Harrisvaccines announced Sept. 21 that it has been granted U.S. Department of Agriculture conditional licensure of its Avian Influenza Vaccine, RNA. This is the first conditional license for highly pathogenic avian influenza (HPAI) granted since the outbreak began in spring 2015.
This is also the first USDA conditional license granted for an avian influenza vaccine utilizing the company's rapid response SirraVax platform technology, which allows for the vaccine to be easily updated to match current and future strains of avian influenza, according to the announcement.
While this is an important first step in implementing a vaccine strategy by USDA, Harrisvaccines said initially, producers will have to wait for USDA authorization before acquiring the vaccine. USDA has called for a solicitation to create a vaccine stockpile for H5 avian influenza for the fall; Harrisvaccines is currently pursuing this opportunity.
"The creation, testing and regulatory approval of the vaccine was a real joint effort by the USDA's Agriculture Research Service, the Center for Veterinary Biologics and Harrisvaccines," said Dr. Mark Mogler, head of research and development at Harrisvaccines. "The ARS' Southeast Poultry Research Laboratory provided both the gene needed to prepare the vaccine at Harrisvaccines and the proper facilities for efficacy testing in chickens."
Harrisvaccines vice president Joel Harris added, "When H5 was confirmed in the spring of this year, our team immediately applied our rapid response technology to bring a solution to Iowa and Midwest poultry and egg producers. Although we cannot sell the vaccine today, we are in a better position to apply this robust and rapidly produced vaccine, if and when the virus reemerges once again."
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, safety, and potency. Further efficacy and potency testing is ongoing. Harrisvaccines has received USDA licensure in the past using SirraVax technology for: Porcine Epidemic Diarrhea Vaccine, RNA (June 2014), Swine Influenza Vaccine, RNA (September 2012), and Autogenous Vaccine, RNA for Rotavirus C (January 2013).