Luciana Bento

Febre amarela: nova vacina está em fase de testes com animais – Notícias

 

Uma nova vacina contra a febre amarela está sendo desenvolvida pela Bio-Manguinhos/Fiocruz, empresa pública brasileira líder mundial na produção do imunizante.

 

De acordo com a epidemiologista Tatiana Noronha, pesquisadora na área de ensaios clínicos com imunobiológicos da Bio-Manguinhos/Fiocruz, este novo imunizante tem um conceito diferente do atual, mas já é utilizado em outras vacinas, como da poliomielite.

 

Ela explica que a vacina contra a febre amarela utilizada hoje – e criada em 1936 – é feita a partir do vírus vivo atenuado, que perde a capacidade de produzir a doença, mas não a de replicar dentro do organismo, estimulando o sistema imunológico.

 

Já a nova vacina será elaborada a partir do vírus inativado (morto), que provoca um estímulo menor das defesas do organismo, necessitando de mais doses, mas oferecendo menos restrições.

 

“O que motivou a produzir essa vacina foi aquela população que não pode receber a atenuada. Além disso, ela produz menos efeitos colaterais”.

 

Segundo a pesquisadora, há casos no mundo em que a inativada chegou a substituir a atenuada, como em relação a poliomielite. “A vacina oral contra a pólio conseguiu erradicar a doença do mundo. Há casos de polio vacinal, mas não se vê mais hoje polio doença. Chegou um determinado momento em que o risco da vacina causar um evento adverso era maior do que o de contrair a doença. Por isso que, por recomendação da OMS, o mundo inteiro está trocando a atenuada por inativada”, afirma.

 

 

Mas, em relação à vacina da febre amarela, não há essa expectativa no momento. “O objetivo não é substituir uma vacina pela outra. Mas nada impede de, no futuro, isso acontecer. Mas há muito estudo pela frente”, diz.

 

Ela ressalta que não é somente a vacina de febre amarela atenuada que dá efeito adverso. “Outras vacinas também dão. Como a febre amarela é doença mais grave, o vírus é parecido com o vírus selvagem então a reação acontece. O risco de ter febre amarela grave é muito maior do que uma reação adversa”.

 

A nova vacina está em fase de testes em animais e não tem previsão ainda para ser lançada. Leia a entrevista a seguir.

 

A Fiocruz está desenvolvendo uma nova vacina contra a febre amarela?

 

Está desenvolvendo uma vacina inativada, mas está em fase muito inicial, fase pré-clínica ainda com animais de laboratório. Não há perspectiva nos próximos anos de ter essa vacina. O que motivou a produzir essa vacina foi aquela população que não pode receber a atenuada. O objetivo não é substituir uma pela outra. Existem dois tipos de vacina: a atenuada, que é a da febre amarela, na qual o vírus atenuado em laboratório perde sua virulência, perde a capacidade de produzir a doença, mas não a de replicar e é justamente isso que estimula o sistema imunológico a produzir anticorpos. E a inativada, que pode ser feita com um pedaço do vírus, por exemplo, e não tem capacidade de se replicar dentro do organismo. Existem vários tipos de inativada. Não posso fornecer detalhes porque é uma questão de desenvolvimento industrial. O objetivo da inativada é obter menos efeitos colaterais. Ela é menos imunogênica, ou seja, estimula menos o sistema imunológico. Por isso tem várias doses. É preciso um maior número de doses para proteger da mesma forma. Já existe esse conceito para outras vacinas.

 

Pode dar um exemplo?

 

As vacinas para coqueluche, difteria, tétano, meningite C. E, para vírus, tem a IPV, que é a de poliomielite inativada. Para zika, há um grupo que desenvolve vacina inativada e outro, atenuada.

 

Antes de 2018, a vacina plena de febre amarela exigia reforço em dez anos. A vacina não mudou. O que mudou, então? 

 

Isso começou com uma recomendação da OMS, em 2013. Foi mais uma avaliação de saúde pública. É necessário vacinar um grande contingente populacional, não tem vacina para todo mundo para fazer mais de uma dose, então vamos priorizar aqueles que nunca se vacinaram. O Brasil estava mantendo uma segunda dose, mas, diante dos casos que estamos vivendo hoje, do risco de urbanização da doença, houve a priorização de todo mundo ter pelo menos uma dose. Na Fiocruz, estamos fazendo estudos, com apoio do Ministério da Saúde, para sustentar essa recomendação da OMS [da vacinação fracionada], que o Ministério da Saúde adotou como uma questão de saúde pública.

 

Mas não há risco em ficar com a vacina vencida?

 

A tendência é a imunidade cair ao longo do tempo. Se houver um controle da circulação do vírus, vacinando a maior parte da população, diminui o risco do não-vacinado, ou de quem não pode tomar a vacina ou de quem já tomou há bastante tempo e o anticorpo caiu ao longo do tempo, de contrair a doença. Não há como erradicar a febre amarela silvestre porque é uma questão ambiental. O mosquito mora na floresta, é um vetor silvestre. O que a gente tem que fazer é manter aquele habitat natural, o homem não entrar lá sem proteção. Existem também outros fatores relacionados à proteção que não é só o anticorpo. O anticorpo a gente consegue mensurar e vê que cai ao longo do tempo, mas tem a memória imunológica, outros marcadores biológicos, imunidade celular, tudo isso está em estudo ainda.

 

O secretário de Saúde do Estado de São Paulo, David Uip, declarou que um dos motivos da baixa adesão à vacinação seria porque a vacina da febre amarela é “imperfeita”, trazendo efeitos colaterais. A vacina é imperfeita?

