Judith Kallenberg, Head of Policy

Gavi’s Vaccine Investment Strategy

WHO Product Development for Vaccines Advisory Committee Meeting Geneva, Switzerland, 8-10 September 2014

Vaccine Investment Strategy (VIS)

2

Evidence-based approach to identifying potential new

vaccine priorities for Gavi support

Evidence review, analyses, stakeholder consultations,

independent expert advise

2008 VIS: HPV, rubella, JE, typhoid

2013 VIS:

Expanded support for yellow fever campaigns

Time-limited investment in global cholera stockpile

Malaria vaccines to be re-assessed in 2016

Rabies study to fill evidence gap

Monitoring maternal influenza developments

VIS process (phase 1)

WHO ‘landscape analysis’ of vaccines in scope: anticipated

licensure within next 5 years

Development of prioritisation criteria through Gavi stakeholder

consultations

Assessment of vaccines against criteria

Development vaccine shortlist for in-depth analysis

2013 vaccines considered:

3

Existing vaccines not

supported by GAVI

‘Pipeline’

vaccines

Potential expansion of

GAVI vaccine support

Cholera Malaria DTP (booster)

Hepatitis A Dengue Hepatitis B (birth dose)

Hepatitis E Enterovirus 71 Measles (additional campaigns)

Influenza Meningococcal (additional serotypes)

Mumps Yellow Fever (additional campaigns)

Poliomyelitis

Rabies

Category VIS Criteria Phase I Indicator

Health impact

Impact on child mortality U5 future deaths averted, 2015 – 2030

U5 future deaths averted per 100,000 vaccinated population

Impact on overall mortality Total 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

Additional impact consid-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 integration Alignment 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 criteria and indicators

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 scenarios

CONFIDENTIAL 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

Methodology for vaccine prioritisation

6

6. Populate scorecards

• Health impact

• Cost

• Implementation feasibility

• Other considerations

7. Compare vaccines against

selected criteria

Consultations identified 5 key criteria to drive

initial prioritization in phase I

7

Category VIS Criteria

Health impact

Impact on child mortality

Impact on overall mortality

Impact on overall morbidity

Additional impact

considerations

Epidemic potential

Global or regional public health priority

Herd immunity

Availability of alternative interventions

Socio-economic inequity

Gender inequity

Disease of regional importance

Implementation feasibility

Capacity and supplier base

GAVI market shaping potential

Ease of supply chain integration

Ease of programmatic integration

Vaccine efficacy and safety

Cost and value for money

Vaccine procurement cost

In-country operational cost

Procurement cost per event averted

Category VIS Criteria

Health impact

Impact on child mortality

Impact on overall mortality

Impact on overall morbidity

Additional impact

considerations

Epidemic potential

Global or regional public health priority

Herd immunity

Availability of alternative interventions

Socio-economic inequity

Gender inequity

Disease of regional importance

Implementation feasibility

Capacity and supplier base

GAVI market shaping potential

Ease of supply chain integration

Ease of programmatic integration

Vaccine efficacy and safety

Cost and value for money

Vaccine procurement cost

In-country operational cost

Procurement cost per event averted

Health impact (mortality and

morbidity) most important

Also consider epidemic diseases

and value for money

Verify additional benefits and

implementation feasibility

In phase II, the full scorecard will

be (re-)considered to inform final

prioritization

VIS process: phase 2 (~6 months)

Further, in-depth assessment of shortlisted vaccines

Comparison with current Gavi portfolio to determine value-add

Independent expert validation of analyses

Development of investment recommendations

8

7

Malaria vaccine may have impact

comparable to Hib

Note: Model outputs shown for Expanded EPI with booster scenario, for illustrative purposes; error bars show highest and lowest value generated by malaria sensitivity analyses and are driven by decay rate of protection; point estimate represents midpoint of Imperial and Swiss TPH models

5,000 1,500

768

668

576541

198

147

63 45 31 2924

0

200

400

600

800

1,000

Rabies HPV Hep B Pneumo Hib Malaria Rota YellowFever

Rubella Influenza Cholera Men A JE

Disruptive epidemic potential(deaths averted less relevant metric)

Future deaths averted per 100k vaccinated1

2

1. Based on deaths averted over 2015-2030; 2. VIS only

11

Vaccine duration of protection is biggest

sensitivity of high impact

Imperial College Swiss TPH

Access to care (25%

decrease or increase)

-600 -400

Transmission (25% - 80% ITN

& treatment coverage)163-220

Vaccine efficacy 50-60% -155 122

Decay rate against

infection (1-5 years)-528 229

-200 200 400

Future deaths averted ('000)

0

Eligibility of

Nigeria-315

Base: 1.3M

200

61

Future deaths averted ('000)

0-200 400

-66

-227

-125 124

-600 -400

Base: 960,000

No sensitivity

analysis run

No sensitivity analysis run

No sensitivity analysis run

Note: For illustrative purposes base case is shown as expanded EPI with booster scenario (midpoint between Imperial College and Swiss TPH model outputs)

