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Sanofi Pasteur Fluzone Intradermal vaccine receives FDA approval

Sanofi Pasteur, a vaccines division of Sanofi, has received the US Food and Drug Administration (FDA) approval for its Fluzone Intradermal 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 vaccine, which features an ultra-fine needle that is 0.06 inches (1.5 mm) in length, contains 9 mcg of hemagglutinin per strain of influenza in a 0.1 mL dose.

The vaccine incorporates a prefilled microinjection system designed to 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.