Brussels, 11th September 2006
The European Commission has given Community-wide authorisation to two avian influenza vaccines. This should ensure that effective vaccines are available for use throughout the EU during the autumn/winter, which is the period of greatest risk of a bird flu epidemic. There are no outbreaks of avian influenza in domestic or wild birds in the EU at the moment, but the risk of the disease will increase in the coming weeks as the autumn migration period begins. Both of the vaccines which have been approved reduce mortality and virus excretion in vaccinated chickens exposed to infection. The two vaccines concerned, Nobilis Influenza H5N2 and Poulvac FluFend H5N3 RG, are 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.
Commission Vice-President Günter Verheugen, responsible for industry and enterprise policy, said: “Due to the current risk of a recurrence of avian influenza in the next migratory season, the Commission felt it appropriate to approve these vaccines under exceptional circumstances. I am also pleased about the strong capacity of the EU’s pharmaceutical industry to innovate and to address urgent challenges so quickly.”
Effective control of avian influenza is considered to be particularly important 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. An authorisation under exceptional circumstances is possible where the applicant is unable to provide comprehensive data on the efficacy and safety under normal conditions of use, but it is in the interest of animal or public health to grant a marketing authorisation subject to specific controls.
The use of these authorised vaccines will be restricted to Member States national competent authorities, as part of disease control campaigns carried out in compliance with EU legislation on the control of avian influenza. Directive 2005/94 on Community measures for the control of avian influenza requires Member States to submit a vaccination plan to the Commission. The Commission has already authorised Italy, France, Netherlands and most recently Germany (see IP/06/1153) to apply such vaccination campaigns against avian influenza.
The European Medicines Agency’s (EMEA) Committee for Medicinal Products for Veterinary Use (CVMP) had responded to the current risk situation by greatly accelerating its scientific assessment. It recommended that these vaccines should be authorised under exceptional circumstances and subject to specific obligations that will be reviewed annually. The Agency concluded that the benefits from immediate authorisation in preparation for the upcoming period of high risk for incursion of avian influenza virus during the autumn and winter of 2006 outweigh the potential risks. The specific obligations are intended to provide additional assurance in relation to the products and to ensure that the applicant has in place a programme of active pharmacovigilance (i.e. reporting of adverse reactions) should they be used in the field.
Authorisation of these products provides assurance of the quality, safety and efficacy of the vaccines should vaccination be used as a measure to control avian influenza in birds.
For more information, see the EMEA website
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 Article 39(7) of
Regulation (EC) No 726/2004 available