{"id":203317,"date":"2025-11-27T00:06:55","date_gmt":"2025-11-27T03:06:55","guid":{"rendered":"https:\/\/penoticias.com.br\/blog\/?p=203317"},"modified":"2025-11-27T00:07:03","modified_gmt":"2025-11-27T03:07:03","slug":"anvisa-aprova-1a-vacina-nacional-contra-a-dengue-de-dose-unica-a-aplicacao-comeca-em-2026","status":"publish","type":"post","link":"https:\/\/penoticias.com.br\/blog\/anvisa-aprova-1a-vacina-nacional-contra-a-dengue-de-dose-unica-a-aplicacao-comeca-em-2026\/","title":{"rendered":"Anvisa aprova 1\u00aa vacina nacional contra a dengue; de dose \u00fanica, a aplica\u00e7\u00e3o come\u00e7a em 2026"},"content":{"rendered":"<p style=\"text-align: center;\"><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone wp-image-191055 \" src=\"https:\/\/penoticias.com.br\/blog\/wp-content\/uploads\/2025\/07\/Vacina-1024x612.jpg\" alt=\"\" width=\"664\" height=\"397\" srcset=\"https:\/\/penoticias.com.br\/blog\/wp-content\/uploads\/2025\/07\/Vacina-1024x612.jpg 1024w, https:\/\/penoticias.com.br\/blog\/wp-content\/uploads\/2025\/07\/Vacina-300x179.jpg 300w, https:\/\/penoticias.com.br\/blog\/wp-content\/uploads\/2025\/07\/Vacina-768x459.jpg 768w, https:\/\/penoticias.com.br\/blog\/wp-content\/uploads\/2025\/07\/Vacina-1536x918.jpg 1536w, https:\/\/penoticias.com.br\/blog\/wp-content\/uploads\/2025\/07\/Vacina.jpg 1920w\" sizes=\"(max-width: 664px) 100vw, 664px\" \/><\/p>\n<p><span style=\"font-size: 8pt;\"><em>Estad\u00e3o Conte\u00fado<\/em><\/span><\/p>\n<p>A primeira vacina brasileira contra a dengue, a Butantan-DV, foi aprovada pela Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) nesta quarta-feira (26), para imuniza\u00e7\u00e3o da popula\u00e7\u00e3o brasileira entre 12 e 59 anos. Produzida pelo Instituto Butantan, \u00e9 a primeira vacina em dose \u00fanica do mundo para a doen\u00e7a.<\/p>\n<p>A expectativa \u00e9 de que a inclus\u00e3o do imunizante no Programa Nacional de Imuniza\u00e7\u00f5es (PNI), etapa essencial para o in\u00edcio da vacina\u00e7\u00e3o, seja feita no come\u00e7o do pr\u00f3ximo ano, segundo o ministro da Sa\u00fade Alexandre Padilha. \u201cA nossa expectativa \u00e9 trabalhar o mais r\u00e1pido poss\u00edvel\u201d, disse o chefe da pasta.<\/p>\n<p>Os pr\u00f3ximos passos s\u00e3o a publica\u00e7\u00e3o do registro pela ag\u00eancia para definir o pre\u00e7o da vacina e o encaminhamento, pelo Minist\u00e9rio da Sa\u00fade, para a contrata\u00e7\u00e3o do imunizante e a defini\u00e7\u00e3o da estrat\u00e9gia de incorpora\u00e7\u00e3o ao PNI.<\/p>\n<p>A aprova\u00e7\u00e3o da vacina \u00e9 sustentada pelos resultados de cinco anos de acompanhamento dos volunt\u00e1rios do ensaio cl\u00ednico de fase 3. No p\u00fablico de 12 a 59 anos, o imunizante mostrou 74,7% de efic\u00e1cia geral na preven\u00e7\u00e3o da doen\u00e7a, 91,6% de efic\u00e1cia contra a dengue grave e com sinais de alarme e 100% de efic\u00e1cia contra hospitaliza\u00e7\u00f5es por dengue.<\/p>\n<p>Isso significa que, cinco anos ap\u00f3s a vacina\u00e7\u00e3o, tr\u00eas em cada quatro volunt\u00e1rios n\u00e3o desenvolveram sintomas da dengue e, entre aqueles que desenvolveram a doen\u00e7a, nove em cada 10 n\u00e3o foram acometidos pela forma grave.<\/p>\n<p>No grupo de pessoas imunizadas com a vacina, nenhuma precisou ser hospitalizada por causa desse quadro.