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SWIFTWATER, Pa. — Sanofi Pasteur has begun shipping the first lots of Fluzone vaccine to U.S. health care providers with the Food and Drug Administration’s licensing of the 2012-13 formulation.
The Sanofi vaccines division said Monday that the initial shipment marks the first of more than 60 million doses of seasonal influenza vaccine that it plans to deliver to health care providers in the United States this flu season.
Due to extended shipping time and earlier incidence of disease, the first doses of Fluzone vaccine were shipped to Alaska and Hawaii and to the Centers for Disease Control and Prevention (CDC) for use in the Vaccines for Children program. Direct shipments to health care providers and distributors will be ongoing with health care providers that have placed reservations with Sanofi Pasteur receiving initial shipments by August and completed orders by the end of September.
Chad Hoover, vice president and chief commercial officer for Sanofi Pasteur U.S., noted that two new virus strains were recommended for the seasonal flu vaccine this year.
"It is a tremendous logistical challenge for public health to try to immunize everyone 6 months of age and older in the few months prior to influenza season. As the supplier of nearly half of the nation’s influenza vaccine, it was a critical challenge for us to be early to market so that health care providers had confidence in their supply of influenza vaccine," Hoover stated. "With the confidence of early vaccine delivery, health care providers can start immunizing sooner and commit to scheduling immunization clinics throughout the season."
Sanofi Pasteur also announced that its Fluzone and Fluzone High-Dose shots have a new, latex-free syringe cap. All presentations of Fluzone vaccine have the designation "does not contain latex," which should ease concerns about use in patients with a latex allergy, the company said
This season Sanofi Pasteur will provide the following flu vaccine options in its Fluzone vaccine family:
• Fluzone vaccine will again be provided this season in a pediatric dose for children 6 months of age through 35 months of age. The 0.25-ml pediatric dose of Fluzone vaccine will be provided in prefilled syringes.
• A 0.5-ml dose of Fluzone vaccine for children 35 months of age and older and adults will be provided in prefilled syringes and unit dose vials.
• Fluzone vaccine also will be available in a 5-ml multidose vial for immunization of children and adults 6 months of age and older.
• Fluzone High-Dose vaccine, which was introduced in 2010 for adults 65 years of age and older, will be widely available this season, the company said. Fluzone HD is formulated to elicit a stronger immune response in adults 65 and older, who often don’t produce as much antibody following immunization as do younger people.
• Fluzone Intradermal vaccine, introduced in 2011 with limited availability, also will be widely available for the 2012-13 flu season. Fluzone Intradermal vaccine features an ultra-fine needle that is 90% shorter than the typical needle used for intramuscular injection of flu vaccine. Fluzone Intradermal vaccine is expected to be an attractive immunization option for adults 18 through 64 years of age, an age group that has among the lowest rates of immunization, according to Sanofi Pasteur.
"With these influenza vaccine options, our goal is to help improve the immunization experience for patients and their health care providers thus helping to improve immunization rates," added Hoover. "There are influenza immunization options to meet the needs of everyone 6 months of age and older."
The CDC recommends flu vaccination for everyone age 6 months and older. Children 6 months through 8 years of age who haven’t previously received two doses of flu vaccine may require two doses ofor the 2012-2013 influenza season and should consult their health care provider.
