Gavi Secretariat Update: Progress, priorities and strategies

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Gavi Secretariat Update: Progress, priorities and strategies Melissa Malhame UNICEF Vaccine Manufacturer Consultation Copenhagen 8-9 October 2014 www.gavi.org

Gavi s impact 2000-2013 2

New vaccines now routine in developing world: pentavalent in all 73 Gavi countries

Programmes continue to accelerate: new vaccine introductions 2011-2015 Routine programme introductions and campaigns Source: Gavi Alliance data as of June 2014. Note: Only the first phase of introductions and campaigns is included. IPV projections are only partially based on country input.

US$ 8.7 billion committed to countries As of 30 June 2014 Source: GAVI Alliance Note: These commitments are from inception until 30 June 2014.

Financing Model

Co-financing: countries taking ownership Source: GAVI Alliance as of June 2014

How the co-financing policy works Source: GAVI Alliance 2014

Co-financing policy Country group Low Income Countries N=34 Intermediate Countries N=15 Graduating Countries N=24 GNI per capita threshold GNI per capita below the World Bank low-income threshold GNI per capita above the World Bank low-income threshold but below the GAVI eligibility threshold GNI per capita above the GAVI eligibility threshold 2015 thresholds Co-financing requirement < $1,045 US$ 0.20 per dose (no annual increase) $1,045 to <$1,580 $1,580 Starts at US$ 0.20 per dose and increases 15% annually Starts at 20% of the projected price of the vaccine (in the year GAVI support ends) and increases linearly over four years to reach the projected price

Illustrative: Ghana s graduation from Gavi s support 12

Doses (Millions) 100 Demand: HPV demand, 2014-2034 1 Base Unconstrained: Total Required Supply for 94 Countries by Financing 90 80 70 60 50 40 30 20 10-269 274 276 277 278 280 281 283 284 260 234 10 12 12 12 12 12 12 12 12 12 194 182 8 3 4 5 5 5 5 5 5 6 6 6 6 6 178 7 172 5 4 4 4 5 170 1 9 11 14 14 15 15 15 15 4 17 167 1-3 - 3 155-23 25 27 28 28 29 30 1 26-25 141 23 23 22 23 23 24 22 18 103 130 2-11 01 2 1 5 - - 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 Other Nigeria Graduated Eligible 2014 SDFv9 Base Uncon (3 dose) 2014 SDFv9 Base Uncon (2 dose) 1. Scenario: National base unconstrained. Gavi eligible demand is forecasted to peak at 30 million doses in 2026 Categories: Eligible: Includes doses that Gavi directly finances and doses that are co-financed by the country. Graduated: Doses related to countries that have introduced HPV with Gavi support and have graduated during the forecasting time period. Other: Doses from Gavi73 countries that introduce HPV without Gavi and non-gavi eligible LMICs. Gavi Alliance SDFv10i HPV CONFIDENTIAL

HPV National programmes Element Assumptions Confidence Country scope Gavi73 and non-gavi eligible lower-middle-income countries (LMICs) n/a Target population 10-year old girls Medium Schedule 2-dose schedule (6-month interval between doses) 2 High Product(s) Wastage factor Co-financing policy Current: Cervarix (2-dose vial) from GSK ; Gardasil (1-dose vial) from Merck Future: New vaccines are expected Wastage = Mixture of 1.05 and 1.11 based on product presentation of 1- and 2- dose liquid vials, respectively. All doses are co-financed by Gavi-eligible countries LMIC demand is fully country-financed After graduation, Gavi support ends and countries fully finance this vaccine. Current products: High Future products: Low Medium High Other No supply or financial constraints applied in the base unconstrained scenario Buffer: 25% of change in demand between years The SDF assumes that products purchased with Gavi support are WHO prequalified. Countries that prefer to self-procure vaccines using Gavi support are required to assure that international standards of quality are met. n/a Gavi Alliance SDFv10i HPV CONFIDENTIAL Note: items in red indicate a change from 2014 SDFv9 1: Base Unconstrained: SDF Assumptions 2: Demand takes into consideration the number of immunocompromised girls that require 3 doses of HPV

Gavi-supported HPV national introductions by 2020 1 Introduced Board Approved Recommendation Not yet applied Introductions current as of Aug 2014 a. Assumes a 3-year demonstration. Uzbekistan b. Approved for demonstration Rwanda Uganda 15 additional Bold = Gavi graduating country 7 countries 7 countries 5 countries 4 countries countries 2013 2014 2015 2016 2017 2018 2019 2020 Total 0 1 1 16 7 7 5 4 41 2014 SDF v10 0 1 7 5 11 8 7 6 44 2014 SDF v9 1. Scenario: National base unconstrained. Gavi Alliance SDFv10i HPV CONFIDENTIAL

