GSK shares positive data for RSV vaccine
GSK have announced new positive data from the AReSVi-006 phase 3 trial which assessed the efficacy of a single dose of Arexvy, the company’s respiratory syncytial virus (RSV) vaccine, against lower respiratory tract disease (LRTD) caused by RSV in adults over the age of 60 across multiple RSV seasons.
The trial showed that one dose of the vaccine was efficacious against both RSV-LRTD and severe LRTD over two full RSV seasons. The vaccine had an 82.6% efficacy against RSV-LRTD in its first season, with this decreasing slightly to 77.3% mid-season two. For severe LRTD the season one efficacy was 94.1% and its mid-season two efficacy was 84.6%. Adults with underlying comorbidities reported a similar pattern of efficacy, demonstrating the benefit of this vaccine within vulnerable populations.
As well as its efficacy, the trial assessed the impact of annual revaccination, finding that cumulative efficacy over two seasons in participants who had a second dose was 67.1%, suggesting that revaccination at 12 months is not necessary. The company aims to continue to assess further revaccination options and optimal timings for revaccination.
Tony Wood, GSK’s chief scientific officer, commented: “Our goal is to provide a high level of protection for older adults most at risk from RSV. These data show the efficacy of a single dose of our vaccine over two RSV seasons against RSV-LRTD, including in the populations most at risk due to age or underlying medical conditions. This reinforces our confidence in its potential to make a significant public health impact. We look forward to discussing these results with regulators and vaccine recommending bodies and to collecting more data from the ongoing clinical development programme.”
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