The U.S. Food and Drug Administration (FDA) has just approved Arexvy, the first respiratory syncytial virus (RSV) vaccine for use in the United States. The vaccine is designed to prevent lower respiratory tract disease caused by RSV in individuals aged 60 and older.
“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.” Peter Marks, M.D., Ph.D., 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.”
RSV is a highly contagious virus that affects all age groups and impacts the lungs and breathing passages. In 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 among adults 65 years of age and older every year in the U.S.
The vaccine’s safety and effectiveness is based on data from an ongoing, randomized, placebo-controlled clinical study conducted in the U.S. and internationally in individuals aged 60 and older. The main study was designed to assess the safety and effectiveness of a single dose in individuals aged 60 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 presented for FDA analysis.
The results showed that 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% among participants who received Arexvy compared to those who received a placebo. The most commonly reported side effects of the vaccine were injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain. However, the FDA is requiring the company to conduct a postmarketing study to assess the signals of serious risks for Guillain-Barré syndrome and acute disseminated encephalomyelitis (ADEM).
Overall, the approval of the first RSV vaccine in the United States is a major step forward in the fight against respiratory infections that can be particularly dangerous for older adults and for those with comprimised immune systems.