The full supply of the vaccine will be added to the Strategic National Stockpile and would be used to protect the public against a terrorist attack in which anthrax spores were released.

"The intentional release of anthrax spores is one of the most significant biological threats we face," Secretary Thompson said. "Acquiring a stockpile of this new anthrax vaccine is a key step toward protecting the American public against another anthrax attack."

Neutralizes Anthrax Toxins

VaxGen, based in Brisbane, Calif., will produce the new anthrax vaccine using purified recombinant protective antigen (rPA), a protein that elicits antibodies that neutralize anthrax toxins, thus providing protective immunity. Evidence from laboratory and animal research has shown that the rPA vaccine is effective in providing protection against aerosol exposure to deadly anthrax spores. In addition, clinical testing has shown the rPA vaccine to be safe in humans.

The vaccine is being evaluated as a three-dose vaccination series. Based on 75 million doses, this regimen would provide sufficient anthrax vaccine to protect 25 million people. The contract awarded today requires VaxGen to obtain licensure from the Food and Drug Administration (FDA) for using the new vaccine in both pre- and post-anthrax exposure settings.

The vaccine will be made using modern manufacturing technologies, and the FDA will review the vaccine production process along with testing of individual test lots of vaccine to assure its safety and effectiveness. The contract with VaxGen is a fixed-price contract, which protects taxpayers from any cost overruns.

Protection Against Bioterrorism

HHS, through its National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, funded the development of rPA vaccine beginning in September 2002 as part of its broader effort to accelerate research into developing new medical countermeasures against potential bioterror attacks. This effort was based on more than a decade of basic rPA vaccine research carried out by the Department of Defense.

This award represents the first contract under the Project BioShield, a new program intended to accelerate the development, purchase and availability of medical countermeasures for biological, chemical, radiological and nuclear threats. President Bush introduced Project BioShield in his 2003 State of the Union address. Congress passed the Project BioShield Act of 2004 and the President signed it into law on July 21, 2004.

New Medical Countermeasure

"In an exceptionally short period of time, we have dramatically accelerated our research capacity to develop a new medical countermeasure against one of the most deadly agents of bioterrorism," said Anthony S. Fauci, M.D., director of NIAID. "Without Project BioShield, we would likely still be years away from a new anthrax vaccine and today's announcement might never have been possible."

HHS' Office of Public Health Emergency Preparedness, which oversees the research and procurement efforts under the Project BioShield program, will manage this new rPA anthrax vaccine contract.