{"id":10758,"date":"2021-06-29T15:28:27","date_gmt":"2021-06-29T18:28:27","guid":{"rendered":"https:\/\/redenoticiaz.com.br\/litoralsp\/2021\/06\/29\/empresa-pede-a-anvisa-o-uso-emergencial-da-covaxin"},"modified":"2021-06-29T15:31:29","modified_gmt":"2021-06-29T18:31:29","slug":"empresa-pede-a-anvisa-o-uso-emergencial-da-covaxin","status":"publish","type":"post","link":"https:\/\/redenoticiaz.com.br\/litoralsp\/2021\/06\/29\/empresa-pede-a-anvisa-o-uso-emergencial-da-covaxin","title":{"rendered":"Empresa pede a Anvisa o uso emergencial da Covaxin"},"content":{"rendered":"<p>A empresa Precisa Comercializa\u00e7\u00e3o de Medicamentos fez um pedido nesta ter\u00e7a-feira (29) para que a Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (<a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\">Anvisa<\/a>) libere o uso emergencial da <strong>Covaxin<\/strong>. O imunizante contra o coronav\u00edrus est\u00e1 sendo investigado pela CPI da Covid devido a compra feita pelo Governo Federal.<\/p>\n<p>No come\u00e7o de junho houve a autoriza\u00e7\u00e3o para que 4 milh\u00f5es de doses da vacina pudessem ser importadas. S\u00f3 que n\u00e3o havia a libera\u00e7\u00e3o para o uso dela no Brasil, at\u00e9 que a Anvisa autorizada. O \u00f3rg\u00e3o ter\u00e1 de 7 a 30 dias para <span class=\"highlight highlighted\">julgar o pedido de uso emergencial, mas esse prazo ainda n\u00e3o est\u00e1 determinado<\/span>. Segundo a ag\u00eancia, as primeiras 24 horas ap\u00f3s o recebimento do pedido ser\u00e3o utilizadas para fazer uma triagem do processo e verificar se os documentos necess\u00e1rios para avalia\u00e7\u00e3o est\u00e3o dispon\u00edveis.<\/p>\n<div class=\"mc-column content-text active-extra-styles \" data-block-type=\"unstyled\" data-block-weight=\"48\" data-block-id=\"9\">\n<p class=\"content-text__container \" data-track-category=\"Link no Texto\" data-track-links=\"\">Se houver informa\u00e7\u00f5es importantes faltando, a Anvisa pode solicitar as informa\u00e7\u00f5es adicionais ao laborat\u00f3rio. S\u00f3 depois disso \u00e9 que ser\u00e1 determinado o prazo para a ag\u00eancia julgar o pedido;\u00a0<span class=\"highlight highlighted\">essas primeiras 24 horas n\u00e3o s\u00e3o contabilizadas nem no prazo de 7, nem no de 30 dias<\/span>\u00a0para avalia\u00e7\u00e3o.<\/p>\n<\/div>\n<div class=\"mc-column content-text active-extra-styles \" data-block-type=\"unstyled\" data-block-weight=\"88\" data-block-id=\"10\">\n<p class=\"content-text__container \" data-track-category=\"Link no Texto\" data-track-links=\"\">Pela norma,\u00a0<span class=\"highlight highlighted\">o prazo de avalia\u00e7\u00e3o \u00e9 de 7 dias quando houver desenvolvimento cl\u00ednico da vacina no Brasil<\/span>\u00a0ou\u00a0<span class=\"highlight highlighted\">quando o relat\u00f3rio ou parecer t\u00e9cnico emitido pela autoridade sanit\u00e1ria estrangeira for capaz de comprovar que a vacina atende aos padr\u00f5es de qualidade, de efic\u00e1cia e de seguran\u00e7a<\/span>\u00a0estabelecidos pela Organiza\u00e7\u00e3o Mundial de Sa\u00fade (OMS) ou pelo Conselho Internacional para Harmoniza\u00e7\u00e3o de Requisitos T\u00e9cnicos para Registro de Medicamentos de Uso Humano (ICH, na sigla em ingl\u00eas) e pelo Esquema de Coopera\u00e7\u00e3o em Inspe\u00e7\u00e3o Farmac\u00eautica (PIC\/S, na sigla em ingl\u00eas).<\/p>\n<h3 data-track-category=\"Link no Texto\">Vacina ainda n\u00e3o liberada<\/h3>\n<p data-track-category=\"Link no Texto\" data-track-links=\"\">Entretanto a Covaxin n\u00e3o aparece entre as 6 vacinas contra o coronav\u00edrus liberadas para o uso emergencial e n\u00e3o foi aprovada pela OMS). <span class=\"highlight highlighted\">O prazo de julgamento do pedido \u00e9 de 30 dias quando n\u00e3o h\u00e1 desenvolvimento cl\u00ednico da vacina no Brasil<\/span>\u00a0ou quando o relat\u00f3rio ou parecer t\u00e9cnico emitido pela autoridade sanit\u00e1ria estrangeira n\u00e3o for capaz de comprovar que vacina atende aos padr\u00f5es de qualidade, de efic\u00e1cia e de seguran\u00e7a estabelecidos pela OMS ou pelo ICH e pelo PIC\/S.