Cumulative efficacy over three RSV seasons was clinically meaningful at 62.9% against RSV-LRTD after a single dose of the vaccine.
RT’s Three Key Takeaways:
- Sustained Efficacy: GSK’s Arexvy vaccine demonstrated cumulative efficacy of 62.9% against RSV-related lower respiratory tract disease (RSV-LRTD) and 67.4% against severe RSV-LRTD over three full RSV seasons in adults aged 60 and older.
- Consistent Safety Profile: The vaccine’s safety and tolerability remained consistent across all three seasons, with the most common side effects being mild reactions such as pain at the injection site, fatigue, and headache.
- Potential for Long-Term Protection: The data suggest that revaccination may be required over time to maintain optimal protection.
GSK plc announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy and safety of a single dose of Arexvy (respiratory syncytial virus vaccine, 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.
These data will be presented today at the CHEST 2024 Annual Meeting, organized by the American College of Chest Physicians.
Arexvy is the first RSV vaccine and was approved based on efficacy in adults aged 60 and older including those who are at increased risk due to certain underlying medical conditions.
Sustained Efficacy Across RSV Seasons
These latest 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 and 67.4% against severe RSV-LRTD compared to placebo. In the third season, the vaccine’s efficacy was 48.0% against RSV-LRTD.
Safety and reactogenicity data were consistent with previous results from the phase III program. In season one, the vaccine was generally well tolerated. The most frequently observed adverse events were pain at the injection site, fatigue, myalgia, headache, and arthralgia within four days of vaccination.
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 hospitalizations, 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 immunization schedules and future revaccination.
Long-Term Data
“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,” says Tony Wood, chief scientific officer at GSK, in a release.
In addition to the presentation at CHEST, the data will be submitted for scientific peer-reviewed publication and to regulators for review.
Photo caption: Arexvy RSV vaccine
File photo
