Document of The World Bank FOR OFFICIAL USE ONLY Report No: PAD5028 INTERNATIONAL DEVELOPMENT ASSOCIATION PROJECT PAPER ON A PROPOSED THIRD ADDITIONAL GRANT IN THE AMOUNT OF SDR 8.8 MILLION (US$12.0 MILLION EQUIVALENT) TO THE REPUBLIC OF THE GAMBIA FOR THE THE GAMBIA COVID-19 PREPAREDNESS AND RESPONSE PROJECT JUNE 6, 2022 UNDER THE COVID-19 STRATEGIC PREPAREDNESS AND RESPONSE PROGRAM (SPRP) USING THE MULTIPHASE PROGRAMMATIC APPROACH (MPA) WITH A FINANCING ENVELOPE OF UP TO US$6 BILLION APPROVED BY THE BOARD ON APRIL 2, 2020 AND UP TO US$12 BILLION ADDITIONAL FINANCNG APPROVED BY THE BOARD ON OCTOBER 13, 2020 Health, Nutrition and Population Global Practice Western And Central Africa Region This document has a restricted distribution and may be used by recipients only in the performance of their official duties. Its contents may not otherwise be disclosed without World Bank authorization. CURRENCY EQUIVALENTS (Exchange Rate Effective May 31, 2022) Currency Unit = Gambia Dalasi (GMD) GMD 53.27 = US$1 SDR 0.7439 = US$1 FISCAL YEAR January 1 − December 31 Regional Vice President: Ousmane Diagana Country Director: Nathan M. Belete Regional Director: Dena Ringold Practice Manager: Gaston Sorgho Task Team Leader: Samuel Lantei Mills ABBREVIATIONS AND ACRONYMS AEFI Adverse Events Following Immunization AF Additional Financing AMC Advance Market Commitment AU African Union AVAT African Vaccine Acquisition Trust AVATT African Vaccine Acquisition Task Team COVAX Facility COVID-19 Vaccines Global Access Facility COVID-19 Coronavirus Disease 2019 CPF Country Partnership Framework DHIS2 District Health Information Software E&S Environmental and Social EPI Expanded Program on Immunization ESCP Environmental and Social Commitment Plan ESMF Environmental and Social Management Framework ESS Environmental and Social Standards EU European Union EUL Emergency Use Listing FM Financial Management FTCF Fast Track COVID-19 Facility GAVI Global Alliance for Vaccines and Immunizations GBV Gender-based Violence GoTG Government of The Gambia GRM Grievance Redress Mechanism GRS Grievance Redress Service IFC International Finance Corporation ISR Implementation Status and Results Report J&J Johnson & Johnson M&E Monitoring and Evaluation MCA Medicine Control Agency MOH Ministry of Health MPA Multiphase Programmatic Approach NGO Non-governmental Organization NHEC National Health Emergency Committee NVDP National Vaccination and Deployment Plan PCU Project Coordination Unit PDO Project Development Objective PEF Pandemic Emergency Financing Facility PHEOC Public Health Emergency Operation Center PPE Personal Protective Equipment SDG Sustainable Development Goal SDR Special Drawing Rights SEA/SH Sexual Exploitation and Abuse/Sexual Harassment SEP Stakeholder Engagement Plan SOP Standard Operating Procedure SPRP Strategic Preparedness and Response Program SRA Stringent Regulatory Authority STEP Systematic Tracking of Exchanges in Procurement UN United Nations UNICEF United Nations Children’s Fund VAC Vaccine Approval Criteria VIRAF Vaccine Readiness Assessment Framework VIRAT Vaccine Introduction Readiness Assessment Tool WBG World Bank Group WHO World Health Organization The Republic of The Gambia Third Additional Financing to The Gambia COVID-19 Vaccine Preparedness and Response Project TABLE OF CONTENTS I. BACKGROUND AND RATIONALE FOR ADDITIONAL FINANCING ........................................ 8 A. Introduction ................................................................................................................. 8 B. Consistency with the Country Partnership Framework ........................................... 10 C. Project Design and Scope .......................................................................................... 10 D. Project Performance .................................................................................................. 11 E. Rationale for Additional Financing ............................................................................ 12 F. National Capacity and COVID-19 Vaccination Plan .................................................. 13 II. DESCRIPTION OF ADDITIONAL FINANCING .................................................................... 19 A. Proposed Changes ...................................................................................................... 19 B. Sustainability .............................................................................................................. 22 III. KEY RISKS ..................................................................................................................... 23 IV. APPRAISAL SUMMARY .................................................................................................. 25 V. WORLD BANK GRIEVANCE REDRESS .............................................................................. 32 VI SUMMARY TABLE OF CHANGES ..................................................................................... 33 VII DETAILED CHANGE(S) .................................................................................................... 33 VIII. RESULTS FRAMEWORK AND MONITORING ................................................................... 38 ANNEX 1: SUMMARY TABLE ON VACCINE DEVELOPMENT AND APPROVAL STATUS .............. 51 ANNEX 2: SUMMARY OF THE PARENT PROJECT COMPONENTS ............................................ 58 LIST OF TABLES Table 1: Summary of Vaccination Readiness Findings from the VIRAT/VRAF 2.0 Assessment .............. 13 Table 2: National Vaccine Coverage and Acquisition Plan .................................................................. 17 Table 3: Priority Groups for Vaccination in The Gambia ..................................................................... 20 Table 4: Project Cost and Financing .................................................................................................. 20 Table 5: Summary of COVID-19 Vaccine Sourcing and Bank Financing ................................................ 21 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) BASIC INFORMATION – PARENT (The Gambia COVID-19 Preparedness and Response Project - P173798) Country Product Line Team Leader(s) Gambia, The IBRD/IDA Samuel Lantei Mills Project ID Financing Instrument Resp CC Req CC Practice Area (Lead) P173798 Investment Project HAWH2 (9542) AWCF1 (6550) Health, Nutrition & Financing Population Implementing Agency: Ministry of Health ADD_FIN_TBL1 Is this a regionally tagged project? No Bank/IFC Collaboration No Expected Approval Date Closing Date Guarantee Environmental and Social Risk Classification Expiration Date 02-Apr-2020 31-Mar-2023 Substantial Financing & Implementation Modalities Parent [✓] Multiphase Programmatic Approach [MPA] [ ] Contingent Emergency Response Component (CERC) [ ] Series of Projects (SOP) [ ] Fragile State(s) [ ] Performance-Based Conditions (PBCs) [ ] Small State(s) [ ] Financial Intermediaries (FI) [ ] Fragile within a Non-fragile Country [ ] Project-Based Guarantee [ ] Conflict [ ] Deferred Drawdown [✓] Responding to Natural or Man-made disaster [ ] Alternate Procurement Arrangements (APA) [ ] Hands-on Expanded Implementation Support (HEIS) Development Objective(s) Page 1 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) MPA Program Development Objective (PrDO) The Program Development Objective is to prevent, detect and respond to the threat posed by COVID-19 and strengthen national systems for public health preparedness Project Development Objectives (Phase 083) To prevent, detect and respond to the threat posed by COVID-19 and strengthen national system for public health preparedness Ratings (from Parent ISR) RATING_DRAFT_NO Implementation Latest ISR 10-Aug-2020 25-Mar-2021 30-Nov-2021 Progress towards achievement of PDO S S S Overall Implementation Progress (IP) S S S Overall ESS Performance S S S Overall Risk M M S Financial Management S S S Project Management S S S Procurement S MS S Monitoring and Evaluation S S S BASIC INFORMATION – ADDITIONAL FINANCING (Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project - P178965) ADDFIN_TABLE Urgent Need or Capacity Project ID Project Name Additional Financing Type Constraints P178965 Third AF to The Gambia Restructuring, Scale Up No COVID-19 Vaccine Preparedness and Response Project Financing instrument Product line Approval Date Investment Project IBRD/IDA 06-Jun-2022 Page 2 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) Financing Projected Date of Full Bank/IFC Collaboration Disbursement 29-Sep-2023 No Is this a regionally tagged project? No Financing & Implementation Modalities Child [✓] Multiphase Programmatic Approach [MPA] [ ] Series of Projects (SOP) [ ] Fragile State(s) [ ] Performance-Based Conditions (PBCs) [ ] Small State(s) [ ] Financial Intermediaries (FI) [ ] Fragile within a Non-fragile Country [ ] Project-Based Guarantee [ ] Conflict [✓] Responding to Natural or Man-made disaster [ ] Alternate Procurement Arrangements (APA) [✓] Hands-on, Enhanced Implementation Support (HEIS) [ ] Contingent Emergency Response Component (CERC) Disbursement Summary (from Parent ISR) Net Source of Funds Total Disbursed Remaining Balance Disbursed Commitments IBRD % IDA 18.00 15.24 2.67 85 % Grants 0.91 0.91 100 % MPA Financing Data (US$, Millions) Financing MPA Program Financing Envelope 18,000.00 MPA FINANCING DETAILS (US$, Millions) MPA FINA NCI NG DET AILS (US$, Millions) Approve d Board Approved MPA Financing Envelope: 18,000.00 MPA Program Financing Envelope: 18,000.00 Page 3 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) of which Bank Financing (IBRD): 9,900.00 of which Bank Financing (IDA): 8,100.00 of which other financing sources: 0.00 PROJECT FINANCING DATA – ADDITIONAL FINANCING (Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project - P178965) PROJECT FINANCING DATA (US$, Millions) SUMMARY -NewFi n1 SUMMARY (Total Financing) Proposed Additional Total Proposed Current Financing Financing Financing Total Project Cost 18.91 12.00 30.91 Total Financing 18.91 12.00 30.91 of which IBRD/IDA 18.00 12.00 30.00 Financing Gap 0.00 0.00 0.00 DETAILS - Additional Financing NewFinEnh1 World Bank Group Financing International Development Association (IDA) 12.00 IDA Grant 12.00 IDA Resources (in US$, Millions) Credit Amount Grant Amount Guarantee Amount Total Amount Gambia, The 0.00 12.00 0.00 12.00 National PBA 0.00 12.00 0.00 12.00 Total 0.00 12.00 0.00 12.00 Page 4 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) COMPLIANCE Policy Does the project depart from the CPF in content or in other significant respects? [ ] Yes [ ✔ ] No Does the project require any other Policy waiver(s)? [ ✔ ] Yes [ ] No Explanation This AF3 is being processed using the following waiver granted through the Global SPRP MPA Project (P173789): Waiver to enable Management approval of individual projects under SPRP rated Substantial for Environmental and Social risks. Has the waiver(s) been endorsed or approved by Bank Management? Approved by Management [✔] Endorsed by Management for Board Approval [ ] No [ ] Explanation The MPA-specific waivers have been endorsed by management as part of the Global SPRP MPA approval. Page 5 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) ESStandards Environmental and Social Standards Relevance Given its Context at the Time of Appraisal E & S Standards Relevance Assessment and Management of Environmental and Social Risks and Impacts Relevant Stakeholder Engagement and Information Disclosure Relevant Labor and Working Conditions Relevant Resource Efficiency and Pollution Prevention and Management Relevant Community Health and Safety Relevant Land Acquisition, Restrictions on Land Use and Involuntary Resettlement Not Currently Relevant Biodiversity Conservation and Sustainable Management of Living Natural Not Currently Relevant Resources Indigenous Peoples/Sub-Saharan African Historically Underserved Traditional Not Currently Relevant Local Communities Cultural Heritage Not Currently Relevant Financial Intermediaries Not Currently Relevant ESStandardsNote NOTE: For further information regarding the World Bank’s due diligence assessment of the Project’s potential environmental and social risks and impacts, please refer to the Project’s Appraisal Environmental and Social Review Summary (ESRS). INSTITUTIONAL DATA Practice Area (Lead) Health, Nutrition & Population Contributing Practice Areas Climate Change and Disaster Screening This operation has been screened for short and long-term climate change and disaster risks Page 6 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) PROJECT TEAM Bank Staff Name Role Specialization Unit Team Leader (ADM Samuel Lantei Mills Health HAWH2 Responsible) Procurement Specialist (ADM Haoussia Tchaoussala Procurement EAWRU Responsible) Laurent Mehdi Brito Procurement Specialist Procurement EAWRU Mamadou Mansour Mbaye Procurement Specialist Procurement EAWRU Financial Management Fatou Mbacke Dieng Financial Management EAWG1 Specialist (ADM Responsible) Social Specialist (ADM Gernot Brodnig Social Development SAWS4 Responsible) Environmental Specialist (ADM Sophie Lo Diop Environment SAWE1 Responsible) Aji Oumie Jallow Team Member Administration AWMGM Amadou Ba Team Member Finance WFACS Anta Tall Diallo Procurement Team Administration AWCF1 Bahie Mary Rassekh Team Member Health HAWH2 Daniel Amponsah Team Member Economic ECRRC Fatou Bintou Mbaye Team Member SEA/SH SAWS4 Jane Kim Lee Team Member CRVS HHNGE Kenneth M. Green Team Member Environment AMIPN Ndiga Akech Odindo Counsel Legal LEGAM Nikolai Alexei Sviedrys Procurement Team STEP EAWRU Wittich Sariette Jene M. C. Jippe Team Member Operations & Administration HAWH2 Seynabou Thiaw Seye Team Member Operations Officer AWMGM Yassin Saine Njie Team Member Administration AWMGM Extended Team Name Title Organization Location Page 7 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) I. BACKGROUND AND RATIONALE FOR ADDITIONAL FINANCING A. Introduction 1. This Project Paper seeks the approval of the World Bank’s Regional Vice President to provide a grant in the amount of SDR 8.9 million (US$12.0 million equivalent) IDA for an additional financing (AF). The AF would support the cost of expanding activities of The Gambia COVID-19 Preparedness and Response Project (P173798) under the coronavirus disease 2019 (COVID-19) Strategic Preparedness and Response Plan (SPRP) using the Multiphase Programmatic Approach (MPA), approved by the Board on April 2, 2020, and the vaccines AF to the SPRP approved on October 13, 2020.1 The primary objectives of the AF are to enable affordable and equitable access to COVID-19 vaccines, help ensure effective vaccine deployment in The Gambia through vaccination system strengthening, and to further strengthen preparedness and response activities under the parent project. The Gambia COVID-19 Preparedness and Response Project in an amount of US$10 million IDA was approved on April 2, 2020 and an AF of US$8 million IDA was approved on April 16, 2021. 2. The purpose of the proposed AF is to provide upfront financing to help the Government purchase and deploy COVID-19 vaccines that meet the World Bank’s vaccine approval criteria (VAC) and strengthen relevant health systems that are necessary for a successful deployment and to prepare for the future. The proposed AF will help vaccinate 26 percent of the country’s population. World Bank financing for the COVID-19 vaccines and deployment will follow the Bank’s VAC. As of April 16, 2021, the Bank will accept as threshold for eligibility of IBRD/IDA resources in COVID-19 vaccine acquisition and/or deployment under all Bank-financed projects: (i) the vaccine has received regular or emergency licensure or authorization from at least one of the Stringent Regulatory Authorities identified by the World Health Organization (WHO) for vaccines procured and/or supplied under the COVAX Facility, as may be amended from time to time by WHO; or (ii) the vaccine has received WHO Prequalification (PQ) or WHO Emergency Use Listing (EUL). The country will provide free of cost vaccination to the population. 3. The need for additional resources to expand the COVID-19 response was formally conveyed by the Government of The Gambia (GoTG) on March 28, 2022, for World Bank financing for the COVID-19 AF. The proposed AF will form part of an expanded health response to the pandemic, which is being supported by Development Partners under the coordination of the GoTG. Additional World Bank Group (WBG) financing will provide essential resources to enable the expansion of a sustained and comprehensive pandemic response that will appropriately include vaccination in The Gambia. 