European Vaccine Action Plan 2015-2020

European Vaccine Action Plan 2015-2020 European Vaccine Action Plan 2015-2020

Abstract The European Vaccine Action Plan 2015–2020 (EVAP) is a regional interpretation of the Global Vaccine Action Plan developed to address the specific needs and challenges related to immunization in the WHO European Region. Aligned with Health 2020 and other key regional health strategies and policies, EVAP was formulated through a consultative process, reviewed by Member States and endorsed by the European Technical Advisory Group of Experts on Immunization before submission to the 64th session of the Regional Committee for Europe in September 2014. EVAP’s aim is to guide Member States in the European Region towards their joint vision of a Region free of vaccine-preventable diseases. It establishes six goals (sustain polio-free status, eliminate measles and rubella, control hepatitis B infection, meet regional vaccination coverage targets at all administrative levels throughout the Region, make evidence-based decisions on introduction of new vaccines and achieve financial sustainability of national immunization programmes) and outlines a path to achieve them through defined objectives, priority action areas, proposed actions and an evaluation and monitoring framework. Keywords HEPATITIS B VACCINE IMMUNIZATION PROGRAMS MEASLES VACCINE POLIOVIRUS VACCINES PUBLIC HEALTH RUBELLA VACCINE Address requests about publications of the WHO Regional Office for Europe to: Publications WHO Regional Office for Europe UN City, Marmorvej 51 DK-2100 Copenhagen Ø, Denmark © World Health Organization 2014 All rights reserved. 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Design and layout: Like ApS, likecph.dk Document number: WHO/EURO:2014-2227-41982-57703 Abbreviations AEFI adverse events following immunization DTP diptheria-tetanus-pertussis ETAGE European Technical Advisory Group of Experts EVAP European Vaccine Action Plan GVAP Global Vaccine Action Plan IBD invasive bacterial diseases JRF WHO/UNICEF Joint Reporting Form NCC national certification commission for poliomyelitis eradication NITAG national immunization technical advisory group NVC national verification commission for measles and rubella elimination RCC Regional Certification Commission for Poliomyelitis Eradication RVC Regional Verification Commission for Measles and Rubella Elimination SCRC Standing Committee of the Regional Committee for Europe UNICEF United Nations Children’s Fund VPD vaccine-preventable disease Photo credits Cover: WHO/J. Christensen / p. i: Thomas Barwick/Getty Images / p. vii: WHO/Christopher Black / p. viii: WHO/B. Kadirov / p. 4: Media for Medical/Getty Images / p. 7: WHO/D. Oganova / p. 8: WHO / p. 13: BSIP/Getty Images / p. 14: Malin Bring / p. 17: WHO/J. Christensen / p. 18: Westend61/Getty Images / p. 21: WHO/D. Oganova / p. 22: Malin Bring / p. 25: Cliff Volpe/Getty Images / p. 26: Media for Medical/Getty Images / p. 29: BSIP/Getty Images / p. 30: BSIP/Getty Images / p. 32: Guido Mieth/ Getty Images / p. 37: WHO/K. Boymatova / p. 41: WHO / p. 42: istockphoto/Tian Zhan / p. 47: Malin Bring / p. 53: WHO/S. Deshevoi / p. 65: WHO/B. Kadirov / p. 66: Alex Martinez/Getty Images / p. 69: BSIP/Getty Images / p. 70: WHO/J. Christensen / p. 74: WHO / p. 78: Getty Images / p. 93: Hero Images/Getty Images / p. 94: WHO / p. 96: istockphoto Foreword VI Background 2 Purpose of the European Vaccine Action Plan 6 Development 8 Guiding principles 10 Structure 14 EVAP goal 1: Sustain polio-free status 20 EVAP goal 2: Eliminate measles and rubella 23 EVAP goal 3: Control hepatitis B infection 24 EVAP goal 4: Meet regional vaccination coverage targets at all administrative levels throughout the Region 26 EVAP goal 5: Make evidence-based decisions about introduction of new vaccines 29 EVAP goal 6: Achieve financial sustainability of national immunization programmes 30 EVAP goals 18 Vision 16 Introduction Contents EVAP objectives 32 EVAP objective 1: All countries commit to immunization as a priority 36 EVAP objective 2: Individuals understand the value of immunization services and vaccines and demand vaccination 42 EVAP objective 3: The benefits of vaccination are equitably extended to all people through tailored, innovative strategies 48 EVAP objective 4: Strong immunization systems are an integral part of a well-functioning health system 54 EVAP objective 5: Immunization programmes have sustainable access to predictable funding and high-quality supply 60 Monitoring and evaluation 66 Monitoring and evaluation framework 68 Monitoring results 69 Implementation at national level 70 Action plan development at national level 72 The role of partners 73 Annex 1. World Health Assembly resolution WHA65.17 endorsing the Global Vaccine Action Plan 74 Annex 2. European Vaccine Action Plan 2015–2020: monitoring and evaluation framework 78 Annex 3. Acknowledgements 94 VI European Vaccine Action Plan 2015 – 2020 The European Vaccine Action Plan 2015–2020 (EVAP) takes us in a new direction with initiative and renewed momentum. Developed at the request of Member States to facilitate the implementation of the Global Vaccine Action Plan (GVAP) in the WHO European Region, it challenges and inspires us to aim beyond our current level of effort and achievement. Resurgence of some vaccine-preventable diseases in the Region over the past five years has served as a wake up call, demanding urgent action. EVAP sets a new course by helping to ensure that immunization programmes are financially sustainable and anchored in well-functioning health systems. It particularly addresses equitable access to vaccination and empowers immunization programmes through new and ambitious strategies. Foreword Building on immunization progress and presenting new ways to take us forward VII Foreword The consultative process that resulted in EVAP brought together WHO, Member States of the European Region and their strategic partners, regional and national advisory bodies, donors and development agencies. This finished product represents a clear commitment to the principles of the European policy framework Health 2020. And it bears testimony to the importance of strong partnerships to pursue the Region’s immu- nization goals, including the elimination of measles and rubella, main- tenance of the Region’s polio-free status, control of hepatitis B infection and evidence-based introduction of new vaccines. It is my privilege to launch this new chapter in the history of immuniza- tion in the European Region. The success of our collective vision for a Region free of vaccine-preventable diseases depends on the sustained commitment of us all to provide sufficient human and financial resources to fully implement this Plan. We stand ready to take on this challenge together in line with Health 2020’s ultimate goal to equitably protect and promote health and well-being across the Region. Zsuzsanna Jakab WHO Regional Director for Europe Introduction

2 European Vaccine Action Plan 2015 – 2020 Background The aim of the global policy is to ensure that the full benefit of vaccination is available to all people Immunization has brought about a remarkable reduc- tion in child mortality in the WHO European Region over the past few decades. Today, nine of every 10 children in the Region receive at least a basic set of vaccinations during infancy and as a result lead healthier, more productive lives. Furthermore, significant advances have been made in developing and introducing new vaccines and expanding the reach of immunization programmes. More people than ever before are being vaccinated and access to and reception of vaccines by people other than infants is increasing. The Sixty-fifth World Health Assembly endorsed the Global Vaccine Action Plan 2011–2020 (GVAP) in resolu- tion WHA65.17 (Annex 1) as the operational framework for implementation of the vision of the Decade of Vac- cines. This policy envisions a world in which all individ- uals enjoy lives free from vaccine-preventable diseases. The aim of the policy is to ensure that the full benefit of vaccination is available to all people, regardless of where they are born, who they are or where they live. The ultimate success of GVAP depends on the commit- ment of Member States and partners. In this context, the Sixty-fifth World Health Assembly requested WHO regional offices to translate GVAP into regional plans. The “European Vaccine Action Plan 2015–2020” (EVAP) was drafted to complement, regionally interpret and adapt GVAP. Despite the wide diversity of health systems in the Eu- ropean Region, national immunization programmes are generally strong and routine national vaccination cover- age is high. Strong demand for immunization services has clearly had beneficial effects, increasing individual and social ability to protect infants and children and progress continues with the introduction of new vac- 1 WHO vaccine-preventable disease monitoring system, 2013 global summary. Global and regional immunization profile: European Region. Geneva: World Health Organization; 2013 (http://apps.who.int/immunization_monitoring/data/gs_eurprofile.pdf, accessed 24 July 2014). 2 CISID: centralized information system for infectious diseases [online database]. Copenhagen: WHO Regional Office for Europe (http://data.euro.who.int/cisid/, accessed 24 July 2014). 3 Back- ground cines to protect more people in more areas from more diseases. Nevertheless, the gains and commitment of the Region continue to be tested. Of the 11.2 million children born in the European Region in 2012, nearly 554 150 did not receive the complete three-dose series of diphtheria, pertussis and tetanus vaccine by the age of one year.1 In 2013 alone, Member States reported 31 685 cases of measles,2 39 367 cases of rubella,2 and wild poliovirus circulation was detected in the Region. Vaccines are available to the vast majority of the popula- tion of the European Region; however, variable com- mitment to action is impeding further progress and the innovative solutions and extension of services neces- sary to fulfil the rights of underserved, marginalized, migrant and disadvantaged children and families. The monitoring of vaccination and disease knowledge and attitudes and health-seeking behaviours are limited in the Region, which compromises the ability of authorities to respond adequately to the specific service delivery and information needs of susceptible and vulnerable populations, to successfully counter anti-vaccination sentiment and to tackle vaccine hesitancy. The capac- ity to manage and respond effectively to public con- cern about events related to vaccine safety also needs strengthening. “Variable commitment to action is impeding further progress.” The European Vaccine Action Plan (EVAP) 2015–2020 has been drafted to complement, regionally interpret and adapt GVAP. http://www.who.int/immunization/global_ vaccine_action_plan/en/ 4 European Vaccine Action Plan 2015 – 2020 5Back- ground The number of countries in the European Region with coherent, implemented legislation on vaccination is cur- rently unknown and multiyear financial commitment to vaccination through a structured, fully integrated plan is highly variable. Regionally, the overall share of total do- mestic expenditure for vaccination is increasing relative to countries’ economic growth. This is largely due to the introduction of new, more expensive vaccines, which re- quire further investment in both vaccine and associated delivery costs. Procurement practices are also variable and vaccine pricing has been identified as one of the key obstacles to the use of new vaccines in middle-income countries that do not have donor support. The increasing complexity of immunization service delivery requires that a larger volume of different types of data be collected, processed, analysed and shared for decision-making at various levels. The quality of data on administrative coverage is suboptimal in many countries, as is the quality of surveillance for vaccine- preventable diseases. The higher demands on immuni- zation programmes are testing whether investment in building human resources capacity is adequate. An inclusive, integrated approach to immunization re- quires the engagement of a wide range of stakeholders and opinion leaders from within the health sector and, more broadly, from sectors affected by the econom- ic and social burden of vaccine-preventable disease. Strategic intra- and intercountry partnerships must be strengthened and maintained to support immunization programmes, to raise the profile of immunization and to gain wide-ranging commitment. Source: Centralized information system for infectious diseases (CIS- ID) (http://data.euro.who.int/cisid/, data extracted 18 July 2014) The data are incomplete because not all Member States reported measles and rubella data for each year indicated. Reported measles and rubella cases (2008-2013) N um be r o f r ep or te d ca se s (in th ou sa nd s) 40 35 30 25 20 15 10 5 0 2008 2009 2010 2011 2012 2013 Measles Rubella 6 European Vaccine Action Plan 2015 – 2020 Purpose of the European Vaccine Action Plan The intention of EVAP is to set a course through a regional vision and goals for immunization and control of vaccine- preventable diseases from 2015 to 2020 and beyond, by defining priority action areas, indicators and targets and proposing a set of actions for each EVAP objective, taking into account the specific needs and challenges of Member States in the European Region. 