News Capsule - National

Sanofi Pasteur gets US government's order to produce A (H1N1) vaccine

Our News Bureau - Mumbai

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group has received the first of its series of orders from the US Department of Health and Human Services (HHS) to commence production of a vaccine to help protect against the new influenza A (H1N1) virus.

This order from HHS was issued pursuant to an existing pandemic stockpile contract between Sanofi Pasteur and the US government that allows HHS to purchase vaccines for viruses with pandemic potential. In addition to this initial HHS order, the company is in discussions with other governments to address their needs for A (H1N1) vaccine.

The HHS order provides for the production of 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 also have not been established at this time. The order is in the amount of $190 million.

"This initial order for A (H1N1) vaccine received 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 - 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)," Pisano commented.

Sanofi Pasteur is awaiting receipt of the seed virus to be used for vaccine production from the US Centre for Disease Control and Prevention (CDC). Once received, the company will begin development efforts to prepare a working seed for vaccine production. Sanofi Pasteur is prepared to commence commercial scale production in June following certification of the working seed by the US Food and Drug Administration (FDA). The company currently estimates it will have the first bulk concentrate vaccine in a few months.

"Our philosophy is to maintain flexibility in our influenza vaccine production, to enable us to answer public health needs wherever they are. We know that seasonal influenza remains a global threat and, in many countries, especially developing countries, H5N1 is still a greater threat than A(H1N1). To this end, we continue our active discussions with WHO and governments around the world to ensure the accessibility of our life-saving vaccines to the greatest number of people," said Pisano.