Aprovada pela Anvisa, vacina contra dengue deve chegar ao Brasil nesta semana

Uma nova vacina contra a dengue deve chegar ao Brasil esta semana. O anúncio foi feito pela Associação Brasileira de Clínicas de Vacinas (ABCVAC). Composta por quatro diferentes sorotipos do vírus causador da doença, a Qdenga, da empresa Takeda Pharma Ltda., foi aprovada pela Agência Nacional de Vigilância Sanitária (Anvisa) em março. De acordo com o órgão regulador, a dose confere “ampla proteção contra a dengue”.

Em nota, a ABCVAC informou que o preço da vacina, disponível inicialmente apenas em laboratórios particulares, deve variar entre R$ 350 e R$ 500 para o consumidor final, dependendo do estado. Em São Paulo, por exemplo, o Preço Máximo ao Consumidor (PMC) autorizado pela Anvisa para as clínicas é R$ 379,40.

“As clínicas devem utilizar esse parâmetro na composição da sua precificação final, que também inclui o atendimento, a triagem, a análise da caderneta de vacinação, as orientações pré e pós-vacina, além de todo o suporte que os pacientes necessitam para se informar corretamente sobre a questão da vacinação”, destacou a ABCVAC.

Indicação

De acordo com a Anvisa, a vacina é indicada para crianças acima de 4 anos, adolescentes e adultos até 60 anos. A Qdenga, portanto, é a primeira dose aprovada no Brasil para um público mais amplo, já que o imunizante que recebeu o aval anteriormente, a Dengvaxia, só pode ser utilizado por quem já teve dengue.

A concessão do registro pela Anvisa permite a comercialização do produto no país, desde que mantidas as condições aprovadas. A vacina, contudo, segue sujeita ao monitoramento de eventos adversos, por meio de ações de farmacovigilância sob a responsabilidade da empresa. A nova vacina estará disponível para administração via subcutânea em esquema de duas doses, com intervalo de três meses entre as aplicações.

“A concessão do registro pela Anvisa permite a comercialização do produto no país, desde que mantidas as condições aprovadas. A vacina, contudo, segue sujeita ao monitoramento de eventos adversos, por meio de ações de farmacovigilância sob a responsabilidade da empresa”, informou.

A eficácia contra a dengue para todos os sorotipos combinados entre indivíduos soronegativos (sem infecção anterior pelo vírus) foi de 66,2%. Já para indivíduos soropositivos (que tiveram infecção anterior pelo vírus), o índice foi de 76,1%.

“A demonstração da eficácia da Qdenga tem suporte principalmente nos resultados de um estudo de larga escala, de fase 3, randomizado e controlado por placebo, conduzido em países endêmicos para dengue com o objetivo de avaliar a eficácia, a segurança e a imunogenicidade da vacina”, informou a Anvisa.

Fonte: Hoje em Dia

 

 

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