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FDA Approves Moderna's mRNA Flu Vaccine After Initially Refusing To Review It
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Fusion42 · 6 August 2026 · Fusion42 review
The FDA has approved Moderna's mRNA-based seasonal flu vaccine, mFlusiva, for adults 50 and over after initially refusing to review it due to comparator vaccine concerns; the approval followed a successful Phase 3 clinical trial demonstrating superior efficacy over standard-dose vaccines.
This Wire brief sits within Fusion42's coverage of Biotech, and 12 sources have reported it between 6 Aug 2026 and 27 Aug 2026.
◆ ◆ The Wire takeaway
The regulatory door is open for mRNA flu vaccines in the US, shaking up competition for your immunisation products if you target adults over 50. You now face a new benchmark for efficacy and safety from Moderna's novel vaccine.
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12 sources · first reported 6 Aug 2026 · latest 27 Aug 2026
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