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, safety, and potency.
When H5 avian influenza was confirmed in the spring of 2015, Harrisvaccines, an Iowa-based vaccine producer, applied its rapid response technology to bring a solution to Iowa and Midwest poultry and egg producers, according to Joel Harris, vice president of Harrisvaccines.
The conditional use permit does not authorize the company to sell the vaccine today, but it does put the company in a better position to apply the vaccine in the case that avian influenza should reemerge in the United States, Harris added.
About the RNA vaccineThe RNA vaccine utilizes the rapid response, SirraVax platform technology, the company stated. This technology allows for the vaccine to be easily updated to match current and future strains of avian influenza. This is an important first step in implementing a vaccine strategy by the USDA. Initially, however, producers will have to wait for USDA authorization before acquiring the vaccine. The 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.”
“The threat posed by avian influenza is extraordinary to both producers and consumers,” said Dr. Hank Harris, Founder and CEO of Harrisvaccines. “Getting a vaccine in the field that matches 100 percent to the H5N2 strain is crucial to ongoing containment efforts. This vaccine is also compatible with diagnostic tests that can differentiate infected from vaccinated birds (DIVA). This makes our vaccine an important tool for eradication efforts and may alleviate any concerns with trading partners abroad.”
According to Jodi French, head of manufacturing and USDA liaison for Harrisvaccines, USDA testing of the company’s avian influenza vaccine provided both the efficacy and safety data necessary for approval by the USDA Center for Veterinary Biologics. Further efficacy and potency studies in chickens and turkeys are ongoing, French added.
Egg company impacted by avian influenza encouraged by licensureThe USDA's decision to issue the conditional approval to RNA vaccine is encouraging to Rembrandt Enterprises, which lost more than half of its layer flock as a result of avian influenza.
"I am encouraged to see a new and promising vaccine receive USDA licensure," said Dave Rettig, CEO of Rembrandt Enterprises. "The impact of avian influenza on the layer industry in Iowa has been devastating. We need to continue moving toward long-term solutions which include a vaccine strategy that can be mobilized quickly and tailored to the virus strains impacting our farms."