Jun 19 2007
HHS Secretary Mike Leavitt has announced the award of two contracts to expand the domestic influenza vaccine manufacturing capacity that could be used in the event of a potential influenza pandemic.
The department has awarded two cost-reimbursable contracts totaling $132.5 million to sanofi pasteur and MedImmune over five years to retrofit existing domestic vaccine manufacturing facilities on a cost-sharing basis and to provide warm-base operations for manufacturing pandemic influenza vaccines. In warm-base operations, the contractor does not shut down the facility.
"We must prepare for a flu pandemic, although it may not be possible to be certain when the next one will come or how severe it will be," Secretary Leavitt said. "These contracts are important advances in the path of preparation because they help the nation build its capacity to respond."
The five-year contracts were awarded to sanofi pasteur, a manufacturer of a U.S.-licensed egg-based inactivated influenza vaccine product, for $77.4 million and to MedImmune, a manufacturer of a U.S.-licensed egg-based live, attenuated vaccine product, for $55.1 million. The contracts provide funding for renovation of manufacturing facilities and manufacturing warm-base operations for two years with options for an additional three years of warm-base operation.
Upon completion, these facilities will expand domestic pandemic vaccine manufacturing capacity by 16 percent. Additionally, these facilities will afford year-round production of pre-pandemic influenza vaccines for the national stockpile, which is limited currently to three months each year.
The HHS Pandemic Preparedness Plan, issued in November 2005, outlines public health preparedness and response activities for an influenza pandemic. Major vaccine goals include the establishment of pre-pandemic influenza vaccine stockpiles for 20 million persons in the critical workforce and the expansion of domestic pandemic vaccine manufacturing surge capacity for 300 million persons within six months of the onset of an influenza pandemic.
HHS' Office of the Assistant Secretary for Preparedness and Response, which oversees medical countermeasure development and acquisition efforts through its Office of Biomedical Advanced Research and Development Authority (BARDA), formerly the Office of Public Health Emergency Medical Countermeasures, will manage these contracts.