EMA committee backs continued availability of next-generation HPAI vaccine amid persistent H5 avian influenza threat across Europe
Amsterdam, Netherlands | 23 June 2026 – In a significant regulatory decision aimed at strengthening Europe’s long-term poultry disease preparedness, the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) has adopted a positive opinion following the re-examination of Innovax ND-H5, recommending a one-year extension of its marketing authorisation granted under exceptional circumstances. The decision ensures continued access to one of Europe’s most advanced vaccines against highly pathogenic avian influenza (HPAI) in poultry.
The recommendation comes as highly pathogenic H5 avian influenza continues to challenge poultry industries worldwide, with recurring outbreaks in commercial poultry and wild bird populations placing renewed emphasis on vaccination as a complementary disease-control strategy alongside surveillance and stringent biosecurity.
Strategic Vaccine for a Persistent Threat
Developed by MSD Animal Health, Innovax ND-H5 received its initial European Commission marketing authorisation in 2024 under the regulatory framework for authorisation in exceptional circumstances, reflecting the urgent public and animal health need for innovative HPAI control tools despite limited long-term field data available at the time of approval.
Unlike conventional inactivated influenza vaccines, Innovax ND-H5 is a live recombinant vector vaccine administered either in ovo or subcutaneously to day-old chicks. The vaccine simultaneously provides protection against:
-
Highly Pathogenic Avian Influenza (H5 clade 2.3.4.4b),
-
Newcastle disease, and
-
Marek’s disease.
This multi-pathogen approach enables hatcheries to integrate avian influenza protection into existing vaccination programmes without adding extra handling steps for birds.
Re-Examination Confirms Positive Benefit-Risk Profile
Following a formal re-examination process, the CVMP concluded that the vaccine continues to demonstrate a favourable benefit-risk balance and recommended extending the validity of its exceptional marketing authorisation for a further year. The committee’s decision allows regulators to continue collecting additional quality, safety and efficacy data while ensuring the product remains available for disease-control programmes.
Under the European Union’s veterinary medicines legislation, products authorised under exceptional circumstances undergo regular scientific review because comprehensive datasets cannot always be generated before authorisation for diseases posing urgent or evolving risks.
Vaccination Increasingly Seen as Essential Biosecurity Tool
Europe’s approach to avian influenza control has evolved considerably over the past several years. While traditional measures—including movement restrictions, surveillance, culling of infected flocks and strict farm biosecurity—remain central to outbreak response, vaccination is increasingly being recognised as an additional layer of protection for high-risk poultry populations.
The current H5 clade 2.3.4.4b lineage has demonstrated an unprecedented ability to circulate across wild bird populations while causing repeated outbreaks in commercial poultry, resulting in substantial economic losses through mortality, compulsory culling, trade restrictions and production disruption.
International organisations, including the World Organisation for Animal Health (WOAH), have encouraged countries to consider strategic vaccination programmes where epidemiologically appropriate as part of integrated disease-control strategies.
Supporting Europe’s Poultry Industry
The extension of Innovax ND-H5’s authorisation provides continued regulatory certainty for poultry producers, hatcheries and veterinary authorities as they strengthen preparedness against future HPAI incursions. The vaccine is designed to reduce:
-
mortality,
-
clinical disease,
-
virus shedding, and
-
onward transmission within poultry populations,
