FDA Approves Short Needle Flu Vaccine

Published Online: Tuesday, May 17, 2011
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By Kate H. Gamble, Senior Editor



The FDA has approved Fluzone Intradermal (Influenza Virus Vaccine), an intradermal microinjection delivery system indicated for active immunization of adults aged 18 to 64 against influenza virus subtypes A and type B. The vaccine is marketed by Sanofi Pasteur, the vaccines division of Sanofi.

“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,” said Olivier Charmeil, President and CEO, Sanofi Pasteur, in a statement. “Sanofi Pasteur is proud to bring this innovation in influenza vaccine administration to the U.S., offering health-care providers a new tool that may help enhance adult influenza immunization rates.”

Fluzone Intradermal vaccine has an ultra-fine needle that is 10% of the length of most intramuscular vaccines for flu. Using a prefilled microinjection system to deposit vaccine antigens into the dermal layer of the skin -- rather than the muscle, like most vaccies -- it generates an immune response from the dendritic skin cells, which are key regulators of the immune system.

In clinical trial data presented in October 2010 at the 48th Annual Meeting of the Infectious Diseases Society of America in Vancouver, Fluzone Intradermal vaccine produced an immune response at rates similar to Fluzone vaccine administered intramuscularly. It contains 9 mcg of hemagglutinin per strain of influenza in a 0.1 mL dose.

The most common local and systemic adverse reactions to Fluzone Intradermal vaccine include erythema, induration, swelling, pain, and pruritus at the vaccination site. Headache, myalgia, and malaise may also occur, along with other adverse reactions. Fluzone Intradermal vaccine should not be administered to anyone with anaphylaxis to any component of the vaccine, including egg protein, or to a previous dose of any influenza vaccine.

For full prescribing information, click here.

Fluzone Intradermal vaccine will be available to health care providers in the United States for the 2011-2012 influenza season. Those who wish to reserve vaccine can do so by visiting www.vaccineshoppe.com or by calling 1-800-822-2463.

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