Positive results for the vaccine against respiratory syncytial virus (Rsv), which demonstrate protection for three complete seasons even in people at greatest risk. The pharmaceutical group GSK today announced new data from the phase III AReSVi-006 (Adult Respiratory Syncytial Virus) study evaluating the efficacy of a single dose of Arexvy – adjuvanted, recombinant vaccine – against lower respiratory tract disease caused by the pathogen in adults aged 60 years and older, including those at greatest risk, for three full seasons. The data will be presented today at the Chest 2024 Annual Meeting, hosted by the American College of Chest Physicians.
Arexvy is the first Rsv vaccine in the world and was approved based on exceptional efficacy in adults aged 60 years and older. Today’s results indicate – the company highlights – that after a single dose of GSK’s Rsv vaccine, the cumulative efficacy over three complete respiratory syncytial virus seasons was clinically significant, leading to a 62.9% reduction against the disease of the lower respiratory tract from Rsv and 67.4% against severe lower respiratory tract disease compared to placebo. In the third season alone, the vaccine’s effectiveness was 48%.
These results highlight efficacy against different subtypes of Rsv, in older adults (70-79 years) and in those with certain underlying medical conditions. Because RSV can exacerbate medical conditions and even lead to hospitalizations, the three-season cumulative efficacy of RSV has the potential for a significant health impact. It could offer healthcare professionals the flexibility to administer the vaccine throughout the year. Over time, it is expected that revaccination will be necessary to maintain an optimal level of protection. GSK will continue to share data on efficacy and immune response, including after revaccination, with health authorities to help decide immunization and revaccination programmes.
The virus causes over 465 thousand hospitalizations and 33 thousand deaths in over 60s every year
RSV is a common contagious virus that affects the lungs and airways of approximately 64 million people of all ages worldwide each year. Causes over 465,000 hospital admissions and 33,000 deaths per year in adults aged 60 years and older in high-income countries
“We are excited by this new data demonstrating how a single dose of Arexvy could help protect millions of older adults at risk of RSV disease for three seasons to benefit public health. This is the only RSV vaccine with efficacy and safety data available for three full seasons. We will continue to provide long-term follow-up data to help health authorities inform future revaccination programmes,” says Tony Wood, Chief Scientific Officer, GSK.
“One dose of Arexvy has demonstrated efficacy in reducing Rsv disease in the lower airways for up to three seasons by 62.9%. Vaccination therefore provides clinically significant protection to adults over the age of 60, as well as patients with comorbidities who run a greater risk of developing serious illness, hospitalization or death from RSV”, comments Alberto Papi, one of the principal investigators of the AReSVi 006 pivotal study, professor of respiratory system diseases, University of Ferrara.
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