Butantan recebe aprovação da Anvisa para início de testes clínicos de vacina desenvolvida pelo Instituto contra Gripe Aviária

Publicado em

WhatsApp
Facebook
Copiar Link
URL copiada com sucesso!

Primeira fase do ensaio clínico convidará voluntários adultos que receberão duas doses do candidato a imunizante; segundo momento da pesquisa deve incluir mais velhos

POR IMPRENSA BUTANTAN (imprensa@butantan.gov.br)

O Instituto Butantan, órgão ligado à Secretaria do Estado da Saúde de São Paulo, recebeu na terça-feira (1º) a aprovação da Agência Nacional de Vigilância Sanitária (Anvisa) para o início dos ensaios em humanos, da sua candidata à vacina contra a Gripe Aviária A (H5N8). Para isso, o Instituto pretende recrutar 700 adultos e idosos voluntários que participarão das fases 1/2 do Estudo em cinco Centros de Pesquisa brasileiros.

A Vacina Influenza Mmonovalente A (H5N8) (inativada, fragmentada e adjuvada) será testada em duas doses com intervalo de 21 dias, primeiramente em adultos de 18 anos até 59 anos e 11 meses e depois em pessoas com 60 ou mais. O Instituto Butantan concluiu os estudos pré-clínicos com resultados favoráveis de segurança e imunogenicidade.

“Estamos em conversas com o Ministério da Saúde, que se mostrou sensível ao avanço dessa discussão. Com a Plataforma aprovada, o Instituto pode produzir um contingente de 30 milhões de doses após os resultados iniciais. Este contingente estratégico pode ser utilizado caso o vírus comece a se disseminar entre humanos e tenha antígenos semelhantes aos representados pela vacina candidata do Instituto Butantan”, afirma o Diretor do Instituto Butantan, Esper Kallás.

O Ministério da Saúde publicou em dezembro de 2024 um Plano de Contingência Nacional do Setor Saúde para Influenza Aviária no qual define as estratégias que deve adotar em caso de situação de emergência relacionada à doença. Uma delas é prover estoques estratégicos de medicamentos e insumos que possam combater a disseminação da doença.

Como será o Estudo?

Inicialmente serão recrutados 70 adultos, que receberão as doses por via intramuscular, em um Centro de Pesquisa no Recife (PE) e, posteriormente, em quatro Centros de Pesquisa localizados em São Paulo (SP), Belo Horizonte (MG), São José do Rio Preto (SP) e em Ribeirão Preto (SP).

O Estudo vai avaliar a segurança e a capacidade de gerar resposta imune contra a Gripe Aviária (imunogenicidade) de duas formulações da vacina, em comparação com Placebo. O estudo permitirá a escolha da dose da vacina.

Um Comitê Independente de Monitoramento de Dados e Segurança vai fazer a análise de segurança do estudo que inclui, entre outras ações, a avaliação preliminar dos dados de segurança dos 70 primeiros adultos recrutados, após a aplicação da primeira dose. Caso a avaliação seja positiva, abre-se uma nova etapa de recrutamento para incluir mais 280 adultos na Pesquisa.

Se o perfil de segurança for favorável na população adulta testada, inicia-se a segunda fase do estudo, na qual haverá o recrutamento de 70 pessoas com 60 anos ou mais. Novamente, se a avaliação de segurança da candidata vacinal for favorável, segue com o recrutamento de voluntários com 60 anos ou mais até completar 350 voluntários. O objetivo é terminar o acompanhamento destes participantes em 2026 e ter um pacote regulatório que contempla uma faixa etária ampla para ser submetido à Anvisa.

“Se durante o Ensaio Clínico for decretada uma epidemia, o Butantan fica à disposição da Anvisa para ver o que pode ser feito para encurtar prazos e adaptar a vacina para contemplar uma diferente variante do vírus da Influenza Aviária”, afirma a Diretora Médica do Butantan, Fernanda Boulos. “Se isso não ocorrer, o estudo permanece sendo referente ao desenvolvimento de uma vacina pré-pandêmica, tornando o Butantan pioneiro em seu desenvolvimento no Brasil e com capacidade de fornecer o produto em caso de necessidade”, reforça a Diretora.

