Sanofi Pasteur, the vaccines division of Sanofi, announced today the Food and Drug Administration (FDA) has approved the companys 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.
"The microinjection delivery system utilized in Fluzone Intradermal vaccine provides reliable and easy delivery of the vaccine into the dermal layer of the skin, an attractive site for immunization," says Olivier Charmeil, president and CEO of Sanofi Pasteur. "Sanofi Pasteur is proud to bring this innovation in influenza vaccine administration to the U.S., offering healthcare 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® or IDflu® vaccines, in more than 40 countries 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.
Fluzone Intradermal vaccine will be available to healthcare providers in the U.S. for the 2011-2012 influenza season. Healthcare providers wishing to reserve vaccine can do so by visiting www.vaccineshoppe.com or by calling 1-800-VACCINE (1-800-822-2463).