Joint National/International Expanded Programme on Immunization and Vaccine Preventable Disease Surveillance Review: Republic of the Union of Myanmar 25 September – 8 October 2016

A joint national/international review was conducted in 10 states and regions in Myanmar on 25 September to 8 October 2016 to assess the national immunization programme and share lessons learnt for preventing and controlling vaccine preventable diseases. This report summarizes the findings and recommendations made during the review. Joint National/International Expanded Programme on Immunization and Vaccine Preventable Disease Surveillance Review Republic of the Union of Myanmar 25 September – 8 October 2016 SEA-Immun-114

i SEA-Immun-114 Distribution: General Joint National/International Expanded Programme on Immunization and Vaccine Preventable Disease Surveillance Review Republic of the Union of Myanmar 25 September – 8 October 2016 ii Joint National/International Expanded Programme on Immunization and Vaccine Preventable Disease Surveillance Review, Republic of the Union of Myanmar, 25 September – 8 October 2016 (SEA-Immun-114) © World Health Organization 2017 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. 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Photo credit: WHO SEARO / Sigrun Roesel iii TABLE OF CONTENT ACRONYMS ............................................................................................................................................... I ACKNOWLEDGEMENTS ........................................................................................................................... IV EXECUTIVE SUMMARY ......................................................................................................................... - 1 - INTRODUCTION ..................................................................................................................................... 10 BACKGROUND ....................................................................................................................................... 12 REVIEW OBJECTIVES .............................................................................................................................. 21 METHODOLOGY ..................................................................................................................................... 22 LIMITATIONS ......................................................................................................................................... 23 FINDINGS AND KEY RECOMMENDATIONS BY TOPIC AREA ..................................................................... 24 GENERAL ..................................................................................................................................................... 24 GOVERNMENT SUPPORT ................................................................................................................................. 24 PROGRESS IN MEETING GLOBAL AND REGIONAL GOALS. ....................................................................................... 46 NUVI ......................................................................................................................................................... 60 CONCLUSION ......................................................................................................................................... 63 ANNEXES ............................................................................................................................................... 64 ANNEX 1. LIST OF PARTICIPANTS IN JOINT NATIONAL/INTERNATIONAL EPI REVIEW ............................................. 64 ANNEX 2. AFP SURVEILLANCE INDICATORS, MYANMAR, 2016 AS OF WEEK 42 ................................................ 67 ANNEX 3. QUALITY OF MEASLES PERFORMANCE INDICATORS, MYANMAR, 2011-2015 ...................................... 68 ANNEX 4. MYANMAR IN THE CONTEXT OF IMMUNIZATION GOALS & TARGETS ................................................... 69 iv List of Tables TABLE 1. EPI SCHEDULE, MYANMAR, 2016 ------------------------------------------------------------------------------------------ 17 TABLE 2. FINANCIAL INDICATORS REPORTED TO WHO, MYANMAR, 2013-2015 (ALL FUND AMOUNTS IN US$) --------------- 18 TABLE 3. VACCINATION COVERAGE: WHO AND UNICEF BEST ESTIMATES AND COUNTRY ESTIMATES. MYANMAR, 2012- 2015. ----------------------------------------------------------------------------------------------------------------------------- 19 TABLE 4. DHS ESTIMATES OF VACCINATION COVERAGE. MYANMAR, 2015-2016 ------------------------------------------------ 20 TABLE 5. VPDS REPORTED TO WHO, 2013 – 2016 -------------------------------------------------------------------------------- 21 TABLE 6. BASELINE COST PROFILE OF IMMUNIZATION PROGRAMME IN 2015 ------------------------------------------------------ 26 TABLE 7. FUTURE IMMUNIZATION PROGRAMME RESOURCE REQUIREMENTS, 2017-2021---------------------------------------- 27 TABLE 8. SOURCES OF EPI VACCINE FUNDING IN MYANMAR AS OF AUGUST 2016 ----------------------------------------------- 33 TABLE 9. AFP AND FEVER/RASH SURVEILLANCE INDICATORS, MYANMAR, 2012 - 2015 ----------------------------------------- 43 List of Figures FIGURE 1. MAP OF MYANMAR ............................................................................................................................. 12 FIGURE 2. ORGANOGRAM OF THE MOHS, MYANMAR.............................................................................................. 14 FIGURE 3. ORGANOGRAM OF THE DOPH, MYANMAR .............................................................................................. 14 FIGURE 4. MAP OF MYANMAR SHOWING SITES VISITED BY THE REVIEW TEAM ............................................................... 23 FIGURE 5. REPORT ROUTING, TIMELINE AND MANDATED ACTIONS FOR AEFI ................................................................. 31 FIGURE 6. REPORTED SERIOUS AEFI CASES, MYANMAR, 2007 - 2015 ........................................................................ 32 FIGURE 7. PERFORMANCE OF ISC IN MYANMAR ...................................................................................................... 34 FIGURE 8. INTEGRATED WEEKLY VPD REPORTING .................................................................................................... 42 FIGURE 9. FIRST AND SECOND DOSE COVERAGE OF MCV, SIAS, AND CASE AND DEATH COUNT, MYANMAR, 1987 – MID- 2016 ..................................................................................................................................................... 51 FIGURE 10. PERCENTAGE OF TOWNSHIPS WITH AT EAST 95% COVERAGE WITH MCV1, BY YEAR. MYANMAR, 2010 - 2015. 51 FIGURE 11. SEROPREVALENCE OF CHRONIC HBV INFECTION IN 18 TOWNSHIPS ............................................................. 54 FIGURE 12. REPORTED DIPHTHERIA CASES BY AGE AND VACCINATION STATUS. MYANMAR, 2016 ..................................... 56 i ACRONYMS 3MDG Three Millennium Development Goal Fund AEFI adverse events following immunization AES acute encephalitis syndrome AFP acute flaccid paralysis BCG Bacille Calmette Guerin bOPV bivalent oral poliovirus vaccine CEPI Central Expanded Programme on Immunization CEU Central Epidemiology Unit CIF case investigation form cMYP comprehensive multi-year plan CRS congenital rubella syndrome CTC controlled temperature chain cVDPV circulating vaccine-derived poliovirus cVDPV2 type 2 vaccine-derived poliovirus DG Director General (of Public Health) DHS Demographic Health Survey DoPH Department of Public Health DoV Decade of Vaccines DTP diphtheria–tetanus-pertussis EPI Expanded Programme on Immunization EVM Effective Vaccine Management GAPIII third edition of the Global Action Plan to minimize post- eradication poliovirus facility-associated risk Gavi Gavi, the Vaccine Alliance GDP gross domestic product GNI gross national income GVAP Global Vaccine Action Plan GSP good supply practices HBV hepatitis B virus HCW health care worker HBeAg hepatitis B e antigen HBsAg hepatitis B surface antigen HepB hepatitis B vaccine HepB-BD hepatitis B vaccine birth dose ii Hib Haemophilus influenzae type B HPV human papilloma virus HSS2 second health system strengthening grant (from Gavi, the Vaccine Alliance) IEC information, education and communication INGO international nongovernmental organization IPAC Immunization Practices Advisory Committee IPV inactivated poliovirus vaccine iSC immunization supply chain JCV Japan Committee "Vaccines for the World's Children" JE Japanese encephalitis M single antigen measles vaccine M2 second dose of single antigen measles vaccine MCV measles antigen containing vaccine MCV1 first dose of measles antigen containing vaccine MCV2 second dose of measles antigen containing vaccine MNTE maternal and neonatal tetanus elimination MoHS Ministry of Health and MoPF Ministry of Planning and MR measles-rubella vaccine (MR) MR1 first dose of measles–rubella vaccine MR2 second dose of measles-rubella vaccine MW midwife Myanmar the Republic of the Union of Myanmar NCCPE National Certification Commission for Polio Eradication NCIP National Committee for Immunization Practices NGO non-governmental organization NHL National Health Laboratory NHP National Health Plan NPERC National Polio Expert Review Committee NPLCC National Polio Laboratory Containment Committee NRA National Regulatory Authority NT neonatal tetanus NUVI new and underutilized vaccine introduction NVC National Verification Committee (for measles and rubella/congenital rubella syndrome elimination) iii OBRA (poliovirus) outbreak response assessment OPV oral polio vaccine OPV3 third dose of oral polio vaccine P1 poliovirus type 1 P2 poliovirus type 2 PCV pneumococcal conjugate vaccine Penta pentavalent vaccine (diphtheria-pertussis-tetanus-hepatitis B- Haemophilus influenzae type B) Pol3 third dose of polio vaccine (either oral or inactivated) PV2 Poliovirus type 2 RCV1 first dose of rubella antigen containing vaccine RHC rural health centre RHSC rural health sub-centre RSO regional surveillance officer SEAR World Health Organization South-East Asia Region SEAR ITAG South-East Asia Regional Technical Advisory Group on Immunization SEARVAP South-East Asia Region Vaccine Action Plan SIA supplementary immunization activity SOP standard operating procedure THE total health expenditure tOPV trivalent oral poliovirus vaccine TT tetanus toxoid TT2 second dose of tetanus toxoid UHC universal health care UNICEF United Nations Children’s Fund US CDC United States Centres for Disease Control and Prevention VDPV vaccine-derived poliovirus VDPV2 type 2 vaccine-derived poliovirus VII Vaccine Independence Initiative VPD vaccine preventable disease VVM vaccine vial monitor WPV wild poliovirus WHO World Health Organization YCH Yangon Children’s Hospital iv ACKNOWLEDGEMENTS The review team would like to gratefully acknowledge the support provided by the Ministry of Health and Sport, the Republic of the Union of Myanmar, the World Health Organization Country Office in the Republic of the Union of Myanmar, and the WHO Regional Office for South-East Asia. Their provision of administrative, management and technical assistance was critical to the successful implementation of the mission. The team would also like to acknowledge the long list of persons throughout the Republic of the Union of Myanmar in multiple offices and agencies who shared their time and gave insights into the status of the Expanded Programme on Immunization and vaccine preventable disease surveillance in Myanmar. The review team would particularly like to acknowledge the commitment and interest of the Union Minister of Health and Sport who found time in his busy schedule for a two hour meeting with the review team to discuss findings and recommendations. - 1 - EXECUTIVE SUMMARY Background and Methodology The Expanded Programme on Immunization (EPI) in the Republic of the Union of Myanmar (Myanmar) has achieved considerable success in preventing and controlling vaccine preventable diseases (VPD). The country has seen a recent increase in government commitment to EPI. Since 2015 (inclusive), Myanmar has successfully introduced four vaccines and intends to introduce three more by end-2019. However, the country faces new challenges as it is forecast to transition from eligibility for funding from Gavi, the Vaccine Alliance (Gavi) and must self-finance all vaccines by 2025. Furthermore, as the country seeks to reach every child with vaccine, it faces unique sociocultural and political challenges. As part of systematic reviews scheduled to be carried out in all World Health Organization (WHO) South-East Asia Region (SEAR) countries, WHO’s Regional Office for South-East Asia and Myanmar’s Ministry of Health and Sport (MoHS) collaborated to conduct a Joint National/International EPI and VPD Surveillance Review in Myanmar from 25 September to 08 October 2016. In 2015, Myanmar had also experienced an outbreak of circulating type 2 vaccine-derived poliovirus (cVDPV2), to which the country responded in accordance with WHO guidelines. This response was assessed concurrently with the EPI and VPD Surveillance Review; the results of the assessment are reported elsewhere.1 The objectives of Myanmar’s Review were to:  Understand which children in Myanmar are not being fully immunized and the reasons that this is occurring. To the extent possible, efforts were made to assess areas with limited access to government services and increased reliance on other providers such as non-governmental organizations (NGOs) or local administrations;  Determine if the VPD surveillance system meets national and global targets and is currently able to detect any VPD outbreaks; this would include laboratory support and data management systems;  Determine if the strategies being implemented for measles and rubella objectives are adequate to maintain or achieve targets;  Assess how strategies and capacities of the immunization programme need to be strengthened to sustain polio-free status and maternal and neonatal tetanus elimination (MNTE), accelerate hepatitis B control and uniformly increase coverage for all routine vaccines; this would include vaccine and supply management, 1 WHO. Regional Office for South-East Asia. Immunization. Documents and Publications. External Second Assessment: Circulating Vaccine-Derived Poliovirus Type 2 (cVPDV2) Outbreak Response, Myanmar, 25 September-8 October 2016. Available at http://www.searo.who.int/entity/immunization/documents/en/ (Accessed Feb 1 2017) - 2 - adverse events following immunization (AEFI) management, financing and sustainability. Myanmar’s Central Epidemiology Unit (CEPI), and WHO’s Regional Office for South- East Asia and Country Office in Myanmar collaborated to assemble a review team of Myanmar members drawn from national and state/regional levels as well as internationals representing a variety of agencies. The team conducted a desk review of relevant policies and guidelines; secondary analysis of available data; interviews with key stakeholders, policy makers, and programme staff; and direct observation of programme implementation at field sites throughout Myanmar. Key Findings Myanmar shows an increasing level of government support with increased funding in 2015 for EPI and the articulation of immunization as one of five health priorities in the new government’s 100-day plan. Historically, Myanmar’s health budget has been low, both in absolute terms and as a proportion of gross domestic product (GDP); this has in turn been reflected in low government funding and a heavy dependency on external funding for the EPI. Recent growth in GDP has translated into an increasing health budget and a 2016 commitment to fund traditional vaccines and co-finance vaccines supported by Gavi. The programme benefits from a number of advisory and oversight bodies, several chaired by the Director General (DG) of Public Health. Reporting of AEFI and response to AEFI has been adequate to detect and mitigate the impact of several major events in recent years. All vaccines used in the country must be licensed by Myanmar’s National Regulatory Authority (NRA). Vaccine is procured annually through the United Nations Children’s Fund (UNICEF). The country underwent an Effective Vaccine Management (EVM) review in 2015 and has developed an improvement plan, in the process of implementation, to respond to the findings of this review.2 Equitable and universal delivery of vaccination in Myanmar is challenged in several different ways. The country’s sociocultural and political diversity requires flexible and creative situation-specific approaches to reach as-yet unreached children. Unfilled sanctioned posts, situations in which the population has grown but the number of sanctioned posts has not expanded accordingly (especially in the growing urban areas), a lack of sanctioned posts for the immunization supply chain (iSC) resulting in cold chain key persons not holding sanctioned posts, and incomplete knowledge in certain topic areas (for example, iSC, some aspects of surveillance) all pose human resource challenges. The need for demand generation has led to a public communications plan which is in the early stages of implementation. Many service delivery challenges have been identified through and are scheduled to be addressed 2 Myanmar cEVM Improvement Plan. 2016-2021. 2015. Ministry of Health and Sport. Republic of the Union of Myanmar - 3 - by the second grant from Gavi for health system strengthening (HSS2) funding which will cover 2017 -2019.3 VPD surveillance is an integral part of the evaluation process to ensure that a country is delivering high quality vaccination services to the entire population. Elimination and eradication goals require that countries raise their surveillance standards and their use of surveillance data to levels beyond those needed for disease control alone. While VPD surveillance in Myanmar is strong enough to detect large outbreaks, its usefulness to the programme is hampered by limited sensitivity, resulting in part from inadequate health worker awareness of surveillance protocols and specimen collection for suspected cases, as well as by incomplete local ownership in terms of data analysis and use. In addition, it is possible that the country’s sociocultural and political diversity impact under-reporting of diseases. The National Health Laboratory (NHL) provides excellent support to the programme, but at times confronts challenges in terms of quality of specimens received and/or incomplete or no case investigation forms (CIF). Myanmar was certified polio-free on 27 March 2014 with all other countries in the region. The last case of indigenous wild poliovirus (WPV) was reported in 2000 and the last imported WPV was identified in 2007. However, the country has experienced cases of circulating vaccine-derived poliovirus (cVDPV), with the most recent cases confirmed in 2015 in Rakhine State. Outbreak response assessments (OBRA) were carried out twice as per the requirements of the Global Polio Eradication Initiative; the second OBRA was conducted concurrently with this EPI and VPD surveillance review. Reports of both first and second assessment are available at: http://www.searo.who.int/entity/immunization/documents/en/ The country achieved MNTE in 2010. Since that time, the country has made continuous efforts to maintain MNTE with a particular focus on ensuring that women receive at least two doses of tetanus toxoid (TT), conducting neonatal tetanus (NT) surveillance, and promoting the presence of skilled attendants at births. Myanmar administers the first dose of measles containing vaccine (MCV1) at 9 months and the second dose (MCV2) at 18 months of age. MCV2 was introduced in 2012; in 2015, following a nationwide measles-rubella vaccine (MR) supplementary immunization activity (SIA) targeting those aged 9 months – 15 years and achieving a reported 94% coverage, Myanmar replaced single antigen measles vaccine (M) at 9 months with MR and plans to begin using MR as MCV2 in 2017. To achieve measles elimination, at least 95% coverage with two doses of MCV must be reached in 100% of districts. In 2015, only 19% of districts achieved at least 95% coverage with MCV1. Measles surveillance indicators suggest substantial surveillance gaps while there is relatively little awareness of rubella and congenital rubella syndrome (CRS). Sentinel CRS surveillance is scheduled to begin in 2017. 