Responsive COVID-19 for Recovery Project Under the Asia Pacific Access Facility (RRP BAN 55077-001)

SECTOR ASSESSMENT (SUMMARY): VACCINES

A. Sector Road Map

1. Sector Performance, Problems, and Opportunities.

1. Bangladesh has achieved impressive improvements in health service coverage and health outcomes since independence in 1971. In the last 50 years from 2020, life expectancy at birth rose from 44 to 72 years,1 while the under-5 mortality rate declined almost tenfold in the same period (from 239.68 to 28.95 deaths per 1,000 live births).2 Since its establishment in 1974, the Expanded Programme on (EPI) has achieved notable success, including: (i) the delivery of high levels of coverage against vaccine-preventable diseases,3 with the proportion of children that are fully vaccinated rising from 2% in 1985 to 82.3% in 2016,4 and (ii) the eradication of smallpox and poliomyelitis. In line with regional (Southeast Asia Regional Vaccine Action Plan) and global targets (Global Vaccine Action Plan), the EPI has successfully introduced and scaled several new vaccines to high coverage levels, including the ,5 rotavirus (not scaled yet),6 measles-rubella,7 and pneumococcal conjugate vaccines.8

2. Development problems. Equity in access and resource limitations are among key development problems highlighted here. Routine coverage is high in Bangladesh (at ≥97% nationally in 2019)9 though unevenly distributed across geographic and socio-economic groups, with coverage as low as 78% among children in Dhaka slums (footnote 4), and with coverage increasing according to income and educational attainment.10 The coronavirus disease (COVID-19) vaccination program will need to prioritize these hard-to-reach groups to ensure equitable distribution. Vaccination coverage was adversely affected by COVID-19-related disruption, particularly in the early outbreak period. Across March and April 2020, for instance, over 284,000 children missed their pentavalent vaccine,11 with disruption of measles vaccination thought to be responsible for a measles outbreak in at least one district.12 Despite initial declines, routine childhood immunization rates have recovered to 2019 levels, in part due to catch-up campaigns initiated by the Government of Bangladesh with technical support from the World Health Organization (WHO).11 Given that Bangladesh has some of the lowest levels of

1 MacroTrends. Bangladesh Life Expectancy 1950–2021 (accessed 28 February 2021). 2 Knoema. Bangladesh - Under-five mortality rate (accessed 28 February 2021). 3 N. Sheikh et al. 2018. Coverage, Timelines, and Determinants of Incomplete Immunization in Bangladesh. Tropical Medicine and Infectious Disease. 3 (72); and S. Luby et. al. 2008. Infectious Diseases and Vaccine Sciences: Strategic Directions. Journal of Health, Population and Nutrition. 26 (3). pp. 295–310. 4 Government of Bangladesh, Ministry of Health and Family Welfare (MOHFW), Directorate General of Health Services (DGHS), EPI. 2017. Bangladesh EPI Coverage Evaluation Survey 2016. Dhaka. 5 L. Childs, S. Roesel and R. Tohme. 2018. Status and progress of hepatitis B control through vaccination in the South- East Asia Region, 1992–2015. Vaccine. 36 (1). pp. 6–14. 6 L. Schwartz et al. 2019. Impact of introduction in children less than 2 years of age presenting for medical care with diarrhea in rural Matlab, Bangladesh. Clinical Infectious Diseases. 69 (12). pp. 2059–2070. 7 H. Sarma et al. 2019. Implementation of the World’s largest measles-rubella mass vaccination campaign in Bangladesh: a process evaluation. BMC Public Health. 19 (1). pp. 1–10. 8 A. Baqui et al. 2018. Pneumococcal impact assessment in Bangladesh. Gates Open Research. 2 (21). 9 WHO, Regional Office for South-East Asia (SEARO). 2019. EPI Factsheet 2019: South-East Asia Region. New Delhi. 10 J. Grundy et al. 2016. Policy opportunities and limitations of evidence-based planning for immunization: lessons learnt from a field trial in Bangladesh. WHO South-East Asia Journal of Public Health. 5 (2). pp. 154–163. 11 United Nations Children’s Fund (UNICEF). 2020. UNICEF hails immunization progress in Bangladesh as monthly uptake surpasses pre-COVID-19 levels. Press Release. 12 October (accessed 28 February 2021). 12 United Nations Office for the Coordination of Humanitarian Affairs. 2020. Bangladesh: Covid 19 and Sajek Measles Outbreak - Briefing Note (31 March 2020) (accessed 12 March 2021). 2

government health expenditure in the world (at $7 per capita),13 and given the ongoing economic and financial pressures of the COVID-19 pandemic, maintaining adequate financing for routine and emergent vaccination programs will need to be a strategic priority for the government.

