Building an integrated serosurveillance platform to inform public health interventions: Insights from an experts' meeting on serum biomarkers.

The use of biomarkers to measure immune responses in serum is crucial for understanding population-level exposure and susceptibility to human pathogens. Advances in sample collection, multiplex testing, and computational modeling are transforming serosurveillance into a powerful tool for public health program design and response to infectious threats. In July 2018, 70 scientists from 16 countries met to perform a landscape analysis of approaches that support an integrated serosurveillance platform, including the consideration of issues for successful implementation. Here, we summarize the group's insights and proposed roadmap for implementation, including objectives, technical requirements, ethical issues, logistical considerations, and monitoring and evaluation.

Enablers and barriers of maternal and neonatal immunization programs in Latin America.

BACKGROUND: The Region of the Americas has a long history of implementing maternal and neonatal immunization (MNI) programs. Our study aimed to understand the state of MNI policies, strategies and implementation practices in Latin America (LA). METHODS: Study conducted in 5 middle-income countries: Argentina, Brazil, Honduras, Mexico and Peru. The methods included a desk review, interviews with national stakeholders and health care providers, focus groups with pregnant women and observations in health facilities. Enablers and barriers were identified and categorized as individual, societal or related to the health system. RESULTS: All 5 participating countries had similar MNI policies and high access to antenatal care. Key enablers were the high acceptability of vaccination during pregnancy, high-level of political will and a national legal framework ensuring free access to vaccines. At the health system level, implementation was facilitated by the existence of immunization advisory committees, a pooled vaccine procurement mechanism, complementary vaccine delivery strategies, conditional cash transfer to users and performance incentives to health facilities. The main programmatic barriers were the lack of adequate MNI information; limited coordination between antenatal and immunization services; inadequate supply, resources and infrastructure; high staff turnover; insufficient training for health care providers; and weak monitoring and reporting systems. CONCLUSION: Middle-income countries in LA have successfully implemented MNI programs and several enablers were identified. To overcome remaining barriers, there is a need to focus on improving the "immunization journey" for pregnant women through providing more clear and timely information to users and providers; removing barriers to access; ensuring adequate supply, human resources and infrastructure; making the health service experience positive; and establishing integrated information systems that allow for monitoring the progress toward achieving MNI goals. Strengthening the MNI programs can also improve equitable access to health services and prepare for the introduction of future vaccines for pregnant women.

Emerging and Reemerging Aedes-Transmitted Arbovirus Infections in the Region of the Americas: Implications for Health Policy.

The increasing geographical spread and disease incidence of arboviral infections are among the greatest public health concerns in the Americas. The region has observed an increasing trend in dengue incidence in the last decades, evolving from low to hyperendemicity. Yellow fever incidence has also intensified in this period, expanding from sylvatic-restricted activity to urban outbreaks. Chikungunya started spreading pandemically in 2005 at an unprecedented pace, reaching the Americas in 2013. The following year, Zika also emerged in the region with an explosive outbreak, carrying devastating congenital abnormalities and neurologic disorders and becoming one of the greatest global health crises in years. The inadequate arbovirus surveillance in the region and the lack of serologic tests to differentiate among viruses poses substantial challenges. The evidence for vector control interventions remains weak. Clinical management remains the mainstay of arboviral disease control. Currently, only yellow fever and dengue vaccines are licensed in the Americas, with several candidate vaccines in clinical trials. The Global Arbovirus Group of Experts provides in this article an overview of progress, challenges, and recommendations on arboviral prevention and control for countries of the Americas.

Systematization of the Introduction of IPV and Switch from tOPV to bOPV in the Americas.

The synchronized introduction of the inactivated polio vaccine (IPV) and the switch from trivalent oral polio vaccine (tOPV) to bivalent oral polio vaccine (bOPV) has constituted an effort without precedents, and with astonishing results. Within the established time frame, all countries in our region managed to carry out the decision, planning, and introduction of this vaccine and subsequent switch to their national immunization schedules.The purpose of this article is to systematize the process of IPV introduction and switch in Latin America and the Caribbean, which constitutes an important piece in the documentation of the polio legacy in the Americas. Regional level as well as country perspectives and viewpoints are described. Analyzing and summarizing the lessons learned from the introduction of IPV and the switch from tOPV to bOPV can be useful for the introduction of new vaccines in the Pan American Health Organization (PAHO) region and in other regions of the world, and to help our own region successfully carry out another synchronized vaccine introduction in the future, if necessary.

The path towards polio eradication over 40 years of the Expanded Program on Immunization in the Americas.

This article synthesizes the important lessons learned from polio eradication in the Region of the Americas, including initial and more recent challenges and best practices, as well as particular factors surrounding attainment of this ambitious goal. Using documents, interviews, and country surveys, the authors describe and analyze the strategies and lessons learned during the 40 years of the Expanded Program on Immunization (1977 - 2017). Some major milestones and chxallenges specifically covered are: the Vaccine-derived Poliovirus (VDPV) outbreak in the Dominican Republic; the regional "mop-up operation;" poliovirus containment in essential facilities; the unprecedented introduction of inactivated polio vaccine (IPV); the synchronized switch from trivalent to bivalent OPV; and the countries' unfailing commitment to the cause.

