James Lyons-Weiler, PhD for Popular Rationalism 12/1/2025
Dr. Vinay Prasad has enacted new policy that will hold vaccines to the same standard of evidence on safety as drugs. This is #RevolutionaryReform at its best.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.
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https://popularrationalism.substack.com/p/the-fda-is-finally-applying-appropriate?utm_source=post-email-title&publication_id=475124&post_id=180422615&utm_campaign=email-post-title&isFreemail=true&r=cjt3t&triedRedirect=true&utm_medium=email