3 Using HSS approach to address country priority areas of immunization: lessons learned and challenges from Myanmar. Presentation made to the Seventh SEAR-ITAG Meeting, 7- 10 June 2016. Ministry of Health and Sport. Republic of the Union of Myanmar. - 4 - Myanmar has intermediate to high hepatitis B endemicity. A major intervention to prevent mother-to-infant transmission of hepatitis B is administration of a dose of hepatitis B vaccine within 24 hours of birth (HepB-BD). Hepatitis B vaccine (HepB) was introduced in 2003, with HepB-BD supported by Gavi. The discontinuation of Gavi support for HepB-BD resulted in discontinuation of HepB-BD as part of EPI. HepB-BD will be (re)introduced in hospitals in the last quarter of 2016. However, reaching regional 2020 hepatitis B control goals will require expansion of the use of HepB-BD beyond hospitals. Myanmar has a functional National Committee for Immunization Practices (NCIP) to guide decisions on new and underutilized vaccine introduction (NUVI). Since 2012 (inclusive), Myanmar has successfully introduced MR, inactivated polio vaccine (IPV), bivalent oral poliovirus vaccine (bOPV) and pneumococcal vaccine (PCV) and plans to introduce Japanese encephalitis (JE) vaccine in 2017, rotavirus vaccine in 2018, and human papilloma virus (HPV) vaccine in 2019. In terms of NUVI, a major challenge faced by Myanmar is expansion of sentinel surveillance sites and generation of burden of disease and economic data to adequately inform decision-making processes. Key Recommendations A. Government Support Advocacy  Look for opportunities to advocate at the highest level (for example, Cabinet) for the EPI. Work with partners [US Centres for Disease Control and Prevention (CDC), WHO and UNICEF] to develop a slide-set showcasing immunization as a ‘best-buy’ which can be used in advocacy. Finance  Advocate at all levels and with all stakeholders for a comprehensive health financing policy in the context of the universal health care (UHC) vision for Myanmar as a pre-requisite for increasing health budget allocations.  Advocate for the CEPI to be an example of increasing national financial shares for essential public health services and of high return on investments in the health sector.  Operationalize the comprehensive Multi-Year Plan 2017-2021 (cMYP) financing strategy options and explore innovative resource mobilization and financial instruments (for example, community participation, an immunization trust fund4, and efficiency gains in service delivery). 4 A detailed explanation of immunization trust funds is provided in Domestic trust funds. In Immunization financing: A resource guide for advocates, policymakers and program managers (website). http://www.immunizationfinancing.org/en/sources-of- financing/domestic-trust-funds# accessed 1 June 2017. - 5 -  Reform and restructure financial management at the central and regional levels to allow effective utilization of available resources, including greater flexibility in funding allocation at peripheral levels and more rapid transfer of funds from central to peripheral level. Oversight Bodies  Explore whether oversight and advisory bodies may wish to follow WHO ‘best practices’ by having chairmanship independent from government. AEFI Surveillance  Develop stringent regulations requiring proper supply regulatory inspection for public and private sectors.  Allocate budget for enhancing AEFI surveillance. Vaccine Licensing, Procurement and Management  Accelerate the approval of the Vaccine Independence Initiative (VII) and initiate its implementation.  Accelerate the implementation of the EVM improvement plan with close monitoring of progress against established milestones and timelines.  Strengthen human resource support for the iSC and management in following ways:  Establish sanctioned posts for cold chain Key persons and supportive staff at all levels;  Redefine necessary qualifications and terms of reference for iSC and management posts particularly at the storage points where large quantities of vaccines are kept (central and state/region sub-depot);  Provide routine training to staff, as well as on-the-job coaching through supportive supervision.  Advocate for a national budget line to ensure stable and predictable funding for the iSC once Gavi’s HSS2 to Myanmar is ended. Demand Generation  Implement and evaluate the impact of the communication activities defined in HSS2.  Conduct training at regional and township levels to improve interpersonal and risk communication skills among basic health staff and volunteers.  Develop simplified materials on immunizations for communities and caregivers. Materials should be tailored to local languages and cultures. - 6 - Service Delivery Short term  Implement HSS2.  Develop a quarterly implementation plan and set up a high-level mechanism of oversight (DG or Minister). Mid/long term  Create national and state/regional-level government budget lines for EPI to cover both vaccine and operational costs (for example, field allowances for midwives (MWs), vaccine transportation, outbreak response, supervision and monitoring).  Create positions and supportive funding for dedicated EPI staff (EPI and cold chain key persons, data focal person) at state/region and township levels.  Allow flexibility and promote local approaches and language to encourage tailoring of service delivery to special populations. B. VPD Surveillance  Focus Regional Surveillance Officer (RSO) responsibility on VPD surveillance and EPI.  Increase frequency of active VPD surveillance in large hospitals.  Provide VPD surveillance-specific refresher training to clinicians and health staff with a specific focus on case definitions, procedures for specimen collection and transport.  Increase laboratory confirmation and genotyping of cases.  Encourage calculation of acute flaccid paralysis (AFP) and fever/rash surveillance indicators at subnational levels to increase ownership. C. Progress in Meeting Global and Regional Goals Polio  For recommendations related to polio, please see those contained in the report of the OBRA conducted from 25 September to 08 October 2016, available at http://www.searo.who.int/entity/immunization/documents/en/ MNTE  In highest-risk communities incompletely reached through routine immunization, TT SIAs targeting women of child bearing age could be considered.  To improve the sensitivity of the existing case based NT surveillance system: o consider community based surveillance in high risk areas; - 7 - o strengthen the maternal and infant death reporting and auditing system and investigate all reported infant deaths; o establish a monitoring mechanism for community based surveillance, comparable to that used for AFP surveillance; o ensure that the NT case investigation form allows supervisors and surveillance personnel at all levels to have a complete understanding of the history and symptoms of the case and to confirm diagnosis of the suspected NT case; and o adapt the case response to the cause(s) of non-protection. If the mother requires vaccination to protect further unborn children, other eligible women in the same community should also be evaluated for TT vaccination status and targeted for immunization based on eligibility.  To increase use of skilled delivery care in high-risk and hard-to-reach areas consider: o strategic re-deployment of MWs to high-risk areas; and o strategic deployment of lady health visitors to fill gaps in skilled birth attendance.  To expand the types of providers able to administer TT vaccine consider: o using auxiliary MWs as TT vaccinators to minimize missed opportunities for TT protection; and o in hard-to-reach areas, partnering with qualified private or NGO sector providers with success and local acceptability operating in those contexts.  To increase use of facility care by communities in close proximity to health centres, consider: o an incentive scheme (for example, conditional cash transfers) for accessible communities; and o vouchers for transport to rural health centres (RHCs). Measles and Rubella  Increase commitment to measles and rubella elimination by: o gaining agreement to 2020 rubella elimination goal once the second dose of MR (MR2) is added to the routine immunization schedule; and o finalizing the National Measles and Rubella Strategy, 2016-2020, ensuring it reflects the rubella elimination goal.  Increase to at least 95% MCV2 coverage in all districts by: o developing costed sub-national measles/rubella elimination work plans with clear designations of responsibility; - 8 - o conducting village-level risk assessment and mitigation; o conducting school-based immunization record checks at school entry; and o conducting SIAs when the population immunity gap equals the size of the birth cohort.  Move from “control” to “elimination” standard surveillance by: o increasing surveillance sites beyond AFP sites to include all health facilities, and train relevant staff; o developing a clear implementation plan, with communication strategy, for fever/rash surveillance, and a field guide with standard operating procedures (SOPs) with clear designation of roles and responsibilities for specimen collection and transport, and train relevant staff; and o finalizing CRS guidelines and establishing CRS sentinel sites in 2017 as planned.  Improve rapid outbreak control and response by: o implementing hospital infection control; o vaccinating high risk adults, including health care workers (HCW), at no cost; and o vaccinating at-risk populations, such as orphaned children cared for within monasteries. Hepatitis B  Develop an immunization specific national hepatitis B operational plan to achieve the 2020 hepatitis B control goal and expand HepB-BD to reach deliveries that occur outside hospitals.  Explore using vaccine for HepB-BD outside the cold chain in RHCs, sub-centres, and home births. This would require using a single dose HepB-BD with vaccine vial monitors and approval by the National Immunization Technical Advisory Group and relevant national regulatory body.  Train HCW on birth dose storage, vaccination, and recording. NUVI  Develop a sustainable immunization financing plan and periodically update it to ensure predictable funding for sustaining routine immunization and NUVI.  Foster partnerships with national/international technical partners (including academia) to generate reliable evidence for decision making on NUVI and related technologies. - 9 -  Implement the cold chain improvement plan with the Gavi HSS2 to expand the cold chain capacity to accommodate JE, rotavirus and HPV vaccine introduction, as well as provide expansion of the cold chain to cover more service delivery points. Conclusion In conclusion, Myanmar has a rapidly evolving EPI which shows evidence of recently- increased government commitment and a high level of engagement from the international community. The programme has successfully introduced a number of new and underutilized vaccines and is supported by a dedicated and hard-working staff. However, Myanmar faces complex social, cultural and political factors leading to pockets of unimmunized children; these factors may also contribute to under-reporting of disease. Reaching these children may require context-tailored approaches. This situation is compounded by service delivery challenges, many of which have been identified and seek to be addressed through Gavi’s HSS2 funding. Service delivery is also challenged by human resource limitations, in particular vacant (but sanctioned) posts. While VPD surveillance is adequate to detect outbreaks, sensitivity of surveillance, specimen collection and laboratory confirmation, and local analysis and use of data will need to be bolstered in order for disease surveillance to optimally inform and guide the EPI. As the programme looks to the future, plans to sustain the gains made through HSS2 and ensure vaccine self-sufficiency by 2025 are critical. 10 INTRODUCTION The Expanded Programme on Immunization (EPI) in the Republic of the Union of Myanmar (Myanmar) has achieved considerable success in preventing and controlling vaccine preventable diseases (VPDs). The country has seen a reduction of > 90% in cases of diphtheria, pertussis and tetanus when compared to the period prior to the implementation of the EPI in 1978. Myanmar achieved maternal and neonatal tetanus elimination (MNTE) in 2010 and was certified polio-free in 2014. Recent years have seen the successful introduction of measles-rubella vaccine (MR), inactivated poliovirus vaccine (IPV), bivalent oral poliovirus vaccine (bOPV) and pneumococcal conjugate vaccine (PCV). Reporting of the EPI target diseases (polio, measles, rubella, diphtheria, pertussis, neonatal tetanus (NT)) and Japanese encephalitis (JE) (for which the vaccine is not yet part of the country’s EPI) are mandatory and is based on clinical and/or laboratory evidence; reporting for some diseases is based on syndromic surveillance. In spite of impressive decreases in the overall morbidity and mortality due to VPDs in Myanmar, gaps in coverage in certain populations have led to disease outbreaks. In 2012 and 2015, Myanmar experienced outbreaks of circulating vaccine-derived poliovirus (cVDPV). Sporadic cases of diphtheria, many based on clinical diagnosis, have been reported annually, with numbers varying from 19 to 87 in the past five years. Myanmar subscribes to the key strategic objectives of the Global Vaccine Action Plan (GVAP) and the global goals of the Decade of Vaccines (DoV) (2011-2020)5 (1) achieve a world free of polio, (2) meet vaccination coverage targets, (3) reduce child mortality, (4) meet global and regional elimination targets, and (5) develop and introduce new vaccines. Myanmar also subscribes to regional goals of eliminating measles and controlling6 rubella and congenital rubella syndrome (CRS) by 2020, as well as accelerating the control of hepatitis B and JE. In line with the World Health Organization (WHO) South-East Asia Region (SEAR) Vaccine Action Plan (VAP), the country also seeks to strengthen routine immunization systems and services, and accelerate the introduction of new vaccines.7 The South-East Asia Regional Technical Advisory Group on Immunization (SEAR- ITAG) recommends that each country should conduct periodic joint national- international programme reviews in addition to its own regular internal programme monitoring. The last international EPI review in Myanmar was conducted in 2008. 5 Global Vaccine Action Plan. World Health Organization. 2013. http://www.who.int/immunization/global_vaccine_action_plan/en/ . Accessed 15 November 2016 6 Defined as a 95% reduction of rubella and CRS as compared with the 2008 baseline nationally and for the Region 7 South-East Asia Regional Vaccine Action Plan 2016-2020. World Health Organization Regional Office for South-East Asia. 2016 (draft) 11 Joint national/international EPI reviews conducted in SEAR, including this one, have three broad objectives, which are to:  provide a snapshot to public health programme directors and public health policy makers on the status of the EPI and VPD surveillance;  assess progress in meeting key national, regional and global goals; and  provide an opportunity to share lessons learned with other countries which share the same goals for preventing and controlling VPDs. This document reports on the findings and recommendations of the Joint National- International EPI and VPD Surveillance Review held in Myanmar from 25 September to 8 October 2016. Recommendations are found at the end of each topic area. 12 BACKGROUND General Myanmar, a South-East Asian country, shares boundaries with the People's Republic of Bangladesh, the Republic of India, and the People’s Republic of China, the Lao People’s Democratic Republic and the Kingdom of Thailand. The country covers approximately 676 000 km2. It is administratively divided into one territory and 14 states or regions with a total of 74 districts. Figure 1. Map of Myanmar In 2014, the population of Myanmar was estimated at 51.5 million. Approximately 28% of the population was aged 0-14 years, 6% was aged more than 65 years and the median age in the country was 27.1 years. The population growth rate was 0.89% with a total fertility rate per woman of 2.29. Life expectancy at birth was 67 years. Under-five mortality per 1000 live births was 72. From 2008 to 2012, the male literacy percentage in those aged >15 years was 92.6% and the female literacy percentage for the same age group was 86.9%. Approximately 28% of households are urban.8 Myanmar has >130 ethnic groups speaking more than 100 languages and dialects. There are eight major 8 The 2014 Myanmar Population and Housing Census. The Union Report. Census Report Volume 2. Department of Population. Ministry of Immigration and Population. Republic of the Union of Myanmar. 2015. 13 ethnic groups: Bamar, Shan, Kayin, Rakhine, Mon, Chin, Kachin and Kayah. Approximately 90% of the population is Buddhist, 5% is Christian, and 4% Muslim. Myanmar is considered a lower middle income country with a gross domestic product (GDP) in 2014 of US$ 64.33 billion and an annual GDP growth rate that year of 8.5%.9 In November 2015, general elections were held resulting in the National League for Democracy forming the national government. Priority areas within health for the government include the strengthening of the immunization programme and health information systems, standardization of working procedures across health sectors, the development of a code of ethics for all health personnel, fostering cooperation between private and public sectors, and responding to outbreaks in a timely and appropriate fashion. Health Services and EPI in Myanmar Health Services In 1993, the National Health Policy was developed which places ‘Health for All’ as a primary objective. The National Comprehensive Development Plan (Health Sector) covers the period from 2010/2011 to 2030/2031. Short-to-medium-term planning is provided through a series of five-year health plans, with the most recent covering the period from 2011/2012 to 2015/2016.10 The Ministry of Health and Sport (MoHS), previously known as the Ministry of Health, is responsible for planning, financing, administrating, regulating and providing health care. The Department of Public Health (DoPH) is one of six departments within the Ministry, and is responsible for immunization which is managed by Central Expanded Programme on Immunization (CEPI) as well as disease surveillance activities; both of these fall under the Central Epidemiology Unit (CEU) (Figures 2 & 3). 9 The World Bank data base (online database). Washington: World Bank; 2016 (http://data.worldbank.org/country/myanmar, accessed 31 July 2016) 10 Myanmar Healthcare. 2014. Ministry of Health. The Republic of the Union of Myanmar. (http://www.moh.gov.mm/file/MYANMAR%20HEALTH%20CARE%20SYSTEM.pdf, accessed 15 November 2016) 14 Figure 2. Organogram of the MoHS, Myanmar Source: Ministry of Health Restructuring, 2015. Ministry of Health and Sport. The Republic of the Union of Myanmar. Figure 3. Organogram of the DoPH, Myanmar Source: Ministry of Health and Sport. The Republic of the Union of Myanmar. 