First doses of 'swine flu' vaccine ship

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Sanofi Pasteur Shipping First Doses of Influenza Vaccine for the

2008-2009 Season.

Article from:

PR Newswire

Article date:

August 1, 2008

SWIFTWATER, Pa. and LYON, France, Aug. 1 /PRNewswire/ -- Sanofi

Pasteur, the vaccines division of sanofi-aventis Group, began shipping

influenza vaccine (Fluzone®, Influenza Virus Vaccine) in the United

States for the 2008-2009 season. The first 1.3 million doses of

influenza vaccine began shipping this week following marketing

clearance of the 2008-2009 formulation by the U.S. Food and Drug

Administration (FDA) on July 14, 2008.

Vaccine shipments to health-care providers and to the Centers for

Disease Control and Prevention (CDC) for distribution through the

Vaccines for Children Program will continue through the fall and are

planned to be completed in October.

This year's influenza vaccine contains three new strains of the

influenza virus, A/Brisbane/59/2007 (H1N1)-like virus; A/Brisbane/

10/2007 (H3N2)-like virus; B/Florida/4/2006-like virus. The three

strains for the new influenza vaccine formulation were confirmed by

the FDA's Vaccines and Related Biological Products Advisory Committee

in February 2008 and correspond with recommendations made by the World

Health Organization in February. Unlike other routinely recommended

vaccines whose formulation remains constant over time, influenza

vaccine is formulated each year to match the strains predicted to

circulate during the upcoming season.

" Introduction of three new strains for the influenza vaccine was

unprecedented and could have resulted in a low yield or delay given

our tight production timeline. Despite these challenges, we are

pleased that once again sanofi pasteur has demonstrated its

reliability in supplying Fluzone vaccine to the U.S. market, " said

Wayne Pisano, President and Chief Executive Officer, sanofi pasteur.

" The early shipment of Fluzone vaccine by sanofi pasteur gives health-

care providers greater flexibility in planning their vaccination

efforts. "

As the world's leading influenza vaccine manufacturer, sanofi pasteur

produces approximately half of the influenza vaccine distributed

worldwide and in the U.S. produced more than 40 percent of the

influenza vaccine distributed for the 2007-2008 influenza season.

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 to produce

vaccine for the 2009-2010 season, will more than double sanofi

pasteur's U.S. production capacity.

" As a manufacturer, one of our primary objectives is to be responsive

to the requests of our customers for early influenza vaccine

shipments. In planning their vaccination efforts, it is important for

health-care providers and the public to realize that while influenza

immunization programs often occur in the early fall, the influenza

season itself does not typically peak until February, with disease

appearing as late as May. This allows many months for providers to

administer influenza vaccine to their patients, " said Pisano.

Influenza Immunization Recommendations

The CDC recommends that health-care providers begin offering influenza

vaccine as soon as vaccine becomes available, and continue

immunization efforts throughout the season. Health-care providers are

urged to continue immunization efforts until the end of influenza

season. Approximately 250 million people, or 4 out of 5 residents of

the U.S., are recommended to receive the influenza vaccine annually.

The CDC recommends an annual influenza immunization for anyone who

wishes to reduce their risk of contracting influenza; children 6

months through 18 years of age; adults over 50 years of age; pregnant

women; and anyone with chronic health conditions, such as asthma,

chronic obstructive pulmonary disease (COPD), heart disease, and

diabetes. The CDC also recommends annual immunization for caregivers

and household contacts of these high-risk groups; such as relatives

and health-care providers.

About Fluzone Vaccine

Fluzone vaccine is given to persons 6 months of age and older for

active immunization against influenza virus types A and B contained in

the vaccine. A Fluzone vaccine formulation (trade name: Fluzone®,

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.

Safety Information

Side effects to Fluzone vaccine are soreness at the injection site

that can last up to 2 days, pain, and swelling; fever, fatigue, and

muscular pain. Other side effects may occur. Fluzone vaccine should

not be administered to anyone with a history of serious allergic

reaction to any vaccine component, including eggs, egg products, or

thimerosal (the only Fluzone vaccine product containing thimerosal is

the multi-dose vial), or to persons who have been previously diagnosed

with Guillain-Barre syndrome (GBS). If you notice any other problems

or symptoms following vaccination, please contact your health-care

professional immediately. Vaccination with Fluzone vaccine may not

protect all individuals.

For more information about Fluzone vaccine, talk to your health-care

professional. The full prescribing information for Fluzone vaccine can

be obtained at http://www.fluzone.com/

About sanofi-aventis

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 .

Sanofi Pasteur, the vaccines division of sanofi-aventis Group,

provided more than a 1.6 billion doses of vaccine in 2007, 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: http://www.sanofipasteur.com/ or http://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, 2007. Other than as required by applicable law,

sanofi-aventis does not undertake any obligation to update or revise

any forward-looking information or statements.

US Media Relations

Len Lavenda

T. +1-570-839-4446

len.lavenda@...

Donna Cary

T. +1-570-839-4732

donna.cary@...

CONTACT: US Media Relations, Len Lavenda, +1-570-839-4446,

len.lavenda@...

; Donna Cary, +1-570-839-4732, donna.cary@...

Web site: http://www.fluzone.com/ http://www.sanofipasteur.us/

http://www.sanofipasteur.com/