Anthrax Vaccine Gains Homeland Security Liability Protections
This article was originally published in The Pink Sheet Daily
Executive Summary
BioPort/Emergent’s BioThrax is first vaccine granted DHS protections under 2002 Homeland Security Act.
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BioThrax , the only vaccine currently FDA-approved for the prevention of anthrax infection, is the first vaccine to be granted liability protections under the "Support Anti-Terrorism by Fostering Effective Technology" (SAFETY) Act of 2002, part of the same law that created the Department of Homeland Security. BioThrax (Anthrax Vaccine Adsorbed or AVA) has been manufactured for decades in Lansing, Mich., by BioPort, now a subsidiary of Gaithersburg, Md.-based Emergent BioSolutions. The SAFETY Act provisions protect sellers of qualified technologies from liability claims that result from the technology being "deployed in defense against or response or recovery from" an act of terrorism, the act reads. The final rule implementing the act was published July 10. The AVA vaccine has been named a "qualified anti-terrorism technology" under SAFETY, and Emergent has been granted both the "designation" and "certification" protections available under the law. Both protections expire July 31, 2011. Benefits provided by "designation" include exclusive federal court jurisdiction for suits, limitation of liability to an amount of insurance coverage to be specified by DHS but that will not unrealistically affect the price of the vaccine, and a bar on punitive damages. "Certification" confers the status of "Approved Product for Homeland Security" and avails Emergent of "a rebuttable presumption" that the company is entitled to the "government contractor defense," which "potentially eliminates liability for claims arising from acts of terrorism," Emergent said. To obtain SAFETY Act coverage, applicants must submit to DHS comprehensive data and materials regarding the safety, efficacy and deployment history of the technology, Emergent said. Emergent is under contract with HHS to provide BioThrax for the Strategic National Stockpile. In May, the department committed to purchase an additional five million doses, for an estimated $120 mil., after Emergent completed deliveries of an initial five million doses in February, eight months ahead of schedule, the company said. - Shirley Haley ([email protected]) |