The first vaccine for respiratory syncytial virus (RSV) has been approved by the U.S. Food and Drug Administration for use in seniors aged 60 and older.
Arexvy, manufactured by GlaxoSmithKline (GSK), is expected to help prevent lower respiratory tract infections caused by RSV, the agency said Wednesday.
“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,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an FDA news release.
“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,” Marks added.
Now that the vaccine is approved, the U.S. Centers for Disease Control and Prevention will weigh later this summer whether all seniors should get the shot or just those considered at high risk for severe infection.
The FDA is also evaluating a competing RSV vaccine from Pfizer, and is expected to next consider the vaccines for use in pregnant women to protect newborns from RSV in the weeks following delivery.
“This is a great first step … to protect older persons from serious RSV disease,” Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases, told the Associated Press. Next, “we’re going to be working our way down the age ladder” for what’s expected to be a string of new protections.
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What is RSV?
RSV is a highly contagious virus that spreads widely during the cold and flu season, with cases typically starting in the fall and peaking in the winter, the FDA said. RSV hit Americans particularly hard during the last cold and flu season, as pandemic restrictions were finally lifted. The virus tore through populations of young children who had never been exposed to it.
In older adults, RSV can cause life-threatening pneumonia and bronchiolitis — swelling of the small airway passages in the lungs. Each year in the United States, RSV leads to approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 and older, according to the CDC.
People infected with RSV usually show symptoms within 4 to 6 days after getting infected. Symptoms of RSV infection usually include: