GUIDELINES FOR APPLICATIONS

Transcription

1 GUIDELINES FOR APPLICATIONS New and Underused Vaccines Support 2013 Application Deadline: 15 September 2013 Document updated: 14 June 2013 This document replaces all previous versions. Important upcoming changes to the GAVI application and reporting process In its meeting on June 2013, the GAVI Alliance Board approved a new Grant Application, Monitoring, and Review process that will change how the Alliance calls for and reviews new applications for support, undertakes monitoring and reviews the renewal of existing support. All modifications will apply from 2014 onwards and all existing and new grants will shift to the new system. GAVI will regularly update countries with further details on these changes, and issue updated guidelines for future application rounds. 1

2 Table of Contents Acronyms and Abbreviations Overview of GAVI support Introduction Eligibility for support and filter requirements for specific vaccines The application and review process in Accessing and completing the online application form in Application assessment and approval Application requirements Checklist of mandatory documents Overall assessment considerations Vaccine supply, presentation and readiness considerations The vaccine introduction grant and operational support for campaigns Vaccine management Monitoring and reporting Financial management Co-financing requirements Vaccine information Pentavalent vaccine Pneumococcal vaccine Rotavirus vaccine Yellow fever vaccine for routine use Yellow fever vaccine for preventive campaigns Meningococcal A conjugate vaccine for preventive campaigns Measles vaccine second dose (MSD) through routine immunisation Measles Rubella (MR) vaccine HPV vaccine national introduction Annex A: Eligible countries and co-financing groupings Countries eligible for GAVI new vaccines support in Countries eligible for Meningococcal preventive campaigns Co-financing groupings in Annex B: Wastage rates per vaccine: routine and campaign Annex C: Other information resources Annex D: Requirements for ICC endorsement of GAVI applications Annex E: GAVI Alliance terms and conditions of support Do you have any questions or comments about these guidelines? Please contact proposals@gavialliance.org and we will direct your to a colleague who will respond. Any feedback is most welcome and will be used to help inform future GAVI communication planning and guidelines development. 2

3 Acronyms and Abbreviations AD Auto-disable (syringes) AEFI Adverse event following immunisation AMC Advance Market Commitment cmyp Comprehensive multi-year plan for immunisation CRS Congenital Rubella Syndrome CSO Civil society organisation DTP3 Diphtheria-Tetanus-Pertussis, 3 rd dose DQA Immunisation data quality audit EPI Expanded programme on immunisation EVM Effective Vaccine Management, an assessment tool GAMR Grant Application and Monitoring Review GDP Gross domestic product GNI Gross national income HSCC Health Sector Coordination Committee Hep B Hepatitis B vaccine Hib Haemophilus influenzae type b HPV Human papillomavirus ICC Inter-Agency Co-ordination Committee for Immunisation ICG International Coordinating Group IRC Independent Review Committee JRF WHO / UNICEF Joint Reporting Form on Vaccine Preventable Diseases LDC UN Least Developed Country Men A Meningococcal A conjugate vaccine MCV Measles containing vaccine MDG Millennium development goals MoF Ministry of Finance MoH Ministry of Health MMR Measles, mumps, and rubella MR Measles and rubella (combined vaccine) MSD Measles second dose NITAG National Immunization Technical Advisory Group NRA National Regulatory Authority NVS New and underused vaccine support PCV Pneumococcal conjugate vaccine Phase 1 GAVI Alliance Phase 1 Support ( ) Phase 2 GAVI Alliance Phase 2 Support ( ) RCV Rubella-containing vaccine RVV Rotavirus vaccine SAGE WHO Strategic Advisory Group of Experts SIA Supplementary Immunization Activities TAG Technical Advisory Group UN United Nations UNFPA United Nations Population Fund UNICEF United Nations Children s Fund WAP Weighted average price WCBA Women of Childbearing Age WHO World Health Organization YF Yellow fever 3