3. EPI at Directorate General of Health Services plays a critical and central role. EPI, within the Directorate General of Health Services (DGHS) of the Ministry of Health and Family Welfare (MOHFW), is responsible for ensuring the quality and safety of implementation of the routine public immunization schedule and immunization campaigns. The National Committee for Immunization Practice is responsible for making technical recommendations on the immunization schedule, immunization practices, and new vaccines and technologies.14 Development partners including the United Nations Children’s Fund (UNICEF), WHO, and GAVI support the EPI on key areas of the vaccine program, including service delivery; vaccine advocacy and communication; surveillance; vaccine supply, quality, and logistics; and program management. Vaccines used in the EPI are procured by the government with procurement support from UNICEF and the planning and implementation of the immunization program are done by the government in collaboration with WHO and other development partners.15 The capacity of EPI headquarters in implementing and administering vaccine programs needs to be strengthened both for routine and COVID-19- related vaccination in the country.

4. Bangladesh has a robust regulatory environment for vaccine deployment. The principal agency for the regulation, licensing and post-marketing pharmacovigilance of vaccines in Bangladesh is the Directorate General of Drug Administration (DGDA), which executes these functions with technical support from the National Committee for Immunization Practice and WHO (footnote 13). Two approval pathways allow for expedited market entry of vaccines to Bangladesh, namely: (i) the No-Objection-Certificate pathway for those vaccines pre-qualified by WHO, and (ii) the Registration/Emergency Use Authorization pathway for those products entering the country through commercial channels. 16 Post-marketing pharmacovigilance and surveillance are undertaken by MOHFW, which has operationalized coordinating committees, guidelines, and tools for active monitoring and reporting of adverse events following immunization (AEFI) at all levels, as well as the EPI which is responsible for the routine facility- and community-based surveillance.17 For COVID-19 vaccination, AEFI expert review committees have been established at all administrative levels (division, district, city corporation, etc.). While the committees support with field level monitoring, hotlines have also been made operational for reporting and public consultations. A digital reporting system has been developed to collate COVID-19 vaccine-related AEFI data for pharmacovigilance reporting. Priorities for strengthening the regulatory capacity of the DGDA include (i) increasing the speed and efficiency of pharmacovigilance and surveillance mechanisms, considering the potential of digital reporting platforms; and (ii) establishing indemnification and liability limitation mechanisms to encourage supplier participation in the vaccine program.

5. Logistics readiness will require investments and reform for optimal performance. An effective vaccine management assessment was conducted in 2014,18 followed by an effective

13 WHO. Global Health Expenditure Database. Domestic general government health expenditure per capita, in US$ (accessed 17 Feb 2020). 14 Government of Bangladesh, MOHFW, DGHS. 2013. National Immunization Policy. Dhaka. 15 Government of Bangladesh, MOHFW, DGHS. 2010. Comprehensive Multi-Year Plan: 2011–2016 Expanded Programme on Immunization (EPI) Bangladesh. Dhaka. 16 Government of Bangladesh, MOHFW, DGHS. 2021. National Deployment and Vaccination Plan for COVID-19 Vaccines in Bangladesh, 3 February 2021. Dhaka. 17 Government of Bangladesh, MOHFW, DGHS, EPI. 2014. Guideline for AEFI Surveillance. Dhaka. 18 Government of Bangladesh. 2015. Gavi Annual Progress Report 2014. Dhaka . 3 vaccine management improvement plan with technical assistance from UNICEF and WHO.19 In response to cold chain storage gaps identified in the assessment, MOHFW began to expand storage capacity across 48 districts, building a mix of walk-in-coolers, walk-in-freezers, and dry stores. For COVID-related logistics, Bangladesh conducted a cold chain equipment inventory assessment of the country on the working assumption that vaccine products would be refrigerated (at 2ºC to 8ºC) or frozen (at –15 ºC to –25 º C) (footnote 16). The assessment identified a shortage of approximately 6 cubic meters of cold room, and 2.40 cubic meters of freezer room storage capacity nationally.20 DGHS is working on arranging additional storage for COVID-19 vaccines by hiring cold rooms from other sources at the national level using their experience during the recent measles and rubella campaign.21 Adequate cold chain storage capacity has been ensured for COVID-19 vaccines by leveraging COVID-19 Vaccines Global Access Facility support of $2.4 million. Priorities for strengthening the logistics management of COVID-19 vaccine products include (i) expanding the existing vaccine inventory management systems to include COVID products, and (ii) digitizing the supply chain and logistics tracking systems.

