Zoetis seeks approval to produce Foot and Mouth (FMD) vaccine
Animal health giant Zoetis has petitioned the U.S. Department of Agriculture for approval to manufacture Foot and Mouth Disease vaccine in the United States.
USDA’s Animal and Plant Health Inspection Service will accept public comment until Sept. 14, 2020, and will then make a decision on the request.
While introduction of live FMD virus into the United States is prohibited by law, the petition states that this attenuated strain of the virus is incapable of causing FMD symptoms or infection in animals. Because this strain is not capable of causing infection, the petitioners believe it should not be prohibited in this country.
According to Dr. Jim Roth, a faculty member of the Iowa State University College of Veterinary Medicine with expertise in immunology and infectious diseases, and the director of the Center for Food Security and Public Health, USDA has developed what is considered a safe version of FMD virus for producing vaccine. The vaccine itself would be inactivated, or killed, virus.
The new technology is a genetically engineered FMD virus not capable of spreading in animals, said Roth. According to USDA, the vaccine “is non-infectious, non-transmissible, and incapable of causing the disease because it has been modified in such a way that it is no longer able to produce infection.”
“The USDA’s FMD-LL3B3D vaccine platform is based on a modified virus which is incapable of causing FMD in animals. As part of the U.S. Select Agent Exclusion process, Zoetis and the USDA-ARS performed extensive research to demonstrate the attenuation of the platform viruses in livestock,” said Christina Lood, Zoetis communications director
Although the technology was developed by USDA researchers at the Plum Island Research station, Zoetis is seeking the approval to produce the actual vaccine.
Zoetis and Texas A and M University released a joint statement in October of 2019 that Zoetis had signed an agreement with the school to establish a facility for “accelerating the development of transboundary and emerging disease vaccines — including those for Foot-and-Mouth Disease.”
This facility, however is for research and development purposes only, not production of vaccines, said Lood.
“As part of the agreement, Zoetis is setting up a 12,800-square-foot secure, biocontainment lab off-campus utilizing modular cleanroom technology. The Transboundary and Emerging Disease Vaccine Development Facility is expected to be operational mid-2020, pending approval by the U.S. Department of Agriculture (USDA) to receive strains of the Zoetis FMD vaccine platform that are non-infectious to cattle and other livestock – and therefore, cannot cause the disease. While FMD vaccines will be the initial focus of the center’s vaccine development, the facility can be expanded to accommodate vaccine development for other emerging diseases in the future,” stated the two entities in the news release.
Roth said that if the live virulent virus were to escape from a manufacturing facility, it would create “devastating effects,” and in fact this has happened at least 15 times in the past 60 years around the world. But he believes the virus Zoetis plans to work with is safe, and he supports their petition to produce it in the United States, presumably on the mainland. In addition, this engineered FMD virus has a genetic signature so that it can be distinguished from virulent FMD virus.
He said FMD vaccine, although not currently used in North America is actually the most widely used vaccine for cattle in the world.
Vials of the finished vaccine would have a shelf-life of a couple of years, so Zoetis would likely not produce FMD vaccine in large quantities for use in the United States unless an outbreak of FMD occurs. Instead, they would probably produce an antigen concentrate which can be kept for about 10 years when frozen with liquid nitrogen. The antigen would then be used to formulate a vaccine quickly if and when it became necessary in the United States, said Roth.
In addition, Lood said Zoetis would assess international markets and may seek licensing in countries with a need for FMD vaccines.
“If we needed it, hopefully there would be a big supply and we could tap into it pretty quickly,” Roth said.
It could take several years to develop a vaccine, said Lood, and any vaccine produced would then need USDA approval in order to make it available for sale.
While currently FMD vaccine is only studied on Plum Island which is USDA high-containment facility located off the coast of New York state, a new facility is being built in Manhattan, Kansas, the home of Kansas State University that will soon replace the Plum Island research facility.
The National Bio and Agro-Defense Facility will be the nation’s only large animal BSL-4 facility built to safely handle pathogens that do not currently have treatments or countermeasures. USDA says it will be fully functional by the year 2022.
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