Document of The World Bank FOR OFFICIAL USE ONLY Report No: PAD4922 INTERNATIONAL DEVELOPMENT ASSOCIATION PROJECT PAPER ON A PROPOSED ADDITIONAL GRANT IN THE AMOUNT OF SDR7.9 MILLION (US$10.5 MILLION EQUIVALENT) AND A PROPOSED ADDITIONAL CREDIT IN THE AMOUNT OF EUR 13.8 MILLION (US$14.5 MILLION EQUIVALENT) TO THE UNION OF COMOROS FOR THE ADDITIONAL FINANCING TO SUPPORT TO COVID-19 VACCINE PURCHASE AND HEALTH SYSTEM STRENGTHENING PROJECT June 9, 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 FINANCING APPROVED BY THE BOARD ON OCTOBER 13, 2020 Health, Nutrition and Population Global Practice Eastern and Southern 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 April 30, 2022) Currency Unit = Comorian Franc (KMF) US$1 = EUR 0.9465 US$1 = SDR 0.74388157 US$1 = KMF 466 FISCAL YEAR January 1 - December 31 Regional Vice President: Hafez M. H. Ghanem Country Director: Idah Z. Pswarayi-Riddihough Regional Director: Amit Dar Practice Manager: Ernest E. Massiah Task Team Leader: Enias Baganizi ABBREVIATIONS AND ACRONYMS AEFI Adverse Event Following Immunization AF Additional Financing AFD French Development Agency (Agence française de développement) AUP Agreed Upon Procedures AVAT African Vaccine Acquisition Trust AVATT African Vaccine Acquisition Task Team CDC Centers for Disease Control and Prevention CERC Contingent Emergency Response Component COMPASS Comprehensive Approach to Health System Strengthening Project (Comores Projet Approche globale de renforcement du Système de Santé) COVAX AMC COVID-19 Vaccines Global Access Advanced Market Commitment COVAX Facility COVID-19 Vaccines Global Access Facility COVID-19 Coronavirus Disease 2019 CPF Country Partnership Framework DHIS2 District Health Information Software 2 ESCP Environmental and Social Commitment Plan ESF Environmental and Social Framework ESMAP Energy Sector Management Assistance Program ESMF Environmental and Social Management Framework ESRS Environmental and Social Review Summary ESS Environmental and Social Standard EUL Emergency Use Listing FCV Fragility, Conflict and Violence FM Financial Management GBV Gender-Based Violence GDP Gross Domestic Product GoC Government of the Union of Comoros GRS Grievance Redress Service HMIS Health management and information system HR Human Resources IDA International Development Association IPF Investment Project Financing IsDB Islamic Development Bank ISR Implementation Status and Results Report MIS Management Information Systems MOH Ministry of Health MPA Multiphase Programmatic Approach NDC Nationally Determined Contribution NVDP National Vaccination and Deployment Plan OCOPHARMA Comorian Office of Pharmaceutical Products PCE Emerging Comoros Plan (Plan Comores Emergent) PIU Project Implementation Unit PPA Performance and Policy Action reproductive, maternal, neonatal, child, and adolescent health and RMNCAH-N nutrition SDFP Sustainable Development Financing Policy SEA Sexual Exploitation and Abuse SEP Stakeholder Engagement Plan SH Sexual Harassment SPRP Strategic Preparedness and Response Program TA Technical Assistance UNICEF United Nations Children's Fund VAC Vaccine Approval Criteria VIRAT Vaccine Introduction Readiness Assessment Tool VRAF Vaccine Readiness Assessment Framework WHO World Health Organization Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening TABLE OF CONTENTS I. BACKGROUND AND RATIONALE FOR ADDITIONAL FINANCING ........................................ 1 A. Introduction ................................................................................................................. 1 B. Consistency with the Country Partnership Framework (CPF) .................................... 2 C. Project Design and Scope ............................................................................................ 2 D. Project Performance .................................................................................................... 3 E. Rationale for Additional Financing .............................................................................. 3 F. National Capacity and COVID-19 Vaccination Plan .................................................... 4 II. DESCRIPTION OF ADDITIONAL FINANCING ...................................................................... 8 A. Proposed Changes ........................................................................................................ 8 B. Sustainability .............................................................................................................. 14 III. KEY RISKS ..................................................................................................................... 15 IV. APPRAISAL SUMMARY .................................................................................................. 18 V. WORLD BANK GRIEVANCE REDRESS .............................................................................. 24 VI SUMMARY TABLE OF CHANGES ..................................................................................... 25 VII DETAILED CHANGE(S) .................................................................................................... 25 VIII. RESULTS FRAMEWORK AND MONITORING ................................................................... 31 ANNEX 1: SUMMATY TABLE ON VACCINE DEVELOPMENT AND APPROVAL STATUS .............. 43 ANNEX 2: PROJECT CLIMATE ADAPTATION AND CLIMATE MITIGATION ACTIVITIES .............. 49 ANNEX 3: TECHNICAL, ECONOMIC AND FINANCIAL ANALYSIS OF THE SUPPORT TO EL MAAROUF HOSPITAL ........................................................................................................... 51 LIST OF TABLES Table 1: National Vaccine Coverage and Acquisition Plan for Comoros ................................................5 Table 2: Priority Groups for Vaccination in Comoros ...........................................................................8 Table 3: Project Cost and Financing .................................................................................................. 11 Table 4: Summary of COVID-19 Vaccine Sourcing and Bank Financing ................................................ 12 Table 5: Summary table of revised indicators .................................................................................... 12 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) BASIC INFORMATION – PARENT (Support to COVID-19 Vaccine Purchase and Health System Strengthening - P175840) Country Product Line Team Leader(s) Comoros IBRD/IDA Maud Juquois Project ID Financing Instrument Resp CC Req CC Practice Area (Lead) P175840 Investment Project HAEH1 (9316) AECS2 (5547) 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 29-Jun-2021 31-Mar-2025 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) i The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) 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 054) This Project’s Development Objective is to support the Government of the Union of Comoros to acquire and deploy COVID-19 vaccines, to strengthen national systems for public health preparedness Ratings (from Parent ISR) RATING_DRAFT_NO Implementation Latest ISR 05-Oct-2021 20-Apr-2022 Progress towards achievement of PDO S S Overall Implementation Progress (IP) S MS Overall ESS Performance S S Overall Risk H S Financial Management S MS Project Management S S Procurement S MS Monitoring and Evaluation S S BASIC INFORMATION – ADDITIONAL FINANCING (Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening - P178615) ADDFIN_TABLE Urgent Need or Capacity Project ID Project Name Additional Financing Type Constraints P178615 Additional Financing to Scale Up Yes Support to COVID-19 Vaccine Purchase and Health System Strengthening Financing instrument Product line Approval Date Investment Project IBRD/IDA 23-Jun-2022 Financing ii The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Projected Date of Full Bank/IFC Collaboration Disbursement 30-Mar-2025 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 20.00 3.66 14.90 20 % Grants 1.00 1.00 0% 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 of which Bank Financing (IBRD): 9,900.00 of which Bank Financing (IDA): 8,100.00 iii The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) of which other financing sources: 0.00 PROJECT FINANCING DATA – ADDITIONAL FINANCING (Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening - P178615) PROJECT FINANCING DATA (US$, Millions) SUMMARY -NewFi n1 SUMMARY (Total Financing) Proposed Additional Total Proposed Current Financing Financing Financing Total Project Cost 21.00 25.00 46.00 Total Financing 21.00 25.00 46.00 of which IBRD/IDA 20.00 25.00 45.00 Financing Gap 0.00 0.00 0.00 DETAILS - Additional Financing NewFinEnh1 World Bank Group Financing International Development Association (IDA) 25.00 IDA Credit 14.50 IDA Grant 10.50 IDA Resources (in US$, Millions) Credit Amount Grant Amount Guarantee Amount Total Amount Comoros 14.50 10.50 0.00 25.00 National PBA 14.50 10.50 0.00 25.00 Total 14.50 10.50 0.00 25.00 COMPLIANCE Policy Does the project depart from the CPF in content or in other significant respects? iv The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) [ ] Yes [ ✔ ] No Does the project require any other Policy waiver(s)? [ ] Yes [ ✔ ] No 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 v The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) PROJECT TEAM Bank Staff Name Role Specialization Unit Team Leader (ADM Enias Baganizi Senior Health Specialist HAEH1 Responsible) Sylvain Auguste Procurement Specialist (ADM Senior Procurement Specialist EAERU Rambeloson Responsible) Maharavo Harimandimby Financial Management Financial Management EAEG2 Ramarotahiantsoa Specialist (ADM Responsible) Specialist Andrianjaka Rado Social Specialist (ADM Senior Social Development SAES3 Razafimandimby Responsible) Specialist Environmental Specialist (ADM Vaniah Emode Andrianjaka Environmental Engineer SAEE3 Responsible) Alfred Jean-Marie Team Member Senior Finance Officer WFACS Borgonovo Antoissi Said Ali Said Team Member Operations Officer AEMKM Eliane Razafimandimby Ep Team Member Senior Health Specialist HAEH1 Ramiandrison Emre Ozaltin Team Member Program Leader HAEDR Natural Resources Erik Reed Environmental Specialist SAEE3 Management Specialist Faly Diallo Team Member Finance Officer WFACS Landiniaina Angelina Team Member Program Assistant AEMMG Rakotonalina Liying Liang Team Member WBG Analyst HAEH1 Marouan Maalouf Counsel Counsel LEGAM Maud Juquois Team Member Senior Economist (Health) HAEH1 Miyuki T. Parris Team Member Senior Operations Officer HAEH1 Pia Helene Schneider Team Member Lead Economist HAEH1 Rija Lalaina Andriantavison Team Member Health Economist HAEH1 Steve Loris Gui-Diby Team Member Senior Economist EAEM2 Tojonirina Domoina Team Member Consultant EAEG2 Andrianasolomalala Yvette M. Atkins Team Member Senior Program Assistant HAEH1 vi The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Extended Team Name Title Organization Location vii The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) I. BACKGROUND AND RATIONALE FOR ADDITIONAL FINANCING A. Introduction 1. This Project Paper seeks the approval of the World Bank Board of Executive Directors to provide additional International Development Association (IDA) financing in the amount of SDR7.9 million (US$10.5 million equivalent grant) and EUR 13.8 million (US$14.5 million equivalent credit), to the Union of Comoros for an Additional Financing (AF) to the Comoros Support to COVID-19 Vaccine Purchase and Health System Strengthening Project (P175840). Comoros is at high risk of debt distress. Under the Debt Sustainability Enhancement Program of the Sustainable Development Finance Policy (SDFP), Comoros did not satisfactorily implement its Performance and Policy Actions (PPAs) and breached a PPA on non-concessional borrowing in FY21. As a result, and as per the SDFP and Performance-based Allocation guidelines, the Union of Comoros is not eligible to receive IDA reallocations for this AF. Hence, a waiver is being requested from IDA’s Executive Directors of the SDFP provisions The Union of Comoros requested a waiver in order for the Union of Comoros to receive an IDA reallocation of a total of US$25 million of additional resources for the Project due to the urgent need for the Government to purchase needed COVID-19 vaccines and support health system strengthening to deliver these vaccines. The SDFP Committee concurs with the requested reallocation after confirming a satisfactory implementation of the Union of Comoros’ FY22 PPAs and compliance with the Non-Concessional Borrowing limit. The primary objectives of the AF are to enable affordable and equitable access to COVID-19 vaccines and help ensure effective vaccine deployment in Comoros through vaccination system strengthening, and to further strengthen preparedness and response activities under the parent project. The AF would support expanding activities under the COVID-19 Strategic Preparedness and Response Program (SPRP) using the Multiphase Programmatic Approach (MPA), approved by the Board of Executive Directors on April 2, 2020, and the vaccines AF to the SPRP approved on October 13, 2021.1 The Comoros COVID-19 Vaccine Purchase and Health System Strengthening parent project (P175840) in the amount of US$20 million IDA, prepared under the SPRP, was approved on June 29, 2021. The AF is being processed under Paragraph 12 (Projects in Situations of Urgent Need of Assistance or Capacity Constraints) of the Bank Policy: Investment Project Financing (IPF) due to urgent needs for vaccines purchase and deployment in a capacity constrained environment. 2. The purpose of the proposed AF is to provide financing to help the government scale up purchase and deployment of COVID-19 vaccines that meet the World Bank’s vaccine approval criteria (VAC) and strengthen relevant health systems necessary to prepare for future variants and outbreaks. The proposed AF will help vaccinate 30 percent of the country’s population, while the COVID-19 Vaccines Global Access Advanced Market Commitment (COVAX AMC) and other co-financers will cover the remaining population to reach 87 percent national target. Most of the funding for health system strengthening will support referral hospitals, including the El Maarouf national referral hospital under 1The World Bank approved a US$12 billion World Bank Group 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 (“the Bank”) and US$6 billion from the International Finance Corporation (IFC). The IFC subsequently increased its contribution to US$8 billion, bringing the FTCF total to US$14 billion. The Additional Financing of US$12 billion (IBRD/IDA) was approved on October 13, 2020, to support the purchase and deployment of COVID-19 vaccines as well as strengthening the related immunization and health care delivery system. 1 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) construction. The need for additional resources to expand the COVID-19 response was formally conveyed to the World Bank by the Government of the Union of Comoros (GoC) in a letter dated May 17, 2022. 