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FDA Accepts Sanofi Pasteur File Submission for Novel Influenza Vaccine Delivered by Intradermal Microinjection
Date:9/13/2010

SWIFTWATER, Pa., Sept. 13 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that it has filed a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Fluzone® Intradermal (Influenza Virus Vaccine).  The file has been accepted by the FDA and an action date is anticipated in the first half of 2011.

"Upon FDA licensure, this new formulation of Sanofi Pasteur's Fluzone vaccine will be the first vaccine available in the U.S. using a novel microinjection system for intradermal delivery of vaccine," said Wayne Pisano, President and Chief Executive Officer, Sanofi Pasteur.  "We believe that Fluzone Intradermal Vaccine could be an important tool in increasing adult immunization rates due to its ease of use for health-care providers and the high-level of interest expressed by patients for this immunization option."

Typically, adult vaccines are administered into the muscle (referred to as intramuscular or IM injection) utilizing a needle 1 inch to 1.5 inches in length (approximately 25 mm to 40 mm) depending on body mass.  Vaccination via the intradermal (ID) route involves introduction of the vaccine into the dermal layer of the skin with an ultra-thin needle of only 1.5 mm in length, or less than one-tenth the length of the standard needles used for the traditional IM route of administration.  The injection volume is only 0.1 mL, or one-fifth the amount injected when vaccine is administered using standard IM administration.

In addition to providing a less invasive option that may be preferred by patients, ID vaccination is believed to stimulate an antibody response by having direct access to the immune system due to the high concentration of specialized immune cells in the dermal layer of the skin. &
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SOURCE Sanofi Pasteur
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