Guidelines on the quality, safety and efficacy of dengue tetravalent vaccines (live, attenuated), Annex 2, TRS No 979

Overview

These Guidelines update the Guidelines for the production and quality control of candidate tetravalent dengue virus vaccines (live). They should be read in conjunction with other WHO guidelines that are referred to in each part. The Guidelines cover dengue tetravalent vaccines (live, attenuated). Other types of dengue virus vaccines under development (e.g. subunit or inactivated vaccines) are outside the scope of these Guidelines. However, some guiding principles provided in these Guidelines (e.g. Part C on clinical evaluation) may be useful for the evaluation of other types of dengue vaccine. For quality control, guiding principles applicable to other types of vaccines – such as inactivated or subunit vaccines – are available elsewhere if the product in development shares similar manufacturing processes. For example, guidelines for human papillomavirus and hepatitis B vaccines may also be useful for subunit vaccines for dengue.

These Guidelines are based on experience gained from candidate dengue tetravalent vaccines (live, attenuated) that have been developed as described below, and will need to be updated as new data become available from additional studies. Part A sets out guidelines for manufacture and quality control. Guidelines specific to the nonclinical and clinical evaluation and environmental risk assessment are provided in parts B, C and D, respectively. Part E provides guidelines for NRAs.

Full version of the WHO Technical Report Series N° 979