Sanofi Pasteur has begun U.S. distribution of its new Fluzone Intradermal flu vaccine, which the company said is the nation's first flu vaccination to use a microinjection system for intradermal delivery.


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Sanofi's Fluzone Intradermal hits U.S. market

September 19th, 2011

SWIFTWATER, Pa. – Sanofi Pasteur has begun U.S. distribution of its new Fluzone Intradermal flu vaccine, which the company said is the nation's first flu vaccination to use a microinjection system for intradermal delivery.

The Sanofi vaccines division said Monday that Fluzone Intradermal features an ultra-fine needle that is 90% shorter than the typical needle used for intramuscular injection of the influenza vaccine.

According to Sanofi Pasteur, in clinical trials Fluzone Intradermal produced an immune response similar to Fluzone vaccine administered intramuscularly. The microinjection system is designed to consistently deposit vaccine antigens into the skin's dermal layer, which contains a high concentration of specialized cells known as dendritic cells that play a key role in generating an immune response.

Typically, adult flu vaccines are administered into the muscle using a needle of 1 inch to 1.5 inches (25 mm to 38 mm) in length, while Fluzone Intradermal features an ultra-fine needle that is 0.06 inches (1.5 mm) in length, Sanofi Pasteur said. Fluzone vaccine contains 15 mcg of hemagglutinin per strain of influenza in a 0.5 mL dose, and Fluzone Intradermal contains 9 mcg of hemagglutinin per strain of influenza in a 0.1 mL dose.

Indicated for people ages 18 to 64, Fluzone Intradermal vaccine is expected to be an attractive new immunization option for that demographic, according to Sanofi Pasteur. The company said it has already introduced similar flu vaccines using the intradermal microinjection system in more than 40 countries, including Australia, Canada and European nations.

Sanofi Pasteur noted that because of the midyear Food and Drug Administration licensing of Fluzone Intradermal, shipment of the new vaccine is starting later than other flu vaccinations, and supplies will be limited for the 2011-12 season. However, distribution is planned nationwide through all types of immunization providers, ranging from private physicians to select locations of retail pharmacy chains.

"Adults 18 through 64 years of age have some of the lowest influenza immunization rates in the U.S., despite public health recommendations for everyone 6 months of age and older to receive an annual influenza immunization," stated Damian Braga, senior vice president of commercial operations at Sanofi Pasteur. "Our commitment to introducing new technologies, such as Fluzone Intradermal vaccine, reflects Sanofi Pasteur's expertise in developing innovative immunization options that can help foster greater vaccine acceptance among adults."

Sanofi Pasteur's other Fluzone vaccines for children, adults and seniors 65 years of age and older began shipping in July. Approximately 60 million doses of Fluzone influenza vaccines will have been shipped by the end of September, the company said.

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