3. COVID-19 patients are treated at the El Maarouf located in the capital city of Moroni and other four regional referral hospitals located in the three Islands of The Union of Comoros. These hospitals need to be strengthened to better take care of the COVID-19 patients and other pathologies. These hospitals, including El Maarouf, need diagnostic and therapeutic materials, well trained health care professionals, essential drugs, oxygen, and other medical equipment not only to take care of patients suffering from COVID-19, but also to meet the health care needs of Comoros’ growing population. Due to the limited availability of specialized health services in Comoros, some patients are referred for treatment abroad and have to bear high associated costs. This has resulted in high health expenses for households and unequal access to care. Comoros needs an efficient, well-functioning national referral hospital (El Maarouf). In addition, Comoros pharmaceutical supply chain management is fragmented and there is need to strengthen the Comorian Office of Pharmaceutical Products (OCOPHARMA) to ensure that essential drugs are available at all levels of the health care system. Finally, Comoros needs a strong health management and information system (HMIS). An HMIS is being developed under the parent project and is not fully functional enough to provide data needed for decision-making yet. The ongoing Comprehensive Approach to Health System Strengthening Project (COMPASS) (P166013) supports this effort at primary and secondary health care and this AF is going to complement at the tertiary level (hospital level). B. Consistency with the Country Partnership Framework (CPF) 4. The World Bank Group’s Fiscal Year 2020-24 CPF for the Union of Comoros (Report No. 145699- KM), discussed by the Board of Executive Directors on July 16, 2020, focuses on building resilience, strengthening human capital, and fostering inclusive growth, as well as addressing the urgent need arising from the impacts of COVID-19. This AF is therefore framed within the first focus area of the CPF: crisis response and building resilience, which includes investing in human capital, disaster recovery, and disaster risk management. 5. The proposed AF supports the health component of the Plan Comores Emergent (PCE) – the national development plan for 2020-2030. The AF contributes to the achievement of Catalyst #3 of the PCE, which is “improved human capital” to unleash growth. The Government intends to develop an equitable and accessible health system under this component. The AF is also in line with the World Bank’s Fragility, Conflict and Violence (FCV) Strategy Pillar 2 on remaining engaged during conflict and crisis situations as well as Pillar 4 of the FCV Strategy, which centers on mitigating the spillovers of FCV. C. Project Design and Scope 6. The PDO of the parent project and this AF is to “support the Government of the Union of Comoros to acquire and deploy COVID-19 vaccines, to strengthen national systems for public health preparedness.” The parent project includes the following components: (i) Vaccines and related supplies provision and deployment. Under this component, the project provides funding to support the acquisition of COVID-19 vaccines and related supplies, activities related to vaccine deployment and delivery, communications and community engagement, and support to COVID-19 response; (ii) Health system 2 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) strengthening for a stronger COVID-19 response. Under this component, the project supports activities related to strengthening health emergency coordination and structures, strengthening of disease surveillance and health management information system, improving energy supply for health structure, and project implementation and monitoring; and (iii) Contingent Emergency Response Component. This component will facilitate access to rapid financing by allowing for the reallocation of uncommitted project funds in the event of a natural disaster, either by a formal declaration of a national emergency or upon a formal request from the Government. This AF does not add new components but scales up activities under existing components. 7. The Ministry of Health (MOH) is the implementing agency for the project. The parent project Implementation Unit (PIU) is placed under the MOH direct management. There is no change in implementation arrangement. D. Project Performance 8. The parent project’s progress toward achievement of the PDO and overall implementation progress was rated respectively Satisfactory and Moderately Satisfactory in the last Implementation Status and Results Report (ISR) of May 15, 2022, and the project continues to make good progress. As of today, disbursements amount to US$3.36 million. The project has not disbursed as desired due to a combination of delayed lifting of disbursement conditions for category 1 due to the government unable to fulfill the conditions on time and technical challenges in the World Bank internal systems. This was linked to problems with the Systematic Tracking of Exchanges in Procurement (STEP) and client connection encountered by the client at the beginning of the project’s implementation. They were not able to submit requests for funds disbursement or process procurement in STEP. However, the retroactive financing for the procurement of 200,000 doses of Sinopharm vaccine by the government in the amount of US$2 million has been recently processed and disbursement has increased to 18 percent. With the reimbursement of the previous expenses of vaccination campaigns, the project disbursement rate will reach 25 percent by June 2022. 9. The PIU has been effectively coordinating project planning and procurement. The PIU supports the management of the parent project and the COMPASS Project and its Contingent Emergency Response Component (CERC) for COVID-19 health response. The PIU has been expanded to cover fiduciary and environmental and social management for this project in coordination with key MOH departments. The main challenge in the implementation of the parent project has been the delay in the recruitment of additional PIU staff, which resulted in increased workload for current staff and delays in finalizing the environmental and social documents, procurement procedures and finalization of the workplan and budget. This has been resolved with the recruitment of the deputy coordinator and procurement officer in January 2022 and of the remaining required staff in April 2022. E. Rationale for Additional Financing 10. This AF is being proposed at a crucial juncture in the GoC’s response to COVID-19. New therapies and COVID-19 vaccines have emerged (see Annex 1 for the latest status). A key rationale for the proposed AF is to provide upfront financing for safe, effective, and timely vaccine acquisition and deployment in Comoros, recognizing that there is currently excess demand for vaccines from both high-income and 3 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) lower-income countries. The proposed AF will form part of an expanded health response to the pandemic. The activities will build on the COVID-19 MPA Program as well as on the Bank’s existing health portfolio in the country, including the COMPASS project, the Nutrition and Women Empowerment Project (P174887) under development, and the Inter- Island Connectivity Project (P173114). The project will rely on coordination at the country level with the work of other development partners. 11. The Union of Comoros requested the Sustainable Development Finance Policy (SDFP) Committee’s for a grant of US$25 million from IDA. Considering that the country is at high risk of debt distress and in view of the previous breach of the zero non-concessional borrowing ceiling, the World Bank and IsDB have agreed to provide concessional financing. IsDB is expected to provide up to US$15 million from a concessional window. These amounts are to contribute to the financing of the Government’s COVID response, health system strengthening and the completion of the El Maarouf hospital. In 2018, the Comorian authorities contracted a EUR 25 million non-concessional loan from the Eastern and Southern African Trade and Development Bank to finalize major structural work and complete five floors, of which US$18.7 million has been disbursed as of November 2021. The government is currently seeking additional funding to complete the construction and ensure efficient management of the hospital. The proposed AF will provide technical assistance (TA) to elaborate and implement a masterplan on a 300-bed hospital on three floors to: (i) ensure efficient hospital size and operations; (ii) support hospital management in the implementation of the masterplan; (iii) purchase basic hospital management information systems; and (iv) and support the government’s response to the COVID-19 pandemic. 12. In addition, this AF will provide TA that will reach beyond El Maarouf hospital to cover other four regional hospitals to strengthen service delivery and management at these hospitals, thereby contributing to the strengthening of the country health system in general. F. National Capacity and COVID-19 Vaccination Plan (i) Vaccine Readiness Assessment 13. Comoros 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 such as the World Health Organization (WHO), United Nations Children’s Fund (UNICEF), and Gavi. This assessment considers the government’s vaccine deployment strategy. Considering the uncertainties related to the COVID vaccine market, including testing, approval, availability, and pricing, which require flexibility, close monitoring and strong Bank support during implementation, the assessment will continue to be an evolving process and will be dynamically revised and updated as necessary to continue to improve project implementation. (ii) National Vaccination and Deployment Plan (NVDP) 14. The GoC has updated the NVDP, which draws on the findings of the Vaccine Readiness Assessment Framework/Vaccine Introduction Readiness Assessment Tool (VRAF/VIRAT) and gap analysis. The primary adjustments are: (i) the use of updated population numbers for percentage calculations; (ii) the introduction of adolescent vaccination with Pfizer (youths aged 12 to 17 are now 4 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) included in the priority groups) and the required logistics; (iii) the decision that Sinopharm is the vaccine to be used by the country for the vaccination of people aged 18 and above; (iv) the mention of the fixed strategy as an additional vaccination modality. 5 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Table 1: National Vaccine Coverage and Acquisition Plan for Comoros Population Source of Number World Vaccines already Targeted (out of financing Vaccines of Bank’s arrived in the doses Estimated VAC Contrac country 820,824 total US$ Status of t Status (IBRD, IDA, needed population)2 the TF, Govt, (millions Other) Shippin ) vaccine Numbe Price % Source Name g Name Doses r ($/dose) ($/dose) Stage 1:3 6% WHO Emergenc Donatio Sinophar y Use Sinophar 100,00 Donation 6.1% 50,000 n from 0 0 100,000 0 - m Listing m 0 China (EUL): May 7th, 2021 Stage 1 total 6.1% 50,000 100,000 Stage 2:4 18.3% Under Under non- non- WHO EUL: Signed Governmen Direct Sinophar Sinophar 200,00 12.2% 100,000 disclosure 0 200,000 disclosure May 7th, on May t purchase m m 0 agreemen agreemen 2021 18, 2021 t t Donatio WHO EUL: Sinophar Sinophar 100,00 Donation 6.1% 50,000 n from 0 0 100,000 0 May 7th, - m m 0 China 2021 18.3 Stage 2 total 150,000 % 2 The total population was 921,113 in the parent project PAD. The Government has used a more recent and accurate estimate since the last vaccination campaign (820,824). 3 This first campaign was focused on the following priority groups: health workers, teachers, militaries, people over 65 years of age, people with co-morbidities 4 This second campaign was extended to the broader population, with a focus on students, sportsmen and people aged 40 and more 6 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Stage 3:5 48.8% Donatio WHO EUL: Sinophar Sinophar 300,00 Donation 18.3% 150,000 n from 0 0 300,000 0 May 7th, - m m 0 UAE 2021 Donatio WHO EUL: Sinophar Sinophar 300,00 Donation 18.3% 150,000 n from 0 0 300,000 0 May 7th, - m m 0 UAE 2021 Donatio WHO EUL: Sinophar Sinophar 200,00 Donation 12.2% 100,000 n from 0 0 200,000 0 May 7th, - m m 0 China 2021 48.8 Stage 3 total 400,000 % Stage 4 (adolescent vaccination): 13.6% WHO EUL: Donation 13.6% 111,492 COVAX Pfizer 0 0 250,000 0 December - Pfizer 0 31, 2020 13.6 Stage 4 total 111,492 % Stage 5 (boosters for vulnerable groups: persons with comorbidity, persons aged 60 and more): 29.8% (Additional financing) WHO EUL: Direct Sinophar Sinophar IDA 29.8% 245,007 0 0 245,007 0 May 7th, - 0 purchase m m 2021 29.8 Stage 5 total 245,007 % National 86.8 711,492 total % 5 This campaign was also extended to the general adult population 7 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) 15. Liability and indemnification issues in vaccine acquisition have been described in Box 2 of the parent project. The project operational documents (Vaccine Delivery and Distribution Manual and Project Implementation Manual) clarify that the country’s regulatory authority is responsible for its own assessment of the project COVID-19 vaccine safety and efficacy and is solely responsible for the authorization and deployment of the vaccines in the country. Vaccines Purchased through African Vaccine Acquisition Trust (AVAT) 16. In late 2020, the African Union (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 and Prevention (CDC), Afreximbank, and the United Nations 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 to ensure that World Bank financing can be used by participating member countries to purchase vaccine doses. 17. 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’s Janssen (J&J/Janssen) COVID-19 vaccine for use by African countries, with an option for 180 million more based on demand. AVAT is negotiating with other suppliers and is expected to secure more doses. World Bank financing and technical assistance are available to help countries obtain vaccines from eligible suppliers through AVAT and deploy them effectively. 