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Introduction Of New Vaccines In The Public Market
1. Introduction of new vaccines in theIntroduction of new vaccines in the
public market of developing countries,
strategy definition and planning
Stefano Malvolti
Director Strategic Vaccine Supply, PATH
2. First of all, let me introduce myself …
• Strategic Vaccine Supply Director @ PATH in
charge of strategic demand and supply
forecasting for GAVI vaccines portfolio
• 2005-2008 Global Head of Forecasting @
Novartis PharmaNovartis Pharma
• 2000-2005 Head Global Sales & Operation
planning / Strategic Planning @ Baxter
Healthcare
• MSc in Business Administration @ Bocconi
University in Milan – dissertation on “Strategy,
mental models and organizational learning”
6/7/2010 2Strategic Vaccine Supply
3. … and let me share the objectives of this
session
• Share best practices in public sector
vaccine demand forecasting
• Stimulate discussion on role of strategic
forecasting as cornerstone of strategy
formulation and implementationformulation and implementation
• Showcase the potential of private-public
partnerships in vaccine introduction
6/7/2010 3Strategic Vaccine Supply
4. This session will focus on six main
themes
• Partnering for introduction - PATH a catalyst
for global health
• Understanding demand potential - strategic
demand forecasting
• Translating strategy into measurable and
operational objectives - strategic planningoperational objectives - strategic planning
• Communicating the strategy - building the
case and managing expectations
• Executing the strategy - introduction planning
and fine tuning strategy and forecasts
• Improving the strategy - activating the
feedback loop
6/7/2010 4Strategic Vaccine Supply
5. • Partnering for introduction - PATH a
catalyst for global health
• Understanding demand potential - strategic
demand forecasting
• Translating strategy into measurable and
operational objectives - strategic planning
This session will focus on six main
themes
operational objectives - strategic planning
• Communicating the strategy - building the
case and managing expectations
• Executing the strategy - introduction planning
and fine tuning strategy and forecasts
• Improving the strategy - activating the
feedback loop
6/7/2010 5Strategic Vaccine Supply
6. PATH a catalyst for global health
An international nonprofit organization that creates
sustainable, culturally relevant solutions, enabling
communities worldwide to break longstanding cycles
of poor health through collaboration with diverse
public- and private-sector partners.public- and private-sector partners.
PATH: Arvind Chengi
• Health technologies
• Maternal and child health
• Reproductive health
• Vaccines and immunization
• Emerging and epidemic
diseases
6/7/2010 6Strategic Vaccine Supply
7. VAD: the partner for vaccine access in
the public health space
Reduce morbidity and mortality from vaccine
preventable diseases by improving access to
appropriate traditional, underutilized, and new
vaccines.
Shape Health Attack Syndromic Advocate for PriorityShape Health
Policy
Attack Syndromic
Diseases
Advocate for Priority
Advocacy
Communication
Demand & Supply
Forecasting
Evidence Generation
Immunization Systems
Policy Development
Project Management
6/7/2010 7Strategic Vaccine Supply
8. Sufficientquantityofsafe,
effectiveappropriate
vaccinetomeetdemand
SVS: the partner for execution of vaccine
introduction in developing countries
• DEMOGRAPHY &
EPIDEMIOLOGY
• PRODUCT PROFILE
• PREFERENCES
• PRICING
• COST OF GOOD
SUPPLY- DEMAND MATCHING
STRATEGIC
DEMAND FORECASTING
6/7/2010 8
quantityofsafe,
effectiveappropriate
vaccinetomeetdemand
FORECASTING PROCESSES & POLICIES
FORECAST MODEL
INFORMATION SHARING PLATFORM
Infrastructure
• COST OF GOOD
• LOGISTIC REQS
• PIPELINE
STRATEGIC
SUPPLY FORECASTING
Strategic Vaccine Supply
9. Agenda
• Partnering for introduction - PATH a catalyst
for global health
• Understanding demand potential -
strategic demand forecasting
• Translating strategy into measurable and
