Global landscape analysis of no-fault compensation programmes for vaccine injuries: A review and survey of implementing countries.

To update the landscape analysis of vaccine injuries no-fault compensation programmes, we conducted a scoping review and a survey of World Health Organization Member States. We describe the characteristics of existing no-fault compensation systems during 2018 based on six common programme elements. No-fault compensation systems for vaccine injuries have been developed in a few high-income countries for more than 50 years. Twenty-five jurisdictions were identified with no-fault compensation programmes, of which two were recently implemented in a low- and a lower-middle-income country. The no-fault compensation programmes in most jurisdictions are implemented at the central or federal government level and are government funded. Eligibility criteria for vaccine injury compensation vary considerably across the evaluated programmes. Notably, most programmes cover injuries arising from vaccines that are registered in the country and are recommended by authorities for routine use in children, pregnant women, adults (e.g. influenza vaccines) and for special indications. A claim process is initiated once the injured party or their legal representative files for compensation with a special administrative body in most programmes. All no-fault compensation programmes reviewed require standard of proof showing a causal association between vaccination and injury. Once a final decision has been reached, claimants are compensated with either: lump-sums; amounts calculated based on medical care costs and expenses, loss of earnings or earning capacity; or monetary compensation calculated based on pain and suffering, emotional distress, permanent impairment or loss of function; or combination of those. In most jurisdictions, vaccine injury claimants have the right to seek damages either through civil litigation or from a compensation scheme but not both simultaneously. Data from this report provide an empirical basis on which global guidance for implementing such schemes could be developed.

Chile's National Advisory Committee on Immunization (CAVEI): Evidence-based recommendations for public policy decision-making on vaccines and immunization.

A National Immunization Technical Advisory Group (NITAG) provides independent, evidence-based recommendations to the Ministry of Health for immunization programmes and policy formulation. In this article, we describe the structure, functioning and work processes of Chile's NITAG (CAVEI) and assess its functionality, quality of work processes and outputs, and integration of the committee into the Ministry of Health policy process using the Assessment tool for National Immunization Technical Advisory Groups. Among its strengths, CAVEI's administrative and work plasticity allows it to respond in a timely manner to the Ministry of Health's requests and proactively raise subjects for review. Representation of multiple areas of expertise within the committee makes CAVEI a robust and balanced entity for the development of evidence-based comprehensive recommendations. High ranking profile of the Secretariat structure furthers CAVEI's competences in policymaking and serves as a bridge between the committee and international initiatives in the field of immunizations.

Experiencia chilena en el comportamiento del SARS-COV-2 y campaña de vacunación en pediatría / Chilean experience in the behavior of SARS-COV-2 and the vaccination in pediatrics

La pandemia por Covid-19 ha provocado millones de hospitalizaciones y muertes en el mundo, principalmente en la población adulta. A pesar de que la población pediátrica se ha visto afectada con una menor frecuencia y severidad que los adultos, no están exentos de casos prolongados, graves y letalidad, destacando la aparición de un nuevo cuadro clínico, como el síndrome inflamatorio multisistémico asociado a Covid-19. Constantes esfuerzos científicos han permitido avanzar de manera efectiva en la implementación de estrategias de vacunación pediátrica masiva contra el Covid-19. Actualmente, en Chile esta estrategia está demostrando ser segura, efectiva y puede colaborar con la reapertura de escuelas y el regreso a clases presenciales, de manera de disminuir las interrupciones y brechas escolares, otorgando otros beneficios indirectos, tales como el mejoramiento de la salud mental y emocional, el incremento de la actividad física y estabilidad familiar, aportando en el mejoramiento del bienestar y calidad de vida de los niños y sus familias.

