GSK’s Arexvy, a recombinant RSV vaccine with the AS01E adjuvant, has been approved in Canada for preventing lower respiratory tract disease (LRTD) caused by RSV in adults aged 50-59 at increased risk.
The vaccine was initially approved for adults aged 60 and older. Canada’s National Advisory Committee on Immunization (NACI) strongly recommends it for adults aged 75 and above, as well as for those aged over 60 in nursing homes and chronic care facilities.
NACI also suggests that adults aged 60-74 may consider RSV vaccination after consultation with their healthcare provider.
The expanded age indication is based on positive results from a Phase 3 placebo-controlled, observer-blind, randomised, multi-country immunogenicity trial.
The study evaluated the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at higher risk for RSV-LRTD due to underlying health conditions.
GSK interim country medical director Michelle Horn said: “The natural age-related decline in immune function we all experience, which can increase our vulnerability to viruses like RSV, becomes more evident the older we get.
“Not surprisingly, incidence of RSV-associated hospitalisations in adults starts to increase at the age of 50.
“For adults with underlying medical conditions, RSV can worsen these conditions and lead to serious consequences.
“We are proud to be the first to provide a vaccine to help protect Canadians aged 50-59 at increased risk of lower respiratory tract disease caused by RSV.”
The expanded age indication for Arexvy in Canada follows similar approvals in the US and the European Union (EU).
In August, the European Commission approved Arexvy for adults aged 50-59 at increased risk of RSV-LRTD.
GSK has also submitted regulatory filings to extend its RSV vaccine to adults aged 50-59 at increased risk in Japan and addiitonal regions, with decisions currently under review.
Ongoing trials are assessing the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and older, with results anticipated later in 2024.
The safety and efficacy of Arexvy in these groups are still under investigation, and approval has not yet been granted in any country for this age group.
