The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) Additional Financing Appraisal Environmental and Social Review Summary Appraisal Stage (AF ESRS Appraisal Stage) Public Disclosure Date Prepared/Updated: 02/21/2021 | Report No: ESRSAFA126 Feb 26, 2021 Page 1 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) BASIC INFORMATION A. Basic Project Data Country Region Borrower(s) Implementing Agency(ies) Ethiopia AFRICA EAST Democratic Republic of Ministry of Health Ethiopia Project ID Project Name P175853 Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 Parent Project ID (if any) Parent Project Name P173750 Ethiopia COVID-19 Emergency Response Practice Area (Lead) Financing Instrument Estimated Appraisal Date Estimated Board Date Health, Nutrition & Investment Project 2/16/2021 3/26/2021 Population Financing Public Disclosure Proposed Development Objective To prevent, detect and respond to the threat posed by COVID-19 and strengthen national systems for public health preparedness in Ethiopia. Financing (in USD Million) Amount Current Financing 0.00 Proposed Additional Financing 0.00 Total Proposed Financing 0.00 B. Is the project being prepared in a Situation of Urgent Need of Assistance or Capacity Constraints, as per Bank IPF Policy, para. 12? Yes C. Summary Description of Proposed Project [including overview of Country, Sectoral & Institutional Contexts and Relationship to CPF] The selection of the target population and vaccine deployment process seek to ensure equity in access for vaccines among key eligible populations. Health inequity is intertwined with the impact of COVID-19 where certain populations Feb 26, 2021 Page 2 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) are at increased risk of severe illness or death. At the national and sub-national levels, data are showing a disproportionate impact of the pandemic on populations already disadvantaged by virtue of their age, health status, residence, occupation, and socioeconomic status and hence the vaccine introduction strategy has given consideration to these disproportionate impact in the selection of vaccine deployment strategies. Phase 1 (20% total population coverage): Phase 1 has a reasonable scenario of the target groups to achieve the goal of reducing mortality and morbidity. It includes the following target groups: • Frontline workers in health care, schools, and other social care services • People over the age of 65 years; and • People under the age of 65 years with underlying conditions that expose them to higher COVID-19 related mortality risk Frontline workers will be prioritized as they are essential to treat and protect the population and come in close contact with infected individuals and provide care for high-mortality risk groups. Initial epidemiological data has shown that adults over 65 years of age and those with certain co-morbidities are at the highest risk of dying from COVID-19. The strategy to be used to reach each of the priority groups will be using the existing primary healthcare approach and other innovative approaches tailored to the context the priority groups. Existing vaccine delivery strategies which are used in the routine EPI system which includes Static (at health facilities or community level); Outreach (fixed community outreach and/or mobile community outreach) However, door to door strategy will also be used for those priority groups who are above the age of 65 and immobile and those bedridden peoples with co-morbidity. Public Disclosure The government has made further prioritization of those target groups in phase 1 taking in to account different scenarios of vaccine availability and based on analysis of global and local epidemiological and scientific evidences and defined who should receive the vaccine sooner than others. Accordingly, those target groups in phase 1 are grouped into Phase 1a and Phase 1b that would have progressive access to the vaccine, based on descending priority. a. Phase 1a (1-10% of total population coverage): is a scenario of very limited vaccine availability for initial distribution. Since frontline workers are not just at risk of being infected but also pose a higher risk of transmitting the virus, it is recommended they are initially prioritized. This is with the assumption that demand for COVID-19 vaccines is likely to outstrip supply, at least initially, it estimates that if COVID-19 vaccines are made available to the country, priority will be given first to protect 3% of the population, this is expected to be sufficient to protect every health and social care worker in the country. This phase also targets those population groups aged > 65 years of age (7% of the population). The major objective of covering those priority groups in Phase 1a is with an objective of protecting the integrity of the health care system, other social care settings and reducing severe morbidity and mortality by reaching out to those who are at most risk (age >65 years). b. Phase 1b (additional 11-20% of population coverage): is a scenario as vaccine supply increases but availability remains limited. This group included those individuals with critical co-morbidities (10%) such as those with HIV/AIDS, TB, Diabetes Mellitus and other chronic diseases. The COVID 19 vaccine introduction strategy has given a higher emphasis to ensuring gender equity. While at a biological level COVID-19 is currently assumed to pose similar risks to men and women, social factors and the distribution of co-morbidities across age and gender introduce different disease burdens from COVID-19 for different Feb 26, 2021 Page 3 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) population groups. For example, Ethiopia’s health system is highly dependent on female health workers (represent 70% of health sector workers) which puts them in a higher risk of exposure to COVID-19. In line with the global trend, local data confirmed that the pandemic disproportionately affected those with compromised immunity either as a result of age (>65 years of age) or co-morbidities. Hence, the vaccine deployment strategy employs house-to-house visit to reach those who have limited ability to visit health facility or outreach sites to receive the vaccine. Proposed New Activities Component 1. Medical Supplies and Equipment [current allocation US$ 51.4 million; proposed AF allocation US$ US$132.1 million]: The support for vaccines when available, which was anticipated in the initial Global COVID-19 MPA, will be added as part of the containment and mitigation measures to prevent the spread of COVID-19 and deaths under Component 1: Emergency COVID-19 Response. Ethiopia will utilize the COVAX AMC facility for vaccine purchase and financing mechanisms. The AF under this component will finance: (i) the procurement of vaccines; (ii) Procurement of vaccination supplies needed for activities outlined in the vaccine deployment plan such as diluents, syringes, and all medical supplies associated with the vaccination response; (iii) cold chain inputs, (iv) maintenance of existing cold chain equipment; (v) infection prevention and waste management; and (vi) vaccine storage and transportation. Component 2. Preparedness, Capacity Building and Training [current allocation US$16 million; proposed AF allocation US$63.2 million]: The AF will finance: (i)the development of a COVID-19 vaccination card, COVID registry, report and analytical tools; training plan for vaccine introduction; (ii) deployment of health professionals; and training on Public Disclosure surveillance, supply chain and others as needed; (iii) iterative development of micro-level deployment plans at national and sub national levels; (iv) establishment of regulatory measures for the procurement/ importation of COVID-19 vaccine and related supplies; vaccine safety, licensure pharmacovigilance; (v) trainings of front line health personnel on vaccine inoculation; (vi) supervision on vaccine safety and Adverse Event Following Immunization (AEFI) monitoring for regulators and EPI officers; (vii) strengthening of regional AEFI investigation task force and support for AEFI case investigations through provision of technical assistance for AEFI; (viii) data protection guideline, draft consent forms, developing SOP; (ix) developing innovative registries for key vaccine target groups, identification of target populations; monitoring and evaluation including establishment of a mechanism to track adverse reactions to vaccines. The AF will further strengthen the testing capacity for COVID-19 at the subnational (regional/state) level; develop/adapt existing vaccine surveillance and monitoring frameworks; strengthen existing national and sub national coordination committees and technical working group for EPI to support the vaccine procurement and deployment; and enhance the existing electronic information system/data and monitoring system used by the EPI Program. Component 3. Community Discussions and Information Outreach [current allocation US$6.5million; proposed AF allocation US$2.4 million]: The AF will finance: i) the development of social mobilization and community engagement strategies (using local