En este artículo se sintetizan las importantes enseñanzas extraídas de la erradicación de la poliomielitis en la Región de las Américas. Se presta especial atención a los retos y las mejores prácticas que se abordaron en un principioy a los más recientes, así como a los factores particulares que han girado en torno al logro de esta meta de gran alcance. Por medio de documentos, entrevistas y encuestas nacionales, las autoras describen y analizan las estrategias y enseñanzas extraídas a lo largo de los 40 años del Programa Ampliado de Inmunización (1977­2017). Entre los hitos y retos más importantes que se abordan en el artículo se encuentran los siguientes: el brote del poliovirus derivado de la vacuna en la República Dominicana; la campaña de vacunación "de seguimiento" a nivel regional; la contención del poliovirus en las instalaciones esenciales; la introducción sin precedentes de la vacuna antipoliomielítica con virus inactivados (VPI); el cambio sincronizado de la vacuna antipoliomielítica oral trivalente por la vacuna antipoliomielítica oral bivalente (conocido como "el switch"); y el compromiso inquebrantable de los países con esta causa.

Este artigo sintetiza os principais ensinamentos da erradicação da poliomielite na Região das Américas, expondo as dificuldades enfrentadas ao início e em um período mais recente, as boas práticas e os fatores inerentes relacionados ao alcance desta meta ambiciosa. A partir de documentos, entrevistas e levantamentos nos países, os autores descrevem e analisam as estratégias empregadas e a experiência obtida ao longo dos 40 anos do Programa Ampliado de Imunização (1977­2017). Entre os marcos e os desafios importantes abordados estão: o surto por vírus da poliomielite derivado da vacina (VDPV) na República Dominicana, a operação regional de "acabamento", a contenção do poliovírus em laboratório, a introdução inédita da vacina contra poliomielite com vírus inativado (VPI), a transição sincronizada da vacina oral contra poliomielite trivalente à bivalente e o firme compromisso dos países com a causa.

Impact and effectiveness of meningococcal vaccines: a review.

OBJECTIVES: To summarize and critically evaluate the evidence on the impact and effectiveness of meningococcal vaccination programs around the world in order to inform decisionmaking in Latin America and the Caribbean. METHODS: A review of the literature was conducted following several components of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. PubMed Central® was searched for papers published in any language from January 1999 - March 2017. RESULTS: In all, 32 studies were included, most of which evaluated the meningococcal C conjugate vaccine. Fourteen studies measured effectiveness and 30 measured impact. The effectiveness of polysaccharide vaccines was 65% - 83.7% (different age groups), while the effectiveness of the conjugate vaccines was 66% - 100%. Incidence decline of laboratory-confirmed meningococcal disease for the conjugate vaccine ranged from 77% - 100% among different ages groups. The only study that evaluated the protein subunit vaccine reported a vaccine effectiveness of 82.9%. CONCLUSIONS: The studies reviewed show impact and effectiveness of both polysaccharide vaccines and conjugate vaccines on vaccine-serogroup meningococcal disease. The conjugate vaccines, however, show higher impact and effectiveness with longer-lasting protection over the polysaccharide vaccines. Given the variance in potential use of a meningococcal vaccine, epidemiological surveillance systems should be strengthened to inform national decisions.

Progress towards a comprehensive approach to maternal and neonatal immunization in the Americas.

Maternal and neonatal immunization (MNI) is a core component of the new immunization model in the Americas, which transitioned from immunization of children to that of the entire family. Immunization during pregnancy protects the mother and the fetus by providing the neonate with maternal antibodies against disease. It has the potential to impact early childhood morbidity and mortality, and thus MNI has gained visibility and priority on the global health agenda. The Region of the Americas is a leader in MNI, as seen by its elimination of congenital rubella syndrome in 2015 and the progress made toward neonatal tetanus elimination. In the Americas, 31 countries currently target pregnant women for influenza vaccination; and 21 countries-over 90% of the Region's birth cohort-have nationwide newborn hepatitis B vaccination. This paper describes the status of MNI in the Americas and identifies gaps in the evidence, obstacles to optimal implementation, and opportunities for future improvements. Catalysts for MNI in the Region have been political commitment, endorsement by scientific societies, an established "culture of vaccination," widespread access to antenatal care, and context-specific communications; however, universal and equitable access for pregnant women and their newborns continues to be a formidable challenge, and additional vaccine safety and effectiveness evidence is needed. Continued efforts to integrate MNI with maternal and child health services will be critical to furthering the MNI platform as well.

