(Updated May 2007)
The GAVI Alliance is a public-private partnership created in 2000 to save children's lives and protect people's health by increasing access to immunisation in poor countries. Its partners include national governments, UNICEF, WHO, the World Bank, the Bill & Melinda Gates Foundation, the vaccine industry, research and technical health institutions, and civil society organisations (CSOs). The Alliance enables the partners to agree goals, share strategies, and coordinate efforts.
The GAVI Alliance is supported by the GAVI Secretariat in Geneva and Washington, DC, by four affiliated charitable entities: The GAVI Fund (the financing arm of the Alliance: tasks include asset management and investment, financial control, auditing and accounting), IFFIm (the International Finance Facility for Immunisation Company – a multilateral development institution designed to accelerate the availability of funds), The GAVI Fund Affiliate (assigns donor pledges to IFFIm for eventual GAVI programme disbursement), and the GAVI Foundation (provides certain contracting and administrative services to the GAVI Alliance Secretariat in Geneva). The GAVI Secretariat and GAVI Fund operate under the single leadership of the Executive Secretary and CEO. Each of the affiliated entities plays a specific and unique role to help support Alliance programmes and has its own Board.
In spite of the significant efforts of individual organisations, at the end of the 1990s approximately 34 million children were born annually in countries and regions with no immunisation programmes or inadequate ones. In sub-Saharan Africa fewer than 50% of all children were being immunised. Three million lives were being lost each year to preventable infectious diseases.
The scale of the global challenge required concerted action. GAVI partners saw the need and an historic opportunity to pool their skills and resources to extend the coverage and effectiveness of global immunisation programmes, especially in the poorest nations.
The GAVI partners committed themselves to jointly accelerating access to existing vaccines, such as protection against hepatitis B and Haemophilus influenzae type b, and to new vaccines at late stages of development, such as protection against certain forms of pneumonia, meningitis and diarrhoea. They also committed to work jointly to strengthen health service delivery systems to help ensure the effectiveness of immunisation programmes.
The GAVI Fund has obtained public financing commitments from the European Commission and the governments of Australia, Canada, Denmark, Germany, France, Ireland, Luxemburg, the Netherlands, Norway, Sweden, the United Kingdom and the United States, and from the private sector, adding to its start-up grant from the Bill & Melinda Gates Foundation and bringing GAVI’s total resources to above $3.5 billion from 2001 to March 2007.
The GAVI Alliance model is designed to aggregate resources to create results beyond the capability of any single agency. It is also designed to make a rapid positive impact, using independent financial and administrative structures to ensure efficient transfer of support from donors to countries. GAVI provides support directly to country governments, not through other agencies. In addition, the inclusive nature of the Alliance encourages vaccine manufacturers to take a positive view of developing country markets and add relevant, affordable products to their portfolios.
The GAVI Alliance differs in a number of ways:
The role that partners play may vary according to specific country needs.
Developing country governments: identify immunisation needs; ensure that national health sectors develop effective, sustainable plans and programmes to extend the reach and quality of services.
Industrialised country governments: ensure that developing country health programmes – immunisation, in particular – receive an adequate proportion of Official Development Assistance (ODA) and that this is channelled through the sector coordination mechanisms.
Research and Technical Health Institutes: represent the knowledge and experience of the research community to the GAVI Board; keep the research community apprised of relevant policy directions being assumed by GAVI partners; provide technical staff for operations and help build capacity for research and development.
Vaccine industry: the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) and the Developing Country Vaccine Manufacturers Network (DCVMN) help ensure development of and market access to advanced, high-quality vaccine products for poor countries; provide technical support from industry perspective.
Civil Society Organisations (CSOs): draw on extensive field experience to provide technical and advocacy support to national government programmes.
The Bill & Melinda Gates Foundation: promotes the benefits of immunisation and contributes substantially to the funding of programmes.
WHO: develops global policies and strategies for immunisation and vaccine development; provides technical health support.
