GSK Reports Positive Data for Arexvy RSV Vaccine Across Three Seasons

GSK plc has unveiled new findings from its AReSVi-006 phase III trial, assessing the effectiveness of a single dose of Arexvy, a respiratory syncytial virus (RSV) vaccine, in adults aged 60 and older. This includes those at heightened risk due to pre-existing medical conditions. The data, covering three complete RSV seasons, will be presented at the CHEST 2024 Annual Meeting organized by the American College of Chest Physicians.

Arexvy, notable for being the world's first RSV vaccine, was initially approved based on its exceptional efficacy in older adults. The latest results reveal that a single dose of GSK’s RSV vaccine maintains a robust efficacy over three RSV seasons. Specifically, the vaccine showed an efficacy rate of 62.9% against lower respiratory tract disease (LRTD) caused by RSV and 67.4% against severe forms of RSV-LRTD. In the third season alone, the vaccine's efficacy was 48.0% against RSV-LRTD.

These findings encompass efficacy against various RSV subtypes and in older adults with certain underlying medical conditions. Given that RSV can exacerbate these conditions and potentially lead to hospitalizations, the cumulative efficacy over multiple seasons is significant. This sustained efficacy provides healthcare professionals the flexibility to administer the vaccine year-round. GSK plans to continue sharing data on efficacy and immune response to inform future revaccination schedules.

RSV is a highly contagious virus that affects the lungs and breathing passages, impacting approximately 64 million people globally each year. Adults are particularly at risk due to factors like comorbidities, compromised immune status, or advanced age. The virus can worsen conditions such as COPD, asthma, and chronic heart failure, leading to severe outcomes like pneumonia, hospitalization, and death. Annually, RSV causes over 465,000 hospitalizations and 33,000 deaths in adults aged 60 and older in high-income countries.

Tony Wood, Chief Scientific Officer at GSK, expressed enthusiasm over the new data, highlighting that a single dose of Arexvy could protect millions of older adults over three seasons, benefiting public health significantly. He emphasized that this is the only RSV vaccine with comprehensive efficacy and safety data available over such an extended period. GSK will persist in providing long-term follow-up data to help guide future revaccination schedules.

Safety and reactogenicity data from the trial were consistent with earlier results from the phase III program. In the first season, the vaccine was generally well-tolerated, with the most common adverse events being injection site pain, fatigue, muscle aches, headache, and joint pain within four days of vaccination.

In addition to its presentation at the CHEST 2024 Annual Meeting, the data will be submitted for peer-reviewed publication and regulatory review.

The AReSVi-006 trial is a randomized, placebo-controlled, double-blind, multi-country phase III study designed to evaluate the efficacy of a single dose of GSK's adjuvanted RSV vaccine in adults aged 60 and above over three years. About 25,000 participants from 17 countries were enrolled. The primary endpoint was vaccine efficacy against RSV-LRTD after one season, with results published in the New England Journal of Medicine in February 2023. Secondary endpoints included vaccine efficacy after two and three RSV seasons and following annual revaccination.

GSK's RSV vaccine contains recombinant RSV glycoprotein F stabilized in the prefusion conformation, combined with the proprietary AS01E adjuvant. First approved by the US FDA in May 2023 for preventing LRTD caused by RSV in individuals 60 years and older, the vaccine has since received approvals in 50 countries, including Europe and Japan, for the same age group. It is also approved in the US and EU for individuals aged 50-59 at increased risk due to specific medical conditions. Regulatory reviews for this indication are ongoing in other countries, including Japan.

In summary, GSK’s new data reinforces the efficacy and safety of Arexvy in protecting older adults against RSV over multiple seasons, highlighting its potential to significantly impact global public health.

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