The Covid-19 pandemic has caused millions of hospitalizations and deaths in the world, mainly in the adult population. Although the pediatric population has been affected less frequently and less severely than adults, they are not exempt from prolonged, severe cases and lethality by SARS-CoV-2, highlighting the appearance of a new clinical picture, such as multisystem inflammatory syndrome associated with Covid-19. Constant scientific efforts have made it possible to effectively advance in the implementation of mass pediatric vaccination strategies against Covid-19. Currently, in Chile this strategy is proving to be safe, effective and can collaborate with the school openings and returning to presential classes, to reduce interruptions and school-gaps, granting other indirect benefits, such as the improvement of mental and emotional health, the increase of physical activity and family stability, contributing to the improvement of the well-being and quality of life of children and their families.

Recomendación del Comité Asesor de Vacunas y Estrategias de Inmunización (CAVEI) sobre vacunación contra viruela símica en Chile / Recommendation of the Advisory Committee on Vaccines and Immunization Strategies on monkeypox vaccination in Chile

La viruela del mono fue declarada emergencia de salud pública de importancia internacional por la Organización Mundial de la Salud el año 2022. En Chile, hasta septiembre se han confirmado sobre 450 enfermos, mayoritariamente hombres jóvenes. Este poxvirus zoonótico se transmite entre humanos por contacto estrecho; la enfermedad es autolimitada y puede ser fatal en inmunocomprometidos. La prevención mediante inmunización es importante. MVA-BN es una de las tres vacunas disponibles, de 3° generación, contiene el virus vaccinia atenuado, no replicante por lo que se puede administrar a pacientes inmunocomprometidos y mujeres embarazadas y está aprobada para viruela símica en personas > 18 años. La información disponible sobre eficacia y efectividad es limitada. El CAVEI recomienda incorporar esta vacuna para interrumpir la cadena de transmisión y reducir el riesgo de enfermedad grave, en dos dosis separadas por 28 días, por vía subcutánea, priorizando el uso post-exposición para contactos estrechos con riesgo de enfermedad grave, idealmente en los primeros 4 días y hasta 14 días post contacto de riesgo y en ausencia de síntomas. Cuando el suministro de vacunas lo permita, se recomienda prevención pre-exposición para personas con alto riesgo ocupacional o por prácticas sexuales. Esta recomendación podría modificarse según la epidemiología, el suministro de vacunas y nueva información científica.

Monkeypox was declared a public health emergency of international concern by the World Health Organization during 2022. In Chile, over 450 patients have been confirmed until September, mostly young men. This zoonotic poxvirus is transmitted from humans to humans through close contact; it is a self-limiting disease and can be fatal in people with immunodeficiency. Prevention by immunization is important. MVA-BN, one of the three vaccines available, it is a third generation vaccine, based on non-replicating modified vaccinia virus, therefore can be administered to immunocompromised patients and pregnant women and it has been approved for monkeypox in people over 18 years of age. The available information on efficacy and effectiveness is limited. The CAVEI recommends incorporating this vaccine to interrupt the chain of transmission and reduce the risk of severe disease, administered subcutaneously in two doses, 28 days apart, prioritizing post exposure use for close contacts of confirmed cases with risk of severe disease, ideally within 4 days of exposure and it can be used up to 14 days after exposure and in the absence of symptoms. When the vaccine supply allows it, its application is recommended as pre-exposure prevention for people with high-risk sexual practices or with occupational risk. This recommendation could be modified according to epidemiology, vaccines supply and new scientific information.

Farmacovigilancia de vacunas y su aplicación en Chile / Vaccine pharmacovigilance and its application in Chile

