PED vaccine gains conditional approval
Posted July 16, 2014
A vaccine that gained conditional approval in June could protect herds against a virus that has killed millions of pigs since spring 2013.
Officials of the Department of Agriculture’s Animal and Plant Health Inspection Service announced that the vaccine against the porcine epidemic diarrhea virus is intended to generate antibody production in sows, which transmit antibodies through milk to neonatal pigs. It is the first USDA-licensed vaccine against the virus, which can kill nearly all neonatal pigs in a herd and cause illness among others.
“Preliminary studies have been promising, and they’ve shown sufficient data that we think the vaccine will be effective,” the announcement states.
The conditional license from APHIS lets the developer, Harrisvaccines Inc., of Ames, Iowa, sell the vaccine. Such licenses are granted on the basis of expectations of safety, purity, and efficacy, the agency announced.
An announcement from Harrisvaccines indicates the company had sold approximately 2 million doses of the vaccine through prescriptions from late 2013 until the announcement in June, and the vaccine had been developed “in a matter of weeks after the outbreak.”
Joelle R. Hayden, an APHIS spokeswoman, noted that the agency’s regulations on biologics include an exemption that allows use of unapproved products when they are prepared by veterinarians for administration to their patients. Harrisvaccines used that exemption to distribute the products without APHIS oversight prior to the conditional approval.