Harrisvaccines on Monday announced it has been granted USDA conditional licensure of the company's Avian Influenza Vaccine, RNA.
This is the first conditional license for highly pathogenic avian influenza granted since the outbreak began in spring 2015.
This is also the first USDA conditional license granted for an avian influenza vaccine utilizing the rapid response, SirraVax platform technology. This technology allows for the vaccine to be easily updated to match current and future strains of avian influenza.
While an important first step in implementing a vaccine strategy, producers will initially 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 joint effort by the USDA's Agriculture Research Service, the Center for Veterinary Biologics.
"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% 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. This makes our vaccine an important tool for eradication efforts and may alleviate any concerns with trading partners abroad."
Avian influenza is a fast-moving, highly contagious disease that has devastated producers across the nation this year.
To date, nearly 50 million chickens and turkeys have been lost to this virus. In Iowa alone, avian influenza has impacted 31 million birds. The impact is staggering, and on May 1, 2015, Iowa Governor Terry Branstad declared a state of emergency in Iowa due to the outbreak. Egg prices since the outbreak have skyrocketed nearly 200% and producers struggle to repopulate as reemergence looms. Reports estimate a more than $2.5 billion decrease in output and an impact on more than 15,000 jobs nationwide.
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.
Further efficacy and potency testing is ongoing.