18. Comoros has subscribed to AVAT mechanism on August 7, 2021 and signed an agreement with UNICEF under the parent Project to serve as the procurement agency. II. DESCRIPTION OF ADDITIONAL FINANCING A. Proposed Changes 19. The changes proposed for the AF entail expanding the scope of activities in the parent project and adjusting its overall design to include technical assistance to El Maarouf hospital. As the proposed activities to be funded under the AF for vaccine deployment and health system strengthening are aligned with the original PDO, the PDO would remain unchanged. The content of the components and the Results Framework of the parent project are adjusted to reflect the expanded scope and new activities proposed under the AF. 20. Vaccine purchasing will be conducted through Component 1. Vaccines and related supplies provision and deployment of the Comoros COVID-19 Vaccine Purchase and Health System Strengthening Project. Comoros will use the COVAX Facility and other sources, including bilateral donations. Given the 8 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) 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 additional financing will allow for booster vaccination efforts if warranted by peer-reviewed scientific knowledge at the time. In the case that booster vaccination is required, priority populations (such as health workers and the elderly) will be given constraints on vaccine production capacity and equity considerations (i.e., tradeoffs between broader population coverage and re-vaccination). 21. The AF will support investments to bring immunization systems and service delivery capacity to the level required to successfully deliver COVID-19 vaccines at scale, through Components 1 and 2 of the parent project. In alignment with the parent project, particular consideration will be given to gender dimensions on access to COVID-19 vaccinations as well as continuity of essential reproductive, maternal, neonatal, child, adolescent health and nutrition (RMNCAH-N) services.6 To this end, the AF is geared to assist the GoC, working with WHO, UNICEF, French Development Agency, and other development partners, to overcome bottlenecks as identified in the COVID-19 vaccine readiness assessment in the country. 22. The AF will support the population groups as summarized in table 2 below: Table 2: Priority Groups for Vaccination Table 2: Priority Groups for Number Share of Vaccination in Population group of population ComorosRanking of vulnerable people (%) group Health workers including community health First 2,873 0.35 workers Second People over 60 years of age 41862 5.1 People with comorbidities Third At-risk groups (Outgoing travelers, point-of- 125,996 15.35 entry personnel, civil security, exposed workers) Fourth Adolescents aged 12 to 17 years (all) 111,491 14 Total 282,222 34.8 (i) Proposed New Activities Component 1: Vaccines and related supplies provision and deployment (parent project US$10.5 million equivalent; AF US$7 million equivalent) 23. Parent project. The parent project finances: (i) the acquisition of COVID-19 vaccines and related supplies, aiming to reach 60 percent of the population; (ii) vaccine deployment and delivery; (iii) communications and community engagement; and (iv) support to COVID-19 response, in particular 6 Factors that constrain access to and use of health services by women in Comoros include limited mobility and financial capacity, competing demands of paid and unpaid work, and limited access to information. While men do worse clinically once infected, women face a higher-than-average risk of COVID-19 infection, death, loss of livelihood, and gender-based violence. 9 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) through the establishment of quarantine sites, support to the public health emergency operations centers, surveys and evaluations, and other activities related to COVID-19 response. 24. Changes: Under this component, the AF will finance the purchase of booster vaccines and deployment costs to achieve up to 85 percent coverage of the population. This component will also provide funding for: (i) additional recruitment and deployment of vaccination teams; (ii) additional cold chain equipment for health facilities. In addition to vaccine purchase ($3 million), this AF will also provide about $4 million to be used to increase the cold chain capacity, especially to be able to handle Pfizer vaccines the country is expecting to receive from the COVAX Facility and for vaccine deployment. Component 2: Health system strengthening for a stronger COVID-19 response (parent project: US$9.5 million equivalent from IDA and US$1 million from the Energy Sector Management Assistance Program (ESMAP) TF; AF: US$18 million equivalent) 25. Parent project. The parent project supports the strengthening of the health system for a stronger COVID-19 response and comprises three subcomponents. Subcomponent 2.1 supports (i) the strengthening of the health emergency coordination and structure, through institutional strengthening, the rehabilitation of health facilities and national and regional vaccine warehouses; (ii) TA, training and equipment to improve coordination and logistics; and (iii) TA, staffing and training to strengthen health system coordination and accountability. Subcomponent 2.2 supports (i) the strengthening of disease surveillance and the Health Management Information System (HMIS); (ii) the deployment and operationalization of the DHIS2 as the main health management information system; (iii) TA to improve data quality and surveillance, in particular through harmonized procedures for surveillance, reporting, diagnosis and response to COVID-19 and other priority diseases to assess the impact that this intervention might have on other programs, the improvement of the interoperability of laboratory and data systems (disease surveillance, drugs and equipment, human resources, vaccine logistics, and medicines supply chain); (iv) the improvement of vaccine-preventable diseases surveillance system; and (v) support to the piloting of innovative digital surveillance approaches to improve monitoring and control of COVID-19 and infectious disease outbreaks. Subcomponent 2.3 support the improvement of energy supply for health structure. Finally, Subcomponent 2.4 supports the costs associated with project implementation and monitoring. 26. Changes: Under this component, the AF will finance additional activities related to health system strengthening, including technical assistance to El Maarouf hospital and other referral hospitals, and to the MOH. More specifically, under Subcomponent 2.1, the AF will finance support: (i) institutional strengthening for MOH to support implementation of activities; (ii) strengthening the capacity of OCOPHARMA to manage the additional logistics associated with health emergencies such as the COVID- 19 pandemic, including procurement of essential medicines for reproductive, maternal, neonatal, child, and adolescent health and nutrition (RMNCAH-N) services; (iii) improving the availability of oxygen in facilities managing severe COVID-19 cases; (iv) strengthening the capacity of El Maarouf and regional hospitals to better play their role as COVID-19 treatment centers; and (v) support the strengthening of the health information system. In addition, under Subcomponent 2.2, the AF will finance technical support to strengthen the HMIS. More specifically, while the parent project supports the development and implementation of the HMIS at the level of primary and secondary health care, the AF will support the establishment on the HMIS at the tertiary level (hospital level). 10 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) 27. This AF will introduce Subcomponent 2.4: Support for the Operationalization of the El Maarouf Hospital and Regional Referral Hospitals. 28. The AF will provide funding to support the functionality of El Maarouf hospital after the construction phase. The support will allow the government to optimize the hospital size and structure to reduce overall investment costs and to manage future operational costs. The following activities will be financed: a. TA to develop a hospital masterplan for the proposed El Maarouf hospital. The masterplan will be produced in two phases. First, the masterplan for El Maarouf will inform the IsDB lending. Second, the masterplan will be expanded to include the broader health system context. The masterplan will provide a vision for a best practice intent for the hospital within the broader health sector context with a realistic budget. Based on an analysis of the current and future health and fiscal context, it will set targets for an efficient, financially sustainable, and equitable hospital, including for medical, technical, operational, and infrastructure investments (e.g., type of departments, number of beds, equipment, type and number of staff, information technology, medical waste management, and an architectural plan to ensure efficient workflow). An investment and operational plan will be developed to facilitate the process of reaching the targets for the hospital in line with the government’s strategy. The investment and operational plan will include an annual action plan to describe on a department level how the proposed investments and activities will be implemented, timelines for implementation, and implications for financial and human resources at each department. The effect on the entire health sector will be assessed to manage risks. The masterplan will be approved by the government. In alignment with the parent project, the masterplan will give particular considerations to integrate gender and disability-sensitive water and hygiene infrastructure into the design of the hospital. b. TA to the hospital management to implement the masterplan and build capacity in hospital management. TA to hospital management will build capacity in all hospitals, help implement the recommendations from the masterplan, monitor and evaluate its effect on health care provision, and propose adjustments where needed. It will help ensure the implementation of: (i) the revised hospital structure, an efficient workflow based on the architectural plan, and hospital waste management; (ii) medical equipment procurement, installation and maintenance; (iii) human resources (HR) recruitment and management, continuous medical education (CME) for staff, and setting up a clinical teaching program to attract medical and nursing students and graduates to work at the hospital; (iv) hospital data and analytics, including medical and patient data and analytics, financial management, and medical management to ensure high quality of care; (v) a roadmap for the accreditation of El Maarouf by the Council for Health Service Accreditation of Southern Africa; and (vi) regular evaluation of progress and hospital performance to make adjustments to the hospital scope and management. Training in proper waste management and disposal systems will ensure optimized treatment, recycling, transport, and disposal of medical waste from the hospital. c. Management information systems (MIS) for efficient hospital management. The AF will procure and install hospital accounting and financial management systems, patient management data systems and electronic health records (EHR), ICD-10 diagnoses and procedural coding systems to track diagnoses of patients and to conduct burden of disease analysis, HR management system and pharmaceutical 11 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) management systems at El Maarouf and four other hospitals and the MOH to establish a centrally managed HR database for the health sector that includes public sector employees and contracted staff; and an online platforms for recruitment and processing of credentials and to regularly update the health workforce database to inform hiring and planning. Administrative and medical staff will be trained in the use of these data systems, and in data analysis to inform annual reporting, planning, and health policy decisions. Data will be used for analysis to inform hospital management decisions. The AF will also support pharmaceutical data systems to strengthen the capacity of the national pharmaceutical office and ensure transparency in pharmaceutical procurement and management across the health system. d. Procurement of basic medical materials for hospitals. The AF will finance basic equipment and materials, such as hospital beds, basic equipment, pharmaceuticals (generics and essential medicines), personal protective equipment, and essential emergency equipment following the WHO standard list for hospitals. 29. In alignment with the parent project, the AF will also pay close attention to gender dimensions. This includes the integration of gender-based violence (GBV) training into training of health staff to increase access to counseling and GBV services. Analytical and technical support to hospital management to minimize COVID-19 disruptions of key RMNCAH-N services. 30. Component 3: Contingent Emergency Response Component (CERC). There is no change to this component. (ii) Financing Arrangements 31. The increase in scope as outlined above will be reflected in an increase in indicative component allocation from US$21 million to US$46 million, with the full amount of the AF being added under Components 1 and 2 (see Table 3 below). Table 3: Project Cost and Parent Project AF TOTAL ESMAP ESMAP Table 3: Project Cost and IDA IDA IDA TF (*) TF FinancingProject Components (US$ (US$ (US$ (US$ (US$ million) million) million) million) million) Component 1: Vaccines and related 10.5 7 17.5 supplies provision and deployment Component 2: Health system strengthening for a stronger COVID-19 9.5 1 18 28.5 1 response Component 3: Contingent Emergency 0 0 0 Response Component (CERC) Total Costs 20 1 25 45 1 (*) ESMAP TF will fund the solarization of health facilities under the parent project. 12 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Table 4: Summary of COVID-19 Vaccine Sourcing and World No. of Specific Doses Estimated vaccines and purchased allocation of Bank FinancingBank Financed sourcing with World World Bank plans Bank financing finance Through direct From other Through COVAX Through AVAT purchase sources7 Purchase: US$2.150M 20.5%8 0% population 0% population 0% population Deployment: population Sinopharm 250,000 covered covered covered US$0.810M covered (P178615) (This AF) Purchase: $2.6M Deployment: 13.6% population 0% population 0% population 0% population Pfizer 130,000 US$0.5M covered covered covered covered (P175840) (Parent project) Purchase: $2M Deployment: 12.2% population 0% population 0% population 0% population Sinopharm 200,0009 US$371,421M covered covered covered covered (P175840) (Parent project) (iii) Results Framework 32. Table 5 below provides a summary indicators revised in the Results Framework to measure overall progress in the coverage and deployment of the COVID-19 vaccine and the gender gaps the project can address, as well as technical assistance to El Maarouf Hospital. The baseline values for hospital performance will be confirmed once more reliable data become available. Table 5: Summary of Revised Indicators Indicator Type Indicator Change Baseline 2021 Target PDO Percentage of the population fully vaccinated, Changed end 3.7% 65% based on prioritized populations as defined in target national plan, by gender PDO sub indicator Percentage of health agents fully vaccinated, New indicator 85% 90% based on the prioritized population in the national plan PDO sub indicator Percentage of people aged 60 and above fully New indicator 44% 90% vaccinated, based on the prioritized population in the national plan PDO sub indicator Percentage of people with comorbidities and in New indicator 4% 90% risk groups fully vaccinated, based on the prioritized population in the national plan 7 Other: Includes coverage financed by the government, bilateral, other multilateral development banks. 