{"id":8027,"date":"2021-06-11T15:59:11","date_gmt":"2021-06-11T15:59:11","guid":{"rendered":"https:\/\/www.ucf.edu.cu\/?p=8027"},"modified":"2021-06-11T16:00:41","modified_gmt":"2021-06-11T16:00:41","slug":"aprueba-el-cecmed-ensayo-clinico-fase-i-ii-con-el-candidato-vacunal-soberana-en-poblacion-pediatrica","status":"publish","type":"post","link":"https:\/\/www.ucf.edu.cu\/?p=8027","title":{"rendered":"Aprueba el CECMED Ensayo Cl\u00ednico Fase I\/II con el candidato vacunal SOBERANA en poblaci\u00f3n pedi\u00e1trica"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8027\" class=\"elementor elementor-8027\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-02b2b92 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"02b2b92\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7c6ecb4\" data-id=\"7c6ecb4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-eaaed08 elementor-widget elementor-widget-text-editor\" data-id=\"eaaed08\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"entry-content\"><div class=\"elementor elementor-8568\" data-elementor-type=\"wp-post\" data-elementor-id=\"8568\" data-elementor-settings=\"[]\"><div class=\"elementor-inner\"><div class=\"elementor-section-wrap\"><section class=\"elementor-section elementor-top-section elementor-element elementor-element-29b7455 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"29b7455\" data-element_type=\"section\"><div class=\"elementor-container elementor-column-gap-default\"><div class=\"elementor-row\"><div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-127c157\" data-id=\"127c157\" data-element_type=\"column\"><div class=\"elementor-column-wrap elementor-element-populated\"><div class=\"elementor-widget-wrap\"><div class=\"elementor-element elementor-element-b8ee348 elementor-widget elementor-widget-text-editor\" data-id=\"b8ee348\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\"><div class=\"elementor-widget-container\"><div class=\"elementor-text-editor elementor-clearfix\"><p>El Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos M\u00e9dicos (CECMED) aprueba el primer ensayo cl\u00ednico a ejecutarse en el pa\u00eds en poblaci\u00f3n pedi\u00e1trica con el candidato vacunal contra la COVID-19, desarrollado por el Instituto Finlay de Vacunas (IFV).<\/p><p>El estudio aprobado es un ensayo fase I\/II, secuencial, abierto, adaptativo y multic\u00e9ntrico, que tiene como objetivos evaluar la seguridad, la reactogenicidad y la inmunogenicidad de los candidatos vacunales profil\u00e1cticos FINLAY-FR- 2 (Soberana 02), aplicado en dos dosis y una dosis de FINLAY-FR-1A (Soberana Plus), separadas por intervalos de 28 d\u00edas. Este esquema de tres dosis es el mismo que se aplic\u00f3 a la poblaci\u00f3n adulta. Se realizar\u00e1 en las edades comprendidas entre 3 y 18 a\u00f1os, divididos en dos grupos, comenzando por los adolescentes de 12 a 18 a\u00f1os, seguido del grupo de ni\u00f1os de 3 a 11 a\u00f1os.<\/p><p>La aprobaci\u00f3n emitida por el CECMED est\u00e1 sustentada sobre la base del contexto epidemiol\u00f3gico actual, con el incremento considerable de casos positivos en la poblaci\u00f3n pedi\u00e1trica y basado en los resultados de seguridad e\u00a0 inmunogenicidad que mostraron los candidatos vacunales, como parte de los ensayos cl\u00ednicos fase I y fase II.<\/p><p>Ambos candidatos, aplicados ya a miles de personas,\u00a0 han demostrado ser seguros y bien tolerados en adultos, tanto en los ensayos cl\u00ednicos realizados como en el estudio de\u00a0 intervenci\u00f3n\u00a0 y los resultados de inmunogenicidad obtenidos en las Fases I y II son consistentes y permitieron el\u00a0 avance a la Fase III, que se encuentra\u00a0 en ejecuci\u00f3n actualmente.<\/p><p>Hasta el 27 de mayo de 2021 se acumulan unos 18 249 casos confirmados con el virus en este grupo poblacional, de los cuales 983 son menores de un a\u00f1o. Aunque la mayor\u00eda de los ni\u00f1os padecen la enfermedad de forma leve, resulta peligroso por las complicaciones que pueden padecer en el periodo de la infecci\u00f3n y las posteriores secuelas que deja el padecimiento.<\/p><p>En este contexto, la vacunaci\u00f3n jugar\u00eda un papel fundamental, ya que podr\u00eda tener un efecto muy positivo en la contenci\u00f3n de la progresi\u00f3n de esta enfermedad.<\/p><p>La Directora del CECMED, MSc. Olga Lidia Jacobo Casanueva explic\u00f3 que el proceso de evaluaci\u00f3n y aprobaci\u00f3n de este ensayo cl\u00ednico ha sido muy riguroso, cumpliendo los requisitos exigidos en poblaciones pedi\u00e1tricas. \u00a0<\/p><p>Manifest\u00f3 que se hace necesario ante la compleja situaci\u00f3n epidemiol\u00f3gica, proteger a nuestros ni\u00f1os y que puedan en breve tiempo volver a la normalidad, asistir a las escuelas, jugar, pasear y hacer las actividades cotidianas, as\u00ed como asegurar tranquilidad en la familia.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>El Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos M\u00e9dicos (CECMED) aprueba el primer ensayo cl\u00ednico a ejecutarse en el pa\u00eds en poblaci\u00f3n pedi\u00e1trica con el candidato vacunal contra la<a class=\"moretag\" href=\"https:\/\/www.ucf.edu.cu\/?p=8027\">Leer m\u00e1s&#8230;<\/a><\/p>\n","protected":false},"author":6,"featured_media":8028,"comment_status":"open","ping_status":"open","sticky":false,"template":"page-post-intra.php","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"class_list":["post-8027","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Aprueba el CECMED Ensayo Cl\u00ednico Fase I\/II con el candidato vacunal SOBERANA en poblaci\u00f3n pedi\u00e1trica - Universidad de Cienfuegos<\/title>\n<meta name=\"description\" content=\"Noticias del \u00e1mbito universitario de la casa de altos estudios de Cienfuegos. 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