Meeting Report MEETING OF NATIONAL IMMUNIZATION TECHNICAL ADVISORY GROUPS FOR ASEAN COUNTRIES - World Health Organization
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Meeting Report MEETING OF NATIONAL IMMUNIZATION TECHNICAL ADVISORY GROUPS FOR ASEAN COUNTRIES 23–24 September 2019 Kuala Lumpur, Malaysia
Meeting of National Immunization Technical Advisory Groups for ASEAN Countries 23–24 September 2019 Kuala Lumpur, Malaysia
WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR THE WESTERN PACIFIC RS/2019/GE/49 (MYS) English only MEETING REPORT MEETING OF NATIONAL IMMUNIZATION TECHNICAL ADVISORY GROUPS FOR ASEAN COUNTRIES Convened by: WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR THE WESTERN PACIFIC Kuala Lumpur, Malaysia 23–24 September 2019 Not for sale Printed and distributed by: World Health Organization Regional Office for the Western Pacific Manila, Philippines March 2020
NOTE The views expressed in this report are those of the participants of the Meeting of National Immunization Technical Advisory Groups for ASEAN Countries and do not necessarily reflect the policies of the conveners. This report has been prepared by the World Health Organization Regional Office for the Western Pacific for Member States in the Region and for those who participated in the Meeting of National Immunization Technical Advisory Groups for ASEAN Countries in Kuala Lumpur, Malaysia from 23 to 24 September 2019.
CONTENTS SUMMARY ........................................................................................................................................................... 1 1. INTRODUCTION .......................................................................................................................................... 3 1.1 Meeting organization ............................................................................................................................ 3 1.2 Meeting objectives ................................................................................................................................ 3 2. PROCEEDINGS ............................................................................................................................................. 4 2.1 Opening ................................................................................................................................................. 4 2.2 Overview of immunization programmes and VPD control in the Western Pacific Region: evaluation, progress and achievements ................................................................................................................... 4 2.3 Overview of immunization programmes and VPD control in the South-East Asia Region .................. 5 2.4 Population movement and migration in Asia and their impact on immunization programme .............. 6 2.5 Evidence-based decision for immunization programme and roles of NITAGs..................................... 7 2.5.1 Global updates on NITAG establishment and strengthening activities ............................................. 7 2.5.2 Experience on evidence-based decision-making process from the Australian Technical Advisory Group on Immunization .................................................................................................................... 7 2.5.3 Brunei Darussalam ............................................................................................................................ 8 2.5.4 Cambodia .......................................................................................................................................... 9 2.5.5 Indonesia ........................................................................................................................................... 9 2.5.6 Lao People’s Democratic Republic ................................................................................................... 9 2.5.7 Malaysia .......................................................................................................................................... 10 2.5.8 Myanmar ......................................................................................................................................... 10 2.5.9 Philippines ....................................................................................................................................... 11 2.5.10 Singapore ........................................................................................................................................ 11 2.5.11 Thailand .......................................................................................................................................... 12 2.5.12 Viet Nam’s National Immunization Technical Advisory Groups: membership, functions and mode of operation ..................................................................................................................................... 12 2.6 Capacity-building and networking among NITAGs ........................................................................... 12 2.6.1 Updates from recent NITAG meeting from the South-East Asia Region ....................................... 12 2.6.2 Study tour experience from the Lao People’s Democratic Republic............................................... 13 2.6.3 Group work: discuss ways of synergistic interaction and mutual collaboration and priority actions for strengthening NITAGs of ASEAN countries ............................................................................ 14 2.7 Feasibility of pooled procurement of vaccines .................................................................................... 16 2.7.1 Revolving Fund – experience from the Pan-American Health Organization: vaccine planning, financing and pooled procurement in Latin America and the Caribbean ........................................ 16 2.7.2 Updates from workshops on ASEAN Vaccine Security and Self-Reliance (AVSSR).................... 16 2.7.3 Survey on pooled procurement of vaccines in the Western Pacific Region .................................... 17 2.7.4 Vaccine production capacity ........................................................................................................... 18 3. CONCLUSIONS AND RECOMMENDATIONS ....................................................................................... 19 3.1 Conclusions ......................................................................................................................................... 19 3.2 Recommendations ............................................................................................................................... 20 3.2.1 Recommendations for Member States ............................................................................................ 20 3.2.2 Recommendations for WHO ........................................................................................................... 20 ANNEXES ........................................................................................................................................................... 23 Annex 1. Agenda Annex 2. List of participants, temporary advisers, observers and Secretariat Immunization / Vaccines / Regional health planning / Southeast Asia
