Le Lézard
Classified in: Health, Covid-19 virus
Subject: FDA

Newly licensed US manufacturing facility to increase availability of Fluzone® High-Dose Quadrivalent (influenza vaccine)


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.

Please see the Prescribing Information, including Patient Information Sheet.

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.|

Media Relations

 Investor Relations Paris

Nicolas Kressmann 

 Eva Schaefer-Jansen

Tel.: +1 (732) 532-5318 

 Arnaud Delepine

Nicolas.Kressmann@sanofi.com 

 Nathalie Pham




 Investor Relations North America


 Felix Lauscher


 Fara Berkowitz


 Suzanne Greco




 IR main line:


 Tel.: +33 (0)1 53 77 45 45


 investor.relations@sanofi.com 




 https://www.sanofi.com/en/investors/contact

Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole.  Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

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

SOURCE Sanofi


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