Vaccine Investment Strategy · Rubella Influenza Cholera Men A JE Disruptive epidemic potential (deaths averted less relevant metric) Future deaths averted per 100k vaccinated 1 2

Judith Kallenberg

Vaccine Investment Strategy

GAVI Alliance Board meeting

Phnom Penh, Cambodia

21-22 November 2013


21-22 November 2013 1

Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec

Expert consultations, analytical work

Country consultations

at regional meetings

Technical

Consultation

Group

Phase I

recommendations

to Board

Phase I

recommendations

to PPC

Final VIS

recommendations

to Board

Final

recommendations

to PPC

Start of VIS

process

Online stakeholder survey

and in-depth country interviews

WHO

landscape

analysis

PPC guidance

on VIS scope

Technical

Consultation

Group

Independent

Expert

Group

Independent

Expert

Group

Technical

Consultation

Group

Vaccine Investment Strategy: evidence-based

process to identify new priority vaccines


21-22 November 2013

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

Assessment framework for shortlisted vaccine

investments

2


21-22 November 2013

5

Cumulative demand estimated to be

760M – 1.2B doses through 2030

2018201720162015

Demand (M doses)

150

100

50

0

203020292028202720262025202420232022202120202019

Expanded EPI with booster

Expanded EPI without booster

EPI with booster

EPI without booster

# countries

introducing0 0 2 3 3 5 5 5 3 4 2 2 0 0 0 0

Note: includes introductions in African countries only (both vaccine licensure and a WHO recommendation are highly

likely to be restricted to Africa; vaccine indication for use in Asia is not expected in the near term); Includes demand

from countries that graduate from GAVI support during 2015-2030 (following GAVI supported introduction)

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

Detailed vaccine assessments

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)

21

37 countries in scope for malaria (Africa)

In scope for malaria

Eligible for GAVI support

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

3


21-22 November 2013

Yellow fever: fund additional campaigns

ASSESSMENT

Continued risk of outbreaks in Africa

WHO: additional mass campaigns to cover remaining

unvaccinated populations in high-risk countries

Future populations protected through routine YF use

RECOMMENDATION

Fund additional campaigns from 2015 (~USD140M)

Secretariat to review planning / funding process, including

risk assessment mechanism, in coordination with WHO

4


21-22 November 2013

Cholera: make catalytic investment in global

stockpile

ASSESSMENT

Disruptive epidemics, inequitable burden

Low global demand and severe supply shortage relative to

estimated need

RECOMMENDATION

Enlarge stockpile to fight outbreaks, gain experience with

vaccine use, shape the market

Insufficient evidence for broad rollout through recurring,

preventive campaigns in endemic settings: re-evaluate in

next VIS

5


21-22 November 2013

Rabies and maternal influenza: re-evaluate in

next VIS

RABIES

Operational feasibility and effectiveness of GAVI support for

rabies vaccines unclear

Re-evaluate in next VIS, and

Fund observational study to fill critical knowledge gaps and

catalyse progress

Mitigate risk of preserving status quo

INFLUENZA

Limited evidence base for impact beyond pregnant woman

Data forthcoming on effects on foetus and infants

Re-evaluate in next VIS

6


21-22 November 2013

Malaria: re-assess investment case in

2015/16

ASSESSMENT

A leading cause of death in young children, strong demand

Bednets and spraying can prevent up to 55% of deaths

Vaccine targets remaining burden; complements other malaria

control interventions

Analysis: incremental impact in Africa ≈ Hib/rotavirus

Expert Committee: supportive based on preliminary data

RECOMMENDATION:

Note reasonable case for support based on current analysis;

await final trial data

Back to PPC/Board for decision in 2015/16

7


21-22 November 2013

Programme funding implications of

recommendations

2014-2020: ~$200M for YF and cholera

2% of vaccine spending

2016-2020: ~$300M for malaria; US$ 230M/year from 2021

Pending future Board approval

Projected programme costs in US$ millions (vaccine + introduction grant + operational cost)

Budget period: 2014-2015 2016-2020 2021-2030

Cholera stockpile 26 89 -

Yellow fever campaigns 14 95 31

Subtotal 40 184 31

Malaria - 287 2,274

Total VIS incl. malaria 40 471 2,305

Current GAVI portfolio* 3,014 6,895 ~10,000

*Based on demand forecast version 8 8


21-22 November 2013

Decide to support new yellow fever vaccine campaigns and request

the Secretariat to develop a process for the funding of individual

campaigns on the basis of robust risk assessments.

Approve a contribution to the global cholera stockpile for use in

epidemic and endemic settings and to that end:

Endorse a net increase in programme budgets for the global cholera

stockpile by US$ 114.5 million for the period 2014-2018. (This

endorsement would constitute acknowledgement of such budget amounts

as an indication of potential future expenditures but would not constitute a

funding approval, decision, obligation or commitment of the GAVI Alliance

or its contributors.);

Approve a net increase of near-term programme liabilities for the global

cholera stockpile (a sub-component of endorsed programme budgets) by

US$ 8.5 million for 2014;

Note the opportunity for the GAVI Alliance to generate impact data based

on the use of the cholera stockpile in emergency settings.

9

The PPC and, where appropriate, the AFC and the EC

recommended to the GAVI Alliance Board that it:


21-22 November 2013

Approve an assessment of the feasibility of GAVI support for

rabies vaccines (to be evaluated in the next Vaccine

Investment Strategy process). A funding request for the

outsourced assessment will be included as part of the

Business Plan in 2015.

Note that based on the current assessment there is a

reasonable case for GAVI support for a malaria vaccine, and

that the Board will consider opening a window if and when

the vaccine is licensed, recommended for use by the joint

meeting of the WHO Strategic Advisory Group of Experts and

the Malaria Programme Advisory Committee (expected in

2015) and WHO pre-qualified, taking into account updated

projections of impact, cost and country demand as reviewed

by the PPC.

10




21-22 November 2013

Note the potential public health impact of vaccinating

pregnant women against seasonal influenza and the

need to assess the emerging evidence of impact of

vaccination on neonates, but decides not to open a

funding window for influenza vaccines at this time.

Approve an amount up to US$ 1.5 million to be

added to the 2014 Business Plan to implement the

Board’s VIS decisions through Secretariat and

partner activities as described in section 5.2 of Doc

07.

11



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Documents

Vaccine Investment Strategy · Rubella Influenza Cholera Men A JE Disruptive epidemic potential (deaths averted less relevant metric) Future deaths averted per 100k vaccinated 1 2