languages) to increase vaccine acceptance and COVID- 19 prevention behaviours; ii) monitor vaccine acceptance /hesitancy; iii) establish compliant handling mechanisms at all levels (Federal MOH, Regional Health Bureau, Woreda Health Office and Facility ). It will further strengthen activities in the parent project including deployment of risk communication officers and other human resources to expand and accelerate vaccine deployment efforts. Component 4. Quarantine, Isolation and Treatment Centers and regulatory infrastructure [current allocation US$ 7.3 million; proposed AF allocation US$ 7.3 million]: The AF will finance the regulatory infrastructure and capacity for Feb 26, 2021 Page 4 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) safety surveillance of the COVID-19 vaccine which include refurbishing and equipping vaccine laboratory under Ethiopia Food and Drug Authority. Ethiopia is currently contracting out the vaccine laboratory testing undertaking which has its own limitation in terms of selecting independent laboratory, establishing and reviewing selection criteria, assembling a list of possible qualified laboratories and caring out the contracting process which will normally be undertaken by the procurement entity responsible for purchasing vaccines and other biological products. The absence of vaccine laboratory in the regulatory body of the health sector has a negative implication on the quality, timelines and cost of the operation. Given that COVID 19 vaccine research and development and vaccine improvement will be the major and critical assignment for the upcoming years, this laboratory will have significant importance in terms of facilitating licensing and registering any potential COVID 19 candidates in the future. Component 5. Project Implementation and Monitoring [current allocation US$ 1 million; proposed AF allocation US$ 2.0 million]: Proposed new activities: The AF will finance: i) the operating costs of mobilizing additional short-term consultants who support vaccine deployment; and ii) Covid-19 hazard pay /risk allowance for staff who will be involved in vaccine deployment efforts. It will further finance additional operating costs to strengthen the existing GMUs. The AF will finance technical assistance to support Ethiopia to establish institutional frameworks for the safe and effective deployment of vaccines. These will include: a) establishment of policies related to ensuring that there is no forced vaccination; b) acceptable approved policy for prioritized intra-country vaccine allocation; c) regulatory standards at the national level, including pharmacovigilance; d) appropriate minimum standards for vaccine management including cold chain infrastructure (with financing as well for the investment to meet those standards as Public Disclosure described below); and e) the creation of accountability, grievances, and citizen and community engagement mechanisms. In addition, the AF will finance upfront community mobilization and advocacy to increase vaccine acceptance. D. Environmental and Social Overview D.1. Detailed project location(s) and salient physical characteristics relevant to the E&S assessment [geographic, environmental, social] The Ethiopia COVID-19 Emergency Response Project (P173750) was approved on April 2, 2020 prepared under the Fast Track COVID-19 Facility (FTCF). Since then, the federal government and the national regional states and city administrations have exerted immense efforts and taken various response measures to contain the transmission of the disease. While measures are expected to slow the spread of the virus, they may have substantial adverse effects on the country’s socio-political situation. As of November 10, 2020, Ethiopia reported 100,327 people have been infected and over 1,537 people have died as a result of COVID-19 outbreak. The recovery rate nationally reached 48% in mid-October while the case fatality rate stood at 1.5%. Of all the deaths recorded until the beginning of October 2020, the majority (60%) were identified during postmortem testing from deaths which occurred in communities. As the number of identified COVID-19 cases has increased substantially and due to the expansion of community transmission (as anticipated by epidemiological models), the government in August 2020 adopted the Community Based Actions and Testing (ComBAT) approach. This innovative approach is tailored to address the immediate needs of the current phase of the epidemic in the country, determine the level of COVID-19 infection within Ethiopia as well as understand the current awareness on COVID-19 prevention measures among the population. Feb 26, 2021 Page 5 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) Given the importance of limiting the spread of COVID-19 to both health and economic recovery, further supporting health system improvements and providing access to COVID-19 vaccines will be critical to accelerate economic and social recovery in Ethiopia. Vaccinations have significant health and economic externalities, and their full social value is usually not reflected in vaccine market prices. Further improvements in the epidemiological surveillance system to move towards integrated epidemiological surveillance (human, animal, phytosanitary, water – one health) are important to Ethiopia. This AF will enable affordable and equitable access to vaccines and play a critical role in further strengthening the health system. There should be consensus to first target heath workers, other essential workers, and the most vulnerable populations, which will include a mix of the elderly, people with co-morbidities, and people in high-population density location such as slums and refugee camps. This prioritization has taken into consideration the risk of each group. Health professionals and other essential workers are prioritized because they have higher risk of infection from COVID-19 than the general population and infected health professionals contribute to health care associated infection transmission to their patient and the persons they care for. The other groups are prioritized because they are at increased risk of developed severe disease. Studies show that there have been notable weaknesses in the cold chain system in healthcare facilities in Ethiopia (e.g. Bezunesh Rogie et al. 2013; Bedasa Woldemichael 2018). The weaknesses among others include: i) storage of vaccines in refrigerators which are not fit for the purpose; ii) shortage of trained personnel and budget for maintenance of the cold chain; iii) lack of technicians for the maintenance of refrigerators (as a result, it takes long to repair refrigerators) and repair of non-functional equipment; iv) fuel shortages for the cold chain system in the health institutions which may use this form of power; v) unreliable power supply, etc. These drawbacks could compromise the potency of the vaccines and the quality of the immunization services. Hence, there is an urgent need to improve Public Disclosure the capacity, knowledge and practice on cold chain management. Since the cold chain system is highly sensitive to power interruption, support for a climate-friendly cold chain for vaccines as well as more energy efficient and renewable energy-based health facilities will be of paramount importance for Ethiopia. The parent project has played an important role in addressing gaps in the water and sanitation facilities of the health facilities. Furthermore, it has played an important role in addressing shortage of personal protective equipment. Various energy sources including solar, grid, diesel generators will be used to power the cold chain infrastructure. COVID-19 vaccine products are temperature-sensitive and must be stored and handled correctly to ensure efficacy and maximize shelf life. Proper storage and handling practices are critical to minimize vaccine loss and limit risk of administering COVID-19 vaccine with reduced effectiveness. It is expected that cold chain storage and handling requirements for COVID-19 vaccine products will vary in temperature from refrigerated (2°C to 8°C) to frozen (-15°C to -25°C) to ultra-cold (-60°C to -80°C) in the freezer or within the dry ice thermal shipper in which product was received. Ethiopia was able to vaccinate 15 million children against measles in July 2020. This campaign ran over a prolonged period to limit crowding and risks of COVID-19 infections. The vaccines were delivered in open and well-ventilated areas. Infection prevention measures, such as mask wearing, physical distancing, handwashing and temperature checks were implemented during the vaccination. Preparatory activities, including training of vaccinators on COVID-19 prevention measures, community awareness activities, and ensuring availability of supplies (vaccines, PPEs and sanitizers), was undertaken before the mass campaign. The Ministry of Health and its partners moved forward to document the successful accomplishment of the SIAs, challenges and best practices so as to use for policy input in conducting mass vaccination during pandemics. Feb 26, 2021 Page 6 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) On