Medical Countermeasures for Botulism

The Threat

A photomicrograph of Clostridium botulinum bacteriaBotulism 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

The response to the threat posed by the botulinum neurotoxin has two arms: mechanical ventilators and antitoxin. 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 initial funds were used in part to establish a source of equine plasma that contains the antitoxin.

Botulinum antitoxins block the action of circulating neurotoxins in the bloodstream. Use of the appropriate antitoxin within 12 to 36 hours of intoxication can 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 BARDA antitoxin program oversees the procurement of the heptavalent Botulinum Antitoxin Therapeutic (hBAT). 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.

In 2006, BARDA awarded a contract to Cangene for the development and manufacturing of hBAT for treatment of botulism.

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