GSK announced in October 2024 that data from the AreSVI-006 (Adult Respiratory Syncytial Virus) Phase III trial of Arexvy indicate that a single dose could offer protection for three RSV seasons. Arexvy is the world’s first RSV vaccine, first approved by the United States FDA in May 2023 for the prevention of lower respiratory tract disease (LRTD) caused by RSV in older adults. The latest trial evaluates the efficacy of a single dose of the recombinant, adjuvanted vaccine against LRTD caused by RSV in adults aged 60 years and older.
RSV is a “common contagious virus” that affects an estimated 64 million people of all ages globally each year. Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age. RSV causes over 465,000 hospitalisations and 33,000 deaths in adults aged 60 and older in high-income countries.
Clinically meaningful efficacy
The results suggest that after a single dose of the vaccine, cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD compared to placebo. In the third season, vaccine efficacy was 48.0% against RSV-LRTD. The data include efficacy against different RSV subtypes, in adults between 70 and 79 years of age, and those with 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.”
Another benefit of this protection is that healthcare professionals might have flexibility to administer the vaccine year-round. Over time, revaccination is “expected to be required to maintain an optimal level of protection”. Therefore, GSK will continue to share efficacy and immune response data to inform decisions on immunisation schedules and future revaccination.
GSK’s Chief Scientific Officer Dr Tony Wood is excited by the data, which show that a single dose could “help protect millions of older adults” 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.”
We look forward to hearing from senior representatives of GSK, including for perspectives on directing vaccine development for older populations, at the Congress in Barcelona this month. Get your tickets to join us here, and don’t forget to subscribe to our weekly newsletters here!
