{"id":6177,"date":"2021-03-25T07:43:00","date_gmt":"2021-03-25T10:43:00","guid":{"rendered":"https:\/\/redenoticiaz.com.br\/litoralsp\/?p=6177"},"modified":"2021-03-25T07:43:00","modified_gmt":"2021-03-25T10:43:00","slug":"sinal-verde-para-teste-do-soro-do-instituto-butantan-em-humanos","status":"publish","type":"post","link":"https:\/\/redenoticiaz.com.br\/litoralsp\/2021\/03\/25\/sinal-verde-para-teste-do-soro-do-instituto-butantan-em-humanos","title":{"rendered":"Sinal verde para teste do soro do Instituto Butantan em humanos"},"content":{"rendered":"<p>A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) concedeu\u00a0hoje\u00a0(24) a anu\u00eancia para pesquisa cl\u00ednica com o soro hiperimune anti-Sars-CoV-2, desenvolvido pelo Instituto Butantan, contra a covid-19. Com isso, o instituto tem autoriza\u00e7\u00e3o para fazer o teste do soro em humanos. At\u00e9 o momento, o soro foi testado somente em animais.<img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.png?id=1404955&amp;o=node\" \/><img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.gif?id=1404955&amp;o=node\" \/><\/p>\n<p>O teste em humanos \u00e9 uma etapa chave para que o Instituto possa avan\u00e7ar no desenvolvimento do medicamento e, posteriormente, solicitar seu registro junto \u00e0 Anvisa, condi\u00e7\u00e3o necess\u00e1ria para que ele seja usado no mercado.<\/p>\n<p>A autoriza\u00e7\u00e3o foi condicionada a um Termo de Compromisso que prev\u00ea a entrega de informa\u00e7\u00f5es complementares. Para o in\u00edcio do estudo, o Butantan ainda dever\u00e1 apresentar tais informa\u00e7\u00f5es, que, segundo a Anvisa, n\u00e3o foram integralmente disponibilizadas.<\/p>\n<p>No in\u00edcio\u00a0de mar\u00e7o o Instituto entregou \u00e0 Anvisa um dossi\u00ea com dados sobre o desenvolvimento da subst\u00e2ncia. A ag\u00eancia fez considera\u00e7\u00f5es sobre o primeiro pedido.<\/p>\n<p>Em seguida, no dia\u00a010 de mar\u00e7o, o Instituto enviou dados sobre o ensaio cl\u00ednico. Em\u00a019 de mar\u00e7o foi realizada uma reuni\u00e3o sobre o protocolo cl\u00ednico. No encontro, t\u00e9cnicos da Anvisa fizeram uma solicita\u00e7\u00e3o adicional de informa\u00e7\u00f5es. Ontem o Instituto Butantan repassou respostas sobre as quest\u00f5es feitas na reuni\u00e3o.<\/p>\n<p>\u201cO objetivo da avalia\u00e7\u00e3o de uma proposta de pesquisa cl\u00ednica \u00e9 verificar se o estudo \u00e9 suficiente para produzir dados confi\u00e1veis sobre a seguran\u00e7a e a efic\u00e1cia do medicamento. Isso envolve a avalia\u00e7\u00e3o do desenho estat\u00edstico da pesquisa, perfil de volunt\u00e1rios, defini\u00e7\u00e3o de doses que ser\u00e3o testadas, entre outros aspectos\u201d, explicou a Anvisa, em nota.<\/p>\n<h4>A produ\u00e7\u00e3o do soro<\/h4>\n<p><a href=\"https:\/\/agenciabrasil.ebc.com.br\/geral\/noticia\/2021-01\/butantan-faz-testes-de-soro-em-animais-para-tratar-covid-19\" target=\"_blank\" rel=\"noopener noreferrer\">O soro foi produzido a partir da inocula\u00e7\u00e3o do v\u00edrus inativo em cavalos<\/a>. O corpo dos animais reage ao microrganismo e produz anticorpos para combater a infec\u00e7\u00e3o. Depois, o sangue dos equinos \u00e9 coletado e esses anticorpos isolados para que possam ser usados contra a doen\u00e7a. O Butantan j\u00e1 \u00e9 refer\u00eancia na produ\u00e7\u00e3o de soros, como os antiof\u00eddicos, que neutralizam os efeitos de venenos de cobras, e o antirr\u00e1bico, contra a raiva.<\/p>\n<p>De acordo com o instituto, o soro tem potencial para evitar o agravamento dos sintomas e curar os pacientes infectados pela covid-19. Ao contr\u00e1rio da vacina, que busca prevenir a infec\u00e7\u00e3o, o soro atua no tratamento da doen\u00e7a. No come\u00e7o do m\u00eas, o Butantan j\u00e1 havia divulgado que o soro demonstrou em testes pr\u00e9-cl\u00ednicos que \u00e9 seguro e efetivo em dois tipos de estudos animais. (agenciabrasil)<\/p>\n<p>&nbsp;<\/p>\n<p>LEIA TAMB\u00c9M<\/p>\n<p><a href=\"https:\/\/redenoticiaz.com.br\/litoralsp\/2021\/03\/24\/tragedia-anunciada-brasil-chega-a-300-mil-vidas-perdidas-pela-covid-19\">Trag\u00e9dia anunciada: Brasil chega a 300 mil vidas perdidas pela Covid-19<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) concedeu\u00a0hoje\u00a0(24) a anu\u00eancia para pesquisa cl\u00ednica com o soro hiperimune anti-Sars-CoV-2, desenvolvido pelo Instituto Butantan, contra a covid-19. Com isso, o instituto tem autoriza\u00e7\u00e3o para fazer o teste do soro em humanos. At\u00e9 o momento, o soro foi testado somente em animais. O teste em humanos \u00e9 uma &hellip;<\/p>\n","protected":false},"author":5,"featured_media":6178,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[23],"tags":[16624,16623],"class_list":["post-6177","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-saude","tag-anvisa-libera-testes-soro-butantan","tag-teste-soro-humanos"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Sinal verde para teste do soro do Instituto Butantan em humanos - Litoral SP<\/title>\n<meta name=\"description\" content=\"A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) concedeu\u00a0hoje\u00a0(24) a anu\u00eancia para pesquisa cl\u00ednica com o soro hiperimune anti-Sars-CoV-2,\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/redenoticiaz.com.br\/litoralsp\/2021\/03\/25\/sinal-verde-para-teste-do-soro-do-instituto-butantan-em-humanos\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sinal verde para teste do soro do Instituto Butantan em humanos - 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