15 In Myanmar, both public and private sectors provide health care, with the private sector providing primarily ambulatory care. The strengthening of community-based health services is considered critical to improving health care in Myanmar. The importance of building national capacity in field epidemiology is also recognized and Myanmar participates in the Association of South-East Asian Nations Plus Three Field Epidemiology Training Network.11 EPI The EPI was launched in Myanmar in 1978. Partner support for the EPI is received from Gavi, the Vaccine Alliance (Gavi) (new vaccine introduction, cold chain expansion, health system strengthening), United Nations Children’s Fund (UNICEF) (procurement of traditional vaccines, education and communication materials and cold chain expansion), WHO (surveillance, capacity building, review meetings, etc.) and the Three Millennium Development Goal Fund (3MDG)12 (operational support to targeted townships, cold chain support). The role of the local community, nongovernmental organizations (NGOs) and women’s organizations is limited to advocacy and social mobilization. A recent focus of immunization services has been the border and hard-to-reach areas which have displaced and vulnerable populations, as well as areas of previous conflict and peri- urban areas. Few NGOs work in these settings. Difficulties in reaching populations have been linked to inadequate staff for immunization; as a result, the MoHS plans to increase the number of staff trained to give vaccinations.13 The government which came to power in 2016 has articulated immunizations as being one of its top five health priorities. A comprehensive multiyear plan (cMYP) for immunization covers 2017-2021. This plan has the following programme objectives:  To strengthen immunization programme management, human resources, financing and service delivery to provide equitable service to all target populations including special strategies for peri-urban, slum, migratory populations, geographically and socially hard- to-reach and conflict areas;  To improve demand creation and ownership of immunization through community participation and communication;  To strengthen immunization supply chain (iSC), vaccine management and build stronger cold chain systems at all levels;  To achieve the goals of eradication, elimination and control of VPDs: and  To maintain zero polio cases (both wild poliovirus (WPV) and VDPV); 11 Health in Myanmar. 2014. Ministry of Health. The Republic of the Union of Myanmar. 12 The 3MDG project is funded by a consortium of agencies – Australian Agency for International Development (AusAID), Danish International Development Agency (Danida), European Union, Swiss Confederation, Sweden, Department for International Development (DFID), and United States Agency for International Development (USAID) 13 Health in Myanmar. 2014. Ministry of Health. The Republic of the Union of Myanmar. 16  To maintain MNTE status;  To achieve elimination of measles and control of rubella and CRS by 2020;  To strengthen and maintain strong surveillance systems for AEFI and other priority VPDs;  To introduce new and underused vaccines and new technology into routine immunization, supported by evidence of disease burden.14 Myanmar has recently seen a number of initiatives to perform in-depth evaluations of and strengthen aspects of its EPI. In 2015, the country conducted an Effective Vaccine Management (EVM) assessment. Key recommendations from this assessment included increasing vaccine storage significantly, assuring temperature control during storage and transport, and strengthening data and programme management.15 In response to this, a cold chain expansion and replacement plan was developed16 and has been partially implemented with funding from 3MDG. In 2016, the country also underwent an evaluation, supported by UNICEF,17 with the development of a Supply Chain Data Use Manual.18 The Joint Appraisal coordinated by Gavi in 2016 noted the following bottlenecks and impediments to the EPI: immunization equities; data quality with specific concerns around denominators; service delivery; cold chain and vaccine management; management of vaccine and injection materials; community participation; and human resource capacity.19 Through Gavi, Myanmar has also received funding for health system strengthening from 2017 to 2019. Although this funding is not EPI-specific, many of the bottlenecks that it seeks to address were noted in the Joint Appraisal and are directly linked to EPI performance. In terms of EPI, the funding will target demand creation, cold chain and vaccine supply management, leadership, management and coordination, service delivery, and data and health information systems.20 Finally, as a lower middle income country, Myanmar is expected to reach full self- sufficiency in terms of vaccine purchase by 2025. A first step is self-sufficiency with regard to the traditional EPI vaccines by 2017. This goal is supported by the proposal for 14 Comprehensive Multi-Year Plan 2017 – 2021. Ministry of Health and Sport. The Republic of the Union of Myanmar. 15 Dissemination of Effective Vaccine Management Assessment (EVMA) Findings. 25 May 2015. UNICEF. Presentation made at Partner Meeting. 16 Myanmar cEVM Improvement Plan. 2016-2021. 2015. Ministry of Health and Sport. Republic of the Union of Myanmar. 17 Immunization Supply Chain Data Use in Myanmar. Situational Report. 201. UNICEF 18 Myanmar Immunization Supply Chain Data Use Manual. Generation, collection, analysis and use of supply chain data. 2016. Ministry of Health and Sport. Republic of the Union of Myanmar. 19 Joint appraisal report. Myanmar. 2016. Gavi, the Vaccine Alliance 20 Using HSS approach to address country priority areas of immunization: lessons learned and challenges from Myanmar. Presentation made to the Seventh SEAR-ITAG Meeting, 7- 10 June 2016. Ministry of Health and Sport. Republic of the Union of Myanmar. 17 subscription to the VII,21 developed by the MoHS and submitted to the Ministry of Planning and Finance (MoPF) for approval.22 Given the depth and robustness of these assessments, the EPI review team has focused its energies on other aspects of the immunization programme while still touching on such critical facets as programme financing and iSC. National EPI Schedule In 2016, the EPI schedule in Myanmar is as summarized below. Table 1. EPI schedule, Myanmar, 2016 Vaccine Age of Administration Bacille Calmette Guerin (BCG) Birth to 2 months DTP-Hib-HepB 2, 4, 6 months Oral Polio Vaccine (OPV) 2, 4, 6 months PCV 2, 4, 6 months IPV 4 months MR 9 months Measles 18 month TT During pregnancy (at first contact and 1 month later) As of 2015, IPV is offered with the second dose of pentavalent vaccine and the second dose of OPV, at the age of four months. PCV has been added to the vaccine schedule as of July 2016. EPI Service Delivery Vaccines in Myanmar are delivered through four different approaches: fixed, outreach, mobile and ‘crash’. Fixed immunization sites are located in maternal child health centres, urban health centres and township hospitals in urban settings, and in rural health centres 21 The VII is a UNICEF-based initiative established in 1991. It provides a financial mechanism to ensure a systematic, sustainable vaccine supply for countries which can afford to finance their own vaccine needs but may require certain support services. 22 Myanmar’s Plan for Subscription to the VII. 2016. Ministry of Health and Sport. Republic of the Union of Myanmar. 18 (RHCs) and sub-centres (RHSCs) in rural areas. Approximately 80% of immunization services are provided through outreach services. Outreach services are defined as ‘monthly, routine immunization services provided by a midwife away from her resident village in areas which are easily accessible’. Hard-to-reach and conflict zones are accessed through mobile or crash approaches. Mobile approaches are described as ‘routine immunization services provided by a midwife away from her resident villages in areas that are not easily accessible. Services may or may not be given monthly, but (are given) a minimum of six times a year’ while crash approaches are ‘special immunization services provided by a group of health workers to cover hard-to-reach areas during the open season at least three times per year. These crash services are normally mobilized as a campaign, require extra resources and target all children under three years of age at least and women of child bearing age’.23 Financing of Immunization Programme Financial indicators reported to WHO for years 2013, 2014 and 2015 are below. Table 2. Financial indicators reported to WHO, Myanmar, 2013-2015 (all fund amounts in US$) Indicator 2015 2014 2013 Are there line items in the national budget specifically for the purchase of vaccines used in routine immunizations? Yes Yes Yes Is there a line item in the national budget for the purchase of injection supplies (such as syringes, needles and safety boxes) used in routine immunization? No No No What amount of government funds are spent on vaccines? 897 000 207 894 1 276 970 What is the total expenditure (from all sources) on vaccines used in routine immunization 8 236 586 1 434 705 2 863 307 Percentage of total expenditure on vaccines financed by government funds 11 14 45 What amount of government funds are spent on routine immunization? 12 464 922 2 820 015 3 137 072 23 Comprehensive Multi-Year Plan 2017 – 2021. pp 10. Ministry of Health and Sport. The Republic of the Union of Myanmar. 19 Indicator 2015 2014 2013 What is the total expenditure (from all sources) on routine immunization? 39 770 004 16 027 477 26 575 161 Percentage of total expenditure on routine immunization financed by government funds? 31 18 12 Source: WHO Immunization Financing Indicators (online database) 2016. WHO. (http://www.who.int/immunization/programmes_systems/financing/data_indicators/en/ accessed 1 November 2016) EPI Performance WHO and UNICEF best estimates for vaccine coverage in Myanmar show that, over the past four years, coverage of antigens has either plateaued or decreased (Table 3). Variations in estimates of national vaccination coverage are evident in the differences among WHO and UNICEF best estimates for vaccine coverage, country estimates and Demographic Health Survey (DHS) 2015-2016 results (Tables 3 & 4). Differences in vaccination coverage between lowest and highest wealth quintiles and between poorest and best performing states/regions as estimated by survey are demonstrated in Table 4. Table 3. Vaccination coverage: WHO and UNICEF best estimates and country estimates. Myanmar, 2012-2015. 2012 2013 2014 2015 BE* CE** BE CE BE CE BE CE BCG 87 87 86 86 86 92 86 94 DTP1- 89 89 90 90 90 92 90 94 DTP3 84 84 75 75 75 88 75 89 HepB 3 58 -- 75 72 75 88 75 89 Hib3 75 72 75 88 75 89 IPV1 8 93 MCV1 84 84 86 86 86 88 86 84 MCV2 80 80 80 82 80 78 TT2plus 85 85 81 81 85 85 83 83 Pol3 87 87 76 76 76 88 76 89 RCV1 86 84 Source: WHO Vaccine-Preventable Diseases: Monitoring System. 2016 Global Summary (online data base). WHO (http://apps.who.int/immunization_monitoring/globalsummary/countries?countrycriteria%5Bcountry%5D%5B 20 %5D=MMR accessed Sept 12, 2016). *BE: WHO and UNICEF best estimates of vaccine coverage; **CE.: Country estimates Table 4. DHS estimates of vaccination coverage. Myanmar, 2015-2016 Nation wide n=852 Lowest wealth quintile Highest wealth quintile Most poorly performing state/region† Best performing state/regio n‡ BCG 87 86 98 76 100 Penta1* 86 82 96 74 100 Penta3** 60 49 84 41 88 Pol3 67 56 85 52 90 Measles 77 75 92 64 96 Source: Ministry of Health and Sports (MoHS) and ICF. Myanmar Demographic and Health Survey 2015-16. May Pyi Taw, Myanmar, and Rockville, Maryland, USA: Ministry of Health and Sports and ICF (https://www.dhsprogram.com/pubs/pdf/FR324/FR324.pdf, accessed 20 June 2017). *Penta1: First dose of pentavalent vaccine (DTP-HepB-Hib) **Penta3: Third dose of pentavalent vaccine †Most poorly performing state/region with regard to coverage for the specific vaccine ‡Best performing state/region with regard to coverage for the specific vaccine VPD Surveillance Myanmar has mandatory monthly aggregate reporting of 17 diseases, including eight VPDs or syndromes, some of whose causes are vaccine preventable. These eight VPDs or syndromes are: acute flaccid paralysis (AFP); measles; tetanus; whooping cough; diphtheria; acute respiratory infection/pneumonia; viral hepatitis and meningitis. AFP, measles and NT have case based reporting, are reported weekly, and are subject to both active and passive surveillance. Routine data analyses performed on the monthly reports by VPD or syndrome include:  number of cases and deaths per month,  number of cases and deaths per township, and  number of cases by sex and age. For deaths, individual descriptions which include name, age, sex and address are available. At present, the reporting and analysis system remains primarily paper- and manually-based. The National Health Laboratory (NHL) provides support for polio, measles, rubella and JE testing. 21 Status of VPDs VPDs reported to WHO for 2013 - 2015 are summarized below. Table 5. VPDs reported to WHO, 2013 – 2016 Source: WHO Vaccine-Preventable Diseases: Monitoring System. 2016 Global Summary (online data base). WHO (http://apps.who.int/immunization_monitoring/globalsummary/countries?countrycriteria%5Bcountry%5D%5B %5D=MMR accessed 21 June 2017). Excludes one type 1 VDPV in 2012 *Polio refers to all polio cases (indigenous or imported) including polio cases caused by cVDPV. The two cVDPV2 cases identified in 2015 are not included in the official report on this website. REVIEW OBJECTIVES This review focused on the following core areas:  government support to EPI,  VPD surveillance,  progress in meeting global and regional goals, and  Considerations around new and underutilized vaccine introduction (NUVI). The objectives of the EPI Review were:  to understand which children in Myanmar are not being fully immunized and the reasons that this is occurring. To the extent possible, efforts were made to assess areas with limited access to government services and increased reliance on other providers such as NGOs or local administrations;  to determine if the VPD surveillance system meets national and global targets and is currently able to detect any VPD outbreaks; this would include laboratory support and data management systems; 2012 2013 2014 2015 2016 Diphtheria 19 38 29 87 136 Japanese encephalitis 14 3 50 113 393 Measles 2 175 1 010 122 6 266 Pertussis 2 14 5 5 2 Polio* 0 0 0 2 0 Rubella 21 23 30 34 10 Tetanus (neonatal) 29 39 32 30 21 22  to determine if the strategies being implemented for measles and rubella objectives are adequate to maintain or achieve targets;  to assess how strategies and capacities of the immunization programme need to be strengthened to sustain polio-free status and MNTE, accelerate hepatitis B control and uniformly increase coverage for all routine vaccines; this would include vaccine and supply management, AEFI management, financing and sustainability. As mentioned previously, in 2015 Myanmar experienced a cVDPV outbreak in the state of Rakhine. A cVDPV outbreak response assessment (OBRA) was scheduled for mid- 2016. As programme areas to be reviewed for the OBRA were also relevant to the EPI review, a decision was taken in conjunction with the MoHS and partners to hold these two evaluations concurrently. Teams traveling to Rakhine as well as to Shan South considered the same issues that all teams did but paid particular attention to AFP surveillance and the quality of polio supplementary immunization activities (SIAs) that were conducted to respond to the cVDPV outbreak. The OBRA is detailed in a separate report.24 METHODOLOGY The MoHS and WHO’s Regional Office for South-East Asia and the WHO Office in Myanmar collaborated to assemble a review team of Myanmar nationals and internationals, including representatives from WHO, UNICEF, the United States Centres for Disease Control and Prevention (US CDC), Gavi, the Bill & Melinda Gates Foundation and the Ministry of Health of Indonesia (Annex 1). The team addressed the core questions through a desk review of relevant policies and guidelines; secondary analysis of available data; interviews with key stakeholders, policy makers, and programme staff; visits to hospitals and direct observation of programme implementation at field sites in Myanmar. From 25 September to 8 October 2016, joint field teams composed of one to two international staff, one or more Myanmar staff from the national level, and varying numbers of Myanmar staff from state/region and township health services visited 10 states or regions as well as reviewed national functions. Each field team visited state/region, and township health facilities. In consultation with WHO’s Regional Office for South-East Asia, the MoHS of Myanmar selected the areas and the facilities for site visits. These sites included urban and rural locations, areas with high and low coverage, hard-to-reach areas, conflict areas, areas with migratory populations, and areas with recent outbreaks of VPDs. The states/regions of Chin, Kachin, Kayah, Magway, Naypitaw, Sagaing, and Shan East were not visited. 24 WHO. Regional Office for South-East Asia. Immunization . Documents and Publications. External Second Assessment: Circulating Vaccine-Derived Poliovirus Type 2 (cVPDV2) Outbreak Response, Myanmar, 25 September-8 October 2016. Available at http://www.searo.who.int/entity/immunization/documents/en/ (Accessed Feb 1 2017) 23 Figure 4. Map of Myanmar showing sites visited by the review team Upon returning to Naypitaw, the field teams presented their findings and assessments to each other through extensive discussions on 5-6 October. The consensus conclusions and recommendations were shared on 7 October at a forum led by the Director General (DG) of the DoPH and attended by government public health programme directors and policy makers from the national, regional, and district levels as well as other key stakeholders. On 8 October the team leader and SEARO focal staff person met with the Minister of Health and Sport to discuss findings and recommendations. LIMITATIONS A two-week review can only reveal a relatively limited view of a country’s EPI. Sites visited may not be fully representative of all immunization sites. In such a short period of time, international reviewers cannot hope to fully appreciate the subtleties of Myanmar’s approach to public health and immunization. In addition, specific topics may require more analysis than is possible given the breadth of the review. Nonetheless, such a review can provide assistance in identifying programme gaps, bring new perspectives and experience from other settings, and identify topics that merit more in-depth follow up. 24 FINDINGS AND KEY RECOMMENDATIONS BY TOPIC AREA General In general, Myanmar has many areas of strength in its immunization and VPD surveillance systems. These include extremely dedicated staff, a very good national laboratory, and renewed commitment to reaching the unreached and improving immunization coverage. Nonetheless, the programme is challenged in a number of ways: financially, it remains heavily dependent on external funding; there are large inequities between townships, particularly those in conflict zones, self-administered regions and other hard-to-reach areas; persistent language, transportation and operational cost barriers for health workers exist; frontline staff are overburdened in the face of sanctioned but vacant posts; and challenges with monitoring and quality of reported data are present. Findings and key recommendations are outlined below. Government Support Context Government support is critical to a well-functioning immunization system. Government support includes high level advocacy for the programme; dedicated and adequate funding; strong governance and policies; vaccine licensing, procurement and management; demand generation; and support for service delivery. Findings Advocacy and Financing Advocacy: Myanmar’s EPI benefits from high-level advocacy through the Minister of Health and Sport. His Excellency’s commitment to EPI was evidenced by his knowledge of and interest in EPI during an exit debriefing. In addition, the DG of Public Health chairs several of the government oversight bodies (see below). Representatives of the government oversight bodies, among the most respected medical practitioners in the country, have come forward in the past years to advocate on behalf of the EPI through the media. A high level advocacy campaign with state representatives is scheduled to be conducted in early November. Nonetheless, during interviews with senior staff and members of oversight bodies, concerns were raised regarding the extent of understanding around the benefits of immunization among parliamentarians and within the Cabinet. 25 Health Financing and Costs of the CEPI Health Expenditures In 2014, Myanmar’s total health expenditure (THE) was 2% of GDP, of which private health expenditures made up 54%. THE per capita in 2014 was US$ 20, at the upper end of the rising trend in THE per capita which has occurred since 2007. Although THE as a percentage of GDP was stable from 2004 to 2014, the percentage represented by government expenditures has increased from a low of 9% in 2005 to a high of 46% in 2014. While the percentage of THE represented by private health expenditures has fallen over time, the percentage of these private health expenditures paid for out of pocket remains high at 94% in 2014, similar to what it has been for the preceding decade. THE as a percentage of GDP and THE per capita remain low when compared to other countries in the region at a similar income level25. While THE in terms of percentage of GDP has remained stable, purchasing power parity has almost doubled from 2008 to 2014.26 Health financing is clearly critical in the context of Sustainable Development Goals and Universal Health Care (UHC), and thus very relevant to the overall financing of the immunization programme. Costs and Financing of CEPI In 2015, the total cost of Myanmar’s immunization programme, including VPD surveillance, was US$ 67.0 million (Table 6). Of this, 19% was spent on vaccine and injection supplies for routine immunization and 41% was spent on SIAs. The remaining costs were allocated to programme management (2%), service delivery (5%), disease surveillance (3%), and advocacy and communication (5%). Fourteen percent was contributed to shared health system costs. This year was unusual in that it saw both a wide age range MR campaign and a polio vaccination outbreak response campaign for children aged less than 5 years, resulting in SIA costs of more than US$ 27 million. Because SIAs are associated with high but non-recurrent costs, it is important to consider the routine immunization programme independent of SIAs when conducting financial analyses of cost projections. 25 In Nepal THE for 2014 represented 6% of GDP and had a per capita value of US$ 40; In Bangladesh, THE for 2014 represented of 3% GDP and had a per capita value of US$ 31. 26 Global Health Expenditures. NHA Indicators. On line database. WHO. (http://apps.who.int/nha/database/ViewData/Indicators/en, accessed 26 November 2016) 26 Table 6. Baseline cost profile of immunization programme in 2015 Cost Category Expenditure in 2015 (US$ ) % of Total Vaccine and Injection Supplies (Routine Immunisation Only) 12 708 157 19 Service Delivery 3 455 111 5 Advocacy and Communication 3 041 338 5 Monitoring and Disease Surveillance 1 752 758 3 Program Management 1 012 618 2 Capital Costs 8 412 403 12 Supplemental Immunization Activities (includes vaccine and operation costs) 27 568 686 41 Shared Health Systems Costs 9 387 619 14 Total 67 338 690 100 Source: Comprehensive Multi-Year Plan 2017 – 2021. MoHS. The Republic of the Union of Myanmar. The government financed 7% of the overall immunization programme (including SIAs) and 14% of the routine immunization programme.27 This funding went for health worker salaries, and operational, transportation, and building costs. Gavi was the largest source of funding, financing 56% of the costs of the programme. The second largest source of financing was 3MDG (15%); funding from this consortium went towards purchasing new cold chain equipment through UNICEF. Other sources of financing were UNICEF for traditional vaccines and injection supplies (5%), Gavi funding passed through UNICEF (6%) and WHO (4%) for training, microplanning, and information, education and communication (IEC)/social mobilization, and US CDC funding channelled through WHO for surveillance and the polio SIA (7%). 27 This figure, drawn from the cMYP, is less than half that reported to WHO: WHO Immunization Financing Indicators (online database) 2016. WHO. (http://www.who.int/immunization/programmes_systems/financing/data_indicators/en/ accessed 1 November 2016). The reason for this discrepancy is unclear. 27 Financial Projections for CEPI, 2017-2021 The cMYP 2017-2021 includes projections for the costs of CEPI. The annual requirements are between US$ 59 million and US$ 73 million with fluctuations mainly explained by the planned SIAs (for example, JE vaccine and MR). The table below aggregates the costs over the five-year period of the plan. Table 7. Future immunization programme resource requirements, 2017-2021 Cost Category US$ % of Total Vaccine Supply and Injection Supplies (Routine Immunization Only) 149 067 618 47 Service Delivery 18 255 600 6 Advocacy and Communication 7 962 181 3 Monitoring and Disease Surveillance 9 250 949 3 Programme Management 22 319 389 7 SIAs (including vaccine and operational costs) 26 048 499 7 Shared Health Systems Costs 62 411 219 20 Total 315 959 384 100 Source: Comprehensive Multi-Year Plan 2017 – 2021. Section 4.2, p. 40 MoHS. The Republic of the Union of Myanmar The main driver of future costs is the introduction of new vaccines (PCV in 2016, JE in 2017, rotavirus in 2018, HPV in 2019). The total costs for traditional and new vaccines are projected to increase from US$ 12.7 million in 2015 to US$ 27.1 million in 2021. With a 2014 gross national income (GNI) of US$1 270 per capita, Myanmar is in a phase of preparatory transition from being eligible to no longer being eligible for Gavi financing. The country is projected to enter the accelerated transition phase with regards to eligibility for Gavi funding in 2020 (depending on actual GNI growth rates). The government of Myanmar is aware that co-financing obligations for Gavi-supported vaccines will increase over time and is developing appropriate budget provisions and plans for 2016 and 2017. More detailed budget requirements, reflecting the most detailed and up to date analyses and projections available, are found in section 4.2 of the cMYP. These projections indicate that CEPI will remain highly dependent on external funding in the coming years: to date the government share of 2017 to 2021 probable or secured CEPI financing is 17%. The MoHS has taken the important decision to improve the financial sustainability 28 of the EPI by committing to finance the traditional vaccines previously covered by UNICEF and to co-finance Gavi-supported vaccines, beginning with co-financing of the Gavi-funded pentavalent vaccine and PCV in 2016 (see Vaccine Procurement and Funding, below). The cMYP 2017-2021 also develops several comprehensive and, at times innovative, strategies to improve the financial sustainability of the EPI. These are to:  increase funding from the government and external partners through conducting advocacy meetings at all levels;  increase spending on the immunization program by building community ownership through community participation and local resource mobilization in immunization service delivery;  improve efficiency of the immunization program through contracting a third party for vaccine transportation in urban settings, establishing a well-functioning EPI store for both vaccines and dry goods; and implementing the EVM improvement plan;  conduct cost-effectiveness studies of new vaccines and VPD surveillance; and  develop a financial sustainability plan, including creation of an “immunization trust fund”.28 Although none of these strategies has been fully explored as yet, they remain an excellent starting point to increase the resource base and the efficiency of the EPI. During field visits, lack of adequate township resources to fund basic operational costs, such as transportation and daily allowances, was noted. Disbursement of funds from central to township level was also noted to involve a complex and slow process. Policy and Governance National and Subnational Plans Myanmar is currently developing a National Health Plan (NHP) 2017 – 2021, which covers communicable and non-communicable disease, including improving new-born and child health, strengthening the health system, and increasing coverage in border, peri-urban and rural areas. Plans for the EPI, including disease and programme-specific objectives, are incorporated into the NHP. In addition, immunization was included among the top priorities of the new government in its ‘100 Days Health Plan’, with a focus on introduction of new vaccines and increasing routine immunization coverage.29 28 Comprehensive Multi-Year Plan 2017 – 2021. Section 4.2, pp 51. MoHS. The Republic of the Union of Myanmar 29 Ministries clarify undertakings in first 100 days. The Republic of the Union of Myanmar President’s Office. (http://www.president-office.gov.mm/en/?q=issues/public-service/id-6550 accessed Nov. 13 2016) 29 The country’s most recent cMYP covers the period from 2017 to 2020.30 An annual work plan is also developed at state/regional level. In addition, each township develops an annual microplan for EPI. National Oversight and Advisory Bodies National oversight and advisory bodies include the National Committee on Immunization Practices (NCIP), the National Committee for the Certification of Polio Eradication (NCCPE), the National Polio Expert Review Committee (NPERC), National Polio Laboratory Containment Committee (NPLCC), the (measles and rubella) National Verification Committee (NVC), and the Adverse Event Following Immunization (AEFI) oversight committee. All committees have membership drawn from a range of disciplines, including paediatricians, public health experts, and epidemiologists; many individuals are members of multiple committees. The NCCPE has functioned since 1999, and reports regularly to the Regional Commission for the Certification of Polio Eradication. The NCIP was established in 2009, with a charter written in 2013. This charter generally follows WHO recommendations, although it does not mandate rotation of members or a chairperson who is independent of government. Due process as outlined in the charter is routinely followed by the NCIP, which makes decisions on the introduction of new vaccines, changes in vaccine schedules, and other vaccine-related issues. All recommendations from the NCIP are referred to the MoHS for approval prior to implementation. Most decisions by the NCIP are unanimous; on the few occasions where a vote is necessary, this vote is conducted anonymously. The committee has formal terms of reference and meets at least twice annually. Members must reveal any conflicts of interest; on the rare occasions that these exist, members recuse themselves from discussion and voting. The decision to introduce a vaccine is made following a review of data, including information as available on the local burden of disease. The agenda for NCIP meetings is proposed by the secretariat, and approved by the MoHS. In general, it reflects matters that are topical for CEPI. The NVC is the most recently constituted advisory body, holding its first meeting in mid-2016. The NCIP, NCCPE, NVC and AEFI oversight committees are chaired by the DG, although his attendance at meetings is often limited by other obligations. The chair of the NPERC is a neurologist, while the chair of the NPLCC is the director of the NHL. The secretariat for all bodies is the EPI Manager. In general, support from the secretariat is excellent, but at times oversight and advisory body members do not have timely access to preparatory materials as these are shared electronically, and not all members have the facilities necessary to download and print documents. 30 Comprehensive Multi-Year Plan 2017 – 2021. Ministry of Health and Sport. The Republic of the Union of Myanmar. 30 AEFI31 Passive surveillance for AEFI prioritizing serious or publicized events was initiated in 2001. In 2015, under the umbrella of the requirements for vaccine safety covered by the 1972 Public Health Law and 1992 National Drug Law, the MoHS issued AEFI surveillance guidelines aligned with WHO recommendations. Currently there is no dedicated budget for vaccine safety in the MoHS budget. The key national authorities implementing AEFI surveillance include the Food and Drug Administration Department, the DoPH and/or Department of Medical Services in charge of the Immunization Programme through the CEU, and the national AEFI oversight committee. Adverse events which occur following immunization with non-EPI vaccines are overseen by the Adverse Drug Reaction Committee, and are not handled by CEPI. All AEFIs reported by health workers are required to initially be investigated by the township medical officer. Deaths, serious AEFIs, and AEFIs of significant public concern are investigated by the CEU and CEPI or AEFI committee once the report of the case is received. The AEFI committee then conducts causality assessment. Aggregated data from minor AEFIs is reported from townships using a hard copy reporting form and, for more serious AEFIs, a case investigation form. These forms are archived at national level, and key variables are entered into an electronic line-list database. The MoHS provides feedback to the public regarding events of social concern. However, there is no mechanism for systematic feedback on AEFI surveillance performance or antigen-specific safety analyses. Advance preparations for risk communication and interaction with the media have been made, including developing an information package and identifying spokespeople; monitoring the media with the recognition that it may be necessary to call a media conference in some circumstances; and, after the crisis has resolved, ensuring follow-up on any commitments that the government has made to the media. In recent years, the AEFI surveillance system in Myanmar has successfully handled several events. In November 2012, following the introduction of Haemophilus influenzae type B (Hib)-containing pentavalent vaccine, AEFI temporally linked to the administration of the pentavalent vaccine occurred. However, assessment showed no causal link, and the programme was able to continue using the pentavalent vaccine. In January 2015, serious AEFIs occurred during a nation-wide MR campaign, and were well-handled. In March 2016, there was a coincidental cluster of neonatal sepsis cases following immunization of babies with hepatitis B vaccine (HepB) in Bagot General Hospital; the programme was able to successfully respond to this cluster. 31 The findings and recommendations regarding AEFI in this report are based on the AEFI reports reviewed and discussions with programme colleagues. This report does not attempt to assess the functionality of pharmacovigilance activities including AEFI as they pertain to the National Regulatory Authority. 31 In 2015, the reported rate of AEFI exceeded 10 cases per 100 000 surviving infants in Myanmar, considered by WHO to be the benchmark for sensitivity of surveillance. In the 2015 MR campaign, a total of 3 473 AEFIs cases were reported of which 3 339 were minor AEFI and 134 serious AEFI. Figure 5. Report routing, timeline and mandated actions for AEFI Source: Adverse Events Following Immunization (AEFI). Manual for Surveillance and Reporting. Expanded Programme on Immunization. Central Epidemiology Unit. Department of Health. The Republic of the Union of Myanmar. 32 Figure 6. Reported serious AEFI cases, Myanmar, 2007 - 2015 Source: Derived from data found in : Case review on AEFI after MR campaign phase 1. PowerPoint presentation. CEU. MoHS. The Republic of the Union of Myanmar. Despite these successes, the programme faces some challenges. These include inadequate good supply practices (GSP) inspection in the private sector, under-reporting of minor events and the lack of a dedicated budget for vaccine safety. In summary, the AEFI surveillance system in Myanmar demonstrates strong capacity in detecting, investigating, classifying and responding to serious AEFI identified in public facilities or vaccine safety events which concern the general public. National Regulatory Authority (NRA) Myanmar’s NRA was not included in this review. The agency is currently in discussion with WHO’s Regional Office for South-East Asia regarding assessment and strengthening of its capacity. However, the agency is mentioned here to note that it will have an increasingly large role to play with the introduction of new vaccines. Ensuring that the NRA meets the expected maturity levels of a regulatory agency in a non-vaccine manufacturing country will be important. Regular assessments of the NRA against established international standards will help to achieve and sustain a fully functional regulatory authority. Vaccine Licensing, Procurement, and Management Vaccine Licensing: All vaccines used in the country (regardless of whether or not they are included in the EPI) must be licensed by the NRA. Vaccine Procurement and Funding: Vaccine is procured annually through UNICEF. The country holds three months worth of vaccine as a buffer at national level, as well as three months worth of vaccine as a buffer at state/regional level. Traditional vaccines (defined in Myanmar as BCG, DTP, OPV, MCV1, and TT) have historically been funded by UNICEF and the Japan Committee "Vaccines for the World's Children" (JCV). New vaccines introduced since 2012 are DTP-HepB-Hib (pentavalent vaccine), MCV2, IPV, 0 20 40 60 80 100 120 140 160 2007 2008 2009 2010 2011 2012 2013 2014 2015 Se ri o u s A EF I ca se s 33 and PCV. These have largely been funded by Gavi. The country is expected to introduce JE vaccine in 201, rotavirus vaccine in 2018, and HPV vaccine in 2019. As mentioned previously, since Myanmar is transitioning out of eligibility for vaccine funding from Gavi (‘Gavi eligibility’), it must self-fund all traditional vaccines as of 2017 and all EPI vaccines as of 2025. Table 8, below, summarizes supported vaccines in Myanmar and their respective funding sources. Table 8. Sources of EPI Vaccine Funding in Myanmar as of August 2016 Name Type Financing source Co-financing required BCG Traditional UNICEF No OPV Traditional UNICEF No First dose of measles/rubella vaccine (MR1) Traditional/Underused UNICEF No TT Traditional UNICEF No Pentavalent New GAVI Yes MCV2 New GAVI No IPV New GAVI No PCV New GAVI Yes Source: Myanmar’s Plan for Subscription to the VII. 2016. MoHS. The Republic of the Union of Myanmar. The MoHS has developed a proposal for vaccine independence for traditional vaccines which includes an in-depth analysis of projected financial needs for self-financed vaccine for the period 2017-2021. This proposal is based upon subscription to UNICEF’s VII, a revolving fund which offers credit lines. An important component of this is a five-year forecast for the national immunization programme’s needs and commitment from the MoPF to prioritize a long term budget allocation for the national immunization programme. At present, the MoHS is working with the MoPF to secure support for a five- year cumulative budget envelope. Myanmar has not experienced vaccine stock outs in the past five years with the exceptions of IPV and DTP, for both of which there were global shortages. 