The Democratic People's Republic of Korea 5-year National Strategic Plan on measles elimination and rubella/congenital rubella syndrome control 2018

Transcription

1 The Democratic People's Republic of Korea 5-year National Strategic Plan on measles elimination and rubella/congenital rubella syndrome control

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3 The Democratic People s Republic of Korea 5-year National Strategic Plan on measles elimination and rubella/ congenital rubella syndrome control SUPPORTED BY WHO and UNICEF country offices for DPR Korea and Gavi The Vaccine Alliance

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5 Contents Preface... v Acknowledgements...vi Abbreviations...vii Executive summary...ix 1. Introduction Background to the National Strategic Plan Components of the new 5-year National Strategic Plan Strengths of DPR Korea that guarantee reaching the NSP goal Background The diseases Background on the global and regional measles rubella situation Current status of measles, rubella and CRS in DPR Korea Recent history, milestones and programmatic achievements Current situation of measles elimination and rubella control in DPR Korea (2016 data) Key lessons learnt from the measles elimination and rubella control activities Functional organigram of the national EPI within the Ministry of Public Health, DPR Korea National strategic goal, objectives and strategies Goal Objectives Strategies iii

6 7. Considerations for operationalization of the 5-year strategic plan from 2019 onwards Verification of measles elimination and rubella/crs control Role of National Verification Committee Main functions of the Regional Verification Committee Contributions to child health and health systems strengthening Sustainability of measles elimination and rubella/crs control beyond Immunization financing plan Timeline for implementation of NSP, financing plan and conceptual framework for sustenance beyond iv

7 Preface The Global Vaccine Action Plan that was endorsed by 194 Member States in the World Health Assembly in May 2012 set the goal of achieving measles and rubella elimination in at least five WHO regions by The South-East Asia Regional Vaccine Action Plan set the target of achieving measles elimination and control of rubella in the Region by These plans gave an impetus to all countries including the Democratic People s Republic of Korea (DPR Korea) to accelerate their efforts towards achieving this goal. In the Sixty-sixth session of the WHO Regional Committee for South-East Asia held on September 2013, DPR Korea endorsed the Regional goal of measles elimination and rubella control by DPR Korea understands the feasibility of measles elimination and rubella control in the country. The country is steadily progressing towards measles elimination with sustained near universal coverage of two doses of measles-containing vaccines (MCVs). With a highly successful supplementary immunization campaign in 2007 following the measles outbreak targeting those aged 6 months to 45 years with a coverage of 99.9%, the country has not recorded a single indigenous measles case to date thereafter, while the national measles and rubella surveillance system has been sensitive enough to detect three imported measles cases in Against this background, considering the need for a paradigm shift in measles elimination and rubella control strategies and activities from the accelerated control phase to the near elimination phase, and also considering the need for replacing MCV vaccine with measles rubella (MR) vaccine to achieve the national goal of rubella control by 2020, the Ministry of Public Health (MoPH) has taken a policy decision to revise the 5-year National Strategic Plan (NSP) on measles elimination and rubella control. The MoPH successfully implemented the first step of the NSP from 2014 to Due to the emerging requirements of assessing the country s progress towards verification of measles elimination and South-East Asia Regional Immunization Technical Advisory Group (ITAG) s recommendation of achieving the Regional goal of rubella control by 2020, the Government decided to update NSP for to describe in detail the second step of the previous NSP Additionally, this was a requirement for applying to Gavi for introduction of MR vaccine in the country. This revised NSP is thus the Government s blueprint for walking the additional steps towards measles elimination and rubella control by The results of implementation of the revised NSP will be another public health achievement for DPR Korea. v

8 Acknowledgements The Ministry of Public Health (MoPH) takes this opportunity to thank World Health Organization and United Nations Children s Fund representatives and their technical teams of the Expanded Programme on Immunization and Vaccine Preventable Diseases for supporting the initiative of revising the National Strategic Plan (NSP) in order to plan for archiving the remaining steps of measles elimination and rubella control. The Ministry also extends sincere thanks to Mr Peter Vanquaille, the external consultant, for his invaluable contributions to the NSP. Last but not least, MOPH is grateful to Gavi, the Vaccine Alliance for supporting this activity as a part of the Targeted Country Assistance support to DPR Korea. vi

9 Abbreviations ADR AEFI CES CHAES cmyp CRS DPRK EPI EQA EQAS EUPS FAQ Gavi HMIS HSS ICC IDSP IEC IFRC IMCI ITAG LMIS MCH MCV MDG MoPH MR NITAG NSP adverse drug reaction adverse event following immunization coverage evaluation survey Central Hygiene and Anti Epidemic Station Comprehensive Multi Year Plan congenital rubella syndrome (the) Democratic People s Republic of Korea Expanded Programme on Immunization external quality assurance external quality assurance system European Programme Support frequently asked questions Gavi, the Vaccine Alliance Health Management Information System Health System Strengthening Interagency Coordinating Committee Integrated Disease Surveillance Programme information, education and communication International Federation of Red Cross Integrated Management of childhood Illness Immunization Technical Advisory Group Logistic Management and Information System mother and child health measles containing vaccine Millennium Development Goal Ministry of Public Health measles rubella vaccine National Immunization Technical Advisory Group National Strategic Plan vii

10 NVC NVS PCCS PEI PIE RCV RI RVC SDG SIA SOP UNICEF VPD WCBA WHO National Verification Committee new vaccine support Post Campaign Evaluation Survey post-introduction evaluation post-introduction evaluation rubella containing vaccine routine immunization Regional Verification Commission Sustainable Development Goal supplementary immunization activity standard operating procedure United Nations Children Fund vaccine preventable disease women of childbearing age World Health Organization viii

11 Executive summary The 5-year National Strategic Plan (NSP) on measles elimination and control of rubella/ congenital rubella syndrome (CRS) guides the Ministry of Public Health (MoPH) and other stakeholders in planning, preparing and implementing different operational strategies and programme activities to achieve the national goal of eliminating measles and controlling rubella/crs by 2020 and sustain these achievements thereafter. The new 5-year NSP ( ) is the natural extension of the previous NSP ( ). The new NSP covers the operational strategies and programme activities that were not implemented in the previous NSP. It also includes strategies required for assessing the country s progress towards verification of measles elimination and achieving rubella/crs control by NSP outlines the national goal of eliminating measles and controlling rubella/crs in the Democratic Peoples Republic of Korea (DPR Korea) by the end of 2020 and five key strategic objectives to achieve the national goal. These objectives are: (i) achieving and maintaining at least 95% population immunity against measles and rubella through routine and/or supplementary immunization; (ii) developing and sustaining a sensitive and timely case-based measles and rubella surveillance system and CRS surveillance in the country that fulfils recommended surveillance performance indicators; (iii) developing and maintaining an accredited measles and rubella laboratory network that supports every province in the country; (iv) developing and maintaining a high level of epidemic preparedness and outbreak response; and (v) strengthening support and linkages to help achieve the above four strategic objectives. NSP lists introduction of measles rubella (MR) vaccine in routine immunization, preceded by a nationwide, wide age-range supplementary immunization activity as the major strategy to achieve Objective 1. Further, NSP provides guidance on planning follow-up campaigns in future with MR vaccine based on evidence generated from MR surveillance data and modelling studies. In relation to Objective 2, NSP highlights the need for a paradigm shift in integrated MR surveillance strategy from the accelerated control phase standard surveillance to the elimination level standard surveillance. As a part of this shift, MoPH will take a policy decision to adopt elimination level surveillance standards, revise national surveillance guidelines in line with WHO s MR Surveillance Guidelines, develop surveillance training curricula and roll out nation-wide surveillance training using the same. The NSP highlights the need for broadening the measles and rubella case definition based surveillance to include fever and rash surveillance, with at least 80% sample collection for serological investigations in order to enhance the sensitivity of the MR surveillance. The NSP advocates strengthening the current national ix

12 CRS sentinel surveillance network with expansion of the sentinel surveillance sites to the lowest administrative Ri level. To achieve Objective 3, the key focus is on enhancing the existing laboratory capacity to perform serological testing on samples collected from all fever rash cases enrolled for surveillance, assuring the quality assurance and quality control of the national laboratory and four provincial laboratories and soliciting WHO support to build laboratory capacity for molecular characterization of measles and rubella viruses. Objective 4 calls for reviewing the current Outbreak Preparedness and Response Guidelines and revising the guidelines with detailed standard operating procedures on outbreak preparedness and the roles and responsibilities of response team members. Objective 5 presents multiple strategies such as advocacy, social mobilization and communication, research and development and strengthening human resource management and capacity. The new NSP outlines considerations for effective operationalization of strategies and activities on measles elimination and rubella control from 2019 onwards. A key message for programme managers in the new NSP is setting the tone for verification of measles elimination in DPR Korea in the coming years. More importantly, NSP looks at sustainability of measles elimination and rubella/crs control beyond 2020 and the futuristic immunization financing plan. The Government s commitment, ownership, equity, cost sharing, building partnerships, investment in strengthening overall health and immunization systems and community involvement through people s bureaus are the major guiding principles that will propel DPR Korea towards achieving measles elimination and rubella control by 2020 and give hope of sustaining it beyond x

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15 1 Introduction 1.1 Background to the National Strategic Plan The 5-year National Strategic Plan ( ) on measles elimination and control of rubella/congenital rubella syndrome is a plan developed by the Ministry of Public Health (MoPH) of the Democratic People s Republic of Korea (DPR Korea) in collaboration with its health partners, World Health Organization (WHO) and United Nations Children s Fund (UNICEF). The Plan aims to guide all stakeholders in planning, preparing and implementing different operational strategies and programme activities to achieve the national, regional and global goals of eliminating measles and controlling rubella/ congenital rubella syndrome (CRS) by 2020 and sustain the achievements thereafter. The MoPH successfully implemented the first step of the previous National Strategic Plan (NSP) ( ), which focused on: (i) enhancement of the surveillance programme by shifting from aggregated to case-based reporting of all fever rash cases; (ii) introducing zero reporting; (iii) strengthening passive surveillance; (iv) electronic data reporting system; and (v) building the ability to diagnose imported measles and rubella cases. In the same period, the National Measles Laboratory significantly improved its quality of work and was accredited by WHO on an annual basis. MoPH also built the capacity of the provincial laboratories in serological diagnosis. 1

