A review of immunization legislation for children in English- and Dutch-speaking Caribbean countries.

Objective: To assess the legislative frameworks concerning childhood vaccination in the English- and Dutch-speaking Caribbean and propose a model legislative framework for Caribbean countries. Methods: This study included a survey of 22 countries and territories in the Caribbean regarding legal vaccination mandates for school entry, budget allocations, sanctions, or exemptions. A legal consultant conducted a comprehensive search and analysis of legislation regarding vaccination among 13 Caribbean countries/territories. A comparative analysis of the legislation under five themes-legislative structure, mandatory vaccination, national immunization schedule, sanctions, and exemptions-formed the basis for the proposed model legislation. Results: Among the 22 Caribbean countries/territories, 17 (77%) had legislation mandating vaccination, 16 (94%) mandated vaccination for school entry, 8 (47%) had a dedicated budget for immunization programs, and 13 (76%) had no legislated national schedules. The source of legislation includes six (35%) using the Education Act, eight (47%) the Public Health Act, and five (29%) a free-standing Vaccination Act. Three countries/territories-Jamaica, Montserrat, and Saint Lucia-had immunization regulations. In 12 (71%) of the 17 countries with legislation, sanctions were included, and 10 (59%) permitted exemptions for medical or religious/philosophical beliefs. Conclusions: Several countries in the Caribbean have made failure to vaccinate a child an offense. By summarizing the existing legislative frameworks and approaches to immunization in the Caribbean, the analysis guides policymakers in making effective changes to immunization legislation in their own countries.

SARS-CoV-2: Virology, epidemiology, immunology and vaccine development.

This first International Alliance for Biological Standardization Covid-19 webinar brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable delegation from low- and middle-income countries, to discuss the virology, epidemiology and immunology of, and the vaccine development for SARS-CoV-2.

Assessing the Evidence for Maternal Pertussis Immunization: A Report From the Bill & Melinda Gates Foundation Symposium on Pertussis Infant Disease Burden in Low- and Lower-Middle-Income Countries.

Implementation of effective interventions has halved maternal and child mortality over the past 2 decades, but less progress has been made in reducing neonatal mortality. Almost 45% of under-5 global mortality now occurs in infants <1 month of age, with approximately 86% of neonatal deaths occurring in low- and lower-middle-income countries (LMICs). As an estimated 23% of neonatal deaths globally are due to infectious causes, maternal immunization (MI) is one intervention that may reduce mortality in the first few months of life, when direct protection often relies on passively transmitted maternal antibodies. Despite all countries including pertussis-containing vaccines in their routine childhood immunization schedules, supported through the Expanded Programme on Immunization, pertussis continues to circulate globally. Although based on limited robust epidemiologic data, current estimates derived from modeling implicate pertussis in 1% of under-5 mortality, with infants too young to be vaccinated at highest risk of death. Pertussis MI programs have proven effective in reducing infant pertussis mortality in high-income countries using tetanus-diphtheria-acellular pertussis (Tdap) vaccines in their maternal and infant programs; however, these vaccines are cost-prohibitive for routine use in LMICs. The reach of antenatal care programs to deliver maternal pertussis vaccines, particularly with respect to infants at greatest risk of pertussis, needs to be further evaluated. Recognizing that decisions on the potential impact of pertussis MI in LMICs need, as a first step, robust contemporary mortality data for early infant pertussis, a symposium of global key experts was held. The symposium reviewed current evidence and identified knowledge gaps with respect to the infant pertussis disease burden in LMICs, and discussed proposed strategies to assess the potential impact of pertussis MI.

The future of immunisation policy, implementation, and financing.

Vaccines have already saved many lives and they have the potential to save many more as increasingly elaborate technologies deliver new and effective vaccines against both infectious diseases--for which there are currently no effective licensed vaccines--such as malaria, tuberculosis, and HIV and non-infectious diseases such as hypertension and diabetes. However, these new vaccines are likely to be more complex and expensive than those that have been used so effectively in the past, and they could have a multifaceted effect on the disease that they are designed to prevent, as has already been seen with pneumococcal conjugate vaccines. Deciding which new vaccines a country should invest in requires not only sound advice from international organisations such as WHO but also a well informed national immunisation advisory committee with access to appropriate data for local disease burden. Introduction of vaccines might need modification of immunisation schedules and delivery procedures. Novel methods are needed to finance the increasing number of new vaccines that have the potential to save lives in countries that are too poor to afford them. Here, we discuss some options.

