Annex 1 - WHO guidelines on non clinical evaluation of vaccines

Overview

Recent progress in biotechnology and basic immunology has led to the development of a broad range of novel vaccines raising exciting possibilities for the prevention of infectious diseases (2, 3). Improvements to already licensed vaccines are also being considered; such improvements will lead to new products as well as to the introduction of new adjuvants. However, the complexity and novelty of these products presents scientific and regulatory challenges because criteria for their safety, potency and quality assessment may not exist. Product diversity and new approaches, technologies and methodologies develop over time; therefore, judgement based on the best science available should always form the basis for deciding on the type and extent of nonclinical evaluation for these products.