{"id":8123,"date":"2021-06-30T12:43:56","date_gmt":"2021-06-30T12:43:56","guid":{"rendered":"https:\/\/www.ucf.edu.cu\/?p=8123"},"modified":"2021-06-30T12:46:29","modified_gmt":"2021-06-30T12:46:29","slug":"suministradas-todas-las-primeras-dosis-de-fase-i-en-el-ensayo-clinico-soberana-pediatria","status":"publish","type":"post","link":"https:\/\/www.ucf.edu.cu\/?p=8123","title":{"rendered":"Suministradas todas las primeras dosis de Fase I en el ensayo cl\u00ednico Soberana Pediatr\u00eda"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8123\" class=\"elementor elementor-8123\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-578c71f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"578c71f\" 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-568a821\" data-id=\"568a821\" 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-00f5827 elementor-widget elementor-widget-text-editor\" data-id=\"00f5827\" 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<p>En la jornada de este lunes recibieron sus primeras dosis de Soberana 02 los 25 ni\u00f1os de 3-11 a\u00f1os que se alistaron como voluntarios de la Fase 1 de Soberana Pediatr\u00eda, que junto a los 25 ya vacunados de 12-18 a\u00f1os completan la muestra de 50 para esta etapa.<\/p><p>Los peque\u00f1os recibieron el aliento y el cari\u00f1o de sus padres, del personal de salud y de los payasos terap\u00e9uticos de La Colmenita.<\/p><p>El ensayo cl\u00ednico en esta primera fase se desarrolla en el Hospital Pedi\u00e1trico Juan Manuel M\u00e1rquez de La Habana.<\/p><p><span class=\"autor\">La fase II del ensayo cl\u00ednico Soberana Pediatr\u00eda comenz\u00f3 hoy aqu\u00ed, <strong>en la cual participaron voluntarios de 12 a 18 a\u00f1os de edad que recibieron la primera dosis de la vacuna anticovid Soberana 02.<\/strong><\/span><\/p><p>El hospital pedi\u00e1trico Juan Manuel M\u00e1rquez de esta capital acogi\u00f3 la vacunaci\u00f3n de 140 sujetos, mientras que los policl\u00ednicos Carlos Juan Finlay y 5 de Septiembre de los municipios Marianao y Playa, respectivamente, atender\u00e1n a 80 cada uno.<\/p><blockquote><p>La doctora Meiby Vicente Gonz\u00e1lez, directora de Investigaciones Cl\u00ednicas del Instituto Finlay de Vacunas (IFV), confirm\u00f3 sobre la ausencia de efectos adversos en los menores vacunados en esa instituci\u00f3n hospitalaria y destac\u00f3 la tranquilidad y confianza de las familias en el inmun\u00f3geno administrado.<\/p><\/blockquote><p>Vicente Gonz\u00e1lez record\u00f3 que el 10 de junio pasado la autoridad regulatoria Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos M\u00e9dicos (Cecmed) autoriz\u00f3 el ensayo cl\u00ednico en edades pedi\u00e1tricas debido al elevado n\u00famero de casos positivos a la COVID-19 en todo el pa\u00eds.<\/p><p>Posterior a esa decisi\u00f3n, comenz\u00f3 el proceso de reclutamiento para seleccionar a los voluntarios y el 14 de junio comenz\u00f3 la aplicaci\u00f3n de la primera dosis de Soberana 02, candidato vacunal desarrollado por el IFV, en voluntarios de 12 a 18 a\u00f1os, precis\u00f3.<\/p><p>Despu\u00e9s de siete d\u00edas, fue elaborado un informe de seguridad por el comit\u00e9 independiente de monitoreo de datos y autorizado por el Cecmed para continuar con la segunda etapa de la fase I (ni\u00f1os de tres a 11 a\u00f1os), este \u00faltimo vacunado un primer grupo la v\u00edspera.<\/p><p><strong>Asimismo, dio paso a la fase II del ensayo cl\u00ednico en menores de 12 a 18 a\u00f1os.<\/strong><\/p><p>Por otra parte, la doctora Leyanis C\u00e9spedes Enrique, investigadora coordinadora de esa fase de la investigaci\u00f3n, coment\u00f3 que el proceso de inclusi\u00f3n y vacunaci\u00f3n realizado en el policl\u00ednico Carlos Juan Finlay este martes incluy\u00f3 la toma de muestra de sangre y una prueba de Reacci\u00f3n en Cadena de la Polimerasa (PCR).<\/p><p><strong>Otros ex\u00e1menes realizados fueron un test de embarazo a las ni\u00f1as que ya menstr\u00faan y un estudio inmunol\u00f3gico,<\/strong> explic\u00f3 C\u00e9spedes Enrique.<\/p><blockquote><p>Confirm\u00f3 la ausencia de eventos adversos hasta el momento en ese vacunatorio, y reiter\u00f3 la seguridad del inmun\u00f3geno y el agradecimiento de los padres de los voluntarios de poder participar en el ensayo cl\u00ednico antiCovid-19.<\/p><\/blockquote><p>En la misma l\u00ednea se pronunci\u00f3 la doctora Miladis Su\u00e1rez Mart\u00ednez, quien asumi\u00f3 la responsabilidad de evaluar por segunda ocasi\u00f3n los signos vitales del menor antes de realizarse el PCR.<\/p><p><em><strong>Tomado de Cubadebate<\/strong><\/em><\/p>\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>En la jornada de este lunes recibieron sus primeras dosis de Soberana 02 los 25 ni\u00f1os de 3-11 a\u00f1os que se alistaron como voluntarios de la Fase 1 de Soberana Pediatr\u00eda, que<a class=\"moretag\" href=\"https:\/\/www.ucf.edu.cu\/?p=8123\">Leer m\u00e1s&#8230;<\/a><\/p>\n","protected":false},"author":6,"featured_media":8124,"comment_status":"open","ping_status":"open","sticky":false,"template":"page-post-intra.php","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"class_list":["post-8123","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Suministradas todas las primeras dosis de Fase I en el ensayo cl\u00ednico Soberana Pediatr\u00eda - 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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