Sanofi Pasteur Ships First of its U.S. Influenza Vaccine Doses for 2017-2018 Season

SWIFTWATER, Pa., July 17, 2017 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN andNYSE: SNY), announced today that its first doses of the Fluzone^® (Influenza Vaccine) portfolio for the 2017-2018 influenza ("flu") season have been released by the U.S. Food and Drug Administration (FDA). Sanofi Pasteur has begun distributing initial shipments, representing the first of nearly 70 million total doses of seasonal influenza vaccine manufactured by the company for this upcoming influenza season. Widespread shipment of Fluzone Quadrivalent, Fluzone High-Dose and Fluzone Intradermal Quadrivalent vaccine to health care provider offices, pharmacies and other immunizers will begin in early August to support fall immunization campaigns.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8081151-sanofi-pasteur-influenza-vaccine-first-shipment-2017/

"As we enter the Swiftwater site's 120^th year, it reminds us of our innovation and growth as we came to understand the science of influenza and its impact on human health," said David P. Greenberg, M.D., Associate Vice President and Regional Medical Head North America, Sanofi Pasteur. "Influenza can be especially severe for the most vulnerable populations, including the elderly, young children and those with compromised immune systems; however, it can also have a serious health impact on otherwise healthy individuals. Sanofi Pasteur is and always has been deeply committed to improving public health by continuously striving to develop new vaccines and on improving existing ones."

According to the U.S. Centers for Disease Control and Prevention (CDC), the single best way to prevent the flu is to get an annual flu vaccination, which is recommended for everyone six months of age and older, with rare exception. The CDC recommends receiving the vaccine as soon as it is available to help with prevention even before the season begins.

As the single largest provider of influenza vaccine to the United States, Sanofi Pasteur provides a wide range of influenza vaccines. The Fluzone vaccine portfolio meets immunization needs across the lifespan, from children as young as six months of age through adults 65 years of age and older, and includes the following products:

• Fluzone High-Dose vaccine, the first influenza vaccine designed specifically for people 65 years of age and older, is the only influenza vaccine approved by the U.S. Food and Drug Administration (FDA) that has been shown in clinical trials to have superior efficacy compared to Fluzone vaccine, its standard-dose comparator, in helping to protect against the flu. During the 2016-2017 season, about 60 percent of adults 65 years of age and older who were vaccinated in the United States received Fluzone High-Dose vaccine, helping to protect this vulnerable population. Since its introduction in 2010, more than 70 million doses of Fluzone High-Dose vaccine have been distributed in the United States.
  
  
  In two observational, comparative effectiveness studies conducted by the CDC, Centers for Medicare and Medicaid Services (CMS) and the FDA of 6 million seniors, Fluzone High-Dose vaccine reduced influenza-associated medical visits and hospitalizations by 22 percent and, during an H3N2-predominated season (2012-2013), reduced post-influenza death by 36 percent compared to standard-dose influenza vaccines. During an H1N1-predominated season (2013-2014), there was a 13 percent reduction in influenza hospitalizations and no significant reduction (2.5 percent) in death.

• Fluzone Quadrivalent vaccine helps protect against four influenza strains (two A strains and two B strains) and is the first four-strain influenza vaccine licensed for use in people six months of age and older.
• There is also a 0.25-mL prefilled syringe (pediatric dose), that has been available for influenza immunization of children six months through 35 months of age since its launch in 2004 and maintains a record of safety and immunogenicity.

• Fluzone Intradermal Quadrivalent vaccine, the first intradermal influenza vaccine for adults 18-64 years of age, offers four-strain protection using a 90 percent smaller, 1.5 mm microneedle.

"Last season, our influenza vaccine represented nearly 50 percent of the U.S. influenza vaccine supply, and we anticipate our global supply of Fluzone High-Dose vaccine will increase significantly over the next few years," said Franck Chassant, Vice President Vaccines Industrial Affairs U.S. and Site Head, Sanofi Pasteur U.S. "Recently, Sanofi has been making significant capital investments at our Swiftwater site. Just this spring, we also opened our new Quality building, which is testament to our focus and commitment to quality, which runs through everything we do within Sanofi Pasteur."

For the 2017-2018 influenza season, Sanofi Pasteur production plans are again accounting for providers choosing not to use live attenuated influenza vaccine (LAIV) during the upcoming flu season. Health care providers wishing to reserve vaccine can do so by visiting www.vaccineshoppe.com or by calling 1-800-VACCINE (1-800-822-2463). Members of the public seeking a specific vaccine option, such as Fluzone High-Dose vaccine, Fluzone Intradermal Quadrivalent vaccine, or Fluzone Quadrivalent vaccine, can search for local providers at www.Fluzone.com.

About Fluzone Vaccines

Indication
Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose vaccines are given to help prevent influenza disease caused by influenza A and B strains contained in each vaccine. Fluzone Quadrivalent vaccine is given to people 6 months of age and older. Fluzone Intradermal Quadrivalent vaccine is given to people 18 through 64 years of age. Fluzone High-Dose vaccine is given to people 65 years of age and older.

For more information about Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose vaccine, talk to your health care professional and see complete Patient Information.

Safety Information
Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose vaccines should not be administered to anyone with a severe allergic reaction (eg, anaphylaxis) to any vaccine component, including eggs, egg products, or thimerosal (the multidose vial is the only presentation containing thimerosal), or to a previous dose of any influenza vaccine.

Tell the doctor if you/your child has ever experienced Guillain-Barré syndrome (severe muscle weakness) after a previous dose of influenza vaccine. If you notice any other problems or symptoms following vaccination, please contact your health care professional immediately.

Side effects to Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, and Fluzone High-Dose vaccines include pain and swelling at the injection site (also itching at the injection site and shivering in adults receiving Fluzone Intradermal Quadrivalent vaccine); muscle aches, fatigue, and headache (also irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever in young children receiving Fluzone Quadrivalent vaccine). Itching, redness, swelling, and firmness at the injection site have occurred more frequently with vaccine administered into the skin compared to vaccine administered into the muscle. Other side effects may occur. Vaccination with Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose vaccine may not protect all individuals.

About Sanofi Pasteur Influenza Vaccine Manufacturing
As the world leader in the research, development and manufacturing of seasonal influenza vaccines, Sanofi Pasteur uses the most innovative technology and processes. For more information about Sanofi Pasteur's influenza vaccine manufacturing process, please view the following infographic ("Production Process for the United States Infographic") and watch a video that provides a glimpse into the Sanofi Pasteur production facilities.

About Influenza
Influenza is a serious respiratory illness that is easily spread and can lead to severe complications, even death. Each year, 5-20 percent of U.S. residents acquire influenza, and many will seek medical care in outpatient settings such as physician's offices and urgent-care clinics. Influenza seasons are unpredictable. In the 2015-2016 influenza season, the CDC estimated 25 million flu illnesses, 11 million flu-associated medical visits and more than 300,000 flu-associated hospitalizations. Adults 65 years of age and older typically account for 50 to 70 percent of flu-related hospitalizations and 70 to 90 percent of flu-related deaths. In fact, last season's cumulative hospitalization rate for adults 65 years of age and older was three times higher than that of younger persons. Among young children, influenza causes more hospitalizations than any other vaccine-preventable disease.

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs.  Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur produces a portfolio of high quality vaccines that matches its areas of expertise and meets public-health demand. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com

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 absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities 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 conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those 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, 2016. 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 Pasteur