UNICEF: sources and procures vaccines; acts as cause advocate and helps raise awareness and mobilise support for child immunisation within international, regional and national communities.
The World Bank Group: manages IFFIm donor account; helps implementing governments develop sustainable financing for immunisation services through lending and debt relief.
The GAVI Alliance Board defines policy for the Alliance and monitors all programme areas. It is composed of high-level partner representatives with four renewable members - WHO, UNICEF, World Bank and Bill & Melinda Gates Foundation – and 13 rotating members representing the interests of other Alliance partners. View current GAVI Board membership.
The Board is currently chaired by Dr Margaret Chan, Director-General of WHO. It meets twice a year and holds periodic teleconferences to review progress and policies.
The GAVI Alliance Executive Committee, established in July 2003, is responsible for the supervision and implementation of GAVI activities. It includes four renewable members of the Board (WHO, UNICEF, World Bank and Bill & Melinda Gates Foundation); developing and industrialised country governments each have one representative rotating member; and the respective vaccine industries of the industrialised and the developing countries each have one rotating member. See Committees & Advisory Groups for members.
The Independent Review Committee (IRC) provides objective advice to the GAVI Alliance Board on country proposals and progress. The IRC is divided into two subgroups: the first of which reviews new applications for support, and the second of which monitors country yearly achievements. Members are selected for their broad expertise in health, specific knowledge of vaccines and immunisation and come from as wide a geographic spread as possible. See Committees & Advisory Groups for members and further details on two subgroups.
GAVI Working Group – technical experts from partner institutions – is responsible for implementing the GAVI Board’s decisions. It is chaired by the Executive Secretary and prepares policy recommendations for Board consideration, ensuring close coordination of partner activity. The Working Group currently includes 13 members. See Committees & Advisory Groups for members.
GAVI Time-Limited Task Teams are formed by the partners to address specific issues or tasks. Current groups include the ADIP Management Committee, the Civil Society Task Team, the GAVI Fund Executive Committee, the Audit and Finance Committee, the Investment Committee and the Development Committee. Former task teams have included the Financing Task Force (now replaced by a standing Immunisation Financing Think-Tank); the Joint IFFIm Group, the Supply Task Team and the Roles and Responsibilities Task Team. See Committees & Advisory Groups for further details.
Regional Working Groups: The Alliance relies upon regional working groups as focal points for programme coordination, consensus building, and advocacy at the regional and sub-regional level, and as a bridge for information flow between country and global levels. Regional working groups do not serve implementing functions; rather they help to coordinate implementation activities of partners. See Committees & Advisory Groups for further details and contact information.
The GAVI Secretariat is responsible for the day-to-day operations of the Alliance. This includes coordinating partner involvement, mobilising resources to fund programmes, programme approvals and disbursements, legal and financial management, and administration for the governing Boards. Offices are located in Geneva, Switzerland and Washington, DC, USA. The Executive Secretary reports to the GAVI Alliance Board and the Secretariat's budget is financed by GAVI Board members.
The GAVI Fund is a member of the GAVI Alliance. It is an in-house financial facility that helps GAVI achieve its fundraising and disbursement objectives. It helps ensure that financial administration costs are kept low – approximately 89% of all funds raised go to support country programmes.
GAVI provides time-limited funding (usually over five years) and other forms of support to strengthen implementing country health systems and immunisation services. It pays for the supply of vaccines against hepatitis B, Haemophilus influenzae type b (Hib) and yellow fever (where endemic) that are recommended by WHO but not yet widely used in the world’s poorest countries. GAVI resources are also being used to investigate accelerating the development and introduction of vaccines against two diseases, rotavirus and pneumococcus, which are responsible for significant mortality in developing countries.
National governments in the world’s 72 poorest countries (GNI in 2003 below US$1000) can apply for support. By the end of 2006 GAVI had made commitments totalling over US$2.2 billion (of those eligible, only Solomon Islands and Timor Leste have not yet approached GAVI for support.
