GSK Announces Positive Data From AReSVi-006 Phase III Trial For RSV Vaccine Arexvy

(RTTNews) - GSK plc (GSK, GSK.L) announced Tuesday new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy of a single dose of Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older, including those at increased risk over three full RSV seasons (NCT04886596).

The results indicate that after a single dose of GSK's RSV vaccine, cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD compared to placebo. In the third season, the vaccine's efficacy was 48.0% against RSV-LRTD.

These results include efficacy against different RSV subtypes, in adults with advancing age (70-79 years of age), and those with certain underlying medical conditions.

Arexvy is the world's first RSV vaccine and was approved based on exceptional efficacy in adults aged 60 and older, including those who are at increased risk due to certain underlying medical conditions.

RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year.