Sanofi pasteur First Manufacturer to Ship Doses of Influenza Vaccine for the 2007-2008 Season- Shipment of Fluzone(R) Influenza Virus Vaccine Begins Across U.S. -
SWIFTWATER, Pa., August 13, 2007 /PRNewswire/ -- Sanofi pasteur, the vaccines division of the sanofi-aventis Group, has begun shipment of influenza vaccine (Fluzone(R), Influenza Virus Vaccine) in the United States for the 2007-2008 season. The first doses of influenza vaccine are being shipped to the Centers for Disease Control and Prevention (CDC) for their distribution in support of the Vaccines For Children (VFC) program and to many other health-care providers including private physicians' offices. This shipment represents the first of approximately 50 million doses planned for production this year.
Sanofi pasteur will begin partial shipments to customers in August as part of the company's split delivery process, which will allow all customers to begin immunizing patients. Vaccine shipments will continue through the fall and are planned to be complete by the end of October.
Each year, sanofi pasteur provides vaccine to hospitals and other health- care facilities; private office-based providers; retail pharmacies; community immunization providers; and to the military, veterans and children through providers' private and public vaccination programs.
As the world's leading vaccine manufacturer, sanofi pasteur produces approximately half of the influenza vaccine distributed worldwide and more than 40 percent of influenza vaccine distributed in the U.S. 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 by the end of 2008 or in early 2009, will more than double U.S. production capacity.
While influenza vaccination typically begins in early fall, CDC data demonstrate that influenza rates typically peak in February, making it important for people to seek influenza immunization throughout the full influenza season. The CDC recommends that health-care providers begin offering vaccination soon after vaccine becomes available, and continue vaccination efforts throughout the season.(1)
Influenza Vaccine Recommendations
The CDC recommends influenza immunization for all persons who want to reduce the risk of becoming ill with influenza or of transmitting the virus to others, including school-aged children. Annual vaccination is especially important for children 6 through 59 months of age, persons aged 50 years and older, pregnant women and anyone 6 months and older with a chronic medical condition, such as asthma and diabetes. The vaccine also is recommended for persons who live with or care for persons at high risk, including household contacts and health-care workers.(1)
About Fluzone Vaccine
Fluzone vaccine is the only influenza vaccine licensed for populations 6 months and older. 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.
The 2007-2008 influenza vaccine formulation contains an A/Solomon Islands/3/2006 (H1N1)-like virus; an A/Wisconsin/67/2005 (H3N2)-like virus; and a B/Malaysia/2506/2004-like virus. The three strains for the new influenza vaccine formulation were confirmed by the Food and Drug Administration's (FDA's) Vaccines and Related Biological Products Advisory Committee in February 2007 and correspond with recommendations made by the World Health Organization in February. Influenza vaccine is formulated each year to match the strains predicted to circulate during the upcoming season.
There are risks associated with all vaccines. The most common local and systemic adverse reactions to Fluzone vaccine include soreness at the vaccination site that can last up to 2 days, pain, and swelling, fever, malaise, and myalgia. Other adverse reactions may occur. Influenza vaccine should not be administered to anyone with a history of hypersensitivity to any vaccine component, including eggs, egg products, or thimerosal (the only presentation that contains thimerosal is the multi-dose vial). Fluzone vaccine should not be administered to individuals who have a prior history of Guillain-Barre syndrome (GBS). As with any vaccine, vaccination with Fluzone vaccine may not protect 100% of individuals.
Before administering Fluzone vaccine, please see full Prescribing Information at www.vaccineplace.com/products.
Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris and in New York .
Sanofi pasteur, the vaccines division of the sanofi-aventis Group, provided more than a billion doses of vaccine in 2006, 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, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
sanofi pasteur sanofi pasteur Patricia Tomsky Len Lavenda U.S. Media Relations U.S. Media Relations Tel: + 1-570-839-4261 Tel: +1-570-839-4446 References (1) Centers for Disease Control and Prevention. Prevention and Control of Influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR Early Release 2007;email@example.com firstname.lastname@example.org
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Posted: August 2007