Advanced vaccinology training globally: Update and impact of the COVID-19 crisis.

The rapid development of innovations and new technologies, the focus on the life-course approach to immunization and equity, and the prevalent hesitancy towards vaccines requires immunization staff to be well-trained and updated regularly in order to deliver quality immunization services to the public. The need for advanced vaccinology training is therefore paramount. In preparation for a second Global Workshop on Advanced Vaccinology Training that took place in March 2022, this paper presents the results of a survey aiming to provide a thorough update of a landscape analysis on advanced vaccinology courses conducted in 2018 and a look at the impact of the COVID-19 crisis. Thirty-three course organizers responded to a survey to provide information on their respective course. Of those, 17 courses are short courses, 11 post-graduate courses and 5 are Master level courses. Most courses are organized on an annual basis. Even though some courses were not sustained overtime, the number of courses has been increasing during the last few years, and at least one vaccinology course is now being offered in each WHO region. Although the training capacity has increased tremendously, the need still exceeds the capacity and many courses have way more applicants than they can select. The most frequent challenges reported included sustainable funding and identifying faculty. The COVID-19 pandemic impacted the delivery of several vaccinology courses, which have been postponed or reformatted to an online or hybrid training event. An e-portal of the global collaboration has been established to facilitate communication between the different courses and to assist future course participants to identify the most suitable course for their needs.

Report of the 2nd workshop of the International Collaboration on advanced vaccinology training.

At a workshop on 22-24 March 2022, leaders of 33 advanced vaccinology courses were invited to meet with partners to further the aims of the International Collaboration on Advanced Vaccinology Training (ICAVT) initiated in 2018 to assist courses in addressing challenges in priority areas and facilitate interactions and exchange of information. This included: an update to the landscape analysis of advanced vaccinology courses conducted in 2018, sharing experiences and good practices in the implementation of virtual training, reviewing the training needs of target audiences, informing courses of the principles, challenges, and added value of accreditation, discussing course evaluations and measurement of course impact, reviewing principles and support needed for quality cascade training, reviewing COVID-19 impact on training and identifying remaining related training needs, and identifying solutions to facilitate refresher courses and ways to facilitate networking of courses' alumni (particularly for virtual courses). The aims were to identify needs and impediments and implement necessary actions to facilitate sharing of information and resources between courses, to identify need for further developments of the e-Portal of the Collaboration (icavt.org) established to facilitate communication between the different courses and assist future course participants identify the most suitable course for them, and to discuss the formalization of the Collaboration. During the workshop, participants looked at several reports of surveys completed by courses and courses' alumni or partners. The COVID-19 pandemic impacted the delivery of some vaccinology courses leading to postponement, delivery online or hybrid training events. Lack of sustainable funding remained a major constraint for advanced vaccinology training and needs to be addressed. The Collaboration was consolidated with responsibilities and benefits for the members better defined. There was strong support for the Collaboration to continue with the organization of educational sessions at future workshops. The meeting re-enforced the view that there was much enthusiasm and commitment for the Global Collaboration and its core values.

Advanced vaccinology education: Landscaping its growth and global footprint.

In preparation for the first Global Vaccinology Training workshop in 2018, a survey of 27 advanced vaccinology courses was conducted to provide a landscape of the vaccinology education around the world. Advanced vaccinology courses have expanded dramatically over the last 20 years, with courses located in almost all regions, but with underrepresentation amongst the Eastern part of the European region, the Eastern Mediterranean and the Western Pacific regions. Most courses are of short duration (<2 weeks), have a global or regional reach, and attract a diverse range of participants from high, middle and low-income countries with representation from public health, academia, industry and less often regulators. Lack of sustainable funding and time commitments of faculty and coordinators is a constraint for most vaccinology courses and needs to be addressed. Continuation and extension of training in vaccinology worldwide will be necessary as increasing number of new and more complex vaccines are introduced, vaccine safety concerns and rumors continue their trend, and reemergence of some vaccine-preventable diseases will require a competent workforce to advance and deploy immunizations to larger populations.

Global immunization: status, progress, challenges and future.