GAVI provides financial support to improve immunisation programmes based on funding applications submitted by individual countries. These reflect national priorities and are jointly developed by governments and national partners who together form an Inter-agency Coordinating Committee (ICC). ICCs are closely involved in programme implementation and in monitoring progress. Continuing support is based on meeting agreed performance goals. This country-driven GAVI model is notably different from traditional funding systems that mandate how resources must be used.
The amount of GAVI support depends on a country’s immunisation goals and population size. For example, up to US$14 million a year is allocated to a large country like Kenya to support the introduction of hepatitis B and Hib vaccines. Azerbaijan, a smaller country that already has good basic coverage, will receive up to US$200,000 a year to introduce hepatitis B.
GAVI allocations are based on proposals received from countries. By the end of 2006, 86% of the US$2.2 billion commitments made for country support were for purchase of vaccines and supplies. The balance was for immunization services support.
Funding decisions are made based on proposals received from countries. These are reviewed by an Independent Review Committee (IRC) which meets at the GAVI Secretariat in Geneva. IRC members are not connected with GAVI and are selected (primarily from low and middle income countries) for their expertise in public health and specific knowledge of vaccines and immunisation. They review proposals in accordance with the policies laid down by the GAVI Alliance Board.
The general criteria for funding are:
1. Well functioning Inter-agency Coordination Committee (ICC) or National Health Sector Coordination Body for health system strengthening (HSS)
2. Application submitted by Ministry of Health and endorsed by Ministry of Finance and the relevant national coordination body
3. Evidence that the proposed support from GAVI is synchronised with national planning and budgeting processes
4. A comprehensive Multi-Year Plan (cMYP) for immunisation is in place, synchronised with the Health Sector Strategic Plan, including:
The IRC provides its recommendations to the GAVI Alliance Board. The Alliance Board then requests the Board of GAVI Fund to provide the finance to support approved proposals.
GAVI introduced the principal of co-financing in 2007 to help ensure the sustainability of country programmes that support the introduction of new vaccines. Countries are requested to contribute a set amount for the first new vaccine, according to their funding capability classification. For each subsequent new vaccine, the co-financed amount increases by US$ 15 cents per dose. These are minimum levels. Least poor countries are expected to scale up co-financing by 15% annually. Other countries can maintain current levels until 2010 after which they will increase gradually.
GAVI supports the use of safe injection equipment, including its disposal, by bundling the supply of new and underused vaccines with auto-disable syringes and safety boxes.
GAVI provides additional support to countries that establish national plans to improve injection safety and waste disposal in the form of auto-disable syringes and safety boxes according to the standard EPI schedule (2-4-6 month spacings vs. an accelerated schedule of 2-3-4 months), or the equivalent cash grant for those that wish to procure their own supplies. This support is available to all countries for a maximum of three years and has been granted in 69 cases by mid-2007.
GAVI seeks to identify gaps in vaccine product availability and stimulate development of products to fill them. The GAVI Task Force on Research and Development (R&D TF) undertook a wide consultation process in 2001 that identified three vaccines – pneumococcal, rotavirus and meningitis A/C conjugate – that should receive high priority. At that time the likelihood of their availability in the near future and the potential benefits of reducing morbidity and mortality in developing countries were both high. In 2006, the first successful ADIP application resulted in approval from the GAVI Alliance Board for financing of vaccines against rotavirus and pneumococcus.
GAVI establishes an overall grant to support country programmes through the first two-year investment phase and releases this in three portions – immediately after programme approval, and following the receipt of satisfactory progress reports for the first and second years. This funding is intended to enable countries to improve immunisation services and is not dependent on achieving targets. However, further funding of US$ 20 per additional immunised child is only available once targets for this intial investment phase have been met and are verified by Data Quality Audits (DQAs).
The WHO/UNICEF Joint Reporting Form numerator for reported DTP3 immunisations is the only source normally accepted by GAVI. GAVI will not accept subsequent changes to the initial baseline figure.
