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2p6g1
A Anvisa decidiu suspender o estudo clínico da CoronaVac após um voluntário apresentar um evento adverso grave. De acordo com a agência, “o evento ocorrido no dia 29 de outubro foi comunicado à Anvisa, que decidiu interromper o estudo para avaliar os dados observados até o momento e julgar sobre o risco/benefício da continuidade do estudo”. Com a interrupção do estudo, nenhum novo voluntário poderá ser vacinado.
Não foram divulgadas mais informações sobre o caso. “Mais detalhes do estudo têm comunicação vedada em conformidade com os compromissos de confidencialidade assumidos no protocolo de desenvolvimento vacinal”, disse a Anvisa em comunicado.
Esse tipo de interrupção faz parte dos procedimentos de estudos clínicos. O mesmo já ocorreu com o imunizante da Johnson & Johnson e da Universidade Oxford em parceria com a Astrazeneca.
A Anvisa considera eventos adversos graves os seguintes acontecimentos: óbito, evento adverso potencialmente fatal, incapacidade ou invalidez persistente ou significativa; evento que exige internação hospitalar do paciente ou prolonga internação; anomalia congênita ou defeito de nascimento; qualquer suspeita de transmissão de agente infeccioso por meio de um dispositivo médico e evento clinicamente significante.
Por que a Anvisa determinou a paralisação dos testes com a vacina?
Os estudos clínicos no Brasil envolvendo a vacina da empresa chinesa Sinovac foram suspensos depois que a Agência Nacional de Vigilância Sanitária (Anvisa) identificou um “evento adverso grave” com um dos milhares de participantes do teste feito em parceria com o Instituto Butantan, de São Paulo.
Em nota, a Anvisa afirmou ter interrompido o estudo “para avaliar os dados observados até o momento e julgar o risco/benefício da continuidade do estudo”. Não há qualquer confirmação de que esse “evento adverso grave”, não detalhado pelo órgão, tenha sido causado pela vacina.
Paralisação semelhante já ocorreu no Brasil com a vacina da parceria europeia AstraZeneca/Oxford, mas depois se percebeu que não havia relação do evento com o imunizante.
Bolsonaro estava certo?
Após Anvisa suspender Coronavac, Bolsonaro diz que “ganhou” de Doria
“Morte, invalidez, anomalia. Esta é a vacina que o Dória queria obrigar a todos os paulistanos tomá-la. O Presidente disse que a vacina jamais poderia ser obrigatória. Mais uma que Jair Bolsonaro ganha presidente” Jair Bolsonaro, no Facebook…
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