8 This represents the vulnerable population: people aged 60 and more, and people having comorbidities. 9 As a retroactive financing of the 200,000 Sinopharm doses purchased by the Government. 13 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Indicator Type Indicator Change Baseline 2021 Target PDO sub indicator Percentage of adolescents aged 12 to 17 fully New indicator 0% 70% vaccinated, based on the prioritized population in the national plan PDO Adoption of El Maarouf Hospital masterplan New indicator No Yes Intermediate Functionality of the hospital management New indicator No Yes Results system Intermediate Bed occupancy rate in El Maarouf Hospital New indicator 40% 80% Results Intermediate Number of eligible COVID-19 vaccine doses Changed end 0% 580,000 Results procured and available in country target Intermediate Percentage of the population who received at Changed end 5% 69% Results least one dose of a COVID-19 vaccine, by gender target (iv) Extension of the Closing Date 33. The closing date for this project will be extended by nine months (from March 31, 2025 to December 31, 2025). This extension is designed to ensure sufficient time to carry out health system strengthening activities under Component 2. All results framework indicators’ end target dates will be aligned with this new closing date. B. Sustainability 34. There is strong political commitment in Comoros to mobilize financial resources for COVID-19 response, including for vaccine purchase and deployment. Having the funds through the proposed AF and parent project for vaccine purchase and deployment will help maintain an enabling environment for other donors, multilateral development banks and UN agencies to also support efforts in the country. Investments under the parent project and the AF are expected to strengthen the health system in the country, ensuring institutional sustainability to deal with infectious diseases. 35. The hospital masterplan financed under this AF will help ensure efficient hospital size and operations and lower investment costs for the government. The new El Maarouf hospital must be planned within the broader health sector context and with a realistic budget. The TA will support the government with a hospital masterplan, including an optimal architectural design to ensure an efficient workflow, and an investment plan for medical equipment and waste management. As Comoros also faces shortages in the health workforce, the masterplan will propose an efficient hospital size within the broader health sector and financial and human resources. It will include a human resource recruitment and training plan with training on-the-job in local hospitals, instead of abroad. 36. The government is committed to improving access to care through El Maarouf hospital while optimizing financial resources. Due to the limited availability of health services in Comoros, patients are referred for treatment abroad. Most expenses for treatment abroad are paid by patients who also seek care in a growing private health sector. This has resulted in high health expenses for households and unequal access to care. Ensuring equitable access to health services, while preserving fiscal sustainability would be critical to build human capital. Once operational, El Maarouf hospital will require a substantial increase in government spending to finance wages, transfers to providers, and maintenance cost. This will risk 14 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) siphoning off funding from secondary and primary care facilities where the poor seek care. The masterplan will prevent this situation with an efficient hospital size. III. KEY RISKS 37. The overall risk to achieving the PDO is Substantial. The risks and mitigation measures identified for the parent project still apply to the AF, and there are additional risks related to the TA. The large-scale acquisition and deployment of COVID-19 vaccines entail certain significant risks. First, global demand for vaccines continues to exceed supply, and vaccines that meet the World Bank’s VAC may not be available to be acquired in a timely manner. Second, a mass vaccination effort stretches capacity, in low-capacity environments such as Comoros, entailing risks. The parent project’s support in health system strengthening for effective vaccine deployment aims to help mitigate these risks. The risks for the TA are related to the political economy surrounding the reconstruction of El Maarouf hospital. Substantial risks are described below. 38. Political and governance risks remain Substantial. 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 will be 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, substandard quality, and fraudulent attempts to gain access to vaccines to be administered 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. This will be further mitigated through the application of anti- corruption guidelines for vaccine purchase and deployment, and robust financial management oversight of the use of funds, as elaborated in the fiduciary risks below. The existence of a new management and coordination framework to manage the COVID-19 crisis should continue to mitigate the political and governance risks related to the vaccination campaign. Considering these mitigation measures, the AF is not expected to increase the political and governance risks of the parent project. Over the past months, the World Bank has led extensive discussions with government and the IsDB on the financial needs for the hospital and conducted a public health expenditure review with a detailed analysis of the hospital sector. Results have been presented and discussed with the government. This intensive policy dialogue has helped to secure the government commitment to the hospital reform. To manage the hospital’s financial performance and ensure the political support by the government to the reform, the AF will strengthen monitoring and evaluation capacity at the MOH and in health facilities to regularly assess progress, financial implications, and identify adverse effects that need to be addressed. 39. Sector strategies and policy risk remains Substantial. Existing health strategies and policies are only partially implemented due to a lack of operationalization plans or realistic budget considering the available financing and weak monitoring and evaluation capacity. This risk will continue to be mitigated by closely monitoring the implementation of the NDVP through TA jointly with other partners, by ensuring adequate reorientations are integrated based on the context and implementation progress, and by investing in data collection and analysis of sector issues to inform strategies. 15 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) 40. Technical design of the AF remains Substantial, considering global uncertainties around vaccine availability and the government’s capacity for and experience with large-scale vaccine deployment. The World Bank will work closely with government officials (MOH) and the UN agencies involved in the pandemic response (WHO and UNICEF) to support the government’s efforts to access the necessary vaccine supply. Vaccine hesitancy is also a major challenge; the in-country vaccination rate is still low despite the availability of vaccines. The World Bank will also work closely with the MOH and partners to improve the communication strategy, especially as the country has decided to target the adolescents. The technical risk to the hospital support is substantial, as the government has limited experience with hospital reforms. The World Bank will therefore work closely with the MOH and hospital management to develop and implement these reforms and ensure the hospital will become operational. 41. Institutional capacity for implementation and sustainability risk remains High. As in the parent project, the AF is designed to address key institutional capacity risks related to vaccine deployment and distribution, but residual risks remain high. Vaccine deployment cold-chain and distribution capacity are currently inadequate in Comoros, especially for the anticipated scale and population group coverage for COVID-19 vaccination. This risk will be mitigated through technical support for immunization system strengthening needs: conducting capacity assessments in coordination with WHO, Gavi, UNICEF, and other partners; and coordinating with other partners in their provision of systems strengthening support. Capacity building in the MOH as well as at El Maarouf hospital and health workforce management systems is embedded in the TA to help mitigate this risk further. 42. Fiduciary risks continue to be Substantial under the AF. The procurement and financial management risks initially assessed for the parent project cover risks associated with the procurement and distribution of vaccines, including fraud and corruption risks. Risks specific to vaccines include: • Procurement: The key procurement risk associated with vaccines relates to: (i) weak bargaining; and (ii) delays in triggering emergency procurement procedures at the country level, which could delay procurement and contract implementation, including payments. These risks under this AF will be mitigated by providing options to support the country’s vaccine acquisition needs. The procurement risk related to health information systems is high too, as there could be substantial delays in delivery and implementation. • Financial Management (FM): The key FM risks relate to: (i) untimely funds flow or lack of liquidity and (ii) lack of adequate controls over the transparent, prioritized distribution and application of vaccines, particularly for the most vulnerable population groups. This AF will use the same methodology as in the parent project to assess and strengthen control systems, facilitate the timely flow of funds, and ensure adequate liquidity to finance project activities. 43. Environmental and social risks classification under the AF remains Substantial. The measures to address social and environmental risks in the parent project remain relevant, including infection prevention and control improvements in health facilities, such as assessment and mitigation measures for medical waste risk management that will be expanded as inoculation sites expand. Experience indicates that moderate environmental risk ratings can be expected for vaccine-related activities if, for example, medical waste and occupational health and safety risks are well-managed. However, the social 16 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) risk is anticipated to be at least substantial in Comoros because there is a broader social risk of inequity in access to vaccines due to political pressures to provide vaccines to groups that are not prioritized for needs or vulnerability or should target groups be misaligned with available vaccines. This includes possible exclusion of population groups based on gender, race, ethnicity, refugee status, religion, or others. 44. Potential environmental risks may arise in relation with El Maarouf hospital, particularly with increased medical waste. These risks will be mitigated through measures such as training in proper waste management and disposal systems that will ensure optimized treatment, recycling, transport, and disposal of medical waste from the hospital. The key benefits from a smaller hospital size, such as improved utilization (occupancy) achieved through improved management and quality of care, will ultimately result in more efficient utilization of limited resources, less medical waste, and better health care for the population. 45. These risks were mitigated through adoption in May 2022 of several mitigation measures to address these risks including revising the project’s Environmental and Social (E&S) instruments to reflect the scope and activities of the AF. An explicit, contextually appropriate, and well-communicated targeting criteria and implementation plan has been developed (e.g., the national vaccination program and any subsidiary programs) including criteria for access to vaccines. The government should ensure that this plan is subject to timely and meaningful consultations in accordance with the Environmental and Social Standard (ESS) 10. There is consensus to first target health workers, essential workers, and the most vulnerable populations, which will include the elderly, people with comorbidities, and people in a high-population density areas such as low-income neighborhoods and refugee camps. The World Bank will also continue to provide technical and implementation support to mitigate this risk. 46. Another potential risk is the increased incidence of reprisals and retaliation especially against healthcare workers and researchers. Mitigation measures related to this risk have been integrated into the updated Stakeholder Engagement Plan (SEP) disclosed on May 25, 2022. In addition, the grievance mechanisms required under the Environmental and Social Framework (ESF) is already in place and equipped to address community, worker, and/or individual grievances related to such issues. This includes priority measures to address labor and working conditions, sexual exploitation and abuse (SEA) and sexual harassment (SH). The new activities under the component 2 including the TA support to the El Maarouf Hospital do not have direct adverse environmental or social impacts. However, the TA activities may induce downstream impacts related to the support to institutions and drafting the master plan. To mitigate these risks, the updated SEP ensures an effective stakeholder engagement during project preparation and implementation. Consultations were carried out during the preparation phase, which identified inputs that informed the design and implementation of the project. A range of stakeholders were consulted, among which disadvantaged or vulnerable groups who have barriers to access to health services or health information campaigns, groups who may have distrust of government health programs and groups who may be hesitant of health interventions such as vaccinations for cultural reasons. 