Vaccines have made a major contribution to public health, including the eradication of one deadly disease, small pox, and the near eradication of another, poliomyelitis.Through the introduction of new vaccines, such as those against rotavirus and pneumococcal diseases, and with further improvements in coverage, vaccination can significantly contribute to the achievement of the health-related United Nations Millennium Development Goals.The Global Immunization Vision and Strategy (GIVS) was developed by WHO and UNICEF as a framework for strengthening national immunization programmes and protect as many people as possible against more diseases by expanding the reach of immunization, including new vaccines, to every eligible person.This paper briefly reviews global progress and challenges with respect to public vaccination programmes.The most striking recent achievement has been that of reduction of global measles mortality from an estimated 750,000 deaths in 2000 down to 197,000 in 2007. Global vaccination coverage trends continued to be positive. In 2007 most regions reached more than 80% of their target populations with three doses of DPT containing vaccines. However, the coverage remains well short of the 2010 goal on 90% coverage, particularly in the WHO region of Africa (estimated coverage 74%), and South-East Asia, (estimated coverage 69%). Elements that have contributed to the gain in immunization coverage include national multi-year planning, district-level planning and monitoring, re-establishment of outreach services and the establishment of national budget lines for immunization services strengthening.Remaining challenges include the need to: develop and implement strategies for reaching the difficult to reach; support evidence-based decisions to prioritize new vaccines for introduction; strengthening immunization systems to deliver new vaccines; expand vaccination to include older age groups; scale up vaccine preventable disease surveillance; improve quality of immunization coverage monitoring and use the data to improve programme performance; and explore financing options for reaching the GIVS goals, particularly in lower-middle income countries.Although introduction of new vaccines is important,this should not be at the expense of sustaining existing immunization activities. Instead the introduction of new vaccine introduction should be viewed as an opportunity to strengthen immunization systems, increase vaccine coverage and reduce inequities of access to immunization services.

Global vaccinology training: Report from an ADVAC workshop.

At a workshop on 7-8 November 2018 the leaders of 26 advanced vaccinology courses met to carry out an extensive review of the existing courses worldwide, in order to identify education gaps and future needs and discuss potential collaboration. The main conclusions of the workshop concerned: opportunities for strengthening and expanding the global coverage of vaccinology training; evaluation of vaccinology courses; updating knowledge after the course; how to facilitate post-course 'cascade' training; developing and sharing best practices; the application of online and innovative approaches in adult education; and how to reduce costs and facilitate wider access to vaccinology training. The importance of collaboration and information exchange through networks of alumni and between courses was stressed. A web platform to provide information about existing courses for potential applicants is needed. Lack of sustainable funding is a constraint for vaccinology training and needs to be addressed.

Improving global monitoring of vaccine safety: a survey of national centres participating in the WHO Programme for International Drug Monitoring.

BACKGROUND: The WHO Programme for International Drug Monitoring (PIDM) was established in 1968 following the thalidomide disaster. The PIDM has had considerable success in analyzing drug-related adverse event reports, but more limited progress has been made in analyzing vaccine-related reports. In June 2005, the Global Advisory Committee on Vaccine Safety, acknowledging these limitations, called for a global consultation to address the need for improved monitoring and analysis of vaccine-related adverse event reports on an international level. OBJECTIVE: In preparation for this consultation and as part of a larger study designed to evaluate the PIDM, a survey of the National Pharmacovigilance Centres of all 76 countries participating in the PIDM at the time the survey was conducted. RESULTS: Thirty-six countries (47%) responded. Of the 36 responding countries, 16 (44%) reported having a separate surveillance system for adverse events following immunizations (AEFIs) and 30 (83%) reported forwarding AEFI reports to the PIDM. Seven of the 36 countries (19%) indicated that one or more population subgroups are systematically excluded from their country's AEFI surveillance system. Five of the seven countries exclude reports concerning recipients of travellers' vaccines; three exclude recipients of vaccines administered by private physicians outside the national immunization programme and supply scheme; and five exclude reports from the military sector. Only half of the respondents knew of the Brighton Collaboration, a major international initiative aimed at the standardization of AEFI definitions. CONCLUSION: The survey identified critical elements that should be addressed quickly to improve global vaccine safety monitoring. Communication between national adverse drug reaction and AEFI surveillance authorities, ability to pay for advancing technology in developing countries, and proper use of services and terminologies are issues of concern.