6. Human resources for overall health sector and retention at hard-to-reach areas. Bangladesh suffers from both an absolute shortage and geographic maldistribution of the health workforce (HRH)22 as well as clustering of health facilities (both public and private) at the district and sub-district headquarters. In 2019, the vacancy rate for DGHS sanctioned posts was above 25%. Less than 20% of HRH are distributed in rural areas, serving 75% of the population. The nurse-to-doctor ratio is the reverse of WHO recommendation of three nurses for one physician, with more than two doctors in practice for every one nurse.23 For COVID-19 , more than 44,000 personnel, comprising 7,344 vaccination teams have been trained and deployed.24 Over 1,000 vaccination sites have been operationalized nationally. Careful medium-to-long term planning of HRH, as well as additional recruitment, will be essential to minimize the disruption that re-deployment of healthcare workers and facilities to COVID-19 vaccination may have on routine service delivery.

7. Medical waste management plan. A national policy and regulatory framework for medical waste management (MWM) are in place, which includes immunization waste. The Medical Waste Management and Processing Rules of 2008 is the primary source of guidance for all stakeholders involved in the disposal of medical waste and include strict environmental health protections. 25 Operationalization of the guidance varies, with no standardized system yet established to manage the healthcare waste generated daily in hospitals, clinics, and households. At the hospital level, medical waste is managed by city corporations, third-party organizations, and nongovernment organizations with broad concerns raised as the capacities and compliance of these stakeholders in the safe disposal of medical waste.26 At upazila (sub-unit of district)-level, pit burning predominates as the main disposal method for medical waste. A recent study

19 WHO, SEARO. 2016. Post-Introduction Evaluation (PIE) of Pneumococcal Conjugated and Inactivated Poliomyelitis Vaccines: Report of the joint national/international mission Bangladesh, 26 November–6 December 2015. New Delhi. 20 Storage calculation single dose vial of 3.5 cubic centimeters volume per dose was considered. 21 WHO, SEARO. 2020. Report: Closer to Measles and Rubella elimination from Bangladesh, 34 million children will be immunized within 6 weeks. News Release. 12 December (accessed on 1 March 2021). 22 S. Ahmed et al. 2011. The Health Workforce Crisis in Bangladesh: Shortage, Inappropriate Skill-Mix and Inequitable Distribution. Human Resources for Health, 9 (3). 23 World Bank. 2015. The Path to Universal Health Coverage in Bangladesh: Bridging The Gap of Human Resources for Health. Washington, DC. 24 WHO. 2021. Morbidity and Mortality Weekly Update (MMWU) No. 51, 15 February 2021 (accessed on 26 February 2021). Dhaka. 25 Government of Bangladesh, Gazette. 2008. Medical Waste Management and Processing Rules of 2008. Dhaka. 26 M. Rahman et al. 2020. Biomedical waste amid COVID-19: perspectives from Bangladesh. The Lancet Global Health. 8 (10). 4

estimated that 6,180 tons of medical waste are disposed of unsafely in Dhaka city alone, posing a serious threat to public and environmental health.27 As a priority, MOHFW and DGHS need to enhance MWM capacity at health facilities, including the establishment of a centralized waste treatment system and the installation of additional capacity for sterilization and disposal. There is also a need to (i) strengthen the capacity of health facility staff at all levels through training and accreditation, and (ii) strengthen oversight and compliance by digitizing the system for tracking MWM.

8. is historically low in Bangladesh as a result of successful EPI. Bangladesh has a high measles, mumps, rubella immunization rate (89) comprared to the average for lower middle countries (74.8), and a routine immunization rate of 99%. The government has successfully introduced and scaled several new vaccine products in recent years. 28 The use of mass vaccination campaigns and social mobilization; the proximity of vaccination centers to local communities; and high levels of community trust toward health care service providers have contributed to the success of new vaccine introducations in Bangladesh.29 An impact evaluation of the recent measles and rubella vaccination campaign revealed that robust outreach and awareness activities had increased public awareness of vaccine benefits and increased vaccine acceptance not only for the campaign but for routine EPI sessions.30 For COVID-19 vaccination, extensive risk communication activities and social mobilization at the community level especially in rural and hard-to-reach areas will be essential to improve vaccine awareness, acceptance, and uptake. Further, a survey was conducted to understand people’s attitudes towards COVID-19 vaccination in the country. 31 Results revealed a high level of acceptance towards the vaccination with 84% respondents indicating an interest in taking vaccines. Respondents (32%) stated they would take the vaccine immediately after start of the immunization program.

