programme budget 2014-2015 performance assessment...

PBPA2014-2015 (April 2016) 1 PA: 1.5 Vaccine-Preventable Diseases

Programme budget 2014-2015 Performance Assessment Programme area: 1.5 Vaccine-Preventable Diseases

OUTCOME 1.5. INCREASED VACCINATION COVERAGE FOR HARD-TO-REACH POPULATIONS AND COMMUNITIES

I. OVERVIEW OF MAJOR ACHIEVEMENTS AND CHALLENGES Good progress continued to be made towards achieving the Global Vaccine Action Plan (GVAP) target on introduction of new and under-utilized vaccines. By the end of 2014: Haemophilus influenzae type B (Hib) vaccine was introduced in 192 countries (189 in 2013). Hepatitis B vaccine for infants was introduced nationwide in 184 countries with global coverage of 82% and as high as 92% in the Region of the Americas and the Western Pacific Region. Pneumococcal vaccine was introduced in 117 countries (103 in 2013); rotavirus vaccine in 74 countries (52 in 2013), and human papillomavirus vaccine (HPV) in 63 countries (55 in 2013). WHO contributed by providing policy, evidence and guidance to countries for their decision making on introduction, implementation planning, guidance and capacity building, through technical support to countries developing country applications to the GAVI Alliance for vaccine introduction support. In 2014, 80 applications were submitted to GAVI, of which 76 (95%) were approved and in 2015, 38 applications were submitted of which 35 (92%) were approved. To guide country’s immunization policies and decisions, WHO also continued providing guidance and support for establishing and strengthening national advisory committees on immunization (NITAGs). Much progress has been achieved: based on analysis of the joint reporting forms (JRFs) for 2014, 115 countries reported the existence of NITAGs with an administrative base (108 in 2013), and 81

countries (76 in 2013), including 41 developing countries and four low‑income countries, had a NITAG complying with the six basic process indicators. Progress was noted in increasing immunization coverage and in introducing new vaccines. During 2014, 115 million infants worldwide (about 86% of surviving infants globally) received three doses of diphtheria-tetanus-pertussis-containing (DTP3) vaccine (up from 84% and 112 million in 2013). By 2014, 129 countries had reached at least 90% coverage of DTP3 vaccine, sustaining the result of 2013. Global measles coverage reached 85% compared to a consistent 84% over the preceding five years. In 2014-2015 WHO provided support to 37 priority countries for conducting supplementary immunization activities (SIAs) through the development of SIA plans, preparation and implementation of SIAs, intra-SIA monitoring, and implementation of post SIAs coverage surveys. In a remarkable achievement, of the 59 countries classified as high priority for Maternal and Neonatal Tetanus Elimination as of 2000, 38 of these countries, including China and India, achieved elimination by the end of 2015. Globally, 130 million women of reproductive age have been reached with at least two doses of tetanus toxoid vaccine between 1999 and 2015. WHO supported a number of validation surveys as well as provided policy and strategic guidance. WHO hosted the secretariat to collect data on the progress against the goals and strategic objectives of the Global Vaccine Action Plan (GVAP) and facilitated the independent review of progress through the Strategic Advisory Group of Experts (SAGE) and reported to the WHO Governing Bodies in 2014 and 2015. Low- and middle-income countries were supported in introducing new vaccines through the provision of evidence for policy-making, strengthening of their National Immunization Technical Advisory Groups (NITAGs) and in preparing applications for support through GAVI. Of particular note was the rapid introduction and scale up of Inactivated Poliovirus Vaccine (IPV) in Oral Poliovirus Vaccine (OPV) using countries, in preparation for the withdrawal of type 2 vaccine from the trivalent OPV (tOPV). A large number of countries were supported in preparing plans for the switch from tOPV to a bivalent OPV (bOPV). In addition, given the urgency of complying with the Polio Endgame Strategy, in 2014 and 2015 WHO provided substantial technical support to 71 countries submitting applications to GAVI for IPV introduction support.


Globally, despite areas of progress, the GVAP assessment report indicated that the world was not on track for achieving the mid-term targets. In response to the lack of progress, reviews of the measles/rubella and the maternal and neonatal tetanus elimination strategies were initiated. New guidance for increasing routine immunization coverage was developed and work initiated on expanding the scope of the “Reach Every District” strategy to “Reach Every Community”. In response to the call from Member States for WHO to facilitate access to sustainable supplies of vaccines for middle-income countries at affordable prices, a middle-income countries strategy was developed and endorsed by the Strategic Advisory Group of Experts (SAGE) and an online platform for reporting vaccine prices to promote vaccine price transparency was established.

II. OUTPUT MEASUREMENT

Output 1.5.1. Implementation and monitoring of the global vaccine action plan as part of the Decade of Vaccines Collaboration strengthened with emphasis on reaching the unvaccinated and under-vaccinated populations

Output indicator

Baseline

Target

Achieved Value:

Number of countries with immunization coverage <70% that develop and implement strategies within their national immunization plans to reach unvaccinated and under-vaccinated populations

5 7 13

Overview of achievements and challenges Using the monitoring and accountability framework endorsed by the World Health Assembly (WHA), data to assess progress against the indicators in the GVAP were collected and analysed, an independent assessment by SAGE was facilitated and the assessment reports were presented to WHO governing bodies in 2014 and 2015. The African Regional Strategic Plan for Immunization 2014-2020, the Plan de Acción sobre Inmunización para la Región de las Américas (RIAP), The Eastern Mediterranean Vaccine Action Plan (EMVAP), the European Vaccine Action Plan 2015-2020 (EVAP), and the Regional Framework for Implementation of GVAP in the Western Pacific Region (WPR) were developed and endorsed by the respective Regional Committees as frameworks for implementation of the Global Vaccine Action Plan (GVAP), taking into consideration the regional specificities and regional challenges. A wide range of policy guidance and technical support was provided by WHO headquarters (HQ) to empower countries to develop and implement strategies to reach higher levels of immunization coverage and ensure availability of adequate programmatic data. In 2014-2015, the Strategic Advisory Group of Experts (SAGE) provided policy recommendations or guidance for nine vaccines (notably Malaria vaccines, provisional recommendations for use of Ebola Vaccines in response to outbreaks and on the use of IPV and the withdrawal of tOPV as part of the polio eradication end game strategy) and on six vaccination-related issues. Withdrawing the type 2 component of oral polio vaccine (OPV) is a crucial part of the Poliomyelitis Eradication and Endgame Strategic Plan, in order to eliminate cases of vaccine-associated paralytic polio or circulating vaccine-derived polioviruses. In preparation for this change, WHO has coordinated the successful introduction of Inactivated Polio Vaccine in 81 countries and supported the plans for the withdrawal of tOPV and its replacement with bOPV in 155 countries. WHO continued to provide technical support to strengthen vaccine-preventable disease surveillance networks (Measles and rubella, invasive bacterial vaccine-preventable diseases, rotavirus, and HPV) which continue to generate data to guide Member States on their policy decision to introduce and evaluate the impact of new vaccines. The surveillance efforts are supported by networks of laboratories. These include the measles and rubella, Invasive Bacterial Vaccine Preventable Diseases (IB-VPD) and rotavirus laboratory networks. These networks provide training, technical support, quality assurance and specialized testing support to the national and subnational networks. The measles and rubella laboratory network is described under output 1.5.2 below. The IB-VPD laboratory network includes 121 Sentinel Hospital Laboratories (SHL), 21 National Laboratories (NL), nine Regional Reference Laboratories (RRL), and one Global Reference Laboratory (GRL). The WHO Rotavirus Surveillance system, includes 88 SHLs, 18 NLs, nine RRLs and one GRL.


Achievements and challenges in countries

Meningitis A, a disease that is feared on the continent because it can kill or cause severe brain damage within hours, is nearly eliminated in Africa through vaccination. The scale up of use of a conjugate meningococcal A conjugate vaccine in the meningitis belt continued and more than 235 million people have been vaccinated to date resulting in the virtual elimination of serogroup A meningococcal disease from meningitis belt countries. Policy recommendations for the use of this vaccine into routine national immunization programmes have been issued. Support to GAVI-eligible countries to apply for GAVI support, develop introduction plans, introduce the vaccines and conduct vaccines continued in 2014-2015. As a result, all GAVI-eligible countries have now been supported to introduce Hib vaccines, and an increasing number have been supported to introduce pneumococcal conjugate and rotavirus vaccines, as well as to plan and conduct pilot introduction projects for HPV vaccines. In an unprecedented effort 81 countries were supported in introducing a single dose of IPV as part of their routine immunization programme in preparation for the withdrawal of type 2 OPV. The introduction of the vaccine had to be carefully managed to ensure that highest risk countries were prioritized for introduction first, and to manage the introduction in the face of supply shortfalls. Updated guidelines, tools and capacity building were provided to countries to support their immunization planning, implementation and monitoring. In particular, the Comprehensive Multi Year planning (cMYP) guide and tool were revised to align with GVAP and using a systems approach to facilitate the integration of the immunization plans into broader national health plans. Capacity building activities were implemented to provide further support to countries to initiate and/or finalize revision of their cMYPs. WHO provided technical assistance to 50 countries for developing or updating cMYP, including Afghanistan, India, Nigeria, Pakistan and Philippines. Fifty countries reported having developed annual plans for immunization in 2014. A new multi-language version of the cMYP costing and financing tool and related User Guide were produced. In addition to cMYPs, WHO has led the support for planning and implementation of Effective Vaccine Management assessments in 33 countries. Post Introduction Evaluations (PIEs) were conducted with WHO support in 35 countries and Expanded Programme for Immunization (EPI) reviews in 16 countries. Support was provided for the development and implementation of action plans and monitoring and evaluation frameworks for implementation of the integrated Global Action Plan for Pneumonia & Diarrohea (GAPPD). The integrated GAPPD action plans were implemented in pilot districts in Zambia and Bangladesh, as well as in four states in India (Bihar, Madhya Pradesh, Rajasthan, Uttar Pradesh). Key activities implemented include subnational planning, advocacy, capacity building of health workers, strengthening supply chain systems and improving systems for programmatic monitoring. Support was also provided to countries with comprehensive approaches for HPV vaccine delivery through documenting integrated delivery in a demonstration project in Madagascar and initiating comprehensive planning as part of national HPV introduction in Uzbekistan. World Immunization Week (WIW) was celebrated in all regions, resulting in over 180 countries simultaneously participating in 2014 and 2015. The WIW activities included introducing new vaccines into national immunization programmes; providing training and workshops for healthcare workers; organizing round-table discussions with political decision makers, medical professionals and parents; extensive communication and advocacy through media and seminars; and mass vaccination campaigns, many of which were integrated with other child-survival interventions. Several challenges faced by countries prevent their achieving their immunization goals. Some of the key challenges include:

• The outbreak of Ebola diverted resources, leading to disruption in service delivery and a decline in immunization coverage.

• Similarly, war and conflict and the resultant refugee crisis caused disruption in other regions.

• Inadequate financial and human resources, management capacity and health system weaknesses remain a challenge for many low- and middle-income countries in implementing their own plans.

• The poor quality of data and lack of capacity to effectively use data for actions also remains a challenge in many countries.


Achievements and challenges at regional and global levels Policy guidance and technical support was provided by HQ to empower countries to develop and implement strategies to reach higher levels of immunization coverage and ensure availability of adequate programmatic data. In 2014-2015, the Strategic Advisory Group of Experts (SAGE) provided policy recommendations on: the introduction of IPV in OPV-using countries and the timing of the withdrawal of type 2 OPV: vaccines against varicella and herpes zoster, human papilloma virus (HPV), pertussis, Japanese encephalitis (JE), hepatitis E, malaria; and the inclusion of meningococcal A conjugate vaccine for routine immunization of infants and young children. A number of vaccination-related issues were also reviewed by SAGE to provide guidance to countries. These included: the immunization supply chain strategy; vaccine hesitancy; non-specific effects of vaccines on childhood mortality; the middle-income country strategy; pain mitigation during vaccination; and integration of immunization and child health services. Based on the SAGE recommendations, position papers were published on hepatitis E, HPV, JE, meningococcal vaccines, pertussis, poliomyelitis and varicella. A position paper on malaria vaccines has been drafted and publication is expected in early 2016. To support countries in increasing vaccination coverage and reduce missed opportunities for vaccination, a number of new tools were developed. The Tailoring Immunization Programmes (TIP) tool developed in EUR was adapted for use in other regions to facilitate the identification of bottlenecks and development of targeted approaches to improve coverage. Adequate guidelines and tools were provided to countries for district micro-planning and implementation of the Reaching Every District (RED) approach. The Global Routine Immunization Strategic Plan (GRISP) was developed and publication is planned in February 2016. A tool to assess missed opportunities for vaccination and to develop strategies for their reduction was developed and pilot tested in four countries. The need to maintain modern vaccines in refrigerated transport and storage has complicated vaccine supply and delivery, especially in countries with tropical climates and an unreliable energy supply. Consequently, WHO has been actively exploring the feasibility of distributing certain heat-stable vaccines in a Controlled Temperature Chain (CTC) to remote and difficult-to-access regions. The conjugate meningococcal A vaccine (MenAfriVac©), was the first such vaccine to be successfully licensed, WHO prequalified, and piloted with CTC. Since that initial success in 2012, four more vaccines have been licensed for CTC: two oral cholera vaccines in 2014 and 2015, a pneumococcal conjugate vaccine, and as of February 2016, a human papillomavirus (HPV) vaccine. Additional efforts are under way in support CTC compatibility for further vaccine products, including hepatitis B and rotavirus vaccines. WHO has successfully implemented an effective CTC strategy during several meningococcal type A vaccination campaigns, and is committed to developing detailed implementation guidelines for each new product to be delivered in a CTC. Over the past decade, sustainable access to affordable vaccines in middle-income countries (MICs) has gained global attention. The focus on immunization in MICs has gained momentum from the realization that the majority of the world’s poor live in MICs where most vaccine-preventable deaths occur (i.e. countries with a gross national income (GNI) of between US$ 1,045 and US$ 12,7361), as well as concern that this group of countries may be missing out on opportunities to introduce new vaccines, given the donor focus on low-income countries. At the request of SAGE in June 2014, WHO convened an MIC Task Force to develop a coordinated strategy and plan of action to enhance sustainable access to vaccines in MICs. The MIC Strategy was presented to SAGE in April 2015 and acknowledged as a strong proposal for a coordinated and comprehensive approach to issues around sustainable access to vaccines in MICs. The establishment of a database platform to improve vaccine price transparency as part of the WHO Vaccine Product, Price and Procurement (V3P) project, was designed to facilitate the appropriate comparison of price information and to provide countries with accurate and reliable data on vaccine product, price and procurement. A total of 40 countries have shared vaccine price data with V3P (through JRFs and the V3P online tool) in 2015, increasing to 1600 the number of records contained in the database. More than 4000 users have accessed the V3P platform in 2015 alone. Presentations of V3P were conducted in the Regional Offices for Africa, Western Pacific (regional technical advisory group issued recommendations supporting the use of V3P in June 2015) and Europe (a workshop to train participants on using price transparency to inform decisions). Work is also being carried out to support countries in graduating from GAVI support, and to provide better guidance to MICs which do not benefit from GAVI support.


The Immunization Practices Advisory Committee (IPAC), established to review and formulate immunization practices, operational standards, tools and technologies to strengthen and improve the delivery of immunization programmes at country level, has launched a “Call to Action on Immunization Supply Chain and Logistics”, endorsed in 2014 by SAGE. In addition, the WHO Multi-dose Vial Policy was revised, and the WHO guidelines for introducing solar-powered vaccine refrigerators and freezer systems and two modules of the WHO Vaccine Management Handbook were finalized. Reliable and timely data are essential for accountability and evidence-based decision-making at all levels of the health system. Member States, WHO and immunization partner agencies therefore all continue to call for better quality data. During 2015, WHO worked across all levels of the Organization and with partner agencies to develop and disseminate several tools designed to improve the quality and utilization of immunization data. Several practical guidance documents were produced: A practical Guide for the design, use and promotion of Home-Based Records in Immunization Programmes (available in English and French); an e-learning module on coverage monitoring (available on iLearn and on the WHO extranet); guidance on Assessing and Improving the Accuracy of Target Population Estimates for Immunization Coverage; a data quality assessment module to be integrated into the overall methodology for National Immunization Programme reviews, and a working draft of a revised WHO Vaccination Coverage Cluster Survey Reference Manual that provides guidance on the design of vaccination coverage surveys, from protocol design, to sample size calculation, cluster selection, field data collection and interpretation of survey results. WHO continued to provide technical support to strengthen vaccine-preventable disease surveillance (measles and rubella, invasive bacterial vaccine-preventable diseases, rotavirus diarrhoea, and HPV) that continue to generate data to guide Member States on their policy decision to introduce and evaluate the impact of new vaccines. The surveillance efforts are supported by networks of laboratories. These include the measles and rubella, Invasive Bacterial Vaccine Preventable Diseases (IB-VPD) and rotavirus laboratory networks. These networks provide training, technical support, quality assurance and specialized testing support to the national and subnational networks. The measles and rubella laboratory network is described under output 1.5.2 below. The IB-VPD laboratory network includes 121 Sentinel Hospital Laboratories (SHL), 21 National Laboratories (NL), nine Regional Reference Laboratories (RRL), and one Global Reference Laboratory (GRL). The WHO Rotavirus Surveillance system, includes 88 SHLs, 18 NLs, 9 RRLs and one GRL. Case-based surveillance data are collected and analysed at WHO HQ and regular surveillance bulletins are published on the WHO website. Support for surveillance included the implementation of the External Quality Assessment (EQA) surveys for the IBVPD proficiency testing (PT) panels for all laboratories participating in the WHO-coordinated surveillance network. Among the 90 laboratories that could submit results to WHO, 83 (92%) did pass the EQA with a passing score of >75%. All except one regional reference laboratory had a passing score of >90%. Human resources capacity is recognized as a key component in achieving set objectives. To strengthen WHO immunization staff capacity (and that of partner agencies), e-learning tools have been developed and piloted, and are to be applied globally. 2014 marked the fortieth anniversary of EPI. To commemorate the event, several articles were published, a video was released and a reception was held during the World Health Assembly. Challenges:

• Need for better coordination with development and implementing partners;

• high dependency on a relatively few funding agencies, which in turn are dependent on their own funding envelopes and affected by changes in priorities, strategic directions and/or funding modalities;

• insufficient human capacity at regional and for some areas global level to meet GVAP implementation needs;

• competing priorities leading to inadequate support for, and prioritization of, immunization activities by Member States; and

• a lack of resources to support non-GAVI eligible middle-income countries.


