Sanofi Pasteur, the vaccines division of sanofi-aventis Group, began shipping influenza vaccine (Fluzone, 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 US Food and Drug Administration (FDA) on July 14, 2008.
Vaccine shipments to health-care providers and to the Centers for Disease Control and Prevention (CDC) for distribution through the Vaccines for Children Programme 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.
Fluzone vaccine is given to persons 6 months of age and older for active immunization against influenza virus types A and B contained in the vaccine. A Fluzone vaccine formulation (trade name: Fluzone, Influenza Virus Vaccine, No Preservative) that does not contain a preservative at any stage in the manufacturing process was introduced in 2004-2005. It is the first FDA-licensed injectable influenza vaccine to be manufactured in this way.
"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 US market," said Wayne Pisano, president and chief executive officer, sanofi pasteur. "The early shipment of Fluzone vaccine by sanofi pasteur gives health-care providers greater flexibility in planning their vaccination efforts."
As the world's leading influenza vaccine manufacturer, sanofi pasteur produces approximately half of the influenza vaccine distributed worldwide and in the US produced more than 40 percent of the influenza vaccine distributed for the 2007-2008 influenza season. Sanofi Pasteur is committed to raising immunization rates and improving global access to vaccines. As part of this commitment, the company is expanding its influenza vaccine production facility in the United States. This expansion, slated to come on-line to produce vaccine for the 2009-2010 season, will more than double sanofi pasteur's US production capacity.
"As a manufacturer, one of our primary objectives is to be responsive to the requests of our customers for early influenza vaccine shipments. In planning their vaccination efforts, it is important for health-care providers and the public to realize that while influenza immunization programs often occur in the early fall, the influenza season itself does not typically peak until February, with disease appearing as late as May. This allows many months for providers to administer influenza vaccine to their patients," said Pisano.