Emergent BioSolutions, Inc., begins safety study for post-exposure three dose anthrax vaccine

Emergent BioSolutions, Inc., a vaccine and therapeutics developer, announced on Thursday the beginning of a safety and immunogenicity study to evaluate a three dose vaccination schedule of BioThrax for administration to individuals exposed to anthrax.
The company is looking to obtain a post-exposure prophylaxis indication for BioThrax. Approval of the PEP indication would expand use of the anthrax vaccine beyond its current pre-exposure prophylaxis indication. BioThrax is currently the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax disease.
The approval would add an indication in which the vaccine would be used in combination with antibiotics in people who have possibly been exposed to anthrax spores. Providing immune protection in this area is key because of the possibility for residual anthrax spores to germinate and cause disease after the currently recommended 60-day course of antibiotic treatment has ceased.
“Emergent is pleased to be working with BARDA to broaden the clinical utility of BioThrax and to further enhance its features in support of the U.S. government's biodefense needs,” Daniel J. Abdun-Nabi, the president and chief operating officer of Emergent BioSolutions, said.
The clinical study involves 200 healthy adult volunteers and will be conducted in four sites within the United States. The company expects preliminary data to be available in the fourth quarter of 2012. The study is being funded by a contract provided by the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services.