Sanofi Pasteur Shipping First Doses of Influenza Vaccine for the 2008-2009 Season

SWIFTWATER, Pa. and LYON, France – Sanofi Pasteur, the vaccines division of sanofi-aventis Group, began shipping influenza vaccine (Fluzone(R), Influenza Virus Vaccine) in the United States for the 2008-2009 season. The first 1.3 million doses of influenza vaccine began shipping this week following marketing clearance of the 2008-2009 formulation by the Food and Drug Administration (FDA) on July 14, 2008.

Vaccine shipments to healthcare providers and to the Centers for Disease Control and Prevention (CDC) for distribution through the Vaccines for Children Program will continue through the fall and are planned to be completed in October.

This year's influenza vaccine contains three new strains of the influenza virus, A/Brisbane/59/2007 (H1N1)-like virus; A/Brisbane/10/2007 (H3N2)-like virus; B/Florida/4/2006-like virus. The three strains for the new influenza vaccine formulation were confirmed by the FDA's Vaccines and Related Biological Products Advisory Committee in February 2008 and correspond with recommendations made by the World Health Organization in February. Unlike other routinely recommended vaccines whose formulation remains constant over time, influenza vaccine is formulated each year to match the strains predicted to circulate during the upcoming season.

"Introduction of three new strains for the influenza vaccine was unprecedented and could have resulted in a low yield or delay given our tight production timeline. Despite these challenges, we are pleased that once again Sanofi Pasteur has demonstrated its reliability in supplying Fluzone vaccine to the U.S. market," said Wayne Pisano, president and CEO of Sanofi Pasteur. "The early shipment of Fluzone vaccine by sanofi pasteur gives healthcare providers greater flexibility in planning their vaccination efforts."

Sanofi Pasteur produces approximately half of the influenza vaccine distributed worldwide and in the U.S. produced more than 40 percent of the influenza vaccine distributed for the 2007-2008 influenza season.

The CDC recommends that healthcare providers begin offering influenza vaccine as soon as vaccine becomes available, and continue immunization efforts throughout the season. Healthcare providers are urged to continue immunization efforts until the end of influenza season. Approximately 250 million people, or 4 out of 5 residents of the U.S., are recommended to receive the influenza vaccine annually. The CDC recommends an annual influenza immunization for anyone who wishes to reduce their risk of contracting influenza; children 6 months through 18 years of age; adults over 50 years of age; pregnant women; and anyone with chronic health conditions, such as asthma, chronic obstructive pulmonary disease (COPD), heart disease, and diabetes. The CDC also recommends annual immunization for caregivers and household contacts of these high-risk groups; such as relatives and healthcare providers.

Source: sanofi-aventis