Accelerating pneumococcal and rotavirus vaccine introduction

1. Accelerating pneumococcal and rotavirus vaccine introduction Dr. Rosamund Lewis GAVI Secretariat GAVI Alliance & Fund Board meetings 28 & 29 November 2007 Good afternoon, Honourable ministers, distinguished members of the board, ladies and gentlemen. Good afternoon, Honourable ministers, distinguished members of the board, ladies and gentlemen.

2. Introduction As we heard from several speakers over the last two days, accelerating pneumococcal and rotavirus vaccine introduction is central the mission of GAVI. It is also critical to the ability of countries to make progress towards the Millennium Development Goals, in particular MDG 4 of reducing child deaths. Through dialogue over the last few months, the GAVI alliance proposes an approach to accelerate introduction of these vaccines, an approach that includes a role for each alliance parnter, additional support from civil society and the private sector through outsourcing, and strengthened coordination. As we heard from several speakers over the last two days, accelerating pneumococcal and rotavirus vaccine introduction is central the mission of GAVI. It is also critical to the ability of countries to make progress towards the Millennium Development Goals, in particular MDG 4 of reducing child deaths. Through dialogue over the last few months, the GAVI alliance proposes an approach to accelerate introduction of these vaccines, an approach that includes a role for each alliance parnter, additional support from civil society and the private sector through outsourcing, and strengthened coordination.

3. Accelerating pneumococcal and rotavirus vaccine introduction: Outline Collaborative process to develop proposal Activities for successful vaccine introduction Current GAVI support for vaccine introduction Lessons learned Proposal to strengthen GAVI support to pneumococcal and rotavirus vaccine introduction Request to board In this presentation we will briefly cover the collaborative process to develop a proposal, a bird�s eye view of activities required for vaccine introduction, what GAVI is already doing to support vaccine introduction in general and the lessons learned from that. We will present the general approach for a proposal to strengthen GAVI support for pneumococcal and rotavirus vaccines, and request your guidance on that approach.In this presentation we will briefly cover the collaborative process to develop a proposal, a bird�s eye view of activities required for vaccine introduction, what GAVI is already doing to support vaccine introduction in general and the lessons learned from that. We will present the general approach for a proposal to strengthen GAVI support for pneumococcal and rotavirus vaccines, and request your guidance on that approach.

4. The collaborative process to date Pneumococcal and rotavirus vaccine investment cases approved in November 2006 for $200 million, with $78 million for strategic and technical activities (Nov 2006) Evaluation of the pneumoADIP / Rotavirus Vaccine Program / Hib Initiative presented to board (May 2007) Discussion paper for accelerating introduction of pneumococcal and rotavirus vaccines (Aug - Sept) Proposals discussed by GAVI Senior Management Team ADIP Management Committee GAVI Working Group GAVI boards for guidance (Nov 2007) This is just to remind you that the pneumococcal and rotavirus vaccine investment cases were approved by the board in November 2006, for a total of $200 million, including $78 million for strategic and technical activities to support introduction till 2010. Of this, the extension of the ADIPs for 2008 will consume $20 million: (RVP $8.8 m, pneumoADIP $11.2 m). You have also just approved the 2008 workplan, which includes $3.6 m for the secretariat and partners, primarily WHO, for the first 6 months of 2008. Following presentation of the ADIP and Hib Initiative evaluation in May 2007, the board asked the secretariat to work with partners to identify the additional support required for introduction of rotavirus and pneumococcal vaccines, who should implement them, and the level of funding required. The discussion paper prepared has been discussed by the GAVI Senior Management Team, the Working Group, the ADIP Management Committee and the expanded vaccine investment strategy steering committee. Countries are represented in these fora. We also put out a request for input through Global Immunization News newsletter, and countries were consulted during a pneumonia prevention advocacy meeting in Tanzania in October. Other systematic efforts to consult countries will be made as we move forward. At this stage we are seeking your guidance on the general approach. This is just to remind you that the pneumococcal and rotavirus vaccine investment cases were approved by the board in November 2006, for a total of $200 million, including $78 million for strategic and technical activities to support introduction till 2010. Of this, the extension of the ADIPs for 2008 will consume $20 million: (RVP $8.8 m, pneumoADIP $11.2 m). You have also just approved the 2008 workplan, which includes $3.6 m for the secretariat and partners, primarily WHO, for the first 6 months of 2008. Following presentation of the ADIP and Hib Initiative evaluation in May 2007, the board asked the secretariat to work with partners to identify the additional support required for introduction of rotavirus and pneumococcal vaccines, who should implement them, and the level of funding required. The discussion paper prepared has been discussed by the GAVI Senior Management Team, the Working Group, the ADIP Management Committee and the expanded vaccine investment strategy steering committee. Countries are represented in these fora. We also put out a request for input through Global Immunization News newsletter, and countries were consulted during a pneumonia prevention advocacy meeting in Tanzania in October. Other systematic efforts to consult countries will be made as we move forward. At this stage we are seeking your guidance on the general approach.

