Harrisvaccines has been granted United States Department of Agriculture (USDA) conditional licensure of the company's Porcine Epidemic Diarrhea Virus (PEDv) Vaccine.
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. a 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.
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.
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).
"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."
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