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.