34 iSC The MoHS, with support from UNICEF, conducted an EVM assessment in 2015 and then developed a comprehensive EVM improvement plan through a consultative process. This assessment demonstrated that, according to the nine assessment criteria used, there had been a 9% overall improvement in Myanmar’s iSC (Figure 7) between 2011 and 2015. Nonetheless, the 2015 evaluation showed that, at that time, Myanmar only met or exceeded WHO minimum standards for two of nine criteria. Figure 7. Performance of iSC in Myanmar Source: Dissemination of EVM Assessment Findings. Partner Meeting, Myanmar. 2015. UNICEF. A comprehensive cold chain capacity gap analysis has also been conducted, followed by the development of a national cold chain replacement and expansion plan based on the gap analysis results. With support from international partners, national cold chain systems are being expanded and upgraded, thus enabling MR campaigns and the introduction of MR, PCV and IPV. The private sector has been engaged to a certain extent to strengthen cold chain repair and maintenance. The country also underwent an evaluation of the iSC data use, with a supply chain data use manual developed in September 2016.32,33 This manual focuses on improving and 32 Immunization Supply Chain Data Use in Myanmar. Situational Report. 2016. UNICEF 33 Myanmar Immunization Supply Chain Data Use Manual. Generation, collection, analysis and use of supply chain data. 2016. Ministry of Health and Sport. Republic of the Union of Myanmar 35 upgrading iSC information & monitoring systems, including building continuous temperature monitoring, and adopting iSC performance indicators and dashboards. During the review, the review team noted the following:  No regular budget was available to ensure distribution of routine EPI vaccines, including distribution from sub-depots to townships and from townships to RHCs/RHSCs. In some regions, vaccines were not bundled with injection devices.  Although performance was adequate at most sub-depots, it varied at township level with some cold chain staff inadequately aware of the use of Fridge Tags. Freeze- sensitive vaccines (for example, HepB) were found to be at risk of freezing in some locations due to inappropriate placement of vaccines in refrigerators. During transportation to service delivery points, vaccines were also jeopardized by the use of wet ice rather than conditioned ice packs. Long outreach sessions were of the greatest concern.  While storage capacity was adequate in most regions, including at township level, there were many service delivery points without refrigerators. The quality of vaccine inventories maintained at regional and township level. Most townships with cold chain equipment at RHCs and RHSCs did not systematically keep updated vaccine inventories. The lack of vaccine-storage refrigerators in hospitals was reported to be a bottleneck to the in-hospital provision of hepatitis B vaccine birth dose (HepB-BD), BCG and other vaccinations.  Many townships visited did not maintain maximum and minimum stock levels of vaccines, but rather used township cold stores as a transit point prior to distribution to midwives. One reason voiced for this was concern around the stability of the power grid.  A multi-dose vial policy34 was still being followed in most places, in part because of a lack of fridges to facilitate the storage of open vaccines at RHCs and RHSCs. Practices to limit vaccine wastage, such as not opening a vaccine vial for a small number of eligible children but rather delaying vaccination or assembling children from different locations, were observed at some sites.  Inadequate management capacity was observed in some townships. Cold chain key persons did not hold sanctioned posts and there were no posts dedicated to assisting with vaccine handling or general cleaning. Key cold-chain-related functions were performed by inadequately trained public health staff. Although staff handling vaccines had some basic knowledge of vaccine management, most reported not having received formal training on cold chain management and EVM. 34 WHO Policy Statement: Multi-dose Vial Policy (MDVP). Revision 2014. Handling of Multi-dose Vaccine Vials after Opening. WHO. Geneva. 2014. (http://apps.who.int/iris/bitstream/10665/135972/1/WHO_IVB_14.07_eng.pdf?ua=1, accessed 1 June 2017) 36 In summary, substantial progress has been made in recent years with regard to the iSC, and further progress can be anticipated with the complete implementation of the comprehensive EVM Improvement Plan and probable improvements in iSC data use. These areas are targeted by Gavi’s second health system strengthening grant (HSS2) funds. Nonetheless, at present gaps remain, as outlined above. Demand Generation Demand generation is emphasized as one of six strategic objectives in the GVAP. In line with this priority, Myanmar’s recently developed cMYP and HSS2 grant both include demand generation as a key programmatic area for investment, with the ultimate goal of achieving and sustaining high and equitable nationwide vaccination coverage. In follow up, the MoHS has recently developed a communication plan to strengthen routine immunization. Implementation of the plan has been delayed due to competing priorities, but it is anticipated that execution will begin by end-2016. The country has successfully generated demand for vaccination in several large national events, including the nationwide MR catch-up SIA, multiple rounds of OPV SIAs in response to the cVPDV2 outbreak, and the introduction of MR, IPV and PCV into the routine system. The field teams observed that in some, but certainly not all, settings parents manifested a fear of AEFI and concerns regarding the administration of multiple injections at a single visit. In some settings, these concerns were reported by health workers to result in drop- out, whereas in other settings health workers seemed able to overcome these fears. Limited interactions between care giver and health provider were also noted in some locations, with incomplete communication regarding type of vaccine given, diseases to be prevented, possible side effects, and follow-up actions in case of AEFI. Some field teams also noted a lack of IEC materials at sites visited, and that available materials were, at times, not in the local language or assumed too high an educational level for the audience. Community and village leaders were noted to play a critical role in linking communities and service providers. Basic health staff mentioned that the ‘100-household’ leaders35 were important in tracing vaccine defaulters and that, during immunization campaigns, these leaders facilitated dissemination of information. Nevertheless, specific measures to actively engage community leaders to support immunization service delivery on a continuous basis have not yet been taken. In summary, Myanmar’s EPI has made a number of successful efforts to engage communities. However, demand generation is challenged by the many complex social, political and geographic situations in the country, resulting in a number of heterogeneous, hard-to-reach population groups. The efforts made to date are not yet adequate to allow the kind of tailored and intensive evidence-based communication strategies which are likely to be necessary to reach these groups, and do not adequately 35 Roughly similar to a village headman 37 address routine immunization. An additional challenge is how best to improve the interpersonal communication skills of basic health staff so that they are able to address concerns raised by parents and communities and enhance community trust, particularly that of hard-to-reach communities. Service Delivery As noted previously in this report, Myanmar has attained significant progress in reaching global and regional disease elimination and control targets and in the recent introduction of new vaccines. However, since 2012, coverage with many EPI antigens has stagnated or, at times, fallen (Table 3). Geography, ethnicity, internal conflict, migration and health system limitations can all challenge the universal and equitable provision of immunizations through the EPI. CEPI is well-aware of these challenges as they are manifested in the context of Myanmar – the first three objectives of the cMYP 2017- 2021, articulated below, directly confront equity in delivery of EPI vaccines:  To provide equitable service to all target children including special strategies for peri-urban slums, migratory populations, and populations in geographically and socially hard-to-reach and conflict area.  To improve demand creation and ownership.  To strengthen iSC. EPI review teams identified a number of categories of children in Myanmar that may be missed by the EPI. These are: children in accessible areas, children in “hard-to-reach” areas, children in conflict and/or ethnic areas, and children in “special populations” (for example, migrants, displaced children, peri-urban slum dwellers, orphans and children cared for in religious settings). While common challenges to service delivery are found nationwide, many populations present additional population-specific challenges which require situation-specific solutions. In support of cMYP implementation, the proposal for HSS2 was put forward; this proposal followed a robust process to detail service delivery challenges. The approved proposal, while not limited to EPI, includes objectives and activities aiming to address many of the challenges identified. These include:  field allowances for midwives to do outreach vaccination and outbreak response, and vaccine transport;  funds for dedicated staff (both EPI and cold chain) at state/regional level;  cold chain expansion;  addition of EPI services in hospitals, and supporting other service providers (NGOs, ethnic health organizations, etc.);  trainings on immunization, cold chain, and surveillance;  funding of microplanning exercises in townships; and  activities to improve data quality. 38 While these activities will lend important support to the EPI, vacant sanctioned posts represent a significant constraint which HSS2 cannot address. Key Strengths and Best Practices Myanmar has a number of areas of strengths and best practices in terms of government support. These areas include:  evidence of increased commitment to the EPI with articulation of immunization as one of the top health priorities for the new government’s 100 day plan, initiatives for high-level advocacy at state/regional level, and the commitment of the MoHS to finance traditional vaccines and core recurrent costs while co-financing Gavi- supported vaccines;  health budget information and CEPI costs and sources of financing available and analysed;  inclusion in the cMYP of accurate forecasting of CEPI costs, including envisaged vaccine introductions, sources of financing and financial gaps;  generally well-functioning oversight bodies which serve as strong advocates for the EPI;  an AEFI surveillance and oversight process which has been able to detect and appropriately respond to several emergencies in recent years; and  an impressive number of in-depth evaluations and plans which have recently been completed and which seek to address a range of challenges confronted by the programme, in particular those associated with service delivery and demand generation. Key Issues and Challenges Key issues and challenges in the area of government support include:  maintaining immunization as an ongoing health priority for the nation, and ensuring advocacy at the highest level to demonstrate the EPI as a ‘best buy’;  very low overall health expenditures and government health budget, resulting in insecure funding and an insufficient CEPI budget;  high programme dependency on external resources, which come mainly from Gavi, UNICEF and WHO;  insufficient financial resources at the township level to cover basic operational costs (for example transport, daily allowances, essential drugs);  complicated and slow financial management processes to channel funding to the districts and townships; 39  consideration of whether oversight bodies may benefit from a membership rotation policy and independence of chairmanship from government, following WHO best practices;  ensuring that plans completed in the wake of recent evaluations are meticulously implemented in a timely fashion, and that planning processes are initiated to maintain gains in the long term;  addressing human resource limitations which cut across many aspects of the EPI. These limitations vary by site, but include unfilled sanctioned posts, lack of sanctioned posts for certain activities (for example, maintenance of iSC), and inadequate training in certain subject areas (for example, maintenance of iSC; interpersonal skills; risk communication). Some of these limitations, but not all, will be addressed by HSS2. Recommendations Recommendations to enhance government support to Myanmar’s EPI are below. Advocacy  Look for opportunities to advocate at the highest level (for example, Cabinet) for the EPI. Work with partners (US CDC, WHO and UNICEF) to develop a slide-set showcasing immunization as a ‘best-buy’ which can be used in advocacy. Finance  Advocate at all levels and with all stakeholders for a comprehensive health financing policy in the context of the UHC vision for Myanmar as a pre-requisite for increasing health budget allocations.  Advocate for the CEPI to be an example of increasing national financial shares for essential public health services and of high return on investments in the health sector.  Operationalize the cMYP 2017-2021 financing strategy options and explore innovative resource mobilization and financial instruments (for example, community participation, an immunization trust fund, efficiency gains in service delivery).  Reform and restructure financial management at the central and regional levels to allow effective utilization of available resources, including greater flexibility in funding allocation at peripheral levels and more rapid transfer of funds from central to peripheral level. Oversight Bodies  Explore whether oversight and advisory bodies may wish to have a clear policy on rotation of members. 40  Explore whether oversight and advisory bodies may wish to follow WHO ‘best practices’ by having chairmanship independent from government.  Ensure that members receive preparatory materials for meetings in a timely fashion and a manner in which they can easily have access to the materials. AEFI Surveillance  Develop stringent regulations requiring proper supply regulatory inspection for public and private sectors.  Allocate budget for enhancing AEFI surveillance.  Continue appropriate stakeholder training at all levels.  Regularly provide feed back on regional and township surveillance performance to encourage AEFI reporting and analysis of the safety of specific antigens. NRA  As possible, encourage ensuring a regulatory agency competent to oversee licensing of imported vaccine. Vaccine Licensing, Procurement and Management  Accelerate the VII proposal and initiate its implementation.  Accelerate the implementation of the EVM improvement plan with close monitoring of progress against established milestones and timelines.  Strengthen human resource support for iSC and management in the following ways:  Establish sanctioned posts for cold chain key persons and supportive staff.  Redefine necessary qualifications and terms of reference for iSC and management posts.  Provide routine training to staff, as well as on-the-job coaching through supportive supervision.  Develop job-aids and standard operating procedures (SOPs) for use at every administrative level.  Consider eventually mapping and prioritizing health facilities below township level to guide further cold chain expansion, permit an increase in the number of immunization sessions, and reduce wastage and missed opportunities to vaccinate children.  Advocate for a national budget line to ensure stable and predictable funding for the iSC once HSS2 ends. Demand Generation  Implement and evaluate the impact of communication activities defined in HSS2. 41  Update the national communication plan for strengthening routine immunization, taking into account lessons learned from major activities such as the cVDPV2 outbreak response that have been conducted since the plan was written.  Conduct training at regional and township levels to improve interpersonal and risk communication skills among basic health staff and volunteers.  Develop simplified materials on immunizations for communities and caregivers. Materials should be tailored to local languages and cultures. Service Delivery Short term:  Implement HSS2  Develop a quarterly implementation plan and set up a high-level mechanism for oversight at the level of DG or Minister. Mid/long term:  Create national and state/regional-level government budget lines for EPI to cover both vaccine and operational costs (for example, field allowances for midwives (MWs), vaccine transportation, outbreak response, supervision and monitoring).  Create positions and supportive funding for dedicated EPI staff (EPI and Cold Chain Key Persons, data focal person) at state/region and township levels.  