GlaxoSmithKline (GSK) has received approval for its vaccine, AREXVY, in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50 to 59 at increased risk for the disease.
This expanded age indication approval stems from the positive outcomes of a Phase III, placebo-controlled, observer-blind, randomised, multi-country immunogenicity trial.
The study evaluated the immune response and safety of the RSV vaccine in adults aged 50 to 59 and those with underlying medical conditions at increased risk for RSV-LRTD.
Regulatory submissions have also been made by the company to prolong the use of the vaccine to the same age group in Japan and other regions.
The decisions are currently under review by the respective regulatory bodies.
Further trials are underway to assess the vaccine’s immunogenicity and safety in adults aged 18 to 49 at increased risk, and immunocompromised adults aged 18 and above. The outcomes will be announced in late 2024.
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AREXVY was previously approved in Canada for use in adults aged 60 and above. It is recommended by the National Advisory Committee on Immunization (NACI) for all adults aged 75 and over, and for those in nursing homes and chronic care facilities aged 60 and older.
NACI also suggests that adults aged 60 to 74 may consider RSV vaccination after consulting with a healthcare provider.
The approval of AREXVY’s expanded age indication in Canada aligns with similar approvals in the European Union (EU) and the US.
GSK interim country medical director Michelle Horn stated: “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, the 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.”
GSK recently agreed to acquire Chimagen Biosciences’ CMG1A46, designed to target B cell-driven autoimmune diseases.
