European agency recommends marketing authorization for avian flu vaccines

A pair of avian influenza vaccines targeting the H5 strain of the virus in birds have received positive opinions from the European Medicines Agency Committee for Veterinary Products (CVMP). The CVMP has also recommended European Union marketing authorization under exceptional circumstances for these immunizations, known as Vaxxitek HVT+IBD+H5 and Vaxxinact H5, by Boehringer Ingelheim.¹

Avian influenza has caused outbreaks in wildlife as well as commercial flocks around the world, including Antarctica. The H5 virus strain is common in avian influenza cases.¹

The Vaxxitek HVT+IBD+H5 and Vaxxinact H5 vaccines could be important for monitoring disease outbreaks, according to Boehringer Ingelheim. These preventive therapies include a biomarker for distinguishing the immune response to vaccination from infection antibodies that, when combined with surveillance, can play a role in reducing the risk of trade restrictions for animal products.¹

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“By continuously monitoring the efficacy of our vaccines and advancing our technologies, we ensure the right protection against the evolving avian influenza virus,” Taoufik Rawi, head of franchise, poultry, for Boehringer Ingelheim, said in a news release.¹ “The positive opinions for Vaxxitek HVT+IBD+H5 and Vaxxinact H5 are critical to increase preparedness against avian influenza outbreaks in Europe.”

The European Commission will ultimately decide on whether marketing authorizations under exceptional circumstances for Vaxxitek HVT+IBD+H5 and Vaxxinact H5 will be granted. These decisions are expected in the coming months, according to Boehringer Ingelheim.¹

The World Organisation for Animal Health has advised that vaccination for avian influenza may be recommended under certain conditions. This international organization, based in Paris, France, suggests that vaccination for avian influenza should be integrated into comprehensive disease control strategies. However, decisions on vaccination against avian influenza rest with each country’s veterinary authority.²

“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,” Armin Wiesler, head of the animal health business unit and member of the board of managing directors for Boehringer Ingelheim, said in the release. Wiesler added that the company is ready to support governments, health authorities and producers with its vaccines and provide expertise for monitoring and for setting up disease control plans.¹

Highly pathogenic avian influenza was detected in Europe and Canada in 2021, and reached the US through seasonal migration of wild birds including waterfowl. Millions of poultry have since been affected throughout the US.³

New outbreaks of the virus have been recently reported in poultry on commercial farms in Iowa, Minnesota, and Wisconsin. Additionally, Nebraska recently reported its first case of H5N1 in dairy cattle after the virus was detected in milk samples.⁴

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References

1. Boehringer Ingelheim obtains two EU CVMP positive opinions for avian influenza vaccines Vaxxitek HVT+IBD+H5 and Vaxxinact H5. News release. Boehringer Ingelheim. November 20, 2025. Accessed November 20, 2025. https://www.boehringer-ingelheim.com/animal-health/veterinary-public-health/boehringer-ingelheim-obtains-two-eu-cvmp-positive-opinions-avian-influenza-vaccines
2. Avian influenza: The use of vaccination. World Organisation for Animal Health. Accessed November 20, 2025. https://www.woah.org/en/disease/avian-influenza/#ui-id-3
3. Highly pathogenic avian influenza: Poultry. Cornell University College of Veterinary Medicine. May 20, 2025. Accessed November 20, 2025. https://www.vet.cornell.edu/highly-pathogenic-avian-influenza-bird-flu-resource-center/poultry
4. Bautista-Alejandre A. New bird flu outbreaks reported in poultry across 3 Midwestern states. dvm360. October 6, 2025. Accessed November 20, 2025. https://www.dvm360.com/view/new-bird-flu-outbreaks-reported-in-poultry-across-3-midwestern-states