the social side, ensuring access for the most vulnerable to the vaccination process is important and the targeting methodology and, equally, the logistical structure need to take this targeting into consideration; a respective global discussion is included in the WHO Framework for Allocation and Prioritization of COVID-19 Vaccination, noting the following groups: • Homeless people and those living in informal settlements or urban slums • Disadvantaged or persecuted ethnic, racial, gender, and religious groups, and sexual minorities and people living with disabilities • Low-income migrant workers, refugees, internally displaced persons, asylum seekers, populations in conflict setting or those affected by humanitarian emergencies, vulnerable migrants in irregular situations, nomadic populations • Hard to reach population groups The project will mitigate the broader social risk of inequity in access to vaccines, such as due to political pressures to provide vaccines to groups that are not prioritized (due to need or vulnerability); or should target groups be misaligned with available vaccines through several measures to ensure vaccine delivery targets the most vulnerable populations, particularly women, elderly, poor, IDPs, refugees, and minorities in accordance with criteria specified in this AF. First, the Bank will support the Government of Ethiopia to develop and adopt an explicit, contextually appropriate, and well-communicated targeting criteria and implementation plan (e.g., the national vaccination program and any subsidiary programs) including criteria for access to vaccines. The Borrower shall ensure that this plan be subject to meaningful consultations in accordance with ESS 10. There should be consensus to first target heath workers, other essential workers, and the most vulnerable populations, which will include a mix of the elderly, people with co-morbidities, and people in high-population density location such as slums and IDPs. However, the Public Disclosure refugees will not be included in the first phase of the project. All targeting criteria and implementation plans will be reflected in country’s national vaccination program. A second aspect are vaccine-tailored outreach activities to address potential rumors and ensure that the vaccination campaign is being ring-fenced from political tensions in the country. In the past, there were incidents of reprisals and retaliation on researchers and health workers which were mainly due to false rumors. This risk will be mitigated through explicit inclusion in robust stakeholder identification and consultation processes. Further, and linked to the social risks stated above, it is important to have clarity on the risks that may arise related to any mandatory aspect of the national program and whether and how this mandatory element relates to cultural, social and traditional community practices and values. Such risks need to be considered in light of the mitigation hierarchy and balanced against the health-related requirements of any mandatory vaccination program. In addition, the grievance mechanisms required under the ESF should be in place and equipped to address community, worked, and/or individual grievances related to such issues. The proposed AF COVID-19 emergency response project will support the following key initiatives: vaccine purchasing; service delivery of COVID-19 vaccination including trainings and deployment of technical assistants; cold chain and logistics; surveillance and monitoring, infection prevention; waste management; and impact evaluation. Hence, no major civil works are expected in this project and any works will take place in existing health facilities. As result, the project is not expected to endanger natural habitats or cultural sites. However, there are potential occupational health and safety risks associated vaccination activities and small-scale renovation activities. Furthermore, there are also risks associated with medical waste management. The implementation of the AF activities in compliance with the requirements of the updated ESMF and ESCP could help to significantly help to address potential EHS risks. D. 2. Borrower’s Institutional Capacity Feb 26, 2021 Page 7 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) The Ethiopian Ministry of Health (MOH) is the implementing agency for the project, including the AF. The Minister’s Office will be responsible for leading the execution of project activities as the Partnership and Cooperation Directorate (PCD) is currently moved from the State Ministers office to the Ministers Office. A National and Sub National Coordinating Committee (NCC) for COVID-19 vaccine introduction will be established and respective Technical Working Group will also be established to serve as a technical wing of the NCC. The Grant Management Unit (GMU) of the MoH’s PCD in collaboration with Maternal and Child Health (MCH) directorate will be responsible for the day-to-day management of activities supported under the project, as well as the preparation of a consolidated annual workplan and a consolidated activity and financial report for the parent and AF project components. The PCD already manages and coordinates several donor-funded projects in the health sector, including the Sustainable Development Goal Program for Results (P123531) and the Ethiopia component of the Africa CDC Regional Project. In addition, MOH- respective directorates, the regional health bureaus, and other key agencies will implement some of the project activities based on their functional capacities and institutional mandates. The Ethiopia Public Health Institute (EPHI) serves as the key technical entity for these subcomponents. . Initially, MOH deployed the staff needed for proper implementation of the environmental and social framework of the parent project. However, there has been continous turnover of staff in the implementing agencies. The Government of Ethiopia and MOH has experience in managing environmental and social risks associated with Bank Projects along the Bank’s Operational Policies. The country also has an appropriate legal framework and established institutions for environmental and social risk management. One of the implementing agencies, the Ethiopian Public Health Institute (EPHI), has existing safety manuals and standard operational procedures for waste handling and disposal. EPHI has a regular training program on biosafety and biosecurity and waste management. Most Public Disclosure of the staff are trained on biosafety and biosecurity and waste management. Staff working in the EPHI’s laboratories are vaccinated according to the specific risk group. In addition, EPHI has been implementing quality management system including biosafety and biosecurity. The Project will provide considerable funding to address these short-comings and it will be important that the Project sources international expertise to achieve international best practices on these matters in line with WHO guidelines. The prepared ESMF to by Ethiopia Ministry of Health builds on and update the existing ESMF prepared under Africa CDC Regional Investment Financing Project (P167916) so that the laboratories to be supported by the Project apply international best practices in COVID-19 diagnostic testing and other COVID-19 response activities. The first phase of the project has shown reasonable results, with coordination continuing to be a challenge, including with regional and local government institutions. This will be important to address also for the logistical challenges around the vaccination campaign to be financed by the AF. The client’s latest environment, health and safety (EHS) report for the parent project shows that considerable attention has been given to meet the EHS compliance requirements of the project. This, according to the report, is evidenced by the following activities: i. EHS focal persons have been assigned at each COVID-19 facility (isolation, treatment and quarantine centers) and trained on the EHS requirement of the project so that they could provide appropriate oversight on the functionality of the EHS risk management system. ii. A range of activities have been implemented to ensure adhere to standard precautions for infection prevention and control (IPC) at COVID-19 facilities which among others include: i) preparation of guidelines for rational use of personal protective equipment, proper health care waste management, environmental cleaning and disinfection, health care worker protection, dead body management during COVID-19, etc.; ii) health care workers (medical professionals, cleaners, porters, security staff, waste handlers and morgue workers) were trained on infection prevention and control; iii) procurement of pedal hand washing facilities and deployment of dedicated and Feb 26, 2021 Page 8 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) trained IPC-WaSH officer for each Quarantine, Isolation and Treatment center; iv) deployment of trained spray man for COVID-19 facility and v) sanitary supplies procured and distributed. iii. Health care waste/general waste management at COVID-19 facilities. In