16 Though the measles rubella (MR) vaccine was not introduced in the national immunization programme, the MoPH conducted a supplementary immunization activity (SIA) campaign with MR vaccine with the support of Caritas, targeting children from 12 months to under 16 years of age in four provinces in December 2015, and the same age group in one province in December By the end of the third quarter of 2017, measles and rubella surveillance was being conducted through 7954 reporting sites spread over the entire country. CRS sentinel surveillance was being conducted through 222 sentinel sites at the provincial and county levels. The second step in NSP outlined the plans to: (i) introduce MR vaccine through SIA and the routine immunization (RI) programme to replace measles-containing vaccine (MCV) 1 and 2 immediately after the SIA; (ii) sustain over 95% immunization coverage of MR1 and MR2 doses nationally; (iii) conduct laboratory-supported casebased fever rash surveillance with 100% serological investigations; (iv) strengthen the laboratory capacity of measles and rubella/crs diagnosis; (v) enhance and sustain the capacity of epidemic preparedness and response to measles and rubella/crs outbreaks; (vi) build the population immunity profile by age against measles and rubella virus by triangulation of multiple methods including serosurveys; (vii) demonstrate the quality of SIA through a coverage evaluation survey (CES) and rapid convenience monitoring; and (viii) conduct a post-introduction evaluation (PIE) to document the lessons learnt from MR introduction. Due to the timing and complexity of the programmatic and operational aspects of the different components of the first NSP, and also due to the emerging requirements for assessing the country s progress towards verification of measles elimination and South- East Asia Regional Immunization Technical Advisory Group (ITAG) s recommendation of reaching the Regional rubella control goal by 2020, the Government decided to develop a new NSP to describe in detail the second step of the previous NSP. In this regard, MoPH organized a national workshop in collaboration with WHO and UNICEF in February 2018 with a view to filling the required strategic details by using the expertise and experience of national and provincial health managers involved in the Expanded Programme on Immunization (EPI) programme. At the same time, the national workshop provided MoPH the ownership of developing the new NSP and opportunity to build more technical capacity in accordance with the new global knowledge in measles, rubella and CRS. The new NSP will provide confidence to the national programme managers to enhance the quality of their work in order to achieve the national, regional and global goal of eliminating measles and controlling rubella/crs by 2020, and sustain the programme thereafter. 2

17 1.2 Components of the new 5-year National Strategic Plan The new NSP was drafted by various programme health managers from the national EPI, Central and regional hygiene and anti-epidemic stations, public health bureaus and medical warehouses at all levels of service provision. The following major components were identified in the national workshop in February 2018 as the main programmatic and operational strategies to reach the goal of measles elimination and rubella/crs control by 2020 and sustain the achievements thereafter. These different components are also illustrated in Fig. 1. MoPH leadership through delegation of tasks and enhancing partnerships Application for new vaccine support from Gavi, the Vaccine Alliance (Gavi) with co-financing from the Government for at least a 5-year period Conducting MR SIA and routine introduction of MR vaccine as part of the national immunization programme Using the MR introduction platform (SIA and routine introduction) to improve the RI programme and the vaccine preventable disease (VPD) surveillance programme with special emphasis on measles, rubella and CRS surveillance Maintaining high immunization coverage with MCV1 and MCV2, which is currently at 98% Strengthening the laboratory-assisted case-based measles and rubella surveillance and expanding the CRS sentinel surveillance to the Ri (rural county) level Maintaining a high level of epidemic preparedness and outbreak response capacity Improvingcase management for measles and rubella Expanding and improving supervision and monitoring of measles elimination and rubella control activities Conduct evaluations, surveys and verifications to assess the progress of measles elimination and rubella/crs control. 3

18 Figure 1: Conceptual diagram DPR Korea s framework to successfully reach the goal of NSP by 2020 Maintain high coverage for MCV1 and 2 (currently at 98%) MoPH leadership delegation of tasks partnership Gavi application for MR and government financial commitment Conduct/use MR SIA in 2019 (at least 95%) and introduce MR in RI Strengthen laboratoryassisted case-based MR surveillance system Increase CRS sentinel sites Improved case management Maintain high level of epidemic preparedness and outbreak response Elimination of measles and rubella/crs control by 2020 Supervision Monitoring Evaluation Verification 1.3 Strengths of DPR Korea that guarantee reaching the NSP goal A unique centralized governing system and respected leadership that guarantees close coordination and collaboration between various ministries and bureaus A vast network for public communication and social mobilization A skilled, dynamic, disciplined and motivated health workforce The country is progressing fast, adapts to new techniques, protocols and health regulations and is eager to strengthen its health system Although resources are limited, the country has a strong will to catch up quickly with the rest of the countries in the region to introduce rubella-containing vaccine (RCV) and accomplish high immunization coverage of MR1 and MR2 replacing MCV1 and 2 An immense pool of around household doctors, each serving around 130 households and knowing all the children in the community stands as a guarantee that no child will be left unvaccinated. 4

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21 2 Background 2.1 The diseases Measles Measles is a highly contagious disease caused by a virus passed through direct contact and through the air. Measles remains one of the leading global causes of death, despite the availability of a safe and effective vaccine. Approximately people died from measles in 2016 mostly children under the age of 5 years. Clinical case definition: Any person in whom a clinician suspects measles infection, or any person with fever and maculopapular (non-vesicular) rash and cough, coryza (runny nose) or conjunctivitis (red eyes) Rubella Rubella is a contagious viral disease and occurs worldwide. It is a mild childhood disease; however, infection in early pregnancy may cause fetal death, or serious birth defects known as CRS. 1 Annex 1 WHO fact sheet on measles, reviewed January

22 Rubella is suspected when fever, maculopapular rash and cervical, suboccipital or postauricular adenopathy or arthralgia/arthritis are diagnosed. Clinical conformation: Rubella cannot be confirmed clinically; laboratory confirmation is required. Laboratory-confirmed rubella case: A laboratory-confirmed case is a suspected case with a positive blood test for rubella-specific IgM. The blood specimen should be obtained within 28 days after the onset of rash. Epidemiologically confirmed rubella case: A patient with a febrile rash illness that is linked epidemiologically to a laboratory-confirmed rubella case. There is no specific treatment for rubella and CRS, but they can be prevented by immunization Congenital rubella syndrome Congenital rubella syndrome (CRS) is a mild childhood illness, but it is an important cause of severe birth defects. When a woman is infected with the rubella virus early in pregnancy, she has a 90% chance of passing the virus on to her foetus. This can cause the death of the foetus, or it may cause CRS. Among birth defects, deafness is the most common, but CRS can also cause defects in the eyes, heart and brain. Suspected CRS case: A health worker should suspect CRS when an infant aged 0 11 months presents with heart disease and/or suspicion of deafness and/or one or more of the following eye signs: white pupil (cataract), diminished vision, pendular movement of the eyes (nystagmus), squint, smaller eyeball (microphthalmus), or larger eyeball (congenital glaucoma). A health worker should also suspect CRS when an infant s mother has a history of suspected or confirmed rubella during pregnancy, even when the infant shows no signs of CRS Background on the global and regional measles rubella situation Measles rubella global and regional situation In May 2012, 194 Member States of the World Health Assembly endorsed the Global Vaccine Action Plan (GVAP), which was a framework to prevent millions of deaths by 2020 through more equitable access to existing vaccines for people in all communities. 2 Annex 2 WHO fact sheet on rubella/crs, reviewed in January

23 WHO estimates indicate that in 2000, children died of measles, the majority in developing countries, and this burden accounted for 5% of all under-5 mortality. During the period , annual reported measles incidence decreased by 87%, from 145 to 19 cases per million persons. In that same period, annual estimated measles deaths decreased by 84%, from to This was possible thanks to global efforts in measles vaccination. Still, as was estimated in 2012 by WHO, 43% of all global deaths due to measles occurred in the South-East Asia Region. Global estimates of the burden of rubella suggest that the number of infants born with CRS in 2008 exceeded , which makes rubella a leading cause of preventable congenital defects. The 2008 estimates suggest that the highest CRS burden is in the South-East Asia Region (approximately 48%). 4 The MR Initiative, which began supporting rubella control and CRS prevention activities in the early 2000s, has resulted in reducing the burden of rubella. The MR Initiative now includes rubella control goals as an integral part of its efforts. The DPR Korea is as yet the only country in the WHO South-East Asia Region that does not offer rubella vaccine through RI in combination with measles and/or mumps vaccine Milestones for global and regional efforts to eliminate measles and control rubella/crs 2000: Millennium Development Goal (MDG) 4. Reduce by two thirds, between 1990 and 2015, the under-5 mortality rate. One indicator of progress toward this target is measles vaccination coverage 2010: World Health Assembly (WHA) sets three milestones for measles control by Increase routine coverage of MCV1 among children aged 1 year to 90% nationally and to 80% in every district Reduce global annual measles incidence to <5 cases per million population Reduce global measles mortality by 95% from the 2000 estimate 2012: World Health Assembly endorses the Global Vaccine Action Plan. The objective elimination of measles in all regions of WHO by CDC. Progress Toward Regional Measles Elimination Worldwide, MMWR. 2017;66(42); (Vynnycky E, Adams E. Report on the global burden of rubella and congenital rubella syndrome, [unpublished data]. 5 Absence of endemic measles virus transmission in a defined geographic area for 12 months, in presence of a high quality surveillance system that meets targets of key performance indicators 9

24 Rubella CRS control in all regions of WHO by : WHO Regional Committee for South-East Asia passes Resolution SEA/ RC66/R5 on measles elimination and rubella/crs control (Box 1) Box 1: Resolution SEA/RC66/R5 During the Sixth session of the WHO Regional Committee for South-East Asia held in September 2013 on measles elimination and rubella/crs control, Resolution SEA/RC66/R5 was passed, through which WHO South-East Asia Region adopted the global plan of eliminating measles and controlling rubella/crs by Vide this resolution, the Regional Committee: decided to adopt the Global Plan in the South-East Asia Region by 2020 urged Member States: to strengthen immunization and surveillance systems, laboratory capacity, increasing and sustaining high levels of immunization coverage, high-quality case-based surveillance and well-functioning AEFI monitoring systems; to conduct epidemiological assessments of population susceptibility to measles and rubella/crs as a way of informing policy and planning preventive strategies to increase immunity levels uniformly; to develop measles elimination and rubella/crs control policy strategies using evidence-based data; to mobilize political, societal and financial support. requested the Regional Director: to provide technical support to Member States; to mobilize the required resources, build on existing partnerships and foster the development of new ones; to report to the Regional Committee every 2 years on the status of global measles elimination and rubella/crs control targets, milestones and progress. 6 Reduction of disease incidence, prevalence, morbidity or mortality to a locally acceptable level where it's a much reduced public health burden; continued intervention is still required. WHO Regional Office for South-East Asia defines rubella and CRS control as reduction of the rubella and CRS incidence by 95% compared to the baseline of

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27 3 Current status of measles, rubella and CRS in DPR Korea 3.1 Recent history, milestones and programmatic achievements 1997: Introduction of MCV1 in the national immunization schedule 2006: Introduction of disease surveillance for MR 2007: Start of mandatory reporting of MR cases in all reporting surveillance sites 2007: Declaration by the Government of a measles outbreak in 35 out of 205 counties on 16 February : Mass nation-wide emergency MCV vaccination campaign following the outbreak in two phases for a total target population of (reported campaign coverage 99%) in the age group of 6 months to 45 years. 7 Vitamin A was included. 2007: Last indigenous measles case was reported : Introduction of MCV2 in the national immunization schedule subsequent to the wide age range supplementary immunization campaign targeting the population aged 6 months to 45 years 7 Regional Office for South-East Asia EPI Fact Sheet DPR Korea

