Seqirus Receives Health Canada Approval for Expanded Age Indication of Its Cell-Based Quadrivalent Influenza Vaccine for People as Young as Six Months

MONTREAL, March 28, 2022 /CNW/ -- Seqirus, a global leader in influenza prevention, announced today that it has received Health Canada approval of FLUCELVAX^® QUAD (Influenza Vaccine), its cell-based quadrivalent influenza vaccine for an expanded age indication for children as young as six months old.¹ With this approval, FLUCELVAX^® QUAD, the first cell-based influenza vaccine available in Canada, is now indicated for everyone eligible to receive an influenza vaccine in Canada.²

FLUCELVAX® QUAD

A Phase 3 clinical study supported the expanded age indication, demonstrating that FLUCELVAX^® QUAD was as safe and immunogenic as a standard quadrivalent seasonal influenza vaccine (QIV) in children six months to <4 years of age during the 2019/20 influenza season in the U.S.³ These data represent the first Phase 3 study of a cell-based influenza vaccine in this population.

"Young children – especially those younger than two – are at a high risk of complications from influenza, which is why annual vaccination is critical for this age group," said Dr. Rupesh Chawla, Pediatric Infectious Disease Specialist. "The clinical study data for FLUCELVAX^® QUAD submitted in support of this approval demonstrate why this vaccine is an important new option to help protect Canadians aged six months and older."

The Canadian Pediatric Society (CPS) encourages annual influenza vaccinations for all children and youth six months or older.⁴ CPS agrees with the National Advisory Committee on Immunization's (NACI) recommendation of using a quadrivalent vaccine containing two strains of influenza A and both lineages of influenza B for children and adolescents, as influenza B causes more mortality and morbidity in children than in adults.³

"Influenza vaccination has always offered a way to minimize the burden of disease on the healthcare system, which has proven to be more important than ever during the COVID-19 pandemic," said Gillian Stafford, Canada Commercial Director, Seqirus. "We continue to remain focused on our public health imperative to help protect as many people as possible against influenza, especially children and people at increased risk of serious disease."

About Seasonal Influenza

Influenza is a common, contagious seasonal respiratory disease and can cause mild to severe illness, which can result in hospitalization or death.⁵ Adults may spread influenza to others from 1 day before symptoms begin to approximately 5 days after symptoms start.⁵ Children and people with weakened immune systems may be infectious longer.

Influenza is related to an average of 12,200 hospitalizations and approximately 3,500 deaths each year in Canada.⁵ Canada's National Advisory Committee on Immunization (NACI) recommends annual influenza vaccination for all individuals six months of age and older.⁵ Further, NACI recommends including all children between 6 and 59 months of age among the particularly recommended recipients of the influenza vaccine.⁵

NACI recommends that healthcare providers in Canada offer the seasonal influenza vaccine as soon as feasible after it becomes available in the fall, since seasonal influenza activity may start as early as October in the Northern Hemisphere.⁵

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers globally, Seqirus is a significant contributor to influenza prevention globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia and leading R&D capabilities, Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries worldwide.

About CSL

CSL (ASX: CSL) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our two businesses, CSL Behring and Seqirus – provides life-saving products to more than 100 countries and employs more than 27,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enable us to identify, develop and deliver innovations so our patients can live life to the fullest. For more information about CSL Limited, visit www.csl.com.

For more information, visit www.seqirus.com and www.csl.com.

Forward-Looking Statements

This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

CAN-QIVc-22-0002

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¹ FLUCELVAX^® QUAD Product Monograph (March 2022). https://pdf.hres.ca/dpd_pm/00065002.PDF. Accessed March 2022.
² National Advisory Committee on Immunization (2021). Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine for 2021–2022. Retrieved from https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/canadian-immunization-guide-statement-seasonal-influenza-vaccine-2021-2022.html. Accessed March 2022.
³ Essink, B., Herringa, M., Jeanfreau, R., et al. (2021). Immunogenicity and Safety of Cell-derived Quadrivalent Influenza Vaccine in Children 6 through 47 Months of Age: A Randomized Controlled Non- Inferiority Trial. Presented at Pediatric Academic Societies 2021. Accessed March 2022.
⁴ Canadian Pediatric Society (2021). Vaccine recommendations for children and youth for the 2021/2022 influenza season. Retrieved from https://cps.ca/documents/position/vaccine-recommendations-2021-2022-influenza-season. Accessed March 2022.
⁵ Government of Canada. (2020). Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine for 2020–2021 Retrieved from: https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/canadian-immunization-guide-statement-seasonal-influenza-vaccine-2020-2021.html. Accessed March 2022.

SOURCE Seqirus Canada