47. Other substantial risks include those associated with data management and privacy. These include risks of inadequate management and storage, or inappropriate sharing of personal data in identification systems, health information systems, and other databases. Given concerns over limited 17 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) data protection and privacy laws and the data security environment in Comoros, these risks will be mitigated through legal and safeguard measures for data privacy under both this AF and the parent project. This includes legal, institutional and technical measures, as well as investments in data security and training of staff. IV. APPRAISAL SUMMARY A. Technical, Economic and Financial Analysis 48. The economic rationale for investment in COVID-19 vaccination is strong, considering the massive and continuing health and economic losses due to the pandemic. As of June 5, 2022, 8,126 people have been confirmed to be infected by the virus and 160 have been confirmed to have died. 49. The successful development, production, and delivery of a vaccine, however, has the best potential to reverse these trends, generating benefits that will far exceed vaccine-related costs. Indeed, a rapid and well-targeted deployment of a COVID-19 vaccine can help reduce the increases in poverty and accelerate economic recovery. A 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 a 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. 50. The pandemic is also having direct 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 their own related 26 deaths, illnesses, and long- term costs. Simultaneous epidemics are overwhelming public health systems in different countries that had few resources to begin with, and services for people with chronic health conditions, as well as mental and substance use disorders have also been disrupted. 51. The AF will play a crucial role in enabling affordable and equitable access to vaccines for Comoros. The economic impact from the pandemic has been devastating. It will be critical for Comoros to reach a minimum level of vaccination coverage to be able to start rebuilding its economy safely. To achieve this, Comoros must secure financing for vaccine purchase to continue the implementation of a large-scale COVID-19 vaccination program. However, Comoros has significant capacity constraints for ensuring an effective vaccination rollout. Delayed deployment of vaccines will exacerbate disadvantages in public health services provision. It will also hinder the country’s ability to recover socially and economically. 18 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) 52. The Government requested support to strengthen the Comorian hospital sector; the World Bank conducted scenario analyses to estimate the fiscal impact. Based on this modeling, the government agreed to a more efficient hospital with 300 beds. The total hospital investment would cost about US$68.7 million, which would increase Comoros’ health expenditure to about 2 percent of Gross Domestic Product (GDP), which is comparable to the Sub-Saharan Africa (SSA) average. The 300-bed hospital will reduce the health expenditure impact of this major investment by about 1 percentage point of GDP. Furthermore, applying utility costs per square meter of a reasonably maintained and air- conditioned hospital would generate utility savings from a smaller hospital size. It should be noted that El Maarouf will likely recruit among experienced health professionals already working within the sector. However, there is a shortage of health workers in Comoros. If they quit their posts to work at El Maarouf, this could have a negative impact on the provision of care for the poor who seek care in other facilities. Considering the fiscal impact of building a hospital and the possible effect on the health workforce, Comoros needs TA to develop and implement a masterplan on the efficient hospital size and health workforce to manage operational cost; TA to support hospital management and implement the masterplan recommendations; and resources to purchase diagnostic and therapeutic material, and basic hospital management information systems. 53. The operating costs, including wages and salaries, transfers to the hospital, and maintenance costs will be lower for a 300-beds hospital compared to the Government proposed 650-bed hospital. According to the El Maarouf hospital director, the current 300-bed hospital with 600 staff has an annual operating budget of about US$2 million, which is mainly financed from revenues from patient payments. In 2019, the government only allocated US$0.7 million to the hospital’s operational costs. A 650 -bed hospital would have considerably higher operating costs than a 300-bed facility. 54. The current masterplan can impact hospital productivity. With fewer beds, El Maarouf will have a higher bed occupancy and more efficient ratios for staff-to-patient and staff-to-occupied beds. The number of beds has been deemed sufficient for outbreaks. The aim is to help build an effective, responsive, and efficient hospital. This includes an efficient HR management system with recruitment of medical graduates from international universities and improved HR planning. TA will build capacity in hospital performance analysis which will immediately show results for hospital management. B. Financial Management 55. An FM assessment was conducted in February 2021 to evaluate whether the project implementing agency responsible of FM aspects meets the minimum FM requirements as per World Bank Policy and Directive. The FM assessment for the parent project was carried out in accordance with the Directives and Policy for IPF, the World Bank Guidance on FM in World Bank IPF Operations issued on February 28, 2017, the Streamlined Financial Management and Disbursement Procedural Measures for Preparation of Operations under COVID-19 Emergency Response updated on March 23, 2020. The FM assessment was conducted to evaluate the adequacy of the FM arrangements in light of the emergency response to be provided against the COVID-19 pandemic health threat, including the modalities for engagement of UN partners. The FM capacity remains adequate. 19 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) 56. The results of the FM assessment indicate that the FM arrangements of the parent project are adequate. Interim financial reports are submitted in a timely manner and are acceptable. Delay has been noted in the recruitment of the external audit firm that should perform the agreed upon procedures (AUP) reviews. These AUP reviews aim at checking compliance with systems, procedures, and controls relating to vaccines management, controls, and distribution. The FM performance of the project is moderately satisfactory. The institutional implementation arrangements for the parent project will remain applicable subject to additional capacity and risk mitigating measures due to increased funds and the nature of activities. 57. To further strengthen the existing arrangements considering the AF, the following additional measures will be put in place: (i) a qualified Finance Officer (FO) will be recruited to support the existing team of the Vaccine Project, and the FO of the COMPASS Project will continue to oversee the Vaccine Project team until this recruitment; (ii) a segregated designated account (DA) will be opened at the Central Bank of Comoros to receive AF funds; and (iii) the contract of the internal auditor recruited under the parent project will also be extended to the AF. C. Procurement 58. 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, the 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 Systematic Tracking of Exchanges in Procurement is used to plan, record, and track procurement transactions. 59. The major planned procurement under this AF will include, among others: (i) streamlined competitive procedures with shorter bidding time; (ii) use of framework agreements including existing ones; (iii) procurement from UN Agencies enabled and expedited by Bank procedures and standard agreements; (iv) increased thresholds for requests for quotations and national procurement, among others; (v) additional capacity or refurbishment of national, subnational and facility based and mobile cold chain equipment and supplies including cold rooms, ice lined refrigerators (ILR) and vaccine carriers; (vi) vehicles, including vaccinator personnel transport; (vii) other technical assistance to support in- country implementation training of front-line delivery workers; and (viii) vaccine logistics and information management systems; (ix) technical assistance to the El Maarouf hospital, including development of the hospital masterplan, hospital management capacity and information systems development; and (x) hospital equipment. A revised Project Procurement Strategy for Development (PPSD) was finalized and submitted to the World Bank for concurrence. The PPSD will integrate a proposed Procurement Plan for the first 18-months of AF implementation. 60. The current demand for COVID-19 vaccines exceeds the supply, making it more difficult for client countries to negotiate terms and conditions. Procurement of vaccines will therefore follow Direct Selection. The selected option for Comoros will be to purchase through COVAX AMC facility to complement donations from bilateral donors. Contracts for vaccines purchase financed by the World Bank will be subject to the World Bank’s prior review irrespective of value and procurement approach. 20 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) 61. The procurement risk is substantial. The World Bank’s oversight of procurement will be done through increased implementation support (e.g., terms of reference of TA, technical specifications and specificities of MIS and detailed costs will be developed with El Maarouf Hospital Managing Director), and, where requested by the government, procurement hands-on expanded implementation support. The World Bank standard prior and post review arrangements apply as specified in the procurement plan. D. Legal Operational Policies . Triggered? Projects on International Waterways OP 7.50 No Projects in Disputed Areas OP 7.60 No . E. Environmental and Social 62. The following five Environmental and Social Standards (ESSs) are relevant to the AF: Assessment and Management of Environmental and Social risk and impact; Labor and Working Conditions; Resource Efficiency and Pollution Prevention and Management; Community Health and Safety; and Stakeholder Engagement and Information Disclosure. In line with the World Bank ESF guidelines, the AF’s environmental and social risk rating is classified as Substantial. Activities are expected to have long-term, positive impacts as the project aims to contribute to improved disease surveillance, monitoring, and containment in the country as well as health systems preparedness for future outbreaks. 63. The project’s main environmental and social risks include: (i) Occupational Health and Safety (OHS) issues for workers in healthcare facilities and laboratories that may be exposed to infectious disease contagion (the future infection spread risk is strongly associated with the management of medical waste generated in laboratories and other facilities; (ii) community health and safety-related risks; (iii) operating laboratories and health centers have a high potential of infecting the wider population if not systematically managed and well-controlled) and; (iv) potential risks surrounding the exclusion of vulnerable groups to access project-supported services and facilities. 64. To assess and manage these risks and impacts consistent with the ESF, the Government has updated (i) the Environmental and Social Commitment Plan (ESCP), which can be adjusted during the project life cycle in keeping with the evolution of environmental and social risks and impacts; and (ii) the Stakeholder Engagement Plan (SEP) including Grievance Mechanism (GM). These have been disclosed by Word Bank on May 19, 2022. The Environmental and Social Management Framework (ESMF) developed under the parent project is still valid for the AF. The ESMF includes measures to mitigate occupational health and safety standards and specific infectious-control strategies, guidelines, and requirements, as recommended by WHO and CDC. In addition, effective administrative and infectious-controlling and engineering controls would be put in place to minimize these risks. 21 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) 65. Environmental and social capacity for ESF implementation. The AF will be implemented by the current PIU of World Bank-supported health projects within the MOH. Current Environmental and Social staff in the PIU supports management of environmental, social, health and safety risks and impacts. The team includes one Environmental Specialist and one Social Mobilization Specialist and will hire two additional environmental and social assistants for Ndzouani and one for Mwali Islands, respectively. The ESCP provides for the implementation of actions to build environmental and social capacity of the PIU and project stakeholders. 66. 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 a Hospitals’ Waste Management Plan and prepared an ESMF for the project by adding WHO standards on COVID-19 response. The plan includes 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 the medical supplies, disposing of the generated waste, and road safety. The AF will continue to use the parent project E&S instruments such as (i) the National Medical Waste Management Plan (NMWMP) and (ii) the ESMF including a SEA-SH action plan, and the Labor Management Procedures have been updated, consulted, and disclosed on December 21, 2021. 67. Gender inequalities and norms are critical considerations when designing policies and interventions in emergency situations and pandemics. They play an important role in who gets access to critical health services. Gender norms also influence risk of exposure to disease, as well as the risk of spreading it. At the same time, biological sex can influence how susceptible a person is to disease and how well they respond to treatment and/or vaccines. Pandemic response should be cognizant of gender- based differences in access to and use of services due to limited mobility and financial capacity. Support should be provided to at-risk groups such as family caregivers (the majority of whom are women) to reduce their risk of getting ill and/or passing it on to others. Moreover, pandemics can create or exacerbate the conditions that put women and girls at greater risk of gender-based violence. In the context of COVID-19, some critical considerations for the AF, similar to the parent project, include: • Biologically, women and men may have a different risk level to a pathogen or response to treatment. • Females and males may also differ in their immunological responses due to underlying conditions. • The elderly, especially women, are especially vulnerable to illness and lack of access to services. • Pregnant women are especially at risk during a pandemic/epidemic. • Women, whether as formal or informal care givers, are at the forefront of the healthcare response for the sick and elderly. This makes them more vulnerable to infection. 