GAVI Board Teleconference

18 July 2000

Topics:

• Outcome of the first review of country proposals
• Next steps

Dr Lomamy Shodu, who chaired the teleconference, welcomed the participants [see attached participant list] and stated that the substance of the day’s discussion would be the report of the independent committee’s review of the first country proposals to the Vaccine Fund.

The "Report by GAVI Review Committee; 8th to 13th July, 2000", discussed with the Working Group members (Landry, Batson, Sakai, Zaffran, Cooke, Godal) and GAVI Board members (Alnwick, Shodu, Suzuki) present in a meeting with the Chair on 14 July and circulated to the full Board on 14 July, contains the recommendations of the independent review committee of the first round of country proposals. The document also outlines five policy issues which need to be reconsidered in the light of the country proposals and the review and it indicates an additional group of five issues that will have to be taken into account in forthcoming rounds of applications.

The Board endorsed the committee’s recommendations as outlined in the document and agreed to keep under strict confidence the information about the individual country proposal review outcomes until the countries themselves are notified.

Outcome of the Review

In total, 24 countries submitted proposals to GAVI for review during this first round; of those, 17 proposals were deemed to contain sufficient documentation for review, however. All 17 countries applied for support from the new and under-used vaccines sub-account; 10 eligible countries applied for support from the immunization services sub-account.

The review separated their decisions on proposals into four categories:

1. Unconditional approval (no proposals received this).
2. Approval with clarifications and/or amendments.
3. Conditional approval only when the application could meet conditions satisfactorily. It was noted that to determine if the country fulfills the conditions, there was a need for someone to make a judgment. The review committee decided that the first and second reviewer of that application will make the judgment through electronic mail communication with the Secretariat.
4. Resubmission, implying a full fresh review process.

Of the 17 applications for support for new and under-used vaccines, 11 countries were approved with clarification, 2 received conditional approval and 3 are being asked to re-submit. Of the 10 applications for support from the immunization services sub-account, 8 were approved with clarification and 2 are being asked to re-submit.

Accurate coverage data and other information are needed by 1 September from the 13 countries that received approval with clarification– for either or both sub-accounts – in order to implement the decision and calculate an award amount for 2001.

More extensive information is needed by 1 October from the 3 countries that received conditional approval – for either or both sub-accounts. Members of the independent review committee will then reassess those proposals.

Total disbursements for the first year from this decision will fall below US$ 50 million and is in line with available resources. Disbursements for later years will be contingent upon satisfactory progress reports and available resources without jeopardizing resources for the next tranches of proposals.

The review process highlighted the crucial role of ICC’s (or equivalent) in countries – to help support and monitor the increased activity required to strengthen immunization services and/or introduce new vaccines. While there are some countries with very strong and effective ICC’s, there are many countries that will require substantial strengthening of these collaboration mechanisms.

The fundamental nature of the information found missing in the country proposals highlights the emerging challenge of helping countries build the capacity for fundamental program components such as data reporting, surveillance and problem-solving. A concerted effort is needed from all of the GAVI partners to identify new resources – human, financial and technical – to support countries in the process of developing proposals, as well as supporting countries whose proposals have been approved and will need to strengthen their immunization services and/or introduce new vaccines.

Some of the early efforts to provide support to countries in the process of developing their GAVI proposals, includes a workshop organized by WHO in Geneva in late August for GAVI partner staff in eligible countries, government health officials and consultants, to educate them about the information requirements for funding and support. AFRO is also organizing a similar workshop in Africa in September.

In order to better accommodate countries’ needs, an additional proposal review has been scheduled for January 2001. Many countries in West Africa will be holding polio NIDs in late October and November, and may need the extra time to prepare their proposals to GAVI so that they can focus on the planning and implementation of the polio NIDs.

Vaccine manufacturers will need more specific information of countries’ vaccine needs as soon as possible, in fact, prior to the end of August, when countries are expected to submit more precise data. To address this urgent need, the Financing Task Force is meeting this week in Washington to develop as precise projections as possible, based on information received thus far from countries, with further clarification possible at the end of August.

