Zoetis receives conditional license from USDA for avian influenza vaccine, H5N2 subtype, killed virus
14 February 2025
2 minute read
By: Zoetis announced that the U.S. Department of Agriculture (USDA), Center for Veterinary Biologics (CVB) has issued the company a conditional license for its Avian Influenza Vaccine, H5N2 Subtype, Killed Virus. The vaccine 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.
Zoetis is committed to supporting poultry producers with scientific solutions for Highly Pathogenic Avian Influenza (HPAI). The decision to vaccinate commercial poultry flocks against HPAI rests solely with national regulatory authorities in partnership with the poultry industry.
According to the USDA’s Animal and Plant Health Inspection Service (APHIS), more than 150 million birds in the U.S. have been affected with HPAI since February 2022, including in 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 HPAI was identified in the U.S. 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. “We first worked on HPAI vaccines in 2001-02 when outbreaks occurred in flocks in Southeast Asia. Our readiness with this most recent vaccine is another example of how we continue to live our purpose to nurture the world and humankind by advancing care for animals, ultimately providing solutions to global animal health challenges.”
Zoetis has a long history of developing vaccines to address avian influenza in multiple countries. In 2016, the company received a conditional license for its H5N1 vaccine and a contract award for the USDA’s National Veterinary Stockpile; this same vaccine was first used by the U.S. Fish & Wildlife Service in 2023 to help protect California condors. Zoetis also holds a USDA license for POULVAC® FLUFEND™ i AI H5N3 RG which has been available in smaller markets outside the U.S. and was used to help protect endangered birds in New Zealand in 2024.
