Carmen Jungbäck Livres

The International Scientific Workshop on Potency Testing of Veterinary Vaccines for Animals took place in Langen, Germany, in December 2010. Before market release, inactivated vaccines are primarily tested in vivo using laboratory animals. Recent efforts have focused on modifying these tests to reduce animal use and stress (Refinement) or replacing them with in vitro methods. Acceptance of these alternatives varies among vaccine manufacturers and regulatory authorities, leading to hesitance in adopting new testing methods. The workshop aimed to advance this field, attracting over 130 participants from industry, academia, and regulatory bodies across 22 countries. Discussions included the current state of replacing in vivo tests, highlighting successful implementations and ongoing challenges. The advantages and disadvantages of existing replacement strategies were examined, and proposals for ensuring the quality of veterinary immunology medicinal products (IVMPs) were presented. The workshop identified hurdles to implementing the 3Rs in potency testing for inactivated veterinary vaccines and proposed a roadmap for future steps toward in vitro testing.

Throughout the world, ‚traditional‘ vaccines have been developed to help control animal diseases. The majority are licensed or registered under a standard set of provisions developed by regulatory authorities. However, there are animal health situations, such as minor species use or minor indications (MUMS), where traditional vaccines have not always been available, or products have not performed as expected, and alternatives such as autogenous/autologous vaccines are sought. Vaccines for MUMS and autologous/ autogenous vaccines therefore present unique licensing and registration issues and are not always allowed by regulatory authorities. This volume presents the proceedings of a meeting held in Langen, Germany, in October 2003, which provided a platform for the exchange of regulatory and field experiences in the USA and Europe. Intense discussions led to conclusions which formed the basis on which, in the wake of this meeting, standards for autologous/autogenous vaccines and products for MUMS can be revised. We have come one step closer to our aim of making sure that even for smaller market segments vaccines of all kinds and in good quality are available. In the meantime, further action for the realization of this aim is ongoing in different committees.