4 1. Overview of GAVI support 1.1 Introduction This document provides information on New and Underused Vaccines Support (NVS) available from the GAVI Alliance. It provides information on the vaccines, eligibility criteria, requirements, and application process to assist countries to submit proposals for the 2013 application round. GAVI s vaccine support presents an opportunity not only for countries to implement vaccines that protect against diseases causing substantial morbidity and/or mortality, but also to build upon the vaccine investments in order to increase immunisation coverage rates, and strengthen routine immunisation services and primary health care health systems. The implementation of vaccines targeted against several important causes of major killer diseases, such as pneumonia, diarrhoea and cervical cancer can be used as a catalyst to scale up complementary health interventions. Vaccines are typically one of the most equitable of health interventions, and their expanded use reinforces efforts to minimise socio-economic, geographic and gender inequities. To maintain and extend the life-saving gains from expanded use of vaccines, countries should ensure the financial sustainability of their national immunisation programme. The objective of the co-financing policy is to increase country ownership of vaccine financing and ensure that countries are on a trajectory towards financial sustainability, to prepare for eventual phasing out of GAVI support. The cofinancing requirements of a country should be reflected in the application and corresponding multi-year plan. Robust in-country systems and capacity for monitoring and tracking progress are critical. New and better data is vital in order to monitor the functioning of a health system and to identify and assess corrective actions. Both country immunisation programmes and the GAVI Alliance model depend on accurate data on coverage and other core indicators to function effectively. To this end, all countries are encouraged to implement plans for a systematic approach to improving routine data quality and improving survey design, frequency, methods and content. In November 2013 the GAVI Alliance Board will consider a new Vaccine Investment Strategy (VIS) for the period The VIS will not change vaccines currently supported by GAVI. The objective of the VIS is to enable upfront, evidence-based decisions about GAVI s next, additional vaccine investments in order to align planning by countries, industry and donors for the introduction of new, priority vaccines. GAVI support for additional vaccines will be dependent on available resources, vaccine development outcomes and WHO normative guidance. In immunisation programme planning for coming years, countries should also consider the expected imminent WHO pre-qualification of both Meningococcal A vaccine and Japanese Encephalitis vaccines, both of which are already approved by the GAVI Alliance Board for addition to the portfolio. Once prequalified, the application process and requirements for these vaccines will be finalised and shared with countries and partners as soon as available. Countries should also consider the near and medium-term implications for their immunisation programmes of the Global Polio Eradication Initiative s Polio Eradication and Endgame Strategic Plan ( ) ( 4

5 New Vaccines Support GAVI support is provided to sustain the accelerated introduction of life-saving new and under-utilised vaccines. Countries can apply for support for the vaccines listed below: Vaccine Yellow fever (YF) (More details page 24) Meningococcal A conjugate (MenA) (More details page 25) Measles-rubella (MR) (More details page 26) Measles second dose (MSD) (More details page 25) Human Papillomavirus (HPV) (More details page 28) Pentavalent (DTP-HepB-Hib) (More details page 21) Pneumococcal (More details page 21) Rotavirus (More details page 23) DTP3 filter requirement 1 See YF section on page 24 See Men A section on page 24 See MR section on page 24 See MSD section on page 24 DTP3 coverage greater than or equal to 70%, based on the latest available WHO/ UNICEF estimates. Other criteria may apply, so please see vaccine specific details in Section 3. Delivery strategy Routine Campaigns Catch-up campaigns Introduction into routine Routine Routine for national introduction Routine Routine Routine Share of vaccine co-financing required (page 20) Co-financing required GAVI pays full vaccine cost GAVI pays full vaccine cost Country pays full vaccine cost In the first five years, GAVI pays the full vaccine cost, after which the Country pays Co-financing required Co-financing required Co-financing required Co-financing required Vaccine introduction grant (page 14) VIG available N/A N/A VIG available VIG available VIG available VIG available VIG available VIG available Campaign operational cost support (page 14) N/A Operational cost support available Operational cost support available N/A N/A N/A N/A N/A N/A Focus on equity and gender To attain MDGs 3, 4 and 5 there is a need to address social and gender inequalities and their impact on access to and use of essential health services, including immunisation and child health services. An effective and efficient introduction of new vaccines and expansion of underused vaccines will require an analysis of barriers to access and delivery, including those related to wealth, geography or gender. The GAVI Alliance has approved a Gender Policy that focuses on: Generating, reporting and analysing new evidence Ensuring gender sensitive policy and funding support Advocating for gender equality as a means to improve coverage and access to services, and Introducing gender sensitive approaches in GAVI Alliance structures. This consists of disaggregating data, including information on geographic, gender and income differences, as relevant and feasible. 1 In addition to the DTP3 coverage filter (based on WHO/UNICEF estimates published in July 2012), countries are eligible to apply for New Vaccines Support if their GNI is equal to or less than US$ 1,550 (World Bank, July 2012). 5

