Sanofi to build new manufacturing facility in Toronto to strengthen domestic pandemic preparedness and increase global supply of high-dose influenza vaccine

• Sanofi announces investment of approximately $925 million (CAD) to build a new vaccine facility in Toronto to increase supply of its differentiated influenza vaccines in Canada, the United States, and Europe
• In partnership with the Governments of Canada, Ontario, and the City of Toronto, the new facility will enhance influenza pandemic preparedness efforts and vaccine manufacturing capacity
• FLUZONE^® High-Dose Quadrivalent has earned recommendations for use over standard-dose influenza vaccine in individual adults 65 years and older by the National Advisory Committee on Immunization (NACI) in Canadaⁱ

TORONTO, March 31, 2021 /CNW/ - Today, Sanofi announced an investment of approximately $925 million (CAD) in a new vaccine manufacturing facility at its existing site in Toronto, Canada. The investment in a new facility will provide additional antigen and filling capacity for Sanofi's FLUZONE^® High-Dose Quadrivalent influenza vaccine, increasing supply availability in Canada, the United States, and Europe.

"As a leading vaccines Company, we continuously look ahead to address the fast-growing demand for those influenza vaccines that have demonstrated clinical superiority against standard-dose vaccines. This new investment to produce FLUZONE^® High-Dose Quadrivalent will help ensure more seniors around the world are better protected against influenza. In addition, it will be a key resource to assist against future pandemics," said Paul Hudson, Chief Executive Officer, Sanofi. "We welcome the ongoing partnership with the Canadian authorities, who supported us to make today's great news a reality; this will make the country, which has a strong legacy in vaccines research and development, one of our key hubs in our effort to protect and improve human health across the globe."

In addition to producing Sanofi's FLUZONE^® High-Dose Quadrivalent influenza vaccine, this new manufacturing facility will strategically grow Canada's bio-manufacturing sector and install industrial scale capacity to strengthen Canada's preparedness for future pandemics. 

"Today's announcement demonstrates Canada's ability to attract foreign investment and to develop facilities with made-in-Canada solutions. This once-in-a-generation investment shows our government's commitment to rebuilding Canada's domestic biomanufacturing sector, focusing on both short-term strategic solutions and a long–term vision. By investing in this project, our government is helping to keep expertise in Canada, creating and maintaining highly skilled jobs, and securing the health and safety of Canadians. By fostering an environment where companies can invest and grow, leading life sciences firms like Sanofi are increasingly looking to this country to establish their manufacturing facilities."  – The Honourable François-Philippe Champagne, Minister of Innovation, Science and Industry

"This is a critical investment as it will create 300 high quality jobs and increase Ontario's capacity to manufacture important vaccines. By supporting companies like Sanofi we will continue to strengthen our excellent pharmaceutical sector and ensure we are prepared for future public health events with Made in Ontario products."  – The Honourable Doug Ford, Premier of Ontario

"This historic investment in Canadian life sciences cements our place as a leading manufacturer of vaccines in Canada and worldwide," said Fabien Marino, Vice President Industrial Affairs and Toronto Site Head. "With the help of our government partners, bringing this new facility on Canadian soil will increase domestic vaccine manufacturing capacity, strengthen future national pandemic preparedness efforts and bolster worldwide supply of our differentiated influenza vaccines."

Following design, construction, testing, and qualification of the facility and equipment, the new Toronto Site facility will be operational by 2026. Currently, Sanofi Pasteur's Toronto Site manufactures millions of doses of vaccines annually that help protect against pertussis, polio, diphtheria, and tetanus, among others, for more than 60 countries worldwide – including Canada. 

Additional Quotes

"It has never been more critical that we build up our domestic production capacity to supply Ontario and all of Canada with flu vaccines. Ontario is the economic engine of Canada, and we can make anything here with our skilled workforce, life sciences sector and strong supply chains," said The Honourable Vic Fedeli, Ontario Minister of Economic Development, Job Creation and Trade. "This partnership will build on Ontario's bio-manufacturing capacity, save lives, create new jobs, and, help prepare us for any future pandemic emergency."

