{"id":23794,"date":"2023-03-16T16:59:41","date_gmt":"2023-03-16T19:59:41","guid":{"rendered":"https:\/\/www.fatosefotosnews.com.br\/anvisa-autoriza-pesquisa-com-vacina-tetravalente-para-gripe-influenza\/"},"modified":"2023-03-16T16:59:41","modified_gmt":"2023-03-16T19:59:41","slug":"anvisa-autoriza-pesquisa-com-vacina-tetravalente-para-gripe-influenza","status":"publish","type":"post","link":"https:\/\/www.fatosefotosnews.com.br\/?p=23794","title":{"rendered":"Anvisa autoriza pesquisa com vacina tetravalente para gripe Influenza"},"content":{"rendered":"<div class=\"post-item-wrap\">\n<p>A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) publicou, nesta quinta-feira (16), a autoriza\u00e7\u00e3o para o in\u00edcio do ensaio cl\u00ednico Fase III da vacina para a gripe influenza tetravalente (fragmentada e inativada) QIV-IB, desenvolvida pelo Instituto Butantan, de S\u00e3o Paulo.<img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.png?id=1516853&#038;o=node\" style=\"width:1px;height:1px\"><img decoding=\"async\" src=\"https:\/\/agenciabrasil.ebc.com.br\/ebc.gif?id=1516853&#038;o=node\" style=\"width:1px;height:1px\"><\/p>\n<p>O estudo pretende avaliar a imunogenicidade e seguran\u00e7a da vacina em lactentes e crian\u00e7as de seis a 35 meses. Segundo a ag\u00eancia, a diferen\u00e7a entre o ensaio cl\u00ednico aprovado hoje (FLQ-02-IB) e o anterior (FLQ-01-IB), de fevereiro,\u00a0\u00e9\u00a0a idade dos participantes.<\/p>\n<p>Enquanto no primeiro os participantes teriam que ter tr\u00eas anos ou mais de idade, no ensaio cl\u00ednico aprovado agora (FLQ-02-IB) ser\u00e3o inclu\u00eddos participantes entre seis e 35 meses, al\u00e9m da dose da vacina ajustada para a idade.<\/p>\n<p>O processo de produ\u00e7\u00e3o da vacina tetravalente \u00e9 semelhante ao da trivalente (fragmentada e inativada) do Instituto Butantan (TIV-IB) que j\u00e1 \u00e9 utilizada nas campanhas nacionais de vacina\u00e7\u00e3o contra a gripe Influenza, do Programa Nacional de Imuniza\u00e7\u00f5es (PNI)\/Minist\u00e9rio da Sa\u00fade.<\/p>\n<p>Enquanto uma das vacinas trivalentes cont\u00e9m o v\u00edrus B (linhagem Yamagata \u2013 TIV-Y-IB) e a outra o v\u00edrus influenza B (linhagem Victoria \u2013 TIV-V-IB), a vacina tetravalente possui as duas cepas da linhagem B na mesma formula\u00e7\u00e3o.<\/p>\n<p>&#8220;Dessa forma, espera-se obter uma vacina influenza tetravalente an\u00e1loga \u00e0 trivalente, mas com uma prote\u00e7\u00e3o adicional contra uma segunda cepa B, determinada sazonalmente pela Organiza\u00e7\u00e3o Mundial da Sa\u00fade (OMS). A adi\u00e7\u00e3o da segunda cepa B de influenza (quarta cepa na vacina) ocorreu na transi\u00e7\u00e3o da vacina influenza sazonal bivalente para a trivalente, ap\u00f3s a pandemia de influenza H1N1 em 2009&#8221;, explicou a Anvisa.<\/p>\n<h2>Pesquisa<\/h2>\n<p>De acordo com o protocolo cl\u00ednico, a ideia \u00e9 incluir cerca de 1,9 mil participantes &#8211; entre 6 a 35 meses &#8211; em 10 centros distribu\u00eddos entre S\u00e3o Paulo, Roraima, Sergipe e Pernambuco. O tempo da participa\u00e7\u00e3o ser\u00e1 de aproximadamente seis meses ap\u00f3s esquema completo de vacina\u00e7\u00e3o, enquanto o total do tempo do estudo estimado ser\u00e1 cerca de 12 meses.<\/p>\n<h2>Ensaios cl\u00ednicos<\/h2>\n<p>Ensaios cl\u00ednicos s\u00e3o os estudos de um novo medicamento, realizados em seres humanos. A fase cl\u00ednica serve para demonstrar a seguran\u00e7a e efic\u00e1cia do medicamento experimental para a indica\u00e7\u00e3o proposta. Havendo a comprova\u00e7\u00e3o de que os benef\u00edcios superam os riscos, o rem\u00e9dio experimental poder\u00e1 ser registrado pela Anvisa e disponibilizado no mercado brasileiro, desde que haja a solicita\u00e7\u00e3o por parte da empresa desenvolvedora\/patrocinadora do desenvolvimento cl\u00ednico.<\/p>\n<\/p>\n<\/div>\n<p class=\"alt-font font-italic my-2 small text-info\">                                                 Edi\u00e7\u00e3o:   Kleber Sampaio                    <\/p>\n<p id=\"infocoweb_fonte\" class=\"infocoweb_fonte\">Fonte: <a target=\"_blank\" href=\"http:\/\/agenciabrasil.ebc.com.br\/saude\/noticia\/2023-03\/anvisa-autoriza-nova-pesquisa-com-vacina-tetravalente-para-influenza#4234b61e-f924-4df1-8ce0-e48e1d5652c5\" rel=\"noopener\">EBC Sa\u00fade<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) publicou, nesta quinta-feira (16), a autoriza\u00e7\u00e3o para o in\u00edcio do ensaio cl\u00ednico Fase III da vacina para a gripe influenza tetravalente (fragmentada e inativada) QIV-IB, desenvolvida pelo Instituto Butantan, de S\u00e3o Paulo. O estudo pretende avaliar a imunogenicidade e seguran\u00e7a da vacina em lactentes e crian\u00e7as de seis [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":23795,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_angie_page":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_themeisle_gutenberg_block_has_review":false,"page_builder":"","footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[167],"tags":[309,2699,2387,4252,805,2931,472],"class_list":["post-23794","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-geral","tag-anvisa","tag-autoriza","tag-gripe","tag-influenza","tag-pesquisa","tag-tetravalente","tag-vacina"],"acf":[],"nelio_content":{"autoShareEndMode":"never","automationSources":{"useCustomSentences":false,"customSentences":[]},"efiAlt":"","efiUrl":"","followers":[],"highlights":[],"isAutoShareEnabled":true,"networkImageIds":[],"permalinkQueryArgs":[],"series":[],"suggestedReferences":[]},"yoast_head":"<!-- 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