Journal Article

Project BioShield: What It Is, Why It Is Needed, and Its Accomplishments So Far

Philip K. Russell

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 45, issue Supplement_1, pages S68-S72
Published in print July 2007 | ISSN: 1058-4838
Published online July 2007 | e-ISSN: 1537-6591 | DOI:
Project BioShield: What It Is, Why It Is Needed, and Its Accomplishments So Far

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Project BioShield is a comprehensive effort involving the US Department of Health and Human Services (HHS), its component agencies, and other partner federal agencies to speed the research, development, acquisition, and availability of medical countermeasures to improve the government's preparedness for and ability to counter chemical, biological, radiological, and nuclear threat agents. The legislation authorizes use of the Special Reserve Fund, which makes available $5.6 billion over 10 years for the advanced development and purchase of medical countermeasures. This appropriation is intended to provide an economic incentive to the pharmaceutical industry to develop medical countermeasures for which the government is the only significant market. Acquisitions under Project BioShield are restricted to products in development that are potentially licensable within 8 years from the time of contract award. In exercising the procurement authorities under Project BioShield, HHS has launched acquisition programs to address each of the 4 threat agents, including Bacillus anthracis (anthrax), smallpox virus, botulinum toxins, and radiological/nuclear agents, originally deemed by the Department of Homeland Security to be threats to the US population sufficient to affect national security. At the time of writing, 7 contracts have been awarded: (1) recombinant protective antigen anthrax vaccine, the next-generation anthrax vaccine (contract terminated in December 2006 for default); (2) anthrax vaccine adsorbed, the currently licensed anthrax vaccine; (3) anthrax therapeutics (monoclonal); (4) anthrax therapeutics (human immune globulin); (5) the pediatric formulation of potassium iodide; (6) Ca- and Zn-diethylenetriaminepentaacetate (DTPA), chelating agents to treat ingestion of certain radiological particles; and (7) botulinum antitoxins. Additional acquisition contracts are expected to be awarded in 2007.

Journal Article.  2432 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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