ABBREVIATIONS ASEAN Association of Southeast Asian Nations EPI Expanded Programme on Immunization GNN Global NITAG Network HPV human papillomavirus JE Japanese encephalitis NIP National Immunization Programme NITAG National Immunization Technical Advisory Group PAHO Pan-American Health Organization PCV pneumococcal conjugate vaccine RITAG Regional Immunization Technical Advisory Group TAG Technical Advisory Group VPD vaccine-preventable disease VDPV vaccine-derived poliovirus WHO World Health Organization
SUMMARY Participants from nine Member States and territories along with representatives from four partner agencies attended a two-day meeting in Kuala Lumpur, Malaysia on 23–24 September 2019 to discuss National Immunization Technical Advisory Groups (NITAGs) of countries within the Association of Southeast Asian Nations (ASEAN) region. Participants shared the status of their NITAGs, or equivalent advisory bodies, and identified strengths and challenges. Using the information shared, participants identified common immunization programme issues and proposed priority action points for strengthening the NITAGs of ASEAN countries. Functioning as a technical advisory group, NITAGs provide evidence-based immunization-related recommendations to national policy-makers and programme managers. The establishment of a functional NITAG in each Member State is one of the strategies to achieve the goals of the Global Vaccine Action Plan, which was endorsed by the World Health Assembly in 2012. Since then, the World Health Organization (WHO), in collaboration with other development partners, has been supporting Member States to establish and strengthen NITAGs. ASEAN’s Post-2015 Health Development Agenda also serves as a solid foundation to strengthen NITAGs by promoting resilient health systems as well as prevention and control of communicable diseases within its 10 Member States. The independence of ASEAN NITAGs allows ministries to make decisions using evidence-based advice for increased public credibility on immunization-related issues. Some NITAGs are able to separate their technical advice on safety, efficacy, and need for new vaccine introduction from financial considerations. All countries demonstrated ongoing efforts to strengthen NITAGs through ongoing staff trainings and regular meetings. Most NITAGs have diverse membership and demonstrate that they consider conflicts of interest of members but not a process for the management of such. Accountability for evidence sits with NITAGs, and they are responsible to the health ministries for providing appropriate advice. WHO will continue to advocate with national governments to ensure adequate funding support for NITAGs. Efforts will be geared towards strengthening ASEAN NITAGs through self-assessment, external evaluations and peer-to-peer trainings. Multilevel communication between national and regional advisory groups will continue to be coordinated by WHO with the purpose of monitoring the implementation of regional strategic frameworks and country-specific priorities. WHO will also continue its cross-collaboration and coordination with ASEAN’s Vaccine Security and Self-Reliance initiative while exploring opportunities for pooled procurement, harmonization of regulatory standards, and vaccine research and development with UNICEF’s Vaccine Independence Initiative. Efforts to develop a network of ASEAN NITAGs in cooperation with the ASEAN Secretariat and other partners. Member States will advocate for funding to support a strong NITAG secretariat. Technical groups should be established to assemble evidence to support the NITAG’s advice on immunization-related policies. Member States are instructed to operationalize NITAG workplans while incorporating monitoring and evaluation mechanisms that assess the implementation of recommendations. Self-assessments and/or external assessments should also be considered. Annual NITAG workplans should also be aligned with national, regional and global strategic frameworks and goals. 1
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1. INTRODUCTION 1.1 Meeting organization National immunization technical advisory groups (NITAGs) provide advice and guidance to national policy-makers and programme managers to enable them to make evidence-based decisions for immunization-related policy and programmes while promoting country ownership. Establishing a functional NITAG in each Member State is one strategy to achieve the goals of the Global Vaccine Action Plan, which was endorsed by the World Health Assembly in 2012. Since 2012, the World Health Organization (WHO), in collaboration with other development partners, has been providing support to Member States to establish and strengthen NITAGs. The Association of Southeast Asian Nations (ASEAN) was established to promote regional peace and stability through active collaboration and mutual assistance in technical and scientific matters. To promote a healthy and caring ASEAN community, countries have adopted the ASEAN Post-2015 Health Development Agenda (2016–2020), which aims to promote resilient health system as well as prevention and control of communicable diseases. This platform and shared agenda among the 10 ASEAN countries provides WHO with a solid foundation to strengthen the NITAGs in the South-East Asia and Western Pacific regions. Considering common immunization policy and programme issues, particularly immunization service delivery and vaccine-preventable disease (VPD) notification among cross-border and migrant populations in countries of the South-East Region, the Expanded Programme on Immunization (EPI) teams from the Western Pacific Region, in collaboration with the team from the South-East Asia Region, organized a two-day meeting of NITAGs for ASEAN countries in Kuala Lumpur, Malaysia, on 23–24 September 2019. 1.2 Meeting objectives The WHO Regional Office for the Western Pacific convenes annual meetings of its Technical Advisory Group (TAG) on Immunization and VPDs. The conclusions and recommendations of the TAG meeting in June 2019 included: (1) Member States to strengthen the functionality and effectiveness of NITAGs or equivalent immunization decision-making bodies to support the formulation of evidence-based immunization policy; and (2) WHO to continue to provide technical support and capacity-building for the development of national plans for evidence‐based introduction of new vaccines. Establishment of a functional NITAG in each Member State is a step towards achieving the goals of the Global Vaccine Action Plan, and WHO in the Western Pacific Region has been supporting the strengthening of NITAGs. The ASEAN health promotion initiative on control of communicable diseases provides a good opportunity for the WHO Western Pacific and South-East Asia regional offices to work together to support strong NITAGs. The participants of the two-day meeting presented on evidence-based decision-making and the roles of NITAGs for each country. Discussions on the second day included capacity-building and networking among NITAGs. Experiences and feasibility of pooled procurement of vaccines were also considered. The objectives of the meeting were: 1) to review the current status of NITAGs, identify common immunization policy and programme issues, and share experience between NITAGs of ASEAN countries; and 2) to discuss ways of synergistic interaction and mutual collaboration and priority actions for strengthening NITAGs of ASEAN countries. 3
