First lots of 2013-2014 seasonal influenza vaccine released for U.S. distribution

Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the first lots of Fluzone^® (Influenza Virus Vaccine) for the 2013-2014 season have been released by the U.S. Food and Drug Administration (FDA) for U.S. distribution and were shipped July 24. This shipment represents the first of more than 60 million doses of seasonal influenza vaccine the company plans to deliver to U.S. health care providers this fall. Influenza vaccine is anticipated to be available to the public from local health care providers and pharmacies in August.

"Although influenza disease typically peaks in the U.S. during the winter, the virus can circulate at any time of year, and in fact, last year, reports of increased levels of influenza disease began in the fall," said David P. Greenberg, M.D., Vice President, U.S. Scientific and Medical Affairs. "Annual immunization of more than 130 million people in a few months is a huge undertaking for health care providers each year, and that is why as the largest producer of influenza vaccine in the U.S., our goal is to deliver a reliable supply of influenza vaccine to support health care providers in planning their fall clinics."

New for 2013-2014

For the 2013-2014 season, two new influenza virus strains have been included in the trivalent seasonal influenza vaccine. There is a new A(H3N2) antigen and a new influenza B antigen. The A(H1N1) component of the vaccine is unchanged since the 2009 pandemic. Last season, influenza A(H3N2) disease predominated in the U.S., and it was particularly severe in older adults.

The 2013-2014 influenza season will be the first in which quadrivalent influenza vaccines will be available in the U.S. Until this year, seasonal influenza vaccines included only one B strain. Fluzone Quadrivalent vaccine includes two A strains and two B strains to help protect against influenza disease. Epidemics of influenza B occur every two to four years in all age groups. Influenza B is a common cause of influenza-related morbidity and mortality in children and has been associated with pneumonia and other respiratory illnesses, nervous system disease, muscle pain and inflammation, and other complications. In recent years, up to 44 percent of influenza-associated deaths in children and adolescents 18 years of age and younger were due to influenza B.

In addition to the strain changes in the 2013-2014 vaccine and the availability of quadrivalent vaccines, Sanofi Pasteur is pleased to announce that no presentations of Fluzone vaccine contain natural rubber latex.

This season, Sanofi Pasteur will provide the following influenza vaccine options in its Fluzone vaccine family to help address the unique immunization needs of children, adolescents, and younger and older adults:

• Fluzone vaccine, upon which health care providers have relied for more than 40 years, is approved for use in people six months of age and older. Fluzone vaccine will be provided in a 0.25mL pediatric dose for children six months through 35 months of age and a 0.5mL dose for children 35 months of age and older and adults. Fluzone vaccine also will be available in a 5 mL multi-dose vial for immunization of people six months of age and older, adolescents, and adults. Fluzone vaccine is the only influenza vaccine licensed by the FDA for children as young as 6 months of age. 
• Fluzone Quadrivalent vaccine, which helps protect against four influenza strains, is the newest addition to Sanofi Pasteur's Fluzone family of influenza vaccines, having been licensed by the FDA in June 2013. Like Sanofi Pasteur's Fluzone vaccine, Fluzone Quadrivalent vaccine is licensed for use in children six months of age and older, adolescents, and adults.
• Fluzone High-Dose vaccine, which was introduced in 2010 for adults 65 years of age and older, will be widely available this season. Adults 65 years of age and older are at greater risk for influenza and its complications because the immune system weakens with age. Older adults often do not produce as much antibody following immunization as do younger people. Fluzone High-Dose vaccine is specifically formulated to elicit stronger influenza antibody responses in adults 65 years of age and older.
• Fluzone Intradermal vaccine, which was introduced in 2011, also will be widely available for the 2013-2014 season. Fluzone Intradermal vaccine features an ultra-fine needle that is 90 percent shorter than the typical needle used for intramuscular injection of influenza vaccine. Fluzone Intradermal vaccine is anticipated 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.

"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," said Dr. Greenberg. "We are pleased to offer many different influenza vaccines to meet the specific needs of every patient six months of age and older."

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 through October, with health care providers who have placed reservations with Sanofi Pasteur receiving initial shipments by the end of August to support fall immunization campaigns.