Sanofi Pasteur: FDA licenses Sanofi Pasteur's new influenza vaccine delivered by intradermal microinjection

Thursday 29 September 2011 - Life sciences

The U.S. Food and Drug Administration (FDA) has approved Sanofi Pasteur's supplemental biologics license application for licensure of Fluzone Intradermal (Influenza Virus Vaccine).

ancien logo Sanofi Pasteur, the vaccines division of Sanofi

Sanofi Pasteur, the vaccines division of Sanofi, announced on 10th May 2011 the U.S. Food and Drug Administration (FDA) registers its new 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.

An influenza virus vaccine with an ultra-fine needle

"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.

Generating an immune response

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.

Find out more

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. The Group is listed on stock exchanges in Paris and New York. 

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2009, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases.

The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development.