Document of The World Bank FOR OFFICIAL USE ONLY Report No: PAD4794 INTERNATIONAL DEVELOPMENT ASSOCIATION PROJECT PAPER ON A PROPOSED ADDITIONAL GRANT IN THE AMOUNT OF SDR 1.6 MILLION (US$2.2 MILLION EQUIVALENT) TO THE REPUBLIC OF GUINEA-BISSAU FOR THE GUINEA-BISSAU COVID-19 VACCINE PROJECT DECEMBER 23, 2021 UNDER THE COVID-19 STRATEGIC PREPAREDNESS AND RESPONSE PROGRAM (SPRP) USING THE MULTIPHASE PROGRAMMATIC APPROACH (MPA) WITH A FINANCING ENVELOPE OF UP TO US$6 BILLION APPROVED BY THE BOARD ON APRIL 2, 2020 AND UP TO US$12 BILLION ADDITIONAL FINANCNG APPROVED BY THE BOARD ON OCTOBER 13, 2020 Health, Nutrition and Population Global Practice Western and Central Africa Region This document has a restricted distribution and may be used by recipients only in the performance of their official duties. Its contents may not otherwise be disclosed without World Bank authorization. CURRENCY EQUIVALENTS (Exchange Rate Effective November 30, 2021) Currency Unit = CFA Franc (FCFA) CFA 578 = US$1 US$1 = SDR 0.7139 FISCAL YEAR January 1 - December 31 Regional Vice President: Ousmane Diagana Country Director: Nathan M. Belete Regional Director: Dena Ringold Practice Manager: Gaston Sorgho Task Team Leaders: Fatoumata Binta Maama Barry, Yemdaogo Tougma ABBREVIATIONS AND ACRONYMS ACG Anti-Corruption Guidelines AEFI Adverse Events Following Vaccination AF Additional Financing AMC Advance Market Commitment APA Advance Purchase Agreement AU African Union AVAT African Vaccine Acquisition Trust Committee for Interagency Coordination for Vaccination (Comité de Coordenação Inter Agência CCIA para a Vaccinação) CECOME Drug Purchasing Center (CECOME-Central das Compras de Medicamentos) CHW Community Health Worker Committee of the Regulatory Authority Pharmacy, Laboratory, Medicines and other Health CI – ARFAME Products (Comissão Instaladora da Autoridade Reguladora Farmácia, Laboratório, Medicamentos e outros Produtos de Saúde) COES Health Emergency Operation Center (Centro Operações Emergências em Saúde) COVAX COVID-19 Vaccine Global Access COVAX-AMC COVAX Advanced Market Commitment COVID-19 Coronavirus Disease CPF Country Partnership Framework CY Calendar Year DHIS2 District Health Information System Software 2 DFIL Disbursement and Financial Information Letter DP Development Partner DRS Regional Health Directions (Direção Regional da Saúde E&S Environmental and Social ESCP Environmental and Social Commitment Plan ESF Environmental and Social Framework ESMF Environmental and Social Management Framework ESS Environmental and Social Standards EU European Union EUL Emergency Use Listing FGM Female Genital Mutilation FM Financial Management FY Fiscal Year GAVI Global Alliance for Vaccines and Immunizations GBV Gender-based Violence GDP Gross Domestic Product GHG Greenhouse Gas Emissions GIIP Good International Industry Practice GoGB Government of Guinea-Bissau GRM Grievance Redress Mechanism GRS Grievance Redress Service HEIS Hands-on Expanded Implementation Support IBRD International Bank for Reconstruction and Development ICWMP Infection Control and Waste Management Plan IDA International Development Association IFC International Finance Corporation IHR International Health Regulations IPF Investment Project Financing ISR Implementation Status and Results Report JEE Joint External Evaluation M&E Monitoring and Evaluation MINSAP Ministry of Public Health (Ministério da Saúde Pública) MoU Memorandum of Understanding MPA Multiphase Programmatic Approach mRNA COVID-19 messenger RNA vaccines NDVP National Deployment and Vaccination Plan NITAG National Immunization Technical Advisory Group NPF New Procurement Framework OECD Organization for Economic Cooperation and Development PAD Project Appraisal Document PCR Polymerase Chain Reaction PDO Project Development Objective PIU Project Implementation Unit POM Project Operational Manual PPE Personal Protective Equipment PPSD Project Procurement Strategy for Development PVS Pharmacovigilance System RAS Health Area Focal Point (Responsável Area Sanitaria) REDISSE Regional Disease Surveillance Systems Enhancement Project SAB Autonomous Region of Bissau (Setor Autonomo Bissau) SEA Sexual Exploitation and Abuse SDGs Sustainable Development Goals SDR Special Drawing Rights SEP Stakeholder Engagement Plan SH Sexual Harassment SII Serum Institute of India Immunization and Epidemiological Surveillance Service (Serviço Imunização Vigilância SIVE Epidemiológica) SMT Supply Management Tool SORT Systematic Operations Risk-Rating Tool SPRP Strategic Preparedness and Response Program SRA Stringent Regulatory Authority STEP Systematic Tracking of Exchanges in Procurement TPM Third Party Monitoring UHC Universal Health Coverage UN United Nations UNDP United Nations Development Programme UNICEF United Nations International Children's Emergency Fund VAC Vaccine Approval Criteria VIRAT Vaccine Introduction Readiness Tool VRAF Vaccine Readiness Assessment Framework WBG World Bank Group WHO World Health Organization Republic of Guinea-Bissau Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project TABLE OF CONTENTS I. BACKGROUND AND RATIONALE FOR ADDITIONAL FINANCING ........................................ 8 A. Introduction ................................................................................................................. 8 B. Consistency with the Country Partnership Framework (CPF) .................................. 10 C. Project Design and Scope .......................................................................................... 11 D. Project Performance .................................................................................................. 11 E. Rationale for Additional Financing ............................................................................ 12 F. National Capacity and COVID-19 Vaccination Plan .................................................. 14 II. DESCRIPTION OF ADDITIONAL FINANCING .................................................................... 31 A. Proposed Changes ...................................................................................................... 31 B. Sustainability .............................................................................................................. 34 III. KEY RISKS ..................................................................................................................... 34 IV. APPRAISAL SUMMARY .................................................................................................. 38 V. WORLD BANK GRIEVANCE REDRESS .............................................................................. 45 VI SUMMARY TABLE OF CHANGES ..................................................................................... 46 VII DETAILED CHANGE(S) .................................................................................................... 46 VIII. RESULTS FRAMEWORK AND MONITORING ................................................................... 51 ANNEX 1: SUMMARY TABLE ON VACCINE DEVELOPMENT AND APPROVAL STATUS .............. 56 ANNEX 2: LATEST COVID-19 SITUATION IN THE COUNTRY .................................................... 57 ANNEX 3: SUMMARY OF THE PARENT PROJECT COMPONENTS ............................................ 60 LIST OF TABLES Table 1: Summary of Vaccination Readiness Findings from the VIRAT/VRAF 2.0 Assessment .............. 15 Table 2: National Vaccine Coverage and Acquisition Plan .................................................................. 27 Table 3: Priority Groups for Vaccination in Guinea-Bissau ................................................................. 32 Table 4: Project Cost and Financing .................................................................................................. 32 Table 5: Summary of COVID-19 Vaccine Sourcing and World Bank Financing ..................................... 33 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) BASIC INFORMATION – PARENT (GUINEA-BISSAU COVID-19 VACCINE PROJECT - P176721) Country Product Line Team Leader(s) Guinea-Bissau IBRD/IDA Fatoumata Binta Maama Barry Project ID Financing Instrument Resp CC Req CC Practice Area (Lead) P176721 Investment Project HAWH3 (9542) AWCF1 (6550) Health, Nutrition & Financing Population Implementing Agency: Office of the High Commissioner for COVID-19 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-Dec-2023 Substantial Financing & Implementation Modalities Parent [✓] Multiphase Programmatic Approach [MPA] [ ] Contingent Emergency Response Component (CERC) [ ] Series of Projects (SOP) [✓] Fragile State(s) [ ] Performance-Based Conditions (PBCs) [ ] Small State(s) [ ] Financial Intermediaries (FI) [ ] Fragile within a Non-fragile Country [ ] Project-Based Guarantee [ ] Conflict [ ] Deferred Drawdown [✓] Responding to Natural or Man-made disaster [ ] Alternate Procurement Arrangements (APA) [✓] Hands-on Expanded Implementation Support (HEIS) Page 1 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Development Objective(s) 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 073) The Project Development Objective is to prevent, detect and response to the threat posed by COVID-19 and strengthen national systems for public health preparedness in Guinea-Bissau. Ratings (from Parent ISR) RATING_DRAFT_NO Latest ISR 05-Oct-2021 Progress towards achievement of PDO S Overall Implementation Progress (IP) S Overall ESS Performance MS Overall Risk H Financial Management MS Project Management S Procurement S Monitoring and Evaluation S BASIC INFORMATION – ADDITIONAL FINANCING (Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project - P178198) ADDFIN_TABLE Urgent Need or Capacity Project ID Project Name Additional Financing Type Constraints P178198 Additional Financing for Scale Up No the Guinea-Bissau COVID- 19 Vaccine Project Financing instrument Product line Approval Date Investment Project IBRD/IDA 23-Dec-2021 Page 2 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Financing Projected Date of Full Bank/IFC Collaboration Disbursement 31-Dec-2023 No Is this a regionally tagged project? No Financing & Implementation Modalities Child [✓] Multiphase Programmatic Approach [MPA] [ ] Series of Projects (SOP) [✓] Fragile State(s) [ ] Performance-Based Conditions (PBCs) [ ] Small State(s) [ ] Financial Intermediaries (FI) [ ] Fragile within a Non-fragile Country [ ] Project-Based Guarantee [ ] Conflict [ ] Responding to Natural or Man-made disaster [ ] Alternate Procurement Arrangements (APA) [ ] Hands-on, Enhanced Implementation Support (HEIS) [ ] Contingent Emergency Response Component (CERC) Disbursement Summary (from Parent ISR) Net Source of Funds Total Disbursed Remaining Balance Disbursed Commitments IBRD % IDA 5.00 4.95 0% Grants % MPA Financing Data (US$, Millions) Financing MPA Program Financing Envelope 18,000,000,000.00 MPA FINANCING DETAILS (US$, Millions) MPA FINA NCI NG DET AILS (US$, Millions) Approve d Board Approved MPA Financing Envelope: 18,000,000,000.00 MPA Program Financing Envelope: 18,000,000,000.00 Page 3 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) of which Bank Financing (IBRD): 9,900,000,000.00 of which Bank Financing (IDA): 8,100,000,000.00 of which other financing sources: 0.00 PROJECT FINANCING DATA – ADDITIONAL FINANCING (Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project - P178198) PROJECT FINANCING DATA (US$, Millions) SUMMARY -NewFi n1 SUMMARY (Total Financing) Proposed Additional Total Proposed Current Financing Financing Financing Total Project Cost 5.00 2.20 7.20 Total Financing 5.00 2.20 7.20 of which IBRD/IDA 5.00 2.20 7.20 Financing Gap 0.00 0.00 0.00 DETAILS - Additional Financing NewFinEnh1 World Bank Group Financing International Development Association (IDA) 2.20 IDA Grant 2.20 IDA Resources (in US$, Millions) Credit Amount Grant Amount Guarantee Amount Total Amount Guinea-Bissau 0.00 2.20 0.00 2.20 National PBA 0.00 2.20 0.00 2.20 Total 0.00 2.20 0.00 2.20 Page 4 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) COMPLIANCE Policy Does the project depart from the CPF in content or in other significant respects? [ ] Yes [ ✔ ] No Does the project require any other Policy waiver(s)? [ ✔ ] Yes [ ] No Explanation This project is being processed using the following waiver(s) granted through the Global SPRP MPA Project (P173789): (i) Waiver to enable Management approval of individual projects under SPRP rated Substantial for Environmental and Social (ES) risks. Has the waiver(s) been endorsed or approved by Bank Management? Approved by Management [✔] Endorsed by Management for Board Approval [ ] No [ ] Explanation The waiver has been already approved for the Global Coronavirus Disease 2019 (COVID-19) Strategic Preparedness and Response Project (SPRP)using the Multiphase Programmatic Approach (MPA), approved by the Board on April 2, 2020, and the vaccines AF to the SPRP approved on October 13, 2020, and its relevant to this AF. Page 5 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) 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 Relevant Resources Indigenous Peoples/Sub-Saharan African Historically Underserved Traditional Not Currently Relevant Local Communities Cultural Heritage Not Currently Relevant Financial Intermediaries Not Currently Relevant ESStandardsNote NOTE: For further information regarding the World Bank’s due diligence assessment of the Project’s potential environmental and social risks and impacts, please refer to the Project’s Appraisal Environmental and Social Review Summary (ESRS). INSTITUTIONAL DATA Practice Area (Lead) Health, Nutrition & Population Contributing Practice Areas Climate Change and Disaster Screening This operation has been screened for short and long-term climate change and disaster risks Page 6 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) PROJECT TEAM Bank Staff Name Role Specialization Unit Fatoumata Binta Maama Team Leader (ADM Health Specialist HAWH3 Barry Responsible) Yemdaogo Tougma Team Leader Health Economist HAWH3 Procurement Specialist (ADM Mountaga Ndiaye Procurement EAWRU Responsible) Financial Management Fatou Mbacke Dieng Financial Management EAWG1 Specialist (ADM Responsible) Social Specialist (ADM Gernot Brodnig Social Development SAWS4 Responsible) Environmental Specialist (ADM Manuela Ravina da Silva Environmental Safeguards SAWE1 Responsible) Carlos Jacinto Mondlane Team Member Disbursement WFACS Faly Diallo Team Member Disbursement WFACS Isabella Micali Drossos Counsel Country Lawyer LEGAM Mohamed I. Diaw Team Member Quality control HAWH3 Rebekka E. Grun Team Member Practice Leader HAWDR Sariette Jene M. C. Jippe Team Member Operations and Administrative HAWH3 Sonia Sanchez Moreno Team Member Operations Officer AWMGW Extended Team Name Title Organization Location Page 7 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) I. BACKGROUND AND RATIONALE FOR ADDITIONAL FINANCING A. Introduction 1. This Project Paper (PP) seeks the approval of the World Bank’s Regional Vice-President to provide a grant in the amount of US$2.2 million equivalent from the International Development Association (IDA) for an Additional Financing (AF). This AF would support the costs of expanding activities of the Guinea-Bissau COVID-19 Vaccine Project (P176721) under the COVID-19 Strategic Preparedness and Response Program (SPRP) using the Multiphase Programmatic Approach (MPA), approved by the Board on April 2, 2020, and the vaccines AF to the SPRP approved on October 13, 2020.1 The primary objective of the AF is to enable affordable and equitable access to COVID-19 vaccines. The Guinea-Bissau COVID-19 Vaccine Project (P176721) in an amount of US$5.0 million equivalent, prepared under the SPRP, was approved on June 29, 2021 and became effective on October 20, 2021. 2. The purpose of the proposed AF is to provide financing to help the Government of Guinea- Bissau (GoGB) to purchase additional COVID-19 vaccine doses through the African Vaccine Acquisition Trust (AVAT), that meet the World Bank’s Vaccine Approval Criteria (VAC). The GoGB’s target for COVID- 19 vaccinations is to have 70 percent of the total population (12 years of age and older) vaccinated by the end of calendar year (CY)23. Currently, only 50.4 percent of the total population is eligible since COVID- 19 vaccines are only being administered to adults 18 years and older. The remaining 19.6 percent of the total population represent adolescents; 12-17 years of age. The AVAT, convened by the African Union (AU), has agreed with the World Bank to provide the AU member states additional access to COVID-19 vaccines through the United Nations Children’s Fund (UNICEF) as a procurement agent. The proposed AF will help vaccinate an additional 15.86 percent of the Guinea-Bissau total population by completing the purchase of 300,000 Johnson and Johnson (J&J) vaccines, which would contribute to increasing the cumulative vaccination coverage. World Bank financing for the COVID-19 vaccines and deployment will continue to follow the World Bank’s VAC. As of April 16, 2021, the World Bank will accept as threshold for eligibility of International World Bank for Reconstruction and Development IBRD/IDA resources in COVID- 19 vaccine acquisition and/or deployment under all World Bank-financed projects: (i) the vaccine has received regular or emergency licensure or authorization from at least one of the Stringent Regulatory Authorities (SRAs) identified by the World Health Organization (WHO) for vaccines procured and/or supplied under the COVAX Facility, as may be amended from time to time by WHO; or (ii) the vaccine has received WHO Prequalification (PQ) or WHO Emergency Use Listing (EUL). The country will continue to provide vaccinations free of charge to the population. 3. The need for additional resources to expand the COVID-19 response was formally conveyed by the GoGB on October 14, 2021 (Ref. No 242/GMPIR/2021). The Government has requested support for the acquisition of additional doses of COVID-19 vaccine in the amount of US$2.2 million from IDA financing. This AF will form part of an expanded health response to the pandemic, which is being 1 The World Bank approved a US$12 billion World Bank Group (WBG) 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 AF of US$12 billion (IBRD/IDA) was approved on October 13, 2020 to support the purchase and deployment of vaccines, as well as strengthening the related immunization and healthcare delivery system. Page 8 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) supported by development partners (DP) under the coordination of the GoGB. Additional World Bank financing will provide essential resources to enable the expansion of a sustained and comprehensive pandemic response that will appropriately include vaccination in Guinea-Bissau. 