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First Conditional License Granted for Avian Influenza Vaccine

Harrisvaccines has been granted a USDA conditional license for the company’s avian influenza vaccine, RNA. This is the first conditional license for the highly pathogenic avian influenza that swept across the Midwest in the spring of 2015.

A conditional license is the first step in getting a vaccine to market. However, the USDA still has to authorize the vaccine before producers can purchase it. Conditional licenses are normally granted to meet an emergency or unmet need and must show a reasonable expectation of efficacy, safety, and potency. Further efficacy and potency testing for this vaccine is ongoing in chickens and turkeys.

The USDA has called for a solicitation to create a vaccine stockpile for
H5 avian influenza for the fall. “Harrisvaccines is prepared to make
several million doses a week once the bid is granted to meet however
much they order,” says Joel Harris, vice president of Harrisvaccines.

The avian influenza vaccine was created using SirraVax technology, which allows the vaccine to be easily updated to match current and future strains of avian influenza. Harrisvaccines has also used SirraVax technology to make vaccines for the pork industry, including the porcine epidemic diarrhea vaccine and swine influenza Vaccine.

“Getting a vaccine in the field that matches 100% to the H5N2 strain is crucial to ongoing containment efforts,” says Dr. Hank Harris, founder and CEO of Harrisvaccines. “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.”

The adaptability of the vaccine via SirraVax and the conditional license are welcome news as fall approaches, which experts fear may cause another outbreak of the highly contagious disease as migratory birds head south for the winter. (Learn what other precautionary measures are being taken to prepare for a potential outbreak this fall.)

“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,” says Joel Harris.

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