Risks and assumptions

Assumptions:

countries and development partners continue to commit to and prioritize immunization in line with their stated commitments to the GVAP goals and strategic objectives;

a continued supply of vaccines of assured quality at affordable prices to meet demand;

sufficient human and other resources available to the Programme to implement planned activities, including in view of the Polio End Game (human resources, infrastructure);

stable governments, absence of insecurity, civil strife, and humanitarian and health emergencies;

climate change will not significantly change the geographical patterns of the burden of vaccine-preventable diseases; and

consideration of Gender, Equity and Human Rights Based approaches during the course of implementation.

Risks:

changing priorities in countries and of the development partners that result in lower priority and support for vaccine preventable diseases and immunization;

countries and development partners fail to increase the commitment needed to achieve GVAP targets;

interruptions in supply of vaccines of assured quality;

high dependency of WHO immunization programme on a limited number of donors and related risks in case of changes in terms of strategic directions and/or funding modalities;

GAVI-graduating and non-GAVI low- and middle-income countries are unable to introduce or sustain new vaccines in national programmes;

conflicts, insecurity, political instability and health emergencies which affect immunization delivery; and

negative impact on the programme in case of unsuccessful Polio End Game replenishment, etc.

Strategies to mitigate the risks include:

review of GVAP progress by WHO Governing bodies (EB, WHA, Regional committees) with prompt actions identified and implementation plans put in place aimed at increasing countries’ and partners commitment; strategies tailored to address specific bottlenecks etc.;

equity indicators integrated in the monitoring and evaluation and accountability frameworks of the programme;

vaccine supply trends monitored more closely; roles and responsibilities and mechanisms to set priorities and engage in related dialogue with producers and recipient countries under discussion; and

capacity building platform under construction to increase WHO’s staff capacity to respond better to the Programme’s needs, etc.

Gender, equity and human rights and social determinants of health WHO’s strategies are highly focused on reaching the unreached, calling for equal access to affordable immunization for all people of all genders in all social and geographic locations. To ensure equity, attention has always been given to improving coverage in low coverage districts and areas through the following: devising innovative strategies to increase routine immunization coverage in hard-to-reach areas; developing adequate district micro planning; implementation of the Reaching Every District (RED) approach; and planning and implementing specific strategies for conflict areas (e.g. periodic intensification of routine immunization using periods of tranquillity, establishing vaccination posts in IDPs and refugee camps and establishing cross border posts for vaccinating the new comers of the refugees).


WHO monitors immunization coverage on the basis of a number of different social and economic determinants, including the sex of the individual and the wealth quintile they belong to. Coverage is generally uniform for both sexes in most countries, with a few rare exceptions, though many countries have wide disparities in coverage by wealth quintile. These are regularly monitored and reported as part of the GVAP assessment report. Human papillomavirus (HPV) causes cervical cancer, which is the fourth most common cancer in women, with an estimated 266,000 deaths and 528,000 new cases in 2012. A large majority (85%) of the global burden occurs in the less developed regions, where it accounts for almost 12% of all female cancers. WHO provides proactive support for policy guidance and application, planning of demonstration projects and vaccine introduction, and cost effectiveness studies, etc. The primary target group in most of the countries recommending HPV vaccination is young adolescent girls aged 9-13.

Output 1.5.2. Intensified implementation and monitoring of measles and rubella elimination, and hepatitis B control strategies facilitated

Output indicator

Baseline

Target

Achieved Value:

Number of priority countries that have conducted supplementary immunization activities to achieve their measles elimination or control goal

0 34 37

Overview of achievements and challenges

The Region of the Americas has become the first in the world to be declared free of endemic transmission of rubella, a contagious viral disease that can cause multiple birth defects, as well as fetal death when contracted by women during pregnancy. This achievement follows a 15-year effort that involved widespread administration of the vaccine against measles, mumps and rubella (MMR) throughout the Western Hemisphere. Rubella and congenital rubella syndrome (CRS) are the third and fourth vaccine-preventable diseases to be eliminated from the Americas, following the regional eradication of smallpox in 1971 and the elimination of polio in 1994. This historic result proves yet again the value of immunization and the importance of ensuring equity in access to vaccines everywhere.. In September 2013, the WHORegional Committee for South-East Asia adopted the goal of measles elimination and rubella/congenital rubella syndrome (CRS) control in the South-East Asia Region by 2020. A Strategic Plan for the Measles Elimination and Rubella/CRS Control in the South-East Asia Region (2014-2020) was published and disseminated in 2015 and countries were supported to draft national strategic plans. Regional surveillance guidelines were also developed. In response to this, all countries have accelerated measles elimination and rubella/CRS control efforts. WHO HQ continued to provide strategic and policy advice to countries for planning and implementing measles and rubella elimination strategies. At the October 2015 SAGE meeting important refinements were made to the global measles and rubella immunization policy: the epidemiological settings in which a dose of measles containing vaccine should be given before nine months of age were determined; and vaccination of HIV-infected children receiving Highly Active Antiretroviral Therapy (HAART) following immune reconstitution. The Global Measles and Rubella Laboratory Network (GMRLN) was developed based on the successful model of the global polio laboratory network. At the end of 2015, the GMRLN included 725 laboratories in 164 countries with new laboratories established in 2015 in Ethiopia, India and Indonesia. WHO continues to monitor the performance of the laboratories to ensure that they comply with established standards and to strengthen capacity for molecular detection and strain characterization. With all regions having regional measles elimination goals, efforts are being enhanced to establish and/or strengthen case-based surveillance and laboratory confirmation. In addition, two workshops were held in the South-East Asia and Eastern-Mediterranean Regions to strengthen capacity in molecular detection and characterization of measles and rubella virus strains. A total of 217 network laboratories were accredited, plus 20 provisionally in 2014-2015.