order to ensure proper medical waste handling and management, waste handlers and cleaners were trained and provided with appropriate personal protective equipment. Color coded dust bins and biohazard bags were procured and distributed to each regional state. Finally, the health care wastes were incinerated. iv. Occupational Health and Safety and Personal Protective Equipment (PPE). In addition to training the health care workers, appropriate PPE has been provided. The adequacy and appropriateness of PPE has monitored by forecasting and planning PPE use. The use of PPE at COVID-19 facilities was monitored and mentored by using standardize check list. Trainings on rational use of PPE and donning and doffing steps have been given to health care workers. A video demonstrating PPE donning and doffing steps was prepared and distributed to regional states. v. EHS Compliance at COVID-19 testing laboratories. COVID-19 testing and processing of samples have been carried out under validated BSc or primary containment materials. All health care workers use PPE by abiding with recommended national protocol during specimen collection. Laboratory professionals who collect and transport specimens took a minimum of two days training on sample collection, safe handling practices and spill decontamination procedures Further, the project made considerable progress in the implementation the Risk Communication and Community Engagement strategy (RCCES) as well as the Stakeholder Engagement plan. The following are the key activities conducted for the last six months: i. Activities to ensure two-way communications, including rapid assessments, use of toll-free numbers, rumors and media monitoring, and live TV programs were undertaken Public Disclosure ii. Several communication materials targeting different audiences (including persons with hearing difficulties) were developed and shared with the public.; iii. Regular daily and weekly briefings have been provided by the minister and EPHI authorities about the pandemic. iv. Orientation on school reopening and prevention and control of COVID19 was given to relevant stakeholders through several meetings. v. All regions were supported financially to train and deploy 1000 volunteers per regions. vi. Behavioral and social risk factors assessments were undertaken, and a national survey is underway. Hence, the activities that have been implemented in the parent project have been of great help to improve the capacity of the client. MoH has developed capacity to manage, train staff and conduct communication campaigns for vaccine distribution and provision in different vaccination programs. II. SUMMARY OF ENVIRONMENTAL AND SOCIAL (ES) RISKS AND IMPACTS A. Environmental and Social Risk Classification (ESRC) Substantial Environmental Risk Rating Substantial The AF will have considerable positive impacts as it will improve the client’s capacity for surveillance, monitoring and containment of COVID-19. On the other hand, the COVID-19 vaccination activities can also have potential environmental, health and safety (EHS) risks if appropriate waste collection, transportation and disposal plans are not put place and implemented. Studies show that there have been notable weaknesses in the cold chain system in Feb 26, 2021 Page 9 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) healthcare facilities in Ethiopia that may compromise the potency of the vaccines and the quality of the immunization services. However, the AF itself could help to address this risk as it plans to finance activities that can improve the cold chain for vaccines. There should also be an appropriate COVID-19 vaccines safety monitoring system to respond to adverse events following immunization (AEFIs) cases, if any. While the cold chain is an integral part of achieving immunization targets, it comes with an environmental cost including both energy emissions (indirect emissions) and leaks of highly GHG potent hydrofluorocarbon (HFC) refrigerant gases (direct emissions). Key measures to address logistics and cold chain include establishing/strengthening the national logistics working group with appropriate terms of reference and standard operating procedures to coordinate COVID-19 vaccines and ancillary products deployment; mapping the potential port(s) of entry, points of storage (stores), and fallback facilities in the country with their respective cold chain storage (2-8C, -20C, -60/70C) and transportation capacity for vaccines and ancillary products; assessing dry storage and cold chain capacity at all levels with regards to the COVID-19 vaccines characteristics and fill the identified supply and logistics gaps and establishing contractual agreements to prepare for vaccine introduction (e.g., vaccine warehousing, transport, waste management, cold chain capacity, etc.) where applicable. There are also occupational health and safety risks associated with the rehabilitation of medical facilities/minor civil works to be financed by the AF (such as repair, rehabilitation and construction of handwashing stations). The Ministry of Health (MoH) should therefore put an appropriate EHS risk management system in place for proper collection, transportation, and disposal of hazardous medical wastes and for minimization of occupational health and safety risks. It should also establish a functioning institutional/implementation arrangement for management environmental Public Disclosure and social risks. The environmental risk of the AF is therefore rated as substantial at this stage. Client's capacity in management of the EHS risks has been taken into account while rating the risk. Social Risk Rating Substantial Key risks related to the AF continue to be public and occupational health risks deriving from engagement with people and samples contaminated with COVID-19. Accordingly, provisions need thus to be in place for proper safety systems, with a focus on quarantine and isolation centers, screening posts, and laboratories to be funded by the project; encompassing above all OHS and waste management procedures. Another social risk of both parent and AF is Gender-Based Violence and Sexual Exploitation at the isolation, quarantine and treatment centers and vaccination sites. The client under the parent project has produced training and communication materials and distributed for healthcare providers and other workers in health facilities including isolation centers. This will continue for the AF as well. Beyond this immediate concern, project implementation needs also to ensure appropriate stakeholder engagement to (i) avoid conflicts resulting from false rumors, and (ii) vulnerable groups not accessing services. The project can thereby rely on the RCCE framework and activities set out since March 2020 to facilitate noted appropriate stakeholder engagement and outreach towards a differentiated audience (concerned public at large, suspected cases and patients, relatives, health workers, etc.) to ensure widespread sharing of project benefits (COVID-19 prevention and treatment) as well as avoidance of potential rumors and social conflicts. The project will develop and adapt an explicit, contextually appropriate, and well-communicated targeting criteria and implementation plan (e.g., the national vaccination program and any subsidiary programs) including criteria for access to vaccines before effectiveness. Further, the project will use the Grievance Redress Mechanism established for the parent project to resolve any issues related with the project implementation. Compared to the parent project, the AF has relatively high security risks. Feb 26, 2021 Page 10 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) In terms of access, the operation moves from collective outreach and individual treatment of sick people towards prevention benefits for individuals. This increases the risk of exclusion of the most vulnerable. The intervention will follow global approaches to vaccine allocation based on a risk and needs basis, thus the framework is expected to be inclusive. However, it will be important, that before project effectiveness logistical structures are established to ensure reaching targeted vulnerable beneficiaries, such as the elderly who may not able to come to health centers, homeless people, people without respective documentation, such as urban migrants without Kebele IDs, etc. The social risk can thus be considered substantial. B. Environment and Social Standards (ESSs) that Apply to the Activities Being Considered B.1. General Assessment ESS1 Assessment and Management of Environmental and Social Risks and Impacts Overview of the relevance of the Standard for the Project: The AF COVID-19 emergency response project will support following activities: vaccine purchasing; service delivery of COVID-19 vaccination including trainings and deployment of technical assistants; cold chain and logistics; surveillance and monitoring, infection prevention and waste management. The key environment, health and safety risks associated with these activities include: i) COVID-19 vaccination activities can have potential environmental, health and safety (EHS) risks if appropriate waste collection, transportation and disposal methods are not put place and implemented. Healthcare facilities could generate biological, chemical wastes, and other hazardous by-products that could be injurious to human health; ii) there may be COVID-19 infections due to inadequate adherence to Public Disclosure occupational health and safety standards that can lead to illness among healthcare workers; iii) there are also environmental, occupational health and safety risks associated with the rehabilitation of medical facilities/minor civil works to be financed by the AF (such as repair, rehabilitation and construction of handwashing stations); iv) drawbacks in the cold chain system of the country may compromise the potency of the vaccines. The Ministry of Health (MoH) should therefore put an appropriate EHS risk management system in place for proper collection, transportation, and disposal of hazardous medical wastes and for minimization of occupational health and safety risks. It should also establish a functioning institutional/implementation arrangement for management environmental and social risks. To this end, MoH shall update the Environmental and Social Management Framework (ESMF) which was prepared for the parent project-that could serve as a basis for the identification and management of EHS risks associated with the AF (so that it will cover among others as vaccine cold chain temperature monitoring plan , Surveillance of Adverse Events Following Immunization plan, COVID-19 vaccine handling and storage). Furthermore, the EHS risk management arrangement that has been put in place for the parent project could also be used for the AF for compliance monitoring and reporting. The parent project’s ESMF has comprehensively covered among others: i) relevant WHO COVID-19 biosafety guidelines; ii) the procedures for the safe handling, storage, and disposal of medical wastes from COVID-19 facilities; iii) the implementation arrangement for environmental and risk management activities; iv) EHS risk management capacity building requirements, iv) templates for preparation of site specific infection control and waste management plan (ICWMP), environmental and social management plan (ESMP) and infection control and prevention protocol. The EHS risks of could therefore be readily addressed if the activities under the AF will be implemented following the requirements of the updated ESMF. Apart from small scale refurbishing, no civil work will be financed in the AF. Feb 26, 2021 Page 11 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) The social risks of the vaccination campaign and related mitigation measures will be outlined in an amended SEP and in the Risk Communication and Citizen engagement Strategy (RCCES). As noted above, in terms of access, the operation moves from collective outreach and individual treatment of sick people towards prevention benefits for individuals. This increases the risk of exclusion of the most vulnerable. The intervention will follow global approaches to vaccine allocation based on a risk and needs basis, thus the framework is expected to be inclusive. However, it will be important, that logistical structures are established to ensure reaching targeted beneficiaries, such as the elderly who may not be able to come to health centers, homeless people, people without respective documentation, such as urban migrants without Kebele IDs, etc. Thus, the specific approach to allocation and implementation of a vaccine campaign need to be assessed on exclusion risks and respective measures developed proposed in the updated ESMF. Compared to the parent project, the AF has relatively high security risks. MoH shall ensure that vaccine prioritization within the country takes into account the vulnerabilities, risks and needs of groups who, because of underlying societal, geographic or biomedical factors, are at risk of experiencing greater burdens from the COVID-19 pandemic. Furthermore, following WHO Framework for Allocation and Prioritization of COVID-19 Vaccination, MoH should develop the immunization delivery systems and infrastructure required to ensure COVID-19 vaccines access to priority populations and take proactive action to ensure equal access to everyone who qualifies under a priority group, particularly socially disadvantaged populations such as : • People living in poverty, especially extreme poverty • Homeless people and those living in informal settlements or urban slums • Disadvantaged or persecuted ethnic, racial, gender, and religious groups, and sexual minorities and people Public Disclosure living with disabilities • Low-income migrant workers, refugees, internally displaced persons, asylum seekers, populations in conflict setting or those affected by humanitarian emergencies, vulnerable migrants in irregular situations, nomadic populations • Hard to reach population groups • Older adults defined by age-based risk • Older adults in high risk living situations (examples: long term care facility, those unable to physically distance) • Groups with comorbidities or health states (e.g. pregnancy/lactation) determined to be at significantly higher risk of severe disease or death • Sociodemographic groups at disproportionately higher risk of severe disease or death • Social groups unable to physically distance (examples: geographically remote clustered populations, detention facilities, dormitories, military personnel living in tight quarters, refugee camps) • Groups living in dense urban neighborhoods • Groups living in multigenerational households MoH shall put appropriate measures/protocols to ensure voluntary consent for vaccination and to ensure that there is no forced vaccination. MoH does not have a mandatory vaccination regulation for the public or a defined group of people. Feb 26, 2021 Page 12 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) The client has prepared an Environmental and Social Commitment Plan (ESCP) and the Stakeholder Engagement Plan (SEP) for the AF and shall allocate the resources necessary for implementation of the ESCP, the ESMF and the SEP to address the potential EHS risks. It will also prepare security management plan. The Ministry of Health (MoH) should therefore put an appropriate EHS risk management system in place for proper collection, transportation, and disposal of hazardous medical wastes and for minimization of occupational health and safety risks. It should also establish a functioning institutional/implementation arrangement for management environmental and social risks. To this end, MoH shall update the Environmental and Social Management Framework (ESMF) which was prepared for the parent project-that could serve as a basis for the identification and management of EHS risks associated with the AF. Furthermore, the EHS risk management arrangement that has been put in place for the parent project could also be used for the AF for compliance monitoring and reporting. The social risks of the vaccination campaign and related mitigation measures will be outlined in an amended SEP and in the Risk Communication and Citizen engagement Strategy(RCCES). As noted above, in terms of access, the operation moves from collective outreach and individual treatment of sick people towards prevention benefits for individuals. This increases the risk of exclusion of the most vulnerable. The intervention will follow global approaches to vaccine allocation based on a risk and needs basis, thus the framework is expected to be inclusive. However, it will be important, that logistical structures are established to ensure reaching targeted beneficiaries, such as the elderly who may not be able to come to health centers, homeless people, people without respective documentation, such as urban migrants without Kebele IDs, etc. Thus, the specific approach to allocation and implementation of a vaccine campaign need to be assessed on exclusion risks and respective measures developed in the ESMF. Ensuring the Public Disclosure contact lists particularly the two categories (65+ and comorbidities including in the IDPs) will be a challenge for the project. The client has prepared an Environmental and Social Commitment Plan (ESCP) and the Stakeholder Engagement Plan (SEP) for the AF and allocate the resources necessary for implementation of the ESCP, the updated ESMF and the SEP to address the potential EHS risks. ESS10 Stakeholder Engagement and Information Disclosure The project recognizes the need for an effective and inclusive engagement with all of the relevant stakeholders and the population at large. The AF will further strengthen the approach established in the parent project to engage with stakeholders based upon meaningful consultation and disclosure of appropriate information, considering the specific challenges associated with COVID-19, including the vaccination campaign. In instances where there is a likelihood of more vulnerable groups in attendance, such as the elderly and those with compromised immune systems or related pre-existing conditions, stakeholder engagement shall minimize close contact. People affected by Project activities shall