6 Applications should therefore address the following, as relevant: The issue of how unequal practices (also described as gender-related barriers) impact coverage of both girls and boys, as well as other non-gender based causes of inequity A gender and equity analysis that contains a discussion of actions to be taken to mitigate barriers In planning documents, in addition to disaggregating data by sex where feasible, countries should disaggregate data by district and other stratifiers of interest (e.g., wealth quintile, urban/rural setting). This is to help identify districts, communities and underserved groups that may need an additional focus. 1.2 Eligibility for support and filter requirements for specific vaccines To apply for support, a country must meet the GAVI eligibility criteria, determined by a country s Gross National Income (GNI) per capita for the latest available year. For 2013, the last available data is from 2011, as reported by the World Bank in July Countries are eligible for GAVI support if their GNI per capita is equal to or less than US$ 1,550. The same GNI per capita levels are also used to determine the level of co-financing required by GAVI. Eligible countries in 2013 and their corresponding cofinancing categories are listed in Annex A. For GAVI new vaccines support, only countries with DTP3 coverage levels greater than or equal to 70%, based on the latest available WHO/UNICEF estimates (published July 2013), are eligible to apply. For Meningitis A, Yellow fever and Measles-rubella vaccines, countries can apply irrespective of DTP3 coverage levels. For further information please see the vaccine specific information in Section 3. Access to pneumococcal vaccines for graduated and graduating countries In June 2010, the GAVI Board approved that all phase II GAVI-eligible countries continue to have access to pneumococcal vaccines through GAVI under the terms and conditions of the Advance Market Commitment (AMC). Therefore, graduated and graduating countries that meet this criteria, but are no longer eligible to receive financial support from GAVI for new vaccines and are not already approved, will continue to be able to apply for pneumococcal vaccines through GAVI. Graduating countries that have not yet applied for pneumococcal vaccines are: Bhutan, Cuba, Indonesia, Mongolia, Sri Lanka, Timor Leste and Ukraine. Please note that the eligibility requirement of at least 70% DTP3 coverage will still apply to these countries. Graduated or graduating countries will need to fully fund the costs of the vaccine from the outset. In order to access the terms and conditions of the Advance Market Commitment [1] (AMC), procurement must be done through UNICEF. The vaccine price that these countries will pay under the AMC is determined by the AMC tail price and is set at a maximum of US$3.50 per dose. These countries are not entitled to receive a vaccine introduction grant. A simplified application process will apply. Further information is provided in separate guidelines; Guidelines for applications: access to pneumococcal vaccines for graduating countries available via your GAVI focal point or WHO country office. [1] More information on the Advance Market Commitment is available on the GAVI web site: 6

7 1.3 The application and review process in 2013 The application process and corresponding timeline for 2013 is summarised below: 15 June 2013: Online application form is launched for submission of NVS applications 15 September 2013: Application submission deadline 8-25 November 2013: Review of applications by GAVI s Independent Review Committee (IRC) Q1 2014: The GAVI Executive Committee will consider and decide on the IRC recommendations. In subsequent weeks, countries will be notified of the final outcome via a Decision Letter or Partnership Framework Agreement 1.4 Accessing and completing the online application form in 2013 Countries will be able to apply for GAVI support through an online application form. The online application form will be launched through the GAVI web site on 15 June At the same time, a guide to the online form will be made available to assist countries to navigate and complete the form. Only one form will need to be completed for the vaccine(s) requested. An application form should be completed by the relevant ministries (e.g. Ministry of Health, Ministry of Finance) in close collaboration with the Inter-Agency Coordinating Committee (ICC) or equivalent national coordinating body, as well as other relevant national stakeholders (see Annex D for details of the requirements for ICC endorsement of applications). The process should allow partners to coordinate their support for the national immunisation programme, with all funding arrangements and programmatic issues reflected in the comprehensive multi-year plan (cmyp). The full application and supporting documentation must be uploaded to the online form. Please see section 2 of this document for more information on the key application requirements. Please note that if approved, your application for New Vaccines Support may be made available on the GAVI website and may be shared at workshops and training sessions. Applications may also be shared with GAVI Alliance partners and GAVI's civil society constituency for post-submission assessment, review and evaluation. 1.5 Application assessment and approval The application review process is conducted as follows: i. Completeness: Applications are checked by the GAVI Secretariat for meeting the mandatory requirements. Incomplete applications will not be submitted to the Independent Review Committee ii. Pre-assessment: Application pre-assessment is managed by the Secretariat, focusing on validity and consistency of data officially received from countries and coordination with other information sources. iii. Independent Review Committee (IRC) meeting: The IRC reviews applications, taking into account the pre-assessment reports, and make recommendations to the GAVI Board or Executive Committee. iv. Updates to countries: The GAVI Secretariat will inform countries of the IRC recommendations following the IRC meeting, in a short period of time after receipt of the IRC Chair s report. This update will include information on the likely timing of supply availability to the country. v. Approval: The GAVI Executive Committee will consider and decide on the IRC recommendations. vi. Confirmation: Countries will be notified of the final outcome via a Decision Letter within subsequent weeks. WHO and UNICEF are also informed to facilitate preparations, including vaccine shipments. 7