7Purpose 8 European Vaccine Action Plan 2015 – 2020 Development Strengthening participation and ownership 9Devel- opment At its 63rd session in Çesme Izmir, Turkey, in September 2013, the Regional Committee requested that a regional vaccine action plan be presented at its 64th session. The Vaccine-preventable Diseases and Immunization Programme of the Regional Office consulted the European Technical Advisory Group of Experts on Immunization (ETAGE) in October 2013 on the scope of EVAP and the regional priorities and challenges that should be addressed. These were presented with a development plan and timeline to the Standing Committee of the Regional Committee for Europe (SCRC) in December 2013. The partners consulted include the United Nations Children’s Fund (UNICEF), the European Centre for Disease Prevention and Control, the United States Centers for Disease Control and Prevention, the United States Agency for International Development, the GAVI Alliance and the European Commission Directorate-General for Health and Consumers. Member States were consulted at the WHO European Regional Meeting of National Immuni- zation Programme Managers from 18–20 March 2014 in Antalya, Turkey, and feedback from dedicated review sessions contributed to further revision of the draft EVAP. In late March, the draft was pre-endorsed by ETAGE. On the basis of feedback from the SCRC in May 2014 and in line with input from Member States and partners during an online consultation in May 2014, the draft EVAP was finalized and endorsed by ETAGE before its submission to the Regional Committee in September 2014. This document provides an overview of EVAP’s goals, objectives, priority action areas and key components of its monitoring and evaluation framework. A shorter version of EVAP was submitted as a working document to the 64th session of the WHO Regional Committee for Europe (EUR/RC64/15). European Vaccine Action Plan 2015–2020 REGIONAL COMMITTEE FOR EUROPE 64th SESSION Copenhagen, Denmark, 15–18 September 2014 © WHO © WHO © WHO A shorter version of EVAP was submitted to the 64th session of the Regional Committee in September 2014 3 The Tallinn Charter: health systems for health and wealth. Copenhagen: WHO Regional Office for Europe; 2008 (http://www.euro.who.int/__data/assets/pdf_file/0008/88613/ E91438.pdf?ua=1, accessed 24 July 2014). 4 Investing in children: the European child and adolescent health strategy 2015–2020 (document EUR/RC64/12). To be submitted to the Regional Committee for Europe in September 2014 for consideration and adoption (http://www.euro.who.int/en/about-us/governance/regional-committee-for-europe/sixty-fourth-session/documentation/ working-documents/eurrc6412-investing-in-children-the-european-child-and-adolescent-health-strategy-20152020, accessed 24 July 2014). 5 European Action Plan for Strengthening Public Health Capacities and Services. Copenhagen: WHO Regional Office for Europe; 2012 (document EUR/RC62/12 Rev.1; http:// www.euro.who.int/en/about-us/governance/regional-committee-for-europe/past-sessions/sixty-second-session/documentation/working-documents/eurrc6212-rev.1-euro- pean-action-plan-for-strengthening-public-health-capacities-and-services, accessed 24 July 2014) 6 Integrated Global Action Plan for Pneumonia and Diarrhoea. Geneva: World Health Organization; 2013 (http://apps.who.int/iris/bitstream/10665/79200/1/9789241505239_eng. pdf, accessed 24 July 2014). 10 European Vaccine Action Plan 2015 – 2020 EVAP echoes the key strategic directions of Health 2020 The objectives of EVAP, expanding on GVAP, echo the policy priorities of Health 2020, through which the Re- gion is committed to reduce inequities and thus signifi- cantly improve the health and well-being of populations, strengthen public health and ensure people-centred health systems that are equitable, sustainable and of high quality (Table 1). Additionally, EVAP takes into consideration the guidance and directions of The Tallinn Charter: Health Systems for Health and Wealth3 (EVAP ob- jective 1), “Investing in children: the European child and adolescent health strategy 2015–2020”4 (EVAP objectives 2 and 3), the European Action Plan for Strengthening Public Health Capacities and Services5 (EVAP objectives 4 and 5) and Ending preventable child deaths from pneumonia and diarrhoea by 2025: the integrated global action plan for pneumonia and diarrhoea (GAPPD)6 (EVAP objectives 1 and 4). Furthermore, EVAP will contribute significantly to meeting the “Renewed commitment to elimination of measles and rubella and prevention of congenital rubella syndrome by 2015 and sustained support for polio-free status in the WHO European Region” endorsed in resolution EUR/RC60/R12. Guiding principles 11 Guiding principles EVAP is aligned with other regional strategies and commitments “Equitable access to immuni- zation as a cornerstone of a well-functioning health system” © David Evans © iStock © Fotolia Investing in children: the European child and adolescent health strategy 2015–2020 REGIONAL COMMITTEE FOR EUROPE 64th SESSION Copenhagen, Denmark, 15–18 September 2014 i The Integrated Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea (GAPPD) Ending Preventable Child Deaths from Pneumonia and Diarrhoea by 2025The integrated Global Action Plan for Pneumonia and Diarrhoea (GAPPD) Regiona l Comm ittee for Europe Sixty-se cond se ssion Malta, 1 0–13 Se ptembe r 2012 Europe an Acti on Plan for Stre ngthen ing Pub lic Heal th Capaci ties and Service s EUR/RC 62/12 12 European Vaccine Action Plan 2015 – 2020 Table 1. Alignment of European Vaccine Action Plan 2015–2020 to Health 2020 policy framework and strategy Improving health for all and reducing health inequalities Tackling the Region’s major health challenges of noncommunicable and communicable diseases Strengthening people-centered health systems, public health capacity and emergency preparedness, surveillance and response Creating resilient communities and supportive environments Improving leadership and participatory governance for health Investing in health through a life-course approach and empowering people EVAP objective 3: The benefits of vaccination are equitably extended to all people through tailored, innovative strategies. All five EVAP objectives are related to reducing the burden of vaccine-preventable disease. EVAP objective 3: The benefits of vaccination are equitably extended to all people through tailored, innovative strategies. EVAP objective 4: Strong immunization systems are an integral part of a well-functioning health system. EVAP objective 2: Individuals understand the value of immuni- zation services and vaccines and demand vaccination. EVAP objective 3: The benefits of vaccination are equitably extended to all people through tailored, innovative strategies. EVAP objective 1: All countries commit to immunization as a priority. EVAP objective 5: Immunization programmes have sustainable access to predictable funding and high-quality supply. EVAP objective 2: Individuals understand the value of immuni- zation services and vaccines and demand vaccination. EVAP objective 3: The benefits of vaccination are equitably extended to all people through tailored, innovative strategies. EVAP objective 5: Immunization programmes have sustainable access to predictable funding and high-quality supply. Health 2020 Strategic objectives Policy priorities European Vaccine Action Plan EVAP objectives EVAP objectives 13 Guiding principles 14 European Vaccine Action Plan 2015 – 2020 The objectives form the operational component of EVAP, for realization of the six goals by 2020. Within the aspirational vision of EVAP, six regional goals have been set, aligned with the Decade of Vaccines and the Global Vaccine Action Plan and in the context of the European Region. To attain these six goals, five EVAP objectives incorporating priority action areas and indicators have been developed. Progress towards achieving both the goals and the objectives will be monitored within a monitoring and evaluation framework (Annex 2). Structure 15 Structure Six regional goals Indicators and targets Five EVAP objectives Indicators and targets Priority action areas Monitoring and evaluation framework 16 European Vaccine Action Plan 2015 – 2020 Vision The EVAP vision incorporates regional principles and directions for immunization programmes during the period covered by EVAP and beyond. The vision reflects joint commitment to a common purpose by Member States, stakeholders and partners, with a long-term collective goal: “A European Region free of vaccine-preventable diseases, where all countries provide equitable access to high-quality, safe, affordable vaccines and immunization services throughout the life course.” 17 Vision EVAP goals Achievement of the vision and the outcomes of the actions undertaken within EVAP will be measured against the following EVAP goals. • Sustain polio-free status. • Eliminate measles and rubella. • Control hepatitis B infection. • Meet regional vaccination coverage targets at all administrative levels throughout the Region. • Make evidence-based decisions on introduction of new vaccines. • Achieve financial sustainability of national immunization programmes. 18 European Vaccine Action Plan 2015 – 2020 19 19 EVAP goals 7 Global polio eradication initiative. Geneva: World Health Organization; 2013 (http://www.polioeradication.org/Portals/0/Document/Resources/StrategyWork/PEESP_EN_ US.pdf, accessed 24 July 2014.) 8 Regional Certification Commission for Poliomyelitis Eradication 20 European Vaccine Action Plan 2015 – 2020 The European Region achieved certification of polio-free status in 2002 and has maintained this status. In line with the Global Polio Eradication Initiative, sustain- ing polio-free status depends largely on high vaccination coverage (EVAP objec- tives 2 and 3), high-quality surveillance (EVAP objective 4) and shifting to bivalent oral poliovirus vaccine and introducing inactivated poliovirus vaccine in line with the Polio Eradication and Endgame Strategic Plan 2013–20187 (EVAP objective 5). Sustain polio-free status EVAP goal 1 Indicator no wild poliovirus transmis- sion re-established in the Region Goal Sustain polio-free status Target 2018: no wild poliovirus transmission re-established in the Region (to be confirmed by the RCC8 at meeting in 2019) 21 21 EVAP goal 1 22 European Vaccine Action Plan 2015 – 2020 9 Regional Verification Commission for Measles and Rubella Elimination 23 23 EVAP goal 2 The Region has set 2015 as the target for interrupting transmission of measles and rubella. Once this target has been met, certification will follow in 2018, after three years of confirmed interrupted transmission. Elimination of measles and rubella will depend largely on obtaining political commitment (EVAP objective 1), achieving high coverage and closing immunity gaps (EVAP objectives 2 and 3) and ensuring high-quality, case-based surveillance (EVAP objective 4). Eliminate measles and rubella EVAP goal 2 Indicator percentage of countries with interruption of endemic measles and rubella trans- mission Goal Eliminate measles and rubella Targets 2015: interruption of en- demic measles and rubella virus transmission for > 12 months, with high-quality surveillance in all countries 2018: measles and rubella elimination by all countries verified by RVC9 10 Provisional indicator to be finalized after establishment of the regional hepatitis B control goal and endorsement by the Regional Committee in 2015. 