New vaccine technologies.

Abstract

New vaccine development for potential use in human medicine is buoyant. New science (genomics and proteomics) is presenting major new opportunities. New approaches (DNA vaccines, new combination vaccines, new formulations, novel delivery routes, new adjuvants) are being vigorously explored. New needs (defence vaccines) are being identified. One common element in all these varied areas is that pre-clinical evaluation of a candidate new vaccine is a pre-requisite before initiation of clinical trials in humans. Laboratory evaluation also usually continues during the clinical phase of vaccine development. Pre-clinical and laboratory evaluations often involve animals. Data from these studies are used to support an application for marketing authorisation. Regulatory Authorities use precedent to help assess these applications. Where no precedent exists the Regulatory Authorities apply risk-benefit analyses based on the perceived risks of a new product or process. These perceived risks are constantly reviewed as experience is gained. The World Health Organisation facilitates the development of scientific consensus on issues that have an impact on the quality and safety of biological medicines, including vaccines. New vaccine technologies often present new challenges for the safety and efficacy evaluation of candidate preparations. Animal models are usually very important in this process. The number of new vaccine candidates seems set to increase in the short-term.