{"id":5003,"date":"2022-04-15T19:49:43","date_gmt":"2022-04-15T22:49:43","guid":{"rendered":"https:\/\/miradouronoticias.com\/site\/?p=5003"},"modified":"2022-04-15T19:49:43","modified_gmt":"2022-04-15T22:49:43","slug":"covid-19-anvisa-pede-mais-dados-para-vacina-em-criancas-de-3-a-5-anos","status":"publish","type":"post","link":"https:\/\/miradouronoticias.com\/site\/2022\/04\/15\/covid-19-anvisa-pede-mais-dados-para-vacina-em-criancas-de-3-a-5-anos\/","title":{"rendered":"Covid-19: Anvisa pede mais dados para vacina em crian\u00e7as de 3 a 5 anos"},"content":{"rendered":"
Segundo ag\u00eancia, dados do Butantan\u00a0s\u00e3o insuficientes para libera\u00e7\u00e3o<\/h3>\n
A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) informou, na noite de\u00a0ontem\u00a0(15), que pediu ao Instituto Butantan mais dados para saber se a libera\u00e7\u00e3o da vacina CoronaVac \u00e9 segura para ser indicada a crian\u00e7as de 3 a 5 anos.\u00a0A ag\u00eancia disse que os estudos enviados pelo instituto s\u00e3o insuficientes para recomendar a libera\u00e7\u00e3o do imunizante contra a covid-19 para a faixa et\u00e1ria.<\/p>\n
A libera\u00e7\u00e3o da vacina foi pedida pelo Butatan \u00e0 Anvisa no dia\u00a011 de mar\u00e7o. O instituto solicitou uma altera\u00e7\u00e3o na bula da CoronaVac, para que ela tamb\u00e9m fosse recomendada para crian\u00e7as de 3 a 5 anos. Atualmente, al\u00e9m da popula\u00e7\u00e3o adulta, o imunizante j\u00e1 est\u00e1 liberado para crian\u00e7as e adolescentes na faixa et\u00e1ria de 6 a 17 anos.<\/p>\n
\u201cAp\u00f3s avalia\u00e7\u00e3o das considera\u00e7\u00f5es das sociedades m\u00e9dicas e dos estudos enviados pelo Instituto Butantan, os especialistas da Anvisa conclu\u00edram que os dados apresentados s\u00e3o insuficientes para a conclus\u00e3o sobre o uso da vacina Coronavac para crian\u00e7as de 3 a 5 anos\u201d, disse a Anvisa.<\/p>\n
A ag\u00eancia reguladora afirmou\u00a0que considera essencial a submiss\u00e3o de dados complementares sobre estudos em andamento para caracterizar o benef\u00edcio da vacina e solicitou ao Butantan um of\u00edcio detalhando todos os dados necess\u00e1rios para o cumprimento dos requisitos para a autoriza\u00e7\u00e3o do uso do imunizante na faixa et\u00e1ria solicitada.<\/p>\n
Entre outros dados, a Anvisa pediu mais informa\u00e7\u00f5es detalhando qual \u00e9 a prote\u00e7\u00e3o conferida pela vacina Coronavac nessa popula\u00e7\u00e3o ap\u00f3s o intervalo de dois a tr\u00eas meses e, tamb\u00e9m, ap\u00f3s a vacina\u00e7\u00e3o completa com o esquema de 2 doses, \u201cem cen\u00e1rio de predomin\u00e2ncia da variante \u00d4micron\u201d.<\/p>\n
A ag\u00eancia tamb\u00e9m quer o tempo de prote\u00e7\u00e3o contra o v\u00edrus apontado nos estudos e dados sobre o protocolo de estudo cl\u00ednico para avalia\u00e7\u00e3o de \u201cimunogenicidade e seguran\u00e7a da terceira dose ou dose de refor\u00e7o da vacina Coronavac em popula\u00e7\u00e3o pedi\u00e1trica (todas as faixas et\u00e1rias\u201d.<\/p>\n
Al\u00e9m disso, tamb\u00e9m foram solicitados ao Butatan dados do relat\u00f3rio cl\u00ednico de fase 3 de estudos da vacina realizados na China para avalia\u00e7\u00e3o comparativa de imunogenicidade em crian\u00e7as e adultos; e de estudos da mesma fase conduzidos na \u00c1frica do Sul, Chile, Mal\u00e1sia e Filipinas, para avaliar a imunogenicidade, seguran\u00e7a e efic\u00e1cia da vacina em crian\u00e7as e adolescentes de 6 meses a 17 anos.<\/p>\n
\n
A ag\u00eancia disse que o prazo para a avalia\u00e7\u00e3o do uso emergencial da CoronaVac na popula\u00e7\u00e3o de 3 a 5 anos ser\u00e1 de at\u00e9 30 dias ap\u00f3s o envio dos dados complementares enviados pelo Butantan.<\/p>\nVacina\u00e7\u00e3o de crian\u00e7as contra a covid-19 na UBS 5 de Taguatinga Sul<\/figcaption><\/figure>\n<\/div>\n
