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U.S. Government Accepts $192 Million of sanofi pasteur H5N1 Bulk Vaccine Antigen for Pandemic Stockpile
Date:4/28/2008

- Vaccine for new strain of virus broadens government readiness program -

SWIFTWATER, Pa. and LYON, France, April 28 /PRNewswire-FirstCall/ -- Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that the U.S. Department of Health and Human Services (HHS) has accepted H5N1 bulk vaccine antigen to produce approximately 38.5 million doses of vaccine to protect against a new strain of avian influenza. Sanofi Pasteur has a multi- year contract with HHS as part of its pandemic program, and will receive a payment of $192.5 million booked in the second quarter of 2008 for acceptance of the bulk vaccine lot. In 2007, sanofi pasteur received $126.9 million for its bulk pandemic vaccine.

The dose calculation is based on antigen concentration of seasonal influenza vaccine, which contains 15 mcg per dose. When the dose calculation is based on concentration of sanofi pasteur's licensed pandemic vaccine, which contains 90 mcg per dose, bulk antigen will yield 6.4 million doses. Since the vaccine is supplied to the government in bulk concentrate form, final formulation will not occur until the vaccine is needed. At that time, the actual number of doses will be determined.

This acceptance represents the U.S. government's latest effort to diversify the vaccine stockpile program to include new strains of the H5N1 virus. The antigen lot accepted today will protect against a clade 2.2 strain of H5N1 virus (A/Barheaded goose/Qinghai Lake/01/2005) that is particularly troubling because it is the first to be identified in an outbreak of migratory birds, which have the potential to spread the virus across continents. This strain of avian influenza H5N1 virus is the strain that currently predominates in 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 of influenza vaccine, sanofi pasteur is active
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SOURCE sanofi pasteur
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