Gavi s Vaccine Investment Strategy

Transcription

1 Gavi s Vaccine Investment Strategy Judith Kallenberg, Head of Policy WHO Product Development for Vaccines Advisory Committee Meeting Geneva, Switzerland, 7-9 September

2 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

3 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 supported by GAVI Pipeline vaccines Potential expansion of GAVI vaccine support Cholera Malaria DTP (booster) Hepatitis A Dengue Hepatitis B (birth dose) Hepatitis E Enterovirus 71 Measles (additional campaigns) Influenza Mumps Poliomyelitis Rabies Meningococcal (additional serotypes) Yellow Fever (additional campaigns) 3

4 Evaluation criteria and indicators Category VIS Criteria Phase I Indicator Health impact Additional impact considerations Implementation feasibility Cost and value for money Impact on child mortality Impact on overall mortality Impact on overall morbidity Epidemic potential Global or regional public health priority Herd immunity Availability of alternative interventions Socio-economic inequity Gender inequity Disease of regional importance U5 future deaths averted, U5 future deaths averted per 100,000 vaccinated population Total future deaths averted, Total future deaths averted per 100,000 vaccinated population Total future cases averted, Total future cases averted per 100,000 vaccinated population Long-term sequelae Epidemic potential of disease Presence of global / regional (UN) resolution on elimination or eradication Herd immunity threshold Current use of alternative interventions for effective disease control (prevention and treatment) and potential for scale up Disproportionate impact on poor Disproportionate impact on one gender 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 Ease of supply chain integration Ease of programmatic integration Vaccine efficacy and safety GAVI demand (by volume) as % of global demand Packed volume (cm3) Alignment with other vaccine schedules and significant change in health worker practices/behavior required Vaccine efficacy (as defined by clinical endpoints) and safety Vaccine procurement cost 1 Total procurement cost to GAVI and countries, In-country operational cost Procurement cost per event averted 2 Incremental in-country operational costs per vaccinated person 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

5 Methodology for vaccine evaluation CONFIDENTIAL DRAFT Modelled vaccination scenarios 1. Identify vaccination scenarios Doses Routine target population Catch-up target population Legend Base case Alternative scenario 3 dose course in 1 month intervals 6 weeks old 5 to <18M 5 to < 18M N/A Excluded because less attractive / not feasible CONFIDENTIAL DRAFT Cumulative GAVI demand estimated to be ~610M doses through Develop demand forecast Demand (M doses) PPC_Malaria GAVI financed Country co-financed Graduated country financed Note: Includes demand from countries that graduate from GAVI support during (following GAVI supported introduction) Flu for IEC_March PPC_Dengue 15 v3.pptx Develop impact estimates 4. Develop cost estimates 5. Assess other disease/vaccine features

6 Methodology for vaccine prioritisation 6. Populate scorecards Health impact Cost Implementation feasibility Other considerations 7. Compare vaccines against selected criteria 6

7 Consultations identified 5 key criteria to drive initial prioritization in phase I Category Health impact Additional impact considerations Implementation feasibility Cost and value for money VIS Criteria Impact on child mortality Impact on overall mortality Impact on overall morbidity Epidemic potential Global or regional public health priority Herd immunity Availability of alternative interventions Socio-economic inequity Gender inequity Disease of regional importance Capacity and supplier base GAVI market shaping potential Ease of supply chain integration Ease of programmatic integration Vaccine efficacy and safety Vaccine procurement cost In-country operational cost Procurement cost per event averted Health impact (mortality and morbidity) most important Also consider epidemic diseases and value for money Verify additional benefits and implementation feasibility In phase II, the full scorecard will be (re)considered to inform final prioritization 7

