ACCELERATING ACCESS TO EBOLA VACCINES AND COUNTRY PERSPECTIVE BOARD MEETING Seth Berkley, Robert Newman, Aurélia Nguyen 10-11 December 2014, Geneva www.gavi.org 0
AGENDA Process of generating Board recommendation 1 Funding landscape and Gavi capabilities 2 Four recommended areas for Gavi action 3 Financial implications 4 Risks 5 1
8-WEEK PROCESS TO GENERATE A BOARD RECOMMENDATION ON EBOLA RESPONSE Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Demand / supply analysis Analysis Options for Current and planned Financial requirements Gavi action partner activities Synthesised Board Potential financing structures recommendations Consultations Partners, donors, regulators, countries, manufacturers, and technical experts 30 External external review of draft experts Board paper 26 Sep: EC 4 Nov: Options 25 Nov: request to development Board paper CEO workshop finalised 2
WHERE CAN GAVI CONTRIBUTE? PARTNER LANDSCAPING AND GAVI CAPABILITY ASSESSMENT Fit with Gavi capabilities? Cost category Critical funding area Est. funding coverage (based on past experience, partner input) Phase I High Clinical t rials Phase II High Phase III High Production at clinical trial scale High Production Scale up / scale optimisation Medium scale up Commercial scale mfg Low Production & Procurement Vaccine procurement Medium procurement Risk mitigation Indemnification Medium Diverted Diverted manufacturer manufacturer Low resources resources Planning & coordination, social mobilisation , IEC , training, HR, transport /logistics/cold chain, Vaccine roll - out Medium waste management, surveillance and monitoring of AEFI , etc. Clinical trials Low Production scale up Low Future outbreak preparedness Procurement Low Vaccine roll - out Low 3
4 RECOMMENDED AREAS FOR GAVI ACTION # cases (illustrative) Potential future outbreak (magnitude Future outbreak unknown) with stockpile present Current outbreak 1 Time Production & Procurement funding 2 2 Funding vaccine roll-out Funding vaccine roll-out 3 Future outbreak preparedness 4 Recovery of health and immunisation systems 4
VACCINE PRODUCTION AND PROCUREMENT 1 ENVELOPE DRIVEN BY LEVEL OF UNCERTAINTY AND EVOLVING LANDSCAPE Procurement-related Recommendation: Envelope signaling Gavi potential spend principles ✓ 1 Utilises Gavi's multilateral mechanism to aggregate and Plan for high vaccine demand coordinate funding ✓ Signals a market for Ebola vaccine 2 Focus on alleviating bottlenecks to and related supplies vaccine availability ✓ Allows addressing of different demand scenarios in an evolving 3 environment Prioritise solutions that are candidate-agnostic ✓ Enables tailored agreements with individual manufacturers 4 ✓ Avoid prematurely locking into a Enables support of multiple market that is not fully understood manufacturers 5
VACCINE PRODUCTION AND PROCUREMENT 1 DETERMINATION OF ENVELOPE SIZE Key drivers of size of US $300 Key drivers of uncertainty around million envelope spend within envelope Actual demand Volume of vaccine Actual demand Up to anywhere from required to combat versus "high 12M courses <100K to >12M current outbreak demand" scenario courses 2-3 Different cost Manufacturer from Number of manufacturers structures, which vaccines are manufacturers (with different vaccine ultimately procured economics) technologies Marginal costs of Funding production and Level of subsidy for Manufacturer costs discussions still unsubsidized each manufacturer evolving scale up costs Funding structures within this envelope will be subject to EC approval 6
FUNDING VACCINE ROLL-OUT 2 BASED ON CURRENT DATA – DETAILED COUNTRY-LEVEL COSTING UNDERWAY Standard campaign A categories B Additional cost C Stockpile with Ebola-specific categories for Ebola cost categories vaccine roll-out cost multiplier assigned • Social mobilisation, • Emergency • Management of IEC 1 , advocacy Operations Centres stockpile • HR and training • Cold chain and • Operational costs logistics for use of • Vehicles and stockpiled courses • Security and crowd transportation in future outbreaks control • Waste management • Increased infection • Surveillance, including control measures for AEFI 2 • Evaluation US$ 38 M 3 US$ 7 M US$ 45 M 1. IEC: Information, education, and communication 2. Adverse Events Following Immunisation 3. Assuming target population of 12M individuals 7
FUTURE OUTBREAK PREPAREDNESS 3 Recommendation 1: Gaps remaining Recommendation 2: Stockpile of first- In-principle commitment to generation vaccines 2nd-generation stockpile • Relatively small • Assure availability of Profile of first generation stockpile required vaccine(s) expected to be effective vaccines for suboptimal for longer-term future outbreaks • To be maintained until application: • Monovalent vaccine • Vaccine availability 2nd generation vaccine • Thermostability concerns becomes available dependent on timing of vaccine development and optimisation Lack of longer-term availability of an effective Ebola vaccine could result in a repeat of the current situation 8
RECOVERY OF HEALTH AND IMMUNISATION 4 SYSTEMS Ebola has crippled health and Recommendations to support recovery immunisation systems (Upon country request) Vaccines and related injection up to 2013 DTP3 1 2014 DTP3 safety devices and programmatic US$ 12.5 M coverage coverage support No Reprogramming of currently additional approved HSS grants Guinea costs <50% 63% up to Increase of HSS funding US$ 30.5 M Liberia <50% 89% Waiving of 2014-15 co-financing up to requirements US$ 2 M Sierra up to Total <50% Leone US$ 45 M 92% 1. Coverage with 3rd dose of a DTP-containing vaccine 9
FINANCIAL IMPLICATIONS OF APPROVING RECOMMENDATIONS Recommendation per Board Paper US$ million Ebola Programme Funding Envelope (2015-2020) Ebola vaccine production and procurement 300 Ebola vaccine roll-out 45 Recovery of health and immunisation systems 45 Sub-total: Ebola Programme Funding Envelope up to 390 Addition to Business Plan budget (2015-2016) Secretariat costs 3.5 Support to WHO & UNICEF 7.0 Support to Civil Society Organisations 0.5 Sub-total: Addition to Business Plan Budget up to 11.0 Total cost of funding the recommendations up to 401 Less: Already provided in Gavi expenditure forecast for 2014-2015 (100) Additional resources required up to 301 Deduct: Resources from other funding agencies / donors TBD Balance to be funded through Gavi TBD 10
RISKS ASSOCIATED WITH RECOMMENDATIONS Risk Potential mitigation(s) Vaccine safety & acceptability not fully • Regulatory advice, WHO recommendation for use • Information to countries evaluated • Gavi investments contingent on WHO recommendation for Gavi investments have no impact on use current outbreak • Short-term agreements guided by WHO recommendations Gavi enters into sub-optimal agreements • Allow adjustments as situation evolves with manufacturers • Manufacturer transparency • Support health system recovery efforts • Plan carefully for vaccine roll out, commit sufficient funding Vaccines do not reach target populations for critical activities Gavi ill-suited to engage in emergency • Leverage existing Gavi mechanisms wherever possible response Human resource diversion hinders • Reprioritise current staff workloads • Hire dedicated staff to manage Ebola-related activities performance of other Gavi efforts • Seek incremental funding for Ebola activities from donors Financial resource diversion hinders who have already pledged resources for Ebola response performance of other Gavi efforts 1. See Section 4.2 of Board Paper for more details 11
THANK YOU www.gavi.org 12
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