FDA yesterday approved the respiratory syncytial virus vaccine, adjuvanted (Arexvy, GlaxoSmithKline Biologicals) for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age or older. This is the first RSV vaccine approved in the U.S. and the first approved for older adults anywhere in the world.
The CDC Advisory Committee on Immunization Practices meets in June when it is expected to make recommendations for this vaccine. The vaccine will be available for older adults before the 2023-24 RSV season, which typically starts ahead of the winter months.
RSV is a highly contagious respiratory virus that infects 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, sometimes resulting in life-threatening pneumonia and bronchiolitis. 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 or older.
The approval is based on the landmark positive pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase 3 trial data. In the trial, the vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% (96.95% CI, 57.9–94.1; 7 of 12,466 vs. 40 of 12,494) against RSV-LRTD in adults aged 60 years or older, meeting the primary endpoint. In addition, efficacy was 94.6% (95% CI, 65.9–99.9; 1 of 4,937 vs. 18 of 4,861) in older adults with at least one underlying medical condition of interest, such as certain cardiorespiratory and endocrine-metabolic conditions. Efficacy against severe RSV-LRTD — an RSV-associated LRTD episode preventing normal, everyday activities — was 94.1% (95% CI, 62.4–99.9; 1 of 12,466 vs. 17 of 12,494).
The vaccine was generally well tolerated with an acceptable safety profile. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, headache, and arthralgia. These were generally mild to moderate and transient.
In April 2023, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion recommending the vaccine for the prevention of LRTD caused by RSV in adults aged 60 years or older. A final European regulatory decision is anticipated in the coming months. Regulatory reviews are also ongoing in Japan and several other countries, GSK said.