US-based vaccine producer Harrisvaccines has been granted United States Department of Agriculture (USDA) conditional licensure of the company’s Porcine Epidemic Diarrhoea virus (PEDv) vaccine.
This is the first USDA conditional license granted for a PEDv vaccine since the initial outbreak, and it will allow the company to sell its vaccine directly to 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% in piglets that are less than one week of age. Since entering the US in April 2013, the virus has spread to nearly 30 states and throughout North America, causing the death of approximately 7 million piglets.
Joel Harris, the company’s head of sales and marketing, 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 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, the company’s founder and CEO. “We recognised 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.
The company, headquartered in Ames, IA, produced its vaccine by utilising its SirraVax RNA particle technology. Read more about it here.