8 As a general rule, countries should expect a lead time of at least six months from receipt of Decision Letter to the first delivery of vaccines and devices, i.e. applications submitted in 2013 that are recommended for approval by the IRC should expect a Decision Letter in Q1 2014, and therefore not plan a vaccine introduction before Q Specific or additional timelines may apply for campaign support and for vaccines with constrained supply, e.g. pneumococcal and rotavirus vaccines. The following table summarises each type of recommendation that can be made by the IRC: Application Outcomes Recommended for approval Recommended for approval with clarifications Recommended for approval with conditions Recommended for resubmission Explanation The application meets all criteria and is recommended for approval of support. The application lacks specific pieces of information. Clarifications must be provided within 30 days of receipt of an official letter. A satisfactory response must be received before the application can be considered officially recommended for approval for GAVI support. The application does not fulfil specific application requirements. Missing requirements must be provided in a subsequent application round to complement the original application. Conditional approvals will be valid for 12 months or until the next application deadline if it occurs after 12 months. If the conditions are not met within that period, a new application must be submitted. The application is significantly incomplete and a full application should be submitted in a future round. The prioritisation mechanism in case of limited financial resources In situations of limited financial resources, not all applications recommended by the IRC may be approved for funding by the Board. Proposals recommended for funding approval by the IRC are submitted to the GAVI Executive Committee, which decide how many applications can be approved in the light of GAVI s available funds. The prioritisation mechanism is only applied should GAVI find that its available resources are limited compared to overall demand in a particular application round. This mechanism was established in order to ensure that in a situation of financial constraints, limited funds are transparently and objectively allocated to countries based on a pre-defined set of criteria. More information on the prioritisation mechanism is available here: 8

9 2. Application requirements 2.1 Checklist of mandatory documents The following are mandatory requirements and must be uploaded to the online application form. Please note that GAVI will not be able to review any applications that do not include all of the mandatory documents listed below: Signatures of the Minister of Health and Minister of Finance or delegated authority Signatures of members of the ICC or equivalent, and all other requirements for ICC endorsement to GAVI applications as outlined in Annex D Minutes of the last three meetings of the ICC or equivalent Comprehensive multi-year plan (cmyp), including the cmyp costing and financing tools The EVM assessment report (from an EVM conducted within the preceding 36 months) The Improvement Plan based on the EVM and progress report on the improvement plan Report from most recent data quality assessment, if one has been completed within the preceding 36 months, as well as data quality improvement plans and progress report on the improvement plan, if available Vaccine introduction plan, including detailed activities and budget for use of the GAVI vaccine grant and operational support for campaigns (see section 2.4 on the latter grants) If applying for MR support, evidence that the country can finance routine introduction of MR, as described in Section 3.8. Please see the following pages for more details on each of these requirements. 2.2 Overall assessment considerations The following points are intended to facilitate planning by countries and partners and to provide an outline of the minimum requirements to support a complete application. Countries must ensure that data, and costing figures are consistent across all documents submitted. General data The specific request for GAVI support, including projected year and month of vaccine introduction, duration, total amount of doses requested and details of the vaccine(s) and presentation(s) requested. The projected date of introduction must be no later than two years from formal notification of GAVI approval, expected for Q (i.e. on or before April 2016). Exceptions may be considered for pneumococcal and rotavirus vaccines due to the current supply situation; please see the vaccine specific information in Section 3. Plans for a national or sub-national phased introduction should also be indicated. If there are delays to introduction due to supply constraints for a specific vaccine, then an updated introduction timeline will be agreed with the country at a later time. For MR and Men A applications, this must include the projected year and month of the campaign. For multi-year campaigns, the application must specify; 1. Timing of campaigns and vaccine requirements per year; and, 2. Plans to conduct an evaluation that includes a vaccination coverage survey soon after the completion of each phase to allow for mid-year campaign corrections. Information on how vaccine coverage will be monitored and reported, including through the administrative data system, as well as through household surveys with probability based sampling. 9

