The World Health Organization held a conference to assess the status of testing and eventual licensing of two candidate Ebola virus vaccines. The agenda and list of participants and the final report are available. I was interested in the following list of key expected milestones:
Mechanisms for evaluating and sharing data in real time must be prepared and agreed upon and the remainder of the phase 1 trials must be started
Agreed common protocols (including for phase 2 studies) across different sites must be developed
Preparation of sites in affected countries for phase 2 b should start as soon as possible
Initial safety data from phase 1 trials will be available
GMP (Good Manufacturing Practices) grade vaccine doses will be available for phase 2 as soon as possible
Phase 2 studies to be approved and initiated in affected and non-affected countries (as appropriate)
As soon as possible after data on efficacy become available:
Planning for large-scale vaccination, including systems for vaccine financing, allocation, and use.
I wonder how a phase 2 study will be conducted, the goal of which is to determine if it is effective and further evaluate its safety. Will this be done in west Africa, where protection against Ebola virus infection can be assessed? If so, will there be controls who receive placebo?
If indeed an Ebola virus vaccine is our best hope in limiting the current outbreak, it won’t be distributed for a while, according to the optimistic expectations of WHO – assuming all proceeds on time, and that the results are favorable.