2. PROCEEDINGS 2.1 Opening Dr Ying-Ru Lo, WHO Representative for Malaysia, Singapore and Brunei Darussalam, in her opening remarks communicate the importance of NITAGs in supporting evidence-based decision-making by providing advice that is independent and credible. She encouraged attending members to share experiences on ways to create synergies and strengthen NITAGs with the common goal of preventing VPDs throughout the ASEAN region. Following these remarks, Dr Sahib, Deputy Director of Communicable Diseases, Malaysia Ministry of Health, welcomed participants to the meeting. 2.2 Overview of immunization programmes and VPD control in the Western Pacific Region: evaluation, progress and achievements Dr Yoshihiro Takashima, EPI Coordinator, WHO Regional Office for the Western Pacific The Western Pacific Region consists of 37 countries and areas, of which seven are ASEAN countries. Between 1988 and 2018, the Region has achieved much progress. The polio eradication initiative was started in 1988, with South Asia and East Asia recording 6000 polio cases in 1990. Thanks to strong efforts by Member States, however, rates were reduced. In 1997, Cambodia reported the last cases of wild poliovirus, and the Region became polio-free in 2000. In 2003, the regional measles elimination initiative was started. In 2018, nine countries and areas in the Western Pacific Region had been verified as having achieved measles elimination (Australia, Brunei Darussalam, Cambodia, Hong Kong SAR (China), Japan, Republic of Korea, Macao SAR (China), New Zealand and Singapore). In 2018, five countries and areas (Australia, Brunei Darussalam, Republic of Korea, Macao SAR (China) and New Zealand) had been verified as having achieved rubella elimination. Before 2000, six countries (Cambodia, China, Lao People’s Democratic Republic, Papua New Guinea, Philippines and Viet Nam) had high mortality due to maternal and neonatal tetanus, but they have now achieved elimination through their strong efforts in implementing the strategies of WHO and the United Nations Children’s Fund (UNICEF). To date, only Papua New Guinea needs support to reach this goal. Chronic hepatitis B affects more than 8% of the Region’s population. Prevalence of hepatitis B surface antigen among 5-year-old children was less than 1% in 2012, reaching target goals. Pneumococcal conjugate vaccine (PCV) has been introduced in 17 countries, and 13 countries have included human papillomavirus (HPV) vaccine. To accelerate the control and elimination of VPD, the Western Pacific has developed a regionwide laboratory network, which started with the polio regional network in 1990; since 1998, the measles and rubella network has been developed. In 2008, Japanese encephalitis (JE) and rotavirus were added to the network. In addition to VPD laboratory data, Member States in the Region have established shared case-based surveillance systems for acute flaccid paralysis (AFP), measles and rubella, JE, invasive bacterial vaccine-preventable diseases (IB-VPD), and rotavirus. The Regional Framework for Implementation of the Global Vaccine Action Plan in the Western Pacific has eight immunization goals: sustaining polio-free status; maternal and neonatal tetanus elimination; measles elimination; accelerated control of hepatitis B; rubella elimination; introduction of new vaccines; meeting regional vaccination coverage targets; and accelerated control of JE. As of 2019, six of the eight goals have been achieved, with measles elimination and meeting regional immunization coverage rates are still lagging. Challenges to be addressed during the next decade will include measles resurgence with increased importations of measles; diphtheria outbreaks (Lao People’s Democratic Republic, Viet Nam, Malaysia and Philippines); and vaccine-derived poliovirus (VDPV). In 2000, the Western Pacific Region was declared polio-free; this has been sustained with the exception of a large wild poliovirus outbreak in China that was imported from Pakistan in 2011. From 2001 to 2012, there were small-scale outbreaks due to circulating VDPV in the 4
Region, but the large-scale outbreaks in the last four years have been due to wild types of poliovirus. Two months ago, there was circulation of wild poliovirus type 2 in the Philippines and China. Future challenges in the Region include: growing population; expanding urbanization; increases in immigration and non-state citizens; vaccine hesitancy; countries transitioning from financial support granted by Gavi, the Global Fund and the Global Polio Eradication Initiative; new global eradication initiatives; repeated outbreaks; increased VPD incidence among other children and adolescents; fewer new vaccines; increased needs and unstable global vaccine supply (i.e. stock-outs) and interrupted immunization services; and diversifying country needs and goals. Immunization programmes will play important roles in reaching the Sustainable Development Goals (SDGs), such as SDG3 to “ensure healthy lives and promote well-being for all at all ages”, and in achieving universal health coverage (UHC) over the next decade. WHO headquarters is working with global immunization partners towards developing an agenda for 2020–2030 that will be submitted and reviewed by Member States at the next World Health Assembly. The South-East Asia and Western Pacific regions are also in the process of developing a regional plan for 2030. Member States and the WHO Secretariat will consider the strategic direction, which must sustain gains and achieve the immunization goals while strengthening preparedness for public health emergencies related to VPDs and promote integration of service delivery and the strategy for disease elimination initiatives along with financing and laboratory surveillance. Expanding immunization services along the life course will provide immunization for adolescents, adults and older people and will also address demographic changes that promote a differentiated approach for different immunization issues, such as minority groups in middle-income countries. National country ownership of financing will be promoted with enhanced partnership and synergy between the health ministry, WHO and other partners. Strategic objectives for the next decade aim to achieve existing goals and strengthen and expand immunization systems and programmes and to manage health intelligence on VPD and immunization and prepare for and respond to public health emergencies related to VPD, with the outcome to control and eliminate more VPDs by 2030. These will be reached through synergy in three areas: universal health coverage, healthier populations/noncommunicable diseases and ageing, and health security and emergencies/environment and climate change. Questions and answers related to the role of social media in promoting vaccine hesitancy and recent concerns in Muslim countries regarding the requirement that vaccines be certified halal. The solution could involve understanding parents’ views and working with religious groups. Hesitancy will be a core focus in the upcoming regional strategic framework. It was also noted that reporting of adverse events following immunization (AEFI) can potentially cause a public health emergency (for example the dengue vaccine in the Philippines). 