Sanofi Pasteur Receives Additional Order from U.S. Government to Produce Influenza...
Mon Sep 21, 2009 12:13pm EDT
Sanofi Pasteur Receives Additional Order from U.S. Government to Produce Influenza A (H1N1) Vaccine
- Company has now committed to produce 75.3 million doses of vaccine for the
U.S. government -
LYON, France and SWIFTWATER, Pa., Sept. 21 /PRNewswire-FirstCall/ -- Sanofi
Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and
NYSE: SNY), announced today that the company has received an additional order
from the U.S. Department of Health and Human Services (HHS) to produce vaccine
to help protect against the Influenza A (H1N1) 2009 virus. The new order is
for the production of bulk antigen equivalent to 27.3 million doses based on
15 mcg of antigen per dose. Specifications for formulation and filling of this
new bulk order will be the subject of a separate order. To date, Sanofi
Pasteur has committed to the U.S. government a total of 75.3 million doses of
Influenza A (H1N1) 2009 Monovalent Vaccine.
"We are pleased to be able to support the U.S. government's pandemic response
efforts through the production of additional doses of A (H1N1) vaccine," said
Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "As the
only company manufacturing inactivated influenza vaccine in the U.S., we
recognize the important role Sanofi Pasteur serves in the country's pandemic
response plan and we have committed our resources to responding to our public
Sanofi Pasteur began commercial production of the new influenza vaccine in
June using the novel virus strain to provide doses for clinical trials and to
respond to the initial order from HHS. Influenza A (H1N1) 2009 Monovalent
Vaccine was licensed by the U.S. Food and Drug Administration on September 15.
Sanofi Pasteur is testing the immunogenicity and safety of the Influenza A
(H1N1) 2009 Monovalent Vaccine produced in the U.S. through clinical trials,
which began in the U.S. on August 6. Final data from these clinical trials
will provide additional information to guide recommendations on the optimal
dosage, number of doses and schedule.
Sanofi Pasteur operates influenza vaccine production facilities in the U.S.
and in France. Production of the new A (H1N1) vaccine for HHS is being
performed at the company's U.S.-based production facility.
About Influenza A (H1N1) 2009 Monovalent Vaccine
The U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated
influenza virus vaccine indicated for active immunization of persons six
months of age and older against influenza disease caused by pandemic (H1N1)
The Influenza A (H1N1) 2009 Monovalent Vaccine is manufactured by the same
process as Sanofi Pasteur's seasonal trivalent influenza virus vaccine
licensed in the U.S. Influenza A (H1N1) 2009 Monovalent Vaccine is formulated
to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1)
v-like virus. Influenza A (H1N1) 2009 Monovalent Vaccine is licensed for
single-dose presentations in syringes and vials and in multi-dose vials. There
is no preservative used in the singledose presentations. Multi-dose vials
contain a preservative.
Safety Information for Influenza A (H1N1) 2009 Monovalent Vaccine
Influenza vaccine should not be administered to anyone with a known severe
hypersensitivity to egg
proteins, any vaccine component or life-threatening reactions after previous
administration of any
influenza vaccine. Recurrence of Guillain-Barre syndrome (GBS) has been
temporally associated with the administration of influenza vaccine. The
decision to give Influenza A (H1N1) 2009 Monovalent Vaccine to individuals who
have a prior history of GBS should be based on careful consideration of the
potential benefits and risks. Vaccination with Influenza A (H1N1) 2009
Monovalent Vaccine may not protect all individuals.
Before administering Influenza A (H1N1) 2009 Monovalent Vaccine, please see
full U.S. Prescribing Information at www.vaccineplace.com/products
About Influenza Vaccine Production at Sanofi Pasteur
Sanofi Pasteur operates influenza vaccine production facilities in Val de
Reuil, France and in Swiftwater, Pa. (U.S.). All Sanofi Pasteur influenza
vaccine facilities have been designed and built to be able to switch from
seasonal influenza vaccine production to pandemic influenza vaccine
Sanofi Pasteur produces approximately 40 percent of the influenza vaccines
distributed worldwide and more than 45 percent of the influenza vaccines
distributed in the U.S. for the 2008-2009 influenza season. More information
about Sanofi Pasteur's pandemic preparedness efforts can be found at
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 (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more
than 1.6 billion doses of vaccine in 2008, 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
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,
2008. Other than as required by applicable law, sanofi-aventis does not
undertake any obligation to update or revise any forward-looking information
Global Media Relations US Media Relations
Pascal Barollier Donna Cary
T. +33-(0)4-37-37-50-38 T. +1-570-957-0717
SOURCE Sanofi Pasteur
Global Media Relations, Pascal Barollier, +33-0-4-37-37-50-38,
, or US Media Relations, Donna Cary,