4. African Vaccine Acquisition Trust (AVAT) is a COVID-19 vaccine procurement agreement signed by all African Union (AU) Member States on March 28, 2021. Beginning in late 2020, the AU embarked on an ambitious effort to vaccinate at least 60 percent of Africa’s population as quickly as possible through a continental approach. The effort to acquire more vaccines has been led by the African Vaccine Acquisition Task Team (AVATT) - the AU Special Envoys for COVID-19, Africa Centers for Disease Control 1 The WBG approved a US$12 billion Fast Track COVID-19 Facility (FTCF or ‘the Facility’) to assist IBRD and IDA countries in addressing the global pandemic and its impacts. Of this amount, US$6 billion came from IBRD/IDA (WBG) and US$6 billion from the International Finance Corporation (IFC). IFC subsequently increased its contribution to US$8 billion, bringing the FTCF total to US$14 billion. The AF of US$12 billion (IBRD/IDA) was approved on October 13, 2020, to support the purchase and deployment of vaccines as well as strengthen the related immunization and health care delivery system. Page 8 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) and Prevention, the African Export-Import Bank (Afreximbank) and the United Nations (UN) Economic Commission for Africa. The AU sees this effort as complementary to COVAX, and the World Bank has worked alongside AVATT since January 2021 to inform the design of the AVAT mechanism and ensure that World Bank financing can be used by participating member countries to purchase vaccine doses. On June 21, 2021, the AU and the World Bank held a joint meeting with African Ministers of Finance to officially launch the partnership to accelerate vaccination in Africa. AVAT has already successfully negotiated 220 million doses of Johnson & Johnson & Janssen (J&J/Janssen) COVID-19 vaccine for use by African countries. AVAT is negotiating with other suppliers and expected to secure more doses. World Bank financing and technical assistance is available to help countries obtain vaccines from eligible suppliers through AVAT and to effectively deploy them. So far, The GoTG has procured 266,667 doses of J&J under the AVAT mechanism with an agreement with the United Nations Children’s Fund (UNICEF) as the procurement agency. Similarly, World Bank financing under this AF will be made available for the purchase of J&J vaccines through AVAT, and other vaccines, as necessary. 5. Critically, the third AF seeks to enable the acquisition of vaccines to support The Gambia’s objective to have a portfolio of options to access vaccines under the right conditions (of value-for- money, regulatory approvals, and delivery time among other key features). The proposed IDA financing will build on this to expand The Gambia’s access to safe vaccines. The availability and terms of vaccines remain fluid and prevent the planning of a firm sequence of vaccine deployment. 6. Latest COVID-19 situation in the country. The Gambia registered its first COVID-19 case on March 17, 2020, and as of May 22, 2022, 12,002 cases have been confirmed, with 365 deaths. The initial confirmed COVID-19 cases were few and were mainly imported cases (25 confirmed cases during March to May 2020), but subsequently, The Gambia experienced local transmission with an average of 100 confirmed COVID-19 cases a day between July and August 2020. Subsequently, there was a sharp decline in October 2020 with an average of 2 cases per day between October 1, 2020 and November 30, 2020. The number of cases started to increase again in January 2021 but declined in March 2021 followed by two further surges (see Figure 1). During May 11 to 19, 2022, only three case was registered. Figure 1. Gambia daily confirmed COVID-19 cases, March 2020 – May 2022 Page 9 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) B. Consistency with the Country Partnership Framework 7. This AF is consistent with The World Bank Country Partnership Framework (CPF), Report No. 154485,2 for the Republic of The Gambia, FY2022–2026 Focus Area 3 (Enhance Human Capital Investments to Develop a Productive Workforce) by supporting ongoing engagements to enhance human capital through improvements in social services, while exploring new avenues to improve the employability of women and youth through skills development. The need to invest in health systems to ensure the productive capabilities of the population is recognized, as is the challenge of overcoming a legacy of limited investment in human capital and social resilience systems. By building the strength of the health system and its resilience to shocks, it is aligned with the focus of the CPF’s Objective 3.1, which focuses on improving the quality and utilization of essential health services. A key result in CPF is to increase in share of population vaccinated against COVID-19. The AF, like the parent project, is also aligned with both global health priorities and IBRD/IDA priorities on improving pandemic preparedness. C. Project Design and Scope 8. The Project Development Objective (PDO) of the parent project and this third AF is to prevent, detect and respond to the threat posed by COVID-19 and strengthen the national system for public health preparedness. The parent project comprised of the following four components. This third AF will support activities through Component 1 of the parent project, in the amount of US$12 million, for scale up activities: (a) Component 1: Emergency COVID-19 Response, in the amount of US$12 million, supports case detection, confirmation, contact tracing, recording, and reporting; Social distancing measures and communication preparedness. Component 2: Strengthening Multi-sector, National Institutions and Platforms for Policy Development and Coordination of Prevention and Preparedness using One Health Approach, in the amount of US$0.6 million, supports strengthening national disease surveillance and diagnostic capacities for public health emergencies and other hazards and enhancing national diseases information and analytical systems Component 3: Supporting National and Sub-national, Prevention and Preparedness, in the amount of US$5.91 million, supports health system strengthening and preparedness activities. Component 4: Implementation Management and Monitoring and Evaluation (M&E) (US$0.4) (b) A detailed description of the project is in Annex 2. 9. The Ministry of Health (MOH) is the implementing agency for the project. The MOH Project Coordination Unit (PCU) is entrusted with the coordination of project activities, as well as fiduciary tasks of procurement and financial management (FM). The PCU is now fully staffed with a PCU coordinator, senior operations officer, operations officer, financial controller, senior accountant, five accountants, procurement specialist, and procurement assistant. The implementation arrangements as stipulated in the Financing Agreement of the parent project (that is, National Health Emergency Committee [NHEC], 2World Bank. 2022. World Bank Group Country Partnership Framework for the Republic of The Gambia, FY2022–2026. Washington, DC: World Bank Group. https://imagebank2.worldbank.org/search/33765123 Page 10 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) MOH, and PCU) are in place and functional. They will continue as the implementation arrangements for the AF. 10. The existing multi-sectoral NHEC, which has responsibility for overall coordination of the implementation and monitoring of the COVID-19 Plan, will continue to provide strategic guidance for overall project implementation. The NHEC is chaired by the Permanent Secretary of Health and co- chaired by WHO Country Representative, and its members comprise representatives of UN agencies, Medical Research Council, line ministries, non-governmental organizations (NGOs), National Disaster Management Agency, The Gambia Red Cross Society, WBG, and others. The six technical committees that report to the NHEC are (a) coordination; (b) epidemiology and laboratory surveillance; (c) case management; (d) communication and social mobilization; (e) psychosocial support; and (f) logistics and safety. D. Project Performance 11. Progress towards the PDO and overall implementation was rated Satisfactory in the last Implementation Status and Results Report (ISR) of November 30, 2021, and the project continues to make good progress. As of June 3, 2022, disbursements amount to US$10 million (for the parent project commitment of US$10 million) and US$5.23 million (for the AF Vaccine Project of US$8 million) while the AF of US$0.91 million from the Pandemic Emergency Financing Facility (PEF) to finance the scale-up of selected activities such as procurement of laboratory equipment, is fully disbursed. 12. The PCU has been coordinating effectively project planning and procurement. Results achieved so far include: (a) In April 2020, when there was an acute global shortage of COVID-19 medical equipment and supplies, including in the United States and Europe, the World Bank supported the MOH in procuring critical medical equipment and supplies. These included the following: 10 high- quality, well-equipped ambulances for intensive care; critical lifesaving medical equipment and supplies including 60 intensive care unit (ICU) beds, 600,000 surgical masks, 1.2 million gloves, 5,000 oxygen masks, four ultrasound machines, 20,000 face shields, 25,000 units of personal protective equipment (PPE, coverall), 30,000 respirators (N95), 205 oxygen flowmeters, three digital 4D color ultrasound machines, four ultrasound scanners and 100 non-touch thermometers; (b) Procurement of laboratory supplies, reagents and test kits, molecular testing, hematology systems, real-time PCR machine, chemistry platform, microbiology systems; and ABBOT Rapid Diagnostic COVID-19 Test kits. (c) The project supported the renovation of the Ndemban Clinic (which was not used in years) and is now functional as a COVID-19 treatment center. (d) International (IDOM) and local (GAP Consultants) consulting firms have completed the architectural design, and Shapoorji Pallonji Mideast (L.L.C.) (an international construction firm with local presence) is undertaking the construction of the (a) National Emergency Treatment Centre Intensive Care Unit (20 beds); (b) the National Emergency Observation and Treatment Centre General Ward (84 beds); (c) the National Public Health Laboratory Page 11 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) and Training Center; (d) National Blood Transfusion Centre , and (e) a Conference Centre. The construction which is financed under The Gambia Essential Health Services Strengthening Project (P173287). (e) Improvement of the National Public Health Laboratory electronic data management system through the procurement of five tablets, information technology (IT) equipment, air conditioner, expansion of local area network andpatients can now access their COVID-19 test results directly in the COVID-19 portal. (f) Procurement of a state-of-the-art environmentally friendly healthcare waste treatment machine, AMB Ecosteryl 250 (www.ecosteryl.com), and AMB Ecosteryl 75 plus, which were delivered in July 2020 and January 2021 respectively. They are automated and employ microwave technology. (g) Construction of two clinical waste treatment centers are almost complete, one located at Farato (for the Ecosteryl 250) and the other at the Edward Francis Small Teaching Hospital (for the Ecosteryl 75 plus). GAP Consultants and Kurubally Construction Company Ltd were competitively selected for the architectural designs and construction respectively. (h) Procurement of seven containerized environmentally friendly and energy efficient dual chamber incinerators (i.e., pre-installed with electrical generator and control panels and other accessories), one for each region, can be moved from one place to another for waste treatment. (i) Procurement of four 10-ton refrigerated waste collection trucks and 90 yellow wheelie bins (660 liters) for Ecosteryl 250 series, and 30 yellow wheelie bins (360 liters) for Ecosteryl 75 plus series will facilitate the collection and transport of healthcare waste from the various health facilities to the waste treatment centers. (j) The project procured IT equipment for PHEOC and for e-surveillance system. MOH has been liaising with several other line ministries and the National Disaster Management Agency to address COVID-19 through the strengthening of the national public health preparedness. (k) The project supported the procurement of 266,667 J&J vaccine doses from AVAT, with UNICEF as the procurement agent. E. Rationale for Additional Financing 13. This AF is being proposed to contribute to the GoTG’s response to COVID-19 to enable affordable and equitable access to COVID-19 vaccines and to play a critical role in further strengthening the health system in The Gambia. The Gambia plans to eventually vaccinate at least 60 percent (1.44 million) of its population. However, only 14.5 percent of the total population is fully vaccinated, but the coverage is higher, at 22.6 percent, for those aged 12 years and older. In addition to the hesitancy, one of the reasons for the low coverage is that about 42 percent of the total population is under 18 years who are currently not eligible for COVID-19 vaccination. Considering that the project has supported the procurement of ultracold freezers, children between aged 12 and 17 years are now eligible for Pfizer or Moderna COVID-19 vaccines. The AF will support the procurement of vaccines to increase the vaccine coverage as well as for booster shots for those already vaccinated. Further, the undisbursed US$2.57 million is already committed to be disbursed by June 30, 2022: a) US$958,367.84 balance due to AVAT for the procured J&J vaccine doses noted above; and b) US$2.4 million for environmentally friendly Page 12 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) incinerators. Thus, without the proposed AF, the project will close earlier than March 31, 2023 and the Government will not be able to afford additional vaccine doses for booster shots and vaccines for any future new variants. Thus, the proposed AF will support the purchase and deployment of COVID-19 vaccine. 14. This AF is being proposed at a crucial juncture in the GoTG response to COVID-19. A critically important change in the state of science since the early stages of the pandemic has been the emergence of new therapies and the production of COVID-19 vaccines. A key rationale for the proposed AF is to provide upfront financing for safe and effective vaccine acquisition and deployment in The Gambia, thus enabling the country to procure safe and effective vaccine at the earliest, recognizing that there is currently excess demand for vaccines from both high-income and lower-income countries. 