Annex 2 - WHO guidelines on non clinical evaluation of vaccines

Overview

These Guidelines are intended to provide guidance to NRAs and manufacturers on the nonclinical and initial clinical evaluation of vaccine adjuvants and adjuvanted vaccines by outlining international regulatory expectations in this area. The Guidelines should be read in conjunction with existing WHO guidelines on nonclinical and clinical evaluation of vaccines. There is substantial diversity among vaccine adjuvants and adjuvanted vaccines and their nonclinical and clinical testing programmes will depend upon product-specific features and their clinical indications. Therefore, the following text is written in the form of WHO Guidelines instead of Recommendations. Guidelines allow greater flexibility than Recommendations with respect to specific issues related to particular adjuvanted vaccines