68. As part of the ESF requirements, World Bank-financed projects can also take steps to mitigate the risks of sexual exploitation, harassment, and abuse. In pandemics, access to services may be reduced due to lockdowns and reduced mobility, and the rule of law becomes fragile, increasing the risks of GBV. For instance, women and girls may be forced into exchanging sexual favors for access to testing, treatment, vaccines or even supplies. Another social risk is that marginalized and vulnerable social groups, including women and disabled populations, may have more barriers to access to COVID-19 services and information. There is also a risk that vaccine deployment plans could leave women behind, considering the larger male mortality of COVID-19 and the tendency in many countries to overlook the 22 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) importance of gender inequalities in social and economic activity. This risk will be reduced by carefully assessing this aspect of deployment. 69. The parent project is gender-tagged (meaning closing a specific gender gap measured by an indicator) and has a number of strategies that the AF will support: (i) integration of gender-responsive approaches in communication strategies with the public, including use of multiple accessible mediums in local languages; (ii) use of targeted messaging, and the creation of responsive platforms for registry of inquiries and grievances through a variety of mediums to target women and different vulnerable groups; (ii) inclusion of interventions to support demand creation/restoration of essential RMNCAH-N services together with COVID-19 vaccinations, critical to averting increases in excess mortality and mobility for women and girls and improving access to sexual and reproductive health and rights; (iii) support for promotion of awareness and use of gender-based violence services, including the expanded network of Integrated Service Centers at health facilities that offer medical, legal, psychosocial support and referrals. In alignment with the parent project, the AF will also pay close attention to gender dimensions through the technical assistance to El Marrouf hospital including integration of GBV training into training of hospital staff to increase access to counselling and GBV services and provision of analytical and technical support to hospital management to minimize COVID-19 disruptions of key RMNCAH-N services 70. As part of the Stakeholder Engagement Plan (SEP), the project implementation will ensure appropriate stakeholder engagement, proper awareness raising and timely information dissemination. This will help: (i) avoid conflicts resulting from false rumors; (ii) ensure equitable access to services for all who need it; and (iii) address issues resulting from people being kept in quarantine. These will be guided by standards set out by WHO as well as other international good practices including social inclusion and prevention of SEA/ SH. 71. Mechanisms to engage citizens and target beneficiaries in providing ideas and feedback on program delivery are helpful in identifying gaps at the point of service delivery . The feedback is on availability of services, access to testing and relevant care, vaccination, and equal treatment. The engagement builds community knowledge and confidence, establishes trust, ensures the government responds to community needs, and optimizes the impact of the COVID-19 emergency response. The parent project incorporates strategies related to citizen engagement that the AF will support, namely: (i) a citizen-oriented design, with a specific sub-component (1.3. Communications and community engagement), which will engage with citizens during implementation, and its mechanisms are described under sub-component 1.3; and (ii) a beneficiary feedback indicator in the project’s Results Frameworks. The number of villages implementing citizen engagement initiatives on COVID-19 will be monitored. F. Grievance mechanism 72. The parent project incorporates a comprehensive project-wide GM which will enable a broad range of stakeholders to channel concerns, questions, and complaints to the various implementation agencies and through COVID-19 call centers with a toll-free number. The process for obtaining a toll- free number is still ongoing, thus the GM of the vaccine project has not recorded any complaints through the implementation agencies. The project GM shall be reinforced to be fully functional at all levels and to handle SEA/SH. 23 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) G. Climate 73. The project has been screened for short and long-term climate change and disaster risks with exposure of the project location and target beneficiaries to climate risks identified as high and risks to project activities identified as moderate. Comoros is comprised of four islands located on the Indian Ocean, off the Eastern coast of Africa. Average annual temperatures in Comoros are projected to increase. Projections show an increase of 9.87 millimeters in mean annual precipitation, however with seasonal trends towards decreases in rainfall during the dry season of June to November and increases in rainfall during the rainy season during the months of December to February. Trends in annual precipitation show that on average, the rainy season has shortened in duration from six months to around three months. In recent years, cyclones and flooding have worsened. Most recently, tropical cyclone Kenneth hit the country on April 2019, resulting in the destruction of 3,818 houses, damage to another 7,017 houses, damage to six health centers, and the flooding of one hospital, underlining the detrimental impact of cyclones and flooding on the country’s infrastructure, including health infrastructure. 74. Comoros has shown its commitment to address climate change, and the climate-related activities for this project align with regional- and national-level climate priorities. Comoros’ national adaptation program of action, the strategic program framework on the natural environment, and accelerated growth strategy outlined in the Sustainable Development for 2015-2019 serve as the basis for the country’s climate change policy. Comoros ratified the Paris Agreement in November 2016 and submitted its first Nationally Determined Contribution (NDC). The NDC outlines key adaptation and mitigation directives to curb the impact of climate change across various sectors. Additionally, a primary tenant of the CPF between Comoros and the World Bank (2021-2024) is to respond to the damage caused by Cyclone Kenneth and the economic impact of COVID-19, by building the population’s resilience to climate and economic shocks through disaster recovery and disaster risk management. The climate- related activities outlined in this project align with national and global priorities to address climate change, including the CPF. The activities to address climate vulnerabilities and enhance climate resilience and adaptation are listed in Table A1 in Annex 2, while activities to mitigate against the impacts of climate change are shown in Table A2 in Annex 2. V. WORLD BANK GRIEVANCE REDRESS 75. Communities and individuals who believe that they are adversely affected by a World Bank- supported project may submit complaints to existing project-level grievance redress mechanisms or the World 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 World Bank’s independent Inspection Panel which determines whether harm occurred, or could occur, as a result of World Bank non-compliance with its policies and procedures. Complaints may be submitted at any time after concerns have been brought directly to the World Bank's attention, and Bank Management has been given an opportunity to respond. For information on how to submit complaints to the World Bank’s corporate Grievance Redress Service (GRS), please visit http://www.worldbank.org/en/projects-operations/products-and-services/grievance- redress-service. For information on how to submit complaints to the World Bank Inspection Panel, please visit www.inspectionpanel.org 24 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) VI SUMMARY TABLE OF CHANGES Changed Not Changed Results Framework ✔ Components and Cost ✔ Loan Closing Date(s) ✔ Legal Covenants ✔ Implementing Agency ✔ Project's Development Objectives ✔ Cancellations Proposed ✔ Reallocation between Disbursement Categories ✔ Disbursements Arrangements ✔ 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 25 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) 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$, millions) Name millions) Vaccines and related 10.50 Revised Vaccines and related 13.50 supplies provision and supplies provision and deployment deployment 26 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Health system 10.50 Revised Health system 32.50 strengthening for a stronger strengthening for a COVID-19 response stronger COVID-19 response Contingent Emergency 0.00 No Change Contingent Emergency 0.00 Response Component Response Component (CERC) (CERC) TOTAL 21.00 46.00 LOAN CLOSING DATE(S) Ln/Cr/Tf Status Original Closing Current Proposed Proposed Deadline Closing(s) Closing for Withdrawal Applications IDA-69760 Effective 31-Mar-2025 31-Mar-2025 31-Dec-2025 30-Apr-2026 IDA-D8970 Effective 31-Mar-2025 31-Mar-2025 31-Dec-2025 30-Apr-2026 TF-B6191 Effective 31-Mar-2024 31-Mar-2024 31-Dec-2025 30-Apr-2026 TF-B6192 Effective 30-Jun-2023 30-Jun-2023 31-Dec-2025 30-Apr-2026 Expected Disbursements (in US$) DISBURSTBL Fiscal Year Annual Cumulative 2021 0.00 0.00 2022 4,340,820.00 4,340,820.00 2023 15,035,880.00 19,376,700.00 2024 14,327,400.00 33,704,100.00 2025 12,295,900.00 46,000,000.00 SYSTEMATIC OPERATIONS RISK-RATING TOOL (SORT) Risk Category Latest ISR Rating Current Rating Political and Governance ⚫ Substantial ⚫ Substantial Macroeconomic ⚫ Low ⚫ Low Sector Strategies and Policies ⚫ Substantial ⚫ Substantial Technical Design of Project or Program ⚫ Substantial ⚫ Substantial Institutional Capacity for Implementation and ⚫ High ⚫ High Sustainability 27 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Fiduciary ⚫ Substantial ⚫ Substantial Environment and Social ⚫ Substantial ⚫ Substantial Stakeholders ⚫ Moderate ⚫ Moderate Other ⚫ Substantial ⚫ Substantial Overall ⚫ Substantial ⚫ Substantial LEGAL COVENANTS1 LEGAL COVENANTS – Support to COVID-19 Vaccine Purchase and Health System Strengthening (P175840) Loan/Credit/TF LEGAL TBL1 Description Status Action IDA-69760 Schedule II, Section 1, A, 2, (e): Not later Partially complied No Change than three (3) months after the Effective with Date, the senior accountant, accountant, and the internal auditor referred to in sub-paragraph (c) of this paragraph shall have been recruited and appointed. IDA-69760 Schedule II, Section 1, A, 2, (f): Not later After delay No Change than three (3) months after the Effective complied with Date the deputy coordinator, the procurement specialist, the monitoring and evaluation specialist, the social mobilization specialist, the two social and environmental assistants, and the environmental specialist referred to in sub-paragraph (c) of this paragraph shall have been recruited and appointed. IDA-69760 Schedule II, Section 1, A, 2, (g): Not later Not complied with No Change than three (3) months after the Effective Date, an external auditor shall have been recruited and appointed recruited on the basis of terms of reference, qualifications, integrity and experience acceptable to the Association. IDA-69760 Schedule II, Section 1, B, 2, (a): by no Complied with Marked for Deletion later than two (2) month after the Effective Date, prepare a draft work plan and budget for Project implementation, setting forth, inter alia: (i) a detailed description of the planned activities, including any proposed conferences and Training, under the Project for the period covered by the plan; (ii) the sources and proposed use of funds 28 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) therefor; (iii) procurement and environmental and social safeguards arrangements therefor, as applicable; and (iv) responsibility for the execution of said Project activities, budgets, start and completion dates, outputs and monitoring indicators to track progress of each activity. LEGAL COVENANTS2 LEGAL COVENANTS – Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Sections and Description The Recipient shall no later than three (3) months after Effectiveness Date, update and adopt the project implementation manual for the Original Project (as so updated, “Project Implementation Manual” or “PIM”) in accordance with terms of reference acceptable to the Association, and furnish to the Association the PIM, containing detailed arrangements and procedures for the implementation of the Project, including with respect to: administration and coordination, monitoring and evaluation, financial management, procurement and accounting procedures, environmental and social safeguards, a grievance redress mechanism, eligibility criteria, personal data collection and processing in accordance with the applicable WHO and national guidelines, roles and responsibilities for Project implementation, the requirements of the Anti-Corruption Guidelines, 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. Without limitation on Section I.B.1, in order to ensure adequate implementation of Part 1.1 and 1.2 of the Project, the Recipient shall no later than three (3) months after Effectiveness Date, update and adopt, the manual for COVID-19 Vaccine delivery and distribution for the Original Project (“Vaccine Delivery and Distribution Manual”), in form and substance satisfactory to the Association, which shall include: (i) rules and procedures for prioritizing intra-country 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; (ii) rules and procedures establishing minimum standards for vaccine management and monitoring, including medical and technical criteria, communications and outreach plan, cold chain infrastructure, and other related logistics infrastructure; (iii) rules and procedures for processing and collection of Personal Data in accordance with national law on Personal Data Protection if it is deemed adequate and good international practice; (iv) vaccine distribution plan, including action plan setting out timeline and steps for immunization; and (v) criteria for the procurement (whether via advance purchase mechanisms, direct procurement or through the COVAX Facility), importation, storage and deployment of Project COVID-19 Vaccines, including increased/equitable access to Project COVID-19 Vaccines. By no later than two (2) month after the Effective Date, prepare a draft work plan and budget for Project implementation, setting forth, inter alia: (i) a detailed description of the planned activities, including any proposed conferences and Training, under the Project for the period covered by the plan; (ii) the sources and proposed use of funds therefor; (iii) procurement and environmental and social safeguards arrangements therefor, as applicable; and (iv) responsibility for the execution of said Project activities, budgets, start and completion dates, outputs and 29 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) monitoring indicators to track progress of each activity. Conditions Type Financing source Description Disbursement IBRD/IDA No withdrawal shall be made under Financing Agreement, Schedule II, Section III, B.1.