United States Department of Health and Human Services has awarded a $97 million contract to Sanofi Pasteur to speed the production process for new influenza vaccines for the U.S.
The five-year award supports the development of advanced techniques using a cell- based, rather than an egg-based, approach to producing influenza vaccines. The contract also calls for plans to establish a U.S.-based, cell cultured influenza vaccine manufacturing facility.
"This action begins the process of speeding up influenza vaccine production, improving surge capacity and scaling up U.S. manufacturing capability," Secretary Leavitt said. "As a result, this should allow the U.S. 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. Scientists must first select the virus strains that they anticipate will be the predominant strains circulating in the U.S. during the following season. These strains are then adapted to grow in eggs. Manufacturers inject each adapted virus strain separately into millions of fertilized eggs, which are subsequently incubated to produce influenza virus. Large batches of these eggs are harvested and blended into a single vaccine product that includes all three influenza virus strains.
Using a cell culture approach to producing influenza vaccine offers a number of benefits. 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. U.S. licensure and manufacture of influenza vaccines produced in cell culture also will provide security against risks associated with egg- based production, such as the potential for egg supplies to be contaminated by various poultry-based diseases. Finally, the new cell-based influenza vaccines will provide an option for people who are allergic to eggs and therefore unable to receive the currently licensed vaccines.
Cell-based influenza vaccines use mammalian cells to grow the influenza viruses used in the vaccine. Under this contract, Sanofi Pasteur, a part of the Sanofi Pasteur Group, 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 U.S. In addition, Sanofi Pasteur will develop plans for a U.S. manufacturing facility capable of producing at least 300 million doses of a pandemic influenza vaccine using this technology.
This contract is one of several contracts that HHS has awarded during the past year to enhance pandemic influenza preparedness and the annual influenza vaccine supply. Earlier awards were made to increase domestic influenza vaccine capacity, secure year round vaccine raw materials and supplies, and develop pandemic-like vaccine candidates for clinical evaluation.
This contract follows the August 2004 release of the draft National Pandemic Influenza Preparedness and Response Plan, which outlines a coordinated national strategy to prepare for and respond to an influenza pandemic. The draft plan may be found online at http://www.hhs.gov/nvpo/pandemicplan and is a result of years of work by the Department.