28 2007: Formation of the Interagency Coordinating Committee (ICC) Health Sector Coordinating Committee (HSCC) with the start of support and as a requirement from Gavi for the measles second dose introduction 2007: Inclusion of the support for strengthening measles and rubella surveillance in the Gavi health system strengthening (HSS)-1 support, and continuation of the same support and inclusion of the establishment of sentinel surveillance for CRS in the Gavi HSS-2 support ( ) 2008: First accreditation of the National Laboratory for MR by WHO. The last accreditation was conducted in : Last rubella case reported June 2014: National Verification Committee (NCV) for measles and rubella formed; adopts the WHO Regional goal of measles elimination and rubella/ CRS control by : Introduction of case-based surveillance for MR and introduction of CRS surveillance in provincial and county hospitals (total of 222 sentinel sites) : MR vaccination campaign in five provinces targeting children between 12 months and under 16 years of age following detection by the surveillance system of 3 imported cases of measles among Chinese nationals of Korean origin, of which genotyping demonstrated a link with China. The reported coverage was 99.8%. 2017: The South-East Asia Regional ITAG recommended to the Government of DPR Korea to introduce MR vaccine no later than 2018, in alignment with the measles elimination and rubella control goal in the Regional Vaccine Action Plan 2017: Considering the absence of indigenous cases of measles from 2007 onwards, the South-East Asia Regional Verification Commission (RVC) for measles elimination embarked on a fact finding mission to DPR Korea and provided recommendations for implementation with a view to being eligible for verification of measles elimination in the country 2017: After analysing the global status of rubella/crs and national Centers for Disease Control and Prevention (CDC) surveillance data, the National Immunization Technical Advisory Group (NITAG) comprising of 13 experts recommended that MR introduction into EPI was needed according to the Regional Strategic Plan for measles elimination and rubella/crs control by

29 3.2 Current situation of measles elimination and rubella control in DPR Korea (2016 data) Building of population immunity for measles through RI of MCV1 and MCV 2 doses The last Indigenous measles case in DPR Korea was recorded in 2007, the same year that the measles SIA was conducted following important outbreaks in the country. The following year, MCV2 was introduced in the routine programme, which helped boost immunity in the general population. Since then, administrative coverage of MCV1 and MCV2 have been sustained close to 98%. Providing routine MCV2 to children in their second year of life has reduced the rate of accumulation of susceptible children to virtually zero; and as a result, the risk of an outbreak is low. After MCV2 introduction, vaccine demand in DPR Korea went up; MCV2 boosted demand for MCV1, slowed accumulation of susceptibles and lengthened the period between SIAs. Adding MCV2 to the schedule had many benefits in terms of catching up missed vaccination doses and improving the herd immunity in the more hard-to-reach areas Building population immunity through the outcome of previous wide age range SIAs As an outbreak response measure, DPR Korea conducted an emergency mass measles supplementary immunization campaign with the support of WHO and UNICEF in This SIA was conducted following a measles outbreak in 35 out of 205 counties in the country. The outbreak reported a total of 3597 measles cases among people in the age bracket of 0 to 45 years. There were 1482 (41%) hospitalizations and 4 deaths (case fatality ratio [CFR] 0.1%) due to the disease. The campaign was conducted in two phases. Phase 1 (14 18 March 2007) targeted children from 6 months to 16 years of age. The reported immunization coverage in Phase 1 was 99.8%. Phase 2 targeted the population between 16 and 45 years of age. The campaign immunized a total of individuals in both phases, amounting to a coverage of 99%. The campaign also acted as a platform to deliver vitamin A supplementation. The strategy of conducting a wide age range SIA covering the population from 6 months to 45 years of age, incorporation of MCV second dose subsequent to the above SIA and maintaining near universal coverage for both MCV1 and MCV 2 doses has resulted in a drastic reduction of measles cases in DPR Korea. The last laboratory 15

30 confirmed indigenous measles case was reported in The national measles and rubella surveillance network was able to detect 3 cases of laboratory confirmed measles in Epidemiological investigations revealed that they were imported cases from China, which was corroborated by the molecular characterization of the measles virus by the genotype strain H. The last laboratory confirmed rubella case was reported in DPR Korea in MCV1 and 2 coverage, measles cases and SIA coverage from 2002 to 2016 are shown in Fig. 2. Laboratory confirmed rubella cases reported from 2002 to 2016 and MR SIA coverage in are given in Fig. 3. Figure 2: MCV1 and 2 coverage, measles cases and SIA coverage in DPR Korea Source: Review of progress towards measles elimination and rubella/crs control in DPR Korea Note: MCV1 at 9 months and MCV2 at 15 months 16

31 Figure 3: Laboratory confirmed rubella cases reported from 2002 to 2016 and MR SIA coverage in Current surveillance strategy for measles and rubella/crs Considering the potential verification of elimination of measles and control of rubella/crs based on the current epidemiological scenario of measles and rubella cases, DPR Korea is at present strengthening its measles and rubella surveillance strategy by following up on the recommendations from the RVC Mission that took place in January RVC Mission recommendations consist of: reporting and investigating all cases with fever and rash; taking blood samples from all enrolled fever and rash cases to conduct IgM serological tests; ensuring that every province reports a non-measles, non-rubella discard rate of 2 or more per population; and expanding CRS sentinel sites to Ri level clinics with a view to achieving a high sensitivity of CRS surveillance, and also examining congenitally deformed infants through specific rubella IgM to illustrate the prevalence of rubella Based on the recommendations of the RVC mission, MoPH is developing a training curriculum and modules to switch from the accelerated control level surveillance strategy to the elimination level surveillance strategy. This will ensure capacity for revised elimination level laboratory-assisted case-based surveillance of measles/rubella and CRS 17

32 surveillance at the lowest level of service through training/orientation of the primary health-care staff. DPR Korea is committed to sustaining a sensitive and timely laboratory-assisted case-based measles and rubella surveillance and CRS sentinel surveillance that fulfils WHO recommended standards of surveillance performance indicators (see Sec 3.2.4). MR surveillance was established in DPR Korea in 2006 using 7954 sites spread over the entire country. CRS surveillance was introduced in 2015 in 222 sites at the provincial and county levels. Currently, though fever and rash cases are detected, the laboratory investigations are conducted only for cases that are compatible with the clinical case definition for measles or rubella (see Secs and 4.1.2). This is contrary to the elimination level surveillance standards recommended by WHO in alignment with the verifying framework of measles for countries in the elimination phase of measles. Household doctors conduct active case search every day, while anti-epidemic doctors conduct detailed epidemiological investigations of reported cases by the household doctors. Currently, the decision to take blood samples for serological investigations is taken by the clinical doctors at Ri hospitals when cases compatible with the clinical case definitions of measles or rubella are referred to the Ri hospitals by the household doctors following field based active surveillance. This practice will change based on the recommendations of the RVC Mission Surveillance performance indicators The following surveillance and lab performance indicators are a reference to the Guidelines on verification of measles elimination and rubella/congenital rubella syndrome control in the WHO South-East Asia Region July 2016 and are at the same time the basis for revising the Guidelines for DPR Korea to comply with the WHO norms and standards for high quality surveillance and laboratory performance. Indicators for high quality of epidemiologic surveillance of measles and rubella Proportion of surveillance units reporting measles and rubella data to the national level and on time (target: 80%) Reporting rate of non-measles non-rubella cases at the national level (target: 2 per population) Proportion of second administrative level units reporting at least two non-measles non-rubella cases per (target: 80% of second-level administrative units) 18

33 Proportion of suspected cases with adequate investigation 8 (target: 80% of suspected cases) Proportion of suspected cases with adequate specimen collection 9 (target: 80% of suspected cases, excluding epidemiologically linked cases) Proportion of specimens received at the laboratory within 5 days of collection (target: 80%) Proportion of laboratory-confirmed chains of transmission (defined as two or more confirmed measles cases) with specimens adequate for detecting measles virus collected and tested in an accredited laboratory (target: 80%). Indicators and suggested targets for epidemiological surveillance quality for CRS Reporting rate of suspected CRS cases at the national level (target: 1 per live births) Proportion of suspected CRS cases with adequate investigation (target: 80% of suspected cases) Proportion of suspected cases with adequate specimen collection (target: 80% of suspected cases) Proportion of confirmed cases with adequate specimen analysed for virus detection (target: 80% of confirmed cases) Proportion of lab-confirmed cases with at least two negative tests for virus detection after 3 months of age, with at least a 1 month interval between tests (target: 80% of confirmed cases) Proportion of confirmed CRS cases detected within 3 months of birth. Indicators and suggested targets for laboratory performance Proportion of measles and rubella network laboratories that are WHOaccredited for serological and, if relevant, for virological testing 10 (target: 100% of laboratories) 8 An adequate investigation includes at a minimum collection of all of the following data from each suspected case of measles: name or identifiers, place of residence, place of infection (at least to district level), age (or date of birth), sex, date of rash onset, date of specimen collection, vaccination status, date of last vaccination, date of notification and date of investigation (excluding cases that are either confirmed as measles by epidemiological linkage or discarded as non-measles by being epidemiologically linked to another laboratory-confirmed case of communicable disease or by epidemiological linkage to a case negative for measles IgM), and travel history. 9 Adequate specimens for serology are those collected within 28 days after rash onset that consist of 0.5 ml serum or 3 fully filled circles of dried blood on a filter paper, or oral fluid. For oral fluid samples, the spongecollection device should be rubbed for about 1 minute along the gum until the device is thoroughly wet; epidemiologically linked cases should be excluded from the denominator. 10 WHO measles laboratory accreditation criteria include (1) annual proficiency test results 90%; (2) at least 90% concordance of NML with RRL confirmatory testing; and (3) passing on-site inspection. 19

34 Table 1: Surveillance performance indicators for measles and rubella Case classification (number) Indicators Measles Rubella Year No. of suspected measles Lab-confirmed Epi-linked Clinically-confirmed Lab-confirmed Epi-linked Discarded non-measles non-rubella cases Annuai incidence of confirmed measles cases per million total population Annuai incidence of confirmed rubella cases per million total population Proportion of all suspected measles and rubella cases that have had an adequate investigation initiated within 48 hours of notification Discarded non-measles nonrubella incidence per total population Proportion of provinces reporting at least two discarded non-measles non-rubella cases per total population Proportion of sub-national surveillance units reporting to the national level on time Target 80% 2 80% 80% Source: SEAR Annual EPI Reporting Form (multiple years) ND no data 20

