Well, that didn’t take long.
It took all of one week to go from an announcement that the Food and Drug Administration was refusing to review Moderna’s application for its mRNA influenza vaccine to news that the agency would review it after all.
For drugmakers and vaccine developers, this reversal is better than the alternative, but it is also one more sign that a usually methodical regulatory agency is now beset by chaos.
There is a change that might allow the agency to try to save face: Instead of considering whether to give the vaccine full approval for all adults over age 50, as initially expected, the FDA will now weigh two different indications: full approval for people ages 50 to 64, and accelerated approval for those aged 65 and up. That means Moderna will have to conduct another study of the vaccine in people over 65 to obtain full approval in that population.
The Moderna approval circus was presided over by Vinay Prasad, the head of the FDA’s Center for Biologics Evaluation and Research, which oversees vaccine regulation. CBER staff had decided to review the application for the Moderna vaccine, but Prasad personally overruled them, insisting on what the FDA calls a “refuse-to-file” letter, or RTF.
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