24 European Vaccine Action Plan 2015 – 2020 The Region has the opportunity to establish and commit to controlling hepati- tis B and achieving further progress in controlling infection. Through EVAP, the Regional Office commits itself to prepare a programme and action plan for the control of hepatitis B infection and identify targets for 2020. The action plan will benefit from the strategic direction and objectives of EVAP and is expected to be discussed at the Regional Committee meeting in 2015. Control hepatitis B infection EVAP goal 3 Indicator percentage of countries that have achieved hepatitis B infection control10 Goal Control hepatitis B infection Target 2020: to be established 25 25 EVAP goal 3 26 European Vaccine Action Plan 2015 – 2020 11 DTP: diphtheria-tetanus-pertussis 27 27 EVAP goal 4 Member States in the WHO European Region are committed to further reducing health inequalities through Health 2020 by taking action on the determinants of health. EVAP frames this commitment within immunization by establishing regional vaccination coverage targets that are higher than those of the GVAP. It promotes a change in the way of working, by tailoring immunization pro- grammes to address inequities (EVAP objectives 2 and 3) and strengthening commitment to and the sustainability and functionality of national immunization programmes (EVAP objectives 1, 4 and 5). Meet regional vaccination coverage targets at all administrative levels throughout the Region EVAP goal 4 Indicator percentage of countries with ≥ 95% coverage with three doses of DTP11-containing vaccine at national level Goal Meet regional vaccination coverage targets at all admin- istrative levels throughout the Region Target 2020: 48 out of 53 countries (90%) with ≥ 95% cover- age with three doses of DTP-containing vaccine at national level 12 NITAG: national immunization technical advisory group 28 European Vaccine Action Plan 2015 – 2020 EVAP stresses the importance of evidence-based immunization policies in fur- ther improving good governance of immunization programmes. Establishing and strengthening independent advisory mechanisms at the national level (national immunization technical advisory groups) is critical for improving leadership and participatory governance (EVAP objective 1). EVAP recommends that countries review the evidence and make informed deci- sions, particularly with regard to the introduction of new vaccines, using all the available information, including disease burden and cost–effectiveness. Make evidence-based decisions on the introduction of new vaccines EVAP goal 5 Indicator percentage of countries that have made an informed decision on new vaccines, following the review of the relevant evidence by their NITAGs12 Goal Make evidence-based deci- sions on introduction of new vaccines Target 2020: at least 90% of all countries with NITAGs have made an informed decision on a defined set of new vaccines, following the review of the relevant evidence by their NITAGs 29 29 EVAP goal 5 30 European Vaccine Action Plan 2015 – 2020 13 Proposed regional indicator. Required data for the indicator already exists in the current JRF, but its definition requires revision. No additional reporting by countries is required. 14 This excludes two countries classified as low income as of 2012. 31 31 EVAP goal 6 Most countries in the Region have achieved financial self-sufficiency for vac- cines, and donor support is limited mainly to technical and financial assistance for operational components of immunization programmes, except in countries currently eligible for support from the GAVI Alliance. In the European Region, the remaining challenge in most countries is allocation of additional financial resources to expand immunization programmes. This will require increased commitment to immunization and sustainable access to long-term domestic funding (EVAP objectives 1 and 5). Achieve financial sustainability of national immunization programmes EVAP goal 6 Indicator percentage of countries that are financially self-suffi- cient for procuring routine vaccines13 Goal Achieve financial sustain- ability of national immuniza- tion programmes Target 2020: at least 5114 of 53 countries (96%) EVAP objectives 32 European Vaccine Action Plan 2015 – 2020 33 33 EVAP objectives The objectives of EVAP and the priority action areas thereunder are the technical and operational components required to achieve its six goals. EVAP incorporates the strategic objectives of GVAP that are relevant to the Region; priority action areas are defined to address regional priorities and challenges. Priority action areas have been set for each of the five EVAP objectives (see figure), with proposed actions that add further specificity and provide a framework for the Regional Office, Member States and partners to achieve the objectives. EVAP objectives 34 European Vaccine Action Plan 2015 – 2020 35 35 EVAP objectives VISION A European Region free of vaccine-preventable diseases, where all countries provide equitable access to high-quality, safe, affordable vaccines and immunization services throughout the life course EVAP OBJECTIVE 3 The benefits of vaccination are equitably extended to all people through tailored, innovative strategies EVAP OBJECTIVE 2 Individuals understand the value of immunization services and vaccines and demand vaccination EVAP OBJECTIVE 4 Strong immunization systems are an integral part of a well-functioning health system EVAP OBJECTIVE 5 Immunization programmes have sustainable access to predictable funding and high-quality supply EVAP OBJECTIVE 1 All countries commit to immunization as a priority EVAP goal 4 Meet regional vaccination coverage targets EVAP goal 3 Control hepatitis B infection EVAP goal 2 Eliminate measles and rubella EVAP goal 5 Make evidence-based decisions EVAP goal 6 Achieve financial sustainability EVAP goal 1 Sustain polio-free status 36 European Vaccine Action Plan 2015 – 2020 Political commitment to immunization as a priority is essential for optimizing the performance and impact of any immunization programme. Through such com- mitment, countries recognize the importance of vaccination as a critical public health intervention and a public good and acknowledge the value that immuniza- tion represents in terms of health, social and economic returns. Introducing and implementing an appropriate legislative framework is a tangible output, which allows ministries and public health agencies to define the national priorities and to make a sustainable commitment to immunization. Engaging with stakeholders and establishing formal, accountable, credible, transparent structures based on evidence-based decisions are required. The integration of immunization plans into broader health plans provides a platform for sustainable financial investment. Integration and commitment can be further enhanced by using immunization performance as one measure of the functionality of an integrated health system. Developing and disseminating advocacy tools and materials to enhance the profile of immunization and increase knowledge about its value and benefits will strengthen commitment to immunization. All countries commit to immunization as a priority EVAP objective1 15 Proposed regional indicator to be introduced in 2015. Required data for the indicator already exist in the current JRF. No additional reporting by countries is required. Indicator to be calculated at regional level from data reported in the JRF. 37 37 EVAP objective 1 Objective All countries commit to immunization as a priority Indicators presence of a NITAG domestic expenditure for routine vaccines per newborn15 Targets 2020: 48 out of 53 countries (90%) have a NITAG 2020: to be determined after assessing baseline value in 2015 38 European Vaccine Action Plan 2015 – 2020 1. Establish and strengthen legislative basis for immunization to enhance financial and programmatic sustainability of national immunization programmes. 2. Develop and utilize costed (multi-year) immunization plans (through engagement and consultation with all stakeholders) that include attainable vaccine-preventable disease burden reduction and programmatic targets, and that are well aligned with broader plans (i.e. health, social sector and government plans). 3. Establish or strengthen monitoring and evaluation mechanisms to assess financial and programmatic sustainability of national immunization programmes. 4. Establish, or strengthen existing, coordination and collaboration mechanisms between immunization stakeholders to enhance performance of the immunization programme through alignment and effec- tive management. 5. Strengthen immunization programme management capacity through continuous sustainable invest- ment in immunization programme administration at all levels (on programme planning, implementa- tion, evaluation). 6. Use immunization coverage as one of the key performance indicators for the national functionality of the overall health system. EVAP objective1 All countries commit to immunization as a priority Proposed actions Enhance governance of national immunization programmes with legislative and managerial tools. Priority action area 1 39 39 EVAP objective 1 1. Establish and support mechanisms to engage opinion leaders to build a strong alliance for the pro- motion of immunization at all levels, including the regional level. 2. Develop and disseminate audience-targeted evidence on the value and benefits of immunization (public health value, averting vaccine-preventable diseases and deaths; eliminating and eradicating targeted vaccine-preventable diseases; minimizing risks, social and economic costs associated with vaccine-preventable diseases). 3. Develop and disseminate the evidence base for the broader impact of immunization for individuals, households, communities and countries (on school enrollment, productivity, physical and cognitive development). 4. Advocate for inclusion of immunization in the agendas, plans and policies of wider governmental and nongovernmental fora both at an intra- and inter-country level. 5. Train immunization programme core staff and provide tools to build alliances, advocate for immuniza- tion and facilitate peer-to-peer exchange of information and best practices. Proposed actions Inform and engage opinion leaders and stakeholders with regard to the value of immunization to enhance commitment to immunization as a priority. Priority action area 2 40 European Vaccine Action Plan 2015 – 2020 1. Establish, or strengthen existing, independent advisory groups on immunization composed of recognized experts that provide evidence-based policy and strategy guidance to national immunization programmes in order to ensure improved credibility and good governance. 2. Establish, or strengthen existing, links with equivalent regional (European Technical Advisory Group of Experts) and global (Strategic Advisory Group of Experts) advisory bodies to promote improved access to and dissemination of immunization policies, strategies and tools. 3. Establish a regional platform for peer-to-peer exchange of information, best practices and tools between national immunization technical advisory groups (NITAGs) to create synergies. 4. Introduce tools to guide the analysis of evidence and methods to evaluate the quality of evidence to strengthen the strategic guidance formulation (decision-making) process. 5. Consider briefing the public on advisory group recommendations to contribute to transparency and credibility. 