35 Completeness and timeliness of monthly reporting (including zero reporting) to WHO Regional Office for specimens received for serological and virological testing (target: 80% of specimens received in the laboratory) Proportion of laboratories (government and private) that conduct measles and rubella diagnostic testing that have adequate quality assurance mechanisms in place (target: 100% of laboratories) Proportion of virus detection and genotyping results (where appropriate) that are completed within 2 months of receipt of specimen (target: 80% of specimens received). Table 1 illustrates the results of DPR Korea s key measles rubella surveillance performance indicators from 2012 to Table 2 is a reference to the most recent mission of the RVC in January 2018 and shows the results of some additional key MR surveillance indicators, including results in Table 2: Additional surveillance indicators results of the RVC Mission January 2018 Note: figures in red indicate the low number of suspected cases and percentage of suspected cases with serological testing, for which the target is 80%. From 2012 to 2016, there were no laboratory-confirmed MR cases except the imported cases from China in However, as an indicator of the sensitivity of MR surveillance, the non-measles, non-rubella discard rate was consistently below the threshold of 2 per cases. This indicates the implications of the current surveillance strategy of conducting detailed epidemiological and laboratory investigation 21

36 of only those cases that are compatible with the clinical case definition of measles and rubella. It calls for a paradigm shift in surveillance from the current case-definition based surveillance strategy to the broad surveillance of fever rash cases throughout the country National Measles and Rubella Laboratory and performance indicators of laboratory surveillance The National Measles and Rubella Laboratory in Pyongyang is part of the global and WHO South-East Asia Regional measles and laboratory network. This lab is being annually accredited by WHO. The last accreditation was performed in The National Measles and Rubella Laboratory participates annually in the external quality assurance system (EQAS) conducted by WHO. In 2017 the National Measles and Rubella Laboratory obtained 100% in the proficiency test for EQAS. A major challenge for this laboratory is the shortage of kits to perform serological tests for all suspected fever and rash cases when the switch is made to elimination level fever rash surveillance mode. DPR Korea currently has four provincial labs that conduct testing for measles rubella and will be seeking WHO support for accreditation in order to create a national network of accredited laboratories. Virology Molecular characterization of measles and rubella viruses remains a weak area in terms of laboratory diagnosis of measles and rubella in the country. Capacity enhancement of molecular characterization of measles and rubella viruses remain an area for focus under laboratory investigations in the national strategy. The laboratory of the National Academy of Medical Science has the capacity to conduct molecular characterization and it was used for genotyping of the imported measles virus in This laboratory has however not been accredited by WHO. DPR Korea seeks WHO support for enhancing the capacity of the National Measles and Rubella Laboratory for molecular characterization. DPR Korea complies with the best practices for serum specimens for measles and rubella IgM detection The analysis of serum specimens for the presence of measles- or rubella-specific IgM antibodies is traditionally regarded as the gold standard for laboratory confirmation. Enzyme immunoassay (EIA) is the method recommended for the WHO measles and rubella laboratory network for the detection of virus-specific IgM antibodies in serum. Fig. 4 shows the algorithm for measles rubella IgM testing and decision/ classification. 22

37 Figure 4: Algorithm for measles rubella IgM testing and decision/classification Table 3 illustrates the laboratory surveillance performance from 2012 to 2016 with detection of positive specimens from imported measles cases in Table 3: Laboratory surveillance performance Year Serum specimen collected from suspected measles cases Serum specimen received in laboratory Specimen positive for measles IgM Specimen positive for rubella IgM % Results within 4 of receipt % positive cases tested for viral detection Genotypes detected No (%) No (%) No. % No. % Measles Rubella (100%) 66 (100%) ND ND (100%) 63 (100%) ND ND (100%) 135 (100%) ND ND (100%) 132 (100%) ND (100%) 73 (100%) Source: SEAR Annual EPI Reporting Form (multiple years) ND no data 23

38 The National Measles and Rubella Laboratory has been able to achieve the set standards of the laboratory surveillance performance indicators under the verifying framework of measles and rubella) (Table 4), except the genotyping component, due to reasons described above. Table 4: Summary of surveillance performance indicators 2017 (1) Number of suspected cases enrolled for surveillance: 505 (2) Number of suspected cases from which adequte specimen of blood taken: 106 (3) Number confirmed as measles by the national measles and rubella lab: 0 (4) Number confirmed as rubella by the national measles and rubella lab: 0 (5) Number of cases epidemiologically linked to confirmed measles cases: 0 (6) Number of cases epidemiologically linked to confirmed rubella cases: 0 (7) Number of cases clinically compatible with measles: 0 (8) Number of cases clinically compatible with rubella: 0 (9) Number of cases discarded as non measles and non rubella: 505 Source: MoPH Key conclusions in relation to DPR Korea s progress towards the goal of measles elimination and rubella/crs control by 2020 There has been no incidence of laboratory confirmed measles following the wide age range (6 months to 45 years) SIA and routine introduction of MCV2. The last reported indigenous case for measles was in Despite not introducing RCVs in the national immunization programme, no laboratory confirmed rubella cases have been reported since Following the wide age range SIA and sustained very high immunization coverage of over 95% for MCV1 and 2 for consecutive years in the routine programme, it is reasonable to conclude that there is a high population immunity to measles in DPR Korea. This has been corroborated in the immunity profile developed by WHO Regional Office for South-East Asia using the global tool for determining immunity profiles (see Fig. 5). Though rubella cases have not been reported since 2012 (except for those who were immunized in the ad hoc SIA for rubella with the support from Caritas), the majority of the population has no immunity as yet to rubella. This warrants the routine introduction of rubella vaccine in the national immunization schedule, preceded by a wide age range SIA with MR vaccine. 24

39 The country has a nation-wide case-based measles and rubella surveillance network capable of detecting all fever rash cases. However, as a result of limiting epidemiological and laboratory investigations only to cases compatible with the clinical case definition of measles and rubella, only 24% of the cases are adequately investigated with laboratory testing. CRS surveillance is in its infancy and the current sentinel site network has the potential to miss cases, given that the current system does not include sentinel sites at the Ri level and also that all suspected cases are not serologically investigated. DPR Korea has the capacity to conduct molecular characterization and this capacity has been utilized in outbreak conditions in the past. Given that this capacity is outside the MoPH, a plan and support is required for molecular characterization of measles and rubella viruses at the WHO accredited National Measles and Rubella Lab in Pyongyang. Figure 5: Immunity profile for measles in DPR Korea, % 90% 80% Percent of population 70% 60% 50% 40% 30% 20% 10% 0% Age (in years) Protected by maternal antibodies Protected by routine vaccination with 2nd dose Unprotected by vaccination Protected by routine vaccination with 1st dose Protected by SIAs DPR Korea s plan to sustain/develop/expand the measles and rubella laboratory case-based surveillance Switch from the current surveillance strategy of accelerated measles control phase to the surveillance strategy of measles elimination phase. This switch 25

40 will include enrolling all fever rash cases and 100% epidemiological and serological investigation of enrolled cases. Ensure availability of adequate serological test kits for 100% serological investigation of measles/rubella/crs through utilizing the Gavi HSS-2 and other partner support. Strengthen rubella and especially CRS sentinel surveillance as per the Regional Guidelines along with introduction of MR vaccine in the routine programme. Emphasize its need for assessing the effectiveness of the introduced MR vaccine for rubella/crs control in the short term, and ultimately their elimination in the long run. In order to achieve surveillance standards of measles and rubella elimination verification framework, improve performance of all quality epidemiological and laboratory surveillance indicators for measles, rubella and CRS. Update and revise national measles, rubella and CRS surveillance guidelines in alignment with the South-East Asia Regional measles/rubella and CRS surveillance guidelines. Develop practical surveillance modules and conduct nationwide surveillance training for clinicians, household doctors and epidemic doctors DPR Korea will comply with the following requirements in relation to CRS Considering the importance of rubella and CRS surveillance to assess the impact of MR vaccine, DPR Korea will use the MR introduction platform to report CRS data to the WHO measles rubella CRS network together with the current measles and rubella case-based reporting. All suspected CRS cases in infants aged under 1 year will be clinically, epidemiologically and laboratory investigated. All febrile rash illnesses in pregnant women will be investigated, including rubella serology. The outcome of the pregnancy will be followed up to exclude CRS. If a rubella outbreak is detected in a geographical location, active surveillance (defined as regular visits by anti-epidemic doctors to CRS reporting/sentinel sites in the catchment area of the outbreak to look for unreported cases) will be initiated to improve detection of suspected CRS in infants aged under 1 year. This will be continued for 9 months after the last reported case of rubella in the locality of outbreak. In the area of outbreak, it is necessary to prospectively follow up of offspring of pregnant women diagnosed with rubella. 26

41 In the immediate future,dpr Korea will introduce MR vaccine in the RI schedule at the ages of 9 and 15 months of age with a SIA targeting children from 9 months to below 15 years of age.this makes women in the childbearing age potentially susceptible to rubella and their offspring to CRS for many more years to come, unless a SIA is conducted that targets women in the year age group. In this context, detection of outbreaks and prompt control measures will help prevent rubella among pregnant women and CRS cases in their newborns, though vaccination of susceptible women with RCV remains the most effective strategy to prevent CRS. 27

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43 4 Key lessons learnt from the measles elimination and rubella control activities Key lessons learnt from the measles elimination and rubella control activities conducted so far in the country are listed in Table 5. Table 5: Key lessons learnt from the measles elimination and rubella control activities A Lessons learnt from epidemic preparedness and response to measles outbreaks 1 Members of the provincial outbreak response teams whose capacity has been enhanced through exposure to timely, updated guidelines with case definitions, protocols, country standard operating procedures (SOPs) and practical training tend to mount a more efficient response to measles outbreaks. 2 Health workers have learnt that the seroconversion after a single dose of MCV is around 85%, while adding the second dose of MCV would seroconvert over 95% of recipients. This knowledge has convinced the health staff to regularly follow up the acceptance of the second dose in the routine EPI programme with mothers and persuade them to have the second dose if they have missed it. This approach has helped prevent outbreaks of measles in DPR Korea as the susceptibility to measles infection decreases. 29

44 3 Strengthening surveillance at the entry point of outbreak zones enables determination of the spread of the outbreak. It also enables initiating of outbreak response immunization to limit the outbreak to within the existing outbreak zone. 4 Issues related to sample collection and transportation of specimens to the national laboratory were often encountered during measles outbreaks. 5 There is a need for frequent and regular training of professionals on epidemic preparedness, surveillance and response for effective outbreak response, as there is a relatively high turnover of staff. B Lessons learnt from introduction of MCV1 and MCV2 routine doses in the national EPI schedule 1 Knowledge and practice acquired through well-designed training and reorientation programmes for household doctors, supervisors and all other health staff involved in immunization activities contributed to achieving and sustaining high coverage following introduction of MCV1 and MCV2. 2 During previous MCV introductions, supervisors encountered transport difficulties to visit immunization clinics. The lesson learnt from this experience is that supervisors cannot perform their job effectively if they are not supported with means of transportation. 3 Previous MCV introductions demonstrated the difficulties associated with the use of manual collection and compilation of immunization data. Therefore, the MR introduction platform should be utilized for extending the electronic/computer-based immunization data management system to the lowest level of reporting in order to ensure timely flow of information from the Ri level to the county level and from the county level to the provincial level. 4 Previous introductions of MCV1, MCV2 and other new vaccines highlight that the cold chain capacity requirements should not be taken for granted. Although reports suggest that the current cold chain capacity is sufficient to accommodate the new MR vaccine, Ri clinics may have difficulties with proper storage facilities due to lack of refrigerators. A cold chain capacity survey needs to be initiated as a preparatory measure for any SIA campaign and routine introduction of MR vaccine. 5 Previous MCV introductions and new vaccine introductions highlight the need for keeping a duplicate of the vaccination record at home with the mother/caregiver. This will help create public awareness and improve the coverage as mothers/caregivers can refer to the card to make timely visits for vaccination. C Lessons learnt from catch up campaigns 1 Campaign guidelines are the basis for any immunization campaign. Campaign forms must be kept simple and uniform. 2 National and provincial supervisors must use a standard supervisory checklist with only key performance indicators that is easy to analyse. 30