5. Activities for successful vaccine introduction As you all know, successful vaccine introduction requires a full range of activities, led by countries and their development partners. During and following vaccine development (which of course is led by industry with contributions from academia), but prior to introduction, activities include those listed here, from establishment of disease burden through high-quality surveillance, economic evaluation, demand forecasting and supply planning, to licensing and pre-qualification. GAVI has primarily supported these activities through the creation of the ADIPS, which are now reaching the end of their extended mandate in 2008. As you have just heard, similar activities are led for a number of vaccines through other mechanisms, such as the BMGF funded meningitis vaccine programme. The introduction phase, led by countries and their partners, also needs to be carefully managed, ensuring integrated progress in all these areas of activity listed here, but now more focused on the country level, such as support for country decision-making, still surveillance, vaccine introduction and financing strategies, and advocacy and social mobilisation. This has been the focus of the work of the Hib initiative. Finally partners continue to support countries following implementation in a variety of programme areas to enhance sustainability.As you all know, successful vaccine introduction requires a full range of activities, led by countries and their development partners. During and following vaccine development (which of course is led by industry with contributions from academia), but prior to introduction, activities include those listed here, from establishment of disease burden through high-quality surveillance, economic evaluation, demand forecasting and supply planning, to licensing and pre-qualification. GAVI has primarily supported these activities through the creation of the ADIPS, which are now reaching the end of their extended mandate in 2008. As you have just heard, similar activities are led for a number of vaccines through other mechanisms, such as the BMGF funded meningitis vaccine programme. The introduction phase, led by countries and their partners, also needs to be carefully managed, ensuring integrated progress in all these areas of activity listed here, but now more focused on the country level, such as support for country decision-making, still surveillance, vaccine introduction and financing strategies, and advocacy and social mobilisation. This has been the focus of the work of the Hib initiative. Finally partners continue to support countries following implementation in a variety of programme areas to enhance sustainability.

6. Countries Vaccines, Communications, Training, Record-keeping, Surveillance & laboratory, Cold chain, Health system / CSO Partners Programme support, Surveillance standards, Surveillance and lab QA, Vaccine quality & regulation, Vaccine procurement, Health system strengthening and financing Outsourced Safety and efficacy, Burden of disease, Surveillance, Economic evaluation, Supply and demand, Advocacy , Special studies Resources also flow from the ADIPs/ Hib Initiative to partners and countries through a variety of mechanisms, including support for activities such as surveillance and research, regional advocacy meetings around vaccine decision-making What we have done so far: Offer vaccines and immunisation-specific funding Offer broad-based, country-driven funding Provide targeted support for partners Create incentives and stabilise the market Turn sequential tasks into parallel work streams Establish and communicate value These activities have been funded through the ADIPs, the Hib Initiative and direct support to countries and partners. Countries Vaccines, Communications, Training, Record-keeping, Surveillance & laboratory, Cold chain, Health system / CSO Partners Programme support, Surveillance standards, Surveillance and lab QA, Vaccine quality & regulation, Vaccine procurement, Health system strengthening and financing Outsourced Safety and efficacy, Burden of disease, Surveillance, Economic evaluation, Supply and demand, Advocacy , Special studies Resources also flow from the ADIPs/ Hib Initiative to partners and countries through a variety of mechanisms, including support for activities such as surveillance and research, regional advocacy meetings around vaccine decision-making What we have done so far: Offer vaccines and immunisation-specific funding Offer broad-based, country-driven funding Provide targeted support for partners Create incentives and stabilise the market Turn sequential tasks into parallel work streams Establish and communicate value These activities have been funded through the ADIPs, the Hib Initiative and direct support to countries and partners.

7. Lessons learned in vaccine introduction, and from the ADIPs and Hib Initiative Vaccine availability alone does not ensure uptake Ensuring the lowest possible price is critical Involving ministries of finance and other stakeholders The introduction phase requires additional support to Determine disease burden, cost-effectiveness and vaccine affordability Support surveillance before, during, after introduction Support one-time introduction activities Support country decision-making Emphasize advocacy Sustain industry relations Integrate and coordinate support across vaccine products and programmes

