GSK has announced new positive data from the Phase 3 AReSVi-006 trial of Arexvy, its recombinant adjuvanted vaccine for the respiratory syncytial virus (RSV).
The results show protection over three RSV seasons using Arexvy.
The randomised, placebo-controlled, double-blind, multi-country trial evaluated the efficacy of a single dose of the vaccine against lower respiratory tract disease (LRTD) caused by RSV.
It enrolled adults aged 60 and older, particularly those at higher risk over three full RSV seasons. Around 25,000 participants were enrolled from 17 countries.
Previously, Arexvy was approved based on its efficacy in adults aged 60 and older, especially those with underlying medical conditions.
In June 2023, GSK shared positive data for the vaccine, indicating protection over two RSV seasons.
The latest findings showed that a single dose of GSK’s RSV vaccine provided a cumulative efficacy of 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD over three RSV seasons, compared to a placebo.
In the third season, the vaccine’s efficacy was 48% against RSV-LRTD.
According to GSK, these results demonstrate efficacy against various RSV subtypes in older adults, specifically those aged 70-79, and in those with certain underlying medical conditions.
Safety and reactogenicity data are consistent with previous Phase 3 results.
GSK chief scientific officer Tony Wood said: “We are excited by these new data which show that a single dose of Arexvy could help protect millions of older adults at risk of RSV disease over three seasons to benefit public health.
“This is the only RSV vaccine with efficacy and safety data available through three full seasons. We will continue to provide data on longer term follow-up to help recommending bodies determine future revaccination schedules.”
The British drugmaker plans to continue providing long-term follow-up data.
In May 2023, the vaccine received US Food and Drug Administration (FDA) approval for preventing LRTD caused by RSV in individuals aged 60 and older. Since then, it has been approved in 50 countries, including Europe and Japan, for the same age group.
Additionally, the vaccine is approved in the US and the European Union (EU) for individuals aged 50-59 with certain underlying medical conditions.
Regulatory reviews for this extended indication are ongoing in other countries, including Japan.