45 3 Success of the measles campaign depended greatly on the unique health infrastructure of DPR Korea and adequate numbers of around sector doctors who could be effectively mobilized for the campaign. 4 The 1-day training conducted by the provincial health staff for the county staff and the Ri sector household doctors on operational details of the measles campaign proved to be instrumental in effectively reaching a wide age range (6 months to 49 years) within the stipulated period of the campaign. 5 Coordination with partners like International Federation of Red Cross (IFRC), WHO, UNICEF, Gavi and Caritas proved to be very complementary and beneficial to the national health system in effectively conducting SIA campaigns. D Lessons learnt during switchover from measles aggregated to case-based surveillance 1 Though the country has shifted to case-based surveillance, timely availability of updated details on eligibility for surveillance and enrolment is important for enrolling adequate numbers of cases. 3 Timeliness of sample collection is not rigorously followed. 4 Despite having shifted to case-based surveillance, blood samples are not taken from all suspected cases due to lack of reagents. 5 Only one laboratory is accredited in the whole country. Not enhancing the capacity of provincial laboratories overwhelms the national laboratory and limits the ability to test and/or isolate the virus. E Lessons learnt from the establishment of CRS sentinel surveillance 1 There is a need to expand sentinel surveillance sites to the Ri level, including obstetric departments in Ri clinics. 2 Despite a CRS sentinel surveillance system having been established, it is not capable of detecting at least 1 CRS case/million neonates as per the WHO standard. 3 All sentinel surveillance sites require standard case definition of CRS to be disseminated. Source: National Workshop group work for NSP development. Pyongyang; February

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47 5 Functional organigram of the national EPI within the Ministry of Public Health, DPR Korea An organigram of the national EPI within the MoPH is given in Fig. 6. Figure 6: Organigram of national EPI Source: Ministry of Public Health, Democratic People s Republic of Korea 33

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49 6 National strategic goal, objectives and strategies 6.1 Goal The goal of the NSP is elimination of measles and control of rubella/crs in DPR Korea by the end of 2020, with future sustainability. 6.2 Objectives Objective 1: Achieve and maintain at least 95% population immunity against measles and rubella through routine and/or supplementary immunization. Objective 2: Develop and sustain a sensitive and timely case-based measles and rubella surveillance system and CRS surveillance in the country that fulfils recommended surveillance performance indicators. Objective 3: Develop and maintain an accredited measles and rubella laboratory network that supports every province in the country. Objective 4: Develop and maintain a high level of epidemic preparedness and outbreak response. Objective 5: Strengthen support and linkages to help achieve the above four strategic objectives. 35

50 6.3 Strategies Programmatic strategies to achieve Objective 1 MR introduction through mass vaccination campaign DPR Korea has developed the following: (i) National Plan for MR Vaccine Introduction; (ii) Plan of Action for MR SIA; and (iii) Operational Guidelines for MR SIA DPR Korea is requesting support from Gavi for introduction of MR through SIA and with co-financing in the routine programme MR SIA is planned for the third quarter of 2019 for a 3-week period. The target age group is 9 months to under 15 years. The first week will be used for school-based immunization. The second week of the campaign will be for clinic-based immunization. The third week will be used for communitybased active searching and vaccinating missed children, pockets of children, or missed communities in hard-to-reach areas. The total target population for the MR SIA is estimated at DPR Korea is requesting Gavi for a total of MR vaccine doses in 10-dose vials for the MR SIA (including 10% wastage), at a cost of US$ Cost for Injection supplies is estimated at US$ Shipping cost is estimated at US$ US. The total cost of the support requested is thus US$ DPR Korea is also requesting operational support offered by Gavi on the basis of US$ 0.65 per targeted child, which adds up to US$ MoPH may add additional interventions such as vitamin A, and is discussing the feasibility of this added health intervention with all stakeholders. (Note: All figures appearing above, and subsequently, are derived from the resource calculations in the Gavi online application format and covers the year of the introduction itself, i.e ) MR introduction in the routine programme MR vaccine introduction will be synchronized across the country right after the MR SIA. Switch from MCV to MR vaccine will be planned simultaneously with start of planning for MR SIA, around 15 to 12 months prior to the launch of the SIA. In order to have a common understanding about planning, preparation and implementation of switch from MCV to MR vaccine throughout the country, MoPH is developing SOPs and will orient all stakeholders and vaccine handlers to ensure that after the introduction of MR in the routine introduction, 36

51 there will be no more MCV used for children in the national immunization programme. Counties will need to submit a switch plan including an inventory of MCV, a cold chain capacity plan and a plan to use up the projected surplus of MCV through local activities such as vaccination of public service providers using the remaining MCVs prior to the start of SIA. DPR Korea is requesting support from Gavi for the introduction of MR vaccine in the routine introduction through co-financing of the MR vaccine at US$ 0.30 per dose for the period of this current NSP. Gavi will also support the rest of the vaccine procurement cost and injection supplies. The total cost for vaccines, injection supplies and shipment for Gavi would be US$ The total co-sharing cost for DPR Korea is estimated at US$ The Government will also apply for the one-time Vaccine Introduction Grant (VIG) of US$ 0.80 per child in the live birth cohort in the year of introduction of MR vaccines, which is The total VIG being requested is estimated at US$ Follow-up MR campaigns A follow-up campaign for children aged 9 months to under 5 years is usually necessary to sustain population immunity 95% for measles and rubella to cease transmission of rubella/measles viruses. The decision for such a campaign should be based on the immunity gap, when the accumulation of susceptible under population reaches equivalence to a birth cohort. If the current RI coverage trends prevail following the MR SIA in 2019, the target group will be very negligible. Therefore, follow-up campaign(s) with MR vaccine for the younger age group may not be necessary if MR1and MR2 will have the same high coverage as MCV1 and 2 in the RI programme as of now. Considering the quick impact of control and eventual elimination of CRS in DPR Korea, the logistic and financial feasibility of a catch-up campaign for women of childbearing age with MR is being discussed by MoPH and its traditional immunization partners WHO and UNICEF. The target group for such a campaign would be all women of childbearing age from 15 to under 50 years of age. MoPH will constantly review surveillance reports and epidemiological data to decide on the need for small-scale catch up or follow-up campaigns for particular groups or localities. To make this decision, MoPH may need partner support for reviewing epidemiological and surveillance data or conducting modelling studies. 37

52 6.3.2 Operational strategies to help achieve Objective 1 The national strategic action plan recommends development of Operational Guidelines for MR SIA where all operational components for MR SIA are described in detail. Key points are discussed below. Coordination and high-level oversight (including roles and responsibilities) Special coordination structure for MR SIA and routine introduction will be formed with description of roles for every institution/organization, as part of this coordination. A control room will be installed at every level to follow up campaign results on a daily basis, address supervision and monitoring issues and formulate advisories for the Government that should trigger corrective actions. Operational planning (macro planning and micro planning) Operational planning consists of macro planning at national and provincial level and micro planning from Ri level up to county and provincial level. Micro planning will start as early as 9 months prior to the proposed start date of the SIA and will include identification and calculation of target groups, resource calculation, planning for logistic distribution, communication and social mobilization, waste management supervision, monitoring plan, daily vaccination teams, etc. As the issue of lack of transportation has been pointed out in the lessons learnt, the MoPH will focus on this in order to ensure and secure transport for vaccines, injection supplies, supervisors and monitors and for sample transportation with adherence to reverse cold chain principles. Communication and social mobilization MoPH, in collaboration with UNICEF, will develop a simple communication plan for the entire country which will be used, with a few adjustments, for all sub-national levels. MoPH, in collaboration with UNICEF and WHO, will develop info-graphics and other information, education and communication (IEC) materials in order to support the communication plan. Various national celebration days, RI days, mass drug administration campaign days for helminthiasis (mebendazole) in 2019, etc. will be used to inform the public about the MR SIA, using key messages as the basis for communication. 38

53 Frequently asked questions (FAQs) have been developed with the most common and tested questions and are part of the annexes in the MR SIA Operational Guidelines. Cold chain and vaccine management As part of the planning for SIA and switchover from MCV to MR vaccine, medical warehouses at all levels will submit a capacity report to the central level, indicating the space available for receiving the MR vaccine. Any gaps will be highlighted and contingency plans will be explained. Any cold chain equipment that needs repairs should be listed in the plan. MoPH will support cold chain equipment repairs in time and plan to procure a stock of spare parts to ensure that all cold chain equipment will be functional. MoPH will seek the support of UNICEF for timely repair of cold chain equipment. MoPH, in partnership with WHO and UNICEF, will organize refresher training for cold chain managers and vaccine handlers at all levels, with specific focus on the most critical issues pointed out in the lessons learnt. Safe immunization practices managing adverse events following immunization Adverse event following immunization (AEFI) committees are already functional in DPR Korea and will be reactivated at Ri and county level. The proposed study tour of the EPI team of DPR Korea to Indonesia in 2018 will be used to understand how AEFI was managed during the MR SIA in Indonesia in During the training sessions, AEFI training will be a included as a module. Special focus will be given to MR SIA using the updated AEFI guidelines, especially in relation to MR vaccine. AEFI designated hospitals and clinics will be listed and visited by national and provincial supervisors to check readiness and undergo on the job training for managing AEFI cases. AEFI kits assembled/procured through Gavi performance-based financing support will be replenished. More kits will be procured to cover all designated hospitals and clinics that will be prepared for treating AEFIs during the SIA. Practical exercises and role plays regarding the dos and don ts in relation to safe immunization practices and injection techniques will be part of the training curriculum for the vaccination teams and team supervisors. 39