15. The proposed AF will form part of an expanded health response to the pandemic. The activities will build on the World Bank’s existing health portfolio in The Gambia, including the COVID-19 MPA- Program, The Gambia COVID-19 Preparedness and Response Project (P173798), and The Gambia Essential Health Services Strengthening Project (P173287) (approved on October 9, 2020) which will support eligible expenditures for health systems strengthening activities. The proposed AF will finance approximately US$4.9 million for vaccine acquisition (purchase and shipment to The Gambia), and about US$7.1 million for in-country deployment-related activities. F. National Capacity and COVID-19 Vaccination Plan (i) Vaccine Readiness Assessment 16. The Gambia has conducted a vaccine-readiness assessment to identify gaps and options to address them, as well as to estimate the cost of vaccine deployment, with the support of international organizations (including WBG, WHO, UNICEF, and Global Alliance for Vaccines and Immunizations [GAVI]). It examined the planning and coordination; budgeting; regulatory; prioritization, targeting, and surveillance; training and supervision; M&E; vaccine, cold chain, logistics, and infrastructure; safety surveillance; and demand generation and communications; and the findings fed into the development of a National Deployment and Vaccination Plan for COVID-19 vaccines. A summary of vaccination readiness assessment findings is shown in Table 1. The vaccine readiness assessment is an evolving process, which will be dynamically revised and updated as necessary to continue to inform project design and implementation. Table 1: Summary of Vaccination Readiness Findings from the VIRAT/VRAF 2.0 Assessment Readiness domain Readiness of government Key gaps to address before deployment Planning and 90 percent completed. Micro-plans will continue to coordination Accountable body and leadership, such as the be updated for future Expanded Program on Immunization (EPI) governance rounds of COVID-19 and management structure, exist and are functioning; vaccination. Standard Operating Procedures (SOPs) for delivery of vaccines were developed; micro-plans are developed by each region for each round of COVID-19 vaccination; Page 13 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) and bi-weekly coordination meetings are held. Budgeting 90 percent completed. Costing of vaccine-related activities has been prepared and estimated to be US$1.6 million excluding vaccine costs. Regulatory 100 percent completed. A mechanism for certification of facilities participating in vaccine delivery is approved. The Gambia Medicine Control Agency (MCA) has issued emergency approval of AstraZeneca, J&J, Pfizer and Sinopharm. Prioritization, 100 percent completed. The target group may be targeting, surveillance Priority groups and target population identification was revised again when vaccine initially done. However, when Pfizer became available is approved for children in the country, the age group has been lowered from 18 aged 12 years and below. years to 13 years and above. Training and 100 percent completed. The WHO COVID-19 supervision Adequate and trained health personnel, for example, in vaccination training and safe injection practices, are available in all participating refresher training for health facilities. workers is ongoing. M&E 60 percent completed. Continue to collect all paper Data collection tools designed and printed; a feedback forms and enter them into system for gathering information from facilities the electronic system. participating in vaccine delivery has been established; human resource capacity is in place for monitoring, evaluating, and reporting on progress at the central level. User devices such as laptops, desktops, printers etc. were procured but poor internet connectivity is hampering real-time data entry, so paper forms are used and later entered into the electronic system. Vaccine, cold chain, 100 percent completed. Vaccine doses allocation to logistics, A distribution strategy — from points-of-entry to the each health facility infrastructure frontline, including transport, stocking, and other (hospitals, minor and major components of the supply chain including protocols for health centers) is yet to be tracking and monitoring the distribution of vaccines and completed. key supplies — is in place through the existing GAVI Cold Chain Equipment Optimization Platform; adequate Procurement of climate- human resources are available to support the friendly ultracold storage is distribution of vaccines and supplies to the frontlines; ongoing. an Effective Vaccine Management assessment of the cold-chain system accounting for additional capacities required for the COVID-19 vaccine has been conducted; and cold storage infrastructure (including recently procured ultracold freezers) is in place in all program participating facilities. Safety surveillance 70 percent completed. Reported AEFIs needs to be Protocols for adapting surveillance systems for vaccine- adequately diagnosed and preventable diseases and Adverse Events Following treated. Immunization (AEFI) to conduct surveillance of events attributable to immunizations have been developed and disseminated to surveillance facilities/sites. Page 14 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) Demand generation 60 percent completed. Misinformation and myths and communication Social mobilization and engagement strategy to need to be dispelled. generate vaccine confidence and demand, including provisions for engaging with national and local media, NGOs, social platforms, and other engagement and advocacy modalities, has been developed. However, vaccine hesitancy remains a challenge. Waste management 80 percent completed. Waste management plan is in place for the treatment and disposal of waste generated during the vaccine campaign (e.g., used and expired vaccine vials, needles and syringes in safety boxes and PPE). Regional sites for containerized incinerators are established. (ii) National Vaccination and Deployment Plan 17. The GoTG prepared the National Vaccination and Deployment Plan (NVDP), which draws on the findings of the Vaccine Introduction Readiness Assessment Tool/Vaccine Readiness Assessment Framework Version 2 (VIRAT/VRAF 2.0) assessment and gap analysis. The NVDP was initially developed to vaccinate 70 percent of the total population, including priority groups. The WHO Allocation Framework target for priority immunization proposed an initial proportional allocation to enable all countries to cover 20 percent of their population. In The Gambia, the priority population include health personnel; community workers (community birth companions, village health workers, and social workers); older people ages 65 years and above; people with preexisting conditions (comorbidities) that place them at higher risk for death, such as diabetes, hypertension, cardiovascular disease, chronic respiratory disease, and obesity (BMI>30); teachers; workers at hotels, restaurants, and bars; and security forces. Following the low uptake among the priority groups and short expiry date of the vaccines (i.e., 36,000 AstraZeneca doses from COVAX in March 2021 had an expiry date of June 28, 2021, while 15,000 AstraZeneca doses from South Africa had an expiry date of April 13, 2021) during the initial round of COVID-19 vaccination deployment in March 2021, the MOH decided to expand COVID-19 vaccination to non-priority groups. 18. Vaccine hesitancy remains a challenge. In June 2021, the Directorate of Health Research of the MOH undertook a qualitative study (interviews of 36 key informants in the Greater Banjul Area) to explore the perceptions on COVID-19 pandemic and COVID-19 vaccination. It revealed generally favorable views of COVID-19 vaccines, but many respondents had not taken the vaccines. Some of the reasons were unavailability of vaccines, perceived side effects and efficacy of the vaccines, and not having the time to go for vaccination. The World Bank also financed a series of eight High Frequency Surveys on the COVID- 19 Impacts on Households. It showed that vaccine hesitancy depended on the COVID-19 situation. For instance, vaccine hesitancy was high during March-June 2021 but with the surge in COVID-19 cases and deaths during July-August 2021, there was a sharp uptake in COVID-19 vaccinations. Given that reaching out to people in the communities for vaccination yielded better results than vaccination at the health facilities, MOH shifted to a community engagement approach in order to increase vaccine uptake. Nevertheless, the vaccination coverage only increased from 9.7 percent of the total population of 2.4 million (with 9.1 percent fully vaccinated) in November 2021 to 13.6 percent of the total population (with 13 percent fully vaccinated) in March 2022. Another notable reason for the low vaccination coverage was Page 15 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) that the health personnel working on COVID-19 vaccination are also involved with other public health programs. Thus, there were days when they were unavailable for COVID-19 vaccination. For instance, there was no nationwide COVID-19 vaccination campaign during February-April 2022 since the immunization team was engaged in a national polio campaign. However, the May 9-15, 2022 national COVID-19 vaccination campaign, which featured the First Lady in the communications campaign, resulted in the increase in the vaccination coverage from 13.6 percent (for one or more COVID-19 vaccine doses) to 18.4 percent. 19. The Gambia plans to eventually vaccinate at least 60 percent (1.44 million) of its population. The Government recognized that the national goal of 70 percent of the population may not be within reach and has reduced it to 60 percent. The second AF supported the procurement of three energy- efficient ultracold freezers which now makes it possible to store Pfizer vaccine doses. This will allow vaccination of children aged 12-17 years and increase the eligible population for vaccination. From May 2022 to June 2023, an estimated US$8.03 million (US$4.86 from the proposed third AF and US$3.17 from other donors) will be required to cover an additional 29 precent of the population to reach the target of 60 percent (see Table 2). Additionally, an estimated US$15.26 million will be required for Pfizer booster shot for 30 percent of the population. 20. The MOH produces COVID-19 vaccination data which are disseminated widely in The Gambia COVID-19 Outbreak Situational Report by email to key stakeholders and also publicly available on the MOH website. More detailed data are also compiled and shared weekly with key MOH personnel and development partners for the vaccination monitoring and planning. The findings are presented in weekly COVID-19 technical working group meetings and in COVID-19 coordination meetings. MOH initially created a portal to allow linkage of COVID-19 vaccination registration with electronic civil registration and vital statistics (eCRVS) system. However, some of the vaccination teams mainly used tally sheets to capture the number of people vaccinated and did not record the full vaccination information. As a result, not all the vaccinations are captured in the database: as of November 20, 2021, 183,118 in the electronic database as against 236,470 recorded using the tally sheets. The use of tally sheets allows computations of the total numbers vaccinated but do not provide accurate disaggregated data. Subsequently, the District Health Information Software (DHIS2) platform has been employed for capturing COVID-19 vaccination data as well as producing COVID-19 vaccination certificate using a QR code, which are issued to people who are fully vaccinated with complete records in the electronic database. For those who do not have complete records in the electronic database, a proof of vaccination is required (by presenting an authentic hard-copy vaccination card) in order for their records to be completed in the system, for subsequent generation of a certificate with a verifiable QR code. 21. The project operational documents (Vaccine Delivery and Distribution Manual/Project Operational Manual) have confirmed that the country’s relevant regulatory authorities are responsible to assess the Project COVID-19 Vaccines’ safety and efficacy, and to authorize their use and deployment. Page 16 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) Table 2: National Vaccine Coverage and Acquisition Plan Source of financing Population targeted Vaccines Number of Estimated total World Contract Vaccines that have doses US$ (millions) Bank’s VAC Status already arrived in the needed Status of country % Number Source Name Price Shipping the vaccine Name Doses (US$/dose) (US$/dose) First stage – March 2021 to April 2022 COVAX Facility grant 0.75 18,000 COVAX AstraZeneca 3 0.18 36,000 0.11 Approved Delivered AstraZenec 36,000 a COVAX Facility grant (France) 0.80 19,200 COVAX AstraZeneca 3 0.18 38,400 0.12 Approved Delivered AstraZenec 38,400 a COVAX Facility grant (USA) 12.60 302,400 COVAX J&J 8 0.5 302,400 2.46 Approved Delivered J&J 302,400 COVAX Facility grant (USA) 1.02 24,570 COVAX Pfizer 20 1.2 49,140 1.04 Approved Delivered Pfizer 49,100 People's Republic of China 4.17 100,000 PRC Sinopharm 16 1.5 200,000 3.50 Approved Delivered Sinopharm 200,000 (PRC) Cooperation grant Senegal 0.21 5,000 Senegal Sinopharm 16 1.5 10,000 0.18 Approved Delivered Sinopharm 10,000 South Africa 0.31 7,500 South AstraZeneca 3 0.18 15,000 0.05 Approved Delivered AstraZenec 15,000 Africa a IDA 2nd AF 11.11 266,667 AVAT J&J 7.5 0.32 266,667 2.09 Approved Delivered J&J 266,667 Total 30.97a 743,337 917,607 9.55 917,607 Second stage – May 2022 to June 2023 COVAX Facility grant (USA 3.12 74,880 COVAX Pfizer 20 1.2 149,760 3.17 Approved Pending Pfizer 149,760 and other donors) IDA 3rd AFb 25.91 621,840 AVAT J&J 7.5 0.32 621,840 4.86 Approved Pending J&J 621,840 Total 29.03 696,720 771,600 8.03 771,600 Grand Total 60 1,440,057 1,689,207 17.58 1,689,207 Second stage – May 2022 to June 2023 – Booster COVAX Facility grant (several 30 720,000 COVAX Pfizer 20 1.2 720,000 15.26 Approved Assumptio Pfizer 720,000 countries) c n Note: a. The 30.97 is referring to availability of vaccines to cover 30.97 percent of the population. b. Assuming the third AF will finance all the remaining required doses to reach 60 percent of the population and no vaccine wastage is uncertain. c. Assuming all the booster doses will be donated. Page 17 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) Box 1. Liability and Indemnification Issues in Vaccine Acquisition • The rapid development of vaccines increases manufacturers’ potential liability for adverse effects following immunization. • Manufacturers want to protect themselves from this risk by including immunity from suit and liability clauses, indemnification provisions, and other limitation of liability clauses in their supply contracts. • Contractual provisions and domestic legal frameworks can all operate to allocate that risk among market participants, but no mechanism will eliminate this risk entirely. For COVAX-financed vaccines: • COVAX has negotiated model indemnification provisions with manufacturers for vaccines purchased and supplied under the COVAX Advance Market Commitment (AMC). • In providing vaccines through COVAX AMC, COVAX requests COVAX AMC Participants to have in place an indemnity agreement directly with manufacturers, and the necessary indemnity and liability frameworks for that purpose – either in the form of the COVAX model indemnification arrangements or prior bilateral arrangements with manufacturers. • The COVAX Facility will have a no-fault compensation scheme for AMC countries as part of its risk mitigation strategy. This will cover vaccines supplied only through COVAX AMC. • The Gambia will have to consider what it will take to implement these indemnification provisions (including statutory implementation) and how they can avail of the benefits of the no-fault compensation scheme. For vaccines purchased outside of COVAX: • The Gambia will need to enter direct indemnification arrangements with manufacturers. • The Gambia does not currently have legislation in place to provide statutory immunity for manufacturers. Country does not have national no fault compensation scheme. • Adoption of any such indemnification provisions or compensation scheme would have to be in accordance with The Gambia’s own national strategy and framework. The Gambia has developed a prototype indemnity agreement for vaccines with manufacturers. Possible World Bank support to The Gambia, depending on needs, may include: Information sharing on (i) statutory frameworks in Organisation for Economic Co-operation and Development countries and other developing countries; and (ii) overall experience in other countries. Page 18 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) II. DESCRIPTION OF ADDITIONAL FINANCING A. Proposed Changes 22. The changes proposed for the AF entail expanding the scope of activities in The Gambia COVID- 19 Preparedness and Response Project (P173798) and the Second AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P176125), adjusting its overall design. As the proposed activities to be funded under the AF for The Gambia are aligned with the original PDO, the PDO will remain unchanged. The existing implementation arrangement will also cater to the implementation of the NDVP. The closing date is proposed to be changed from March 31, 2023 to June 30, 2023 to allow sufficient time to complete the vaccination activities. (i) Proposed new activities 23. The project components will remain unchanged except for the component description on COVID-19 vaccination data. This third AF will entail scaling up of the following activities under Component 1: a) purchase of COVID-19 vaccine; b) deployment of COVID-19 vaccine delivery including risk communication and community engagement; and c) AEFI testing (laboratory equipment and supplies); and d) AEFI treatment (including medical equipment for COVID-19 treatment centers). Regarding COIVD- 19 vaccination data management, it is proposed to change the component description as follows: Second AF - Supporting Monitoring and Performance Management by: (A) linking Project COVID- 19 Vaccine vaccination registration with the establishment of an electronic civil registration and vital statistics system and produce vaccination registration dashboards for real-time progress monitoring of vaccine coverage and adverse events, and (B) improving the quality and completeness of Project COVID-19 Vaccine vaccination data. Third AF - Supporting Monitoring and Performance Management by: (A) using DHIS2 platform for capturing COVID-19 vaccination data and for producing COVID-19 vaccination certificate with a QR code, and (B) improving the quality and completeness of Project COVID-19 Vaccine vaccination data. 24. Vaccine purchasing will be done through Component 1 of The Gambia COVID-19 Preparedness and Response Project (P173798) and the Second AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P176125). The support for vaccines when available, which was anticipated in the initial Global COVID-19 MPA, will be added as part of the containment and mitigation measures to prevent the spread of COVID-19 and deaths under Component 1: Emergency COVID-19 Response. The Gambia will purchase vaccines through AVAT. Given the recent emergence of COVID-19, there is no conclusive data available on the duration of immunity that vaccines will provide. While some evidence suggests that an enduring response will occur, this will not be known with certainty until clinical trials follow participants for several years. As such, this AF will allow for re-vaccination efforts if they are warranted by peer- reviewed scientific knowledge at the time. In the case that re-vaccination is required, limited priority populations (such as health workers and the elderly) will need to be targeted for re-vaccination given constraints on vaccine production capacity and equity considerations (i.e., tradeoffs between broader Page 19 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) population coverage and re-vaccination). As a prudent and contingent measure, budget for funding has been retained for re-vaccination, if needed, of such a subset of the population. 