10 The GAVI Alliance recommends that countries institutionalise routine mechanisms to track data quality over time, and that countries conduct two household surveys every five years one that captures a full birth cohort and one interim coverage survey. Target(s) for the vaccination campaign and/or target(s) for the birth cohort to be covered by the new vaccine(s), as applicable taking into account the month of introduction in the first year. Information on the current vaccination schedule used in the national immunisation programme. Justification for the vaccine, including national or regional data on disease burden, if available. Countries must provide adequate data on incidence or burden of disease(s), based either on reported cases or appropriate estimate of the burden of disease (if necessary, also referencing regional literature and surveillance data), and using cmyp data, if available. For countries conducting campaigns, a description of the campaign must be included, specifying plans for social mobilisation and microplanning, including strategies for the hard to reach or insecure areas. Such countries must also submit the relevant documentation to support the estimates of the size of the target populations in the application. Vaccine introduction planning The comprehensive Multi-Year Plan, based on the Health Sector Strategic Plan and valid for at least one year from the proposed date of introduction, referring to the introduction of the new vaccine(s). Support may be requested for the duration of the cmyp. If there are delays due to supply constraints, once supply is confirmed and discussions take place to confirm the new introduction timeline, GAVI will request an updated introduction plan and the most up-to-date version of the cmyp from the country. An Effective Vaccine Management (EVM) assessment report, or equivalent, conducted within the 36 months preceding the application, and corresponding Improvement Plan updated or developed no more than six months prior to application submission. Both are mandatory for all applications. The Improvement Plan is based on the EVM or equivalent, conducted in the 36 months prior to the application submission date. The Improvement Plan must include an itemised account of actions taken, consistent data on cold chain capacity and readiness to accommodate the new vaccine(s), stating how the cold chain expansion, if required, will be financed, and when it will be in place. More information on the EVM is in Section 2.5. The report from a data quality assessment should be submitted with the application, if one has been completed within the previous 36 months. This can be from routine mechanisms to track data quality, or from periodic assessments. An improvement plan, and progress report on implementation of the improvement plan, should be submitted if available. A Vaccine Introduction Plan that should include: i. A situation analysis of the immunisation programme including any barriers to access and delivery, e.g. related to wealth, geography, or gender ii. Objectives, targets, milestones and justification for the vaccine introduction or campaign, using either local or regional disease burden data iii. Analyses of the current and future costing and financing of the programme, including cofinancing requirements) iv. An outline of all preparatory activities, including a monitoring and evaluation framework and plans to initiate the process for establishing appropriate disease surveillance system and adverse events reporting (AEFI) and planned vaccine effectiveness studies v. A communication plan, with a corresponding budget and monitoring and evaluation framework 10

11 vi. A high level budget for proposed use of the Vaccine Introduction Grant or operational support for campaigns. Please note that a more detailed budget, including specifics on unit costs and funding sources, will need to be submitted by the country prior to release of funds by GAVI. A summary of lessons learned from the introduction of previous new and underused vaccines in the country and actions taken in response to recommendations made after an earlier post-introduction evaluation (PIE), if applicable. WHO recommends that countries conduct a PIE within 6-12 months after the introduction of a new vaccine. If a country has completed a PIE, a summary must be submitted as part of the Annual Progress Report. Information on the PIE tool is available on the WHO web site: Financing and procurement Suitable details on how co-financing will be planned and sustained in the short to medium term. Government commitment (shown by signature to the application) to meet the applicable cofinancing requirements for the vaccine(s) from their year of introduction. Please note that cofinancing levels differ by co-financing group; please see Annex A.3 for more details. If a country will self-procure, details on how this will be done. (This does not apply to preventive campaigns for Measles and Meningitis A.) Please see details on the GAVI self-procurement policy: Involvement of the ICC and members in the application A description of partner participation in preparing the application. The Terms of Reference or Standard Operating Principles for the ICC, including details on the ICC membership, quorum, dispute resolution process and meeting schedules. The role, responsibility and functions of the ICC in relation to the implementation of all immunisation initiatives and overall health sector planning should be made clear. Please see Annex D for a list of the requirements for ICC endorsement of GAVI application. Requirements for routine vaccines For routine vaccines, the yearly total vaccine requirement will be calculated using this formula: Yearly total vaccine requirement = [Target # of individuals to be immunised with the first dose * doses needed for full vaccination] + [Doses for wastage] + [Buffer stock doses] In relation to this formula, please note the following: The target number of individuals to be immunised with the first dose should be adjusted according to the month of introduction. The number of doses needed for full vaccination varies by vaccine and presentation. Wastage doses are calculated by multiplying the doses needed to fully vaccinate the targets by the wastage factor, which is derived from the wastage rate provided by the country. Countries are encouraged to aim for realistic and appropriate wastage rates informed by an analysis of their own wastage data. In the absence of country-specific data, countries may use indicative and maximum wastage values as shown in Annex B. In the first year of a new vaccine introduction, buffer stock is calculated as 25% of the total number of doses required, including wastage doses, and in subsequent years is adjusted for the previous year s stock balance, where appropriate. 11

