The five-year award supports the development of advanced techniques using a cell- based, rather than an egg-based, approach to producing influenza vaccines.
Under the contract, Sanofi Pasteur will develop, scale-up, and manufacture clinical investigational lots of inactivated influenza vaccines using human cells. These vaccines will be tested in human clinical trials in adult, elderly, and pediatric populations within the US.
In addition, Sanofi Pasteur will develop plans for a US manufacturing facility capable of producing at least 300 million doses of a pandemic influenza vaccine using this technology.
“This action begins the process of speeding up influenza vaccine production, improving surge capacity and scaling up US manufacturing capability,” said HHS Secretary Mike Leavitt. “As a result, this should allow the US to have influenza vaccines in a more timely, less laborious manner, and it provides another tool for responding to and controlling a global influenza pandemic.”
Currently licensed influenza vaccines are produced in chicken eggs in a process that takes nearly nine months. Using a cell culture approach, vaccine manufacturers can bypass the step needed to adapt the virus strains to grow in eggs. In addition, cell culture-based influenza vaccines will help meet surge capacity needs in the event of a shortage or pandemic, since cells may be frozen in advance and large volumes grown quickly.