Category: Approval/Launch Region: North America · United States Company: Glaxosmithkline Inc

US FDA approves first RSV vaccine from GSK

US FDA approves first RSV vaccine from GSK
The approval makes GSK, which has been neck-and-neck with Pfizer in RSV vaccine development, the first company to tap into a multi-billion-dollar market and puts it ahead of rivals such as Moderna Inc and Bavarian Nordic . The U.S. Food and Drug Administration has approved GSK Plc's respiratory syncytial virus (RSV) vaccine, the British drugmaker said on Wednesday, making it the first shot to be cleared for protection against a common respiratory disease that can be fatal for older people. The vaccine was approved for people aged 60 and older, the company said. The approval makes GSK, which has been neck-and-neck with Pfizer in RSV vaccine development, the first company to tap into a multi-billion-dollar market and puts it ahead of rivals such as Moderna Inc and Bavarian Nordic . Analysts have estimated the market for RSV vaccines to cross $10 billion by 2030. GSK expects the vaccine to be available before the next RSV season in the United States, Chief Commercial Officer Luke Miels told Reuters on Wednesday before the approval. He said the vaccine would be priced above $120 per shot provided the data from a study, which is expected soon, shows that it protects for two RSV seasons.

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