Initial RSV Vaccine Approved in the U.S.

The U.S. Food and Drug Administration today approved Arexvy™, the first single-dose, respiratory syncytial virus (RSV) vaccine approved for use in the United States.

GSK plc's Arexvy is approved for preventing lower respiratory tract disease (LRTD) caused by RSV in individuals 60 and older.

The U.S. launch is planned before the start of the 2023/24 RSV season.

"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, in a press release on May 3, 2023.

"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 U.S."

The safety and effectiveness of Arexvy are 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.

Data for a single dose of Arexvy from the first RSV season of the study were available for the FDA's analysis. 

John Kennedy, MD, President American Medical Group Association (AMGA), commented, “For decades, AMGA and the healthcare community at large have been active in finding ways to increase adult immunizations."

"As a result, we are pleased that we can now add an RSV vaccine to providers’ options for patient care."

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.

The FDA granted approval of Arexvy to GlaxoSmithKline Biologicals and required the company to conduct a postmarketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM. In addition, although not an FDA requirement, the company has committed to evaluating atrial fibrillation in the postmarketing study.

On April 26, 2023, European Medicines Agency recommended a marketing authorization in the European Union for Arexvy.

Other RSV vaccine candidates are completing late-stage clinical studies.