Positive opinion for EU avian influenza vaccines
European Medicines Agency has adopted positive opinions recommending the
granting of community authorisations for avian influenza vaccines for use in
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.
reduce mortality and virus excretion in vaccinated chickens exposed to
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
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.
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