FDA approves 1st RSV vaccine

The FDA approved GSK's respiratory syncytial virus vaccine intended for adults 60 and older on May 3. It's the first RSV vaccine cleared in the world, the drugmaker said.

The vaccine, called Arexvy, is approved for prevention of lower respiratory tract disease caused by RSV. Lower respiratory tract disease can affect the lungs and be life-threatening if it progresses to pneumonia bronchiolitis, and every year, RSV leads to about 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among older adults, the FDA said. 

In a phase 3 study, the vaccine reduced the risk of developing the disease by 82.6 percent and lowered the risk of developing a severe form of the disease by 94.1 percent.

GSK said the product will be ready for the 2023-24 RSV season.

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