Guidelines for the production and quality control of candidate tetravalent dengue virus vaccines (live). Annex 1, TRS No. 932, 2006

Overview

Full version of WHO Technical Report Series, No. 932, 2006

This document provides guidance to national regulatory authorities (NRAs) and vaccine manufacturers on the production and quality control of candidate live attenuated dengue virus vaccines by outlining the international regulatory expectations for product characterization. It should be read in conjunction with the WHO guidelines on nonclinical evaluation of vaccines (1), and the WHO guidelines on clinical evaluation of vaccines: regulatory expectations (2), to gain an understanding of the whole process of vaccine evaluation. Clinical evaluation of vaccines against dengue presents special challenges and WHO has developed specific guidance on clinical testing programmes (3), which should also be consulted. As candidate live attenuated dengue virus vaccines are still under development, the following text is presented in the form of guidelines rather than recommendations. Guidelines allow greater flexibility than recommendations with respect to expected future developments in the field. The document is thus provided for guidance to health administrators.