La inmunización materna y neonatal es un componente central del nuevo modelo de inmunización en la Región de las Américas, que pasó de la inmunización infantil a la de toda la familia. La inmunización durante el embarazo protege a la madre y el feto dando al recién nacido los anticuerpos maternos contra las enfermedades. Tiene el potencial de repercutir en la morbilidad y la mortalidad en la primera infancia, por lo que la inmunización materna y neonatal ha adquirido visibilidad y prioridad en la agenda mundial de salud.La Región de las Américas ocupa una posición de liderazgo en materia de inmunización materna y neonatal, como lo demuestra la eliminación del síndrome de rubéola congénita en el 2015 y los avances logrados para la eliminación del tétanos neonatal. Actualmente en 31 países de la Región se da prioridad a las embarazadas para que reciban vacunación antigripal y en 21 países ­más de 90% de la cohorte de nacimiento de la Región­ se incluye la vacunación de los recién nacidos contra la hepatitis B a nivel nacional.En este documento se describe la situación de la inmunización materna y neonatal en la Región de las Américas y se señalan las lagunas en la evidencia, los obstáculos a la implementación óptima y las oportunidades para las mejoras futuras. Los catalizadores de la inmunización materna y neonatal en la Región han sido el compromiso político, el aval de las sociedades científicas, una "cultura de vacunación" establecida, el acceso generalizado a la atención prenatal y las comunicaciones específicas para cada contexto; sin embargo, el acceso universal y equitativo de las embarazadas y los recién nacidos sigue siendo un reto enorme y se necesitan más datos científicos sobre la seguridad y efectividad de las vacunas. La continuación de los esfuerzos para integrar la inmunización materna y neonatal en los servicios de salud maternoinfantil será fundamental para promover también la plataforma a favor de esta inmunización.

A imunização materna e neonatal é peça fundamental do novo modelo de imunização nas Américas, com a transição da vacinação de crianças à vacinação de toda a família. A vacinação da gestante protege a mãe e o feto ao proporcionar ao recém-nascido anticorpos maternos contra doenças. A imunização materna e neonatal possivelmente repercute na primeira infância reduzindo a morbidade e a mortalidade e, portanto, ganhou visibilidade sendo considerada prioritária na agenda global de saúde.A Região das Américas é líder em imunização materna e neonatal, tendo alcançado a eliminação da síndrome da rubéola congênita em 2015 e avançado para a eliminação do tétano neonatal. Existem atualmente programas de vacinação contra influenza para gestantes em 31 países e programas nacionais de vacinação contra hepatite B para recém-nascidos em 21 países (com uma cobertura superior a 90% da coorte de nascidos vivos na Região).Este artigo apresenta um panorama da imunização materna e neonatal nas Américas, destaca as lacunas nas evidências científicas e os obstáculos à implementação ideal dos programas de vacinação e aponta oportunidades futuras para melhorias. Entre os fatores responsáveis pelo incentivo à imunização materna e neonatal na Região estão o compromisso político, o endosso das sociedades científicas, uma "cultura de vacinação" estabelecida, o amplo acesso à assistência pré-natal e a comunicação contextualizada. Porém, o acesso universal e equitativo das gestantes e seus recémnascidos à vacinação é ainda um grande desafio e se fazem necessárias mais evidências sobre a segurança e a efetividade das vacinas. Além disso, é imprescindível o empenho contínuo para integrar a imunização materna e neonatal aos serviços de saúde materno-infantil e seguir promovendo a plataforma de imunização materna e neonatal.

The path towards polio eradication over 40 years of the Expanded Program on Immunization in the Americas / El camino hacia la erradicación de la poliomielitis en los 40 años del Programa Ampliado de Inmunización en la Región de las Américas / Trajetória da erradicação da poliomielite ao longo dos 40 anos do Programa Ampliado de Imunização nas Américas

SUMMARY This article synthesizes the important lessons learned from polio eradication in the Region of the Americas, including initial and more recent challenges and best practices, as well as particular factors surrounding attainment of this ambitious goal. Using documents, interviews, and country surveys, the authors describe and analyze the strategies and lessons learned during the 40 years of the Expanded Program on Immunization (1977 - 2017). Some major milestones and challenges specifically covered are: the Vaccine-derived Poliovirus (VDPV) outbreak in the Dominican Republic; the regional "mop-up operation;" poliovirus containment in essential facilities; the unprecedented introduction of inactivated polio vaccine (IPV); the synchronized switch from trivalent to bivalent OPV; and the countries' unfailing commitment to the cause.

RESUMEN En este artículo se sintetizan las importantes enseñanzas extraídas de la erradicación de la poliomielitis en la Región de las Américas. Se presta especial atención a los retos y las mejores prácticas que se abordaron en un principio y a los más recientes, así como a los factores particulares que han girado en torno al logro de esta meta de gran alcance. Por medio de documentos, entrevistas y encuestas nacionales, las autoras describen y analizan las estrategias y enseñanzas extraídas a lo largo de los 40 años del Programa Ampliado de Inmunización (1977-2017). Entre los hitos y retos más importantes que se abordan en el artículo se encuentran los siguientes: el brote del poliovirus derivado de la vacuna en la República Dominicana; la campaña de vacunación "de seguimiento" a nivel regional; la contención del poliovirus en las instalaciones esenciales; la introducción sin precedentes de la vacuna antipoliomielítica con virus inactivados (VPI); el cambio sincronizado de la vacuna antipoliomielítica oral trivalente por la vacuna antipoliomielítica oral bivalente (conocido como "el switch"); y el compromiso inquebrantable de los países con esta causa.