A review of immunization legislation for children in English- and Dutch-speaking Caribbean countries

[ABSTRACT]. Objective. To assess the legislative frameworks concerning childhood vaccination in the English- and Dutch-speaking Caribbean and propose a model legislative framework for Caribbean countries. Methods. This study included a survey of 22 countries and territories in the Caribbean regarding legal vaccination mandates for school entry, budget allocations, sanctions, or exemptions. A legal consultant conducted a comprehensive search and analysis of legislation regarding vaccination among 13 Caribbean countries/ territories. A comparative analysis of the legislation under five themes—legislative structure, mandatory vaccination, national immunization schedule, sanctions, and exemptions—formed the basis for the proposed model legislation. Results. Among the 22 Caribbean countries/territories, 17 (77%) had legislation mandating vaccination, 16 (94%) mandated vaccination for school entry, 8 (47%) had a dedicated budget for immunization programs, and 13 (76%) had no legislated national schedules. The source of legislation includes six (35%) using the Education Act, eight (47%) the Public Health Act, and five (29%) a free-standing Vaccination Act. Three countries/ territories—Jamaica, Montserrat, and Saint Lucia—had immunization regulations. In 12 (71%) of the 17 countries with legislation, sanctions were included, and 10 (59%) permitted exemptions for medical or religious/ philosophical beliefs. Conclusions. Several countries in the Caribbean have made failure to vaccinate a child an offense. By summarizing the existing legislative frameworks and approaches to immunization in the Caribbean, the analysis guides policymakers in making effective changes to immunization legislation in their own countries.

[RESUMEN]. Objetivo. Evaluar los marcos legislativos relativos a la vacunación infantil en el Caribe de habla inglesa y neerlandesa y proponer un modelo de marco legislativo para los países del Caribe. Métodos. En este estudio se incluyó una encuesta en 22 países y territorios del Caribe sobre los requisitos legales de vacunación para el ingreso escolar, asignaciones presupuestarias, sanciones o exenciones. Un consultor jurídico realizó una búsqueda y un análisis exhaustivos de la legislación relativa a la vacunación en 13 países y territorios del Caribe. Un análisis comparativo de la legislación dividido en cinco temas (estructura legislativa, vacunación obligatoria, calendario nacional de vacunación, sanciones y exenciones) formó la base del modelo de legislación propuesto. Resultados. Entre los 22 países y territorios del Caribe, 17 (77%) contaban con leyes sobre vacunación obligatoria, 16 (94%) exigían la vacunación para el ingreso escolar, 8 (47%) tenían un presupuesto dedicado a los programas de vacunación y 13 (76%) no disponían de calendarios nacionales estipulados por ley. Entre las fuentes de la legislación, seis países y territorios (35%) empleaban la ley de educación, ocho (47%) la ley de salud pública y cinco (29%) una ley independiente de vacunación. Tres países y territorios —Jamaica, Montserrat y Santa Lucía— disponían de regulaciones sobre vacunación. Doce (71%) de los 17 países con legislación tenían sanciones y 10 (59%) permitían exenciones por creencias médicas o religiosas o filosóficas. Conclusiones. Varios países del Caribe han tipificado como delito el no vacunar a un niño o niña. Al resumir los enfoques y marcos legislativos existentes para la vacunación en el Caribe, este análisis ofrece orientaciones a los responsables de formular las políticas para que realicen modificaciones efectivas en la legislación relativa a la vacunación en sus propios países.

[RESUMO]. Objetivo. Avaliar as estruturas da legislação relativas à vacinação em crianças no Caribe de língua inglesa e holandesa e propor um modelo de legislação para os países caribenhos. Métodos. Este estudo incluiu uma pesquisa relativa à exigência legal em 22 países e territórios do Caribe de vacinação para admissão em escolas, alocações orçamentárias, sanções ou isenções. Um consultor jurídico realizou ampla pesquisa e análise da legislação relativa à vacinação em 13 países/territórios do Caribe. Uma análise comparativa da legislação referente a cinco temas – estrutura legislativa, vacinação obrigatória, cronograma nacional de imunização, sanções e isenções – formou a base para o modelo de legislação proposto. Resultados. Entre os 22 países/territórios caribenhos, 17 (77%) tinham legislação que exigia a vacinação; em 16 (94%), a vacinação era obrigatória para admissão na escola; 8 (47%) tinham orçamento exclusivo para programas de imunização; e em 13 (76%), a legislação não contemplava cronogramas nacionais. Com relação à fonte da legislação, seis (35%) países usavam a legislação de educação; oito, (47%) a Legislação de Saúde Pública; e cinco (29%), legislação de vacinação independente. Três países/territórios - Jamaica, Montserrat e Santa Lúcia - tinham regulamentações para imunização. Dos 17 países com legislação, 12 (71%) incluíam sanções e 10 (59%) permitiam isenções por crenças médicas ou religiosas/filosóficas. Conclusões. Diversos países do Caribe estabelecem que não vacinar uma criança é violação da lei. Ao resumir as estruturas de legislação existentes e as abordagens da imunização no Caribe, a análise orienta os formuladores de políticas a realizar mudanças efetivas na legislação de imunização em seus próprios países.

