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FDA Gives Fast Track Status to Three Biodefense Vaccine Programs From Computer Sciences' DVC Company

September 14 - Three biodefense vaccine development programs from DVC, a Computer Sciences Corporation company, have been granted "Fast Track" status by the U.S. Food and Drug Administration (FDA).

Fast Track designation allows the FDA to expedite review of drugs and biologics that demonstrate the potential to address unmet medical needs and are intended to treat serious or life-threatening conditions.

DVC is working the Department of Defense Joint Vaccine Acquisition Program (JVAP) Product Management Office on the programs that are aimed at developing recombinant vaccines for plague and botulinum neurotoxin serotypes A and B and Venezuelan equine encephalitis.

"At DVC, our mission is to expedite the development of biodefense products to protect the nation's operating forces and citizens," said DVC Chief Scientific Officer Dr. Robert V. House. "We do this by applying for Fast Track status, which enables us to work closely with the FDA to more efficiently meet military biodefense needs."

JVAP's mission is to develop, produce and stockpile FDA-licensed vaccine products to protect the warfighter against biological warfare agents. JVAP consolidates Department of Defense efforts for the advanced development, testing, FDA licensing, production and storage of biological defense vaccines.

The safety and efficacy of these vaccines in humans has not been established. These products are currently under clinical investigation and have not been licensed by the FDA.

DVC is part of CSC's Enforcement, Security and Intelligence organization, which CSC created in 2001 to support programs enhancing U.S. security.

 

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