{"id":12595,"date":"2020-12-17T18:16:15","date_gmt":"2020-12-17T21:16:15","guid":{"rendered":"https:\/\/jornalfatosenoticias.com.br\/?p=12595"},"modified":"2020-12-17T18:16:20","modified_gmt":"2020-12-17T21:16:20","slug":"anvisa-critica-criterios-para-uso-emergencial-da-coronavac","status":"publish","type":"post","link":"https:\/\/jornalfatosenoticias.com.br\/index.php\/2020\/12\/17\/anvisa-critica-criterios-para-uso-emergencial-da-coronavac\/","title":{"rendered":"Anvisa critica crit\u00e9rios para uso emergencial da Coronavac"},"content":{"rendered":"\n<h6 class=\"wp-block-heading\"><em>Ag\u00eancia fez declara\u00e7\u00e3o no \u00e2mbito de um comunicado sobre vacinas emergenciais e o novo prazo de dez dias para libera\u00e7\u00e3o<\/em><\/h6>\n\n\n\n<p>A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) disse que os crit\u00e9rios para a autoriza\u00e7\u00e3o de uso emergencial da Coronavac na China &#8220;n\u00e3o s\u00e3o transparentes e n\u00e3o h\u00e1 informa\u00e7\u00f5es dispon\u00edveis sobre os crit\u00e9rios atualmente empregados pelos \u00f3rg\u00e3os chineses para essa tomada de decis\u00e3o&#8221;. A autoriza\u00e7\u00e3o foi obtida para a Coronavac em junho no pa\u00eds asi\u00e1tico.<br>A declara\u00e7\u00e3o da ag\u00eancia brasileira foi dada no \u00e2mbito da divulga\u00e7\u00e3o do prazo de dez dias para decis\u00e3o sobre uso emergencial de vacinas em solo brasileiro. A Anvisa refor\u00e7ou sua posi\u00e7\u00e3o sobre autoriza\u00e7\u00f5es autom\u00e1ticas de uso a partir de libera\u00e7\u00f5es concedidas por ag\u00eancias reguladores estrangeiras.<br>&#8220;Caso venha a ser autorizada a replica\u00e7\u00e3o autom\u00e1tica estrangeira no Brasil, sem a devida submiss\u00e3o de dados \u00e0 Anvisa, s\u00e3o esperados o enfraquecimento e a retarda\u00e7\u00e3o na condu\u00e7\u00e3o do estudo cl\u00ednico no Brasil, al\u00e9m de se expor a popula\u00e7\u00e3o brasileira a riscos que n\u00e3o ser\u00e3o monitorados pela empresa desenvolvedora da vacina&#8221;, explicou.<br>Sobre as autoriza\u00e7\u00f5es emergenciais, a Anvisa disse se tratar de uma &#8220;solu\u00e7\u00e3o transit\u00f3ria, para um p\u00fablico-alvo restrito, que deve ser constantemente monitorado e ajustado&#8221;. &#8220;\u00c9 consenso internacional que a AUE (autoriza\u00e7\u00e3o de uso emergencial) \u00e9 uma alternativa v\u00e1lida, mas que somente deve ser considerada em atendimento \u00e0 legisla\u00e7\u00e3o e aos regulamentos t\u00e9cnicos nacionais espec\u00edficos de cada pa\u00eds, considerando ainda quest\u00f5es \u00e9ticas e cient\u00edficas inerentes a cada na\u00e7\u00e3o&#8221;, declarou a ag\u00eancia brasileira.<br>A Anvisa disse ainda ser preciso considerar a &#8220;potencial influ\u00eancia de quest\u00f5es relacionadas \u00e0 geopol\u00edtica&#8221;, o que, segundo a ag\u00eancia, pode &#8220;permear as discuss\u00f5es nacionais e eventualmente decis\u00f5es de autoridades estrangeiras relacionadas \u00e0 vacina da covid-19&#8221;.<br>A Coronavac est\u00e1 sendo desenvolvida no Brasil com a participa\u00e7\u00e3o do Instituto Butant\u00e3. O imunizante se encontra em fase 3 de estudos e o governo de S\u00e3o Paulo planeja us\u00e1-lo a partir do dia 25 de janeiro, data que marcaria o in\u00edcio da campanha de vacina\u00e7\u00e3o.<br>Apesar dessa previs\u00e3o, os dados sobre efic\u00e1cia ainda n\u00e3o foram apresentados \u00e0 Anvisa, que possui a compet\u00eancia de concess\u00e3o do registro do produto. O Butant\u00e3 prev\u00ea apresentar os dados no dia 23 deste m\u00eas, ap\u00f3s um novo adiamento da divulga\u00e7\u00e3o dos n\u00fameros.<\/p>\n\n\n\n<p><strong><em>Fonte: <a href=\"https:\/\/www.terra.com.br\/vida-e-estilo\/saude\/anvisa-critica-criterios-para-uso-emergencial-da-coronavac,21ab96dbffead4a046535c7b65f9a40bihthlalg.html\">Terra<\/a><\/em><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ag\u00eancia fez declara\u00e7\u00e3o no \u00e2mbito de um comunicado sobre vacinas emergenciais e o novo prazo de dez dias para libera\u00e7\u00e3o A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) disse que os crit\u00e9rios para a autoriza\u00e7\u00e3o de uso emergencial da Coronavac na China &#8220;n\u00e3o s\u00e3o transparentes e n\u00e3o h\u00e1 informa\u00e7\u00f5es dispon\u00edveis sobre os crit\u00e9rios atualmente empregados pelos [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":12596,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[1209,6567,6482,563],"class_list":["post-12595","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-saude","tag-anvisa","tag-autorizacao","tag-coronavac","tag-vacina"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Anvisa critica crit\u00e9rios para uso emergencial da Coronavac - Jornal Fatos e Not\u00edcias<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/jornalfatosenoticias.com.br\/index.php\/2020\/12\/17\/anvisa-critica-criterios-para-uso-emergencial-da-coronavac\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" 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