"The expansion of Sanofi's Toronto Site is a true testament to the strength of Toronto's medical and healthcare sector. This new vaccine manufacturing facility in Toronto will not only give confidence to Canadians that work is underway to address the ongoing need for vaccines now and in the future, but that Toronto is a city in which businesses can grow and thrive. I want to thank everyone involved including my colleague Deputy Mayor Michael Thompson for playing a role in bringing this partnership to fruition and helping us improve our ability to create vaccines domestically which will ensure that we are prepared in the future." – His Worship, John Tory, Mayor of Toronto

About the Sanofi Pasteur Canadian Facilities

Founded as the Connaught Antitoxin Laboratories and University Farm in 1917, Sanofi Pasteur's Canadian facility has supported numerous scientific breakthroughs while making significant public health contributions. One hundred years ago, the Toronto Site was home to some of the initial research for the discovery of insulin, as well as large-scale commercial insulin production for all of Canada until the 1980s. It also produced a highly accessible antitoxin for diphtheria, the leading public health threat to Canadian children in the early 1900s and was an important partner in the eradication of polio in North America and smallpox around the world.

In 2018, Sanofi made another historic investment at the Toronto Site, to establish one of the most advanced vaccine bulk manufacturing facilities in the world. At the time, this was the largest investment ever made by Sanofi globally into a single facility, more than $500M (CAD). This manufacturing facility will produce seven antigens: five-component-pertussis, plus diphtheria and tetanus, to help meet global demand for more life-saving vaccines for children and adults worldwide. License approval for Canada and the United States is expected in 2024 for the five-component-pertussis and in 2025 for diphtheria and tetanus. Link to press release.

About FLUZONE^® High-Dose Quadrivalent

FLUZONE^® High-Dose Quadrivalent influenza vaccine is available in the US and some European countries and will be available in Canada in 2021 for use in adults 65 years and older. FLUZONE^® High-Dose Quadrivalent is also approved in Australia. This vaccine has received marketing authorizations in 25 countries in Europe (under the name Efluelda™ outside of the UK). Older adults have an elevated risk of pneumoniaⁱⁱ, heart attackⁱⁱⁱ and stroke^iv following influenza and are at the greatest risk of influenza-related hospitalization and death. The high-dose influenza vaccine has four times more antigen than standard-dose vaccine and is intended to give people 65 years and older a better immune response and therefore, better protection against influenza.^v NACI has recommended that high-dose influenza vaccine should be used over standard-dose influenza vaccine for individual adults 65 years and older.ⁱ

Sanofi Pasteur's commitment to improve influenza prevention

Sanofi Pasteur is committed to researching and developing differentiated solutions to protect people of all ages and risk groups against influenza and its complications.

As the largest manufacturer of influenza vaccines in the world, Sanofi Pasteur produces influenza vaccines each year across five international sites: Swiftwater (Pennsylvania, United States), Pearl River (New York, United States), Val-de-Reuil (France), Ocoyoacac (Mexico) and Shenzhen (China).  

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

_______________________________
^i	National Advisory Committee on Immunization (NACI). Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine for 2021 2022. March 2021. https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/healthy-living/canadian-immunization-guide-statement-seasonal-influenza-vaccine-2020-2021/naci-2020-2021-seasonal-influenza-stmt-eng.pdf
^ii	An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI) - A Review of the Literature of High Dose Seasonal Influenza Vaccine for Adults 65 Years and Older https://www.canada.ca/content/dam/phac-aspc/migration/phac-aspc/naci-ccni/assets/pdf/influenza-vaccine-65-plus-vaccin-contre-la-grippe-65-plus-eng.pdf
^iii	Kwong JC, Schwartz KL, Campitelli MA, Chung H, Crowcroft NS, Karnauchow T, Katz K, Ko DT, McGeer AJ, McNally D, Richardson DC, Rosella LC, Simor A, Smieja M, Zahariadis G, Gubbay JB. Acute Myocardial Infarction after Laboratory-Confirmed Influenza Infection. N Engl J Med. 2018 Jan 25;378(4):345-353.https://www.nejm.org/doi/pdf/10.1056/NEJMoa1702090?articleTools=true
^iv	Warren-Gash C, Blackburn R, Whitaker H, McMenamin J, Hayward AC. Laboratory-confirmed respiratory infections as triggers for acute myocardial infarction and stroke: a self-controlled case series analysis of national linked datasets from Scotland. Eur Respir J. 2018 Mar 29;51(3):1701794. https://pubmed.ncbi.nlm.nih.gov/29563170/
^v	FLUZONE^®High-Dose Quadrivalent Product Monograph. Sanofi Pasteur Ltd. June 2020.

SOURCE Sanofi Canada

Media Relations Contact: Allison Reynolds, [email protected]