HHS Secretary Mike Leavitt announced today that the department has awarded contracts totaling $132.5 million to three vaccine makers for the advanced development of H5N1 influenza vaccines using an immune system booster called an adjuvant. An adjuvant is a substance that may be added to a vaccine to increase the body?s immune response to the vaccine?s active ingredient, called antigen.
?In the event of an influenza pandemic, a vaccine that uses adjuvant could provide a way to extend a limited vaccine supply to more people,? Secretary Leavitt said. ?These contracts are a continuation of our aggressive multi-pronged approach to a potentially critical public health challenge.?
The Department has awarded five-year contracts to GlaxoSmithKline for $63.3 million and to Novartis Vaccines and Diagnostics, Inc. for $54.8 million. In addition, HHS is funding IOMAI Corporation for $14.4 million for 15 months to complete Phase 1 clinical trials of their candidate vaccine. IOMAI may receive an additional $114 million in funding upon successful completion of the Phase 1 trials. Phase I trials are the first stage of testing in people and normally include a small (usually less than 100) group of healthy volunteers. Overall the three contracts support advanced development work through Phase 3 clinical trials in the U.S. that are aimed at obtaining U.S. licensure for the product. In addition, the contracts support the establishment of U.S.-based manufacturing capabilities.
Under the contracts each company will build up its capacity to produce within six months after the onset of an influenza pandemic either 150 million doses of an adjuvant-based pandemic influenza vaccine or enough adjuvant for 150 million doses of a pandemic influenza vaccine. In addition to supporting the development of each company?s antigen-sparing vaccine candidate, the contracts also require each company to provide its proprietary adjuvant for U.S. Government-sponsored, independent evaluation with influenza vaccines from other manufacturers.