RESUMO Este artigo sintetiza os principais ensinamentos da erradicação da poliomielite na Região das Américas, expondo as dificuldades enfrentadas ao início e em um período mais recente, as boas práticas e os fatores inerentes relacionados ao alcance desta meta ambiciosa. A partir de documentos, entrevistas e levantamentos nos países, os autores descrevem e analisam as estratégias empregadas e a experiência obtida ao longo dos 40 anos do Programa Ampliado de Imunização (1977-2017). Entre os marcos e os desafios importantes abordados estão: o surto por vírus da poliomielite derivado da vacina (VDPV) na República Dominicana, a operação regional de "acabamento", a contenção do poliovírus em laboratório, a introdução inédita da vacina contra poliomielite com vírus inativado (VPI), a transição sincronizada da vacina oral contra poliomielite trivalente à bivalente e o firme compromisso dos países com a causa.

Impact and effectiveness of meningococcal vaccines: a review / Examen del impacto y la efectividad de las vacunas antimeningocócicas / Impacto e efetividade das vacinas meningocócicas: uma revisão sistemática

ABSTRACT Objectives To summarize and critically evaluate the evidence on the impact and effectiveness of meningococcal vaccination programs around the world in order to inform decisionmaking in Latin America and the Caribbean. Methods A review of the literature was conducted following several components of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. PubMed Central® was searched for papers published in any language from January 1999 - March 2017. Results In all, 32 studies were included, most of which evaluated the meningococcal C conjugate vaccine. Fourteen studies measured effectiveness and 30 measured impact. The effectiveness of polysaccharide vaccines was 65% - 83.7% (different age groups), while the effectiveness of the conjugate vaccines was 66% - 100%. Incidence decline of laboratory-confirmed meningococcal disease for the conjugate vaccine ranged from 77% - 100% among different ages groups. The only study that evaluated the protein subunit vaccine reported a vaccine effectiveness of 82.9%. Conclusions The studies reviewed show impact and effectiveness of both polysaccharide vaccines and conjugate vaccines on vaccine-serogroup meningococcal disease. The conjugate vaccines, however, show higher impact and effectiveness with longer-lasting protection over the polysaccharide vaccines. Given the variance in potential use of a meningococcal vaccine, epidemiological surveillance systems should be strengthened to inform national decisions.

RESUMEN Objetivos Resumir y evaluar críticamente los datos científicos sobre la repercusión y la eficacia de los programas de vacunación antimeningocócica en todo el mundo para orientar la toma de decisiones en América Latina y el Caribe. Métodos Se realizó un examen de la bibliografía siguiendo varios componentes de las directrices correspondientes a los elementos de notificación preferidos para revisiones sistemáticas y metanálisis. Se hicieron búsquedas en PubMed Central® para encontrar documentos publicados en cualquier idioma desde enero de 1999 hasta marzo del 2017. Resultados En total, se incluyeron 32 estudios, en cuya mayoría se evaluaba la vacuna antimeningocócica conjugada contra el serotipo C. En 14 estudios se midió la efectividad y en 30, el impacto. La efectividad de las vacunas polisacarídeas se encontraba entre 65% y 83,7% (grupos etarios diferentes), mientras que la de las vacunas conjugadas, entre 66% y 100%. Gracias a la vacuna conjugada, la disminución de la incidencia de la enfermedad meningocócica confirmada en laboratorio varió entre 77% y 100% en diferentes grupos etarios. En el único estudio en el que se evaluó la vacuna de subunidades proteínicas se notificó que su efectividad era de 82,9%. Conclusiones Los estudios examinados muestran el impacto y la efectividad tanto de las vacunas polisacarídeas como de las vacunas conjugadas en relación con la enfermedad meningocócica causada por los serotipos utilizados en las vacunas. Sin embargo, las vacunas conjugadas demuestran que tienen un mayor impacto y efectividad que las vacunas polisacarídeas para dar una protección más duradera. En vista de la varianza del posible uso de una vacuna antimeningocócica, se deben fortalecer los sistemas de vigilancia epidemiológica para orientar las decisiones nacionales.

RESUMO Objetivos Sumarizar e analisar de maneira crítica as evidências sobre o impacto e a efetividade dos programas de vacinação contra doença meningocócica em todo o mundo para subsidiar a tomada de decisão na América Latina e no Caribe. Métodos Uma revisão da literatura científica foi realizada de acordo com vários componentes das diretrizes dos Principais itens para relatar revisões sistemáticas e meta-análises (PRISMA). Foi feita uma pesquisa da base de dados PubMed Central® em busca de estudos publicados em qualquer idioma de janeiro de 1999 a março de 2017. Resultados Trinta e dois estudos foram selecionados, sendo que a maioria avaliou a vacina conjugada contra o meningococo C. Quatorze artigos avaliaram a efetividade da vacina e 30, o impacto. A efetividade das vacinas polissacarídicas foi de 65% a 83,7% (em diferentes faixas etárias) e a das vacinas conjugadas foi de 66% a 100%. A redução com o uso da vacina conjugada da incidência de doença meningocócica confirmada por laboratório variou de 77% a 100% em diferentes faixas etárias. O único estudo que avaliou a vacina de subunidade proteica informou uma efetividade de 82,9%. Conclusões Os estudos examinados indicam impacto e efetividade da vacina polissacarídica e da vacina conjugada para doença meningocócica do respectivo sorogrupo vacinal. As vacinas conjugadas demonstram maior impacto e efetividade e proteção mais duradoura em relação às vacinas polissacarídicas. Diante da variação do uso em potencial da vacina meningocócica, os sistemas de vigilância epidemiológica devem ser reforçados visando subsidiar a tomada de decisão das autoridades nacionais.

