- The European Medicines Agency’s (EMA’s) Committee for Veterinary Medicinal Products (CVMP) has adopted positive opinions for two Boehringer poultry vaccines against the highly pathogenic H5 avian influenza virus1.
- VAXXITEK® HVT+IBD+H5 is the first trivalent vaccine offering combined protection against Marek’s disease, Infectious Bursal Disease and H5 avian influenza in chickens and turkeys in one single shot.
- VAXXINACT® H5 is an inactivated vaccine that protects chickens, turkeys, and ducks against avian influenza (H5 virus subtype).
Boehringer Ingelheim, a global leader in preventive medicines for livestock, obtained positive opinions by the European Medicines Agency (EMA) recommending the granting of marketing authorisations under exceptional circumstances2 for its avian influenza vaccines VAXXITEK® HVT+IBD+H5 and VAXXINACT® H5. Both vaccines immunize birds against the H5 avian influenza virus, which is currently causing outbreaks across Europe.
Strengthening outbreak preparedness in the European Union
Avian influenza, commonly referred to as avian flu or bird flu, is a highly contagious disease affecting domestic and wild birds. The H5 strain is one of the most prevalent avian influenza virus strains causing outbreaks in both wildlife and commercial flocks. As avian influenza is a highly regulated and notifiable disease, there is vigilant monitoring. To contain avian influenza outbreaks, large numbers of birds often need to be culled, leading to significant economic losses for poultry producers and possible restrictions in international trade.
As the virus continues to evolve, innovative vaccine solutions are an effective way to help prevent and manage avian flu outbreaks. Decisions regarding vaccination against avian influenza rest with the national authorities of each country. International institutions like WOAH (World Organization for Animal Health) recommend integrating vaccination into bird flu control strategies3.
“Transboundary Animal Diseases like avian influenza will continue to be a threat, so new approaches to control these infectious diseases in animals, especially livestock, are increasingly important. Boehringer Ingelheim is committed to investing in research and innovation, and we are ready to support governments, health authorities and producers with our vaccines and expertise in monitoring and in setting up robust disease control plans,” says Armin Wiesler, Head of the Animal Health Business Unit and Member of the Board of Managing Directors.
Global impact of highly pathogenic avian influenza H5
Since 2021, highly pathogenic avian influenza H5 has caused unprecedented outbreaks, spreading across most continents globally and leading to massive poultry losses. The outbreaks have expanded to new regions such as Latin America and even Antarctica. The economic impact has been severe, with tremendous financial damage to the poultry industry, disruptions in egg and poultry meat availability, and trade restrictions.
Containing bird flu: The role of DIVA vaccines in biosecurity and surveillance
VAXXITEK® HVT+IBD+H5 and VAXXINACT® H5 are so called DIVA (Differentiate Infected from Vaccinated Animals) vaccines that can play an important role in monitoring disease outbreaks. These vaccines include a biomarker that distinguishes the immune response to vaccination from antibodies caused by infection. In combination with surveillance efforts, DIVA vaccines are essential for reducing the risk of trade restrictions, as they enable both, exporters and importers to differentiate between vaccinated and infected animals, ensuring confidence in the safety of traded animal products.
“By continuously monitoring the efficacy of our vaccines and advancing our technologies, we ensure the right protection against the evolving avian influenza virus. The DIVA feature allows our customers to implement their surveillance programs and support safe trade while vaccinating,” says Taoufik Rawi, Head of Franchise, Poultry. “The positive opinions for VAXXITEK® HVT+IBD+H5 and VAXXINACT® H5 are critical to increase preparedness against avian influenza outbreaks in Europe.”
Following the CVMP’s positive opinions, the European Commission is expected to decide on marketing authorizations under exceptional circumstances in the coming months.
References
1CVMP summary of positive opinion for Vaxxitek HVT+IBD+H5, October 9, 2025, https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vaxxitek-hvtibdh5
CVMP summary of positive opinion for Vaxxinact H5, October 6, 2025, https://www.ema.europa.eu/en/medicines/veterinary/EPAR/vaxxinact-h5
2 Article 25 et seq. Regulation (EU) 2019/6
3 World Organisation for Animal Health (WOAH) avian influenza overview page https://www.woah.org/en/disease/avian-influenza/#ui-id-3 (Last accessed November 17th, 2025)
Boehringer Ingelheim – Animal Health business
Boehringer Ingelheim provides innovation for preventing and treating diseases in animals. The company offers a wide range of vaccines, parasite-control products, and medicines for pets, horses, and livestock to veterinarians, animal owners, farmers, and governments. As a leader in animal health, Boehringer Ingelheim values that the health of humans and animals is deeply connected and strives to make a difference for people, animals, and society. Learn more at www.boehringer-ingelheim.com/animal-health.
Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.