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FDA approves Moderna's mRNA flu vaccine after prior refusal
The FDA reversed its initial decision to refuse to review Moderna's application following public outcry, enabling the agency to move forward with the filing.
The FDA has approved Moderna’s mRNA flu vaccine, marking a reversal from the agency’s earlier stance on the application, according to NYT Business.
The outlet said the FDA initially refused to even review the submission, then changed course after a public outcry.
The approval clears the way for the application to proceed with regulatory consideration following the agency’s reconsideration.