SWIFTWATER, Pa., Dec. 1 /PRNewswire/ -- Sanofi pasteur, the vaccines business of the sanofi-aventis Group, will supply 62 million doses of influenza vaccine (Fluzone(R), Influenza Virus Vaccine) to the U.S. market for the 2005-2006 season -- 12 million more doses than the company originally planned to provide. The company shipped more than 58 million doses to customers by the end of November -- six weeks ahead of the original schedule. The remaining 3.5 million doses will be delivered in January to the late season stockpile established by the U.S. Centers for Disease Control and Protection (CDC).
As the most consistent and reliable supplier of injectable influenza vaccine to the U.S. market for many years, sanofi pasteur has made every effort to address public health needs in the most equitable manner possible based on uncertainties arising from market supply disruptions both this year and last year. Sanofi pasteur began shipping influenza vaccine in early August, which was far in advance of other manufacturers and the company is supplying more doses to more providers than ever before. All sanofi pasteur’s confirmed orders were delivered in full this season without reduction.
During the current immunization season, the company estimates it supplied more than 90 percent of the U.S. public sector influenza vaccine market needs, which is significantly more than the company has supplied in prior years. In fact, almost 30 percent of sanofi pasteur’s total influenza vaccine supply was shipped to the public sector. Approximately 30 percent of the company’s supply was shipped to private sector physicians either directly or through distributors, and approximately 10 percent of total doses went to community immunization providers, including the Visiting Nurses Associations. The balance was shipped to hospitals, long-term care facilities, medical centers, academic institutions and corporations.
Once again, the company utilized a split-delivery process that resulted in all customers receiving at least a partial delivery of their orders by the end of October. Although this shipping process is more time consuming and costly for sanofi pasteur, the company has continued the process because it 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 consistently increased its production and modified distribution plans to provide early shipments to providers that have been identified as most critical in reaching priority high-risk patients designated by the CDC. These providers include long-term care facilities, Veteran’s Administration Hospitals, physicians with pediatric patients and Federal, state, county and city public health departments.
To help address the longer-term needs of the country, sanofi pasteur has begun construction of a new manufacturing facility that will double the company’s capacity to produce influenza vaccine for both routine influenza immunization and in case of an influenza pandemic. The new facility is expected to be completely online for the 2008-2009 influenza season.
Influenza Immunization
While it is optimal to be vaccinated against influenza before 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 aged 6 through 23 months, as this age group has been found to be at increased risk for influenza-related hospitalizations. 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 24 months.
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 who care for at-risk patients.
All other healthy individuals under age 50 and anyone who wishes to decrease their risk of influenza infection are also encouraged to seek vaccination.
Fluzone vaccine is the only influenza vaccine approved for all populations 6 months and older. In 2004-2005, sanofi pasteur introduced a new Fluzone formulation (trade name: Fluzone(R) Influenza Virus Vaccine, No Preservative) that does not introduce a preservative at any stage in the manufacturing process. It is the first FDA-approved injectable influenza vaccine to be manufactured in this way.
The 2005-2006 influenza vaccine formulation contains the A/New Caledonia/20/99/IVR-116 (H1N1); A/New York/55/2004/X-157 (H3N2) (an A/California/07/2004-like strain); and B/Jiangsu/10/2003 (a B/Shanghai/361/2002-like strain). The three strains for the new influenza vaccine formulation were confirmed by the Food & Drug Administration (FDA), Center for Biologics Evaluation & Research, Vaccines & Related Biological Products Advisory Committee in March 2005. The FDA’s decision corresponds with recommendations made by the World Health Organization in February. Influenza vaccine is reformulated each year to match the strain predicted to circulate in the coming season.
Safety Information
The most common side effects from influenza vaccine are pain and swelling at the vaccination site that can last up to two days. Some people may have mild fever, myalgia (muscle aches), or feel tired for a day or two after receiving the influenza vaccine. Other systemic reactions can occur.
Injectable influenza vaccine is made from killed strains of the viruses predicted to be the main causes of influenza in the coming season. Because the viruses are killed, it is impossible to get influenza from the vaccine.
People who have had previous reactions to the vaccine or people who are allergic to eggs (the viruses used in the vaccine are grown in eggs), egg products, or thimerosal should not receive influenza vaccine. Persons with acute febrile illness usually should not be vaccinated until their symptoms have abated. However, minor illnesses with or without fever do not contraindicate the use of influenza vaccine, particularly among children with mild upper respiratory tract infection or allergic rhinitis.
For full prescribing information, see the package insert at http://www.sanofi-pasteur.us.com.
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 nearly a billion doses of vaccine in 2004, making it possible to protect more than 500 million people across the globe, which is about 1.4 million per day. 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 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, 2004. 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-aventis Group subsidiaries in the United States include Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.
sanofi pasteur Len Lavenda sanofi pasteur US Media Relations Tel: 570-839-4446 Len.Lavenda@sanofipasteur.com
sanofi pasteur
CONTACT: Len Lavenda of sanofi pasteur US Media Relationsm,+1-570-839-4446, Len.Lavenda@sanofipasteur.com
