FDA Approves First RSV Vaccine for Individuals 60 and Older
On May 3rd, the Food and Drug Administration (FDA) approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the U.S. Arexvy has been approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older.
From the FDA news release:
“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 Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “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.”
RSV is a highly contagious virus that causes infections of the lungs and breathing passages in individuals of all age groups. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. In older adults, RSV is a common cause of LRTD, which affects the lungs and can cause life-threatening pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). According to the Centers for Disease Control and Prevention (CDC), each year in the U.S., RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older.
In June 2023, the CDC’s Advisory Committee on Immunization Practices (ACIP) will make recommendations on the appropriate use of the vaccine in the U.S. The vaccine will be available for older adults before the 2023-24 RSV season, which typically starts ahead of the winter months.