Note: the target audience is assumed to know the basics of the DQA and of the reward system implemented by GAVI. The answers provided refer to a number of terms related to the DQA methodology. The DQA briefing paper or the brief introduction will be a good reference for less experienced readers.
1. Is the DQA justified?
YES, GAVI partners feel that the new performance-based approach promoted by GAVI necessitates an investment in a data verification tool. This reassures partners about the validity of reported data and justifies investment from donors. Furthermore the DQA is a useful diagnostic tool for evaluating reporting systems, helping countries to identify their weaknesses, and producing recommendations for improvement.
2. Is the DQA approach equitable between countries?
YES, the tool is standardised; the same methodology is applied by a trained independent auditing company in all countries receiving ISS funds (with the exception of countries receiving a small – US$100,000 – amount of money from GAVI).
3. Is the DQA costly?
As an exercise conducted by external auditors, the DQA is relatively costly (around US$45,000 per audit) when compared with other assessments that could be conducted by partners or national experts. However, the cost of other type of surveys (such as an immunisation coverage survey) conducted externally would be higher. One of the reasons for the relatively small sample sizes in the DQA has been the cost factor.
4. Are the four sampled districts representative of one country, even if the country has more than 100 districts?
YES, both the sampling method and the sample sizes were validated by statistical experts (from Ohio State University) and can be used whatever the number of districts in one country. Using random selection, the survey provides a representative picture of the monitoring and reporting systems of a country. Additionally, the small sample (four districts and 24 health units) implicitly requires a country to have good practices and undertake corrective measures in virtually all centres, which, if reached, will promote an equally high monitoring quality level.
5. Are the DQA measurements precise?
Not precise enough; the measures (including the verification factor, VF) have very large confidence intervals (CI), usually greater than +/-20% (at the 95% confidence level) with the width increasing with intra and inter district variability. This width was an argument not to take the CIs into account for the access to rewards. This limits considerably the comparability of VFs across time and place. The interpretation of the VF is very non-statistical because of the limitation on the ability to draw valid statistical comparisons and conclusions.
6. Is the pass/fail approach to determine access to rewards acceptable?
The original approach to adjust rewards mathematically based on a verified number has proven difficult. As the verification was to be conducted starting at the most peripheral level (i.e. health unit), a sample of health units had to be used, making the measures not precise enough. Instead, the pass/fail decision follows the approach of the lot quality assurance survey, in which a lot is accepted or rejected if a threshold is reached. The approach has also the advantage of being simple (yes/no).
7. Is the threshold (80%) approach to determine access to rewards acceptable?
YES, as long as one threshold has to be taken. This approach allows a 20% verification gap. The approach has allowed 34 out of 43 audited countries (until end 2005) to be eligible for rewards. If a country’s verification factor (VF) is below the threshold, the opportunity of conducting a coverage survey is still possible, allowing the country to be eligible for rewards for one year.
8. Is the Verification Factor (VF) a single valid indicator of a country reporting system?
The VF correlates well (significantly) with the quality indices at health unit and district level, meaning that lower VFs indicate weaker monitoring systems. However, each level of the system (national/district/health unit) needs to be looked at independently to tackle specific weaknesses: one single measure cannot reflect all problems. At this stage, it is felt that the VF is a valid measure of accuracy and can be used as a basis for deciding on rewards. All countries (10) which passed the second DQA after they had failed the first one (until end 2006) were able to pass the second one with an improved VF value. This was also due to actions undertaken to improve their reporting system based on the findings of the first DQA.
9. What should be done in a country to prepare for a DQA?
As a start, the DQA process should be well understood by all ICC partners so that the best collaboration can happen between the auditing company and the country officials during the audit, resulting in fruitful discussions. The DQA briefing paper provides the basics of the DQA process. Then a country should also look at various indicators of the quality of its monitoring system (e.g. variance between different coverage estimates, reporting completeness, etc) to determine where the weaknesses are and where and how the situation should be improved. Data quality assessments and supervisory checklists are two tools that can be used for a precise diagnosis and guide appropriate actions.
