Following the announcement of Elanco’s partnership with Medgene to commercialize a vaccine for avian influenza (HPAI) in dairy cattle, we spoke with Tim Bettington, Elanco’s EVP of corporate strategy and market development, about next steps for the alliance.
The USDA has previously approved Medgene’s vaccine platform technology for cattle, allowing the company to accelerate H5N1 vaccine development, with the shot now in the final stages of review for a conditional license nod.
Though Bettington told us that while discussions with regulatory bodies have taken place, and there are estimates and projections, a definitive timeline for approval has not yet been set.
“Unlike the FDA, which follows a structured review period (e.g., a 90-day review with feedback around the 88th day), the USDA process is less predictable.”
Safety and efficacy studies
When asked whether the partners now just have to sit tight and wait for conditional approval, Bettington explained, “Yes and no. While there is some waiting involved, work is still being done. Moving from conditional to full approval requires additional safety and efficacy studies. Conditional approval is granted based on initial safety and some efficacy data, but full approval requires more comprehensive evidence.”
Medgene is currently conducting trials in California to support the transition toward full approval. The vaccine, built on an existing USDA-approved platform designed for use across multiple species (including pigs, chickens, and cows), has already undergone safety evaluations.
Asked about the vaccine having any potential negative impacts on milk production, Bettington assured: “We don’t believe so. A 100-cow study is currently underway in California specifically to evaluate this. As with most products, initial testing is done on a smaller group of animals to establish proof of concept, efficacy, and safety before scaling up for full approval. We expect results from this study soon, which will allow us to answer this question more definitively.”
Vaccine durability and dosing
On the duration of protection, Bettington noted: “Currently, we expect the vaccine to require two doses per year. The vaccine shows strong efficacy, but one dose does not provide complete control, which is why a two-dose protocol is recommended. After two doses, we’ve observed 100% performance. At this stage, the plan is to follow a two-dose regimen per year.”
The initial annual capacity for vaccine production will be 10 million doses, with discussions ongoing about expanding production.
“Elanco would need to take over manufacturing to enable that, but it is possible. We have a facility in Fort Dodge, Iowa, which serves as our major global manufacturing site. Any future expansion would require investment on our end. However, we anticipate this vaccine will become an annual-use product over time and part of the regular protocol.”
Distribution agreement and expansion potential
Elanco has entered into a three-year exclusive distribution agreement with Medgene, which developed the proprietary vaccine platform. “Medgene does not have full nationwide reach to all dairy farms, but we can help bridge that gap. The agreement is subject to change, but discussions have also focused on expanding the platform’s use for HPAI and other species, though nothing has been finalized.”
While additional work would be needed to expand the vaccine’s use to other species, Bettington said that if the jab is approved for cattle, it could theoretically be adapted for other species.
It could also be potentially used worldwide. However, he acknowledged the challenges of an international push:
“Expanding internationally presents challenges, as some countries only allow conditional approval while others require full approval.”
The base platform is not yet approved outside the US, meaning full approval in the US would be necessary before leveraging that data for global expansion.
Medgene, as a smaller company, faces high costs for international approvals, which is where the agreement can play a crucial role, whereby revenue from the partnership could be set against those expansion efforts. “However, for now, discussions have focused on the US, as current manufacturing capacity cannot support global distribution at this stage.”
Vaccine distribution
The vaccine requires cold chain storage, and distribution will be managed through Elanco’s existing network, similar to its other products.
Industry willingness to vaccinate
On the changing landscape regarding concerns over trade impacts from vaccinating animals against bird flu, Bettington explained: “In the past, concerns about trade and exports created reluctance to vaccinate. However, France has successfully vaccinated against HPAI, effectively eliminating the disease, making it the only country to do so despite trade implications. That success is a strong example of vaccine efficacy.”
The poultry industry remains divided on vaccination. While breeders are open to vaccination, exporters – concerned about trade impacts – are more hesitant, he remarked.
This split contrasts with the dairy industry, where producers are largely in favor of vaccination. “Many state agriculture secretaries in key states have already expressed interest in a vaccine,” Bettington noted.
Additionally, support is growing from the poultry industry for cattle vaccination, as controlling the virus in cattle could reduce the risk of spread to chickens and humans, he said.
From a One Health perspective, vaccinating cattle is seen as a proactive step in controlling the disease across multiple species and minimizing overall public health risks, added the Elanco lead.
Profitability and long-term outlook
When asked about the financial potential of the partnership, Bettington stated: “We see this as a valuable opportunity, particularly in combination with the innovation we’re bringing to the market, such as Bovaer in the US and the rest of our dairy portfolio. This strengthens our position in the industry. While the partnership does create value for us, it’s also about leadership and supporting dairy farmers for the future.
“There’s an expectation that industry leaders invest in long-term solutions, and we view this as both the right thing to do for the dairy industry and a smart business decision.
“That said, this isn’t our biggest revenue-generating opportunity – once again, it’s more about serving our customers and strengthening relationships in the dairy sector.”
Credit: feednavigator.com