Next steps:

As there is no unconditional approval recommended there will be no need at this stage to request release of funds from the Vaccine Fund Board.

The GAVI Secretariat and Working Group are developing individual letters to all of the countries that submitted proposals to GAVI to inform them of the outcome of the review; the letters will be delivered to the relevant ministries of health and ICC members no later than 31 July.

Those countries whose proposals were approved but require clarifications will receive specific information about this in the above information letter with an invitation to provide the requested clarifications or additional information to the GAVI Secretariat by 1 September. The Secretariat will then work with the GAVI Working Group to verify that the data are acceptable and calculate resulting awards. The GAVI Board will then request the Vaccine Fund Board to release funds.

Those countries whose proposals have received conditional approval of support will also receive specific information about this in the above information letter with an invitation to provide information about the fulfillment of these conditions by 1 October whereupon this information will be assessed by two members of the independent review committee before any decision is made on support.

Those countries whose applications do not fall in the above categories will have to resubmit by 15 October or in later rounds. As indicated above, an additional opportunity for country submissions will be provided in January 2001.

Based upon the experiences from the first round and recommendations of the review committee the guidelines and the country proposal form will be modified. This task is planned to be finalized by mid-August whereupon the new guidelines and proposal forms will be sent out to eligible countries to be used in forthcoming rounds.

An international press announcement of the first Fund awards will be more appropriate at the beginning of September, when information about the country awards is more complete and specific, rather than at the beginning of August. During August, members of the Advocacy Task Force will work with countries to develop their communications plans around the launch of the GAVI funding and the subsequent advocacy efforts to support immunization programs.

The international and country announcements of the Vaccine Fund review outcomes will be good opportunities to include bilateral donors to demonstrate their contributions to the GAVI efforts.

GAVI Secretariat

Modified 20th July, 2000

Report by GAVI Review Committee

8th to 13th July, 2000

INTRODUCTION

By 7 July 2000, the GAVI Secretariat received 24 applications; of which 7 applications were incomplete. In view of the heavy workload by review members and time constraints, it was decided by the chairperson of the review committee in consultation with the GAVI Secretariat not to review these seven proposals.

REVIEW PROCEDURE

Review principles were understood by all. To avoid conflict of interest, every reviewer signed a form on "confidentiality and conflict of interest undertaking" at the very beginning of the review process. During the committee discussion, any reviewer having a possible conflict of interest was not present in the discussion. This rule was observed and practiced throughout the review process.

There were seventeen applications eligible for review. Each application was independently reviewed by two reviewers. In case of conflicting opinion between the two, a third opinion from another reviewer was assigned. Each reviewer was responsible to objectively assess the application and put checks on a scoring form. The form provided by the Secretariat incorporated all review criteria stipulated in the guidelines.

The first reviewer was responsible to draft comments on three major domains in the application

• The interagency coordination committee – ICC
• Immunization assessment in the last three years
• Multi-year strategic plan for immunization both for routine services and in the introduction, integration of new and under- used vaccine.

Based on these comments, specific recommendations were proposed. The first and second reviewer reported their comments and recommendations to the committee. Discussion and opinions from the committee were considered in the report. A second round discussion on decisions and recommendations for each of the seventeen applications was finalized as the review committee decision.

Comments from experts outside the review committee were given after decisions on each application were reached. Relevant information not available in the applications such as disease burden was provided by the Secretariat. The Secretariat helped to verify figures and other arithmetic calculations.

OUTCOME OF THE REVIEW

Discussion on the outcome of the reviews led to a consensus on four possible outcomes.

1. Unconditional approval.
2. Approval with clarifications and / or amendments.
3. Conditional approval only when the application could meet conditions satisfactorily. It was noted that to determine if the country fulfills the conditions, there was a need for someone to make a judgment. The review committee decided that the first and second reviewer of that application will make the judgment through electronic mail communication with the Secretariat.
4. Resubmission. Note that re-submission implies a full fresh review process. Decision was made for specific request(s) on the two sub-accounts: immunization services and new vaccines introduction. Decision and recommendation by review committee were conveyed to GAVI Working Group and GAVI Board for final decision on the application.