Lote reserva

O Instituto começou a estudar a possibilidade de fazer uma vacina contra a Gripe Aviária ainda em 2023. O processo está sendo desenvolvido com a cepa do vírus Influenza tipo A (H5N8), fornecida ao Instituto Butantan pelo Centro de Controle e Prevenção de Doenças dos Estados Unidos (CDC).

Durante o desenvolvimento da vacina contra Gripe Aviária – incluindo os ensaios pré-clínicos – foi incluída na vacina uma Cepa H5 de importância epidemiológica atual, por se tratar de uma variante altamente patogênica que mais se aproxima da Cepa circulante nas Américas. Com isso, o Butantan já tem disponível um lote reserva de vacinas pronto para ser usado na pesquisa clínica.

Em 2018, o Instituto chegou a fazer Estudo Fase 1 com uma outra vacina pandêmica de Gripe Aviária A (H7N9), em parceria com Organização Mundial de Saúde (OMS), com a Autoridade de Pesquisa e Desenvolvimento Biomédico Avançado do Departamento de Saúde e Serviços Humanos dos Estados Unidos (BARDA), e com o Instituto de Pesquisa em Doenças Infecciosas dos Estados Unidos (IDRI). Na lógica da preparação para pandemia, houve mudança de rota, devido ao avanço dos casos de Gripe A (H5N1).

“Fomos testando lotes, cada um com três candidatas vacinais, para avaliar o rendimento e a produtividade de cada Cepa. Com base na melhor escolha, avançou-se para os estudos pré-clínicos coordenados pela equipe da Diretora do Centro de Desenvolvimento e Inovação do Butantan, Ana Marisa Chudzinski-Tavassi”, afirma o Diretor do Centro Bioindustrial do Butantan, Ricardo Oliveira.

Risco de pandemia preocupa

A transmissão da Gripe Aviária em humanos, considerada esporádica, ocorre após contato próximo com uma ave infectada e/ou suas fezes. A forma de transmissão mais plausível é o contato com as penas, pele, mucosas e aerossóis, isto é, pela manipulação do animal infectado vivo ou morto – este último na manipulação em frigoríficos, por exemplo – e depois de encostar a mão contaminada nos olhos, nariz ou boca, segundo a OMS.

Não há, até o momento, comprovação da transmissão do vírus de humano para humano, embora um artigo da revista Science relata a possibilidade cada vez mais próxima de isso ocorrer devido às mutações do vírus – se antes ele só atingia aves, agora já infecta vacas e humanos que têm contato com os bovinos.

A possível disseminação entre pessoas preocupa cientistas pela alta mortalidade do vírus em humanos (próxima de 50%), e pela gravidade dos sintomas, que podem variar de uma conjuntivite com sintomas leves de Gripe a uma Doença Respiratória Aguda Grave, levando à morte.

“O vírus de Influenza A(H5N1) está sendo transmitido de aves para aves, de aves para mamíferos, de mamíferos para mamíferos, de aves para humanos e mamíferos para humanos. Só não vimos ainda a transmissão de pessoa para pessoa, mas existe um potencial do vírus adquirir essa capacidade, o que é muito perigoso porque aumenta o risco de uma pandemia”, afirma o Pesquisador Científico e Gerente de Desenvolvimento e Inovação de Produtos do Butantan, Paulo Lee Ho.

No Brasil não há casos registrados da doença em pessoas, embora este ano tenha sido notificado pelo Ministério da Agricultura e Pecuária (MAPA) a infecção em aves comerciais de uma granja no município de Montenegro (RS) e de outros Estados do país, que estão sob investigação. A pasta esclarece que está rastreando as granjas com atuais focos e adotando medidas sanitárias nos locais, nas proximidades e entre pessoas que trabalham nas granjas.