Progress towards a comprehensive approach to maternal and neonatal immunization in the Americas / Progreso hacia un método integral de inmunización materna y neonatal en la Región de las Américas / Avanços rumo a um enfoque amplo de imunização materna e neonatal nas Américas

ABSTRACT Maternal and neonatal immunization (MNI) is a core component of the new immunization model in the Americas, which transitioned from immunization of children to that of the entire family. Immunization during pregnancy protects the mother and the fetus by providing the neonate with maternal antibodies against disease. It has the potential to impact early childhood morbidity and mortality, and thus MNI has gained visibility and priority on the global health agenda. The Region of the Americas is a leader in MNI, as seen by its elimination of congenital rubella syndrome in 2015 and the progress made toward neonatal tetanus elimination. In the Americas, 31 countries currently target pregnant women for influenza vaccination; and 21 countries—over 90% of the Region's birth cohort—have nationwide newborn hepatitis B vaccination. This paper describes the status of MNI in the Americas and identifies gaps in the evidence, obstacles to optimal implementation, and opportunities for future improvements. Catalysts for MNI in the Region have been political commitment, endorsement by scientific societies, an established "culture of vaccination," widespread access to antenatal care, and con-text-specific communications; however, universal and equitable access for pregnant women and their newborns continues to be a formidable challenge, and additional vaccine safety and effectiveness evidence is needed. Continued efforts to integrate MNI with maternal and child health services will be critical to furthering the MNI platform as well.

RESUMEN La inmunización materna y neonatal es un componente central del nuevo modelo de inmunización en la Región de las Américas, que pasó de la inmunización infantil a la de toda la familia. La inmunización durante el embarazo protege a la madre y el feto dando al recién nacido los anticuerpos maternos contra las enfermedades. Tiene el potencial de repercutir en la morbilidad y la mortalidad en la primera infancia, por lo que la inmunización materna y neonatal ha adquirido visibilidad y prioridad en la agenda mundial de salud. La Región de las Américas ocupa una posición de liderazgo en materia de inmunización materna y neonatal, como lo demuestra la eliminación del síndrome de rubéola congénita en el 2015 y los avances logrados para la eliminación del tétanos neonatal. Actualmente en 31 países de la Región se da prioridad a las embarazadas para que reciban vacunación antigripal y en 21 países —más de 90% de la cohorte de nacimiento de la Región— se incluye la vacunación de los recién nacidos contra la hepatitis B a nivel nacional. En este documento se describe la situación de la inmunización materna y neonatal en la Región de las Américas y se señalan las lagunas en la evidencia, los obstáculos a la implementación óptima y las oportunidades para las mejoras futuras. Los catalizadores de la inmunización materna y neonatal en la Región han sido el compromiso político, el aval de las sociedades científicas, una "cultura de vacunación" establecida, el acceso generalizado a la atención prenatal y las comunicaciones específicas para cada contexto; sin embargo, el acceso universal y equitativo de las embarazadas y los recién nacidos sigue siendo un reto enorme y se necesitan más datos científicos sobre la seguridad y efectividad de las vacunas. La continuación de los esfuerzos para integrar la inmunización materna y neonatal en los servicios de salud maternoinfantil será fundamental para promover también la plataforma a favor de esta inmunización.

RESUMO A imunização materna e neonatal é peça fundamental do novo modelo de imunização nas Américas, com a transição da vacinação de crianças à vacinação de toda a família. A vacinação da gestante protege a mãe e o feto ao proporcionar ao recém-nascido anticorpos maternos contra doenças. A imunização materna e neonatal possivelmente repercute na primeira infância reduzindo a morbidade e a mortalidade e, portanto, ganhou visibilidade sendo considerada prioritária na agenda global de saúde. A Região das Américas é líder em imunização materna e neonatal, tendo alcançado a eliminação da síndrome da rubéola congênita em 2015 e avançado para a eliminação do tétano neonatal. Existem atualmente programas de vacinação contra influenza para gestantes em 31 países e programas nacionais de vacinação contra hepatite B para recém-nascidos em 21 países (com uma cobertura superior a 90% da coorte de nascidos vivos na Região). Este artigo apresenta um panorama da imunização materna e neonatal nas Américas, destaca as lacunas nas evidências científicas e os obstáculos à implementação ideal dos programas de vacinação e aponta oportunidades futuras para melhorias. Entre os fatores responsáveis pelo incentivo à imunização materna e neonatal na Região estão o compromisso político, o endosso das sociedades científicas, uma "cultura de vacinação" estabelecida, o amplo acesso à assistência pré-natal e a comunicação contextualizada. Porém, o acesso universal e equitativo das gestantes e seus recém--nascidos à vacinação é ainda um grande desafio e se fazem necessárias mais evidências sobre a segurança e a efetividade das vacinas. Além disso, é imprescindível o empenho contínuo para integrar a imunização materna e neonatal aos serviços de saúde materno-infantil e seguir promovendo a plataforma de imunização materna e neonatal.