REVIEW RESULTS

There was no conflict of opinion requiring third opinions. Decisions on each application were reached consensus between the two reviewers and the committee members.

RECOMMENDATIONS

The experience gained from the review of application forms and scoring sheets were discussed at length and recommendations were made which we hope will be useful for future reviews.

Terms of reference of the review committee

The review committee suggests the following additions to the terms of reference

1. Objective technical review of the applications.
2. Confidentiality, impartiality and avoid conflict of interest. However, in view of conditional approval only when application could satisfactory meet conditions; the first and second review might need to hold the review report and scoring sheet for future reference.
3. Post-review activities on conditional approval and other matters that GAVI might request.

Recommendation on application format

1. A cover sheet should contain an executive summary and synopsis of proposal and relevant documents.
2. An explicit statement is needed on which sub-account the country requests from GAVI: immunization service and/or new and under used vaccine.
3. In the guideline, application assessment criteria must be clarified to applicants.
4. An explicit statement of immunization schedule of current vaccine and requested new vaccines, choice of new vaccine [mono-valent or polyvalent and its justifications] and dose-vial is requested. The anticipated implications of chosen vaccine on EPI operations and current immunization schedule should be provided.
5. There is a need for a separate section on injection safety plan to highlight its importance with a reference to a fuller supporting document.
6. There is a need for a plan to reduce vaccine wastage rate.
7. There is a need for the government long term resource mobilization plan.
8. Documentation is needed on country experience on current implementation if applicable e.g. Hepatitis B vaccine storage capacity, staff training, cold chain, logistics, drop out rate, wastage rate and other related programmatic issues.
9. Guidance is needed on target setting, x% of buffer stocks and other arithmetic calculations in the application form.
10. Reorganize the application form in such a way as followed:

• Immunization services
• Immunization assessment
• Coverage
• Drop out
• Wastage rate
• Safe injection practices
• Experience of use of new vaccine (if any)
• Multi-year strategic plan stemming from immunization assessment (or any other existing information). It is noted that multi-year plan should include: current EPI situation (coverage, immunization schedule, waste rate, drop out, safety injection, morbidity and mortality, surveillance), disease reduction initiatives, new vaccine experiences, plan of action for the next five years (including goal, objectives, targets, strategies on service delivery, training, IE&C, M&E, social mobilization). Note that immunization coverage with each antigen and dose should be in the table in multi-year plan.
• Funding request from GAVI for sub-account
  
  
  • immunization service
  • new and under-used vaccine
    
    Introduction/integration of new vaccine and a detailed introduction plan, doses, AD syringes, including documentation of any experience.

Recommendation to GAVI Secretariat

1. Transmit recommendations and feed back to countries.
2. Support on-going programs and improve quality of proposal through technical cooperation between developing countries, meetings (managerial and problem solving and experience sharing) at regional, sub-regional level.
3. Ample time for reading and very thorough assessment is required for independent review committee.
4. Problems on figures – during the review process, there was a need for checks and validations; better clarity of application form will help reduce errors on data.
5. The upcoming request for proposal for new and under-used vaccine should be taken as an opportunity to procure high cost new multi-valent vaccine in a smaller dose-vial to optimize utilization and lower wastage rate.
6. A high quality immunization assessment is a crucial input for a sound multi-year immunization plan and application; GAVI partners to provide supports to eligible countries on comprehensive immunization assessment upon requests.
7. Government needs a long-term resource mobilization plan and a technical support plan engaging partner agencies at all level for sustainable immunization services including capacity building.
8. During GAVI launching event, ICC takes this opportunity to increase public awareness and advocacy to "count down" number of unprotected children. Recognition Day to reward "champion districts".

GAVI first review - policy issues for discussion by GAVI board

Current policy – Every dose of new and under-utilized vaccine procured for the Vaccine Fund by UNICEF will be accompanied by an auto-disable syringe (AD) and means for improving safety of disposal (capacity within a safety box)

Issue – Should the Vaccine Fund provide auto disable syringes for use with new and underutilized vaccines for countries that are currently receiving these vaccines for sources other than the Vaccine Fund?