O país já havia notificado um foco de infecção em aves silvestres em 2023. “Ter uma vacina pronta, com uma Plataforma já testada, que mostra que produz anticorpos contra o vírus, é o objetivo do Butantan. Não é para já comercializar, mas para propor um estoque estratégico”, afirma o Diretor do Butantan, Esper Kallás.

Foto: imprensa butantan

170 comentários em “Butantan recebe aprovação da Anvisa para início de testes clínicos de vacina desenvolvida pelo Instituto contra Gripe Aviária”

  1. prodentim ProDentim has
    actually made an obvious difference in my dental health and wellness.
    My dental practitioner also commented on exactly how much healthier my gums look.
    The supplement is simple to take and has a pleasant taste.
    I extremely advise ProDentim to anyone wanting to boost their oral hygiene.

    Responder
  2. Woah! I’m really digging the template/theme of this site. It’s simple, yet effective. A lot of times it’s challenging to get that “perfect balance” between usability and visual appearance. I must say that you’ve done a great job with this. Also, the blog loads extremely quick for me on Safari. Outstanding Blog!

    Responder
  3. I liked up to you will obtain performed right here. The comic strip is attractive, your authored subject matter stylish. nevertheless, you command get bought an nervousness over that you would like be delivering the following. unwell without a doubt come more previously again as exactly the similar nearly a lot incessantly within case you shield this increase.

    Responder
  4. Have you ever thought about publishing an e-book or guest authoring on other websites? I have a blog based on the same ideas you discuss and would love to have you share some stories/information. I know my subscribers would enjoy your work. If you are even remotely interested, feel free to shoot me an email.

    Responder
  5. Читателям предоставляется возможность рассмотреть разные аспекты темы и сделать собственные выводы на основе предоставленных данных. Это сообщение отправлено с сайта https://ru.gototop.ee/

    Responder
  6. Hey are using WordPress for your blog platform? I’m new to the blog world but I’m trying to get started and set up my own. Do you need any coding expertise to make your own blog? Any help would be really appreciated!

    Responder
  7. What i don’t understood is if truth be told how you’re no longer really a lot more neatly-appreciated than you may be now. You are so intelligent. You understand therefore significantly in the case of this topic, produced me in my view consider it from a lot of various angles. Its like women and men don’t seem to be interested except it¦s something to accomplish with Lady gaga! Your personal stuffs great. At all times maintain it up!

    Responder
  8. Aw, this was a really nice post. In idea I would like to put in writing like this additionally – taking time and precise effort to make a very good article… however what can I say… I procrastinate alot and certainly not appear to get something done.

    Responder
  9. Nice read, I just passed this onto a colleague who was doing a little research on that. And he actually bought me lunch because I found it for him smile Thus let me rephrase that: Thank you for lunch! “Dreams are real while they last. Can we say more of life” by Henry Havelock Ellis.

    Responder
  10. Fantastic blog! Do you have any tips and hints for aspiring writers? I’m hoping to start my own site soon but I’m a little lost on everything. Would you suggest starting with a free platform like WordPress or go for a paid option? There are so many options out there that I’m completely overwhelmed .. Any tips? Bless you!

    Responder
  11. Hello there! This is kind of off topic but I need some guidance from an established blog. Is it tough to set up your own blog? I’m not very techincal but I can figure things out pretty quick. I’m thinking about making my own but I’m not sure where to start. Do you have any tips or suggestions? Thank you

    Responder
  12. The next time I read a blog, I hope that it doesnt disappoint me as much as this one. I mean, I know it was my choice to read, but I actually thought youd have something interesting to say. All I hear is a bunch of whining about something that you could fix if you werent too busy looking for attention.

    Responder
  13. NuStar Online Casino Login and Register pages are designed to guide users through account access and registration processes. These pages typically focus on clear instructions, secure access, and step-by-step guidance to help users understand how to create or access an account efficiently.

    Responder
  14. My coder is trying to persuade me to move to .net from PHP. I have always disliked the idea because of the expenses. But he’s tryiong none the less. I’ve been using Movable-type on various websites for about a year and am worried about switching to another platform. I have heard good things about blogengine.net. Is there a way I can import all my wordpress posts into it? Any kind of help would be really appreciated!

