Targeted Diseases and Immunization. Strategic plan

Transcription

1 Targeted Diseases and Immunization Strategic plan Communicable Diseases Unit WHO Regional Office for Europe

2 Mission To provide technical support to WHO European Region Member States to ensure that populations are protected from preventable disease, disability and death through strong and sustainable immunization systems. Introduction Immunization, a highly cost-effective and life-saving intervention used to control and potentially eliminate vaccine-preventable, improves population health. Effective immunization programmes have been an integral part of public health services in the WHO European Region (the Region) for decades, contributing to the global eradication of smallpox in the 1970s and enabling polio-free certification of the WHO European Region in In the 1990s, the resurgence of diphtheria in many countries of the Community of Independent States (CIS) reaffirmed the need for maintaining a focus on strengthening routine immunization programmes and ensuring high population immunity to control such. The 2005 World Health Assembly Resolution WHA58.15 urged all Member States to adopt the Global Immunization Vision and Strategy as a framework for strengthening national immunization programmes during the 2006 and 2015 timeframe, with the objectives of achieving higher vaccination coverage and equity in access to immunization; improving access to existing and future vaccines; and extending the benefits of vaccination linked with other health interventions to age groups beyond infancy. The 2005 WHO Regional Committee for Europe Resolution EUR/RC55/R7 entitled Strengthening national immunization systems through measles and rubella elimination and prevention of congenital rubella infection in WHO s European Region urged Member States to commit themselves and give high priority to achieving the measles and rubella targets for These are to strengthen routine immunization programmes by achieving and maintaining high vaccination coverage with childhood vaccines; to ensure all children, adolescents and women of childbearing age have equal access to safe and high-quality immunization services; to ensure that epidemiological surveillance, including laboratory networks, is sufficient to achieve and sustain disease elimination targets; to support the implementation of an immunization week for advocacy to promote immunization; and to foster appropriate partnerships with governmental and intergovernmental agencies, nongovernmental organizations and other relevant partners. To meet the challenges of implementing these objectives and recommendations within the Region, the Targeted Diseases and Immunization Programme (TDI) of the WHO Regional Office for Europe has developed this strategic plan. The purpose of the strategic plan is to provide a framework for planning and implementing activities by establishing priorities and objectives for the period , allowing for progress to be monitored and measured. The plan is aligned with the planning process for the WHO mid-term strategic planning for the next three biennia, , and The plan is specifically intended for use by TDI, however it also provides the Regional Member States and partners with a vision and identifies strategies and approaches that will be used to meet the immunization and targeted disease control targets for The plan is divided into three strategic areas, each with its own scope, goal and set of objectives for These strategic areas are (i) immunization systems strengthening, (ii) targeted disease initiatives and (iii) surveillance, laboratory and monitoring. The objectives and strategies identified are intended to be consistent with the Global immunization vision and strategy and the Global framework for immunization monitoring and surveillance documents developed by WHO Geneva adapted to the needs of the WHO European Region. 2 of 14

3 Situation Overview The Targeted Diseases and Immunization programme (previously Vaccine-preventable Diseases and Immunization programme) has a long history of fruitful collaboration with key partners including the national ministries of health, the US CDC, USAID, Rotary, CVP Path and UNICEF who are also present in most of priority countries of the Region. TDI also collaborates closely with the European Centre for Disease Prevention and Control (ECDC), whose mandate includes surveillance and response capacity for vaccine-preventable within 30 (27 EU Member states and 3 Candidate countries) of the 53 Member States of the WHO European Region. Average routine immunization coverage levels are generally high in the Region. Vaccinepreventable disease incidence is variable across the Region and generally low, which in some countries and some groups has led to disinterest and questioning the necessity and relevance of vaccination. Moreover, certain groups categorically reject vaccination, resulting in large groups of children unprotected from highly infectious and serious such as measles and even polio. In addition, speculation about the safety of vaccines has also deterred some groups from vaccinating children. In some cases negative media coverage has sustained these effects for prolonged periods of time. Parental trust in immunization has declined and activities must continue to re-establish this trust. This must include effective surveillance, investigation and communication relating to adverse events following immunization (AEFI) by national and regional immunization programmes, whenever they may occur. To address some of the issues mentioned above, the WHO Regional Office for Europe developed and implemented the European Immunization Week (EIW). This is an annual advocacy and communication initiative carried out in 2005, 2007 and 2008, to highlight the importance of immunization. The initiative targets a number of priority communities, including parents, health care workers and politicians depending on the needs of the participating countries. The EIW has proved a very useful tool to encourage the deeper analysis of negative attitudes towards immunization and to develop appropriately targeted activities to redress the balance. The Region has remained Polio-free for the five years since certification in However, a trend of weakening vaccination coverage (for oral polio vaccine) is evident; several countries report national coverage levels lower than previous years; moreover, reported coverage is dangerously low at the sub-national level in several geographical areas of the Region. Great progress has been seen in measles and rubella elimination since the 2005 Regional Committee Resolution to eliminate these by In 2007, the percentage of Member States reporting a measles incidence of less than 1 case per million population rose to 60% (32/53). Furthermore, the number of countries reporting a very high incidence rate (>1 per ) decreased to 10 from 16 in The Regional average vaccination coverage for measles-containing vaccine (MCV1) has reached 94%, just 1% short of WHO target. The use of rubella vaccine has also increased dramatically, with 98% (52/53) of Member States now using rubella in their routine vaccination schedule. Just measles cases were reported for the whole Region in 2007, compared to over cases in 2006, demonstrating that immunization strategies are being very effectively implemented and that surveillance including virological analysis has also become more sensitive than in previous years. However, focus must remain on the Member States who still have a measles incidence of more than one case per million. The Regional Laboratory Network (Labnet) continues to support Member States with the provision of diagnostics and technical support, including annual accreditation visits. The Labnet also continues to strengthen and expand, incorporating measles and rubella and other targeted into its responsibilities while maintaining the primary focus on polio. 3 of 14

4 Many countries are in the planning phase of introducing new vaccines against Hib (Haemophilus influenzae type b) and rotavirus, which can be a long and complex process. Data on disease burden needs to be gathered before policy decisions are made. A regional plan was developed by a group of experts to guide Member States through this process. Support for improving immunization quality and safety continues to play an important role in strengthening immunization programmes. Technical support is continuously provided for key components such as vaccine regulation, procurement, vaccine management, surveillance of AEFI, injection safety and sharps disposal. Overarching strategies Communication, Partnership, Management The objectives identified in the strategic plan are to be achieved through a series of strategies listed under three Strategic Areas. However overarching strategies including communication and advocacy; partnership and networking; resource mobilization and programme planning and management, will contribute to reaching the objectives and are key strategies for any immunization programme. ~ working to improve partnerships with Member States and governmental and non-governmental agencies/organizations, including the provision of regular updates to the Regional Committee; ~ implementing strong and effective resource mobilization and management practices; ~ providing regular and up to date information to Member States, partner organizations and the public via well maintained web sites; ~ holding regular advocacy and communication activities such as the European Immunization Week; ~ ensuring the ongoing programme oversight by ETAGE (the European Technical Advisory Group of Experts). 4 of 14

5 Strategic Area 1 - Immunization Systems Strengthening Scope: Goal: All vaccines and vaccine-preventable that are part of routine immunization programmes in the Region. All Member States will have maintained vaccination coverage for children and adolescence of 95% 1 or more using quality-assured vaccines. Objectives by 2013: Political commitment and resource mobilization 1. All Member States will have a multi-year immunization strategy and action plan approved at the ministerial level, providing all appropriate requirements for effective implementation including financial and human resource needs. ~ enhancing capacity and providing tools to support effective decision making for developing national immunization policies, strategies and planning processes, including sustainable funding for all vaccines used; ~ supporting the establishment and work of evidence-based country advisory committees on immunization; ~ working with governments and partners to identify resource gaps and unmet financing requirements and mobilize technical and financial assistance from governments, partners, Global Alliance for Vaccine Initiative (GAVI), and bilateral donors. Quality-assured vaccines, supply and safety 2. All Member States will have a functional National Regulatory Authority and/or use WHO prequalified vaccines. ~ advocating and providing technical support for capacity building in the area of vaccine regulation Each Member State will experience less than 5% vaccine stock out in the district cold stores. ~ working with Member States to establish mechanisms for accurate forecasting and timely procurement of vaccines at competitive prices and in quantities sufficient to avoid shortage; ~ assisting Member States to achieve the minimum global standards for effective vaccine management (cold chain, stock management and vaccine distribution and handling). 1 Or the appropriate percentage of high risk groups defined by Member States in the case of seasonal influenza 2 WHO also works as a technical collaborator with the European Medicines Agency (EMEA) 5 of 14