Cost-effectiveness analysis of pneumococcal conjugate vaccine introduction in Paraguay.

OBJECTIVE: To describe a cost-effectiveness analysis of 10- or 13-valent pneumococcal conjugate vaccine (PCV10 or 13) introduction in Paraguay compared to no vaccination. METHODS: The integrated TRIVAC vaccine cost-effectiveness model (version 2.0) jointly developed by the Pan American Health Organization's ProVac Initiative and the London School of Hygiene & Tropical Medicine was applied from the government and societal perspectives to estimate the cost-effectiveness (CE) of PCV introduction during 2010 and 2011. The cost-effectiveness ratios of PCV10 and PCV13 were separately compared to non-vaccination. The model calculated health and economic benefits of vaccination for 10 birth cohorts of children <5 years of age. A base case scenario with two primary doses at 2 and 4 months and a booster dose at 12 months (2+1 schedule) and alternate scenarios with varying parameters were considered. RESULTS: With PCV10 introduction, the incremental costs of the vaccination program would be approximately US$ 67 million to vaccinate all 10 cohorts of children; with PCV13, US$ 87 million. Health services costs avoided by the government with PCV10 would be US$ 19.5 million; with PCV 13, US$ 17.7 million. From the societal perspective, savings were much greater: with PCV10, US$ 43 million; with PCV13, US$ 35 million. For the higher priced PCV13, the average cost-effectiveness ratio was better than for PCV10 when compared to no vaccination, but regardless both were cost effective for government and society based on a threshold of 3× GDP per capita in Paraguay (2009 US$ 2516). The number of averted meningitis and all-cause pneumonia cases and deaths was greater with PCV13 than with PCV10 when compared to no vaccination. CONCLUSION: The introduction of either PCV10 or PCV13 would be cost effective when compared to no vaccination, and in some scenarios, highly cost effective in Paraguay. The outcomes of these analyses demonstrate that a pneumococcal vaccine could substantially reduce morbidity and mortality in children <5 years in Paraguay.

Cost-effectiveness analysis of 10- and 13-valent pneumococcal conjugate vaccines in Peru.

OBJECTIVE: To evaluate the cost-effectiveness of introducing the 10-valent pneumococcal conjugate vaccine (PCV10) versus the 13-valent PCV (PCV13) to the National Immunization Schedule in Peru for prevention of pneumococcal disease (PD) in children <5 years of age. METHODS: The integrated TRIVAC vaccine cost-effectiveness model from the Pan American Health Organization's ProVac Initiative (version 2.0) was applied from the perspective of the Government of Peru. Twenty successive cohorts of children from birth to 5 years were evaluated. Clinical outcomes were pneumococcal pneumonia (PP), pneumococcal meningitis (PM), pneumococcal sepsis (PS) and acute otitis media from any causes (AOM). Measures included prevention of cases, neurological sequelae (NS), auditory sequelae (AS), deaths and disability adjusted life years (DALYs). A sensitivity analyses was also performed. FINDINGS: For the 20 cohorts, net costs with PCV10 and PCV13 were US$ 363.26 million and US$ 408.26 million, respectively. PCV10 prevented 570,273 AOM; 79,937 PP; 2217 PM; 3049 PS; 282 NS; 173 AS; and 7512 deaths. PCV13 prevented 419,815 AOM; 112,331 PN; 3116 PM; 4285 PS; 404 NS; 248 AS; and 10,386 deaths. Avoided DALYs were 226,370 with PCV10 and 313,119 with PCV13. Saved treatment costs were US$ 37.39 million with PCV10 and US$ 47.22 million with PCV13. Costs per DALY averted were US$ 1605 for PCV10, and US$ 1304 for PCV13. Sensitivity analyses showed similar results. PCV13 has an extended dominance over PCV10. CONCLUSION: Both pneumococcal vaccines are cost effective in the Peruvian context. Although the net cost of vaccination with PCV10 is lower, PCV13 prevented more deaths, pneumococcal complications and sequelae. Costs per each prevented DALY were lower with PCV13. Thus, PCV13 would be the preferred policy; PCV10 would also be reasonable (and cost-saving relative to the status quo) if for some reason 13-valent were not feasible.

ProVac Global Initiative: a vision shaped by ten years of supporting evidence-based policy decisions.

