Sanofi Pasteur announces that shipping of the 2010-2011 formulation of its seasonal influenza vaccine Fluzone® Influenza Virus Vaccine is underway in the U.S. This first shipment represents the first of more than 70 million doses of seasonal influenza vaccine the company plans to deliver to U.S. healthcare providers this season.
The first influenza vaccine doses were shipped this week following marketing clearance of the 2010-2011 formulation by the Food and Drug Administration (FDA) on July 23, 2010. The initial shipment was directed primarily to the Centers for Disease Control and Prevention (CDC) for use in the federal Vaccines for Children Program.
The CDC has expanded its recommendation for annual influenza vaccination this year to include everyone 6 months of age and older. The CDC recommends that healthcare providers begin offering influenza vaccine as soon as the vaccine becomes available and to continue vaccination efforts throughout the season in order to prevent missed opportunities to protect people from influenza. Influenza disease activity typically peaks in the winter during February and March. So, those who have not obtained their immunization early in the season still will have time to do so prior to the peak of influenza season. Influenza vaccination is of value even in December and January, or into the spring, as long as influenza viruses are in circulation.
Fluzone vaccine is intended for use in children 6 months of age and older through adulthood and is available as a no-preservative vaccine in single-dose prefilled syringes or vials for both children and adults. Fluzone vaccine is also provided in multi-dose vials, which contain preservative. Fluzone® High-Dose (Influenza Virus Vaccine), available for the first time this season, is for adults 65 years of age and older and is only available in single-dose, no-preservative, prefilled syringes.
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 adult Fluzone vaccine.
Both Fluzone vaccine and Fluzone High-Dose vaccine are inactivated influenza virus vaccines indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. The indication for Fluzone High-Dose vaccine is based on the immune response elicited by the vaccine, as there have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine.