The production and control of these autogenous vaccines is not under European regulation but national ones with different levels of requirements including the pharmacovigilance system. At the same time, the production and use of autogenous vaccines has evolved from strictly national production and use to a cross border approach: isolates are sent to manufacturers in another EU member state. Moreover, autogenous vaccines are used in epidemiological links, which describes vaccination of young animals using antigens that are isolated from sites where they will be housed at older age. The current legislation does not cover this situation. Variable national regulations, multi national organisation of the supply and absence of clear definitions of use lead to uncertainty and confusion in the field as well as to questions on the quality and safety of the autogenous vaccines used in farms.
The purpose of this conference is to start from an overview on the current situation and needs from the perspective of regulators, scientists, manufacturers and the end-user (veterinarians). The main focus will be on food producing animals, including fish. Further, proposals will be presented for a harmonized approach which will lead to a better understanding of the rational for the intended use, better knowledge on the nature of isolates and improved production and quality of the final products. In addition, advanced techniques and methods will be presented and discussed to identify and propagate isolates, to upgrade production and to quickly estimate safety and even efficacy of autogenous vaccines by in vitro methods.
Recommendations will be drafted on how to improve the EU-legislation and communication between the EU-Member States on autogenous vaccines and on ways to increase transparency on quality and safety of the vaccines.
The meeting is sponsored jointly by the University of Gent-PROVAXS, Belgium and IABS-EU (International Alliance for Biological Standardization for Europe). Lyon, France. IABS-EU is the European Affiliate of IABS (International Alliance for Biological Standardization).
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