GenVec Inc. announced that the USDA's Animal and Plant Health Inspection Service (APHIS) has issued a conditional license for the company's foot-and-mouth disease (FMD) vaccine for use in cattle.
APHIS issued the conditional license to Antelope Valley Bios Inc., which manufactured the vaccine under a contract from GenVec. The vaccine was developed and tested under a contract with the U.S. Department of Homeland Security's Science and Technology Directorate. This is the first FMD vaccine licensed by the USDA Center for Veterinary Biologics.
"This conditional approval is a significant event as it represents GenVec's first approved product," noted Bryan T. Butman, Ph.D., GenVec's Senior Vice President of Vector Operations and the Head of GenVec's FMD program. "This achievement demonstrates GenVec's ability to bring its technology through the regulatory review process and validates the utility of our core technology to make effective genetic vaccines."
The FMD vaccine, initially discovered and tested by the USDA Agricultural Research Service, was developed by GenVec scientists in collaboration with the DHS S&T Directorate's Targeted Advanced Development Branch at Plum Island Animal Disease Center.
GenVec's novel FMD vaccine approach utilizes GenVec's proprietary adenovector technology and is manufactured on a proprietary GenVec cell line that is capable of producing antigens without the use of the highly contagious FMD virus. Because the vaccine is produced without using live or killed virus materials, it can be produced cost effectively in the U.S. and around the world.
Under the conditional license, the product may be distributed as authorized by Federal emergency management officials within USDA, should the need for the product arise. APHIS issues conditional licenses in the event of an emergency situation, limited market or other special circumstance. In this case, the special circumstance was the need for an FMD vaccine that was capable of being manufactured in the U.S. that allowed for the differentiation between infected and vaccinated animals. The vaccine will now be available to agriculture officials in the event of an FMD emergency situation.
In a related, but separate effort, GenVec has licensed to Merial, the animal health division of Sanofi, the rights to develop and commercialize GenVec's proprietary vaccine technology for use against foot-and-mouth disease in cattle.