9. Tracking vaccine administration. All health facilities (public, private, and nongovernment organization) maintain a standard vaccination register for the target population of the health facility. For routine vaccination, all health facilities report monthly on the number of patients vaccinated within their catchment area (footnote 13). Immunization records are provided to the client on an immunization card which also outlines the routine immunization schedule. Bangladesh is the only country in the world that has integrated into District Health Information System version 2, the entire supply chain information system, cold chain information system, and routine EPI service delivery data (reporting rate was 100% as of August 2018). Routine health information is now readily available on time, in a format accessible to all.32 Expanding the existing District Health Information System version 2 platform to include COVID-19 vaccines will be important, if used after the emergency phase.

2. Government’s Sector Strategy

27 G. Faisal et al. 2021. Challenges in medical waste management amid COVID-19 pandemic in a megacity Dhaka. Journal of Advanced Biotechnology and Experimental Therapeutics. 4 (1). pp. 106–113. 28 J. Uddin et al. 2013. Introduction of New Vaccines: Decision-making Process in Bangladesh. Journal of Health, Population and Nutrition. 31 (2). pp. 211–217. 29 M. Tana et. al. 2013. Child Vaccination and its Impacts on Health and Health Related Matters in Noakhali Region of Bangladesh. Bangladesh Pharmaceutical Journal. 16 (2). pp. 125–129. 30 M.J. Uddin et. al. 2016. Evaluation of impact of measles rubella campaign on vaccination coverage and routine immunization services in Bangladesh. BMC Infectious Diseases. 16 (411). 31 Institute of Health Economics, University of Dhaka and Bangladesh CoMo Modeling Team. 2021. People’s Attitudes Towards Vaccination against COVID 19: Evidence from Bangladesh. Dhaka. 32 UNICEF, Regional Office for South Asia. 2019. Health System Strengthening. Transforming the health information system in Bangladesh through the implementation of DHIS2. Kathmandu. 5

10. Government’s COVID-19 Vaccination Allocation Plan. The DGHS developed the National Deployment and Vaccination Plan for COVID-19 Vaccines in Bangladesh (NDVP) (footnote 16) which guides the procurement, deployment, and monitoring of COVID-19 vaccines (including MWM). The NDVP specifically accounts for the needs of vulnerable populations, including the displaced persons from Myanmar. The government aims to vaccinate 80% of the population, using a phased approach to deployment. The DGDA issued an Emergency Use Authorization33 for the Oxford/AstraZeneca vaccine product manufactured by the Serum Institute of (SII), with the first doses arriving in early February 2021.34 A vaccination prioritization schedule was developed which aligns with the WHO’s Strategic Advisory Groups of Experts on Immunization guidelines on equitable allocation in the context of limited supply (footnote 16). Although the government has mobilized significant domestic resources to support the vaccination program, external financing will be required to reach the 80% population target.

B. Major Development Partners: Strategic Foci and Key Activities

11. With technical support from WHO and UNICEF, Bangladesh applied successfully to join the COVID-19 Vaccines Global Access Facility Advanced Market Facility. As per the COVID-19 Vaccines Global Access Facility allocation, the country expects to receive vaccine doses equal to 20% of its population (34,561,877) followed by additional doses equal to at least 40% of its population (69,123,754) based on the availability of vaccine and weighted allocation. Further, DGHS is exploring the purchase of vaccines through bilateral negotiation with manufacturing companies/countries. In the first tranche, the government has procured doses to cover an estimated 7.8% of its population with a total expense of $120 million for vaccine procurement and $60 million for operational cost of vaccine deployment (footnote 16). In addition to ADB’s proposed $940 million support through the Responsive COVID-19 Vaccines for Recovery Project under the Asia Pacific Vaccine Access Facility for the procurement of vaccines that cover 11.6% of population, immediate financing support for the COVID-19 vaccine program from development partners is likely to include: (i) World Bank financing of $500 million for the procurement of vaccines that cover 11% of population and operational cost for vaccinating 31% of population, (ii) Asian Infrastructure Investment Bank financing of $500 million for the operational cost for vaccine deployment, (iii) Agence Française de Développement financing of €150 million budget support for the implementation of the vaccination plan and social protection for vulnerable groups, (iv) Kreditanstalt für Wiederaufbau financing of €200 million support for operational costs of vaccine deployment and health systems strengthening and €20 million grant for supporting the COVID-19 vaccination to the displaced persons from Myanmar, (v) Japan International Cooperation Agency financing of $300 million budget support for the COVID-19 vaccination program.35

