GSK’s RSV vaccine approved by FDA for older adults

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

The US Food and Drug Administration’s (FDA) decision makes Arexvy the first RSV vaccine for older adults to be approved anywhere in the world.

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 170,000 hospitalisations and approximately 14,000 deaths each year in the US.

The company’s 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.

The Advisory Committee on Immunization Practices will make recommendations next month on the appropriate use of the vaccine, which is expected to be available for older adults in the US before the 2023/24 RSV season.

The approval comes less than a week after the European Medicines Agency’s human medicines committee recommended the vaccine for this same patient population. The final decision from the European Commission is expected in the coming months, while regulatory reviews are ongoing in Japan and several other countries.

GSK’s chief scientific officer, Tony Wood, said: “Today marks a turning point in our effort to reduce the significant burden of RSV… Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.”

A clinical trial that aims to expand the population who may benefit from RSV vaccination into adults aged 50 to 59 years is fully recruited, the company said, with results expected this year.