The approval was based on the overall Phase 3 trial in which Arexvy showed a high vaccine efficacy of 82.6% for LRTD prevention and 94.6% efficacy in those with underlying medical conditions
GSK vaccines headquarters in Belgium. (Credit: GSK plc)
GSK announced that Health Canada has approved Arexvy (respiratory syncytial virus vaccine – recombinant, AS01E adjuvanted) in Canada to prevent lower respiratory tract disease (LRTD) in individuals 60 years of age and older.
Arexvy has a combination of recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) with GSK’s patented AS01E adjuvant.
The approval was based on the overall Phase 3 clinical trial programme.
In the trial, Arexvy demonstrated a high vaccine efficacy of 82.6% for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in older patients.
The RSV vaccine also showed 94.6% efficacy in those with underlying medical conditions.
The vaccine was generally well tolerated and had an acceptable safety profile across various studies.
GSK country medical director Marni Freeman said: “A solution for RSV infection has been something scientists have been pursuing for decades. With the approval of Arexvy, we are excited to be able to offer an option to help protect the nearly 10 million Canadians aged 60 and older3 who are at risk of RSV disease.
“We’re hopeful that with a vaccine now available for older Canadians, the virus’ burden on our healthcare system will also be dramatically improved.
“We look forward to working with provincial, territorial, and national health authorities to ensure older Canadians at greatest risk of RSV infection can access the vaccine.”
The vaccine availability in Canada is expected ahead of the RSV season in 2023/2024.
GSK’s RSV older adult vaccine approval in Canada follows clearance in the US and Europe. Additionally, regulatory reviews are underway in Japan and several other countries.
COPD Canada executive committee member Henry Roberts said: “Having the opportunity to receive a vaccine that can prevent RSV infection for older Canadians, including those who are at higher risk of severe outcomes, is a welcome advancement and is a major step forward from a public health perspective.”
Last month, the pharmaceutical major secured approval from UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Arexvy to treat LRTD.