“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”

Although RSV is a disease that’s often associated with babies and young children, it can also be dangerous for seniors. In the US, an estimated 159,000 adults 65 and older are hospitalized each year with RSV, and an estimated 10,000 to 13,000 die as a result of their infection.

In healthy adults and older children, it usually causes mild cold-like symptoms that go away with self-care, but older adults, including those with underlying medical conditions, are at increased risk for serious illness.

A Centers for Disease Control and Prevention advisory panel will meet in June to make recommendations on the appropriate use of the vaccine.

In a clinical trial of nearly 25,000 older adults whose results were published in the New England Journal of Medicine, the GSK vaccine was 83% effective at preventing lower respiratory tract disease caused by the virus.

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