Dalan Animal Health Announces Successful Efficacy Trials for its Honeybee Vaccine, Advancing Toward Full USDA Licensure

The successful vaccine trials for honeybees, together with recent breakthrough results from clinical trials for disease prevention in shrimp, further validate the versatility of Dalan's innate immunity platform across species and position the company as the pioneer in effective and sustainable health management for critical, high-value food production animals.

ATHENS, Ga., Nov. 4, 2025 /PRNewswire/ -- Dalan Animal Health, Inc., the pioneering bioscience company that brought the world's first vaccine for honeybees to market, today announced successful completion of honeybee vaccine efficacy trials that represent a significant step toward obtaining full licensure from the United States Department of Agriculture (USDA) Center for Veterinary Biologics.

The clinical trials, designed to meet USDA requirements for advancing from conditional to full licensure, demonstrated strong efficacy of Dalan's groundbreaking vaccine in protecting honeybee colonies against American Foulbrood (AFB). The company plans to submit the clinical data to USDA this month for review and approval.

"These successful efficacy trials represent a major regulatory milestone for Dalan and the beekeeping industry," said Dr. Annette Kleiser, CEO and Founder of Dalan Animal Health. "This past summer, we performed efficacy trials similar to those we conducted for our conditional license. The results were excellent, and we plan to submit the data for USDA approval this month. We still have work to do before we can apply for full licensure and expect it for the 2027 season at the earliest, but this is a significant step forward in our regulatory journey."

Regulatory Pathway to Full Licensure

Dalan's honeybee vaccine received conditional USDA licensure in December 2022, making history as the first vaccine ever approved for an insect species. The pathway to full licensure requires additional safety data demonstrating consistent performance under field conditions, along with comprehensive manufacturing documentation.

The summer 2025 trials were specifically designed to meet USDA's rigorous standards for full licensure and replicated the trial design that supported the company's conditional license. The successful results validate the vaccine's reliability and effectiveness in real-world beekeeping operations.

Full USDA licensure will enable broader commercial distribution, remove conditional use restrictions, and position the vaccine as a standard tool in integrated pest management (IPM) programs for beekeepers nationwide.

Broad Spectrum Protection

Dalan's vaccine provides broad spectrum effects, addressing American Foulbrood—a devastating bacterial disease that can destroy entire apiaries. In addition, customers have reported overall improvements in the strength and health of vaccinated colonies compared to non-vaccinated colonies. This includes an observed correlation of reduced Deformed Wing Virus in vaccinated colonies over the course of the summer. DWV is one of the primary viral pathogens transmitted by varroa mites, and a leading cause of colony losses worldwide.

With commercial beekeepers experiencing unprecedented colony losses exceeding 60% in recent seasons, the vaccine's dual-disease protection addresses both bacterial and viral threats that compromise bee health and productivity. This positions Dalan's vaccine as a complementary tool alongside varroa mite control measures in comprehensive colony health management.

Industry Impact and Commercial Readiness

The U.S. honeybee pollination services market represents over $15 billion in annual agricultural value, with bees essential to more than 100 crops. American Foulbrood outbreaks can quarantine entire beekeeping operations, while DWV infection weakens colonies and reduces productivity.

The company will continue marketing its vaccine under the current conditional license while pursuing full licensure, ensuring beekeepers have access to this innovative disease prevention tool during the regulatory advancement process.

About Dalan Animal Health

Dalan Animal Health (www.dalan.com) is a pioneer in bioscience innovation, developing vaccines for invertebrate species that are critical to global food security. Using its proprietary technology platform to effectively train the innate immune system, Dalan has achieved historic breakthroughs with the first USDA-approved vaccine for honeybees and is advancing a vaccine for shrimp designed to protect from critical diseases including White Spot Syndrome Virus and Early Mortality Syndrome. Dalan's biotech innovation has been recognized through numerous international awards such as TIME's Best Inventions, Fast Company's Next Big Things in Tech, and most recently featured in FORBES. The company is headquartered in Athens, Georgia at the University of Georgia.

For more information about Dalan's honeybee vaccine and beekeeping resources, visit www.dalan.com.

Forward-Looking Statements
This press release contains forward-looking statements regarding regulatory timelines, full licensure expectations, and commercial plans. Actual results may differ due to regulatory review processes, additional data requirements, or other factors beyond the company's control. These statements are based on current expectations and involve risks and uncertainties.

SOURCE Dalan Animal Health, Inc.