The European Medicines Agency has today published a reflection paper that offers guidance on the approval of vaccines for emergency use in birds against H5 and/or H7 avian influenza virus.

The reflection paper sets out the Agency's current thinking of the data requirements for any new avian fluenza vaccine for emergency use in birds and is intended as a guide for pharmaceutical companies and to the national authorities in the EU Member States.

The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) also gives a commitment to consider accelerating the review of any such emergency vaccine submitted for approval to the Agency.

By setting out the minimum data requirements, the Committee is aiming to ensure that any emergency vaccine meets the high standards demanded in Europe, without prejudicing public and animal health.

The reflection paper can be found on the EMEA website at the following URL: emea.eu.int/pdfs/vet/iwp/4685306en.pdf

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