La inmunización se encuentra entre las intervenciones en salud pública más exitosas y costo efectivas de todas las épocas, siendo su beneficio tan importante como su seguridad. Las vacunas, como cualquier otro medicamento, pueden generar eventos adversos, los que deben ser monitorizados permanentemente por sistemas de vigilancia. Esta disciplina recibe el nombre de Farmacovigilancia de Vacunas (FVV), encargada de estudiar los Eventos Supuestamente Atribuidos a la Vacunación ó Inmunización (ESAVI). El objetivo de este trabajo es revisar la evolución del sistema de farmacovigilancia de vacunas en Chile. El sistema de FVV chileno se basa en la vigilancia pasiva, y contempla la notificación obligatoria al Instituto de Salud Pública (ISP) de todos los ESAVI detectados, por parte de profesionales de la salud, directores de establecimientos y titulares de registro sanitario, priorizando las notificaciones de ESAVI serios e incluyendo la monitorización de todas las vacunas usadas en el país, tanto las que se encuentran incorporadas al Programa Nacional de Inmunización (PNI), como las que se encuentran fuera de este. El sistema de FVV chileno se caracteriza por un trabajo colaborativo permanente entre el ISP y el PNI, y parte de sus desafíos incluyen generar capacidades y alianzas estratégicas con la academia para la realización de estudios post comercialización sobre seguridad de vacunas. Finalmente, es importante destacar que tanto el marco normativo promulgado el año 2010, como la elaboración de procedimientos, el trabajo permanente con el PNI, y la conformación de un comité de expertos de ESAVI, y las diferentes estrategias de retroalimentación, son medidas implementadas que han contribuido a mejorar la tasa de reporte nacional y el análisis de los casos.

Immunization is among the most successful and cost-effective public health interventions of all times, its benefits being as important as its safety. Vaccines, like any other medicine, can generate adverse events, which must be permanently monitored by surveillance systems. Vaccine Pharmacovigilance (VPV) is the discipline responsible for studying Adverse Events Following Immunization (AEFI). The objective of this article is to review the evolution of the pharmacovigilance system of vaccines in Chile. The Chilean VPV system is based on passive surveillance, and establishes the mandatory reporting of all AEFI detected by healthcare workers, directors of healthcare facilities, and Marketing Authorization holders, to the Public Health Institute of Chile (PHI), prioritizing the reporting of serious ESAVI and including the monitoring of all vaccines used in the country, both those that are incorporated into the National Immunization Program (NIP), and those that are outside of it. The Chilean VPV system is characterized by a permanent collaborative work between the PHI and the NIP, and its challenges include generating capacities and strategic alliances with the academy to carry out post-marketing studies on vaccine safety. Finally, it's important to point out that the regulatory framework promulgated in 2010, as well as the elaboration of procedures, the permanent work with the NIP, the formation of an AEFI expert committee, and the different feedback strategies implemented, have contributed in improving case analysis and the national reporting rate.

Early expression of monocyte chemoattractant protein-1 correlates with the onset of isoproterenol-induced cardiac fibrosis in rats with distinct angiotensin-converting enzyme polymorphism.

INTRODUCTION: Isoproterenol treatment of Brown Norway and Lewis rats (high and low plasma angiotensin-I-converting enzyme activity, respectively) results in similar cardiac hypertrophy but higher cardiac fibrosis in Brown Norway rats. MATERIALS AND METHODS: Rats were infused in vivo with isoproterenol for two or 10 days. Cardiac fibrosis and inflammation were evaluated histochemically. We measured the mRNAs of pro-fibrotic factors (transforming growth factor beta(1), endothelin-1) and pro-inflammatory factors (monocyte chemoattractant protein-1). In studies with cardiac fibroblasts incubated with isoproterenol in vitro , we measured cell proliferation, angiotensin-I-converting enzyme and matrix metalloprotease 2 activities and deposition of collagen type I and fibronectin. RESULTS: After treatment with isoproterenol for two days, there were large areas of myocardial injury and numerous inflammatory foci in the left ventricle, these being greater in Brown-Norway than in Lewis rats. After treatment with isoproterenol for 10 days, there were large areas of damage with extensive collagen deposition only in the left ventricle; both strains exhibited this damage which was, however, more severe in Brown-Norway than in Lewis rats. After treatment with isoproterenol for two, but not 10, days, greater amounts of monocyte chemoattractant protein-1 mRNA were found in Brown Norway than in Lewis rats. Cell proliferation, activities of angiotensin-I-converting enzyme and matrix metalloprotease 2, amounts of collagen type I and fibronectin were similar in cardiac fibroblasts from both strains; changes after isoproterenol (10 microM) were also similar in both strains. CONCLUSION: We conclude that the greater cardiac fibrosis in Brown Norway rats treated with isoproterenol correlates with the early and higher expression of proinflammatory factors.