www.gavi.org Gavi’s Vaccine Investment Strategy Judith Kallenberg, Head of Policy WHO Product Development for Vaccines Advisory Committee Meeting Geneva, Switzerland, 7-9 September 2015
www.gavi.org
Gavi’s Vaccine Investment Strategy
Judith Kallenberg, Head of Policy
WHO Product Development for Vaccines Advisory Committee MeetingGeneva, Switzerland, 7-9 September 2015
Vaccine Investment Strategy (VIS)
2008 VIS:
• HPV, rubella, JE, typhoid
2013 VIS:
• Expanded support for yellow fever campaigns
• Time-limited contribution to global cholera stockpile
• Learning agenda: rabies and cholera studies to fill evidence gaps
• Malaria vaccines to be re-assessed in 2015/16
Evidence-based approach to identifying potential new
vaccine priorities for Gavi support
• Evidence review, analyses, stakeholder consultations, independent
expert advice
2
VIS process (phase 1)
1. WHO ‘landscape analysis’ of vaccines in scope: anticipated licensure within next 5 years
2. Development of prioritisation criteria through Gavi stakeholder consultations
3. Assessment of vaccines against criteria
4. 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
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 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 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
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
Healthimpact
Impact on child mortality
Impact on overall mortality
Impact on overall morbidity
Additionalimpact
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
Healthimpact
Impact on child mortality
Impact on overall mortality
Impact on overall morbidity
Additionalimpact
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)
1. Further, in-depth assessment of shortlisted vaccines
2. Comparison with current Gavi portfolio to determine value-add
3. Independent expert validation of analyses
4. Country consultations
5. Development of investment recommendations
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
VIS lessons learned
• VIS process led to a set of defensible investment recommendations
and consensus among key Gavi stakeholders
• Success factors: robust evidence-base; clear decision framework
and full transparency of the process; active stakeholder engagement
and consultation; independent expert validation of analyses
• Multi-step process with many qualitative and quantitative inputs;
methodology evolved in the course of the process
• Evaluation criteria formed a framework to help facilitate comparison
and prioritisation; ranking difficult: no single algorithm can do
justice to the diverse considerations relevant for prioritisation
• Limited focus on DALYs and inability to conduct comprehensive CEA
• Critical and consistent evidence gaps for some vaccines: missed
opportunities?
9
VIS 2008: Typhoid update
• 2008 VIS recommended a one-time catch up campaign
targeting children 1-14 yo + routine immunisation of infants
• Assumptions: A TCV was expected to reach WHO PQ status in
2011; 24 countries projected to apply for typhoid vaccine support
• Taking stock:
• Timeline of lead conjugate (Bharat) PQ unclear
• Demand uncertainties
• SAGE review of TCVs in 2017/2018
• Potential way forward: refresh investment case for typhoid in
parallel to new VIS strategy
• Need to better understand (and generate) demand; engage with
research community pre-2018
10
VIS 2013: Malaria / rts,s next steps
Gavi Board requested an updated assessment following
conclusion of trials and SAGE recommendation
• Updated demand scenarios, impact estimates and
comparison with impact of current Gavi vaccines
• Updated cost and value for money estimates
• Preliminary implementation approaches in coordination with
the Global Fund (application process, M&E, etc.)
December 2015 / June 2016: Gavi Board review of options
for a possible role in supporting rts,s implementation
11
VIS 2013: updates on VIS learning agenda
Cholera
• Evidence gaps: lack of vaccine effectiveness data for targeted
vaccination strategy, unsure of demand and impact and
programmatic feasibility
• Decision: global cholera vaccine stockpile contribution for
epidemic response + research investment to understand role of
OCV in endemic settings
Rabies
• Evidence gaps: lack of understanding of burden, lack of ability to
predict demand; equity and feasibility issues related to whether Gavi
would need to support Rabies Immunoglobulines (risk issue),
sustainability issues
• Decision: investment in research on feasibility of Gavi support
for rabies vaccines
12
Three work streams under learning agenda to inform VIS 2018
Sept 2015 Sep 20172014
Assessments
inform 2018 VIS
Implement
Assessments
Commission assessments
2018
• Cholera: Cost-efficient strategies for OCV use in endemic
settings
• Rabies 1: Evaluate the feasibility and logistic requirements of
increasing access to post-exposure prophylaxis rabies
vaccination in existing programmatic experiences
• Rabies 2: Estimate (vaccine-preventable) rabies burden and
vaccination impact in endemic Gavi countries
Planned activities for learning agenda
Cholera
1. Mass campaign in 1-14yo in endemic setting in Bangladesh;
focus on feasibility/coverage
2. 5-year and age-specific VE and impact in Haiti (TBC)
Rabies
1. Prospective burden and impact measurement in Chad, Mali,
Cote d’Ivoire
2. Leverage existing country data to strengthen disease burden
estimates and descriptive analysis of existing program
management, with a focus on Asian countries
Next steps for VIS 2018
• Explore typhoid conjugate vaccine research engagement
• Implement learning agenda for cholera and rabies
• Monitor other vaccine developments (influenza, RSV, etc.)
• Q4 2015 / Q1 2016: partner meeting to plan for VIS 2018
• Process and timelines
• Metrics and inputs
• Scope of potential investments
• Key evidence gaps/needs
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