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Seqirus announces Health Canada approval of first cell-based seasonal influenza vaccine

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MONTREAL, Dec. 11, 2019 /CNW/ - Seqirus, a global leader in influenza prevention, announced today that its cell-based quadrivalent influenza vaccine (QIVc) has received approval from Health Canada for use in people 9 years of age and older. Marketed as FLUCELVAX® QUAD, the vaccine offers protection against four influenza virus strains — A(H3N2), A(H1N1) and two B virus strains

QIVc is produced using innovative cell-based technology and was first licensed in the U.S. in 2016.2 All four vaccine-viruses in FLUCELVAX ® QUAD are grown in MDCK cells, which eliminates the risk of egg adaptation during the manufacturing process.3 FLUCELVAX® QUAD may therefore offer a truer match to World Health Organization-recommended vaccine strains than traditional egg-based influenza vaccines, with the potential to provide better protection each season.4

"As the only global vaccine company solely dedicated to the prevention of influenza, Seqirus is proud to bring the first cell-based influenza vaccine to Canada," said Gillian Stafford, Commercial Operations Director, Canada, Seqirus. "The technology underpinning FLUCELVAX QUAD represents our ongoing commitment to protecting people and communities from seasonal influenza, global pandemic threats and the potentially devastating consequences of both."

Research has shown that some H3N2 viruses undergo changes when they are grown in eggs, leading to the hypothesis that these changes may reduce the effectiveness of standard egg-based influenza vaccines in H3N2-dominated seasons. A recent study has shown that the H3N2 strain changed during the egg manufacturing process seven out of ten years (2008-2018)5 and is one of the reasons why flu vaccine effectiveness against that strain has ranged from 7 per cent to 46 per cent during this time.6 It has also been shown that hospitalisation rates were higher in those years when H3N2 was the dominant circulating strain.7,8,9

Cell-based vaccines are currently being used in the United States, Australia and across Europe. In those countries with FLUCELVAX® QUAD, data related to the vaccine's effectiveness is encouraging," says Dr. Rupesh Chawla, Pediatric Infectious Disease Specialist. "Influenza continues to have a large impact on our health system, so it's promising to have a new vaccine option that will be able to benefit Canadians for years to come."

FLUCELVAX® QUAD was approved by Health Canada on the basis of immunogenicity and safety of the QIVc compared to a cell-based trivalent influenza vaccine.1

Recently published real-world effectiveness studies have suggested improved effectiveness over egg-manufactured vaccines during seasons that are dominated by H3N2 strains. 10,11,12

Seasonal influenza in Canada

Influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalisation and in some cases death. Because airborne or touch transmission to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease is highly contagious.13

During the 2018-19 flu season, Canada saw more than 39,000 cases of seasonal influenza.14 In an average flu season, 12,000 Canadians will be hospitalized and 3,500 Canadians will die.15 Despite the severity of the consequences of influenza, only 38.3% of Canadians received their seasonal influenza vaccine in the 2017-18 flu season.16 According to the Government of Canada, vaccination is still the most effective way to protect against the flu and flu-related complications.17

About Seqirus

Seqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 20,000 people with operations in more than 60 countries.

Seqirus was established on July 31, 2015 following CSL's acquisition of the Novartis influenza vaccines business. As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza and a transcontinental partner in pandemic preparedness.

Seqirus operates state-of-the-art production facilities in the U.S., the UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and a commercial presence in more than 20 countries.

For more information visit http://www.seqirus.com and http://www.csl.com.

1 FLUCELVAX® QUAD Product Monograph, November 22, 2019

2FLUCELVAX® QUADRIVALENT US Prescribing Information, Seqirus USA Inc. Revised 04/19

3Rajaram S., Van Boxmeer J., Leav B., et al. (2018). Retrospective evaluation of mismatch from egg-based isolation of influenza strains compared to cell-based isolation and the possible implications for vaccine effectiveness. Presented at IDWeek 2018, October 2018.

4Centres for Disease Control (CDC). Cell-Based Flu Vaccines. November 2016. https://www.cdc.gov/flu/protect/vaccine/cell-based.htm Accessed October 2018.

5Rajaram et al. Retrospective Assissment of the Antigenic Similarity of Egg-Propogates and Cell Culture-Propogated Reference A/H3N2 Influenza Viruses Compared with Circulating A/H3N2 Viruses Across Influenza Seasons 2003-2018.

6Belongia E. et al. Influenza Vaccine Effectiveness: Defining the H3N2 Problem. Clin Infect Dis. 2019 May 17

Belongia E. et al. Influenza Vaccine Effectiveness: Defining the H3N2 Problem. Clin Infect Dis. 2019 May 17

a.ca/content/dam/phac-aspc/migration/phac-aspc/publicat/ccdr-rmtc/14vol40/dr-rm40-17/assets/pdf/ccdrv40i17a02-eng.pdf

8Public Health Agency of Canada. Influenza in Canada 2010-2011. Season. 2013. Available at: http://publications.gc.ca/collections/collection_2015/aspc-phac/HP40-87-2013-eng.pdf

9CCDR. Statement on Seasonal Influenza vaccines for 2011-2012. Available at: http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/11vol37/acs-dcc-5/assets/pdf/acs-dcc-5-eng.pdf

10Eick-Cost AA et al. Relative Effectiveness of Cell-Based Influenza Vaccines Compared with Egg-Based Influenza Vaccines, Active Component U.S. Service Members, 2017–18 Season Presented at ICEID 2018; August 26-29, 2018; Atlanta, GA. p.109

11Boikos C et al. Effective of the Cell Culture – and Egg- Derived, Seasonal Influenza Vaccine during the 2017-2018 Northern Hemisphere Influenza Seasin. Presented at the National Foundation for Infectious Diseases 2018 Clinical Vaccinology Course; November 9-10, 2018; Bethesda, MD

12Izurieta HS et al. J Infect Dis. 2018;epub:1-10. (p. 4 -8)

13Health Canada. Flu (Influenza): For Health professionals. Retrieved from:https://www.canada.ca/en/public-health/services/diseases/flu-influenza/health-professionals.html. Accessed November 25, 2019

14Infection Prevention and Control Canada. https://ipac-canada.org/influenza-resources.php. Accessed November 11, 2019.

15Government of Canada. https://www.canada.ca/en/public-health/services/diseases/flu-influenza/health-professionals.html. Accessed September 17, 2019.

16Public Health Agency of Canada. http://publications.gc.ca/collections/collection_2019/aspc-phac/HP40-198-2018-eng.pdf. Accessed September 26, 2019.

17Government of Canada. https://www.canada.ca/en/public-health/services/diseases/flu-influenza/get-your-flu-shot.htmlAccessed November 9, 2019.

SOURCE Seqirus

For further information:

MEDIA CONTACT: Polina Miklush, Director, Communications, Seqirus, Polina.Miklush@Seqirus.com;

Emily Williams, H+K Strategies, (416) 413-4644, Emily.williams@hkstrategies.ca