administration’s top vaccine official has acknowledged that federal regulators failed to detect — or act upon — evidence that COVID‑19 vaccines caused the deaths of American children. An internal memo from the director of the Center for Biologics Evaluation and Research states that at least ten pediatric deaths were attributable to the vaccines, marking the first such admission by the agency. The disclosure has triggered a sweeping overhaul of vaccine approval standards in the United States.
For the first time, the FDA is admitting that children died because of vaccination — and that the agency did not recognize these deaths in real time. That recognition is reshaping the nation’s vaccine regulatory framework more fundamentally than any action since the introduction of recombinant vaccine technologies.
The memo’s author, FDA vaccine CBER chief Vinay Prasad, describes a methodical review undertaken by agency staff that examined nearly one hundred pediatric death reports. The reviewers concluded that no fewer than ten were likely or probably caused by vaccination. The language is unequivocal: the deaths were “after and because of” vaccine administration. He further notes that passive reporting, physician reluctance, and form‑completion burden suggest that the true count is higher.
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Editor’s Note: Appointed on May 6 to lead the Center for Biologics Evaluation and Research (CBER), Dr. Vinay Prasad resigned his post in July. He was reinstated weeks later after FDA Commissioner Dr. Marty Makary asked him to return.