M72/AS01E Tuberculosis Vaccine Candidate - consensus-generating consultation on the development pathway

Overview

On 30-31 July 2019, the WHO convened in Geneva a meeting to generate consensus on the clinical development pathway for the M72/AS01E tuberculosis (TB) vaccine candidate developed by GSK. This meeting is a follow-up to the high-level consultation on accelerating the M72/AS01E TB vaccine, held in Geneva on 5 April 2019 and convened in light of the significant degree of protection provided by this vaccine against the development of active TB disease among adults with latent Mycobacterium tuberculosis (Mtb) infection (LTBI) in a phase 2b trial conducted in South Africa, Kenya and Zambia. The point estimate of vaccine efficacy after at least two years of follow-up following vaccination was 54% (90% CI, 14-75; P = 0.04).

The meeting on 5 April 2019 highlighted a lack of consensus on the clinical development pathway forward. The purpose of this new consultation was to generate consensus recommendation about next steps and regulatory development strategic options for further development of the M72/AS01E vaccine candidate. This plan should then be conveyed to developers and funders. A forum for WHO to present its recommendations to funders is planned to be organized in the late 2019.