Sanofi Pasteur wins multi-million US government order for H1N1 vaccine
Sanofi Pasteur, the vaccines division of the sanofi-aventis group, has received the first of a series of orders from the US Department of Health and Human Services (HHS) to begin production of an H1N1 vaccine.
Sanofi Pasteur, the vaccines division of the sanofi-aventis group, has received the first of a series of orders from the US Department of Health and Human Services (HHS) to begin production of an H1N1 vaccine.
In addition to this initial US$190m order, the company is in discussions with other governments to address their needs for a vaccine to protect against influenza A.
The HHS order includes 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 in August. Final formulation, filling and distribution of the vaccine have not yet been established.
"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," said Wayne Pisano, president and ceo of Sanofi Pasteur.
The company developed and licensed the first pre-pandemic vaccine for H5N1.
Sanofi Pasteur has received the seed virus to be used for vaccine production from the US Centers for Disease Control and Prevention (CDC) and has begun the development process that will yield a working seed for vaccine production. Commercial production will start in June following certification of the working seed by the US Food and Drug Administration (FDA).
Sanofi Pasteur operates influenza vaccine production facilities in Swiftwater, PA and Val de Reuil in France. Initial H1N1 production will be at Swiftwater.
Sanofi Pasteur has two licensed influenza production facilities in Swiftwater. The most recent was licensed during May and will have a capacity of approximately 100 million doses of seasonal influenza vaccine a year. The other facility is capable of producing 50 million doses a year. The H1N1 production can take place at both.
The facility in France is currently producing the trivalent seasonal influenza vaccine for the 2009/2010 season, with a capacity of 120 million doses a year. Val De Reuil is also capable of producing the new H1N1 vaccine.
Sanofi Pasteur produces approximately 40% of the influenza vaccines distributed worldwide. The company developed the first and only US-licensed avian influenza vaccine for humans.