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Ames, Iowa-based vaccine producer, Harrisvaccines, today announced it has been granted United States Department of Agriculture (USDA) conditional licensure of the company’s Porcine Epidemic Diarrhea Virus (PEDv) Vaccine, RNA utilizing its SirraVaxSM RNA Particle Technology. This is the first USDA conditional license granted for a PEDv vaccine since the initial outbreak, and it will allow Harrisvaccines to sell their 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 percent in piglets that are less than one week of age. Since entering the U.S. 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.
“Using our unique rapid-response production methods, we were able to create a vaccine in a matter of weeks after the outbreak,” says Joel Harris, Head of Sales and Marketing for Harrisvaccines. “Since late 2013, we have sold nearly 2 million doses of this vaccine through veterinary prescription and we are now thrilled to say it has been granted a USDA conditional license.”
“The impact of this disease has been devastating,” said Dr. Hank Harris, Founder and CEO of Harrisvaccines. “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 licenses 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).
June 16, 2014 - Harrisvaccines
