The Association of European Manufacturers of Autogenous Vaccines and Sera, EMAV, has published a comprehensive Manual of Autogenous Vaccines. This unique publication was prepared by well recognised scientists from veterinary universities in Europe, experienced veterinary experts and specialists from the circle of EMAV member companies.
The Manual covers the importance of Autogenous Vaccines (AV) for a modern vaccine portfolio and general aspects of their use including basic epidemiological aspects and a discussion of newly introduced terms like epidemiological unit and epidemiological link. Authors discuss specific keeping, management and production conditions influencing the use of AV for food producing animal species, small animals, Zoo animals and captive wildlife extensively and present pathogen-related examples for the production and application of AV in the veterinary practice today.
In the process of a harmonisation of manufacturing and use of AV by implementation of the Reg. (EU) 2019/6 a separate GMP criteria catalogue has to be developed for these products as a stand-alone document. Proposals for such a GMP guidance for AV have been published by EMAV and scientifically qualified by an international panel of experts in a symposium with IABS, the International Alliance for Biological Standardisation. Recommendations for the implementation of the new EU GMP standard for AV were formulated and published.
As soon as the new GMP manufacturing rules for AV become legally binding, these products will only be produced within the EU by manufacturers who hold a GMP certificate dedicated to AV. Such products can then be supplied directly to veterinarians in all member states by manufacturers holding the new EU GMP certificate. These vaccines are available only by prescription and it will be up to the prescribing veterinarian to assess whether animals belong to an epidemiological unit or to confirm the epidemiological link. It is precisely for this purpose that this Manual is also intended to provide assessment guidance.
The EMAV Manual for Autogenous Vaccines in available at EMAV e.V. - Publications from EMAV.