GSK’s RSV vaccine shows long-term efficacy in late-stage older adults study

GSK has shared positive new data from a late-stage study of its respiratory syncytial virus (RSV) vaccine in adults aged 60 years and older.

Results from the ongoing phase 3 AReSVi-006 trial show that a single dose of Arexvy is effective against RSV-caused lower respiratory tract disease (LRTD) and severe LRTD over two full RSV seasons.

A similar pattern of long-term vaccine efficacy was also observed in adults with underlying comorbidities and in advancing age, which the company says reinforces the impact the vaccine could have on those most at risk of severe RSV outcomes.

RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a higher risk for severe disease.

This is partly due to age-related decline in immunity. RSV can also exacerbate other conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure.

Overall, RSV infections in older adults account for over 270,000 hospitalisations and approximately 20,000 in-hospital deaths each year in Europe.

The European Commission approved Arexvy for the prevention of RSV-caused LRTD in adults aged 60 years and older earlier this month, making it the first RSV vaccine for older adults to be granted European Marketing Authorisation.

The decision was supported by positive results from AReSVi-006, in which the vaccine showed 82.6% overall efficacy against RSV-LRTD.

The vaccine was approved in the US the month prior for the same patient population, and regulatory reviews in Japan and other counties are ongoing.

Commenting on the latest results, GSK’s chief scientific officer, Tony Wood, said: “Our goal is to provide a high level of protection for older adults most at risk from RSV. This data shows 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.”