6. Assess regularly the performance and impact of NITAGs against indicators set by WHO. Proposed actions Strengthen the national immunization technical advisory mechanism to formulate and implement evidence-based policies. Priority action area 3 All countries commit to immunization as a priorityEVAP objective1 41 41 EVAP objective 1 42 European Vaccine Action Plan 2015 – 2020 Individuals understand the value of immunization services and vaccines and demand vaccination EVAP objective2 16 VPD: vaccine-preventable disease 17 Proposed regional indicator to be introduced in 2015 from data already in the JRF. Proxy indicator for assessing communication planning capacity. 43 43 EVAP objective 2 Protecting the public health gains made by immuniza- tion programmes and improving their impact depend on individuals understanding the benefits and risks of vaccination and the diseases it prevents, demanding vaccination as both their right and their responsibility, making evidence-informed choices, being encouraged to seek immunization services, taking responsibility to protect children, adolescents and adults throughout the life course and being sufficiently engaged and empow- ered to influence health service provision and overcome barriers to vaccination. EVAP positions immunization as a right and a responsi- bility, thus recognizing vaccination as a responsible pub- lic health measure and prompting countries to view the immunization gap not as a burden but as an opportunity to advocate for commitment. It also presents a basis for which countries, partners and stakeholders can hold each other accountable. Generating and maintaining demand for immunization services and addressing vac- cine hesitancy in the European Region will require use of traditional and new social communication platforms, optimizing the role of front-line health care workers, identifying and leveraging immunization champions and agents of change, tailoring immunization programme advocacy and communication to susceptible popu- lations, including mobile, marginalized and migrant populations, and communicating the benefits of immu- nization and the risks presented by vaccine-preventable diseases. The barriers to vaccine demand are complex and context specific. They include social, cultural and other behavioural determinants, and programmes must therefore moni- tor and assess general public and subgroup attitudes, knowledge and behaviour more frequently, to inform and tailor programme delivery and response. Success in countering anti-vaccination sentiment and safety concerns will depend on this in particular. Indicator percentage of countries that have a communications plan in case of a VPD16 outbreak17 Objective Individuals understand the value of immunization services and vaccines and demand vaccination Target 2020: all 53 countries have a communications plan in case of a VPD outbreak 44 European Vaccine Action Plan 2015 – 2020 1. Introduce research methods to monitor public perceptions, knowledge, attitudes and opinions. Ensure that research-practice mechanisms are in place to assure evidence-informed communication and messaging. 2. Open and maintain dialogue through multiple communication channels; with particular emphasis on utilizing social media and new media technology. 3. Implement multi-channel vaccination advocacy and communication activities and dedicated media campaigns, using traditional and new media to transmit information that responds to people’s con- cerns and fears. 4. Monitor and respond to inaccurate or false information and anti-vaccination sentiment. 5. Ensure a timely, transparent and trustworthy response to reported or suspected adverse events fol- lowing immunization or vaccine safety scares. 6. Expand the immunology and vaccinology components of the basic medical education curricula and provide health worker in-service training opportunities – through medical education institutions, health authorities and health professional associations and societies. 7. Train health workers on risk communication in order to maximize the role they play in allaying vaccine safety fears, tackling vaccine hesitancy and emphasizing the benefits and value of vaccines. Individuals understand the value of immunization services and vaccines and demand vaccination Proposed actions Ensure that individuals receive information about the risks of vaccine-preventable diseas- es and the benefits of and risks of vaccination, and that trust in vaccines, immunization services and health authorities is enhanced. Priority action area 1 EVAP objective2 45 45 EVAP objective 2 1. Map and recruit new voices and agents of change, including educators, religious leaders, traditional and social media personalities, family physicians, community health workers, health mediators and trained immunization champions. 2. Cultivate relationships with media, encouraging balanced immunization reporting and immunization training of national and subnational media, ultimately increasing the share of voice in the media for the benefits of vaccines, especially online. 3. Engage, enable and support in-country professional associations and societies, academic institutions and civil society organizations, to advocate the value of vaccines to communities, policy-makers and the media. 4. Link national and subnational authorities and immunization service providers with the global elimina- tion and eradication advocacy efforts (Global Polio Eradication Initiative and Measles & Rubella Initia- tive), so that they may maximize utilization of global initiative communication and advocacy resources, materials and expertise. Proposed actions Engage new partners, advocates, champions and ambassadors to convey messages and maintain a positive media environment. Priority action area 2 46 European Vaccine Action Plan 2015 – 2020 Individuals understand the value of immunization services and vaccines and demand vaccinationEVAP objective2 1. Develop evidence-informed communication plans for new vaccine introduction. 2. Leverage the routine immunization communications and advocacy legacy to support new vaccine introduction. At the same time, maximize the opportunity presented by vaccine introduction to promote immunization services and advocate for vaccination. 3. Include a public opinion, knowledge and attitudes research component in all post-introduction evaluations Proposed actions Build the risk communication capacity of authorities, so that they can prepare and imple- ment communication strategies and campaigns based on reliable research and evidence in order to stimulate demand for routine childhood vaccination and for inclusion of new and underused vaccines in the national immunization schedule. Priority action area 3 47 47 EVAP objective 2 48 European Vaccine Action Plan 2015 – 2020 National immunization programmes should provide services to everyone to ensure that every individual can benefit from good health throughout the life course without the negative consequences of vaccine-preventable diseases. Every individual in society should be eligible to receive all appropriate vaccines, irrespective of their geographical location, age, gender, educational level, socio- economic status, ethnicity, nationality or religious or philosophical affiliation. Member States should ensure that immunization policies are non-discriminatory and that the services are fully inclusive and user-friendly, particularly for mar- ginalized communities and minorities. While some underserved groups have been identified in the Region, operational research, including social research, is needed to identify other such populations and to determine the causes of their inadequate access. Tools and approaches to identify susceptible populations, determine barriers to vaccination and imple- ment new, evidence-based strategies or service components should be applied to meet the needs of underserved populations, including adolescents and adults not usually targeted by immunization programmes. Research is required to iden- tify the main causes of low coverage of vaccination, assess systematic and pro- grammatic issues and socioeconomic and cultural barriers, determine the best The benefits of vaccination are equitably extended to all people through tailored, innovative strategies EVAP objective3 18 Percentage of countries with ≥ 95% coverage with three doses of DTP-containing vaccine at national level. (Same as the indicator of EVAP Goal 4.) 19 Proposed regional indicator to be introduced in 2015. The data required for the indicator are already in the current JRF. No additional reporting by countries is required. 49 49 EVAP objective 3 approaches for vaccinating individuals of various age groupings and assess the most effective interventions for reaching different groups. In humanitarian crises, outbreaks and emergencies, equitable access must be assured for all affected groups. Integrated electronic immunization registries are a powerful tool for identifying unvaccinated and undervac- cinated individuals and groups and for monitoring the success of immunization programmes. The development and extension of such registries and their integration into broader health and social registries should be ac- tively encouraged. The extent of implementation and ap- propriate use of electronic immunization registries in the European Region is not yet known. A baseline assess- ment will be conducted in 2015 to permit measurement of improvement during the period covered by EVAP. Strategies that successfully reach and improve coverage of underserved populations should be documented and shared to ensure best practice throughout the Region. Indicators percentage of countries with ≥ 95% coverage with three doses of DTP-containing vaccine at national level18 percentage of countries with ≥ 90% of districts with ≥ 90% coverage with three doses of DTP-containing vaccine19 Objective The benefits of vaccination are equitably extended to all people through tailored, innovative strategies Targets 2020: 48 out of 53 countries (90%) with ≥ 95% cover- age with three doses of DTP-containing vaccine at national level 2020: all countries with ≥ 90% of districts with ≥ 90% coverage with three doses of DTP-containing vaccine 50 European Vaccine Action Plan 2015 – 2020 1. Make use of immunization programme data (vaccination coverage and disease epidemiology data) and other information to identify underserved populations (groups). 2. Utilize operational research and social sciences to identify underlying causes for inequities. 3. Ensure that there is no legal barrier to accessing immunization services by underserved populations. Proposed actions Identify underserved populations (groups) and the causes of inequities on a regular basis. Priority action area 1 The benefits of vaccination are equi- tably extended to all people through tailored, innovative strategiesEVAP objective3 51 51 EVAP objective 3 1. Develop and implement tailored approaches that address underlying causes in eliminating inequities through improving accessibility and quality of immunization services. 2. Involve representatives of underserved and marginalized populations throughout the process of devel- oping and delivering tailored service delivery approaches. 3. Develop and implement target-group-specific immunization delivery approaches when expanding immunization beyond infancy and early childhood within the framework of a life-course approach. 4. Pay special attention to migrants, international travellers and marginalized communities, in ensuring their eligibility and access to (culturally) appropriate immunization services and information. 5. Apply oversight to ensure that immunization policy is nondiscriminatory and that services are fully inclusive and user friendly, particularly for marginalized communities and minorities. 6. Develop plans and standard operating procedures for timely and effective response to vaccine-pre- ventable diseases during outbreaks, humanitarian crises and emergencies. 7. Build upon proven-effective approaches in reaching underserved groups, such as the “Reaching Every District” strategy. (Microplanning for immunization service delivery using the Reaching Every District strategy, Geneva: World Health Organization; 2009 (http://www.who.int/immunization/sage/9_Final_ RED_280909.pdf, accessed 24 July 2014)). 