Sanofi Pasteur Shipping First Doses of Influenza Vaccine for the 2008-2009 Season
SWIFTWATER, Pa. and LYON, France, Aug. 1 /PRNewswire/ -- 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 U.S. 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 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 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 U.S. 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 U.S. 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.
Influenza Immunization Recommendations
The CDC recommends that health-care providers begin offering influenza vaccine as soon as vaccine becomes available, and continue immunization efforts throughout the season. Health-care 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 health-care providers.
About Fluzone Vaccine
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(R), 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.
Safety Information
Side effects to Fluzone vaccine are soreness at the injection site that can last up to 2 days, pain, and swelling; fever, fatigue, and muscular pain. Other side effects may occur. Fluzone vaccine should not be administered to anyone with a history of serious allergic reaction to any vaccine component, including eggs, egg products, or thimerosal (the only Fluzone vaccine product containing thimerosal is the multi-dose vial), or to persons who have been previously diagnosed with Guillain-Barre syndrome (GBS). If you notice any other problems or symptoms following vaccination, please contact your health-care professional immediately. Vaccination with Fluzone vaccine may not protect all individuals.
For more information about Fluzone vaccine, talk to your health-care professional. The full prescribing information for Fluzone vaccine can be obtained at www.Fluzone.com
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris and in New York .
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than a 1.6 billion doses of vaccine in 2007, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, sanofi pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward- looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2007. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
CONTACT: US Media Relations, Len Lavenda, +1-570-839-4446,
len.lavenda@sanofipasteur.com; Donna Cary, +1-570-839-4732,
donna.cary@sanofipasteur.com
Web site: http://www.fluzone.com/
http://www.sanofipasteur.us/
http://www.sanofipasteur.com/