GSK's RSV Vaccine AREXVY Approved in Canada for Adults Aged 50-59
Key Insights
GSK's AREXVY vaccine has been approved in Canada for adults aged 50-59 at increased risk of lower respiratory tract disease (search) (LRTD) caused by RSV.
The approval is based on positive Phase III trial outcomes, which demonstrated the vaccine's immunogenicity and safety in the specified age group with underlying conditions.
Regulatory submissions are under review in Japan and other regions to extend the vaccine's use to the same age group, potentially expanding its availability.
GlaxoSmithKline (GSK) has secured approval in Canada for its respiratory syncytial virus (search) (RSV) vaccine, AREXVY, to prevent lower respiratory tract disease (search) (LRTD) in adults aged 50 to 59 who are at increased risk. This decision expands the vaccine's availability to a younger demographic facing heightened vulnerability to RSV-related complications.
The approval is based on data from a Phase III, placebo-controlled, observer-blind, randomised, multi-country immunogenicity trial. The study assessed the immune response and safety profile of AREXVY in adults aged 50 to 59, specifically focusing on individuals with underlying medical conditions that elevate their risk of RSV-LRTD.
Regulatory Submissions and Ongoing Trials
GSK has also submitted regulatory applications to extend the use of AREXVY to the same age group in Japan and other regions. These submissions are currently under review by the respective regulatory bodies. Further trials are underway to evaluate the vaccine's immunogenicity and safety in adults aged 18 to 49 at increased risk and immunocompromised adults aged 18 and above, with results expected in late 2024.
Previous Approvals and Recommendations
AREXVY was previously approved in Canada for adults aged 60 and over. The National Advisory Committee on Immunization (NACI) recommends it for all adults aged 75 and over, as well as 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.
Expert Commentary
GSK interim country medical director Michelle Horn noted, "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."
The approval of AREXVY's expanded age indication in Canada aligns with similar approvals in the European Union (EU) and the US, reflecting a global effort to protect older adults from the risks associated with RSV infection.