8. Track each individual’s immunization status, preferably through introduction of electronic immuniza- tion registries that are well integrated within health information systems and leverage other relevant civil registries. 9. Train immunization managers and service providers to implement new strategies and tailored approaches to underserved and marginalized populations (training on planning and implementing tailored approaches, communication skills, engaging existing community structures and civil society organizations in planning and implementing tailored approaches, monitoring and evaluation). Proposed actions Design and implement tailored, innovative strategies to address identified causes of inequity. Priority action area 2 52 European Vaccine Action Plan 2015 – 2020 1. Supervise implementation and monitor performance of tailored approaches in reaching underserved groups and reducing inequities. 2. Document and disseminate best practices in reaching underserved groups. Proposed actions Create a system and capacity to ensure equitable delivery. Priority action area 3 The benefits of vaccination are equi- tably extended to all people through tailored, innovative strategiesEVAP objective3 53 53 EVAP objective 3 54 European Vaccine Action Plan 2015 – 2020 The relationship between a strong national immuniza- tion programme and a well-functioning health system is mutually beneficial. National immunization programmes benefit from integration into strong health systems by coordination with other programmes, the private sector, partners and communities to deliver existing and intro- duce new vaccines, ensure vaccination throughout the life course and attain quality, equity and coverage goals. Integration of immunization into broader health sys- tems policy is essential for a coordinated, multidiscipli- nary approach to building cohesive, non-fragmented, well-functioning immunization services, working in synergy with other public health and individual care programmes and linked to national health policy values, priorities and strategies. Immunization service delivery can support other public health priorities, and other health programmes should support immunization. Particularly when new vaccines are being introduced and during campaigns and emergencies, vaccination is one component of a wider public health effort and should be integral to comprehensive disease control strategies and plans. A strong immunization programme requires well- trained, competent staff, high-quality data and informa- tion, laboratory-based surveillance of vaccine-prevent- able disease, coordinated systems management and effective monitoring, evaluation and communication. Sufficient human resources with adequate knowledge and skills are the most important element for ensuring the success of increasingly complex immunization pro- grammes and increasingly ambitious goals. Continuous medical education and structured learning systems within the broader health context are required. The functionality of national regulatory authorities is critical in assuring vaccine quality. Post-marketing surveillance is of particular importance for informing decision-making on risk mitigation and responding to vaccine safety concerns. Strategies are required to ensure that sufficient sup- plies (for example, of vaccines and safe injection mate- rials) are available at the right time, at the right place and in the right condition in order to reach vaccination coverage goals. Strong immunization systems are an integral part of a well- functioning health system EVAP objective4 20 Global indicator to be calculated at regional level from data in JRF. No additional reporting by countries is required. 21 WHO and UNICEF estimates on national immunization coverage grade of confidence based on reported and survey coverage data. 22 Global indicator. Required data already exist in the current JRF. No additional reporting by countries is required. Vaccine-preventable disease surveillance will consist at a minimum of country-wide surveillance for poliomyelitis, measles and rubella, and hospital-based sentinel surveillance for IBDs and rotavirus 23 Proposed regional indicator. Required data already exist in the current JRF. No additional reporting by countries is required. 24 AEFI: adverse events following immunization 55 55 EVAP objective 4 Indicators percentage of countries with less than 5% drop-out rate between first and third dose of DTP-containing vaccine percentage of countries with sustained coverage with DTP-containing vaccines of ≥ 90% for three or more consecutive years20 percentage of countries with immunization coverage data assessed as of high quality by WHO and UNICEF21 percentage of countries with case-based surveillance for vaccine-preventable diseases22 percentage of countries with sustained access to WHO- accredited polio and measles- rubella laboratories23 presence of an expert review committee to assess causality for AEFI24 percentage of countries with no stock-outs for any routine vaccine at national level Targets 2020: all 53 countries with < 5% dropout rate between first and third dose of DTP-containing vaccines 2020: all countries with sus- tained coverage with DTP- containing vaccines of 90% or greater for three or more consecutive years 2020: all countries with high-quality immunization coverage data 2015: all 53 countries have country-wide surveillance for po- liomyelitis, measles and rubella 2020: 40 out of 53 countries (75%) have sentinel site surveil- lance for IBDs and rotavirus 2020: all 53 countries have sustained access to WHO- accredited polio and measles- rubella laboratories 2020: all 53 countries have an expert review committee in place 2020: 50 out of 53 countries (95%) with no stock-outs for any routine vaccine at national level Objective Strong immunization systems are an integral part of a well-functioning health system 56 European Vaccine Action Plan 2015 – 2020 1. Ensure that global disease eradication and elimination initiatives (polio eradication, measles–rubella elimination) are incorporated into national immunization programmes and do not operate inde- pendently. 2. Ensure that new vaccine (rotavirus, pneumococcal, human papilloma virus vaccine) introduction plans are accompanied by comprehensive plans to control targeted diseases in a more effective manner. 3. Ensure coordination between the public and private sectors for new vaccine introduction, administra- tion of vaccines, reporting of vaccine-preventable diseases and vaccinations; and ensure the quality of vaccination delivered by private providers. 4. Consider expanding immunization beyond infancy and early childhood by inclusion of vaccines (as appropriate to national priorities) in national immunization programmes through a life-course approach. 5. Ensure that national immunization programme components (such as vaccine procurement, vaccine regulations, vaccine pharmacovigilance, laboratory-based vaccine-preventable disease surveillance, immunization information systems) are well integrated with broader (health) system components. 6. Ensure coherence and alignment with broader health policies (child and adolescent health, public health and health systems policies). 7. Ensure active engagement of immunization advocates in planning and management of health system changes (decentralization, changes in service provision and financing) to secure and reposition essential functions of the national immunization programmes within restructured health systems. 8. Ensure that essential functions of immunization programmes are kept centralized under decentral- ized health systems (so that the public good aspect of immunization is not neglected, inequities are not exacerbated and economies of scale are not lost). Strong immunization systems are an integral part of a well-functioning health system Proposed actions Develop comprehensive, coordinated approaches within the immunization programme and the health system. Priority action area 1 EVAP objective4 57 57 EVAP objective 4 1. Improve the quality of immunization data and promote its analysis and use on a regular basis at all administrative levels (facility, subnational and national levels) to improve programme performance (through introduction of standard operating procedures). 2. Develop and promote the use of new information technologies for collection, transmission and analysis of immunization data within immunization information systems that are well integrated with communicable disease and health information systems. 3. Assess quality of immunization data by checking validity of immunizations and accuracy of processed data and target population data for immunizations. 4. Further strengthen and expand laboratory-based and case-based vaccine-preventable disease sur- veillance systems to generate information for decision-making and monitor the impact of immuniza- tion. 5. Strengthen the quality of laboratories through introduction of quality assurance and accreditation systems. 6. Strengthen data management systems so that laboratory-based surveillance and epidemiology data systems reconcile and support each other. 7. Ensure capacity for vaccine safety activities, including capacity to collect and interpret safety data, with particular emphasis on newly developed and introduced vaccines. 8. Ensure that adverse events following immunization (AEFI) surveillance systems (pharmacovigilance) are in place and are an integral part of regional and global networks. 9. Secure monitoring and surveillance systems and their functionality in health systems in transition. Proposed actions Strengthen monitoring and surveillance systems. Priority action area 2 58 European Vaccine Action Plan 2015 – 2020 1. Ensure that immunization and other primary health care programmes have adequate human resourc- es to plan and deliver predictable high-quality services, and efficiently use existing human resources (through incentive mechanisms). 2. Increase levels of pre-service and in-service training for human resources, and develop new, relevant curricula that approach immunization as a component of comprehensive disease control. 3. Utilize new learning techniques to intensify capacity building efforts, and promote and support learn- ing at all levels (such as e-learning, peer-to-peer, twinning, networking). 4. Enhance sustainability of in-service training activities through integration with continuous medical education and accreditation systems. 5. Ensure synergies between training and supervision efforts. Proposed actions Strengthen the capacity of managers and front-line workers. Priority action area 3 Strong immunization systems are an integral part of a well-functioning health systemEVAP objective4 59 59 EVAP objective 4 1. Develop and introduce standards and operating procedures for immunization supply systems that are well integrated with broader supply systems. 2. Explore introduction of new technologies and innovative solutions to immunization supply systems and waste management systems. 3. Adopt systematic approaches to assess the quality of immunization supply systems on a regular basis, and develop and implement immunization supply system improvement plans. 4. Apply similar standards to the quality of supply systems that are not directly supervised by national immunization programmes (private sector supply and outsourced systems). 5. Minimize the environmental impact of energy, materials and processes used in immunization supply systems, where applicable and affordable. 6. Staff supply systems with adequate competent, motivated and empowered personnel at all levels. 