Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant

由于参与者出现原因不明的疾病，强生暂停新冠疫苗研究

The study of Johnson & Johnson’s Covid-19 vaccine has been paused due to an unexplained illness in a study participant.

由于一位研究参与人员患上原因不明的疾病，强生决定暂停新冠疫苗研究。

A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board — an independent committee that watches over the safety of patients in the clinical trial — would be convened. The document was obtained by STAT.

一份发给外界研究人员（负责进行由6万名患者参加的临床试验）的文件表明，研究目前已达到“暂停规定”，用于招募研究参与人员的在线系统已经关闭，数据和安全监督委员会-一家独立的、密切关注临床试验中患者安全情况的委员会将会召开会议。目前该文件已由STAT获取。

Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The company declined to provide further details.

STAT与强生取得联络后，强生证实研究已暂停并表明，暂停是由于“研究参与人员出现原因未明的疾病”。公司拒绝透露更多细节。

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information,” the company said in a statement.

公司在一份声明中表示：“我们必须尊重该参与者的隐私。我们也正在了解更多有关该参与者的患病情况。在我们分享更多的信息之前，我们需要了解所有事实。”

J&J emphasized that so-called adverse events — illnesses, accidents, and other bad medical outcomes — are an expected part of a clinical study, and also emphasized the difference between a study pause and a clinical hold, which is a formal regulatory action that can last much longer. The vaccine study is not currently under a clinical hold. J&J said that while it normally communicates clinical holds to the public, it does not usually inform the public of study pauses.

强生强调表示，所谓的不良事件，比如疾病、事故以及其他不良药物结果都是临床研究中预期的一部分。强生同时也强调了研究暂停和临床限制之间的区别。临床限制是正式的监管行动，其持续时间会更长。疫苗研究目前不处于临床限制阶段。强生表示，通常其会将临床限制通报给大众，但一般不会将研究暂停告知大众。

The data and safety monitoring board, or DSMB, convened late Monday to review the case. J&J said that in cases like this “it is not always immediately apparent” whether the participant who experienced an adverse event received a study treatment or a placebo.

数据和安全监管委员会（DSMB）于上周一召开会议以对案例进行审查。强生表示，在类似的这种情况中，出现不良反应的参与者是接受研究治疗还是安慰剂并非立刻知晓。

Though clinical trial pauses are not uncommon — and in some cases last only a few days — they are generating outsized attention in the race to test vaccines against SARS-CoV-2, the virus that causes Covid-19.

尽管临床试验暂停并不鲜见，并且在某些情况下仅仅持续数日，但是暂停会引起大量的关注，特别是在大家都在竞相测试SARS-CoV-2，一种引起新冠病毒的疫苗。

Given the size of Johnson & Johnson’s trial, it’s not surprising that study pauses could occur, and another could happen if this one resolves, a source familiar with the study said.

考虑到强生试验的规模，研究暂停完全在意料之内。如果该问题得到了解决，那么还可能出现其他的问题，一位熟悉研究的人员表示。

“If we do a study of 60,000 people, that is a small village,” the source said. “In a small village there are a lot of medical events that happen.”

“如果我们的研究对象是6万人，那么相当于是一个小村庄。在这个小村庄内，会出现许多医疗事件”，该人员表示。

On Sept. 8, a large study of another Covid-19 vaccine being developed by AstraZeneca and Oxford University was put on hold because of a suspected adverse reaction in a patient in the United Kingdom. It’s believed that the patient had transverse myelitis, a spinal cord problem. Studies of the vaccine resumed roughly a week after it was paused in the United Kingdom, and have since been restarted in other countries as well. It remains on hold, however, in the United States. 

9月8日，另一个由AstraZeneca和牛津大学所研发的新冠疫苗大型研究项目也由于英国的一位患者出现疑似副作用而处于暂停状态。据说，该患者有横断性脊髓炎，即一种脊髓疾病。疫苗研究大约在英国暂停一周后又继续启动并也开始在其他国家重新启动。然而，该项目在美国仍处于暂停状态。

Johnson and Johnson began enrolling volunteers in its Phase 3 study on Sept. 23. Researchers planned to enroll 60,000 participants in the United States and other countries.

9月23日，强生开始为第3期研究招募志愿者。研究人员计划在美国和其他国家招募6万名参与者。

以上内容摘自CNBC，编辑：Susan