CSC announced that DynPort Vaccine Company LLC (DVC), a CSC company, has been notified by the Department of Defense (DoD) that all future funding for advanced development of plague vaccine will be allocated to the existing DVC contract with the Joint Project Manager Chemical, Biological and Medical Systems' Joint Vaccine Acquisition Program (JVAP) Joint Product Management Office.
According to the decision, DVC will continue development of a recombinant plague vaccine candidate, rF1V, up to and including possible licensure by the US Food and Drug Administration (FDA). The vaccine candidate is currently in phase 2 clinical trials, a company press release stated.
"We are pleased with the DoD's decision to move forward with development of rF1V," said Dr. Robert V. House, president of DVC. "This will allow us to focus our full energies on developing this crucial vaccine for protecting our nation's warfighters."
"We are very pleased that a decision has been made regarding a future plague vaccine for the DoD," said Richard Nidel, Deputy Joint Product Manager for the Joint Vaccine Acquisition Program.
Work will be performed by DVC at its headquarters in Frederick, Md., and at various subcontractor sites.
The rF1V plague vaccine candidate is designed to provide protection against the plague bacterium Yersinia pestis in aerosolized form. The vaccine was originally identified and developed by scientists working at the US Army Medical Research Institute of Infectious Diseases (USAMRIID). Their work involved the identification of suitable protein antigens and the development of the processes used to assess the performance of the vaccine. Further development and manufacture of the vaccine candidate has been achieved by DVC under the DoD JVAP contract. DVC has served as prime systems contractor for the JVAP since 1997.
The safety and efficacy of this product in humans has not been established. The product is currently under clinical investigation and has not been licensed by the FDA.
As part of the JPEO-CBD, JVAP's mission is to develop, produce, and stockpile FDA-licensed vaccine products to help protect the warfighter against biological warfare agents. JVAP consolidates the Department of Defense's efforts for the advanced development, testing, FDA licensing, production and storage of biological defense vaccines and other biologics.
The United States Army Medical Research Institute for Infectious Diseases (USAMRIID), located at Fort Detrick, Md., is the lead medical research laboratory for the US Biological Defense Research Program, and plays a key role in national defense and in infectious diseases research. The Institute's mission is to conduct basic and applied research on biological threats resulting in medical solutions (such as vaccines, drugs and diagnostics) to protect the warfighter. USAMRIID is a subordinate laboratory of the US Army Medical Research and Materiel Command.
DynPort Vaccine Company LLC (DVC) manages product development programs and provides consulting, technical and program management services to U.S. government agencies and companies in the biotechnology and pharmaceutical industries.
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