INTRODUCTION: The Pan American Health Organization (PAHO) created the ProVac Initiative in 2004 with the goal of strengthening national technical capacity to make evidence-based decisions on new vaccine introduction, focusing on economic evaluations. In view of the 10th anniversary of the ProVac Initiative, this article describes its progress and reflects on lessons learned to guide the next phase. METHODS: We quantified the output of the Initiative's capacity-building efforts and critically assess its progress toward achieving the milestones originally proposed in 2004. Additionally, we reviewed how country studies supported by ProVac have directly informed and strengthened the deliberations around new vaccine introduction. RESULTS: Since 2004, ProVac has conducted four regional workshops and supported 24 health economic analyses in 15 Latin American and Caribbean countries. Five Regional Centers of Excellence were funded, resulting in six operational research projects and nine publications. Twenty four decisions on new vaccine introductions were supported with ProVac studies. Enduring products include the TRIVAC and CERVIVAC cost-effectiveness models, the COSTVAC program costing model, methodological guides, workshop training materials and the OLIVES on-line data repository. Ten NITAGs were strengthened through ProVac activities. DISCUSSION: The evidence accumulated suggests that initiatives with emphasis on sustainable training and direct support for countries to generate evidence themselves, can help accelerate the introduction of the most valuable new vaccines. International and Regional Networks of Collaborators are necessary to provide technical support and tools to national teams conducting analyses. Timeliness, integration, quality and country ownership of the process are four necessary guiding principles for national economic evaluations to have an impact on policymaking. It would be an asset to have a model that offers different levels of complexity to choose from depending on the vaccine being evaluated, the availability of data, and the time frame of the decision. CONCLUSION: Decision support for new vaccine introduction in low- and middle-income countries is critical to maximizing the efficiency and impact of vaccination programs. Global technical cooperation will be required. In the future, PAHO and WHO have an opportunity to expand the reach of the ProVac philosophy, models, and methods to additional regions and countries requiring real-time support. The ProVac Global Initiative is proposed as an effective mechanism to do so.

Evidence-based decision-making for vaccine introductions: Overview of the ProVac International Working Group's experience.

INTRODUCTION: Pan American Health Organization's (PAHO) ProVac Initiative aims to strengthen countries' technical capacity to make evidence-based immunization policy. With financial support from the Bill and Melinda Gates Foundation, PAHO established the ProVac International Working Group (IWG), a platform created for two years to transfer the ProVac Initiative's tools and methods to support decisions in non-PAHO regions. METHODS: In 2011, WHO Regional Offices and partner agencies established the IWG to transfer the ProVac framework for new vaccine decision support, including tools and trainings to other regions of the world. During the two year period, PAHO served as the coordinating secretariat and partner agencies played implementing or advisory roles. RESULTS: Fifty nine national professionals from 17 countries received training on the use of economic evaluations to aid vaccine policy making through regional workshops. The IWG provided direct technical support to nine countries to develop cost-effectiveness analyses to inform decisions. All nine countries introduced the new vaccine evaluated or their NITAGs have made a recommendation to the Ministry of Health to introduce the new vaccine. DISCUSSION: Developing countries around the world are increasingly interested in weighing the potential health impact due to new vaccine introduction against the investments required. During the two years, the ProVac approach proved valuable and timely to aid the national decision making processes, even despite the different challenges and idiosyncrasies encountered in each region. The results of this work suggest that: (1) there is great need and demand for technical support and for capacity building around economic evaluations; and (2) the ProVac method of supporting country-owned analyses is as effective in other regions as it has been in the PAHO region. CONCLUSION: Decision support for new vaccine introduction in low- and middle-income countries is critical to guiding the efficient use of resources and prioritizing high impact vaccination programs.

TRIVAC decision-support model for evaluating the cost-effectiveness of Haemophilus influenzae type b, pneumococcal and rotavirus vaccination.

The TRIVAC decision support model has been used widely in Latin America and other regions to help national teams evaluate the cost-effectiveness of Haemophilus influenzae type b (Hib) vaccine, pneumococcal conjugate vaccine (PCV) and rotavirus vaccine (RV). We describe the structure and functioning of this model, and identify the parameters with the greatest influence on the results. The TRIVAC model is a spreadsheet software program that calculates incremental cost-effectiveness ratios (ICERs) and other indicators for three childhood vaccines (Hib, PCV and RV) utilising parameters such as demography, disease burden, vaccine costs, vaccine coverage, vaccine efficacy, health service utilisation and costs. There is a good deal of uncertainty about the local values of many of the parameters that have most influence on the cost-effectiveness of these new vaccines. Cost-effectiveness models can be used to explore the implications of different values of these parameters. However, for such models to be seen as relevant and helpful by decision-makers, they need to be transparent, flexible, easy to use, and embedded in a process which is owned and led by national teams. In this paper the key drivers of cost-effectiveness in the model are identified by one-way sensitivity analyses, run for each vaccine in 147 countries. The data used are mainly from standard international sources and the published literature. The primary indicator was the discounted cost per Disability Adjusted Life-Year (DALY) averted, from a government perspective, over a 20-year period (2013-2032). For all three vaccines, the ICER was most sensitive to changes in relative coverage (the coverage of the children who would have become diseased or, more importantly, died if the population had not been vaccinated, as a % of overall national coverage) and the herd effect multiplier. Other influential parameters for all three vaccines were: the incidence and case fatality of disease, the baseline trend in disease mortality in the absence of vaccination, vaccine efficacy, vaccine price and the % decline in vaccine price per year. Important vaccine-specific parameters included the cost of Hib meningitis sequelae, PCV serotype coverage and the rotavirus gastro-enteritis (RVGE) admission rate. While vaccine efficacy, herd effects, disease mortality and vaccine price are commonly cited as important drivers of cost-effectiveness, this analysis highlights the potentially important influence of relative coverage, a parameter rarely considered in models of vaccine impact and cost-effectiveness.

