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The deadly swine disease porcine epidemic diarrhea virus (PEDV), which is currently hampering pig production in 20 US states, has prompted an Iowa animal health company to quickly produce what it believes could be a potential vaccine solution.
Already a pig vaccine specialist, the Ames-based Harrisvaccines has now produced and shipped 770,000 doses of iPED vaccine to affected pig herds in badly-hit parts of the US. The initial marketing comes under the 'US Code of Federation Regulations 9 CFR 107' which currently permits sales in six states by veterinary prescription only. The states where the vaccine is being used include top pig producers Iowa and North Carolina.
Harrisvaccines is working with the Center for Veterinary Biologics in Ames to receive US Department of Agriculture (USDA) conditional licensing to sell the vaccine commercially direct to farmers and in all parts of the country and potentially internationally.
PEDV first surfaced in the US in April, has affected at least 1,645 pig farms and is spreading rapidly (Animal Pharm, January 3). Each farm could represent thousands of infected animals and the USDA is now concerned the national pig inventory is falling. The disease is particularly fatal to piglets. The clinical signs of the virus include severe diarrhea and vomiting. The disease was first discovered in the UK 40 years ago and has badly affected Chinese pig production in recent years.
Speaking to Animal Pharm from Ames, the founder of Harrisvaccines Dr Hank Harris, said his company has a strong understanding of the threat that foreign animal diseases pose and has been heavily involved in research into these diseases including classical swine fever, African swine fever and foot and mouth disease.
When the first cases of PEDV were confirmed in the US Harrisvaccines immediately began researching a vaccine. Previous related work with other coronaviruses, including
with partner AlphaVax’s work with Severe Acute Respiratory Syndrome (SARS) (Animal Pharm, November 1), led to the rapid development and production of a PEDV vaccine. Harrisvaccines started iPED experimental sales just months after the first confirmations of the disease.
"PEDV is very difficult to propagate in the laboratory in vitro, but the sequence of an important gene was readily available electronically via the Internet and was used to produce our vaccine. Harrisvaccines’ unique technology does not require a live or killed virus for the production of a vaccine; therefore we were able to create a vaccine using only this electronic gene sequence. Harrisvaccines has a broad network of swine veterinary consultants that we rely upon for feedback as to vaccine efficacy under field conditions," said Dr Harris.
Dr Harris has dedicated much of his professional career to swine research and has worked for over four decades with infectious diseases of swine, developing vaccines and rearing systems. Harrisvaccines was officially formed in 2006 after acquiring licensing agreements with Alphavax and Iowa State University. Swine vaccines quickly became the focus of the fledgling company.
The Alphavirus vaccine platform was licensed from Alphavax resulting in the first vector based vaccine for the prevention of porcine reproductive and respiratory syndrome virus and swine influenza (Animal Pharm, October 9). Harrisvaccines currently has 19 full-time employees with advanced degrees in microbiology, molecular biology and veterinary medicine.
Dr Mark Mogler, head of research, told Animal Pharm the company's vaccine RNA particle technology used in iPED has been previously used by other researchers to produce experimental vaccines against SARS, which is also caused by a coronavirus.
"Using that experience, combined with published reports about PEDV and related viruses, we were able to proceed with vaccine design very quickly. The platform nature of the RNA Particle lends itself nicely to rapid development of vaccines for novel pathogens," said Dr Mogler.
"The evaluation of iPED has been conducted at Harrisvaccines facilities in Ames. Harrisvaccines has worked closely with South Dakota State University to show that the iPED vaccine induces virus neutralizing antibodies (VNA) to PEDV. Studies are in progress to determine the level of VNA needed in sow colostrum/milk to protect piglets challenged with PEDV. iPED vaccine enhances the amount of protection to PEDV in sows previously exposed to the virus by increasing VNA levels."
Jodi French, head of regulatory affairs and quality assurance at Harrisvaccines, said the prospective conditional license is granted for products that are needed to address an emergency situation or for products that are needed in the industry that do not yet have a full license.
"The general idea is a conditional license is a way to fast track a product into the marketplace, while simultaneously allowing the firm to move that product towards a full license. In addition, a conditional license allows for a product to be field evaluated as to efficacy and to develop improvements if necessary, giving it the full testing and endorsement of USDA. We expect to have the licensing requirements for our iPED RNA conditional license completed in early 2014," said Ms French.
Harrisvaccines has five other animal vaccines available through veterinary prescription. The company believes vaccines tend to give better protection when the level of challenge by an infectious agent is decreased due to improved sanitation and biosecurity.
January 9, 2014 - Harrisvaccines