A total of 39 priority countries were supported in 2014-2015 in planning, implementing and monitoring supplementary immunization activities with measles containing vaccines.

Achievements and challenges in countries WHO provided support to 37 priority countries for conducting supplementary immunization activities (SIAs) through the development of SIA plans, preparation and implementation of SIAs, intra-SIA monitoring, and implementation of post SIAs coverage surveys. The Molecular EQA programme was established with 55 network laboratories participating, and capacity building workshops conducted in Moscow and Entebbe. Draft Seroprevalence guidelines were developed. Genotyping is increasingly becoming an integral part of surveillance, with 11504 measles sequences uploaded to MeaNS, and 326 rubella sequences uploaded to RubeNS, in 2014 and 2015, respectively. A number of maternal and neonatal tetanus (MNT) elimination validation surveys (LQAs) were supported, resulting in three more countries validated as having eliminated MNT: India, Cambodia and Mauritania. In addition MNT elimination was confirmed in 16 out of 17 regions in the Philippines. Challenges:

Competing priorities, as well as emergency (e.g., Ebola) and security constraints in some countries;

the quality of SIAs and campaigns, which need to be improved to ensure results towards elimination goals;

lack of predictable and adequate financial resources to implement the planned activities, especially related to the implementation of measles and MR SIAs and TT campaigns, largely due to lack of government commitment to covering their portion of the operational costs and late release of funds; and

stock-outs of measles vaccines due to supply shortages and inflexibility of some countries towards procuring globally available WHO prequalified vaccines.

Achievements and challenges at regional and global levels

HQ continued to provide strategic and policy advice to countries for planning and implementing measles and rubella elimination strategies. At the October 2015 SAGE meeting, some refinements were made to global measles and rubella immunization policy: the epidemiological settings in which a dose of measles containing vaccine should be given before 9 months of age were determined. This dose should be considered a supplementary dose (i.e., MCV0) and not counted as one of the two recommended doses in the child’s immunization schedule; the available evidence on safety and immunogenicity of rubella and mumps-containing vaccines support their use from six months of age. Hence, countries using MR or MMR in their national schedule should use the combined vaccine rather than measles-only formulations in children <1 year (starting as early as six months of age); and SAGE recommended that an additional dose of MCV be administered to HIV-infected children receiving Highly Active Antiretroviral Therapy (HAART) following immune reconstitution. Progress has been made with regard to the development of new guidelines and tools to improve the quality of MR SIAs (e.g., SIA readiness assessment, intra-SIA monitoring, coverage surveys, use of ITCs etc.). An E-learning course on 'Conducting high quality SIAs' is being prepared for completion by June 2016. A global MR consultant training was successfully carried out resulting in a pool of well-trained consultants to support SIAs. Using the WHO model published in the Lancet in 2012, the time series of global and regional measles mortality estimates was updated for the period 2000-2014 and published in the WER/MMWR on 13 November 2015. This publication was accompanied by a press release and good media coverage highlighting the fact that measles vaccination has saved an estimated 17.1 million lives since 2000. Planned further refinements to the model include using the actual age-specific breakdown of measles cases from surveillance data (rather than a modelled age distribution), a change in the probability of infection risk for susceptible cases (change from exponential to logistic function), and incorporating a reporting efficiency close to 100% for countries reporting zero cases in certain years (i.e. small islands with good surveillance). This work will need to be completed in 2016 to enable the refined model to be used for estimating measles deaths in 2015.


New MNT SAGE working group established to review evidence and provide guidance to help accelerate MNT elimination in countries. Challenges:

Emergency and security constraints in some countries.

Insufficient human and financial resources to implement scaled up activities needed to achieve elimination goals (e.g., timely completion and roll out of the SIA guidelines and tools; operational costs of SIAs and TT campaigns; and to allow enhanced surveillance and laboratory capacity, advocacy and social mobilization etc.

Measles global vaccines supply shortage;

Lack of demand for vaccination and hesitancy in some regions and countries.

Risks and assumptions

Assumptions:

Countries and development partners continue to commit to and prioritize their support for accelerated disease control goals and objectives in line with the GVAP.

Continued supply of vaccines to meet demand.

Sufficient human and other resources available to the Programme to implement planned activities, including in view of the Polio End Game (human resources, infrastructure).

Stable national governments, and absence of insecurity, civil strife and humanitarian and health emergencies.

Optimal quality of implemented activities (SIAs, campaigns).

Consideration of Gender, Equity and Human Rights Based approaches during the course of implementation.

Risks:

Evolving priorities in countries and of development partners result in lower priority statis and support for vaccine preventable diseases and immunization.

Countries and development partners fail to sustain and increase the commitment (including funding) needed to achieve GVAP disease control goals.

Interruptions in supply of vaccines of assured quality.

General high dependency of WHO immunization programme on a limited number of donors and related risks in case of changes in terms of strategic directions and/or funding modalities.

Conflicts, insecurity, political instability and health emergencies which affect immunization delivery.

Low quality of e.g., SIAs, campaigns and other activities result in inadequate progress toward GVAP targets.

Negative impact on the programme of unsuccessful Polio End Game replenishment, etc. Strategies to mitigate the risks include:

Review of GVAP progress by WHO Governing bodies (EB, WHA, regional committees) with prompt actions identified and implementation plans put in place aimed at increasing countries’ and partners commitment; strategies tailored to address specific bottlenecks etc.

Proactive advocacy and dialogue with national governments and partners with a focus on coordination, planning and monitoring mechanisms, as well as increased commitment.

Equity indicators integrated in the monitoring and evaluation and accountability frameworks of the programme.

Vaccine supply trends monitored more closely; roles and responsibilities and mechanisms to set priorities and engage in related dialogue with producers and recipient countries under discussion.

