@caroljsroth No resentment here. Glad I retired at 57. Moved overseas to a beach life and now call Mexico our home. I was fortunate. I understand people love their lives, their careers and whatnot. That is great, but that wasn't me. Do what you love. Play your own game.
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.
@delbigtree and @JeffereyJaxen 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.
@RJR1225@Acyn So he has renounced sharia law? Has he reounced anything with regards to Islam? No and he won't. Remember is part of Islamic ideology to lie and deceive to win power. Wake up, you are about to become a 2nd class citizen if they win.