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The same mRNA technology that made the COVID-19 vaccine possible will soon be used in flu vaccines for older Americans. The FDA has approved a new shot from Moderna — called "mFlusiva" — for adults ages 50 to 64. The company is also seeking full approval for adults 65...

30,744 次观看 • 1 个月前 •via X (Twitter)

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The FDA has approved Moderna's mRNA flu vaccine, the first flu shot using mRNA technology to reach the US market. The approval comes months after the same agency refused to even file Moderna's original application. Vinay Prasad, who took over the FDA's biologics division after Peter Marks, rejected the initial application in writing, citing the trial as not adequate and well controlled. His internal memo to FDA staff, later leaked to the Washington Post, called the annual flu vaccine framework an evidence-based catastrophe of low quality evidence, poor surrogate assays, and uncertain effectiveness measured with poor methods. Twelve former FDA chiefs responded by blasting his move to tighten vaccine standards in the New England Journal of Medicine. Prasad has since left the agency. ICAN submitted a letter to the FDA's independent VRBPAC committee before the vote laying out the problems: the vaccine was compared not against placebo but against a GSK product that Prasad himself called not best in class, the absolute influenza risk reduction was only 0.8% while the adverse reaction profile ran at 6.4%, the trial used a single season of data, and Part A of the trial produced more patient deaths than the comparator flu shot. The committee approved it anyway. Del Bigtree and Jefferey Jaxen walk through why this matters beyond the flu shot itself: mRNA technology, justified under COVID emergency conditions, is now entering the routine recommended schedule through a non-emergency approval, and will be the first mRNA product included in the vaccine injury compensation table. The flu shot is currently approved for adults 50 and older, fast-tracked for 65 and older.

The HighWire

19,164 次观看 • 1 个月前