GSK's Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults approved in Canada
- Canadians aged 60 years and older can now better protect themselves against RSV disease
- Approval of Arexvy was based on a comprehensive Phase III clinical trial program that showed high vaccine efficacy of 82.6% for prevention of lower respiratory tract disease caused by RSV in older adults, and 94.6% efficacy in those with underlying medical conditions
- Vaccine availability in Canada expected ahead of the 2023/24 peak RSV season
MISSISSAUGA, ON, Aug. 4, 2023 /CNW/ - Arexvy (respiratory syncytial virus vaccine - recombinant, AS01E adjuvanted) has been approved in Canada for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older.1 The approval of Arexvy builds on GSK's extensive portfolio of vaccines available to help protect people of all ages from a variety of infectious diseases and is the first RSV vaccine for older adults to be approved in Canada.
RSV is a common, contagious virus that affects the lungs and respiratory airways. The virus can affect all ages, but the impact of RSV in older adults is significant. RSV caused an estimated 470,000 hospitalizations and 33,000 deaths in those aged 60 years and above in high-income countries in 2019.2
Marni Freeman, Country Medical Director, GSK, 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."
RSV season in Canada is typically from October until May, with most cases occurring in the winter months.4 For most people, the virus causes cold-like symptoms, but for older adults and adults with certain health conditions it can lead to more serious infection and complications such as pneumonia, hospitalization and even death.5,6 Older adults are at greater risk due in-part to the natural decline in immune function with age. Underlying medical conditions such as diabetes, chronic heart and lung disease6 can be exacerbated by RSV, leading to severe outcomes.
Henry Roberts, Executive Committee Member, COPD Canada, said: "Even if people with COPD or other chronic conditions have been taking sufficient steps to manage their illness, RSV can still have a serious impact on their health. Until now, RSV was one of the major respiratory infectious diseases with no vaccine or specific treatment available for older adults. 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."
The approval of Arexvy, is based on positive data from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial, where the vaccine demonstrated high overall vaccine efficacy of 82.6% against RSV-Lower Respiratory Tract Disease (LRTD). A 94.6% efficacy was also observed against RSV-LRTD in adults with comorbidities. Vaccine efficacy against LRTD was also consistent across both RSV-A and RSV-B subtypes which both circulate concurrently during the RSV season (84.6% and 80.9% respectively).
Across multiple studies, the vaccine was generally well tolerated with an acceptable safety profile. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, and headache. These were typically mild to moderate and transient.
Approval of GSK's RSV older adult vaccine in Canada follows authorizations in the US, Europe and the UK. Regulatory reviews are ongoing in Japan and several other countries.
Arexvy is expected to be available in Canada ahead of the 2023/24 peak RSV season.
GSK's RSV older adult vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01E adjuvant. In Canada, Arexvy is indicated for the prevention of RSV-LRTD in individuals 60 years of age and older and is to be given intramuscularly as a single dose.1
The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.
The Product Monograph, posted at www.ca.gsk.com, should be consulted for complete administration and safety information. Prior to being posted online, the Product Monograph is also available by calling 1-800-387-7374.
RSV is a common contagious virus affecting the lungs and breathing passages.7 For adults 60 and older, data suggest an increased risk for severe RSV infection that can lead to hospitalization.8,9 Older adults are at high risk for severe disease due in part to age-related decline in immunity, and older adults with underlying conditions are at even greater risk for severe disease.6 RSV can exacerbate conditions, including chronic obstructive pulmonary disease (COPD), asthma, diabetes and congestive heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.6
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1 | Arexvy Product Monograph (2023), GSK. Available at: www.gsk.ca |
2 | Savic M, Penders Y, Shi T, Branche A, Pirçon J-Y. Respiratory syncytial virus disease burden in adults aged 60 years and older in high-income countries: a systematic literature review and meta-analysis. Influenza Other Respir Viruses 2022 November 11 (Epub ahead of print). [PMID: 36369772]. Accessed 6 December 2022. Available at: Respiratory syncytial virus disease burden in adults aged 60 years and older in high–income countries: A systematic literature review and meta–analysis - Savic - Influenza and Other Respiratory Viruses - Wiley Online Library |
3 | Statistics Canada. Demographic estimates by age and sex, provinces and territories. Available at: Population estimates on July 1st, by age and sex (statcan.gc.ca) |
4 | Government of Canada. Respiratory syncytial virus (RSV): For health professionals; https://www.canada.ca/en/public-health/services/diseases/respiratory-syncytial-virus-rsv/health-professionals.html#Surveillance (accessed May 3, 2023). |
5 | Centers for Disease Control and Prevention. Symptoms and Care of RSV. Accessed April 24, 2023. Available at: Symptoms and Care of RSV (Respiratory Syncytial Virus) | CDC |
6 | Centers for Disease Control and Prevention. RSV in Older Adults and Adults with Chronic Medical Conditions. Accessed April 24, 2023. Available at: https://www.cdc.gov/rsv/high-risk/older-adults.html |
7 | Canadian Lung Association. Respiratory Syncytial Virus (RSV). Accessed June 16, 2023. Available at: https://www.lung.ca/lung-health/lung-disease/respiratory-syncytial-virus-rsv. |
8 | Branche AR, Saiman L, Walsh EE, et al. Incidence of respiratory syncytial virus infection among hospitalized adults, 2017-2020. Clin Infect Dis 2022;74(6):1004-11. |
9 | Belongia EA, King JP, Kieke BA, et al. Clinical features, severity, and incidence of RSV illness during 12 consecutive seasons in a community cohort of adults ≥60 years old. Open Forum Infect Dis 2018;5(12):1-10. |
SOURCE GlaxoSmithKline Inc.
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