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FDA Approves Moderna's mRESVIA, First mRNA-Based Single-Dose RSV Vaccine for Seniors

May 31, 2024, 03:08 PM

The U.S. Food and Drug Administration (FDA) has approved Moderna's respiratory syncytial virus (RSV) vaccine, mRESVIA, for adults aged 60 and older. This marks Moderna's second approved product following its Covid-19 vaccine, Spikevax, and the first mRNA-based vaccine for RSV. The approval provides Moderna with a new revenue stream and positions it alongside competitors GSK and Pfizer, who received FDA approval for their RSV vaccines last year. The vaccine is the only single-dose, pre-filled syringe RSV vaccine and is the third available RSV vaccine. The Centers for Disease Control and Prevention (CDC) will meet next month to make formal vaccine recommendations for the 2024-25 RSV season.