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00:02The Food and Drug Administration reversed course on Moderna's application to market the first
00:07mRNA flu shot after initially issuing a refuse-to-file letter, according to NPR.
00:12FDA Commissioner Marty Makkari said the letter was part of an ongoing dialogue and that companies
00:17can request a detailed review. The agency had said Moderna failed to compare its vaccine to
00:22a CDC-recommended high-dose flu shot in its main trials. Moderna said the FDA agreed to
00:27its study design 18 months ago. The company said it included separate trial data comparing
00:32its mRNA shot to a high-dose flu vaccine and that the FDA never indicated it would refuse
00:37to review the application. An FDA spokesperson said the agency met with Moderna. The company
00:43amended its application and the agency accepted it for review. For all things money, visit Benzinga.com.
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