Swiftwater, Pa – July 30, 2010 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that shipping of the 2010-2011 formulation of its seasonal influenza vaccine Fluzone® Influenza Virus Vaccine is underway in the U.S. This first shipment represents the first of more than 70 million doses of seasonal influenza vaccine the company plans to deliver to U.S. health-care providers this season. Sanofi Pasteur is the largest supplier of influenza vaccines among the five licensed U.S. manufacturers and the only company producing inactivated influenza vaccine in the U.S.
The first influenza vaccine doses were shipped this week following marketing clearance of the 2010-2011 formulation by the U.S. Food and Drug Administration (FDA) on July 23, 2010. The initial shipment was directed primarily to the Centers for Disease Control and Prevention (CDC) for use in the federal Vaccines for Children Program.
The CDC has expanded its recommendation for annual influenza vaccination this year to include everyone 6 months of age and older. The CDC recommends that health-care providers begin offering influenza vaccine as soon as the vaccine becomes available and to continue vaccination efforts throughout the season in order to prevent missed opportunities to protect people from influenza. Influenza disease activity typically peaks in the winter during February and March. So, those who have not obtained their immunization early in the season still will have time to do so prior to the peak of influenza season. Influenza vaccination is of value even in December and January, or into the spring, as long as influenza viruses are in circulation.
About Fluzone and Fluzone High-Dose Vaccines
Fluzone vaccine is intended for use in children 6 months of age and older through adulthood and is available as a no-preservative vaccine in single-dose prefilled syringes or vials for both children and adults. Fluzone vaccine is also provided in multi-dose vials, which contain preservative. Fluzone® High-Dose (Influenza Virus Vaccine), available for the first time this season, is for adults 65 years of age and older and is only available in single-dose, no-preservative, prefilled syringes.
Fluzone High-Dose vaccine contains 60 mcg of hemagglutinin per strain of influenza virus in the vaccine as compared to 15 mcg of influenza virus hemagglutinin per strain of influenza virus in standard-dose adult Fluzone vaccine.
Both Fluzone vaccine and Fluzone High-Dose vaccine are inactivated influenza virus vaccines indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. The indication for Fluzone High-Dose vaccine is based on the immune response elicited by the vaccine, as there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine.
Safety Information for Fluzone Vaccine and Fluzone High-Dose Vaccine
Side effects to Fluzone and Fluzone High-Dose vaccines are soreness, pain and swelling at the injection site; fever, headache, fatigue and muscular pain. Other side effects may occur. Fluzone and Fluzone High-Dose vaccines should not be administered to anyone with a history of serious allergic reaction to any vaccine component, including eggs, egg products or thimerosal (the only Fluzone vaccine product containing thimerosal is the multi-dose vial). Tell the doctor if you or 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. Vaccination with Fluzone or Fluzone High-Dose vaccine may not protect all individuals.
Before administering Fluzone High-Dose vaccine or Fluzone vaccine, please see full Prescribing Information at www.vaccineplace.com/products
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, please visit: www.sanofi-aventis.com
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2009, 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.us
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-aventis’ 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-aventis, 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 products candidates, the absence of guarantee that the products 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 as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2009. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