A review of immunization legislation for children in English- and Dutch-speaking Caribbean countries / Revisión de los marcos legislativos sobre vacunación infantil en países de habla inglesa y neerlandesa del Caribe / Revisão da legislação relativa à imunização em crianças nos países do Caribe de língua inglesa e holandesa

ABSTRACT Objective. To assess the legislative frameworks concerning childhood vaccination in the English- and Dutch-speaking Caribbean and propose a model legislative framework for Caribbean countries. Methods. This study included a survey of 22 countries and territories in the Caribbean regarding legal vaccination mandates for school entry, budget allocations, sanctions, or exemptions. A legal consultant conducted a comprehensive search and analysis of legislation regarding vaccination among 13 Caribbean countries/territories. A comparative analysis of the legislation under five themes—legislative structure, mandatory vaccination, national immunization schedule, sanctions, and exemptions—formed the basis for the proposed model legislation. Results. Among the 22 Caribbean countries/territories, 17 (77%) had legislation mandating vaccination, 16 (94%) mandated vaccination for school entry, 8 (47%) had a dedicated budget for immunization programs, and 13 (76%) had no legislated national schedules. The source of legislation includes six (35%) using the Education Act, eight (47%) the Public Health Act, and five (29%) a free-standing Vaccination Act. Three countries/territories—Jamaica, Montserrat, and Saint Lucia—had immunization regulations. In 12 (71%) of the 17 countries with legislation, sanctions were included, and 10 (59%) permitted exemptions for medical or religious/philosophical beliefs. Conclusions. Several countries in the Caribbean have made failure to vaccinate a child an offense. By summarizing the existing legislative frameworks and approaches to immunization in the Caribbean, the analysis guides policymakers in making effective changes to immunization legislation in their own countries.

RESUMEN Objetivo. Evaluar los marcos legislativos relativos a la vacunación infantil en el Caribe de habla inglesa y neerlandesa y proponer un modelo de marco legislativo para los países del Caribe. Métodos. En este estudio se incluyó una encuesta en 22 países y territorios del Caribe sobre los requisitos legales de vacunación para el ingreso escolar, asignaciones presupuestarias, sanciones o exenciones. Un consultor jurídico realizó una búsqueda y un análisis exhaustivos de la legislación relativa a la vacunación en 13 países y territorios del Caribe. Un análisis comparativo de la legislación dividido en cinco temas (estructura legislativa, vacunación obligatoria, calendario nacional de vacunación, sanciones y exenciones) formó la base del modelo de legislación propuesto. Resultados. Entre los 22 países y territorios del Caribe, 17 (77%) contaban con leyes sobre vacunación obligatoria, 16 (94%) exigían la vacunación para el ingreso escolar, 8 (47%) tenían un presupuesto dedicado a los programas de vacunación y 13 (76%) no disponían de calendarios nacionales estipulados por ley. Entre las fuentes de la legislación, seis países y territorios (35%) empleaban la ley de educación, ocho (47%) la ley de salud pública y cinco (29%) una ley independiente de vacunación. Tres países y territorios —Jamaica, Montserrat y Santa Lucía— disponían de regulaciones sobre vacunación. Doce (71%) de los 17 países con legislación tenían sanciones y 10 (59%) permitían exenciones por creencias médicas o religiosas o filosóficas. Conclusiones. Varios países del Caribe han tipificado como delito el no vacunar a un niño o niña. Al resumir los enfoques y marcos legislativos existentes para la vacunación en el Caribe, este análisis ofrece orientaciones a los responsables de formular las políticas para que realicen modificaciones efectivas en la legislación relativa a la vacunación en sus propios países.