6 4. All Member States will have adopted the recommended best practices for injection safety and healthcare waste management for immunization and will have documented their progress in implementation. ~ working with Member States to ensure accurate forecasting and timely procurement of injection material and safe disposal equipment; ~ providing technical support for the development and implementation of a comprehensive plan for injection safety and sharps collection, treatment and disposal, linked to infection control. Access to and utilization of immunization services 5. All Member States will have vaccination coverage of 95 % or more nationally and 90% or more in all districts for DPT3, polio3, HepB3, MCV1 and MCV2, with drop-out rates for DTP3 of less than 5% at national level and 10% at district level. ~ supporting Member States with materials to optimize immunization programme management and delivery capacity; ~ promoting effective immunization delivery strategies to increase access for hard to reach population (e.g. the Reach Every District strategy); ~ assisting in the modification of national policies to reduce missed opportunities and false contraindications and supporting the accelerated implementation of new policies; ~ providing tools and methods on interpretation and use of appropriate information (disease incidence, administrative coverage, vaccine wastage, stock management) for effective management. 6 of 14

7 Strategic Area 2 - Targeted Disease Initiatives Scope: Goal: All targeted vaccine-preventable identified for special attention 3 by WHO Regional Office for Europe. All Member States achieve the Regional targeted disease reduction, eradication or control priorities. Objectives by 2013: Diseases with eradication and elimination targets 1. All Member States will have sustained polio-free status and implemented globally harmonized national policies and regulations on polio after Global certification. 2. All Member States will have achieved and sustained measles, rubella and congenital rubella elimination targets by ~ maintaining political commitment for these initiatives; ~ strengthening and sustaining integrated epidemiological and laboratory surveillance for polio, measles, rubella and congenital rubella; ~ providing technical support for supplemental immunization activities as needed to address susceptible populations and groups at high risk for these ; ~ maintaining a system for monitoring and certifying eradication/elimination status of Member States, including action plans in the case of poliovirus importation, in line with the IHR (International Health Regulations); ~ providing guidelines on developing long-term polio policy and regulation infrastructure, including polio virus containment and destruction, polio vaccination and oral polio vaccine (OPV) cessation and stock piles. Diseases for introduction of new vaccines 3. All Member States will be using evidence-based criteria 4 for the introduction of new vaccines 5. ~ developing and promoting the use of common criteria to assess the introduction of or change in vaccines used; ~ enhancing collaboration with key partners, including the private sector, for the promotion of selected new vaccines; 3 Targeted vaccine-preventable ; for eradication (polio), for elimination (measles, rubella), and for control (diphtheria, pertussis, bacterial pneumonia, meningitis and seasonal influenza). 4 Criteria consistent with the estimated disease burden; vaccine cost effectiveness; immunization programme schedules [i.e. timing and use of combination vaccines]; country s economic development and health system priorities and other factors, including benchmarks concurrent with countries with similar per capita income. 5 Among new vaccines; Hib, rotavirus, meningococcal, pneumococcal, human papilloma-virus (HPV). 7 of 14