12 New vaccine support, campaigns and strengthening routine services GAVI s new vaccine support presents an opportunity for countries to strengthen routine immunisation services; an opportunity that countries should reflect in their plans for introducing a new vaccine. For example, introducing a new vaccine can provide the basis to re-train health workers on strategies which strengthen routine immunisation services and contribute resources to invest in parts of the EPI and wider health system which can help increase coverage with all vaccines. The launch of a new vaccine can mobilise communities to increase demand for immunisation services. Campaigns also provide unique challenges and opportunities to also strengthen routine immunisation services. GAVI provides support for planned campaigns, e.g. reflected in the cmyp, intended to accelerate population immunity using Meningitis A vaccine or measles-rubella vaccine. Countries needing assistance for outbreak or epidemic responses should seek support from sources other than GAVI. To be considered for support, country applications should describe how the campaign activities will contribute to strengthening routine immunisation services and achieve high campaign coverage. This applies to applications for any vaccine to be delivered through a campaign. Applications must include specific activities to: Be undertaken as part of the planning and implementation of the campaign that will strengthen routine immunisation services Assess, via a rigorous and independent survey, or comparable approach, the level of coverage achieved through the campaign Countries are also strongly encouraged to evaluate the implementation of the routine strengthening activities completed during the campaign. 2.3 Vaccine supply, presentation and readiness considerations Impact of supply availability Given the unprecedented scale up of demand for some new GAVI supported vaccines, the global vaccine supply for some vaccines will not meet all country requirements in the short term. This means that some countries may have to introduce later than planned. For campaign vaccines, indicative campaign dates should be provided in the application but will not be confirmed until decision letters have been received and confirmed with UNICEF Supply Division to ensure sufficient lead time for vaccine production and shipment of devices. For more details on supply, please see each vaccine specific section. If the introduction date is postponed due to insufficient availability of supply or country readiness (based on the date originally indicated in the application), the number of years of approved GAVI support will remain unchanged, irrespective of any graduation from GAVI support. The requirement to co-finance the vaccine will begin only once the supply commences and will increase in line with the standard co-financing policy. GAVI will work closely with countries and their partners to help address any such situations. Once supply is confirmed and discussions take place to confirm the new introduction timeline, GAVI will request an updated introduction plan and the most up-to-date version of the cmyp from the country. Additional requirements may also apply under the new Grant Application, Monitoring and Review system, effective from 2014 onwards (see section 2.6 for more information on this change). 12

13 GAVI is making all efforts to limit the number of countries affected by supply constraints and to reduce any delays. We are carefully monitoring country vaccine preferences and readiness to introduce, and working closely with manufacturers to explore all options for the best use of available supply. To minimise the risk of delays, realistic timelines should be set for the completion of preparatory activities, including cold chain expansion and rehabilitation, health worker training and local vaccine licensing as required. Vaccine preferences The application form will request the country to rank their first, second and third preference of vaccine presentation, if appropriate. The country should take into account its intended vaccine introduction date, the vaccine presentation and characteristics, and co-financing requirement to determine its preference (see Section 3 for details per vaccine). The first preferred choice should be justified. For a variety of reasons, GAVI may not be in a position to accommodate all countries first product preferences, and in such cases, GAVI will contact the country and partners to explore alternative options. A country will not be obliged to accept its second or third preference, however GAVI will engage with the country to fully explore a variety of factors (such as implications on introduction timing, cold chain capacity, disease burden, etc.) which may have an implication for the most suitable selection of vaccine. If a country does not indicate a second or third preference, it will be assumed that the country prefers to postpone introduction until the first preference is available. It should be noted that this may delay the introduction in the country. For information on vaccine presentations, please consult the UNICEF Product Menu: Changes in presentation of a vaccine After approval for support, a country may wish to switch to a different product presentation of a vaccine containing the same antigen, (e.g. from lyophilised pentavalent to liquid pentavalent or to a different number of doses per vial). In such cases the introduction plan and cmyp should be updated, reviewed and endorsed by the ICC to ensure that it addresses issues such as cold chain and storage capacity as well as the relevant in-service training plans for health providers. The information should then be included in the Country Renewal Request and submitted to the GAVI Secretariat which determines if it is consistent with the previous approval. UNICEF Supply Division will advise if and when the revised request can be accommodated at the earliest, based on availability of the vaccine presentation requested and will coordinate the timing with the country, as applicable, based on in-country stock levels, pending deliveries, retraining requirements, etc. Due to high demand in the early years of introduction, requests for a switch of pneumococcal or rotavirus vaccine presentation will not be considered at this time (with the exception of switches from rotavirus two-dose to rotavirus three-dose, since supply of the three-dose vaccine is available). Countries wishing to switch presentation are requested to communicate this in their Country Renewal Request. Please note that a request to switch will be considered based on the evolving supply situation and other factors, and is currently projected to be implemented at the earliest from Countries can apply (through the Renewal Request or if urgent on an ad hoc basis via a letter to GAVI and the procurement partner) for an additional grant to facilitate transition to a new product for an existing antigen, if it can demonstrate that at least two of the following three criteria are met: 13

