Sector Assessment (Summary): Vaccines
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Responsive COVID-19 Vaccines for Recovery Project Under the Asia Pacific Vaccine 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 Immunization (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 hepatitis B,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 vaccination 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 rotavirus vaccine 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 conjugate vaccine 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