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US accepts $192 mln of H5N1 bulk vaccine

Sanofi Pasteur, the vaccines division of Ssanofi-Aventis Group, announce that the US Department of Health and Human Services (HHS) has accepted H5N1 bulk vaccine antigen to produce approx. 38.5 mln 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 programme, and will receive a payment of $192.5 mln booked in the second quarter of 2008 for acceptance of the bulk vaccine lot. In 2007, Sanofi Pasteur received $126.9 mln 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 mln 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.
According to the company, this acceptance represents the US government's latest effort to diversify the vaccine stockpile programme to include new strains of the H5N1 virus. The antigen lot accepted will protect against a clade 2.2 strain of H5N1 virus 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 US site in Swiftwater, PA.
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