RESUMO Objetivo. Avaliar as estruturas da legislação relativas à vacinação em crianças no Caribe de língua inglesa e holandesa e propor um modelo de legislação para os países caribenhos. Métodos. Este estudo incluiu uma pesquisa relativa à exigência legal em 22 países e territórios do Caribe de vacinação para admissão em escolas, alocações orçamentárias, sanções ou isenções. Um consultor jurídico realizou ampla pesquisa e análise da legislação relativa à vacinação em 13 países/territórios do Caribe. Uma análise comparativa da legislação referente a cinco temas - estrutura legislativa, vacinação obrigatória, cronograma nacional de imunização, sanções e isenções - formou a base para o modelo de legislação proposto. Resultados. Entre os 22 países/territórios caribenhos, 17 (77%) tinham legislação que exigia a vacinação; em 16 (94%), a vacinação era obrigatória para admissão na escola; 8 (47%) tinham orçamento exclusivo para programas de imunização; e em 13 (76%), a legislação não contemplava cronogramas nacionais. Com relação à fonte da legislação, seis (35%) países usavam a legislação de educação; oito, (47%) a Legislação de Saúde Pública; e cinco (29%), legislação de vacinação independente. Três países/territórios - Jamaica, Montserrat e Santa Lúcia - tinham regulamentações para imunização. Dos 17 países com legislação, 12 (71%) incluíam sanções e 10 (59%) permitiam isenções por crenças médicas ou religiosas/filosóficas. Conclusões. Diversos países do Caribe estabelecem que não vacinar uma criança é violação da lei. Ao resumir as estruturas de legislação existentes e as abordagens da imunização no Caribe, a análise orienta os formuladores de políticas a realizar mudanças efetivas na legislação de imunização em seus próprios países.

[Global immunization policies and recommendations: objectives and process]. / Recommandations et politiques vaccinales mondiales : le rôle de l'OMS.

The World Health Organization (WHO) has a dual mandate of providing global policies, standards and norms as well as support for member countries in applying such policies and standards to national programmes with the aim to improve health. The vaccine world is changing and with it the demands and expectations of the global and national policy makers, donors, and other interested parties. Changes pertain to : new vaccines and technologies developments, vaccine safety issues, regulation and approval of vaccines, and increased funding flowing through new financing mechanisms. This places a special responsibility on WHO to respond effectively. WHO has recently reviewed and optimized its policy making structure for vaccines and immunization and adjusted it to the new Global Immunization Vision and Strategy, which broadens the scope of immunization efforts to all age groups and vaccines with emphasis on integration of immunization delivery with other health interventions. This includes an extended consultation process to promptly generate evidence base recommendations, ensuring transparency of the decision making process and added communication efforts. This article presents the objectives and impact of the process set to develop global immunization policies, norms, standards and recommendations. The key advisory committees landscape contributing to this process is described. This includes the Strategic Advisory Group of Experts, the Global Advisory Committee on Vaccine Safety and the Expert Committee on Biological Standardization. The elaboration of WHO vaccine position papers is also described.

Assessments of global drivers of vaccine hesitancy in 2014-Looking beyond safety concerns.

Vaccine hesitancy has become the focus of growing attention and concern globally despite overwhelming evidence of the value of vaccines in preventing disease and saving the lives of millions of individuals every year. Measuring vaccine hesitancy and its determinants worldwide is important in order to understand the scope of the problem and for the development of evidence-based targeted strategies to reduce hesitancy. Two indicators to assess vaccine hesitancy were developed to capture its nature and scope at the national and subnational level to collect data in 2014: 1) The top 3 reasons for not accepting vaccines according to the national schedule in the past year and whether the response was opinion- or assessment-based and 2) Whether an assessment (or measurement) of the level of confidence in vaccination had taken place at national or subnational level in the previous 5 years. The most frequently cited reasons for vaccine hesitancy globally related to (1) the risk-benefit of vaccines, (2) knowledge and awareness issues, (3) religious, cultural, gender or socio-economic factors. Major issues were fear of side effects, distrust in vaccination and lack of information on immunization or immunization services. The analysis revealed that 29% of all countries had done an assessment of the level of confidence in their country, suggesting that vaccine confidence was an issue of importance. Monitoring vaccine hesitancy is critical because of its influence on the success of immunization programs. To our knowledge, the proposed indicators provide the first global snapshot of reasons driving vaccine hesitancy and depicting its widespread nature, as well as the extent of assessments conducted by countries.

Strengthening and sustainability of national immunization technical advisory groups (NITAGs) globally: Lessons and recommendations from the founding meeting of the global NITAG network.