7. Establish information systems and where affordable, electronic systems, that help staff to accurately track available supply and to monitor quality of the cold chain system. Proposed actions Strengthen infrastructure and logistics. Priority action area 4 60 European Vaccine Action Plan 2015 – 2020 The financial sustainability of a national immunization programme is crucial to its continued impact and performance in achieving national, regional and global disease prevention goals. Financial sustainability includes secured long-term domestic funding to meet programme objectives and efficient use of available resources. In view of the investment required, strong decision-making process- es must be based on economic evaluation to support and justify investment in vaccines and vaccination. Promoting the benefits of immunization among deci- sion-makers is important for increasing investment. Strengthening immunization financing, finding new, innovative financing mech- anisms and enhancing resource mobilization to sustain financial resources are necessary to achieve the expanding objectives of national immunization programmes. Evidence-based justification for greater investment will require strengthened national immunization technical advisory groups. A planned approach is required to move towards greater financial self-sufficiency in the funding of both vaccines and essential services of national immunization pro- grammes, especially in low- and middle-income countries. Immunization programmes have sustainable access to predictable funding and high-quality supply EVAP objective5 61 61 EVAP objective 5 25 Fully functional: for countries that produce vaccines, all functions (marketing authorization and licensing, post-marketing surveillance, lot release, laboratory access, regulatory inspections and supervision of clinical trials); for countries with self-procurement, at least marketing authorization and licensing, post-marketing surveillance, lot release and laboratory access; for countries that procure vaccines through United Nations agencies, at least marketing authorization and licensing and post-marketing surveillance. 26 Proposed regional indicator to be introduced in 2015. Data required for the indicator already exist in the current JRF, but the definition requires revision. No additional reporting by countries is required. Access to quality-assured vaccines at affordable prices is a major component of efficient use of funds. This requires an efficient procurement system and a fully functional regulatory authority. Predictable, transparent pricing and innovative pro- curement mechanisms are needed to alleviate funding pressure and scale-up the use of existing vaccines at af- fordable prices. Exploring the best procurement options to meet country needs and better understanding of the vaccine market will empower self-procuring countries to operate appropriately in the global vaccine market to secure a sustainable, affordable supply. Networking and information exchange among nation- al regulatory authorities in the Region will result in effective standardization, alignment and compatibility of normative and regulatory processes. Capacity in licensing and registration, particularly in middle-income countries, should be developed in a planned, systematic way to enhance competition and ensure vaccine quality. Indicator percentage of countries with a fully functional25 national regulatory authority26 Objective Immunization programmes have sustainable access to predictable funding and high-quality supply Target 2020: all countries have a fully functional national regulatory authority (or have access to regional quality assurance mechanisms) 62 European Vaccine Action Plan 2015 – 2020 1. Establish a commitment from governments to allocate adequate financial resources to immunization as required, to meet programme objectives. 2. Conduct representative epidemiological, immunological, social and operational studies and investiga- tions of vaccine impact to guide advocacy efforts on benefits of immunization and value of vaccines. 3. Advocate for benefits of immunization to sustain political commitment to immunization (in order to sustain and take forward immunization achievements) in alignment with Objective 1. 4. Allocate adequate funding for operational activities to improve the quality of immunization services, such as training, supervision, monitoring, surveillance, advocacy and communication. 5. Identify and implement strategies that lead to increased programme efficiency without compromising equity gains. 6. Increase reliability of funds through earmarking and ensuring timely disbursement of funds. 7. Develop the next generation of innovative financing mechanisms to increase and sustain funding for immunization, as required. Proposed actions Allocate adequate financial resources to national immunization programmes to achieve their objectives in the context of achievement of financial self-sufficiency. Priority action area 1 Immunization programmes have sustainable access to predictable funding and high-quality supplyEVAP objective5 63 63 EVAP objective 5 1. Improve efficiency of vaccine procurement systems based on regular performance assessment find- ings. 2. Improve knowledge on the specificities of vaccine procurement and global market dynamics to opti- mize actions and activities in countries. 3. Support price transparency efforts regionally and globally through increased sharing of vaccine price information. 4. Optimize competitiveness in the local vaccine market through increasing the range of available quali- ty-assured vaccines. 5. Explore pooled negotiation, innovative procurement mechanisms and information exchange of best practices to optimize outcomes. 6. Support and engage with global efforts in defining explicit criteria for access to vaccine prices (partic- ularly for middle-income countries). Proposed actions Increase access to quality-assured vaccines at affordable prices. Priority action area 2 64 European Vaccine Action Plan 2015 – 2020 1. Conduct assessment of national regulatory authorities on a regular basis (against established inter- national standards for required functions) and formulate institutional development plans that address challenges. 2. Implement institutional development plan activities and recommendations to strengthen national regulatory authority functions. 3. Harmonize national vaccine quality assurance activities with regional and global systems. 4. Build and support networks of regulators to share best practices and to improve quality assurance capacities. Proposed actions Strengthen regulatory mechanisms to ensure access to and use of quality-assured vac- cines in national immunization programmes. Priority action area 3 Immunization programmes have sustainable access to predictable funding and high-quality supplyEVAP objective5 65 65 EVAP objective 5 Monitoring and evaluation 66 European Vaccine Action Plan 2015 – 2020 67 Monitoring 68 European Vaccine Action Plan 2015 – 2020 In resolution WHA65.17, the World Health Assem- bly urged Member States to report every year to the regional offices on lessons learnt, progress made, remaining challenges and updated actions to reach the national immunization targets and requested the WHO Secretariat to monitor progress and report annually to the Health Assembly on progress towards achievement of global immunization targets, using the proposed monitoring and evaluation framework (Annex 1). On the basis of guidance from the ETAGE, a regional monitoring and evaluation framework, aligned with the global framework, has been developed to monitor progress in implementation of EVAP (Annex 2). In order not to overburden Member States, they may use the existing WHO/UNICEF Joint Reporting Form (JRF) to report data for EVAP monitoring and evalua- tion. To use the JRF for this purpose, the Secretariat of the Regional Office suggests minor changes to some indicators, with no new indicators or variables. It is proposed that the same timelines for reporting will be used. The Secretariat will prepare annual progress reports on the implementation of EVAP (including reporting on GVAP indicators) in the Region on the basis of these data, which will be reviewed by the ETAGE and submitted to the Health Assembly through the Executive Board. Streamlined reporting on progress towards regional goals Monitoring and evaluation framework Monitoring results Progress towards achieving the EVAP goals and objectives, as measured by the respective indicators, will serve as the basis for monitoring throughout the decade. It is therefore essential that reporting on the JRF by Member States be timely and complete. 69 Monitoring Implementation at national level 70 European Vaccine Action Plan 2015 – 2020 71 71 Imple- mentation Implementation at national level 72 European Vaccine Action Plan 2015 – 2020 Developing effective national policies and strategies on vaccine-preventable diseases and immunization and setting up mechanisms for their implementa- tion and monitoring require the active involvement of all stakeholders, guided by national immunization programmes. Therefore, the starting point for action must be shared recognition by all stakeholders of the need for a national immunization plan that addresses national priorities and challenges and provides clear strategic and operational guidance on meeting national targets aligned with regional and global ones. Member States should consider taking the following steps to ensure successful outcomes. • Review, prepare or update national immunization plans in line with the strategic guidance provided by EVAP and national priorities, with the engagement of all stakeholders. • Develop or update actions on the basis of lessons learnt, and target remaining challenges. • Cost the national immunization plan, and identify any funding gaps. • Ensure that adequate financial resources are allocat- ed to meet the objectives. • Ensure that accountable monitoring and evaluation mechanisms are in place to monitor implementation. EVAP provides guidance to Member States in formula- ting national immunization plans that reflect key issues and challenges in the Region. It thus orients all stake- holders towards a unified regional vision and provides strategic and operational guidance for policy-makers and planners for addressing priorities and challenges most efficiently and effectively through the proposed strategies and actions. The WHO Regional Office for Europe will continue to support Member States in protecting their populations against vaccine-preventable diseases. Action plan development at national level 73 73 Imple- mentation The contributions of national and regional partners ensure adoption of a shared approach and optimized efforts to protect the health of individuals. Country actions and initiatives to reach EVAP objectives should be technically supported and complemented by the activities of the Region’s immunization partners and donors. Important partners for Member States include UNICEF, the European Commission and its institutions and agencies (such as the European Centre for Disease Prevention and Control), partners and donors of the Measles and Rubella Initiative and the Global Polio Eradication Initiative, including the United States Centers for Disease Control and Prevention, the United States Agency for International Development, the GAVI Alliance and Rotary International, European bilateral development agencies, academic institutions, WHO collaborating centres, professional associations and civil society and nongovernmental organizations. The role of partners Collaborative action to protect and promote health “EVAP orients all stakeholders towards a unified regional vision.” Annex 1: World Health Assembly resolution WHA65.17 endorsing the Global Vaccine Action Plan 74 European Vaccine Action Plan 2015 – 2020 75 Annex 1 A1 Document A65/22 76 European Vaccine Action Plan 2015 – 2020 The Sixty-fifth World Health Assembly, Having considered the report on the draft global vaccine action planA1; Recognizing the importance of immunization as one of the most cost-effective interventions in public health, which should be recognized as a core component of the human right to health; Acknowledging the remarkable progress made in immunization in several countries to ensure that every eligible individual is immunized with all appropriate vac- cines, irrespective of geographical location, age, gender, disability, educational level, socioeconomic level, ethnic group or work condition; Applauding the contribution of successful immuniza- tion programmes in achieving global health goals, in particular in reducing childhood mortality and morbidity, and