FDA Licenses New Influenza Vaccine Designed Specifically For People 65 Years of Age and Older

Fluzone® High-Dose (Influenza Virus Vaccine) strengthens immune response in the 65+ population, an age group that suffers disproportionately from influenza and its complications

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental biologics license application (sBLA) for licensure of Fluzone High-Dose (Influenza Virus Vaccine). The new vaccine, for adults 65 years of age and older, will be available to health-care providers for immunizations administered this fall in preparation for the upcoming 2010-2011 influenza season.

This new addition to Sanofi Pasteur's vaccine portfolio reflects our long-standing commitment to public health and to research and development of new vaccines for enhanced prevention of influenza," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "In 2011 the first baby boomers will turn 65 and, by the year 2030, the number of adults over age 65 is anticipated to double and surpass 70 million people, or 20 percent of the U.S. population. We are excited to introduce Fluzone High-Dose vaccine which will provide health-care professionals with a new vaccine to help prevent influenza in their patients over the age of 65.

Fluzone High-Dose vaccine was specifically designed to generate a more robust immune response in people 65 years of age and older. This age group typically does not respond as well to the standard dose of influenza virus vaccines as younger individuals because they have weakened immune systems.

This indication is based on the immune response elicited by Fluzone High-Dose vaccine and there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine.

Fluzone High-Dose vaccine contains 60 mcg of hemagglutinin per strain of influenza virus in the vaccine as compared to 15 mcg of influenza virus hemagglutinin per strain of influenza virus in standard-dose Fluzone vaccine.