    Responder
  15. Hi! This is my first visit to your blog! We are a collection of volunteers and starting a new project in a community in the same niche. Your blog provided us valuable information to work on. You have done a marvellous job!

    Responder
  16. Can I just say what a relief to find someone who actually knows what theyre talking about on the internet. You definitely know how to bring an issue to light and make it important. More people need to read this and understand this side of the story. I cant believe youre not more popular because you definitely have the gift.

    Responder
  17. Hi there! I know this is kind of off topic but I was wondering which blog platform are you using for this site? I’m getting sick and tired of WordPress because I’ve had issues with hackers and I’m looking at options for another platform. I would be awesome if you could point me in the direction of a good platform.

    Responder
  18. Hey very nice blog!! Guy .. Beautiful .. Wonderful .. I will bookmark your blog and take the feeds also?KI’m satisfied to seek out numerous useful information here within the put up, we want develop extra techniques on this regard, thanks for sharing. . . . . .

    Responder
  19. Excellent blog you have here but I was wanting to know if you knew of any message boards that cover the same topics talked about in this article? I’d really love to be a part of community where I can get responses from other experienced individuals that share the same interest. If you have any suggestions, please let me know. Many thanks!

    Responder
  20. Hi, I think your site might be having browser compatibility issues. When I look at your website in Safari, it looks fine but when opening in Internet Explorer, it has some overlapping. I just wanted to give you a quick heads up! Other then that, fantastic blog!

    Responder
  21. What i do not understood is in reality how you’re not really a lot more well-favored than you might be right now. You are so intelligent. You know thus significantly when it comes to this subject, produced me in my opinion believe it from numerous numerous angles. Its like women and men aren’t fascinated except it is something to accomplish with Woman gaga! Your own stuffs great. All the time handle it up!

    Responder
  22. I am no longer positive the place you are getting your info, but great topic. I needs to spend a while finding out more or understanding more. Thanks for excellent info I used to be looking for this information for my mission.

    Responder
  23. I’ve recently started a web site, the information you provide on this site has helped me greatly. Thank you for all of your time & work. “The man who fights for his fellow-man is a better man than the one who fights for himself.” by Clarence Darrow.

    Responder
  24. I know this if off topic but I’m looking into starting my own weblog and was wondering what all is needed to get set up? I’m assuming having a blog like yours would cost a pretty penny? I’m not very web smart so I’m not 100 certain. Any suggestions or advice would be greatly appreciated. Many thanks

    Responder
  25. The next time I read a blog, I hope that it doesnt disappoint me as much as this one. I imply, I know it was my option to read, however I really thought youd have one thing interesting to say. All I hear is a bunch of whining about something that you would fix for those who werent too busy in search of attention.

    Responder
  26. Aw, this was a really nice post. In idea I would like to put in writing like this moreover – taking time and actual effort to make an excellent article… however what can I say… I procrastinate alot and in no way appear to get something done.

    Responder
  27. You could certainly see your enthusiasm within the paintings you write. The sector hopes for even more passionate writers such as you who are not afraid to mention how they believe. Always follow your heart. “He never is alone that is accompanied with noble thoughts.” by Fletcher.

    Responder
  28. Hello there I am so delighted I found your web site, I really found you by error, while I was searching on Digg for something else, Regardless I am here now and would just like to say thanks a lot for a fantastic post and a all round entertaining blog (I also love the theme/design), I don’t have time to look over it all at the minute but I have book-marked it and also included your RSS feeds, so when I have time I will be back to read more, Please do keep up the fantastic job.

    Responder
  29. What i do not understood is actually how you’re not really much more well-liked than you may be right now. You’re very intelligent. You realize therefore significantly relating to this subject, made me personally consider it from so many varied angles. Its like men and women aren’t fascinated unless it is one thing to do with Lady gaga! Your own stuffs excellent. Always maintain it up!

    Responder
  30. I would like to thnkx for the efforts you have put in writing this blog. I am hoping the same high-grade blog post from you in the upcoming as well. In fact your creative writing abilities has inspired me to get my own blog now. Really the blogging is spreading its wings quickly. Your write up is a good example of it.

