Positive opinion for EU avian influenza vaccines

The two vaccines concerned, Nobilis Influenza H5N2 from Intervet International, and Poulvac FluFend H5N3 RG, from Fort Dodge Animal Health, are both inactivated, adjuvanted avian influenza vaccines for administration by injection. Nobilis Influenza H5N2 is for use in chickens and Poulvac FluFend H5N3 RG is for use in both chickens and Pekin ducks.

The Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) assessed the application for marketing authorisation for each vaccine and decided that the benefits of the products outweigh potential risks. These opinions will now be passed to the Commission to be transformed, according to the legal decision-making process, into marketing authorisations valid throughout the European Union.

Both vaccines reduce mortality and virus excretion in vaccinated chickens exposed to infection.

The use of these products will be restricted to administration as part of disease control campaigns carried out by national competent authorities in compliance with European Community legislation on the control of avian influenza.

The CVMP has recommended that these vaccines should be authorised under exceptional circumstances and subject to specific obligations that will be reviewed annually.

Authorisation of these products would provide assurance to national authorities of the quality of the vaccines should vaccination be used as a measure to control avian influenza in birds. Effective control of avian influenza in birds is considered to be particularly important at the present time not only in the interests of animal health but also to reduce the likelihood of the emergence of a human pandemic strain of the virus.