14 The switch to a different product is requested by GAVI or its procurement partners The new product requires larger cold chain capacity and requires an expansion at country level The new product represents a change in terms of administration and handling for health workers or other staff involved in the vaccine management and requires additional training because the product features are new to the country The size of the grant for product switches will correspond to one third of a full vaccine introduction grant (rounded to $0.25 per child for infant vaccines and $0.8 per girl for HPV vaccines). 2.4 The vaccine introduction grant and operational support for campaigns In June 2012, the GAVI Alliance Board reviewed and approved changes to the vaccine introduction grant and operational support for campaigns policy. This policy came into effect as of 01 September 2012 and applies to all new introductions and campaigns. Details on the Board decision is available here: Under this policy, when countries have been approved for a new vaccine, they will also receive a onetime cash grant to support a share of the additional costs related to the new vaccine introduction or delivery of campaign, with the remainder being funded by the Government. This is on the basis that the country meets the financial management requirements outlined in section 2.7. Note that the grant or operational support cannot be used to fund co-financing obligations or purchase of vaccines. If there is a subsequent change in the size of a target population in a country, the grant amount will not be recalculated. Vaccine introduction grant The aim of GAVI s vaccine introduction grant is to facilitate the timely and effective implementation of critical activities in the national vaccine introduction plan in advance of a new vaccine introduction. Pre-introduction activities that can be funded through the GAVI vaccine introduction grant may include but are not limited to health worker training, information, education and communication (IEC) and social mobilisation, microplanning, expansion or rehabilitation of some cold chain equipment and additional vehicles if needed, printing and purchase of materials (such as immunisation cards), technical assistance, and modifications to the surveillance systems. The government is encouraged to work with civil society organisations and other in-country partners to determine how these activities are best carried out. Funding levels for introduction of vaccines into the routine system GAVI support NVS Vaccines for routine $0.80 (per child in the birth cohort) or lump sum $100,000 (the higher of) $2.40 (per girl) or lump sum $100,000 (the higher of) Pentavalent, Rotavirus, Pneumococcal, Measles Second Dose, Measles-Rubella routine, Yellow Fever routine, HPV 14

15 Operational support for campaigns The aim of GAVI s operational support for campaigns is to facilitate the timely and effective delivery of vaccines to the target population. In addition to the pre-introduction activities outlined above, the following types of expenses may also be included: volunteer incentives for vaccine delivery or monitoring, health workers and supervisor per diems, cold boxes and ice packs, transport, monitoring and evaluation and civil society organisation and/or volunteer incentives for social mobilisation. Funding levels for vaccines used in campaigns GAVI support $0.65 (per target person) NVS Vaccines for campaigns MenA campaign Measles-Rubella campaign What are the pre-requisites to obtain the grant or operational support for campaigns? In order to obtain this grant, countries must define the activities they plan to conduct, the budget detailing the full non-vaccine costs (in line with the vaccine introduction plan) and activities for which the grant will be used. The application form contains specific tables that must be completed in relation to this support. For activities not covered by the grant, countries should indicate a budget and an alternate funding source. Countries must report on the use of grants in their annual reporting to GAVI. Cash grants will be subject to fiduciary oversight measures and will only be provided after the fulfilment of all requirements by the country. Introduction grants and operational support for vaccine campaigns of US$250,000 or more require mandatory audits when these funds are directly disbursed to countries. One quarter of the grants below $250,000 will be selected at random for audit, meaning that all countries are expected to maintain adequate books and records for these amounts. 2.5 Vaccine management Effective Vaccine Management Assessment (EVM) Vaccine wastage must be minimised through good planning and efficient vaccine management systems, such as effective temperature monitoring. It is mandatory for a country applying for NVS to conduct an EVM assessment, including an assessment of supply chain, vaccine storage and transport capacities in the country. The EVM assessment, or equivalent, must have been conducted within 36 months prior to the application date, in this case after September It will remain valid to support GAVI NVS applications for three years, after which time it will need to be repeated. The EVM assessment and related Improvement Plan is mandatory for all applications. A country can conduct such an assessment either on its own or seek assistance from partner organisations. The EVM and immunisation supply chain planning tools are available from WHO for guidance: An integral part of the EVM assessment is the Improvement Plan and progress report on the implementation of the Plan, updated no later than six months before application submission, which must also be included in the application documents. GAVI needs to ensure that cold chain capacity, vaccine management, real time temperature and stock monitoring, data communication and other key 15