54 Waste management The introduction of the new MR vaccine will generate increased immunization waste, especially from the MR campaign. National policy for waste management will be applied for collecting, transporting and treatment of all immunization waste. This policy will include strict protocols for disposal of used syringes. DPR Korea will apply existing waste management regulations and facilities to collect and dispose all generated waste including sharps in a safe and secure manner. All used syringes and vials will be collected and sent to county hospitals where incineration facilities are available on a daily basis. During the campaign stage, safety boxes will be required for Ri clinics or vaccination teams. Arrangement for transportation will be made on a daily basis. A recording and reporting format will be developed and distributed to make notes on waste disposal activities. Campaign monitors will oversee the process of waste management. Routine introduction of MR vaccine will follow the same process but without additional increase in syringes and vials. Simple SOPs will be developed by MoPH and will be the basis for practical training of the vaccination teams and immunization waste handlers. Supervision monitoring and evaluation National and provincial supervisors will be trained in supportive supervision techniques. A special orientation will be conducted for monitors who will monitor the planning, preparation and implementation of switch from MCV to MR vaccines, and help ensure that no MCV is used along with MR once the SIA is declared over. National and international external monitors will be formed and oriented on the monitoring techniques, questionnaires and the rapid convenience monitoring (RCM) method. WHO SIA Readiness Assessment Tool will be the basis for the monitoring questionnaires, to be used at certain times to monitor readiness for planning and preparations for MR SIA at every level. MoPH will conduct a SIA midterm evaluation based on the intra-campaign supervision and monitoring reports and will conduct a post SIA campaign coverage evaluation survey (PCCS) and PIE for routine introduction of MR, in collaboration with WHO and UNICEF. Recording and reporting Tools and MR SIA campaign forms will be developed and standardized. They will be a part of the annexes of the Operational Guidelines for the MR SIA. 40

55 Orientation training MoPH, in collaboration with WHO and UNICEF will develop a training curriculum and specific modules for specific target groups. A training plan is outlined in the Operational Guidelines for MR SIA. The focus for the various training modules will be on learning through practical exercises and role plays. Training will start with training of trainers (ToT) and continue as cascade training. The EPI Technical Team of WHO and UNICEF country offices will support the MoPH in conduct of the training, which will be at par with international standards. MoPH will coordinate with the Ministry of Education to orient school doctors, school principals and teachers. Partnerships MoPH has a long history of partnership with WHO and UNICEF for implementing health programmes in the country. It has requested technical advice and financial support to plan and prepare for the introduction of MR vaccine and implement the same in the country. MoPH has taken the opportunity to apply for New Vaccine Support from Gavi specifically for the introduction of MR vaccine. MR introduction will consist of a wide age-range SIA and introduction to the RI programme with co-financing This is the fourth application for new vaccine DPR Korea is making to Gavi subsequent to measles second dose, pentavalent and inactivated polio vaccine (IPV) applications. In September 2006, DPR Korea applied for a Gavi grant for HSS Phase 1, in which immunization was an important component. In 2014, HSS Phase 2 was approved by Gavi. Building on this partnership of trust and collaboration, DPR Korea is again applying to Gavi for the MR vaccine. MoPH is working together with WHO and UNICEF as technical partners in a number of areas as given below. Development of the MR SIA operational plan Facilitation of training sessions and workshops for introduction of MR vaccine Development of communication materials Strengthening the cold chain system to accommodate the MR SIA Development of vaccine management guidelines, particularly in relation to the MR SIA MR programme monitoring and evaluation Supportive supervision 41

56 Post campaign coverage evaluation survey (PCCS) PIE following MR SIA and routine introduction Development of programmatic and operational guidelines for SIA and introduction in the RI programme. MoPH is also requesting WHO to support procurement of specific test kits and reagents for serological testing for measles and rubella in the integrated measles and rubella surveillance programme. MoPH will also enter into partnerships with other international organizations present in the country that have proven to be resourceful in the wider term, such as Caritas, IFRC/National Korean Red Cross Society and European Programme Support (EUPS) groups. MoPH will also coordinate the MR programme with the Education Committee and various transportation related agencies. Strengthening the RI programme with the introduction of the MR vaccine DPR Korea is determined to maintain the current level of immunization coverage as for MCV1 and 2 when it will be replaced by MR 1 and 2. The ultimate aim is 100% coverage of all children in the target age group. According to the report of the National Coverage Evaluation Survey conducted in June 2017, the reason for lower immunization coverage than the national average in some areas of the north-east region such as Ryanggang province was the insufficient number of children to open a vial of vaccine. Although the dropout rate of pentavalent vaccine was low at the national level (crude dropout 1%; valid dropout 1.5%), there was a much higher dropout than the average in some regions, such as Jagang province. Data analysis indicated that it was related to fear of side effects. MoPH will therefore use the opportunity of MR introduction to focus on north-east regions such as Ryanggang province, Jagang province and Kangwon province to develop a detailed strategy for improving immunization service delivery, promoting activities to look for dropouts, establishing supportive supervision, improving the vaccine supply and logistic system, providing training to health workers and improving overall health education. This will be supplementary to and synergistic with similar activities carried out under the current Gavi HSS 2 support in the same areas. Considering the current under-reporting of AEFI, MoPH will use the opportunity of introduction of MR vaccine to improve and expand AEFI surveillance to be able to detect the threshold of 10 AEFI cases per surviving infants recommended by the Global Advisory Committee on Vaccine Safety (GACVS) 42

57 The EPI coordination group under the delegated authority of the MoPH will especially focus on investigating AEFIs in a timely manner and conduct appropriate risk communication measures where necessary. MoPH will look for any vaccine hesitancy cases, explore reasons for vaccine hesitancy and communicate with such families with a view to ensuring their acceptance of the MR vaccine by stressing its value. MoPH recognizes the importance of improving the quality of immunization data to ensure the validity of immunization coverage, reaching the set target of 98% coverage and identifying any areas or groups with low figures of immunization coverage. From time to time, MoPH will conduct CESs/other methods of rapid coverage assessment, build immunity profiles, conduct seroprevalence surveys and carry out other coverage evaluations as a part of programme reviews Programmatic strategy to achieve Objective 2 There is need of a paradigm shift in integrated MR surveillance strategy (as discussed earlier in Section 3.2.7) to move surveillance standards from the accelerated control phase to the elimination level. Based on this requirement, MoPH will take a policy decision to adopt elimination level surveillance standards and revise the national surveillance guidelines in line with the WHO South-East Asia Regional MR surveillance guidelines. This will ensure adherence of the national MR surveillance system to the MR verification framework. MoPH will develop surveillance training curricula and roll out nation-wide surveillance training using the new integrated MR surveillance guidelines. Measles and rubella surveillance In the current context of DPR Korea, timely measles and rubella surveillance is critical to sustain the measles-free status, initiate timely control of rubella outbreaks and interrupt new chains of measles transmission (imported, import related or indigenous). Surveillance allows: early confirmation, detection and timely response to outbreaks analysis of any ongoing transmission (import, import related or indigenous) in order to mount more effective containment response, including outbreak response vaccination measures estimation of the underlying true incidence of measles, rubella, impact of the MR vaccine introduction and disease incidence trend analysis. 43

58 Under the proposed revised national surveillance guidelines, and based on the shift in strategy to conduct laboratory-assisted case-based surveillance for measles and rubella, health workers must stick to the following surveillance requirements under the MR verifying framework: Elimination standard: broadening the case definition to fever and rash Take blood samples from all suspected fever rash cases for serological investigations. Operational aspects of the surveillance objectives will be highlighted in the proposed revised national surveillance guidelines. At the same time, equal focus will be centred on capacity building of the staff in elimination standard integrated rubella and measles surveillance in terms of orientation/training. MoPH recognizes that there is a strong need to strengthen this area in order to progress towards the goal of measles elimination and rubella control by The activities proposed under the programmatic strategy to achieve Objective 2 are as follows: Adoption of elimination-level integrated measles and rubella surveillance Nationwide implementation of laboratory-assisted case-based surveillance for measles and rubella Specimen collection for 100% of all enrolled cases and transportation to the laboratory, respecting principles of reverse cold chain Laboratory testing as per WHO standards (serology, virus isolation and genotype determination). DPR Korea still has a big pool of individuals susceptible to rubella infections. In the event of a big outbreak of fever and rash (where 100% serological investigation is not practical, contrary to the elimination standard surveillance guidelines), investigation of 5 to 10 cases for such an outbreak is recommended with measles and rubella-specific IgM tests. Improved data management computerized data management from Ri to provincial level, measles and rubella updated surveillance registries with household doctors, Ri and provincial level anti-epidemic doctors appropriate to the new surveillance strategy Installing data quality improvement mechanisms to ensure availability of valid and reliable high quality surveillance data Establishing and using core minimum indicators for laboratory case-based measles and rubella surveillance in line with the verifying framework 44

59 Analysing epidemiology and laboratory indicators as per standard verifying surveillance indicators, compiling weekly bulletins and annual bulletins and sharing data with WHO Establishing provincial outbreak preparedness and response teams. Development of training modules for case/outbreak detection of rubella and measles, case investigation, case reporting, case management and outbreak management Establishing and conducting surveillance reviews monthly review at county hygiene and anti epidemic stations (HAESs), quarterly reviews at provincial HAESs, bi-annual reviews at Central Hygiene and Anti Epidemic Institute (CHAEI) and annual joint reviews with WHO. CRS surveillance MoPH is planning on strengthening the CRS surveillance network with expansion of the sentinel sites to the Ri level. After expansion of the CRS sentinel sites, MoPH will be conducting orientation and training for the household doctors, highlighting the following minimum CRS surveillance programmatic and operational requirements: Conducting routine surveillance for CRS, focusing on identifying infants under 1 year of age, although some defects associated with CRS surveillance may not be detectable until an older age. Gradually, DPR Korea can develop a system through the household doctors to detect and investigate congenital defects of children above I year of age Implementation of the expanded CRS surveillance under the supervision of National CRS Surveillance Coordinator/Coordinating Unit Conduct initial and refresher training for staff involved in CRS surveillance Sharing surveillance data monthly; reporting the number of suspected CRS cases (including zero reporting); epidemiological and laboratory investigation of all suspected CRS cases in infants aged under 1 year Investigation of all febrile rash illnesses in pregnant women with a mechanism to prospectively follow up the outcome of the pregnancy; conducting surveillance of live births for CRS Ensuring quality assurance of CRS surveillance; conduct quality assessments and regular monitoring of CRS surveillance Analysis of CRS surveillance data as per agreed core minimum of epidemiological and laboratory surveillance indicators. 45

