GSK’s RSV vaccine is the only RSV vaccine with efficacy and safety data available through 3 full seasons, including in people at increased risk
Safety and reactogenicity data are consistent with previous results from phase III programme
GSK will continue to provide data on longer term follow-up to help recommending bodies determine future revaccination schedules
GSK plc (LSE/NYSE: GSK) today announced 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).1 These data will be presented today at the CHEST 2024 Annual Meeting, organised by the American College of Chest Physicians.

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. Today's 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 (97.5% CI, 46.7-74.8, 48 of 12,468 vs 215 of 12,498) and 67.4% against severe RSV-LRTD (95% CI, 42.4-82.7, 15 of 12,468 vs 75 of 12,498) compared to placebo. In the third season, the vaccine’s efficacy was 48.0% against RSV-LRTD (95% CI, 8.7-72.0, 16 of 4,988 vs 61 of 10,031).

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. Since RSV can exacerbate medical conditions and potentially lead to hospitalisations, cumulative efficacy over three RSV seasons has the potential for significant health impact. It has the potential to offer health care professionals flexibility to administer the vaccine year-round. Over time, revaccination is expected to be required to maintain an optimal level of protection. GSK will continue to share efficacy and immune response data, including on revaccination, with recommending bodies to inform decisions on immunisation schedules and future revaccination.

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.2 Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age. RSV can exacerbate multiple conditions, including COPD, asthma, and chronic heart failure, and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.3 Each year RSV causes over 465,000 hospitalisations and 33,000 deaths in adults aged 60 and older in high-income countries.4

Tony Wood, Chief Scientific Officer, GSK, 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.”

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https://www.gsk.com/en-gb/media/press-releases/gsk-presents-positive-data-for-arexvy-its-rsv-vaccine-indicating-protection-over-three-rsv-seasons/