This article was originally published on ContagionLive®.
GSK announces promising results for its respiratory syncytial virus (RSV) vaccine, Arexvy, for three seasons of RSV against RSV-related lower respiratory tract disease (RSV-LRTD) in adults aged 60 and over. The overall cumulative efficacy was 62.9%. This vaccine is the only one with efficacy and safety data available over three seasons, including in people who are at higher risk due to underlying health conditions. 1
The vaccine demonstrated cumulative efficacy of 62.9% against respiratory syncytial virus-related lower respiratory tract disease in older adults over three seasons. |Image credit: MargJohnsonVA – Stock.adobe.com
The study results were presented at the CHEST 2024 Annual Meeting and showed efficacy against severe RSV-LRTD of 67.4%. In the third season, vaccine efficacy against RSV-LRTD was 48% (95% CI, 8.7-72). The safety profile is consistent with previous phase 3 results, with injection site pain, fatigue, myalgia, headache, and joint pain within four days of vaccination as the most frequently reported side effects.
GSK will continue to provide long-term efficacy and immune response data to inform revaccination schedules. RSV affects an estimated 64 million people worldwide and can cause severe outcomes, resulting in more than 465,000 hospitalizations and 33,000 hospitalizations annually in adults over 60 in high-income countries. More than 100 people have died.
Tony Wood, GSK’s chief scientific officer, said in a statement: “Single-dose Alexby protects millions of older people at risk of RSV disease over three seasons and improves public health. “We are excited about these new data that show the potential for benefit.” “This is the only RSV vaccine with efficacy and safety data available through three seasons. We are providing data on long-term follow-up to help recommending agencies determine future revaccination schedules. We will continue to provide it.”
Arexvy was approved by the FDA in May 2023 to prevent RSV-LRTD in individuals age 60 and older. It has since been approved in 50 countries, including Europe and Japan. The approval was based on US Phase 3 trial data that showed 82.6% efficacy against RSV-related lower respiratory tract disease and 94.6% efficacy in patients with comorbidities. Arexvy combines a preF fusion protein with an AS01 adjuvant to enhance immune responses in the elderly population. 2
Ongoing research aims to provide further insight into the long-term efficacy of the vaccine and the potential need for re-vaccination.
References
GSK has announced positive data for its respiratory syncytial virus (RSV) vaccine, Arexvy, demonstrating protection across three RSV seasons. G.S.K. October 8, 2024. Accessed October 21, 2024. https://www.gsk.com/en-gb/media/press-releases/gsk-presents-positive-data-for-arexvy-its-rsv-vaccine-indicating -protection-over-three-rsv-seasons/ Cosdon, N. FDA approves GSK’s Arexvy as the world’s first RSV vaccine for older adults. infectious disease. May 3, 2024. Accessed October 21, 2024. https://www.contagionlive.com/view/fda-approves-gsk-s-arexvy-as-the-world-s-first-rsv-vaccine-for-older -Adult
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