辉瑞新冠疫苗Ⅲ期临床试验出现副作用,目前仍在调查

2020-09-16 林怡龄 亿欧

暨上周阿斯利康新冠疫苗因受试者出现不良反应暂停临床试验后,本周,辉瑞的新冠疫苗也出现了波折。

暨上周阿斯利康新冠疫苗因受试者出现不良反应暂停临床试验后,本周,辉瑞的新冠疫苗也出现了波折。

据路透社报道,辉瑞在周二(15日)表示,在Ⅲ期临床试验中,注射了辉瑞研发的新冠疫苗疫苗或安慰剂的参与者出现了轻度至中度的副作用。副作用包括疲劳、头痛、发冷和肌肉疼痛。其中一些参与者也出现了包括高烧在内的发烧症状。

由于这些数据是来自双盲试验,辉瑞和参与者并不知道到底是谁接受了疫苗还是安慰剂。不过,辉瑞的疫苗研究与开发负责人Kathrin Jansen指出,独立数据监控委员会“可以访问非盲数据,因此,如果他们有任何安全隐患,他们会及时通知我们。但是他们至今并没有那么做。”

辉瑞表示,目前已在Ⅲ期临床试验中招募了29000人,以测试他们与德国合作伙伴BioNTech合作开发的实验性冠病疫苗。另外,其曾计划将临床试验规模增至44000人。辉瑞高管在一次投资者电话会议上表示,截至目前,已有超过12000名试验参与者注射了第二剂疫苗。

针对这次波折,辉瑞表示自己的科学家也在观察是否有令人担忧的不良事件出现。辉瑞介绍称,到目前为止,疲劳是该试验中最常见的副作用。

而此前因副作用而暂停临床试验的阿斯利康新冠疫苗,则在获得英国监管部门药物及健康产品监管局批准后,已在英国和巴西恢复临床试验,而在美国的试验则仍被搁置,等待FDA调查。

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    2020-09-17 ms4000000956890434

    快点吧!

    0

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    2020-09-17 公卫新人

    新冠肺炎,疫情何时才能消失

    0

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    2020-09-16 lovetcm

    #新冠病毒疫苗#接种后发烧太常见了!

    0

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