15

# of responses

80

60

40

20

0

Challenging

and not

desirable

11

Challenging

but beneficial

52

Feasible

and could be

beneficial

76

Respondents positive on ability

to add new visits for 5-17M age group

Respondents emphasized that vaccine could not

displace other malaria interventions

# of responses

100

0

Vaccine

would have

no effect on

other

interventions

3

Vaccine

would likely

boost other

interventions

6

Vaccine may

reduce need

for other

interventions

11

Vaccine

would reduce

need for other

interventions

14

RTS,S is impt

add, but still

need for other

interventions

102

50

150

Country openness to new schedule and awareness

that vaccine cannot replace other interventions

Question: Please indicate the

statement(s) that most closely

apply in your country

Question: Please indicate the statement(s) that

most closely apply in your country

Source: 2013 GAVI Phase II country consultation survey

Note: question only posed to 136 respondents ranking malaria as first or second priority for introduction

16

Area of focus Unique implementation requirements Unique costs

Policies and

processes

WHO position TBD; few required GAVI policy changes currently

foreseen; coordination with the GFATM required N/A

Supply Account for supply constraints through 2020 (impact likely small) No direct costs

Health workforce HR/training requirements for RTS,S similar to those for vaccines

already in health system

N/A

Social mobilisation,

education,

communication

Manage risk to program credibility if efficacy lower than other

vaccines in use (eg. rota)

Additional training/social mobilisation/programmatic investments

for initiating new routine visits for immunisation (expanded EPI

scenario only)

Cost accounted

for in

operational

costs1

Supply chain

infrastructure and

logistics

Requirements for RTS,S similar to those for vaccines already in

health system N/A

Surveillance No unique surveillance requirements N/A

Planning,

coordination,

integration

Expanded EPI scenario would require infrastructure to support at

least one additional touch point

Manage potential for older (not eligible) age groups to present for

vaccination (implications for forecasting in intro year)

Coordinate with malaria control program to ensure vaccine does

not undermine the use of other malaria interventions

Focused

organizational

effort

Glo

ba

l

leve

lC

ou

ntr

y l

eve

l

Unique but manageableMay not be manageable in short

term / within current GAVI model

Implementation would require managing possible

global supply shortage and communication needs

1. Expected to be covered by GAVI Vaccine Introduction Grant, MoH, partners

Assessment framework for shortlisted

vaccine investments

9

Step 1:

analysis

Step 2:

synthesis

Step 3:

recommendation

Direct health impact

Cost and value for money

(relative to current portfolio)

Market-shaping potential

Country views

Global/country

implementation requirements

Key benefits

Key challenges

and risks

Recommendation

and implications

Potential to prevent

disruptive epidemics

Conclusions / lessons learnt

VIS process led to a set of defensible investment

recommendations and consensus among key Gavi

stakeholders

Multi-step process with many qualitative and quantitative

inputs; detailed methodology evolved in the process

Evaluation criteria formed a framework to help facilitate

comparison and prioritisation; no single algorithm can do

justice to the diverse considerations relevant for prioritisation

Critical success factors: robust evidence-base; clear decision

framework and full transparency of the process; active

stakeholder engagement and consultation; independent

expert validation of analyses

10

www.gavi.org

THANK YOU

Back-up

12

Step 1: define plausible vaccination

scenarios

Assessed different possible

scenarios based on disease

epidemiology, vaccine product

profiles, WHO recommendations

Identified "base case" scenario for

modelling purposes

Scenarios specify target

population, age cohort, dosing

Most vaccines delivered outside

EPI

eg. flu vaccination of pregnant women;

cholera periodic vaccination

campaigns of high risk populations

CONFIDENTIAL 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

Step 2: forecast demand and uptake in GAVI-

eligible countries

14

CONFIDENTIAL DRAFT

14Flu for IEC_March 15 v3.pptxPPC_Dengue

In the forecast, seven dengue focus countries

would introduce with GAVI support in 2015-2030

0

1.0

2.0

0.00

# of country introductions

0.5

1.5

20302021 2022

0

2023

0

2024

0

2025

1

2026

2

2027

1

2028

2

0

20292020

00

2018

1

2019

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

Country scope based on eligibility,

known disease burden, likely interest

Timing based on burden and

historical introduction patterns

In-country coverage and uptake

assumptions

Wastage and drop-out assumptions

Outputs: annual # doses and #

vaccinated persons, modelled for

2015-2030

eg. cholera forecast: 19 countries

introduce by 2030, requiring 880M

doses

Step 3: quantitative health impact analysis to

populate scorecard

15

Health impact modelling

Ranked outcomes across vaccines

to determine relative score

eg. 120k deaths averted puts

cholera in middle (yellow) tier on

‘mortality impact’ criterion

Step 4: cost analysis to populate scorecard

16

Price forecast * demand forecast

Ranked outcomes across vaccines to

determine relative score

In-country operational cost index

eg. $680M puts IPV in low (green) tier on

‘total procurement cost’ criterion

Step 5: qualitative assessment of other disease

and vaccine features to populate scorecard

17

Measurable indicator(s) for

additional impact criteria and

implementation feasibility criteria

Transparent scoring method for

each qualitative criterion

eg. availability / scalability of

alternative interventions; impact on

gender inequity