8 Country level Global level 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 to add new visits for 5-17M age group Respondents emphasized that vaccine could not displace other malaria interventions Malaria vaccine may have impact comparable to Hib Question: Please indicate the statement(s) that most closely apply in your country # of responses Question: Please indicate the statement(s) that most closely apply in your country # of responses 150 Future deaths averted per 100k vaccinated , ,000 1, Rabies HPV Hep B Pneumo Hib Malaria Rota Yellow2 Fever 1. Based on deaths averted over ; 2. VIS only Disruptive epidemic potential (deaths averted less relevant metric) Vaccine duration of protection is biggest sensitivity of high impact Rubella Influenza Cholera Men A JE 24 Imperial College Base: 1.3M Swiss TPH Base: 960, Implementation would require managing possible 11 global supply shortage and communication needs 40 0 Feasible Challenging Challenging RTS,S is impt Vaccine and could be but beneficial and not add, but still would reduce Area of focus Unique implementation beneficial requirements desirable Unique need costs for other need for other interventions interventions Policies and WHO position TBD; few required GAVI policy changes currently Source: 2013 GAVI Phase II country consultation survey N/A processes foreseen; coordination with the GFATM required Note: question only posed to 136 respondents ranking malaria as first or second priority for introduction Supply Account for supply constraints through 2020 (impact likely small) No direct costs HR/training requirements for RTS,S similar to those for vaccines N/A Health workforce already in health system Manage risk to program credibility if efficacy lower than other Cost accounted Social mobilisation, vaccines in use (eg. rota) for in education, Additional training/social mobilisation/programmatic investments operational communication for initiating new routine visits for immunisation (expanded EPI costs 1 scenario only) Vaccine may Vaccine Vaccine reduce need would likely would have for other boost other no effect on interventions interventions other interventions 15 Note: Model outputs shown for Expanded EPI with booster scenario, for illustrative purposes; error bars Decay show highest rate against and lowest value generated by malaria sensitivity analyses and are driven by decay rate of protection; point infection estimate (1-5 represents years) midpoint of Imperial and Swiss TPH models No sensitivity analysis run Supply chain infrastructure and logistics Requirements for RTS,S similar to those for vaccines already in health system N/A Vaccine efficacy 50-60% Surveillance No unique surveillance requirements N/A Transmission (25% - 80% ITN & treatment coverage) Access to care (25% decrease or increase) -220 No sensitivity analysis run 163 No sensitivity analysis run Planning, coordination, integration Expanded EPI scenario would require infrastructure to support at least one additional touch point Manage potential for older (not eligible) age groups to present for vaccination (implications for forecasting in intro year) Coordinate with malaria control program to ensure vaccine does not undermine the use of other malaria interventions Focused organizational effort Eligibility of Nigeria Expected to be covered by GAVI Vaccine Introduction Grant, MoH, partners Unique but manageable May not be manageable in short term / within current GAVI model Future deaths averted ('000) Future deaths averted ('000) Note: For illustrative purposes base case is shown as expanded EPI with booster scenario (midpoint between Imperial College and Swiss TPH model outputs) 11

9 VIS lessons learned VIS process led to a set of defensible investment recommendations and consensus among key Gavi stakeholders Success factors: robust evidence-base; clear decision framework and full transparency of the process; active stakeholder engagement and consultation; independent expert validation of analyses Multi-step process with many qualitative and quantitative inputs; methodology evolved in the course of the process Evaluation criteria formed a framework to help facilitate comparison and prioritisation; ranking difficult: no single algorithm can do justice to the diverse considerations relevant for prioritisation Limited focus on DALYs and inability to conduct comprehensive CEA Critical and consistent evidence gaps for some vaccines: missed opportunities? 9

10 VIS 2008: Typhoid update 2008 VIS recommended a one-time catch up campaign targeting children 1-14 yo + routine immunisation of infants Assumptions: A TCV was expected to reach WHO PQ status in 2011; 24 countries projected to apply for typhoid vaccine support Taking stock: Timeline of lead conjugate (Bharat) PQ unclear Demand uncertainties SAGE review of TCVs in 2017/2018 Potential way forward: refresh investment case for typhoid in parallel to new VIS strategy Need to better understand (and generate) demand; engage with research community pre

11 VIS 2013: Malaria / rts,s next steps Gavi Board requested an updated assessment following conclusion of trials and SAGE recommendation Updated demand scenarios, impact estimates and comparison with impact of current Gavi vaccines Updated cost and value for money estimates Preliminary implementation approaches in coordination with the Global Fund (application process, M&E, etc.) December 2015 / June 2016: Gavi Board review of options for a possible role in supporting rts,s implementation 11

12 VIS 2013: updates on VIS learning agenda Cholera Evidence gaps: lack of vaccine effectiveness data for targeted vaccination strategy, unsure of demand and impact and programmatic feasibility Decision: global cholera vaccine stockpile contribution for epidemic response + research investment to understand role of OCV in endemic settings Rabies Evidence gaps: lack of understanding of burden, lack of ability to predict demand; equity and feasibility issues related to whether Gavi would need to support Rabies Immunoglobulines (risk issue), sustainability issues Decision: investment in research on feasibility of Gavi support for rabies vaccines 12

13 Three work streams under learning agenda to inform VIS Sept 2015 Sep Commission assessments Implement Assessments Assessments inform 2018 VIS Cholera: Cost-efficient strategies for OCV use in endemic settings Rabies 1: Evaluate the feasibility and logistic requirements of increasing access to post-exposure prophylaxis rabies vaccination in existing programmatic experiences Rabies 2: Estimate (vaccine-preventable) rabies burden and vaccination impact in endemic Gavi countries

14 Planned activities for learning agenda Cholera 1. Mass campaign in 1-14yo in endemic setting in Bangladesh; focus on feasibility/coverage 2. 5-year and age-specific VE and impact in Haiti (TBC) Rabies 1. Prospective burden and impact measurement in Chad, Mali, Cote d Ivoire 2. Leverage existing country data to strengthen disease burden estimates and descriptive analysis of existing program management, with a focus on Asian countries

15 Next steps for VIS 2018 Explore typhoid conjugate vaccine research engagement Implement learning agenda for cholera and rabies Monitor other vaccine developments (influenza, RSV, etc.) Q / Q1 2016: partner meeting to plan for VIS 2018 Process and timelines Metrics and inputs Scope of potential investments Key evidence gaps/needs 15

16 THANK YOU