Alternative Test Methods & Biologicals/Vaccines

Biologicals are products derived from biological sources, including immunobiologicals (such as vaccines and sera), hormones, and blood products. These type of products must undergo strict quality control before use in human or veterinary applications. Vaccines are recognised as a highly cost effective tool for preventing infectious diseases. Their importance is likely to increase in the future given the emergence of antibiotic-resistant strains of bacteria, viral infections, as well as the high incidence of infections in large livestock industries etc.

Traditionally, laboratory animals have played a major role in quality control of vaccines. Still, many laboratory animals used in Europe are required for testing the safety and potency of batches of vaccines for veterinary and human application.

Declining use of animals

Despite the increasing use of vaccines, the number of animals used for quality control is likely to decrease in the near future. The concept of vaccine quality control is changing as emphasis is being put on ensuring the consistency of production of a vaccine and not regarding each batch produced as a unique product. The characteristics of a new batch of a vaccine should be similar to those of a batch which has been shown to be safe and efficacious.

Over the last two decades, many alternative methods to classical animal tests for the quality control of vaccines have been developed and successfully implemented. New generations of vaccines are being developed which are better defined and allow the use of in vitro and physico-chemical methods for their quality control, thus using less or no animals for the quality control of batches.

The Institute for Health and Consumer Protection (IHCP) is host to the EU’s principal organisation for the scientific validation of alternative methods to animal testing – EURL ECVAM, the European Union Reference Laboratory the Validation of Alternative Methods, formally established in 2011. EURL ECVAM has inherited the specific competence of the former European Centre for the Validation of Alternative Methods (ECVAM), a policy action within the Joint Research Centre of the European Commission, which coordinated the validation of alternative approaches to animal testing in the European Union since 1991.

EURL ECVAM has a long tradition in the development and validation of methods which replace, reduce or refine (the 'Three Rs') the use of animals. Research laboratories across the EU are able to submit alternative methods which they have developed for scientific validation by EURL ECVAM.

The former ECVAM has been involved as sponsor, coordinator and participating laboratory in a number of pre-validation and validation studies on alternative methods for the quality control of human vaccines and veterinary vaccines. ECVAM also contributed financially to the compilation of manuals and expert reports, and organised training in test methods. Recent activities focussed on the consistency approach and its possible use for established vaccines. Moreover, ECVAM organised a total of 11 workshops and published workshop reports on the use of alternative methods for the quality control of vaccines, antibodies and hormones.