Allow flexibility and promote local approaches to encourage tailoring of service delivery to special populations. VPD Surveillance Context Highly sensitive VPD surveillance systems are essential for the immediate detection of and response to VPD outbreaks. In addition, a sensitive surveillance system is required to guide Myanmar’s EPI by indicating programmatic areas which require strengthening. Finally, highly sensitive VPD surveillance systems are critical as the country strives to maintain polio-free status and MNTE while reaching measles elimination by 2020 and rubella and CRS control by 2020. Findings Surveillance data are collected through integrated weekly reporting of VPDs, with case based reporting for AFP, NT, and fever/rash (Figure 8). Passive surveillance occurs at the RHC and RHSC levels. MWs and Grade 2 public health supervisors collect information from community members (for example, village administrators, auxiliary midwives, community health workers) weekly, and report to the township level. However, at times this system is challenged by overburdened frontline workers, due at times to sanctioned but vacant posts and at others to mismatches between the number of 42 sanctioned posts and the true population. In addition, in some cases there are mismatches between the language and culture of the staff, and the actual population being served. Hospital-based reporting occurs weekly, and is primarily passive. Active surveillance occurs in some, but not all, hospitals. Zero reporting is used consistently for both RHC and hospital-based surveillance. Private hospitals do not consistently report suspected VPD cases. Training related to VPD surveillance occurs mainly through SIAs and new vaccine introduction trainings. Relatively little data analysis is routinely conducted at township level. Figure 8. Integrated weekly VPD reporting Source: Guideline on Measles and Rubella Surveillance & Outbreak Investigation 2016. MoHS. The Republic of the Union of Myanmar. VPD surveillance is supported by the NHL, located in Yangon. A second laboratory, in Mandalay, will support Upper Myanmar. Staff for the Mandalay laboratory is trained and equipment is in place, but the laboratory has not yet begun processing specimens. The NHL will have the ability to conduct cell-culture and genotyping in the future, as staff has received training from the regional reference laboratory in Thailand. Laboratory equipment is working well, and staff retention is high. There is an adequate supply of enzyme-linked immunosorbent assay testing materials for measles. In proficiency testing from WHO’s Regional Office for South-East Asia, the NHL received 100% on all tests (polio, measles, rubella, JE). However, the quality of specimens received can be problematic: laboratory staff noted that blood specimens received from remote areas are often haemolysed. Funding is not provided for specimen collection and transport. A national network of regional surveillance officers (RSOs), financed through polio funds, supports VPD surveillance. One RSO is assigned to each region/state. Each RSO is responsible for both EPI and VPD surveillance. Surveillance responsibilities include monitoring and supervision of data collection and performing data analysis. RSOs also have other administrative responsibilities in the state public health departments. NH 43 Table 9. AFP and fever/rash surveillance indicators, Myanmar, 2012 - 2015 Target 2012 2013 2014 2015 AFP cases 457 404 389 336 Non-polio AFP rate (per 100 000 children under 15 years of age) ≥ 2 2.21 1.91 1.82 2.34 % adequate stool sample specimens > 80% 97% 95% 96% 93% Total suspected measles cases 2349 1217 479 243 Discarded non-measles, non-rubella rate (per 100 000 population) >2 0.34 0.34 0.57 0.42 Source: EPI Fact Sheet. Myanmar. World Health Organization Regional Office for South-East Asia. 2016 During field visits, team members noted that, in general, knowledge regarding AFP surveillance was higher among health staff and community members than knowledge about surveillance for any other VPD. Clinicians and health staff described being sensitized to AFP detection and reporting through recent polio SIAs. Since 2013, national non-polio AFP rates per 100 000 children less than 15 years of age have improved from 1.91 to 2.34 (target ≥ 2 per 100 000 children aged less than 15 years). Procedures for stool collection and transportation to the NHL function well. Since 2012, the percentage of adequate stool specimens has been consistently above the target of 80% (Table 9). Case investigation forms (CIFs) are compulsory and the NHL will not accept specimens without a completed CIF. However, at township level, timely recording of stool sample results in the CIF is inconsistent. Reviewers observed that, at times, stool sample results were recorded, but not in a timely fashion; at other times these results were not recorded at all on the CIF. Clinicians, health staff, and community members were less knowledgeable regarding fever/rash surveillance than AFP surveillance. In most cases, the focus of disease reporting is on suspected cases of measles based on the previous clinical case definition (that is, fever, rash and at least one of the following: cough, coryza or conjunctivitis) rather than on the recently adopted definition of all fever/rash cases (that is, without regard for cough, coryza or conjunctivitis). The rate of discarded non-measles, non- rubella cases per 100 000 population per year has been consistently below the target of >2/100 000 since 2012 (Table 9). The percentage of laboratory results available within four days of specimen receipt by the laboratory improved from 52% in 2014 to 93% in 2015 (target 80%). Blood specimens arriving from remote locations for measles and rubella testing are, at times, haemolysed. There is limited focus on rubella surveillance, 44 and case based surveillance for CRS has not yet started, although CRS surveillance guidelines have been drafted and sentinel sites selected. Key surveillance findings for NT, diphtheria, pertussis, and JE are provided below. • NT is detected primarily by passive reporting of cases by clinicians, MWs, and community volunteers. • Diphtheria has been increasingly reported since 2015 (Table 5). At present there is no routine laboratory supported case based surveillance for diphtheria. Specimens arriving at the NHL may not be accompanied by a CIF and the laboratory may only receive a clinical note (for example name, age, and request for laboratory test). Culture isolation and sensitivity are conducted according to conventional methods. Most of the diphtheria cases reported in 2016 were not laboratory confirmed. • Pertussis The NHL is unable to isolate B. pertussis because specimen transport and culture are both difficult. The NHL is not yet able to do molecular testing for B pertussis. A clinical case definition is used for case reporting. • JE: The number of reported cases has increased in recent years (Table 5). Surveillance for JE is hospital-based at sentinel sites. Epidemiologists from the CEU and laboratorians meet on a monthly basis to review and compare epidemiologic and laboratory data, and conduct case classification. Data analysis is conducted at CEU level with strong support from WHO, which in some instances performs primary data analysis (for example, calculation of fever/rash surveillance indicators). In summary, Myanmar’s VPD surveillance system is adequate to detect large disease outbreaks. However, lack of sensitivity, limited laboratory confirmation, and limited local data analysis limit the system’s usefulness in guiding the country’s numerous disease eradication, elimination and accelerated control goals. In addition, the country’s sociocultural and political diversity may impact reporting of diseases. Specifically, increasing the sensitivity of fever/rash surveillance is critical to meeting measles elimination and rubella and CRS control goals by 2020. Key Strengths and Best Practices Myanmar has a number of key strengths and best practices with regard to VP surveillance, including  consistent weekly reports, including zero reporting;  excellent data analysis at central level, relying in part on support by WHO staff; and  good NHL support. 45 Key Issues and Challenges Myanmar also has a number of key Issues and challenges as it seeks to improve its VPD surveillance system. These include:  overburdened frontline health staff, particularly MWs, who are responsible for surveillance;  inadequate surveillance-specific training, particularly at township level;  lack of local ownership and use of surveillance data;  competing responsibilities of RSOs in addition to VPD surveillance and EPI responsibilities;  concern regarding the sustainability of the RSO network given current reliance on polio funding;  strong likelihood of incomplete detection and reporting of VPDs, particularly fever/rash, diphtheria, NT, and JE. There is difficulty with specimen transport from remote sites, and private hospitals do not routinely report VPDs;  inadequate funds for specimen collection and transport;  possibly cultural barriers to reporting among some of the country’s many minority groups; and  lack of consistent integration of private health sector, international nongovernmental organization (INGO) and NGO health centres into the surveillance reporting network. Recommendations Recommendations to increase the ability of surveillance data to guide the national EPI and the usefulness of the data collected are below.  Fill sanctioned but vacant posts and review MW to population ratios.  Provide VPD surveillance specific refresher training to clinicians and health staff (including MWs) with a specific focus on case definitions and procedures for specimen collection and transport.  Encourage monthly calculation of AFP and fever/rash surveillance indicators by subnational levels to increase ownership.  Over time, move toward greater national autonomy for all data analysis (that is, decrease dependence on WHO for data analysis).  Focus RSO responsibility on VPD surveillance and EPI.  Explore use of alternative methods for specimen collection and point-of-care diagnostics for fever/rash surveillance.  Encourage laboratory confirmation of suspected cases and use of genotyping.  As the private health care sector expands, ensure that private hospitals are integrated into VPD reporting. 46 Disease-specific recommendations are included in the section ‘Progress in Meeting Global and Regional Goals’. Progress in Meeting Global and Regional Goals. Context Myanmar’s current cMYP has the following disease-specific goals:  To maintain zero polio cases (both WPV and VDPV).  To maintain MNTE.  To achieve elimination of measles and control of rubella and CRS by 2020. In addition to targeting polio, MNTE, and measles and rubella/CRS, regional goals articulated in the SEAR Vaccine Action Plan (SEARVAP) also include accelerated control of hepatitis B and JE. The situational analyses presented below are based on a review of national documents and observations of the field teams. Findings Polio Myanmar was certified polio-free on 27 March 2014 – together with all countries in the Region. The last case of indigenous WPV was reported in 2000 and the last case of imported WPV was identified in 2007. However, VDPV cases were reported in 2006 (poliovirus type 1 (P1) - one case), 2007 (P1 - four cases), 2010 (poliovirus type 2 (P2) - one case) and 2012 (P1 - one case). In 2015, two polio cases due to cVDPV2 were confirmed in Maungdaw Township, Rakhine State, Myanmar. The first case, a male child of 2 years and 6 months of age, had onset of AFP on 16 April 2015 and stool specimens collected on 25 and 26 April 2015 revealed VDPV2. On 7 November 2015, a VPDV2 was isolated from a 16-month old boy from Maungdaw Township, Rakhine State who developed AFP on 5 October 2015. A genetic link to the previously-isolated VPDV2 was confirmed on 7 December 2015, resulting in confirmation of virus circulation. The genetic changes of the isolates detected in April and October 2015 suggest that the cVDPV2 may have been circulating for more than one year. OBRAs were carried out twice as per the requirements of the Global Polio Eradication Initiative; the second OBRA was conducted concurrently with this EPI and VPD surveillance review. Reports of both first and second assessment are available at: http://www.searo.who.int/entity/immunization/documents/en/ Since 2015, AFP surveillance has been strengthened throughout the country and specifically in Rakhine. While, at the national level in 2015, the required operational target of a non-polio AFP rate above 2 per 100 000 children less than 15 years of age per year and adequate stool collection percentage of 93% has been achieved, several 47 areas in the country have not reached the AFP surveillance target; the non-polio AFP rate was less than 2/100 000 children less than 15 years of age per year in 7(41%) of 17 states and regions. However, in 2016, AFP surveillance indicators improved throughout the country. The annualized non-polio AFP rate at the time of the review was 3.06/100 000 children less than 15 years of age per year and the percentage of adequate stool specimen collection was 93% as of epidemiological week 39. All 17 states and regions except one (Shan-East) had achieved the target for the non-polio AFP rate above 2/100 000 children less than 15 years of age and only one state (Kachin) had an adequate stool sample collection percentage below 80%. In Rakhine State, the non-polio AFP rate in 2015 was 1.63 per 100 000 children less than 15 years of age and the adequate stool sample collection fell short of the target at 78%. Nonetheless, surveillance improved in 2016 with an annualized non-polio AFP rate of 3.16 with adequate stool collection percentage of 92% as of epidemiological week 39. After the confirmation of the cVDPV2 outbreak in December 2015, the MoHS instructed all states/regions and townships to intensify AFP surveillance. Trainings and orientations were conducted for all basic health staff and clinicians on AFP surveillance, and outpatient department and emergency registries were searched for unreported AFP cases. Systems were put in place to ensure immediate notification of AFP cases by telephone from all states/regions and townships. Frequently asked questions and the corresponding answers as well as IEC materials on surveillance were developed and distributed to all health facilities. Posters were displayed in hospitals and health facilities. Monitoring of reports has been strengthened at national, state and regional level. Daily/weekly reports to state/region from townships and from all states/regions (including all townships) to national level as well as a weekly situation review by national staff using maps and other means of documenting surveillance performance have been implemented. At least five contacts of every AFP case in Rakhine State had stool samples collected and, during SIAs, systematic searches for AFP cases were conducted by vaccination teams. Contact sampling guidelines have been developed and the AFP surveillance guidelines have been updated and translated into Burmese. The country has identified three sites for environmental surveillance - two sites in Rakhine and one site in Yangon and environmental surveillance guidelines have been developed. The NHL in Yangon has trained staff and designated separate facilities for sewage sample testing. As soon as laboratory equipment and supplies are available, testing of samples will commence. Poliovirus type 2 (PV2) laboratory containment per the third edition of the Global Action Plan to minimize post-eradication poliovirus facility-associated risk (GAPIII) phase 1 requirements is progressing. Following the updating of the list of biomedical laboratories, a new survey is being conducted to identify Sabin2/OPV2 infectious and potentially infectious materials. All cVDPV2 materials have already been destroyed. 48 Myanmar successfully switched from use of trivalent oral poliovirus vaccine (tOPV) to bOPV on 29 April 2016; this switch was confirmed by the National Switch Validation Committee. All remaining stocks of tOPV were destroyed as per national guidelines. The national routine immunization coverage based upon administrative data and reported to WHO for the third dose of oral polio vaccine (OPV3) was 89% in 2015 but WHO and UNICEF best estimates put this at 76%.36 Performance is not uniform and there are several pockets of low coverage; three states/regions reported OPV3 coverage less than 80% in 2015 and 15% of townships had OPV3 coverage less than 80% in 2015.37 The government has initiated several innovative actions to improve coverage in low performing area which are described in section ‘EPI Service Delivery’ of this report. The government has updated the national polio outbreak response plan and also developed standard operating procedures on responding to PV2 outbreaks in the future. MNTE Since 1999, Myanmar has been implementing the WHO-UNICEF recommended strategies to reach MNTE. In Myanmar these have included:  immunization of pregnant women with TT (two doses of TT at each pregnancy) beginning in 1978 and extending throughout the country by 1985, protecting over 90% of pregnant women nationwide since 2006;  immunization of approximately five million women of reproductive age with three properly-spaced doses of TT in high risk townships areas, selected by using the recommended WHO algorithm and its cut off points;  improving clean delivery coverage to 58% through an increased number of institutional deliveries and deliveries done by midwives supported by auxiliary MWs; and  implementing NT surveillance through an integrated disease surveillance system with AFP and measles detection, reporting and investigation of suspected NT cases, and case response, with about 30 NT cases reported annually since 2009. In 2010, MNTE was validated. The validation survey revealed a TT protection rate of more than 90% in the three townships surveyed, selected to be among the most poorly performing in the country, and over 90% of births were attended by skilled attendants. The validation report is available at: http://www.who.int/wer/2010/wer8543.pdf?ua=1 In its efforts to maintain MNTE, the country has regularly conducted risk assessments at township level and sought WHO recommendations on short and long term strategies, 36 Source: WHO Vaccine-Preventable Diseases: Monitoring System. 2016 Global Summary (online data base). WHO (http://apps.who.int/immunization_monitoring/globalsummary/countries?countrycriteria%5B country%5D%5B%5D=MMR accessed Sept 12, 2016) 37 WHO/UNICEF joint reporting form (JRF), 2015 49 with a particular focus on ensuring that women receive at least two doses of TT, NT surveillance and skilled attendants at births, particularly in potentially high risk townships. Immunization To maintain high protection levels against tetanus, particularly in women of child bearing age, the WHO Reaching Every District strategy and Intensification of Routine Immunization approach were used. Nonetheless, many hard-to-reach populations are reported to have been missed. Funding allocated for the operational costs required to reach the unreached was insufficient, the microplanning process was inadequately detailed, and monitoring and supervision were unable to confirm that hard-to-reach communities had been prioritized and reached. Despite these constraints, excellent acceptance and demand from communities that were targeted is acknowledged to have existed. Three rounds of TT SIAs were subsequently implemented in the 22 most poorly performing townships in 2014 in order to sustain MNTE. NT surveillance About 30 NT cases have been reported annually in Myanmar for the past few years, with no township reporting an NT rate above 1/1 000 live births through an integrated disease surveillance system which includes zero reporting, health facility record reviews, case investigation and NT case response in some confirmed cases. However, townships at potential risk for NT, with low routine immunization coverage for DTP3 and the second dose of tetanus toxoid (TT2) and a low percentage of deliveries attended by skilled birth attendants, are silent and report zero cases, most probably due to incomplete detection of suspected cases. Antenatal and delivery care Myanmar has made significant progress in bringing life-saving antenatal and delivery services to target beneficiaries through accelerated efforts to train MWs and post them in every RHSC. Furthermore, large numbers of auxiliary MWs have been trained in the recent past to be posted at village level and undertake delivery care. The current system relies heavily on home-based and community-based service delivery and is effective in reaching physically-accessible populations. However, there is a need to shift attention further to hard-to-reach areas and communities at high risk for poor maternal, neonatal and child health. Measles and Rubella Measles and rubella are both eradicable diseases. As of September 2013, all six WHO Regions have set target dates for measles elimination while two have set target dates for rubella elimination. At the World Health Assembly in 2012, all Member States endorsed the GVAP. Elimination of measles and rubella in five of six WHO regions is one of the 50 four high level goals in this document, situating global measles and rubella elimination as an integral part of the DoV global immunization agenda. In September 2013, WHO’s Regional Committee for South-East Asia resolved to eliminate measles and control rubella and CRS by 2020. In line with this Regional goal, Myanmar set the goal of measles elimination and rubella/CRS control by 2020. In June 2016, the SEAR ITAG recommended that countries that had introduced MR set an elimination (as opposed to control) goal by 2020 for rubella. Myanmar formed a measles and rubella NVC in 2016, and presented a situational analysis of its measles and rubella status to the Regional Verification Committee in August 2016. The country is finalizing its National Strategy on Measles Elimination and Rubella Control (2016-2020). In 1987, Myanmar introduced single antigen measles vaccine (M), administered at 9 months of age, into its routine EPI schedule, and added a second dose (M2), administered at 18 months of age, in 2012. Measles-rubella vaccine (MR1) replaced the first dose of M in the routine schedule in 2015, and a second dose of MR (MR2) is scheduled to replace M2 in 2017. Since its introduction, measles antigen containing vaccine (MCV) use has resulted in Myanmar reaching more than 90% measles mortality reduction (Figure 9). However, to achieve measles elimination, at least 95% coverage with two doses of MCV must be reached in 100% of districts. In 2015, only 19% of districts achieved at least 95% coverage with MCV1, not MCV2 (Figure 10). To fill immunity gaps, measles SIAs are conducted periodically, with periodicity determined by MCV1 and MCV2 coverage. Most frequently, SIAs are conducted every three years. In 2015, Myanmar conducted an MR SIA which targeted all children from 9 months to 15 years of age and reported 94% administrative coverage. Measles and rubella case based surveillance began in 2010 using a case definition suitable for measles “control” -- fever and rash with cough, coryza, or conjunctivitis (known as the ‘three C’s’). The case definition recommended for measles/rubella “elimination” is more sensitive – fever and rash surveillance (without one of the ‘3 Cs’). Initiation CRS sentinel surveillance is planned for 2017. Laboratory confirmation is conducted at the NHL, with plans to also be able to do this at the new laboratory in Mandalay. Myanmar does not use any alternative laboratory methodologies (for example, dried blood spot or saliva) for testing specimens for measles or rubella. Laboratory testing of specimens for measles and rubella is done in parallel. Although performance indicators suggest 100% specimen collection from reported measles cases, the 2015 discarded measles rate of 0.42/100 000 is far below the 2/100 000 target (Table 8). This indicator is considered a measure of the sensitivity of the surveillance system; a low value thus suggests a high likelihood of substantial surveillance gaps. Because a measles “control” rather than “elimination” surveillance definition is widely used, only clinically-confirmed measles cases are reported. Perhaps 51 due to the lack of awareness of rubella as a disease, few rash and fever illnesses are initially reported as suspected rubella cases. Figure 9. First and second dose coverage of MCV, SIAs, and case and death count, Myanmar, 1987 – mid-2016 Source: National Verification Committee for Measles Elimination and Rubella/CRS control. Myanmar. Presentation to 1 st RVC Meeting, New Delhi, India. 