<\/p>\n<p>O estudo, conduzido entre 2016 e 2024, avaliou a Butantan-DV em mais de 16 mil volunt\u00e1rios residentes em 14 Estados brasileiros. Resultados anteriores do acompanhamento de 2 anos e de 3,7 anos foram publicados no The New England Journal of Medicine e na The Lancet Infectious Diseases, respectivamente.<!--more--><\/p>\n<p>Em 2024, o Brasil registrou 6,5 milh\u00f5es de casos prov\u00e1veis de dengue, quatro vezes mais do que em 2023, de acordo com o Minist\u00e9rio da Sa\u00fade. Em 2025, at\u00e9 meados de novembro, foram notificados 1,6 milh\u00e3o de casos prov\u00e1veis. Desde o come\u00e7o dos anos 2000, mais de 20 milh\u00f5es de brasileiros j\u00e1 tiveram a doen\u00e7a.<\/p>\n<p>O Instituto Butantan j\u00e1 deu in\u00edcio \u00e0 produ\u00e7\u00e3o do imunizante em seu parque industrial, tendo mais de um milh\u00e3o de doses prontas para serem disponibilizadas ao PNI no pr\u00f3ximo ano.<\/p>\n<p>O instituto fechou uma parceria internacional com a empresa chinesa WuXi para aumentar a produ\u00e7\u00e3o, mas o desenvolvimento continua sendo 100% nacional. O acordo permitir\u00e1 ampliar a capacidade de fornecimento para entregar aproximadamente 30 milh\u00f5es de doses no segundo semestre de 2026.<\/p>\n<p>A aposta do Minist\u00e9rio da Sa\u00fade \u00e9 de que a vacina nacional trar\u00e1 maior ades\u00e3o da popula\u00e7\u00e3o por ser de dose \u00fanica e pela prote\u00e7\u00e3o mais ampla do que a vacina dispon\u00edvel atualmente no Brasil, da fabricante japonesa Takeda. H\u00e1 ainda 18 milh\u00f5es de doses j\u00e1 contratadas da vacina japonesa, que continuar\u00e3o sendo utilizadas para imuniza\u00e7\u00e3o da popula\u00e7\u00e3o brasileira.<\/p>\n<p>Em comunicado enviado \u00e0 imprensa, o Instituto Butantan cita um relat\u00f3rio publicado por pesquisadores do Reino Unido na Human Vaccines &amp; Immunotherapeutics, em 2018, que mostra como programas de imuniza\u00e7\u00e3o com menos doses est\u00e3o associados a uma melhor cobertura vacinal e enfrentamento da doen\u00e7a.<\/p>\n<p>Padilha diz que, no momento, o maior desafio do governo em rela\u00e7\u00e3o \u00e0 vacina\u00e7\u00e3o n\u00e3o \u00e9 a log\u00edstica e a distribui\u00e7\u00e3o dos imunizantes, mas as campanhas antivacinas. \u201cTem gente que espalha mentira, inclusive colega m\u00e9dico que ganha dinheiro espalhando fake news, inventando detox vacinal\u201d, afirma o ministro em refer\u00eancia \u00e0 reportagem do Estad\u00e3o.<\/p>\n<p><strong>Como funciona a Butantan-DV?<\/strong><\/p>\n<p>Composto pelos quatro sorotipos do v\u00edrus da dengue, o imunizante se mostrou seguro e eficaz tanto em pessoas com infec\u00e7\u00e3o pr\u00e9via como naquelas que nunca tiveram contato com o pat\u00f3geno, afirma o Instituto Butantan.<\/p>\n<p>A vacina utiliza a tecnologia de v\u00edrus atenuado, que \u00e9 segura e j\u00e1 usada em diversos outros imunizantes no Brasil e no mundo.<\/p>\n<p>A maioria das rea\u00e7\u00f5es observadas nos estudos foi de leve a moderada, sendo as principais dor e vermelhid\u00e3o no local da inje\u00e7\u00e3o, dor de cabe\u00e7a e fadiga. Eventos adversos s\u00e9rios relacionados \u00e0 vacina foram raros e todas as pessoas se recuperaram.<\/p>\n<p>Durante os cinco anos de acompanhamento dos volunt\u00e1rios nos estudos cl\u00ednicos, a vacina demonstrou n\u00e3o perder a efic\u00e1cia. Ainda n\u00e3o h\u00e1 dados mostrando se ser\u00e1 necess\u00e1rio aplicar uma dose de refor\u00e7o da vacina em um per\u00edodo mais longo, o que ser\u00e1 avaliado no decorrer do processo de implementa\u00e7\u00e3o do imunizante.