Gavi Unicef Vaccine Industry Consultation. Dominic Hein Market Shaping / Gavi. October Reach every child

Transcription

1 Gavi Unicef Vaccine Industry Consultation Dominic Hein Market Shaping / Gavi October 2018 Reach every child

2 Gavi commitments to countries US$ billion committed since 2001 New and underutilised vaccine support (NVS) US$ 10,263 million 75.1% US$ billion Health System Strengthening (HSS) US$ 2,035 million 14.9% Operational support US$ million 3.8% Immunisation Services Support (ISS) US$ 361 million 2.6% Vaccine introduction grant US$ million 1.4% CCEOP US$ million 0.9% Injection safety support (INS) US$ million 0.8% Civil society organisations (CSOs) US$ 29.4 million 0.2% Graduation Grant US$ 13.6 million 0.1% HPV Demo - cash support US$ 6.2 million 0.05% Product Switch Grant US$ 2.8 million 0.02% Ebola EPI Recovery Plan US$ 12.7 million 0.09%

3 Projected Gavi vaccine expenditure % of vaccines support expenditure on three vaccines (penta, pneumo, rota) Total supported doses* billion Total vaccine expenditure** US $ billion Pneumo (Gavi & AMC-funded) US $ billion (45%) Rotavirus US $ 727 million (13%) Pentavalent US $ 622 million (11%) Human Papillomavirus US $ 314 million (6%) Measles- Rubella US $ 304 million (5%) Yellow Fever US $ 304 million (5%) IPV US $ 284 million (5%) Meningitis A US $ 214 million (4%) Typhoid US 65 million (1%) Japanese Encephalitis US 21 million (0.4%) Source: Financial Forecast v15, Nov 2017 *Includes Gavi-funded doses plus co-financed doses (expect for 2016 where dose figures do not include co-financed doses) **Included Gavi-funded expenditure only Other vaccines US $ 230 million (4%)

4 Country share of vaccine costs Gavi s co-financing policy prepares countries for self-financing and financial sustainability Purpose: To enhance ownership and put countries on a trajectory towards financial sustainability to prepare for phasing out of Gavi support 100% of vaccine cost Fully selffinancing Initial self-financing Preparatory transition Accelerated transition Manufacturers commitments to fully-transitioned countries Years (variable duration) WB Low-income country threshold (variable duration) Phase 1 Eligibility threshold (5 years) Phase 2 (5 years) Access to Gavi / UNICEF tenders End of Gavi financing Increasing GNI per capita Countries pay US$0.20/dose. No annual increase in co-financing Co- financing becomes linked to price. Countries increase their contribution from the starting fraction by 15% a year Linear increase over 4 years to full co-financing Governments independently financing vaccines Note: For countries in accelerated transition phase, the liner increase in co-financing is applicable for renewal of vaccine support. The co-financing support for new vaccines is currently under discussion.

5 Countries completing Gavi support Pre Currently transitioning Albania Ukraine China Bhutan Honduras Mongolia Guyana Indonesia Kiribati Angola Armenia Bolivia Georgia Timor Leste India Lao PDR Nicaragua Sao Tomé and Principe Solomon Islands Bosnia and Herzegovina Turkmenistan Sri Lanka Moldova Azerbaijan Congo Rep. Cuba Nigeria Papua New Guinea Uzbekistan Vietnam Before Gavi Transition Policy

6 22 introductions achieved so far in 2018 Moldova IPV routine Uzbekistan IPV routine Kyrgyzstan IPV routine Mauritania MR routine (1 st D) MR campaign Sierra Leone IPV routine Liberia Measles campaign Togo MR campaign Ghana IPV routine Côte d Ivoire MR routine (1st D) MR campaign Angola MR campaign Rwanda IPV routine Afghanistan Rota routine Zimbabwe HPV routine HPV campaign Tanzania HPV routine IPV routine Mozambique MR campaign Tajikistan IPV routine Myanmar JE routine Indonesia JE campaign Introductions to 4 June 2018