National Immunization Technical Advisory Groups (NITAGs) provide independent, evidence-informed advice to assist their governments in immunization policy formation. However, many NITAGs face challenges in fulfilling their roles. Hence the many requests for formation of a network linking NITAGs together so they can learn from each other. To address this request, the Health Policy and Institutional Development (HPID) Center (a WHO Collaborating Center at the Agence de Médecine Préventive - AMP), in collaboration with WHO, organized a meeting in Veyrier-du-Lac, France, on 11 and 12 May 2016, to establish a Global NITAG Network (GNN). The meeting focused on two areas: the requirements for (a) the establishment of a global NITAG collaborative network; and (b) the global assessment/evaluation of the performance of NITAGs. 35 participants from 26 countries reviewed the proposed GNN framework documents and NITAG performance evaluation. Participants recommended that a GNN should be established, agreed on its governance, function, scope and a proposed work plan as well as setting a framework for NITAG evaluation.

An update of the global burden of pertussis in children younger than 5 years: a modelling study.

BACKGROUND: Since the publication in 2003 of a model to estimate the disease burden of pertussis, new evidence of the protective effect of incomplete pertussis vaccination against severe pertussis has been reported. We revised the model to provide new estimates of regional and global pertussis cases and deaths for children younger than 5 years. METHODS: We developed a revised model with data from 2014 to estimate pertussis cases and deaths. Pertussis cases were defined according to the WHO clinical case definition, as a coughing illness lasting at least 2 weeks with paroxysms of coughing, inspiratory whooping, or post-tussive vomiting. We used UN population estimates and WHO and UNICEF data on national pertussis immunisation coverage. Estimates were made for vaccine effectiveness against pertussis cases and deaths for one, two, and three doses of vaccination, probability of infection in low and high coverage countries, and case fatality ratios in low and high mortality countries in two age groups: infants younger than 1 year and children aged 1-4 years. We did sensitivity analyses with a range of input parameters to assess the effect of uncertainty of the input parameters on the model outputs. FINDINGS: We estimated that there were 24·1 million pertussis cases and 160 700 deaths from pertussis in children younger than 5 years in 2014, with the African region contributing the largest proportions (7·8 million [33%] cases and 92 500 [58%] deaths). 5·1 million (21%) estimated pertussis cases and 85 900 (53%) estimated deaths were in infants younger than 1 year. In the sensitivity analyses, the estimated number of cases ranged from 7 million to 40 million and deaths from 38 000 to 670 000. INTERPRETATION: Our estimates suggest that, compared with the 1999 estimates published in 2003 (30·6 million pertussis cases and 390 000 deaths from pertussis in children younger than 5 years), the numbers of cases and deaths of pertussis have fallen substantially. Model sensitivity emphasised the importance of better surveillance to improve country-level decision making and pertussis control. FUNDING: None.

Moving forward on strengthening and sustaining National Immunization Technical Advisory Groups (NITAGs) globally: Recommendations from the 2nd global NITAG network meeting.

National Immunization Technical Advisory Groups (NITAGs) provide independent, evidence-informed advice to assist their governments in immunization policy formation. This is complex work and many NITAGs face challenges in fulfilling their roles. Inter-country NITAG collaboration opportunities have the potential to enhance NITAG function and grow the quality of recommendations. Hence the many requests for formation of a network linking NITAGs together so they can learn from each other. The first Global NITAG Network (GNN) meeting, held in 2016, led to a push to launch the GNN and grow the network. At the second GNN meeting, held June 28-29, 2017 in Berlin, the GNN was formally inaugurated. Participants discussed GNN governance, reflected on the April 2017 Strategic Advisory Group of Experts (SAGE) on Immunization conclusions concerning strengthening of NITAGs and also shared NITAG experiences in evaluation and inter-country collaborations and independence. They also discussed the role of Regional Technical Advisory Groups on Immunization (RTAGs) and regional networks. A number of issues were raised including NITAGs and communications, dissemination of recommendations and vaccine implementation as well as implications of off-label recommendations. Participants were alerted to immunization evidence assessment sites and value of sharing of resources. They also discussed potential GNN funding opportunities, developed an action plan for 2017-18 and selected a Steering Committee to help move the GNN forward. All participants agreed on the importance of the GNN and the value in attracting more countries to join the GNN.

Off-label use of vaccines.

