Tuesday, May 10, 2011

FDA Licenses Sanofi Pasteur’s New Influenza Vaccine


Fluzone
percent smaller needle
® Intradermal (Influenza Virus Vaccine) first to offer an immunization option with 90
Lyon, France – May 10, 2011 –
SNY announced today the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental biologics license application (sBLA) for licensure of Fluzone Intradermal (Influenza Virus Vaccine). Fluzone Intradermal vaccine is indicated for active immunization of adults 18 through 64 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. “ easy delivery of the vaccine into the dermal layer of the skin, an attractive site for immunization said Olivier Charmeil, President and CEO, Sanofi Pasteur. “
innovation in influenza vaccine administration to the U.S., offering health-care providers a new tool
that may help enhance adult influenza immunization rates.
The new formulation of Fluzone Intradermal vaccine is the first influenza vaccine licensed in the U.S.
that uses a novel microinjection system for intradermal delivery. Fluzone Intradermal vaccine features an ultra-fine needle that is 90 percent shorter than the typical needle used for intramuscular injection of influenza vaccine. Sanofi Pasteur has previously licensed microinjection intradermal influenza vaccines, marketed as Intanza
including Australia, Canada and countries in Europe. Fluzone Intradermal vaccine incorporates a new, easy-to-use, prefilled microinjection system
designed to consistently deposit vaccine antigens into the dermal layer of the skin of adults. The dermal layer contains a high concentration of specialized cells known as dendritic cells, which play a key role in generating an immune response. In clinical trials, Fluzone Intradermal vaccine produced an immune response at rates similar to Fluzone vaccine administered intramuscularly.
Typically, adult influenza vaccines are administered into the muscle utilizing a needle 1 inch to 1.5 inches (25 mm to 38 mm) in length. Fluzone Intradermal vaccine features an ultra-fine needle that is 0.06 inches (1.5 mm) in length. Fluzone vaccine contains 15 mcg of hemagglutinin per strain of  influenza in a 0.5 mL dose. Fluzone Intradermal vaccine contains 9 mcg of hemagglutinin per strain of influenza in a 0.1 mL dose.
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SANThe microinjection delivery system utilized in Fluzone Intradermal vaccine provides reliable and,”Sanofi Pasteur is proud to bring this® or IDflu® vaccines, in more than 40 countries