Under the Project BioShield Act (2004) (PDF - 191 KB), Pandemic and All-Hazards Preparedness Act (2006) (PDF -248 KB), and Pandemic and All-Hazards Reauthorization Act (2013) (PDF - 284 KB), BARDA’s strategy to support advanced development of critical medical countermeasures targets biothreats that have been determined by the Department of Homeland Security as Material Threats. The material threat determination for botulinum toxin (botulism) was issued in June 2004. The goal of BARDA’s Botulinum Program is to develop a single product that is effective against all seven known serotypes of botulinum toxin, which addresses a significant gap in preparedness for this biothreat and public health concern. Development of a heptavalent botulinum antitoxin supports the Public Health Emergency Medical Countermeasures Enterprise (PHECME) and BARDA strategic goals of developing countermeasures for “at-risk” individuals.
This program was one of the first supported under Project BioShield (PBS). BARDA has provided PBS funds to support the late stage development and procurement of a heptavalent botulinum antitoxin (HBAT) produced in hyperimmune horses. The HBAT product was licensed under the Animal Rule by the FDA in March 2013, becoming the second product supported under PBS to achieve this milestone. HBAT is the only licensed botulinum antitoxin available and is effective against all seven known serotypes. The product has been used to treat over 150 cases of naturally occurring cases of botulinum intoxication in infants and others. Under the BARDA program, the PHEMCE has achieved the goal of developing and delivering a product to the Strategic Nation Stockpile (SNS) to address the threat of botulism. In addition, BARDA has delayed additional deliveries to maintain preparedness levels at, or above, the requirement through 2025. BARDA has provided additional PBS funds to collect enough plasma to manufacture additional treatment courses of the product. The plasma is stored at the manufacturer in a BARDA-controlled facility and can be manufactured into the final product to replace expiring product currently held in the SNS.
BARDA anticipates initiating a project to maintain its herd of hyper-immune horses, which have taken millions of dollars over and several years to generate and maintain as part of the botulism preparedness and response effort. The Botulinum Program’s future efforts will include fulfilling the Phase IV post-marketing commitments and requirements under licensure of the HBAT product, rather than making additional investments in other candidate products. These long-term strategies will maintain current preparedness levels to protect Americans from botulism for the next decade.