Sanofi won FDA approval for Fluzone Intradermal flu vaccine system. Indicated for ages 18 through 64, the system uses a microinjection needle to deliver the vaccine into the dermis. This is a big improvement in comfort over intramuscular injections, and the fact that Sanofi is making the new product available for the next flu season should help soothe the nerves of needle phobics.
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 health-care providers in the U.S. for the 2011-2012 influenza season.
Press release: FDA Licenses Sanofi Pasteur’s New Influenza Vaccine Delivered by Intradermal Microinjection…