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Press release from PR Newswire

Sanofi Pasteur Begins Shipping Fluzone® Influenza Virus Vaccine in U.S. for 2012-2013 Season

Monday, July 16, 2012

Sanofi Pasteur Begins Shipping Fluzone® Influenza Virus Vaccine in U.S. for 2012-2013 Season11:00 EDT Monday, July 16, 2012- Early shipments of flu vaccine allow health care providers to begin immunization and clinic plans with confidence in vaccine supply -SWIFTWATER, Pa., July 9, 2012 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the first lots of Fluzone vaccine began shipping to U.S. health care providers following Food and Drug Administration (FDA) licensure of the 2012-2013 formulation. This initial shipment represents the first of more than 60 million doses of seasonal influenza vaccine the company plans to deliver to health care providers in the U.S. this influenza season."This year, two new virus strains were recommended for the seasonal influenza vaccine formulation," said Chad Hoover, Vice President, Chief Commercial Officer, Sanofi Pasteur U.S. "It is a tremendous logistical challenge for public health to try to immunize everyone 6 months of age and older in the few months prior to influenza season. As the supplier of nearly half of the nation's influenza vaccine, it was a critical challenge for us to be early to market so that health care providers had confidence in their supply of influenza vaccine. With the confidence of early vaccine delivery, health care providers can start immunizing sooner and commit to scheduling immunization clinics throughout the season," Hoover added. In addition to the strain change in the 2012-2013 vaccine, Sanofi Pasteur is pleased to announce that its syringe presentations of Fluzone and Fluzone High-Dose vaccines have a new syringe cap that does not contain latex. All presentations of Fluzone vaccine have the designation "does not contain latex," which should mitigate concerns about use in patients with a latex allergy. This season Sanofi Pasteur will provide the following influenza vaccine options in its Fluzone vaccine family to help address the unique immunization needs of each age group: Fluzone vaccine, approved for use in persons 6 months of age and older upon which health care providers have relied for more than 40 years, will again be provided this season in a pediatric dose for children 6 months of age through 35 months of age. The 0.25 mL pediatric dose of Fluzone vaccine will be provided in pre-filled syringes. The 0.5 mL dose of Fluzone vaccine for children 35 months of age and older and adults will be provided in prefilled syringes and unit dose vials. Fluzone vaccine also will be available in a 5 mL multi-dose vial for immunization of children and adults 6 months of age and older. Fluzone vaccine is the only influenza vaccine licensed by the FDA for children as young as 6 months of age.    Fluzone High-Dose vaccine, which was introduced in 2010 for adults 65 years of age and older, will be widely available this season. Adults 65 years of age and older are at greater risk for influenza and its complications because the immune system weakens with age. They often do not produce as much antibody following immunization as do younger people. Fluzone High-Dose vaccine is specifically formulated to elicit a stronger immune response in adults 65 years of age and older following immunization with the vaccine.  Fluzone Intradermal vaccine, which was introduced in 2011 with limited availability, also will be widely available for the 2012-2013 season. Fluzone Intradermal vaccine features an ultra-fine needle that is 90 percent shorter than the typical needle used for intramuscular injection of influenza vaccine. Fluzone Intradermal vaccine is anticipated to be an attractive immunization option for adults 18 through 64 years of age, an age group that has among the lowest rates of immunization. "With these influenza vaccine options, our goal is to help improve the immunization experience for patients and their health care providers thus helping to improve immunization rates," said Hoover. "There are influenza immunization options to meet the needs of everyone 6 months of age and older."Due to extended shipping time and earlier incidence of disease, the first doses of Fluzone vaccine were shipped to Alaska and Hawaii and to the Centers for Disease Control and Prevention (CDC) for use in the Vaccines for Children program. Direct shipments to health care providers and distributors will be ongoing with health care providers who have placed reservations with Sanofi Pasteur receiving initial shipments by August and completed orders by the end of September. Sanofi Pasteur is still accepting orders for all presentations of Fluzone vaccine. 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 or Fluzone Intradermal vaccine can search for local providers at www.Fluzone.com starting in early August. Immunization Recommendations and TimingThe CDC recommends influenza vaccination for everyone 6 months of age and older. Children 6 months through 8 years of age who have not previously received two doses of influenza vaccine may require two doses of vaccine for the 2012-2013 influenza season and should consult their health care provider about the number of doses of influenza vaccine required based on their prior immunization history. Health care providers are recommended to begin offering influenza vaccine as soon as the vaccine becomes available and continue vaccination efforts throughout the entire influenza season. Influenza disease activity typically peaks in February, so individuals who are not immunized early in the season still have time to do so prior to the peak of influenza activity. Influenza vaccination is beneficial in December and January, or even into the spring, as long as influenza viruses are still in circulation. About InfluenzaInfluenza is a serious respiratory illness that is easily spread and can lead to severe complications, even death. Each year in the U.S., 5 to 20 percent of the population gets the flu and an estimated 226,000 people are hospitalized from influenza-related complications. Influenza seasons are unpredictable and can be severe. Depending on virus severity during the influenza season, annual deaths can range from a low of 3,000 to a high of about 49,000 people. Combined with pneumonia, influenza is the nation's ninth leading cause of death. Vaccination is safe and effective and the best way to help prevent influenza and its complications. About Fluzone VaccinesIndicationFluzone, Fluzone High-Dose and Fluzone Intradermal vaccines are indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccines.Fluzone vaccine is approved for use in persons 6 months of age and older. Fluzone High-Dose vaccine is approved for use in persons 65 years of age and older. Fluzone Intradermal vaccine is approved for use in persons 18 through 64 years of age.Approval of Fluzone High-Dose vaccine is based on superior immune response relative to Fluzone vaccine. Data demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine relative to Fluzone vaccine are not available.Safety InformationThe most common local and systemic adverse reactions to Fluzone and Fluzone High-Dose vaccines include soreness, pain and swelling at the vaccination site; fever, headache, fatigue (malaise) and muscle aches (myalgia). Redness, firmness (induration), swelling and itching (pruritus) at the vaccination site occur more frequently with Fluzone Intradermal vaccine than with Fluzone vaccine. Other adverse reactions following Fluzone Intradermal vaccine may include pain, headache, myalgia and malaise. Other adverse reactions may occur with any Fluzone vaccine.Fluzone, Fluzone Intradermal and Fluzone High-Dose vaccines should not be administered to anyone with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein, egg products or thimerosal (the multi-dose vial of Fluzone vaccine is the only presentation that contains thimerosal), or to a previous dose of any influenza vaccine. The decision to give Fluzone, Fluzone Intradermal or Fluzone High-Dose vaccine should be based on the potential benefits and risks, especially if Guillain-Barre syndrome has occurred within six weeks of receipt of a prior influenza vaccine. Vaccination with Fluzone, Fluzone Intradermal or Fluzone High-Dose vaccines may not protect all individuals.Before administering Fluzone, Fluzone Intradermal or Fluzone High-Dose vaccines, please see the full Prescribing Information available at www.sanofipasteur.us or www.vacineshoppe.comAbout SanofiSanofi, a global and diversified health care leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of health care with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer health care, emerging markets, animal health and the new Genzyme. 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 offers the broadest range of vaccines protecting against 20 infectious diseases. 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 or www.sanofipasteur.usForward Looking StatementsThis 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, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies 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, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.Contacts:Sanofi Pasteur U.S. Media Relations Donna Cary T. (570) 957-0717 mediaUS@sanofipasteur.com www.sanofipasteur.usSOURCE Sanofi Pasteur