8 ~ providing technical support and training tools to support the development of operational plans for introducing new vaccines. Control of priority bacterial and viral 4. The burden of childhood bacterial meningitis will have decreased by 40% within the Region, including a 20% reduction in hospital admissions for meningitis due to any cause in children under 2 years after introduction of Hib vaccine and for countries currently using Hib vaccine, an 80% reduction in hospitalizations for bacterial meningitis after the introduction of conjugate meningococcal and pneumococcal vaccines. ~ promoting the use of Hib vaccine in all Member States; ~ promoting the use of conjugate meningococcal and pneumococcal vaccines in Member States, so that each vaccine is used in countries representing at least 35% of the Region s population. 5. The incidence and mortality of pertussis will have decreased within the Region. ~ promoting the adoption of a complete routine pertussis vaccination schedule in infants and children calling for at least 4 doses by years of age 6. ~ implementing sentinel surveillance for hospitalized pertussis in all Member States based on standardized case-definitions and guidelines to increase awareness of the burden and epidemiology of the disease (e.g. age specific case fatality rates) and the impact of changes in the routine schedule. 6. All Member States will be using annual seasonal influenza vaccination and will have 75% or more coverage in the high-risk groups defined. ~ providing technical support in assessing disease burden; ~ establishing or enhancing routine seasonal influenza surveillance; ~ supporting national efforts to decrease the disease burden caused by influenza. 7. All Member States will maintain vaccination coverage for diphtheria with primary immunization (DTP3) by 12 months of age at 95% or more ~ maintaining political commitment to control diphtheria through maintaining high vaccination coverage in children and adults; ~ providing technical support to continue optimal surveillance and supplementary vaccination if appropriate. 6 In countries where the incidence of pertussis has been considerably reduced by successful immunization, a booster dose administered 1 6 years after the primary series is warranted. The optimal timing of this booster dose as well as the possible need for additional booster doses of DTP depends on the epidemiological situation and should be assessed by individual national programmes. 8 of 14

9 Strategic Area 3 Surveillance, Laboratory and Monitoring Scope: Goal: Surveillance data, including laboratory information, is used to adjust programme activities to ensure that the goals are met as stated in the Strategic Plan. Ensure the provision of high-quality epidemiological and laboratory data enabling the achievement regional immunization and disease control objectives. Objectives by 2013: Regional Office surveillance capacity 1. A robust Regional computerized data management system, integrating reportable, laboratory and immunization programme indicators from all Member States will be in place, with swift analysis capacity providing data for action. ~ creating and documenting linkages between surveillance and information system databases and analytic software for statistical and graphical analyses, including mapping; ~ integrating surveillance activities, databases and software with key partners involved in surveillance (e.g. ECDC), regional disease-specific laboratory networks and regional components of WHO global surveillance programmes; ~ issuing regular communication bulletins on targeted for partners in Member States and other key organizations (monthly for VPDs and weekly or bi weekly for influenza); 2. Appropriate laboratory networks will be maintained for the targeted ; selected GAVI-eligible countries will have access to laboratory services for rotavirus and invasive bacterial. 100% of countries will have access to laboratory services for influenza, polio and measles/rubella. 8 countries will have access to laboratory services for rotavirus surveillance; 5 countries will establish a laboratory-based surveillance for invasive bacterial. ~ ensuring the coordination of the laboratory services; ~ providing advice on the appropriate centers of laboratory expertise, assisting with referral of specimens to the WHO-accredited laboratories, etc. ~ supporting the assessment of need process 7 ; ~ providing support for training. 7 The assessment of need process would include epidemiological and social significance, sustainability, organism s pathogenicity, etc. 9 of 14

10 Member States surveillance for immunization systems strengthening 3. All Member States will be using a core set of common data collection and reporting standards and indicators and report these indicators to WHO on at least an annual basis and at least 90% of Member States will be validating their coverage estimates by coverage surveys. ~ providing definitions, guidelines and training tools for the collection, analysis, and reporting of appropriate immunization management information (coverage, vaccine wastage, stock management, contraindications to vaccination); ~ providing technical support for strengthening the surveillance systems in countries, and the data management capacity at national and sub-national; ~ promoting district level reporting (e.g. RED strategy). 4. All Member States will have in place a responsive surveillance system for adverse events following immunization. ~ providing definitions, guidelines and training tools to strengthen national and local AEFI surveillance for monitoring quality and safety of vaccines and immunization services. Member States surveillance for targeted disease initiatives 5. All Member States will have implemented national case-based surveillance for targeted for elimination, eradication and control and report this information to WHO on at least a monthly basis (including zero case reports). ~ providing definitions, guidelines and training tools for the collection, analysis, and reporting of polio, acute flaccid paralysis (AFP), measles, rubella and congenital rubella; ~ monitoring timeliness and completeness of reporting of these ; ~ coordinating and sharing data information with partners organizations (e.g. ECDC, WHO Collaborating Centres). 6. All Member States will have implemented surveillance for priority bacterial and viral targeted for control, including at least annual reporting to WHO. ~ providing definitions, guidelines and training tools for the collection, analysis, and reporting of bacterial meningitis, pertussis, influenza, rotavirus, etc. ~ implementing sentinel surveillance for specific, based on standardized case-definitions and guidelines to increase awareness of the persistence of disease and the impact of changes in the routine schedule. 10 of 14

