Gavi’s Vaccine Investment Strategy Judith Kallenberg, Head of Policy WHO Product Development for Vaccines Advisory Committee Meeting Geneva, Switzerland, 7-9 September 2015 www.gavi.org Vaccine Investment Strategy (VIS) Evidence-based approach to identifying potential new vaccine priorities for Gavi support • Evidence review, analyses, stakeholder consultations, independent expert advice 2008 VIS: • HPV, rubella, JE, typhoid 2013 VIS: • Expanded support for yellow fever campaigns • Time-limited contribution to global cholera stockpile • Learning agenda: rabies and cholera studies to fill evidence gaps • Malaria vaccines to be re-assessed in 2015/16 2 VIS process (phase 1) 1. WHO ‘landscape analysis’ of vaccines in scope: anticipated licensure within next 5 years 2. Development of prioritisation criteria through Gavi stakeholder consultations 3. Assessment of vaccines against criteria 4. Development vaccine shortlist for in-depth analysis 2013 vaccines considered: Existing vaccines not ‘Pipeline’ Potential expansion of supported by GAVI vaccines GAVI vaccine support Cholera Malaria DTP (booster) Hepatitis A Dengue Hepatitis B (birth dose) Hepatitis E Enterovirus 71 Measles (additional campaigns) Influenza Meningococcal (additional serotypes) Mumps Yellow Fever (additional campaigns) Poliomyelitis Rabies 3 Evaluation criteria and indicators Category VIS Criteria Phase I Indicator U5 future deaths averted, 2015 – 2030 Impact on child mortality U5 future deaths averted per 100,000 vaccinated population Total future deaths averted, 2015 – 2030 Health Impact on overall mortality Total future deaths averted per 100,000 vaccinated population impact Total future cases averted, 2015 - 2030 Impact on overall morbidity Total future cases averted per 100,000 vaccinated population Long-term sequelae Epidemic potential Epidemic potential of disease Global or regional public health priority Presence of global / regional (UN) resolution on elimination or eradication Additional Herd immunity Herd immunity threshold impact Current use of alternative interventions for effective disease control (prevention and Availability of alternative interventions consid- treatment) and potential for scale up erations Socio-economic inequity Disproportionate impact on poor Gender inequity Disproportionate impact on one gender Disease of regional importance Burden concentrated in a subset of GAVI countries within the same region Capacity and supplier base Capacity to meet GAVI demand and # of manufacturers by 2020 GAVI market shaping potential GAVI demand (by volume) as % of global demand Implement- ation Ease of supply chain integration Packed volume (cm3) Alignment with other vaccine schedules and significant change in health worker feasibility Ease of programmatic integration practices/behavior required Vaccine efficacy and safety Vaccine efficacy (as defined by clinical endpoints) and safety Cost and Vaccine procurement cost1 Total procurement cost to GAVI and countries, 2015 - 2030 value for In-country operational cost Incremental in-country operational costs per vaccinated person money Procurement cost per event averted2 Procurement cost per death / case averted 1. Procurement cost includes vaccine, syringe, safety box, and freight 2. Scoring based on cost per future death averted Methodology for vaccine evaluation CONFIDENTIAL DRAFT Modelled vaccination scenarios 1. Identify vaccination scenarios Doses Routine target Catch-up target Legend population population Base case Alternative scenario 6 weeks old 5 to <18M Excluded because less attractive / not feasible CONFIDENTIAL DRAFT 3 dose course in 1 month intervals Cumulative GAVI demand estimated to be 5 to < 18M N/A ~610M doses through 2030 2. Develop demand forecast Demand (M doses) 200 1 0 150 0 0 PPC_Malaria 10 100 198 152 2 0 50 1 0 60 3 0 0 0 1 1 1 41 3 4 4 5 6 0 0 21 20 20 19 18 0 0 0 12 0 0 16 0 0 0 0 0 0 0 1 0 1 0 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 GAVI financed Country co-financed Graduated country financed Note: Includes demand from countries that graduate from GAVI support during 2015-2030 (following GAVI supported introduction) Flu for IEC_MarchPPC_Dengue 15 v3.pptx 15 5. Assess other disease/vaccine features 3. Develop impact 4. Develop cost estimates estimates Methodology for vaccine prioritisation 6. Populate scorecards • Health impact • Cost • Implementation feasibility • Other considerations 7. Compare vaccines against selected criteria 6 Consultations identified 5 key criteria to drive initial prioritization in phase I Category VIS Criteria Health impact (mortality and Impact on child mortality Health morbidity) most important Impact on overall mortality impact Impact on overall morbidity Also consider epidemic diseases and Epidemic