1- 4 August, 2016. Figure 10. Percentage of townships with at east 95% coverage with MCV1, by year. Myanmar, 2010 - 2015. Source: Derived from data presented in National Verification Committee for Measles Elimination and Rubella/CRS control. Myanmar. Presentation to 1 st RVC Meeting, New Delhi, India. 1- 4 August, 2016. Hepatitis B Chronic hepatitis B virus (HBV) infection is a major cause of cirrhosis and liver cancer worldwide. Perinatal transmission is the main source of chronic HBV infection in high 52 prevalence settings; 90% of children with perinatally acquired infections will remain chronically infected and ultimately develop liver cirrhosis and cancer. Universal infant immunization with three doses of HepB, with the first dose provided within 24 hours of birth, is the most cost-effective prevention and control strategy for HBV infection. HepB is heat-stable and freeze sensitive.38,39,40 Vaccine stability data show that HepB can be stored at 37°C for 30 days without losing its potency based on multiple studies.41 ,42,43,44,45 In May 2016, the World Health Assembly endorsed the global target of achieving a hepatitis B surface antigen (HBsAg) seroprevalence of ≤1% among children under 5 years of age by 2020, and eliminating viral hepatitis by 2030 as part of the Global Health Sector Strategy for Viral Hepatitis Control. In June 2016, the SEAR ITAG recommended the establishment of a target of ≤ 1% HBsAg seroprevalence among children aged 5 years by the year 2020 and the fifth goal of the SEARVAP focuses on accelerating hepatitis B control in the Region. A National Strategic Plan on Viral Hepatitis (2016- 2020) is currently under development in Myanmar. Myanmar has high intermediate endemicity of chronic HBV infection. A nationwide survey conducted in 2015 among persons aged from 15 to 80 years old living in 18 townships reported an overall seroprevalence of HBsAg of 6.5% with higher prevalence in men (8.95%) compared to women (5.47%) and wide variability in prevalence across townships (Figure 11). The burden of chronic HBV infection among people who inject drugs and blood donors has been reported to be 7.3% and 2.3%, respectively. There are no data on the prevalence of chronic HBV infection and particularly hepatitis B e antigen 38 Chen D, Tyagi A, Carpenter J, et al. Characterization of the freeze sensitivity of a hepatitis B vaccine. Human Vaccines. 2009;5(1):26–32. 39 Matthias DM, Robertson J, Garrison M, Newland S, Nelson C. Freezing temperatures in the vaccine cold chain: A systematic literature review. Vaccine. 2007;25: 3980–3986. 40 Temperature Sensitivity of Vaccines. 2006. World Health Organization (http://apps.who.int/iris/bitstream/10665/69387/1/WHO_IVB_06.10_eng.pdf , accessed Nov. 6 2016) 41 Van Damme P, Cramm M, Safary A, et al. Heat stability of a recombinant DNA hepatitis B vaccine. Vaccine. 1992;10:366–367. 42 Hipgrave et al. Immunogenicity of a locally produced hepatitis B vaccine with the birth dose stored outside the cold chain in rural Vietnam. American Journal of Tropical Medicine and Hygiene. 2006; 74 (2) 255-260. 43 Otto BF, Suarnowa IM, Stewart T, Nelson C, Ruff TA, Widjawa A, Maynard JE. At-birth immunization against hepatitis B using a novel pre-filled immunization device stored outside the cold chain. Vaccine. 1999; 18: 498-502. 44 Wang et al. Hepatitis B vaccination of newborn infants in rural China: evaluation of a village- based, out of cold chain delivery strategy. Bulletin of the World Health Organization. 2007. 85: 688-694. 45 Sutanto A, Suarnawa IM, Nelson CM, Stewart T, Indijati Soewarso T. Home delivery of heat- stable vaccines in Indonesia: outreach immunization with a prefilled, single-dose injection device. Bulletin of the World Health Organization. 1999; 77(2): 119-126. 53 (HBeAg) (a marker of infectiousness and indicator of risk of mother to child transmission) among pregnant women and no data on HBsAg prevalence in children aged 5 years. In 2003, Gavi supported the introduction of HepB and HepB-BD in Myanmar. However, after Gavi withdrew financing for the birth dose, HepB-BD was removed from the national immunization schedule. Currently, HepB is provided as a component of pentavalent vaccine with WHO and UNICEF estimating coverage of 75%.46 In the fourth quarter of 2016, HepB-BD, targeting children born in hospitals, is scheduled to be (re)introduced into the national immunization schedule. Vaccine seen in state/township and hospital refrigerators was a single-dose vaccine without vaccine vial monitors (VVMs), thus limiting its use outside of the cold chain but under temperature control in settings where cold chain does not exist, such as RHCs, RHSCs and home deliveries. However, this formulation will reportedly be replaced by one that includes a VVM in the near future. According to field observations and physician reports, over the past few years all pregnant women have routinely been screened for HBsAg. In public hospitals, pregnant HBsAg-positive women are counselled to have their babies vaccinated with HepB-BD. However, as this vaccine was not part of the EPI at the time of the review, costs associated with its administration needed to be covered out-of-pocket. Most women were reported to purchase the vaccine and have it administered. Locally developed HepB-BD vaccination registers were seen in public hospitals. However, the information recorded in these registers varied from hospital to hospital, at times lacking such important information as the date of the child’s birth, critical for enabling timely administration of HepB-BD. In private hospitals, babies were reported to be routinely vaccinated with HepB-BD, purchased by the family. However, at the private hospitals visited, no HepB-BD registers were available. In private and public hospitals, the vaccine was stored in the hospital pharmacy refrigerator along with other medicines. 46 WHO Vaccine-Preventable Diseases: Monitoring System. 2016 Global Summary (online data base). WHO (http://apps.who.int/immunization_monitoring/globalsummary/countries?countrycriteria%5Bcoun try%5D%5B%5D=MMR accessed Sept 12, 2016) 54 Figure 11. Seroprevalence of chronic HBV infection in 18 townships Source: National Prevalence Survey Report 2015, Department of Medical Research, MoHS. The Republic of the Union of Myanmar Reaching high coverage with HepB-BD is critical to decreasing vertical transmission of HBV in Myanmar. However, reaching high coverage will require addressing a number of challenges. As only 36% of deliveries are estimated to occur in hospital,47 limiting HepB- BD administration to hospital deliveries will not allow the country to reach the hepatitis B control goal of ≤1% among children aged 5 years by 2020. The 5 September 2016 operational plan of the Myanmar National Strategic Plan on Viral Hepatitis (2016-2020) foresees HepB-BD expansion to township health centres and home deliveries in 2019; while this would expand coverage, it would be too late to reach the 2020 SEAR hepatitis B control goal. In Myanmar, MWs provide antenatal care, conduct deliveries, and also provide routine vaccines; as such, MWs are sensitized to the importance of vaccination. All MWs interviewed during the field visit to Mon stated their willingness to provide HepB-BD to babies delivered in RHCs, RHSCs and homes, providing a mandate to do so existed and there was RHC/RHSC cold chain equipment or government-endorsed out-of-cold chain vaccine use, particularly for home deliveries. While recent HepB-BD guidelines, registration and monthly reporting forms have been distributed to some township hospitals, no formal training on storing and recording of HepB-BD has been conducted thus far, resulting in variable quality and completeness of HepB-BD vaccination recording between hospitals. Cold chain keepers and immunization staff have not been trained on the appropriate storage of the highly freeze- sensitive HepB, resulting in vaccine vials being stored next to freezer level. This could potentially lead to freezing and a subsequent decrease in vaccine effectiveness . Finally, the absence of documentation of HepB-BD vaccination in private hospitals and 47 Available at http://data.unicef.org/maternal-health/delivery-care.html Accessed Nov. 6 2016 7.84% 7.49% 5.03% 3.90% 4.95% 9.15% 7.14% 12.29% 5.71% 4.01% 6.21% 7.10% 7.33% 6.25% 3.29% 6.79% 5.16% 6.47% 0% 2% 4% 6% 8% 10% 12% 55 subsequent lack of reporting of vaccination data to township or state public health departments leads to inaccurate estimation of HepB-BD coverage. JE A discussion of issues related to JE is found in the next section of the report, ‘NUVI’. Diphtheria Diphtheria is a potentially fatal disease caused by Corynebacterium diphtheria. Most infections are subclinical, or mild. Following the primary immunization series, immunity lasts approximately 10 years. Exposure to circulating C. diphtheria may prolong protective immunity through boosting. In the absence of natural boosting, booster doses of vaccine are required to maintain protection. Diphtheria is not a disease targeted for elimination or accelerated control globally, regionally or nationally. However, because the MoHS raised concerns about sporadic cases of diphtheria and small diphtheria outbreaks in Myanmar, the review team decided to include this topic in the EPI review. DTP was among the first vaccines introduced by Myanmar. DTP3 coverage in Myanmar for 2013, 2014 and 2015 was estimated to be 75% annually.48 Diphtheria cases reported to WHO are as follows: 2012: 19; 2013: 38; 2014:29; 2015:87.49 As of August, 2016, a total of 69 cases and 12 deaths had been reported for the year, with cases focused in Ayeyarwady (15), Mandalay (10) and Yangyon (20). Cases reported in 2016 were distributed across age groups and vaccination status (Figure 12). However, review of 2016 laboratory data showed relatively few specimens tested for C. diphtheria, none of which were positive. Laboratory personnel reported specimens arriving without CIF. The lack of laboratory confirmation raises questions as to whether all reported cases are truly diphtheria, increasing the difficulty of using these data to guide policy. 48 WHO Vaccine-Preventable Diseases: Monitoring System. 2016 Global Summary (online data base). WHO (http://apps.who.int/immunization_monitoring/globalsummary/countries?countrycriteria%5B country%5D%5B%5D=MMR accessed Sept 12, 2016) 49 WHO Vaccine-Preventable Diseases: Monitoring System. 2016 Global Summary (online data base). WHO (http://apps.who.int/immunization_monitoring/globalsummary/countries?countrycriteria%5B country%5D%5B%5D=MMR accessed Sept 12, 2016 56 Figure 12. Reported diphtheria cases by age and vaccination status. Myanmar, 2016 Source: MoHS. The Republic of the Union of Myanmar. Epidemiological Investigation of Diphtheria Cases. Presentation to Indian National Technical Advisory Group on Immunization, Oct. 5 2016. Key Strengths and Best Practices As it strives to reach disease-specific goals, Myanmar has demonstrated a number of key strengths and best practices. These include:  commitment to maintaining polio-free status, as evidenced by a vigorous response to the 2015 cVDPV2 outbreak;  ongoing efforts to maintain MNTE, as demonstrated through high TT2 coverage;  recent increase in commitment to measles elimination and rubella control, as evidenced by the recent introduction of MR, the successful 2015 MR SIA, the formation of the NVC, and plans to initiate sentinel CRS surveillance; and  plans to (re)-introduce HepB-BD in hospitals by end-2016. Key Issues and Challenges Key issues and challenges for Myanmar in meeting disease-specific goals are:  achieving and maintaining universally high coverage with three doses of polio vaccine and ensuring that AFP surveillance remains universally robust;  maintaining high TT2 coverage and increasing the percentage of births attended by skilled birth attendants in hard-to-reach areas;  increasing commitment to measles and rubella elimination; increasing MCV2 coverage to 95% or better in all townships; moving from ‘control’ to ‘elimination’ surveillance; and improving rapid outbreak response and control; 57  increasing coverage with HepB-BD adequately to meet 2020 regional targets; and  improving laboratory-supported surveillance for diphtheria Recommendations Polio For recommendations related to polio, please see those contained in the report of the 25 September – 8 October 2016 OBRA, available at http://www.searo.who.int/entity/immunization/documents/en/ MNTE Efforts to strengthen routine immunization should continue, especially in high risk populations in which women of childbearing age should receive TT based on eligibility. If these efforts still fail to reach communities, ‘stand-alone’ (that is, not as part of SIAs for other antigens) TT SIAs for the highest risk communities targeting women of child bearing age should be considered. In some situations, these could also be combined with SIAs for measles and rubella. To improve the sensitivity of the existing case based NT surveillance system, the following is recommended.  Consider community based surveillance in high risk areas with the support of Women’s Association members, community based volunteers, the Myanmar Health Assistance Associations, auxiliary midwives and other community leaders.  Strengthen the maternal and infant death reporting and auditing system and investigate all reported infant deaths.  Establish a monitoring mechanism for community based surveillance, comparable to that used for AFP surveillance. This could be done by using reported neonatal deaths and comparing these with the expected number of neonatal deaths, based on available reference data such as the national neonatal death rate and survey data.  Ensure that the NT case investigation form allows supervisors and surveillance personnel at all levels to have a complete understanding of the history and symptoms of the case and to confirm diagnosis of the suspected NT case. Surveillance staff should be retrained on the use of the investigation form and principles of verbal autopsy.  Adapt the case response to the cause(s) of non-protection. If the mother requires vaccination to protect further unborn children, other eligible women in the same community should also be evaluate for TT vaccination status and targeted for immunization based on eligibility. To increase use of skilled delivery care in high-risk and hard-to-reach areas consider: o strategic re-deployment of MWs to high-risk areas; 58 o strategic deployment of lady health visitors to fill gaps in skilled birth attendance; and o direct distribution of clean delivery kits to pregnant women where skilled delivery care is inaccessible or under-used. However, it is recognized that this recommendation may not be able to be implemented by CEPI. To expand the types of providers able to administer TT vaccine consider: o when eventually feasible, using auxiliary MWs as TT vaccinators to minimize missed opportunities for TT protection; and o in hard-to-reach areas, partnering with qualified private or NGO sector providers with success and local acceptability operating in those contexts. To increase use of facility care by communities in close proximity to health centres, consider: o an incentive scheme (for example, conditional cash transfers) for accessible communities; and o vouchers for transport to RHCs. Measles and rubella Recommendations to help Myanmar reach measles elimination and control rubella are below.  Increase commitment to measles and rubella elimination by: o gaining NITAG agreement to 2020 rubella elimination goal once MR2 is added to the routine schedule; o finalizing National Measles and Rubella Strategy, 2016-2020, ensuring it reflects rubella elimination goal; and o having the EPI measles programme periodically reviewed by the NVC.  Increase to at least 95% MCV2 coverage in all townships by: o developing costed sub-national measles/rubella elimination work plans with clear designations of responsibility; o conducting village-level risk assessment and mitigation; o ensuring introduction and scale-up of MR2 in the routine immunization programme; o monitoring village microplans to ensure implementation; o strengthening defaulter tracking; o creating vaccine demand; o conducting school-based immunization record checks at school entry; and 59 o conducting SIAs when the estimated population immunity gap equals the size of the birth cohort.  Move from “control” to “elimination” standard surveillance by: o ensuring implementation of elimination-standard surveillance (as proposed in 2016 September workshop50) with active search after case confirmation; o increasing surveillance sites beyond AFP sites to include all health facilities, and train relevant staff; o developing a clear implementation plan, with communication strategy, for fever/rash surveillance, and a field guide with SOPs with clear designation of roles and responsibilities for specimen collection and transport, and training of relevant staff; o evaluating dried blood spots for case confirmation in areas of the country where collection and transportation of whole blood/serum are not feasible; and o finalizing CRS guidelines and establishing CRS sentinel sites in 2017 as planned.  