KANSAS CITY, Mo. – An Ames, Iowa-based company is reportedly just days away from receiving conditional license from the US Dept. of Agriculture for a vaccine that has been shown to stop the spread of Porcine Epidemic Diarrhea virus (PEDv). To date, approximately 2 million doses of Harrisvaccines’ “IPED+” vaccination have been prescribed by veterinarians since August and this number is expected to spike in the weeks and months to come. Prior to USDA approval, such prescriptions are allowed with the prescription of a veterinarian (under 9 CFR 107.1), and the results show promise, according to the company.

“While we wait to get USDA approval we are able to get these prescriptions into the field,” said Joel Harris, spokesman for the company and son of its founder Hank Harris. The elder Harris is an expert on infectious hog disease research whose work dates back to the 1970s when Hog Dysentery was prevalent in the US. He has also worked for many years as a professor at Iowa State Univ. before founding the company in the mid-2000s.

While not considered a silver bullet solution for PEDv, Harrisvaccines’ progress is well known and being used by many in the pork industry, including the producers working with the major processing companies. PEDv-focused vaccines currently only account for about 50 percent of the company’s business, which is based on selling herd-specific vaccines, using its SirraVax technology. They have been used by livestock producers since early 2012 for diseases including Swine Influenza, Rotavirus, Clostridium and Swine Dysentery among others.

Described by many as the 2014 scourge of the industry, PEDv has killed approximately 8 million pigs and has been discovered in herds throughout 30 states since its discovery in the US in May 2013. Outbreaks have also been reported outside the US, in Canada, Mexico, Japan and South Korea.

“All our vaccines are made the same way,” Joel Harris said. The process uses data from the virus (RNA) to develop what look like virus particles using the gene sequence from the RNA. Once injected, the particles target the pig’s cells to replicate the RNA to generate an immune response inside the animal that is very targeted. “So when they encounter the actual live virus in the field, the animal will have already built up a strong immunity against it,” says Harris. Thus far the vaccines have been given to previously exposed animals and are administered to sows close to the time when they are farrowing to ensure the immunity is passed on to piglets. “What we’ve seen is there is a statistically higher antibody level in those vaccinated sows vs. non-vaccinated ones.”

“There’s still a lot to learn about PEDv, but we know that we’re increasing an immune level,” beyond what natural exposure achieves, Harris said. The vaccine used in combination with natural exposure has proven to boost immune levels significantly more.

Harrisvaccines has relied on satisfied users of its other vaccines to try the PED+ and their willingness and feedback has been valuable in developing protocols related to dosage, frequency, time from farrowing and monitoring efficacy.

With its approval, the USDA is acknowledging the technology offers a reasonable expectation of efficacy. “So getting that USDA stamp of approval is important for us because it would be more accessible for veterinarians to buy without our involvement or for producers to buy from us directly,” Harris said. The approval would also open up opportunities to export the vaccine on a larger scale. To date, the company has exported upwards of 150,000 doses of it to Canada under an emergency provision.

After receiving the conditional license, Harris says the company plans to move forward to receive full USDA approval and market the vaccine more broadly to distributors and veterinarians.