The order is a part of present pandemic stockpile contract between Sanofi and the US government that allows HHS to purchase vaccines for viruses with pandemic potential. Besides this HHS order, the company is in talks with other governments to meet their needs for A(H1N1) vaccine.
Sanofi will commence development efforts as soon as it receives the seed virus to be used for vaccine production from the US Centers for Disease Control and Prevention (CDC). Commercial scale production may begin in June following the certification of working seed by the FDA. Initially, production of A(H1N1) vaccine for HHS will occur in its vaccine production facility in Swiftwater, PA, US.
The dosage requirements for the vaccine will be based on clinical trials, which could begin in August. Final formulation, filling and distribution of the vaccine have not been established yet.