Approval is for use among adults 60 and older
The U.S. Food and Drug Administration (FDA) has okayed the first-ever respiratory syncytial virus (RSV) vaccine for use in the U.S. The vaccine, Arexvy, is approved for the prevention of lower respiratory tract disease in individuals age 60 and older.
RSV is a highly contagious virus that causes infections of the lungs and breathing passages. It is seasonal, typically starting during the fall and peaking in the winter. in individuals of all age groups. While RSV affects people of all ages, among older adults it is a common cause of lower respiratory tract disease (LRTD), which affects the lungs and can cause life-threatening pneumonia and bronchiolitis. According to the U.S. Centers for Disease Control and Prevention, RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths annually among adults 65 and older.
“Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “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.”
According to the FDA, Arexvy’s safety and effectiveness is based on the agency’s analysis of data from an ongoing, randomized, placebo-controlled clinical study in which a single dose is administered to individuals age 60 years 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. 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 have received Arexvy and 12,500 participants have received a placebo. Those who received the vaccine were found to have 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% compared with those who received the placebo.
Among a subset of the trial participants, the most commonly reported side effects by individuals who received Arexvy were injection site pain, fatigue, muscle pain, headache and joint stiffness/pain. Among all participants, atrial fibrillation within 30 days of vaccination was reported in 10 participants who received Arexvy and 4 participants who received placebo.
The FDA granted approval of Arexvy to GlaxoSmithKline Biologicals.