2.3 Overview of immunization programmes and VPD control in the South-East Asia Region Dr Sudhir Khanal, Technical Officer, Immunization and Vaccine Development (IVD), WHO Regional Office for South-East Asia The WHO South-East Asia Region comprises 11 Member States that have endorsed the South-East Asia Regional Vaccine Action Plan 2016–2020. The annual review of the Plan’s eight goals in 2019 showed that all goals are on track, except for measles elimination and rubella/congenital rubella syndrome (CRS) control, which is off track. An overview of progress towards all eight goals was presented. In terms of the routine immunization goal, there has been significant progress on immunization systems strengthening in the Region. As a result, most Member States have reached coverage with the diphtheria–tetanus–pertussis (DTP3) vaccine of above 90%. Out of all routine vaccines, coverage of inactivated polio vaccine (IPV) and second dose of measles-containing vaccine (MCV2) has been suboptimal for multiple reasons, but efforts to improve these coverage levels are ongoing. Global coverage of DTP3 is stagnant, but the Region’s coverage is improving. There have been more than 18 000 cases of diphtheria in the Region due to waning immunity and vaccination gaps. 5
Over the last 18 years, coverage for measles-containing vaccine (MCV) has increased. As a result, the number of measles cases has decreased, although Myanmar and Thailand saw increased numbers in 2018. Five countries (Bhutan, Democratic People’s Republic of Korea, Maldives, Sri Lanka and Timor-Leste) have been verified as having eliminated measles. Regional coverage of rubella- containing vaccine (RCV) has reached 83%, and six countries have been verified as having controlled rubella/congenital rubella syndrome. In 2017, a midterm review of the Strategic Plan for Measles Elimination and Rubella and Congenital Rubella Syndrome Control in the South-East Asia Region, 2014–2020 concluded that, while significant progress has been made, the Region is off track for measles elimination and rubella control. Polio-free status has been maintained, and no wild poliovirus type cases have been reported since 2011. Vaccine-derived poliovirus type 1 (VDPV1) was detected in Myanmar in June 2019. A polio transition plan has been developed in five countries (Bangladesh, India, Indonesia, Myanmar and Nepal), and work is being conducted with partners and countries to mobilize resources for these efforts. JE vaccine was introduced nationwide in four countries (Myanmar, Nepal, Sri Lanka and Thailand), while two countries (India and Indonesia) have introduced it in high-risk areas. All countries have introduced hepatitis B vaccine in their national immunization programme (NIP) schedules, and eight countries are providing hepatitis B birth dose. A regional expert panel has verified hepatitis B control in four countries (Bangladesh, Bhutan, Nepal and Thailand) in the Region. All 11 countries have introduced at least one new vaccine either at national or subnational levels or to high-risk areas/populations. Three out of the 11 countries manufacture WHO prequalified (WHO-PQ) vaccines; another three countries self-procure and two have mixed procurement processes. All countries report vaccine pricing data to the WHO through the WHO/UNICEF Joint Reporting Form (JRF) for the Vaccine Product, Price and Procurement (V3P) database/Market Information for Access to Vaccines (MI4A). 2.4 Population movement and migration in Asia and their impact on immunization programme Dr Leena Bhandari, Chief Migration Health Officer, International Organization for Migration Migration patterns in the South-East Asia and Western Pacific regions are unprecedented, and the population is likely to grow due to political and economic circumstances. It is estimated that East Asia will require 275 million immigrants aged 15–64 years by 2030 to maintain a steady working-age population. These circumstances, along with environmental impacts caused by climate change, will promote more migration in the ASEAN region. At the World Health Assembly in 2019, Member States advocated the promotion of health of refugees and migrants. Health threats in remote parts of the world can spread, and many countries are not prepared for such threats. Immunization is the most cost-effective public health intervention, annually preventing 1.5 million deaths, although global vaccine coverage has stagnated in recent years. There have been achievements in the region, including the cessation of wild poliovirus and a reduction in measles, JE and hepatitis B transmission. High-quality in-country and regional surveillance systems have been established, improving the measurement of the burden of VPDs and providing information for effective disease outbreak responses and vaccine effectiveness. The United Nations High Commissioner for Refugees (UNHCR), UNICEF and WHO have recommended that refugees and migrants be immunized following the schedule of their host countries, but there have been large gaps in providing and financing targeted health services for such populations. One of the main health challenges is the lack of comprehensive health policies. Given the high transmissibility of VPDs combined with the harsh living condition of migrants, children are especially vulnerable to infections. Genetic sequencing in India has shown an association between VDPV infections and migration. Information gaps related to immunization schedules coupled with language barriers affect the health care of migrants. Undocumented status does not allow them to access health services, resulting in poor health outcomes among migrant children. Health promotion in schools to migrant children should therefore be considered. Non-exclusive policies through cross-border collaboration should be in place to better serve the health needs of vulnerable migrant populations. 6