16 aspects meet the requirements for new vaccine introduction. For each area of the EVM that needs improvements, the IRC requires that the Improvement Plan include a timeline, a budget of committed resources for these activities and funding gaps, if any. The Improvement Plan should also include M&E indicators for monitoring the progress. GAVI will pay particular attention to the Improvement Plan and the report on progress against the plan. Planning and coordinating in-country The ICC or equivalent national coordinating body, including any technical EPI advisory groups such as the NITAG, should be closely involved in the process of deciding whether to introduce a new vaccine to ensure that all information and options have been taken into account, and to guide effective integration of immunisation initiatives. Vaccine procurement In the procurement of vaccines and associated injection safety supplies, countries may select either: The supplies in kind from GAVI, procured through UNICEF Supply Division or PAHO s Revolving Fund, or An equivalent cash grant, applicable to the GAVI portion only, in lieu of supplies for self-procurement. The second option, to select a cash grant, does not apply to pneumococcal vaccines. Countries wanting to introduce pneumococcal vaccines must procure through UNICEF Supply Division (SD) including the cofinanced portion. For other vaccines and equipment, self-procuring countries must: Indicate how the funds will be transferred to the country, and how vaccine and injection safety supplies will be procured and managed Plan their vaccine procurement and co-financing contributions in accordance with country planning and budget cycles, clearly indicating the timing of procurements in the application If national authorities wish to use an alternative mechanism to UNICEF or PAHO s Revolving Fund for procurement and delivery of supplies (partly financed by GAVI), the country is required to submit the following information with their application: A description of the mechanism and the vaccines or commodities to be procured by the country Assurance that vaccines will be procured from the WHO list of pre-qualified vaccines, indicating the specific vaccine from the list of pre-qualification and specifically from whom they intend to purchase it. For the procurement of locally-produced vaccines directly from the manufacturer, assurance should also be provided that the vaccine has been licensed by the National Regulatory Authority (NRA), with evidence of licensure of the product, and that the NRA meets WHO published indicators for a functional vaccine regulatory system, as assessed by WHO. Countries that prefer to self-procure vaccines using GAVI support must assure that international standards of assured quality are met. In this case, the self-procurement policy must be consulted: After the GAVI Board or Executive Committee approves an application, GAVI will conduct a review of the proposed procurement mechanism to assess whether it satisfies generally acceptable procurement methods and to provide any recommendations on minimum reporting requirements and improvements. The country will receive the total funding for the procurement in a lump-sum from GAVI only after it agrees to conform to the above-mentioned GAVI recommendations. This amount will be based on the equivalent value of the UNICEF weighted average price or estimated prices for such vaccines (by presentation, as appropriate). If a country s negotiated procurement price is higher than UNICEF s 16

17 weighted average price or estimated price, the government must pay the difference in order to purchase enough vaccines to reach the target population. If the price is lower than UNICEF s weighted average price or estimated price, the country can retain the excess funds and should report how they were used in the immunisation programme in the subsequent monitoring reports to GAVI. All countries may procure their co-financed portion through UNICEF or an alternative mechanism (to be specified in the application). In the former option, countries should transfer funds directly to UNICEF as outlined in the Procurement Services Memorandum of Understanding between UNICEF and the country (either to UNICEF Supply Division or to the country office). Co-financed funds should not be transferred to the GAVI Secretariat. The country agrees with the procurement partner to share information with GAVI on the status of the purchase of co-financed portion of the vaccines and supplies. 2.6 Monitoring and reporting The principles and key elements of the new Grant Application, Monitoring and Review system approved by the GAVI Alliance Board on June 2013 will impact the monitoring of support and the renewal requests for continued funding from 2014 onwards. The key elements of the monitoring system are set out below and further details of the new system will continue to be developed over the coming period. Under the new system, monitoring will be transformed from an annual Geneva-based Monitoring IRC review focused on grant renewal, to a strengthened routine monitoring function that is ongoing and builds on country mechanisms. The closer routine monitoring will be combined with reviews of grant renewal requests and recommendations by a High Level Review Panel. The High Level Review Panel will undertake a holistic annual review of GAVI s portfolio of support for each individual country. The IRC will continue to review new applications as well as requests for funding extensions (for the latter, at the start of a new country strategy and planning cycle, generally every five years). Routine monitoring will be enhanced by: New tools, in line with national monitoring and evaluation frameworks, that may include scorecards to track a set of standard indicators across all grants, with additional activities based on a countries risk / impact profile New processes, such as more in-depth risk assessments and action plans undertaken each quarter. If necessary, GAVI will seek more in-depth information through an in-country review mission. Reporting requirements will change, and GAVI will inform countries of the new requirements as soon as updates are available. The Annual Progress Report (APR) will be replaced by a Country Renewal Request and the details of this will be communicated as soon as they are available. The GAVI Alliance will regularly update countries with further details on these changes. National authorities are required to monitor and report on the number and proportion of children in the target population immunised in a timely manner and the allocation and use of funds to co-finance the vaccines and associated injection safety materials. Monitoring will be based on submission of the following: Information on progress against targets from routine monitoring systems as well as from periodic independent surveys and surveillance or vaccine effectiveness data 17