Autogenous Vaccines: Quality of production and movement in a common market (by IABS)

There is a lack of vaccines ad us vet, as the existing licensing procedures within EU are demanding concerning the scientific requirements, the length, costs and complexity of procedures. Therefore, vaccines manufacturers tend to focus on the licensing and manufacture of products that have defined development pathways, demonstrated veterinary need, and reasonable expectations for a return on investment. As a consequence the market for autogenous vaccines to meet “niche” customer needs increased despite a minimally-regulated situation, especially in terms of manufacturing quality. There is no mutual recognition of GMP or GMP like certificates. Vaccination in general and in particular autogenous vaccines contribute to the use and reduction of antibiotics in food producing animals.

There are no harmonised provisions concerning the manufacture and control of autogenous vaccines, not to mention the non communication and non information of authorities concerning the movement of vaccines and vaccinated animals within the EU and beyond.

First attempt to harmonise some requirements was the CMDv paper on this item and now the revision of the vet legislation in EU.

The meeting is intended to initiate productive conversations with manufacturers, competent authorities and users to develop a draft proposal how to form a common market which will improve overall disease control in the community, especially for diseases that suffer from a lack of conventionally-authorised products. The proposal should support the efforts of the French and Czech EU-Presidencies in 2022.

Key items will be: GMP /GMP-like requirements,  mutual recognition of inspections, import and export of autogenous vaccines, relevance and impact on diagnostics and the information on vaccinated animals whenever they are moved to allow an epidemiological surveillance.