强生公司暂停新冠疫苗研究 接种者出现不明原因症状

原标题：强生公司暂停新冠疫苗研究 接种者出现不明原因症状

{image=1}

当地时间12日，美国强生公司发表声明称，由于其中一名参与研究的志愿者出现“不明原因症状”，已暂停正在进行的新冠疫苗研究。

Johnson & Johnson said on Monday it had temporarily paused its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant， delaying one of the highest-profile efforts to contain the global pandemic。

强生公司并没有透露“不明原因症状”具体是什么。公司声明写道：“我们必须尊重参与者的个人隐私。我们现在也在了解其症状，在分享更多信息之前，要厘清所有事实。”

强生公司还表示，内部临床和安全医生等多方正在审查和评估该参与者的健康状况。

The participant‘s illness is being reviewed and evaluated by an independent data and safety monitoring board as well as the company’s clinical and safety physicians， Johnson & Johnson said in a statement。 The company declined to elaborate about the illness due to privacy concerns。

强生公司表示，临床试验过程中出现不良事件是临床研究的预期部分。因此，在大规模临床试验中，出现暂停现象并不罕见。

强生公司同时强调了“研究暂停”同“临床搁置”的区别，称后者系正式的监管措施，可持续更长时间，而目前该疫苗只是处于“研究暂停”的状态。

J&J， which reports quarterly financial results on Tuesday morning， said that such pauses are normal in big trials， which can include tens of thousands of people。 It said the “study pause” in giving doses of the vaccine candidate was different from a “regulatory hold” required by health authorities。 The current case is a pause。

{image=2}

值得注意的是，此前另一款被寄予厚望的新冠疫苗也曾在试验阶段被暂停。

这款由全球领先制药公司阿斯利康和牛津大学合作研发的新冠疫苗，已经得到了美国政府12亿美元的投资。但今年9月，在英国的一次疫苗测试中，有一名患者也出现了“不明原因症状”。该疫苗的测试研究在英国暂停大约一周后逐步恢复，此后在其他国家也重新开始测试，但在美国的测试至今仍被搁置，等待官方的评估和审查。

此外，据报道，强生和阿斯利康暂停的疫苗都为腺病毒载体新冠疫苗，两次事件引发行业内对于腺病毒载体新冠疫苗技术路线的担忧。

However， J&J‘s move follows a similar one by AstraZeneca。 In September， AstraZeneca paused late-stage trials of its experimental coronavirus vaccine， developed with the University of Oxford， due to an unexplained illness in a UK study participant。 While trials in the UK， Brazil， South Africa and India have resumed， the U.S。 trial is still on hold pending a regulatory review。

Dr。 William Schaffner， a professor of infectious diseases at the Vanderbilt University School of Medicine， said by email that “Everybody is on the alert because of what happened with AstraZeneca，” adding that it could take a week to gather information。

强生公司的新冠疫苗三期临床研究于9月份正式启动，疫苗研究规模达6万人，是美国正在测试的六种新冠疫苗之一。

Last month， J&J said its experimental COVID-19 vaccine produced a strong immune response against the novel coronavirus in an early-to-mid stage clinical trial， following which the company kicked off a final 60，000-person trial， whose results had been expected by the end of this year or early 2021。

责任编辑：张玉 SN234