11 Member State laboratory networks 7. All Member States will have in place an operational national laboratory network in line with WHO recommended quality for the targeted for elimination, eradication and control. 100% of countries will have access to WHO-accredited/recognised laboratories. ~ providing technical support of laboratory networks for these ; ~ providing technical support to assist with the ongoing monitoring of the quality of laboratory performance; ~ providing the annual proficiency testing methodology to ensure the highest quality laboratory network services. 8. All Member States will have access to advice on appropriate laboratory methods for the identification of targeted vaccine-preventable. ~ establishing and maintaining an informal advisory body on laboratory services in the Region. 11 of 14

12 Baseline indicators for 2008 Objective for 2013 Baseline indicator Source/Date Strategic Area 1 - Immunization Systems Strengthening 1 All Member States will have a multi-year immunization strategy and action plan approved at the ministerial level, providing all appropriate requirements for effective implementation including financial and human resource needs - 39 (80%) of 49 reporting countries reported that they have a multi-year immunization plan - 21 (54%) of 39 reporting countries reported that the multi year plan includes a costing WHO/UNICEF Joint Reporting Form (2008) 2 All Member States have a functional National Regulatory Authority (NRA) and/or use WHO pre-qualified vaccines 3 Each Member State will experience less than 5% vaccine stock out in the district cold stores 4 All Member States will have adopted the recommended best practices for injection safety and healthcare waste management for immunization and will have documented their progress in implementation - 35 (90%) of 40 countries have a fully functional NRA - 2 of 5 countries with a non functional NRA are using WHO pre-qualified vaccines - 6 (16%) of 38 reporting countries reported national-level stock-out of at least one antigen - 3 of the 6 countries reported stock-outs of multiple antigens - 26 (56%) of 46 reporting countries have a national activity workplan for immunization injection safety - 26 (56%) of 46 reporting countries have a national activity workplan for waste management WHO situation analysis on quality and safety (2008) WHO/UNICEF Joint Reporting Form (2008) WHO/UNICEF Joint Reporting Form (2008) 5 All Member States have a coverage of 95 % or more nationally and 90% or more in all districts for DPT3, polio3, HepB3, MCV1 and MCV2 with drop-out rates for DTP3 of less than 5% at national level and 10% at district level Number of countries with coverage < 95% at national level Vaccine dose No. Total countries % BCG DTP HepB MCV Pol (41%) of 22 reporting countries reported DTP drop-out more than 10% at national level - 13 (59%) of 22 reporting countries reported 0 districts with DTP drop-out rate greater then 10% - 42 (86%) of 49 reporting countries provided sub national (1 st ) level coverage - 15 (43%) of 35 reporting countries reported >95% DTP3 coverage in all districts - 16(45%) of 35 reporting countries reported >95% MCV coverage in all districts 2008 WHO/UNICEF estimates for coverage at national level WHO/UNICEF Joint Reporting Form (2008) for the rest of the indicators Strategic Area 2 Targeted Disease Initiatives 1-53 (100%) of 53 countries are Polio-free All Member States will have - 17 (32%) of 53 countries have an action plan sustained polio-free status and in case of poliovirus importation implemented globally - 0 (0%) of 53 countries have policy and harmonized national policies regulation implemented (this can only be put in and regulations on polio after place after global certification) Global certification WHO targeted vaccinepreventable surveillance 12 of 14

