Guidelines on the quality, safety and efficacy of Ebola vaccines, Annex 2, TRS No 1011

Overview

The unprecedented scale and severity of the Ebola virus disease (EVD) epidemic in West Africa in 2014–2016 led to calls for the urgent development and licensing of an Ebola vaccine. A considerable amount of work was subsequently undertaken over a short period of time and a series of international consultations held on related public health issues and on Ebola vaccine development, evaluation and licensing. The development of Ebola vaccines and implications for future immunization policy recommendations are being monitored by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization. In addition, as part of ongoing WHO measures to support the development of Ebola vaccines, guidance was prepared on the scientific and regulatory considerations relating to their quality, safety and efficacy.

This document provides information and guidance on the development, production, quality control and evaluation of candidate Ebola vaccines in the form of WHO Guidelines rather than WHO Recommendations. This allows for greater flexibility with respect to the expected future of Ebola vaccine development, production, quality control and evaluation. Given that this is a very dynamic field both in terms of technologies and clinical trial designs, these WHO Guidelines should be read in conjunction with other relevant recent guidelines.

Full version of  WHO Technical Report Series No. 1011