SWIFTWATER, Pa., and LYON, France, Nov. 27 /PRNewswire/ -- Sanofi pasteur, the vaccines business of the sanofi-aventis Group, announced that it has completed shipping 50 million doses of influenza vaccine (Fluzone(R), Influenza Virus Vaccine) to the U.S. market, fulfilling its original production plans for the 2006-2007 season. The company began shipping vaccine in August and continued with multi-phased shipments of doses throughout the fall, in order to help providers keep on track with their immunization plans for the 2006-2007 season.
In response to customer demand, sanofi pasteur has been able to produce additional influenza vaccine, more than it had originally projected for the season. The company will continue to produce approximately 3-4 million more doses this year for delivery in December.
Sanofi pasteur is also proud to support National Influenza Vaccination Week (November 27 - December 3), which highlights the importance of following U.S. Centers for Disease Control and Prevention (CDC) recommendations for receiving influenza immunizations from fall into the winter months. The Week is cosponsored by the CDC and the National Influenza Vaccine Summit, which is a public-private partnership sponsored by the CDC and the American Medical Association.
The largest manufacturer of influenza vaccine and a supplier of 40 percent of the nation’s injectable influenza vaccine supply across a broad spectrum of customers, sanofi pasteur is a consistent and responsible member of the Immunization Community. As such, the company utilized a multi-phased delivery process that resulted in all customers receiving a partial delivery of their orders by September. Although this shipping process is more time consuming and costly for sanofi pasteur, the company has continued it because this policy has been recognized as key to facilitating the immunization of priority patients early in the season.
To keep pace with the nation’s growing and changing immunization needs, sanofi pasteur has expanded its influenza vaccine production capability. In July 2005, construction began on a new influenza vaccine production facility in Swiftwater, Pennsylvania, that will more than double the company’s U.S. capacity. The new plant is expected to come online for the 2008-2009 influenza season.
Influenza Immunization
While it is optimal to be vaccinated against influenza before the disease appears in the community, the CDC indicates that influenza vaccination is still beneficial in December and throughout the influenza season.
Influenza immunization is now recommended for healthy children 6 through 59 months of age. Children younger than 9 years of age receiving influenza vaccine for the first time require two doses, one month apart. The vaccine is also recommended for household contacts and out-of-home caregivers of all children younger than 59 months of age.
Other groups that have been identified as being at risk for developing serious influenza-related complications include the elderly and adults and children with chronic diseases, such as asthma and diabetes. Influenza vaccination is also recommended for those 50 to 64 years of age, household contacts of at-risk individuals, and health-care workers.
All other healthy individuals under 50 years of age and anyone who wishes to decrease their risk of influenza infection are also encouraged to seek vaccination.
Fluzone vaccine is the only influenza vaccine licensed for populations 6 months and older. In 2004-2005, sanofi pasteur introduced a new 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. It is the first FDA-licensed injectable influenza vaccine to be manufactured in this way.
The 2006-2007 influenza vaccine formulation contains the A/New Caledonia/20/99 (H1N1)-like virus; an A/Wisconsin/67/2005 (H3N2)-like virus (A/Wisconsin/67/2005 or A/Hiroshima/52/2005 strains); and B/Malaysia/2506/2004-like virus (B/Malaysia/2506/2004 or B/Ohio/1/2005 strains). The three strains for the new influenza vaccine formulation were confirmed by the Food and Drug Administration (FDA)'s Vaccines and Related Biological Products Advisory Committee in March 2006 and correspond with recommendations made by the World Health Organization in February. Influenza vaccine is reformulated each year to match the strains predicted to circulate in the coming season.
Safety Information
Fluzone vaccine is indicated in persons 6 months and older for active immunization against influenza virus types A and B contained in the vaccine. The most common adverse reactions to Fluzone vaccine are soreness at the vaccination site that can last up to 2 days, pain, and swelling; fever, malaise, and myalgia. 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). As with any vaccine, vaccination with Fluzone vaccine may not protect 100% of individuals. Fluzone vaccine should not be administered to individuals who have a prior history of Guillain-Barre syndrome (GBS). Because intramuscular injection can cause injection site hematoma, Fluzone vaccine should not be given to persons with any bleeding disorder, such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefits clearly outweigh the risk of administration. If the decision is made to administer Fluzone vaccine to such persons, it should be given with caution, with steps taken to avoid the risk of hematoma formation following injection.
Please see full Prescribing Information at http://www.sanofipasteur.us.
About sanofi-aventis
The sanofi-aventis Group is the world’s third-largest pharmaceutical company, 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 disease, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris and in New York .
Sanofi pasteur, the vaccines business of the sanofi-aventis Group, sold more than a billion doses of vaccine in 2005, making it possible to protect more than 500 million people across the globe. The company offers the broadest range of vaccines, providing protection against 20 bacterial and viral diseases. For more information, please visit: http://www.sanofipasteur.com
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. 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 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 “expect,” “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, 2005. 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: sanofi pasteur Pascal Barollier International Media Relations Tel: + 33-(0)4-37-37-51-41 pascal.barollier@sanofipasteur.com Len Lavenda U.S. Media Relations Tel: +1-570-839-4446 len.lavenda@sanofipasteur.com
sanofi pasteur
CONTACT: Pascal Barollier, International Media Relations,+33-(0)4-37-37-51-41, pascal.barollier@sanofipasteur.com; or Len Lavenda,U.S. Media Relations, +1-570-839-4446, len.lavenda@sanofipasteur.com, bothof sanofi pasteur