potential value for money Global or regional public health priority Herd immunity Additional impact Availability of alternative interventions considerations Socio-economic inequity Gender inequity Disease of regional importance Capacity and supplier base GAVI market shaping potential Implementation . Verify additional benefits and Ease of supply chain integration feasibility implementation feasibility Ease of programmatic integration Vaccine efficacy and safety . In phase II, the full scorecard will be (re)considered to inform final prioritization Vaccine procurement cost Cost and value In-country operational cost for money Procurement cost per event averted 7 VIS process: phase 2 (~6 months) 1. Further, in-depth assessment of shortlisted vaccines 2. Comparison with current Gavi portfolio to determine value-add 3. Independent expert validation of analyses 4. Country consultations 5. Development of investment recommendations Country openness to new schedule and awareness that vaccine cannot replace other interventions Respondents positive on ability Respondents emphasized that vaccine could not to add new visits for 5-17M age group displace other malaria interventions Question: Please indicate the Question: Please indicate the statement(s) that statement(s) that most closely most closely apply in your country apply in your country Malaria vaccine may have impact # of responses # of responses 80 150 comparable to Hib 76 60 102 52 Future deaths averted per 100k vaccinated1 100 5,000 1,500 40 1,000 Disruptive epidemic potential 50 (deaths averted less relevant metric) Implementation would require20 managing possible 800 768 11 14 11 6 668 3 global supply shortage and0 communication needs0 576 Feasible Challenging Challenging RTS,S is impt Vaccine Vaccine may Vaccine Vaccine 600 541 and could be but beneficial and not add, but still would reduce reduce need would likely would have Area of focus Unique implementationbeneficial requirementsdesirable Unique needcosts for other need for other for other boost other no effect on interventions interventions interventions interventions other Policies and . WHO position TBD; few required GAVI policy changes currently interventions . N/A 400 Vaccine duration of protection is biggest processes foreseen; coordinationSource: 2013 with GAVI the Phase GFATM II country required consultation survey Note: question only posed to 136 respondents ranking malaria as first or second priority for introduction 15 level sensitivity of high impact Global Supply . Account for supply constraints through 2020 (impact likely small) . No direct costs 198 200 147 . HR/training requirements for RTS,S similar to those for vaccines . N/A Health workforce already in health system 63 45 31 29 24Imperial College Swiss TPH . Manage risk to program credibility if efficacy lower than other . Cost accounted 0 Social mobilisation, vaccines in use (eg. rota) for in Rabies HPV Hep B Pneumo Hib Malaria Rota Yellow2 Rubella Influenza Cholera Men A JE education, . Additional training/social mobilisation/programmatic investments operational Fever Base: 1.3M Base: 960,000 communication for initiating new routine visits for immunisation (expanded EPI costs1 1. Based on deaths averted over 2015-2030; 2. VIS only scenario only) Note: Model outputs shown for Expanded EPI with booster scenario, for illustrative purposes; error bars Decayshow highestrate against and Supply chain -528 229 No sensitivity analysis run . Requirements for RTS,S similar to those for vaccines already in lowest value generated by malaria sensitivity analyses and are driven by decay rate of protection; point infectionestimate (1 represents-5 years) infrastructure and . N/A midpoint of Imperial and Swiss TPH models health system 7 logistics Vaccine efficacy 50-60% -155 122 -125 124 Country level Surveillance . No unique surveillance requirements . N/A . Expanded EPI scenario would require infrastructure to support at Transmission (25% - 80% ITN least one additional touch point . Focused -220 163 No sensitivity analysis run Planning, & treatment coverage) . Manage potential for older (not eligible) age groups to present for organizational coordination, vaccination (implications for forecasting in intro year) effort integration . Coordinate with malaria control program to ensure vaccine does Access to care (25% No sensitivity -66 61 decrease or increase) analysis run not undermine the use of other malaria interventions May not be manageable in short Eligibility of 1. Expected to be covered by GAVI Vaccine -315 -227 Unique but manageable Nigeria Introduction Grant, MoH, partners term / within current GAVI model 16 -600 -400 -200 0 200 400 -600 -400 -200 0 200 400 Future deaths averted ('000) Future deaths averted ('000) Note: For illustrative