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US FDA approves first mRNA flu shot from Moderna
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The shot, mFlusiva, was given a traditional approval for adults aged 50 to 64, and an accelerated approval for those 65 years and older.
The company also submitted separate late-stage data showing the vaccine generated stronger antibody responses than Sanofi's high-dose flu vaccine in adults 65 and older.
MFlusiva would compete with flu vaccines from Sanofi, GSK, CSL Seqirus, and AstraZeneca.
Advertisement AdvertisementAdvertisement AdvertisementJefferies analysts had forecast $750 million in U.S. sales of Moderna's flu shot and combination COVID-flu vaccine by 2030.
Former FDA Commissioner Marty Makary and former vaccine chief Vinay Prasad were forced to resign earlier this year amid controversies over vaccine and rare-disease drug reviews, including Moderna's flu vaccine application.