25. The AF will support population groups identified in accordance with the NVDP and the new immunization target of the Government, as summarized in Table 3 below. Table 3: Priority Groups for Vaccination in The Gambia Estimated Percentage of Priority Groupa Number Population 1a Health personnel 8,478 0.35 1b Community workers (community birth companions, village health 2,184 0.09 workers, and social workers) 1c Older people aged 65 years and above 75,850 3.11 1d People with preexisting conditions (comorbidities) that place them at 300,000 12.30 higher risk for death, such as diabetes, hypertension, cardiovascular disease, chronic respiratory disease, and obesity (BMI > 30) 2a Teachers (public and private) 19,329 0.79 2b Workers at hotels, restaurants, and bars 4,311 0.18 2c Security forces 18,500 0.76 b 3 Rest of the population 986,850 40.46 Note: a. Some people may belong to more than one group; b. Children have been excluded from the approved vaccines but may eventually become eligible. For instance, Pfizer vaccine has been approved for 12-17 year olds. (ii) Financing Arrangements 26. The increase in scope as outlined above is reflected in an increase in indicative Component 1 allocation from US$12 million to US$24 million, with the full amount of the AF being added under Component 1 (see Table 4 below). Table 4: Project Cost and Financing Secon Third AF Parent Project Project Components PEF d AF Cost Total Cost Cost Cost Component 1: Emergency COVID-19 Response 4.0 0.00 8.00 12.00 24.00 Component 2: Strengthening Multi-sector, National 0.6 0.00 0 0 0.60 Institutions and Platforms for Policy Development and Coordination of Prevention and Preparedness using One Health Approach Component 3: Supporting National and Sub-national, 5.0 0.91 0 0 5.91 Prevention and Preparedness Component 4: Implementation Management and M&E 0.4 0.00 0 0 0.40 Total Costs 10.0 0.91 8.00 12.00 30.91 Page 20 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) Table 5: Summary of COVID-19 Vaccine Sourcing and Bank Financing World Bank Financed Specific No. of Doses Estimated vaccines and purchased with allocation of World sourcing plans World Bank Bank financing finance Through Through Through From COVAX AVAT direct other purchase sources 0% population 11.11% 0% 0% J&J 266,667 Purchase: US$ 2 covered population population population (AVAT) million covered covered covered Deployment: US$ (this was 0.005 million completed (syringes and under the safety boxes) second Other*: US$0 AF) million (Second AF, P176125) 0% population 25.91% 0% 0% J&J 621,840 Purchase: US$4.9 covered population population population (AVAT) million covered covered covered Deployment: (third AF) US$7.1 million Other*: US$0 million (Third AF) (iii) Retroactive Financing 27. Retroactive financing with a ceiling of US$0.5 million equivalent will support vaccine deployment activities such as printing of data collection tools, procurement vehicles and motorcycles, and sexual exploitation and abuse (SEA)/sexual harassment (SH)/gender-based violence (GBV) related activities. (iv) Changes in Institutional Arrangements for NVDP Implementation and Oversight 28. No changes in the institutional arrangements will occur. (v) Changes in disbursement categories 29. Disbursement categories will be the same as for the second AF. The total amount of new financing is expected to be fully disbursed by the end of June 2023. (vi) Results Framework 30. The proposed changes to the project Results Framework regarding the PDO-level and intermediate results indicators is described as follows: Page 21 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) Revision of PDO-level Results Indicators • Population vaccinated, which is included in the priority population targets defined in national plan (Percentage) – increased the endline date from March 31, 2023 to June 30, 2023, in line with the proposed change in closing date. • Hospitals with PPE and infection control products and supplies, without stock-outs on the first day of each quarter (Percentage)– for deletion since data is not available at the health facility level. • Diagnosed cases treated per approved protocol (percentage) – to change the definition from number of diagnosed cases treated per approved protocol to number of admitted diagnosed cases treated per approved protocol. Revision of Intermediate Results Indicators • Emergency Ambulance Services operational (number) – to change to Emergency Ambulances operational (number) and increase endline target from 9 to 20; to change end target date from March 31, 2022 to March 31, 2023. • Health centers reporting stock-out of tracer Infection prevention and control materials on the first day of each month (Percentage) – for deletion since data is not available at the health facility level • Costed plan to collect, package and transport samples to the WHO recommended laboratories for COVID-19 and future emergencies developed and implemented (Text) - for deletion since at the beginning of the COVID-19 pandemic the National Public Health Laboratory could not do COVID-19 testing but has been doing so for the past 2 years • Health personnel (such as nurses and Public Health Officers) trained in capacity and skills to administer the COVID-19 vaccine, female (Number) - for deletion since data is not available by sex. However, to keep the aggregate indicator for males plus females • Electronic COVID-19 vaccination registration system linked to electronic civil registration and vital statistics system established (Text) – for deletion since it was subsequently decided to use the DHIS2 platform to capture COVID-19 vaccination data to facilitate generation of COVID-19 vaccination certificate using a QR code. • Health and community workers with the knowledge to provide quality and comprehensive care to GBV survivors (recognize, medically manage & refer survivors to appropriate services using survivor centered approach) - (Percent) – new indicator to track improved quality of GBV service provision, a priority in the World Bank Regional Gender Action Plan. B. Sustainability 31. There is strong political commitment in The Gambia to mobilize financial resources for COVID-19 response, including for vaccine purchase and deployment. Having the funds through the proposed third AF for vaccine purchase and deployment will establish an enabling environment for other donors, multilateral development banks and UN agencies to also support efforts in the country. Investments under Page 22 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) the parent project and the AF are expected to strengthen the health system in the country, ensuring institutional sustainability to deal with infectious diseases. III. KEY RISKS 32. The overall risk to achieving the PDO with the expanded scope and AF for vaccination is Substantial. The proposed AF supports the parent PDO and aims to reduce the risk that the PDO is not achieved by supporting the country-level scale-up of vaccine purchase and deployment. However, COVID- 19 vaccination scale-up introduces new risks to the project that will be mitigated to the extent possible but still entails new residual risks. Specific risk assessments and associated mitigation measures related to planned vaccination are informed by the findings of the VRAF in The Gambia and are described below. 33. The large-scale acquisition and deployment of COVID-19 vaccines entails certain significant risks. First, the initial vaccines that meet World Bank’s VAC may not be the most effective for the specific context of The Gambia, or may not be available to be acquired in a timely manner. Second, a mass vaccination effort stretches capacity, in particular in low-capacity environments such as The Gambia, entailing risks. The proposed World Bank support for The Gambia to develop vaccination acquisition strategies and investment in deployment system capacity specifically aims to mitigate these risks: The Gambia has opted for vaccine(s) with at least 60 percent efficacy; and the EPI, which has a good track record of introducing new and underused vaccines into routine public health services, is being strengthened for COVID-19 vaccination. In addition to the vaccines from the COVAX Facility, The Gambia is purchasing vaccines through a coordinated approach convened by the AU. 34. Political and governance risks are assessed as Substantial. The Government developed a National COVID-19 Preparedness and Response Plan in March 2020 and set up a ministerial-level COVID- 19 task force chaired by the Vice President to ensure proper coordination and monitoring of the COVID- 19 response. There may be political risks to the AF related to the commitment and ability of the authorities to ensure appropriate targeting of the AF-supported vaccines to reach the priority populations, based on objective public health criteria, and ability to manage public sentiment should there be a gap between vaccine targets and vaccine delivery. These risks are being mitigated through the assurance mechanisms that this AF will support such as the establishment of an acceptable policy and plan for prioritized intra- country allocation. There are also risks related to governance of vaccine purchase and deployment, such as potential fraud and substandard quality. In addition, there are risks associated with fraudulent attempts to gain access to vaccines not following approved protocols of priority populations or for personal gain. This includes the risk of elite capture and of corruption in the implementation of the vaccination program. Additional mitigation measures include the application of anti-corruption guidelines for vaccine purchase and deployment, and robust FM oversight of the use of funds, as elaborated in the fiduciary risks below. Despite these mitigation measures, the AF is expected to increase the overall political and governance risks to the parent project. 35. Macroeconomic risks are assessed as Substantial. A prolonged COVID-19 pandemic will increase the pressure on external and fiscal balances over the medium term and is causing major disruptions in many sectors, including tourism in The Gambia. Nevertheless, the Government has allocated US$10 million to the COVID-19 response, and development partners have deployed a large array of technical and financial assistance to help mitigate the impact of the pandemic. The medium-term outlook is broadly Page 23 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) positive with the economy expected to gradually recover, driven by robust private consumption and rapidly growing public investment. Further, the proposed AF specifically aims to mitigate this risk by providing financing for vaccine purchase and promoting prioritized deployment to vulnerable groups. Residual macroeconomic risks will remain as the country aims to scale vaccine access to higher coverage levels if the global shortage of COVID-19 vaccines persists. Despite the mitigation measures, the AF is expected to increase the overall macroeconomic risk of the parent project. 36. Institutional capacity for implementation and sustainability risks are assessed as Moderate. Previously, the PCU had limited experience working on WBG operations. Currently, the PCU is fully staffed with a PCU coordinator, senior operations officer, operations officer, Financial Controller, a senior accountant and five accountants, procurement specialist, procurement officer, and procurement assistant, and the PCU staff continue to receive hands-on training. Further, progress toward the achievement of the PDO and implementation progress are both rated Satisfactory. Nevertheless, there is a risk regarding how the compensation issues related to pharmaceutical firms’ liability shield will be addressed for those firms supplying the COVID-19 vaccines. However, The Gambia has developed a prototype indemnity agreement for vaccines with manufacturers. Vaccine deployment, cold-chain and distribution capacity, especially for the anticipated scale and population group coverage for COVID-19 vaccination, could be a challenge. Nevertheless, The Gambia has the adequate storage capacity to handle both routine vaccines and the COVID-19 vaccine at temperatures between 2°C and 8°C and the proposed AF will support the procurement of ultracold freezers. 37. Fiduciary risks associated with vaccines are assessed as Moderate. (a) Procurement. The key procurement risks associated with vaccines (which were noted as High) do not apply the third AF: (i) vaccines are no longer in short supply; and (ii) through World Bank-Facilitated Procurement (BFP) under Hands-on Expanded Implementation Support (HEIS), the MOH requested for Bank support in procuring vaccines through the AVAT mechanism and the same will be done under the third AF. The full-time PCU Procurement Specialist, Procurement Officer and Procurement Assistant will continue to provide procurement support to the project during implementation; the development of skills on the Bank's procurement rules and procedures and the lessons learned during the implementation of the procurement of vaccines during the second AF. Procurement training was provided to PCU staff. (b) FM. The FM Risk is rated as Moderate due to the satisfactory FM performance of the parent project and second AF. 38. Environmental and social (E&S) risks are rated Substantial. The measures to address social and environmental risks presented in the original project remain relevant insofar as the activities planned with this third AF will mainly scale up the existing activities. The focus will continue to be on infection prevention and control improvements and medical waste management in health care facilities and other inoculation sites. Addressing possible inequity to vaccine access will continue to be mitigated to ensure vaccine delivery targets the most vulnerable populations in accordance with criteria specified in the ongoing MOH COVID-19 pandemic protocols. The potential risk of reprisals and retaliation especially against health care workers and researchers will continue to be mitigated through MOH guidance and the stakeholder engagement processes. Capacity of the MOH to manage the E&S risks continues through Page 24 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) ongoing support and training for dedicated MOH E&S safeguards focal points the senior operations officer at the PCU and other targeted stakeholders. IV. APPRAISAL SUMMARY A. Technical, Economic and Financial Analysis 39. The rapid spread of the Omicron variant has brought renewed attention and a new urgency to the worldwide COVID-19 vaccination effort as a critical intervention to prevent virus mutations and new variants. One year into the global vaccine rollout, the world continues to face a dual challenge: supply issues related to the unequitable access to vaccines, including capacity constraints to administer available vaccines, and demand issues related to vaccine hesitancy. As of mid-April 2022, 64.6 percent of the world population has received at least one dose of a COVID-19 vaccine. However, only 14.7 percent of people in low-income countries have received at least one dose. The economic rationale for investment in a COVID- 19 vaccine is strong, considering the massive and continuing health and economic losses due to the pandemic. As of mid-April 2022, over 490 million COVID-19 cases and nearly 6.2 million deaths have been confirmed worldwide. Global growth rebounded to 5.5 percent in 2021. However, according to the World Bank’s Global Economic Prospects (January 2022), global growth is expected to decelerate to 4.1 percent in 2022, reflecting continued COVID-19 flare-ups, diminished fiscal support, and lingering supply bottlenecks. Although output and investment in advanced economies are projected to return to pre- pandemic trends next year, they will remain markedly below pre-pandemic levels in emerging markets and developing economies. 