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越南为新冠疫苗研发活动创造最为便利条件

2021-08-03 13:58

(人民报)8月2日,越南卫生部副部长、新冠疫苗临床试验研究和发展特别工作组组长陈文舜主持与卫生部科技与培训局、军医学院、中央流行病学与卫生院、胡志明市巴斯德研究所科学家之间的在线会议,旨在检查督促由Nanogen制药生物技术股份公司研发的新冠疫苗Nanocovax一期、二期和三期临床试验及研究结果报告编制进度。

据Nanogen公司消息,新冠疫苗Nanocovax已进入三期临床试验,分为两个阶段,其中3a阶段接种试验者1000人、3b阶段接种试验者1.2万人。

3a阶段1000名受试者的D42结果表明,所有接种试验者体内均产生中和性抗体Surrogate;99.2%的受试者抗蛋白S的免疫球蛋白G(IgG)抗体血清转换比参照高出3倍。目前,该公司正按照研究提纲详细跟踪3a和3a阶段所有接种试验者的健康状况。

在申请新冠疫苗Nanocovax紧急使用许可授权的同时,Nanogen建议卫生部、国家生物医学研究伦理理事会考虑开展3c阶段研究工作(受试者约50万至100万名);此外,在获得紧急使用许可授权之后对12至18岁儿童进行研究。

听取各位资深专家的报告之后,陈文舜表示,卫生部一向支持并为各公司、个人参加新冠疫苗研发工作创造所有便利条件。因此,卫生部已调集全国一流专家和科学家参与新冠疫苗评估、研究和审定工作。

卫生部要求Nanogen公司在2021年8月15日之前提交新冠疫苗Nanocovax二期临床试验和三期临床试验早期研究数据报告,从而上交国家生物医学研究伦理理事会和卫生部许可签发委员会批准紧急使用新冠疫苗Nanocovax。(完)

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