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Gavi’s Investment Strategy

Deepali Patel

THIRD WHO CONSULTATION ON GLOBAL ACTION PLAN FOR (GAP III) , , 15-16 November 2016

www..org Vaccine Investment Strategy (VIS)

Evidence-based approach to identifying new vaccine priorities for Gavi support

Strategic investment Conducted every 5 years decision-making (rather than first-come- first-serve) Transparent methodology

Consultations and Predictability of Gavi independent expert advice programmes for long- term planning by Analytical review of governments, industry evidence and modelling and donors

2 VIS is aligned with Gavi’s strategic cycle and replenishment

2011-2015 Strategic 2016-2020 Strategic 2021-2025 period period

2008 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

RTS,S pilot funding decision VIS #1 VIS #2 VIS #3 MenA, YF mass campaigns, JE, HPV stockpile, Mid 2017 : vaccine ‘long list’ , Rabies/cholera studies, Oct 2017 : methodology Typhoid Malaria – deferred Jun 2018 : vaccine shortlist conjugate Dec 2018 : investment decisions

3 VIS process

Develop Collect data Develop in-depth methodology and Apply decision investment decision framework for cases for framework with comparative shortlisted evaluation analysis vaccines criteria Phase I Narrow long list Phase II Recommend for Identify long list to higher priority Gavi Board of vaccines vaccines approval of selected vaccines

Stakeholder consultations and independent expert review

4 Evaluation criteria (VIS #2 – 2013)

Additional Health Implementation Cost and value impact impact feasibility for money considerations

Impact on child Capacity and supplier Vaccine procurement Epidemic potential mortality base cost1 Impact on overall Global or regional GAVI market shaping In-country mortality public health priority potential operational cost Impact on overall Ease of supply chain Procurement cost per Herd morbidity integration event averted2 Availability of Ease of alternative programmatic interventions integration Socio-economic and inequity safety Gender inequity Disease of regional importance

5 1. Procurement cost includes vaccine, syringe, safety box, and freight 2. Scoring based on cost per future death averted How was maternal assessed in VIS 2013? (I) Health Impact: Total future deaths averted per 100K vaccinated, 2015-2030

Value for Money: Cost per death averted, 2015-2030 (USD, ’000) How was maternal influenza vaccine assessed in VIS 2013? (II)

Benefits Challenges • Potentially high impact across 3 key • Uncertainty about data for and groups: pregnant women, foetuses, foetal mortality • Requires change in manufacturer • Opportunity to strengthen maternal production (from once a year to year- immunisation platform and Gavi's round) and/or change in stock management for once-yearly release contribution to maternal and child health • Low country demand (and understanding of disease burden) vis-à-vis other vaccine • Low cost per death averted priorities

Recommendations: • No funding window at this time • Monitor results of studies on fetal, neonatal and infant mortality • Evaluate implementation feasibility, logistics of seasonal vaccine supply, surveillance and strain matching, and optimal delivery strategies for pregnant women in the next VIS

7 A preliminary look at candidate investments in scope for consideration in VIS #3 (2018)

Returning candidates: Incremental investments: New: • RTS,S • Meningococcal multivalent • RSV • Dengue (conjugate) • Group B • Maternal influenza • Cholera (routine and/or Streptococcus extended stockpile) • Rabies PEP • Norovirus? • DTP booster • • ETEC? • birth dose • Typhoid conjugate • PCV catch-up • Hexavalent (penta/IPV) •

Data gathering to 2017 begin in 2017

8 Some key inputs needed for next VIS

Relevance/demand • Expected demand from Gavi-eligible countries over 10-15 year timeframe? • Priority vs. other (outstanding) vaccine introductions, other public health priorities, and available alternative interventions? Implementation & coverage • Likely strategy in Gavi-eligible countries? Eg, target population, dosing, schedule, national/sub-national • What coverage could realistically be achieved in the target population? • Key barriers to reaching the target population?

Impact • Efficacy, duration of protection, disease burden in Gavi countries? • Impact on inequity? Outbreak preparedness? Cost • Per dose or per target person cost range? Implementation costs?

9 THANK YOU

www.gavi.org Gavi-supported vaccines

*

Refers to theRefers first Gavi-supportedto the first Gavi-supported introduction introduction of each vaccine. of each vaccine.

*Contribution towards stockpile for outbreak response 2014-2018

11 Maternal influenza vaccine – VIS 2013 ‘scorecard’ Phase I Category VIS Criteria Phase I Indicator Evaluation 170,000 U5 future deaths averted, 2015 – 2030 Impact on child mortality 46 U5 future deaths averted per 100,000 vaccinated pop 200,000 total future deaths averted, 2015 – 2030 Health Impact on overall mortality 56 total future deaths averted per 100,000 vaccinated pop impact 5.8 million total future cases averted, 2015 – 2030 Impact on overall morbidity 1600 total future cases averted per 100,000 vaccinated pop No long term sequelae Epidemic potential No disruptive epidemic potential Global or regional public health priority No global or regional resolution on elimination or eradication Additional Herd immunity threshold of ~80% impact Availability of alternative interventions No alternative to prevent; case management to alleviate symptoms consid- erations Socio-economic inequity No disproportionate impact on poor Gender inequity Pregnant women are at higher risk of death and severe disease Disease of regional importance Disease burden distributed across GAVI countries Capacity and supplier base Current capacity meets >100% of GAVI demand; 20+ manufacturers by 2020 GAVI market shaping potential GAVI demand <10% of global demand Imple- Ease of supply chain integration Packed volume between 3 and 12 cc / dose (5.8 cc / dose) mentation Fully aligns with neonatal vaccine schedule, possible need for behavior Ease of programmatic integration feasibility change due to off-label vaccine use in pregnant women ~70% vaccine efficacy in adults; 63% in <6 month olds through transfer of Vaccine efficacy and safety protection from mother to child; no evidence of causal link to adverse events Vaccine procurement cost1 $490 million procurement cost to GAVI and countries, 2015 - 2030 Cost and value for In-country operational cost Low: routine delivery within health system, single dose $2400 procurement cost per death averted, $84 procurement cost per case money Procurement cost per event averted2 averted

12 1. Procurement cost includes vaccine, syringe, safety box, and freight 2. Scoring based on cost per future death averted