The decision to vaccinate commercial poultry flocks against highly pathogenic avian influenza (HPAI) rests solely with national regulatory authorities in collaboration with the poultry industry, the company stated.
Zoetis announced on February 13, 2025 that the U.S. Department of Agriculture, Center for Veterinary Biologics (CVB) has issued the company a conditional license for its avian influenza vaccine, H5N2 subtype, inactivated virus. The vaccine is labeled for use in chickens. The conditional license was granted following demonstration of safety, purity, and a reasonable expectation of efficacy based on serological data.
Zoetis stated that it 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 collaboration 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 by HPAI from February 2022 to February 2025, including backyard and commercial flocks. A conditional license is used to meet an emergency condition, limited market, local situation, or other special circumstances and is issued for a finite period of time. Conditional licenses may be renewed at the discretion of the CVB.
“When a new HPAI strain 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 of global biologics research and development at Zoetis. “We first worked on HPAI vaccines in 2001-02 when outbreaks occurred in Southeast Asian flocks. Our preparedness with this latest vaccine is another example of how we continue to live our purpose of nourishing the world and humanity by advancing animal care, ultimately providing solutions to global animal health challenges.“
Zoetis has a long history in 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 and 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.