Critical areas for investment, such as strengthened human resources, implementation costs, vaccine cold chain and storage should be considered by partners and UN agencies. Immunization services should be tailored for groups that have suboptimal coverage. 2.5 Evidence-based decision for immunization programme and roles of NITAGs 2.5.1 Global updates on NITAG establishment and strengthening activities Ms Louise Henaff, Technical Officer, Department of Immunization, Vaccines and Biologicals, WHO headquarters In 2010–2018, the number of countries with NITAGs fulfilling all Global Vaccine Action Plan requirements almost tripled from 41 to 114. As a result, around 85% of the world’s population resides in countries with well-functioning NITAGs. Throughout the years, their role has expanded from providing evidence-based recommendations on new vaccine introduction to general recommendations on NIPs. As a result, trainings have been a major component for NITAG strengthening. Guidelines with training materials are made available to all country NITAGs through the NITAG Resource Center (NRC), an online resource platform. WHO headquarters supports regional initiatives where NITAGs can network and collaborate via subregional trainings. Recommendations and workplans of other countries are shared to strengthen NITAGs and to build capacity. The preliminary results of a scoping exercise by WHO headquarters show that a three-day workshop is sufficient for a successful NITAG training. Materials should be tailored to each country’s context, and follow-up is critical for capacity-building. Creative approaches are also encouraged for post-training workshops. Future WHO efforts at the global level include revamping the NITAG Resource Center, which was first launched in 2015 with the purpose of centralizing information related to guidelines, trainings, and information on NITAGs. A new website will be available in January 2020. The 4th Annual Global NITAG Network (GNN) Meeting is scheduled to take place in February 2020. The network’s main objective is to function as a global platform to efficiently share knowledge while liaising with regional NITAG networks to address country-specific needs that strengthen processes for evidence-based decision-making. The Meeting will be co-organized with the United States Centers for Disease Control and Prevention (US CDC) and will take place back to back with the US Advisory Committee on Immunization Practices (US ACIP) meeting, allowing GNN participants to also attend the American NITAG meeting. GNN membership allows NITAG members to have access to policy updates, engage with other NITAG members, and participate in GNN and regional meetings to contribute on strategic issues. As a GNN member, responsibilities include participating in surveys, providing input to GNN documents, attending GNN-organized meetings and actively communicating updated information on country NITAGs to the GNN secretariat. There are four areas of work outlined in the GNN workplan: knowledge sharing, evaluation, capacity-building and meeting structures. Moving forward, WHO headquarters will work on revamping the NITAG Resource Center, establishing a GNN working group on training, revising training materials, and developing new guidelines and training materials. 2.5.2 Experience on evidence-based decision-making process from the Australian Technical Advisory Group on Immunization Professor Ross Andrews, Epidemiologist, Global and Tropical Health Division, Menzies School of Health Research, Darwin, Australia Australia has a birth cohort of 300 000 children who are offered protection against 17 VPDs across eight states and territories through a government-funded vaccination programme. The Australian 7
Technical Advisory Group on Immunization (ATAGI) provides advice on whether vaccines should be included in the NIP based on evidence of vaccine safety, efficacy, disease burden and other considerations. Its function is to equip the Minister for Health with necessary advice to improve the uptake and equity of access to vaccines. The ATAGI recommendations are an output of two processes: the preparatory phase and the pre-submission phase, which requires the participation of manufacturers/suppliers, an independent ATAGI Working Group and the Pharmaceutical Benefits Advisory Committee (PBAC). A key pillar of the new vaccine introduction recommendation process is ATAGI’s annual meeting with manufacturers. A working group is established and supported by the National Centre for Immunisation Research and Surveillance (NCIRS). This advice pathway identifies key questions and gathers data from the review of published and unpublished literature. Knowledge gaps are identified, and evidence is provided for discussion, but ATAGI provides the final recommendation. There are typically nine steps in generating recommendations: key questions, gathering data, epidemiological review, vaccine characteristics, important factors, identify gaps, draft recommendations, discuss at ATAGI and profile output. Vaccines are not introduced into the NIP unless there are positive recommendations from the PBAC, which is a separate decision-making body. As an ATAGI member, responsibilities include providing technical advice and clinical guidance on the medical administration of vaccines, review of ATAGI publications and its operational procedures. The PBAC decides whether the cost of the vaccine will be reimbursed by the government based on an internal tendering process with industry. The recently established Australian Regional Immunisation Alliance (ARIA), for example, is another independent group that collaborates with governments and global immunization partners, nongovernmental organizations and other partners with the aim of strengthening immunization to reduce the impact of VPDs in Australia and the WHO South-East Asia and Western Pacific regions. 2.5.3 Brunei Darussalam Dr Linda Lai, Senior Medical Officer, Child Health Immunization, EPI Manager, Ministry of Health Brunei Darussalam is a small nation located in northern Borneo that is divided into four main districts. Childhood immunization is routinely conducted through the child and maternal health services where 95% of immunizations are carried out. Brunei Darussalam’s NIP offers routine vaccines nationwide, while some newer vaccines are available through the private sector. Several vaccines have been introduced in the country with the most recent change taking place in 2012/13 with the introduction of the hexavalent (DTaP-IPV and HPV) vaccine. To date, there is no formal advisory body or NITAG providing recommendations on immunization to the Ministry of Health. In 2011, when changes were made to the NIP, an ad hoc committee chaired by director general of the Ministry of Health was created to make decision on the programme. However, there are no formal procedures or guidelines for the committee, which is mainly comprised of Ministry staff. Brunei Darussalam’s Vaccine Committee was responsible for implementing the NIP schedule changes in 2011/12, and their recommendations were presented to an executive committee of the Ministry and the Minister of Health and was later approved by the Ministry of Finance for budgetary purposes. Although there is no NITAG, there is recognition of the need for a committee to specialize in immunization-related recommendations. In 2017, the World Health Assembly recognized NITAGs as a basis for strong and effective immunization programmes, motivating Brunei Darussalam’s interest to establish such a group. No changes have been made to the country’s EPI since 2012, but there are plans to introduce new vaccines in the near future. Establishing a NITAG will support evidence-based recommendations that will endorse immunization-related issues to higher management levels. Having a NITAG will also improve the relationship of the Ministry of Health with other departments and engage other relevant members that support immunization (the private sector and so on). A 2019 working paper has been drafted, which is under review by the Minister of Health, and the terms of reference will be shared with potential NITAG members. The terms of reference outline the technical advice to the government on the control of VPDs, policy analysis and advice on the evidence related to new vaccines and their effectiveness. Members will be elected by the chairperson, and meetings will be held at least once a year. Possible 8
