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Moderna said that the FDA will review the company’s flu vaccine after all, now that the two sides agreed to an amended filing.
The company said Wednesday that following a type A meeting with US regulators, it will apply for standard approval in the 50 to 64 age group and accelerated approval in adults 65 and older. It will conduct a post-marketing study in the older age group to produce additional clinical data. The FDA set an Aug. 5 deadline to decide on both submissions, and if approved, Moderna said mRNA-1010 could be available for the upcoming flu season.
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