operational objectives - strategic planningoperational objectives - strategic planning
• Communicating the strategy - building the
case and managing expectations
• Executing the strategy - introduction planning
and fine tuning strategy and forecasts
• Improving the strategy - activating the
feedback loop
6/7/2010 9Strategic Vaccine Supply
10. Demand
ForecastDosage
Target
population
Intro Date
Demography
& Epidemiology
Simple modeling allow focusing
discussion on key strategic variables
WHO &
Concomit-
ant intro
6/7/2010 10
Coverage
Target
Coverage
Introduction
Analogue
Coverage
Analogue
Uptake
Wastage
Buffer
Stocks
Required
Supply
(SDF)
Co financing
& Pricing
Cost to
GAVI
Independent variables
Dependent variables
Product
Share
Conjoint
Supply
Availability
Supply
Forecast
Cost to
Country
Strategic Vaccine Supply
11. Demographic, coverage &size of private
market determines target population
Total
Population
Crude Birth
Rate
Current
Birth Cohort
Infant Mortality
Rate
Surviving
Routine
Past Birth
Cohorts
Catch-Up
Surviving
Surviving
Infants
Vaccinated via
public support
Vaccinated in
EPI
Routine
Immunization
Coverage
Catch-Up
Coverage
Vaccinated in
Catch-Up
campaigns
Total
Vaccinated
Surviving
population at
age x
Private market
6/7/2010 11Strategic Vaccine Supply
12. Decision making process mirrored into
estimate of introduction dates
Interest &
Intention to
Pre-Intro
Activities
IRC
Review &
Board
Application
Submission
Application
Preparation
Projected
Intro
Success Ratio based
on historical data
Standard time+
potential additional
delay
Min. 6 months Min. 3 months Min. 12 months1-2 years
6/7/2010 12
Intention to
Apply
Activities
Board
Approval
(twice p.a)
Submission
(twice p.a)
Preparation
Intro
Date
WHO regional offices & HQ
UNICEF regional offices & HQ
via NUVI quarterly calls & meetings
WHO
GAVI Program Delivery
CCL & Large Country Input
Concomitant
Introduction
Strategic Vaccine Supply
13. Standardized approach for coverage
projections allow focusing on exceptions
1. If historical coverage increases steadily, continue up to 90%
2. If decreasing, flat, or variable, increase 1% per annum (p.a.) up to 90%
3. If previously above 90% return to that level at 1% p.a.
4. If steady above 90%, remain at that level
Example 1 :
Niger has a steady
Niger Coverage Trend vs. Rules
60%
70%
80%
90%
100%
Coverage
6/7/2010Strategic Vaccine Supply 13
Niger has a steady
trend (rule 1), which
is continued up to
90%
Example 2 :
Mozambique has a
flat trend (rule 2),
which is projected to
increase at 1% p.a.
Mozambique Coverage Trend vs. Rules
60%
65%
70%
75%
80%
85%
90%
95%
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Coverage
Manually Chosen Historical Data
0%
10%
20%
30%
40%
50%
60%
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Coverage
Manually Chosen Historical Data
14. Time to peak estimate dependent on
country size
• Small countries (birth cohort < 1m SI) take 2 years to uptake
• Med/Large countries (birth cohort between 1m and 3.5m SI) take
3 years to uptake
• Very Large (birth cohort >3.5m SI): take 4 years to uptake**
• Different uptake is used for catch-up campaigns
6/7/2010 14
Year 1 Year 2 Year 3 Year 4
Small 50% 100% 100% 100%
Med/Large 45% 75% 100% 100%
Very Large 35% 65% 85% 100%
First 4 years of Penta coverage
40%
60%
80%
100%
120%
Small Large All
Small 68% 91% 108%
Large 62% 85% 81%
All 64% 88% 95%
Year 1 Year 2 Year 3
Strategic Vaccine Supply
15. Uptake speed dependent on vaccine type
• New Vaccine replacing analogue: Penta, Rubella
• New Vaccine with analogue schedule: Pneumo, YF, JE
• New Vaccine with slightly different schedule (partial analogue
overlap): Rota, MenA
• New Vaccine with no overlap (non-EPI): HPV, Typhoid
Vaccine replacing analogue: Penta, Rubella
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
Assume: Small countries take 1.75 years to uptake Samll: 0% 60% 100%
Large countries take 2.5 years to uptake Large: 0% 50% 90% 100%
Exception: Indonesia, Pakistan, and Nigeria Exception: 0% 40% 70% 90% 100% 20%
40%
60%
80%
100%
6/7/2010 15
Exception: Indonesia, Pakistan, and Nigeria Exception: 0% 40% 70% 90% 100%
