Harrisvaccines’ PEDv Vaccine Wins Conditional License

Porcine Epidemic Diarrhea Vaccine, RNA, gains USDA support in the fight against PEDv.

A batch of Harrisvaccines’ PEDv vaccine awaits shipment.

Amy Mayer/Harvest Public Media

A vaccine formulated to fight porcine epidemic diarrhea virus (PEDv), which has killed an estimated 7 million piglets across the United States in just over a year, has been awarded a conditional license, manufacturer Harrisvaccines reported today.

The vaccine was introduced in August 2013 under the brand name iPED and quickly gained favor among veterinarians and pork producers. The newly licensed vaccine was renamed Porcine Epidemic Diarrhea Vaccine, RNA, which reflects its SirraVax RNA Particle Technology.

The U.S. Department of Agriculture conditional license — the first granted for a PEDv vaccine — allows Harrisvaccines to sell the vaccine directly to veterinarians and swine producers, the company stated.

Conditional licenses are sometimes issued to meet an emergency or unmet need, Harrisvaccines noted.

“A conditionally licensed product must show a reasonable expectation of efficacy, and all safety and purity requirements must be met,” the Ames, Iowa, company added.

Harrisvaccines moved quickly in 2013 to develop a vaccine for PEDv, which is spread through feces, causes severe diarrhea and vomiting, and kills up to 100 percent of infected young pigs.

“The impact of this disease has been devastating,” said Hank Harris, DVM, Ph.D., the founder and CEO of 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 company has sold nearly 2 million doses through veterinary prescription since the vaccine was released.

The vaccine’s development required experts in genetics, who went to work within days of the disease’s confirmation in May 2013.

“At first, we located the Spike gene sequence online from the known Chinese strain of PED,” Joel Harris, the company’s head of sales and marketing, stated in a May update. “We took the code of the gene electronically and synthesized it to insert into our production platform process.

“Using our unique SirraVax RNA Particle technology, we were able to insert that gene from the virus within the RNA Particle to make the vaccine,” he said. “When vaccinated, the animal expresses high levels of virus-neutralizing antibodies while stimulating both a cellular and humoral immune response.”

 

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