be provided with accessible and inclusive means to raise concerns and grievances. To ensure this approach, the project is implementing a component on “Risk Communication and Community Engagement” (RCCE), funded with more than 8m USD, encompassing behavioral and sociocultural risk factors assessment, production of RCCE strategy and training documents, production of communication materials, media and community engagement, and documentation. This outreach will include information on the vaccination campaign moving forward. The health sector has been the target of rumors and conspiracy theories throughout the last years. Feb 26, 2021 Page 13 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) The ongoing RCCE intervention should have provided sufficient reliable information to communities to consequently also understand the vaccination component and to address related concerns, but the project will need to remain vigilant addressing those rumors and have emergency plans in place in case they would threaten the operation. The RCCE strategy outlines how rumors and misinformation are identified and addressed. Particularly, rumors and misinformation monitoring, analysis and response have been done and this will continue to be implemented. There is a dedicated team who monitors media platforms and public feedback and quickly develop countering messages to defuse and dispel such rumors. In addition, community radio phone-ins and conversations, social media, free toll lines, feedback from health extension workers and community volunteers and risk perception surveys will be used to gather rumors and misinformation can be gathered. A rumor and misinformation monitoring sheet which is developed during the parent project will be used to monitor and analyze rumors. Media monitoring and community engagement will be increased, and rumors will be addressed immediately, usually within 24-hours. To further strengthen the communication and outreach and community information flow during the vaccination, the AF has also assigned about 3m USD. The SEP is amended in parallel and also address how to equip medical personnel with the necessary information to engage pro-actively with beneficiaries. The approaches taken will thereby ensure that information is meaningful, timely, and accessible to all affected stakeholders, including usage of different languages, addressing cultural sensitivities, as well as challenges deriving from illiteracy or disabilities. The project will ensure that information disclosure takes place in an on-going and satisfactory manner, with clear and accessible messaging on safety of vaccines, principles of fair, equitable and inclusive vaccines access and allocation, as well as rationale for prioritizing certain groups where stakeholder engagement takes place in an on-going manner, at different levels, with different partners, and in a culturally Public Disclosure appropriate manner. Due to the expected country-wide implementation of activities, the differences of areas and socioeconomic groups will equally be taken into consideration during rollout of the RCCE. The client as part of the parent project has also put in place a GRM to enable stakeholders to air their concerns/ comments/ suggestions, if any. The national COVID-19 hotline has been established and serving for the public. Based on the experience of the national hotline, the project, with financing from the AF, will establish regional COVID-19 hotlines to provide more in-depth information about COVID-19 (i.e., symptoms, testing options, referrals, vaccine related information and so forth) and information about how to access other essential health services during the pandemic. The AF will also ensure the continued functioning of a Grievance Redress Mechanism, including the operation of a hotline. The operators of the hotlines will be equipped with the knowledge that is required to provide information about the vaccines. The client will also strengthen its immunization pharmacovigilance system. Taking into consideration the uniqueness and complexity of the vaccine safety monitoring of COVID-19 vaccine, the capacities to identify, report, investigate, and analyze adverse events following immunization and determine the cause of and respond to safety issues. The client will adopt and use COVID-19 vaccines safety surveillance manual developed by the World Health Organization. B.2. Specific Risks and Impacts A brief description of the potential environmental and social risks and impacts relevant to the Project. ESS2 Labor and Working Conditions Feb 26, 2021 Page 14 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) Like the parent Project, the AF will be implemented in accordance with the applicable requirements of ESS 2, in a manner acceptable to the Association, including through, inter alia, implementing adequate occupational health and safety measures (including emergency preparedness and response measures), setting out grievance arrangements for different categories of workers. Most activities supported by the project is are being conducted by health- and laboratory workers, i.e. civil servants employed by the Government of Ethiopia. Activities encompass thereby treatment of patients as well as assessment of samples and provision of vaccines. The key risk is contamination with COVID-19 (or other contagious illnesses as patients taken seriously ill with COVID-19 are likely to suffer from illnesses which compromise the immunes system), which can lead to illness and death of workers). The project will ensure the application of OHS measures as outlined in the ESMF (including ESMP and ICMWP) noted under ESS1 as well as WHO guidelines. This encompasses procedures for entry into health care facilities, including minimizing visitors and undergoing strict checks before entering; procedures for protection of workers in relation to infection control precautions; provision of immediate and ongoing training on the procedures to all categories of workers, and post signage in all public spaces mandating hand hygiene and PPE; ensuring adequate supplies of PPE (particularly facemask, gowns, gloves, handwashing soap and sanitizer); and overall ensuring adequate OHS protections in accordance with General EHSGs and industry specific EHSGs and follow evolving international best practice in relation to protection from COVID-19. Also, the project will regularly integrate the latest guidance by WHO as it develops over time and experience addressing COVID-19 globally. Thereby, Child labor is forbidden in accordance with ESS2 and Ethiopian law, i.e. due to the hazardous work situation, for any person under the age of 18. Public Disclosure The project may outsource minor works to contractors. The envisaged works will thereby be of minor scale and thus pose limited risks. The workers will not work in contaminated areas. Also, no large-scale labor influx is expected due to the same circumstance. In line with ESS2 as well as the Ethiopian law, the use of forced labor or conscripted labor in the project is prohibited. The project also ensures a basic, responsive grievance mechanism to allow workers to quickly inform management of labor issues, such as a lack of PPE and unreasonable overtime via the Ministry of Health. Labor Management Procedures (LMP) proportional to the activities, risks and impacts to be annexed with the updated ESMF will be prepared before effectiveness. The LMP will provide an estimated number of workers; detailed information on the work terms and conditions; and procedures to address workers grievances. It will also include a requirement that MoH shall notify to the Bank if certain rights (such as overtime compensation, annual or sick leave, or severance) have been suspended for healthcare workers or other essential workers due to COVID-19 emergency measures. ESS3 Resource Efficiency and Pollution Prevention and Management Medical wastes and chemical wastes (including reagents, infected materials, etc.) from the health facilities can have significant impact on environment and human health. Wastes that may be generated from medical facilities/ labs could include liquid contaminated waste, sharps, chemicals and other hazardous materials. Each beneficiary medical facility/lab, following the requirements of the ESMF, WHO COVID-19 guidance documents, shall prepare and follow Feb 26, 2021 Page 15 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) the Infection Control and Medical Waste Management Plan (ICMWP) to prevent or minimize such adverse impacts. The ESMF that has been prepared for the parent project has a template for preparation of site-specific instruments (ESMPs) and hazardous medical waste plans and provides guidance related to transportation and management of medical wastes, and medical goods or expired products. The client’s technical capacity to manage hazardous and medical waste in line with GIIP such as infrastructure, facilities and specialized companies for collection and treatment of hazardous and medical waste which operate in the country still needs improvement. To address this gap, the ESMF requires training and implementation of medical