Philadelphia, PA – GSK has released promising new data from the AReSVi-006 Phase III trial, which evaluated the efficacy and safety of a single dose of AREXVY, the world’s first Respiratory Syncytial Virus (RSV) vaccine, in preventing lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older. The data, spanning three full RSV seasons, includes results for adults at increased risk due to underlying health conditions.
The trial results show that a single dose of AREXVY provided a clinically meaningful cumulative efficacy of 62.9% against RSV-related LRTD (97.5% CI, 46.7-74.8) and 67.4% against severe RSV-LRTD (95% CI, 42.4-82.7) across three RSV seasons. In the third season alone, the vaccine demonstrated 48.0% efficacy against RSV-LRTD (95% CI, 8.7-72.0). These findings are based on the analysis of data from 24,966 adults aged 60 years and older.
Safety and reactogenicity findings were consistent with earlier data from the Phase III program, confirming the vaccine was generally well tolerated. The most common adverse events reported within four days of vaccination included injection site pain, fatigue, muscle aches, headache, and joint pain.
AREXVY's efficacy was consistent across various RSV subtypes and populations, including adults aged 70-79 and those with underlying medical conditions such as COPD, asthma, and chronic heart failure, which place them at greater risk for severe RSV outcomes. Given that RSV can exacerbate these conditions and lead to severe health complications, the vaccine's protection over three seasons is expected to significantly impact public health.
“The potential health impact of a single dose of AREXVY protecting older adults for three RSV seasons is substantial, especially given the increased risk that RSV poses to this population,” said Tony Wood, Chief Scientific Officer at GSK. “This is the only RSV vaccine with safety and efficacy data extending over three seasons. We remain committed to sharing further data on long-term protection and revaccination schedules to support public health decisions.”
RSV is a highly contagious virus that affects the lungs and respiratory passages, with an estimated 64 million people globally contracting RSV each year. Adults, particularly those with comorbidities or compromised immune systems, face heightened risks of severe outcomes, including hospitalization and death. In the U.S. alone, approximately 177,000 adults aged 65 and older are hospitalized annually due to RSV, with an estimated 14,000 deaths resulting from these cases.
GSK will continue to share long-term data on efficacy, immune response, and revaccination to inform future immunization guidelines. The results highlight the potential of AREXVY to provide year-round protection for older adults and help prevent RSV-related complications.
