Harrisvaccines has announced USDA licensure of the company’s swine influenza vaccine, approved by the Department’s Center for Veterinary Biologics (CVB) for disease caused by H3N2 swine influenza virus (SIV).
The vaccine is the first to be licensed by the USDA CVB that utilizes RNA Particle Technology. Dr. Kurt Kamrud, vice president of research at Harrisvaccines, led the company’s development and application of RNA Particle Technology - with the ultimate goal of producing a swine influenza vaccine that could be manufactured faster and safer than those produced using modified live or inactivated/killed virus technologies.
This groundbreaking platform allows for the manufacture of vaccines without ever isolating a live virus from infected animals. Only a gene from an infected animal is required to prepare vaccines in as little as four weeks
The vaccine, licensed as Swine Influenza Vaccine, RNA, Product Code 19A5.D0, was initially submitted to USDA CVB for licensing in 2009.
“When we submitted our license application in 2009, the USDA didn’t have an established category into which the product fit,” said Jodi French, USDA liaison at Harrisvaccines. "There were additional regulatory hoops to jump through in order to achieve this first license.”
In addition to USDA licensure of the vaccine, Harrisvaccines received a U.S. Veterinary Biologics Establishment License, #592, which approves the Ames-based facility for future manufacture of new vaccines for a broader spectrum of veterinary applications, from swine and cattle to companion animal and farmed aquaculture.
“We were founded in 2006, so this has been a long, challenging road to licensure for a novel technology to be used in animal health,” Harrisvaccines founder and president Dr. D.L. “Hank” Harris said. “These USDA licenses mark a major milestone, and perhaps most importantly, signal that this technology is a key fixture in our country’s continuing fight against biological threats and ever-changing pathogens.”
“With USDA licensure of both the SIV H3N2 vaccine and our Ames manufacturing facility, we expect additional licenses for vaccines manufactured using RNA Particle Technology to be issued on more condensed timelines. With new strains of this virus identified as recently as July of this year, we’re particularly interested in our potential to manufacture custom, farm-specific vaccines in a matter of weeks instead of months,” Harris said.