Vaccine potency test

Authors:

Coenraad FM. Hendriksen

Publication:

Expert Review of Vaccines 8, 313-322

Publish Date:

09 January 2014

Background

Traditional vaccine potency testing in research and development and preclinical testing has largely relied on animal models, which involve immunising and then challenging laboratory animals. While these models have been vital for demonstrating vaccine efficacy, their use is increasingly questioned due to issues with relevance, reliability, cost, and ethics.

Summary

This paper reviews the evolution of vaccine potency testing, highlighting the shift from traditional animal-based immunisation-challenge models to alternatives. It discusses how these alternatives, which include modifications to existing in vivo tests, serology-based methods, and in vitro antigen quantification, aim to refine, reduce, or replace animal use.

Key Actions

Wherever possible, replace or reduce the number of animals needed by using in vitro or other alternatives, such as the consistency approach.

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Further questions

New vaccine testing methods improve animal welfare through various refinement, reduction and replacement strategies. This includes modifying existing in vivo tests by incorporating more humane endpoints or using serology instead of direct challenge procedures. Developing in vitro antigen-quantification tests and adopting a ‘consistency approach’ in quality control, which relies on in vitro analytical tools and quality systems, further reduces and refines the need for live animal testing.
The UK National Centre for the 3Rs (NC3Rs) is leading a project to review animal use requirements within the WHO biologics guidelines. This initiative aims to review current animal tests and identify opportunities for implementing the 3Rs and alternative testing methods. Following an initial review, the NC3Rs launched a new project, funded by the Bill & Melinda Gates Foundation, to accelerate the global adoption of non-animal testing. This effort seeks to reduce the millions of animals used annually, alleviate financial burdens, save time and facilitate faster access to cheaper biological products worldwide.

Authors

Coenraad FM Hendriksen - Netherlands Vaccine Institute