4. Critically, the proposed AF seeks to enable the acquisition of COVID-19 vaccines to support Guinea-Bissau’s objective to have a portfolio of options to access vaccines under the appropriate conditions (of value-for-money, regulatory standards, and delivery time, among other key features). Guinea-Bissau’s strategy and access to vaccines are anchored in the COVAX facility framework,2 which is being supported under the parent project. In addition to vaccines acquired through COVAX, this AF will exclusively support vaccine acquisition via AVAT convened by the AU. AVAT has secured and negotiated, through UNICEF, additional access to vaccines that will contribute to cover up to 60 percent of the population of countries that request for it. When firm contracts are in place between UNICEF, as the appointed procurement agent, and the manufacturers, UNICEF will conclude contracts with participating countries for the supply of the vaccines. These contracts will be reviewed by the World Bank to ensure that they comply with all operational policies and provide value-for-money in terms of both price and delivery times before financing from this grant can be disbursed toward the member country upon its request. The availability and terms of vaccines remain fluid and prevent the planning of a firm sequence of vaccine deployment, especially as the actual delivery of vaccines is unlikely to be immediate. In sum, the proposed financing enables a portfolio approach that will be adjusted during implementation in response to developments in the country’s pandemic situation and the global market for vaccines. 5. Latest COVID-19 situation in the country. Guinea-Bissau registered its first COVID-19 case on March 24, 2020, and as of December 7, 2021 there were 6,444 confirmed cases and 149 deaths (see Annex 2 for more information). Following the first case detection, the country experienced a significant increase in the number of daily cases, which peaked in the second week of May 2020 (first wave) and the first week of February 2021 (second wave). Similarly, to other neighboring countries, Guinea-Bissau experienced a third wave in July-August 2021 due to the delta variant. Confirmed cases doubled in July-August 2021 compared to the number of confirmed cases throughout the first year of the pandemic (the country registered 27 percent of all cumulative confirmed cases in this period). There is a potential fourth wave, due to the Omicron variant. However, confirmed cases have remained steady as of December 7, 2021. Guinea-Bissau is ranked 14th out of 15 in the highest number of cases and highest number of deaths due to COVID-19 in West Africa. 6. The COVID-19 Vaccination campaign started on April 2, 2021 with priority groups as planned in the National Deployment and Vaccination Plan (NDVP). As of December 7, 2021, 388,626 doses were administered, with 12.5 percent of the total population fully vaccinated, and 35 percent of the eligible targeted population (18 years of age and older) fully vaccinated. Guinea-Bissau has surpassed their objective of 20 percent of the target population fully vaccinated before the end of CY21. In terms of Adverse Events Following Immunization (AEFIs), the country has registered 532 moderate AEFI cases, five severe AEFI cases, and four deaths are being investigated to determine if it is due to COVID-19 vaccinations. The main challenges with the COVID-19 vaccination campaigns include (see Annex 2 for additional information): (i) low turnout for COVID-19 vaccinations; (ii) weaknesses in communication and community sensitization which have also led to low turnout due to the lack of information on safety and 2The Government of Guinea-Bissau entered into an agreement with COVAX on December 7, 2020 to receive vaccines for up to 20 percent of the population through the COVAX Facility. Page 9 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) efficacy; (iii) the short shelf-life of the vaccines received through COVAX, including the bilateral donations, which has in some cases led to vaccine waste due to low vaccination turnout; (iv) vaccine storage challenges and cold chain capacity at central and regional levels stopped the country from accepting new vaccine donations in October 2021; (v) active surveillance to detect and report AEFIs needs to be strengthened; (vi) the coordination challenges between the various agencies and partners hampering COVID-19 vaccination efforts; and (vii) a national strike of healthcare workers in the public sector that impacted the availability of health professionals as of the end of October 2021. Moreover, as the country increases its vaccine coverage, more emphasis will have to be made on vaccination of adolescents (12-17 years of age), which represent approximately 19.6 percent of the national target. 7. To address some of these challenges, the Government instituted/implemented the following changes: (i) to address the vaccine hesitancy, (a) the Government has opened eligibility to all persons over 18 years of age since the first campaign (April 2021); (b) implemented vaccination campaigns rather than focusing only on fixed health facilities; (c) recently required vaccination (from November 2021) for the use of public transport, entry into schools and universities and travel between regions or a valid negative Polymerase Chain Reaction (PCR) test within the last 15 days3; and (d) intensified communication for vaccination throughout the country; (ii) to solve storage challenges, (a) the Government asked the Central Drug Purchasing Office (CECOME-Central das Compras de Medicamentos) to store some of the Sinopharm vaccines that take up a lot of space (one vial = one dose); (b) vaccination campaigns have been accelerated, such as the last vaccination campaign (October-November 2021) which was successful and freed up space; (c) additional refrigerators and freezers have also arrived in the country to allow for more central storage, including for vaccines that require ultra-cold storage; (iv) to address coordination issues, the Office of the High Commissioner for COVID-19 and the Ministry of Public Health (Ministério da Saúde Pública, MINSAP) are meeting more regularly to ensure better planning and deployment of COVID-19 vaccines; and (v) to address the health care providers' strike and its impact on vaccine deployment , the Government will continue to deploy temporary vaccination teams during vaccination campaigns and to use the Military Health Services as vaccination sites (opening of seven additional vaccination sites managed by the Military Health Services). The Government is also preparing a specific strategy to ensure the vaccination of adolescents (12-17 years old). The NDVP, which was revised in November 2021 (to be validated in end of December 2021), provides additional details regarding the planned strategy for adolescents. B. Consistency with the Country Partnership Framework (CPF) 8. This AF is consistent with the Guinea-Bissau CPF FY18-23 (Report No. 114816-GW), which proposes a selective program under Focus Areas 2, Objective 5: Increase access to quality health services for COVID-19 and maternal and child health. This includes improving health outcomes, through improved access to quality care and increased accountability within the public health system and strengthening information systems for disease surveillance and rapid response to disease outbreaks. This is a priority to help improve productivity, especially among the poorest, and to build the human capital of the next 3The decree states that as of November 10, partially vaccinated populations (one of two doses) or those with a valid negative PCR test within the last 15 days will be able to access public transportation, schools/universities, and travel between regions. As of January 10, 2022, populations will need to be fully vaccinated (two doses) or have a valid negative PCR test within the last 15 days to access these same locations. Page 10 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) generation. The AF, like the parent project, is also aligned with both global health priorities and IBRD/IDA priorities on improving pandemic preparedness. C. Project Design and Scope 9. The Project Development Objective (PDO) of the parent project and this AF is to prevent, detect and respond to the threat posed by COVID-19 and strengthen national systems for public health preparedness in Guinea-Bissau. The parent project is strengthening the capacity of the Guinea-Bissau Government, and more specifically, the Office of the High Commissioner of COVID-19 and MINSAP to acquire and distribute COVID-19 vaccines across the country. This includes improvements in coordination, surveillance, and response and timely information sharing with the public. The parent project has two components as follows: (a) Emergency COVID-19 Response and (b) Project Management and Monitoring and Evaluation (M&E) (refer to parent project4 for additional details). 10. The Office of the High Commissioner for COVID-19 will remain the implementing agency for the project. The Office of the High Commissioner for COVID-19 will be responsible for the overall coordination, oversight and technical implementation of the project. The Regional Disease Surveillance Systems Enhancement (REDISSE) II Project (P159040) Project Implementation Unit (PIU), which was established in 2017 within the MINSAP, will report directly to the Office of the High Commissioner for COVID-19 and will be responsible for the day‐to‐day project management, including fiduciary management (procurement and Financial Management [FM]). The Immunization and Epidemiological Surveillance Service (SIVE, Serviço Imunização Vigilância Epidemiológica) coordinated by the MINSAP is responsible for COVID-19 vaccinations and deployment, including the quantification and forecasting of supply needs. D. Project Performance 11. The parent project’s progress towards achieving the PDO was rated Satisfactory in the last Implementation Status and Results Report (ISR) of October 5, 2021. The project has recently become effective (October 20, 2021) and therefore, there is no disbursement at this time under the project. Implementation progress is expected in the next few months as the PIU works to meet the legal covenants under the project. 12. The PIU has been effectively coordinating project planning and procurement. Although the project only recently became effective, the PIU has prepared, finalized, and disclosed the Environmental and Social Framework (ESF) Instruments that were required.5 A medical waste management assessment during the COVID-19 vaccination campaigns is being prepared by the PIU, which will also help to inform the revised ESF instruments. Moreover, a written notice was provided by the GoGB dated December 9, 2021, informing the World Bank that the Director of Military Health Services of the Armed Forces is a member of the Technical Working Group on COVID-19 Vaccinations as of August 12, 2021 (Office of the High Commissioner for COVID-19 Decree no. 04/ACCOVID 19/2021). Therefore, updates are expected in the ESF instruments and measures will be included in the Project Operational Manual (POM) that will be 4 https://projects.worldbank.org/en/projects-operations/project-detail/P176721 5 The following ESF Instruments were disclosed by the Recipient on October 20, 2021: Environmental and Social Commitment Plan (ESCP) and an Environmental and Social Management Framework (ESMF) including a Sexual Exploitation and Abuse/ Sexual Harassment (SEA/SH) Action Plan and Labor Management Procedures (LMP). The Stakeholder Engagement Plan (SEP) was disclosed by the Recipient on October 19, 2021. Page 11 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) prepared for the project and adopted no later than one month after this AF effectiveness. There are several positions within the PIU that need to be filled: (i) recruitment of the accountant has been finalized and the person took office of June 8, 2021 and the (ii) recruitment of the Administrative and FM Specialist, M&E Specialist, Social Specialist, Internal and External Auditors, and Third Party Monitoring (TPM) firm are in progress. The Terms of References (ToR) for the recruitment of a firm to prepare the Administrative and FM Manual as well as the POM have been validated by the World Bank and recruitment is ongoing. The Annual Work Plan and Budget is in progress and will be updated to reflect the AF to be submitted to the World Bank for no-objection by January 31, 2022. The accounting software has been updated, but will be further updated for the AF no later than one month after AF effectiveness. E. Rationale for Additional Financing 13. Guinea-Bissau’s health system faces severe shortcomings to adequately respond to a pandemic on the scale of the COVID-19, which makes access to COVID-19 vaccines even more critical. The country’s capacity for detection and reporting (which encompasses laboratory systems, real-time surveillance and reporting, the epidemiological workforce, and data integration across human/animal/environmental health sectors) is considered among the least prepared as per the Global Health Security Index (with a score of 23.4 vs average of 41.9, and a ranking of 145).6 The Joint External Evaluation (JEE) of the implementation of International Health Regulations (IHR) (2005) completed in July 2019 found very low capacity in a number of areas, including: (i) legal framework; (ii) financing; (iii) coordination; (iv) biosafety and biosecurity; (v) the national laboratory system; (vi) points of entry; (vii) emergency preparedness and coordination; and (viii) emergency medical teams. In the absence of health system’s capacity to detect, prevent the spread, and respond to a pandemic such as COVID-19, widespread access to vaccines becomes even more paramount for the country’s recovery. 14. The proposed AF will play a critical role in increasing access to affordable vaccines in Guinea-Bissau. The additional vaccines that will be procured through this financing will enable the country to increase its vaccination coverage of the total population by 15.86 percent. Moreover, the vaccines that will be purchased are one-dose regimens (J&J), which will enable an increase in fully vaccinated people, particularly in hard-to-reach areas that are difficult for follow-up with patients. The financing for the parent project will ensure that some of the COVID-19 vaccines that will be procured are WHO-approved for adolescents (12-17 years of age). COVID-19 vaccination is essential to protecting lives and enabling the country to reopen safely. The global economy will not recover fully until people feel they can live, socialize, work, and travel with confidence. Given the importance of limiting the spread of COVID-19 to both health and economic recovery, providing access to COVID-19 vaccines will be critical to accelerate economic and social recovery. 15. The proposed project will be implemented in close coordination with other DPs in Guinea-Bissau, as elaborated in Box 1. The project will support Guinea-Bissau to effectively roll out its COVID-19 vaccination strategy as defined in the NDVP. 6 https://www.ghsindex.org/wp-content/uploads/2019/10/2019-Global-Health-Security-Index.pdf Page 12 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Box 1: Ongoing Supportive Roles for Partner Agencies in Implementation WHO Roles Financing amount (US$) - Provide technical assistance to the SIVE of the MINSAP and the Office of the High Commissioner Unknown for COVID-19 in developing the COVID-19 deployment and vaccination plans, including the quantification, and forecasting of supply needs (vaccines and immunization-related supplies; • - Provide technical leadership to support vaccine introduction, implementation of vaccine deployment, M&E base on the global and regional WHO guidance; • - Provide technical support and guidance on the existing assessment and, pending resources for immunization, health systems to prepare the National Plan for deployment for Introduction of COVID-19 vaccine; • - Provide technical support in preparing appropriate regulatory pharmacovigilance authorities for vaccine licensing and emergency authorization for use in the national vaccination program; and - Provide technical support to strengthen COVID-19 surveillance, as well as for supervision and management. UNICEF Roles - Provide technical assistance to the SIVE of the MINSAP and to the Office of the High Commissioner Unknown of COVID-19 in developing the COVID-19 deployment and vaccination plans, regarding the logistics cold chain supply; - Undertake procurement actions to manage the purchasing and import procedures of the vaccines and related ancillary material; - Provide technical support to the Health Emergency Operation Center (Centro Operações Emergências em Saúde- COES), the MINSAP, and to the Office of the High Commissioner for COVID- 19 to develop a communication/demand generation and communication strategy (includes advocacy, communications, social mobilization, risk and safety communication, community engagement, and training) to generate confidence, acceptance and demand for COVID-19 vaccines; - Support supervision and verification of the COVID-19 vaccination deployment, in close collaboration with the WHO. GAVI/COVAX’s Roles - - Provide COVID-19 vaccines for the first 20 percent of the population7; • Vaccines for 20 - - Provide technical assistance related to the development of the CPVID-19 NDVP; and percent of the - - Provide support to expand cold chain. population (including freight costs) = US$5,510,400 • Technical Assistance = US$371,993 • Cold Chain: US$80,000 AU/AVAT’s Role • - The AVAT convened by the AU negotiated, through UNICEF, additional access to vaccines that would • 300,000 vaccine doses contribute to taking the total population covered up to 60 percent in countries that request for it. (costs covered through this AF – IDA grant) 16. This project is being proposed at a critical juncture in the GoGB’s response to COVID-19. A critically important change in the state of science since the early stages of the pandemic has been the emergence of new therapies and the successful development and expanding production of COVID-19 vaccines (see Annex 1 for status). A key rationale for the project is to provide upfront financing for safe and effective vaccine acquisition and deployment in Guinea-Bissau thus enabling the country to acquire the vaccine at the earliest, recognizing that there is currently excess demand for vaccines from both high- income and lower-income countries. 