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Can’t find a non-paywalled article yet but FDA just sad they would actually review Moderna’s flu application. Lmao.
US FDA reverses course, will review Moderna's modified flu vaccine application
US FDA reverses course, will review Moderna's modified flu vaccine application
Moderna said on Wednesday the U.S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application, after the company made modifications.
“… The FDA has accepted Moderna's revised approach seeking full approval for the shot for adults aged between 50 and 64, and accelerated approval for those aged 65 and above, the company said, adding that it will also conduct a post-marketing study in older adults.
… The regulator is expected to make a decision on the candidate by August 5.“