Sanofi Pasteur files Fluzone Intradermal influenza virus vaccine sBLA with FDA

Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that it has filed a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Fluzone® Intradermal (Influenza Virus Vaccine).  The file has been accepted by the FDA and an action date is anticipated in the first half of 2011.

"Upon FDA licensure, this new formulation of Sanofi Pasteur's Fluzone vaccine will be the first vaccine available in the U.S. using a novel microinjection system for intradermal delivery of vaccine," said Wayne Pisano, President and Chief Executive Officer, Sanofi Pasteur.  "We believe that Fluzone Intradermal Vaccine could be an important tool in increasing adult immunization rates due to its ease of use for health-care providers and the high-level of interest expressed by patients for this immunization option."

Typically, adult vaccines are administered into the muscle (referred to as intramuscular or IM injection) utilizing a needle 1 inch to 1.5 inches in length (approximately 25 mm to 40 mm) depending on body mass.  Vaccination via the intradermal (ID) route involves introduction of the vaccine into the dermal layer of the skin with an ultra-thin needle of only 1.5 mm in length, or less than one-tenth the length of the standard needles used for the traditional IM route of administration.  The injection volume is only 0.1 mL, or one-fifth the amount injected when vaccine is administered using standard IM administration.

In addition to providing a less invasive option that may be preferred by patients, ID vaccination is believed to stimulate an antibody response by having direct access to the immune system due to the high concentration of specialized immune cells in the dermal layer of the skin.  The microinjection system was designed to consistently deposit vaccine antigens in the dermal layer of the skin of adults irrespective of a person's gender, age, ethnicity or body mass.

Sanofi Pasteur's novel ID influenza vaccine candidate could overcome the technical difficulties that have historically limited the use of this route of administration and provides reliable intradermal influenza immunization.  This innovation in influenza immunization has been made possible with the development of a new, easy-to-use, pre-filled microinjection system developed in collaboration with BD (Becton, Dickinson and Company).

"In February, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention expanded the recommendation for annual influenza immunization to everyone 6 months of age and older by adding all healthy adults over the age of 18 years to those previously recommended," said Pisano. "The use of innovative technologies to develop new vaccines offering health-care providers and the public options for complying with immunization recommendations fulfills our mission of supporting public health in increasing immunization rates by providing vaccine solutions tailored to the specific needs of all segments of the population."

Sanofi Pasteur is seeking licensure of Fluzone Intradermal Vaccine in the U.S. for adults 18 years through 64 years of age.  Clinical trials, involving more than 5,800 adults in the U.S., were conducted to evaluate the vaccine dose, vaccine safety and the ability of the vaccine to induce an immune response.  The Phase III clinical trial compared the ID vaccine, containing 9 mcg of hemagglutinin of each of three seasonal influenza strains, to the standard-dose IM vaccine, containing 15 mcg of hemagglutinin of each of the three influenza strains.  Sanofi Pasteur already has licensed a microinjection system influenza vaccine, marketed as Intanza® / IDflu®, in Europe, Australia, New Zealand and other countries.