Sanofi Pasteur Begins Shipping Influenza Vaccine in U.S. for 2010-2011 Season
Early shipments support national goal to increase immunization rates
Jul 30, 2010
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.
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
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
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