40. The successful development, production, and delivery of a vaccine, however, offer the best potential to reverse these trends, generating benefits that will far exceed vaccine-related costs. Indeed, a rapid and well-targeted deployment of COVID-19 vaccine can help reduce increases in poverty and accelerate economic recovery. Even at levels of imperfect effectiveness, COVID-19 vaccine that is introduced and deployed effectively to priority populations can assist in significantly reducing mortality and the spread of the coronavirus and accelerating a safe reopening of key sectors that are impacted. It can also reverse human capital losses by ensuring schools are reopened. The effective administration of COVID-19 vaccine will also help avoid the associated health care costs for potentially millions of additional cases of infection and associated health-related impoverishment. Global experience with immunization against diseases shows that by avoiding these and other health costs, vaccines are one of the best buys in public health. For the most vulnerable population groups, especially in countries without effective universal health coverage, the potential health-related costs of millions of additional cases of COVID-19 infection in the absence of a vaccine represent a significant or even catastrophic financial impact and risk of impoverishment. The pandemic is also having dire effects on other non-COVID health outcomes. Increased morbidity and mortality due to interruption of essential services associated with COVID-19 containment measures hinder access to care for other health needs of the population, including maternal and childcare services. Routine immunization services have been affected, threatening polio eradication, and potentially leading to new outbreaks of preventable diseases, with related deaths, illnesses, and long- term costs. Simultaneous epidemics are overwhelming public health systems in different countries that had few resources to begin with, and the services required to address the needs of people with chronic health conditions and mental and substance use disorders have also been disrupted. Page 25 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) 41. While the uncertainty around the costs and effectiveness of COVID-19 vaccine makes it difficult to calculate its cost-effectiveness, the effective launch of COVID-19 vaccine will have direct benefits in terms of averted costs of treatment and disability, as well as strengthened health systems. Estimated COVID-19 treatment costs from low- and middle-income countries stand at US$50 for a non-severe case and US$300 for a severe case. This excludes the costs of testing for negative cases, as well as the medical costs associated with delayed or foregone care-seeking, which usually results in higher costs. The estimated cost of vaccinating 60 percent of the population of The Gambia is US$17.58 million; even if the vaccine averts some non-severe cases and no other benefits are considered, the investment will break even. Further, investments in vaccine delivery systems generate health and economic benefits beyond just delivering the COVID-19 vaccine. First, investments in last-mile delivery systems to administer the COVID-19 vaccine to remote communities will require the strengthening of community health systems, which can have spillover effects on the effective delivery of other services, helping to close the significant urban-rural gap. Second, as the COVID-19 vaccine is introduced and lockdowns and movement restrictions are eased, patients can continue to access care for other conditions. Third, the economic benefits of slowing down the economic downturn are likely to significantly exceed the US$17.58 million needed to vaccinate 60 percent of the population, aside from the immediate health benefits. Given both the economic and health system benefits, an effectively deployed COVID-19 vaccine presents significant benefits. B. Financial Management 42. In line with the guidelines stated in the FM Practices Manual issued by the FM Sector Board on March 1, 2010, and as last revised in September 2021 a FM assessment was conducted for the parent project. The FM arrangements for this third AF will be the same as those under the parent project and second AF, including the FM risk assessed which is Moderate. As mitigating measures have been implemented for the parent project to address FM capacity constraints, the FM satisfies the WBG’s minimum requirements. 43. The FM arrangements will be based on the existing arrangements in place within the PCU which also has the fiduciary responsibility of The Gambia Essential Health Services Strengthening Project (P173287). The overall FM performance of the PCU is Satisfactory. The PCU is familiar with the World Bank FM requirements. The interim un-audited financial reports (IFRs) for the ongoing projects are submitted on time and acceptable to IDA. 44. The pace of disbursements of the AF will be significantly influenced by the availability of vaccines. Disbursement for the project will follow the existing disbursement arrangements for the original Project. Disbursements under the ongoing project are transactions based. Direct Payment method will apply as appropriate. The same Designated Account (DA) used for the second AF will be used to facilitate payment for eligible expenditures. 45. The scope of project audit will include audit of vaccination financing including the audit of funds spent on deployment of vaccines. The auditor will review a sample of such transactions to confirm the eligibility of the respective expenditures. Consolidated Audited Financial Statements (original project and AF) will be submitted to IDA six months after the end of each accounting period. The auditor will issue an opinion on the Audited Project consolidated Financial Statements and in compliance with International Page 26 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) Federation of Accountant (IFAC) and a specific opinion on the purchase and deployment of vaccines will be required. 46. In order to ensure readiness for implementation and maintain an adequate FM system an addendum needs to be signed with the current external auditor to include this third AF in its scope of intervention and customize the accounting software for the AF bookkeeping. C. Procurement 47. Procurement under the AF will be carried out in accordance with the World Bank’s Procurement Regulations for IPF Borrowers for Goods, Works, Non-Consulting and Consulting Services, dated November 2020. As with the parent project and second AF, the proposed AF will be subject to the World Bank’s Anticorruption Guidelines, dated October 15, 2006, revised in January 2011, and as of July 1, 2016. The project will use the Systematic Tracking of Exchanges in Procurement (STEP) to plan, record, and track procurement transactions. 48. The major planned procurement under the AF is vaccines and the logistics required to deliver to the country’s ports of entry. The current demand for COVID-19 vaccines exceeds the supply in the market which makes it more difficult for client countries to negotiate terms and conditions. The COVAX Facility will not entail any procurement since it is being provided as no cost to The Gambia. The contracts for vaccine purchase would be subject to the WBG’s prior review. The Project Procurement Strategy for Development and the Procurement Plan in STEP have been updated to reflect any additional procurement. 49. The procurement risk is Moderate. Specifically, procurement of COVID-19 vaccines is special and has unique risks but The Gambia previously procured vaccines from AVAT with UNICEF as the procurement agent. The WBG’s oversight of procurement is done through increased implementation support and increased procurement post review based on a 20-percent sample for procurement activities that the WBG’s prior review will not apply. D. Legal Operational Policies . Triggered? Projects on International Waterways OP 7.50 Projects in Disputed Areas OP 7.60 . 50. No legal operational policies (Projects on International Waterways OP 7.50 or Projects in Disputed Areas OP 7.60) have been triggered for the proposed AF. E. Environmental and Social 51. Activities under the third AF will have positive impacts as they will continue to improve capacity for surveillance, monitoring, and containment of COVID-19. The potential environment, health, and safety Page 27 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) risks associated with the continued COVID-19 pandemic will continue to be mitigated following established protocols by the MOH. Such measures address reagents and equipment used in the project- supported activities, facilities treating patients that generate biological and chemical waste and other hazardous by-products. These risks will continue to be mitigated with occupational health and safety standards and specific infection-control actions recommended by the WHO and Centers for Disease Control and Prevention. These vulnerabilities will be addressed through targeting and improving health care interventions described earlier as well as surveillance monitoring. 52. In line with the WHO Interim Guidance (February 12, 2020) on ‘Laboratory Biosafety Guidance related to the novel coronavirus (2019-nCoV)’ and other guidelines, the parent project developed an Infection Control and Waste Management Plan (ICWMP) included in the Environmental and Social Management Framework (ESMF) for the project by adding to it the WHO standards on COVID-19 response. The ICWMP provides management measures such as minimization, recycling and reuse, identification, segregation and packaging of waste, proper handling of waste, safe storage of waste, safe and proper transportation of waste, quantification of waste, occupational health and safety. The plan includes also training of staff to be aware of all hazards they might encounter. This provides for the application of international best practices in COVID-19 diagnostic testing and handling of medical supplies, disposing of the generated waste, and road safety. 53. Grievance Redress Mechanism (GRM). Communities and individuals who believe that they are adversely affected by a project supported by the World Bank may submit complaints to existing project- level grievance mechanisms or the Bank’s Grievance Redress Service (GRS). The GRS ensures that complaints received are promptly reviewed in order to address project-related concerns. Project affected communities and individuals may submit their complaint to the Bank’s independent Accountability Mechanism (AM). The AM houses the Inspection Panel, which determines whether harm occurred, or could occur, as a result of Bank non-compliance with its policies and procedures, and the Dispute Resolution Service, which provides communities and borrowers with the opportunity to address complaints through dispute resolution. The MOH has developed a comprehensive GBV/SEA/SH and GRM Action Plan, which details measures to prevent and respond to project related SEA/SH including managing related grievances. The AF will support the implementation of code of conduct and GRM Handbook and Register for registration of complaints for GBV in the context of COVID-19, Stakeholder Consultations, training of health personnel, proper awareness raising, and timely information dissemination. Complaints may be submitted to the AM at any time after concerns have been brought directly to the attention of Bank Management and after Management has been given an opportunity to respond. For information on how to submit complaints to the Bank’s Grievance Redress Service (GRS), please visit http://www.worldbank.org/GRS. For information on how to submit complaints to the Bank’s Accountability Mechanism, please visit https://accountability.worldbank.org. 54. E&S compliance of the parent project continues to be rated as satisfactory. The following E&S instruments for the parent project have been developed and updated for the Third AF and publicly disclosed: Page 28 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) • ESMF for The Gambia COVID-19 Preparedness and Response Project (P173798)3 • Stakeholder Engagement Plan (SEP) for The Gambia COVID-19 Preparedness and Response Project (P178965)4 • Environmental and Social Commitment Plan (ESCP) for The Gambia COVID-19 Preparedness and Response Project (P178965)5 • Environmental and Social Review Summary (ESRS) for The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965)6 • Environmental and Social Management Plan (ESMP) For Installation and Operation of Medical Incinerators (P178965))7 • Environmental and Social Impact Assessment The Gambia COVID-19 Preparedness and Response Project (P173798)8 • Resettlement Plan The Gambia COVID-19 Preparedness and Response Project (P173798)9 • Environmental and Social Management Plan (ESMP) The Gambia COVID-19 Preparedness and Response Project (P173798)10 • Environmental and Social Management Plan (ESMP) The Gambia COVID-19 Preparedness and Response Project (P173798)11 • Environmental and Social Management Plan (ESMP) for Medical Equipment and Supplies (P173798)12 3 Updated ESMF Third AF The Gambia COVID-19 Preparedness and Response Project (P173798) (May 5, 2022). Washington, D.C. World Bank Group. https://documents.worldbank.org/en/publication/documents- reports/documentdetail/099050005072228001/p1737980c1a858040b0bc0550958dc763c. This was updated and disclosed on the World Bank website on May 5, 2022 and on the Ministry of Health website on June 6, 2022. 4Additional Financing Stakeholder Engagement Plan (SEP) - Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project - P178965 (English). Washington, D.C.: World Bank Group. http://documents.worldbank.org/curated/en/099105106012224732/P17896508802f0040b5e00dd88106b362b . This was updated and disclosed on the World Bank website on May 31, 2022 and on the Ministry of Health website on June 6, 2022. 5 Additional Financing Environmental and Social Commitment Plan (ESCP) - Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project - P178965 (English). Washington, D.C.: World Bank Group. http://documents.worldbank.org/curated/en/099105106012242383/P17896500b3f690809b6d0a96ac2854da5. This was updated and disclosed on the World Bank website on May 31, 2022 and on the Ministry of Health website on June 6, 2022. 6 Additional Financing Environmental and Social Review Summary (ESRS) - Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project - P178965 (English). Washington, D.C.: World Bank Group. http://documents.worldbank.org/curated/en/099105006012240444/P17896504931530820a88b01024d77cba65. This was updated and disclosed on the World Bank website on May 31, 2022 and on the Ministry of Health website on June 6, 2022. 