US FDA expands GSK’s RSV vaccine approval to adults aged 50 to 59

By Thomson Reuters Jun 7, 2024 | 5:06 PM

By Sriparna Roy and Christy Santhosh

(Reuters) -The U.S. Food and Drug Administration approved the expanded use of GSK’s respiratory syncytial virus (RSV) vaccine on Friday in adults aged between 50 and 59, making it the first shot endorsed for that age group.

The shot, branded Arexvy, as well as vaccines from rivals Pfizer and Moderna are already approved for people aged 60 and older for the indication.

RSV, which typically causes cold-like symptoms, is a leading cause of pneumonia in toddlers and older adults, leading to about 177,000 hospitalizations and 14,000 deaths in the United States annually.

Arexvy has dominated the U.S. RSV vaccine market since its launch last year, outperforming sales of rival Pfizer’s Abrysvo to wrest a two-thirds market share in the first quarter.

The U.S. Centers for Disease Control and Prevention (CDC) is yet to sign off on the use of GSK’s vaccine in the expanded patient population.

A CDC panel of independent experts will convene between June 26 to 28.

The company expects panel members to discuss the use of the shot in the expanded population in the upcoming meeting, Leonard Friedland, director, scientific affairs and public health, vaccines at GSK told Reuters, ahead of the decision.

(Reporting by Sriparna Roy, Christy Santhosh and Puyaan Singh in Bengaluru; Editing by Pooja Desai and Vijay Kishore)