Abstract
Although few diseases have had a greater impact on human history, currently there is no vaccine available for protection against plague that is licensed by the Food and Drug Administration (FDA). DynPort Vaccine Company LLC, a CSC company (DVC), is managing the advanced development of a recombinant plague vaccine (rF1V) for the United States Department of Defense that will provide protection against plague aerosols, the most likely form a biological weapon would take. The vaccine was originally developed at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). To meet the requirements for licensure in the shortest possible time, DVC developed a strategy for the integration of data from USAMRIID with data from clinical and nonclinical studies conducted by DVC. This strategy is based on the parallel development and validation of assays for the analysis of animal and human immune responses to the vaccine that facilitated the transfer of the candidate from the developing lab at USAMRIID. These assays also form the foundation of our approach to the licensure of the rF1V vaccine using the FDA Animal Rule.
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