A conditional license has been granted by USDA's Center for Veterinary Biologics for production of a bio-engineered foot-and-mouth disease vaccine for cattle. The license was issued to Antelope Valley Bios of Lincoln, an affiliated company of Benchmark BioLabs.
This conditional license is the result of a four-year collaboration between Antelope Valley Bios, with GenVec Inc., of Gaithersburg, Md., Department of Homeland Security (DHS) Science and Technology Directorate and the Plum Island Animal Disease Center near Greenport, New York, says Timothy Miller, president of Benchmark BioLabs.
FMD is a devastating disease of cattle, sheep and swine that is endemic in many countries, according to Miller. The United States, however, has been declared free of foot-and-mouth disease, and USDA has multiple layers of protection to continuously safeguard American livestock from the threat of contracting this economically catastrophic disease, he adds.
Among the USDA preparedness programs have been provision for FMD vaccine supplies in the event these would be needed during a future FMD outbreak.
Miller says that development and manufacturing of a conventional FMD vaccine inside the United States, however, had never been possible because the handling of the FMD virus during vaccine production had been considered an unjustifiable risk to the livestock population in this country.
To control the risk of FMD being released into the American livestock population, federal law has long prohibited handling live FMD virus anywhere inside the United States (with the exception of Plum Island Animal Disease Center, which is located on an island), even where such work would be aimed at FMD prevention and/or vaccination studies.
As a result, USDA has been unable to acquire U.S.-originated FMD vaccine for use in its emergency vaccine stockpiling efforts. So, it has had to source emergency supplies from abroad. Only a limited number of FMD vaccine types are available from non-U.S. suppliers.
In order to improve vaccine acquisition, flexibility and preparedness a new technology was developed by collaboration of scientists from PIADC and DHS' Science and Technology Directorate with the biotechnology firm, GenVec Inc. This work resulted in a unique vaccine candidate being bioengineered as a first of its kind: an avirulent adenovirus bioengineered to express certain key FMD proteins. The vaccine candidate was developed to be able to survive injection and immunize animals but to be incapable of longer-term survival outside a laboratory or production plant setting.
This vaccine candidate was the basis for a manufacturing process brought to practical application by Benchmark Biolabs at its Lincoln headquarters. The technology platform the collaborators arrived at allows vaccine production to be completed without ever having to handle live FMD virus, Miller says. "The new technology results in production of vaccine in a fully contained safe manufacturing setting at Benchmark's Antelope Valley Bios with no risk of FMD exposure of any U.S. livestock.
"Because the vaccine protects against FMD but does not contain the FMD virus itself, the FMD-protective antibody produced by vaccinated animals will be readily differentiated from the antibody produced as a result of the disease exposure itself," Miller says. "As a result, in an outbreak situation, cattle vaccinated with this new vaccine would readily be distinguished by simple serum tests from cattle exposed to the disease. The availability of this vaccine to governmental authorities during management of a future FMD emergency would be a powerful new tool never before available to veterinary authorities facing FMD management responsibilities."
The bioengineered FMD vaccine was proven highly efficacious in testing by the DHS within their high-level containment Plum Island testing facilities near Greenport, New York, Miller explains. Field testing proved the vaccine can be safely administered to cattle under normal U.S. cattle production conditions.
To learn more about Benchmark Biolabs, Inc. visit www.benchmarkbiolabs.com