GSK has shared positive results from a late-stage trial of its respiratory syncytial virus (RSV) vaccine in adults aged 50 to 59 years, including those with certain underlying medical conditions.
RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, certain populations are at a higher risk for severe disease, such as older adults, the immunocompromised and those with underlying medical conditions.
Arexvy has already been approved in the US, Europe and several other countries to protect adults aged 60 years and older against RSV-caused lower respiratory tract disease (LRTD).
Results from a phase 3 trial have now shown that Arexvy elicited an immune response in adults aged 50 to 59 at an increased risk of RSV disease, including those with chronic pulmonary disease, cardiovascular disease, kidney disease, liver disease or diabetes, that was non-inferior to that observed in adults aged 60 and above.
The co-primary endpoint was also met for the broader group of adults in this age group, GSK said, adding that safety and reactogenicity data was consistent with results from the initial phase 3 programme of Arexvy.
Final results from the trial will be presented at an upcoming medical conference and the company has outlined that the data will be submitted to regulators, including the US Food and Drug Administration, to support potential label expansions for the vaccine.
Tony Wood, chief scientific officer at GSK, said: “This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD.
“We will submit this data for regulatory review as quickly as possible with the goal of offering adults in this age group the option of a vaccine for the first time.”
GSK’s original application for the use of Arexvy in adults aged 60 years and older 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 this age group.
Positive vaccine efficacy was also observed in those with co-morbidities of interest, such as certain cardiorespiratory and endocrino-metabolic conditions, which the company said reinforces the impact the vaccine could have on those most at risk of severe RSV outcomes.