Sanofi Pasteur announces U.S. government order of H1N1 vaccine

5/26/2009

SWIFTWATER, Pa. Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, on Monday announced it has received the first of what is expected to be a series of orders from the U.S. Department of Health and Human Services to commence production of a vaccine to help protect against the novel H1N1 influenza virus. The order is in the amount of $190 million.

“This initial order for A(H1N1) vaccine received [today] under our existing contract is part of a major effort by Sanofi Pasteur to support global public health efforts to prepare the world for the possibility of an influenza pandemic,” stated Wayne Pisano, president and CEO of Sanofi Pasteur. “Production of a new vaccine is not a simple task and there are a number of necessary and complex steps that must be taken before a vaccine can be made available to the public, but we have experience on our side. Previously, we developed and licensed the first pre-pandemic vaccine for H5N1, and we look forward to further demonstrating our experience and expertise in vaccine development as we prepare for this new threat from A(H1N1).”

The dosage requirements for the new vaccine are yet to be determined and will be based on clinical trials, which could begin as early as August, the company stated. Final formulation, filling and distribution of the vaccine also have not been established at this time.

Sanofi Pasteur is awaiting receipt of the seed virus to be used for vaccine production from the Centers for Disease Control and Prevention, which could be delivered as early as the end of May, according to a CDC press conference held Friday.

Sanofi Pasteur is prepared to commence commercial scale production in June following certification of the working seed by the Food and Drug Administration. The company currently estimates it will have the first bulk concentrate vaccine in a few months. However, the company will be better able to determine the timing once the seed virus is received and development of working seed is underway.

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