The United States Department of Health and Human Services (HHS) this week placed an initial order with Sanofi Pasteur (Lyon, France) for a vaccine to fight influenza A (H1N1) infection. Valued at $190 million, the order is pursuant to an existing contract between the agency and the company and provides for the production of the bulk vaccine. However, Sanofi Pasteur still awaits the seed virus from the US Centers for Disease Control. Once the seed virus is obtained, the company says it will have a better timeline of when the vaccine might be available. Typically, it takes approximately six months to develop and manufacture an influenza vaccine. Also to be determined are the dosage requirements and the final formulation, filling, and distribution of the vaccine. Sanofi Pasteur says it “is prepared to commence commercial-scale production in June following certification of the working seed by the US Food and Drug Administration.”
The vaccine order follows an initial order by HHS of GSK’s influenza A (H1N1) antigen as the company’s proprietary AS03 adjuvant system, which the company already used in Phase II trials of an adjuvanted influenza A H5N1 (avian flu) vaccine. According to a May 15 release, GSK is also waiting on a seed virus from the World Health Organization. The company says it has also received orders from the governments of France, Finland, Belgium, and the United Kingdom for an influenza A (H1N1) adjuvanted vaccine.
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