Segundo ag\u00eancia, dados do Butantan\u00a0s\u00e3o insuficientes para libera\u00e7\u00e3o A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) informou, na noite de\u00a0ontem\u00a0(15), que pediu ao Instituto Butantan mais dados para saber se a libera\u00e7\u00e3o da vacina CoronaVac \u00e9 segura para ser indicada a crian\u00e7as de 3 a 5 anos.\u00a0A ag\u00eancia disse que os estudos enviados pelo instituto s\u00e3o […]<\/p>\n","protected":false},"author":4,"featured_media":5004,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12,22],"tags":[],"class_list":["post-5003","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-destaque-4","category-saude"],"yoast_head":"\n
Covid-19: Anvisa pede mais dados para vacina em crian\u00e7as de 3 a 5 anos - Miradouro 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:\/\/miradouronoticias.com\/site\/2022\/04\/15\/covid-19-anvisa-pede-mais-dados-para-vacina-em-criancas-de-3-a-5-anos\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Covid-19: Anvisa pede mais dados para vacina em crian\u00e7as de 3 a 5 anos - Miradouro Not\u00edcias\" \/>\n<meta property=\"og:description\" content=\"Segundo ag\u00eancia, dados do Butantan\u00a0s\u00e3o insuficientes para libera\u00e7\u00e3o A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) informou, na noite de\u00a0ontem\u00a0(15), que pediu ao Instituto Butantan mais dados para saber se a libera\u00e7\u00e3o da vacina CoronaVac \u00e9 segura para ser indicada a crian\u00e7as de 3 a 5 anos.\u00a0A ag\u00eancia disse que os estudos enviados pelo instituto s\u00e3o […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/miradouronoticias.com\/site\/2022\/04\/15\/covid-19-anvisa-pede-mais-dados-para-vacina-em-criancas-de-3-a-5-anos\/\" \/>\n<meta property=\"og:site_name\" content=\"Miradouro Not\u00edcias\" \/>\n<meta property=\"article:published_time\" content=\"2022-04-15T22:49:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/miradouronoticias.com\/site\/wp-content\/uploads\/2022\/04\/vacinacao_de_criancas_covid-19_ubs_5_de_taguatinga_sul_jfcrz_abr_1601220027.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1170\" \/>\n\t<meta property=\"og:image:height\" content=\"700\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Cl\u00e1udia Olyver\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Cl\u00e1udia Olyver\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/miradouronoticias.com\/site\/2022\/04\/15\/covid-19-anvisa-pede-mais-dados-para-vacina-em-criancas-de-3-a-5-anos\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/miradouronoticias.com\/site\/2022\/04\/15\/covid-19-anvisa-pede-mais-dados-para-vacina-em-criancas-de-3-a-5-anos\/\"},\"author\":{\"name\":\"Cl\u00e1udia Olyver\",\"@id\":\"https:\/\/miradouronoticias.com\/site\/#\/schema\/person\/73440d8c82222950df86f3e1a16aad3b\"},\"headline\":\"Covid-19: Anvisa pede mais dados para vacina em crian\u00e7as de 3 a 5 anos\",\"datePublished\":\"2022-04-15T22:49:43+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/miradouronoticias.com\/site\/2022\/04\/15\/covid-19-anvisa-pede-mais-dados-para-vacina-em-criancas-de-3-a-5-anos\/\"},\"wordCount\":511,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/miradouronoticias.com\/site\/#organization\"},\"image\":{\"@id\":\"https:\/\/miradouronoticias.com\/site\/2022\/04\/15\/covid-19-anvisa-pede-mais-dados-para-vacina-em-criancas-de-3-a-5-anos\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/miradouronoticias.com\/site\/wp-content\/uploads\/2022\/04\/vacinacao_de_criancas_covid-19_ubs_5_de_taguatinga_sul_jfcrz_abr_1601220027.jpg\",\"articleSection\":[\"Destaque 4\",\"Sa\u00fade\"],\"inLanguage\":\"pt-BR\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/miradouronoticias.com\/site\/2022\/04\/15\/covid-19-anvisa-pede-mais-dados-para-vacina-em-criancas-de-3-a-5-anos\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/miradouronoticias.com\/site\/2022\/04\/15\/covid-19-anvisa-pede-mais-dados-para-vacina-em-criancas-de-3-a-5-anos\/\",\"url\":\"https:\/\/miradouronoticias.com\/site\/2022\/04\/15\/covid-19-anvisa-pede-mais-dados-para-vacina-em-criancas-de-3-a-5-anos\/\",\"name\":\"Covid-19: Anvisa pede mais dados para vacina em crian\u00e7as de 3 a 5 anos - 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