USDA's Animal and Plant Health Inspection Service this week issued the first conditional license for a vaccine that may aid in the control of porcine epidemic diarrhea virus.
The license was issued to Harrisvaccines, Inc. of Ames, Iowa. It will be used to vaccinate sows with the intent that they build antibody, and transmit that antibody through their milk to newborn piglets. It is intended to protect the piglets against PEDV.
Conditional licenses are issued based on full safety, purity testing, and an expectation of efficacy. Preliminary studies have been promising, and they've shown sufficient data that APHIS thinks the vaccine will be effective.
The company will continue working toward completing the requirements for a full license. In the meantime, there are no restrictions on vaccine use under the conditional license.
APHIS supports and encourages the rapid development of new vaccines, particularly in emergency situations. When a company obtains a conditional license, they are able to bring an important disease management tool to producers safely and quickly.
Full licensing can occur subsequently while producers get the products they need to protect animal health.
"Using our unique rapid-response production methods, we were able to create a vaccine in a matter of weeks after the outbreak," says Joel Harris, head of sales and marketing for Harrisvaccines, said in a statement. "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 license is in addition to the recent announcement of availability of $26.2 million in funding to combat these diseases.
APHIS also issued a Federal Order requiring the reporting of new detections of PEDV and other new swine enteric coronavirus disease to APHIS or State animal health officials. The Federal Order requires that operations reporting these viruses work with their veterinarian or USDA or State animal health officials to develop and implement a reasonable management plan to address the detected virus and prevent its spread.
Sen. Debbie Stabenow, D-Mich., chairwoman of the Senate Committee on Agriculture, supported APHIS' decision to grant Harrisvaccines a conditional license.
"I applaud USDA for their continued commitment to combatting the spread of this deadly virus, which has impacted pork producers in Michigan and across the country," Stabenow said in a statement Tuesday.
"The unmitigated spread of this virus not only threatens pork producers, but also has serious implications for the economy as consumers and businesses will all feel the impact of diminishing swine herds. USDA's efforts to help control the spread of the virus will go a long way in stabilizing the potential fallout for consumers and businesses and I'm pleased they have been aggressive and committed to finding a vaccine."