(b) under Category (2) unless and until the Recipient has provided evidence (i) that the ESMF has been updated and published all in form and substance acceptable to the Association, (ii) of the completion of the works at the El Maarouf Hospital through the submission by the Recipient of the signed provisional site acceptance report in accordance with Article 130 of the Recipient’s Procurement Code, in form and substance satisfactory to the Association, and (iii) that the engineering and health and safety audit certifies that the El Maarouf hospital renovation is complete and was conducted in accordance with good international industry standards, in form and substance satisfactory to the Association. Type Financing source Description Disbursement IBRD/IDA No withdrawal shall be made Financing Agreement, Schedule II, Section III, B.1.(c): For Emergency Expenditures under Category (3) unless and until all of the following conditions have been met in respect of said expenditures: (i) (A) the Recipient has determined that an Eligible Crisis or Emergency has occurred, and has furnished to the Association a request to withdraw Financing amounts under Category (3); and (B) the Association has agreed with such determination, accepted said request and notified the Recipient thereof; and (ii) the Recipient has adopted the CERC Manual and Emergency Action Plan, in form and substance acceptable to the Association. 30 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) VIII. RESULTS FRAMEWORK AND MONITORING Results Framework COUNTRY: Comoros RESULT_NO_PDO Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening Project Development Objective(s) This Project’s Development Objective is to support the Government of the Union of Comoros to acquire and deploy COVID -19 vaccines, to strengthen national systems for public health preparedness Project Development Objective Indicators by Objectives/ Outcomes RESULT_FRAME_TBL_ PD O Indicator Name PBC Baseline End Target Support the Government of the Union of Comoros to acquire and deploy COVID-19 vaccines Percentage of the population fully vaccinated, based on prioritized populations as defined in national plan, by gender 3.70 65.00 (Percentage) Rationale: The final target was revised to reflect the addition of adolescents to the vaccination targets Action: This indicator has been Revised End target date set to december 31, 2025. Percentage of females fully vaccinated, based on the 42.10 50.00 prioritized population in the national plan (Percentage) 31 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) RESULT_FRAME_TBL_ PD O Indicator Name PBC Baseline End Target Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. Percentage of health agents fully vaccinated, based on the 85.00 90.00 prioritized population in the national plan (Percentage) Rationale: Action: This indicator is New Health workers are defined as a priority group in the NVDP. Thus the percentage of vaccinated needs to be reported. Percentage of people aged over 60 fully vaccinated, based on 44.00 90.00 the prioritized population in the national plan (Percentage) Rationale: Percentage of people aged 60 o 65 are defined as a priority group in the NVDP. Thus the percentage of vaccinated needs to Action: This indicator is New be reported. Percentage of people with comorbidities and in risk groups fully vaccinated, based on the prioritized population in the 4.00 90.00 national plan (Percentage) Rationale: People with comorbidities and risk groups are defined as a priority group in the NVDP. Thus the percentage of vaccinated Action: This indicator is New needs to be reported. Percentage of adolescents aged 12 to 17 fully vaccinated, based on the prioritized population in the national plan 0.00 70.00 (Percentage) Rationale: Adolescents aged 12 to 17 are defined as a priority group in the NVDP. Thus the percentage of vaccinated needs to be Action: This indicator is New reported. Adoption of the El Maarouf hospital master plan (Yes/No) No Yes 32 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) RESULT_FRAME_TBL_ PD O Indicator Name PBC Baseline End Target Rationale: The availability of the master plan is critical as it will set the framework for the WB support to El Maarouf and other Action: This indicator is New hospitals. Support the GoC to strengthen its national systems for public health prepardness Number of health facilities and national/regional stores rehabilitated with resilient infrastructure and solarized (Number) 0.00 24.00 Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. PDO Table SPACE Intermediate Results Indicators by Components RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline End Target Vaccines and related supplies provision and deployment Percentage of the population who received at least one dose of a 5.00 69.00 COVID-19 vaccine, by gender (Percentage) Rationale: The final target was revised to reflect the addition of adolescents to the vaccination targets Action: This indicator has been Revised End target date set to december 31, 2025. Percentage of females who received at least one dose of a COVID-19 vaccine (Percentage) 42.10 50.00 33 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline End Target Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. Number of eligible COVID-19 vaccine doses procured and 0.00 580,000.00 available in country (Number) Rationale: Additionnal doses will be purchased to fill the following gaps: (i) vaccination of adolescents (new priority group), (ii) population increase during project implementation period, (iii) the additional doses required for yearly vaccination of Action: This indicator has been Revised people with comorbidities, in risk groups and aged 60 or more. End target date set to december 31, 2025. Number of sites for which requested cold chain equipment have 0.00 24.00 been installed and are functional (Number) Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. The e-vaccination tool is integrated in the DHIS2 for COVID-19 No Yes vaccination monitoring (Yes/No) Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. Proportion of adverse events following immunization (AEFI) reported and investigated based on national guidelines 15.00 80.00 (Percentage) Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. Number of villages implementing citizen engagement initiatives 197.00 350.00 on COVID-19 vaccination and prevention measures (Number) 34 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline End Target Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. Completion rate of communication activities for demand 0.00 80.00 generation and acceptance of the COVID-19 vaccine (Percentage) Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. Health system strengthening for a stronger COVID response Number of health centers equipped with solar power to deliver 0.00 22.00 health services (Number) Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. Number of coordination units that are functional (Number) 0.00 4.00 Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. Percentage of frontline health care workers with the knowledge to recognize, medically manage, and refer GBV survivors to 0.00 30.00 appropriate services (Percentage) Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. Percentage of female health workers with the knowledge to recognize, medically manage, and refer GBV survivors to 0.00 66.00 appropriate services (Percentage) 35 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline End Target Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. Number of public health facilities reporting data in the DHIS2 0.00 21.00 (Number) Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. Percentage of grievances addressed within 2 weeks of initial 0.00 75.00 complaint being recorded (Percentage) Rationale: Action: This indicator has been Revised End target date set to december 31, 2025. Functionality of the hospital management system (Yes/No) No Yes Action: This indicator is New Bed occupancy rate in El Maarouf hospital (Percentage) 40.00 80.00 Action: This indicator is New IO Table SPACE Monitoring & Evaluation Plan: PDO Indicators Mapped Methodology for Data Responsibility for Data Indicator Name Definition/Description Frequency Datasource Collection Collection Percentage of the population fully Numerator: Number of the Vaccination Quarterly Project monitoring PIU vaccinated, based on prioritized people who are fully campaign populations as defined in national plan, by vaccinated (who have reports 36 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) gender received recommended COVID-19 vaccine doses in accordance with standard vaccination guidelines). Denominator: Country’s population. Data are disaggregated by gender. The indicator is the % of Vaccination Percentage of females fully female vaccinated out of Quarterly campaign Project monitoring PIU vaccinated, based on the prioritized the overall population reports population in the national plan vaccinated Numerator: Number of Vaccination Percentage of health agents fully health agents vaccinated Quarterly campaign Project monitoring PIU vaccinated, based on the prioritized Denominator : Total reports population in the national plan number of health agents Numerator: Number of Percentage of people aged over 60 people aged 60 o 65 Vaccination fully vaccinated, based on the vaccinated Quarterly campaign Project monitoring PIU prioritized population in the national Denominator : Total reports plan number people aged 60 o 65 Numerator: Number of people with comorbidities Percentage of people with Vaccination and risk groups vaccinated comorbidities and in risk groups fully Quarterly campaign Project monitoring PIU Denominator : Total vaccinated, based on the prioritized reports number of people with population in the national plan comorbidities and risk groups Numerator: Number of Percentage of adolescents aged 12 to Vaccination adolescents aged 12 to 17 17 fully vaccinated, based on the Quarterly campaign Project monitoring PIU vaccinated prioritized population in the national reports Denominator : Total plan number of adolescents 37 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) aged 12 to 17 Project Adoption of the El Maarouf hospital Yearly MOH Reports PIU reports master plan Number of health facilities and national/regional stores rehabilitated with resilient infrastructure and solarized (with full autonomous solar capacity). The Acquisition infrastructure needs to be Number of health facilities and execution and (i) gender resilient, with Quarterly Project monitoring PIU national/regional stores rehabilitated with investments separate bathrooms for resilient infrastructure and solarized reports males/females and with female bathrooms containing the necessary equipment; and (ii) handicap resilient, with necessary measures to allow access to individuals with low mobility. 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 Numerator: Number of Vaccination Percentage of the population who people who received at Quarterly campaign Project monitoring PIU received at least one dose of a COVID-19 least one dose of a COVID- reports vaccine, by gender 19 vaccine. Denominator: 38 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Country's population. Data are disaggregated by gender. Vaccination Percentage of females who received Quarterly campaign rep Project monitoring PIU at least one dose of a COVID-19 orts vaccine Number of eligible COVID- 19 vaccine doses, Number of eligible COVID-19 vaccine Quarterly SMT Project monitoring PIU purchased through the doses procured and available in country project, that are available in country. Acquisition Number of sites for which Number of sites for which requested cold execution and requested cold chain Quarterly Project monitoring PIU chain equipment have been installed and investment re equipment have been are functional ports installed are functional Annual review The e-vaccination tool is The e-vaccination tool is integrated in the report integrated in the DHIS2 for Biannually Project monitoring PIU DHIS2 for COVID-19 vaccination (section on COVID-19 vaccination monitoring DGEPS/DISS) monitoring Numerator: Number of AEFI events reported that Vaccination Proportion of adverse events following are investigated in Quarterly campaign Project monitoring PIU immunization (AEFI) reported and accordance with national reports investigated based on national guidelines guidelines. Denominator: Total number of severe AEFI events reported. Number of villages Community Number of villages implementing citizen implementing community Quarterly engagement Project monitoring PIU engagement initiatives on COVID-19 initiatives allowing reports (DPS, vaccination and prevention measures diagnosis, planning and DRS, National 39 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) implementation of citizen Associations) engagement plans for promotion of COVID-19 vaccination and preventive measures. Numerator: Number of communications activities conducted (includes meetings, awareness Communicatio campaigns, traditional and ns plan social media productions, Completion rate of communication implementati community interventions, Quarterly Project monitoring PIU activities for demand generation and on reports and other communications acceptance of the COVID-19 vaccine (section on materials) for demand DPS) generation and acceptance of the COVID-19 vaccine. Denominator: Total number of communications activities planned. Number of health facilities Project Number of health centers equipped with that have been equipped Quarterly Project monitoring PIU/Ministry of health reports solar power to deliver health services with functional solar power provided by the project. Number of coordination units that are functional. A coordination unit is considered functional if (i) Annual review Number of coordination units that are at least 80% of planned Quarterly report (sectio Project monitoring PIU functional coordination meetings are n on CNPEV) conducted and (ii) at least one supportive supervision visit is conducted every quarter. 