AMES, Iowa — The USDA has approved the creation, but not distribution, of a vaccination for avian influenza.

The conditional licensure by the USDA has allowed Iowa-based producer Harrisvaccines to manufacture the highly pathogenic avian influenza (HPAI) vaccination, RNA, but it cannot be used until the USDA approves the use of the vaccination, explained Joelle Hayden, public affairs specialist for the USDA Animal and Plant Health Inspection Service (APHIS). "We have not approved the use of vaccine to respond to HPAI to date; however, we are preparing to ensure that vaccine is available should the decision be made to use it," she said.

It is the first license, conditional or otherwise, for HPAI since the outbreak began last December. The conditional license means the company will have the vaccination ready for release in case of an emergency, such as HPAI reappearing in the coming months. "The company will conduct additional potency and efficacy studies during the one-year period of conditional licensure," Hayden reported.

The USDA will continue monitoring and evaluating the vaccination before full licensure may be granted. The USDA must approve the use of the vaccination as part of the eradication program before it will be released for public use. "In other words, poultry companies cannot purchase vaccine doses on their own and vaccinate their poultry."

Even if the vaccine is approved, it would be used at the direction of the USDA and in concurrence of the state veterinarian. Producers will not be able to directly pur-chase and use the vaccine, Hayden said.

Harrisvaccines announced the conditional license on Sept. 21. At the same time, it announced the technology used in the vaccination will use its rapid response SirraVax platform technology, which should allow for easily updated vaccinations for future strains of HPAI.

"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. This makes our vaccine an important tool for eradication efforts and may alleviate any concerns with trading partners abroad," said Dr. Hank Harris, founder and CEO of Harrisvaccines. "The threat posed by avian influenza is extraordinary to both producers and consumers."

Joel Harris, vice president of Harrisvaccines, said the conditional license allows the company to be in a better position to apply the vaccination, when the virus reemerges.

To date, roughly 50 million chickens and turkeys have died as a result of the virus. Harrisvaccines estimates $2.5 billion in decreased output and an impact on more than 15,000 jobs this year as a result of HPAI. Dr. David Halvorson, professor emeritus at the University of Minnesota. addressed attendees at the U.S. Poultry and Egg Assoc. Live Production and Welfare Seminar. "We failed to understand the potential scope of the outbreak. No one planned for 40 introductions of avian influenza. That left us short on people and resources," he explained.

He discussed the need for employee training and education, as well as the need for a biosecurity plan that incorporates line of separation, peripheral buffer area, personnel and equipment, wild bird programs, live and dead bird movement, manure movement and egg movement. Halvorson also stressed the need for review and constant improvement.

"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," said Dave Rettig, CEO of Rembrandt Enterprises.

APHIS’ Center for Veterinary Biologics granted the conditional license after Harrisvaccines submitted data that supported product safety and efficacy, Hayden reported.