The FDA has approved Moderna's RSV vaccine, mRESVIA (mRNA-1345), for adults aged 18-59 at increased risk of lower respiratory tract disease, expanding its previous approval for those 60 and older; the company plans to make the vaccine available for both age groups in the U.S. for the 2025-2026 respiratory virus season, following positive Phase 3 trial results demonstrating safety and immunogenicity in the younger adult population.
Moderna Inc. has secured an expanded U.S. Food and Drug Administration approval for its respiratory syncytial virus (RSV) vaccine, mRESVIA (mRNA-1345), now covering adults aged 18-59 at increased risk, in addition to the previously approved cohort of adults aged 60 and older since May 2024. This development, supported by positive Phase 3 study results demonstrating safety and immunogenicity with generally well-tolerated adverse reactions such as injection site pain, fatigue, headache, myalgia, and arthralgia, significantly broadens the addressable market for mRESVIA. The company plans commercial availability for both approved age groups in the U.S. for the 2025-2026 respiratory virus season, a key factor for future revenue streams. This regulatory milestone is underscored by a 'strongly positive' sentiment score of 0.7 (0.8 specifically for MRNA) and a market impact score of 0.6. Despite Moderna's stock (MRNA) closing Thursday's regular trading at $27.35, down $0.40 (1.44%), it experienced a slight gain of $0.10 (0.36%) in after-hours trading, suggesting a potential delayed positive market interpretation of this news.
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