May 3, 2023 -- The U.S. Food and Drug Administration (FDA) said Wednesday that it has approved the use of GlaxoSmithKline Biologicals’ Arexvy vaccine for respiratory syncytial virus (RSV).
Arexvy is the first RSV vaccine approved for use in the U.S. It is indicated for the prevention of lower respiratory tract disease caused by the virus in individuals 60 years of age and older.
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.
The FDA noted that in older adults, RSV is a common cause of lower respiratory tract disease, which affects the lungs and can cause life-threatening pneumonia and bronchiolitis, a swelling of the small airway passages in the lungs.
According to the U.S. Centers for Disease Control and Prevention (CDC), RSV leads to approximately 60,000 to 120,000 hospitalizations and 6,000 to 10,000 deaths among adults 65 years of age and older each year in the U.S.
In an analysis of emergency department visits for influenza, respiratory syncytial virus (RSV), and COVID-19, the CDC revealed that U.S. weekly RSV cases peaked at more than 16,000 people in November and dropped significantly as the respiratory season faded.
While there are vaccines for COVID-19 and influenza, they have not been available for RSV.
"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, PhD, director of the FDA's Center for Biologics Evaluation and Research, said 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."
The safety and effectiveness of Arexvy is based on the FDA's analysis of data from an ongoing, randomized, placebo-controlled clinical study conducted in the U.S. and internationally in individuals 60 years of age and older.
The main clinical study of Arexvy was designed to assess the safety and effectiveness of a single dose administered to individuals 60 years of age and older. Participants will remain in the study through three RSV seasons to assess the duration of effectiveness and the safety and effectiveness of repeat vaccination, the FDA said, adding that data for a single dose of Arexvy from the first RSV season of the study were available for the FDA's analysis.
In the study, approximately 12,500 participants received Arexvy and 12,500 participants received a placebo. Among the participants who have received Arexvy and the participants who have received a placebo, the vaccine significantly reduced the risk of developing RSV-associated LRTD by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%.