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据路透社报道,巴西联邦卫生监管机构Anvisa在一份声明中表示,周六,该国暂停使用中国科兴生物技术有限公司研发的超过1200万剂新冠疫苗,这些疫苗是在未经授权的工厂生产的。
Anvisa表示,监管机构周五接到圣保罗布坦研究所的通知,称该厂已生产了25批(1210万剂)疫苗。布坦研究所是一家生物医学中心,与科兴合作在当地灌装和完成疫苗的生产。
巴西监管机构说:“该生产单位……没有经过检查,也没有得到 Anvisa批准紧急使用上述疫苗的授权。”Anvisa补充说,这项禁令是“一项避免使民众面临可能的迫在眉睫风险的预防措施”。
该监管机构称,Butantan还告诉Anvisa,同一家工厂还生产了17批共计900万剂疫苗,正在运往巴西的路上。
监管机构表示,在90天的禁令期间,Anvisa将寻求对科兴疫苗生产工厂进行检查,并进一步了解生产过程的安全性。
巴西今年早些时候推行疫苗接种期间,绝大多数接种的疫苗都来自科兴。
周六,巴西报告了21804例确诊病例,692个死亡病例。
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