Scott Gottlieb, CPA


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NEWS BYTES
April 2007


HHS Funds Advanced Development of H5N1 Influenza Vaccines
Three New Contracts Will Focus On Antigen-Sparing Vaccines

U.S. Department of Health and Human Services

 

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.

Initial clinical studies of H5N1 vaccine in humans have shown that two 90-microgram doses of the vaccine are required to stimulate a level of immune response that researchers anticipate would provide protection for an individual against the H5N1 strains that have been spreading among birds in Asia. However, the addition of adjuvant to these candidate vaccines may reduce the amount of antigen (active ingredient) per dose needed to achieve effective individual protection.

HHS’ effort to pursue adjuvant-based vaccine is part of a broader effort by the department to accelerate the development and production of new technologies for influenza vaccines within the U.S. For example, in May 2006 HHS announced a $1 billion investment to support the advanced development of cell-based production technologies for influenza vaccines and will help to modernize and strengthen the nation's influenza vaccine production by creating an alternative to producing influenza vaccines in eggs.

The H5N1 strain of avian flu has spread to more than 40 countries and has led to the deaths of hundreds of millions of additional birds, which has heightened concern about the possibility of a human flu pandemic. Furthermore, the number of avian flu cases in humans has reached more than 260 cases in 10 countries. More than half of those persons infected have died. To date, H5N1 avian influenza has remained primarily an animal disease, but should the virus acquire the ability for sustained transmission among humans, the potential for an influenza pandemic would have grave consequences for global public health.

More information on pandemic preparedness including information on vaccines can be found online at http://www.pandemicflu.gov/vaccine/index.html.

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