 

Não existe nada perfeito na vida, mas essa vacina é altamente eficaz, altamente efetiva. Há dados históricos mundo afora que comprovam isso. No mundo, a febre amarela foi controlada com a vacina. O que acabou com a urbanização da febre amarela na década de 1930? A vacina teve um papel muito importante a curto prazo. Em regiões endêmicas, como a amazônica, as crianças tomam essa vacina no primeiro ano de vida há décadas. Você não vê criança morrendo de febre amarela. Existem eventos adversos, a gente não esconde. Mas várias outras vacinas dão eventos adversos. Acredito que ele fez essa declaração pelo fato de se tratar de uma vacina atenuada que pode levar a evento adverso grave.

 

 

Quais outras vacinas dão eventos adversos?

 

Por exemplo, a vacina oral contra a poliomielite, que conseguiu erradicar a doença das Américas e praticamente eliminar a pólio do mundo. Há casos de pólio vacinal, mas a gente já não vê mais hoje pólio doença. Chegou um determinado momento em que o risco da vacina causar um evento adverso era maior do que o de contrair a doença. Por isso que, por recomendação da OMS, o mundo inteiro está trocando a atenuada por inativada.

 

Até o Brasil?

 

Os países que têm condições, como o nosso, estão substituindo. Onde isso não é possível, como nos países da África, porque a vacina inativada é mais cara e de menor acesso, a OMS orientou a tirar um tipo de vírus. A vacina tem três tipos de vírus e eles tiraram um justamente porque esse vírus já foi eliminado do mundo e quem toma vacina poderia ter reação adversa. Estou dando esse exemplo porque não é só a vacina de febre amarela atenuada que dá efeito adverso. Outras vacinas também dão. Como a febre amarela é uma doença mais grave, o vírus é parecido com o vírus selvagem, então a reação acontece. O risco de ter febre amarela grave é muito maior do que ter uma reação adversa.

 

 

No futuro, a tendência será essa nova vacina da febre amarela substituir a atual?

 

Tem muito estudo ainda para isso. Mas a ideia não é substituir, mas sim atingir a população que não pode receber a vacina atenuada, como o indivíduo em quimioterapia, a gestante que não mora em área de risco, mas quer viajar, o bebê abaixo de nove meses. As vacinas inativadas são muito focadas em crianças menores de um ano que não têm o sistema imunológico desenvolvido. Mas nada impede de, no futuro, isso acontecer. Mas há muito estudo pela frente.

 

A Fiocruz mudou a conduta para focar na maior produção de vacina contra a febre amarela?

 

Sim. De 2017 para cá concentramos todos os esforços nisso. Para se ter ideia, de 2011 a 2017, produzimos cerca de 160 milhões de doses da vacina. Só no ano passado foram 60 milhões, ou seja, em torno de 40%. Então, toda a produção foi focada na febre amarela. Mas existe a limitação de maquinário, de pessoal, de tempo. O processo de elaboração da vacina leva de dois a seis meses.

 

A genética então não está ajudando em nada as vacinas?

 

O que a genética está ajudando, particularmente, na febre amarela é a gente entender melhor por que alguns indivíduos têm eventos adversos graves. Há um protocolo de estudo genético que está aprovado e em andamento para que possamos entender melhor por que o fator individual faz com que uma pessoa não consiga bloquear o vírus vacinal, levando a um caso de evento adverso grave.

 

 

Como surgiu a iniciativa de fracionar a vacina da febre amarela?

 

A vacinação ainda é a maneira mais eficaz de controle da febre amarela. A febre amarela tem se comportado no país de maneira endêmica na região amazônica, com uma expansão no sentido Leste-Sul e períodos cíclicos. A cada oito anos surgem casos de epizootias e em humanos em regiões sem sinal da doença. O que estamos vivendo hoje já vivemos no passado de maneira menos intensa porque não eram áreas de elevado contingente populacional. Naquela ocasião, a Fiocruz reviu os estudos para tentar reduzir a dose da vacina. São quatro produtores mundiais da vacina contra a febre amarela: a Bio-Manguinhos, a Sanofi Pasteur, o Instituto Pasteur e uma indústria da Rússia. Os quatro elaboram vacinas de vírus atenuados produzidos em células embrionárias de ovo de galinha. Então, em termos de qualidade de produção, de eficácia e de segurança são semelhantes. Historicamente, sabemos que a vacina da febre amarela tem potência 12 vezes maior do que a mínima preconizada pela OMS. Em 2009, se levantou a ideia: por que não reduzir a dose dessa vacina para aumentar a capacidade de produção? Um estudo permitiu observar que a redução da dose manteve proteção semelhante da vacina que é usada há décadas, a chamada dose plena ou dose padrão. Não fizemos exatamente um fracionamento, o fracionamento é realizado no momento da aplicação, mas sim uma diluição em laboratório que serviu de embasamento para a OMS recomendar um quinto da dose.

 

Esse estudo é aquele com jovens militares do Rio de Janeiro?

 

Sim, com recrutas com uma média de 19 anos. Cerca de 800 foram vacinados no momento da entrada no exército. Não foi possível resgatar todos os participantes, apenas 318 indivíduos. Esses dados ainda não foram publicados, o artigo está em fase final de elaboração. Observamos que não há diferença entre cada dose reduzida em relação à dose plena a respeito da imunidade após oito anos. Por que oito anos? Porque foi o tempo que tivemos para estudar, já que esses indivíduos foram vacinados em 2009. Mas a ideia é acompanhá-los anualmente. Por meio da análise de anticorpos, percebemos que todos estão com proteção muito acima da necessária. A fracionada é equivalente à padrão.

R7 Saúde

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Luciana Bento

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