60 General aspects common to measles, rubella/crs surveillance are as follows: In general, the case investigation should include laboratory analysis of each case. As per the testing protocol, specimens will be initially tested for measles; and if the result is negative, for rubella (see Section 2.1). Cases of febrile rash illnesses in pregnant women should be investigated for confirming the diagnosis of rubella. Using the unique strength of following up cases through the household doctor network in DPR Korea, outcomes of pregnancy of women diagnosed as having rubella and their live newborns will be subject to surveillance for confirming CRS. Regardless of the type of surveillance (case based, sentinel, aggregated), designated reporting sites at all levels should report at a specified frequency, e.g. weekly or monthly even if there are zero cases (often referred to as zero reporting ). Besides highlighting the specific MR surveillance aspects and the CRS surveillance aspects, MoPH, partly in collaboration with partners, will focus on the following aspects that will strengthen vaccine preventable surveillance in general: enhancing the epidemiological capacity of the central and provincial level hygienic and anti-epidemic station officials, including an international-level training in field epidemiology; providing operational support for sample transport and supervision/ monitoring; support for expanding the e-reporting system to include the lower level reporting; establishing data management teams at county and provincial levels to ensure timeliness, completeness and quality of vaccine preventable surveillance data; developing a mechanism for quarterly, bi-annual and annual VPD surveillance reviews at county, provincial and national levels Programmatic strategy to achieve Objective 3 DPR Korea is rapidly progressing towards measles elimination and rubella/crs control. MoPH is using the opportunity of MR introduction to strengthen rubella and CRS surveillance. It agrees with the health partners that the country needs WHO support for accreditation of the in-country measles and rubella laboratory network. The laboratory network should have the capacity to: 46

61 collect samples from all fever rash cases and conduct serologicae testing for measles, rubella and CRS; ensure quality assurance and quality control of laboratory procedures at the national and four provincial level laboratories; provide training to laboratory technicians to enhance their capacity in laboratory diagnosis; perform molecular characterization of measles or rubella virus. MoPH will seek WHO support to develop the molecular characterization capacity of the National Measles Laboratory. Strengthening the laboratory network Under the strategy to achieve Objective 3, MoPH commits to strengthen the laboratory network as follows: Participation of the National Measles and Rubella Laboratory in the annual accreditation process by WHO Expansion of the national MR laboratory network to four provincial laboratories in addition to the National Measles and Rubella Laboratory. MoPH will request WHO support for accreditation of these four laboratories annually Facilitating participation of the national and provincial measles and rubella laboratories in the national laboratory network in the annual external quality assurance (EQA) programme coordinated by WHO Linking laboratory data with epidemiological data and using data for evaluating the measles elimination and rubella control programme Sharing laboratory data with the WHO Regional lab network as agreed upon with WHO Regional Office Supporting the public health authorities in diagnosis during measles/rubella and/or CRS outbreaks Training field staff on specimen collection, storage and transportation of samples to the national and provincial laboratories Development of laboratory guidelines, manuals and SOPs Operational/logistical and technical support: Improving laboratory algorithms and SOPs Improving supervision of laboratory activities 47

62 Procurement of laboratory equipment, developing SOPs for bio-safety, storage of reagents and management of samples Procurement of sufficient quantities of measles and rubella/crs specific tests, reagents and other consumables Programmatic strategy to achieve Objective 4 With the revision of the NSP, MoPH is reviewing the current Outbreak Preparedness and Response Guidelines. MoPH will revise and complete the guidelines with detailed SOPs and roles and responsibilities. The revised guidelines will specifically be related to measles and rubella, but be flexible enough to be used as a blueprint for responding to any vaccine preventable communicable disease outbreak. Given that DPR Korea is prone to natural calamities frequently, the guidelines will have a section on responding to communicable diseases in natural disasters, including measles. Operational components as part of the preparedness guidelines Organizing and training rapid response teams, including development of terms of references (TORs) Developing risk assessment indicators through analysis of surveillance data and developing risk profiles for measles and rubella Exercising response protocols with all partners involved Stockpiling response (and containment) vaccines, drugs, medical kits and communication equipment, including buffer stocks Preparing budget plan to support the above programme lines Maintaining a roster of human resources required for preparing and responding to outbreaks Providing training and orientation on all operational aspects of the preparedness and response plan during the preparedness phase Testing SOPs on preparedness by exercising on mock situations at regular intervals. Activities that will be clearly described in the SOPs in the response guidelines Initiating outbreak investigation, developing syndromic outbreak case definition, enrolment of cases for describing the outbreak Confirmation of patient diagnosis (clinical, epidemiological and lab) Epidemiological analysis and describing the outbreak in terms of person, time and place 48

63 Developing the hypothesis related to the source and mode of transmission Developing the comprehensive plan of interventions, protocols for isolating patients and contacts and prompt case management Emergency outbreak response immunization criteria and protocols following a risk analysis Added health interventions such as providing vitamin A, deworming medicine, etc. Conduct of active surveillance for CRS including prospective follow up of pregnant women affected by rubella during an outbreak for the outcome of their pregnancies Programmatic and operational strategies to achieve Objective 5 The following programmatic and operational strategies may be a repetition of strategies listed earlier to achieve Objectives 1, 2, 3, or 4; but at the same time, they are overarching strategies to help achieve all four objectives. MoPH, in collaboration with WHO and UNICEF will prepare/implement the following: Develop advocacy, social mobilization and communication materials: for MR Introduction SIA, switch from MCV to MR for sensitizing the public to come to Ri clinic for MR SIA, suspected AEFIs, or when fever and rash occur (to capture measles and rubella cases and carry out their prompt management) Follow up of pregnant women to prospectively detect potential CRS cases Develop guidelines/sops for MR immunization during a public health emergency which can be the framework for responding with outbreak immunization during other VPD outbreaks Research and development: Serological surveys to determine the population immunity levels for measles and rubella in the post MR introduction era with a view to determining follow-up campaigns Seroprevalence surveys for the non-vaccinated group, especially women of child bearing age, to decide if a special catch-up campaign would be needed for specific non-vaccinated age groups Using the sentinel surveillance sites to determine the disease burden of CRS and describe its epidemiology in the country 49

64 Improve management and capacity of human resources at all levels: Develop training curricula and modules to inform, orient and train human resources. These modules will include adult training techniques focused on practical exercises, demonstrations, group-work and role-plays Development of training curricula will take into consideration all recommendations in reports of the: (i) RVC mission to DPR Korea; (ii) EVM assessment; (iii) PIE mission; (iv) external Gavi HSS review; (v) EPI and VPD surveillance review; (6) switch from trivalent to bivalent oral polio vaccine; and (vii) various other reports on measles SIA in 2007 and lessons learnt from strengthening the RI programme, especially during implementation of the Gavi HSS support. Following are the key training and orientation packages that will be developed: Orientation for MR introduction MR SIA Training on SOPs for switchover from MCV to MR Training for outbreak preparedness and response Training for surveillance and laboratory best practices, i.e. enhancing the capacity of central laboratory staff in order to detect molecular characteristics of measles and rubella viruses, bio-safety measures and laboratory diagnostic aspects of measles and rubella for the provincial laboratories Training for immunization data managers and other data handlers MoPH will identify and utilize synergistic linkages of integrated programme efforts with: Integrated Management of Childhood Illness (IMCI) to improve case management, which will lead to reducing mortality and morbidity due to measles birth defect surveillance efforts of the Maternal and Child Health Section of the MoPH Integrated Disease Surveillance Programme (IDSP) to ensure cost-effective measles, rubella and CRS surveillance in a low endemic setting overall supply and logistics system in MoPH integrated Health Management Information System (HMIS) and Logistic Management and Information System (LMIS) linkage between the AEFI surveillance system and the adverse drug reaction (ADR) monitoring system to improve and strengthen the latter 50

65 linkage between the MR introduction efforts and immunization system strengthening efforts of the Gavi HSS grant to include improving coverage and equity, expanding cold chain capacity for new vaccine introduction, strengthening cold chain monitoring through provision and usage of temperature control devices, procurement of solar drive refrigerators to encounter the grid electricity problems in rural areas, strengthening laboratory diagnostics of VPDs, service quality improvement, improving monitoring and supportive supervision, training of service delivery staff, provision of transportation means for vaccines delivery, monitoring and supervision, study tours to learn from peers in other countries, etc. MoPH is using the MR introduction to establish linkages with other departments in the Government and is forging solid partnerships with international organizations, which are resulting in strengthening all four objectives to reach the main goal of measles elimination and rubella/crs control by 2020: Gavi for MR support with government co-financing WHO UNICEF for technical support and vaccine procurement Caritas assistance for MR campaign IFRC and the National Korean Red Cross Society Education committee and transportation-related agencies. 51

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67 7 Considerations for operationalization of the 5-year strategic plan from 2019 onwards The context, scenario and circumstances of MR introduction have changed following the development of the current Comprehensive Multi-Year Plan (cmyp) Therefore, there is a need for updating the cmyp with all programmatic and operational aspects of the MR introduction plan including budget estimations, specifically for MR SIA. The next cmyp ( ) needs to contain the cost of routine MR vaccine as a recurring expenditure, and also the cost of CRS surveillance expanded to the Ri level MoPH will update/develop the Annual EPI Operational/Work Plan for 2019 including all planned activities regarding MR introduction (SIA and routine introduction plans) Annual immunization (EPI) operational/work plans in subsequent years will include dynamic changes in activities related to achieving at least 95% coverage for two MR doses and laboratory-assisted surveillance of measles, rubella and CRS. Components of this plan may include following programmatic and key operational components: Catch-up outreach sessions in hard-to-reach areas where necessary 53

68 A wide age range catch-up campaign for women of childbearing age (16 years to under 50 years of age). A follow-up campaign for children aged 9 months to under 6 years, to be carried out 5 years post SIA 2019 if the need arises Refresher training on surveillance of measles and rubella and laboratory diagnostics of measles and rubella to be done from time to time Updating the epidemic preparedness and response plan and simulation exercises. 54

69 8 Verification of measles elimination and rubella/crs control Verification of measles elimination requires meeting three criteria and five lines of evidence. These criteria and the country situation with evidence as in March 2018 are given in Table 6. Table 6: Criteria and evidence of measles elimination and rubella/crs control by 2020 Three criteria Documentation of the interruption of endemic measles/rubella virus transmission for a period of at least 36 months from the last known endemic case Country situation No indigenous measles cases (laboratory confirmed) have been reported since 2007 No laboratory confirmed rubella cases have been reported since 2012 The presence of a high-quality surveillance system that is sensitive and specific enough to detect imported and import-related cases A robust sensitive surveillance is present. However, the surveillance strategy has to be shifted to elimination level casebased fever rash surveillance with 100% adequate laboratory investigation of all cases. MoPH presents plans for this strategy in the present NSP 55

70 Genotyping and molecular evidence that supports the interruption of endemic transmission Five lines of evidence Capacity for molecular characterization of measles/rubella viruses is present in the laboratory of the Academy of Medical Science Neither capacity verification nor accreditation has been done by WHO MoPH plans to seek WHO support to build the capacity of the national lab as a reference lab for the EPI to generate molecular evidence Epidemiologic characteristics of measles and rubella over time Genotyping and molecular evidence of sustained interruption of endemic virus transmission Epidemiological surveillance and laboratory performance quality High population immunity Sustainability of measles elimination in the context of national immunization programme sustainability High immunization coverage has been sustained for MCV1 and 2 doses consistently; RCV is yet to be introduced Genotyping capacity has to be developed in the National Measles and Rubella Laboratory Laboratory performance is high. Nonmeasles, non-rubella discard rate is below 2/ population and only 24% cases are adequately investigated Immunity for measles is high. There is no immunity for rubella except for the population exposed to the MR SIA supported by Caritas As per the WHO/UNICEF Joint Reporting Form (JRF) financial sustainability indicators, external donor dependency is high Specific indicators are suggested for each line of evidence. 8.1 Role of National Verification Committee The role of the NVC is as follows: to advise MoPH, EPI Coordination Group and VPD surveillance units on requirements for verification; to compile and review information to monitor progress towards measles elimination and rubella/crs control, and assess if the country can verify 56

