BioPharma Dive1 min read
saveFDA advisory panel backs Moderna's experimental flu vaccine in adults 50-64, supports accelerated review for 65+
read at BioPharma Dive ↗RegulatoryPositive
The FDA's advisory committee voted unanimously to recommend Moderna's mRNA-1010 flu vaccine for adults aged 50 to 64, and also found it beneficial for those 65 and older.
The 9-0 vote allows Moderna to pursue standard approval for the younger cohort and accelerated approval for the older group, with the agency expected to decide by early August.
Committee members said the trial data were clear and robust, indicating a strong safety and efficacy profile, and noted that approval would help the United States prepare for emerging or pandemic flu strains.
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This writeup was produced by pharmadog from original reporting by BioPharma Dive.
Original headline: “Moderna flu vaccine wins unanimous support from FDA panel”
read at BioPharma Dive ↗1,102 words · retrieved Jun 18
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