12. The risk communication working group led by UNICEF has actively started working to produce risk communication materials and their adaptation for different groups and audiences.36 DGHS, with support from UNICEF, conducted assessments on cold chain, storage, and distribution requirements for the COVID-19 vaccine. The United States Agency for International Development is providing technical assistance in surveillance, training, and information systems.

33 Government of Bangladesh, DGDA. 2021. Pharmacovigilance Protocol for COVID-19 Vaccines, January 2021. Dhaka. 34 Bangladesh launched the COVID-19 vaccination on 27 January 2021. All the vaccine receivers (a total of 567) were kept under medical observation for seven days, and the nationwide vaccination campaign started on 7 February 2021. WHO. 2021. Morbidity and Mortality Weekly Update (MMWU) No. 49, 31 January 2021. Dhaka (accessed on 1 March 2021). 35 Development Coordination (accessible from the list of linked documents in Appendix 2 of the report and recommendation of the President). 36 Communication with Communities Working Group and Inter-sector Coordination Group. 2020. COVID-19 Risk Communication and Community Engagement Update, 14–20 May 2020 (accessed 11 March 2021). 6

C. Institutional Arrangements and Processes for Development Coordination for COVID-19 Vaccines Response

13. The government coordinates development partners’ support to its COVID-19 vaccination program at the COVID-19 Vaccine Preparedness and Deployment Core Committee led by the Additional Director General for Planning and Development under the Directorate General of Health Services (DGHS) of the MOHFW. The core committee includes members from various departments of DGHS and representatives of development partners, including ADB, the World Bank, WHO, UNICEF and United States Agency for International Development, which serves as a platform to coordinate the support from different partners to the government to avoid any duplication of resource allocation. ADB has started joining coordination meetings since 11 March 2021, and liaises with DGHS and development partners for coordination on vaccine needs, allocation and financing plans.

D. ADB Experience and Assistance Program

14. The Bangladesh–ADB partnership started in 1973 when the country was reconstructing from the damage of the War of Liberation. ADB’s Bangladesh program evolved over time in close alignment with the country’s priorities beginning with a focus on infrastructure investments and broadening into other areas over time.37 With the support of ADB, the Local Government Division of the government has been providing primary health care services in urban areas from 1998 under the Urban Primary Health Care Project I and II and the Urban Primary Health Care Services Delivery Project, which will continue to provide for the next 5 years up to 2023 under Urban Primary Health Care Services Delivery Project–II.38 ADB has also supported the government through the COVID-19 response, including (i) immediate support of $500 million under the COVID-19 pandemic response option to mitigate immediate effects of COVID-19 on health and economic sectors, and (ii) additional support of $100 million through the COVID-19 Response Emergency Assistance Project to support the health system investments and community response to the pandemic.39

37 ADB. 2013. Bangladesh–ADB: 40 Years of Development Partnership. Manila. 38 Government of Bangladesh. Urban Primary Health Care Services Delivery Project-II (accessed 1 March 2021). 39 Government of Bangladesh, Cabinet Division. 2021. Memo no. 04.00.0000.321.16.005.20-36. Dated 18 January 2021. Dhaka. 7

Problem Tree for Vaccines

Direct Failure to achieve global health and economic security

effects

Poor health outcomes Disrupted economic growth Negative externalities

Core Low coverage of COVID-19 vaccinations problem

Insufficient supply of COVID-19 Health sector supply side Demand-side challenges Root vaccines challenges causes

Government must procure Inadequate rapid tracking and Inadequate communication activities vaccines from abroad against reporting mechanisms for AEFI backdrop of high demand Insufficient vaccine inventory Vaccine hesitancy, though quite Inability to domestically produce tracking and monitoring low, among communities COVID-19 vaccines rapidly mechanisms

Insufficient medical waste management capacity

Insufficient human resources for both routine services and emergency COVID-19 vaccination

AEFI = adverse events following immunization, COVID-19 = coronavirus disease. Source: Asian Development Bank.