Moderna held further discussions with regulators and announced that the agency would accept the company’s application for approval of its flu vaccine that uses mRNA technology. The Food and Drug Administration reversed its decision on Moderna’s flu vaccine and has agreed to review it for possible approval.
Just last week, Moderna announced that the agency had rejected its application for review of a new flu vaccine. The F.D.A. said the company’s research design had been flawed.
But in subsequent discussions, the agency had relented and agreed to begin a review, the company said on Wednesday. As part of the revised approach, Moderna said that it had agreed to split up its application for the flu vaccine based on age. It plans to seek standard approval for people 50 to 64 years old, and accelerated approval for those 65 and older. The company also said it had agreed to conduct an additional study among those 65 and older once the vaccine reached the market.
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