Improve rapid outbreak control and response by: o designating rapid response teams with appropriate standard operating procedures; o implementing hospital infection control; o vaccinating high risk adults, including health care workers (HCW) at no cost; and o vaccinating at-risk populations, such as orphaned children cared for within monasteries. Hepatitis B Recommendations to accelerate control of hepatitis B are below.  Develop an immunization specific national hepatitis B operational plan to achieve the 2020 SEAR hepatitis B control goal and expand HepB-BD to reach deliveries that occur outside hospitals.  Train HCW on storage of vaccine for HepB-BD, vaccination, and dose recording.  Explore using vaccine for HepB-BD outside the cold chain in RHCs, RHSCs, and home births. This would require using a single dose HepB-BD with VVM and approval by the NITAG and relevant national regulatory body. The current WHO 50 Regional workshop on surveillance standards for measles, rubella and priority vaccine- preventable diseases. Kathmandu, Nepal, 19-23 September 2016. World health Organization Regional Office for South-East Asia, 2017/ (http://www.searo.who.int/entity/immunization/documents/regional_workshop_surveillance_stan dards_2016.pdf?ua=1, accessed 1 June 2017). 60 recommendation51supports countries that choose to pursue an out-of-cold-chain policy for a given monovalent hepatitis B vaccine and strongly recommends that, when doing so, they follow the current Immunization Practices Advisory Committee (IPAC) recommendations for out-of-cold-chain use and controlled temperature chain (CTC) use of vaccine.52  Engage the private sector to promote birth dose reporting.  Estimate HBsAg seroprevalence in pregnant women and children using pre- collected sera such as the recent micronutrient survey. Diphtheria Recommendations to increase diphtheria control are below.  Conduct trainings on specimen collection and CIF completion for diphtheria.  Consider liaising with WHO-India (through WHO’s Regional Office for South-East Asia) to explore India’s experience with diphtheria surveillance, and materials developed to date.  Ensure that reported cases of diphtheria without laboratory specimens meet the diphtheria clinical case definition.  Consider vaccinating unvaccinated individuals living in crowded settings (for example, institutionalized orphans). NUVI Context The SEARVAP includes, as one of its goals, accelerating the introduction of new vaccines and related technologies. Myanmar aligns itself with the GVAP and SEARVAP in prioritizing the introduction of new and underutilized vaccines. As outlined above, Myanmar has introduced many new vaccines in the past decade and a half: HepB (2003); Hib as pentavalent (2008); MR1 (2015); IPV (2015); bOPV (2015); and PCV (2016). The cMYP 2017-2021 outlines plans for introduction of JE and HPV vaccines, as well as rotavirus vaccine. Findings Myanmar has a functional NCIP which guides decisions on NUVI. Gavi has supported Myanmar since 2002; since that time the country has secured the commitment of 51 WHO. Meeting of the Strategic Advisory Group of Experts on immunization, October 2016 – conclusions and recommendations Weekly Epidemiological Record No. 408, 201609, 8914, 561405–584420 available at http://www.who.int/wer (accessed Feb. 27 2017) 52 Immunization Practices Advisory committee (IPAC) Statement. Out of cold chain (OCC) and Controlled Temperature Chain (CTC) use of vaccines. Available at: http://www.who.int/immunization/programmes_systems/policies_strategies/IPAC_statement_OC C_CTC_October_2016.pdf?ua=1 (Accessed Feb. 27, 2017) 61 US$ 147 million for new vaccine support, of which US$ 117.9 million have been disbursed. In addition to many other needs, the HSS2 grant will support additional cold chain to accommodate the introduction of cMYP-designated new vaccines. As mentioned above, cold chain was expanded in advance of the introduction of PCV; this met 80% of PCV cold chain needs, with the remaining 20% to be installed by end-2016. JE vaccine will be introduced through a two-phase SIA in 2017, with government, Gavi, WHO and UNICEF financing. JE vaccine will be incorporated into routine immunization in 2018 with that year’s vaccine costs supported by the Programme for Appropriate Technology for Health; co-financing from Gavi may also be available. Rotavirus and HPV vaccines are expected to be introduced in 2018 and 2019 respectively. Despite these successes, challenges exist. With an ever-increasing number of new vaccines and associated costs, countries, including Myanmar, need to prioritize vaccine introductions along with other public health interventions. Burden of disease data need to be generated and economic analyses conducted to inform decision making; these tasks are complicated by insufficient expertise within the CEU and inadequate financial resources. In addition and as mentioned previously, at present Myanmar’s EPI is heavily reliant on external funding sources to sustain itself, and will need to achieve financial independence by 2025. Currently, nationwide VPD surveillance activities are limited to diseases targeted by traditional vaccines. Although Hib vaccine and PCV have been introduced, no invasive bacterial VPD surveillance exists, limiting Myanmar’s ability to assess the impact of either Hib (in pentavalent formulation) vaccine or PCV. Surveillance for acute encephalitis syndrome (AES)/JE is confined to sentinel sites at a few major hospitals. Substantial strengthening of laboratory-supported AES/JE surveillance is needed to comprehensively understand the epidemiology of JE in Myanmar. Similarly, sentinel surveillance of rotavirus gastroenteritis is limited to Yangon Children’s Hospital (YCH). Analysis of case based data collected at YCH would indicate how representative patients are of the broader country and the extent to which YCH findings can be extrapolated nationally to guide decision making. Strengthening both AES/JE and rotavirus surveillance by increasing the number of sentinel sites and ensuring adequate laboratory support would not only provide increased evidence in advance of vaccine introduction, but also permit an evaluation of the impact of JE and rotavirus vaccines once they are introduced. Key Strengths and Best Practices Myanmar’s key strengths in terms of NUVI are:  the existence of a functional NCIP; and  a history of successful introduction of new vaccines. 62 Key Issues and Challenges Myanmar also has a number of key Issues and challenges as it seeks to increase the number of vaccines included in the EPI. These issues and challenges are:  reaching financial self-sufficiency for all vaccines by 2025;  developing burden of disease and economic data on which to base decisions regarding NUVI and with which to evaluate the impact of vaccines, once introduced; and  ensuring adequate cold chain capacity to accommodate all vaccines foreseen for introduction. Recommendations To support the NUVI, Myanmar should consider the following recommendations:  Develop a sustainable immunization financing plan and periodically update it to ensure predictable funding for sustaining routine immunization and NUVI.  Foster partnerships with national and international technical partners (including academia) to generate reliable evidence for decision making on NUVI and related technologies.  Strengthen surveillance for rotavirus and AES/JE by expanding the number and geographic representativeness of sentinel sites while ensuring adequate laboratory support.  Implement the cold chain improvement plan with funding from HSS2 to expand the cold chain capacity in order to accommodate JE and HPV vaccines and rotavirus vaccine introduction. 63 CONCLUSION In conclusion, Myanmar has a rapidly evolving EPI which shows evidence of recently increased government commitment and a high level of engagement from the international community. Although historically Myanmar’s health budget has been low, both in absolute terms and as a proportion of GDP, recent growth in GDP has translated into an increasing health budget and a 2016 commitment to fund traditional vaccines and co-finance Gavi-supported vaccines. Since the EPI began, the country has seen a dramatic reduction in VPDs. More recently, Myanmar has successfully introduced a number of new and underutilized vaccines, including rubella (as MR), IPV, bOPV, and PCV. The programme is supported by a dedicated and hard-working staff. However, despite their commitment, staff cannot compensate for the human resource challenges posed by unfilled sanctioned posts and limited capacity in specific subject areas. In addition, Myanmar faces complex social, cultural and political factors leading to pockets of unimmunized children, and which may also contribute to under-reporting of diseases; many of these factors require context-tailored approaches. This situation is compounded by service delivery challenges which have been identified and seek to be addressed through HSS2 funding. While VPD surveillance is sensitive enough to detect large outbreaks, in order to optimally guide the programme, sensitivity of surveillance, specimen collection and laboratory confirmation, and local analysis and use of data will need to be bolstered. As the programme looks to the future, plans to sustain the gains made through HSS2 as well as plans to ensure vaccine self-sufficiency as of 2025 are critical. Finally, although evaluation of the NRA is outside of this review, it is worth noting that a regulatory agency competent to oversee licensing of imported vaccine will become increasingly important as the country’s EPI matures. 64 ANNEXES Annex 1. List of participants in joint national/international EPI review Name Position and Organization Reviewers from Myanamr Dr Aung Naing Oo Assistant Director, EPI, Department of Public Health, Ministry of Health and Sport Dr Thiha Aung Deputy State Public Health Director, State Public Health Department, Rakhine State Dr Naing Naing Tun Assistant Director, EPI,State Public Health Department, Kayin State Dr Than Lwin Aung Assistant Director, EPI, Regional Public Health Department, Ayerwaddy Region Dr Pyae Pyoe Swe Team Leader, SDCU/EPI, Regional Public Health Department, Sagaing Region Dr Hnin Nweni Aye Team Leader, SDCU/EPI, Regional Public Health Department, Mandalay Region Dr Z Lwang Khaung Team Leader, SDCU/EPI, State Public Health Department, Kachin Dr Kyaw Soe Moe Medical Officer, EPI, Department of Public Health, Ministry of Health and Sport Dr Aye Aye Mar Assistant Director, EPI, Naypitaw Council Dr Daniel Lynn Team Leader, SDCU/EPI, State Public Health Department, Shan North Dr Tin Tun Win Medical Officer, EPI, Department of Public Health, Ministry of Health and Sport Dr Pyae Phyo Wai Medical Officer, EPI, Department of Public Health, Ministry of Health and Sport Dr Kyaw Khine San Assistant Director, Emergency, Department of Public Health, Naypitaw Dr Win Pa Pa Htay Assistant Director, EPI, State Public Health Department, Mon State 65 Name Position and Organization Dr Aung Kyaw Moe Assistant Director, EPI, Department of Public Health, Ministry of Health and Sport Dr Htoo Myint Swe Medical Officer, CEU, Department of Public Health, Naypitaw Dr Saing Win Zaw Hlaing Deputy Director State Public Health Director, State Public Health Department, Shan South Dr Phone Myat Hein Team Leader, SDCU/EPI, Regional Public Health Department, Yangon Region Dr Tin Thitsar Lwin Assistant Director, Epidemiologist, Regional Public Health Department, Yangon Region Dr Myat Phyu Pyar Aye Team Leader, SDCU/EPI, Regional Public Health Department, Tanintharyi Region Dr Chan Myae Aye Thaung Assistant Director, EPI, Regional Public Health Department, Magway Region Dr Thit Thit Nwe Team Leader, SDCU/EPI, State Public Health Department, Mon Dr Aye Mya Chan Thar Assistant Director, EPI, Department of Public Health, Ministry of Health and Sport International Reviewers (including WHO and UNICEF Country Office participants) Dr K. Lisa Cairns Independent Consultant, Team Leader, Victoria, Canada Dr Yasho Vardhan Pradhan Independent Consultant, Temporary Advisor, Kathmandu, Nepal Dr Graham Tallis Coordinator, Surveillance, Monitoring and Information, Polio Eradication Department, WHO Headquarters, Geneva, Switzerland Mr Dirk Gehl Senior Country Officer, Country Programmes, Gavi, the Vaccine Alliance, Geneva, Switzerland Dr Robb Linkins Chief, Accelerated Disease Control and VPD Surveillance, Global Immunization Division, Centres for Disease Control and Prevention, Atlanta, USA 66 Name Position and Organization Dr Rania Tohme Team Lead, Targeted Vaccine Preventable Diseases, Global Immunization Division, Centres for Disease Control and Prevention, Atlanta, USA Dr Cynthia Snider Epidemiologist, Polio Eradication Branch, Global Immunization Division, Centres for Disease Control and Prevention, Atlanta, USA Dr Kristen E. VanderEnde Epidemiologist, Polio Eradication Branch, Global Immunization Division, Centres for Disease Control and Prevention, Atlanta, USA Mr Muamar Muslih Epidemiologist, Direktorate of Surveillance and Health Quarantine, Ministry of Health, Republic of Indonesia Dr Xiaojun Wang Immunization Specialist, Young Child Survival and Development, UNICEF, Bangkok, Thailand Dr Jeff Partridge Senior Programme Officer, Polio Programme, Global Development, Bill & Melinda Gates Foundation, Seattle, USA Dr Shuyan Zuo EPI Technical Officer, WHO/China Country Office, Beijing, China Dr Daniel Ngemera Immunization Specialist, UNICEF/Myanmar Country Office, Yangyon, Myanmar Dr Tin Htut Health Specialist, UNICEF/Myanmar Country Office, Yangyon, Myanmar Dr Thiha Htun UNICEF Field Office, Yangyon, Myanmar Dr Nay Myo Thu Medical Officer, EPI, UNICEF/Myanmar Country Office, Yangyon, Myanmar Dr Rajendra Bohara EPI Technical Officer, WHO/Myanmar Country Office, Yangyon, Myanmar Dr Tin Tin Aye EPI Technical Officer, WHO/Myanmar Country Office, Yangyon, Myanmar Dr Ye Hla EPI Technical Officer, WHO/Myanmar Country Office, Yangyon, Myanmar Dr Sigrun Roesel Technical Officer – VPD/IVD, WHO-SEARO, New Delhi, India (Mission Coordinator) Annex 2. AFP surveillance Indicators, Myanmar, 2016 as of Week 42 Non- Polio AFP Case Pend- ing Confir- med Polio (Wild/ VDPV) Compat i-ble Case Others AYEYARWADY 1,698,246 51 41 44 - 35 9 3.21 2.55 98 BAGO 1,290,306 39 31 58 - 47 11 5.57 4.51 98 CHIN 247,024 7 6 8 - 7 1 4.01 3.51 100 KACHIN 465,370 14 11 10 - 8 2 2.66 2.13 90 KAYAH 93,558 3 2 3 - 2 1 3.97 2.65 100 KAYIN 535,434 16 13 23 - 21 2 5.32 4.86 96 MAGWAY 1,222,287 37 30 27 - 20 7 2.73 2.03 96 MANDALAY 1,472,107 44 36 34 - 28 6 2.86 2.35 94 NAY PYI TAW 284,312 9 7 5 - 3 2 2.18 1.31 100 MON 599,936 18 15 17 - 16 1 3.51 3.30 100 RAKHINE 1,007,114 30 24 30 - 21 9 3.69 2.58 97 SAGAING 1,456,019 44 35 32 - 28 4 2.72 2.38 94 SHAN EAST 167,728 5 4 3 1 2 1 2.21 1.48 100 SHAN NORTH 670,502 20 16 16 1 11 5 2.95 2.03 94 SHAN SOUTH 824,549 25 20 22 - 20 2 3.30 3.00 100 TANINTHARYI 402,587 12 10 18 - 14 4 5.54 4.31 94 YANGON 1,528,021 46 37 29 1 24 5 2.35 1.94 93 Total 14,827,218 445 359 379 3 307 72 - - - 3.16 2.56 96 Annuali zed AFP Rate Annuali zed Non- Polio AFP Rates % of Adequ- ate Stool Total no. of reported AFP Case Hot Case State/Region <15 Population Minimum Expected Non Polio AFP Cases (3/100,000 pop) Annualiz ed Expecte d Non Polio AFP Cases (w.1- w.42) Status Annex 3. Quality of measles performance indicators, Myanmar, 2011-2015 Source: National Verification Committee for Measles Elimination and Rubella/CRS control. Myanmar. Presentation to 1 st RVC Meeting, New Delhi, India. 1- 4 August, 2016. Annex 4. Myanmar in the context of immunization goals & targets GVAP Strategic Objectives Key indicators to monitor progress at national level Status of Myanmar All countries commit to immunization as a priority  Presence of a legal framework of legislation that guarantees financing  Presence of an independent technical advisory group  Separate budget line for vaccines but not for other elements of the EPI.  Established 2009. Individuals and communities understand the value of vaccines and demand immunization as both their right and responsibility Level of public trust in immunization as monitored through knowledge, attitude and practice surveys Formal KAP survey not available. Community support for vaccinations variable. The benefits of immunization are equitably extended to all people  Percentage of townships with < 80% DTP3 coverage  Coverage gaps between the lowest and highest wealth quintile  14%  Unknown. Strong immunization systems are an integral part of a well- functioning health system  DPT1 to MCV1 dropout rates  Quality of immunization data  4% in 2015 based on WHO/UNICEF best estimates.  Questions around reliability of denominators used to calculate administrative coverage. Coverage surveys not routinely done. Immunization programmes have sustainable access to predictable funding, quality supply and innovative technologies Percentage of routine immunization costs financed through government budgets  In 2015, 31% 53 53 WHO Immunization Financing Indicators (online database) 2016. WHO. (http://www.who.int/immunization/programmes_systems/financing/data_indicators/en/ accessed 1 November 2016). Note that this figure is twice that reported in the cMYP (2017 – 2021). The reasons for this discrepancy are unclear 70 GVAP Strategic Objectives Key indicators to monitor progress at national level Status of Myanmar Country, regional and global research development innovations maximize the benefits of immunization  Capacity for vaccine manufacturing  Capacity to conduct clinical trials  Capacity to conduct relevant operational research  No vaccines manufactured  Limited capacity in government institutions and academia to conduct clinical trials and relevant operational research. SEARVAP Goals Status of Myanmar Polio-free status is maintained cVDPV outbreak in Rakhine in 2015. Outbreak response assessment indicated that persistent cVDPV circulation unlikely. However, some gaps remain in surveillance (see Annex 2). Elimination of maternal and neonatal tetanus is sustained Achieved Measles is eliminated and rubella/CRS controlled Recent increase in commitment with nationwide SIA in 2015, introduction of MR as MCV1, formation of NVC and drafting of National Plan. Challenges remain in terms of reaching adequate two dose coverage in all townships, achieving surveillance targets, and integrating rubella/CRS control. Control of Japanese encephalitis is accelerated JE vaccine introduction foreseen nationwide in 2017. Sentinel site surveillance needs expansion to provide a comprehensive picture of country’s epidemiology. Control of hepatitis B is accelerated HepB-BD has been re-introduced for use in hospitals as of last quarter 2016. However, use will need to be expanded beyond hospitals to reach recommended 2020 target. Routine immunization systems and services are strengthened 2013: 45 2014: 83 015: 85 Introduction of new vaccines and related technologies is accelerated 2015: Introduction of MR, IPV, bOPV 2016: Introduction of PCV 71 GVAP Strategic Objectives Key indicators to monitor progress at national level Status of Myanmar Adequate production and availability of safe and efficacious vaccines is ensured All EPI vaccines currently procured through UNICEF. Proposal for subscription to VII submitted to MoPF to cover traditional EPI Vaccines. Self-sufficiency in all vaccines required by 2025. Institutional plan for NRA should be developed to ensure that imported vaccines are accessible, safe and efficacious. A joint national/international review was conducted in 10 states and regions in Myanmar on 25 September to 8 October 2016 to assess the national immunization programme and share lessons learnt for preventing and controlling vaccine preventable diseases. This report summarizes the findings and recommendations made during the review. Joint National/International Expanded Programme on Immunization and Vaccine Preventable Disease Surveillance Review Republic of the Union of Myanmar 25 September – 8 October 2016 SEA-Immun-114