www.gavi.org

Gavi’s Vaccine Investment Strategy

Judith Kallenberg

WHO Product Development for Vaccines Advisory Committee MeetingGeneva, Switzerland, 8-10 June 2016

Gavi-supported vaccines

2

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

*Contribution towards cholera vaccine stockpile for outbreak response 2014-2018

*

Gavi-funded vaccine uptake

Number of national introductions or campaigns

3 #vaccineswork

* Five countries have introduced pentavalent vaccine independently of Gavi financing.

** Gavi has supported introductions of rubella vaccine into the routine systems in Lao People’s Democratic Republic and Nepal through

vaccine introduction grants.

Source: Gavi data as of 31 December 2015.

4

Vaccine introductions and campaigns in 2014

Vaccine Investment Strategy (VIS)

Evidence-based approach to identifying new vaccines for

Gavi support

• Evidence review, analyses, stakeholder consultations, independent

expert advice

• Enabling predictable vaccine programming and investment decisions

(rather than first-come-first-serve)

• Ensuring predictability of Gavi programs to help long-term planning

by countries, industry and donors

5

VIS occurs every five years, aligned with strategic cycle and replenishment

6

VIS #1

HPV

Rubella

JE

Typhoid

conj.

MenA

VIS #2

YF mass campaigns

Cholera stockpile

Rabies/cholera

studies

Malaria – deferred

2011-2015 Strategic period

2011 2015

2008

2012 2013

$$$

2016 2017 2018 2020

2016-2020 Strategic period

VIS #3

$$$

2021

2021-2025

RTS,S

pilots?

Looking forward to VIS #3

Scope: licensure <5 years

Expected candidates for consideration

Returning candidates / incremental investments:

• Dengue

• (maternal) influenza

• rabies PEP

• Hepatitis E

• RTS,S

7

• meningococcal multivalent

• Cholera

• DTP booster

• Hepatitis B birth dose

• Typhoid

• PCV catch-up

• Norovirus?

• ETEC?

New:

• RSV

• Group B Streptococcus

Data gathering to begin in 2017

VIS process

Analysis of WHO landscape vaccines for initial

prioritisation

In-depth analysis of shortlisted vaccines and development of

recommendations

External Expert Review vaccine analyses

PPC review prioritisation

approach and shortlist

Board decisionshortlist

Phase 1 stakeholder consultations Phase 2 stakeholder consultations

Technical Consultation Group Technical Consultation Group

Analysis

Governance

Consultations

PHASE I PHASE II

Jun-Dec 20182017- Jun 18

External Expert

Review VIS

PPC review VIS

Board decision VIS

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Category VIS Criteria Phase I Indicator

Healthimpact

Impact on child mortalityU5 future deaths averted, 2015 – 2030

U5 future deaths averted per 100,000 vaccinated population

Impact on overall mortalityTotal future deaths averted, 2015 – 2030

Total future deaths averted per 100,000 vaccinated population

Impact on overall morbidity

Total future cases averted, 2015 - 2030

Total future cases averted per 100,000 vaccinated population

Long-term sequelae

Additionalimpactconsid-erations

Epidemic potential Epidemic potential of disease

Global or regional public health priority Presence of global / regional (UN) resolution on elimination or eradication

Herd immunity Herd immunity threshold

Availability of alternative interventions Current use of alternative interventions for effective disease control (prevention and treatment) and potential for scale up

Socio-economic inequity Disproportionate impact on poor

Gender inequity Disproportionate impact on one gender

Disease of regional importance Burden concentrated in a subset of GAVI countries within the same region

Implement-ation

feasibility

Capacity and supplier base Capacity to meet GAVI demand and # of manufacturers by 2020

GAVI market shaping potential GAVI demand (by volume) as % of global demand

Ease of supply chain integration Packed volume (cm3)

Ease of programmatic integrationAlignment with other vaccine schedules and significant change in health worker practices/behavior required

Vaccine efficacy and safety Vaccine efficacy (as defined by clinical endpoints) and safety

Cost and value for money

Vaccine procurement cost1 Total procurement cost to GAVI and countries, 2015 - 2030

In-country operational cost Incremental in-country operational costs per vaccinated person

Procurement cost per event averted2 Procurement cost per death / case averted

Evaluation indicators (VIS 2013)

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

Methodology for vaccine evaluation

1. Identify vaccination scenariosCONFIDENTIAL DRAFT

PPC_Malaria 10

Modelled vaccination scenarios

Doses Catch-up target population

Routine target population

3 dose course in 1 month intervals

6 weeks old 5 to <18M

5 to < 18M N/A

Legend

Base case

Alternative

scenario

Excluded because less attractive / not

feasible

CONFIDENTIAL DRAFT

15Flu for IEC_March 15 v3.pptxPPC_Dengue

Cumulative GAVI demand estimated to be

~610M doses through 2030

Note: Includes demand from countries that graduate from GAVI support during 2015-2030 (following GAVI supported introduction)

200

150

100

50

0

2030

16

61

2029

18

5 1

2028

19

4 1

2027

20

4 0

2026

20

3 0

2025

21

3 0

2024

60

2 0

2023

198

1 0

2022

41

1 0

2021

152

0 0

2020

1 00

2019

1 00

2018

120 0

2017

0 00

2016

0 00

2015

0

Demand (M doses)

00

GAVI financed Country co-financed Graduated country financed

2. Develop demand forecast

4. Develop cost

estimates

3. Develop impact

estimates

5. Assess other

disease/vaccine

features

Lessons learned

Varied data availability and data quality a challenge for

comparisons

Uncertainty of projections for pipeline vaccines, e.g.

Typhoid

Improve communication of Gavi data needs to inform

vaccine research priorities pre-VIS

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Key inputs needed for the VIS

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RELEVANCE / DEMAND

• Expected demand from Gavi-eligible countries over 10-year

timeframe?

o Priority vs. other (outstanding) vaccine introductions, other public

health priorities, and available alternative interventions?

VACCINATION STRATEGY & COVERAGE

• Likely vaccination strategy in Gavi-eligible countries? 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?

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?

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