Agência reguladora da UE começa a analisar a Coronavac
A agência reguladora da União Europeia (UE) anunciou nesta terça-feira que começou a analisar a Coronavac, vacina contra covid-19 desenvolvida pela chinesa Sinovac e usada no Brasil, para avaliar se o imunizante é eficaz e seguro. Este é o primeiro passo para uma possível aprovação para uso emergencial nos 27 países da região.
Em um comunicado, a Agência Europeia de Medicamentos (EMA, na sigla em inglês) disse que a decisão de iniciar a revisão contínua da Coronavac se baseia em resultados preliminares de estudos laboratoriais e clínicos com a vacina. “Esses estudos sugerem que a vacina desencadeia a produção de anticorpos e pode ajudar a proteger contra a doença”, disse a agência.
Especialistas da EMA vão avaliar os dados disponíveis para decidir se os benefícios da Coronavac superam os riscos. A revisão continuará até que “evidências suficientes estejam disponíveis para um pedido formal de autorização para comercialização”.
A avaliação da EMA foi anunciada um dia depois de a Comissão Europeia ter anunciado planos para...
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