GAVI Alliance. Aurelia Nguyen, Director Policy & Market Shaping. IPC Meeting 30 May 2013

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1 GAVI Alliance Aurelia Nguyen, Director Policy & Market Shaping IPC Meeting 30 May 2013

2 GAVI Update GAVI Alliance Overview 4 Strategic Goals 3 Market Shaping Objectives GAVI Supported Vaccines Critical Procedures Strategic Demand Forecasting Role of WHO PQ Supply Chain Project Risk Management

3 GAVI Alliance overview The GAVI Alliance: an innovative partnership Public-private partnership with a singleminded focus in closing critical gaps in the provision of vaccines Success of the Alliance Immunised 370 million children Prevented >5.5 million future deaths Accelerated vaccine introductions in over 70 countries Strengthened health systems to deliver immunisation Helped shape the market for vaccines Additional 370M children immunised Sources: WHO-UNICEF coverage estimates for , as of July Coverage projections for 2012, as of September World Population Prospects, the 2010 revision. New York, United Nations, 2010; (surviving infants)

4 GAVI Alliance overview Mission and strategic goals To save children s lives and protect people s health by increasing access to immunisation in poor countries 1 2 The vaccine goal Accelerate the uptake and use of underused and new vaccines 3 4 The financing goal Increase the predictability of global financing and improve the sustainability of national financing for immunisation The health systems goal Contribute to strengthening the capacity of integrated health systems to deliver immunisation The market shaping goal Shape vaccine markets to ensure adequate supply of appropriate, quality vaccines at low and sustainable prices

5 GAVI Alliance overview Market shaping objectives GAVI s success depends upon the vaccine markets providing appropriate and affordable vaccines

6 GAVI Alliance overview GAVI programme support portfolio includes 8 different vaccines GAVI supported vaccines supplied by UNICEF SD Vaccine Programme Presentation (Form) # Awarded manufacturers Yellow Fever Routine, Campaign, Stockpile 2013 product availability 5 dose ampoule + diluent (Lyo) 1 Very limited supply $ dose vial + diluent (Lyo) 2 Very limited supply $ WAP/ dose DTP-HepB- Hib Routine 1 dose vial (Liquid) 2 Supply exceeds demand $ dose vial (Liquid) 3 Limited supply $ dose vials (Lyo) 1 Very limited supply $2.95 Rota-1 Routine 1 dose squeeze-tube (Liquid) 1 Very limited supply 1.88/$2.51 Rota-5 Routine 1 dose applicator (Liquid) 1 Limited supply $5.00** PCV 10 Routine 2 dose vial (Liquid) 1 Very limited supply $3.50* PCV 13 Routine 1 dose vial (Liquid) 1 Very limited supply $3.50* MenA Campaign, Stockpile 10 dose vial + diluent (Lyo) 1 Limited supply $0.53 HPV Routine 1 and 2 dose vials (Liquid) 2 Supply exceeds demand - MR Campaign 10 dose vial (Lyo) 1 Supply exceeds demand $0.52 Measles SD Routine 10 dose vial 3 Supply exceeds demand $0.26 * The price of PCV-10 and PCV-13 to GAVI supported countries is $3.50, but for a number of doses, the price to the supplier will be topped up to $7.00 based on any Advanced Market Commitment (AMC) funding due under each contract ** The price of Rota-5 is for a single country. Free of charge doses will be made available in , provided a certain quantity is procured at the price of $5.00.

7 Critical Procedures Strategic Demand Forecasts provide a view on longterm country demand for each GAVI-supported vaccine SDFs ensure timely, transparent and accurate market information; making demand more predictable Purpose: The SDF provides view on the most likely country demand based on demographic, programmatic and other local environmental factors and constraints. The SDF aims to estimate when demand will effectively materialize in the countries, e.g. when the product is going to be consumed. The SDF includes the entire demand generated in each country irrespective of the source of financing. Periodicity, horizon, time buckets Data sources Key assumptions Stakeholders Opportunities for Improvement Twice annually (Feb/Aug); years 3 plus 20; 1 year time interval UN Population Prospect, WHO measles and DTP coverage, GAVI policies (eligibility, cofinancing) and prices, product subteams Adoption timing as per subteam; products as per WHO PQ and product pipeline analyses VI, Industry, Board, Donors Alignment/benchmarking of data sources and assumptions around uptake and analogue coverage

8 Critical Procedures SDF data informs procurement and supply-chain strategy development; and is shared with manufacturers for capacity planning Example: Rota SDF v7.0 scenarios: total required supply* from GAVI73 incl. countries graduating before introduction 180 Gap = DTP2 & DTP1 160 Millions of doses Gap largely due to difference in uptake assumptions Gap = UNPOP & country administrative data Gap due to supply constraint Base scenario Country request scenario High scenario Supply constrained scenario * As if entire market were rota 2

9 Critical Procedures WHO QSS* mission: support/sustain access to assured-quality and safe vaccines and biologicals WHO PQ evaluation provides UN procurement agencies with independent advice on quality, safety and efficacy of vaccines and related supplies Vaccines quality & regulation Prequalification of vaccines & equipment Leverage PQ decisions for national licensure (accelerate access) Secure supply and seek alternative sources of priority vaccines Norms and standards for biologicals Update/develop biological standards for vaccines & promote a Regulatory Science agenda for vaccines Establish/sustain a network of WHO Collaborating Centres for standardisation & evaluation NRA regulatory strengthening Global / regional networking of regulators championed & catalysed Sustained/increased functionality of NRA s Promote policy coherence between NRA s and technical advisory groups Global vaccine safety Global Advisory Committee on Vaccines Safety (vaccine risk assessments) Global vaccine safety partnership Promote enhanced pharmacovigilence capacity in LIC s and MIC s *QSS = Quality, Safety and Standards

