Results for GSK’s RSV vaccine candidate published in New England Journal of Medicine

GSK’s respiratory syncytial virus (RSV) vaccine candidate met its phase 3 primary endpoint of efficacy against RSV-lower respiratory tract disease (LRTD) in adults aged 60 years and older, according to results recently published in the New England Journal of Medicine.

There are currently no vaccines approved anywhere in the world for RSV, a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can be dangerous, especially for infants and older adults.

RSV infections in older adults account for approximately 60,000 to 160,000 hospitalisations and 6,000 to 10,000 deaths in the US each year, according to the Centers for Disease Control and Prevention.

“Although RSV often results in mild symptoms, it can have devastating consequences for older adults and has a global burden that can approach that of seasonal influenza,” said Professor Martinón-Torres, coordinator of the vaccine clinical trials unit at the Instituto de Investigación Sanitaria de Santiago in Spain.

GSK’s ongoing AReSVi-006 trial showed that vaccine efficacy against RSV-LRTD was 82.6% over a median follow-up of 6.7 months, with seven cases in the vaccine group and 40 in the placebo.

Efficacy against severe RSV-LRTD, defined as LRTD with at least two lower respiratory signs or assessed as severe by the investigator and confirmed by the external adjudication committee, was 94.1%.

Positive vaccine efficacy was also observed in participants with comorbidities of interest, underlining the potential impact of the candidate on populations most at risk of severe RSV outcomes.

Tony Wood, chief scientific officer at GSK, said the company was “delighted” at the publication of the data.

“We look forward to making the vaccine available as quickly as possible, pending regulatory decisions, and sharing more data from our ongoing clinical development programme as we work to get ahead of this potentially debilitating virus,” he said.

According to a statement from GSK, the company remains ‘on track’ to supply the vaccine candidate ahead of the 2023-24 northern hemisphere RSV season, pending regulatory decisions in the US, EU, Japan and other countries.

Pfizer and Moderna also have their own RSV vaccines for older adults in phase 3 clinical development, both of which have demonstrated positive results in recent months.