take 4 years to uptake
New Vaccine with analogue schedule: Pneumo, YF, JE
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
Assume: Small countries take 2 years to uptake Samll: 0% 50% 100%
Large countries take 3 years to uptake Large: 0% 45% 75% 100%
Exception: Indonesia, Pakistan, and Nigeria Exception: 0% 35% 65% 85% 100%
take 4 years to uptake
New Vaccine with slightly different schedule: Rota, MenA
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
Assume: Small countries take 2.5 years to uptake Samll: 0% 50% 90% 100%
Large countries take 3.5 years to uptake Large: 0% 40% 70% 90% 100%
Exception: Indonesia, Pakistan, and Nigeria Exception: 0% 30% 55% 75% 90% 100%
take 4.5 years to uptake
New Vaccine with no overlap (non-EPI): HPV, Typhoid
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
Assume: Small countries take 3 years to uptake Samll: 0% 40% 75% 100%
Large countries take 4 years to uptake Large: 0% 25% 50% 75% 100%
Exception: Indonesia, Pakistan, and Nigeria Exception: 0% 20% 40% 60% 80% 100%
take 5 years to uptake
0%
20%
40%
60%
80%
100%
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
0%
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
0%
20%
40%
60%
80%
100%
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
0%
20%
40%
60%
80%
100%
Year 0 Year 1 Year 2 Year 3 Year 4 Year 5
Strategic Vaccine Supply
16. Scarce information available make
validation process even more crucial
Assumption Ptrimary Source Benchmarks and alternative inputs
Introduction date WHO (NUVI) UNICEF - Local sources
Cross vaccines validation
Uptake (time to match
target coverage)
AVI WHO / Analogues / Intelligence from
other sources
Target Coverage
(historical data)
WHO-UNICEF
estimate
cMYP – Specific studies
Target Coverage GAVI-WHO GAVI / Benchmarks
6/7/2010Strategic Vaccine Supply 16
Target Coverage
(projections)
GAVI-WHO
standard rule (draft)
GAVI / Benchmarks
Target population UNPD Country applications
Dosage Vaccine specific
Wastage/Buffer stocks WHO GAVI / Specific Studies
Vaccination Schedule WHO
Product Share Market Research
Supply availability SVS Intelligence from other sources
Pricing / Co-financing GAVI
17. Agenda
• Partnering for introduction - PATH a catalyst
for global health
• Understanding demand potential - strategic
demand forecasting
• Translating strategy into measurable and
operational objectives - strategic planningoperational objectives - strategic planning
• Communicating the strategy - building the
case and managing expectations
• Executing the strategy - introduction planning
and fine tuning strategy and forecasts
• Improving the strategy - activating the
feedback loop
6/7/2010 17Strategic Vaccine Supply
18. Process to be designed to ensure
multiple input and sign-off
SVS
benchmarks
assumption
Assumption
owners provide
input
SVS runs
forecast
Feedback
Feedback
6/7/2010Strategic Vaccine Supply 18
SVS
consolidates all
countries
(with and w/o India)
SVS Sub team
reviews and
approves draft
SVS Director
presents to PLT
for approval
AVI AMT / GAVI
reviews and
approves
Version Locked
Feedback
SVS Director
distributes
19. Assumptions clearly spelled out define
conditions for the forecast to be true
Finance &
support
• No global financial and supply constraints included into the demand forecast
• GAVI support based on revised eligibility approved by November 2009 board (prev. slide)
• One round of applications in September 2010, 2 rounds p.a. from 2011
• NVS support at country level (no separate state support)
• Once approved, GAVI commitment to countries ensures 5 years protection from graduation
• Financing available for product purchase & introduction costs (AMC / GAVI / local gov’nt)
confirmed after prioritization work
• Sustainable co-financing prices (also after 2010 policy revision)
• PAHO single price clause not impacting negatively intention to introduce from manufacturers
6/7/2010Strategic Vaccine Supply 19
• PAHO single price clause not impacting negatively intention to introduce from manufacturers
Target
Population
• Surviving Infants based on 2008 UN population prospect, medium variant for population, birth