10. What should be done if a country’ fails’ the DQA?
The country Interagency Coordinating Committee (ICC) should convene and review recommendations described in the report. An action plan should be prepared (to be submitted with the next GAVI annual report). Actions should be discussed with the Regional Working Group and needs reported to the implementing partners. As an important action to be taken rapidly in the country, the availability of tally sheets and registers at the health unit should be promoted. A systematic follow-up based on the findings and recommendations of the DQA is crucial and is one of the key actions for the country to eventually improve coverage.
11. What should be done if a country ‘passes’ the DQA?
Even if the accuracy measure (the verification factor, VF) indicates a reliable reporting system, a number of improvement areas might have been identified during the DQA, needing an appropriate follow-up and corrective measures. As the DQA is also looking at other indicators such as the vaccine wastage and adverse event following immunisation surveillance implementation (reflected in the quality indices), it is perfectly possible to have a good coverage accuracy but a significant weakness in the monitoring of another area. The ICC should review those weaknesses and the report recommendations in order to implement ad hoc follow-up measures.
The GAVI Fund has obtained public financing commitments from the European Commission and the governments of Australia, Canada, Denmark, Germany, France, Ireland, Luxemburg, the Netherlands, Norway, Sweden, the United Kingdom and the United States, and from the private sector, adding to its start-up grant from the Bill & Melinda Gates Foundation and bringing GAVI’s total resources to above $3.5 billion from 2001 to March 2007.
The GAVI Alliance model is designed to aggregate resources to create results beyond the capability of any single agency. It is also designed to make a rapid positive impact, using independent financial and administrative structures to ensure efficient transfer of support from donors to countries. GAVI provides support directly to country governments, not through other agencies. In addition, the inclusive nature of the Alliance encourages vaccine manufacturers to take a positive view of developing country markets and add relevant, affordable products to their portfolios.
The GAVI Alliance differs in a number of ways:
The role that partners play may vary according to specific country needs.
Developing country governments: identify immunisation needs; ensure that national health sectors develop effective, sustainable plans and programmes to extend the reach and quality of services.
Industrialised country governments: ensure that developing country health programmes – immunisation, in particular – receive an adequate proportion of Official Development Assistance (ODA) and that this is channelled through the sector coordination mechanisms.
Research and Technical Health Institutes: represent the knowledge and experience of the research community to the GAVI Board; keep the research community apprised of relevant policy directions being assumed by GAVI partners; provide technical staff for operations and help build capacity for research and development.
Vaccine industry: the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) and the Developing Country Vaccine Manufacturers Network (DCVMN) help ensure development of and market access to advanced, high-quality vaccine products for poor countries; provide technical support from industry perspective.
Civil Society Organisations (CSOs): draw on extensive field experience to provide technical and advocacy support to national government programmes.
The Bill & Melinda Gates Foundation: promotes the benefits of immunisation and contributes substantially to the funding of programmes.
WHO: develops global policies and strategies for immunisation and vaccine development; provides technical health support.
UNICEF: sources and procures vaccines; acts as cause advocate and helps raise awareness and mobilise support for child immunisation within international, regional and national communities.
The World Bank Group: manages IFFIm donor account; helps implementing governments develop sustainable financing for immunisation services through lending and debt relief.
The GAVI Alliance Board defines policy for the Alliance and monitors all programme areas. It is composed of high-level partner representatives with four renewable members - WHO, UNICEF, World Bank and Bill & Melinda Gates Foundation – and 13 rotating members representing the interests of other Alliance partners. View current GAVI Board membership.
The Board is currently chaired by Dr Margaret Chan, Director-General of WHO. It meets twice a year and holds periodic teleconferences to review progress and policies.
The GAVI Alliance Executive Committee, established in July 2003, is responsible for the supervision and implementation of GAVI activities. It includes four renewable members of the Board (WHO, UNICEF, World Bank and Bill & Melinda Gates Foundation); developing and industrialised country governments each have one representative rotating member; and the respective vaccine industries of the industrialised and the developing countries each have one rotating member. See Committees & Advisory Groups for members.
