Gavi's Vaccine Investment Strategy

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 purposes base case is shown as expanded EPI with booster scenario (midpoint between Imperial College and Swiss TPH model outputs) 11 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 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-2018

10 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 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 Three work streams under learning agenda to inform VIS 2018

2014 2018 Sept 2015 Sep 2017

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 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 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.) • Q4 2015 / Q1 2016: partner meeting to plan for VIS 2018 • Process and timelines • Metrics and inputs • Scope of potential investments • Key evidence gaps/needs

15 THANK YOU