{"id":2680,"date":"2021-01-13T07:42:16","date_gmt":"2021-01-13T10:42:16","guid":{"rendered":"https:\/\/redenoticiaz.com.br\/litoralsp\/2021\/01\/13\/autorizacao-para-uso-emergencial-da-vacina-pode-sair-no-domingo\/"},"modified":"2021-01-13T09:05:59","modified_gmt":"2021-01-13T12:05:59","slug":"autorizacao-para-uso-emergencial-da-vacina-pode-sair","status":"publish","type":"post","link":"https:\/\/redenoticiaz.com.br\/litoralsp\/2021\/01\/13\/autorizacao-para-uso-emergencial-da-vacina-pode-sair","title":{"rendered":"Autoriza\u00e7\u00e3o para uso emergencial das vacinas pode sair no domingo"},"content":{"rendered":"<p>A Diretoria Colegiada da Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) deve se reunir no pr\u00f3ximo domingo (17) para discutir os pedidos de autoriza\u00e7\u00e3o para uso emergencial de vacinas contra a covid-19 e bater o martelo sobre as solicita\u00e7\u00f5es. Segundo comunicado oficial da Anvisa, a data \u00e9 o pen\u00faltimo dos 10 dias estipulados como limite para este tipo de exame pela ag\u00eancia reguladora.<img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.png?id=1398504&amp;o=node\" \/><img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.gif?id=1398504&amp;o=node\" \/><\/p>\n<p>O Instituto Butantan, em parceria com a farmac\u00eautica chinesa Sinovac, e a Funda\u00e7\u00e3o Oswaldo Cruz (Fiocruz), parceira do cons\u00f3rcio Astrazeneca\/Oxford, entraram com requerimentos de autoriza\u00e7\u00e3o em car\u00e1ter emergencial para suas respectivas vacinas.<\/p>\n<h4>Como \u00e9 a an\u00e1lise<\/h4>\n<p>Na primeira etapa da an\u00e1lise, verificou-se se a documenta\u00e7\u00e3o e as informa\u00e7\u00f5es essenciais estavam nos materiais apresentados pelos centros de pesquisa. Ap\u00f3s essa triagem, os t\u00e9cnicos da Anvisa passaram a examinar os relat\u00f3rios enviados e os dados constantes nos requerimentos submetidos.<\/p>\n<p>Para que o exame seja finalizado, as duas institui\u00e7\u00f5es solicitantes precisam enviar o conjunto da documenta\u00e7\u00e3o \u00e0 ag\u00eancia reguladora. Caso haja atraso no encaminhamento ou complementa\u00e7\u00e3o, a tomada de decis\u00e3o pode ser adiada.<\/p>\n<p>Conforme a \u00faltima atualiza\u00e7\u00e3o, do in\u00edcio da noite desta ter\u00e7a-feira (12), 33,7% da documenta\u00e7\u00e3o entregue pelo Butantan estava pendente de complementa\u00e7\u00e3o; 5,4% ainda n\u00e3o haviam sido apresentados; 40,17% foram conclu\u00eddos e 20,13% est\u00e3o em an\u00e1lise.<\/p>\n<p>Entre os pontos que precisam de material adicional est\u00e1 o desfecho da an\u00e1lise de efic\u00e1cia do estudo cl\u00ednico da fase 3 (a \u00faltima etapa) e testes de pureza, identidade e pot\u00eancia da vacina, al\u00e9m de dados de seguran\u00e7a e efic\u00e1cia em subgrupos de pacientes por status de infec\u00e7\u00e3o. Hoje o Instituto divulgou informa\u00e7\u00f5es adicionais sobre a efic\u00e1cia da vacina.<\/p>\n<p>J\u00e1 no caso da vacina da Astrazeneca\/Oxford\/Fiocruz, 14,4% do material repassado \u00e0 Anvisa precisa ser complementado; 32,39% foram conclu\u00eddos e 53,17% est\u00e3o em an\u00e1lise. Entre os pontos que necessitam de mais informa\u00e7\u00f5es est\u00e1 o processo de fabrica\u00e7\u00e3o, incluindo atributos cr\u00edticos de qualidade.(agenciabrasil)<\/p>\n<p>&nbsp;<\/p>\n<p><strong>LEIA TAMB\u00c9M<\/strong><\/p>\n<p><a href=\"https:\/\/redenoticiaz.com.br\/blog\/geral\/saude\/butantan-revela-eficacia-de-5038-da-vacina-da-coronavac\/12\/01\/2021\/\">Butantan revela efic\u00e1cia de 50,38% da vacina da CoronaVac<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Diretoria Colegiada da Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) deve se reunir no pr\u00f3ximo domingo (17) para discutir os pedidos de autoriza\u00e7\u00e3o para uso emergencial de vacinas contra a covid-19 e bater o martelo sobre as solicita\u00e7\u00f5es. Segundo comunicado oficial da Anvisa, a data \u00e9 o pen\u00faltimo dos 10 dias estipulados como limite para &hellip;<\/p>\n","protected":false},"author":5,"featured_media":2686,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[23],"tags":[8435,1454,1807,1456,2844],"class_list":["post-2680","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-saude","tag-anvisa-avalia-coronavac","tag-astrazeneca","tag-fiocruz","tag-oxford","tag-vacina-covid-19"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Autoriza\u00e7\u00e3o para uso emergencial das vacinas pode sair no domingo - Litoral SP<\/title>\n<meta name=\"description\" content=\"(Anvisa) deve se reunir no pr\u00f3ximo domingo (17) para discutir os pedidos de autoriza\u00e7\u00e3o para uso emergencial de vacinas contra a covid-19 e bater o\" \/>\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\/01\/13\/autorizacao-para-uso-emergencial-da-vacina-pode-sair\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Autoriza\u00e7\u00e3o para uso emergencial das vacinas pode sair no domingo - 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