The Independent Review Committee (IRC) provides objective advice to the GAVI Alliance Board on country proposals and progress. The IRC is divided into two subgroups: the first of which reviews new applications for support, and the second of which monitors country yearly achievements. Members are selected for their broad expertise in health, specific knowledge of vaccines and immunisation and come from as wide a geographic spread as possible. See Committees & Advisory Groups for members and further details on two subgroups.
GAVI Working Group – technical experts from partner institutions – is responsible for implementing the GAVI Board’s decisions. It is chaired by the Executive Secretary and prepares policy recommendations for Board consideration, ensuring close coordination of partner activity. The Working Group currently includes 13 members. See Committees & Advisory Groups for members.
GAVI Time-Limited Task Teams are formed by the partners to address specific issues or tasks. Current groups include the ADIP Management Committee, the Civil Society Task Team, the GAVI Fund Executive Committee, the Audit and Finance Committee, the Investment Committee and the Development Committee. Former task teams have included the Financing Task Force (now replaced by a standing Immunisation Financing Think-Tank); the Joint IFFIm Group, the Supply Task Team and the Roles and Responsibilities Task Team. See Committees & Advisory Groups for further details.
Regional Working Groups: The Alliance relies upon regional working groups as focal points for programme coordination, consensus building, and advocacy at the regional and sub-regional level, and as a bridge for information flow between country and global levels. Regional working groups do not serve implementing functions; rather they help to coordinate implementation activities of partners. See Committees & Advisory Groups for further details and contact information.
The GAVI Secretariat is responsible for the day-to-day operations of the Alliance. This includes coordinating partner involvement, mobilising resources to fund programmes, programme approvals and disbursements, legal and financial management, and administration for the governing Boards. Offices are located in Geneva, Switzerland and Washington, DC, USA. The Executive Secretary reports to the GAVI Alliance Board and the Secretariat's budget is financed by GAVI Board members.
The GAVI Fund is a member of the GAVI Alliance. It is an in-house financial facility that helps GAVI achieve its fundraising and disbursement objectives. It helps ensure that financial administration costs are kept low – approximately 89% of all funds raised go to support country programmes.
GAVI provides time-limited funding (usually over five years) and other forms of support to strengthen implementing country health systems and immunisation services. It pays for the supply of vaccines against hepatitis B, Haemophilus influenzae type b (Hib) and yellow fever (where endemic) that are recommended by WHO but not yet widely used in the world’s poorest countries. GAVI resources are also being used to investigate accelerating the development and introduction of vaccines against two diseases, rotavirus and pneumococcus, which are responsible for significant mortality in developing countries.
National governments in the world’s 72 poorest countries (GNI in 2003 below US$1000) can apply for support. By the end of 2006 GAVI had made commitments totalling over US$2.2 billion (of those eligible, only Solomon Islands and Timor Leste have not yet approached GAVI for support.
GAVI provides financial support to improve immunisation programmes based on funding applications submitted by individual countries. These reflect national priorities and are jointly developed by governments and national partners who together form an Inter-agency Coordinating Committee (ICC). ICCs are closely involved in programme implementation and in monitoring progress. Continuing support is based on meeting agreed performance goals. This country-driven GAVI model is notably different from traditional funding systems that mandate how resources must be used.
The amount of GAVI support depends on a country’s immunisation goals and population size. For example, up to US$14 million a year is allocated to a large country like Kenya to support the introduction of hepatitis B and Hib vaccines. Azerbaijan, a smaller country that already has good basic coverage, will receive up to US$200,000 a year to introduce hepatitis B.
GAVI allocations are based on proposals received from countries. By the end of 2006, 86% of the US$2.2 billion commitments made for country support were for purchase of vaccines and supplies. The balance was for immunization services support.
Funding decisions are made based on proposals received from countries. These are reviewed by an Independent Review Committee (IRC) which meets at the GAVI Secretariat in Geneva. IRC members are not connected with GAVI and are selected (primarily from low and middle income countries) for their expertise in public health and specific knowledge of vaccines and immunisation. They review proposals in accordance with the policies laid down by the GAVI Alliance Board.
