Towards fewer animal tests for quality control of vaccines

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Mar 17, 2011
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'The consistency approach for quality control of vaccines – a strategy to improve quality control and implement 3R'. Report from the meeting (11-12 January 2010, Brussels, Belgium)

The European Centre for Validation of Alternative Methods (ECVAM), together with the European Partnership for Alternative Approaches to Animal Testing (EPAA) organized a joint workshop on the consistency approach, and its potential to reduce the number of animal tests used in the quality control of human and veterinary vaccines. The meeting brought together experts from Europe and North America, representing regulatory bodies, competent authorities for vaccine licensing, vaccine manufacturers, academia and animal welfare.

Vaccines can be difficult to characterize due to the complexity and variable heterogeneity of the molecular structure of their active components. Therefore regulators require that quality control is performed on each batch/lot of vaccine, before it is placed on the market. Such tests often involve animal tests. 

The consistency approach, discussed during the meeting, means that a vaccine is thoroughly characterized during its development. It is based on a principle that the quality of the final batch of vaccine is a consequence of the strict application of a quality system throughout the whole vaccine production process.  The participants of the meeting discussed the possibility of introducing this approach into established vaccine production, where it has a potential of replacing in vivo tests.

The report indicates further developments for this approach, and emphasizes the continuing need for co-ordination and harmonization. It also gives recommendations for work to be undertaken in order to encourage acceptance an implementation of the consistency approach. EPAA will follow up the recommendations of the workshop report and will launch its committee on the consistency approach on 7 April 2011

Read more:

Meeting report: 'The consistency approach for quality control of vaccines – A strategy to improve quality control and implement 3Rs,' by F. De Mattia, J.-M. Chapsal, J. Descamps, M. Halder, N. Jarrett, I. Kross, F. Mortiaux, C. Ponsar, K. Redhead, J. McKelvie and C. Hendriksen, Biologicals. Volume 39, Issue 1, January 2011, Pages 59-65.

doi:10.1016/j.biologicals.2010.12.001