GSK’s Arexvy has been shown to protect older adults against respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD) over three full RSV seasons.
Results from the phase 3 AReSVi-006 trial showed that a single dose of the vaccine in adults aged 60 years and older yielded a cumulative efficacy of 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD compared to placebo over three seasons.
According to the new data presented at this year’s CHEST Annual Meeting, the vaccine’s efficacy in the third season was 48% against RSV-LRTD and 43.3% against severe RSV-LRTD.
Estimated to impact 64 million people globally every year, RSV is a common respiratory virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, certain groups are at a high risk of severe disease, including older adults, infants and immunocompromised individuals.
Arexvy is already approved to prevent RSV-LRTD in adults aged 60 years and older in 50 countries, including the EU and US. The vaccine was also recently approved by the European Commission and US Food and Drug Administration for use in individuals aged 50 to 59 years who are at an increased risk of RSV-LRTD due to certain underlying medical conditions, and GSK has filed regulatory submissions to extend the use of the vaccine to this population in other markets.
GSK noted that cumulative efficacy data over three RSV seasons could offer healthcare professionals the flexibility to administer Arexvy year-round, adding that it will continue to share efficacy and immune response data with recommending bodies to inform decisions on immunisation schedules and future revaccination.
Tony Wood, GSK’s chief scientific officer, said: “We are excited by this new data which shows 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.”
The company is also evaluating the vaccine in younger groups, including in higher-risk adults aged 18 to 49 years and in immunocompromised adults aged 18 and over, with readouts for these trials expected later this year.