71 elimination in accordance with established criteria and recommended lines of evidence; to conduct field visits when needed to monitor progress, assess data quality and validate analyses and assessments; to supervise and guide development of the annual progress report and verification documentation at the country level; and if necessary, propose additional analyses or feasible alternatives if standard verification data are insufficient or inconsistent; to review and validate the verification report, providing conclusions and recommendations before submitting the report to the RVC; to provide programmatic guidance consistent with verification criteria and lines of evidence. 8.2 Main functions of the Regional Verification Committee Three main functions in relation to individual countries and the Region towards measles elimination and rubella/crs control are as follows: Normative function: To review and establish criteria and procedures, including a plan of action, for monitoring progress and verifying the achievements Verification functions: (i) to verify achievement, maintainance and progress of measles elimination and rubella/crs control; (ii) post-verification role to sustain the achievement and prevent re-establishment of endemic measles or rubella virus transmission by continuing the same strategies recommended for eliminating measles Advisory functions: (i) to advise the NVCs on verification criteria, requirements and procedures, including guidance on reviewing data needed for verification and proper documentation; (ii) to review the annual reports submitted by NVCs and provide feedback; and (iii) to conduct field visits when needed to monitor progress, verify evidence and provide guidance to NVCs and the Government. With a view to assessing the current status of progress towards verification of measles elimination and providing specific recommendations to bridge the gaps, a mission was undertaken by the RVC on January The recommendations of the members of the RVC mission are given in Table 7. 57

72 Table 7: RVC recommendations and DPR Korea s status of activity Build immunity against rubella Introduce RCV in RI following a catch-up SIA with RCV Country s activity status Plan is developed planned for Q3 in 2019 Strengthen surveillance Revise the surveillance guide to elimination standard by broadening case definition to fever and rash Ensure that every province has a non-measles non-rubella discard rate of 2 or more per Ensure capacity for revised case-based surveillance at lowest level of service through training/orientation Plan is under way Plans are under way to enrol all fever rash cases and carry out 100% adequate serological investigation Nation-wide training has been planned in 2018 based on the revised surveillance guidelines Strengthen laboratory capacity Serology for 100% fever and rash cases to be conducted Strengthen capacity to conduct molecular epidemiology (viral detection and genotyping) for any serologically confirmed measles or rubella case Planned need operational support National Measles and Rubella Laboratory needs to be updated in terms of molecular evidence Sustainibility Revise measles elimination and rubella control strategy to meet elimination standard Have a written outbreak preparedness and response plan Develop a post-elimination sustainability plan Vaccine sustainability plan to be developed Periodic review and refresher training for anti-epidemic team, laboratory teams and household doctors This document fulfils this recommendation Planned Planned Planned Planned 58

73 9 Contributions to child health and health systems strengthening Table 8 describes how inputs related to MR introduction improve health and immunization system strengthening. Table 8: Contributions to child health and HSS Programme focus Inputs Health and immunization system strengthening including maternal and child health MR SIA Improved micro planning Improved cold chain system Improved capacity of health staff Increased budget for transportation Improved surveillance and laboratory capacity Add specific HSS messages into communication and social mobilization messaging The opportunity is present for other health programmes such as disease surveillance programmes (beyond VPD) and MCH programmes to benefit from the increased resources, better planning efforts, improved infrastructure, capacity building of the staff, integrated communication and IEC materials offered through the SIA platform 59

74 Programme focus Inputs Health and immunization system strengthening including maternal and child health MR in the routine programme Provide more equipment and resources for routine vaccination clinics/sites and staff Increase the number of fixed routine vaccination sites Can bring other services (either routine or exceptional health services) to people living in hard-to-reach areas Add other health interventions such as vitamin A, mebendazole and family planning to the immunization service Incorporating IMCI during the training on preparedness and response to measles outbreaks Training on improved case management of measles cases Joint training, content auditing, supervision and monitoring of training programmes Improved case management of other childhood infections Capacity building of primary health-care staff on case detection, homebased management and referrals Better integration of IMCI and EPI programmes Reducing mortality and morbidity MCH mother and child health; IMCI Integrated Management of Childhood Illness MoPH will continue to explore synergies between the MR programme and other child health interventions. The measles elimination and rubella/crs control programme will invest in strengthening routine vaccination and disease surveillance services as its primary strategy. Over time, this can lead to a broader health-care system strengthening. 60

75 10 Sustainability of measles elimination and rubella/crs control beyond 2020 The new 5-Year NSP on measles elimination and rubella/crs control takes into consideration that re-introduction of measles and outbreaks of rubella in DPR Korea can occur. Though the measles virus is highly contagious and can easily spread from person to person across international borders through ports of entry, the likelihood is low given the very high immunity profile of the population. The same cannot be said about rubella infections, given the low population immunity against it. Sensitive surveillance systems are therefore necessary to detect imported measles and rubella virus early so that appropriate control measures can be implemented. In the post-verification stage, DPR Korea will maintain a sensitive surveillance system to detect measles and rubella cases. In addition, the country will maintain the high levels of vaccination coverage with two doses of MR in the RI programme and conduct follow-up MR campaigns if there is a need, based on epidemiological evidence. To sustain the achievements and avoid complacency that may set in in an eliminated setting, DPR Korea will develop a post-elimination sustainability plan with the following components: A strong coordination structure with high level of government commitment and partner support 61

76 A framework to maintain measles elimination and rubella control strategy: Sustain high immunization coverage for MR1 and MR2 Arrange financial and logistic support to implement a one-time catch-up campaign for women of childbearing age (15 to under 50 years) with partners as early as possible, subsequent to the SIA in 2019 Carry out enhanced sentinel surveillance of CRS till the country reaches the status of rubella and CRS elimination Maintain a high level of epidemic preparedness and outbreak response to respond to any imported or import-related measles transmission or rubella outbreak Maintain a high level of supervision and monitoring of measles elimination and rubella control activities and evaluation of the objectives of the NSP on measles elimination and rubella/crs control Update the outbreak preparedness and response plan Develop and operationalize a vaccine sustainability plan Describe and conduct periodic reviews and refresher training as follows: Train household doctors, anti-epidemic teams, laboratory teams, cold chain managers, vaccine handlers and logistic managers Analyze epidemiological data Develop capacity of molecular characterization plan Develop and implement immunization financing plans to support sustaining of MR activity plan (see Chapter 11). DPR Korea is committed to use the opportunity of financial support for the MR programme from Gavi and technical support from other health partners to achieve the Sustainable Development Goals (SDGs), which will contribute to the economic progress of the country. Contributions to the SDGs will be through: sustaining high MR1 and MR2 coverage with a view to eliminating diseases, negating their health implications and reducing the financial burden on the national health system and resources; promoting and achieving the concept of fully immunized children to strengthen capacity of the youth as the future workforce of the country; 62

77 using the MR experience as the best example to demonstrate the most genderequitable public health intervention in the public health system; keeping the country free of measles and rubella/crs with a view to reducing the burden on women taking care of their sick children at home; keeping the country free from measles and rubella/crs will keep the young workforce healthy, reduce medical costs and productivity losses. 63

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79 11 Immunization financing plan DPR Korea has benefited from Gavi HSS support, which has been fundamental in providing finances to strengthen the health system in the country to deliver immunization outcomes. This support was necessary to achieve equitable immunization coverage through improvements in access to services, quality of care, health infrastructure, immunization management information systems and the health workforce. Parallel to the implementation of the HSS grant for improving the health system for immunization outcomes, MoPH is being financially supported for vaccine costs and operational costs (procurement of vaccines and injection supplies, supplies for surveillance, etc.) by WHO and UNICEF. This financial support from the UN agencies present in the country during the past 3 decades for immunization activities has been fundamental in enabling the country to sustain the immunization outcomes and saving lives through the immunization programme in the existing environment of economic sanctions and complex political situations. Despite these difficulties and the numerous financial challenges to sustaining the immunization programme, MoPH is abiding by its global commitments to pursue the goal of measles elimination and rubella control. The Government acknowledges that continued support from its partners (WHO, UNICEF) and global health initiatives such as Gavi is pivotal for immunization financing in the next decade. However, the Government has now displayed ownership of the measles elimination and rubella control programme by contributing to vaccine cost through co-financing with Gavi for MR and cost sharing of the operational cost with WHO and UNICEF. Through 65

80 co-financing of MR vaccine, MoPH will be able to introduce another new vaccine to maintain the immunization outcomes achieved so far in the EPI and progress towards the goal of measles elimination and rubella/crs control by Given the anticipated economic difficulties in the context of the complex geopolitical situation as also the need for sustaining activities to progress towards measles elimination and rubella control by 2020, Conceptual framework 2 of the financial plan for the period of this NSP ( ) is given in Fig. 7. Figure 7: Conceptual framework 2 Gavi support for rubella/crs elimination DPRK commitment of co financing EPI Program WHO UNICEF and other partners Support for SIA target Sustain high coverage of MR1 and MR2 in Routine program Sustain supervisión - monitoring and Evaluation Gender equality in education with 100% access to Health Sustain communication social mobilizationn General partnership and economic investment protection and prioritization of the most Vulnerable population SUSTAINING MEASLES ELIMINATION AND RUBELLA/CRS control Beyond 2020 Sustain Training and Capacity Building improved access to information, data and Internet 66

81 12 Timeline for implementation of NSP, financing plan and conceptual framework for sustenance beyond 2022 Year-wise activity planning Annex 3 gives the year-wise activity planning for implementing NSP Annex 4 gives the Gantt chart of outlined activities. Financing plan The estimated cost as per projected activity is given in Annex 5 based on the budgeting and planning template of Gavi. Conceptual framework Conceptual framework to sustain measles elimination and control (or eliminate) rubella/ CRS in DPR Korea beyond 2020 is given in Fig. 8 (Conceptual framework 3). 67

82 Figure 8: Conceptual Framework 3 to sustain measles elimination and control (or eliminate) rubella/crs in DPR Korea beyond 2020 Maintain high coverage for MR 1 and MR 2 Sustain quality Laboratory assisted Case based MR surveillance Maintain quality CRS sentinel reporting maintain high level of epidemic preparedness and outbreak response MoPH leadership delegation of tasks - partnership Sustain Elimination of measles and rubella/crs control (or elimination?) beyond 2020 government financial commitment and allocating resources Conduct Follow-up campaigns based on epidemiological and surveillance evidence Maintain high standard case management Supervision Monitoring Evaluation - Verification 68