Sanofi Pasteur received a $190 million order from the U.S. Department of Health and Human Services (HHS) to begin production of a vaccine to help protect against the A(H1N1) flu virus.

This order was issued under an existing pandemic stockpile contract between Sanofi Pasteur and the U.S. government that allows HHS to purchase vaccines for viruses with pandemic potential.

The HHS order provides for the production of the bulk vaccine and related activities. 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. Final formulation, filling and distribution of the vaccine have not been established yet.

“This initial order for A(H1N1) vaccine 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,” said Wayne Pisano, president and chief executive officer 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).”

Sanofi Pasteur is waiting to receive the seed virus to be used for vaccine production from the U.S. Centers for Disease Control and Prevention (CDC). The company will then begin development efforts to prepare a working seed for vaccine production. Sanofi Pasteur is prepared to begin commercial scale production in June following FDA certification of the working seed. The company currently estimates it will have the first bulk concentrate vaccine in a few months.

Production of the A(H1N1) vaccine will initially occur in Sanofi Pasteur’s recently licensed flu vaccine production facility in Swiftwater PA. Once ongoing seasonal flu production is finished in the second facility in Swiftwater, the A(H1N1) vaccine will be produced in both Swiftwater facilities.