and hazardous medical waste plan in compliance with GIIP. The cold chain system should be energy efficient and should also try to rely on sustainable energy sources whenever practicable. The Project activities will consider alternatives and implement technically feasible activities to reduce project related GHG emissions such as use of the renewable energy sources and implementation of the energy efficiency measures in health care facilities. Every vaccine storage unit/container must have a temperature monitoring device. CDC recommends digital data loggers (DDLs). One vaccine product is stored at ultra-cold temperatures and will require a DDL that can register these temperatures. CDC is currently exploring options to support acquisition of DDLs for use with ultra-cold vaccines. However, the client should continue to identify options to obtain DDLs for use with ultra-cold vaccines, in addition to the DDLs needed for storage of refrigerated and frozen (-20°C) vaccines. DDLs using a buffered temperature probe provide the most accurate measurement of vaccine temperatures. However, many manufacturers use pure propylene glycol (freezing point -59°C) or a glycol mixture with a warmer freezing point in their probes. For accurate temperature monitoring of ultra-cold vaccines, it is essential that an air-probe or a probe designed specifically for Public Disclosure ultra-cold temperatures is used with the DDL. MoH shall comply with CDC requirements for vaccine management, including storage and handling, temperature monitoring at all times, complying with instructions for dealing with temperature excursions, and monitoring expiration dates (CDC- COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations, Oct 2020). If vaccines, sharps, vaccine vials and other supplies have to discarded/disposed of, the client shall follow the medical waste management procedure specified in the ESMF. MoH shall use the Logistics Monitoring Information System (LMIS) which is designed to track and trace Vaccine Vial Monitor (VVM) status, batch numbers, manufacturer, etc. If any damage happens, those specific lots will be separated and accounted in the LMIS and finally properly disposed of. To maintain temperature during transportation to health care facilities, the distribution of vaccines from central vaccine store to all provinces (regions) will be delivered by refrigerated trucks (diesel fueled cooling system). Solar powered and diesel-powered refrigerators will be used as a back-power sources if the electricity from hydropower interrupts as appropriate. All Walk in Cold Rooms (WICRs) and Walk in Freezers (WIFRs) are equipped with standard Remote temperature Monitoring Device (RTMD)which enables to alert via email and text messages. Some 1400 health facilities are also equipped with RTMDs which can alert excursions. However, bulk of vaccine swill be stored only at national and subnational levels with appropriate temperature. Ethiopian pharmaceutical supply Agency (EPSA) center and the 17 EPSA hubs are fully equipped with backup generators. EPSA will be delivering vaccines to districts only for the first dose at a time and the second dose will be consigned at the regional hubs. The health facilities will be consigning stock only for the first-round dose, most of the health facilities are equipped with modern Solar Direct Derives (SDDs) with autonomy up to 84 hours. Ethiopian pharmaceutical supply Agency (EPSA) has a working modality to ensure accountability for each transaction, each vial is captured in the STV (Stock transfer Feb 26, 2021 Page 16 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) voucher) and receive POD (proof of delivery); model 19 for every transaction. The updated ESMF will have a guideline related to the transport, storage, handling and disposal of COVID-19 vaccines. ESS4 Community Health and Safety In line with safety provisions in ESS2, it is equally important to ensure the safety of communities in relation to the pandemic. As noted above, medical wastes and general waste from health centers and quarantine and isolation centers have a high potential of carrying micro-organisms that can infect the community at large if they are is not properly disposed of. Health facilities, laboratories, quarantine and isolation centers, and screening posts, will thereby have to follow respective procedures with a focus on appropriate waste management of contaminated materials as well as protocols on the transport of samples and workers cleaning before leaving the work place back into their communities. The project will thereby follow the provisions outlined in the ESMF, noted in ESS1. Secondly, the operation of quarantine and isolation centers needs to be implemented in a way that both, the wider public, as well as the quarantined patients are treated in line with international best practice. This includes addressing avoidance of any form of Sexual Exploitation and Abuse as well as protocols in case of use of security personnel (see parent project for further details). Public Disclosure Specifically, to the AF and the vaccine campaign, first of all it should be stated that quality control for the vaccine will be organized globally and medical risk management for the vaccine itself shall not be done on the national level (i.e. in reference to vaccine reliability as well as potential side effects). That being said, the establishment of feasible cold chains within the country is a risk to be managed by the client and details will be included in the ESMF, as much as the appropriate provision of vaccines to beneficiaries. An effectively managed supply chain is crucial to the successful deployment of COVID-19 vaccines. Based on the current information, it is assumed that most vaccines will be stored at +2 °C to +8 °C, with exceptions that some vaccines that would require ultra-cold chain (UCC) equipment (-70 °C). Either frozen phase change material or dry ice in lieu of traditional cold packs could be used during transport. The client will need to conduct assessment of the existing supply chain system to be able to identify and address gaps, such as in storage, distribution, temperature monitoring and tracking, tracking and reporting vaccine stocks. The client will also undertake the following to ensure effective deployment of the vaccines. The deployment plan and standard operating procedures (SOPs), including on maintaining cold chain, will be communicated to all levels of the supply chain managers. Health professionals, including vaccinators, will be trained on infection prevention control measures and cold chain maintenance. In addition, continuous monitoring of data recording and reporting mechanism for vaccines and cold chain equipment and robust oversight and data-driven management, including systems for monitoring adherence to cold chain practices will be in place. The client will also strengthen its immunization pharmacovigilance system. Taking into consideration the uniqueness and complexity of the vaccine safety monitoring of COVID-19 vaccine, the capacities to identify, report, investigate, and analyze adverse events following immunization and determine the cause of and respond to safety issues. The client will adopt and use COVID-19 vaccines safety surveillance manual developed by the World Health Organization. Feb 26, 2021 Page 17 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) MoH should put an appropriate arrangement for vaccine cold chain temperature monitoring in line with GIIP which should cover the whole vaccine chain transport, storage and handling. The updated ESMF will have emergency preparedness and response (EPR) measures to address a plan for safe cold chain management during power outages and natural disasters. To address security concerns on the delivery of vaccines to certain parts of the country, a site-specific assessment shall be made, and a security management plan shall be prepared to the satisfaction of the Bank. The assessment and the vaccination campaign will be done in collaboration with the Ministry of Peace and its parastatal agencies to ensure the safe delivery of vaccines and related supplies. The Ministry of Peace and its parastatal agencies are responsible to ensure the maintenance of public order and security. The project in conflict affected areas may concider the use of security or military personnel. Hence,the client will prepare, adopt and enforce standards, protocols and codes of conduct for use of security personnel in the conflict affected areas. Further, the personnel that will be engaged in the vaccine distribution will be adequately instructed and trained, prior to deployment and on a regular basis, on the use of force and appropriate conduct (including in relation to civilian-security engagement, SEA and SH, and other relevant areas). The COVID-19 vaccine to be procured shall be deemed safe and approved by 3 Stringent Regulatory Authorities in three regions or one with WHO pre-qualification and approval by 1 Stringent Regulatory Authority according to its Project Appraisal Document for the COVID-19 Multi Phase Programmatic Approach Additional Financing. In cases where the Bank