FX.co ★ GSK Announces Positive Data From AReSVi-006 Phase III Trial For RSV Vaccine Arexvy

GSK plc (GSK, GSK.L) released new insights on Tuesday from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial, which assesses the effectiveness of a single dose of Arexvy—an adjuvanted recombinant vaccine against the respiratory syncytial virus (RSV)—in preventing lower respiratory tract disease (LRTD) in adults aged 60 and above. This study spans three complete RSV seasons and includes individuals at heightened risk (NCT04886596).

The findings reveal that one dose of GSK's RSV vaccine delivers a cumulative efficacy of 62.9% in preventing RSV-LRTD and 67.4% in combating severe RSV-LRTD over the three RSV seasons, as compared to a placebo. In the third RSV season alone, vaccine efficacy stood at 48.0% against RSV-LRTD.

This evidence encompasses various RSV subtypes and is effective in older adults, specifically those aged between 70 and 79, as well as individuals with certain pre-existing medical conditions.

Arexvy stands as the world’s pioneering RSV vaccine, earning approval for its notable efficacy in adults 60 years and older, especially those who present increased risks due to underlying health factors.

RSV is a widespread virus targeting the lungs and respiratory passages, affecting an estimated 64 million individuals annually across all age groups worldwide.