Nina Schwalbe

Update from the GAVI Secretariat

SAGE Meeting

Geneva,13-15 April 2010

Topics to be addressed

� Update on key developments

� Review, eligibility, graduation and donation policies

� AMC

� Accelerated Vaccine Initiative (AVI)

� Priorities for 2010

� Strategic plan – 2011-2015

� Co-financing, prioritization and performance based funding

� Financing country demand

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Update on key developments

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Board decisions December 2009

� Review

� No new applications approved until spring 2010

� Eligibility and Graduation

� GNI < $1500 using World Bank data, adjusted and updated annually

� Coverage requirement of 70% for new vaccines (regional vaccines excluded – JE, YF, men A)

� Existing commitments honored through 2015

� Donations of vaccines

� Only accepted in exceptional circumstances

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Advance Market Commitment (AMC)

� First round of supply offers signed 23 March

GSK will supply 30 million doses annually from January 2012 for a period up to 10 years.

Pfizer Inc. will supply 30 million doses annually from January 2013 for a period up to 10 years

GSK and Pfizer to provide 7.2 million, 24.2 million, and 20 million doses for the years 2010, 2011 and 2012 as part of Capacity Development Period.

� Independent Advisory Committee meeting April 16th 2010 to discuss AMC eligibility

� Baseline Study will be completed June 2010

� Payment system between the AMC Donors, the IBRD, GAVI and UNICEF established

Moving forward from the ADIPs – AVI up and running for 18 months

� New Sub-teams being formed where emphasis is needed

� Building a platform for new vaccine introduction

� Collaboration with Bill and Melinda Gates Foundation increased with an observer

*: ‘Technical Assistance Consortium. consisting of PATH, JHU, CDC (merged RVP, Pneumo ADIP and Hib

Initiatives)5

3 sub teams so far:

� Cold Chain and Logistics (New)

� Large Countries

� Strategic Vaccine Supply

AVI

Management

Team

WHO

GAVI Sec

ProgramDelivery

UNICEF

SupplyDivision

AVI

Manager

UNICEF

Program

Division

AVI TAC*

9 permanent members

2 others being formed:• Advocacy and Communication• Special Studies

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AVI technical work-streams

Generate informed

country decisions

� Generate health and economic impact data

� Generate safety, immunogenicity and efficacy data

� Present vaccine data to decision makers

� Support country level decision making

� Assess country readiness

� Set up global and regional decision support policies

Ensure sufficient

supply

� Prequalify Pneumo and Rota vaccines

� Build sufficient manufacturing capacity

� Make price and supply agreements with suppliers

� Develop strategic supply strategy

� Ensure vaccines are GAVI appropriate

Facilitate country

introduction

� Ensure availability of in-country cold chain capacity

� Prepare country immunization and health systems

� Enhance vaccine management capability

� Train health care professionals

� Create community level social mobilization

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Generate informed country decision:AVI Special Studies

Study Location Vaccine End

Optimization of Dosing /

Delivery

Landscape analysis of dosing schedules Desk basedAll pneumococcal vaccines

9/2010

Understanding the impact of breastfeeding and age of administration on the immunogenicity

Pakistan Rotarix 12/2010

Herd ImmunityIntroduction of vaccine and an assessment of the population and indirect effects of vaccination

Bangladesh Rotarix TBC

Effectiveness

Assess the impact of a national introduction of vaccines among children in populations representative of GAVI-eligible countries through short-term vaccine effectiveness studies

South Africa, Honduras, Bolivia, Peru

Pneumococcal and rotavirus vaccines

12/2010

Development of pneumococcal conjugate vaccine impact-assessment manual and generic case-control study protocol

Desk basedPneumococcal vaccines

12/2010

Strain review and meta-analysis of trial data to look at strain specific protection Desk basedLive oral rotavirus vaccines

1/2010

Demonstration Projects to

Measure Costs and Benefits

Assessment of the economic impact of national introduction of vaccines among children in populations representative of GAVI-eligible countries through collection and evaluation of associated health care and societal costs

South Africa, Honduras, Bolivia, Peru

PCV7 and rotavirus vaccines

12/2010

Cost-Benefit Analysis and Acceptability

Creation, maintenance, and country training on use of web based tools that link disease burden and economic impact to model region and country specific estimates and enable country derived cost effectiveness analyses

Desk-basedNot vaccine specific

12/2010 - 3/2011

SafetyPost-marketing safety monitoring of the rotavirus vaccines in Bolivia and Honduras, assessing potential risk of intussusception among children inadvertently vaccinated after 15 weeks of age

Bolivia, Honduras Rotateq12/2010 -3/2011

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FinancialForecast

(USD)

Co-financing

&Pricing

Strategic

Demand

Forecast(doses)

Wastage & Buffer Stocks

Dosage per course

Vaccinated

Infants

Ensure sufficient supply - strategic demand forecasts

Target population(Surviving

Infants)

Introduction dates

Immunization coverage

Coverage Uptake

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Sources and assumptions benchmarked and validated

Assumption Primary Source Benchmarks and alternative inputs

Target population UN Country census

Introduction dates WHO UNICEF/Local sources

Cross vaccines validation

Target Coverage

(projections)

WHO benchmarks

Uptake (time to match

target coverage)

UNICEF WHO / analogues / intelligence from other sources

Dosage Vaccine specific

Wastage/Buffer stocks WHO Specific studies

Supply availability UNICEF/GAVI Intelligence from manufacturers

Co-financing GAVI Policy

Price GAVI UNICEF, information from manufacturers, independent research

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Facilitate country introduction:WHO and UNICEF leading activities to prepare vaccine roll-out