40 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Numerator: number of health workers with the Percentage of frontline health care knowledge to recognize, workers with the knowledge to recognize, medically manage, and Quarterly Project report Project monitoring PIU/MoH medically manage, and refer GBV refer GBV survivors to survivors to appropriate services appropriate services Denominator: total number of health workers Percentage of female health workers with the knowledge to recognize, Quarterly Project report Project monitoring PIU/MoH medically manage, and refer GBV survivors to appropriate services Number of targeted public Number of public health facilities Quarterly DHIS2 Project monitoring PIU health facilities reporting reporting data in the DHIS2 data in the DHIS2. Numerator: Number of Annual review grievances addressed reports Percentage of grievances addressed within 2 weeks of initial Quarterly (section on Project monitoring PIU within 2 weeks of initial complaint being complaint being recorded. vaccination recorded Denominator: Total project) number of grievances recorded. The hospital management information system is operational and used in other hospitals (The Project Functionality of the hospital management equipment for hospital Biannually PIU reports system management information system are available AND The patient record system and/or HR management system is functional. 41 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Number of beds effectively occupied by a patient for curative care divided by the Ministry of number of beds available Yearly Routine data PIU Bed occupancy rate in El Maarouf hospital Health for curative care in the hospital multiplied by 365 days. Multiplied by 100 (In El Maarouf hospital) ME IO Table SPACE 42 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) ANNEX 1: SUMMATY TABLE ON VACCINE DEVELOPMENT AND APPROVAL STATUS Stringent Regulatory WHO EUL 10 Manufacturer / Name of Vaccine Agency approval Platform NRA of Record WHO EUL holder Status of assessment received for WHO EUL 1. BNT162b2/COMIRNATY United Kingdom: Nucleoside EMA ▪ Finalized: 31/12/2020 BioNTech Manufacturing Tozinameran (INN) December 2, 2020 modified mNRA ▪ Additional sites: GmbH Canada: December − Baxter Oncology GmbH 9, 2020 Germany (DP). United States of 30/06/2021 America: December − Novartis Switzerland. 11, 2020 08/07/2021 European Union: − Mibe (Dermapharm) December 21, 2020 Germany (DP). Switzerland: 16/07/2021 December 19, 2020 − Delpharm, Saint-Remy Australia: January FRANCE (DP). 25, 2021 17/09/2021 − Sanofi-Aventis Deutschland GmbH. Germany 18/06/2021 − Siegfried Hameln GmbH, Germany (DP). 11/11/2021 − Patheon Italia S.p.A, Italy (DP). 07/12/2021 − Catalent Agnani. 21/01/2022 − Exela Pharma Sciences, 10 https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_02April2022.pdf 43 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Stringent Regulatory WHO EUL 10 Manufacturer / Name of Vaccine Agency approval Platform NRA of Record WHO EUL holder Status of assessment received for WHO EUL LLC, NC. 16/03/2022 ▪ 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 44 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Stringent Regulatory WHO EUL 10 Manufacturer / Name of Vaccine Agency approval Platform NRA of Record WHO EUL holder Status of assessment received for WHO EUL 2. AZD1222 Vaxzevria UK: December 30, EMA ▪ Core data finalized. 16 2020 Recombinant April 2021 AstraZeneca, AB EU: January 29, 2021 ChAdOx1 ▪ Additional sites: Australia: February adenoviral − SK-Catalent 16/04/2021 16th, 2021 (overseas vector − Wuxi (DS). 30/04/2021 manufacturing); encoding the − Chemo Spain. March 21st, 2021 (for Spike protein 04/06/2021 local manufacturing antigen of the − Amylin Ohio US (DP). by CSL – Seqirus) SARS-CoV-2. 23/07/2021 Canada: February 26, 2021 − WuXi Biologics, Germany (DP) 08/03/2022 MFDS KOREA ▪ Finalized. 15 Feb 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) 45 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Stringent Regulatory WHO EUL 10 Manufacturer / Name of Vaccine Agency approval Platform NRA of Record WHO EUL holder Status of assessment received for WHO EUL 3. Covishield Recombinant DCGI ▪ Finalized. 15 Feb 2021 Serum Institute of (ChAdOx1_nCoV- ChAdOx1 − DS and DP Manjari Bk India Pvt.Ltd 19) adenoviralvector Pune. 12/11/2021 encoding the Spike protein antigen 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: January (LNP) August 2021 12th, 2021 − ModernaTx. Norwood UK: January 8, 2021 (DS) − Catalent Indiana, LLC (DP) − Lonza Biologics, Inc. Portsmouth, USA (DS) − Baxter, Bloomington, USA (DP) MFDS ▪ Finalized. 23 December 2021 46 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Stringent Regulatory WHO EUL 10 Manufacturer / Name of Vaccine Agency approval Platform NRA of Record WHO EUL holder Status of assessment received for WHO EUL 6. Sinopharm / BIBP 1 SARS-CoV-2 Inactivated, NMPA ▪ Finalized. 07 May 2021 Vaccine (Vero produced in Vero ▪ 2 and 5 dose Beijing Institute of Cell), Inactivated cells presentation (new BiologicalProducts Co., Ltd. (lnCoV) manufacturing site) -- (BIBP) TBC after ongoing inspection 7. COVID-19 Inactivated, ▪ Finalized. 01 June 2021 Sinovac Life Sciences Co., Vaccine (Vero produced in Vero ▪ 2 dose presentation. Ltd.Sinovac Life Sciences Cell), cells 30 September 2021 Co., Ltd. Inactivated/ CoronavacTM 8. Ad26.COV2.S USA: February 27th, Recombinant, EMA ▪ Core data finalized (US 2021 replication- +NL sites). 12 March Janssen–Cilag International Canada: March 5th, incompetent 2021 NV 2021 adenovirus type ▪ Additional sites: EU: March 11th, 26 (Ad26) − Aspen RSA (DP). 2021 vectored vaccine 25/06/2021 Switzerland: March encoding the − Catalent Agnani Italy 22nd, 2021 (SARS-CoV-2) (DP). 02/07/2021 UK: May 28th, 2021 Spike (S) protein − Grand River Aseptic Australia: June 25th, Manufacturing Inc., 2021 USA. 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 - 47 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Stringent Regulatory WHO EUL 10 Manufacturer / Name of Vaccine Agency approval Platform NRA of Record WHO EUL holder Status of assessment received for WHO EUL 25°C to -15°C. 16/03/2022 9. SARS-CoV-2 Vaccine, Whole-Virion DCGI ▪ Finalized. 03 Nov 2021 Bharat Biotech, India Inactivated (Vero Cell)/ Inactivated Vero ▪ Suspension of supply COVAXIN Cell due to outcomes of post EUL inspection (14 – 22 March 2022). 02 April 2022 10. NVX- Recombinant EMA ▪ Finalized. 20 December CoV2373/Nuvaxovid nanoparticle 2021 prefusion spike protein formulated with Matrix-M™ adjuvant 48 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) ANNEX 2: PROJECT CLIMATE ADAPTATION AND CLIMATE MITIGATION ACTIVITIES The proposed project intends to address these vulnerabilities and enhance climate resilience and adaptation through the following activities: Table A1: Climate Adaptation Activities Project Sub-component Climate-related action How activity & Cost will address climate-related vulnerabilities Component 2a: TA to Incorporate measures to improve the hospitals resilience Improve the develop a hospital to climate shocks into architectural plans, specifically: resilience of the masterplan for the • Drainage to prevent hospital flooding hospital to proposed El Maarouf • Secure roofs to prevent roof damage from heavy climate shocks hospital (US$1.7 million) winds in cyclones • Raising storage to prevent damage from flooding • Ensuring there are sufficient exits to evacuate people safely during climate shocks • Ensuring there are safe areas in the hospital to shelter patients and staff during climate shocks • Other measures as identified during the needs’ assessment Incorporation of climate emergency preparedness and Improve the response in training plans: hospital’s The hospital’s HR and training plan will be developed to preparedness include training for hospital employees, including both for and health workers and administrative staff, on preparing for resilience to and responding to climate shocks. climate shocks Appointment of a climate focal point within the Improve the management structure: hospital’s As part of the governance and management structure plan, preparedness a climate focal point will be appointed within the for and management structure. The role of the focal point will be resilience to to: (i) coordinate preparedness and response to climate climate shocks emergencies; and (ii) support implementation of climate adaptation measures in the hospital Component 2b: TA to Incorporate climate emergency preparedness and Improve the the hospital response training into HR and CME in the Comoros: hospital’s management to TA will be provided for development of curriculum modules preparedness implement the and materials for emergency preparedness and response for and masterplan and build training resilience to capacity in hospital climate shocks 49 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) management (US$8.6 Develop Climate Emergency Preparedness and Response Improve the million) Plans for El Maarouf Hospital hospital’s TA will be provided to develop plans to prepare for and preparedness respond to climate emergencies, such as floods and for and cyclones resilience to climate shocks The project also intends to mitigate against the impacts of climate change through the measures outlined below. Table A2: Climate Mitigation Activities Project Sub- Climate-related action Contribution component & Cost to mitigation Component 2a: TA to Incorporation of climate mitigation measures in the hospital’s Reduce the develop a hospital architectural plans: hospitals masterplan for the The hospital’s architectural plans will include climate mitigation contribution proposed El Maarouf measures including installation of solar power, energy efficiency to hospital (US$1.7 improvements identified based on an energy efficiency greenhouse million) assessment incorporated in the needs assessment, and the use gas of light emitting diode lights emissions 50 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) ANNEX 3: TECHNICAL, ECONOMIC AND FINANCIAL ANALYSIS OF THE SUPPORT TO EL MAAROUF HOSPITAL Benefits from the masterplan and its implementation will immediately outweigh total AF project cost of US$22 million significantly. Benefits will materialize immediately due to lower upfront investment costs of about EUR 60 million for a smaller El Maarouf hospital. It is estimated that the key direct benefits from the smaller hospital size (utility and maintenance cost savings and staff cost savings from staff optimization) are relatively modest for the government, due to the underfunding of operations and maintenance costs for hospitals and relatively low staff costs. However, it will ease the already high financial burden for patient who pay high user fees. Applying utility costs per square meter of a reasonably maintained and air-conditioned hospital, would generate utility savings from a smaller hospital size. Training in proper waste management and disposal systems will ensure optimized treatment, recycling, transport, and disposal of medical waste from the hospital. The key benefits from a smaller hospital size such as improved utilization (occupancy) achieved through improved management and quality of care will ultimately result in more efficient utilization of limited resources, less medical waste, and better health care for the population. It is difficult to estimate the impact of the AF on the rest of the health sector. A smaller hospital size would prevent major imbalances in the health labor market that could seriously affect the health status of the poor and hamper the COVID response in rural health facilities. If carried out properly, the El Maarouf hospital will also have a positive demonstration effect and thus provide an impetus for other hospital managers to effectively manage their health facilities. All these indirect benefits are difficult to quantify and contribute to the direct returns of the project. The TA provided under this AF will help substantially reduce the financial impact of a 650-bed hospital on government health expenditures (see Table 6 for more detailed information). In 2020, Comoros’ government health expenditure (GHE) of 1.6 percent of GDP was below the SSA average of 1.9 percent in 2018 (Figure 1). Project cost for investing into a 650-bed facility would amount to 120 million Euros (US$137 million equivalent) as suggested in the government project document. Disbursements have started in 2019 and the hospital is expected to be finalized in 2023. Scenario 1 in Table 6 assumes that the remaining project cost will be spent equally over five years until 2025. Recurrent expenditures are assumed to increase annually by 20 percent caused by increases in government expenditures on wages, maintenance, utility and other transfers to health facilities. Under a 650-bed scenario 1, government health expenditures as a share of GDP will immediately jump to 2.9 percent in 2021 (table 6) and will stay above 3 percent (Figure 2). With a smaller 300-bed hospital in Scenario 2, the total project investment would cost about US$68.7 million which would bring Comoros’ health expenditure up to about 2 percent of GDP comparable to the SSA average (Figure 1). This means that the AF of US$8 million for TA to optimize the El Maarouf hospital size will reduce the government health expenditure impact of such a major investment by about 1 percentage point of GDP. It will also safe the Government about US$70 million in future debt. 51 The World Bank Additional Financing to Support to COVID-19 Vaccine Purchase and Health System Strengthening (P178615) Figure 1: Government Health Expenditures (GHE) Figure 2: Comoros GHE in % of GDP, as % of GDP (2018 - 2020) Projections for Scenarios 1 and 2 5.0 4.5 3.1% 3.2% 3.9 3.5% 2.9% 2.9% 3.0% 4.0 3.2 3.5 3.8 3.0% 2.4% 2.5 2.8 2.2% 2.1% 2.2% 3.0 1.9 2.1 2.4 2.5 2.5% 1.8% 2.0% 2.0 1.4 1.5 1.6 1.6 1.7 2.0% 1.6% 1.0 1.5% 1.0% 0.0 Sao Tome &… Dominican… Comoros… 0.5% Rwanda Mauritius Jamaica Tanzania Madagascar Ghana LMIC Seychelles South Africa SSA average Eswatini Cabo Verde Caribbean 0.0% 2019 2020 2021 2022 2023 2024 2025 Hospital 650 beds Hospital 300 beds Source: Staff calculations based on data from World Development Indicators (WDI) and national authorities. Table A3: Financial Impact of the El Maarouf Hospital Investment in Comoros Actual Projections 2019 2020 2021 2022 2023 2024 2025 Total Nominal GDP in million US$ (IMF) 1,186 1,253 1,336 1,419 1,506 1,602 1,698 Scenario 1: El Maarouf w/ 650 beds (E120M) Gov health expenditure (GHE) in % of GDP 2.2% 1.6% 2.9% 2.9% 3.0% 3.1% 3.2% GHE in million KMF 11,396 8,421 16,534 17,842 19,412 21,296 23,556 GHE in million US$ ($1 = 430 KMF) 26.50 19.58 38.45 41.49 45.14 49.52 54.78 Gov recurrent health spending in million US$ 9.68 15.21 15.21 18.25 21.90 26.28 31.54 Gov project cost El Maarouf w/ 650 beds (E120M) in million US$ ($1 = 0.8 Euro) 16.8 4.4 23.2 23.2 23.2 23.2 23.2 137.4 Scenario 2: El Maarouf w/ 300 beds (E 60M) GHE as a share of GDP 2.2% 1.6% 1.8% 2.0% 2.1% 2.2% 2.4% GHE in million US$ ($1 = 430 KMF) 26.50 19.58 24.71 27.75 31.40 35.78 41.04 Gov recurrent health spending in million US$ 9.68 15.21 15.21 18.25 21.90 26.28 31.54 Gov project cost El Maarouf w/ 300 beds (E 60M) in million US$ ($1 = 0.8 Euro) 16.8 4.4 9.5 9.5 9.5 9.5 9.5 68.7 Source: Government financial data and Project Document for El Maarouf hospital. Note: Assumption for government recurrent health spending: 20% annual growth starting 2022 52