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The dose calculation is based on antigen concentration of seasonalinfluenza vaccine, which contains 15 mcg per dose. When the dose calculationis based on concentration of sanofi pasteur's licensed pandemic vaccine, whichcontains 90 mcg per dose, bulk antigen will yield 6.4 million doses. Since thevaccine is supplied to the government in bulk concentrate form, finalformulation will not occur until the vaccine is needed. At that time, theactual number of doses will be determined.
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This acceptance represents the U.S. government's latest effort todiversify the vaccine stockpile program to include new strains of the H5N1virus. The antigen lot accepted today will protect against a clade 2.2 strainof H5N1 virus (A/Barheaded goose/Qinghai Lake/01/2005) that is particularlytroubling because it is the first to be identified in an outbreak of migratorybirds, which have the potential to spread the virus across continents. Thisstrain of avian influenza H5N1 virus is the strain that currently predominatesin birds of Europe, the Middle East, and Africa.
The bulk antigen was produced at sanofi pasteur's U.S. site in Swiftwater,PA. As the world leader in research, development and manufacturing ofinfluenza vaccine, sanofi pasteur is actively involved in projects in the U.S.and Europe with the goal of developing a vaccine to protect against a pandemicinfluenza virus.
In June 2007, sanofi pasteur completed construction of a new manufacturingfacility that is expected to more than double its capacity to produce bothseasonal and pandemic influenza when it begins production in early 2009.Sanofi Pasteur leads the way in pandemic preparedness with the first and onlyU.S. licensed avian influenza vaccine for humans and has successfully achievedmanufacturing scale-up of this first generation vaccine using proven, licensedand existing technology.
About Pandemic Influenza
An influenza pandemic is a global epidemic of an especially virulentvirus, newly infectious for humans, and for which there is no preexistingimmunity. This is why pandemic strains have such potential to cause severemorbidity and mortality. The H5N1 viral strain has been identified by globalhealth authorities as being a potential cause of a pandemic. In an attempt tominimize the impact of a pandemic, many countries are developing national andtransnational plans against a possible influenza pandemic situation.According to the World Health Organization (WHO), there have been 381 cases ofavian influenza transmitted to humans since 2003, with 240 resulting in death.
Sanofi Pasteur and Pandemic Preparedness
Sanofi Pasteur is committed to global pandemic preparedness. SanofiPasteur is investing in major expansions of its seasonal influenza vaccineproduction facilities in the U.S. and France, which could be used to producepandemic influenza vaccine if the need arises. For more information pleasevisit http://pandemic.influenza.com
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,develops and distributes therapeutic solutions to improve the lives ofeveryone. Sanofi-aventis is listed in Paris (EURONEXT PARIS: SAN) and in NewYork (NYSE: SNY);
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, providedmo
