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FDA工作人员建议监测接受辉瑞或Moderna新冠疫苗注射的人可能出现贝尔氏麻痹症(面瘫的一种)的情况,称这不一定是副作用,但在少数试验参与者身上出现此现象,这种情况值得注意。
周二公布了一项报告显示,在Moderna的3万多名临床试验参与者中,有4例贝尔氏麻痹症的报告。其中三名参与者接受的是疫苗而不是安慰剂注射。辉瑞公司的试验同样在约43000名参与者中,有4例贝尔氏麻痹症的报告。而这4例贝尔氏麻痹症患者都注射了疫苗而不是安慰剂。
FDA工作人员还表示,没有足够的数据将这些病例与注射疫苗直接联系起来,但这值得密切关注。
FDA staff recommended monitoring people who received Pfizer or Moderna's coronavirus vaccine for possible Bell's palsy (a type of facial paralysis), saying that this is not necessarily a side effect, but this phenomenon occurred in a small number of trial participants. Worth noting.
A report was released on Tuesday showing that of Moderna's more than 30,000 clinical trial participants, 4 cases of Bell's Palsy have been reported. Three of the participants received the vaccine instead of a placebo injection. Pfizer’s trial also included 4 reports of Bell’s Palsy among approximately 43,000 participants. And these 4 patients with Bell's Palsy were all injected with the vaccine instead of a placebo.
FDA staff also said that there is not enough data to directly link these cases to the vaccine injection, but this deserves close attention. source
指尖新闻:高信噪比,一目了然
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