Zoetis Receives Conditional License from USDA for Avian Influenza Vaccine, H5N2 Subtype, Killed Virus

Rhea-AI Summary

Zoetis (ZTS) has received a conditional license from the USDA's Center for Veterinary Biologics for its Avian Influenza Vaccine, H5N2 Subtype, Killed Virus for use in chickens. The license was granted based on safety, purity, and reasonable efficacy expectations from serology data.

The vaccine addresses the Highly Pathogenic Avian Influenza (HPAI) crisis, which has affected over 150 million birds in the U.S. since February 2022. The conditional license is issued for a time to meet emergency conditions and can be renewed at the CVB's discretion.

This development builds on Zoetis's extensive experience in avian influenza vaccines, including their 2016 H5N1 vaccine for the USDA's National Veterinary Stockpile and their POULVAC® FLUFEND™ i AI H5N3 RG vaccine used internationally.

Positive

• Received USDA conditional license for new H5N2 avian influenza vaccine
• Addresses large market need with over 150 million affected birds since 2022
• Builds on established track record in avian influenza vaccines

Negative

• License is conditional and temporary, requiring renewal
• Vaccine deployment depends on regulatory authorities' approval

Insights

Veterinary Industry Analyst

The USDA's conditional license for Zoetis's H5N2 avian influenza vaccine marks a strategic expansion of their poultry vaccine portfolio. This development is particularly significant given that HPAI outbreaks have affected over 150 million birds since 2022, causing substantial economic disruption in the $35.5 billion U.S. poultry industry.

The conditional license mechanism, designed for emergency conditions and markets, offers Zoetis a first-mover advantage in addressing an urgent market need. This strategic positioning is enhanced by their established presence in avian influenza vaccines, including their 2016 H5N1 vaccine and POULVAC FLUFEND product line.

Several key factors amplify the business significance of this development:

• The vaccine addresses a critical market need in the commercial poultry sector, where HPAI outbreaks can lead to complete flock losses and significant economic damage
• Zoetis's demonstrated capability in rapidly responding to emerging strains strengthens their competitive moat in the animal health vaccine market
• The conditional license pathway allows for faster market entry while gathering additional efficacy data, potentially leading to a full license

The revenue potential extends beyond the U.S. market, as Zoetis's experience with regulatory approvals and vaccine deployment in multiple countries positions them to address global HPAI challenges. Their track record of protecting endangered species, including California condors and New Zealand birds, also demonstrates the broader applicability of their vaccine technology.

PARSIPPANY, N.J.--(BUSINESS WIRE)-- Zoetis today 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 labelled 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.

About Zoetis

As the world’s leading animal health company, Zoetis is driven by a singular purpose: to nurture our world and humankind by advancing care for animals. After innovating ways to predict, prevent, detect, and treat animal illness for more than 70 years, Zoetis continues to stand by those raising and caring for animals worldwide – from veterinarians and pet owners to livestock producers. The company’s leading portfolio and pipeline of medicines, vaccines, diagnostics and technologies make a difference in over 100 countries. A Fortune 500 company, Zoetis generated revenue of $9.3 billion in 2024 with approximately 13,800 employees. For more information, visit www.zoetis.com.

DISCLOSURE NOTICES

Forward-Looking Statements: This press release contains forward-looking statements, which reflect the current views of Zoetis with respect to expectations regarding products, product approvals or licenses, products under development and other future events. These statements are not guarantees of future performance or actions. Forward-looking statements are subject to risks and uncertainties. If one or more of these risks or uncertainties materialize, or if management's underlying assumptions prove to be incorrect, actual results may differ materially from those contemplated by a forward-looking statement. Forward-looking statements speak only as of the date on which they are made. Zoetis expressly disclaims any obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. A further list and description of risks, uncertainties and other matters can be found in our most recent Annual Report on Form 10-K, including in the sections thereof captioned “Forward-Looking Statements and Factors That May Affect Future Results” and “Item 1A. Risk Factors,” in our Quarterly Reports on Form 10-Q and in our Current Reports on Form 8-K. These filings and subsequent filings are available online at www.sec.gov, www.zoetis.com, or on request from Zoetis.

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View source version on businesswire.com: https://www.businesswire.com/news/home/20250214307661/en/

Media Contacts:

Laura Panza

1-973-975-5176 (o)

laura.panza@zoetis.com



Jennifer Albano

1-862-399-0810 (o)

jennifer.albano@zoetis.com



Investor Contacts:

Nick Soonthornchai

1-973-443-2792 (o)

nick.soonthornchai@zoetis.com



Steve Frank

1-973-822-7141

steve.frank@zoetis.com

Source: Zoetis Inc.

FAQ

What is the significance of ZTS's new H5N2 avian influenza vaccine approval?

The USDA's conditional license allows Zoetis to provide a vaccine solution for the ongoing HPAI crisis that has affected over 150 million birds in the U.S. since February 2022.

How long will ZTS's conditional license for the H5N2 vaccine last?

The conditional license is issued for a finite period and can be renewed at the discretion of the USDA's Center for Veterinary Biologics.

What is ZTS's track record with avian influenza vaccines?

Zoetis has been developing avian influenza vaccines since 2001-02, received a conditional license for H5N1 vaccine in 2016, and holds a license for POULVAC® FLUFEND™ i AI H5N3 RG used internationally.

How many birds have been affected by HPAI since 2022 that ZTS's vaccine could help?

According to the USDA's APHIS, more than 150 million birds in the U.S. have been affected with HPAI since February 2022, including both backyard and commercial flocks.