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Moderna Secures USFDA Approval for First mRNA-Based Seasonal Flu Vaccine mFlusiva
['Sheeba Farhat', 'Written']
Medical News, Health News Latest, Medical News Today - Medical Dialogues |
Bengaluru: The 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.