Second High-level meeting on Ebola vaccines access and financing 8 January 2015 WHO headquarters, Executive Board Room Geneva, Switzerland Chair: Helen Rees, Chair of the WHO SAGE1 Ebola Vaccine Working Group Context The 2014 Ebola virus disease (EVD) outbreak is the largest and most complex Ebola outbreak on record, with an unprecedented number of affected countries, thousands of cases and deaths in the general population, and hundreds of infected health-care workers. The escalating scale and mortality of the outbreak has reinforced the urgent need for the accelerated development and availability of specific, effective medical interventions for EVD. The most advanced candidate Ebola vaccines will enter Phase III efficacy clinical trials in West Africa in January/February 2015, and – if shown effective – will be available for deployment a few months later. Objectives There are six main aspects of Ebola vaccine development and future use that will be addressed. Namely: - 1 Provide an update on the emerging safety and immunogenicity results of Phase I clinical trials; Review the candidate Ebola vaccines pipeline; Review manufacturers’ plans to extend the safety database (e.g. through Phase II evaluation); Review the status of preparation for Phase III efficacy trials in the three most affected West African countries; Provide an update on the decision of the Gavi Board to financially support the introduction of Ebola vaccines; Discussed possible decision-making processes for large-scale implementation. WHO Scientific Advisory Group of Experts AGENDA 08:30-09:30 Registration and coffee 09:30-09:45 Welcome address (Dr Margaret Chan Director General) Objectives of the meeting (Dr Helen Rees) 09:45-10:45 Session 1: Safety and immunogenicity results of Phase I clinical trials 09:45-10:15 10:15-10:45 ChAd3-ZEBOV vaccine rVSV-ZEVOV vaccine 10:45-11:00 General discussion Ripley Ballou, GSK Mark Feinberg, Merck Vaccines 11:00-12:20 Session 2: Review of Ebola vaccines in or close to phase 1 clinical evaluation 11:00-11:20 11:20-11:35 Ad-MVA prime boost vaccine Johan Van Hoof, J&J Recombinant Glycoprotein (GP) Nanoparticle Gregory Glenn, Novavax vaccine The Russian candidate Ebola vaccine Oleg Kiselev, Influenza Research Institute, St. Petersburg Other Ebola vaccine candidates Robin Robinson, US-HHS/BARDA General discussion 11:35-11:50 11:50-12:05 12:05-12:20 12:20-12:50 12:20-12:30 12:30-12:40 12:40-12:50 12:50-13:50 Session 3: Plans for extending the safety database beyond Phase 1 ChAd3-ZEBOV vaccine rVSV-ZEVOV vaccine Ripley Ballou, GSK Mark Feinberg, Merck Vaccines The joint AVAREF review process of Ebola Matthias Stahl, WHO clinical trial applications Lunch Break 13:50-15:45 13:50-14:10 14:10-14:35 Session 4: Preparation of Phase III efficacy trials The changing Ebola epidemic in the three John Edmunds, LSHTM most affected countries RCT trial in Liberia Elizabeth Higgs, US-NIH, for the Liberian USG Clinical Research Program 14:35-15:00 Stepped-wedge trial in Sierra Leone 15:00-15:25 Ring vaccination trial in Guinea 15:25-15:45 General discussion on timing and shared implementation challenges Samuel Kargbo, for the Sierra Leone - US-CDC collaboration Ana Maria Henao Restrepo, WHO, on behalf of the Guinea collaboration 15:45-16:15 Coffee Break 16:15-17:15 Session 5: Financing of Ebola vaccines and implementation of vaccination campaigns 16:15-16:35 16:35-16:55 16:55-17:15 17:15-17:30 Gavi planned investments into Ebola vaccines Seth Berkley, GAVI procurement and deployment From evidence to vaccination: proposed Jean-Marie Okwo-Bele, triggers and decision-making process WHO General discussion Conclusion and next steps