challenges include trying to ensure that the committee keep up to date with the latest evidence and the lack of resources to collect local data. 2.5.4 Cambodia Mr Ork Vichit, Manager, National Immunization Program, Ministry of Health Cambodia has a population of 15 million and a birth cohort of 368 000 within its 100 operational districts. A Technical Working Group for Health (TWGH) was established in 2006 under circular no. 519 which was signed by the Health Minister with the purpose of improving aid effectiveness in Cambodia. The Working Group has four main roles and functions: information sharing among key stakeholders, providing advice to the Ministry of Health on immunization strategies and policies, monitoring the performance of immunization, and facilitating intra- and intersectoral harmonization and alignment of immunization activities. There are 45 members within the Working Group, mainly Ministry of Health staff, bilateral and multilateral partners as well as paediatricians and gynaecologists. Members are mandated to ensure effective coordination in responding to health challenges, to be achieved by identifying priorities for discussion and improving mobilization of resources. The Working Group facilitates the implementation, monitoring and evaluation, and, where necessary, modification of the Health Strategic Plan. It is chaired by the Minister of Health or, in the event of his absence, by the Secretary of State. Their responsibilities include implementing the objectives of the Working Group and disseminating the minutes of the monthly meetings to all attending members. It also prepares and agrees on the annual workplan. 2.5.5 Indonesia Professor Sri Rezeki Hadinegoro, Head of Indonesia Technical Advisory Group on Immunization, Ministry of Health Indonesia is made up of five main islands that are subdivided into 34 provinces and 514 districts, with 2632 hospitals serving an infant population of 4.8 million. Since 1999, the Government’s system has been decentralized. The NITAG provides technical guidance to make evidence-based immunization- related and programme decisions. The Indonesian Technical Advisory Group on Immunization (ITAGI) received its formal name when it was established in 2007. Two members were replaced after a decree in 2016. The office is located under the directorate of the CDC. Core members are independent experts without conflicts of interest, most from academic organizations, appointed for a three-year term. ITAGI’s function is to provide technical advice on immunization schedules for both the private and public sectors, review articles for evidence-based decision-making and provide technical advice to help the government make decisions on immunization issues. Meetings are not open to the public, and vaccine manufacturers might be invited on an ad hoc basis. A summary of the discussion is used as information and shared, but the minutes of the meeting remain confidential. Items for the meeting agenda can be submitted by committee members and other stakeholders. Recent topics include changes of the epidemiology of VPDs, new vaccine introduction and new evidence on existing vaccine products. ITAGI plays a small role in the introduction of new vaccines, the most important factor being availability, cost and financial sustainability. It might take years to operationalize an ITAGI recommendation once accepted by the Ministry of Health. In the case of PCV, introduction was recommended in 2011, but the actual implementation only took place in 2017. 2.5.6 Lao People’s Democratic Republic Dr Phimmasone Sirimanotham, Core Member of Lao NITAG, Ministry of Health The Lao People’s Democratic Republic has a population of 7.1 million, of which 25% live below the poverty line and 71% in rural areas. Since 2013, the country’s NITAG has provided independent technical recommendations on immunization, but it was restructured and its terms of reference revised 9
in 2017. The terms of reference include providing technical advice to the Ministry of Health as well as presenting information to the inter-country committee (ICC) on a biannual basis. The secretariat must cooperate and coordinate with every party, and materials are disseminated along with the meeting invitations as instructed by the NITAG chair. A budget and annual plan is developed for implementation by the NITAG. It can establish working groups that are dedicated to assessing new vaccine introductions, for example for PCV, rotavirus and HPV vaccines. There have been three national meetings and workplans developed that have generated recommendations to introduce the HPV, rotavirus and influenza vaccines. NITAG members have attended three Strategic Advisory Group of Experts (SAGE) meetings for capacity-building and training. 2.5.7 Malaysia Dr A’Aisah Senin, Head of Sector, Vaccine Preventable, Food and Waterborne Diseases, Disease Control Division, Ministry of Health Malaysia’s NITAG equivalent is known as the National Immunization Policy and Practice Committee (NIPPC). It is the highest decision-making body on immunization. Members are appointed by the Director General of Health for a three-year term. There are four subcommittees that support NIPPC which are chaired by different national health divisions. Each subcommittee discusses different immunization-related topics, including a vaccine’s use and cost, the implementation of the national child immunization programme, pharmacovigilance and vaccine safety, and health education and promotion. They then report back to the NIPPC. Subcommittees can have more than one meeting a year. NIPPC meetings are held annually to discuss national reports on measles and rubella elimination and the maintenance of polio-free status. Any new proposal of vaccine introduction or changes in the current NIP is discussed in these meetings. Updates on WHO position papers and other relevant information on vaccines are also presented. Malaysia achieved polio-free status in 2000, and the decision to include PCV in the NIP was discussed and made in 2018. The elements considered for recommending introduction of a new vaccine include a disease burden assessment, cost-effectiveness analysis, vaccine-specific service delivery strategies, surveillance, monitoring and evaluation, and vaccine regulation and registration. Vaccination is not mandatory in Malaysia, but there is interest in passing an immunization law due to growing vaccine hesitancy, although the Government has preferred efforts geared towards immunization advocacy. Since 2009, PCV introduction has been frequently included in the NITAG agenda, and it was finally approved for introduction in 2018. 