Overview: What do we know about dengue
vaccine introduction and implementation?



       Richard T. Mahoney, PhD


      ...
Five elements of vaccine introduction


      Establishment and dissemination of disease burden
       data and cost effe...
“Why are we talking about these things
now? Isn’t it too early? We don’t even
have a licensed vaccine!”
   How long will ...
Establishment and dissemination of disease burden data
         and cost effectiveness computations


   Status
    – Lim...
Vaccine introduction trials and
       effectiveness evaluations

   Status
    – Multiple vaccines under development.
  ...
Establishment of an international
     consensus on recommendations for
                vaccine use
   Status
    – High ...
Assurance of adequate and
        competitive vaccine supply
   Status
    – Developer/producers in U.S., Europe, Brazil,...
Vaccine Supply (millions of doses)
Doses for all vaccines supplied by GAVI



                                          12...
Creation of funding mechanisms to
    supply vaccine to countries unable to
       finance their own procurement
   Statu...
Summary

   No, it’s not too early. It’s LATE!
Prevention Board Report - The DPB’s
statement as to the way forward.

   “Status Report and Road Map for Dengue
    Vacci...
Proposed Americas Work Plan

   July 2009 Americas DPB meeting
   September 2009 Draft report to Board members
   Novem...
GAVI countries in the Americas

   Bolivia
   Cuba
   Guyana
   Haiti
   Honduras
   Nicaragua
Vaccine dose estimates in
            Public Sector in Americas

            Estimated five-year need (millions)
         ...
Mahoney Panama Dpb July 2009 V2
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Mahoney Panama Dpb July 2009 V2

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Overview of Americas Dengue Prevention Board meeting on Implementation, Panama City, July 8-10, 2009

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Mahoney Panama Dpb July 2009 V2

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 10. Summary  No, it’s not too early. It’s LATE!
  11. 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
  12. 12. 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
  13. 13. GAVI countries in the Americas  Bolivia  Cuba  Guyana  Haiti  Honduras  Nicaragua
  14. 14. 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

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