RSV Vaccine Approved for Middle Aged Adults

GSK plc today announced that the U.S. Food and Drug Administration (FDA) has approved Arexvy™ (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk.

In the United States, Arexvy is approved for use in adults 60 and older and recommended by the U.S. CDC and its vaccine committee (ACIP) using shared clinical decision-making.  

Professor Ann R. Falsey, University of Rochester School of Medicine, said in a press release on June 7, 2024, "I am thrilled that GSK's vaccine is now approved for adults aged 50-59 at increased risk of RSV-LRTD. When it comes to the risks associated with RSV, age is just a number—an important number, but not the only factor to consider."

GS has also filed regulatory submissions to extend the use of Arexvy in Europe, Japan, and other geographies, with regulatory decisions undergoing review.

Clinical trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over are expected to be completed in H2 2024.

As of June 2024, the U.S. FDA has approved three RSV vaccines.