BRIDGEWATER, N.J., April 4, 2023 /PRNewswire/ -- Sanofi and the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), celebrated today the groundbreaking of a new, state-of-the-art formulation and filling facility at Sanofi's Swiftwater site in Pennsylvania.

The new formulation and filling facility will be a two-story building complete with current Good Manufacturing Practices (cGMP) formulation, filling, and support areas. The filler will be capable of filling syringe and vials using isolator barrier technology and single use technology for flexibility. This manufacturing facility represents one of three significant manufacturing investments made at the site, supported by federal funds, as part of a contract awarded earlier on December 5, 2019 by BARDA to increase domestic production capabilities for recombinant pandemic influenza vaccines.

Rakesh Kakkar US Head of Vaccine Manufacturing and Supply, Sanofi: "This groundbreaking event marks another significant step in our longstanding relationship with BARDA. Past pandemics confirmed that public-private partnerships are key to providing a relevant and quick answer to pandemic situations. Our Swiftwater site, and Sanofi teams globally, have the highest level of expertise in helping to protect people against flu and its complications. We are committed to maintaining continuous efforts to prepare for the next flu pandemic." 

The Sanofi-BARDA contract supports the clinical development of an adjuvanted recombinant pandemic influenza vaccine that utilizes the same technology as Sanofi's recombinant quadrivalent influenza vaccine. The contract also expands the Swiftwater site's capacity to be a center of excellence for pandemic preparedness by enhancing vaccine manufacturing, adding both recombinant and adjuvant technologies to the current egg-based platform capabilities.

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120D00002.

About Pandemic Preparedness

As the world's largest manufacturer of seasonal flu vaccines, Sanofi has established capability and can play its part to bring any new pandemic infection under control. Sanofi has extensive expertise and experience in flu prevention, providing over 250 million doses of flu vaccines every year to more than 120 countries. Sanofi also developed and registered vaccines to address the 2009 A/HIN1 pandemic in a matter of weeks.

Egg-based vaccine supply would well contribute to support a global influenza pandemic response should it arise either from A/H5N1 or any other influenza strain. The objective of Sanofi's contract with BARDA is to expand pandemic influenza preparedness and leverage another – recombinant, protein-based – technology to deliver a pandemic vaccine.

About Recombinant Technology

Production of recombinant flu vaccines does not require an egg or cell-grown vaccine virus or the candidate vaccine virus. Instead, recombinant vaccines are created synthetically by using the virus's genetic instructions, ensuring exact match of the vaccine with the circulating virus strain. 

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

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Sanofi Disclaimers or 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 regarding the marketing and other potential of the product, or regarding potential future revenues from the product. 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, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, 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. 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, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.