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WHO sets timeline for ebola vaccine

03 October 2014 | News | By BioSpectrum Bureau

 WHO has set up a milestone to be achieved in order to bring the vaccine to patients

WHO has set up a milestone to be achieved in order to bring the vaccine to patients

Singapore: From September 29-30, 2014, WHO organized an expert consultation to assess the groundwork of ebola vaccine development and concluded with an expected milestone to develop and launch the vaccines.

The panel of experts reiterated that to accelerate the assessment and licensure of the vaccines, randomized controlled trials could help in providing robust data, in the shortest amount of time, to judge whether a vaccine is safe and induces protection.

"Trials must be expedited, while preserving ethical and safety standards. Efficacy data of high quality must be gathered. Trials need to be carefully designed so that they concomitantly address the most important questions regarding safety, immunogenicity, and efficacy," the panel echoed.

Concluding the two day brain storming session, WHO has set up a milestone to be achieved in order to bring the vaccine to patients at fastest possible time.

October 2014: 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

October-November 2014: Agreed common protocols (including for phase 2 studies) across different sites must be developed

October-November 2014:
Preparation of sites in affected countries for phase 2 b should start as soon as possible

November-December 2014: Initial safety data from phase 1 trials will be available
January 2015: GMP (Good Manufacturing Practices) grade vaccine doses will be available for phase 2 as soon as possible

January-February 2015: 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.

 

 

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