USDA this week granted the first conditional license for a vaccine against Porcine Epidemic Diarrhea Virus (PEDv) to Harrisvaccines of Ames, Iowa.
The vaccine, utilizing Harrisvaccine’s SirraVaxSM RNA Particle Technology, had already been available by prescription only, but now the conditional approval allows it to be sold directly to swine producers battling PEDv. The vaccine is used on sows who then pass antibodies on to their piglets.
“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. “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 USDA generally grants conditional licenses in order to meet an emergency or unmet need. A conditionally licensed product must show a reasonable expectation of efficacy and all safety and purity requirements must be met.
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PEDv was first discovered in the United States in April 2013 and has since spread to nearly 30 states causing the death of over seven million piglets.