<\/p>\n<p>O vice-presidente da Sociedade Brasileira de Imuniza\u00e7\u00f5es (SBIm), Renato Kfouri, diz que os dados de seguran\u00e7a s\u00e3o \u201cmuito adequados\u201d e que o perfil de toler\u00e2ncia de eventos adversos \u00e9 satisfat\u00f3rio. \u201cUma vacina extremamente segura e eficaz\u201d, afirma o especialista.<\/p>\n<p>\u201cA dengue \u00e9 uma doen\u00e7a em franca expans\u00e3o, hoje mais da metade da popula\u00e7\u00e3o mundial vive em zona de risco para a doen\u00e7a e n\u00f3s precisamos de estrat\u00e9gias diferentes de preven\u00e7\u00e3o, j\u00e1 que o controle do mosquito, o controle do vetor, especialmente em tempos de aquecimento global, s\u00f3 tende a expandir\u201d, comenta.<\/p>\n<p>Kfouri tamb\u00e9m alerta para o fato de que as altera\u00e7\u00f5es clim\u00e1ticas e o aquecimento global favorecem a prolifera\u00e7\u00e3o do mosquito da dengue e de outras doen\u00e7as transmitidas por vetores e, por isso, \u201ca necessidade de vacinas passa a ser primordial para controle de tantas doen\u00e7as, especialmente nas popula\u00e7\u00f5es de pa\u00edses tropicais\u201d.<\/p>\n<p><strong>Amplia\u00e7\u00e3o do p\u00fablico-alvo<\/strong><\/p>\n<p>O Instituto Butantan pretende ampliar a faixa et\u00e1ria de vacina\u00e7\u00e3o tanto para o p\u00fablico pedi\u00e1trico quanto para aquele acima de 60 anos. Para isso, j\u00e1 recebeu aprova\u00e7\u00e3o da Anvisa para avaliar a vacina da dengue na popula\u00e7\u00e3o de 60 a 79 anos. Se os resultados da pesquisa forem satisfat\u00f3rios, ser\u00e1 poss\u00edvel solicitar \u00e0 ag\u00eancia reguladora a inclus\u00e3o desse grupo nas recomenda\u00e7\u00f5es do imunizante.<\/p>\n<p>Mais dados tamb\u00e9m dever\u00e3o ser coletados para avaliar a poss\u00edvel inclus\u00e3o das crian\u00e7as de 2 a 11 anos nas recomenda\u00e7\u00f5es da vacina.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Estad\u00e3o Conte\u00fado A primeira vacina brasileira contra a dengue, a Butantan-DV, foi aprovada pela Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) nesta quarta-feira (26), para imuniza\u00e7\u00e3o da popula\u00e7\u00e3o brasileira entre 12 e 59 anos. Produzida pelo Instituto Butantan, \u00e9 a primeira vacina em dose \u00fanica do mundo para a doen\u00e7a. A expectativa \u00e9 de que a &#8230; <a title=\"Anvisa aprova 1\u00aa vacina nacional contra a dengue; de dose \u00fanica, a aplica\u00e7\u00e3o come\u00e7a em 2026\" class=\"read-more\" href=\"https:\/\/penoticias.com.br\/blog\/anvisa-aprova-1a-vacina-nacional-contra-a-dengue-de-dose-unica-a-aplicacao-comeca-em-2026\/\" aria-label=\"Read more about Anvisa aprova 1\u00aa vacina nacional contra a dengue; de dose \u00fanica, a aplica\u00e7\u00e3o come\u00e7a em 2026\">Ler mais<\/a><\/p>\n<div class='heateorSssClear'><\/div><div  class='heateor_sss_sharing_container heateor_sss_horizontal_sharing' data-heateor-sss-href='https:\/\/penoticias.com.br\/blog\/anvisa-aprova-1a-vacina-nacional-contra-a-dengue-de-dose-unica-a-aplicacao-comeca-em-2026\/'><div class='heateor_sss_sharing_title' style=\"font-weight:bold\" ><\/div><div class=\"heateor_sss_sharing_ul\"><a aria-label=\"Facebook\" class=\"heateor_sss_facebook\" 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