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Sanofi Pasteur Shipping First Doses of Influenza Vaccine for the 2008-2009 Season

Saturday, August 2, 2008 General News J E 4
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SWIFTWATER, Pa. and LYON, France, Aug. 1 Sanofi Pasteur,the vaccines division of sanofi-aventis Group, began shipping influenzavaccine (Fluzone(R), Influenza Virus Vaccine) in the United States for the2008-2009 season. The first 1.3 million doses of influenza vaccine beganshipping this week following marketing clearance of the 2008-2009 formulationby the U.S. Food and Drug Administration (FDA) on July 14, 2008.

Vaccine shipments to health-care providers and to the Centers for DiseaseControl and Prevention (CDC) for distribution through the Vaccines forChildren Program will continue through the fall and are planned to becompleted in October.

This year's influenza vaccine contains three new strains of the influenzavirus, A/Brisbane/59/2007 (H1N1)-like virus; A/Brisbane/10/2007 (H3N2)-likevirus; B/Florida/4/2006-like virus. The three strains for the new influenzavaccine formulation were confirmed by the FDA's Vaccines and RelatedBiological Products Advisory Committee in February 2008 and correspond withrecommendations made by the World Health Organization in February. Unlikeother routinely recommended vaccines whose formulation remains constant overtime, influenza vaccine is formulated each year to match the strains predictedto circulate during the upcoming season.

"Introduction of three new strains for the influenza vaccine wasunprecedented and could have resulted in a low yield or delay given our tightproduction timeline. Despite these challenges, we are pleased that once againsanofi pasteur has demonstrated its reliability in supplying Fluzone vaccineto the U.S. market," said Wayne Pisano, President and Chief Executive Officer,sanofi pasteur. "The early shipment of Fluzone vaccine by sanofi pasteur giveshealth-care providers greater flexibility in planning their vaccinationefforts."

As the world's leading influenza vaccine manufacturer, sanofi pasteurproduces approximately half of the influenza vaccine distributed worldwide andin the U.S. produced more than 40 percent of the influenza vaccine distributedfor the 2007-2008 influenza season. Sanofi Pasteur is committed to raisingimmunization rates and improving global access to vaccines. As part of thiscommitment, the company is expanding its influenza vaccine production facilityin the United States. This expansion, slated to come on-line to producevaccine 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 tothe requests of our customers for early influenza vaccine shipments. Inplanning their vaccination efforts, it is important for health-care providersand the public to realize that while influenza immunization programs oftenoccur in the early fall, the influenza season itself does not typically peakuntil February, with disease appearing as late as May. This allows many monthsfor providers to administer influenza vaccine to their patients," said Pisano.

Influenza Immunization Recommendations

The CDC recommends that health-care providers begin offering influenzavaccine as soon as vaccine becomes available, and continue immunizationefforts throughout the season. Health-care providers are urged to continueimmunization efforts until the end of influenza season. Approximately 250million people, or 4 out of 5 residents of the U.S., are recommended toreceive the influenza vaccine annually. The CDC recommends an annual influenzaimmunization for anyone who wishes to reduce their risk of contractinginfluenza; children 6 months through 18 years of age; adults over 50 years ofage; pregnant women; and anyone with chronic health conditions, such asasthma, chronic obstructive pulmonary disease (COPD), heart disease, anddiabetes. The CDC also recommends annual immunization for caregivers andhousehold contacts of these high-risk groups; such as relatives andhealth-care
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