Guidelines in progress aimed at improving quality of measles and MR campaigns (including in emergency and political insecurity situations); technical support for planning and monitoring; capacity building platform to improve WHO’s staff capacity under construction; training to allow quick access to a pool of quality consultants etc.


Gender, equity and human rights and social determinants of health Measles and MR SIAs attempt to close equity gaps by ensuring that unreached communities are targeted using specific strategies. During the SIAs, various countries included mobile vaccination teams, extended the number of vaccination days, and set up outreach and temporary sites in remote areas in order to reach unreached communities. The establishment and implementation of the Regional Hepatitis B Control Goals will also contribute to the implementation of a gender, equity and human rights approach through the introduction and strengthening of routine immunization and by providing all children with an equal opportunity to be protected against hepatitis B. Rubella infection just before conception and in early pregnancy may result in miscarriage, fetal death or congenital defects known as congenital rubella syndrome (CRS). The highest risk of CRS is found in countries with high rates of susceptibility to rubella among women of childbearing age. The WHO recommendation to introduce rubella-containing vaccines aims to decrease mobility of the disease. Similarly, people of all ages can get tetanus but the disease is particularly common and serious in newborn babies and their mothers when the mothers` are unprotected from tetanus by the vaccine, tetanus toxoid. Tetanus can be prevented through immunization with tetanus-toxoid-containing vaccines (TTCV). Neonatal tetanus can be prevented by immunizing women of reproductive age with TTCV, either during pregnancy or outside pregnancy. This protects the mother and - through a transfer of tetanus antibodies to the fetus - also her baby.

Output 1.5.3. Target product profiles for new vaccines and other immunization-related technologies defined and research priorities to develop vaccines of public health importance and overcome barriers to immunization agreed

Output indicator

Baseline

Target

Achieved Value:

Number of new preferred product characteristics for new vaccines and policy recommendations for their use

Not applicable

At least one

two

Overview of achievements and challenges The biennium saw the largest ever outbreak of Ebola Virus Disease affecting several countries in West Africa. WHO played a major role in accelerating and coordinating the clinical evaluation of several candidate vaccines against Ebola viruses and sponsored a large phase 3 clinical trial of a recombinant vesicular stomatitis virus (rVSV) vaccine using a novel ring vaccination strategy in Guinea. Based on the available data, including the interim efficacy data from the Guinea trial, WHO also issued provisional guidance on the use of Ebola vaccines in response to outbreaks. The outbreak of Ebola Virus Disease in West Africa led to a massive effort to accelerate the development and use of Ebola vaccines in an effort to curtail the outbreak. The department played a major role in developing a target product profile (TPP) for Ebola vaccines and in coordinating the early phases of clinical evaluation of the available candidate vaccines and acted as the sponsor of a large phase 3 clinical trial of the rVSV-ZEBOV vaccines, the interim results from which were published in 2015 suggesting that the vaccine had very high efficacy and effectiveness. Development of the first WHO preferred product characteristics document for second generation malaria vaccines was completed. Work to develop the preferred product characteristics and clinical development pathways for Respiratory Syncytial Virus (RSV) and Group A Streptococcus vaccines were initiated. Draft TPP are under development for MERS-CoV and Zika vaccine. Draft preferred product characteristics (PPC) are available for RSV, Herpes Simplex virus and Group B Streptococcal vaccines.


WHO developed a novel process to enable joint decision-making by the Immunization Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Committee (MPAC) who recommended to WHO in October 2015 that subnational pilot studies of RTS,S/AS01 malaria vaccine under field conditions should be implemented in between three and five sub-Saharan African countries in order to answer remaining questions mainly concerning the programmatic feasibility of vaccine roll-out and other issues on vaccine safety and impact. The WHO Product Development for Vaccines Advisory Committee (PDVAC) was established in 2014 to provide strategic advice and recommendations to WHO related to vaccines at the Phase 2 stage of clinical evaluation or earlier, based on SAGE guidance. The committee’s remit covers areas in low- and middle-income countries where there is a substantial disease burden but no vaccines or products currently exist and there is some ongoing product development activity which may benefit from WHO guidance. This committee may also have a role where first generation vaccines are licensed but development of improved second generation products is a priority for WHO. Since its creation in April 2014, the PDVAC has completed a “horizon scanning” of 20 pathogens using the committee’s mechanism. Three pathogens were highlighted for WHO activities subject to availability of funds.

Achievements and challenges in countries During the biennium 2014-2015, WHO partners achieved the milestone of over 235 million people aged one to 29 years immunized with MenAfriVac within the meningitis belt countries of Africa. The 14-year WHO/PATH Meningitis Vaccine Project partnership came to a close at the end of December 2014. The MVP partnership achieved great success and all key milestones were reached. All clinical studies were completed, in particular among the infant population. Closure activities for clinical trials, archiving and regulatory and ethics submissions were conducted on time. The regulatory clearance and policy recommendation, required for implementation of the next step of the meningitis control strategy, were respectively obtained and formulated before the end of 2014. MenAfriVac (5 micrograms) received the SAGE recommendation that countries completing mass vaccination campaigns among 1-29 yeas-olds introduce the vaccine into the routine childhood immunization programme within one to 5 years following campaign completion, along with a one-time catch-up campaign for young children born since the initial mass vaccination and who will be outside the target age for routine immunization. The Indian regulatory authority (DCGI) approved the MenAfriVac paediatric variation and WHO prequalification was granted. Further, to ensure continued progress and the successful transition of key interventions into existing routine immunization and disease surveillance programmes, appropriate funding was secured for a transition period of three years. This allowed the programme to continue successfully during the first transition year of 2015, with about 20 million additional people being immunized with MenAfriVac during mass campaigns, and the first six meningitis belt countries applying for GAVI funding for vaccine introduction in their routine immunization programmes. Further continued and enhanced disease surveillance was implemented and research activities modelling the vaccine effect and assessing its economic impact were launched. Other challenges include:

1. Lack of adequate social mobilization around demonstration projects, allowing rumours and resulting in vaccine refusal among populations in several countries;

2. insufficient technical expertise within national regulatory authority ethics committees in some countries to authorize and monitor clinical trial activities; and

3. sustaining results in MenA would require continued resources and dedication from countries.