The general criteria for funding are:
1. Well functioning Inter-agency Coordination Committee (ICC) or National Health Sector Coordination Body for health system strengthening (HSS)
2. Application submitted by Ministry of Health and endorsed by Ministry of Finance and the relevant national coordination body
3. Evidence that the proposed support from GAVI is synchronised with national planning and budgeting processes
4. A comprehensive Multi-Year Plan (cMYP) for immunisation is in place, synchronised with the Health Sector Strategic Plan, including:
The IRC provides its recommendations to the GAVI Alliance Board. The Alliance Board then requests the Board of GAVI Fund to provide the finance to support approved proposals.
GAVI introduced the principal of co-financing in 2007 to help ensure the sustainability of country programmes that support the introduction of new vaccines. Countries are requested to contribute a set amount for the first new vaccine, according to their funding capability classification. For each subsequent new vaccine, the co-financed amount increases by US$ 15 cents per dose. These are minimum levels. Least poor countries are expected to scale up co-financing by 15% annually. Other countries can maintain current levels until 2010 after which they will increase gradually.
GAVI supports the use of safe injection equipment, including its disposal, by bundling the supply of new and underused vaccines with auto-disable syringes and safety boxes.
GAVI provides additional support to countries that establish national plans to improve injection safety and waste disposal in the form of auto-disable syringes and safety boxes according to the standard EPI schedule (2-4-6 month spacings vs. an accelerated schedule of 2-3-4 months), or the equivalent cash grant for those that wish to procure their own supplies. This support is available to all countries for a maximum of three years and has been granted in 69 cases by mid-2007.
GAVI seeks to identify gaps in vaccine product availability and stimulate development of products to fill them. The GAVI Task Force on Research and Development (R&D TF) undertook a wide consultation process in 2001 that identified three vaccines – pneumococcal, rotavirus and meningitis A/C conjugate – that should receive high priority. At that time the likelihood of their availability in the near future and the potential benefits of reducing morbidity and mortality in developing countries were both high. In 2006, the first successful ADIP application resulted in approval from the GAVI Alliance Board for financing of vaccines against rotavirus and pneumococcus.
GAVI establishes an overall grant to support country programmes through the first two-year investment phase and releases this in three portions – immediately after programme approval, and following the receipt of satisfactory progress reports for the first and second years. This funding is intended to enable countries to improve immunisation services and is not dependent on achieving targets. However, further funding of US$ 20 per additional immunised child is only available once targets for this intial investment phase have been met and are verified by Data Quality Audits (DQAs).
The WHO/UNICEF Joint Reporting Form numerator for reported DTP3 immunisations is the only source normally accepted by GAVI. GAVI will not accept subsequent changes to the initial baseline figure.
Note: the target audience is assumed to know the basics of the DQA and of the reward system implemented by GAVI. The answers provided refer to a number of terms related to the DQA methodology. The DQA briefing paper or the brief introduction will be a good reference for less experienced readers.
1. Is the DQA justified?
YES, GAVI partners feel that the new performance-based approach promoted by GAVI necessitates an investment in a data verification tool. This reassures partners about the validity of reported data and justifies investment from donors. Furthermore the DQA is a useful diagnostic tool for evaluating reporting systems, helping countries to identify their weaknesses, and producing recommendations for improvement.
2. Is the DQA approach equitable between countries?
YES, the tool is standardised; the same methodology is applied by a trained independent auditing company in all countries receiving ISS funds (with the exception of countries receiving a small – US$100,000 – amount of money from GAVI).
3. Is the DQA costly?
As an exercise conducted by external auditors, the DQA is relatively costly (around US$45,000 per audit) when compared with other assessments that could be conducted by partners or national experts. However, the cost of other type of surveys (such as an immunisation coverage survey) conducted externally would be higher. One of the reasons for the relatively small sample sizes in the DQA has been the cost factor.
