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Biosecurity News in Brief
NIAID, BARDA Award Anthrax Vaccine Contracts, Ebola/Marburg ContractsBy Kunal Rambhia, October 6, 2008 On September 26, 2008, the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) awarded contracts to PharmAthene1 and Emergent BioSolutions2 to develop a next generation anthrax vaccine. The contract with PharmAthene is for $83.9 million, and $29.7 million is being awarded to Emergent BioSolutions. The contract with PharmAthene is for a third generation recombinant protective antigen (rPA) vaccine that does not need cold chain storage. Both the PharmAthene and the Emergent contracts call for vaccines that can be stored at 35°C for 3 years and that require only 1 or 2 doses.1,2 Under the terms of the PharmAthene contract, $13.2 million, with an option of an additional $9.7 million, will be used for pre-clinical safety, stability, and dosage testing as well as for development of animal models.1 The contract awarded to Emergent BioSolutions is for further development of its AV7909 anthrax vaccine. AV7909 is composed of Emergent’s BioThrax, the only FDA-licensed anthrax vaccine, and an immunity-enhancing adjuvant. BioThrax is administered in 6 doses spread out over 18 months; initial studies of AV7909 indicate that only 2 doses will be required to confer the same level of protection. The bulk of the contract, $24.9 million, will be used for safety and efficacy trials and stability tests.2 In related news, on October 1, 2008, Emergent BioSolutions announced that the company had signed a contract with the U.S. Department of Health and Human Services (HHS) for an additional 14.5 million doses of BioThrax for delivery to the Strategic National Stockpile (SNS). This contract is worth up to $404 million and will provide the federal government additional doses of the current vaccine, BioThrax, for the short term while second and third generation vaccines are developed. Delivery to the SNS under this contract is slated for fall 2009 and will continue through fall 2011. Emergent currently has a contract worth $448 million to deliver 18.75 million doses of BioThrax to the SNS. Together, the two contracts will result in 33.25 million doses of BioThrax in the SNS.3 In additional news, HHS, under Project BioShield, intends to add a second generation anthrax vaccine to the SNS to supplement the stockpile of BioThrax. As reported by the Biosecurity Briefing in March 2008, HHS issued a Request for Proposals (RFP) for 25 million doses of a second generation rPA anthrax vaccine. Both PharmAthene and Emergent BioSolutions responded to the RFP and were notified in mid-September that their proposals had been accepted on their technical merits and were being considered for procurement contracts. PharmAthene is developing a second generation anthrax vaccine that is deliverable by intramuscular injection in three doses.4 Phase I and II clinical trials have already been completed for PharmaAthene’s SparVax, and the trials indicated that the vaccine “appears to be well tolerated and induces an immune response in humans.”4 Emergent BioSolutions also is developing a second generation rPA anthrax vaccine. Emergent’s vaccine is composed of a purified protein and adjuvant to induce neutralizing antibodies against anthrax toxin. Both vaccines are under consideration, and announcement of awards is not likely to come before the end of 2008.5 Finally, on September 30, 2008, NIAID and BARDA awarded 2 contracts for development of a multivalent Ebola and Marburg vaccine to Crucell Holland BV and Integrated BioTherapeutics, Inc.6 The requirements of these contracts are that the vaccine protect against the four strains (Zaire, Sudan, Ivory Coast, Reston) of Ebola and against one strain of Marburg (Ci67, Musoke, other). The vaccine must also confer protection in, at most, 2 doses. Crucell is working with the Vaccine Research Center (VRC) at NIH, using an adenovirus vector platform for delivery of the vaccine. Its award is for $29.8 million with options that could add $40.5 million to the contract.7 Integrated BioTherapeutics is using a virus-like particle (VLP) vaccine platform and is working with collaborators at the United States Army Research Institute of Infectious Diseases (USAMRIID).8 The award for Integrated BioTherapeutics was $22.5 million with options that could increase the contract by $42.7 million. References
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