Achievements and challenges at regional and global levels

During 2014-2015, a large-scale outbreak of Ebola virus disease, which was declared a Public Health Emergency of International Concern, affected a number of West African countries. The slow progress in containing the outbreak underscored the urgent need for a vaccine against the Ebola virus. WHO held a series of international consultations and activities including interactions with international scientific institutions, ethical, and regulatory bodies, vaccine development and public health partner agencies, industry and funders’ communities, and participated in consortiums to facilitate Ebola vaccine assessments. Critically, a consortium of technical agencies led by a WHO team successfully carried out a trial of Ebola vaccine using the ring vaccination strategy (based on the smallpox eradication strategy) while in parallel conducting a trial of the same vaccine on frontline workers.


Preliminary results from analyses of the interim data from the Guinea Phase III efficacy vaccine trial were published within a record time of six months in the British journal The Lancet, showing that VSV-EBOV (Merck, Sharp & Dohme) is highly effective against Ebola. At regional level, the African Vaccine Regulatory Forum (AVAREF) network served as a platform for the coordination of regulatory and ethics reviews and approvals of clinical trial applications (CTAs). Similarly, networking was effective in building the capacity of weak countries through joint and assisted reviews of CTAs. Networking among research sites also facilitated building the capacity of clinical investigators in the countries which hosted the trials. Coordination and working closely across the three levels of the Organization facilitated research and development. In December 2015, WHO convened the global community to map out the next steps towards licensure of microarray patches (MAPs). MAPs represent a novel vaccine delivery methodology that has the potential to significantly improve vaccination coverage by making vaccination faster, safer and more acceptable by replacing needles and syringes, as well as removing the need for vaccine transport and storage in a cold chain, enabling vaccine administration by minimally-trained volunteers and virtually eliminating vaccine wastage. MAPs are currently in preclinical development for a number of existing vaccines, including influenza, tetanus toxoid, measles-rubella, and inactivated poliovirus vaccine, as well as for vaccines currently in development such as inactivated rotavirus and dengue vaccines. The 2015 consultation involved MAPs developers, vaccine manufacturers, regulators, funders and other key stakeholders charged with better defining and addressing the technical, financial and programmatic challenges facing product development, identifying scientifically-based evidence where available, and proposing research priorities where gaps still exist. The Advisory Committee (IVIR-AC) provides advice and recommendations on immunization and vaccine-related implementation research, including reviews of the relevance and applicability of quantitative methods, agenda setting and prioritization of research, and reviews of implementation progress and best practices. IPAC advises WHO on the formulation of immunization strategies and operational standards, the tools and technologies necessary to reach and sustain high levels of immunization coverage in order to promote immunization services of high quality. During the IVIR-AC meeting in 2014, it was recommended by the Advisory Committee that the WHO Secretariat should facilitate an information hub on the vaccine preventable disease burden and disease/economic impact. The hub links existing vaccine specific expert sub-groups in order to provide the immunization community with the latest evidence on VPD burden and vaccine impact. A first meeting of the Tuberculosis Technical Expert Group (TB-TEG) has taken place, providing advice to WHO on the clinical trial plans for two of the most advanced TB vaccine candidates. Guidance documents have been prepared and published on HIV regarding the use of adaptive clinical trial designs in the development of HIV vaccines, best practices in “vaccine-induced seropositivity (VISP)” (which describes how HIV vaccine recipients in clinical trials often test false positive for HIV infection with certain common HIV diagnostics), and the use of adenoviral vaccine vectors in HIV vaccine development. During 2014 and 2015 two expert consultations were convened to review clinical data on typhoid conjugate vaccines and to advise IVB on the pathway for SAGE revision of global policy on typhoid vaccines. With the approval of SAGE, a SAGE working group on typhoid vaccines is to be established in early 2016. A pilot to assess feasibility of enteric fever surveillance in the existing Invasive Bacterial Disease surveillance network and to support future typhoid conjugate vaccine impact was initiated. The WHO Dengue Technical Advisory Group on Dengue Vaccines in Late Stage Development met several times to review the latest clinical trial data from the leading dengue vaccine candidate. A SAGE working group was established. A consultation on mathematical modelling of dengue vaccine impact was held, which formed the basis for a comparative review of dengue vaccine impact models. Review of the available evidence on immunization schedules for Hepatitis B and DTP vaccines has been completed and the summary of the evidence and proposed recommendations were presented by SAGE in 2015. Following SAGE and IVIR-AC recommendations, a multi-disciplinary team was established to review the evidence and identify the research questions that will inform policy in relation to non-specific effects of vaccines. The work is ongoing on reviewing the immunological evidence and identifying the related research questions.


Challenges: limited financial and human resources are generally a main constraint to implementing a larger spectrum of activities in this area. Due to the funding trends the work is implemented through a number of projects.

Risks and assumptions Assumption:

• countries will be committed to implementation of the planned research studies;

• adequate funds are available to implement planned activities;

• adequate human resources are dedicated to implementation of the activities; and

• Gender, Equity, Human Rights and Ethics Based approaches are considered during the course of implementation.

Risks:

• lack of commitment by countries to implementation of the planned research studies;

• insufficient funding available to implement research activities or complete projects; and

• inadequate human resources available to implement activities including those arising from emergencies (e.g., Ebola).

Strategies to mitigate the risks include:

• review GVAP progress including research by WHO governing bodies (EB, WHA, regional committees) with prompt actions identified and implementation plans put in place aimed at increasing countries’ and partners commitment;

• proactive advocacy and dialogue with country governments and partners; and

• advisory bodies and other mechanism continue to help set priorities.

Gender, equity and human rights and social determinants of health Selection of trial sites and participants for Ebola vaccine respected the principal norms of research ethics by ensuring that communities had equal access. Trial subjects ranged from children to adults, taking into consideration that the risk of EVD was across gender and age.


