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1.
Rev Panam Salud Publica ; 47: e19, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36686892

RESUMEN

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.

2.
Artículo en Inglés | PAHO-IRIS | ID: phr-56994

RESUMEN

[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.


Asunto(s)
Inmunización , Legislación , Política Informada por la Evidencia , Toma de Decisiones , Política de Salud , Pediatría , Región del Caribe , Inmunización , Toma de Decisiones , Política de Salud , Pediatría , Región del Caribe , Inmunización , Política de Salud , Pediatría , Región del Caribe
3.
Rev. panam. salud pública ; 47: e19, 2023. tab, graf
Artículo en Inglés | LILACS-Express | LILACS | ID: biblio-1424276

RESUMEN

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.

4.
Vaccine ; 40(47): 6689-6699, 2022 11 08.
Artículo en Inglés | MEDLINE | ID: mdl-36273989

RESUMEN

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.


Asunto(s)
COVID-19 , Vacunología , Humanos , Pandemias/prevención & control , COVID-19/prevención & control , Organizaciones
5.
Vaccine ; 40(39): 5683-5690, 2022 09 16.
Artículo en Inglés | MEDLINE | ID: mdl-36030127

RESUMEN

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.


Asunto(s)
COVID-19 , Vacunas , COVID-19/prevención & control , Humanos , Pandemias/prevención & control , Vacunología
7.
Vaccine ; 38(30): 4664-4670, 2020 06 19.
Artículo en Inglés | MEDLINE | ID: mdl-32475535

RESUMEN

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.


Asunto(s)
Vacunas , Vacunología , Humanos , Recursos Humanos
8.
Vaccine ; 37(22): 2871-2881, 2019 05 16.
Artículo en Inglés | MEDLINE | ID: mdl-30898392

RESUMEN

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.


Asunto(s)
Vacunología/métodos , Educación Médica Continua/métodos , Humanos , Vacunas/uso terapéutico
9.
Vaccine ; 35(50): 6925-6930, 2017 12 15.
Artículo en Inglés | MEDLINE | ID: mdl-29103592

RESUMEN

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.


Asunto(s)
Comités Consultivos , Política de Salud , Programas de Inmunización/organización & administración , Humanos , Cooperación Internacional
10.
Lancet Infect Dis ; 17(9): 974-980, 2017 09.
Artículo en Inglés | MEDLINE | ID: mdl-28623146

RESUMEN

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.


Asunto(s)
Salud Global , Modelos Estadísticos , Vacuna contra la Tos Ferina/administración & dosificación , Tos Ferina/epidemiología , Tos Ferina/mortalidad , Preescolar , Humanos , Esquemas de Inmunización , Lactante , Recién Nacido , Vigilancia de la Población , Vacunación/métodos , Tos Ferina/prevención & control
11.
Vaccine ; 35(23): 3007-3011, 2017 05 25.
Artículo en Inglés | MEDLINE | ID: mdl-28456526

RESUMEN

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.


Asunto(s)
Comités Consultivos , Salud Global , Política de Salud , Programas de Inmunización/organización & administración , Comités Consultivos/legislación & jurisprudencia , Comités Consultivos/organización & administración , Comités Consultivos/estadística & datos numéricos , Congresos como Asunto , Francia , Humanos , Programas de Inmunización/legislación & jurisprudencia , Programas de Inmunización/estadística & datos numéricos , Programas de Inmunización/tendencias , Colaboración Intersectorial , Vacunas
12.
PLoS One ; 12(3): e0172310, 2017.
Artículo en Inglés | MEDLINE | ID: mdl-28249006

RESUMEN

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.


Asunto(s)
Actitud Frente a la Salud , Inmunización , Encuestas y Cuestionarios , Vacunas , Femenino , Humanos , Masculino
13.
Vaccine ; 35(18): 2329-2337, 2017 04 25.
Artículo en Inglés | MEDLINE | ID: mdl-28341112

RESUMEN

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.


Asunto(s)
Uso Fuera de lo Indicado , Vacunas/administración & dosificación , Aprobación de Drogas , Humanos , Vigilancia de Productos Comercializados , Vacunas/efectos adversos
14.
Clin Infect Dis ; 63(suppl 4): S123-S133, 2016 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-27838664

RESUMEN

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.


Asunto(s)
Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/inmunología , Atención Prenatal , Vacunación , Tos Ferina/prevención & control , Costo de Enfermedad , Países en Desarrollo , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificación , Femenino , Salud Global , Política de Salud , Humanos , Inmunidad Materno-Adquirida , Programas de Inmunización , Lactante , Recién Nacido , Masculino , Evaluación de Resultado en la Atención de Salud , Vigilancia de la Población , Embarazo , Atención Prenatal/métodos , Vacunación/métodos , Tos Ferina/epidemiología , Tos Ferina/mortalidad
15.
Vaccine ; 34(11): 1325-30, 2016 Mar 08.
Artículo en Inglés | MEDLINE | ID: mdl-26859237

RESUMEN

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.