& infant mortality rates (Cameroon & Congo based on more updated country census)
Products • All products WHO pre-qualified, meet or exceed AMC profile and have suitable presentation
• Mix of international and developing countries suppliers ensures no capacity constraint; first
dev’ countries products to become available in 2015
• India preference for introduction with local manufacturer can be derogated in the first years
• Schedule = 6, 10 and 14 weeks of age with DTP or Pentavalent / No Booster – some
countries as India may have different schedule
• Presentation = 1-dose and 2-dose liquid vials
20. Close feedback loop activated between
workplan and forecasts
6/7/2010 20Strategic Vaccine Supply
21. Agenda
• Partnering for introduction - PATH a catalyst
for global health
• Understanding demand potential - strategic
demand forecasting
• Translating strategy into measurable and
operational objectives - strategic planningoperational objectives - strategic planning
• Communicating the strategy - building the
case and managing expectations
• Executing the strategy - introduction planning
and fine tuning strategy and forecasts
• Improving the strategy - activating the
feedback loop
6/7/2010 21Strategic Vaccine Supply
24. Agenda
• Partnering for introduction - PATH a catalyst for
global health
• Understanding demand potential - strategic
demand forecasting
• Translating strategy into measurable and
operational objectives - strategic planningoperational objectives - strategic planning
• Communicating the strategy - building the case
and managing expectations
• Executing the strategy - introduction planning
and fine tuning strategy and forecasts
• Improving the strategy - activating the feedback
loop
6/7/2010 24Strategic Vaccine Supply
26. Monitoring of introduction progress
critical for project success
Action Responsible Deadline Status Comments
Availability of Financial Resources ☺ ? N/A
GAVI finances cover country’s introduction GAVI ☺ ? N/A
Vaccine co-pay terms met GAVI ☺ ? N/A
Country’s local financial needs budgeted GAVI/WHO ☺ ? N/A
Supply Considerations ☺ ? N/A
Vaccine and injection supplies confirmed UNICEF SD ☺ ? N/A
PentaPneumoRubellaRotaJE
Country 6Country 1 Country 3Country 2 Country 4 Country 5 Country 6 Country 7 Country 8
Approval or registration requirements met UNICEF SD ☺ ? N/A
Country Preparedness ☺ ? N/A
Logistics WHO/UNICEF ☺ ? N/A
Cold chain infrastructure has sufficient
capacity at central, regional and district
levels
WHO/UNICEF ☺ ? N/A
Transport WHO/UNICEF ☺ ? N/A
Sufficient Waste Management capacity WHO/UNICEF ☺ ? N/A
Training & Mobilization WHO ☺ ? N/A
Advocacy and communication WHO ☺ ? N/A
Monitoring & Evaluation Capacity ☺ ? N/A
Surveillance (AEFI and sentinel) WHO ☺ ? N/A
Programmatic monitoring UNICEF ☺ ? N/A
RubellaYellowFeverMeningitisATyphoidHPV
6/7/2010 26Strategic Vaccine Supply
27. Resources monitoring & corrective plans
in place to deal with alternative scenarios
• Resources for critical work plan areas
closely monitored by introduction team
and appropriate risk-mitigation plans
prepared in case of resources at risk
• Areas lagging behind in implementation• Areas lagging behind in implementation
carefully assessed by introduction team
and appropriate plans developed /
resources identified
6/7/2010 27Strategic Vaccine Supply
28. Agenda
• Partnering for introduction - PATH a catalyst
for global health
• Understanding demand potential - strategic
demand forecasting
• Translating strategy into measurable and
operational objectives - strategic planningoperational objectives - strategic planning
• Communicating the strategy - building the
case and managing expectations
• Executing the strategy - introduction planning
and fine tuning strategy and forecasts
• Improving the strategy - activating the
feedback loop
6/7/2010 28Strategic Vaccine Supply
29. Feedback loop between strategy & execution
activate to ensure alignment and consistency
Project Goal
Execution
6/7/2010Strategic Vaccine Supply 29
Strategy
definition
Planning
Resource
mobilization