8. ADIP Management Committee Recommendations Scale up support to partners to mainstream core activities in line with their mandates Outsource additional activities in time-limited manner Ensure strong coordination through GAVI Secretariat ADIP contributions Evidence base (burden of disease, surveillance, impact studies, vaccine efficacy trials) leading to WHO recommendations and position papers Economic evaluation: Hib, pneumo, rotavirus Shaping the market: demand forecasting, relations with industry, tiered pricing, AMC Advocacy and support to country decision making ADIP management Initially the ADIP MC consisted primarily of scientific experts. It has now been strengthened with stronger coordination from the secretariat and presence of permanent observers who provide critical expertise and coordination (a member of the GAVI board, WHO, expertise in advocacy, and developing country experience) ADIP contributions Evidence base (burden of disease, surveillance, impact studies, vaccine efficacy trials) leading to WHO recommendations and position papers Economic evaluation: Hib, pneumo, rotavirus Shaping the market: demand forecasting, relations with industry, tiered pricing, AMC Advocacy and support to country decision making ADIP management Initially the ADIP MC consisted primarily of scientific experts. It has now been strengthened with stronger coordination from the secretariat and presence of permanent observers who provide critical expertise and coordination (a member of the GAVI board, WHO, expertise in advocacy, and developing country experience)

9. Review support to countries This includes study of the systems costs for vaccine introduction Many GAVI policies will be reviewed by 2010, mid-way through phase II. Use this opportunity to fully review support to countries Review support to countries This includes study of the systems costs for vaccine introduction Many GAVI policies will be reviewed by 2010, mid-way through phase II. Use this opportunity to fully review support to countries

10. Support to partners Transition and mainstream ADIP activities Scale according to scope and scale Increase resources direct to partners for support to countries in traditional areas linked to mandate. Need guidance from board here on role of GAVI and funding flows. Support to partners Transition and mainstream ADIP activities Scale according to scope and scale Increase resources direct to partners for support to countries in traditional areas linked to mandate. Need guidance from board here on role of GAVI and funding flows.

11. Create new pneumococcal and rotavirus introduction support mechanism Transition ADIP activities outsourced for independence and flexibility focus on industry relations, advocacy, special projects may include catalytic action in other programme areas (extent uncertain, funding discussions) $78 million already approved for 2007-2010 request proposals for detailed design and costing secretariat coordination (guidance re staff implications) Eventually include other selected vaccines ready for introduction funding period 5 years or to end of phase II Governance to be discussed in light of new governance arrangements (management committee with board link ?) Outsourced activities could include extended contracts for ADIP host institutions for selected activities, to maximise efficiency and continuity Create new pneumococcal and rotavirus introduction support mechanism Transition ADIP activities outsourced for independence and flexibility focus on industry relations, advocacy, special projects may include catalytic action in other programme areas (extent uncertain, funding discussions) $78 million already approved for 2007-2010 request proposals for detailed design and costing secretariat coordination (guidance re staff implications) Eventually include other selected vaccines ready for introduction funding period 5 years or to end of phase II Governance to be discussed in light of new governance arrangements (management committee with board link ?) Outsourced activities could include extended contracts for ADIP host institutions for selected activities, to maximise efficiency and continuity

12. Strong role for developing countries and their institutions, and for regional and country to country peer support Strong role for developing countries and their institutions, and for regional and country to country peer support

13. And finally, coordination of these activities will be necessary to maximize the chances of success. The ADIP mgmt committee recommends strong coordination from the secretariat, with the capacity and authority to do the job. Other options discussed include coordination by an alliance partner, for example WHO, or coordination outsourced along with some of the technical support functions.And finally, coordination of these activities will be necessary to maximize the chances of success. The ADIP mgmt committee recommends strong coordination from the secretariat, with the capacity and authority to do the job. Other options discussed include coordination by an alliance partner, for example WHO, or coordination outsourced along with some of the technical support functions.

14. Collaboration: Partner mandates and leadership

15. Next steps in 2008 First quarter Costed detailed proposal for 2008-2015 Present to executive committee Request proposals for outsourced functions if approved Scale up secretariat coordination activities June to December Initiate transition of ADIP activities Launch new project

16. The GAVI Alliance & Fund Boards are requested to provide guidance on: The approach to accelerate pneumococcal and rotavirus vaccine introduction for 2008-2015 Transition activities to Alliance partners according to their mandates Establish an integrated structure to support both pneumococcal and rotavirus vaccine introduction emphasis on industry relations, advocacy, special studies Consider the ADIP MC recommendation to strengthen the secretariat capacity to coordinate. The relative emphasis on these strategies. Partners: surveillance, programme support etc The corollary here is that funding must in some way, directly or indirectly, follow responsibility. Integrated structure with emphasis on industry relations, advocacy and special studies MC recommendations possible implications for head count The appropriate balance for these strategies and funding modalities for them. Partners: surveillance, programme support etc The corollary here is that funding must in some way, directly or indirectly, follow responsibility. Integrated structure with emphasis on industry relations, advocacy and special studies MC recommendations possible implications for head count The appropriate balance for these strategies and funding modalities for them.