PHILADELPHIA, PA — GSK plc (LSE/NYSE: GSK) has released new data from the AReSVi-006 Phase III trial, demonstrating the efficacy and safety of its RSV vaccine, AREXVY, over three full RSV seasons in adults aged 60 and above. This landmark trial provides compelling evidence of the vaccine’s effectiveness in reducing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).
AREXVY, the world’s first RSV vaccine, initially received approval due to its exceptional performance in older adults, including those at increased risk due to underlying health conditions. The recent findings show that a single dose of AREXVY maintains a cumulative efficacy of 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD over three seasons. The vaccine’s performance in the third season remained significant, with a 48% efficacy rate.
GSK’s Chief Scientific Officer, Tony Wood, highlighted the impact of these findings, stating, “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.”
The trial also confirmed that the vaccine is well-tolerated, with adverse reactions primarily including injection site pain, fatigue, and muscle aches. Safety and reactogenicity data align with previous trials, reinforcing AREXVY’s reliability as a protective measure against RSV.
RSV is a highly contagious virus that affects the respiratory system, posing significant risks for older adults, especially those with conditions like COPD, asthma, and heart failure. Each year, approximately 177,000 adults aged 65 and older are hospitalized in the U.S. due to RSV, with an estimated 14,000 fatalities.
Approved by the U.S. FDA in May 2023, AREXVY is also sanctioned for use in Europe, Japan, and 48 other countries for individuals 60 years and older, and in the U.S. and EU for those aged 50-59 with increased risk factors. Regulatory reviews for expanded use are ongoing globally.
The release of these new data highlights AREXVY’s potential to significantly reduce the burden of RSV in older populations, offering a viable option for year-round vaccination. GSK plans to continue sharing long-term efficacy data to guide health authorities in developing future vaccination schedules.
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