Topic Country/region Activity Status Timing

Launch Support RwandaSupported the launch and PR campaign around first PCV introduction in Africa

Done Q1-2 2009

Cold Chain

Global Global data base on cold chain updated On-going

Cambodia, Pakistan, Solomon Islands

Cold chain assessments Done Q1-Q2 2009

Mongolia, Kiribati, PNG Cold chain assessments planned Planned Q4 2009

Afghanistan, Eritrea, Ethiopia, Ghana, Guinea, Kenya Madagascar, Malawi, Mozambique, Niger, Nigeria, Tanzania, Uganda, Vietnam, Yemen Zambia

Evaluation of Vaccine Supply Management / Vaccine Management assessments on-going

On-going Q3-4 2009

Waste Management

Rwanda, Mozambique, Mali, Mauritania, Honduras, Nicaragua, Nepal, Indonesia, Bhutan, India, Mongolia, Uzbekistan, Yemen

Health Centre Waste Management (HCWM) support: through assessments, training, production of a video, distance learning, translation of modules, funding

Done Q1-2 2009

Vaccine Management 18 AFRO countries (Francophone)Mid-level-Management (MLM) for EPI staff, training course

Done Q2 2009

Post-Introduction Evaluations

Cameroon, C.A.R., Chad, Congo, Djibouti, Sudan, Togo

PIEs conducted in countries to evaluate impact of NV introduction on immunization programme and make adjustments

On-going 2009-15

Training India Study of healthcare workers in 7 states Done Q2 2009

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Priorities for 2010

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Operating principles

GAVI 2011 - 2015 strategy development

Mission

Strategic goals

Business plan

KPIsand

targets

Roles and responsibilities

Objectives

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Strategy: Deliverables

Phase I – defining the "what"

� June 2010 A draft strategy document outlining the overall mission, strategic goals, operating principles, roles/ responsibilities and key objectives for the period 2011 -2015

Phase II – developing the "how"

� December 2010 A comprehensive business plan on how to achieve the strategy with clear activities, specific indicators with established targets for objectives/activities, accountabilities and indicative budget

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Strategy: Current progress

� Through the consultation process so far, we have received some consistent suggestions for the refinement of GAVI's mission, strategic goals, objectives, key performance indicators, and operating principles

� Work continues on indicators and targets

� Board will review progress to date at Oslo retreat on 19-20 April

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Suggestion for GAVI’s mission 2011 -2015

Remains unchanged from 2007 - 2010

GAVI’s mission: “To save children's lives and protect people's health by increasing access to immunisation in poor countries."

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Suggested GAVI strategic goals 2011 -2015

Strategic goals 2007 - 2010 Suggested revisions

1. Accelerate the uptake and use of underused and new vaccines and associated technologies and improve vaccine supply security

2. Contribute to strengthening the capacity of the health system to deliver immunization and other health services in a sustainable manner

1. Accelerate the uptake and use of underused and new vaccines

2. Contribute to strengthening the capacity of health systems to deliver immunisation services [as part of integrated health services]

3. Increase the predictability and sustainability of long-term financing for national immunisation programmes

3. Increase the predictability of global financing and improve the sustainability of national financing for immunisation

4. Increase and assess the added value of GAVI as a public private global health partnership through improved efficiency, increased advocacy and continued innovation

4. [Incorporated into operating principles]

5. Shape vaccines markets

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Suggested operating principles 2011 - 2015

As a public private partnership the GAVI Alliance provides [catalytic] funding to countries and demonstrates “added-value”by:1.Contributing to achieving the Millennium Development Goals (MDGs) 2.Supporting nationally-defined priorities, integrated delivery, budget processes and decision-making 3.Advocating for immunisation in the context of a broader set of [equitable and] cost-effective public health interventions 4.Focusing on innovation, efficiency, performance and results 5.Maximising cooperation and accountability among partners[through an appropriately sized Secretariat]

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Prioritization

1. Finalise approach for ranking GAVI’s vaccine portfolio based on (i) framework developed for the vaccine investment strategy (VIS) and (ii) market shaping considerations

2. Develop a mechanism to rank IRC-recommended country

proposals based on robust criteria

3. Develop a means for projecting resource availability in order to determine how many new multi-year commitments over a given period, GAVI can afford to fund

4. Develop operating guidelines for prioritising vaccines and IRC-recommended proposals, and allocating available resources in a dynamic funding environment

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Co-financing review

1. Review the experience to date with the current co-financing policy as well as similar policies from other organizations

2. Define policy objectives for the policy for the period beyond 2011

3. Recommend option(s) for updated co-financing

policy; including levels, country groupings and default procedures

4. Develop a process for future updates of the policy

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Performance based financing

� Develop options paper on next generation

1. Incentives for routine strengthening

� Build upon success of ISS

� Ensure incentives cascade down

2. Vaccine supply systems support

� Within New Vaccine window, create incentives for improved management of vaccines in country

3. Innovation challenge grants

� Direct support to CSO organizations focused on underperforming districts

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Projected expenditures 2010-2015 by programme

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Financing country demand 2010-2015

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What can be done if financing gap is met

By 2015:

� All GAVI-eligible countries using pentavalent vaccines

� 47 countries using pneumococcal vaccines (13 applications already approved)

� 41 countries using rotavirus vaccines (4 applications already approved)

� 18 countries using one or more of the vaccines prioritised in the Vaccine Investment Strategy: JE, HPV, typhoid, rubella, Meningitis A

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Potential impact of GAVI: 2010-2015

If sufficiently financed, GAVI Alliance programmes will prevent a further 4.2 million deaths by 2015

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