28/12/2015 10H29 - Actualizado 28/12/2015 10H29

Anvisa aprueba la cifra récord de la primera vacuna contra el dengue en Brasil

Mesmo liberada pela Anvisa, ainda falta a definição do valor de cada dose.
foto: gcn.net.br
foto: gcn.net.br

Se fue el lunes (28), la aprobación de la primera vacuna contra el dengue récord en Brasil: un Dengvaxia, Francés Sanofi Pasteur. Aunque aprobado para su comercialización por la Agencia Nacional de Vigilancia Sanitaria (Anvisa), ainda falta a Câmara de Regulação do Mercado de Medicamentos definir o valor de cada dose, processo que dura em média três meses, mas não tem prazo máximo.

Inicialmente, o medicamento será disponibilizado para a rede particular de laboratórios. Definido o preço, a Comissão Nacional de Incorporação de Tecnologias no SUS vai avaliar se vale a pena incorporar o produto ao sistema público de imunizações. O governo vai avaliar custo, efetividade e impactos epidemiológico e orçamentário da incorporação da vacina ao Sistema Único de Saúde.

A vacina é indicada para pessoas entre 9 mi 45 anos e protege contra os quatro tipos do vírus da dengue. A promessa do fabricante é de proteção de 93% contra casos graves da doença, reducción 80% das internações e eficácia global de 66% contra todos os tipos do vírus. O medicamento deve começar a ser vendido no país no primeiro semestre de 2016 e a capacidade de produção do laboratório é de 100 millones de dosis por año.

O imunizante deve ser aplicado em três doses, com intervalos de seis meses, sin embargo, de acordo com a diretora médica da Sanofi, Sheila Homsani, a partir da primeira dose o produto protege quase 70% de las personas. “A vacina tem eficácia a partir da primeira dose, protegendo em torno de 70% dos imunizados. A necessidade das outras doses vem porque a proteção vai caindo com o tempo, não se mantém sem as outras duas. A proteção só se mantém por muitos anos quando se tomam as três doses”, explicou Sheila.

A principios de este mes, o México foi o primeiro país a registrar a vacina contra a dengue da Sanofi, por ahora, a única registrada no mundo. Em seguida o produto teve liberação nas Filipinas. O Brasil é o terceiro país a ter o registro do imunizante. O desenvolvimento clínico do produto envolveu mais de 20 estudios, y más 40 mil participantes, entre crianças, adolescentes e adultos, en 15 países.

Dados do Ministério da Saúde mostram que até a primeira semana de dezembro, 839 pessoas morreram em decorrência da dengue, aumentado 80% en relación a 2014.

fuente: Agencia Brasil

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