GSK’s RSV vaccine approved by EC for older adults

GSK’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older.

The EC's decision, which follows a recent recommendation from the European Medicines Agency’s human medicines committee, makes Arexvy the first RSV vaccine for older adults to be granted European Marketing Authorisation.

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 high 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.

GSK’s EU application was supported by positive results from its phase 3 AReSVi-006 trial, in which the vaccine showed 82.6% overall efficacy against RSV-LRTD in adults aged 60 years and older – the trial's primary endpoint.

Positive vaccine efficacy was also observed in those with comorbidities of interest, such as certain cardiorespiratory and endocrino-metabolic conditions, underlining the potential impact of the candidate on populations most at risk of severe RSV outcomes.

Tony Wood, chief scientific officer at GSK, said: “Thousands of older adults across Europe suffer serious respiratory illness due to RSV each year. This authorisation for Arexvy means eligible adults can be vaccinated against RSV disease for the first time."

The company said it expects the vaccine to be available before the next RSV season, which typically starts in autumn.

"Our strong manufacturing capability and scale, including from our vaccine manufacturing site in Belgium, means we are ready to deliver the vaccine as countries begin to launch,” Wood said.

The approval comes just over a month after Arexvy was approved in the US for the same patient population, making it the world’s first RSV vaccine to be approved for older adults.

A similar vaccine from Pfizer, also for adults aged 60 years and older, was approved in the US a few weeks later.

The US Centers for Disease Control and Prevention’s advisory committee is set to meet later this month to discuss the vaccines which, pending sign off, are expected to be available in the US before the next RSV season.