AMES - Harrisvaccines has become the first in the nation to receive USDA conditional licensure for a vaccine created to battle a porcine virus that has killed millions of pigs in the United States.
The Ames-based vaccine producer announced Monday that it will now be allowed to sell its vaccine directly to veterinarians and swine producers battling porcine epidemic diarrhea virus.
PEDv, which appears to have entered the U.S. in the spring of 2013, is characterized by vomiting and diarrhea in older animals and extreme dehydration in baby pigs, almost always leading to death in piglets less than one week old.
The highly contagious disease is not zoonotic, which means it cannot spread to humans, but has been confirmed in pigs in 30 U.S. states.
"Using our unique rapid-response production methods, we were able to create a vaccine in a matter of weeks after the (2013) outbreak," Joel Harris, head of sales and marketing for Harrisvaccines said in a press release. "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 licensure.
"When we first launched the product, we had to work directly with veterinarians and producers, side by side. We didn't have the USDA stamp of approval," he said.
So the company began submitting data to USDA so it would be easier for Harrisvaccines to distribute the product, not only domestically but hopefully internationally as well, Harris said.
Prior to receiving conditional licensure the company had very limited distribution of the vaccine, he said.
"We couldn't market it or go through distributors. We couldn't talk about efficacy," Harris said. "Now, we can say, 'The USDA says the data looks very promising ... with a reasonable expectation of efficacy.'"
"The impact of this disease has been devastating," said Dr. Hank Harris, founder and chief executive officer 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."
A conditional license is generally granted by USDA in order to meet an emergency or unmet need. All safety and purity requirements must be met.
"It was our unique technology that allowed us to do this faster than anyone," said Harris, referring to the company's SirraVaxSM RNA Particle technology platform that allows it to develop rapid-response, herd-specific products for animal diseases.