    Responder
  31. Nice post. I learn one thing tougher on totally different blogs everyday. It is going to always be stimulating to read content material from different writers and follow a little something from their store. I’d want to use some with the content on my blog whether you don’t mind. Natually I’ll provide you with a hyperlink in your net blog. Thanks for sharing.

    Responder
  32. This blog is definitely rather handy since I’m at the moment creating an internet floral website – although I am only starting out therefore it’s really fairly small, nothing like this site. Can link to a few of the posts here as they are quite. Thanks much. Zoey Olsen

    Responder
  33. Nice post. I learn something more challenging on different blogs everyday. It will always be stimulating to read content from other writers and practice a little something from their store. I’d prefer to use some with the content on my blog whether you don’t mind. Natually I’ll give you a link on your web blog. Thanks for sharing.

    Responder
  34. This blog is definitely rather handy since I’m at the moment creating an internet floral website – although I am only starting out therefore it’s really fairly small, nothing like this site. Can link to a few of the posts here as they are quite. Thanks much. Zoey Olsen

    Responder
  35. I’ve been surfing on-line more than three hours as of late, but I by no means discovered any fascinating article like yours. It is beautiful worth enough for me. Personally, if all site owners and bloggers made good content as you probably did, the internet will likely be much more useful than ever before.

    Responder
  36. Thanks for sharing superb informations. Your website is so cool. I’m impressed by the details that you have on this site. It reveals how nicely you understand this subject. Bookmarked this web page, will come back for extra articles. You, my friend, ROCK! I found just the information I already searched all over the place and just couldn’t come across. What a perfect site.

    Responder
  37. My partner and I stumbled over here from a different page and thought I may as well check things out. I like what I see so i am just following you. Look forward to looking over your web page yet again.

    Responder
  38. I’m extremely impressed with your writing skills and also with the layout on your weblog. Is this a paid theme or did you customize it yourself? Anyway keep up the excellent quality writing, it’s rare to see a great blog like this one nowadays..

    Responder
  39. This design is steller! You definitely know how to keep a reader amused. Between your wit and your videos, I was almost moved to start my own blog (well, almost…HaHa!) Great job. I really enjoyed what you had to say, and more than that, how you presented it. Too cool!

    Responder
  40. A powerful share, I simply given this onto a colleague who was doing a bit analysis on this. And he in actual fact purchased me breakfast because I found it for him.. smile. So let me reword that: Thnx for the treat! But yeah Thnkx for spending the time to debate this, I really feel strongly about it and love studying extra on this topic. If doable, as you change into experience, would you mind updating your blog with extra details? It’s highly useful for me. Large thumb up for this weblog submit!

    Responder
  41. Just desire to say your article is as astonishing. The clarity for your post is simply great and i can suppose you’re knowledgeable in this subject. Well along with your permission allow me to grasp your feed to stay updated with forthcoming post. Thanks one million and please carry on the gratifying work.

    Responder
  42. It’s the best time to make some plans for the longer term and it is time to be happy. I’ve learn this submit and if I could I want to recommend you some fascinating issues or suggestions. Maybe you could write next articles referring to this article. I desire to learn even more issues approximately it!

    Responder
  43. Have you ever considered about including a little bit more than just your articles? I mean, what you say is important and all. But think about if you added some great images or videos to give your posts more, “pop”! Your content is excellent but with images and video clips, this blog could certainly be one of the greatest in its niche. Amazing blog!

    Responder
  44. Amazing blog! Do you have any suggestions for aspiring writers? I’m hoping to start my own website soon but I’m a little lost on everything. Would you recommend starting with a free platform like WordPress or go for a paid option? There are so many options out there that I’m completely confused .. Any ideas? Cheers!

    Responder
  45. What’s Taking place i am new to this, I stumbled upon this I have discovered It positively helpful and it has aided me out loads. I’m hoping to give a contribution & help different customers like its helped me. Good job.