their potential for reducing mortality and morbidity across the life-course; Noting that the introduction of new vaccines targeted against several important causes of major killer diseas- es such as pneumonia, diarrhoea and cervical cancer can be used as a catalyst to scale up complementary interventions and create synergies between primary health care programmes; and that beyond the mortality gains, these new vaccines will prevent morbidity with resulting economic returns even in countries that have already succeeded in reducing mortality; Global Vaccine Action Plan SIXTY-FIFTH WORLD HEALTH ASSEMBLY Agenda item 13.12 WHA65.17 26 May 2012 77 Annex 1 Concerned that, despite the progress already made, disease eradication and elimination goals such as the eradication of poliomyelitis, the elimination of measles, rubella, and maternal and neonatal tetanus cannot be met without achieving and sustaining high and equitable coverage; Concerned that low-income and middle-income coun- tries where the adoption of available vaccines has been slower may not have the opportunity to access newer and improved vaccines expected to become available during this decade; Alarmed that globally routine immunization services are not reaching one child in five, and that substantial gaps persist in routine immunization coverage within countries; Recalling resolutions WHA58.15 and WHA61.15 on the global immunization strategy, 1. ENDORSES the Global Vaccine Action Plan; 2. URGES Members States: 1 to apply the vision and the strategies of the Global Vaccine Action Plan in order to develop the vaccines and immunization components of their national health strategy and plans, paying particular atten- tion to improving performance of the Expanded Programme on Immunization, and according to the epidemiological situation in their respective countries; 2 to commit themselves to allocating adequate hu- man and financial resources to achieve the immuni- zation goals and other relevant key milestones; 3 to report every year to the regional committees during a dedicated Decade of Vaccines session, on lessons learnt, progress made, remaining challenges and updated actions to reach the national immunization targets; 3. REQUESTS the Director-General: 1 to foster alignment and coordination of global immunization efforts by all stakeholders in support of the implementation of the Global Vaccine Action Plan; 2 to ensure that the support provided to the Global Vaccine Action Plan’s implementation at regional and country level includes a strong focus on strengthening routine immunization; 3 to identify human and financial resources for the provision of technical support in order to implement the national plans of the Global Vaccine Action Plan and monitor their impact; 4 to mobilize more financial resources in order to support implementation of the Global Vaccine Action Plan in low-income and middle-income countries; 5 to monitor progress and report annually, through the Executive Board, to the Health Assembly, until the Seventy-first World Health Assembly, on pro- gress towards achievement of global immunization targets, as a substantive agenda item, using the proposed accountability framework to guide discus- sions and future actions. Tenth plenary meeting, 26 May 2012, A65/VR/10 Annex 2: European Vaccine Action Plan 2015–2020: monitoring and evaluation framework 78 European Vaccine Action Plan 2015 – 2020 79 Annex 2 A2 RCC: Regional Certification Commission A3 NCC: National certification commission 80 European Vaccine Action Plan 2015 – 2020 EVAP goal 1: Sustain polio-free statusEVAP goals no wild poliovirus transmission re-established in the Region Indicator confirmed absence of re-established transmission of wild polio- virus in the Region by RCCA2 (based on review of annual country reports on population immunity level and quality of poliovirus surveillance submitted by the NCCsA3) Operational definition annual country updates submitted by NCCs for review by RCC Data source and collection 2013: no wild poliovirus transmission re-established in the Region (confirmed by the RCC at meeting in June 2014)Baseline 2018: no wild poliovirus transmission re-established in the Region (to be confirmed by the RCC at meeting in 2019)Target 2015–2018: no wild poliovirus transmission re-established in the Region (to be confirmed by the RCC annually)Milestone A4 RVC: Regional Verification Commission A5 NVC: National verification commission A6 Provisional indicator to be finalized after establishment of the regional hepatitis B control goal and endorsement by the Regional Committee in 2015. A7 The proposed operational definition of the indicator is “number of countries with prevalence of hepatitis B infection < 1% in a selected age cohort”, but this is subject to change or revision during establishment of the regional control goal. A8 JRF: WHO/UNICEF Joint Reporting Form 81 Annex 2 EVAP goal 3: Control hepatitis B infectionEVAP goal 2: Eliminate measles and rubella percentage of countries with interruption of endemic measles and rubella transmission percentage of countries that have achieved hepatitis B infection controlA6 number of countries with interruption of endemic measles and rubella virus transmission for > 12 months, with high-quality surveillance verified by RVCA4 number of countries that have achieved hepatitis B infection controlA7 annual country updates submitted by NVCsA5 for review by RVC JRFA8 , annual 2012: 16 countries interrupted endemic measles virus transmis- sion and 19 countries interrupted rubella virus transmission 2014 or earlier: to be measured or estimated during establish- ment of regional control goal in 2015 2015: interruption of endemic measles and rubella virus trans- mission for > 12 months, with high-quality surveillance in all countries 2018: measles and rubella elimination by all countries verified by RVC 2020: to be established 2014–2015: monitoring of number of countries with verified interruption of endemic measles and rubella virus transmission by RVC 2016: establish regional hepatitis B control goal A9 DTP: diphtheria-tetanus-pertussis 82 European Vaccine Action Plan 2015 – 2020 EVAP goal 4: Meet regional vaccination coverage targets at all administrative levels throughout the RegionEVAP goals percentage of countries with ≥ 95% coverage with three doses of DTPA9-containing vaccine at national levelIndicator number of countries with ≥ 95% coverage with three doses of DTP-containing vaccine at national level Operational definition JRF, annual Data source and collection 2013: 27 out of 53 countries (51%) Baseline 2020: 48 out of 53 countries (90%) with ≥ 95% coverage with three doses of DTP-containing vaccine at national levelTarget 2018: 42 out of 53 countries (80%) 2015–2020: monitor and report trend in number of countries meeting target annually at regional levelMilestone A10 NITAG: national immunization technical advisory group A11 Provisional indicator to be finalized after identification of a defined set of new vaccines. The initial set of new vaccines will consist of rotavirus, pneumococcal and HPV vaccines, which could be extended by the Regional Office on the basis of consultations with countries. A12 Proposed regional indicator. Required data for the indicator already exists in the current JRF, but its definition requires revision. No additional reporting by countries is required. 83 Annex 2 EVAP goal 6: Achieve financial sustainability of national immunization programmes EVAP goal 5: Make evidence-based decision on introduction of new vaccines percentage of countries that have made an informed decision on new vaccines, following the review of the relevant evidence by their NITAGsA10 percentage of countries that are financially self-sufficient for procuring routine vaccinesA12 number of countries that have made an informed decision on a defined set of new vaccines,A11 following the review of the relevant evidence by their NITAGs number of countries that are financially self-sufficient for procuring routine vaccines (domestic resources) JRF, annual JRF, annual 2014: to be measured in 2015 2012: 46 out of 53 countries (87%) 2020: at least 90% of all countries with NITAGs have made an informed decision on a defined set of new vaccines, following the review of the relevant evidence by their NITAGs 2020: at least 51 of 53 countries (96%) (except two low-income countries as of 2012) 2018: to be determined after assessing baseline value in 2015 2015–2020: monitor and report trend in number of countries meeting the target on annual basis at regional level 2016: 46 out of 53 countries (87%) 2018: 48 out of 53 countries (91%) 2015–2020: monitor and report on trend in number of countries meeting the target at regional level 84 European Vaccine Action Plan 2015 – 2020 EVAP objective 1: All countries commit to immunization as a priorityEVAP objectives presence of a NITAG Indicator number of countries that have established a NITAG that meets all WHO criteria for functionality (written terms of reference; legislative basis; minimum expertise represented; at least one meeting per year; agenda and background documentation; disclosure of conflicts of interest) Operational definition JRF (status and functionality of NITAG as reported); annual Data source and collection 2013: 23 out of 53 countries (76%) have a NITAG Baseline 2020: 48 out of 53 countries (90%) have a NITAG Target 2016: 30 out of 53 countries (57%) have a NITAG 2018: 40 out of 53 countries (76%) have a NITAG 2015–2020: monitor and report trend in establishment of NITAGs annually at regional level Milestone A13 Proposed regional indicator to be introduced in 2015. Required data for the indicator already exist in the current JRF. No additional reporting by countries is required. Indicator to be calculated at regional level from data reported in the JRF. A14 VPD: vaccine-preventable disease A15 Proposed regional indicator to be introduced in 2015 from data already in the JRF. Proxy indicator for assessing communication planning capacity. 85 Annex 2 EVAP objective 2: Individuals understand the value of immunization services and vaccines and demand vaccination domestic expenditure for routine vaccines per newbornA13 percentage of countries that have a communications plan in case of a VPDA14 outbreakA15 expenditure for routine vaccines from domestic resources, as reported in JRF size of birth cohort as reported in JRF (domestic expenditure for routine vaccines, birth cohort) number of countries that have a communications plan in case of a VPD outbreak JRF; annual JRF; annual 2014: to be measured in 2015 2014: to be measured in 2015 2020: to be determined after assessing baseline value in 2015 2020: all 53 countries have a communications plan in case of a VPD outbreak 2016: to be determined after assessing baseline value in 2015 2018: to be determined after assessing baseline value in 2015 2015–2020: monitor and report annually on trend in government expenditure on vaccines at regional level 2018: to be determined after assessing baseline value in 2015 2015–2020: monitor and report trend annually at regional level A16 Percentage of countries with ≥ 95% coverage with three doses of DTP-containing vaccine at national level. (Same as the indicator of EVAP Goal 4.) 86 European Vaccine Action Plan 2015 – 2020 EVAP objective 3: The benefits of vaccination are equitably extended to all people through tailored, innovative strategiesEVAP objectives percentage of countries with ≥ 95% coverage with three doses of DTP-containing vaccine at national levelA16 number of countries with ≥ 95% coverage with three doses of DTP-containing vaccine at national level JRF; annual 2013: 27 out of 53 countries (51%) coverage with three doses of DTP-containing vaccine at national level 2020: 48 out of 53 countries (90%) with ≥ 95% coverage with three doses of DTP-containing vaccine at national level 2018: 42 out of 53 countries (80%) coverage with three doses of DTP-containing vaccine at national level 2015–2020: monitor and report annually on trend in number of countries meeting the target at regional level Indicator Operational definition Data source and collection Baseline Target Milestone A17 Proposed regional indicator to be introduced in 2015. The data required for the indicator are already in the current JRF. No additional reporting by countries is required. 