Sanofi pasteur, the vaccines business of the sanofi-aventis Group, began shipping influenza vaccine (Fluzone(R), Influenza Virus Vaccine) to the U.S. market for the 2006-2007 season. The shipment represents the first of approximately 50
million doses planned for production this year.
The most consistent and reliable supplier of injectable influenza
vaccine for many years, sanofi pasteur is expected to supply approximately
half of the global influenza vaccines market. This shipment will help
providers start to successfully implement their immunization plans for the
upcoming influenza season.
As in past years, the company will use a split-delivery process so that
all customers will receive at least a partial delivery of their orders by
the end of September. 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 equitably distributing doses and
facilitating the immunization of priority patients across the maximum
number of providers.
Shipments will continue until December as the company produces 50
million doses of influenza vaccine for this season. It is important to
remember that the influenza season lasts from October through April, with
February typically being the period of most intense disease activity.
Therefore, it is still valuable to obtain an influenza vaccination in
December, January and beyond.
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 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 24 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/52/2005strains); 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
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 should not receive influenza vaccine. Persons allergic to
thimerosal should receive a thimerosal-free version of the 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
sanofi-pasteur.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 (EURONEXT: SAN) and in New York
(NYSE: SNY).
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:
sanofi-pasteur.us
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, 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.
Sanofi pasteur
sanofi-pasteur.us
View drug information on Fluzone Preservative-free.
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