First USDA Conditional Licence for PEDV Vaccine

US - Harrisvaccines has become the first company in the US to be granted a conditional licence from the USDA for a porcine epidemic diarrhoea virus (PEDV) vaccine.
calendar icon 17 June 2014
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Ames, Iowa-based vaccine producer, Harrisvaccines, has been granted United States Department of Agriculture (USDA) conditional licensure of the company’s Porcine Epidemic Diarrhea Virus (PEDv) Vaccine, RNA using its SirraVaxSM RNA Particle Technology.

This is the first USDA conditional licence granted for a PEDv vaccine since the initial outbreak, and it will allow Harrisvaccines to sell its vaccine directly to the veterinarians and swine producers battling PEDv.

PEDv is a highly contagious swine disease that entered the United States in April 2013. PEDv causes vomiting and diarrhea in older animals and extreme dehydration and mortality of up to 100 per cent in piglets that are less than one week of age. Since entering the US just one year ago, PEDv has spread to nearly 30 states and throughout North America, causing the death of millions of piglets. PEDv is not a zoonotic disease, and therefore cannot spread to humans but it has cost the pork industry and consumers hundreds of millions of dollars.

Joel Harris, Head of Sales and Marketing for Harrisvaccines, said: “Using our unique rapid-response production methods, we were able to create a vaccine in a matter of weeks after the outbreak. Since late 2013, we have sold nearly two million doses of this vaccine through veterinary prescription and we are now thrilled to say it has been granted a USDA conditional licence.”

Dr Hank Harris, Founder and CEO of Harrisvaccine, commented: “The impact of this disease has been devastating. At Harrisvaccines, we recognized the great threat that PEDv posed to the industry immediately and that is why we are able to introduce the first USDA conditionally licensed PEDv vaccine on the market.”

The USDA generally grants conditional licences in order to meet an emergency or unmet need. A conditionally licensed product must show a reasonable expectation of efficacy and all safety and purity requirements must be met. Harrisvaccines has received USDA licensure in the past using SirraVaxSM technology for its Swine Influenza vaccine (September 2012) and an Autogenous Vaccine, RNA for Rotavirus C (January 2013).

Headquartered in Ames, Iowa, Harrisvaccines focuses on revolutionising animal health vaccines and enhancing productivity in the swine, cattle, equine and farmed aquaculture industries. Using state-of-the-art advanced molecular science, Harrisvaccines employs their unique SirraVaxSM RNA Particle (RP) technology platform to develop rapid-response, herd-specific products for animal diseases.

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