is supporting vaccine distribution, but the vaccines to be used do not fit the above approval criteria, the regional Environmental and Social Standards Advisor (ESSA) shall be consulted for guidance. Public Disclosure It is important to consider infection control measures that are currently necessary when selecting COVID-19 vaccination clinic settings : • Providing specific appointment times or other strategies to manage patient flow and avoid crowding and long lines. • Ensuring sufficient staff and resources to help move patients through the clinic flow as quickly as possible • Limiting the overall number of clinic attendees at any given time, particularly for people at higher risk for severe illness from COVID-19 • Setting up a unidirectional site flow with signs, ropes, or other measures to direct site traffic and ensure physical distancing between patients • When feasible, arranging a separate vaccination area or separate hours for people at increased risk for severe illness from COVID-19, such as older adults and people with underlying medical conditions • Making available a point of contact for any reasonable accommodation needs for people with disabilities • Selecting a space large enough to ensure a minimum distance of 6 feet between patients in line or in waiting areas for vaccination, between vaccination stations, and in postvaccination monitoring areas The quantity of COVID-19 vaccine transported to a satellite, temporary, or off-site COVID-19 vaccination clinic should be based on the anticipated number of COVID-19 vaccine recipients and the ability of the vaccination provider to store, handle, and transport the vaccine appropriately. This is essential to minimizing the potential for vaccine wastage and spoilage. • COVID-19 vaccines may be transported—not shipped—to a satellite, temporary, or off-site COVID-19 vaccination clinic setting using vaccine transportation procedures outlined in the upcoming COVID-19 addendum to CDC’s Vaccine Storage and Handling Toolkit. The procedures will include transporting vaccines to and from the provider site at appropriate temperatures, using appropriate equipment, as well as monitoring and documenting temperatures. Feb 26, 2021 Page 18 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) • Upon arrival at the COVID-19 vaccination clinic site, vaccines must be stored correctly to maintain appropriate temperature throughout the clinic day. • Temperature data must be reviewed and documented according to guidance in the upcoming COVID-19 addendum to CDC’s Vaccine Storage and Handling Toolkit. • At the end of the clinic day, temperature data must be assessed prior to returning vaccine to fixed storage units to prevent administration of vaccines that may have been compromised. • As with all vaccines, if COVID-19 vaccines are exposed to temperature excursions at any time, the temperature excursion should be documented and reported according to the national immunization program’s procedures. The vaccines that were exposed to out-of-range temperatures must be labeled “do not use” and stored at the required temperature until further information on usability can be gathered or further instruction on disposition or recovery is received. To mitigate and reduce gender-based violence and sexual exploitation risks of the project at the isolation, quarantine and treatment centers and vaccination sites, the client under the parent project has produced training and communication materials and distributed for healthcare providers and other workers in health facilities including isolation and quarantine sites. Further, the client has prepared Covid-19 focused operating procedures and tools for the parent project, and monitor their use and adherence at health facilities, isolation and quarantine centers. The AF will continue implementing the procedures prepared as well as trainings and communications. A standard reporting mechanism that includes referral and feed-back and complaint mechanism will be established and properly implemented in line with international good practice, including confidentiality and overall a survivor-centered approach. The project, as part of the communication component, has and will continue to include messages related to GBV and sexual harassment, as well as GBV referral services. Such services, including legal protection and hotlines, Public Disclosure are being made available free of charge, and where there are gaps, the Ministry of Health and its regional bureau counterparts will provide the necessary resources to strengthen it. ESS5 Land Acquisition, Restrictions on Land Use and Involuntary Resettlement As with the parent project, the AF will not cover civil works requiring land acquisition, restriction on land use and involuntary resettlement. However, should the need arise for the project to acquire land, appropriate plans in accordance with ESS5 guidelines will be prepared and cleared by the Bank prior to any displacement. ESS6 Biodiversity Conservation and Sustainable Management of Living Natural Resources No major construction or rehabilitation activities are expected in this project and all works will be conducted within existing facilities. Hence, likely impacts of the project on natural resources and biodiversity are low. However, if medical and chemical wastes are not properly disposed of, they can have impacts on living natural resources. Site specific waste management plans will be prepared following the requirements of the ESMF. ESS7 Indigenous Peoples/Sub-Saharan African Historically Underserved Traditional Local Communities Feb 26, 2021 Page 19 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) Due to the country-wide rollout of activities, it is likely that it will also affect people meeting the criteria of ESS7, notably in the emerging regions and potentially pastoralists at its borders. The project will ensure respect of human rights, dignity, aspirations, identity, culture and livelihoods of SSAHUTLC and avoid adverse impacts on them or, when avoidance is not possible, minimize, mitigate or compensate for such impacts. On the vaccine campaign, expectedly, the focus will be on urban areas first. But in case SSAHUTLC will be targeted, respective engagement on the demand side (i.e. potential cultural concerns around vaccines) as well as supply side (i.e. cold chain towards remote or pastoralist communities) will need to be ensured by the client. This will be ensured via the Project’s communication and outreach strategy as well as stakeholder engagement plan as outlined under ESS10: the project will ensure that such communities are appropriately informed and can share in the benefits of the project in an inclusive and culturally appropriate manner (i.e. prevention and treatment). Consultations and vaccination campaigns in these areas will be conducted through partnership with relevant SSAHUTLC organizations and traditional authorities. Consultations will clearly communicate that there is no forced vaccination. Stakeholder engagement and vaccinations will be conducted with extra precautions to minimize COVID- 19 transmission risks, especially for SSAHUTLC living in more remote areas or in voluntary self-isolation. At the same time, the ESMF will ensure functioning cold chain requirements throughout the country. No situations which would require FPIC are foreseen. The project activities are not expected to impact intangible cultural heritage of IP/SSAHUTLC, who may have certain traditional medicinal practices. Public Disclosure ESS8 Cultural Heritage No construction or rehabilitation activities are expected in this project. Hence, likely impact of the project on cultural heritage is low. ESS9 Financial Intermediaries This standard is not relevant for the suggested project interventions. C. Legal Operational Policies that Apply OP 7.50 Projects on International Waterways No OP 7.60 Projects in Disputed Areas No B.3. Reliance on Borrower’s policy, legal and institutional framework, relevant to the Project risks and impacts Is this project being prepared for use of Borrower Framework? No Feb 26, 2021 Page 20 of 21 The World Bank Ethiopia COVID-19 Emergency Response Project Additional Financing P175853 (P175853) Areas where “Use of Borrower Framework” is being considered: N/A. IV. CONTACT POINTS World Bank Contact: Enias Baganizi Title: Senior Health Specialist Telephone No: 5358+6069 / 251-011-51766069 Email: ebaganizi@worldbank.org Contact: Roman Tesfaye Title: Senior Operations Officer Telephone No: 5358+6140 / 251-011-5176140 Email: rtesfaye@worldbank.org Borrower/Client/Recipient Borrower: Democratic Republic of Ethiopia Implementing Agency(ies) Implementing Agency: Ministry of Health Public Disclosure V. FOR MORE INFORMATION CONTACT The World Bank 1818 H Street, NW Washington, D.C. 20433 Telephone: (202) 473-1000 Web: http://www.worldbank.org/projects VI. APPROVAL Task Team Leader(s): Enias Baganizi, Roman Tesfaye Practice Manager Iain G. Shuker Cleared on 21-Feb-2021 at 12:07:28 GMT-05:00 (ENR/Social) Maria Do Socorro Alves Da Cunha (SAESSA) Concurred on 26-Feb-2021 at 11:18:22 GMT- Safeguards Advisor ESSA 05:00 Feb 26, 2021 Page 21 of 21