USDA issues conditional license for H5N2 vaccination
The vaccine from Zoetis, Avian Influenza Vaccine, H5N2 Subtype, Killed Virus, is for poultry and has been demonstrated to be safe, pure, and to have a reasonable expectation of efficacy
Anton Dios/stock.adobe.com
The US Department of Agriculture (USDA), Center for Veterinary Biologics (CVB), issued Zoetis a conditional license for its Avian Influenza Vaccine, H5N2 Subtype, Killed Virus. The vaccination, labeled for use in chickens, was granted the conditional license because its serology data showed it demonstrates safety, purity, and has a reasonable expectation of efficacy
“When a new strain of HPAI was identified in the US in early 2022, our scientists immediately began work to update our previous avian influenza vaccine,” said Mahesh Kumar, PhD, senior vice president, global biologics research and development at Zoetis, in an organizational release.1
On February 8, 2022, the USDA Animal and Plant Health Inspection Service (APHIS) confirmed highly pathogenic avian influenza (HPAI) was detected in a commercial flock in the United States.2 The virus has continued to spread to other species, including dairy cattle, and even human cases are beginning to be reported. At this time, APHIS has confirmed 146 flocks with HPAI, after being tested, with 94 being commercial flocks, 47 backyard flocks, and a total of 20.04 million birds confirmed infected.2
RELATED: From poultry to public health: Understanding the H5N1 threat
A USDA conditional license, like Zoetis’ avian influenza vaccine, H5N2 Subtype, Killed Virus, allows a product to be used to meet an emergency condition, limited market, local situation, or any other special circumstance and is issued for a finite period, and can be renewed at the discretion of the CVB.
In 2016, Zoetis had received a conditional license for its H5N1 vaccine as well as a contract award for the USDA’s National Veterinary Stockpile. The vaccination was then used in 2023 by the US Fish & Wildlife Service to help protect California condors. Additionally, Zoetis has a USDA license for POULVAC FLUFEND i AI H5N3 RG, which is available in smaller markets outside of the United States, and was used in 2024 to protect endangered birds in New Zealand.1
“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,” Kumar continued.
References
- Zoetis Receives Conditional License from USDA for Avian Influenza Vaccine, H5N2 Subtype, Killed Virus, for Chickens. News release. February 14, 2025. Accessed February 17, 2025. https://news.zoetis.com/press-releases/press-release-details/2025/Zoetis-Receives-Conditional-License-from-USDA-for-Avian-Influenza-Vaccine-H5N2-Subtype-Killed-Virus/default.aspx
- HPAI Confirmations in Commercial and Backyard Flocks. US Department of Agriculture Animal and Plant Health Inspection Service. Accessed February 17, 2025. https://www.aphis.usda.gov/livestock-poultry-disease/avian/avian-influenza/hpai-detections/commercial-backyard-flocks