7 The current aspiration is for COVAX donor-funded doses to reach 20 percent of AMC Participants’ populations, depending on, e.g., vaccine development success, dose price, vaccine characteristics, and available resources. Page 13 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) 17. The proposed AF will form part of an expanded health response to the pandemic. The activities will build on COVID-19 MPA-Program Guinea-Bissau Vaccine Project (US$5 million - P176721), as well as on the World Bank’s existing health portfolio in the country, which also includes US$6.5 million from the REDISSE Phase II - (P159040). F. National Capacity and COVID-19 Vaccination Plan (i) Vaccine Readiness Assessment 18. Guinea-Bissau has completed the implementation of the readiness assessment based on the Vaccine Readiness Assessment Framework (VRAF) in tandem with the Vaccine Introduction Readiness Tool (VIRAT). This work is the result of a coordinated effort led by the SIVE of the MINSAP and the Office of the High Commissioner for COVID-19 with the close support from technical officers and consultants from the World Bank, the WHO and the UNICEF, in close collaboration with COES focal points (see Table 1 for a summary on the findings of the VIRAT/VRAF assessment). The country has completed and finalized most of the preparedness steps for the introduction and roll out of the COVID-19 vaccines. Critical areas that have been finalized include: (i) the identification of high risk and vulnerable categories; (ii) gap analysis of delivery and storage capacity at the eleven health regions, including Bijagos archipelago; (iii) delivery strategy plans for program roll-out; (iv) social mobilization and communication plan; (v) quantification of needs related to cold chain supply and ancillary supplies (syringes, safety boxes); and (v) AEFI active surveillance plan. Overall, the VIRAT/ VRAF have been instrumental in supporting the country in assessing their state of readiness as well as defining the roadmap to design the COVID-19 NDVP. Page 14 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Table 1: Summary of Vaccination Readiness Findings from the VIRAT/VRAF 2.0 Assessment8 Readiness Readiness of Government Key Gaps to Address Before Domain Deployment Planning and The Office of the High Commissioner for COVID-19 has been established by a Presidential Decree (n. A draft of the NDVP 2.0 has been Coordination 19/2020) issued on June 5th, 2020. The Office of the High Commissioner’s mission is to coordinate elaborated and will be submitted to the national response to COVID-19, with the goal to reduce the health, social and economic impact CCIA by the end of December 2021 for of the pandemic in Guinea Bissau. validation and approval. This is expected to include more emphasis on A permanent Working Group has been established by a Decree issued by the Office of the High plans for vaccination plans/strategy for Commissioner for COVID-19 on December 10, 2020. This Technical Committee is in charge of all adolescents. technical aspects of the process of immunization (including the elaboration of a NDVP) and is composed of different technical subcommittees, which will include the focal points of the existing pillars of COES: Coordination, Logistics, Clinical Management, Communication, Infection, Prevention and Control. ToRs and composition of the Working Group have been updated and included in an Office of High Commissioner of COVID-19 Decree dated August 10th, 2021, which includes the support of the Military Health Services. The first version of the NDVP has been finalized on February 9, 2021 and adopted by the Committee for Interagency Coordination for Vaccination (Comite’ de Coordenacao Inter Agencia para a Vaccinacao, CCIA) and by Multisectoral Coordination Committee to respond to COVID-19 (Comite de Coordenação Multissectorial resposta a COVID-19-CCMC). The NDVP was updated in March 2021 and it aims to cover 70 percent of the population. For the country to reach 70 percent coverage, adolescents (12-17 years of age) will have to also be vaccinated once vaccines approved by WHO for this group are available in the country. MINSAP SIVE teams at central, regional, and local level deploy the vaccines. At regional and local levels, SIVE focal points assure supervision and coordination, in collaboration with Regional Health Directions (Direção Regional da Saúde, DRS) focal points. SIVE Logistic department is responsible for vaccine transportation from central to regional levels and their storage. Regional Health Directorates 8 A multi-partner effort led by WHO and UNICEF developed the Vaccine Introduction Readiness Assessment Tool (VIRAT) to support countries in developing a roadmap to prepare for vaccine introduction and identify gaps to inform areas for potential support. Building upon the VIRAT, the World Bank developed the Vaccine Readiness Assessment Framework (VRAF) to help countries obtain granular information on gaps and associated costs and program financial resources for deployment of vaccines. To minimize burden and duplication, in November 2020, the VIRAT and VRAF tools were consolidated into one comprehensive framework, called VIRAT-VRAF 2.0. Page 15 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Readiness Readiness of Government Key Gaps to Address Before Domain Deployment are responsible for the transportation of the vaccines and of the ancillary materials to Health Areas. At the Health Area level, Health Area Focal Point (Responsáveis Área Sanitária, RAS) coordinate and supervise immunization operations. SIVE logistic team is also responsible for the cold chain, in collaboration with Regional SIVE focal points. In November 2021, the GoGB has also signed a decree that makes it mandatory to be vaccinated to use public transportation, to enter schools/universities and to travel across regions (November 10, 2021 - January 9, 2022, partially vaccinated [one of two doses] and from January 10, 2022, fully vaccinated [two of two doses/ one of one dose]). People would need to present their vaccination card before participating in any of these activities. If the person is not vaccinated, they must present a valid negative PCR test within the last 15 days. This decree was created to increase vaccination coverage as it continued to remain low. The October 25-November 9, 2021 vaccination campaign benefitted from this decree with the country being able to reach 20 percent of its targeted population. Budgeting The full costing of the NDVP has been finalized by the Working Group appointed by the Office of the n/a High Commissioner for COVID-19 and approved/validated by the CCIA and the “Comite Multisectorial de Coordenação da Resposta a COVID-19” on Feb 9th, 2021. The costing exercise estimated the financial resources needed to carry out the vaccination campaign in terms of equipment and logistics (vaccines and ancillary products, waste management) cold chain needs, trainings and central, regional and local level, active surveillance of AEFIs, social mobilization and communication, operational costs of the campaign, including micro-planification and beneficiaries census operations. The budget is taking into consideration the different phases of the vaccine administration process and the different costs of the supply cold chain according to the storage temperature of three vaccine candidates. NDVP 2.0 has been costed with the assistance of a WHO consultant in October 2021. The document will be submitted to the CCIA for validation and approval by the end of December 2021. Regulatory Vaccines and therapeutics are regulated in Guinea-Bissau by the Legal Regime of Pharmaceutical n/a Activities (Regime Juridico das Atividades Farmaceuticas - Boletim Oficial 26 Agosto 2010). Any regulation and guidelines regarding the introduction of COVID-19 vaccine needs to be in accordance with this framework. Page 16 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Readiness Readiness of Government Key Gaps to Address Before Domain Deployment The C.I. (Comissão Instaladora) of Regulatory Authority Pharmacy, Laboratory, Medicinal and other Health Products (Autoridade Reguladora Farmácia, Laboratório, Medicamentos e outros Produtos de Saúde, CI-ARFAME) has been established in July 2017 by the Government. MINSAP Decree n. 11 dated March 4th, 2021 enabled CI-ARFAME to issue special import authorization for vaccines which received WHO pre-qualification. On March 8th, 2021, UNICEF officially asked CI-ARFAME for a special import authorization regarding the vaccine selected by the country and provided by COVAX Advance Market Commitment (AMC) (AstraZeneca, manufactured by Serum Institute of India -SII). An Indemnification Agreement between the country and the AZ manufacturer has been signed on March 4th, 2021 and Special import authorization was issued by CI-ARFAME on March 9th, 2021. Decree n. 11 has been utilized to issue special import authorizations to all other vaccines at present available in Guinea Bissau (Sinopharm, J&J). Prioritization, Vaccination Targets - Programmatic objectives have been defined by the working group led by the n/a targeting, Office of the High Commissioner for COVID-19 and the SIVE/MINSAP teams, with the participation surveillance of the main stakeholders at central and sub-national levels. As specified in the NDVP, the GoGB aims to cover 70 percent of its population. The NDVP has two phases: (i) Phase 1 has two target groups: Phase 1.A, where the objective was to vaccinate 3 percent of the high priority target group, which includes health workers (including community health workers – CHWs) and people with co-morbidities (such as HIV, tuberculosis, diabetes, acute respiratory diseases, hypertension, cardiovascular diseases, kidney chronic diseases); (ii) Phase 1.B, aimed to cover up to 17 percent of the population, which include: people over 50 years of age, education sector workers (teachers and support staff), traditional healers, army and army veterans, police and National Guard members, firefighters, prisoners, customs and entry points personnel, civil aviation personnel and other vulnerable groups; and (iii) Phase 2, aims to cover the remaining 50 percent of the population, which would include adolescents (12-17 years of age) once WHO- approved vaccines are available for this group in the country. These categories have been identified following the recommendations of WHO Strategic Advisory Group of Experts on Immunization (SAGE) group and Guinea-Bissau specific priorities. Page 17 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Readiness Readiness of Government Key Gaps to Address Before Domain Deployment However, it is important to note that due to low turnout at COVID-19 vaccination campaigns, the GoGB opened up access to COVID-19 vaccines to all eligible persons (18 years and over) since the first vaccination campaign in April 2021. The GoGB continues communication to increase vaccination coverage among priority groups as noted in the NDVP. Service Points of delivery – Guinea-Bissau has a relatively good vaccination coverage of the population n/a delivery with the existing health care providers of the country. Vaccination operations are being carried out using primarily fixed points (national and regional hospitals, health centers, private and religious health care providers). Advanced and mobile strategies are also used to reach out to beneficiaries living at a distance of more than 5 km (advanced) and 15 km (mobile) from the nearest health structure and who cannot reach the fixed points and frontline workers (like entry points). The Government has opened seven additional vaccination centers, managed by the military health services for better vaccination site coverage. The strategy is built on previous experience of SIVE in the immunization campaigns in the country. Vaccination started in Autonomous Region of Bissau (Setor Autonomo Bissau, SAB) in April 2021, followed by Bafata and Biombo Health Regions. The operations were extended to the other eight Health Regions of the country in August 2021, including the islands (Bijagos and Bolama Health Regions). Moreover, starting from August 2021, vaccination centers managed by Military Health Services in Bissau’s urban area and in Biombo Health Regions (Safim) are operational on a daily basis. These vaccination centers are located strategically in crowded areas, like markets and high circulation spots. During the general strike of public function in October 2021, to cope with the lack of health technicians available, 47 teams composed by Medicine Faculty students and students that graduated recently were trained and deployed in Bissau urban area for a few days to speed up the vaccination campaign. The teams also included 40 medical doctors from the Cuban Brigade and nurses and additional support was provided by the Red Cross. The vaccination campaign is being implemented following the usual SIVE procedures and guidelines. Vaccination teams. Each team is composed of five persons: two vaccinators (a nurse assistant, Page 18 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Readiness Readiness of Government Key Gaps to Address Before Domain Deployment nurse, and/or medical doctor), two data assistants in charge of inserting beneficiary information in registration tools (one is filling paper tools, the other is using ODK software), and a volunteer (those preparing the logistics for the vaccination at health centers, such as organizing queues). At the national level, 713 vaccination teams are operational: • 213 using the fixed strategy • 303 using the “Advanced strategy” • 196 using the “Mobile strategy” Training and Training has been carried out at all levels: central, regional, and local level. Each vaccination team Total persons to be trained: supervision is composed of two vaccinators (a nurse assistant, nurse, and/or medical doctor), one volunteer, n. 1,.424 health technicians as and two data assistants. Technicians in charge of inserting beneficiary information in the vaccinators registration tools (on paper and electronic format using tablets). Training of vaccination teams has n. 712 volunteers started in the capital Bissau (SAB) on March 29th, 2021. In May 2021, training of the teams in n. 712 data assistants for the Bafata and Biombo health regions has been carried out. registration of individual data in paper format The remaining eight Health Regions technicians were trained starting from August 2021. As noted n. 712 data assistants for the above, to deal with the general strike of healthcare workers, medical students and recent registration of individual data in graduates were also trained to support the October 2021 vaccination campaign. electronic format (ODK), using tablets. Data managers charged with the insertion of individual data in District Health Information System Trainings about data management in Software 2 (DHIS 2) platform were also trained in every Health Region. software platforms (ODK and DHIS2) using tablets will be completed in Supervision operations are carried out at three levels: December 2021, as the country does 1. Central level (SIVE/MINSAP) not have 712 tablets available. 2. Regional level (DRS Directors and DRS vaccination focal points) Smartphones will be used instead. 3. Local level (Health Area supervisors) Supervision teams are reinforced by technical assistants contracted by the main financial and technical partners of the country for the vaccination campaign (WHO, UNICEF, World Bank). Page 19 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Readiness Readiness of Government Key Gaps to Address Before Domain Deployment Monitoring and Data quality – For the tracking and monitoring system for the deployment of the COVID-19 n/a evaluation vaccine, the country has an electronic logistics and supply management tool (SMT) which has appropriately been tracking the activities of the routine immunization program. The country is using the DHIS2 platform, which is widely used in the African continent, for data registration and monitoring of beneficiaries. Infrastructure – At the central and local levels, all health facilities are equipped with means of n/a communication (mobile phones and tablets). The energy supply is constant and uninterrupted through solar panels. Performance management and M&E - Management and M&E tools were elaborated by the n/a Working Group. Data registration is carried out in three steps: 1. Data about COVID-19 vaccination campaign are collected on paper format by vaccination teams daily. 2. Data are inserted in ODK and DHIS2 software at the regional level. 3. Database manager and its team at central level (SIVE/PAV) proceed with the consolidation of the data coming from the regional level and to their analysis. The digital vaccine card is operational since the week of November 1, 2021 with a QR code, which ensures authenticity. Vaccine, cold Logistics and cold chain – The immunization supply chain is following the usual SIVE/PAV circuit: Given the existing infrastructure, chain, logistics, • Entry point in Bissau national airport and storage at central level in SIVE/PAV premises, considerable logistical challenges to infrastructure • Transportation to Bissau urban area hospitals and health centers identified as fixed reach remote areas are expected, which vaccination posts; some of the costs will be covered via • Transportation to Regional level and storage; and the parent project and expected by June • Transportation to local level. 2022. Logistic plans started from local level (health areas) using Micro-plans, drafted by RAS according to Cold chain identified gaps include: the location of the target groups identified. -n. 1 mixed refrigerated truck (includes ancillary materials and vaccines); An assessment of the needs in terms of equipment necessary for transportation of vaccines and -n. 8 Solar fridges “mix SDD” must be auxiliary material has been made and information is provided in the framework of the logistics installed to properly equip eight new plan. health centers; -n.10 standard electrical Refrigerators UNICEF has purchased six freezers for the storage of COVID-19 messenger RNA vaccines (mRNA) (10 Regional health directorates); Page 20 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Readiness Readiness of Government Key Gaps to Address Before Domain Deployment such as Moderna or Pfizer (these vaccines are not available in the country at this time, but are -n. 10 Freezers (10 DRSs), including expected to be purchased or donated in the coming months). This cold chain equipment will not be ultra-cold freezers; sufficient, but World Bank financing in the parent project can finance additional cold chain -n. 100 isothermal boxes (health equipment. centers). The transportation gaps identified are: - Vehicle purchase (eight motorbikes and one speedboat) for vaccine and medical equipment transportation. The gap in equipment/supplies will be financed by the World Bank (parent project) and other partners (Global Alliance for Vaccines and Immunizations - GAVI). After finalization with GAVI regarding cold chain supplies and equipment needs, the Government will inform the World Bank of the remaining needs. Vaccines, Personal Protective Equipment (PPE) and other medical and non-medical supplies – n/a Guinea-Bissau, an AMC 92 eligible country, is using COVAX as one of the main mechanisms for acquiring vaccines. COVAX mechanism, through the AMC and the dose-sharing mechanism, contributed to vaccine donations to reach approximately 20 percent of the estimated total population. GAVI is covering costs of some ancillary supplies such as needles and cold boxes and transport to the country’s international airport and a part of the cold supply chain needs (US$80,000). Procurement and delivery of the vaccine will be undertaken by the UNICEF Supply Division. On top of COVAX mechanism, the country has also received doses from bilateral donors and other international institutions. Doses of vaccines received so far: • COVAX AMC: 57,600 (Astrazeneca) • AU/MTN: 12,000 (Astrazeneca) • Bilateral Portugal: 100,000 (Astrazeneca) Page 21 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Readiness Readiness of Government Key Gaps to Address Before Domain Deployment • Bilateral Senegal: 4,000 (Astrazeneca) + 6,070 (Sinopharm) • Bilateral People’s Republic of China: 300,000 (Sinopharm) • Bilateral USA: 302,400 (Janssen) • Total doses received so far: 782,070 Waste management – The most used approach, at central, regional, and local levels, is the “bury No national guidelines regarding and burn” approach. At present only two incinerators are fully operational (in Clininca Madrugada vaccination waste management are in (Bissau) and Cumura Hospital (Biombo Health Region). The incinerators in SIVE premises (Bissau), place in Guinea Bissau. A national plan Buba (Quinara Region, south), and Bafata (Bafata Region, east) are not operational due to lack of was supposed to be elaborated in 2020 protection and septic tank. but COVID-19 emergency did not allow the arrival of the international A waste management plan is included in the NDVP but it is not operationalized yet. consultant identified to carry out the task. Actions to be undertaken with urgency are the following: • Finalize an Addendum to the Agreement between Clinica Madrugada in Bissau and AC COVID-19 for the utilization of the incinerator to start up the COVID-19 vaccination waste management process (by end December 2021) • Mobilization of financial resources to rehabilitate/operationalize the three incinerators already installed in SIVE (Bissau), Buba and Bafata (by end December 2021) • Operationalization of CECOME incinerators in three de Agosto Page 22 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Readiness Readiness of Government Key Gaps to Address Before Domain Deployment premises (training of CECOME technicians by UNDP recruited international consultant) (by end December 2021) • Installation of the new eight incinerators in the Health Regions purchased with World Bank REDISSE II funds by June 2022. The installation will be covered under the parent project (Q1-2 2022) Following the rehabilitation and operationalization of the existing incinerators and the installation of the new eight incinerators, each Health Regions should be able to manage and treat their waste production properly. Safety Vaccine safety surveillance – The country has documented guidelines for the management of AEFI. At present the country does not have Surveillance AEFI Active surveillance activities are carried out regularly during vaccination campaigns by health legal procedures which compels drugs technicians. A plan of management and follow up of COVID-19 vaccine pharmacovigilance has and vaccine manufacturers to draft risk been elaborated in the framework of the NDVP. management plans and to submit it to the National Regulation Authority (C.I. Tools for the management and the follow up of AEFI of routine and vaccination campaigns have ARFAME). A draft of these procedures been developed and are utilized by health technicians. exists but it must be promulgated by a Presidential Decree. Ad hoc monitoring tools have been elaborated. Ad hoc trainings about COVID-19 vaccines that result in AEFI has been carried out at central and regional level Relevant Legislation needs to be drafted and approved by the National Assembly A Committee for AEFI Management (Comité de Farmacovigilancia) has been established at central and the Government. There is no level in Bissau and is operational in active surveillance activities during and after every vaccination timeline available at this time. round. Page 23 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Readiness Readiness of Government Key Gaps to Address Before Domain Deployment A committee for the investigation of suspected deaths of COVID-19 is established at central level and is composed of 10 experts (all physicians). At Regional level, an AEFI Commission is operational and is composed of three members: one from DRS, one from a Regional Lab, and one from a Regional Hospital. At the local level, a focal point (health technician) has been identified and is active in every Health Area. Currently, the following AEFIs have been registered in the country: • moderate AEFIs: 532 • severe AEFIs: 5 • deaths under investigation: 4 Demand Community engagement and advocacy – Guinea Bissau has a Strategic Communication Plan An assessment is needed on the low generation and (2017-2020) for routine vaccinations and for vaccination campaigns. This plan has been elaborated turnout of young women for COVID-19 communication with the technical support of WHO, UNICEF, National Institute of Public Health (Instituto Nacional vaccinations. There seems to be some de Saúde, and the State Secretariat for Communication (Secretaria de Estado da Comunicação). misinformation on the COVID-19 This plan foresees the involvement of different stakeholders at the local level: traditional, vaccines impact fertility and therefore, administrative, and religious authorities, local and international NGOs, and community health women who have not birthed a child agents. seem to be less likely to seek out the COVID-19 vaccine. This assessment will A specific Communication/Mobilization plan has been drafted in the framework of the National be conducted by WHO and UNICEF in Immunization Plan for COVID-19 vaccine. It’s involving local, traditional, and religious authorities, the coming months. local CBOs/NGOs, associations, groups of young people, students, women, and local residents. Community Health Agents are playing a key role in sensitization activities at community level. A communication plan for the vaccination of adolescents will be The communication plan includes actions to tackle rumors and local misinformation about the critical once WHO-approved vaccines vaccination campaign, dealing with cultural and traditional patterns especially in rural areas. for this group are in the country. As of April 2021, community mobilization plan and sensitization activities have been carried out at Portugal will continue to support the central level (SAB), involving all main stakeholders previously mentioned. country in developing a better strategy to increase vaccination rates among Community mobilization efforts have been extended to Bafata and Biombo Health Regions in May women. 2021 to help create demand before rolling out the second round of the vaccination campaign Page 24 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Readiness Readiness of Government Key Gaps to Address Before Domain Deployment which started on May 22, 2021 in these two Health Regions. The main Regional administrative and traditional authorities have been directly involved to help address vaccine hesitancy issues. After the first round of vaccination campaign, carried out from April 2-10, 2021 in SAB, the Communication Committee has been reinforced with an international consultant contracted by UNICEF and drafted a new Action plan which is addressing the weaknesses identified. A new strategy based on segmentation of information by target group has been elaborated in order to address vaccine hesitancy in Guinea-Bissau, as a low turnout has been registered in urban areas. Community sensitization activities and the involvement of the main regional and local administrative and traditional authorities has been carried out starting from August 2021, when the vaccination campaign has been extended to the other eight Health Regions of the country, including the remote areas (islands, remote and scarcely inhabited east and south areas). A rapid diagnostic, formative and qualitative research about behaviors on COVID-19 vaccination has been carried out during October 2021 in four Health Regions (SAB, Gabu, Cacheu, Tombali) to analyze the main constraints and cultural patterns impacting the vaccination turnout and to shape the communication and sensitization activities accordingly. To address vaccine hesitancy, all the Government Ministries have been personally mobilized in October 2021 during the massive national vaccination campaign (October 25th – November 9th). As in many neighboring countries, the proportion of women getting vaccinated compared to men is lower. As of November 7, 2021, 41 percent of vaccines administered were to women compared to 59 percent to men. This has slightly increased from October 25, 2021 (only 35 percent of vaccines administer were to women). This increase seen in vaccination coverage is due to some of the mandatory vaccination policies the GoGB has put in place (i.e., public transport, schools/universities, and travel across regions). Communication activities have also been strengthened targeting priority groups, particularly women. This also included ensuring vaccination centers were located closer to where women work (i.e., markets, etc). Page 25 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) (ii) National Deployment and Vaccination Plan (NDVP) 19. Guinea-Bissau finalized its first version of the COVID-19 NDVP on February 9th, 2021, which draws on the findings of the VRAF/VRAT 2.0 assessment and gap analysis. Guinea-Bissau’s vaccine strategy is to have 70 percent of the population fully vaccinated by the end of CY2023 (12 years of age and older). The Office of the High Commissioner for COVID-19 established a Working Group in December 2020, which is working as the National Immunization Technical Advisory Group (NITAG). Within such coordination mechanism, several sub-committees have been established: these sub-committees focus on: (i) identification of target groups; (ii) logistics, including vaccine cold chain, equipment and waste management; (iii) social mobilization and communication activities to enhance the population demand; (iv) training of technical staff; (v) pharmacovigilance activities, including active surveillance of AEFIs; (vi) coordination; (vii) M&E activities; and (viii) supervision. Guinea-Bissau surpassed its objective of 20 percent of the target population fully vaccinated by the end of CY21. A progressive and stepwise increase of coverage for another 50 percent of the population to reach 70 percent coverage in the following years will be possible if the country manages to get the WHO-approved vaccines for adolescents (12-17 years of age). As of November 15, 2021, the country has received a total of 782,070 doses including 173,600 of AstraZeneca, 306,070 of Sinopharm and 302,400 of J&J. These vaccine doses were received from COVAX, AU/AVAT, and bilateral partners (Senegal, People’s Republic of China, Portugal, and United States of America). 20. A mixed vaccination strategy is being adopted for vaccine deployment. There is fixed, mobile and advanced mobile units, as follows: (i) fixed strategy: vaccination centers identified in the premises of the health care providers of the country (national and regional hospitals, health centers type A, B, and C); and (ii) advanced and mobile strategies to reach out beneficiaries living at a distance of more than 5 km (“Advanced”) and 15 km (“mobile”) from the nearest health structure and who cannot reach the fixed points and frontline workers (like entry points). The strategy is being built on previous experience of SIVE in the immunization campaigns in the country. Page 26 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Table 2: National Vaccine Coverage and Acquisition Plan As of November 15, 2021 World Estimated Bank’s Number total cost to Population Targeted VAC Vaccines already arrived in Source of Vaccines of doses Government Contract status (n. 1,891,690) Status of the country financing needed (US$ the (IBRD, IDA, millions) Vaccine TF, Govt, other) Price Shipping % Number Source Name(s) Name Doses (US$/dose) (US$/dose) Stage 1: Phase I – CY2021 – Population 18 years of age and older9 to reach 20 percent of the population First and second allocations VAC received on April COVAX AMC 1.52 28,800 COVAX AMC AZ 0 0.00 2 0.00 AZ 57,600 compliant 13, 2021 (28,800) and August 14, 2021 (28,800) AU and MTN AU and MTN VAC Donation on Group 0.32 6,000 Group AZ 0 0.00 2 0.00 AZ 12,000 compliant March 22, 2021. Limited Limited Government Government VAC Donation on April 0.11 2,000 AZ 0 0.00 2 0.00 AZ 4,000 of Senegal of Senegal compliant 3, 2021. Government Government VAC Donation on April 0.16 3,035 Sinopharm 0 0.00 2 0.00 Sinopharm 6,070 of Senegal of Senegal compliant 3, 2021. Donation on July Government Government VAC 13, 2021 and 2.64 50,000 AZ 0 0.00 2 0.00 AZ 100,000 of Portugal of Portugal compliant September 10, 2021. Donation in People’s People’s VAC August 2021 and Republic of 7.93 150,000 Republic of Sinopharm 0 0.00 2 0.00 Sinopharm 300,000 compliant October 2, 2021. China China (COVAX) 9 The population that is eligible at this time to get vaccinated in Guinea-Bissau are 18 years of age and over. Page 27 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) World Estimated Bank’s Number total cost to Population Targeted VAC Vaccines already arrived in Source of Vaccines of doses Government Contract status (n. 1,891,690) Status of the country financing needed (US$ the (IBRD, IDA, millions) Vaccine TF, Govt, other) Price Shipping % Number Source Name(s) Name Doses (US$/dose) (US$/dose) Government Donation on of the United United States VAC 7.32 138,503 J&J 0 0.00 1 0.00 August 7, 2021. J&J 148,200 States of of America compliant (COVAX) America Stage 1 Total 20.0 378,338 0.00 AZ 618,173 Stage 2/ Phase II – CY22 and CY23 (Population 12 years of age and older10) Government Donation on of the United United States VAC 8.66 163,897 J&J 0 0.00 1 0.00 August 7, 2021. J&J 154,200 States of of America compliant (COVAX) America IDA Grant Request was (parent VAC 15.86 300,000 AVAT J&J 7.5 1.03 1 2.56 submitted to - - project and compliant AVAT. AF) Additional allocations from COVAX AMC 0.69 12,969 COVAX AMC AZ 0.00 0.00 2 0.00 - COVAX AMC are - - expected in CY2022. IDA grant These may be (parent 6.50 123,000 AVAT/COVAX J&J 7.50 1.03 1 1.05 - purchased via - - project) COVAX or AVAT. 10Currently, only adults 18 years of age and older are eligible for COVID-19 vaccines. Once the country received WHO-approved vaccines for adolescents (12-17 years of age), the GoGB plans to open eligibility to this group. Only vaccines that are approved for use for adolescents is Pfizer, which is currently not available in the country. Page 28 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) World Estimated Bank’s Number total cost to Population Targeted VAC Vaccines already arrived in Source of Vaccines of doses Government Contract status (n. 1,891,690) Status of the country financing needed (US$ the (IBRD, IDA, millions) Vaccine TF, Govt, other) Price Shipping % Number Source Name(s) Name Doses (US$/dose) (US$/dose) These may be purchased via COVAX or AVAT. Government/ These vaccines IDA grant will need to be 18.29 379,680 AVAT/COVAX Unknown 7.00 1.03 2 5.56 (parent approved for use project) of adolescents (12 years of age and up). – mRNA vaccines. Stage 2 Total 50.0 945,845 9.16 163,897 National 70.0 1,324,183 9.16 782,070 Total Page 29 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Box 1: Liability and Indemnification Issues in Vaccine Acquisition For all countries - Guinea-Bissau: • The rapid development of vaccines increases manufacturers’ potential liability for adverse effects following immunization. • Manufacturers want to protect themselves from this risk by including immunity from suit and liability clauses, indemnification provisions, and other limitations of liability clauses in their supply contracts. • Contractual provisions and domestic legal frameworks can all operate to allocate that risk among market participants, but no mechanism will eliminate this risk entirely. For COVAX-financed vaccines for AMC countries: • COVAX has negotiated model indemnification provisions with manufacturers for vaccines purchased and supplied under the COVAX AMC. • In providing vaccines through the COVAX AMC, COVAX requests COVAX AMC participants to have in place an indemnity agreement directly with manufacturers, and the necessary indemnity and liability frameworks for that purpose—either in the form of the COVAX model indemnification arrangements or prior bilateral arrangements with manufacturers. • The COVAX facility will have a no-fault compensation scheme for AMC countries as part of its risk mitigation strategy. This will cover vaccines supplied only through COVAX AMC. • Guinea-Bissau will have to consider what it will take to implement these indemnification provisions (including statutory implementation) and how they can avail of the benefits of the no-fault compensation scheme. For vaccines purchased through AVAT: • The Advance Purchase Agreement (“APA”) signed on March 28, 2021 by AVAT, Janssen Pharmaceutica NV (“Janssen”) and the African Export-Import Bank includes indemnification provisions in favor of Janssen for vaccines purchased and supplied under the APA. Participating countries will assume those indemnification obligations upon execution and delivery of a deed of adherence to the APA. • As a condition for the delivery of vaccine doses under the APA, participating countries shall also participate in or establish and adequately fund an NFCS in accordance with certain minimum requirements. Participating countries shall either: (i) participate in the NFCS to be established by AVAT, or (ii) establish and maintain their own NFCS. For the avoidance of doubt, AMC countries will not be able to rely on their participation in the COVAX NFCS to meet the conditions under the Janssen APA. • For vaccines purchased through AVAT, Guinea-Bissau will have to consider how to implement the indemnification provisions and NFCS requirements under the APA with Janssen. For vaccines purchased outside of COVAX AND AVAT: • Guinea-Bissau will need to enter direct indemnification arrangements with manufacturers. • Guinea-Bissau does not currently have legislation in place to provide statutory immunity for manufacturers. Country does not have national no-fault compensation scheme. Page 30 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) • Adoption of any such indemnification provisions or compensation scheme would have to be in accordance with Guinea-Bissau’s own national strategy and framework. Possible World Bank support to Guinea-Bissau, depending on needs, may include information sharing on (i) statutory frameworks in Organization for Economic Co-operation and Development countries and other developing countries; and (ii) overall experience in other countries; provide training and workshops for government officials to familiarize them with the issues. For World Bank-financed contracts, World Bank can provide Hands-on Expanded Implementation Support (HEIS). 21. The project operational manual (POM) will make clear that the country’s regulatory authority is responsible for its own assessment of the project COVID-19 Vaccines’ safety and efficacy and is solely responsible for the authorization and deployment of the vaccines in the country. II. DESCRIPTION OF ADDITIONAL FINANCING A. Proposed Changes 22. The changes proposed for the AF entail expanding the scope of activities in the parent project. As the proposed activities to be funded under the AF for Guinea-Bissau are aligned with the original PDO, the PDO will remain unchanged. 23. The content of the components and the Results Framework of the parent project (Annex 4) are adjusted to reflect the expanded scope under the AF. The implementation arrangements and closing date will remain the same. (i) Proposed New Activities 24. Vaccine purchasing will be done through Component 1 of the Global COVID-19 MPA. The support for vaccines was added as part of the containment and mitigation measures to prevent the spread of COVID-19 and deaths under Component 1: Emergency COVID-19 Response (parent project: US$4.7 million; AF: US$2.2 million). Specifically, Sub-component 1.1: COVID-19 Vaccine Acquisition, Planning and Distribution (parent project: US$2.62 million; AF: US$2.2 million) will receive AF. Guinea-Bissau will use the option for vaccine purchase and financing mechanisms through AVAT. Deployment of these vaccines will be covered under the parent project. This financing will enable the GoGB to complete a purchase of an additional 300,000 J&J vaccine doses, which will increase the coverage of the total population by 15.86 percent. This AF will enable the country to progress towards its 70 percent target coverage in terms of vaccine acquisition. Moreover, this AF will also allow for re-vaccination efforts if they are warranted by peer-reviewed scientific knowledge at the time. In the case that re-vaccination is required, limited priority populations (such as health workers and the elderly) will need to be targeted for re-vaccination given constraints on vaccine production capacity and equity considerations (i.e., tradeoffs between broader population coverage and re-vaccination). Page 31 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Table 3: Priority Groups for Vaccination in Guinea-Bissau Ranking of Priority groups Population % of Population vulnerable estimates groups First Public and private Healthcare workers, including Community 15,690 0.83 Health Agents Population with underlying conditions 41,060 2.17 Sub-total 56,750 3.00 Second Population over the age of 50 166,469 8.8 Police, National Guard, Border control and customs agents, 16,922 0.9 firefighters, and Civil Protection Teachers and school support staff 13,092 0.69 Army (estimation) 40,000 2.11 People working in public and private markets, restaurants, 65,831 3.48 locals, banks Other essential workers 19,230 1.01 Sub-total priority groups 321,544 17.00 Third Population over the age of 12 945,845 50.00 Sub-total 945,845 50.00 Total 1,324,183 70.00 25. The overall budget of this AF will be US$2.2 million equivalent, all allocated to Component 1 for vaccine acquisition (see Table 4 below). Table 5 provides a summary of vaccine sourcing and World Bank financing. Table 4: Project Cost and Financing Parent AF1 Project Parent Project Cost Cost (US$ Project + AF Project Components (US$ million) million) (US$ million) Component 1: Emergency COVID-19 Response 4.7 2.2 6.9 Sub-component 1.1: COVID-19 Vaccine Acquisition, Planning 2.62 2.2 4.82 and Distribution Sub-component 1.2: COVID-19 Vaccine Planning and 2.08 0.0 2.08 Distribution Component 2: Project Management and M&E 0.30 0.0 0.30 Total Costs 5.00 2.2 7.2 Page 32 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Table 5: Summary of COVID-19 Vaccine Sourcing and World Bank Financing Source of vaccine financing and population coverage Doses purchased National plan World Bank-financed Specific vaccines with World Estimated allocation of target (population and sourcing plans Bank finance World Bank financing (US$) %) COVAX Through Through Through Other* (2 doses grant direct COVAX AVAT assumed) purchase COVAX AMC; AU/South Africa Telecom Company; bilateral donations (Senegal and Purchase: US$0.0 Stage 1: 20% 11.49 - - - 8.51 0 People’s Republic Deployment: US$0.0 of China) and bilateral donations via COVAX (USA, Portugal) Parent Project Purchase: US$2.62 million Deployment: US$2.38 COVAX AMC; AVAT; million and Bilateral Stage 2: 50% 9.35 18.29 22.36 - XYZ 1,563,89611 donations from USA AF (COVAX) Purchase: US$2.2 million Deployment: US$0.00 million (ii) Changes in Institutional Arrangements for NDVP Implementation and Oversight 26. The Office of the High Commissioner for COVID-19 will remain the implementing agency of the AF. The High Commissioner will be responsible for the overall coordination, oversight, and technical implementation of the project. The REDISSE II Project (P159040) PIU, which was established in 2017 within the MINSAP, will report directly to the Office of the High Commissioner for COVID-19 and will be responsible for the day‐to‐day project management, including fiduciary management (procurement and FM) and will: (i) coordinate project activities; (ii) ensure the FM of the project activities in all components; and (iii) prepare consolidated annual work plans, budgets, M&E, and the implementation report of the project to be submitted to the World Bank. The SIVE coordinated by the MINSAP is responsible for COVID- 19 vaccinations and deployment, including the quantification and forecasting of supply needs. The project’s Administrative and FM Manual and POM will integrate the AF activities and the roles and responsibilities of the additional actors within one month of effectiveness. (iii) Retroactive Financing 27. Retroactive financing is not anticipated to be used under the proposed AF. 11 300,000 doses of J&J vaccine doses through AVAT using AF1 and part of the parent project financing (doubled to 600,000 since 2-dose regimens are assumed) with the remaining doses purchased/acquired under the parent project. Since the country expects to receive donations from COVAX AMC (18.5 percent), these doses have not been included in this calculation. Page 33 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) (iv) Changes in the disbursement categories 28. The are no changes expected in the disbursement categories. (v) Results Framework 29. To measure overall progress in coverage and deployment of the COVID-19 vaccines, the two PDO indicators are being revised: • Population vaccinated (percentage) [by sex] will be revised to Target population fully vaccinated (percentage) [by sex]. This will enable monitoring of the population that is included in the country’s target coverage. The expectation is that at least 60 percent of the target population will be fully vaccinated (50.4 percent of the total population – adults 18 years old and over). • Population vaccinated, which is included in the priority population targets defined in national plan (percentage) [by sex] will be revised to Population in the priority group fully vaccinated (percentage) [by sex]. This provides clarity to ensure monitoring of the most vulnerable groups. 30. To ensure that services are broadly available to GBV survivors, the following intermediate indicator will be added: • Health centers that provide psychosocial services to GBV survivors (number) B. Sustainability 31. The proposed AF will play a critical role in enabling affordable and equitable access to vaccines in Guinea-Bissau. There is strong political commitment in Guinea-Bissau to mobilize financial resources for COVID-19 response, including for vaccine purchase. Having the funds through this project for vaccine purchase and deployment will establish an enabling environment for other donors, including United Nations (UN) agencies to also support efforts in the country. COVID-19 vaccination, along with improved diagnostics and therapeutics, is essential to protecting lives and enabling the country to reopen safely. The global economy will not recover fully until people feel they can live, socialize, work, and travel with confidence. Given the importance of limiting the spread of COVID-19 to both health and economic recovery, providing access to COVID-19 vaccines will be critical to accelerate economic and social recovery in Guinea-Bissau. III. KEY RISKS 32. The overall risk is maintained as High. There are significant risks for implementation of the proposed operation, as described below. The project is a well-grounded response to the COVID-19 pandemic that will focus on vaccine purchase and deployment in a country marked by limited public sector capacity and a weak health system. The large-scale acquisition and deployment of COVID-19 vaccines entails certain 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 entailing risks. The World Bank will work with GoGB to partner with service providers that can acquire and/or deliver the vaccines. The World Bank will also work with the country to consider trade-offs and to determine the appropriate approach and risk balance. The remaining risk must Page 34 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) be considered against the risk of the country having less timely and effective deployment of vaccines, potentially exacerbating development gaps and eroding past development gains. While a considerable degree of risk is inherent in a project of this urgency, important mitigation measures have been integrated into its design. 33. Political and governance risk is maintained as High. United Nations Integrated Peacebuilding Office in Guinea-Bissau mission was present in the country for the November 2019 elections, and completed its mission in December 2020. Given the restrictions in direct coordination with the Government, close coordination with other donor partners (within and outside the health sector) will play an important role in mitigating the political and governance risks. Moreover, financing of vaccine procurement and deployment comes with some risks. For instance, to reach the 70 percent coverage of the population, adolescents (12-17 years of age) will have to be vaccinated. However, at this time, the country does not have WHO-approved vaccines for this population group. This may create pressure on Guinea-Bissau to deploy vaccines that are not approved for this group. The World Bank has defined regulatory standards that will be applicable to all vaccines being financed through the institution. A TPM Agency will also be recruited under the parent project that will monitor vaccine deployment and provide updates on a monthly basis. Moreover, more emphasis will be put on purchasing vaccines and acquiring the appropriate equipment for WHO-approved vaccines for adolescents through World Bank financing. The other risk relates to the commitment and ability of the authorities to ensure appropriate targeting of the vaccines to priority populations, based on objective public health criteria. This risk will be mitigated through the assurance mechanisms that this project will support, such as the establishment of an acceptable policy and plan for prioritized intra-country allocation. There are also risks related to governance of vaccine purchase and deployment, such as potential fraud and substandard quality. In addition, there are risks associated with fraudulent attempts to gain access to vaccines to be administered not following approved protocols of priority populations or for personal gain. This will be mitigated through a rigorous inspection regime and Anti-Corruption Guidelines (ACGs) for vaccine purchase and deployment. This includes traceability of supply. Moreover, Guinea-Bissau has not developed required national regulations to protect manufacturers from indemnification and liability claims following AEFIs from the COVID-19 vaccines. This will be mitigated through the regional no-fault compensation scheme that is available to COVAX AMC countries as well as AVAT. 34. Macroeconomic risk for Guinea-Bissau is maintained at Substantial. Real Gross Domestic Product (GDP) growth contracted by 1.4 percent in 2020, but it is forecasted to recover quickly with estimates for 2021 reaching 3.3 percent and 4.0 percent in 2022. The COVID-19 crisis makes an already vulnerable country economy even more unstable. At the onset of the pandemic, the narrow economic base oriented towards cashews, particularly on the fiscal side, made the macroeconomic environment very vulnerable to external and internal shocks. However, Guinea-Bissau’s economy has rebounded in 2021. Cashew nuts are Guinea-Bissau's main source of exports. The end of supply chain disruptions and a rebound in international cashew nut prices and demand explain the rebound in the economy. It is important to note, however, that there is still insufficient fiscal space for the purchase of vaccines at scale and other COVID-19 related response interventions. The project specifically aims to mitigate this risk by providing financing for vaccine purchase and promoting prioritized deployment to vulnerable groups, which may ease pressures on public health sector budget. Residual macroeconomic risk will remain as the country aims to scale vaccine access to higher coverage levels. Page 35 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) 35. Sector strategies and policies are weak, and the risk is maintained as Substantial. The existing National Health Sector Development and the National Health Workforce Plans were not fully implemented, in part due to the disconnection of these documents with the fiscal reality of the country. The Guinea-Bissau National COVID-19 Response Plan as well as the NDVP prepared addresses the COVID- 19 context and the existing National plans will be updated in CY2022 to reflect the global pandemic. 36. Technical design is maintained Substantial. The uncertainties around the timing of when COVID- 19 vaccines will be available and the supply chain capacity to implement such a large vaccination effort may compromise the achievement of project’s objectives. This is particularly relevant for the adolescent population that represents approximately 20 percent of the target population. The parent project will support the country in financing vaccines that are WHO-approved for use by this group. Moreover, additional equipment to improve the cold chain capacity, particularly for ultra-cold freezers, will need to be strengthened, which is expected under the parent project. The World Bank will work closely with government officials (i.e., MINSAP and the Office of the High Commissioner) as well as UN agencies involved in the pandemic response (WHO, UNICEF, e.g.), to support the process of acquiring and delivering the COVID-19 vaccines as well as cold chain equipment. 37. Institutional capacity risk for implementation is rated as High. The extent of government capacity, technical and operational, is weak. Partnerships with UN system organizations (WHO, UNICEF) will mitigate some of this risk during the relatively short implementation time of this project. Moreover, the healthcare workers strike of October 2021 reduced the number of available vaccinators in the country. To mitigate this risk, the GoGB trained 83 medical and nursing students with the support of WHO and UNICEF, recruited 40 doctors from the Cuban Brigade and received support from the Red Cross to administer vaccines during the last vaccination campaign (October 25-November 9, 2021). They paid vaccinators at the end of each day using mobile money. Moreover, the Military Health Services are implicated in the vaccination campaign as additional support. The personnel from the Military Health Services support the administration of vaccines. In the medium and long-term, existing Health Projects (REDISSE II and MCH Projects) have actions to support institutional capacity building. Notwithstanding the progress made in the routine immunization program in Guinea-Bissau, vaccine deployment cold-chain and distribution capacity need to be strengthened given the anticipated scale and population group coverage for the COVID-19 vaccination. This risk will be mitigated by this project and technical support for immunization system strengthening, including capacity assessments in coordination with the WHO, GAVI, UNICEF and other partners, and coordinating with other partners in their provision of systems strengthening support. 38. Fiduciary risks have been revised to Substantial. • Procurement: The procurement risk remains Substantial. The key procurement risk associated with the COVID-19 vaccines relates to: (i) disruption in the supply chain; (ii) the complexity of the vaccines market given the significant market power enjoyed by vaccine manufactures; (iii) inability of the market to supply adequate quantities of vaccines to meet the demand; (iv) the limited market access due to advance orders by developed countries; (v) weak bargaining power by individual countries; and (vi) delays in triggering national emergency procurement procedures which could delay procurement and contract implementation including payments. The risks under this project will be reduced by providing options to support the country’s needs for direct or advance purchase, including possible technical assistance. Page 36 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) • FM: The FM risk has been revised from High to Substantial because the mitigation measures that have been identified during project preparation such as the recruitment of the FM team, the TPM and Internal Auditor are ongoing. The accountant has been recruited and the administrative and financial officer and internal auditor recruitments are at the final stage. The accounting software has been customized for the bookkeeping of the project. 39. The anticipated overall environmental and social (E&S) risks remain as Substantial. The AF will purchase an additional 300,000 J&J vaccines, and deployment of these will be covered under the parent project, which will lead to an increase of medical waste to be properly handled under the parent project. The purchase of vaccines is considered as low risk, but due to the environmental and social risks of the disposal of the medical waste generated, the E&S risks of the parent project are rated as Substantial. These medical wastes include waste generated from vaccine delivery, such as sharps and used and expired vaccine vials, as well as used/contaminated PPEs. Risks identified, as mentioned in the parent project’s Project Appraisal Document (PAD), relate to environmental and occupational health and safety issues, the potential for medical waste mismanagement, and community health, and safety due to the handling, transportation, and disposal of healthcare waste. Therefore, special handling and awareness is required, as medical waste materials pose an infectious risk to healthcare workers and other ancillary workers and community members that may get in contact with it, if not adequately managed and disposed of. While the social risk of the project remains Substantial the activities of the AF are low risk as the purchase of the additional vaccines is unlikely to entail any additional impacts. It is important to note, however, that SEA/SH risks in the country remain high and the parent project will continue to address this challenge. 40. Stakeholder risk is rated as Moderate. Civil society is weak and fragmented in Guinea-Bissau. Additionally, even though donor investments have been stable in the health sector, fragmentation and lack of a well-defined health sector strategy risk the achievement of sustainable medium- and long-term impacts. The lack of strategy has resulted in sub-optimal results in previous donor investments. The project will seek to incorporate activities specifically on citizen engagement through community engagement in the parent project. Moreover, Guinea-Bissau has been addressing vaccine hesitancy and is building vaccine literacy so that the public will accept immunization when appropriate. The accelerated pace of vaccine development has further heightened public anxieties and has in some instances compromised acceptance. Therefore, there are risks related to the continuation of the COVID-19 pandemic and the roll-out of the COVID-19 immunization plan. These include (i) set of challenges related to the implementation of preventive responses and control measures and (ii) pressure from groups being unable to access vaccines in the initial phases due to limited availability of vaccines and/or limited deployment capacity. In Guinea-Bissau, the population strongly believes in the positive effects of vaccination as shown by the progress made in coverage rates. Clear and consistent communication by government officials will ensure that public confidence is built in COVID-19 vaccination program, and this will include explaining how vaccines work, their level of effectiveness, and the importance of population- wide coverage to achieve community immunity in an adequate and health literacy appropriate fashion. Credible and culturally appropriate health and risk communication will be vital in influencing positive health behaviors among the priority vaccination groups. Page 37 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) IV. APPRAISAL SUMMARY A. Technical, Economic and Financial Analysis 41. The economic rationale for investment in a COVID-19 vaccine campaign is strong, considering the massive and continuing health and economic losses due to the pandemic. As of December 7, 2021, more than 267.16 million people have been infected and over 5.27 million have died.12 The global economy contracted by 4.3 percent in 2020, but forecasts for 2021 show it is expected to bounce back at the fastest post-recession pace in 80 years and expand by 5.6 percent. Similarly, the COVID-19 pandemic also caused the economy of Guinea-Bissau to suffer in 2020 and it contracted by 1.4 percent, in real terms. However, it is forecasted to recover quickly and real GDP growth for 2021 should reach 3.3 percent, and 4 percent in 2022. Agriculture is still the mainstay of the country’s economy driven by cashew nut production, which generates about 95 percent of the country’s foreign exchange, 17 percent of fiscal revenues, and accounts for over 47 percent of GDP. Over 80 percent of the population relies on agriculture for their livelihood and the sector employs close to 70 percent of the country’s work force - most of whom are women.13 Lockdown measures in 2020 to contain the pandemic have had significant impact on domestic and global cashew demand and prices. 42. The successful delivery of a vaccine has the best potential to generate 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. Even at levels of imperfect effectiveness, a COVID-19 vaccine that is introduced and deployed effectively to target 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 remain open. 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 (UHC), the potential health- related costs of millions of additional cases of COVID-19 infection in the absence of a vaccine represent a significant or even catastrophic financial impact and risk of impoverishment. The pandemic is also having dire effects on other non-COVID health outcomes. Increased morbidity and mortality due to interruption of essential services associated with COVID-19 containment measures hinder access to care for other health needs of the population, including maternal and childcare services, routine immunization services have been affected, threatening polio eradication and potentially leading to new outbreaks of preventable diseases, with their own related deaths, illnesses, and long-term costs. Simultaneous epidemics are overwhelming public health systems in different countries that had few resources to begin with, and services needed to address the needs of people with chronic health conditions, and mental and substance use disorders have also been disrupted. 12 COVID-19 Data Repository by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University as of November 7, 2021, available at: https://ourworldindata.org/coronavirus-data 13 Female employment in agriculture in Guinea-Bissau was 70.7 percent in 2019, compared with 65.8 percent for male employment-http://datatopics.worldbank.org/gender/country/guinea-bissau Page 38 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) 43. While the uncertainty around the costs and effectiveness of a COVID-19 vaccine makes it difficult to calculate its cost-effectiveness, the effective launch of a COVID-19 vaccine will have direct benefits in terms of averted costs of treatment and disability, as well as strengthened health systems. Estimated COVID-19 treatment costs from low- and middle-income countries are US$50 for a non-severe case and US$300 for a severe case. This excludes costs of testing of negative cases, as well as the medical costs associated with delayed or forgone care-seeking, which usually results in higher costs. Twenty percent of the 1.9 million population in Guinea-Bissau (an estimated 378,294 people) were prioritized for COVID-19 vaccinations. Although the Government reached the 20 percent target before the end of CY21, there are still priority populations that need to be reached such as those with underlying health conditions and the elderly. This is critical due to the poor health indicators in the country. 44. Investments in vaccine delivery systems generate health and economic benefits beyond just delivering the COVID-19 vaccine. First, investments in last-mile delivery systems to administer the COVID- 19 vaccine to remote communities will require strengthening community health systems, which can have spillover effects to effective delivery of other services, helping close the significant urban-rural gap. Second, as the COVID-19 vaccine is introduced and lockdowns and movement restrictions are eased, patients can continue to access care for other conditions. Third, the economic benefits of slowing down the economic downturn are likely to significantly exceed the costs needed to vaccinate the population, leaving aside the immediate health benefits. Given both the economic and health system benefits, an effectively deployed COVID-19 vaccine presents significant benefits. B. Financial Management 45. In line with the guidelines as stated in the FM Practices Manual issued by the FM Sector Board on March 1, 2010, an FM assessment was conducted for the parent project. The existing PIU of the World Bank-financed health sector operations will have both the coordination and fiduciary responsibilities of the AF activities. The FM arrangements will be based on the existing arrangements in place within the PIU. The overall FM performance of the parent project is Moderately Satisfactory due to the vacant administrative and financial officer position, the pending preparation of the POM, and the pending recruitments of the TPM and the internal auditor. However, the accountant has been recruited and the accounting software has been updated for the project bookkeeping. 46. FM mitigation measures. In order to accommodate the project in the existing FM system and mitigate the fiduciary risk, the following measures should be taken: (a) no later than one month after effectiveness: (i) recruitment of the financial and administration officer; (ii) finalize the Administrative and FM Manual to include the specificities of the project; (iii) customize the existing accounting software to include the bookkeeping of the AF activities; (iv) recruit an internal audit consultant who will cover the three World Bank-financed projects; (v) contract a TPM to report on the transparency in the distribution of vaccines and if distribution is consistent with the vaccine deployment plan; and (b) no later than six months after effectiveness, recruit an external auditor to conduct the audit of the project and AF financial statements. 47. The speed of disbursements of the project will be significantly influenced by the availability of vaccines. The World Bank will provide financial and risk assurances to manufacturers under advance purchase mechanisms. Disbursement arrangements applicable to the parent project will apply. Page 39 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) 48. The conclusion of the assessment is that the FM arrangements are adequate to meet the World Bank’s minimum requirements under World Bank Policy and Directive on Investment Project Financing (IPF) effective in 2018. 49. The overall FM risk is Substantial due to inadequate staffing and weak internal control environment. C. Procurement 50. Procurement under the proposed 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. The proposed AF will be subject to the World Bank’s Anticorruption Guidelines “Guidelines on Preventing and Combating Fraud and Corruption in Projects Financed by IBRD Loans and IDA Credits and Grants”, dated October 15, 2006, revised in January 2011, and as of July 1, 2016. 51. The Recipient has revised the Project Procurement Strategy for Development (PPSD) and the 12-month Procurement Plan and it was approved by the World Bank. The PPSD found that all COVID-19 vaccines being purchased will come from the international market, countries with additional doses, and several global mechanisms supporting low- and middle-income countries. The Procurement Plan specifies for each contract: (i) a description of the activities/contracts; (ii) the selection methods to be applied; (iii) the estimated cost; (iv) time schedules; (v) the World Bank’s review requirements; and (vi) any other relevant procurement information. The Recipient shall submit to the World Bank, for its review and approval, any updates of the Procurement Plan. The project will use the Systematic Tracking of Exchanges in Procurement (STEP) to plan, record, and track procurement transactions. 52. The main planned procurement under this project is vaccine purchase. 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. 53. The current demand for COVID-19 vaccines exceeds the supply in the market which makes it more difficult for client countries to negotiate terms and conditions. Procurement of vaccines will therefore follow Direct Selection. Guinea-Bissau will make use of AVAT as the main mechanism to purchase vaccines under this AF. All freight costs for vaccines delivered to the country from AVAT are included in the costs of the vaccine. The parent project will support the country to cover the operational costs, including freight costs, and costs for additional vaccines, if needed. 54. The procurement risk is estimated at Substantial. Procurement of COVID-19 vaccines and ancillary supplies are subject to high level of uncertainties in terms of prices and quantities that will be made available through different purchasing options. The Substantial risk will be mitigated by recent practical trainings on the World Bank’s New Procurement Framework (NPF) for the PIU staff, support throughout procurement processes, and other needs as they arise. The REDISSE (P159040) Project also provided ample experience as it relates to the procurement of some of the supplies and equipment for the COVID-19 response. Page 40 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) 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 55. Activities under the AF will fill a critical gap by providing financing for the acquisition of additional safe and effective COVID-19 vaccines to prevent further spread of COVID-19 and deaths caused by the virus. The purchase of an additional 300,000 J&J vaccines will be deployed through the parent project. The parent project may also finance the acquisition of mRNA vaccines such as Pfizer and Moderna. The increase of vaccine deployment poses risks to the environment, health, and safety due to the dangerous nature of the pathogen (COVID-19) and the reagents and equipment used in vaccination activities. The identified risks will be mitigated in the parent project in accordance with the ESF and triggered ESS standards, following WHO protocols for managing risks associated with COVID-19, Environmental, Health and Safety Guidelines and Good International Industry Practice (GIIP). 56. To mitigate against adverse risks to health and the environment, the parent project already developed and disclosed the Environmental and Social Management Framework (ESMF) on October 20, 2021 based on WHO protocols for managing risks associated with COVID-19. The ESMF covers E&S infections control measures and procedures for the safe handling, storage, and processing of COVID-19 vaccines and materials including the techniques for preventing, minimizing, and controlling E&S impacts during the operation of project supported laboratories and medical facilities. The relevant parts of WHO’s COVID-19 Quarantine Guideline and COVID-19 biosafety guidelines are also incorporated into the ESMF. The guidelines include provisions to address the needs of patients, including the most vulnerable. To manage generated medical waste, the ESMF includes an Infection Control and Waste Management Plan (ICWMP) template adopting GIIP, Environment, Health and Safety in line with Centers for Disease, Control and Prevention and WHO COVID-19 guidance documents for its environmentally sound and safe management and disposal of the medical waste. Based on this template, each targeted health facility under the parent project will develop its own ICWMP for proper handling, transport and disposal of generated medical waste. The ESMF will be revised and disclosed by effectiveness date of the AF to strengthen short-term immediate measures to ensure that the medical waste generated by the parent project and AF is adequately managed, building on best international practices and WHO protocols for its collection, storage, transportation, and final disposal. The measures to be included are proper storage facilities for hazardous waste, such as sharps and used and expired vaccine vials, as a result of the project activities, and establishing a Memorandum of Understanding (MoU) with a private clinic in Bissau (Clinica Madrugada) which has an operational incinerator in place. Moreover, the ESMF will also be revised to include additional measures regarding the participation of the Military Health Services in the vaccination campaigns, which will also include SEA/SH measures. The ESMF will also include measures to handle the cold chain for vaccine transport, storage and distribution. As the parent project will finance the installation of eight incinerators in different regions of the country, before the start of this activity the ICWMP/ESMPs should be developed and implemented. The ESMF would also require to be revised to include an Page 41 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) assessment of the potential air pollution generated by the operation of the incinerators, including an estimate of gross Greenhouse Gas Emissions (GHG) resulting from the project, and will consider technically and financially feasible measures to minimize project-related air emissions. 57. The ESMF includes a set of measures to prevent, mitigate and respond to SEA/SH risks recommended by the Technical Note on SEA/SH for Health, Nutrition and Population Practice Group COVID-19 Response Operations14 including a code of conduct with clauses against SEA/SH and sanctions, information campaigns on where gender-based violence (GBV) services are available and two-way feedback mechanisms. The ESMF will be revised to ensure that a short-term immediate ICWMP is in place by AF effectiveness. In addition to the ESMF, the Environmental and Social Commitment Plan (ESCP) was developed including key measures and actions with specific timeframes, for which the Client agreed upon to follow throughout the project lifetime. The ESCP was updated and disclosed by the Recipient on December 17, 202115 to reflect new developments of the parent project and AF. 58. The project will continue to ensure appropriate stakeholder engagement, as reflected in the Stakeholder Engagement Plan (SEP), which was disclosed on May 13, 2021 for the parent project. While the activities of the AF are unlikely to require major changes to the SEP, the Plan was updated and disclosed by the Recipient on December 17, 202116 to reflect new developments of the parent project and AF such as the involvement of the Military Health Services in the vaccination campaign. 59. Gender gap analysis. 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 and how fast, to critical health services. Gender norms also influence risk of exposure to disease, as well as 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. In a pandemic, this has multiple implications. On the one hand, the pandemic response must be cognizant of the gender-based differences in access to and use of services due to limited mobility and financial capacity; and on the other, support needs to 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 especially put women and girls at greater risk of GBV. In the context of COVID-19, some critical considerations for projects include: • Biologically, women and men may have a different risk level to a pathogen or response to treatment (men are being infected and are dying at higher rates than women); • 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; 14 https://worldbankgroup.sharepoint.com.mcas.ms/sites/gsg/HealthySocieties/Documents/COVID- 19/Technical%20Note%20on%20addressing%20SEAH%20in%20HNP%20COVID%20response%20operations.pdf 15 https://www.accovid-gw.org/post/plano-de-compromisso-ambiental-e-social-pcas-pt-dezembro-de-15-2021-projeto-de- vacina-covid-19 16 https://www.accovid-gw.org/post/plano-de-envolvimento-das-partes-interessadas-financiamento-adicional-de-projeto-de- vacina-19-gb Page 42 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) • 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; and • Risk of increased GBV: 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. 60. Prior to the pandemic, women in Guinea-Bissau experienced more inequality than their male counterparts, particularly in rural areas. The Organization for Economic Cooperation and Development(OECD) Social Institutions and Gender Index found that discrimination is higher among women with early and forced marriages, married women having to ask for consent from their husbands as it relates to their combined assets (women have to be appointed by their husbands as administrators of the couple’s assets) (Civil Code, Art. 1674), women being “disciplined by their husbands” as being acceptable by society, and Female Genital Mutilation (FGM) still being widespread even with notable changes in the law criminalizing the practice. Another issue is that women do not report cases of domestic violence and abuse. During the COVID-19 pandemic, women have been disproportionally impacted by the COVID-19 pandemic due to the reduction of economic growth as well as an increase in the burden of domestic care.17 Women are mostly dependent on the informal economic sector (selling fish, catering, trading of fruits and other foods) and agricultural sector (cashews) that have been impacted by the pandemic in Guinea-Bissau. Therefore, the mobility restrictions and closure of certain markets significantly impacted the amount of income that they could bring in. Moreover, 59 percent of health workers in Guinea-Bissau are women; 72 percent of which are nurses, midwives, and CHWs, and therefore are more exposed to COVID-19.18 During these turbulent times, women also bear the brunt of domestic care such as taking care of children, cooking, and cleaning. This is then compounded by a potential increase of domestic abuse and GBV in Guinea-Bissau where gender inequality is already high and FGM is widespread.19 An SEA/SH Action Plan has been prepared under the parent project’s ESMF to identify measures to address SEA, and SH. During the implementation of the SEA/SH Action Plan, any additional risks and needs will be monitored to adapt the measures as needed. Due to the lack of psychosocial support services in healthcare facilities, the parent project will support improved referral pathways and support for GBV survivors in healthcare facilities. This will ensure that psychosocial support services are broadly available. 61. As part of the ESF requirements, World Bank projects can also take steps to mitigate the risks to ensure vulnerable population groups, including women, have access to the COVID-19 vaccines, mitigate risks of SEA/SH, and address vaccine hesitancy. For instance, marginalized and vulnerable social groups, including women and disabled populations, have more barriers to access to COVID-19 services, vaccination, and information. Early vaccination coverage data was showing that women were less vaccinated than men. Although there has been a larger male mortality of COVID-19 and the tendency in many countries is to overlook the importance of gender inequalities in social and economic activity, it is important to not leave women behind. Moreover, there is also misinformation regarding the COVID-19 vaccines, which has increased vaccine hesitancy. For instance, there is misinformation spreading that 17 UNDP. 2020. Socio-economic Impact Analysis of COVID-19 in Guinea-Bissau. Available at: file:///C:/Users/wb408116/Downloads/Guinea_Bissau_SocioEconomicImpact_UN.pdf 18 Guinea-Bissau National Health Plan 2018-2022 19 UNFPA (2020, April 27). Impact of the COVID-19 Pandemic on Family Planning and Ending GBV, Female Genital Mutilation and Child Marriage. Available at: https://www.unfpa.org/resources/ impact-covid-19-pandemic-family-planning-and-ending-gender- based-violence-female-genital Page 43 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) COVID-19 vaccines may cause infertility, which has impacted the vaccination coverage among women and adolescent girls. Therefore, special attention will be paid to vaccine access for vulnerable groups and to vaccine hesitancy through the parent project. The Government’s social engagement strategy to reduce vaccine hesitancy includes active disinformation management through social listening, review, and follow- up with exposed groups. WHO and UNICEF also plan to conduct a study to understand the vaccine hesitancy among this group and to find solutions. Portugal will also continue to support the country improve its communication and community engagement with women. 62. In late September 2021, as cases from the third wave was declining, vaccine coverage among women was around 36 percent. After a successful vaccination campaign from October 25, 2021 to November 9, 2021, vaccination coverage among women increased to 45 percent. The GoGB improved communication and community engagement and ensured that vaccination sites were closer to where women work and live. This approach will continue to be used for vaccine deployment to increase the coverage of COVID-19 vaccines among women. The AF will continue to monitor the number of women that will be vaccinated in the general population and among the priority groups and the parent project will ensure training of healthcare workers on GBV/SEA/SH to improve patient care. 63. Citizen Engagement. The involvement of the local population is essential to the success of the project to ensure smooth collaboration between project staff and local communities, and to minimize and mitigate E&S risks related to the proposed project activities. In the context of infectious diseases, broad, culturally appropriate, and adapted awareness-raising activities are particularly important to properly sensitize the communities to the risks related to infectious diseases. As such, the parent project prepared the SEP with the overall objective of defining a program for stakeholder engagement, including public information disclosure and consultation, throughout the entire project cycle. The SEP outlines the ways in which the project team will communicate with stakeholders. It ensures that the GoGB engages in continuous, meaningful, and safe consultations on policies and procedures (including grievances) with all stakeholders, providing them with timely, understandable, and accessible information throughout the project life cycle. Under the parent project, other mechanisms will also be used to engage citizens, and target beneficiaries more specifically, in: (i) providing ideas and feedback on program delivery; (ii) identifying gaps at the point of service delivery (information availability, access to testing and vaccination, access to relevant care, equal treatment etc.); (iii) building community knowledge and confidence, establishing trust; and (iv) ensuring governments respond to community needs (including vulnerable groups). The beneficiary feedback will be integrated in project interventions. An indicator was also included in the results framework during the preparation of the parent project to track the share of claims registered in the Grievance Redress Mechanism (GRM) addressed in a timely manner. 64. GRM. The parent project incorporates a comprehensive GRM, which is annexed to the ESMF, which provides multiple reporting channels for individuals and communities who feel aggrieved by project activities with accessible, timely, effective, and culturally appropriate opportunities to raise their project- related complaints and concerns. This also includes complaints that are SEA/SH related as well as referrals to GBV services. There is a GRM established at the Office of High Commissioner for COVID-19 for COVID- 19 grievances and a GRM established for the REDISSE Project also supported the COVID-19 response activities. Page 44 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) 65. Climate Co-Benefits. The project has been screened for climate change and disaster risks and is highly exposed to extreme temperature, extreme precipitation, flooding, drought, sea level rise and storm surges. This exposure risk is assessed at this level for both the current and future timescales. The country is particularly vulnerable to changes in the sea level since over half of the population lives in the coastal zone. Heat waves have also increased in region impacting the health of the elderly and other vulnerable groups. These exposure risks lead to an increase in several climate related health risks such as increases in: (i) vector borne diseases including malaria and dengue; (ii) water and food borne disease such as campylobacter, salmonella an e-coli; and (iii) increased risk of extreme weather event related health effects such as traumatic injury, drowning and impacts on communicable and non-communicable diseases and mental health as well as disruption to access to healthcare further compounding the problem. The most at-risk groups from climate-related exposures coincide with those vulnerable to COVID-19. These include, women, who form a large proportion of frontline workers in Guinea-Bissau including health workers, caregivers, and teachers; the elderly; individuals who are ill, including with chronic diseases; the poor, displaced and marginalized who mostly reside in crowded locations with poor access to water and sanitation. However, the risk on project activities and outcomes is categorized as ‘moderate’. 66. The parent project addresses the above-described climate vulnerabilities and assists the GoGB in climate adaptation and mitigation activities. The proposed AF is exclusively financing vaccine acquisition and therefore no Climate Co-Benefits are expected. Under Component 1: Emergency COVID- 19 Response (AF1: US$2.2 million), the COVID-19 vaccine acquisition will consume US$2.2 million. This includes the costs of the COVID-19 vaccines, international freight, procurement fees to UNICEF. While no direct climate financing is expected to be assigned at this time to any of these investments, it is expected that some suppliers are taking active steps to ensure climate resilient considerations are taken into account during the manufacturing, shipment and distribution stages of the vaccines. The World Bank team, together with UNICEF, WHO, GAVI and the AVAT will continue to explore these areas in order to provide latest information on any specific climate adaptation and mitigation actions taken with regard to the vaccines. V. WORLD BANK GRIEVANCE REDRESS 67. 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 Bank’s Grievance Redress Service (GRS). The GRS ensures that complaints received are promptly reviewed in order to address project-related concerns. Project affected communities and individuals may submit their complaint to the Bank’s independent Inspection Panel which determines whether harm occurred, or could occur, as a result of 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 Bank’s corporate GRS, please visit: For information on how to submit complaints to the World Bank Inspection Panel, please visit www.inspectionpanel.org. Page 45 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) VI SUMMARY TABLE OF CHANGES Changed Not Changed Results Framework ✔ Components and Cost ✔ Implementing Agency ✔ Project's Development Objectives ✔ Loan Closing Date(s) ✔ Cancellations Proposed ✔ Reallocation between Disbursement Categories ✔ Disbursements Arrangements ✔ Legal Covenants ✔ Institutional Arrangements ✔ Financial Management ✔ Procurement ✔ Implementation Schedule ✔ Other Change(s) ✔ VII DETAILED CHANGE(S) MPA PROGRAM DEVELOPMENT OBJECTIVE Current MPA Program Development Objective The Program Development Objective is to prevent, detect and respond to the threat posed by COVID-19 and strengthen national systems for public health preparedness Proposed New MPA Program Development Objective Page 46 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) 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$, millions) Name millions) Emergency COVID-19 4.70 Revised Emergency COVID-19 6.90 Response Response Page 47 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Project Management and 0.30 No Change Project Management 0.30 M&E and M&E TOTAL 5.00 7.20 Expected Disbursements (in US$) DISBURSTBL Fiscal Year Annual Cumulative 2021 0.00 0.00 2022 1,500,000.00 1,500,000.00 2023 3,500,000.00 5,000,000.00 2024 2,200,000.00 7,200,000.00 2025 0.00 7,200,000.00 2026 0.00 7,200,000.00 2027 0.00 7,200,000.00 2028 0.00 7,200,000.00 SYSTEMATIC OPERATIONS RISK-RATING TOOL (SORT) Risk Category Latest ISR Rating Current Rating Political and Governance ⚫ High ⚫ High Macroeconomic ⚫ Substantial ⚫ Substantial Sector Strategies and Policies ⚫ Substantial ⚫ Substantial Technical Design of Project or Program ⚫ Substantial ⚫ Substantial Institutional Capacity for Implementation and ⚫ High ⚫ High Sustainability Fiduciary ⚫ High ⚫ Substantial Environment and Social ⚫ Substantial ⚫ Substantial Stakeholders ⚫ Moderate ⚫ Moderate Other Overall ⚫ High ⚫ High Page 48 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) LEGAL COVENANTS2 LEGAL COVENANTS – Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Sections and Description Schedule 2, Section I.A.1: The Recipient shall enable, throughout Project implementation, the High Commissioner for COVID-19 to be responsible for technical coordination and implementation of the Project. Schedule 2, Section I.A.2: Without limitation to Section I.A.1 above, the Recipient shall maintain, throughout Project implementation, the Project Implementation Unit (“PIU”), to be responsible for day to day execution, coordination and implementation of the Project (including procurement, financial management, environmental and social, monitoring and evaluation, supervision and reporting). To this end, the Recipient shall take all actions, including the provision of funding and the maintenance of key personnel (including a coordinator, a financial and administrative officer, an accountant, a monitoring and evaluation specialist and a social specialist) all with terms of reference, qualifications and experience satisfactory to the Association, and other resources satisfactory to the Association, to enable the PIU to perform said functions, as further detailed in the Project Operational Manual and the Administrative and Financial Management Manual. Schedule 2, Section I.B.1: Without limitation to Section 3.01 of this Agreement, the Recipient shall ensure that the Project is carried out in accordance with the National COVID-19 Deployment and Vaccination Plan (NDVP), all in a manner acceptable to the Association. Schedule 2, Section I.B.2.A: The Recipient shall, not later than one (1) month after the Effective Date, or such later date as agreed by the Association, update and adopt the revised Project Operational Manual in a manner and on terms acceptable to the Association. Schedule 2, Section I.B.3.A: The Recipient shall, not later than one (1) month after the Effective Date, or such later date as agreed by the Association, update and adopt the Administrative and Financial Management Manual in a manner and on terms acceptable to the Association. Schedule 2, Section I.B.4.A: The Recipient shall: (i) not later than one (1) month after the Effective Date, or such later date as agreed by the Association, prepare and furnish to the Association, a work plan and budget (“Work Plan and Budget”), satisfactory to the Association. Schedule 2, Section I.C: For purposes of assisting the Recipient in the administration and deployment of Project COVID-19 Vaccines in accordance with the NDVP, the Recipient shall, through the Office of the High Commissioner for COVID-19, and not later than one (1) month after the Effective Date, or such later date as agreed by the Association, appoint and thereafter maintain the TPM Agency, with terms of reference, qualifications and experience satisfactory to the Association. Schedule 2, Section I.E: 1.Without limitations to the provisions of Section I.F.2 of this Schedule and if during Project implementation, the Recipient decides to use its military or security forces, the Recipient shall: (a) prior to any involvement of its military and/or security forces in the carrying out of Project activities, send a written notice to the Association (in accordance with Section 11.01(b) of the General Conditions) communicating such decision, including the name of the military or security unit; and (b) all activities carried out by said military or security unit under the Project shall be under the control of MINSAP and shall be undertaken exclusively for the purposes related to the Project. All goods, services, Operating Costs, and Training financed by the Financing proceeds may be used by said military or security unit under the direction and control of MINSAP and the Office of the High Commissioner for COVID-19 and strictly in accordance with the Project Operational Manual and other arrangements or protocols that the Association may require for carrying out these activities. 2. Except as the Association may otherwise agree, the Recipient shall ensure that the ownership of any assets Page 49 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) generated, goods procured, and works constructed by the military or security unit referred to in paragraph 1 of this Section I.E, out of the Financing proceeds shall be transferred to, or shall vest, with MINSAP or any equivalent or appropriate line ministry or agency agreed with the Association. Schedule 2, Section IV.1.A:The Recipient shall, not later than one (1) month after the Effective Date, or such later date as agreed by the Association: customize the Project’s accounting software, in form and substance satisfactory to the Association. Schedule 2, Section IV.1.B:The Recipient shall, not later than one (1) month after the Effective Date, or such later date as agreed by the Association: recruit an internal auditor with qualifications, experience and terms of reference, satisfactory to the Association. Schedule 2, Section IV.2: The Recipient shall, not later than one (1) month after the Effective Date, or such later date as agreed by the Association, recruit a financial and administrative officer, a social specialist and a monitoring and evaluation specialist within the PIU, with terms of reference, qualifications and experience satisfactory to the Association. Schedule 2, Section IV.3: The Recipient shall, not later than six (6) months after the Effective Date, or such later date as agreed by the Association, recruit an external auditor with qualifications, experience and terms of reference, satisfactory to the Association. Conditions Type Financing source Description Effectiveness IBRD/IDA The Recipient has updated, consulted upon, disclosed and adopted the revised Environmental and Social Management Framework in form and substance satisfactory to the Association. Type Financing source Description Effectiveness IBRD/IDA The Recipient has updated and disclosed the revised Labor Management Procedures in form and substance satisfactory to the Association. Type Financing source Description Effectiveness IBRD/IDA the Recipient has updated, disclosed and adopted the revised Stakeholder Engagement Plan in form and substance satisfactory to the Association. Page 50 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) VIII. RESULTS FRAMEWORK AND MONITORING Results Framework COUNTRY: Guinea-Bissau RESULT_NO_PDO Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project Project Development Objective(s) The Project Development Objective is to prevent, detect and response to the threat posed by COVID-19 and strengthen national systems for public health preparedness in Guinea-Bissau. Project Development Objective Indicators by Objectives/ Outcomes RESULT_FRAME_TBL_ PD O Indicator Name PBC Baseline End Target To prevent and respond to the COVID-19 pandemic in Guinea-Bissau Target population fully vaccinated (by sex) (Percentage) 0.00 60.00 Rationale: Action: This indicator has been Revised This indicator is being revised to enable the monitoring of the population included in the Government's national target. By sex (Percentage) 0.00 45.00 Action: This indicator has been Revised Population in the priority group fully vaccinated (Percentage) 0.00 20.00 Action: This indicator has been Revised Rationale: Page 51 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) RESULT_FRAME_TBL_ PD O Indicator Name PBC Baseline End Target This indicator is being revised to provide clarity. By sex (Percentage) 0.00 40.00 Action: This indicator has been Revised PDO Table SPACE Intermediate Results Indicators by Components RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline End Target Component 1: Emergency COVID-19 Prevention, Preparedness and Response Essential and frontline health workers benefitting from the first phase of vaccine deployment who are women (as percentage of 0.00 100.00 the total women among essential and frontline) (Percentage) COVID-19 vaccinators trained (Number) 0.00 360.00 Risk Communication and Community Engagement Strategy for COVID-19 Vaccination developed (Yes/No) No Yes Pharmacovigilance System (PVS) adapted to detect Adverse Events Following Vaccination (AEFI) for the COVID-19 Vaccines No Yes (Yes/No) Healthcare workers and community-based nurses trained on gender-based violence/sexual exploitation and abuse/sexual 0.00 300.00 harassment (Number) Health centers that provide psychosocial services to GBV survivors (Number) 0.00 20.00 Page 52 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline End Target Rationale: Action: This indicator is New To ensure that health services are broadly available to survivors of GBV. Component 2: Program Management and Monitoring & Evaluation (M&E) Claims registered in the Project's grievance redress mechanism 0.00 75.00 (GRM) addressed in a timely manner (Percentage) IO Table SPACE Monitoring & Evaluation Plan: PDO Indicators Mapped Methodology for Data Responsibility for Data Indicator Name Definition/Description Frequency Datasource Collection Collection Numerator: Number of people that have received a full series of a COVID-19 PIU/Office of the High Quaterly DHIS2 Routine monitoring Target population fully vaccinated (by sex) vaccine as part of the Commissioner/MINSAP Government's national target; Denominator: Total target population Numerator: Number of females that have received a full series of a COVID-19 PIU/Office of the High Quarterly DHIS2 Routine monitoring By sex vaccine as part of the Commissioner/ MINSAP Government's national target; Denominator: Total target population Population in the priority group fully Numerator: Population Quarterly DHIS2 Routine monitoring PIU/Office of the High vaccinated who is part of the priority Commissioner/ MINSAP Page 53 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) group that has received the full-series of a COVID-19 vaccine Denominator: Total population of Guinea- Bissau Numerator: Number of females part of the priority group that has received the full-series of a COVID-19 PIU/Office of the High vaccine Quarterly DHIS2 Routine monitoring By sex Commissioner/ MINSAP Denominator: Total population in the priority group that has received the full-series of a COVID-19 vaccine 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 Essential and frontline health workers National PIU/National benefitting from the first phase of vaccine Immunization Quaterly Routine monitoring Immunization deployment who are women (as Program/MIN Program/MINSAP percentage of the total women among SAP essential and frontline) Monthly Report Routine Monitoring Data PIU/MINSAP COVID-19 vaccinators trained Risk Communication and Community PIU/Office of the High Quaterly Report Routine Monitoring Engagement Strategy for COVID-19 Commissioner/MINSAP Vaccination developed Page 54 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) Pharmacovigilance System (PVS) adapted to detect Adverse Events Following Quarterly Report Routine Monitoring MINSAP Vaccination (AEFI) for the COVID-19 Vaccines Healthcare workers and community- PIU/Office of High based nurses trained on gender-based Quarterly Report Routine monitoring Commissioner/ MINSAP violence/sexual exploitation and abuse/sexual harassment Number of health centers Office of the High Health centers that provide psychosocial Quarterly Report Routine Monitoring that provide psychosocial Commissioner/ MINSAP services to GBV survivors services to GBV survivors Claims registered in the Project's Quarterly MINSAP Routine Monitoring Data PIU/MINSAP grievance redress mechanism (GRM) addressed in a timely manner ME IO Table SPACE Page 55 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) ANNEX 1: SUMMARY TABLE ON VACCINE DEVELOPMENT AND APPROVAL STATUS Status of Vaccines Approvals by SRAs and WHO (as of December 20, 2021) Vaccine SRA Emergency Use Approval WHO PQ/EUL20 BNT162b2/COMIRNATY United Kingdom (UK): December 2, 2020 WHO EUL: December 31, Tozinameran (INN) - Canada: December 9, 2020 2020 Pfizer BioNTech USA: December 11, 2020 European Union: December 21, 2020 Switzerland: December 19, 2020 Australia: January 25, 2021 mRNA-1273 - Moderna USA: December 18, 2020 WHO EUL: April 20, 2021 Canada: December 23, 2020 European Union (EU): January 6, 2021 UK: January 8, 2021 Switzerland: January 12, 2021 AZD1222 (also known UK: December 30, 2020 WHO EUL: February 15, as ChAdOx1_nCoV19/ EU: January 29, 2021 2021 for vaccines commercialized as Australia: February 16th, 2021 (overseas manufactured by SK Bio COVISHIELD in India) - manufacturing); March 21, 2021 (for local and Serum Institute of AstraZeneca/Oxford manufacturing by CSL – Seqirus) India (SII) Canada: February 26, 2021 Ad26.COV2.S - Johnson USA: February 27, 2021 WHO EUL: March 12 2021 & Johnson Canada: March 5, 2021 EU: March 11, 2021 Switzerland: March 22, 2021 SinoPharm/BIBP WHO EUL: May 7, 2021 20 WHO. Status of COVID-19 vaccines with WHO EUL/PQ evaluation process. December 20, 2021 edition. https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_20Dec2021.pdf Page 56 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) ANNEX 2: LATEST COVID-19 SITUATION IN THE COUNTRY 1. Latest COVID-19 Situation in the country. The first confirmed case of COVID-19 in Guinea- Bissau was registered on March 24, 2020. As of December 7, 2021, there were 6,444 confirmed cases and 149 deaths (Figure 2.1).21 By the same date, across the African continent, there 8.53 million22 confirmed cases of COVID-19 and 219,492 deaths.23 Guinea-Bissau’s positive cases per 100,000 inhabitants is in line with neighboring countries (Guinea-Bissau - 312, Senegal- 441, Guinea- 233, Gambia- 412). This applies as well to the number of deaths per 100,000 inhabitants (Guinea-Bissau - 7, Senegal- 11, Guinea- 3, Gambia- 14). Similarly, to other neighboring countries, Guinea-Bissau experienced a third wave in July-August 2021 due to the delta variant. Confirmed cases have doubled in July-August 2021 compared to the number of confirmed cases throughout the first year of the pandemic (the country has registered 27 percent of cumulative confirmed cases in this period since the beginning of the pandemic). Guinea-Bissau is ranked fourteenth in the highest number of cases and highest number of deaths due to COVID-19 in West Africa. Figure 2.1: COVID-19 in Guinea-Bissau a) Number of weekly confirmed cases b) Number of confirmed deaths Source: COVID-19 Data Repository by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University as of December 7, 2021, available at: https://ourworldindata.org/coronavirus/country/guinea-bissau 2. COVID-19 vaccinations began on April 2, 2021 in Guinea-Bissau using the NDVP guidelines regarding the vulnerable categories. The first round of vaccination was implemented in Bissau (Setor Autonomo Bissau) from April 2-10, 2021, as the capital has registered the majority of the cases and the deaths since the beginning of the pandemic in Guinea Bissau, using 12,000 doses of AstraZeneca vaccine donated by a South African telecommunications company and dispatched through the AU. A total of 11,229 persons received their first dose of the vaccine in SAB Health Region and in Cumura Health Area, with a loss rate of 6 percent during this campaign. The campaign resumed in SAB on May 23, 2021 and it was extended into the Bafata and Biombo Health Regions on May 22, 2021 using the AstraZeneca doses provided by the COVAX AMC and the Government of Senegal. The country continued to use the vaccination campaign strategy to 21 Source: https://ourworldindata.org/coronavirus/country/guinea-bissau 22 Source: https://ourworldindata.org/coronavirus/country/africa 23 Source: https://www.statista.com/statistics/1170530/coronavirus-deaths-in-africa/ Page 57 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) increase coverage rates. As of November 15, 2021, the country received the following doses (total: 782,070): • COVAX AMC: 57,600 (Astrazeneca) • AU/MTN: 12,000 (Astrazeneca) • Bilateral Portugal: 100,000 (Astrazeneca) • Bilateral Senegal: 4,000 (Astrazeneca) + 6.070 (Sinopharm) • Bilateral China: 300,000 (Sinopharm) • Bilateral USA: 302,400 (J&J) 3. Starting from August 2021, the vaccination campaign was extended to the whole territory, covering the 11 Health Areas of Guinea Bissau. As of December 7, 2021, 388,626 doses have been administered, or 12.5 percent of the total population is fully vaccinated, and 35.0 percent of the targeted eligible population (18 years of age and over) has been fully vaccinated. In terms of AEFIs, as of December 7, 2021, the country has recorded 532 cases of moderate AEFIs, five cases of severe AEFIs, and four deaths that are being investigated to determine if they were caused by COVID-19 vaccinations. To address vaccine hesitancy issues, the Government has ramped up its risk communication and community engagement activities. Moreover, in November 2021, the GoGB has also signed a decree that makes it mandatory to be vaccinated to use public transportation, to enter schools/universities and to travel across regions. People would need to present their vaccination card before participating in any of these activities. This decree was created to increase vaccination coverage as it continued to remain low. The October 25- November 9, 2021 vaccination campaign benefitted from this decree with the country being able to reach 20 percent of its targeted population. For the country to reach its 70 percent target, more emphasis will have to be made in acquiring vaccines approved for us by adolescents (12-17 percent). Approximately 30 percent of the target population are adolescents and at this time, only Pfizer vaccines are WHO approved for use for this group. Ultra-cold storage is also limited, which will need to be addressed since the country plans to acquire mRNA vaccines such as Pfizer. 4. There are gendered implications of the COVID-19 pandemic that has disproportionately affected women in Guinea-Bissau. Women are mostly dependent on the informal economic sector (selling fish, catering, trading of fruits and other foods) and agricultural sector (cashews) that have been impacted by the pandemic in Guinea-Bissau, which has led to reduced incomes as well as an increase in the burden of domestic care.24 Moreover, 59 percent of health workers in Guinea-Bissau are women; 72 percent of which are nurses, midwives, and CHWs, and therefore are more exposed to COVID-1925. During these turbulent times, women also bear the brunt of domestic care such as taking care of children, cooking, and cleaning. This is then compounded by a potential increase of domestic abuse and GBV in Guinea-Bissau where gender inequality is already high and FGM is widespread.26 24 UNDP. 2020. Socio-economic Impact Analysis of COVID-19 in Guinea-Bissau. Available at: file:///C:/Users/wb408116/Downloads/Guinea_Bissau_SocioEconomicImpact_UN.pdf 25 Guinea-Bissau National Health Plan 2018-2022 26 UNFPA (2020, April 27). Impact of the COVID-19 Pandemic on Family Planning and Ending GBV, Female Genital Mutilation and Child Marriage. Available at: https://www.unfpa.org/resources/ impact-covid-19-pandemic-family-planning-and-ending-gender- Page 58 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) 5. Early vaccination coverage data was showing that women were less vaccinated than men. Although there has been a larger male mortality of COVID-19 and the tendency in many countries is to overlook the importance of gender inequalities in social and economic activity, it is important to not leave women behind. Moreover, there is also misinformation regarding the COVID-19 vaccines, which has increase vaccine hesitancy. For instance, there is misinformation spreading that COVID-19 vaccines may cause infertility, which has impacted the vaccination coverage among women and adolescent girls. The Government’s social engagement strategy to reduce vaccine hesitancy includes active disinformation management through social listening, review, and follow-up with exposed groups. WHO and UNICEF also plan to conduct a study to understand the vaccine hesitancy among this group and to find solutions. 6. In late September 2021, as cases from the third wave was declining, vaccine coverage among women was around 36 percent. After a successful vaccination campaign from October 25, 2021 to November 9, 2021, vaccination coverage among women increased to 45 percent. The GoGB improved communication and community engagement and ensured that vaccination sites were closer to where women work and live. This approach will continue to be used for vaccine deployment to increase the coverage of COVID-19 vaccines among women. 7. The COVID-19 pandemic has also impacted the continuity of essential services, particularly at the beginning of the pandemic. The health system in Guinea-Bissau was already fragile before the COVID-19 pandemic. It has some of the highest prevalence of HIV and tuberculosis infections in West Africa, and one of the highest maternal and mortality rates and lowest life expectancies in the world.27 Lockdown measures, curfews and transport disruptions have compounded the problem and, in some instances prevented vulnerable populations from accessing healthcare. Access to certain supplies and routine vaccinations was limited. 28 For instance, insecticide-treated bed nets used to reduce malaria cases that are usually distributed in one common area in a community had to be distributed using a door-to-door strategy to enable physical distancing. Moreover, immunization coverage also decreased in 2020 with only 27 percent districts with at least 80 percent of children 0-11 months vaccinated with three doses of Diphtheria and Tetanus Toxoids/Acellular Pertussis Vaccine-containing/Penta vaccine and 69 percent of children under one years old receiving measles containing vaccine. This trend continues with stockouts expected for routine vaccinations. 8. Moreover, public sector healthcare workers in Guinea-Bissau are on strike for the past ten months to demand better pay, risk allowances and improve health sector working conditions such as the availability of supplies, equipment, and infrastructure. Several hospitals and private clinics are at their maximum capacity. The hospitals and health centers of the country, including the Simão Mendes National Hospital (the largest public hospital in the country), are closed. During this time, patients are using military hospitals and private clinics for treatment and care. based-violence-female-genital. 27 UNDP. 2020. COVID-19 Socio-Economic Impact Analysis for Guinea-Bissau. 28 UNICEF. Guinea-Bissau COVID-19 Situation Report no.24 – December 2020. Page 59 of 60 The World Bank Additional Financing for the Guinea-Bissau COVID-19 Vaccine Project (P178198) ANNEX 3: SUMMARY OF THE PARENT PROJECT COMPONENTS 1. The Guinea-Bissau Vaccine Project (P176721) was approved on June 29, 2021 and became effective on October 20, 2021. The PDOs are aligned to the results chain of the COVID-19 SPRP MPA. The PDO is to prevent, detect and respond to the threat posed by COVID-19 and strengthen national systems for public health preparedness in Guinea-Bissau. 2. The proposed project will support the GoGB efforts to further strengthen its response to COVID-19 pandemic by purchasing COVID-19 vaccines, preparing the immunization system for the deployment of the COVID-19 vaccine, and supporting the distribution of these vaccines. The proposed project will strengthen the national immunization and related health delivery system in a way that will promote an effective COVID-19 response and generate, as far as feasible, long-lasting resilience. Purchasing vaccines is just one step in a complex, multi-dimensional effort that involves detailed planning and implementation of a vaccine deployment program in Guinea-Bissau. This includes a variety of issues such as effective microplanning, safe and appropriate transportation, storage, training, ancillary materials, registration, and effective vaccine logistics and a suitable information management system. Political support, technical assistance services, training, social mobilization campaigns, and mechanisms that remove demand-side barriers to access are also essential to foster confidence and promote the early take-up of vaccines. 3. Component 1: Emergency COVID-19 Response (US$4.7 million equivalent). Vaccine purchasing is being done through Component 1. In Sub-component 1.1: COVID-19 Vaccine purchasing (US$2.62 million), the project supports the GoGB to purchase vaccines to cover up to 30 percent of the population (of which COVAX AMC will cover 20 percent and 10 percent financed by IDA’s funds). In Sub-component 1.2: COVID-19 Vaccine planning and distribution (US$2.08) supports the GoGB to implement the COVID- 19 NDVP and ensure the necessary conditions are in place to implement it, and to strengthen Guinea- Bissau’s ability to respond to COVID-19 and future outbreaks. This includes support in: (i) program planning and management, (ii) distribution of vaccines, consumables and strengthening the immunization supply chain system; and program delivery. 4. Component 2: Project Management and M&E (US$0.3 million equivalent). The component supports the coordination and management of project activities, including procurement of goods and their distribution across health facilities within Guinea-Bissau, which will be coordinated by the Office of the High Commissioner for COVID-19. Further, it also supports strengthening existing data and monitoring systems (immunization and public health). Page 60 of 60