13 2 All Member States will have achieved and sustained measles, rubella and congenital rubella elimination targets by All Member States will be using evidence-based criteria for the introduction of new vaccines - 24 (45%) of 53 reporting countries reported measles incidence >1 per 1 million population - 6 of 8 GAVI-eligible countries carrying out rotavirus hospital-based sentinel surveillance - 3 of 8 of GAVI-eligible countries carrying out rotavirus vaccine cost-effectiveness studies WHO/UNICEF joint reporting form (2007) and monthly MR reporting. WHO targeted vaccinepreventable surveillance ( studies, sentinel sites) 4 The burden of childhood bacterial meningitis will have decreased by 40% within the Region, including a 20% reduction in hospital admissions for meningitis due to any cause in children under 2 years after introduction of Hib vaccine and for countries currently using Hib vaccine, an 80% reduction in hospitalizations for bacterial meningitis after the introduction of conjugate meningococcal and pneumococcal vaccines 5 The incidence and mortality of pertussis will have decreased within the Region 6 All Member States will be using annual seasonal influenza vaccination and will have 75% or more coverage in the defined high-risk groups 7 All Member States will maintain vaccination coverage for diphtheria with primary immunization (DTP3) by 12 months of age at 95% or more cases (at least) per 100,000 children <5 years within the Region - 34 (68%) of 50 reporting countries have Hib in their routine schedule WHO targeted vaccinepreventable surveillance ( studies, sentinel sites) - 26,097 cases within the Region WHO/UNICEF Joint Reporting Form (2008) - 12 of 29 EU Member states achieved 50% uptake in the elderly (unpublished VENICE data) - 14/44 reporting countries have DPT3 coverage <95% WHO/UNICEF joint reporting form (2007) Strategic Area 3 Surveillance, Laboratory and Monitoring 1 A robust Regional computerized data management system, integrating reportable, laboratory and immunization programme indicators from all Member States will be in place, with swift analysis capacity providing data for action - % of surveillance and monitoring reports being generated using CISID data - CISID is currently being strengthened for accuracy of indicators. Overall regional capacity to provide information for action has been enhanced in last two years 2 Appropriate laboratory networks will be maintained for the targeted ; selected GAVI-eligible countries will have access to laboratory services for rotavirus and invasive bacterial. 100% of countries will have access to laboratory services for influenza, polio and measles/rubella. 8 countries - 100% of the WHO polio national and subnational laboratories are accredited - 98% of the WHO measles/rubella national and sub-national laboratories are accredited - 83% (44/53) have WHO-recognised national influenza centres WHO targeted vaccinepreventable surveillance WHO targeted vaccinepreventable surveillance 13 of 14

14 will have access to laboratory services for rotavirus surveillance; 5 countries will establish a laboratory-based surveillance for invasive bacterial. 3 All Member States will be using a core set of common data collection and reporting standards and indicators and report these indicators to WHO on at least an annual basis and at least 90% of Member States will be validating their coverage estimates by coverage surveys (61%) of 49 countries submitted the annual joint reporting form on time - 4 countries did not submitted joint reporting form in (76%) of 49 countries provided administrative coverage (DTP3) - 42 (86%) of 49 countries provided subnational level coverage % completeness for measles reporting % timeliness for measles reporting - >90% completeness for AFP reporting - >80% timeliness for AFP reporting % completeness for AFP samples at laboratory 57% (30/53) of countries for weekly and bi weekly seasonal influenza WHO targeted vaccinepreventable surveillance 4 All Member States will have in place a responsive surveillance system for adverse events following immunization 5 All Member States will have implemented national casebased surveillance for targeted for elimination/eradication and report this information to WHO on at least a monthly basis (including zero case reports) 6 All Member States will have implemented surveillance for priority bacterial and viral targeted for control, including at least annual reporting to WHO 7 All Member States will have in place an operational national laboratory network in line with WHO recommended quality for the targeted for elimination, eradication and control. 100% of countries will have access to WHOaccredited laboratories 8 All Member States will have access to advice on appropriate laboratory methods for the identification of targeted vaccine-preventable - 46 (98%) of 47 reporting countries have an AEFI surveillance system - 35 (74%) of 47 reporting countries reported AEFI and serious AEFI cases - 45 (96%) of 47 countries reported a national measles case-based surveillance system in place - 30 (65%) of 46 countries reported a national rubella case-based surveillance system in place - 19 (42%) of 49 reporting countries reported having a system in place, with laboratory confirmation, to measure the impact of vaccination against invasive bacterial, for example bacterial meningitis or pneumonia - 100% of the WHO polio, measles, rubella laboratories covered by the External Quality Assurance (EQA) system - 100% of the national influenza laboratories are covered by regional and global WHO EQA programmes WHO/UNICEF Joint Reporting Form (2008) WHO/UNICEF Joint Reporting Form (2008) WHO/UNICEF Joint Reporting Form (2008) WHO targeted vaccinepreventable surveillance - Regional advisory body being established WHO targeted vaccinepreventable surveillance 14 of 14