This article reviews the off-label recommendations and use of vaccines, and focuses on the differences between the labelled instructions on how to use the vaccine as approved by the regulatory authorities (or "label"1), and the recommendations for use issued by public health advisory bodies at national and international levels. Differences between public health recommendations and the product label regarding the vaccine use can lead to confusion at the level of vaccinators and vaccinees and possibly result in lower compliance with national vaccination schedules. In particular, in many countries, the label may contain regulatory restrictions and warnings against vaccination of specific population groups (e.g. pregnant women) due to a lack of evidence of safety from controlled trials at the time of initial licensure of the vaccine, while public health authorities may recommend the same vaccine for that group, based on additional post-marketing data and benefit risk analyses. We provide an overview of the different responsibilities between regulatory authorities and public health advisory bodies, and the rationale for off-label use2 of vaccines, the challenges involved based on the impact of off-label use in real-life. We propose to reduce off-label use of vaccines by requiring the manufacturer to regularly adapt the label as much as possible to the public health needs as supported by new evidence. This would require manufacturers to collect and report post-marketing data, communicate them to all stakeholders and regulators to extrapolate existing evidence (when acceptable) to other groups or to other brands of a vaccine (class effect3). Regulatory authorities have a key role to play by requesting additional post-marketing data, e.g. in specific target groups. When public health recommendations for vaccine use that are outside labelled indications are considered necessary, good communication between regulatory bodies, public health authorities, companies and health care providers or vaccinators is crucial. Recommendations as well as labels and label changes should be evidence-based. The rationale for the discrepancy and the recommended off-label use of a vaccine should be communicated to providers.

Implementing efficient and sustainable collaboration between National Immunization Technical Advisory Groups: Report on the 3rd International Technical Meeting, Paris, France, 8-9 December 2014.

Many experts on vaccination are convinced that efforts should be made to encourage increased collaboration between National Immunization Technical Advisory Groups on immunization (NITAGs) worldwide. International meetings were held in Berlin, Germany, in 2010 and 2011, to discuss improvement of the methodologies for the development of evidence-based vaccination recommendations, recognizing the need for collaboration and/or sharing of resources in this effort. A third meeting was held in Paris, France, in December 2014, to consider the design of specific practical activities and an organizational structure to enable effective and sustained collaboration. The following conclusions were reached: (i) The proposed collaboration needs a core functional structure and the establishment or strengthening of an international network of NITAGs. (ii) Priority subjects for collaborative work are background information for recommendations, systematic reviews, mathematical models, health economic evaluations and establishment of common frameworks and methodologies for reviewing and grading the evidence. (iii) The programme of collaborative work should begin with participation of a limited number of NITAGs which already have a high level of expertise. The amount of joint work could be increased progressively through practical activities and pragmatic examples. Due to similar priorities and already existing structures, this should be organized at regional or subregional level. For example, in the European Union a project is funded by the European Centre for Disease Prevention and Control (ECDC) with the aim to set up a network for improving data, methodology and resource sharing and thereby supporting NITAGs. Such regional networking activities should be carried out in collaboration with the World Health Organization (WHO). (iv) A global steering committee should be set up to promote international exchange between regional networks and to increase the involvement of less experienced NITAGs. NITAGs already collaborate at the global level via the NITAG Resource Centre, a web-based platform developed by the Health Policy and Institutional Development Unit (WHO Collaborating Centre) of the Agence de Médecine Préventive (AMP-HPID). It would be appropriate to continue facilitating the coordination of this global network through the AMP-HPID NITAG Resource Centre. (v) While sharing work products and experiences, each NITAG would retain responsibility for its own decision-making and country-specific recommendations.

Vaccine safety controversies and the future of vaccination programs.

In the years following the hepatitis B vaccination/multiple sclerosis controversy, a number of new issues regarding vaccine safety have been raised, in some cases leading to more debate and confusion. Against this background, an international group of experts was convened to review the current points of view concerning the use of thimerosal as a preservative and its potential risks; the suggested link between thimerosal-containing vaccines and acute lymphoblastic leukemia; the alleged association between aluminum-containing vaccines/macrophagic myofasciitis and general systemic complaints; a possible link between vaccination and autoimmune pathology; and a hypothetical link between measles-mumps-rubella vaccination and autism. At present, there are no data to conclude that childhood vaccines, and in particular hepatitis B vaccine, pose a serious health risk or justify a change in current immunization practice. However, vaccine "scares" continue to have an international impact on immunization coverage. Creating a positive environment for immunization can be achieved by repositioning the value of vaccines and vaccination, supported by evidence-based information. The role of international organizations, the media, and the industry in the implementation of communication strategies was discussed and the impact of litigation issues on vaccination was evaluated. The Viral Hepatitis Prevention Board confirms its commitment to current recommendations for universal and risk group hepatitis B vaccination and further encourages the conduct of vaccine safety studies and the dissemination of their results.