European Medicines Agency Positive On Third Avian Influenza Vaccine For Birds

Main Category: Bird Flu / Avian Flu
Article Date: 16 Mar 2007 - 10:00 PDT

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The European Medicines Agency has adopted a positive opinion recommending the granting of a Community authorisation for a third avian influenza vaccine for use in birds. The vaccine, Nobilis Influenza H7N1, from Intervet International BV, is an inactivated, adjuvanted avian influenza vaccine for administration by injection in chickens and ducks. The vaccine reduces clinical signs, mortality, virus excretion and transmission of virus in vaccinated chickens exposed to infection and reduces virus excretion and transmission of virus in vaccinated ducks exposed to infection. The use of this product 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 Agency's Committee for Medicinal Products for Veterinary Use (CVMP) adopted a positive opinion at its meeting of 13-15 March 2007, recommending that this vaccine should be authorised under exceptional circumstances and subject to specific obligations that will be reviewed annually. The CVMP concluded that the benefits from immediate authorisation in preparation of possible outbreaks 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. While the previously approved avian influenza vaccines use the H5 strain, Nobilis Influenza H7N1 uses the H7 strain, in accordance with the CVMP reflection paper on data requirements for vaccines against H5 or H7 highly pathogenic avian influenza virus, issued in February 2006. The paper, which was prepared in direct response to the occurrence of avian influenza in the European Union, reflects the fact that current concerns about avian influenza in both man and birds focus mainly on the H5 strains, but that the threat of outbreaks due to highly pathogenic H7 strains in birds should not be ignored.

In the context of its avian influenza preparedness activities, the CVMP also adopted a guideline on accelerated assessment and, by granting a positive opinion for this product, the Committee continues to fulfil its previously stated commitment to review applications for avian influenza vaccines as quickly as possible, whilst ensuring a scientifically sound and thorough assessment. Authorisation of this product provides assurance to national authorities of the quality of the vaccine should vaccination be used as a measure to control avian influenza in birds.

1. A summary of the opinion with more details is available on the EMEA website here emea.eu.int/htms/vet/opinion/opinion.htm.

2. The 'Reflection paper: minimum data requirements for an authorisation under exceptional circumstances for vaccines for emergency use in birds against H5 and/or H7 highly pathogenic avian influenza virus' can be found here emea.eu.int/pdfs/vet/iwp/4685306en.pdf.

3. The 'Guideline on the procedure for accelerated assessment pursuant to Article 39(8) of Regulation (EC) No 726/2004' can be found here emea.eu.int/pdfs/vet/regaffair/3299506en.pdf.

4. The CVMP gave positive opinions for two avian influenza vaccines, Nobilis Influenza H5N2, from Intervet International B.V., and Poulvac FluFend H5N3 RG, from Fort Dodge Animal Health BV in July 2006. A press release was issued at the time of the opinion and is available here. The European Public Assessment Report (EPAR) for Nobilis Influenza H5N2 is available here; the EPAR for Poulvac FluFend H5N3 RG is available here.

emea.europa.eu

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