7 Environmental and Social Management Plan (ESMP) The Gambia COVID-19 Preparedness and Response Project (P173798). December 23 2021. Washington, D.C. World Bank Group. http://documents.worldbank.org/curated/en/099320012232120093/Gambia0COVID010700final0Dec02202021 8 Environmental and Social Impact Assessment The Gambia COVID-19 Preparedness and Response Project (P173798) (January 10, 2022). Washington, D.C. World Bank Group. http://documents.worldbank.org/curated/en/099125001102217765/Gambia0Nationa0atment0Centre0ESIA0 9 Resettlement Plan The Gambia COVID-19 Preparedness and Response Project (P173798) (December 20, 2021). Washington, D.C. World Bank Group. http://documents.worldbank.org/curated/en/099315012202120114/Resettlement0A0ID0Project00P1737980 10 Environmental and Social Management Plan (ESMP) The Gambia COVID-19 Preparedness and Response Project (P173798). Edward Francis Small Teaching Hospital Clinical Waste Treatment Centre. (June 17, 2021). Washington, D.C.: World Bank Group. http://documents.worldbank.org/curated/en/558421623948773312/Environmental-and-Social-Management-Plan- ESMP-The-Gambia-COVID-19-Preparedness-and-Response-Project-P173798 11 Environmental and Social Management Plan (ESMP) The Gambia COVID-19 Preparedness and Response Project (P173798). Page 29 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) 55. The project implementation will ensure appropriate stakeholder engagement, proper awareness raising, and timely information dissemination. Through various citizen engagement mechanisms such as consultations and grievance redress mechanism, the project will capture beneficiaries feedback. The analysis of the complaints database as well as the feedback received will inform the project interventions and any necessary corrective measures that will be identified by the beneficiaries. 56. The PCU has a Senior Operations Officer who is the main coordinator and focal point for E&S issues, supported by the MOH Environmental Health Program Manager, the Health Communications Manager and the SEA/SH/GBV Focal Point. Implementation of the E&S agenda has been satisfactory. The same PCU has been implementing the E&S requirements of The Gambia COVID-19 Preparedness and Response Project (P173798) since April 2020 and the parent project. 57. As part of the PCU commitment to monitor and report on the status of E&S due diligence, E&S Due Diligence Reports are submitted quarterly to the WBG. Together with the WBG E&S specialists, the report has been structured to follow both the ESCP and ESMF commitments. All required project actions are being tracked and reported on. The WBG has organized a series for virtual capacity-building events: (a) a virtual orientation on November 17, 2020, for 37 key stakeholders working on this project to ensure an appropriate E&S Due Diligence Report is carried out; (b) three-day training (December 1–3, 2020) on implementing the E&S framework in WBG-financed projects for implementing agencies; (c) workshop on SEA/SH risk management in World Bank-financed operations in The Gambia during December 8–10, 2020; and (d) training on May 26, 2021, for more than 24 participants and the topics covered included expanding the stakeholder communication program, ESMPs, SEA/SH Action Plan, and HCW treatment. 58. The AF will contribute to one World Bank Regional Gender Action Plan priority i.e., addressing GBV with quality GBV services (as noted above with the implementation of the comprehensive SEA/SH/GBV action plan). The Gambia is ranked 142th in the 2019 Gender Inequality Index (which takes into consideration three dimensions: reproductive health, empowerment and the labor market). Globally, some progress on women’s rights has been achieved. The maternal mortality ratio (MMR) has decreased by 36 percent, from 932 maternal deaths per 100,000 live births in 2000 to 597 per 100,000 live births in 2017. This is inversely correlated with the proportion of births attended by skilled health personnel, which increased from 44.1 percent in 1990 to 56.6 percent in 2010 and to 82.7 percent in 2018. Therefore, work still needs to be done in The Gambia to achieve gender equality. In addition, the empowerment of women is low with a proportion of women ages 20–24 that reported being married or in union before age 18 over 30 percent. As of April 2022, only 8.62 percent of parliament seats are held by women down from the 10.34 percent prior to the 2022 elections. GBV is a common problem that needs to be addressed in the Gambia. According to the 2019-20 Demographic and Health Survey, 36.3 percent of women ages 15–49 indicated that a husband is justified in beating or hitting his wife if she refuses to have sexual intercourse with him. Moreover, women of reproductive age (ages 15–49) often face barriers with respect to their For Ministry of Health Clinical Waste Treatment Centre, Farato. (June 17, 2021). Washington, D.C. World Bank Group. http://documents.worldbank.org/curated/en/681251623948853351/Environmental-and-Social-Management-Plan-ESMP-The- Gambia-COVID-19-Preparedness-and-Response-Project-P173798 12 Environmental and Social Management Plan (ESMP) The Gambia COVID-19 Preparedness and Response Project (P173798) (June 4, 2020). For Medical Equipment and Supplies. Washington, D.C. World Bank Group. http://documents.worldbank.org/curated/en/567651591316470981/Environmental-and-Social-Management-Plan-ESMP-The- Gambia-COVID-19-Preparedness-and-Response-Project-P173798 Page 30 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) sexual and reproductive health and rights—despite progress, the proportion of women using modern contraceptive methods stood at 17.1 percent in 2020. 59. In The Gambia, only 35.7 percent of indicators needed to monitor the Sustainable Development Goals (SDGs) from a gender perspective are available, with gaps in key areas such as unpaid care and domestic work, key labor market indicators such as gender pay gap, and skills in information and communication technology. In addition, many areas such as gender and poverty, women’s access to assets including land, physical and SH, and gender and the environment currently lack comparable methodologies for comprehensive and periodic monitoring. These gender data and its gaps help understand the situation of women and girls in The Gambia and the need for achieving the gender-related SDGs commitments, as part of the efforts to address these gaps. 60. In summary, the pandemic has exacerbated the conditions that put women and girls at greater risk of GBV. Therefore, this third AF proposes to contribute to an improved quality of treatment to the victims of GBV. To ensure that health service providers provide quality services to support GBV survivors, the MOH will provide training to improve the knowledge on recognizing and referring GBV survivors to appropriate services, following the WHO standards. The MOH has developed a comprehensive GBV/SEA/SH and GRM Action Plan, which details measures to prevent and respond to project related SEA/SH including managing related grievances. The AF will support the implementation of code of conduct and GRM Handbook and Register for registration of complaints for GBV in the context of COVID-19, Stakeholder Consultations, training of health personnel, proper awareness raising, and timely information dissemination. An intermediate level results indicator had been added to the results framework track the percentage of health and community workers with knowledge to recognize, medically manage, and refer GBV survivors to appropriate services. Climate Vulnerability and Resilience 61. This project has been screened for climate change and disaster risks. The overall potential risks in The Gambia were assessed as ‘moderate’ in the Summary Climate and Disaster Risk Screening Report. The exposure rating was assessed as ‘high’ due to extreme temperature, precipitation and flooding, drought, sea level rise, storm surge, and coastal erosion. This exposure risk is assessed at this level for both the current and future time scales. An increase in heat and rainfall events may lead to food insecurity due to the population’s heavy reliance on rain-fed crops that are vulnerable to persistent drought.13 Droughts can also lead to dust storms, which would have serious respiratory health consequences for a population that has lower respiratory tract infections as the second major cause of mortality in 2017. Extreme rainfall events and flooding may lead to an increased number of breeding grounds for mosquitoes, water contamination, injuries, drowning and infrastructure damage. Therefore, it is critical to put sustainable and climate-resilient measures in place to reduce the impact of climate change on the population. However, the risk on project activities and outcomes is categorized as ‘moderate’ as the project will implement adaptation measures to ensure climate resilience in the future. 62. Climate mitigation activities in the third AF (i.e., procurement of medical and laboratory equipment) expand on the adaptation and mitigation measures in the parent project and second AF 13International College of Business and Human Resource Development (ICOBAHRD) at Kanifing and the Center for International Earth Science Information Network (CIESIN) at Columbia University. 2011. Climate Change and Development in The Gambia: Challenges to Ecosytem Goods and Services. Kanifing, The Gambia. Page 31 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) including climate friendly 47 incinerators (i8-M70 dual chamber incineration with flue gas treatment, https://www.inciner8.com/), Ecosteryl 250 series and 75 plus series waste-treatment machines (http://ecosteryl.com/), which employ microwave technology, construction of two clinical waste treatment of waste, and three ultracold freezers (B Medical Systems Sarl - S0003104) for storing ultracold COVID-19 vaccines. V. WORLD BANK GRIEVANCE REDRESS 63. Grievance Redress. Communities and individuals who believe that they are adversely affected by a project supported by the World Bank may submit complaints to existing project-level grievance mechanisms or the Bank’s Grievance Redress Service (GRS). The GRS ensures that complaints received are promptly reviewed in order to address project-related concerns. Project affected communities and individuals may submit their complaint to the Bank’s independent Accountability Mechanism (AM). The AM houses the Inspection Panel, which determines whether harm occurred, or could occur, as a result of Bank non-compliance with its policies and procedures, and the Dispute Resolution Service, which provides communities and borrowers with the opportunity to address complaints through dispute resolution. Complaints may be submitted to the AM at any time after concerns have been brought directly to the attention of Bank Management and after Management has been given an opportunity to respond. For information on how to submit complaints to the Bank ’s Grievance Redress Service (GRS), please visit http://www.worldbank.org/GRS. For information on how to submit complaints to the Bank’s Accountability Mechanism, please visit https://accountability.worldbank.org. Page 32 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) VI SUMMARY TABLE OF CHANGES Changed Not Changed Results Framework ✔ Components and Cost ✔ Loan Closing Date(s) ✔ Implementing Agency ✔ Project's Development Objectives ✔ Cancellations Proposed ✔ Reallocation between Disbursement Categories ✔ Disbursements Arrangements ✔ Legal Covenants ✔ Institutional Arrangements ✔ Financial Management ✔ Procurement ✔ Other Change(s) ✔ VII DETAILED CHANGE(S) MPA PROGRAM DEVELOPMENT OBJECTIVE Current MPA Program Development Objective The Program Development Objective is to prevent, detect and respond to the threat posed by COVID-19 and strengthen national systems for public health preparedness Proposed New MPA Program Development Objective Page 33 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) EXPECTED MPA PROGRAM RESULTS Current Expected MPA Results and their Indicators for the MPA Program Progress towards the achievement of the PDO would be measured by outcome indicators. Individual country- specific projects (or phases) under the MPA Program will identify relevant indicators, including among others: • Country has activated their public health Emergency Operations Centre or a coordination mechanism for COVID-19; • Number of designated laboratories with COVID-19 diagnostic equipment, test kits, and reagents; • Number of acute healthcare facilities with isolation capacity; • Number of suspected cases of COVID-19 reported and investigated per approved protocol; • Number of diagnosed cases treated per approved protocol; • Personal and community non-pharmaceutical interventions adopted by the country (e.g., installation of handwashing facilities, provision of supplies and behavior change campaigns, continuity of water and sanitation service provision in public facilities and households, schools closures, telework and remote meetings, reduce/cancel mass gatherings); • Policies, regulations, guidelines, or other relevant government strategic documents incorporating a multi- sectoral health approach developed/or revised and adopted; • Multi-sectoral operationalmechanism for coordinated response to outbreaks by human, animal and wildlife sectors in place; • Coordinated surveillance systemsin place in the animal health and public health sectors for zoonotic diseases/pathogens identified as joint priorities; and • Mechanisms for responding to infectious and potential zoonotic diseases established and functional; and • Outbreak/pandemic emergency risk communication plan and activities developed and tested Proposed Expected MPA Results and their Indicators for the MPA Program COMPONENTS Current Component Name Current Cost Action Proposed Component Proposed Cost (US$, (US$, millions) Name millions) Component 1: Emergency 4.23 Revised Component 1: 24.00 COVID-19 Response Emergency COVID-19 Response Page 34 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) Component 2: 0.60 Component 2: 0.60 Strengthening Multi-sector, Strengthening Multi- National Institutions and sector, National Platforms for Policy Institutions and Development and Platforms for Policy Coordination of Prevention Development and and Preparedness using One Coordination of Health approach. Prevention and Preparedness using One Health approach. Component 3: Supporting 5.71 Revised Component 3: 5.91 National and Sub-national, Supporting National and Prevention and Sub-national, Preparedness Prevention and Preparedness Component 4: 0.40 Component 4: 0.40 Implementation Implementation Management and Management and Monitoring and Evaluation Monitoring and Evaluation TOTAL 10.94 30.91 LOAN CLOSING DATE(S) Ln/Cr/Tf Status Original Closing Current Proposed Proposed Deadline Closing(s) Closing for Withdrawal Applications IDA-D5970 Effective 31-Mar-2022 31-Mar-2023 30-Jun-2023 30-Oct-2023 IDA-D8020 Effective 31-Mar-2023 31-Mar-2023 30-Jun-2023 30-Oct-2023 TF-B4724 Closed 31-Jan-2021 31-Jan-2021 31-Jan-2021 31-May-2021 Expected Disbursements (in US$) DISBURSTBL Fiscal Year Annual Cumulative 2020 6,290,879.51 6,290,879.51 2021 6,449,989.63 12,740,869.14 2022 5,000,000.00 17,740,869.14 2023 12,000,000.00 29,740,869.14 2024 169,130.86 29,910,000.00 Page 35 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) SYSTEMATIC OPERATIONS RISK-RATING TOOL (SORT) Risk Category Latest ISR Rating Current Rating Political and Governance ⚫ Substantial ⚫ Substantial Macroeconomic ⚫ Substantial ⚫ Substantial Sector Strategies and Policies ⚫ Moderate ⚫ Moderate Technical Design of Project or Program ⚫ Moderate ⚫ Moderate Institutional Capacity for Implementation and ⚫ Moderate ⚫ Moderate Sustainability Fiduciary ⚫ Moderate ⚫ Moderate Environment and Social ⚫ Substantial ⚫ Substantial Stakeholders ⚫ Moderate ⚫ Moderate Other Overall ⚫ Substantial ⚫ Substantial LEGAL COVENANTS2 LEGAL COVENANTS – Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) Sections and Description Project Operations Manual Financing Agreement: Schedule 2, Section 1, B, 2(a) The Recipient shall within 15 days of the Effective date, update and adopt a Project operations manual containing detailed guidelines and procedures for the implementation of the Project, including with respect to: (i) administration and coordination, monitoring and evaluation, financial management, procurement and accounting procedures, environmental and social safeguards, corruption and fraud mitigation measures, a grievance redress mechanism, collection and processing of Personal Data in accordance with good international practice, roles and responsibilities for Project implementation, (ii) rules and procedures for prioritizing intra-country Project COVID-19 Vaccine allocation following principles established in the WHO Fair Allocation Framework, including an action plan setting out the timeline and steps for implementing such rules; (iii) rules and procedures establishing minimum standards for Project COVID-19 Vaccine management and monitoring, including medical and technical criteria, communications and outreach plan, cold chain infrastructure, and other related logistics infrastructure; (iv) Project COVID-19 Vaccine distribution plan, including action plan setting out timeline and steps for immunization; and such other arrangements