2.5.8 Myanmar Dr Yee Cho, National Professional Officer, WHO Country Office, presenting on behalf of NITAG members Myanmar is divided into 14 administrative states and regions and 330 townships with functional units for health-care services. To date, the Government financially supports 26% of vaccine costs while 74% is covered by Gavi. By 2025, the Government intends to finance all its vaccine costs. All vaccines are procured through UNICEF and are part of the essential health package of the universal health coverage (UHC) platform. There are plans to expand the NIP by introducing two more vaccines by 2020. Myanmar’s NITAG is the highest technical advisory group and is an independent body providing recommendations to the Ministry of Health and Sports on immunization policies. In 2017, the NITAG was re-established and further strengthened from its 2012 function and structure. Members are retired technical experts in paediatrics, microbiology and public health. The nomination process is led by the country’s EPI and officially nominated by the Ministry of Health and Sports. Member’s declare potential conflicts of interest verbally. The terms of reference are similar to other countries in region, including providing recommendations on vaccine-specific regulations, policies and strategies that are based on evidence. Decisions are made by consensus and discussion of the current epidemiology of VPDs. Meeting minutes are drafted by the secretariat and shared with NITAG members for review and 10
endorsement. Recent recommendations have included targeting the uncovered population in non-government-controlled areas (NGCA) as well as switching back from RotaVac to Rotarix. Accessibility to international network and local evidence-based data provide strengths and opportunities for NITAG members. 2.5.9 Philippines Dr Maria Wilda Silva, Medical Specialist II, Disease Prevention and Control Bureau, Department of Health The Philippines has more than 7000 islands, which are subdivided into three main geographic regions. From 1990 to 2008, its population has increased by 45% and half reside in the island of Luzon. The National Immunization Committee (NIC) was established in 1986 and was reconstituted following the dengue vaccine controversy in 2018. Its function serves as a forum to coordinate all aspects of the NIP where its core members have voting rights. There are 10–15 NITAG core members with voting rights; they are independent and do not represent a particular group or stakeholder. Experts in vaccinology, health economics, epidemiology, infectious diseases and other fields are all represented. There are biannual as well as ad hoc meetings. Potential conflicts of interest are declared in every meeting, and those with conflicting interests are not allowed to vote. Those who are employed by pharmaceutical companies or have consultancies, relatives and/or financial interests with pharmaceutical companies are not allowed to vote. The agenda items of the NIC are determined by the Department of Health or by members. Preparation takes place 3–12 months before the meeting, with documents circulated to members. The NIC decision-making process starts by selecting health issues presented by the Family Health Department which are then communicated by the NIC Chair to its members. A technical working group is formed with the function of gathering and appraising the evidence. Background documents are drafted along with a summary of all the evidence collected. A plenary presentation is conducted among the NIC, and recommendations are drafted and submitted to the Family Health Department. Examples of recent recommendations include the introduction of the JE vaccine, a booster dose of DTP during the second year of life, a shift from PCV13 to PCV10 and immunization of senior citizens against dengue. 2.5.10 Singapore Mr Yuske Kita, Senior Public Health Officer (Strategy and Prevention), Communicable Diseases Division, Ministry of Health, Singapore Singapore’s Expert Committee on Immunization (ECI) was established in 1975. Its key responsibilities focused on providing recommendations on the control of VPD among children through immunization, but priorities have shifted to include vaccines through the entire life course. There are 17 members, made up of eight core members, eight institutional representatives and a secretary. Each member has a renewable three-year term. Members are appointed by the Director of Medical Services and are all asked to declare their conflicts of interest at the beginning of each term and during face-to-face meetings. Core members are three paediatricians, two infectious disease specialists, two vaccine researchers/immunologists and a microbiologist. Roles of the secretariat include preparing background materials as well as collating and determining the agenda of the meeting in consultation with the ECI Chair. There are one or two face-to-face annual meetings and multiple consultations via email. ECI meetings are closed and exclude the participation of the pharmaceutical industry, only allowing selected internal and external stakeholders as observers. During the decision-making process, documents are circulated prior to the meeting and the decision is made through consensus, taking into consideration three factors: disease burden, vaccine safety and efficacy, and the cost-effectiveness of the vaccine. Communication is part of the implementation of recommendations following its approval. Recommendations are issued to doctors and health-care institutions through a circular. Future activities include enhancing and establishing a more standardized and robust economic evaluation of vaccines for inclusion of national programmes along with clearer governance. 11
2.5.11 Thailand Dr Piyanit Tharmaphornpilas, Senior Medical Advisor, Office of the Senior Expert Committee, Department of Disease Control, Ministry of Public Health Thailand’s advisory committee was initially established in 1970. In 2018, under the vaccine security act, the NITAG became one of the four subcommittees under the national vaccine committee (NVC). The NVC usually does not intervene in the decision-making process of the NITAG. Its recommendations are communicated to the Ministry of Public Health, which is responsible for its implementation. The NITAG composition includes academicians and technical experts on immunization, epidemiology, vaccine research, financing and quality assurance, and other specialties. The NITAG’s main function as a subcommittee is to provide advice and recommendations on vaccines for people of all ages as well as the vaccine’s administration to successfully reach its target population. The implementation of recommendations is beyond the NITAG’s scope of work and expertise. New vaccines are only introduced if they are cost-effective, have an acceptable budget impact and are included in the essential drugs list. If the National Health Security Office does not have funds in its budget, then the NITAG recommendations will be postponed. This was the case with HPV vaccine introduction where the NITAG had provided recommendations for its introduction since 2014. Due to lack of funds, the vaccine’s use was piloted as a school-based provincewide programme until 2017, since when the vaccine has been used nationwide for grade 5 schoolgirls. 