III. SUMMARY OF FINANCIAL IMPLEMENTATION FOR THE PROGRAMME AREA

2014-2015 (US$ 000) AFRO AMRO SEARO EURO EMRO WPRO HQ Total

WHA approved budget 163,200 9,300 40,800 12,300 39,300 26,100 55,800 346,800

Funds Available (as at 31 Dec 2015)

Flexible Funds 17,231 3,233 3,821 842 3,171 1,960 6,730 36,988

Voluntary Contributions Specified 106,062 10,811 19,347 12,372 22,410 20,165 58,814 250,008

Total 123,293 14,044 23,168 13,214 25,581 22,125 65,544 286,996

Funds available as a % of budget 76% 151% 57% 107% 65% 85% 117% 83%

Staff costs 26,443 7,997 5,441 4,688 5,987 7,081 30,362 87,999

Activity costs 81,768 5,798 15,888 7,929 18,353 13,295 25,130 168,161

Total expenditure 108,211 13,795 21,329 12,617 24,340 20,376 55,492 256,160

Expenditure as a % of approved budget 66% 148% 52% 103% 62% 78% 99% 74%

Expenditure as a % of funds available 88% 98% 92% 95% 95% 92% 85% 89%

Staff expenditure by Major Office 30% 9% 6% 5% 7% 8% 35% 100%

Major financial implementation issues which affected programme delivery In spite of seeming to be adequately funded when compared to the Programme budget, the programme area suffers from inadequate and untimely financial resources for some activities/areas (e.g., MNT elimination, measles and rubella, routine immunization strengthening, support to non-GAVI eligible and middle-income countries). The high dependency of the programme area on a limited number of donors (e.g., GAVI, BMGF) exposes it to related risks in case of any changes in their strategic directions and/or funding modalities. A large part of the funding comes with strict project/activity and/or geographical/country specificity leaving some areas chronically underfunded and unable to support non-targeted countries. Most of the grants are re-negotiated annually and come in several non-pledge instalments which results in limited long-term visibility, continued reprioritzation of activities and, consequently, delays (especially in the first quarter of each year). Donors are reluctant to commit for staff which results in inadequate human capacity at most WHO Programme levels. In order to put in place efficiency measures to mitigate some of the funding constraints, efforts have been made to:

• search for cost savings (e.g., video-conferences instead of face to face meetings);

• prioritizing activities based on impact and long-term vision;

• investing in improvement of planning across all levels of WHO and coordination with partner agencies;

• putting in place mechanisms for regular programmatic updates, financial planning and monitoring etc.;

• enhancing communication on the contribution and objectives of programmes (including from the Secretariat); and

• enhancing advocacy and providing guidance to national governments to ensure adequate financial planning and commitment for immunization.


IV. LESSONS LEARNT AND OUTLOOK FOR 2016-2017 Lessons learnt in 2014-2015 In 2016 the focus will remain on addressing the main challenges impeding progress in relation to GVAP targets. To improve commitment by countries and organizations (funding and action) that have endorsed the GVAP, WHO plans to:

• continue investing in: guidance and capacity building instruments; establishment of in-country advisory bodies; and provision of proactive technical support to ensure adequate and timely planning, implementation monitoring, and tailoring of strategies in countries;

• enhance advocacy to Member States through advocacy visits, continued reporting during WHA and regional committees sessions, finalizing development of regional vaccine action plans, etc.;

• strengthen dialogue and coordination mechanisms among partner agencies to ensure the best availability and use of resources. Look to involve more in-country partners (civil society organizations, professional associations) Define related roles and responsibilities while promoting country ownership;

• promote sharing and full adoption of country immunization plans by health care workers; and

• review and, if required, refine strategies and tactics for measles, rubella and maternal and neonatal tetanus elimination, and promote greater use of subnational data to target efforts in disease control.

To improve quality and use of data for programme management and improvement, WHO will continue to advocate that countries invest in improving data quality at the local level and use the data to strengthen accountability and improve understanding of the programmatic issues; WHO will also continue work with other technical agencies to further develop and deploy tools to help countries with the practical task of improving the quality and use of data, with limited personnel available. To ensure affordability and supply of vaccines, efforts are being made to conduct, in coordination with partner agencies, assessments of the extent to which the reported national-level stock-outs are affecting local vaccine supply and delivery, and of the root causes of these stock-outs. Work is also under way to make the pricing information provided by countries and the technical agencies publicly available, and to collaborate jointly on finding solutions. WHO also plans to finalize a strategy and provide support to Middle Income Countries (MICs) that are not eligible for GAVI funding to ensure access to a sustainable supply of new vaccines at affordable prices. WHO will also focus on strengthening integration with other child survival and high impact interventions and on extending the benefits of immunization to adolescents and adults, including conducting studies on how opportunities to vaccinate people are being missed by healthcare workers, developing guidelines on fully integrating vaccination into all aspects of the healthcare system, and addressing missed vaccination opportunities. WHO also plans to expand its existing guidance on immunization in humanitarian emergencies to demonstrate how routine and other immunization services can best be maintained despite disruptive situations such as war and disease outbreaks.

Impediments due to any outbreak and emergency response including the response to the Ebola crisis There has been no impact of any outbreak and emergency response including the response to the Ebola crisis on the work under this programme area


Outlook for 2016-2017: Planning for Sustainable Development Goals (SDGS)

Proper implementation of the GVAP should ultimately lead to achievement of SDG 3 “Ensure healthy lives and promote well-being for all at all ages”. Strengthening routine immunization, introducing new vaccines, setting research priorities and facilitating vaccine development will continue to contribute to reducing mortality in children under five years old (3.2) and other populations. A SAGE working group set up to provide guidance on better MNT strategies and efforts to advocate for commitment to the elimination goal will contribute to a reduction in maternal deaths. Planned malaria pilots and related evidence reviews will contribute to reducing mortality and morbidity from malaria. Hepatitis B control goals implemented in several WHO regions will continue to contribute to reducing the number of new hepatitis B infections. Work on vaccine pricing, MIC strategy, continued research to bring new vaccines to use and provide related guidance, will ensure better access to affordable vaccines and a reduction in mobility and mortality in populations. Continued support to costed multiyear planning, cost effectiveness evidence, work on in-country resource planning and mobilization, and advocacy efforts will help improve countries’ financial planning and sustainability, thereby contributing to Goal 1 aimed at ensuring access to basic services by populations.

programme budget 2014-2015 performance assessment...

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