and procedures as shall be required for the effective implementation of the Project, in form and substance satisfactory to the Association (“Project Operations Manual”). Schedule 3, Section 1, B, 3(a) The Recipient shall, not later than one (1) month after the Effective Date, prepare and furnish to the Association, a work plan and budget containing all activities proposed to be included in the Project and a proposed financing plan for expenditures required for such activities, setting forth the proposed amounts and sources of financing. Page 36 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) Conditions Type Financing source Description Effectiveness IBRD/IDA Article IV, 4.01 The Additional Condition of Effectiveness consists of the following, namely that the Recipient has updated the ESMF in a manner acceptable to the Association. Page 37 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) VIII. RESULTS FRAMEWORK AND MONITORING Results Framework COUNTRY: Gambia, The RESULT_NO_PDO Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project Project Development Objective(s) To prevent, detect and respond to the threat posed by COVID-19 and strengthen national system for public health preparedness Project Development Objective Indicators by Objectives/ Outcomes RESULT_FRAME_TBL_ PD O Indicator Name PBC Baseline End Target Strengthen the national public health preparedness capacity to prevent, detect and respond Suspected cases of COVID-19 cases reported and investigated 0.00 50.00 per approved protocol (Percentage) Isolation and treatment centers with pandemic preparedness and response plans per Ministry of Health Guidelines 0.00 50.00 (Percentage) Health staff trained in infection prevention per MOH-approved 0.00 500.00 protocols (Number) Hospitals with personal protective equipment and infection control products and supplies, without stock-outs on the first day 0.00 50.00 of each quarter (Percentage) Rationale: Action: This indicator has been Marked for Deletion Data is not available at the health facility level Diagnosed cases treated per approved protocol (Percentage) 0.00 50.00 Page 38 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) RESULT_FRAME_TBL_ PD O Indicator Name PBC Baseline End Target Rationale: To change the definition from number of diagnosed cases treated per approved protocol to number of admitted diagnosed Action: This indicator has been Revised cases treated per approved protocol Population vaccinated, which is included in the priority 0.00 40.00 population targets defined in national plan (Percentage) Rationale: Action: This indicator has been Revised Increased the endline date from March 31, 2023 to June 30, 2023, in line with the proposed change in closing date. Population vaccinated, which is included in the priority population targets defined in national plan, female 0.00 20.00 (Percentage) Rationale: Action: This indicator has been Revised Increased the endline date from March 31, 2023 to June 30, 2023 PDO Table SPACE Intermediate Results Indicators by Components RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline End Target Component 1: Emergency COVID-19 Response Public Health Emergency Operation Center (PHEOC) activated and operationalized to support coordination and planning for Not operational Operational COVID-19 or other future emergencies (Text) Points of Entries equipped and staff trained in SOPs (including for infection prevention and control, screening of passengers 0.00 9.00 (Number) Page 39 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline End Target Rapid-response teams members trained and equipped to 0.00 80.00 investigate cases and conduct contact tracing (Percentage) Table-top simulation exercises and findings documented to Report on table-top simulation exercises with inform future preparedness and response activities (Text) None recommendations or lessons learned Supervisory visits undertaken to nine Points of Entry (Number) 0.00 27.00 Border officers trained on COVID-19 prevention and control and 0.00 50.00 contact tracing (Number) Community-based nurses and PHO trained on COVID-19 prevention and control and contact tracing (Number) 0.00 100.00 Emergency Ambulances operational (Number) 0.00 20.00 Rationale: Action: This indicator has been Revised Change to Emergency Ambulances operational (number) and increase endline target from 9 to 20 MoU signed with Republic of Senegal PHES (Text) None signed Table-top simulation exercises conducted (Number) 0.00 10.00 Sites for treatment of healthcare waste established (Number) 0.00 7.00 COVID-19 sensitization campaigns conducted in all regions 0.00 7.00 (Number) Grievances responded to within stipulated service standards for response (Percentage) 0.00 40.00 Population vaccinated, which is included in the priority 0.00 960,000.00 population targets defined in national plan (Number) Population vaccinated, which is included in the priority 0.00 480,000.00 population targets defined in national plan, female (Number) Page 40 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline End Target Health personnel (such as nurses and Public Health Officers) trained in capacity and skills to administer the COVID-19 vaccine 0.00 200.00 (Number) Health personnel (such as nurses and Public Health Officers) trained in capacity and skills to administer the COVID-19 0.00 100.00 vaccine, female (Number) Rationale: Action: This indicator has been Marked for Deletion Data is not available by sex Electronic COVID-19 vaccination registration system linked to electronic civil registration and vital statistics system established No COVID-19 vaccination database in place Electronic COVID-19 vaccination system established (Text) Rationale: Dropped since it was subsequently decided to use the DHIS2 platform to capture COVID-19 vaccination data to facilitate Action: This indicator has been Marked for Deletion generation of COVID-19 vaccination certificate using a QR code. Implementation of a civil society-based mechanism to monitor, report and facilitate responses to problems in the COVID-19 Civil society-based monitoring mechanism not in place Civil society-based monitoring mechanism in place response (Text) Health and community workers with the knowledge to provide quality and comprehensive care to GBV survivors (recognize, 0.00 60.00 medically manage & refer survivors to appropriate services using survivor cente (Percentage) Rationale: Action: This indicator is New To track improved quality of GBV service provision Component 2: Strengthening Multi-sector, National Institutions and Platforms for Policy Development Electronic Integrated Disease Surveillance Response (IDSR) using None Established DHIS2 platform interfaced with laboratory management Page 41 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline End Target information system established (Text) Component 3: Supporting National and Sub-national, Prevention and Preparedness Health centers reporting stock-out of tracer Infection prevention and control materials on the first day of each month 0.00 50.00 (Percentage) Rationale: Action: This indicator has been Marked for Deletion Drop since data is not available at the health facility level Costed plan to collect, package and transport samples to the WHO recommended laboratories for COVID-19 and future No plan Plan in place emergencies developed and implemented (Text) Rationale: Action: This indicator has been Marked for Deletion At the beginning of the COVID-19 pandemic the National Public Health Laboratory could not do COVID-19 testing but has been doing so for the past 2 years Standard Operating Procedures (SOPs) on sample collection, None SOP in place packaging, transportation and testing of samples (Text) Treatment centres renovated/constructed and/or equipped (Number) 0.00 2.00 IO Table SPACE Monitoring & Evaluation Plan: PDO Indicators Mapped Methodology for Data Responsibility for Data Indicator Name Definition/Description Frequency Datasource Collection Collection Suspected cases of COVID-19 cases The numerator is number Six-monthly PHEOC Records kept by PHEOC PHEOC and MOH M&E reported and investigated per approved of suspected cases COVID- administrative Unit Page 42 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) protocol 19 cases that are reported data and investigated per approved protocol and the denominator is number of suspected COVID-19 cases Numerator is number of Isolation and treatment centers with pandemic preparedness and response PHEOC Isolation and treatment centers with plans per Ministry of PHEOC and MOH M&E Six-monthly administrative Records kept by PHEOC pandemic preparedness and response Health Guidelines and Unit data plans per Ministry of Health Guidelines denominator is number of Isolation and treatment centers designated for COVID-19 isolation and treatment Number of health staff PHEOC PHEOC and MOH M&E Health staff trained in infection trained in infection Six-monthly administrative Records kept by PHEOC Unit prevention per MOH-approved protocols prevention per MOH- data approved protocols Numerator is number of hospitals with personal protective equipment and Hospitals with personal protective PHEOC infection control products PHEOC and MOH M&E equipment and infection control products Six-monthly administrative Records kept by PHEOC and supplies, without Unit and supplies, without stock-outs on the data stock-outs on the first day first day of each quarter of each quarter and the denominator is number of hospitals The numerator is number PHEOC PHEOC and MOH M&E Diagnosed cases treated per approved Six-monthly Records kept by PHEOC of diagnosed cases treated administrative Unit protocol per approved protocol and data Page 43 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) the denominator is number of diagnosed cases Numerator: Number of people vaccinated against COVID-19 nationally, which is included in the priority population targets defined in national plan, through Bank-financed vaccine purchase or deployment of EPI Program Population vaccinated, which is included vaccines COVID-19 vaccine EPI Program and MOH Six-monthly administrative in the priority population targets defined *100 electronic database M&E Unit data in national plan Denominator: National population in the same period Total national population is 2,438,899, female population is 1268227, and male population is 1,170,671 Numerator: Number of females vaccinated against COVID-19 nationally, which is included in the priority Population vaccinated, which is EPI Program population targets defined COVID-19 vaccine EPI Program and MOH included in the priority population Six-monthly administrative in national plan, through electronic database M&E Unit targets defined in national plan, data Bank-financed vaccine female purchase or deployment of vaccines *100 Denominator: National population in the same Page 44 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) period Total national population is 2,438,899, female population is 1,268,227, and male population is 1,170,671 Formula to use= (1,268,227/2,438,899)*nati onal vaccination estimate (it was 9.7% in Nov 2021) ME PDO Table SPACE Monitoring & Evaluation Plan: Intermediate Results Indicators Mapped Methodology for Data Responsibility for Data Indicator Name Definition/Description Frequency Datasource Collection Collection Public Health Emergency Operation Center (PHEOC) Public Health Emergency Operation has dedicated toll-free PHEOC Center (PHEOC) activated and telephone lines, equipped Six- PHEOC and MOH M&E administrative Records kept by PHEOC operationalized to support coordination with computers and monthly Unit data and planning for COVID-19 or other future communication equipment emergencies and emergency vehicles, and a designated National Focal Point Points of Entries equipped and staff PHEOC All 9 Points of Entries are Six- PHEOC and MOH M&E trained in SOPs (including for infection administrative Records kept by PHEOC equipped and the staff monthly Unit prevention and control, screening of data trained passengers Rapid-response teams members trained Numerator is number of Six- PHEOC PHEOC and MOH M&E Records kept by PHEOC and equipped to investigate cases and rapid-response teams monthly administrative Unit conduct contact tracing members trained and data Page 45 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) equipped to investigate cases and conduct contact tracing and denominator is number of rapid-response teams members Table-top simulation exercises are carried out PHEOC Table-top simulation exercises and Six- PHEOC and MOH M&E and the findings administrative Records kept by PHEOC findings documented to inform future monthly Unit documented to inform data preparedness and response activities future preparedness and response activities PHEOC Six- PHEOC and MOH M&E Supervisory visits undertaken to nine administrative Records kept by PHEOC monthly Unit Points of Entry data Cumulative number of PHEOC Border officers trained on COVID-19 Six- PHEOC and MOH M&E border officers trained on administrative Records kept by PHEOC prevention and control and contact monthly Unit COVID-19 prevention and data tracing control and contact tracing Cumulative number of PHEOC Community-based nurses and PHO community-based nurses Six- PHEOC and MOH M&E administrative Records kept by PHEOC trained on COVID-19 prevention and and PHO trained on COVID- monthly Unit data control and contact tracing 19 prevention and control and contact tracing Number of Emergency PHEOC Six- PHEOC and MOH M&E Ambulances for the administrative Records kept by PHEOC Emergency Ambulances operational monthly Unit transport of COVID-19 data cases that are operational PHEOC MoU signed with Republic Six- PHEOC and MOH M&E MoU signed with Republic of Senegal administrative Records kept by PHEOC of Senegal PHES within one monthly Unit PHES data year of start of project Page 46 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) PHEOC Cumulative number of Six- PHEOC and MOH M&E administrative Records kept by PHEOC Table-top simulation exercises conducted table-top simulation monthly Unit data exercises conducted Number of sites with advance technology incinerators and non- incinerators for the Six- PCU administr Sites for treatment of healthcare waste treatment of healthcare Records kept by PCU PCU and MOH M&E Unit monthly ative data established waste procured and installed PHEOC Cumulative number of Six- PHEOC and MOH M&E COVID-19 sensitization campaigns administrative Records kept by PHEOC COVID-19 sensitization monthly Unit conducted in all regions data campaigns conducted MOH directorate of Numerator is number of health Records kept by MOH grievances addressed MOH directorate of Every 6 promotion directorate of health Grievances responded to within stipulated within 7 working days; health promotion and months and promotion and service standards for response denominator is number of education education ad education on grievances grievances reported to ministrative MOH records Number of people EPI Program Population vaccinated, which is included vaccinated against COVID- COVID-19 vaccine EPI Program and MOH Annual administrative in the priority population targets defined 19 nationally, which is electronic database M&E Unit data in national plan included in the priority population targets defined Page 47 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) in national plan, through Bank-financed vaccine purchase or deployment of vaccines Number of females vaccinated against COVID- 19 nationally, which is Population vaccinated, which is EPI Program included in the priority COVID-19 vaccine EPI Program and MOH included in the priority population Annual administrative population targets defined electronic database M&E Unit targets defined in national plan, data in national plan, through female Bank-financed vaccine purchase or deployment of vaccines Number of health Health personnel (such as nurses and personnel (such as nurses EPI Program COVID-19 vaccine EPI Program and MOH Public Health Officers) trained in capacity and Public Health Officers) Annual administrative electronic database M&E Unit and skills to administer the COVID-19 trained in capacity and data vaccine skills to administer the COVID-19 vaccine Number of female health Health personnel (such as nurses and personnel (such as nurses EPI Program COVID-19 vaccine EPI Program and MOH Public Health Officers) trained in and Public Health Officers) Annual administrative electronic database M&E Unit capacity and skills to administer the trained in capacity and data COVID-19 vaccine, female skills to administer the COVID-19 