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US FDA approves first mRNA flu shot from Moderna
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Mobile - Health
HealthUS FDA approves Moderna’s first mRNA seasonal flu vaccine mFlusiva for adults 50+ after trial data showed higher effectiveness and stronger antibody responsesThe U.S. Food and Drug Administration has approved Moderna's flu vaccine for people aged 50 and older, the company said on Wednesday, marking the first approval of a messenger RNA-based vaccine for seasonal flu.
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.
Jefferies 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.