Sanofi Pasteur, the vaccines division of Sanofi, announced today
the 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.

“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. “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.” 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.