Asunto(s)
Comités Consultivos/organización & administración , Cooperación Internacional , Vacunación/normas , Conferencias de Consenso como Asunto , Política de Salud , Programas de Inmunización , Paris , Organización Mundial de la Salud
17.
Vaccine ; 33(36): 4365-7, 2015 Aug 26.
Artículo en Inglés | MEDLINE | ID: mdl-26165917

RESUMEN

It has long been acknowledged that there is little interaction between National Immunization Technical Advisory Groups (NITAGs) in the North and even less between those in the North and those in the South. Three international meetings of NITAGs recommended establishing an international network of NITAGs centred on a core functional structure and platform to facilitate future exchanges. The SIVAC Initiative (as part of a WHO Collaborating Center) followed-up with this recommendation, and launched an interactive platform involving all NITAGs worldwide in an active network and open collaboration: the NITAG Resource Center (NRC), accessible at http://www.nitag-resource.org. The NRC offers NITAG members and secretariats a centralized access to NITAG recommendations from around the world, systematic reviews, scientific publications, technical reports, updates from partners, and upcoming immunization events. A dedicated network manager will proactively update all contents through a strong network of regional and national focal points. The NRC is a first step towards a more fruitful and global collaboration between NITAGs.


Asunto(s)
Control de Enfermedades Transmisibles/métodos , Control de Enfermedades Transmisibles/organización & administración , Política de Salud , Programas de Inmunización/métodos , Programas de Inmunización/organización & administración , Servicios de Información , Conducta Cooperativa , Humanos , Cooperación Internacional
18.
Vaccine ; 33(34): 4215-7, 2015 Aug 14.
Artículo en Inglés | MEDLINE | ID: mdl-25896378

RESUMEN

Based on the concerns about vaccine hesitancy and its impact on vaccine uptake rates and the performance of national immunization programmes, the Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on Vaccine Hesitancy [1], carried out a review, and proposed a set of recommendations directed to the public health community, to WHO and its partners, and to the World Health Organization (WHO) member states. The final recommendations issued by SAGE in October 2014 fall into three categories: (1) those focused on the need to increase the understanding of vaccine hesitancy, its determinants and the rapidly changing challenges it entails; (2) those focused on dealing with the structures and organizational capacity to decrease hesitancy and increase acceptance of vaccines at the global, national and local levels; (3) and those focused on the sharing of lessons learnt and effective practices from various countries and settings as well as the development, validation and implementation of new tools to address hesitancy.


Asunto(s)
Conocimientos, Actitudes y Práctica en Salud , Programas de Inmunización , Aceptación de la Atención de Salud , Vacunas , Humanos , Cooperación del Paciente , Salud Pública , Características de la Residencia , Negativa del Paciente al Tratamiento , Vacunación , Organización Mundial de la Salud
19.
Vaccine ; 33(34): 4157-60, 2015 Aug 14.
Artículo en Inglés | MEDLINE | ID: mdl-25896380

RESUMEN

Despite a wide array of safe and effective vaccines in use globally, with major impacts on health worldwide, the WHO Strategic Advisory Group of Experts (SAGE) on Immunization has been repeatedly confronted with reports of hesitancy towards accepting specific vaccines or vaccination programmes. This paper summarizes the rationale for a SAGE review of the issue of vaccine hesitancy, its impact and ways to address it, and the convening of a Vaccine Hesitancy Working Group in March 2012 to prepare for the SAGE review. It describes the methods used and mode of operations, and advances in the relatively new field of research on vaccine hesitancy. It further elaborates and references the work conducted, including a series of products, conclusions and recommendations that emerged from the SAGE review in October 2014.


Asunto(s)
Conocimientos, Actitudes y Práctica en Salud , Programas de Inmunización , Aceptación de la Atención de Salud , Negativa del Paciente al Tratamiento , Educación , Humanos , Cooperación del Paciente , Vacunación/psicología , Vacunas , Organización Mundial de la Salud
20.
Lancet Infect Dis ; 15(3): 340-7, 2015 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-25661473

RESUMEN

Global vaccine stockpiles, in which vaccines are reserved for use when needed for emergencies or supply shortages, have effectively provided countries with the capacity for rapid response to emergency situations, such as outbreaks of yellow fever and meningococcal meningitis. The high cost and insufficient supply of many vaccines, including oral cholera vaccine and pandemic influenza vaccine, have prompted discussion on expansion of the use of vaccine stockpiles to address a wider range of emerging and re-emerging diseases. However, the decision to establish and maintain a vaccine stockpile is complex and must take account of disease and vaccine characteristics, stockpile management, funding, and ethical concerns, such as equity. Past experience with global vaccine stockpiles provide valuable information about the processes for their establishment and maintenance. In this Review we explored existing literature and stockpile data to discuss the lessons learned and to inform the development of future vaccine stockpiles.


Asunto(s)
Control de Enfermedades Transmisibles/métodos , Enfermedades Transmisibles Emergentes/prevención & control , Reserva Estratégica , Vacunas , Enfermedades Transmisibles Emergentes/epidemiología , Salud Global , Humanos , Vacunas/provisión & distribución
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