Canada approves GSK's RSV vaccine for adults 50-59

GlaxoSmithKline (GSK) has secured the approval for its vaccine, AREXVY, in Canada, aimed at preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50 to 59 who are at an increased risk of the disease. This approval for expanded age indication follows positive results from a Phase III immunogenicity trial that was placebo-controlled, observer-blind, and conducted across multiple countries. The trial assessed the immune response and safety of the RSV vaccine in adults within the 50 to 59 age range, including those with underlying health conditions that elevate their risk for RSV-LRTD.

In addition to the Canadian approval, GSK has 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 authorities. GSK is also conducting further trials to evaluate the vaccine's immunogenicity and safety in adults aged 18 to 49 who are at increased risk, as well as in immunocompromised adults aged 18 and above. The outcomes of these studies are anticipated to be revealed by late 2024.

Previously, AREXVY had been approved in Canada for adults aged 60 and older. The National Advisory Committee on Immunization (NACI) recommends the vaccine for all adults aged 75 and above, and for those aged 60 and older residing in nursing homes and chronic care facilities. NACI also suggests that adults aged 60 to 74 consider RSV vaccination after consulting with a healthcare provider.

The recent approval of AREXVY for the expanded age indication in Canada is consistent with similar approvals in the European Union (EU) and the United States. Michelle Horn, GSK's interim country medical director, highlighted the increased vulnerability to viruses like RSV due to the natural age-related decline in immune function. She noted that the incidence of RSV-associated hospitalizations begins to rise at the age of 50 and that for adults with underlying medical conditions, RSV can exacerbate these conditions, leading to serious health outcomes.

In recent developments, GSK has also agreed to acquire Chimagen Biosciences’ CMG1A46, a product designed to target B cell-driven autoimmune diseases. This acquisition aligns with GSK's strategic efforts to enhance its portfolio and address a broader range of health challenges.

The expanded approval of AREXVY in Canada represents a significant step in the fight against RSV, particularly for adults at an increased risk. As further trials continue and additional regulatory approvals are pursued, GSK remains committed to providing effective solutions to prevent serious respiratory diseases and improve public health outcomes.