As Elanco deepens its commitment to dairy animal health, the company’s new partnership with Medgene marks a major milestone in tackling Highly Pathogenic Avian Influenza (HPAI) in cattle. We spoke with Tim Bettington, EVP of Corporate Strategy and Market Development at Elanco, to explore next steps and long-term implications of this breakthrough collaboration.

Elanco and Medgene are progressing toward conditional approval for a first-of-its-kind avian influenza vaccine designed for use in dairy cattle. The USDA has previously approved Medgene’s core vaccine platform technology for cattle, allowing the company to expedite development of its H5N1-specific solution. The vaccine is currently in the final stages of regulatory review.

Regulatory Path: Conditional to Full Approval

While timelines remain uncertain, Bettington clarified that discussions with regulatory agencies are ongoing. Unlike the FDA’s structured 90-day review process, the USDA approach is less predictable, making the path to approval more nuanced.

“Conditional approval is based on initial safety and efficacy data,” explained Bettington. “To move toward full approval, we need to conduct additional studies proving broader safety and longer-term effectiveness.”

Medgene is actively running trials in California, with a focus on safety and the vaccine’s impact on milk production. A 100-cow trial is currently underway to assess whether the vaccine affects milk yield—preliminary indications suggest no adverse effects.

Vaccine Protocol, Efficacy, and Dosage

According to Bettington, the vaccine is expected to require two doses annually. “One dose offers some protection, but two doses have shown 100% efficacy in trials,” he said.

Initial production capacity is pegged at 10 million doses per year. However, expansion plans are already under discussion. Elanco may take over manufacturing at its Fort Dodge, Iowa facility to scale up supply once demand increases. “We envision this vaccine becoming a staple in annual dairy herd health protocols,” Bettington added.

Strategic Distribution and Platform Expansion

The partnership includes a three-year exclusive distribution agreement, leveraging Elanco’s broad reach to deliver the vaccine to dairy farms nationwide. Medgene, a biotech innovator with a proprietary vaccine platform, lacks extensive national distribution—but Elanco’s network fills that gap.

There is also potential to adapt the vaccine for use in other species beyond cattle, though such developments would require additional studies and approvals. Global rollout is a longer-term goal, with the current focus remaining on the U.S. market. Regulatory requirements and high approval costs are barriers to international expansion—particularly for smaller companies like Medgene.

Cold Chain Storage and Logistics

The vaccine will require cold chain storage, similar to many biologics. Elanco plans to integrate the distribution into its existing infrastructure, ensuring efficient delivery and quality control across regions.

Shifting Industry Perspectives on Vaccination

Traditionally, the livestock industry has been hesitant to adopt avian influenza vaccines due to concerns over trade restrictions. However, France’s successful vaccination campaign—eliminating HPAI despite initial export worries—has shifted global perceptions.

“Producers in the dairy sector are largely supportive of vaccination,” Bettington shared. “Several state agriculture leaders have already voiced interest.”

Even poultry stakeholders are starting to back cattle vaccination, recognizing its potential to reduce viral transmission to birds and humans. From a One Health perspective, controlling HPAI in cattle could significantly reduce cross-species infection risks.

A Long-Term Vision for Dairy Health and Sustainability

While the partnership isn’t expected to be a major revenue driver for Elanco in the near term, Bettington emphasized its strategic value. “It’s about strengthening our dairy portfolio, supporting producers, and reinforcing our leadership in animal health innovation,” he said.

Paired with initiatives like the U.S. rollout of Bovaer and ongoing sustainability efforts, the HPAI vaccine underscores Elanco’s long-term commitment to advancing dairy industry resilience and food security.

“We’re investing in the future of animal agriculture—not just for profit, but to provide real, scalable solutions for farmers and the health of both animals and people,” Bettington concluded.