Sanofi to help manufacture Moderna COVID-19 vaccine, supporting global supply demands

BRIDGEWATER, N.J., April 26, 2021 /PRNewswire/ -- Sanofi has entered into an agreement with Moderna, under which Sanofi will help manufacture Moderna´s COVID-19 vaccine, supporting the COVID-19 pandemic and vaccine supply needs.

Sanofi will leverage its established infrastructure and manufacturing expertise at its site in Ridgefield, NJ, to perform fill and finish of up to 200 million doses of Moderna's COVID-19 vaccine, starting in September 2021.

"Since the beginning of the pandemic, we have been mobilizing on multiple fronts and we showed solidarity across the industry", said Paul Hudson, Chief Executive Officer, Sanofi. "We are one of the few pharmaceutical companies to leverage many industrial partnerships to improve global supply and access to COVID-19 vaccines, while in parallel, also continuing to develop our two COVID-19 vaccine programs. I would also like to acknowledge the contributions of the Department of Health and Human Services, and the Biden administration, to facilitate this new partnership."

This marks Sanofi's third commitment to provide manufacturing support. Earlier this year, Sanofi announced the company will provide support to BioNTech for 125 million doses for the European Union. In February, Sanofi announced one of its manufacturing site in France would support Johnson & Johnson for the production of its COVID-19 vaccine at a rate of approximately 12 million doses per month. Sanofi is the only large manufacturer to support all three vaccine efforts.

Sanofi continues to be actively involved in discussions with governments and organizations to identify additional areas of pandemic response where the company can make a meaningful impact.

Sanofi continues to prioritize development of its two COVID-19 vaccine candidates

• Sanofi is collaborating with GSK on a COVID-19 vaccine candidate using the same recombinant protein-based manufacturing technology as one of Sanofi's seasonal influenza vaccines, combined with GSK's established pandemic adjuvant platform.
    
  On February 22, 2021, Sanofi and GSK announced the beginning of a new Phase 2 study with an improved antigen formulation. Enrollment of total 720 participants was completed on March 8 and results are expected in Q2 2021. This vaccine is anticipated to be available in Q4 2021 pending Phase 3 outcomes and regulatory authorizations. 
  
  This effort is supported by the United States' Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response under contract W15QKN-16-9-1002.
    
• In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio. In March 2021, Sanofi and Translate Bio initiated a Phase 1/2 clinical trial of their mRNA COVID-19 vaccine candidate, in order to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels.

Find out more about our COVID-19 vaccine candidates.

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

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.

SOURCE Sanofi

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