10 Project in development Supply Chain Strategy Vaccines should be supplied in the right quantity, at the right place, at the right time, in the right condition and at the right cost Identified as a strategic priority by the Board, December 2012 Phase I: Landscape analysis (E2E supply chain mapping) Phase II: Strategy development Examples of priority projects underway: Standardized bar codes for secondary and packaging and above Cold chain equipment procurement project

11 Draft Supply Chain strategy objectives & indicators A well-functioning supply chain will enable the delivery of immunization to every child at lowest possible cost Cost Optimization Vaccine availability Product quality Objectives Right cost Right vaccines; Right place; Right time; Right quantities Right condition Example Indicators Lowest possible cost per dose administered Total supply chain cost 1 Vaccine Utilization Rate (wastage) Vaccine Stock Turnover % of freight-forwarding cost as value of vaccine 2 Pricing Product presentation System design Managing wastage Stock levels Supply meets demand at all levels of the supply chain, at all times Stock out rate at facilities/supply pts. Vaccine Availability Index 3 Supply Frequency and Timeliness Rate of vaccine consumption Viability of vaccines is maintained throughout the supply chain Double zero (storage temperature alarm) Product quality from manufacturer Example Levers Global supply-demand balance Use of data to manage resupply End to end system Timelines of delivery Inventory management Service delivery strategy Heat/freeze exposure Appropriate administration (mgmt. at last mile) Time to admin vs. shelf life Product design 1 Need to be further defined which cost components are included 2 Sub indicator of total supply chain cost 3 Indicator to measure the percentage of time that the store is free of stock-outs (zero doses in stock) that could disrupt immunization services

12 Outcome of landscape Analysis End-to-end vaccine supply chain Global Supply Chain GAVI board decision to add vaccine Vaccine market shaping strategy GAVI Board GAVI Recipient countries Alliance partners Application and approvals (for new Vx) Recipient countries IRC Demand and supply planning Annual Progress Review (for existing Vx) GAVI Secretariat UNICEF, WHO Vaccine manufacturers Recipient Countries GAVI Funds Fund transfer to UNICEF SD Tendering Donors Countries UNICEF PRG Vaccine manufacturers Country Funds Vaccine production Vaccine manufacturers Ordering MoH of recipient countries; UNICEF, GAVI Cold chain Information flow Vaccine flow Fund flow Delivery to countries Freight forwarders contracted by UNICEF In-country Supply Chain Data 4 Varying system designs between countries to address in deep-dive 1 Monitoring and forecasts (central coordination) MoH UNICEF SD WHO Campaign MoH HC facility/ Outreach MoH District level 3 MoH Sub-national level 2,3 MoH National warehouse MoH Customs clearance UNICEF CC agent Mobile MoH Delivery or pick-up depending on country 1 1 Supply chain designs differs by countries Some countries have additional layer (zonal ) after regional depots, making it a 5-level SC; Others have fewer levels under a hub concept;down to district level, transportation can be delivered by upper level, or collected by lower level 2 Regional, zonal or state level depots or hubs 3 Health office and/or storage 4 Data includes logistics/supply information (eg. how much was received, used, remains on hand) and service information

13 Risk Management Board level review Current highest risks: Low quality data Misuse of funds Rota vaccine shortage Failure to sustain impact after graduation Risk register Strategic Goal Dept. Risk Likelihood of risk Potential negative impact Resp. (director) Risk mitigation strategy Residual risk Evolution (post of risk in Internal and external developments Mitigation actions in the past quarter Next steps mitigation the past actions) quarter 1) Engagement of suppliers to increase production and solicitation of offers; 2) allocation process to optimize health outcomes, with clear communications to countries to manage SG1 CP Shortage of rota vaccines in the period High High expectations; Director, Vaccine 3) consultation on product preferences to firm up Implementation demand; 4) proactively monitoring demand, utilization and High Stable 1) Merck confirming development plan for new a) brainstorming meeting with private sector to presentation with VVM and smaller cold chain identify potential solution to absence of VVM requirements to be completed by end of 2015 and large cold chain footpring of R3 vaccine vaccine uptake, particularly in countries with large birth cohorts 5) communication strategy to address country delays 1) Allocation process to optimize health outcomes, with clear communications to countries to manage SG1 CP Shortage of pneumo vaccines in 2013 High Medium expectations; Director, Vaccine 2) Continue negotiation with suppliers to explore Implementation opportunity of increased supply availability 3) Proactively monitoring demand, utilization and Medium 1) Third AMC tender round almost completed Decreased with likely increase of supply availability starting from the end of 2013 vaccine uptake, particularly in countries with large birth cohorts

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15 GAVI Alliance overview New market entrants help to secure supply and increase price competition 2001: 5 suppliers from 5 countries Price decline of pentavalent vaccine and number of manufacturers 2012: 10 suppliers from 8 countries Source: UNICEF Supply Division, 2013 Indian manufacturer cuts price of childhood vaccine by 30%, 18 April 2013: A supply agreement with Biological E Ltd of India makes the five-in-one shot available to GAVI for just $1.19 per dose, compared to the 2012 weighted average price of $

16 Critical Procedures GAVI-supported vaccines are procured via three pathways: UNICEF SD, PAHO RF & Selfprocurement When procuring vaccines and associated injection safety supplies with GAVI funds, countries may select either: 1. The supplies in kind from GAVI, procured through UNICEF or PAHO s Revolving Fund, or 2. The equivalent cash grant from GAVI to be used for self-procurement, in lieu of supplies Global supply base for a product Functional National Regulatory Authority Prequalification by WHO for UN List of products List of products Procured by UN agencies (UNICEF SD; PAHO RF) Self-procurement by countries