GSK's Arexvy vaccine approved for wider age range

The Food and Drug Administration said the vaccine for respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) is now allowed to be used on adults aged 50 to 59, after having been approved last year for individuals 60 years and older.

GSK said more than 13 million adults have a medical condition that increases their risk of severe RSV outcomes.

An estimated 42,000 hospitalisations happen each year in adults aged 50 to 64, with RSV exacerbating underlying medical conditions like COPD, asthma and diabetes.

"Today's approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50-59 who are at increased risk. For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD," said Tony Wood, GSK's chief scientific officer.

"The regulatory application was supported by positive results from a phase III trial [NCT05590403][5] evaluating the immune response and safety of GSK's RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions."