Document of The World Bank FOR OFFICIAL USE ONLY Report No: PAD4909 INTERNATIONAL BANK FOR RECONSTRUCTION AND DEVELOPMENT PROJECT PAPER ON A PROPOSED ADDITIONAL LOAN IN THE AMOUNT OF EUR 20.9 MILLION (US$22 MILLION EQUIVALENT) AND A GRANT FROM THE IBRD FUND FOR INNOVATIVE GLOBAL PUBLIC GOODS SOLUTIONS IN THE AMOUNT OF US$1.8 MILLION TO THE REPUBLIC OF TUNISIA FOR A TUNISIA COVID-19 RESPONSE PROJECT UNDER THE COVID-19 STRATEGIC PREPAREDNESS AND RESPONSE PROGRAM (SPRP) USING THE MULTIPHASE PROGRAMMATIC APPROACH (MPA) WITH A FINANCING ENVELOPE OF UP TO US$ 6 BILLION APPROVED BY THE BOARD ON APRIL 2, 2020 AND UP TO US$ 12 BILLION ADDITIONAL FINANCING APPROVED BY THE BOARD MAY 27, 2022 Health, Nutrition & Population Global Practice Middle East And North Africa Region This document has a restricted distribution and may be used by recipients only in the performance of their official duties. Its contents may not otherwise be disclosed without World Bank authorization. CURRENCY EQUIVALENTS (Exchange Rate Effective April 30, 2022) Currency Unit = EUR EUR 1 = US$1.05 US$1 = EUR 0.95 FISCAL YEAR January 1 - December 31 Regional Vice President: Ferid Belhaj Country Director: Jesko S. Hentschel Regional Director: Keiko Miwa Practice Manager: Rekha Menon Task Team Leader(s): Denizhan Duran, Luc Laviolette ABBREVIATIONS AND ACRONYMS Acronym Explanation ADM Accountability and Decision-Making Matrix AF Additional Financing AMC Advance Market Commitment APA Alternate Procurement Arrangements AVAT African Vaccine Acquisition Taskforce BIBP Beijing Institute of Biological Products Co., Ltd CERC Contingency Emergency Response Component COVID-19 Coronavirus disease 2019 DSSB Basic Health Services Directorate - Direction des Soins de Santé de Base DFIL Disbursement and Financial Information Letter EMA Emergency Market Authorization ESMF Environmental and Social Management Framework ESRS Environmental and Social Review Summary ESS Environmental and Social Standards EU European Union EUL Emergency Use Listing EUR Euro FY Fiscal Year GAVI Global Alliance for Vaccines and Immunization GDP Gross Domestic Product GOT Government of Tunisia GPG IBRD Fund for Innovative Global Public Goods Solutions GRS Grievance Redress Service IBRD International Bank for Reconstruction and Development IDA International Development Association IFC International Finance Corporation IMF International Monetary Fund IFR Interim Unaudited Financial Reports ISR Implementation Status and Results Report MENA Middle East and North Africa MFDS Ministry of Food and Drug Safety MOH Ministry of Health MPA Multiphase Programmatic Approach mRNA Messenger RNA NCD Non-communicable diseases NMPA National Medical Products Administration NRA National Regulatory Agency PAD Project Appraisal Document PCR Polymerase Chain Reaction PCT Central Pharmacy of Tunisia - Pharmacie Centrale de Tunisie PDO Project Development Objective POM Project Operational Manual PPE Personal Protective Equipment PQS Performance, Quality, Safety RSA Regional Safeguards Advisor SARS Severe acute respiratory syndrome SOP Series of Projects SORT Systematic Operations Risk-Rating Tool SPRP Strategic Preparedness and Response Program TA Technical Assistance TOR Terms of Reference UGPO Project Implementation Unit – Unité de gestion de projets par objectif UK United Kingdom UN United Nations UNDP United Nations Development Program UNOPS United Nations Office for Project Services UNICEF United Nations Children's Fund US United States USAID United States Agency for International Development USFDA United States Federal Drug Agency VAC Vaccine Approval Criteria WBG World Bank Group WHO World Health Organization TABLE OF CONTENTS I. BACKGROUND AND RATIONALE FOR ADDITIONAL FINANCING ........................................ 7 A. Introduction ................................................................................................................. 7 B. Consistency with the Country Partnership Framework (CPF) .................................... 8 C. Project Design and Scope ............................................................................................ 8 D. Project Performance .................................................................................................... 9 E. Rationale for Additional Financing ............................................................................ 11 II. DESCRIPTION OF ADDITIONAL FINANCING .................................................................... 16 A. Proposed Changes ...................................................................................................... 16 B. Sustainability .............................................................................................................. 19 III. KEY RISKS ..................................................................................................................... 20 IV. APPRAISAL SUMMARY .................................................................................................. 22 V. WORLD BANK GRIEVANCE REDRESS .............................................................................. 24 VI SUMMARY TABLE OF CHANGES ..................................................................................... 26 VII DETAILED CHANGE(S) .................................................................................................... 26 VIII. RESULTS FRAMEWORK AND MONITORING ................................................................... 31 ANNEX 1: SUMMARY TABLE ON VACCINE DEVELOPMENT AND APPROVAL STATUS .............. 43 ANNEX 2: LATEST COVID-19 SITUATION IN TUNISIA ............................................................. 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) BASIC INFORMATION – PARENT (Tunisia COVID-19 Response project - P173945) Country Product Line Team Leader(s) Tunisia IBRD/IDA Luc Laviolette Project ID Financing Instrument Resp CC Req CC Practice Area (Lead) P173945 Investment Project HMNHN (9320) MNC01 (392) Health, Nutrition & Financing Population Implementing Agency: Ministry of Health ADD FIN TBL1 Is this a regionally tagged project? No Bank/IFC Collaboration No Expected Approval Date Closing Date Guarantee Environmental and Social Risk Classification Expiration Date 30-Apr-2020 31-Mar-2025 Moderate 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 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) 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 012) To prevent, detect and respond to the threat posed by COVID-19 and strengthen national systems for public health preparedness. Ratings (from Parent ISR) RATING_DRAFT_NO Implementation Latest ISR 21-Jul-2020 25-Mar-2021 05-Aug-2021 17-Feb-2022 Progress towards achievement of PDO S S S S Overall Implementation Progress (IP) S S S S Overall ESS Performance S MS MS MS Overall Risk M M H S Financial Management S S MS MS Project Management S S S S Procurement S MS MS MS Monitoring and Evaluation S S S S BASIC INFORMATION – ADDITIONAL FINANCING (Second Additional Financing to Tunisia COVID-19 Response Project - P178540) ADDFIN_TABLE Urgent Need or Capacity Project ID Project Name Additional Financing Type Constraints P178540 Second Additional Restructuring, Scale Up Yes Financing to Tunisia COVID-19 Response Project Page 2 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Financing instrument Product line Approval Date Investment Project IBRD/IDA 27-May-2022 Financing Projected Date of Full Bank/IFC Collaboration Disbursement 31-Jul-2025 No Is this a regionally tagged project? No Financing & Implementation Modalities Child [✓] Multiphase Programmatic Approach [MPA] [ ] Series of Projects (SOP) [ ] Fragile State(s) [ ] Performance-Based Conditions (PBCs) [ ] Small State(s) [ ] Financial Intermediaries (FI) [ ] Fragile within a Non-fragile Country [ ] Project-Based Guarantee [ ] Conflict [✓] Responding to Natural or Man-made disaster [ ] Alternate Procurement Arrangements (APA) [ ] Hands-on, Enhanced Implementation Support (HEIS) [✓] Contingent Emergency Response Component (CERC) Disbursement Summary (from Parent ISR) Net Source of Funds Total Disbursed Remaining Balance Disbursed Commitments IBRD 120.00 81.32 35.82 69 % IDA % Grants % MPA Financing Data (US$, Millions) Financing MPA Program Financing Envelope 18,000.00 MPA FINANCING DETAILS (US$, Millions) MPA FINA NCI NG DET AILS (US$, Millions) Approve d Board Approved MPA Financing Envelope: 18,000.00 Page 3 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) MPA Program Financing Envelope: 18,000.00 of which Bank Financing (IBRD): 9,900.00 of which Bank Financing (IDA): 8,100.00 of which other financing sources: 0.00 PROJECT FINANCING DATA – ADDITIONAL FINANCING (Second Additional Financing to Tunisia COVID-19 Response Project - P178540) PROJECT FINANCING DATA (US$, Millions) SUMMARY -NewFi n1 SUMMARY (Total Financing) Proposed Additional Total Proposed Current Financing Financing Financing Total Project Cost 120.00 23.80 143.80 Total Financing 120.00 23.80 143.80 of which IBRD/IDA 120.00 22.00 142.00 Financing Gap 0.00 0.00 0.00 DETAILS - Additional Financing NewFinEnh1 World Bank Group Financing International Bank for Reconstruction and Development (IBRD) 22.00 Non-World Bank Group Financing Trust Funds 1.80 IBRD Fund for Innovative GPG Solutions 1.80 COMPLIANCE Policy Does the project depart from the CPF in content or in other significant respects? Page 4 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) [ ] Yes [ ✔ ] No Does the project require any other Policy waiver(s)? [ ] Yes [ ✔ ] No ESStandards Environmental and Social Standards Relevance Given its Context at the Time of Appraisal E & S Standards Relevance Assessment and Management of Environmental and Social Risks and Impacts Relevant Stakeholder Engagement and Information Disclosure Relevant Labor and Working Conditions Relevant Resource Efficiency and Pollution Prevention and Management Relevant Community Health and Safety Relevant Land Acquisition, Restrictions on Land Use and Involuntary Resettlement Not Currently Relevant Biodiversity Conservation and Sustainable Management of Living Natural Not Currently Relevant Resources Indigenous Peoples/Sub-Saharan African Historically Underserved Traditional Not Currently Relevant Local Communities Cultural Heritage Not Currently Relevant Financial Intermediaries Not Currently Relevant ESStandardsNote NOTE: For further information regarding the World Bank’s due diligence assessment of the Project’s potential environmental and social risks and impacts, please refer to the Project’s Appraisal Environmental and Social Review Summary (ESRS). INSTITUTIONAL DATA Practice Area (Lead) Health, Nutrition & Population Contributing Practice Areas Climate Change and Disaster Screening This operation has been screened for short and long-term climate change and disaster risks Page 5 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) PROJECT TEAM Bank Staff Name Role Specialization Unit Team Leader (ADM Denizhan Duran HMNHN Responsible) Luc Laviolette Team Leader HMNDR Procurement Specialist (ADM Abdoulaye Keita EMNRU Responsible) Financial Management Jean Charles Amon Kra EMNGU Specialist (ADM Responsible) Environmental Specialist (ADM Amos Abu SMNEN Responsible) Social Specialist (ADM Eloise Sophie Fluet SMNSO Responsible) Ahmed Zouari Team Member EMNGU Andrianirina Michel Eric Team Member Disbursement WFACS Ranjeva Asma Ben Abdallah Team Member Operations MNCTN Elena Segura Labadia Counsel LEGAM Fatima-Ezzahra Mansouri Team Member HMNHN Georges Tony Abou Rjaily Team Member WFACS Karim Chabir Team Member EMNRU Leila Chelaifa Team Member MNCTN Majda Benzidia Team Member EPVGE Mohamed Adnene Environmental Specialist SMNEN Bezzaouia Ravindra Cherukupalli Team Member HMNHN Yassine Kalboussi Team Member HMNHN Extended Team Name Title Organization Location Page 6 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) I. BACKGROUND AND RATIONALE FOR ADDITIONAL FINANCING A. Introduction 1. This Project Paper seeks the approval of the World Bank Regional Vice President for the Middle East and North Africa (MENA) region to provide an additional financing (AF) to the Tunisia COVID-19 Response Project (P173945) (parent project) in the amount of US$23.8 million equivalent, financed by a loan from the International Bank for Reconstruction (IBRD) in the amount of EUR 20.9 million (US$22 million equivalent) and a grant in the amount of US$1.8 million from the IBRD Fund for Innovative Global Public Goods Solutions (GPG). The parent project, in the amount of US$20 million, was approved by the World Bank on April 30, 2020, as part of the COVID-19 Strategic Preparedness and Response Plan (SPRP) using the Multiphase Programmatic Approach (MPA), approved by the World Bank Board of Executive Directors on April 2, 2020 1, and became effective on June 1, 2020. A first AF, in the amount of US$100 million, was approved by the World Bank on March 26, 2021, and became effective on May 26, 2021. This first AF expanded the activities of the parent project in Tunisia, providing funds to fully vaccinate 57 percent of the Tunisian population against COVID-19, and strengthen the vaccine deployment system. To date, this financing, as well as bilateral and multilateral donations, have enabled Tunisia to fully vaccinate 53 percent of its population against COVID-19, resulting in Tunisia exceeding its coverage rate target of 50 percent full immunization by the end of 2021. Tunisia currently has a sufficient vaccine stock, both in the country as well as in the pipeline, to fully vaccinate 70 percent of its population and to provide boosters for priority populations. Despite progress in vaccine coverage, Tunisia continues to experience very limited health system capacity through the COVID-19 pandemic, as manifested by the highest COVID-19 case mortality rates in the MENA region as well as the world. The proposed second AF will therefore strengthen the resiliency of clinical, emergency and surgical care capacity, which will contribute to Tunisia’s recovery from COVID-19 through reducing the burden of severe COVID-19 cases as well as climate-related health crises. 2. The AF is being proposed at a pivotal point during a period of economic and political difficulties. All major macro-economic indicators have worsened, and Tunisia is facing international loan repayments in the next year. The sharp decline in the Tunisian economy in 2020 (-9.2 percent) has been followed by a slow economic recovery in 2021. As a result, the COVID-19 related contraction of the Gross Domestic Product (GDP) between 2019 and 2021 is the most severe in the region among non-fragile and conflict- affected countries. Moreover, the economic rebound has been well below expectations with only 3 percent against an initial forecast of 5.8 percent, putting even further pressure on government spending. Given this macroeconomic situation, which is further exacerbated by the impact of the war in Ukraine through increases in food and energy prices, it is difficult for the Government of Tunisia (GOT) to mobilize domestic resources in a predictable manner for the purchase of medical equipment which will strengthen health system capacity. In parallel, Tunisia has entered a new political phase. Following unrest linked to the impact of the COVID-19 and the economic crisis, the President invoked Article 80 of the Constitution on July 25, 2021. The exceptional measures were subsequently extended through the issuance of Presidential Decree 117 of September 22, 2021, which partially suspends the application of the 2014 1On October 13, 20201, the World Bank Board of Executive Directors approved an additional financing (PAD4185) to the Global COVID-19 MPA in the amount of US$12 billion. Page 7 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Constitution. The political climate in Tunisia poses additional economic and social uncertainty. The economic downturn has also significantly impacted the government’s health budget, which saw a 16 percent reduction in 2022 compared to 2021, most of which has impacted the investment budget including the procurement of medical equipment.2 The proposed second AF will help close the financing gap emerging from these significant budget reductions, thus enabling improvements in the delivery of clinical, emergency, and surgical care. B. Consistency with the Country Partnership Framework (CPF) 3. The proposed second AF is consistent with the World Bank Group (WBG) twin goals, country and regional strategies. Strengthening the capacity of the health system in Tunisia will contribute to reducing poverty and boosting shared prosperity in a sustainable manner and accelerate the recovery of human capital losses. The AF will support Pillar 1 and Pillar 4 of the WBG’s COVID-19 Response Approach Paper, Saving Lives, Scaling-Up Impact and Getting Back on Track. The AF also contributes to the implementation of the WBG’s MENA enlarged strategy (2019) by addressing gaps in human capital, including modernization of the health system, in pursuit of Universal Health Coverage (UHC). The AF is also consistent with the Tunisian Country Partnership Framework (CPF) (FY16-20) (Report No. 104123-TN) discussed by the World Bank Executive Directors on May 1, 2016, which was extended by one year to FY21 through the CPF Performance and Learning Review (Report No. 123957-TN) (May 22, 2018). Specifically, it supports Pillar 3 (Promoting Human Development and Social Inclusion) objectives of improving nutrition, hygiene, and reducing under-five mortality rates. By building the strength of the health system and its resilience to shocks, the AF is aligned with the focus of the CPF Objective 2, which focuses on improving health services. The proposed second AF, like the parent project and the first AF, is also aligned with both global health priorities and IBRD/IDA priorities on improving pandemic preparedness, and significantly enhances the World Bank’s support to the Tunisian health system. 3 C. Project Design and Scope 4. The Project Development Objective (PDO) design and implementation arrangements of the parent project and the first AF will be maintained. The PDO of the parent project is to prevent, detect and respond to the threat posed by COVID-19 and strengthen national systems for public health preparedness. The project includes four components: Component 1: Emergency COVID-19 Response (US$102.85 million), Component 2: Supporting Health Systems Strengthening (US$14.75 million); Component 3: Implementation, Management, Monitoring and Evaluation (US$2.1 million), and a no-cost Component 4: Contingency Emergency Response Component (CERC). The PDO and the project design, including the components structure, and institutional arrangements will remain unchanged under the second AF. Moreover, no new components will be added, but Component 2 will be scaled up by an additional US$23.8 million. The additional funds will be used to procure medical supplies and capital 2 https://www.tunisienumerique.com/2022-baisse-du-budget-du-ministere-de-la-sante-de-16-pas-de-trace-de-lhopital-de- kairouan/ 3 The project appraisal document (PAD) for the parent project (P173945): https://documents1.worldbank.org/curated/en/887021588714435366/pdf/Tunisia-COVID-19-Response-Project.pdf; the project paper for the first additional financing (P175785): https://documents1.worldbank.org/curated/en/754341617069835875/pdf/Tunisia-COVID-19-Response-Project-Additional- Financing.pdf Page 8 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) medical equipment to further strengthen clinical, surgical and emergency health care delivery, thus strengthening the resiliency of the health system. A Level II restructuring is proposed to modify the results framework to reflect the expanded scope of Component 2. The technical audit requirement in the original Loan Agreement for the parent project will be eliminated, given the fact that the government did not procure lab testing equipment and supplies under Component 1 as was originally planned. Given the progress in implementation of the project, the overall risk rating is reduced to Substantial. All risk mitigation measures of the parent project remain applicable. The Ministry of Health (MOH) will continue to be the implementing agency. The Directorate of Basic Healthcare (Direction des soins de santé de Base- DSSB) within the MOH, in charge of the National Immunization Program rollout, will continue to ensure the day-to-day implementation of project activities and their monitoring. The project management unit (Unite de gestion par objectif-UGPO), within the MOH, will continue to be responsible for the fiduciary and environmental and social safeguards management aspects. D. Project Performance 5. The parent project and the first AF have contributed to a strong COVID-19 vaccination program performance and helped close key equipment gaps in COVID-19 response. Tunisia currently has a full vaccination rate of 54 percent of the national population (68 percent for the target population of above 12 years of age), one of the highest among countries in the African continent as well as in the MENA region. Over 70 percent of adults (above age 18) have already been fully immunized, and 40 percent of the highest risk groups have already received a booster. The project has contributed to reaching this rate through financing enough doses to cover 57 percent of the national population. As of May 2022, over 61 percent of the purchased doses have already arrived in the country, with the rest scheduled to arrive through the rest of 2022; over 80 percent of the doses that have arrived in the country have already been deployed. The project also continues to support key dimensions of COVID-19 vaccine deployment, such as the procurement of syringes, implementation of communication campaigns to reduce hesitancy, strengthening of warehouse capacity, and strengthening the information system. Reducing inequities in vaccine coverage continues to be a priority for the government, and mobile outreach campaigns continue to be implemented. In addition to vaccine procurement and deployment, the project is also supporting the procurement of key medical equipment to respond to COVID-19 and strengthen intensive care capacity, for which additional resources are needed. 70 percent of the parent project and the first AF has been disbursed as of May 6, 2022 (US$81.32 million out of US$120 million). 6. Progress towards the achievement of the PDO and overall implementation progress are rated Satisfactory in the last Implementation Status and Results Report (ISR) of February 10, 2022, reflecting the success of the vaccination campaign in Tunisia as well as project implementation. The environmental and social safeguards, financial management, and procurement are rated Moderately Satisfactory. The Environmental and Social Management Framework (ESMF), the Stakeholder Engagement Plan (SEP) and the Labor Management Procedures (LMP), which were updated and disclosed on the World Bank and MOH websites on October 26, 2021, have been further updated to reflect the current performance of the project and changes in financing, and will be redisclosed prior to the launch of activities under the proposed second AF. The Project Operational Manual (POM) has been finalized and cleared by the World Bank on December 10, 2021. The POM will be updated to reflect the activities under the AF. There are no overdue audit or financial reports. Page 9 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) 7. Significant progress has been made in the implementation of Component 1 (Emergency COVID- 19 Response - US$102.85 million). Fifty-eight percent (US$68.37 million) of allocated funds have been disbursed with the remaining funds being fully committed. The funds have been utilized for the procurement of personal protective equipment (PPE) as well as Pfizer vaccines, with the entirety of the funds under the parent project disbursed. The first AF has mobilized US$83 million for the procurement of COVID-19 vaccines, which have been allocated to two contracts. The first is a bilateral contract signed between the GOT and Pfizer for 8,002,800 doses. Of these 8,002,800 doses, the World Bank is financing 6,378,907 doses. In order to reflect this arrangement, a separate agreement between the Central Pharmacy of Tunisia (PCT) and the MOH was signed for vaccines financed by the World Bank, including cost of delivery and distribution from the port of entry to health facilities, for these 6,378,907 doses. 4 As of May 6, 2022, 5,062,590 of these doses have been delivered to Tunisia, and disbursements have been completed. The second contract was signed between the GOT and the African Vaccine Acquisition Trust (AVAT) and the African Import-Export Bank in the form of a Commitment Undertaking Agreement, 1.3 million of which have already been delivered. Combined, the procurement of Pfizer and Janssen vaccines will exhaust the resources allocated to Component 1, resulting in Tunisia having procured with project funds enough vaccines to fully vaccinate 57 percent of the population (9,960,234 doses), which complement the bilateral and multilateral vaccine donations (Table 2). 8. The entirety of resources under Component 2 (Supporting Health Systems Strengthening (US$14.75 million) has been committed to support COVID-19 vaccine delivery and to strengthen the resiliency of the Tunisian health system. Given the significant amount of donations of vaccines and equipment received by the Tunisian government during the COVID-19 surge in the first half of 2021, the resources under this Component had to be reprogrammed for additional needs within the scope of the project. The procurement plan which received the no-objection of the World Bank on March 31, 2022, includes support for procurement of ancillary supplies for vaccines (i.e., syringes, alcohol, other medical supplies), technical assistance (TA) for communication, strengthening the primary care information system through scaling up the vaccine information system (eVax), and support for waste management, storage, and logistics. These activities are under implementation. The government plans for use the remainder of funds under Component 2 for the procurement of additional personal protective equipment, capital medical equipment such as oxygen therapy equipment, laryngoscopes, oximeters, ventilators, and hospital beds to support COVID-19 response. Previous waves of COVID-19 have demonstrated the significant and urgent need to strengthen hospital capacity in Tunisia to respond to current and future health challenges. The upcoming disbursements of funds available under this Component will further strengthen health system resiliency. 9. Progress has been made in the implementation of Component 3 (Implementation, Management, Monitoring and Evaluation - (US$2.1 million) to strengthen project management. Recruitment is in progress to hire consultants to support project implementation in the areas of procurement, financial management, environmental and social compliance, communication, 4 The Pfizer purchase agreement was signed between the PCT and Pfizer on February 26, 2021 for 2,000,700 doses to be delivered by the end of quarter 3 of 2021. The first amendment between PCT and Pfizer was signed on May 3, 2021, which added a further 2,000,700 doses to be delivered by the end of quarter 3 of 2021. A second amendment was signed between PCT and Pfizer on September 17, 2021, which added a further 4,000,400 doses to be delivered by the end of quarter 1 of 2022, amounting to a total of 8,002,800 doses. The PCT-Pfizer contract, its two subsequent amendments, as well as the PCT-Ministry of Health agreement have all been reviewed and cleared by the World Bank Operational Procurement Review Committee (OPRC) in November 2021.5 All data in this paragraph is from Our World in Data and Tunisian eVax open data platform, accurate as of May 23, 2022. Page 10 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) coordination, monitoring and evaluation, as well as the launch of Iterative Beneficiary Monitoring (IBM) surveys to measure project performance and assess the success of communication and citizen engagement efforts. Six support staff have been hired to support grievance management, and almost 90 percent of all grievances received since the beginning of the campaign have been resolved. E. Rationale for Additional Financing 10. The AF is being proposed as Tunisia is recovering from the significant impact of COVID-19 on its health system. Tunisia is one of the countries hardest hit by COVID-19 in the MENA region. Since the beginning of the pandemic, Tunisia has recorded a total of over 1.04 million confirmed cases and 28,628 confirmed deaths from COVID-19. 5 Tunisia has experienced multiple surges, with the most severe one in July-August 2021. A fifth surge, caused by the more transmissible Omicron variant, was experienced in January – February 2022. These surges have overwhelmed the health system and resulted in the highest confirmed COVID-19 deaths per population in the MENA region and one of the highest in the world, with 2,400 deaths per million population, exposing constraints in intensive care capacity. While Tunisia has reached high vaccination rates due to proactive vaccine procurement arrangements as well as mobilization of surge vaccine deployment capacity, it needs to concentrate on recovering from the shock of COVID-19, through strengthening the health system’s capacity to respond to the current disease burden as well as future shocks. 11. COVID-19 has revealed the limitations of the Tunisian health system in terms of clinical, emergency, and surgical care capacity, particularly at the hospital level. Even as Tunisia has recorded significant health gains over the past few decades, since 2011, various health outcomes have been stagnating or declining. Key indicators such as under-5 and infant mortality rates have increased slightly between 2011-2018. The majority of the disease burden in Tunisia is for chronic diseases, such as heart disease, stroke, hypertension, chronic kidney disease, diabetes, and chronic lung disease; conditions which put the majority of the Tunisian population at risk for severe COVID-19. 6 low and inequitable access, as well as low quality of care affect proper management of these conditions: 19 percent of the population is diabetic, but only 28 percent of this population has their blood sugar controlled. Similarly, 36 percent of the Tunisian population has hypertension, but less than a third have their blood pressure controlled.7 These low levels of effective coverage result in a severe burden of serious cases, which are managed at tertiary health facilities. Given low levels of service availability at the primary care system, most of these cases are managed at hospitals which suffer from significant physical resource capacity constraints. During the COVID-19 pandemic, 35 percent of Tunisian households indicated disruptions to care-seeking for essential health services, highlighting disruptions to access to clinical, emergency, and surgical services, which has further contributed to an increased chronic disease burden. 8 This was reflected in the high levels of excess mortality due to COVID-19: Tunisia’s excess mortality rate of 324 per 100,000 is three times its recorded COVID-19 mortality rate, and is the second highest in the MENA region, demonstrating 5 All data in this paragraph is from Our World in Data and Tunisian eVax open data platform, accurate as of May 23, 2022. 6 https://www.healthdata.org/tunisia 7 Tunisian Health Examination Survey (THES), 2017 8 COVID-19 Household Monitoring Dashboard. https://www.worldbank.org/en/data/interactive/2020/11/11/covid-19-high- frequency-monitoring-dashboard Page 11 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) the limits of the health system in managing the direct and indirect effects of the pandemic. 9 The high levels of excess mortality reflect both an underreporting in COVID-19 mortality, as well as increases in mortality due to foregone care. The recent budget cut on the MOH budget of 16 percent has further diminished the capacity of the health system, particularly the diagnosis and treatment of non- communicable diseases (NCDs), as well as effective transportation and management of emergency cases. 12. The proposed second AF will contribute to enabling Tunisia to further strengthen its health system capacity and resiliency, reducing the future burden of severe COVID-19 and improving its ability to withstand future health challenges. Tunisia’s high level of excess mortality during the COVID-19 pandemic demonstrated the constraints of its health system to prevent morbidity and mortality during a period of increased demands on the health system. In this sense, improved investments in the clinical, emergency, and surgical care capacity of the health system will have a twofold effect in improving the resiliency of the health system: first, through strengthening the management of chronic cases with a significant impact, such as chronic kidney disease and cardiovascular conditions, there will be a reduction in the severity of COVID-19 cases, therefore reducing the reliance on intensive care units as well as hospital-based case management. Second, expanded health system capacity will increase the health system’s capacity to protect essential clinical, emergency, and surgical services even when demand on health services significantly increases. In the context of the implementation of the National Health Policy as well as the focus on improving access to health services, this proposed second AF focuses on procurement to respond to the most immediate policy needs in the delivery of clinical, emergency, and surgical services. 13. The proposed second AF will also strengthen Tunisia’s ability to withstand future climate- related health shocks. Tunisia is considered highly vulnerable to climate change and is expected to experience adverse impacts from increased temperatures, increased aridity, reduced precipitation, and rising sea levels. 10 In addition to the risk posed by potential future waves of COVID-19, Tunisia is also facing substantial health risks that will arise due to the impact of climate change on extreme heat and droughts, especially in the Southern and Central regions of the country. Climate change is expected to significantly increase cases of both infectious diseases such as vector-borne and diarrheal diseases, as well as NCDs such as respiratory and cardiovascular diseases which are further exacerbated by heatwaves, drought, and air pollution. 11 In particular, climate change can exacerbate the burden of severe kidney and cardiovascular diseases, both of which are already particularly high in Tunisia. 12 This poses a risk of further overwhelming the health system, which is already facing significant resource constraints: the impact of climate change would not only increase the immediate disease burden, but also further increase foregone care. The proposed scale-up of Component 2 to further strengthen health system resiliency will ensure expansion of clinical and emergency care capacity, through the procurement of medical equipment to further reinforce the health system. This procurement will improve access and quality of care and 9 Excess mortality is defined as the difference between the number of deaths during the pandemic and the number of expected deaths in the absence of the pandemic. Wang, H., Paulson, K.R., Pease, S.A et al, 2022. Estimating excess mortality due to the COVID-19 pandemic: a systematic analysis of COVID-19-related mortality, 2020–21. The Lancet S0140673621027963. https://doi.org/10.1016/S0140-6736(21)02796-3 10 https://climateknowledgeportal.worldbank.org/country/tunisia 11 Republic of Tunisia, Ministry of Health (2010). Stratégie d’adaptation du secteur de la santé au changement climatique. 12 Borg, M.A., Bi, P. The impact of climate change on kidney health. Nat Rev Nephrol 17, 294–295 (2021). https://doi.org/10.1038/s41581-020-00365-4 & Baaghideh, M., & Mayvaneh, F. (2017). Climate Change and Simulation of Cardiovascular Disease Mortality: A Case Study of Mashhad, Iran. Iranian journal of public health, 46(3), 396–407. Page 12 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) contribute to reducing the burden of severe COVID-19 surge. This will also enable Tunisia’s ability to mitigate the adverse effects of climate change, through expanded hospital care capacity that can be used for climate-related health emergencies. The funds under the Recipient-Executed GPG trust fund will also be utilized to assess specific areas to strengthen the climate resiliency of the Tunisian health system. 14. Investments under the proposed second AF complement existing and upcoming support from other development partners. As indicated in Table 1, Tunisia has received a significant amount of complementary investments from partners to focus on strengthening vaccine deployment capacity, especially for cold chain and communications. The government has been coordinating partner investments and utilizing World Bank project resources to ensure complementarity with grants and donations that are received from partners. However, most of this support has focused on direct COVID- 19 response and case management, particularly at the primary care level. Therefore, a substantial need remains to strengthen health infrastructure capacity, especially at the hospital level, which handles the majority of chronic, emergency, and surgical interventions in the Tunisian health system, and which faces the most significant medical equipment gaps. Table 1: Supportive Roles for Partner Agencies in Implementation Partner Roles and activities Financing amount 13 World Health • TA for support on vaccine introduction, implementation US$2.3 million for tests and Organization of vaccine deployment and monitoring and evaluation diagnostics for COVID-19 (WHO) based on global and regional guidance. US$5 million for COVID-19 case • TA in developing the deployment and vaccination plans, management as well as the National COVID-19 Vaccination strategy. US$500,000 for surveillance, • Technical support to the national committees and communication, and rapid response stakeholders on the definition of policy objectives, US$2.4 million for trainings and strategy, targets, and safety. purchase of personal protective • Recruitment of consultants to support information equipment systems, stock management, and grievance US$235,000 for continuity of management. essential services • Acquisition of 380 computers (300 in progress). US$100,000 for studies and • Donations of consumables (10,000 liters of alcohol). communication campaigns • Strengthening disease surveillance capacity, communication, and mobilizing rapid response capacity with the training of 122 health workers and 150 scouts. • Strengthening cold chain capacity through -80 freezers and temperature monitoring for vehicles and cold rooms. • Development of clinical guidelines and training of health workers in COVID-19 response and vaccination. 13Data obtained from the government and partners as of 26 January 2022. All amounts are grants or in-kind donations. The table excludes vaccine donations which have already arrived, which is described in table 3. Page 13 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Global • TA on quantifying operational cold chain needs. US$3 million for cold chain Alliance for • Support implementing communications interventions. strengthening Vaccines and • Financing cold chain equipment (180 Performance, US$470,000 for TA on cold chain Immunization Quality, Safety - PQS fridges, 3 freezers below -20 US$7.6 million for procurement of (UNICEF) degrees, 3 freezers below -80 degrees, 460 consumables and medical equipment temperature recorders. for COVID-19 response and • Serving as a procurement agent for vaccines delivered vaccination through COVAX, as well as cold chain equipment $1.2 million for design and financed by COVAX. implementation of communication campaigns US$1.2 million for oxygen production Arab • Financing cold chain equipment. US$635,714 Development Fund (FADES) Global • Provision of vaccines to cover up to 20 percent of the Vaccines (in kind) for 20 percent of Alliance for population (AMC) 14 including syringes for donated the population; and Vaccines and vaccines. US$232,640 for cold chain support 15 Immunization • Financing cold chain equipment procurement and TA (Gavi)/COVAX (447 fridges, 177 freezers, 36 PQS fridges. United States • 411 PQS fridges for vaccine storage (together with US$4 million; exact cost figures for Agency for Japan). fridges not available and US$4 International • 20 freezers (-20 degrees, together with Japan) and 3 - million includes 270 oxygen Development 80 freezers (together with Gavi). generators, 110 disinfection units, (USAID) • Renovation of Chebbi cold storage warehouse. and 20 water treatment units • Acquisition of 1,661 temperature recorders (together with Japan and Gavi). Doctors of • Hiring of consultants for grievance management and Not available the World information system management. (Médecins du monde) Japan • Purchase of 434 PQS fridges, 28 freezers and 955 US$1.2 million for cold chain temperature recorders. US$1 million for last mile vaccine • 4x4 vehicles for last mile delivery. delivery • 16 portable Electrocardiogram (EKG) machines and 73 US$4.5 million for intensive care newborn incubators. equipment Germany • 500 vaccine carriers. In-kind donations Development • 450 freezers and 3200 icepacks. Bank (KfW) • 10,000 doses of monoclonal antibodies. • 600,000 donations of Pfizer doses (to arrive). United Nations • Disaster Risk Reduction Project, funded by Swiss US$1.8 million for the Disaster Risk Development Cooperation, to provide TA on risk reduction as well as Reduction Project 14COVAX AMC procurement can go up to 20 percent. 15Cold chain support from GAVI to include 60 fridges 200-250 liters (Satisfying the Performance, Quality and Safety (PQS) Standards), 60 voltage regulators, and 500 fridge tags. Page 14 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Programme personal protective equipment and waste management US$480,000 for purchase of personal (UNDP) protective equipment European • 2 refrigerated trucks, 168 vaccine carriers, 324 fridges, In-kind donations Union (EU) • 15 electrical generators for regional warehouses and 164 electrical generators for district warehouses 15. Tunisia has secured enough doses of COVID-19 vaccines to reach its vaccination targets for 2022. While the outlook for COVID-19 vaccination needs remain uncertain, due to proactive purchase arrangements as well as donations, Tunisia has secured enough doses to fully vaccinate 70 percent of its population and provide boosters to priority groups (above 50 years of age) who have completed their full course of vaccination within the last 5 months. Table 2 demonstrates the current vaccine coverage and acquisition plan by source of financing, demonstrating sufficient vaccination capacity. Table 2: National Vaccine Coverage and Acquisition Plan (accurate as of April 27, 2022) Source of Population targeted Vaccines Number of World Contract Doses financing doses Bank status already VAC arrived in status the country % Number Source Name IBRD (first 30.00% 3,581,327 AVAT Janssen 3,581,327 Eligible In process 1,036,800 AF) IBRD (first 26.72% 3,189,454 Direct Pfizer 6,378,907 Eligible Signed AF) procurement 5,062,590 GOT 6.79% 810,547 Direct Pfizer 1,621,093 Eligible Signed procurement GOT 2.51% 300,000 Direct Sputnik 600,000 Not Signed 600,000 procurement eligible GOT 9.01% 1,075,000 Direct Sinovac 2,150,000 Eligible Signed 2,150,000 procurement Donations 2.12% 252,500 Donation Sinopharm 505,000 Eligible Signed 505,000 (COVAX (United Arab AMC and Emirates) other) Donations 4.82% 575,000 Donation Sinovac 1,150,000 Eligible Signed 1,150,000 (COVAX (Algeria, AMC and Turkey, other) China) Donations 15.70% 1,873,500 Donation AstraZeneca 3,747,000 Eligible Signed 3,747,000 (COVAX (COVAX, AMC and France, Saudi other) Arabia, other EU members) Donations 0.59% 70,000 Donation Sputnik 140,000 Not Signed 140,000 (COVAX (Serbia, eligible AMC and Russia) other) Page 15 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Donations 8.41% 1,004,000 Donation Janssen 1,004,000 Eligible Signed 1,004,000 (COVAX (France, AMC and United other) States) Donations 7.12% 849,420 Donation Pfizer 1,698,840 Eligible Signed 1,698,840 (COVAX (COVAX) AMC and other) Donations 11% 1,300,000 Donation Pfizer 2,600,000 Eligible To arrive 0 (COVAX (COVAX) AMC and other) Donations 5.75% 686,085 Donation Moderna 1,372,170 Eligible Signed 1,372,170 (COVAX (COVAX) AMC and other) Total 130.53% 15,566,832 26,548,337 18,466,400 II. DESCRIPTION OF ADDITIONAL FINANCING A. Proposed Changes 16. The proposed AF and level II restructuring include the following changes to the project: (a) Scale-up of existing Component 2: The AF will increase the allocation under Component 2 by US$ 23.745 million (total amount for proposed second AF of US$ 22 million, plus the GPG grant of US$ 1.8 million, minus front-end fee) to further strengthen surge capacity for clinical, routine, and emergency health service delivery. This brings the total value of Component 2 to US$ 38.495 million. (b) Addition of two new PDO indicators to the results framework: (1) “Number of hospitals equipped with chronic case management equipment” with a target of 25 hospitals; and (2) “Number of hospitals with strengthened emergency care capacity” with a target of 10 teaching hospitals to reflect the expanded scope. (c) Dropping of two indicators from the results framework: i. PDO indicator “Number of tests conducted for COVID-19 using Polymerase Chain Reaction (PCR) machines,” given the fact that procurement under the scope of the project has not focused on PCR tests. ii. Intermediate Results Indicator “Percentage of sampled Project supported health facilities and laboratories that have received equipment verified for installation and functionality”, given the fact that the government did not procure lab testing equipment and supplies under component 1 and therefore this requirement is no longer relevant. (d) Elimination of the legal covenant of the original Loan Agreement for the parent project on the Page 16 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) requirement of technical audit 16, given the fact that the government did not procure lab testing equipment and supplies under Component 1 as was originally planned and therefore this requirement is no longer relevant. 17. The proposed second AF will scale up Component 2 to expand health system capacity and resiliency, which will improve case management and reduce the mortality and morbidity associated with severe COVID-19, as well as other chronic conditions. The purchase of medical equipment under Component 2 will focus on three priority areas identified by the MOH: • Strengthening clinical capacity for the management of NCDs, particularly through the acquisition of medical equipment for diagnosis (e.g. scanners) as well as treatment (e.g. dialyses); • Strengthening emergency capacity (e.g. pediatric ambulances, management of trauma and other injuries); • Strengthening surgical capacity for conditions with priority gaps (e.g. urology and blood transfusion). Within each of the areas, the list of medical equipment to be procured has been determined on the basis of four factors: (a) conditions which will need to be managed effectively to reduce the future impact of severe COVID-19; (b) conditions for which there are the most urgent medical equipment needs due to the recent fiscal crisis; (c) conditions for which there are only medical equipment gaps and absorptive capacity (i.e. no infrastructure or human resource constraints); and (d) conditions which pose the most significant disease and financial burden, for which morbidity can be reduced through timely diagnosis and care at government hospitals. 18. Through increased capacity for clinical, emergency, and surgical care, the scale up of Component 2 will also significantly contribute to mitigating the impact of climate change in Tunisia. The procured medical equipment under Component 2 will help diagnosis and management of diseases by increasing clinical, emergency, and surgical care capacity. In particular, this will support the improvement of health service delivery for populations in climate-stressed areas, which also face the most significant medical equipment gaps. Where relevant and possible, energy efficient equipment will be procured. 19. Grant funding obtained from the IBRD GPG will also be implemented under Component 2 as a recipient-executed trust fund, focusing on TA activities to improve the resiliency of the health system. The resources will be utilized to further develop the resiliency of the health system as well as innovation in the health sector through three pathways. First, the digitization of the national health information system, through incorporating lessons learned from the implementation of the COVID-19 vaccine information system (eVax), will be supported, with the funds complementing investments under the parent project and the first additional financing both in terms of procurement as well as mobilization of technical support. Second, capacity building and governance strengthening support will be provided to 16“For purposes of carrying out the verification of the distribution, delivery, installation, functionality, and use of lab testing equipment and supplies purchased under Component 1 of the Project, the Borrower, through MoH, shall: (a) select and hire a verification agent under terms of reference acceptable to the World Bank, as defined in the POM; and (b) furnish to the World Bank, each verification report covering a period of six (6) months not later than forty-five (45) days after the end of such period. (Section I.C of Schedule 2-Technical Audits).” Page 17 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) the MOH to support the design and implementation of the National Health Policy, complementing a World Bank-Executed trust fund. Finally, investments under this fund would also support studies as well as the definition of specific initiatives to improve the energy efficiency and climate resiliency of the health system. Rapid implementation of reforms to strengthen the health system will improve the system’s resiliency in withstanding future health shocks. 20. No changes will be made to Components 3 or 4. Component 3 has sufficient resources to continue strengthening implementation, management, monitoring and evaluation capacity; no further needs for project management or coordination are anticipated as the same arrangements will be utilized for the implementation of the proposed second AF. Component 4, a no-cost CERC, will be maintained (see Table 3). Table 3: Project Cost and Financing Project Components Original AF-I AF-II Total financing (US$ (US$ (US$ (US$ million) million) million) million) 17 Component 1: Emergency COVID-19 Response 19.85 83 0 102.85 Component 2: Supporting Health Systems 0 14.75 23.745 38.495 Strengthening Component 3: Implementation, Management, 0.1 2 0 2.1 and Monitoring and Evaluation Component 4: CERC 0 0 0 0 Front-end fee 18 0.05 0.25 0.055 0.355 Total Project Costs 20 100 23.8 143.8 17 The entirety of the original project and AF-I are funded as an IBRD loan. Of the US$23.8 million for AF-II, US$22 million is an IBRD loan and US$1.8 million is a Recipient-Executed Trust Fund under the IBRD Global Public Goods (GPG) Solutions Window. 18 This is the amount payable pursuant to Section 2.03 of the Loan Agreement in accordance with Section 2.07 (b) of the General Conditions Page 18 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Table 4: Summary of COVID-19 Vaccine Sourcing and World Bank Financing Source of vaccine financing and population coverage Doses National World Bank- Specific vaccines purchased Estimated allocation plan target financed and sourcing with World of World Bank (population COVAX Through Other** plans Bank financing %)* grant Through direct finance COVAX purchase Purchase: US$0million Deployment: Second AF US$0million (P178540) Other: US$23.8million (Other financing for 0% 0% 0% 0% 0% N/A 0 clinical, emergency, and surgical capacity strengthening, as well as strengthening health system resiliency) Purchase: US$83million Bilateral purchase Deployment: from Pfizer, US$9.25million First AF multilateral Other: US$5.5million 120%* 20% 0% 57% 43% 9,960,234 (P175785) purchase of (Other financing for Janssen from vaccine deployment AVAT and strengthening health system resiliency) Total Purchase: US$83million 9,960,234 Deployment: US$9.25million Other: US$27.5million *: Totals exceed 100 percent due to the use of vaccines for boosters **Other: Includes coverage by the government and non-COVAX donated doses. Split between COVAX and donations might not be fully accurate given various bilateral donations which were channeled through COVAX. B. Sustainability 21. The GOT has demonstrated strong political commitment to plan and operationalize vaccine purchase and deployment, as well as strengthen the health system. The majority of expenditures associated with vaccine deployment have been financed through the government budget, and the government has effectively used project resources in complementarity with domestic and donated resources. Investments under the parent project, first AF and the proposed second AF are expected to continue to strengthen the health system in the country, ensuring resiliency and sustainability to respond Page 19 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) to future health emergencies, also through creating fiscal space to ensure continuity of essential services. The investments under the second AF will further strengthen the government’s ability to increase the capacity of its health system to respond to future health emergencies, contributing to financial sustainability by reducing the need for recurrent health expenditures in the future through ensuring timely diagnosis and treatment of conditions. III. KEY RISKS 22. The overall risk rating to achieving the PDO will be revised from High to Substantial based on (i) the assessment of the impact of the residual risk to the achievement of the project ‘s outcomes, and (ii) the current and planned mitigation measures put in place under the parent project and the first AF, which remain relevant. The proposed second AF adds additional resources for the activities in the original design under Component 2 and does not entail any additional risks. The previous year of project implementation has demonstrated the strength of the vaccine deployment system implemented by the GOT, which has resulted in lower-than-expected residual risks to the achievement of the PDO. The equipment which will be procured under this AF closes existing gaps in the health system and does not involve any additional risks. The paragraphs below describe the most relevant risks, including those that have changed since the preparation of the first AF. 23. The political and governance risks associated with this AF remain High. The exceptional measures were subsequently extended through the issuance of Presidential Decree 117 of September 22, 2021, which partially suspends the application of the 2014 Constitution A new Cabinet was appointed on October 11, 2021, which has also launched a national online consultation exercise on the future governance model involving citizens and announced a plan for parliamentary elections to be held in December 2022. The planned elections pose political and governance risks for short-term implementation of clinical, emergency, and surgical case management, given the substantial and ongoing level of turnover at the MOH that can potentially slow down the implementation of project activities as well as result in service delivery interruptions. The political uncertainty also hinders the implementation of medium- and longer-term reform initiatives which would further strengthen the health system. The political and governance risks will continue to be mitigated throughout the AF and main project implementation, through: (i) ongoing high-level dialogue with the authorities; (ii) close coordination and alignment with sector development partners dialogue and messaging; and (iii) the provision of TA financed by World Bank and Recipient-executed trust fund resources that facilitate implementation of the project and associated sector reforms. 24. The macroeconomic risk is rated High. The residual macroeconomic risk to achieve the project objectives is revised from Substantial to High due to the country’s current economic and budgetary crisis, which has exacerbated since the preparation of the first AF. Tunisia is experiencing severe fiscal pressures. After the dramatic decline of GDP growth in 2020, Tunisia’s economic recovery has been slow in 2021, given the drop in international demand for key sectors such as tourism and transport. The slow recovery has increased further the already high unemployment rate by 3.3 percentage point to 18.4 percent by the third quarter of 2021. The rate is particularly high among youth, women, and in the western part of the country. The rising debt (84 percent of GDP in 2021), the lack of reforms, and the delay in the start of negotiations with the International Monetary Fund (IMF) has caused limitations in the access of the Tunisian government to international capital markets with sovereign ratings declining in 2021. These are Page 20 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) all factors contributing to compressing the space for key government spending, including the health budget, which has seen a 16 percent cut in 2022 compared to the previous year. The budget cut has particularly impacted the investment budget, which includes the procurement of medical equipment for the reinforcement of routine and emergency care services. The debt crisis also impacts other recurrent expenditures, such as salaries and the procurement of essential medicines, which has the potential to cause disruptions in the coverage of clinical, emergency, and surgical interventions supported by the proposed second AF. The situation has further been exacerbated by the impact of the war in Ukraine, with impact on food security as well as the overall macroeconomic landscape. The additional funds would help the government close the equipment procurement needs which emerge from this budget cut, as well as maintain budgetary space for other key health expenditures that would otherwise be constrained due to the procurement of vaccines. The residual macroeconomic risk to project sustainability will remain high given that the country aims to meet a short-term financing and procurement gap while aiming to continue strengthening the resiliency of the health system against current and future health emergencies. The risk will be mitigated through continued dialogue, together with key development partners, including the IMF, to create favorable conditions for structural reforms which could facilitate renewed access to international financing. In addition, advice provided by the World Bank and other partners on ways to achieve greater efficiency in public spending, could help increase fiscal space. 25. Fiduciary risk remains Substantial. Financial management (FM) risk remains Substantial. The key FM risk factors relate to: (i) additional workload for government project FM staff due to the increase in the FM activity; (ii) delays in finalizing FM staffing; (iii) lack of an effective internal audit function in the project which could contribute to efficiency of resource use and performance; and (iv) the use of a spreadsheet and data extracted from the national budget execution software “ADEB” which led to some challenges in terms of quality and timeliness in the preparation of the Interim Unaudited Financial Reports (IFRs) and project annual financial statements. To mitigate these risks, the terms of reference (TOR) of the external auditor will be revised to include the scaled-up activities of the AF and to cover the fiduciary risks derived from this second AF including physical verifications of medical equipment procured to strengthen clinical, emergency, and surgical care capacity. Finally, capacity building activities of the project FM team and effective hands-on support will be provided by the World Bank team to ensure satisfactory FM performance and timely fiduciary compliance, including the recruitment and training of consultants. Procurement risk has been reduced to Substantial from High, given that the envisioned medical equipment under Component 2 could be procured through competitive procurement or through United Nations (UN) Agencies (UNICEF and United Nations Office for Project Services, UNOPS), which is expected to significantly reduce the risks associated with the overall procurement capacity and regulations. To further support and accelerate procurement capacity, UGPO and relevant technical directorate capacity will continue to be reinforced by external consultants for better planning and management of procurement aspects, including contract executions. An action plan will be developed and finalized by the MOH. The World Bank will continue to provide additional procurement training and enhanced implementation support throughout the project duration. With the cancellation of the selection of the technical auditor whose role was to provide assurance for the correct execution of procurement of PPE under the parent project, the TOR of the external auditors will be amended to include the review of the execution of contracts under Components 1 and 2, to ensure proper management of associated risks. 26. Environment and social risks are rated as Moderate. No additional risks are envisioned through the scale up of Component 2, and the MOH possesses the right clinical guidelines to ensure sound Page 21 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) environmental and social implementation of the project, as detailed in the ESRS. The key environmental risks include potential Occupational Health and Safety (OHS) risks for health workers involved in the management of cases, as well as on management of medical wastes, which are rated as moderate. MOH has a strong experience with managing these risks, as highlighted under the implementation of the parent project. Key social risks include potentially unfair distribution of purchases made under the project. The capacity of the MOH, particularly, the UGPO, will continue to be reinforced through implementation to manage these risks. 27. Institutional capacity risk is reduced from High to Substantial. In the course of the past year, Tunisia has reached one of the highest full COVID-19 vaccination rates in the African continent as well as in the MENA region, demonstrating high institutional capacity across financing, vaccine delivery, resource availability, and governance to purchase and deploy vaccines across both technical and operational aspects. The ongoing recruitment of additional consultants will further strengthen institutional capacity and enable the mitigation of residual risk. IV. APPRAISAL SUMMARY A. Technical, Economic and Financial Analysis 28. The Technical, Economic and Financial summary for this AF is consistent with the analysis presented in the Project Paper for the first AF to the project. 19 B. Financial Management 29. The FM appraisal summary for this AF is consistent with the analysis presented in the Project Paper for the first AF of the Project. 20 FM arrangements for the second AF will be based on the existing implementation arrangements. To mitigate the identified challenges in the parent project including the first AF, a FM staff with qualifications and experiences including familiarity with World Bank FM procedures is being hired. This staff will be fully dedicated to work on the FM aspects of the project. Furthermore, a proper accounting software is required to facilitate recording of transactions and financial reporting. The FM section of the original POM will be updated. The TOR of the external auditor will be revised to include the AF and to cover the fiduciary risks derived from this second AF including physical verifications of medical equipment procured to strengthen routine and emergency care service delivery. Finally, capacity building activities of the project FM team and effective hands-on support will be provided by the World Bank team to ensure satisfactory FM performance and timely fiduciary compliance. These actions should be implemented within 1 to 3 months following the effectiveness date of the second AF. 19 The project appraisal document (PAD) for the parent project (P173945): https://documents1.worldbank.org/curated/en/887021588714435366/pdf/Tunisia-COVID-19-Response-Project.pdf; the project paper for the first additional financing (P175785): https://documents1.worldbank.org/curated/en/754341617069835875/pdf/Tunisia-COVID-19-Response-Project-Additional- Financing.pdf 20 Ibid Page 22 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) 30. Two new Designated Accounts (DA-C and DA-D) will be opened at the Central Bank of Tunisia under terms and conditions acceptable to the World Bank. The ceilings of DA-C and DA-D will be mentioned in the Disbursement and Financial Information Letter (DFIL). While the loan resources will be transferred to the DA-C, GPG funds will be transferred to DA-D. The DFIL will define the threshold for Direct Payment, which will be the preferred method for all payment exceeding that threshold. An initial advance up to the ceiling of the DA-C and DA-D will be made and subsequent disbursements will be made against submission of Statements of Expenditures (SOE) reporting on the use of the initial/previous advance. In case of the use of UNOPS, one of the UN Agencies for the procurement of equipment or provision of services, a Standard Form Agreement between the government and the UN Agency will have to be signed, and an application for withdrawal of proceeds will be prepared by the UGPO and submitted to the World Bank. The compliance with the World Bank’s Environmental and Social Framework will be included in the Memorandum of Understanding to be signed between the government and UN Agencies. The special World Bank disbursement procedures will be used to establish a “Blanket Commitment” to allow the amount to be advanced. Funds withdrawn from the IBRD loan account will be deposited directly into the UN Agency’s bank account provided by them for the project activities to be implemented by the UN Agency. The amount advanced will be documented through the quarterly “simplified” IFR as actual expenditures are incurred by the UN Agency. C. Procurement 31. The procurement appraisal summary for this AF is consistent with the analysis presented in the Project Paper for the first AF to the project. 21 Procurement under this AF entails the acquisition of goods to further strengthen surge capacity of the health system (for clinical, routine, and emergency health service delivery). Procurement of goods under Component 2 has experienced delays due to certain factors, including the high number of involved directorates involved in the determination of needs as well as procurement rules. In order to address these delays and given the urgent need to close this medical equipment gap, competitive procurement methods as well as direct selection of UNOPS would be considered for the procurement of medical equipment under Component 2. Sufficient fiduciary measures will be included to ensure an effective implementation. UNOPS has a local office in Tunis and is already involved in several projects funded by development partners in Tunisia. The Project Procurement Strategy for Development will be updated to reflect potential UNOPS involvement as a supplier for the procurement of medical equipment under Component 2. Other options than UNOPS will also be considered for the procurement of medical equipment. As mentioned under the discussion on fiduciary risk, to address the procurement capacity shortcomings, an action plan will be developed and finalized with the MOH to continue to build to provide additional procurement training and enhanced implementation support throughout the project duration. D. Legal Operational Policies . Triggered? Projects on International Waterways OP 7.50 No 21 Ibid Page 23 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Projects in Disputed Areas OP 7.60 No . E. Environmental and Social 32. The Environment and Social appraisal summary for the AF is consistent with the analysis presented in the Project Paper for the first AF of the Project. 22 F. Gender 33. The appraisal summary for gender for this AF is consistent with the analysis presented in the Project Paper for the first AF of the Project. 23 This proposed second AF is aligned with the measures instituted by the parent project and its first AF to address gender gaps. Data will continue to be collected as part of the results framework on the gender-disaggregated results indicators through the implementation of the proposed second AF. Data on gender gaps for access to high quality diabetes and hypertension care demonstrates that, while a fewer percentage of women have their blood sugar controlled than men, hypertension control rates are higher for women than for men. Gender- disaggregated data is not available for other clinical, emergency, and surgical care interventions which will be scaled up through the proposed second AF, even though health care-seeking rates are higher for women (93 percent) than for men (85 percent). 24 Targeted information campaigns to help close gender gaps will continue to be implemented. G. Climate 34. The climate appraisal summary for the AF is consistent with the analysis presented in the Project Paper for the first AF. 25As mentioned before, this AF further seeks to strengthen climate resiliency through strengthening the capacity of the health system to manage health risks which will be exacerbated due to climate change, as well as conduct assessments to diagnose ways to improve the climate resiliency of the health system. Preliminary assessment of the second AF for climate co-benefits is underway and will be finalized prior to AF approval. H. Citizen Engagement 35. The Citizen Engagement appraisal summary for the AF is consistent with the analysis presented in the Project Paper for the first AF. 26 V. WORLD BANK GRIEVANCE REDRESS 22 Ibid 23 Ibid 24 Tunisian Health Examination Survey (THES), 2017 25 Ibid 26 Ibid Page 24 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) 36. Communities and individuals who believe that they are adversely affected by a World Bank supported project may submit complaints to existing project-level grievance redress mechanisms or the World Bank’s Grievance Redress Service (GRS). The GRS ensures that complaints received are promptly reviewed in order to address project-related concerns. Project affected communities and individuals may submit their complaint to the World Bank’s independent Inspection Panel which determines whether harm occurred, or could occur, as a result of World Bank non-compliance with its policies and procedures. Complaints may be submitted at any time after concerns have been brought directly to the World Bank's attention, and World Bank Management has been given an opportunity to respond. For information on how to submit complaints to the World Bank’s corporate GRS, please visit http://www.worldbank.org/en/projects-operations/products-and-services/grievance-redress- service. For information on how to submit complaints to the World Bank Inspection Panel, please visit www.inspectionpanel.org Page 25 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) VI SUMMARY TABLE OF CHANGES Changed Not Changed Results Framework ✔ Components and Cost ✔ Legal Covenants ✔ Procurement ✔ APA Reliance ✔ Implementing Agency ✔ Project's Development Objectives ✔ Loan Closing Date(s) ✔ Cancellations Proposed ✔ Reallocation between Disbursement Categories ✔ Disbursements Arrangements ✔ Institutional Arrangements ✔ Financial Management ✔ 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 Page 26 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Proposed New MPA Program Development Objective 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 Page 27 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) COMPONENTS Current Component Name Current Cost Action Proposed Component Proposed Cost (US$, (US$, millions) Name millions) Emergency COVID-19 102.85 No Change Emergency COVID-19 102.85 Response Response Implementation 2.10 No Change Implementation 2.10 Management and Management and Monitoring and Evaluation Monitoring and Evaluation Support Health Systems 14.75 Revised Support Health Systems 38.50 Strengthening Strengthening Contingency Emergency 0.00 No Change Contingency Emergency 0.00 Response Component Response Component TOTAL 119.70 143.45 Expected Disbursements (in US$) DISBURSTBL Fiscal Year Annual Cumulative 2020 20,470,316.00 20,470,316.00 2021 23,892,000.00 44,362,316.00 2022 40,000,000.00 84,362,316.00 2023 35,000,000.00 119,362,316.00 2024 20,000,000.00 139,362,316.00 2025 4,437,684.00 143,800,000.00 2026 0.00 143,800,000.00 SYSTEMATIC OPERATIONS RISK-RATING TOOL (SORT) Risk Category Latest ISR Rating Current Rating Political and Governance  High  High Macroeconomic  Substantial  High Sector Strategies and Policies  Moderate  Moderate Technical Design of Project or Program  Moderate  Moderate Institutional Capacity for Implementation and  Substantial  Substantial Sustainability Page 28 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Fiduciary  Substantial  Substantial Environment and Social  Substantial  Moderate Stakeholders  Substantial  Substantial Other Overall  Substantial  Substantial LEGAL COVENANTS1 LEGAL COVENANTS – Tunisia COVID-19 Response project (P173945) Loan/Credit/TF LEGAL TBL1 Description Status Action IBRD-91120 No later than thirty (30) days after the Complied with No Change Effective Date, or any later date as agreed by the Bank, prepare a manual acceptable to the Bank (“Project Operational Manual” or “POM”), and immediately thereafter, implement the Project in accordance with the POM (section I.A.1(b)(i) of Schedule 2) IBRD-91120 For purposes of carrying out the Not yet due Marked for Deletion verification of the distribution, delivery, installation, functionality, and use of lab testing equipment and supplies purchased under Component 1 of the Project, the Borrower, through MoH, shall: (a) select and hire a verification agent under terms of reference acceptable to the Bank, as defined in the POM; and (b) furnish to the Bank, each verification report covering a period of six (6) months not later than forty-five (45) days after the end of such period. (Section I.C of Schedule 2-Technical Audits). LEGAL COVENANTS2 LEGAL COVENANTS – Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Sections and Description OPS LEGAL CONVENANT CHILD NODATA No information available Conditions Page 29 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Page 30 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) VIII. RESULTS FRAMEWORK AND MONITORING Results Framework COUNTRY: Tunisia RESULT NO PDO Second Additional Financing to Tunisia COVID-19 Response Project Project Development Objective(s) To prevent, detect and respond to the threat posed by COVID-19 and strengthen national systems for public health preparedness. Project Development Objective Indicators by Objectives/ Outcomes RESULT_FRAME_TBL_ PD O Indicator Name PBC Baseline Intermediate Targets End Target 1 2 To prevent, detect and respond to the threat posed by COVID-19 (Action: This Objective has been Revised) Number of health facilities and laboratories provided with personal protective equipment under the project 0.00 228.00 228.00 228.00 (Number) Number of tests conducted for COVID-19 using Polymerase Chain Reaction (PCR) 17,558.00 300,000.00 600,000.00 600,000.00 machines (Number) Action: This indicator has been Marked for Deletion Percentage of priority populations vaccinated based on targets defined in 0.00 30.00 50.00 50.00 national plan, total (Percentage) Page 31 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) RESULT_FRAME_TBL_ PD O Indicator Name PBC Baseline Intermediate Targets End Target 1 2 Percentange of priority populations vaccinated based on targets defined in 0.00 30.00 50.00 50.00 national plan by gender (Percentage) Number of hospitals equipped with chronic case management equipment 0.00 25.00 (Number) Action: This indicator is New Number of hospitals with strengthened emergency care capacity (Number) 0.00 10.00 Action: This indicator is New PDO Table SPACE Intermediate Results Indicators by Components RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline Intermediate Targets End Target 1 2 Emergency COVID-19 response Percentage of Project supported health facilities and laboratories confirming receipt of equipment within 14 days of 0.00 100.00 100.00 100.00 in-country delivery of such equipment (Percentage) Supporting Health System Strengthening Functional National Coordinating No committee with clear terms of Committee (or the engagement of an Committee established and Committee established and reference, roles, responsibilities and operational operational existing committee) for COVID-19 vaccine regular meetings defined Page 32 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline Intermediate Targets End Target 1 2 introduction is in place (Text) COVID-19 vaccine delivery strategies to Operational strategies defined to Operational strategy defined to reach identified target groups are defined identify and deliver vaccines to identify and deliver vaccines to and include women in hard to reach No specific strategies defined targeted groups to ensure high targeted groups to ensure high areas and frontline health workers (Text) coverage coverage Percentage of people reached by messages and/or materials to explain the 0.00 50.00 70.00 70.00 vaccination campaign, total (Percentage) Percentage of people reached by messages and/or materials to explain 0.00 50.00 70.00 70.00 the vaccination campaign by gender (Percentage) Percentage of beneficiaries reporting that community engagement processes were effective (transparent, inclusive, 0.00 60.00 70.00 70.00 responsive), total (Percentage) Percentage of beneficiaries reporting that community engagement processes were effective (transparent, 0.00 60.00 70.00 70.00 inclusive, responsive), by gender (Percentage) Functional health management and information system to deploy the COVID- No functional health management Information system for COVID-19 Information system for COVID-19 19 vaccine is in place, including identification, registration and follow up and information system for COVID- vaccine deployment is in place and vaccine deployment is in place and 19 vaccine in place functional functional with recipients by gener age and locality (Text) Number of of freezers, fridges, cold boxes, and vaccine carriers procured to 0.00 2,819.00 2,939.00 2,939.00 upgrade the national cold chain to support delivery of COVID-19 vaccines Page 33 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) RESULT_FRAME_TBL_ IO Indicator Name PBC Baseline Intermediate Targets End Target 1 2 and improve national capacity (Number) Percentage of female community workers (as a share of total community 0.00 50.00 60.00 60.00 workers) providing vaccine information compared to baseline (Percentage) Share of people agreeing with the importance of the vaccine, total 41.00 60.00 70.00 70.00 (Percentage) Share of people agreeing with the importance of the vaccine, by gender 41.00 60.00 70.00 70.00 (Percentage) Implementation Management and Monitoring and Evaluation (Action: This Component has been Marked for Deletion) Percentage of sampled Project supported health facilities and laboratories that have received equipment verified for 0.00 60.00 100.00 100.00 installation and functionality (Percentage) Action: This indicator has been Marked for Deletion IO Table SPACE Monitoring & Evaluation Plan: PDO Indicators Mapped Methodology for Data Responsibility for Data Indicator Name Definition/Description Frequency Datasource Collection Collection Number of health facilities The Ministry Unité de Gestion Par Number of health facilities and Every six Reporting system of the and laboratories provided of Health Objectif (UGPO) and laboratories provided with personal months MOH with personal protective (MOH) MOH protective equipment under the project equipment (PPE) and Page 34 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) maintaining same level of PPE throughout the Project The Ministry Unite de gestion par Number of tests conducted for COVID-19 Every six Reporting system of Number of tests conducted of Health objectif (UGPO) and using Polymerase Chain Reaction (PCR) months MOH for COVID-19 using PCR (MOH) MOH machines Data to be obtained The definition of priority from the populations has changed tablets/information since the project was system that MOH is prepared; as such, this deploying for indicator will track the full vaccinations. vaccination rate for the Numerator defined as entire population. The number of priority target of reaching 50 individuals receiving a Ministry of Health, Ministry of percent full vaccination full course of a safe and Direction des soins de Percentage of priority populations Health (MOH) nationally remains the Quarterly effective COVID-19 santé de base (DSSB) & vaccinated based on targets defined in information same. vaccine as per MOH and Unité de gestion par national plan, total systems WHO guidelines, objectif (UGPO) There is currently no including but not limited gender gap in vaccination to priority social coverage, with the vaccine workers, elderly, rates by gender being vulnerable identical and 50 percent of populations and those all those being vaccinated with comorbidities being women. Denominator defined as the total population. Percentange of priority populations Ministry of Data to be obtained Ministry of Health, Quarterly vaccinated based on targets defined Health (MOH) from the Direction des soins de in national plan by gender information tablets/information santé de base (DSSB) & Page 35 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) systems system that MOH is Unité de gestion par deploying for objectif (UGPO) vaccinations. Percentage of those women individuals defined as priority populations by the MOH receiving a full course of a safe and effective COVID-19 vaccine. Number of hospitals equipped with chronic case MOH, Directorate of Every six MOH Data will be collected Number of hospitals equipped with management equipment, Medical Equipment and months reporting from MOH hospitals chronic case management equipment including both for diagnosis Directorate of Hospitals (e.g. scanners) as well as treatment (e.g. dialyses). Number of hospitals with strengthened emergency MOH Directorate of care capacity under the Every six MOH to validate the Number of hospitals with strengthened MOH Equipment and project (e.g. pediatric months collected data emergency care capacity Directorate of Hospitals ambulances, equipment for management of trauma and other injuries) 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 Percentage of Project supported health Numerator: Number of Every six The Ministry Reporting system of Unité de Gestion Par facilities and laboratories confirming Project supported health months of Health MOH Objectif (UGPO) and Page 36 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) receipt of equipment within 14 days of in- facilities and laboratories (MOH) MOH country delivery of such equipment confirming receipt of equipment for COVID-19 response within 14 days of delivery into the country Denominator: Number of identified health facilities and laboratories for COVID- 19 response that the Project will be supporting Health facilities and laboratories provided with personal protective equipment (PPE) and maintaining same level of PPE throughout the Project Self-reported by Ministry of Health, Establishment of a National Direction des soins de Ministry of Ministry of Health, Coordinating Committee santé de base (DSSB) & Functional National Coordinating Health (MOH) Direction des soins de (or the engagement of an Unité de gestion par Committee (or the engagement of an Quarterly information santé de base (DSSB) & existing committee) for objectif (UGPO) & existing committee) for COVID-19 vaccine systems and Unité de gestion par COVID-19 vaccine documents submitted introduction is in place audit reports objectif (UGPO) introduction is in place and (charters, terms of operational references, meeting minutes) COVID-19 vaccine delivery strategies to For each target group, Ministry of Self-reported by Ministry of Health, reach identified target groups are defined including priority 20 Quarterly Health (MOH) Ministry of Health, Direction des soins de and include women in hard to reach areas percent but also the entire information Direction des soins de santé de base (DSSB) & and frontline health workers population, service delivery systems and santé de base (DSSB) & Unité de gestion par Page 37 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) modalities delivered audit reports Unité de gestion par objectif (UGPO) including financing, service objectif (UGPO) & delivery/platform of strategy submitted delivery, human resource and governance implications and including women in hard to reach areas and frontline health workers Self-reported by Percentage of people Ministry of Health, reached by messages Ministry of Ministry of Health, Direction des soins de and/or materials to explain Health (MOH) Direction des soins de Percentage of people reached by santé de base (DSSB) & the vaccination campaign. Quarterly information santé de base (DSSB) & messages and/or materials to explain the Unité de gestion par The indicator is to be systems and Unité de gestion par vaccination campaign, total objectif (UGPO) & calculated based on a audit reports objectif (UGPO) messages sampled population to be developed/delivered reached by surveys Self-reported by Percentage of women Ministry of Health, reached by messages Ministry of Ministry of Health, Direction des soins de and/or materials to explain Health (MOH) Direction des soins de Percentage of people reached by santé de base (DSSB) & the vaccination campaign. Quarterly information santé de base (DSSB) & messages and/or materials to explain Unité de gestion par The indicator is to be systems and Unité de gestion par the vaccination campaign by gender objectif (UGPO) & calculated based on a audit reports objectif (UGPO) messages sampled population to be developed/delivered reached by surveys Percentage of beneficiaries Three Ministry of Self-reported by Ministry of Health, Percentage of beneficiaries reporting that reporting that community times Health (MOH) Ministry of Health, Direction des soins de community engagement processes were engagement processes throughout information Direction des soins de santé de base (DSSB) & effective (transparent, inclusive, were effective the life of systems, santé de base (DSSB) & Unité de gestion par responsive), total (transparent, inclusive, the surveys Unité de gestion par objectif (UGPO) Page 38 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) responsive). The project: objectif (UGPO) beneficiaries population is first to a sampled population to be establish a reached by surveys baseline, second as a mid-line and third to inform end target achieveme nt Three times throughout the life of Percentage of women the beneficiaries reporting that project: Self-reported by Ministry of Ministry of Health, Percentage of beneficiaries reporting community engagement first to Ministry of Health, Health (MOH) Direction des soins de that community engagement processes were effective establish a Direction des soins de information santé de base (DSSB) & processes were effective (transparent, inclusive, baseline, santé de base (DSSB) & systems, Unité de gestion par (transparent, inclusive, responsive), responsive). The second as a Unité de gestion par surveys objectif (UGPO) by gender beneficiaries population is mid-line objectif (UGPO) a sampled population to be and third reached by surveys to inform end target achieveme nt Functional health management and Information system Ministry of Self-reported by Ministry of Health, Quarterly information system to deploy the COVID- established and functional Health (MOH) Ministry of Health, Direction des soins de 19 vaccine is in place, including to identify, register, trace information Direction des soins de santé de base (DSSB) & Page 39 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) identification, registration and follow up and follow up with COVID- systems and santé de base (DSSB) & Unité de gestion par with recipients by gener age and locality 19 vaccine recipients, first audit reports Unité de gestion par objectif (UGPO) for the priority population objectif (UGPO) & and then for the entire whether the system is population, including established and information by gender, age functional or not and locality. Information system is expected to be integrated with tablets and other data collection modalities vaccinators are using. Number of freezers , fridges, cold boxes, and vaccine carriers procured Number of of freezers, fridges, cold boxes, to be deployed at national, and vaccine carriers procured to upgrade regional and district levels Reporting Audits and quarterly Quarterly MOH/DSSB the national cold chain to support delivery for the storage of COVID- from DSSB reports of COVID-19 vaccines and improve 19 vaccines and other national capacity childhood vaccines, including those that require ultra cold chain storage Self-reported by Percentage of female Ministry of Health, Ministry of Ministry of Health, Percentage of female community workers community workers (as a Direction des soins de Health (MOH) Direction des soins de (as a share of total community workers) share of total community Quarterly santé de base (DSSB) & information santé de base (DSSB) & providing vaccine information compared workers) providing vaccine Unité de gestion par systems Unité de gestion par to baseline information compared to objectif (UGPO) objectif (UGPO) baseline Share of people agreeing with the Share of people agreeing Quarterly Ministry of Self-reported by Ministry of Health, importance of the vaccine, total with the importance of the Health (MOH) Ministry of Health, Direction des soins de Page 40 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) vaccine on a basis of a information Direction des soins de santé de base (DSSB) & sampled population to be systems, santé de base (DSSB) & Unité de gestion par reached by surveys surveys Unité de gestion par objectif (UGPO) objectif (UGPO) Share of women agreeing Self-reported by with the importance of the Ministry of Ministry of Health, Ministry of Health, vaccine based on a Health (MOH) Direction des soins de Direction des soins de Share of people agreeing with the sampled population to be Quarterly information santé de base (DSSB) & santé de base (DSSB) & importance of the vaccine, by gender reached by surveys. Please systems, Unité de gestion par Unité de gestion par refer to reporting caveat surveys objectif (UGPO) objectif (UGPO) highlighted under the total indicator. Number of sampled health facilities and laboratories will be at least 30 percent of total Project supported health facilities and laboratories Numerator: Number of Project Percentage of sampled Project supported supported health facilities Unité de Gestion Par Verification/A Desk-based and on-site health facilities and laboratories that have and laboratories that have Annual Objectif (UGPO) and udit Agency verification received equipment verified for received equipment MOH installation and functionality verified for installation and functionality Denominator: Number of sampled Project supported health facilities and laboratories that have received Project supported equipment Page 41 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) ME IO Table SPACE Page 42 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) ANNEX 1: SUMMARY TABLE ON VACCINE DEVELOPMENT AND APPROVAL STATUS As of December 19, 2021 Manufacturer / Name of Vaccine Stringent WHO EUL (Emergency Use Listing) 27 WHO EUL holder Regulatory Agency (SRA) Platform NRA of Record Status of assessment approval for WHO EUL received 1. Pfizer BioNTech Manufacturing BNT162b2/COMIRNATY United Nucleoside EMA  Finalized: GmbH Tozinameran (INN) Kingdom: modified mNRA 31/12/2020 December 2,  Additional sites: 2020 − Baxter Oncology Canada: GmbH Germany December 9, (DP). 30/06/2021 2020 − Novartis United States of Switzerland. America: 08/07/2021 December 11, − Mibe (Dermapharm) 2020 Germany (DP). European 16/07/2021 Union: − Delpharm, Saint- December 21, Remy FRANCE (DP). 2020 17/09/2021 Switzerland: − Siegfried Hameln December 19, GmbH, Germany 2020 (DP). 11/11/2021 Australia: − Patheon Italia S.p.A, 27 https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_15Dec2021_0.pdf Page 43 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Manufacturer / Name of Vaccine Stringent WHO EUL (Emergency Use Listing) 27 WHO EUL holder Regulatory Agency (SRA) Platform NRA of Record Status of assessment approval for WHO EUL received January 25, Italy (DP). 2021 07/12/2021  Shelf-life extension: 09 months at -70 to - 90°C. 20/09/2021 − Sanofi-Aventis Deutschland GmbH Germany 06/10/2021  Diluent suppliers: − Pfizer Perth, AustraliaFresenius Kabi, USA 18/06/2021 United States  Additional sites: Federal Drug − Pharmacia & Agency Upjohn, (USFDA) Kalamazoo (DP)PGS McPherson (DP) 16/07/2021 − Exelead, Inc. Indianapolis USA 30/09/2021 2. AstraZeneca, AB AZD1222 Vaxzevria UK: December Recombinant EMA  Core data finalized. 30, 2020 ChAdOx1 16 April 2021 EU: January 29, adenoviral  Additional sites: 2021 vector − SK-Catalent Page 44 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Manufacturer / Name of Vaccine Stringent WHO EUL (Emergency Use Listing) 27 WHO EUL holder Regulatory Agency (SRA) Platform NRA of Record Status of assessment approval for WHO EUL received Australia: encoding the − Wuxi (DS). 16 April February 16th, Spike protein 2021 2021 (overseas antigen of the − Chemo Spain. 30 manufacturing); SARS-CoV-2. April 2021 March 21st, 2021 − Amylin Ohio US (DP). (for local 23 July 2021 manufacturing by MFDS KOREA  Finalized. 15 Feb CSL – Seqirus) 2021 Canada: February Japan  Finalized. 09 July 26, 2021 MHLW/PMDA 2021  Additional site: − Nipro Pharma Corporation Ise, Japan. 11 October 2021 Australia  Finalized. 09 July Therapeutic 2021 Goods  Additional site: Administration − Siam Bioscience Co., (TGA) Ltd Thailand. 11 October 2021 3. Serum Institute of India Pvt.Ltd Covishield Recombinant DCGI  Finalized. 15 Feb (ChAdOx1_nCoV-19) ChAdOx1 2021 adenoviralvector − DS and DP Manjari encoding the Bk Pune. Spike protein 11/12/2021 antigen of the SARS-CoV-2. Page 45 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Manufacturer / Name of Vaccine Stringent WHO EUL (Emergency Use Listing) 27 WHO EUL holder Regulatory Agency (SRA) Platform NRA of Record Status of assessment approval for WHO EUL received 4. COVOVAX™ Recombinant DCGI  Finalized. 17 COVID-19 vaccine nanoparticle December 2021 (SARS-CoV-2 rS prefusion spike Protein protein Nanoparticle formulated with [Recombinant]) Matrix-M™ adjuvant 5. Moderna mRNA-1273 USA: December mNRA-based EMA  Finalized. 30 April 18, 2020 vaccine 2021 Canada: encapsulated in USFDA  Additional Sites. 06 December 23, lipid August 2021 2020 nanoparticle − ModernaTx. EU: January 6, (LNP) Norwood (DS) 2021 − Catalent Indiana, LLC Switzerland: (DP) January 12th, − Lonza Biologics, Inc. 2021 Portsmouth, USA UK: January 8, (DS) 2021 − Baxter, Bloomington, USA (DP) 6. Sinopharm / BIBP1 SARS-CoV-2 Vaccine Inactivated, NMPA  Finalized. 07 May Beijing Institute of Biological (Vero Cell), produced in Vero 2021 Products Co., Ltd. (BIBP) Inactivated(lnCoV) cells  2 and 5 dose presentation (new manufacturing site) -- to be confirmed after ongoing inspection Page 46 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) Manufacturer / Name of Vaccine Stringent WHO EUL (Emergency Use Listing) 27 WHO EUL holder Regulatory Agency (SRA) Platform NRA of Record Status of assessment approval for WHO EUL received 7. Sinovac Life Sciences Co., Ltd. COVID-19 Vaccine Inactivated,  Finalized. 01 June Sinovac Life Sciences Co., Ltd. (VeroCell), produced in Vero 2021 Inactivated/ cells  2 dose CoronavacTM presentation. 30 September 2021 8. Janssen–Cilag International NV Ad26.COV2.S USA: February Recombinant, EMA  Core data finalized 27th, 2021 replication- (US +NL sites). 12 Canada: March incompetent March 2021 5th, 2021 adenovirus type EU: March 11th, 26 (Ad26)  Additional sites: 2021 vectored vaccine − Aspen RSA (DP). 25 Switzerland: encoding the June 2021 March 22nd, (SARS-CoV-2) − Catalent Agnani Italy 2021 Spike (S) protein (DP). 02 July 2021 UK: May 28th, − Grand River Aseptic 2021 Manufacturing Inc., Australia: June USA. 05 Nov 2021 25th, 2021 − MSD (Merck(, West Point/PA, USA (DP). 05 Nov 2021 9. Bharat Biotech, India SARS-CoV-2 Vaccine, Whole-Virion DCGI  Finalized. 03 Nov Inactivated (Vero Cell)/ Inactivated Vero 2021 COVAXIN Cell Page 47 of 48 The World Bank Second Additional Financing to Tunisia COVID-19 Response Project (P178540) ANNEX 2: LATEST COVID-19 SITUATION IN TUNISIA 1. Tunisia is one of the countries hardest hit by COVID-19 in the Middle East and North Africa (MENA) region, and the risk posed by the appearance of new variants continues to put pressure on the health and economic situation in the country. Since the beginning of the pandemic, Tunisia has recorded a total of over 1.04 million confirmed cases and 28,628 deaths.28 While COVID-19 cases were relatively flat until late July 2020, the number of cases spiked in September 2020. A series of lockdowns and curfews, which aimed at limiting the spread of the COVID-19 virus in 2021, have failed to reduce the number of new cases and deaths. Thus, Tunisia has had one of the highest mortality rates from COVID-19 in the world, particularly during the fourth wave between July and August 2021, exposing the weaknesses of the health system. A fifth surge is currently underway, due to the more transmissible Omicron variant: the highest amount of daily new cases since the beginning of the pandemic has been confirmed on January 24, 2022, with case numbers declining since then. Given the relatively high vaccination rate, the fifth surge has not translated in a significant surge in hospitalizations, and has resulted in 20 percent as many deaths per capita as in the previous surge of July-August 2021. This is attributable to high vaccine coverage for the elderly who face the highest risk for morbidity and mortality: 83 percent of the population above age 50, and 84 percent above age 60, are fully vaccinated. The threat of future variants indicates the need for reinforced immunity through 2022 and expanded vaccination coverage. 2. Testing and hospital capacity has been scaled up significantly since the beginning of the pandemic, but significant constraints have remained. Almost 4 million PCR tests have been conducted since the beginning of the pandemic, and while test positivity rate has remained below 10 percent outside of surges, it has been close to 50 percent during the peaks of COVID waves witnessed in July-August, demonstrating overwhelmed capacity. The high share of mortality has demonstrated the strain on the health system. Following the surge of July-August, the government has substantially increased its health system capacity, with an increase of intensive care beds from 60 in the beginning of the pandemic to 338, with an expansion of up to 409 planned in the coming months. An additional 3,000 medical and paramedical workers have also been recruited to provide surge capacity. 3. As indicated in the body of the project paper, Tunisia has made significant progress with vaccination, especially compared to other countries in the region as well as other middle-income countries. As described in detail, this success has been attributable to proactive procurement arrangements through bilateral and multilateral deals and donations; a flexible and dynamic deployment system facilitating choice and access; as well as coordination across agencies which has resulted in consistent communication and information systems. 28 All data in this paragraph is from Our World in Data and Tunisian eVax open data platform, accurate as of May 23, 2022. Page 48 of 48