USDA issues conditional license for avian influenza vaccine

More than 150 million birds in the US have been affected by highly pathogenic avian influenza since February 2022. Photo: Bert Jansen

The US Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) has issued a conditional license for an avian influenza vaccine, H5N2 subtype, killed virus. The vaccine, manufactured by Zoetis, is labeled for use in chickens.

The conditional license was granted on the demonstration of safety, purity, and reasonable expectation of efficacy based on serology data.

According to the USDA’s Animal and Plant Health Inspection Service, more than 150 million birds in the US have been affected by highly pathogenic avian influenza since February 2022, including backyard and commercial flocks. A conditional license is used to meet an emergency condition, limited market, local situation or other special circumstance and is issued for a finite period of time. Conditional licenses may be renewed at the discretion of the CVB.

“When a new strain of highly pathogenic avian influenza [HPAI] was identified in the US in early 2022, our scientists immediately began work to update our previous avian influenza vaccine,” said Mahesh Kumar, Ph.D., senior vice president, global biologics research and development at Zoetis. He added: “We first worked on HPAI vaccines in 2001-02 when outbreaks occurred in flocks in Southeast Asia.”

The decision to vaccinate commercial poultry flocks against highly pathogenic avian influenza rests solely with national regulatory authorities in partnership with the poultry industry.