Second High-level meeting on Ebola vaccines access and financing

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