The document discusses five elements that are important for the introduction and implementation of dengue vaccines: establishing disease burden data and cost-effectiveness analyses, conducting vaccine introduction trials and effectiveness evaluations, developing international recommendations for vaccine use, ensuring adequate and competitive vaccine supply, and creating funding mechanisms for procurement. It also outlines the current status and challenges for each of these elements and proposes next steps like developing country-specific plans through regional seminars.

1. Overview: What do we know about dengue
vaccine introduction and implementation?
Richard T. Mahoney, PhD
Director, Vaccine Access
Pediatric Dengue Vaccine Initiative
International Vaccine Institute
Seoul, Korea

2. Five elements of vaccine introduction
 Establishment and dissemination of disease burden
data and cost effectiveness computations
 Vaccine introduction trials and effectiveness
evaluations
 Establishment of an international consensus on
recommendations for vaccine use
 Assurance of adequate and competitive vaccine
supply
 Creation of funding mechanisms to supply vaccine
to countries unable to finance their own
procurement
Mahoney R and Maynard J, Introduction of new vaccines into developing countries, Vaccine,
19, pp 646-52, 1999.

3. “Why are we talking about these things
now? Isn’t it too early? We don’t even
have a licensed vaccine!”
 How long will it take to develop, validate,
distribute, and plan for use of provisional
immunization strategies?
 How long will it take to develop an easily
useable, country-specific economic model
and have a large number of endemic
countries apply it in decision making?
 How long will it take for several NRAs to
have the tools and capability to review
applications for licensure of new vaccines?
 ……

4. Establishment and dissemination of disease burden data
and cost effectiveness computations
 Status
– Limited studies on disease burden
– Few studies on cost effectiveness of vaccination
 Challenges
– High morbidity but not well quantified – need more studies
– High economic impact – need comparative studies with
other diseases
– Don’t know how vaccine will be delivered – cost
implications – need provisional immunization strategies
– Don’t know cost of vaccine – need cost of goods studies

5. Vaccine introduction trials and
effectiveness evaluations
 Status
– Multiple vaccines under development.
– PDVI has established an international Field Site
Consortium with >10 members
– Developers/producers also have identified other
field sites for clinical evaluation
 Challenges
– Need to develop protocols for Phase 4 trials
– Need to evaluate use of multiple vaccines in one
country
– Need to mobilize funding

6. Establishment of an international
consensus on recommendations for
vaccine use
 Status
– High priority among policy makers in endemic countries
(PDVI studies)
– Low to ? priority among policy makers in global health
community
– WHO Guidelines on Vaccine Evaluation, strong efforts by
PAHO
– Controversy about potential safety issues, e.g. ADE
 Challenges
– Need to develop provisional strategies for vaccine delivery
– Need to plan for SAGE review and WHO/PAHO support
– Need to expand information and communication
programs, e.g. convene Global Summit

7. Assurance of adequate and
competitive vaccine supply
 Status
– Developer/producers in U.S., Europe, Brazil, India, and Vietnam
– Preliminary market studies estimate global need of several
hundred million doses – Americas public sector alone may need
up to 100 million doses
– WHO beginning work on updated Guidelines for Production
 Challenges
– sanofi pasteur, with most advanced candidate, planning 100
million dose plant – need more global capacity
– Other developer/producers farther back in development –
unknown capacity plans
– Pre-qualification assessments
– Need more sophisticated potential market studies
– Unknown cost of production – what is the lower limit of price?

8. Vaccine Supply (millions of doses)
Doses for all vaccines supplied by GAVI
120
100
80
(millions)
Industrialized
60
Emerging
40
20
Source: GAVI Report
2007
0
2001 2002 2003 2004 2005 2006 2007

9. Creation of funding mechanisms to
supply vaccine to countries unable to
finance their own procurement
 Status
– GAVI and PAHO Revolving Fund potentially available
– Middle income endemic countries probably willing to buy
with own funds
 Challenges
– “Competition” with rotavirus, pneumococcal vaccine, HPV,
and potentially JE and malaria – need to understand how
to address this competition
– No funds actually in view for dengue vaccine procurement
– need to begin specific efforts to mobilize funds

10. Summary
 No, it’s not too early. It’s LATE!

11. Prevention Board Report - The DPB’s
statement as to the way forward.
 “Status Report and Road Map for Dengue
Vaccine Introduction and Implementation.”
 Use Report along with “Provisional
Immunization Strategies” and “Opportunities
and Challenges Report” and others as basic
documents for national or regional seminars
to begin planning for introduction
 Update as more information becomes
available

13. Proposed Americas Work Plan
 July 2009 Americas DPB meeting
 September 2009 Draft report to Board members
 November 2009 Monograph ready for publication
 December 2009 PDVI publishes Monograph
 Throughout 2010 – national/regional seminars?
 (Asia Pacific Report should be available mid-2010)
 2011/2012 – Global Summit

14. GAVI countries in the Americas
 Bolivia
 Cuba
 Guyana
 Haiti
 Honduras
 Nicaragua

15. Vaccine dose estimates in
Public Sector in Americas
Estimated five-year need (millions)
12-23 Per year
Schedule month 2-14yr Total average
2-Dose 90.5 240.1 330.6 66.6
3-Dose 134.5 337.4 471.9 94.4