    Responder
  46. I would like to thnkx for the efforts you have put in writing this website. I am hoping the same high-grade blog post from you in the upcoming as well. In fact your creative writing abilities has encouraged me to get my own blog now. Really the blogging is spreading its wings quickly. Your write up is a good example of it.

    Responder
  47. you are in point of fact a excellent webmaster. The web site loading speed is incredible. It kind of feels that you are doing any distinctive trick. Moreover, The contents are masterwork. you’ve done a great task on this subject!

    Responder
  48. Undeniably imagine that which you stated. Your favorite justification appeared to be at the web the simplest thing to be aware of. I say to you, I definitely get irked while folks consider worries that they just do not recognise about. You managed to hit the nail upon the highest as neatly as defined out the whole thing without having side effect , other folks could take a signal. Will probably be again to get more. Thank you

    Responder
  49. The following time I learn a weblog, I hope that it doesnt disappoint me as much as this one. I mean, I do know it was my choice to learn, however I actually thought youd have something attention-grabbing to say. All I hear is a bunch of whining about something that you can repair if you happen to werent too busy in search of attention.

    Responder
  50. Good, I should certainly pronounce, impressed with your site. I had no trouble navigating through all tabs as well as related information ended up being truly simple to do to access. I recently found what I hoped for before you know it in the least. Reasonably unusual. Is likely to appreciate it for those who add forums or something, site theme . a tones way for your customer to communicate. Excellent task.

    Responder
  51. Hello There. I found your blog using msn. This is a really neatly written article. I’ll be sure to bookmark it and come back to learn extra of your helpful information. Thank you for the post. I will certainly comeback.

    Responder
  52. I don’t even know the way I ended up right here, but I thought this post was great. I do not realize who you are however definitely you’re going to a famous blogger in the event you are not already 😉 Cheers!

    Responder
  53. I have been exploring for a little for any high-quality articles or weblog posts on this kind of area . Exploring in Yahoo I finally stumbled upon this site. Studying this info So i am glad to convey that I’ve a very good uncanny feeling I discovered exactly what I needed. I most without a doubt will make sure to do not put out of your mind this site and give it a look on a relentless basis.

    Responder
  54. Thanks for every other magnificent article. The place else may just anybody get that type of information in such a perfect manner of writing? I’ve a presentation next week, and I am on the look for such info.

    Responder
  55. I got what you mean , thankyou for posting.Woh I am thankful to find this website through google. “Money is the most egalitarian force in society. It confers power on whoever holds it.” by Roger Starr.

    Responder
  56. Admiring the hard work you put into your blog and detailed information you present. It’s good to come across a blog every once in a while that isn’t the same out of date rehashed material. Excellent read! I’ve bookmarked your site and I’m adding your RSS feeds to my Google account.

    Responder
  57. Hello are using WordPress for your blog platform? I’m new to the blog world but I’m trying to get started and set up my own. Do you require any html coding knowledge to make your own blog? Any help would be greatly appreciated!

    Responder
  58. This is the best blog for anyone who wants to seek out out about this topic. You realize so much its almost onerous to argue with you (not that I truly would want…HaHa). You undoubtedly put a new spin on a subject thats been written about for years. Great stuff, simply great!

    Responder
  59. What i do not understood is actually how you’re not actually much more well-liked than you might be now. You are very intelligent. You realize thus considerably relating to this subject, produced me personally consider it from numerous varied angles. Its like men and women aren’t fascinated unless it is one thing to do with Lady gaga! Your own stuffs excellent. Always maintain it up!

    Responder
  60. Excellent post. I was checking continuously this blog and I am impressed! Extremely helpful information particularly the last part 🙂 I care for such info a lot. I was seeking this certain information for a very long time. Thank you and best of luck.

    Responder
  61. I am really loving the theme/design of your web site. Do you ever run into any browser compatibility issues? A handful of my blog visitors have complained about my blog not working correctly in Explorer but looks great in Firefox. Do you have any recommendations to help fix this issue?

    Responder

Deixe um comentário para boostaro Cancelar resposta

Jornal Digital
Jornal Digital EdiÇÃo Digital – 758