Project BioShield

Medical Countermeasures for Anthrax

The Threat

Anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis, which can cause human disease via gastrointestinal, cutaneous, or inhalational (pulmonary) routes. Although clinical manifestations of the disease differ by route, inhalational anthrax is the most lethal. The threat from a potential antibiotic-resistant strain of B. anthracis is also recognized.

On January 20, 2004, the Secretary of Homeland Security determined that anthrax is a material threat to the U.S. population sufficient to affect national security.

HHS Medical Countermeasure Efforts

The U.S. Department of Health and Human Services (HHS) is pursuing a comprehensive strategy to address the threat of anthrax, and has made a substantial investment in the acquisition of medical countermeasures for the Strategic National Stockpile (SNS). This comprehensive approach includes acquisition of vaccines, antibiotics, and therapeutics to meet immediate public health needs in the event of an attack. Antibiotics remain a cornerstone of the response strategy to anthrax.  The SNS now has sufficient quantities of this antibiotic regimen for over 40 million individuals.

Project BioShield

On July 21, 2004, President George W. Bush signed into law the Project BioShield Act of 2004 (Project BioShield) as part of a broader strategy to defend America against the threat of weapons of mass destruction. The purpose of Project BioShield is to accelerate the research, development, purchase, and availability of effective medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) agents.

Under Project BioShield, the Office of the Assistant Secretary for Preparedness and Response is currently overseeing procurement of anthrax vaccines for the SNS and the development and procurement of therapeutics that directly target B. anthracis.

Anthrax Vaccines

Anthrax vaccines offer pre-exposure protection to those who are at risk from anthrax, and they may provide added protection when given with antibiotics as part of post-exposure prophylaxis.  HHS is committed to the development and acquisition of a next-generation anthrax vaccine, based on the needs articulated in the 2002 Institute of Medicine report The Anthrax Vaccine: Is It Safe? Does It Work?  On May 14, 2007, the Office of the Biomedical Advanced Research and Development Authority (BARDA) issued a Sources Sought Notice for an Anthrax recombinant Protective Antigen (rPA) vaccine for the Strategic National Stockpile.  The Department of Health and Human Services determined that it will need to make an initial purchase of 25 million doses of an anthrax rPA vaccine.  The rPA Sources Sought responses were received on June 11, 2007 and BARDA is currently reviewing the submitted information.  A Request for Proposals (RFP) for rPA is expected in the fall of 2007.

An interagency group of experts determined that it was appropriate to pursue the acquisition of Anthrax Vaccine Adsorbed (AVA), an anthrax vaccine licensed for pre-exposure use. This recommendation was accepted by the Secretaries of Health and Human Services and Homeland Security and approved by the Office of Management and Budget.  HHS awarded a $122.7 million contract to BioPort Corporation (currently Emergent BioSolutions) in May, 2005 for five million doses of the AVA vaccine. On May 5, 2006, HHS purchased an additional five million doses of AVA at a cost of $120 million.  On April 18, 2007, HHS announced its intention to acquire 10.4 million doses of a licensed anthrax vaccine, with an option to purchase up to an additional 8.35 million doses.

Anthrax Therapeutics: Development and Procurement

The primary mortality and morbidity of B. anthracis is mediated through toxemia. Antibiotics target the B. anthracis bacteria itself.  Antitoxins are required to neutralize the effects of the toxins and may contribute to a more successful therapeutic outcome.

An interagency group of experts determined that it was appropriate to pursue the acquisition of anthrax therapeutics. This recommendation was accepted by the Secretaries of Health and Human Services and Homeland Security and, following approval by the Office of Management and Budget, HHS moved forward with the procurement of these countermeasures. On June 20, 2006, HHS awarded a contract for 20,000 treatment courses of ABthrax, an anthrax therapeutic treatment from Human Genome Sciences for $165,205,217.  On July 28, 2006, HHS awarded a contract for 10,000 treatment courses of Anthrax Immune Globulin (AIG) from Cangene Corporation for $143,833,719.