4. Are the four sampled districts representative of one country, even if the country has more than 100 districts?
YES, both the sampling method and the sample sizes were validated by statistical experts (from Ohio State University) and can be used whatever the number of districts in one country. Using random selection, the survey provides a representative picture of the monitoring and reporting systems of a country. Additionally, the small sample (four districts and 24 health units) implicitly requires a country to have good practices and undertake corrective measures in virtually all centres, which, if reached, will promote an equally high monitoring quality level.
5. Are the DQA measurements precise?
Not precise enough; the measures (including the verification factor, VF) have very large confidence intervals (CI), usually greater than +/-20% (at the 95% confidence level) with the width increasing with intra and inter district variability. This width was an argument not to take the CIs into account for the access to rewards. This limits considerably the comparability of VFs across time and place. The interpretation of the VF is very non-statistical because of the limitation on the ability to draw valid statistical comparisons and conclusions.
6. Is the pass/fail approach to determine access to rewards acceptable?
The original approach to adjust rewards mathematically based on a verified number has proven difficult. As the verification was to be conducted starting at the most peripheral level (i.e. health unit), a sample of health units had to be used, making the measures not precise enough. Instead, the pass/fail decision follows the approach of the lot quality assurance survey, in which a lot is accepted or rejected if a threshold is reached. The approach has also the advantage of being simple (yes/no).
7. Is the threshold (80%) approach to determine access to rewards acceptable?
YES, as long as one threshold has to be taken. This approach allows a 20% verification gap. The approach has allowed 34 out of 43 audited countries (until end 2005) to be eligible for rewards. If a country’s verification factor (VF) is below the threshold, the opportunity of conducting a coverage survey is still possible, allowing the country to be eligible for rewards for one year.
8. Is the Verification Factor (VF) a single valid indicator of a country reporting system?
The VF correlates well (significantly) with the quality indices at health unit and district level, meaning that lower VFs indicate weaker monitoring systems. However, each level of the system (national/district/health unit) needs to be looked at independently to tackle specific weaknesses: one single measure cannot reflect all problems. At this stage, it is felt that the VF is a valid measure of accuracy and can be used as a basis for deciding on rewards. All countries (10) which passed the second DQA after they had failed the first one (until end 2006) were able to pass the second one with an improved VF value. This was also due to actions undertaken to improve their reporting system based on the findings of the first DQA.
9. What should be done in a country to prepare for a DQA?
As a start, the DQA process should be well understood by all ICC partners so that the best collaboration can happen between the auditing company and the country officials during the audit, resulting in fruitful discussions. The DQA briefing paper provides the basics of the DQA process. Then a country should also look at various indicators of the quality of its monitoring system (e.g. variance between different coverage estimates, reporting completeness, etc) to determine where the weaknesses are and where and how the situation should be improved. Data quality assessments and supervisory checklists are two tools that can be used for a precise diagnosis and guide appropriate actions.
10. What should be done if a country’ fails’ the DQA?
The country Interagency Coordinating Committee (ICC) should convene and review recommendations described in the report. An action plan should be prepared (to be submitted with the next GAVI annual report). Actions should be discussed with the Regional Working Group and needs reported to the implementing partners. As an important action to be taken rapidly in the country, the availability of tally sheets and registers at the health unit should be promoted. A systematic follow-up based on the findings and recommendations of the DQA is crucial and is one of the key actions for the country to eventually improve coverage.
11. What should be done if a country ‘passes’ the DQA?
Even if the accuracy measure (the verification factor, VF) indicates a reliable reporting system, a number of improvement areas might have been identified during the DQA, needing an appropriate follow-up and corrective measures. As the DQA is also looking at other indicators such as the vaccine wastage and adverse event following immunisation surveillance implementation (reflected in the quality indices), it is perfectly possible to have a good coverage accuracy but a significant weakness in the monitoring of another area. The ICC should review those weaknesses and the report recommendations in order to implement ad hoc follow-up measures.