Scenarios for HPV National Programmes: Standard parameters set for 2014 SDFv10 Scenario Population source Introduction dates Demand projection assumption 1 Impact projection assumption 1 Uptake Doses / curve 2 course Low 90% of UN WPP Medium Pessimistic view DTP2 DTP2 Two year uptake 2 doses Base - Unconstrained UN WPP Medium Standard view DTP1 DTP2 Two year uptake 2 doses High 110% of UN WPP Medium Optimistic view DTP1 DTP2 Two year uptake 2 doses Note: red font indicates a change from 2014 SDFv9 1: Girls enrolled in school to reach coverage projection, Girls not enrolled in school to reach 70% of coverage projection. Projection assumption: (Girls in school)*(coverage) + (Girls out of school)*(coverage)*70% 2. In Year 1: 80% and in Year 2: 100%, except for countries with a history of phased introductions. Gavi Alliance SDFv10i HPV CONFIDENTIAL

Courses, (Millions) HPV Demand: Range created by variations in assumptions for introduction dates and population 90 Comparison of Total Required Supply for 94 Countries 80 70 60 50 40 30 20 10-15 million dose difference in 2020, largely driven by sensitivity around population and intro dates 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 Base Unconstrained High Low 2014 SDFv9 Base Unconstrained (3 dose) 2014 SDFv9 Base Unconstrained (2 dose) Gavi Alliance SDFv10i HPV CONFIDENTIAL

External dissemination of SDF: What, Who, & How? Detailed SDF PPTs Industry SDF PPTs What: 94 country demand, detailed adoption timing, MS assumptions, various cuts of data Who: Specific Gavi Alliance partners How: Vaccine sub-teams and mygavi Get access to industry PPTs by contacting mko@gavi.org What: 94 country demand, removes sensitive country and market shaping information Who: DCVMN and IFPMA networks How: mygavi and yearly in person meetings Public SDF What: 73 country demand, disease overview, Gavi s support Who: Visitors to Gavi Alliance website How: Posted annually to Gavi Alliance website

Financing Model

Source: GAVI Alliance Market shaping objectives

Supply and Procurement Roadmaps Developed for each vaccine Three levels of confidentiality Market intelligence Objectives prioritized GAVI Strategy Market analysis Target outcomes Objective 1 Target outcome TO 1 Target outcome TO 2 Objective 2 Target outcome TO 8 Action plan Interventions Accountable, Responsible, Supporting Measured Output Due Date / Status For TO 1 For TO 2 Etc. 21

The next period is an acceleration: donors supporting Gavi s peak procurement / impact 22

Creating a supply chain strategy In 2013, GAVI Alliance partners began co-developing an immunisation supply chain strategy. Alliance Taskforce Countries Global health community Private sector/ other partners

The Immunisation Supply Chain Strategy How to create an environment of continuous improvement? How will we get there? Establish fundamentals through 3+1 Approach 1 Supply chain managers 2 Comprehensive supply chain plans 3 Supply chain dashboards +1 System redesign (select countries only) Support for Continuous improvement: Use a more robust EVM process to assess supply chain progress and areas needing improvement Develop a more robust planning process linked to comprehensive multiyear plans Make funding available for implementation Create better equipment, training programs, information systems, etc. Provide direct support and more comprehensive tools, guidance, and assistance The Goal Availability Immunisation available to all who appear for a session Potency Vaccines are potent and safe at the point of immunisation Efficiency Resources are used responsibly and efficiently

Strategic enablers Goals Principles Mission Gavi, the Vaccine Alliance - strategy 2016-2020 PRELIMINARY Country-led Community-owned Globally engaged To save children s lives and protect people s health by increasing equitable use of vaccines in lower income countries Catalytic & sustainable Accelerate equitable uptake and coverage of vaccines Coverage and equity Introduction and scale-up of new vaccines Flexible response to special needs of fragile countries 1 2 Integrated Innovative Collaborative Accountable Increase effectiveness and efficiency of immunisation delivery as an integrated part of strengthened health systems Integrated comprehensive immunisation systems Supply chains, health information systems, demand generation and gender sensitive approaches Engagement of civil society, private sector and other partners Improve sustainability of national immunisation programmes 4 Shape markets for vaccines and other immunisation products 3 National and sub-national political commitment Allocation and management of national human and financial resources Sustained performance after graduation 4 Adequate and secure supply Appropriate and sustainable prices Incentivise development of suitable and quality products A) Country leadership management & coordination B) Resource mobilisation C) Advocacy D) Monitoring & Evaluation

Goal-level indicators Objectives Goals Gavi strategy 2016-2020 4 a b c Shape markets for vaccines and other immunisation products Ensure adequate and secure supply of quality vaccines Reduce prices of vaccines and other immunisation products to an appropriate and sustainable level Incentivise development of suitable and quality vaccines and other immunisation products Indicator on healthy market dynamics (e.g., # of suppliers, # countries obtaining first choice, vaccines and other products) Reduction in price (vaccines and other products) for GAVI countries, access to appropriate prices for graduated countries and LMICs Reduction in the delivery cost of immunisation Indicator on innovation (e.g., thermo-stable vaccines; delivery technologies)

Gavi working towards Replenishment in January 2015 to fund this 2016-20 strategy Angela Merkel will host a pledging conference in Berlin on January 27 th Gavi is formally included in Germany s G7 agenda Donor to donor peer outreach at the highest levels Industry contributions will be spotlighted at the pledging conference

Thank you www.gavi.org