Recommendation - In accordance with WHO/UNICEF/UNFPA joint statement on Safety of Immunization injections, the provider of the vaccines should also provide to the country the AD syringes and means for safer disposal.

Issue – Should the Vaccine Fund provide new and underutilized vaccines to countries without providing the AD syringes and means for disposal?

Recommendation – The Vaccine Fund can provide vaccines without AD syringes if the requesting government can document safe injection using sterilizable syringes and national plans that are in compliance with the WHO-UNICEF-UNFPA "Bundling Policy" with special reference to the schedule for transition to AD syringes

Current Policy – The Vaccine Fund should not replace an existing support for new and underutilized vaccines.

Issue – Country has time limited support for new vaccine and request the Vaccine Fund to provide vaccine to address the same disease in years following termination of existing support.

Recommendation – As a catalytic provider of vaccines the Vaccine Fund will generally not replace existing providers of vaccines. On a case by case basis, GAVI will provide vaccines to countries that are currently using a vaccine if the government and the partners can demonstrate that this investment will increase the total resources dedicated to immunization. In no case will the Vaccine Fund replace government funds. Special incentives will be considered for countries with > 80% DTP3 coverage and 100% government vaccine financing.

Current Policy – n/a

Issue – Should the Vaccine Fund provide new vaccines to countries with obvious well-documented weaknesses in the routine system for delivering vaccines without a request for support from the Vaccine fund for infrastructure support.

Recommendation – New vaccines should be provided to countries that can demonstrate an acceptable plan for improving delivery systems and the required funding independent of the source of the funding. Vaccines should not be provided to countries that do not document appropriate plans and source of funds to improve the infrastructure of the delivery systems.

Current Policy – none

Issue – Due to the increased costs of newer vaccines, vaccine wastage will have a profound impact on overall program costs.

Recommendation – The Vaccine Fund will initially provide countries vaccine with an estimated wastage rate of up to 25%. This rate must progressively decrease to 15% within three years.

Additional points:

The above policy issues directly relate to the operating principles of the Vaccine Fund. In addition, two major policy directions endorsed by the GAVI board must be more clearly spelled out when countries are invited to request support from the Vaccine Fund. These are described in the GAVI Immunization Strategy " Immunize Every Child" and relate to Polio eradication and sustainability.

Polio eradication: Countries will be requested to document that plans are in place and funded which will enable them to meet the requirements and targets of the Global Polio eradication initiative

Sustainability: countries will be requested to provide a resource mobilization plan. This plan will include the following elements.…..

Guidelines/form improvements – The board should be informed of improvements to the guidelines but these should not be considered policy changes and as such do not require board approval.

Schedule for Review – October 15; January 2001; and ????

GAVI first review – some generic issues

The review process highlighted some generic weaknesses in the guidelines and proposal form that did not generate sufficient clarity on policy directions and attention in the submitted proposals. They are as follows:

• Baseline data and targets
  
  Baseline data on number of children immunized with DTP3 which tally with population and coverage data;
  
  Realistic annual targets for number of children to be immunized for years 1-5;
  
  Realistic targets for hepB and Hib which correspond with current and planned DTP coverage;
  
  Need for verification of baseline data by rapid assessment during the first year.
  
  
• Estimation of needs of vaccine doses and AD syringes which includes wastage and buffer stock.
  
  With regard to the newer and more expensive vaccines high wastage rates need to be reduced. A maximum wastage rate of 25% will be allowed with a requirement for plans to reduce wastage progressively down to 15%.
  
  
• Resource mobilization
  
  Plans for resource mobilization will be required taking into account the implications of the introduction of newer, more expensive vaccines.
  
  
• Polio eradication
  
  GAVI attaches great importance to the successful finalization of polio eradication. Countries will be requested to clarify their plans and confirm their commitment to polio eradication. In order not to cause any conflicts with forthcoming plans for NIDs during the next few months GAVI will invite countries to an extra round of country proposals in January 2001.
  
  
• Injection safety
  
  Countries will be required to affirm their commitment to WHO-UNICEF policies on injection safety including a timetable to achieve these. This a a complex area that will require further policy development by the lead GAVI partners.

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