87 Annex 2 EVAP objective 4: Strong immunization systems are an integral part of a well-functioning health system percentage of countries with ≥ 90% of districts with ≥ 90% coverage with three doses of DTP-containing vaccineA17 percentage of countries with < 5% drop-out rate between first and third dose of DTP-containing vaccine number of countries with ≥ 90% of districts with ≥ 90% coverage with three doses of DTP-containing vaccine number of countries with < 5% drop-out rate between first and third dose of DTP-containing vaccine ((DTP1-DTP3)*100)/DTP1) JRF; annual JRF; annual 2014: to be measured in 2015 2013: 20 out of 53 countries (38%) with < 5% dropout rate between first and third dose of DTP-containing vaccines 2020: all countries with ≥ 90% of districts with ≥ 90% coverage with three doses of DTP-containing vaccine 2020: all 53 countries with < 5% dropout rate between first and third dose of DTP-containing vaccines 2018: to be decided 2015–2020: monitor and report annually on trend in number of countries meeting the target at regional level 2018: 90% of countries with < 5% dropout rate 2015–2020: monitor and report trend annually in drop-out rate between first and third dose of DTP-containing vaccines at regional level A18 Global indicator to be calculated at regional level from data in JRF. No additional reporting by countries is required. 88 European Vaccine Action Plan 2015 – 2020 EVAP objective 4: Strong immunization systems are an integral part of a well-functioning health systemEVAP objectives percentage of countries with sustained coverage with DTP-con- taining vaccines of ≥ 90% for three or more consecutive yearsA18Indicator number of countries with sustained coverage with DTP-contain- ing vaccines of ≥ 90% for three or more consecutive years Operational definition JRF; annual Data source and collection 2013: 25 out of 53 countries (47%) with sustained coverage with DTP-containing vaccines of ≥ 90% for three or more consecutive years Baseline 2020: all countries with sustained coverage with DTP-containing vaccines of 90% or greater for three or more consecutive yearsTarget 2018: 40 out of 53 countries (76%) with sustained coverage with DTP-containing vaccines of ≥ 90% for three or more consecutive years 2015–2020: monitor and report annually on trend in number of countries with sustained coverage at regional level Milestone A19 WHO and UNICEF estimates on national immunization coverage grade of confidence based on reported and survey coverage data. A20 Global indicator. Required data already exist in the current JRF. No additional reporting by countries is required. Vaccine- preventable disease surveillance will consist at a minimum of country-wide surveillance for poliomyelitis, measles and rubella, and hospital-based sentinel surveillance for IBDs and rotavirus diarrhoea with laboratory confirmation of cases. A21 IBD: invasive bacterial disease 89 Annex 2 percentage of countries with immunization coverage data assessed as of high quality by WHO and UNICEFA19 percentage of countries with case-based surveillance for vaccine-preventable diseasesA20 number of countries with immunization coverage data assessed as of high quality by WHO and UNICEF number of countries that have established country-wide surveil- lance for poliomyelitis, measles and rubella, number of countries that have sentinel site surveillance for IBDsA21 and rotavirus coverage as reported in JRF annually; and WHO and UNICEF estimate of national immunization coverage JRF; annual 2013: 50 out of 53 countries 2013: 27 out of 53 countries (50%) have country-wide surveillance for poliomyelitis, measles and rubella; and 20 out of 53 countries (38%) have sentinel site surveillance for IBDs A21 and rotavirus 2020: all countries with high-quality immunization coverage data 2015: all 53 countries have country-wide surveillance for polio- myelitis, measles and rubella 2020: 40 out of 53 countries (75%) have sentinel site surveillance for IBDs and rotavirus 2018: 52 out of 53 countries 2015–2020: monitor and report annually on trend in immunization coverage data assessed as of high quality by WHO and UNICEF at regional level 2015–2020: monitor and report annually on trend in number of countries with case-based surveillance at regional level A22 Proposed regional indicator. Required data already exist in the current JRF. No additional reporting by countries is required. 90 European Vaccine Action Plan 2015 – 2020 EVAP objective 4: Strong immunization systems are an integral part of a well-functioning health systemEVAP objectives percentage of countries with sustained access to WHO-accredited polio and measles-rubella laboratories A22Indicator number of countries with both national polio and measles-rubella laboratories accredited by WHO or with access to WHO-accredited laboratories Operational definition JRF and WHO database on accreditation of laboratories; annual Data source and collection 2013: all 53 countries have sustained access to WHO-accredited polio and measles-rubella laboratoriesBaseline 2020: all 53 countries have sustained access to WHO-accredited polio and measles-rubella laboratoriesTarget 2015–2020: monitor and report annually on sustained access at regional levelMilestone A23 AEFI: adverse events following immunization A24 Serious AEFI: a serious adverse event after vaccination is one that poses a potential threat to the health or life of a recipient leading to hospitalization, disability or incapacity, congenital abnormality or birth defect or death. A cluster is two or more cases of the same adverse event related in time, place or vaccine administered. 91 Annex 2 presence of an expert review committee to assess causality for AEFI A23 percentage of countries with no stock-outs for any routine vaccine at national level number of countries with an expert review committee to assess causality for cases and clusters of serious AEFI A24 number of countries with no stock-outs for any routine vaccine at national level JRF and WHO database on national regulatory authorities; annual JRF; annual 2013: 26 out of 53 countries (49%) have an expert review committee in place 2012: 41 out of 53 countries (77%) with no stock-outs for any routine vaccine at national level 2020: all 53 countries have an expert review committee in place 2020: 50 out of 53 countries (95%) with no stock-outs for any routine vaccine at national level 2018: 45 out of 53 countries (85%) have an expert review commit- tee in place 2015–2020: monitor and report annually on trend at regional level 2018: 48 out of 53 countries (90%) with no stock-outs for any routine vaccine at national level 2015–2020: monitor and report annually on trend at regional level A25 Fully functional: for countries that produce vaccines, all functions (marketing authorization and licensing, post-marketing surveillance, lot release, laboratory access, regulatory inspections and supervision of clinical trials); for countries with self-procurement, at least marketing authorization and licensing, post-mar- keting surveillance, lot release and laboratory access; for countries that procure vaccines through United Nations agencies, at least marketing authorization and licensing and post-marketing surveillance. A26 Proposed regional indicator to be introduced in 2015. Data required for the indicator already exist in the current JRF, but the definition requires revision. No additional reporting by countries is required. 92 European Vaccine Action Plan 2015 – 2020 EVAP objective 5: Immunization programmes have sustainable access to predictable funding and high-quality supplyEVAP objectives percentage of countries with a fully functionalA25 national regula- tory authority A26Indicator number of countries with a fully functional national regulato- ry authority (or that have access to regional quality assurance mechanisms) to ensure quality of vaccines used in national immunization programmes Operational definition JRF and WHO database on national regulatory authorities; annual Data source and collection 2013: 39 out of 53 countries (74%) have a fully functional national regulatory authority (or have access to regional quality assurance mechanisms) Baseline 2020: all countries have a fully functional national regulatory authority (or have access to regional quality assurance mecha- nisms) Target 2018: 48 out of 53 countries (90%) have a fully functional national regulatory authority (or have access to regional quality assurance mechanisms) 2015–2020: monitor and report annually on trend in number of countries meeting the target at regional level Milestone 93 Annex 2 Annex 3: The European Vaccine Action Plan was developed through a consultative process 94 European Vaccine Action Plan 2015 – 2020 95 Annex 3 96 European Vaccine Action Plan 2015 – 2020 Acknow- ledgements 97 Annex 3 The European Vaccine Action Plan reflects the collec- tive vision and ambition of the 53 Member States of the WHO European Region to promote and protect health by reducing the burden of vaccine-preventable diseases. It was developed through a consultative process, and the WHO Regional Office for Europe would specifically like to thank the following contributors for their valua- ble input: At national level • immunization programme managers and all other attendees of the WHO Regional Meeting of Immunization Programme Managers in Antalya, Turkey, 18–20 March 2014 • ministries of health of the 53 Member States of the WHO European Region • national immunization technical advisory groups • national certification commissions for poliomyelitis eradication • national verification commissions for measles and rubella elimination • national public health institutes At regional level • European Centre for Disease Prevention and Control • European Commission Directorate-General for Health and Consumers • United Nations Children’s Fund Regional Office for Central, Eastern Europe and the Commonwealth of Independent States • Rostropovich-Vishnevskaya Foundation • Rotary International • SIVAC Initiative, Agence de Medicine Preventive • European Forum of Medical Associations • European Society for Paediatric Infectious Diseases • Participants in the online forum for consultation on the European Vaccine Action Plan • Standing Committee of the WHO Regional Committee for Europe • European Technical Advisory Group of Experts • Regional Certification Commission for Poliomyelitis Eradication • Regional Verification Commission for Measles and Rubella Elimination At global level • GAVI Alliance • United Nations Children’s Fund • United States Centers for Disease Control and Prevention • United States Agency for International Development • Partners of the Global Polio Eradication Initiative • Partners of the Measles and Rubella Initiative • International Association of Immunization Managers • WHO headquarters • WHO Strategic Advisory Group of Experts The WHO Regional Office for Europe Albania Andorra Armenia Austria Azerbaijan Belarus Belgium Bosnia and Herzegovina Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Georgia Germany Greece Hungary Iceland Ireland Israel Italy Kazakhstan Kyrgyzstan Latvia Lithuania Luxembourg Malta Monaco Montenegro Netherlands Norway Poland Portugal Republic of Moldova Romania Russian Federation San Marino Serbia Slovakia Slovenia Spain Sweden Switzerland Tajikistan The former Yugoslav Republic of Macedonia Turkey Turkmenistan Ukraine United Kingdom Uzbekistan World Health Organization Regional Office for Europe UN City, Marmorvej 51, DK-2100 Copenhagen Ø, Denmark Tel.: +45 45 33 70 00. Fax: +45 45 33 70 01 Email: contact@euro.who.int Web site: www.euro.who.int The World Health Organization (WHO) is a specialized agency of the United Nations created in 1948 with the primary responsibility for international health matters and public health. The WHO Regional Office for Europe is one of six regional offices throughout the world, each with its own programme geared to the particular health conditions of the countries it serves. Member States: WHO/EURO:2014-2227-41982-57703