SWIFTWATER, Pa., June 17, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research has granted approval to Sanofi Pasteur, the vaccines global business unit of Sanofi, for an additional influenza manufacturing facility located in Swiftwater, PA.
The newly completed facility further expands production and distribution of Sanofi's Fluzone® High-Dose Quadrivalent for the upcoming 2021-2022 influenza season in the United States and will create up to 200 additional manufacturing jobs. Commercialization activities for the U.S. market are underway, with plans to support other countries in the future.
"We are experiencing fast-growing demand for our vaccine in the U.S. and globally, given the 10 years of data demonstrating protection from flu and its related complications," said Elaine O'Hara, Head of North America Commercial Operations for Sanofi Pasteur. "Our new facility will complement our existing capacities to produce enough high-dose vaccine for all people 65 and older in as many countries as possible this flu season and beyond, supporting the needs of healthcare providers and patients."
About Fluzone High-Dose Quadrivalent
Fluzone High-Dose Quadrivalent is a vaccine indicated for prevention of influenza disease caused by influenza A and B strains contained in the vaccine. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older.1
Fluzone High-Dose Quadrivalent is the only vaccine approved by the U.S. FDA for superior flu protection in adults 65 years of age and older, compared to a standard-dose flu vaccine.1 With 4-strain protection, Fluzone High-Dose Quadrivalent builds on the legacy of the trivalent formulation, which was clinically proven to be 24.2% more effective at preventing flu than standard-dose Fluzone (Influenza Vaccine) in adults 65+.2 Based on data from Fluzone High-Dose (Influenza Vaccine), side effects were slightly more frequent after vaccination with Fluzone High-Dose compared to a standard-dose vaccine.1
In addition, Fluzone High-Dose has demonstrated protection against influenza and its related complications including cardiorespiratory events, pneumonia and hospitalization.3
The efficacy of trivalent formulation is relevant to Fluzone High-Dose Quadrivalent since both products are manufactured according to the same process and have overlapping compositions.1
Outside of the U.S., Sanofi's High-Dose influenza vaccine has also 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 Canada, along with a recommendation for priority use in older adults by Germany's Standing Committee on Vaccination (STIKO).4,5
Sanofi's commitment to influenza prevention
As the leading manufacturer of influenza vaccines, Sanofi is committed to researching, developing and manufacturing vaccines proven to help protect people against influenza and its related complications.
Sanofi produces influenza vaccines each year across five international sites: Swiftwater (Pennsylvania, United States), Pearl River (New York, United States), Val-de-Reuil, Ocoyoacac (Mexico) and Shenzhen (China). As the largest manufacturer of influenza vaccines in the world, Sanofi has been continuously investing to expand manufacturing capabilities and distributed more than 250 million doses of influenza vaccines globally in 2020.
Editor's Note: This new vaccine manufacturing facility further demonstrates Sanofi's overall growth strategy, with vaccines contributing as a key growth driver through differentiated products, market expansion and new launches. It builds upon recent investments in France, Canada and Singapore to strengthen the company's leadership and capacity to advance the research of new vaccines and produce them on a massive scale.
IMPORTANT SAFETY INFORMATION
Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction to any component of the vaccine, including eggs or egg products, or after previous dose of any influenza vaccine.
Tell your health care provider if you have ever had Guillain-Barré syndrome (severe muscle weakness) after a previous influenza vaccination.
If Fluzone High-Dose Quadrivalent is given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected.
Vaccination with Fluzone High-Dose Quadrivalent may not protect all people who receive the vaccine.
For Fluzone High-Dose Quadrivalent, in adults 65 years of age and older, the most common side effects were pain, redness, and/or swelling where you got the shot; muscle ache, headache, and general discomfort. Other side effects may occur.
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.|
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1 Fluzone High-Dose Quadrivalent [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.
2 DiazGranados CA, et al. N Engl J Med. 2014;371(7):635-645 https://www.nejm.org/doi/full/10.1056/nejmoa1315727
3 J.K H Lee, G.K.L Lam, T. Shin et al, Efficacy and effectiveness of high-dose influenza vaccine in older adults by circulating strain and antigenic match: An updated systemic review and meta-analysis, Vaccine, https://doi.org/10.1016/j.vaccine.2020.09.004
4 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 2021–2022
5 Epidemiological Bulletin 1/2021. Decision and scientific justification of the STIKO for the update of the influenza vaccination recommendation for people aged ≥60 years