Vaccination legislation in Latin America and the Caribbean.

Governments have the authority and responsibility to ensure vaccination for all citizens. The development of vaccination legislation in Latin America and the Caribbean (LAC) parallels the emergence of sustainable, relatively autonomous, and effective national immunization programs. We reviewed vaccination legislation and related legal documents from LAC countries (excluding Canada, Puerto Rico, the United States, and the US Virgin Islands), and described and assessed vaccination legislation provisions. Twenty-seven of the 44 countries and territories in the Region have proposed or enacted vaccination legislation. Provisions vary substantially, but legal frameworks generally protect the sustainability of the immunization program, the individual's right to immunization, and the state's responsibility to provide it as a public good. Of the legislation from countries and territories included in the analysis, 44 per cent protects a budget line for vaccines, 96 per cent mandates immunization, 63 per cent declares immunization a public good, and 78 per cent explicitly defines the national vaccine schedule. We looked for associations between vaccination legislation in LAC and national immunization program performance and financing, and conclude with lessons for governments seeking to craft or enhance vaccination legislation.

Indicators to assess National Immunization Technical Advisory Groups (NITAGs).

A National Immunization Technical Advisory Group (NITAG) is an expert advisory committee that provides evidence-based recommendations to the Ministry of Health (MoH) to guide immunization programs and policies. The World Health Organization (WHO), the Initiative for Supporting National Independent Immunization and Vaccine Advisory Committees (SIVAC) at Agence de Médecine Préventive (AMP) and the US Centers for Disease Control and Prevention (US CDC) engaged NITAG stakeholders and technical partners in the development of indicators to assess the effectiveness of NITAGs. A list of 17 process, output and outcome indicators was developed and tested in 14 countries to determine whether they were understandable, feasible to collect, and useful for the countries. Based on the findings, a revised version of the indicators is proposed for self-assessment in the countries, as well as for global monitoring of the NITAGs.

Monitoring of progress in the establishment and strengthening of national immunization technical advisory groups.

The majority of industrialized and some developing countries have established technical advisory bodies to guide and formulate national immunization policies and strategies. These are referred to as National Immunization Technical Advisory Groups (NITAGs), WHO and its partners have placed a high priority on assisting in the establishment or strengthening of functional, sustainable, and independent NITAGs. To enable systematic global monitoring of the existence and functionality of NITAGs, in 2010, WHO and UNICEF included related questions in the WHO-UNICEF Joint Reporting Form (JRF) that provides an official means for WHO and UNICEF to collect indicators of immunization programme performance. This paper presents the status of NITAGs based on the analysis of the 2010 JRF. Although 115 countries (64% of responders) reported having a NITAG in 2010, only 50% of countries reported the existence of a NITAG with a formal administrative or legislative basis. Despite limitations in the ability to compare 2010 JRF data with that from a 2008 global survey, it appears that substantial progress has been achieved globally over with 43 committees reporting affirmatively about six NITAG process indicators, compared with 23 in the 2008 survey. Impressive progress has been observed in the proportion of countries reporting NITAGs with formal terms of reference (24% increase), a legislative or administrative basis (10% increase), and a requirement for members to disclose their interests (14% increase). Some of the poorest developing countries now enjoy support from a NITAG which meet all six process indicators. These may serve as examples for other countries.

Performing Country-led Economic Evaluations to Inform Immunization Policy: ProVac Experiences in Latin America and the Caribbean.

New vaccines have been demonstrated to be effective in reducing morbidity and mortality, particularly in children, but come at increased costs to societies, governments, and their national immunization programs compared with other traditional childhood vaccines. Rational allocation of available resources requires systematic collection of the evidence base to decide whether to introduce a new vaccine, an important component of which is cost-effectiveness analysis. In this article, we develop in-depth case studies to examine the country experience of conducting cost-effectiveness analysis with the support of Pan American Health Organization ProVac Initiative and the implications of its process for decision making on new vaccine introduction in Latin America and the Caribbean. Key lessons regarding how cost-effectiveness analysis may be effectively used to inform evidence-based immunization policy are highlighted, drawing from the experience of Nicaragua and Paraguay. Based on the lessons identified, the vision going forward will focus on promoting the sustainability of multidisciplinary country teams while continuing to prioritize capacity development as an overarching guiding principle for preparing countries to face future new vaccine policy decisions.