Tag: Immunogenicity
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Moderna Withdraws Combo Vaccine Application: A Real-Time Validation of the FDA’s New Direction
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (May 22, 2025) — One day after the FDA unveiled its updated COVID-19 vaccine approval framework—and the NEJM article by Prasad and Makary detailed the reasoning—Moderna quietly withdrew its application for its mRNA-1083 combination flu/COVID-19 shot. The timing is not coincidental. It reflects exactly what the new policy is designed to…
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Explaining FDA’s Position: My Take on Prasad and Makary
by James Lyons-Weiler, PhD, Popular Rationalism, ©2025 (May 21, 2025) — “The FDA is now saying: Here are restricted groups we will likely approve your products for, now show it is effective and safe in those groups.” When the FDA released its new framework for COVID-19 vaccine policy via a “Sounding Board” article in the New England…