Accelerated Introduction of New Vaccines

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Accelerated Introduction of New Vaccines

• Prof. Jan Holmgren

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Outline

• Background GAVI new vaccines
• The ADIP Management Committee
• Moving forward
• Present proposals
• I - Pneumococcal surveillance
• II - Rota clinical trials
• Management Committe recommendations
• Proposed timeline

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Background GAVI new vaccines

• GAVI objectives ? Accelerate the introduction of
  new vaccines
• 2002 Accelerated Development and Introduction
  Plans (ADIPs)
• PneumoADIP
• Rotavirus Programme
• 2005 Hib Initiative
• Progress and Achievements
• Vaccine value establish, communicate, deliver

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The Management Committee

• Mandate
• Ensure ADIPs progress achievements
• Offer guidance to GAVI Board
• Members
• Expertise
• Representation of stakeholders
• Seattle decisions
• financial technical reports endorsed

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Moving forward

• ADIP evaluation
• March Joint EC recommendations
• Request for investment cases
• Request for recommendation by the MC to move
  forward with critical time-sensitive activities
  towards introduction of vaccines (independent of
  evaluation outcome)

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Present proposals - I

• Rotavirus vaccine
• Phase 3 clinical trials of Merck vaccine in
  Africa and Asia
• Time-sensitivity
• Costs 15 million
• The Management Committee has reviewed and
  endorsed the proposal and recommends approval by
  the GAVI Alliance Board

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Present proposals - II

• Pneumococcal vaccine
• Evaluating the impact of introduction of the
  7-valent pneumococcal vaccine in Gambia and in
  the Kilifi District of Kenya
• Time-sensitivity
• Costs 7.3 million
• The Management Committee has reviewed and
  endorsed the proposal and recommends approval by
  the GAVI Alliance Board

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Proposed timeline

• June / July GAVI Alliance / Fund Boards
• Request for investment cases
• Additional funding ADIPs
• Hib Initiative Work Plan
• September Joint ECs
• Progress on investment cases and GAVI evaluation
• November Joint GAVI Boards
• ADIP evaluation
• Review of investment cases

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For decision

• The Board is requested to
• Confirm the request by the Alliance and Fund ECs
  for investment cases for the introduction of
  rotavirus and pneumococcal vaccines, to be
  submitted to the November 2006 joint meeting of
  the GAVI Alliance and GAVI Fund Boards.
• Approve US 15 million for the completion of
  clinical trials of rotavirus vaccines in Africa
  and Asia during the period 2006 2009 (following
  endorsement by the ADIP Management Committee).
• Approve US 7.3 million for the surveillance
  activities needed for the assessment of the
  impact of the pneumococcal vaccine in the Gambia
  and Kenya for the period 2006 2007 (following
  endorsement by the ADIP Management Committee).
• Approve the Hib Initiative 2006 2007 Work Plan
  and budget (following endorsement by the ADIP
  Management Committee).