Project BioShield

Medical Countermeasures for Botulism

The Threat

Botulism is a serious paralytic illness caused by neurotoxins produced by several Clostridium botulinum strains.  Exposure to botulinum toxins can lead to death due to respiratory failure unless ventilation is assisted mechanically; therefore, rapid diagnosis and access to intensive medical care and antitoxin are vitally important.

On June 9, 2004, the Secretary of Homeland Security determined that botulinum toxins present a material threat to the U.S. population sufficient to affect national security.

HHS Medical Countermeasures Efforts

Botulinum antitoxins block the action of circulating neurotoxins in the bloodstream.  Use of the appropriate antitoxin within 12 to 36 hours of intoxicationcan prevent worsening of the effects of botulinum toxin.  Separate antitoxins already exist for the seven known subtypes of toxin produced by Clostridium species.  A combination of all seven antitoxins (heptavalent antitoxin) is effective against all these subtypes. The Department of Defense acquired heptavalent equine botulinum antitoxin through the mid-1990s and maintains a limited stockpile.  Additionally, the Centers for Disease Control and Prevention (CDC) previously awarded a competitive contract to process existing bulk equine antitoxin to augment the limited national supply. In FY2004, prior to enactment of the Project BioShield legislation, $50 million was obligated from the Special Reserve Fund provided in the FY2004 Department of Homeland Security Appropriations Act for support of the botulinum antitoxin program.  These initialfunds were used in part to establish a source of equine plasma that contains the antitoxin.

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 the United States 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 the adverse health effects of chemical, biological, radiological, and nuclear (CBRN) agents.

An interagency group of experts established the requirement for botulinum toxin countermeasures.  Botulinum antitoxin derived from the immune globulin found in equine blood plasma was the only product thought suitable for Project BioShield acquisition, based on post-exposure effectiveness and the maturity of this product.  The Subcommittee recommended acquisition of 200,000 doses of heptavalent equine botulinum antitoxin.  The Secretaries of Health and Human Services and Homeland Security jointly recommended this acquisition and, following approval by the President, HHS implemented this acquisition.   

On May 30, 2006, a contract utilizing the BioShield-authorized Special Reserve Fund was awarded to Cangene Corporation of Winnipeg, Canada, for the manufacture of 200,000 doses of Heptavalent Botulism Antitoxin and delivery to the Strategic National Stockpile at a cost of $362.6 million.