vaccine Web-based electronic COVID-19 vaccination Electronic COVID-19 vaccination EPI Program registration system linked Records kept by MOH MOH Births and Deaths registration system linked to electronic Annual administrative to electronic civil EPI Program Registry civil registration and vital statistics system data registration and vital established statistics system established Page 48 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) A civil society-based Implementation of a civil society-based mechanism in place to PCU Six- mechanism to monitor, report and monitor, report and administrative Records kept by PCU PCU monthly facilitate responses to problems in the facilitate responses to data COVID-19 response problems in the COVID-19 response Numerator is number of Health and community workers with the knowledge to provide quality and comprehensive Health and community workers with the care to GBV survivors SEA/SH/GBV knowledge to provide quality and (recognize, medically Action Plan SEA/SH/GBV Action Plan comprehensive care to GBV survivors Annual MOH PCU manage & refer survivors progress progress report (recognize, medically manage & refer to appropriate services report survivors to appropriate services using using survivor centered survivor cente approach) (prior to training) and denominator number of health and community workers trained Electronic Integrated Disease Surveillance Electronic Integrated Disease Surveillance PHEOC Response (IDSR) using Six- PHEOC and MOH M&E Response (IDSR) using DHIS2 platform administrative Records kept by PHEOC DHIS2 platform interfaced monthly Unit interfaced with laboratory management data with laboratory information system established management information system established Numerator is the number PHEOC Health centers reporting stock-out of Six- PHEOC and MOH M&E of health centers reporting administrative Records kept by PHEOC tracer Infection prevention and control monthly Unit stock-out of tracer data materials on the first day of each month infection prevention and Page 49 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) control materials (such as detergents and disinfectants, gloves, surgical face masks/shields, and safety/sharp boxes) on the first day of each month; and denominator is the total number of health centers nationally Costed plan is developed Costed plan to collect, package and and implemented for PHEOC transport samples to the WHO collecting, packaging and Six- Records kept by PHEOC PHEOC and MOH M&E administrative recommended laboratories for COVID-19 transporting samples to the monthly Unit data and future emergencies developed and WHO recommended implemented laboratories for COVID-19 and future emergencies SOPs is developed for PHEOC Standard Operating Procedures (SOPs) on Six- PHEOC and MOH M&E sample collection, administrative Records kept by PHEOC sample collection, packaging, monthly Unit packaging, transportation data transportation and testing of samples and testing of samples Cumulative number of PHEOC Six- PHEOC and MOH M&E Treatment centres renovated/constructed treatment and isolation administrative Records kept by PHEOC monthly Unit and/or equipped centres renovated and/or data equipped ME IO Table SPACE Page 50 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) ANNEX 1: SUMMARY TABLE ON VACCINE DEVELOPMENT AND APPROVAL STATUS List of COVID-19 vaccines meeting World Bank Approval Criteria as of 04/14/2022 Manufacturer Name of Vaccine SRA approval WHO EUL 14 / WHO EUL received holder Platform NRA of Status of Record assessment for WHO EUL 1. BNT162b2/COMIRNATY United Kingdom: Nucleoside EMA ▪ Finalized: 31/12/2020 Tozinameran (INN) December 2, 2020 modified ▪ Additional sites: BioNTech Manufacturing mNRA − Baxter Oncology GmbH Canada: December GmbH Germany (DP). 30/06/2021 9, 2020 United States of − Novartis Switzerland. America: 08/07/2021 December 11, − Mibe (Dermapharm) 2020 Germany (DP). 16/07/2021 European Union − Delpharm, Saint-Remy (EU): December FRANCE (DP). 17/09/2021 21, 2020 − Sanofi-Aventis Deutschland Switzerland: GmbH. December 19, Germany 18/06/2021 2020 − Siegfried Hameln GmbH, Australia: January Germany (DP). 11/11/2021 25, 2021 − Patheon Italia S.p.A, Italy (DP). 07/12/2021 − Catalent Agnani. 21/01/2022 − Exela Pharma Sciences, LLC, NC. 16/03/2022 14 https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_23Dec2021.pdf Page 51 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) ▪ Shelf life extension: 09 months at -70 to - 90°C. 20/09/2021 ▪ Diluent suppliers: − Pfizer Perth, Australia. 20/00/2021 − Fresenius Kabi, USA. 20/09/2021 − Pfizer Manufacturing, Belgium. 30/11/2021 − Kwang Myung Pharm Co., Ltd. 12/01/2022 ▪ Booster dose approved for adults 18 years of age and older 14/12/2021 ▪ Age extension to children 5-11 years of age 12/02/2022 USFDA ▪ Additional sites: − Pharmacia & Upjohn, Kalamazoo (DP)PGS McPherson (DP). 16/07/2021 − Exelead, Inc. Indianapolis USA. 30/09/2021 Page 52 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) 2. AZD1222 Vaxzevria UK: December 30, EMA ▪ Core data finalized. 16 2020 Recombinant April 2021 EU: January 29, ChAdOx1 ▪ Additional sites: AstraZeneca, AB 2021 adenoviral − SK-Catalent 16/04/2021 Australia: February vector − Wuxi (DS). 30/04/2021 16th, 2021 encoding the − Chemo Spain. 04/06/2021 (overseas Spike protein − Amylin Ohio US (DP). manufacturing); antigen of the 23/07/2021 March 21st, 2021 SARS-CoV-2. (for local − WuXi Biologics, Germany manufacturing by (DP) 08/03/2022 CSL – Seqirus) Canada: February ▪ Finalized. 15 Feb 2021 MFDS KOREA 26, 2021 Japan ▪ Finalized. 09 July 2021 MHLW/PMDA ▪ Additional site: − Nipro Pharma Corporation Ise, Japan. 11/10/2021 Australia TGA ▪ Finalized. 09 July 2021 ▪ Additional site: − Siam Bioscience Co., Ltd Thailand. 11/10/2021 COFEPRIS ▪ Finalized. 23 December (Mexico) 2021 ANMAT (Argentina) Page 53 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) 3. Covishield Recombinant DCGI ▪ Finalized. 15 Feb 2021 (ChAdOx1_nCoV- ChAdOx1 − DS and DP Manjari Bk Pune. Serum Institute of India 19) adenoviral 12/11/2021 Pvt.Ltd vector encoding the Spike proteinantigen of the SARS- CoV-2. 4. COVOVAX™ Recombinant DCGI ▪ Finalized. 17 December COVID-19 nanoparticle 2021 vaccine (SARS- prefusion spike CoV-2 rS Protein protein Nanoparticle formulated with [Recombinant]) Matrix-M™ adjuvant 5. mRNA-1273 USA: December 18, mNRA-based EMA ▪ Finalized. 30 April 2021 2020 vaccine ▪ Shelf life extension to Canada: December encapsulated 09 months -20±5°C. 23, 2020 in lipid 14/02/2022 EU: January 6, 2021 nanoparticle USFDA ▪ Additional Sites. 06 Switzerland: (LNP) August 2021 January 12th, 2021 − ModernaTx. Norwood (DS) UK: January 8, 2021 − Catalent Indiana, LLC (DP) − Lonza Biologics, Inc. Portsmouth, USA (DS) − Baxter, Bloomington, USA (DP) MFDS ▪ Finalized. 23 December 2021 Page 54 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) 6. 1 SARS-CoV-2 Inactivated, NMPA ▪ Finalized. 07 May 2021 Sinopharm / BIBP Vaccine (Vero produced in ▪ 2 and 5 dose Beijing Institute of Biological presentation (new Cell), Inactivated Vero cells Products Co., Ltd. (BIBP) manufacturing site) -- (lnCoV) TBC after ongoing inspection 7. COVID-19 Inactivated, ▪ Finalized. 01 June 2021 Sinovac Life Sciences Co., Ltd. Vaccine (Vero produced in ▪ 2 dose presentation. Sinovac Life Sciences Co., Ltd. Cell), Vero cells 30 September 2021 Inactivated/ CoronavacTM 8. Ad26.COV2.S USA: February Recombinant, EMA ▪ Core data finalized (US 27th, 2021 replication- +NL sites). 12 March Canada: March incompetent 2021 5th, 2021 adenovirus type EU: March 11th, 26 (Ad26) ▪ Additional sites: Janssen–Cilag International 2021 vectored − Aspen RSA (DP). NV Switzerland: vaccine 25/06/2021 March 22nd, 2021 encoding the − Catalent Agnani Italy (DP). UK: May 28th, (SARS-CoV-2) 02/07/2021 2021 Spike (S) protein − Grand River Aseptic Australia: June Manufacturing Inc., USA. 25th, 2021 05/11/2021 − MSD (Merck), West Point/PA, USA (DP). 05/11/2021 − Sanofi Pasteur France (DP). 27/01/2022 ▪ Storage conditions extension: at 2-8°C from 4.5 months to 11 months within the 24 months of shelf-life at - 25°C to -15°C. Page 55 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) 16/03/2022 9. SARS-CoV-2 Vaccine, Whole-Virion DCGI ▪ Finalized. 03 Nov 2021 Inactivated (Vero Cell)/ Inactivated Vero ▪ Suspension of supply COVAXIN Cell due to outcomes of Bharat Biotech, India post EUL inspection (14 – 22 March 2022). 02 April 2022 Page 56 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) 10. NVX- Recombinant EMA ▪ Finalized. 20 December CoV2373/Nuvaxovid nanoparticle 2021 prefusion spike protein formulated with Matrix-M™ adjuvant Page 57 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) ANNEX 2: SUMMARY OF THE PARENT PROJECT COMPONENTS Project Components (Parent Project, First and Second AF) Component 1: Emergency COVID-19 Response (US$12 million equivalent) 1. This component supports the following activities: (a) Case detection, confirmation, contact tracing, recording, and reporting. Enhancing case detection, confirmation, tracing, recording and reporting through, among others, (i) strengthening disease surveillance systems; (ii) strengthening the capacity of the Public Health Emergency Operation Center (PHEOC); (iii) combining detection of new cases with active contact tracing locally and at various points of entry; (iv) providing on-time data and information for guiding decision-making, response, and mitigation activities; (v) strengthening the health management information system to facilitate recording and on-time virtual sharing of information; (vi) developing a public health emergency plan; and (vii) implementing the recipient’s health care waste management plan including, among others, medical waste management and establishment of disposal systems such as incineration and non-incineration cluster treatment of healthcare waste generated in health facilities. The project will also contribute to, among others, (i) strengthening the supply chain management system; (ii) developing a 2021−2023 national emergency preparedness plan anchored in the 2021−2025 national health sector strategic plan; (iii) capacity building for strengthening the national results-based financing program; and (iv) finalizing the essential health care package and improving quality of care. (b) Social distancing measures and communication preparedness. Supporting the implementation of social distancing measures through, among others, (i) development and implementation of guidelines related to social distancing measures; (ii) development and production of risk communication and community engagement materials, to target different cohorts of population with a special focus on poor, hard to reach, marginalized communities and women and girls; (iii) community engagement and social mobilization of target audiences; (iv) operationalization of existing or new laws and regulations on social distancing measures; and (v) support of preventative actions complementary to social distancing including the promotion of personal hygiene, the promotion of handwashing and proper cooking, the distribution and use of masks, and the promotion of community participation in slowing the spread of the pandemic. (c) Supporting Project COVID-19 Vaccine acquisition and deployment through inter alia: i. Providing planning and management support for the development and implementation of regional micro-plans to ensure proper distribution of the Project COVID-19 Vaccines. ii. Strengthening the Recipient’s regulatory framework and standards on medicines/vaccines registration system, national pharmacovogilance system and AEFI system. iii. Providing logistics and cold-chain support through: (A) facilitating advance acquisition mechanisms, procurement, transportation and storage of Project COVID-19 Vaccines; (B) Page 58 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) procurement of requisite vaccination supplies and other COVID-related supplies including diagnostic tests and drugs for side-effects; (C) development and implementation of a Project COVID-19 Vaccine delivery and distribution plan; (D) development and dissemination of protocols and SOPs for monitoring purposes; and (E ) improving the cold chain system, using energy efficient technologies. iv. Facilitating program delivery by: (A) supporting community engagement and advocacy on COVID- 19 and Project COVID-19 Vaccine; (B) supporting delivery and dissemination of the Project COVID- 19 Vaccine to target population; (C) improving Project COVID-19 Vaccine safety and surveillance systems; (D) supporting waste management of Project COVID-19 Vaccine waste through procurement of incinerators. v. Supporting Monitoring and Performance Management by: (A) linking Project COVID-19 Vaccine vaccination registration with the establishment of an electronic civil registration and vital statistics system and produce vaccination registration dashboards for real-time progress monitoring of vaccine coverage and adverse events; and (B) improving the quality and completeness of Project COVID-19 Vaccine vaccination data. Component 2: Strengthening Multi-sector, National Institutions and Platforms for Policy Development and Coordination of Prevention and Preparedness using One Health Approach (US$0.6 million equivalent) 2. This component supports strengthening national disease surveillance and diagnostic capacities for public health emergencies and other hazards and enhancing national diseases information and analytical systems. Component 3: Supporting National and Sub-national, Prevention and Preparedness (US$5.91 million equivalent) 3. This component supports the following activities: (a) Developing and implementing a costed plan for the collection, packaging, transportation and testing of COVID-19 samples to the WHO-recommended laboratories for COVID-19 (that is, Medical Research Council in The Gambia and Pasteur Institute in Dakar, Senegal), including, among others, preparation of associated SOPs, guidelines, and terms of reference and provision of containers for handling specimens. (b) Strengthening the capacities of laboratories in various health facilities for the provision of full hematology, biochemistry, microbiology, and other critical services and the provision of critical consumables; reagents; PPEs such as gloves, surgical mask, respirator, eye protection, and isolation gowns to health workers for their safety; other infection prevention and control materials (including detergents and disinfectants and safety/sharp boxes); and other equipment stock for emergencies. (c) Providing training to medical and veterinary laboratory personnel on handling highly specialized PPE and testing of hazardous biological samples efficiently and effectively. (d) Acquiring vehicles, motorcycles, and ambulances for emergency operations and cold- chain apparatus for transportation of biological surveillance samples and blood products. Page 59 of 60 The World Bank Third AF to The Gambia COVID-19 Vaccine Preparedness and Response Project (P178965) (e) Acquiring emergency medical and nonmedical supplies such as gloves, surgical masks, respirators, eye protection wear, and isolation gowns as well as infection prevention and control materials for health workers and health facilities. (f) Supporting rehabilitation and upgrading of selected treatment and isolation centers and rehabilitation and/or construction of a designated public health emergency treatment center. (g) Supporting rehabilitation and/or construction of new laboratories. Component 4: Implementation Management and M&E (US$0.40 million equivalent) 4. This component supports the following activities: • The MOH PCU would be entrusted with the coordination of project activities, as well as fiduciary tasks of procurement and FM. • The project will support strengthening the capacity of the PCU and the MOH for day-to-day implementation, coordination, supervision, and overall management (including fiduciary aspects, M&E, carrying out of audits, and reporting) of project activities and results all through the provision of technical advisory services, training, operating costs, and non- consulting services and acquisition of goods for the purpose. • A senior operations officer to support project implementation including, among others, (a) assist the MOH environmental and social (E&S) safeguards focal points to implement the ESCP and help ensure the project is carried out in accordance with the Environmental and Social Standards (ESS); (b) develop and follow up with the implementation of the Project Operations Manual; and (c) prepare project reports. Page 60 of 60