GlobeNewswire Inc | Mar 31, 2021 10:05AM EDT

March 31, 2021

Sanofi to build new facility in Canada to increase global availability of high-dose influenza vaccine

-- Sanofi announces investment of more than 600 million 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 and Ontario, and the City of Toronto, the new facility will also enhance influenza pandemic preparedness efforts -- Fluzone High-Dose Quadrivalent influenza vaccine has four times more antigen than standard-dose vaccine and is specifically designed to provide superior protection against influenza for older adultsi

PARIS March 31, 2021 Sanofi today announced an investment of more than 600 million 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 Sanofis Fluzone High-Dose Quadrivalent influenza vaccine, helping to increase 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. Fluzone High-Dose provides a long-term competitive advantage and this new investment will ensure more seniors around the world are better protected against influenza and its complications. 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 todays 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.

Franois-Philippe Champagne, Minister of Innovation, Science and Industry said, Todays announcement demonstrates Canadas ability to attract foreign investment and to develop facilities with made-in-Canada solutions. This once-in-a-generation investment shows our governments commitment to rebuilding Canadas domestic biomanufacturing sector, focusing on both short-term strategic solutions and a longterm 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,

Sanofi expects this new facility to be operational in 2026, following design, construction, testing and qualification of the facility and equipment.

Fluzone High-Dose Quadrivalent influenza vaccine is currently manufactured exclusively by Sanofi Pasteur, Sanofis vaccines global business unit, at its Swiftwater, Pennsylvania Site in the United States. Sanofi Pasteur has been continuously investing in expanding manufacturing capabilities for influenza vaccines. Two new, additional facilities in Swiftwater, Pa., US and Val-de-Reuil, France will start to operate in the coming years.

Editors Note: This investment in a new vaccine manufacturing facility further demonstrates Sanofis overall growth strategy, with vaccines contributing as a key growth driver through differentiated products, market expansion and new launches.

About Fluzone High-Dose Quadrivalent influenza vaccine

Fluzone High-Dose Quadrivalent influenza vaccine is available in the United States and some European countries, and will be available in Canada in 2021, for use in adults 65 years and older, and has also been approved in Australia. The vaccine has received marketing authorizations in 25 countries in Europe (under the name Efluelda outside of the UK) for use in adults 60 years of age and older. The high-dose vaccine has four times more antigen than standard-dose vaccine and is specifically designed to provide superior protection against influenza for older adults.ii Older adults have an elevated risk of pneumonia, heart attack and stroke following influenza and are at the greatest risk of influenza-related hospitalization and death.

Sanofi Pasteurs High-Dose influenza vaccine 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 Canadaiii, along with a recommendation for priority use in people 60years of age and older by Germanys Standing Committee on Vaccination (STIKO).iv Fluzone High-Dose Trivalent influenza vaccine demonstrated superior protection against influenza in adults aged 65 and above compared to standard-dose formulationv.

About the Sanofi Pasteur Canadian FacilitiesFounded 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 hundredyears ago, the TorontoSite was home tosome of the initial research for the discovery of insulin, as well aslarge-scale commercial insulin productionfor all of Canadauntil 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, at approximately 335 million. 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 the United States and Canada is expected in 2024 for the five-component-pertussis and in 2025 for diphtheria and tetanus.

Sanofi Pasteurs commitment to improve influenza prevention

As the leading manufacturer of influenza vaccines, Sanofi Pasteur is committed to researching and developing differentiated and proven solutions to protect people of all ages and risk groups against influenza and its complications.

During the 2020-2021 influenza season, Sanofi Pasteur supported health authorities in efforts to strengthen influenza vaccination campaigns in the unique context of the COVID-19 pandemic. Sanofi Pasteur delivered 20 percent more doses this year, reaching an unprecedented production level of 250 million doses, across its influenza vaccine portfolio. Eight countries in Europe, and Israel, procured Fluzone High-Dose Quadrivalent in 2020 through special importation to provide an additional protection to their older citizens

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



About Sanofi

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

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

Sanofi, Empowering Life



Investor Relations Contacts Paris Eva Schaefer-Jansen Arnaud Delepine Yvonne NaughtonMedia Relations ContactsAshleigh Koss Tel: +1 (908) 205-2572Ashleigh.Koss@sanofi.com Investor Relations Contacts North America Felix Lauscher Fara Berkowitz Suzanne GrecoNicolas KressmannTel.: +1 (732) 532 53-18 Nicolas.Kressmann@sanofi.com IR main line: Tel.: +33 (0)1 53 77 45 45 investor.relations@sanofi.com



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iDiazgranados, C. A., et al. (2014). Efficacy of High-Dose versus Standard-Dose influenza vaccine in older adults. New England Journal of Medicine, 371(7), 635-645iiDiazgranados, C. A., et al. (2014). Efficacy of High-Dose versus Standard-Dose influenza vaccine in older adults. New England Journal of Medicine, 371(7), 635-645iii Public Health Agency of Canada (2020. An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI) Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine for 20212022

iv Epidemiological Bulletin 1/2021. Decision and scientific justification of theSTIKOfor the update of the influenza vaccination recommendation for people aged 60 years. Accessed March 9, 2021.

v DiazGranados CA, et al. N Engl J Med. 2014;371(7):635-645 https://www.nejm.org/doi/full/10.1056/nejmoa1315727



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