{"id":5459,"date":"2020-10-23T23:23:40","date_gmt":"2020-10-23T23:23:40","guid":{"rendered":"https:\/\/noti-america.com\/site\/repdom\/2020\/10\/23\/los-ensayos-clinicos-no-determinaran-si-la-vacuna-anticovid-salva-vidas-2\/"},"modified":"2020-10-23T23:23:40","modified_gmt":"2020-10-23T23:23:40","slug":"los-ensayos-clinicos-no-determinaran-si-la-vacuna-anticovid-salva-vidas-2","status":"publish","type":"post","link":"https:\/\/noti-america.com\/site\/repdom\/2020\/10\/23\/los-ensayos-clinicos-no-determinaran-si-la-vacuna-anticovid-salva-vidas-2\/","title":{"rendered":"&#8220;Los ensayos cl\u00ednicos no determinar\u00e1n si la vacuna anticovid salva vidas&#8221;"},"content":{"rendered":"<p><strong>NOTI-AMERICA (REPUBLICA DOMINICANA) <\/strong><\/p>\n<p><strong>MADRID, ESPA\u00d1A_\u00a0<\/strong>El mundo espera con ansia que al menos una de las farmac\u00e9uticas en la carrera de la vacuna d\u00e9 con un ant\u00eddoto que nos proteja del\u00a0coronavirus, pero\u00a0los ensayos cl\u00ednicos actuales, desarrollados a contrarreloj, no salvar\u00e1n vidas. Esta es la advertencia que ha lanzado este mi\u00e9rcoles\u00a0Peter Doshi, editor asociado de\u00a0British Medical Journal\u00a0y especialista en desarrollo de f\u00e1rmacos de la facultad de farmacia de la Universidad de Maryland. Y es que para este experto las pruebas solo muestran si la vacuna previene\u00a0la infecci\u00f3n, y la mayor\u00eda de los casos estudiados son leves.<\/p>\n<p>\u201cNinguno de los ensayos actualmente en curso est\u00e1 dise\u00f1ado para detectar una reducci\u00f3n en cualquier resultado grave como hospitalizaciones, uso de cuidados intensivos o muertes\u201d, se\u00f1ala Doshi. \u201cTampoco se est\u00e1n estudiando las vacunas para determinar si pueden interrumpir la transmisi\u00f3n del virus\u00bb, a\u00f1ade. El problema que destaca este experto es la selecci\u00f3n del voluntariado. La mayor\u00eda de participantes cuentan con un mismo perfil entre los que no se incluyen personas que requieran hospitalizaci\u00f3n o que est\u00e9n en riesgo de morir. La Administraci\u00f3n de Medicamentos y Alimentos (FDA) ya se percat\u00f3 de este problema cuando decidi\u00f3 elaborar una gu\u00eda m\u00e1s estricta para la autorizaci\u00f3n de emergencia de uno de los remedios anti Covid-19.<\/p>\n<p><strong>\u00abLa mayor\u00eda de los voluntarios de Pfizer o Moderna son casos leves\u00bb<\/strong><\/p>\n<p>Entre las nuevas reglas destacaba que los fabricantes de vacunas estaban obligados a disponer de\u00a0al menos cinco casos graves de Covid-19 en el grupo de placebo para cada ensayo. Un punto que perjudicaba a\u00a0Pfizer\u00a0ya que, mientras que las investigaciones que llevan a cabo\u00a0Moderna\u00a0y\u00a0Astrazeneca\u00a0requieren que la mayor\u00eda de los pacientes tengan dos o m\u00e1s s\u00edntomas para para juzgar la eficacia de la vacuna, es decir, exigen un poco m\u00e1s de gravedad,\u00a0su ensayo profundiza en pacientes con casos levemente sintom\u00e1ticos, como fiebre o dolor de garganta.<\/p>\n<p>Pese al endurecimiento de las normas, Pfizer fue la primera farmac\u00e9utica en informar que\u00a0el mes que viene solicitar\u00eda al regulador estadounidense la autorizaci\u00f3n\u00a0de su ant\u00eddoto. D\u00edas m\u00e1s tarde\u00a0Moderna anunci\u00f3 lo mismo. Sin embargo, no hay que olvidar que hace un mes estas dos farmac\u00e9uticas sacaron a la luz\u00a0informes secretos\u00a0sobre el desarrollo de sus vacunas. Y, en concreto,\u00a0Moderna se\u00f1alaba que no sabr\u00eda hasta 2021 si su vacuna funciona, meses m\u00e1s tarde de lo que tiene previsto lanzarla al mercado.<\/p>\n<p><strong>\u00abDoshi pide a las farmac\u00e9uticas que reconfiguren sus ensayos\u00bb<\/strong><\/p>\n<p>En este sentido, Doshi ha pedido a las empresas que reconfiguren sus ensayos para incluir datos sobre la prevenci\u00f3n de enfermedades graves y muerte. \u00abLa gente espera que la parte m\u00e1s grave del iceberg de la Covid-19 &#8211; las admisiones en la UCI, las hospitalizaciones y las muertes \u2013 sea con lo que acabe la vacuna\u00bb, ha insistido. Todav\u00eda no es demasiado tarde para agregar pacientes con s\u00edntomas graves. \u00abLos juicios est\u00e1n en curso, todav\u00eda estamos a tiempo\u00bb, ha apuntado Doshi en declaraciones a la CNN.<\/p>\n<p><strong>Entonces, \u00bfqu\u00e9 eval\u00faan los ensayos cl\u00ednicos?<\/strong><\/p>\n<p>El objetivo de los ensayos cl\u00ednicos de las farmac\u00e9uticas que se encuentran en fase III es conseguir que un cierto n\u00famero de participantes se contagien. Una vez que eso ocurre observan si hay m\u00e1s infecciones entre las personas que recibieron la vacuna o las que recibieron placebo. De esta forma pueden comprobar si la inyecci\u00f3n previene la infecci\u00f3n. No obstante, esto no significa que las vacunas salven a las personas de enfermedades graves o la muerte. \u00abEs poco probable que una enfermedad grave que requiera ingreso hospitalario, que ocurre en solo una peque\u00f1a fracci\u00f3n de los casos sintom\u00e1ticos de Covid-19, ocurra en cantidades significativas en los ensayos\u00bb, ha concluido.<\/p>\n<p>Fuente: ED economia Digital<\/p>\n<p>Redes Personales:<\/p>\n<p>Instagram: @cersocastillo<\/p>\n<p>Facebook: Cerso Felipe Castillo Carri\u00f3n<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>NOTI-AMERICA (REPUBLICA DOMINICANA) MADRID, ESPA\u00d1A_\u00a0El mundo espera con ansia que al menos una de las farmac\u00e9uticas en la carrera de la vacuna d\u00e9 con un ant\u00eddoto que nos proteja del\u00a0coronavirus, pero\u00a0los ensayos cl\u00ednicos actuales,&#46;&#46;&#46;<\/p>\n","protected":false},"author":90,"featured_media":5460,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"image","meta":{"_acf_changed":false,"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[4],"tags":[],"class_list":["post-5459","post","type-post","status-publish","format-image","has-post-thumbnail","hentry","category-internacionales","post_format-post-format-image"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.9 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>&#8220;Los ensayos cl\u00ednicos no determinar\u00e1n si la vacuna anticovid salva vidas&#8221; - Rep. 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