7 Installations of Cold Chain Equipment in first 2 countries / 11 deployments to be complete in CCEOP deployment plan 2 deployments complete or ongoing Haiti (complete) DRC (ongoing) > 24,800 refrigerators installed by end of 2018 > 72,200 by deployments to be complete by end of 2018 Pakistan Kenya Djibouti S. Sudan Niger Sierra Leone Liberia Uganda Malawi 23 deployments to start in 2018 and continue until 2022 Guinea Togo Tanzania Cameroon Eritrea Vietnam Myanmar Kyrgyzstan Ethiopia Somalia Rwanda Solomon Islands PNG CAR Côte d Ivoire Gambia Nepal Benin Mauritania Uzbekistan Burkina Faso Senegal Madagascar

8 Vaccine Investment Strategy (VIS) Through the Vaccine Investment Strategy (VIS), Gavi determines which vaccine support programmes are made available to countries. VIS Phases: Evaluation Criteria & Vaccine Shortlisting Board decision on new decision framework (Nov 2017). Analysis of WHO landscape vaccines for Board decision on shortlist (Jun 2018) VIS Phase: Vaccine Investment Cases In-depth analysis of shortlisted vaccines and Dec 2018 Board decision A new strategy is developed every 5 years when Gavi takes stock of available and expected vaccines and sets new priorities through in-depth analysis and widespread consultations

9 The VIS 2018 process began in spring 2017 and will continue until the end of 2018 Stakeholder consultations SC (Sept) SC call (Jan) SC (Mar) SC (Sept) Board (June) PPC (Oct) Board (Nov) PPC (May) Board (Jun) PPC (Oct) Board (Nov) Endemic Criteria Short-list Epidemic Technical Briefing Approach Criteria & Approach Investment Decisions Polio Considerations Scenarios SC = Steering Committee PPC = Programme & Policy Committee 9

10 Financial implications: Ranking criteria: Secondary criteria: Evaluation framework for vaccines for endemic disease prevention Criteria Health impact Value for money Equity and social protection impact Proposed indicators Total future deaths averted , and per 100,000 vaccinated Total future cases averted , and per 100,000 vaccinated Vaccine procurement cost per death averted Vaccine procurement cost per case averted Disproportionate impact of disease on vulnerable groups Special benefits of vaccination for women and girls Direct medical cost averted Economic impact Indirect cost averted Epidemic potential of disease Global health security impact Impact of vaccination on antimicrobial resistance (AMR) Criteria Other impact Gavi comparative advantage Implementation feasibility Proposed indicators Total U5 deaths averted , and per 100,000 vaccinated Total DALYs averted , and per 100,000 vaccinated Vaccine procurement cost per DALY averted Degree of vaccine market challenges Potential for Gavi support to catalyse additional investment Ease of supply chain integration Need for health care worker behaviour change Feasibility of vaccination time point Acceptability in target population Long-term financial implications Optimal use of current and future alternative interventions Alternate interventions (prevention and treatment) Broader health system No specific indicator evaluated case-by-case benefits Vaccine cost Total procurement cost to Gavi and countries, Operational cost Additional implementation costs Incremental in-country operational costs per vaccinated person Additional costs for introduction Evaluation criteria for vaccines for epidemic preparedness and response is in the process of development 10

11 Vaccines considered for investment in the Vaccine Investment Strategy (VIS) 2018 Vaccines / products linked to current investment New vaccine / product Endemic Disease Prevention Diphtheria, Tetanus, Pertussiscontaining boosters Hepatitis B (birth dose) Cholera (preventive immunisation) Meningococcal (multivalent conjugate) Rabies Malaria* Hepatitis A Dengue Influenza (maternal) RSV maternal vaccine and mab Epidemic Preparedness and Response Ebola (2 nd generation) Pandemic influenza Hepatitis E Chikungunya Zika Polio Eradication IPV (post-2020) * Not for investment decision in 2018 as Gavi-supported pilots are ongoing. Treated as comparator in VIS 2018.