<\/p>\n<h3 data-track-category=\"Link no Texto\">Investiga\u00e7\u00e3o da CPI<\/h3>\n<p>A CPI da Covid segue investigando a compra da Covaxin que o Governo Federal fez. O primeiro motivo \u00e9 porque ela foi a vacina negociada mais cara at\u00e9 o momento. Para se ter uma ideia, o valor \u00e9 de US$ 15 a unidade (equivalente a cerca de R$ 74). O valor \u00e9 3 vezes maior que a vacina da\u00a0<strong>AstraZeneca<\/strong>\u00a0(US$ 5,25) e tamb\u00e9m\u00a0<span class=\"highlight highlighted\">\u00e9 mais caro do que o valor de compra que foi oferecido ao Brasil da vacina da Pfizer<\/span>, de US$ 10 (cerca de R$ 49) a dose \u2013\u00a0recusada v\u00e1rias vezes pelo governo.<\/p>\n<p>O contrato para a compra da Covaxin foi firmado entre o Minist\u00e9rio da Sa\u00fade e a Precisa Medicamentos, empresa respons\u00e1vel pela ponte entre o governo federal e o laborat\u00f3rio que produz a vacina na \u00cdndia.\u00a0<span class=\"highlight highlighted\">A empresa \u00e9 a \u00fanica intermedi\u00e1ria que n\u00e3o possui v\u00ednculo com a ind\u00fastria de vacinas<\/span>.<\/p>\n<p><span class=\"highlight highlighted\">Ele foi assinado antes de a Anvisa autorizar a importa\u00e7\u00e3o da vacina. E isso gerou cr\u00edticas<\/span>\u00a0pelo Planalto em rela\u00e7\u00e3o a outras vacinas.<\/p>\n<p>Em depoimento ao Minist\u00e9rio P\u00fablico Federal (MPF), o ex-coordenador de Insumos Estrat\u00e9gicos do Minist\u00e9rio da Sa\u00fade, Luis Ricardo Fernandes Miranda, disse que recebeu uma &#8220;press\u00e3o at\u00edpica&#8221; para compra da Covaxin por parte de superiores de dentro da Sa\u00fade\u00a0\u2013 entre eles o tenente-coronel Alex Lial Marinho, ex-coordenador-geral de Aquisi\u00e7\u00f5es de Insumos Estrat\u00e9gicos para Sa\u00fade do Minist\u00e9rio da Sa\u00fade.<\/p>\n<div class=\"mc-column content-text active-extra-styles \" data-block-type=\"unstyled\" data-block-weight=\"27\" data-block-id=\"19\">\n<p class=\"content-text__container \" data-track-category=\"Link no Texto\" data-track-links=\"\">O Minist\u00e9rio P\u00fablico Federal em Bras\u00edlia tamb\u00e9m abriu uma investiga\u00e7\u00e3o para apurar o contrato firmado pelo Minist\u00e9rio da Sa\u00fade com a Precisa Medicamentos para compra da vacina.<\/p>\n<p data-track-category=\"Link no Texto\" data-track-links=\"\"><strong>LEIA TAMB\u00c9M<\/strong><\/p>\n<p data-track-category=\"Link no Texto\" data-track-links=\"\"><a href=\"https:\/\/redenoticiaz.com.br\/blog\/2021\/06\/26\/cpi-depoimentos-revelam-pressao-e-irregularidades-na-compra-da-covaxin\">CPI: Depoimentos revelam press\u00e3o e irregularidades na compra da Covaxin<\/a><\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>A empresa Precisa Comercializa\u00e7\u00e3o de Medicamentos fez um pedido nesta ter\u00e7a-feira (29) para que a Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) libere o uso emergencial da Covaxin. O imunizante contra o coronav\u00edrus est\u00e1 sendo investigado pela CPI da Covid devido a compra feita pelo Governo Federal. No come\u00e7o de junho houve a autoriza\u00e7\u00e3o para que &hellip;<\/p>\n","protected":false},"author":6,"featured_media":10759,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[23],"tags":[24,11017,20391,26727,26728],"class_list":["post-10758","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-saude","tag-anvisa","tag-covaxin","tag-cpi-da-covid","tag-pedido-de-uso-emergencial","tag-precisa-comercializacao-de-medicamentos"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Empresa pede a Anvisa o uso emergencial da Covaxin - Litoral SP<\/title>\n<meta name=\"description\" content=\"pedido nesta ter\u00e7a-feira (29) para que a Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) libere o uso emergencial da Covaxin. 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