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13th GAVI BOARD MEETING
Washington, DC, 6-7 July 2004
FINAL SUMMARY REPORT
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12. Report of the ADIP Management Committee
- The ADIP Management Committee has reviewed and endorsed the progress of both the Rotavirus and Pneumococcal ADIPs.
- The rapid progress of the new rotavirus vaccines are an exciting development with attention of the two lead companies being focused on the needs of both the developed and developing world. Glaxo Smithkline (GSK) is planning to launch its product first in middle income countries prior to introduction in Europe. Merck & Co, plans to file its product simultaneously in the developed and middle income countries.
- The Rotavirus ADIP is working with both companies to conduct studies in developing countries, where rotavirus diarrhea has a high mortality/morbidity, as it is uncertain how either product will perform in Vaccine Fund eligible countries.
- Considering the experience with Hib, reliable disease burden data must be available before considering widespread introduction of rotavirus vaccines in Vaccine Fund eligible countries.
- WHO is in contact with the Mexican national regulatory authority (NRA) about moving ahead on the pre-qualification process of the NRA, a step needed for the NRA to function as a reference authority. The timeline for the process is unclear.
- Regina Rabinovitch will from now on represent the Gates Foundation on the ADIP Management committee, replacing Rick Klausner.
DECISIONS
The Board:
12.1 Endorsed the report of the meeting and the progress of the Rotavirus and Pneumococcal ADIPs
12.2 Requested the Rotavirus ADIP to explore opportunities to participate in testing and pilot introduction of the rotavirus vaccine candidates to, (1) develop necessary data for support of widespread introduction in developing countries including Vaccine Fund eligible countries and (2) address issues of strategic importance to GAVI & The Vaccine Fund such as assessing the feasibility of the vaccine's introduction in poor countries with weak health infrastructure.
12.3 Agreed to establish a small, time-limited group to explore with GSK and Merck (at this stage) the technical, scientific and cost characteristics required for early introduction of rotavirus vaccines in Vaccine Fund eligible countries. Price/volume negotiations would then be conducted with the companies.
12.3.1 The composition of the group is: John Wecker, Rotavirus ADIP Exec. Dir.; Orin Levine, Pneumococcal ADIP Exec. Dir.; Jan Holmgren, Chair of ADIP Mgmt Comm; Kevin Reilly, Member Mgmt Comm; Regina Rabinovich, Gates Foundation; Steve Jarrett, UNICEF Supply Division; Jacques-Francois Martin, The Vaccine Fund, Marie-Paule Kieny, WHO, and Tore Godal, GAVI Secretariat.
12.3.2 The group will need to begin work immediately; its terms of reference will be shared with the Executive Committee and the Board.
12.3.3 The Group will report through the ADIP Management Committee to the full Board at its next meeting.
12.4 Requested UNICEF to clarify why it has not yet signed the Memorandum of Understanding (MOU) with the Rotavirus ADIP at PATH. The UNICEF representative promised to provide the Board with a written update by email, as the information was not available at the time.
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