2.5.12 Viet Nam’s National Immunization Technical Advisory Groups: membership, functions and mode of operation Professor Nguyen Tran Hien, Senior Researcher, National Institute of Hygiene and Epidemiology, Chair of Viet Nam’s NITAG Viet Nam has a population of 94 million that reside in four regions. The country’s EPI offers eight vaccines to children less than 1 year old. Viet Nam’s first immunization advisory committee was established in 1998 by the Ministry of Health. The committee’s TOR encompasses four main responsibilities: providing guidance on targeted immunization delivery, conducting assessments and research on immunization effectiveness, review of national immunization-related policies, and the development of standard operating procedures for its operation and function. As of 2017, the committee has been re-established with 16 committee members comprising paediatricians, epidemiologists, microbiologists, immunologists, and public health and other specialists. Eight members make up the committee’s secretariat. Members are selected through a nomination process for a five-year term and are required to declare any conflict of interest. NITAG members meet twice a year, and additional meetings can take place following requests from the Ministry of Health. The decision-making process is initiated by the secretariat, which collects, synthesizes and compiles background information and disseminates it to NITAG members. Decisions are made by consensus with approval from more than 50% of members. Working groups are established depending on the discussion topic. Summary of recommendations are prepared by the secretariat and are submitted to the Chair for approval. Potential activities for strengthening Viet Nam’s NITAGs include the development of operational regulations and the organization of workshops on specific issues with the purpose of sharing and updating information. 2.6 Capacity-building and networking among NITAGs 2.6.1 Updates from recent NITAG meeting from the South-East Asia Region Dr Sudhir Khanal, Technical Officer, Immunization and Vaccine Development (IVD), WHO Regional Office for South-East Asia The World Health Assembly’s 2017 and 2018 resolutions urge countries to strengthen country ownership and credibility through NITAGs, with the goal of improving national evidence-based 12
recommendations through a transparent process from an independent body. The WHO South-East Asia Regional Vaccine Action Plan 2016–2020 includes strengthening NITAGs as one of its strategic priority areas. Thailand was the first country to establish one in 1960, while Timor-Leste was the latest in 2015. Most NITAGs in the Region were established between 2007 and 2008. The scope of work in the Region includes providing guidance on immunization, introducing new vaccines and technologies, and updating information on safety and quality of vaccines. There are six indicators measuring NITAG functions: formal terms of reference, legislative mandate, representatives from five technical areas, agenda distributions, declarations of conflict of interest and at least two meetings annually. When measured against these indicators, all 11 countries in the Region had well-functioning and strong NITAGs. The question remains: Why measure and work on capacity-building if the Region’s NITAGs are already well established and functional? In response, there have been discussions on expanding this list of indicators to assess its functional effectiveness. There have been efforts to enhance collaboration and coordination between NITAGs and the South-East Asia Regional Immunization Technical Advisory Groups (SEAR-ITAG). In 2016, NITAGs started providing reports to the SEAR-ITAG and a year later the format of these reports were revised to include country-specific reporting on the eight goals of the Regional Vaccine Action Plan. Country NITAG reports are assigned two reviewers by the SEAR-ITAG chair. This report is then presented by the NITAG chairs in their respective annual meeting. Conclusions presented by NITAG chairs are compiled and then presented in the SEAR-ITAG. In March 2019, the WHO Regional Office for South-East Asia organized a regional meeting on strengthening the capacity of NITAGs to guide and monitor NIPs. Recommendations from this meeting included the review of the current terms of reference by health ministries and NITAG members, formalization of processes for policy briefs and members’ declaration of interest. Progress has been made since this meeting. Orientation meetings following the regional recommendations and format were conducted in Bhutan and Bangladesh, and Nepal has a similar meeting planned for November 2019. All NITAGs in the Region revisited workplans to include essential activities, and an external evaluation of NITAGs commissioned by the Regional Office is currently in progress. 2.6.2 Study tour experience from the Lao People’s Democratic Republic Dr Panome Sayamoungkhoun, Deputy Director, Mother and Child Center and EPI Manager, Ministry of Health The Lao NITAG was established in 2013, comprising experts and professionals from several departments. Its initial functioning was suboptimal because of limited expertise in the committee. In 2017, five senior officials travelled to Canberra to learn from ATAGI with the objective of studying its terms of reference and member selection, as well as learning how to organize and manage NITAG meetings, generate recommendations, and coordinate with other committees. These experiences were then communicated to the Lao Health Minister. As a result of this study tour, the NITAG was reformed in 2017 with new members recruited based on their technical expertise, reflecting improved and revised terms of reference. Recommendations are now successfully generated by the NITAG. In February 2020, the HPV vaccine will be introduced, although there are still issues related to funding gaps despite the government’s plan to co-finance the vaccine with Gavi’s support. The introduction of the rotavirus vaccine is being postponed due to a global shortage. Typhoid vaccines were also discussed, but the NITAG has requested stronger evidence to support introduction. As a result, the US CDC will support the collection of more data on typhoid disease burden. This will be further discussed by the NITAG in the coming months. There have been issues in procuring influenza vaccine through UNICEF after its price more than doubled from US$1.50 to US$3.50 per dose. The NITAG must now provide strong recommendations for the vaccine’s continued procurement and whether financing this more expensive vaccine is worth it. 13
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