12 Re-emergence of Ebola in DRC Ninth DRC outbreak since discovery in reported cases, 25 reported deaths Vaccine doses available via Gavi Advance Purchase Commitment (APC) First use of vaccine since the 2014 West African outbreak First dose given 13 days after outbreak declared, 1,199 vaccinated to date Gavi provided US$1m for operational costs to deploy vaccine

13 Milestones to Ebola vaccine availability West African outbreak 2014 Board approved funding envelope for Ebola 2015 Gavi offered an APC to all manufacturers that had a vaccine in Phase I+ Late 2015 Gavi Board approved one agreement, prepayment to Merck contingent on their commitment to: Apply for WHO Emergency Use Assessment Listing Ensure 300,000 doses of investigational vaccine available Submit for licensure by end of 2017 More than 17,500 doses deployed in DRC

14 Mission 2 3

15 In , three strategic priorities drive a more ambitious market shaping agenda Healthy markets Delivering on healthy markets The Alliance will move beyond singular objectives to advance the overall healthy market dynamics of its vaccine markets Long-term view Taking a long-term view of markets The Alliance will shape markets with a view to longer-term impact and the role of countries as increasingly independent financiers of immunisation programmes Innovation Driving innovation to better meet country needs The Alliance will pursue a common agenda on product innovation to inform product choices and support Alliance goals on immunisation coverage and equity

16 Healthy Markets Framework: used to guide market shaping

17 Market shaping indicators Market shaping 4 ALL ON TRACK 1 Number of vaccine markets with sufficient & uninterrupted supply of appropriate vaccines 2 Weighted average price per course: Pentavalent, Rotavirus and Pneumococcal 3 Number of products with improved characteristics procured 4 Number of Gavi vaccine markets with moderate or high healthy market dynamics

18 Accelerating innovation: Vaccine Innovation Prioritisation Strategy (VIPS) Goal: An Alliance wide effort to drive product innovation to better meet country needs and support Alliance goals on immunisation coverage and equity VIS-like framework Focusing on innovations in vaccine products attributes Outcomes: An Alliance common voice Through a clear and aligned perspective on prioritisation of vaccine innovations To provide greater clarity to manufacturers and partners to make investment decisions. 18

19 Monitoring Gavi market shaping externalities In 2017, 8 key Gavi market shaping externalities were identified based on a collaborative process And these will be measured from 2018 onwards based on a defined monitoring plan Category Investments in research and development Supply security for countries and sustainability for manufacturers Affordability for countries Externality: Gavi s market shaping activities may result in unintended changes in A B Investment in vaccine development for antigens where disease burden is predominantly in Gavi-supported countries and middle-income countries Investment in improvements to existing vaccines in Gavi portfolio, e.g. investments in thermo-stability C Investment in development of new cold chain equipment A Manufacturer diversity for Gavi-funded products 1, including overall number and geography B Global capacity to produce and availability of Gavi-funded products C D A Global capacity to produce and availability of non-gavi-funded products targeted at low- and middle-income countries Range of presentations of existing products available to Gavi-supported countries Price trends and price volatility for Gavi-funded products in non-gavisupported countries 1 All references to products in the framework refer to vaccines and CCE

20 Demand forecast documents for industry Folder on Gavi website accessible to industry Includes: Most recent strategic forecast per vaccine Base Demand Forecasts (the volume forecast underlying Gavi financial forecast) Calendar of anticipated updates Recent/upcoming updates New document posted with more information and analysis of the last Base Demand Forecast Anticipate 2-3 more strategic forecasts in next few months, as well as calendar update Next Base Demand Forecast by January Contact for access, or with questions and suggestions

21 Market Shaping tools available for public use on Gavi website Supply and Procurement Strategy Gavi Base Demand Forecast Public roadmap summaries

22 Gavi s mid-term review (2018) 2 ND REPLENISHMENT BERLIN 2015 Secured funding for Investment Opportunity MID-TERM REVIEW December 2018 Abu Dhabi Report back to donors on progress towards commitments made in the Investment Opportunity Secure continued support from donors and partners Lay the foundations for next replenishment 3 RD REPLENISHMENT TBD 2020 Secure funding for

23 Gavi has started process to define strategy How does Gavi finish the job? 18 of 1,000 children will be dying of vaccine-preventable diseases in 2020; at current pace, U5 mortality SDG target will be missed. How can the Gavi/ immunisation platform be used to accelerate the scale-up of other health interventions? Immunisation: 8 touchpoints per child in first 9 years of life, 500m touchpoints each year worldwide. To what extent should Gavi engage in reaching the unreached in MICs? More than two-thirds of world s poor live in MICs today; more than half of underimmunised in MICs in How can Gavi s tools contribute to global health security? Number of outbreaks has grown steadily from 1980 to 2010, over 3-fold increase.