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因志愿者出现不良反应 牛津新冠疫苗试验暂停 Oxford vaccine trial on hold because of safety issue

中国日报网 2020-09-10 08:54

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牛津大学和阿斯利康合作研发的新冠疫苗已经进入三期临床试验,但由于其中一名志愿者出现不明原因的疾病,牛津疫苗试验现已暂停。据悉,牛津疫苗是最早进入三期临床试验的新冠疫苗。

 

A scientist checks quality control of vaccine vials for correct volume at the Clinical Biomanufacturing Facility (CBF) in Oxford, Britain, April 2, 2020. Sean Elias/REUTERS 

 

Clinical trials for the University of Oxford's COVID-19 vaccine have been put on hold, drug maker AstraZeneca said Tuesday.

制药公司阿斯利康9月8日表示,牛津大学新冠疫苗的临床试验已被暂时叫停。

"Our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee," the company said in a statement. "This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials."

该公司在一份声明中称:“我们启动了标准审查程序并自动中止了疫苗接种,让独立委员会可以核查安全数据。每当其中一名试验对象出现可能无法解释的疾病时,就必须在调查期间采取这一常规行动,以确保我们试验的正当性。”

AstraZeneca, which is working with the University of Oxford on a coronavirus vaccine, began its phase 3 clinical trials in the US last week. NBC News has confirmed that the pause has affected trial sites in the US.

阿斯利康正在和牛津大学合作研发新冠疫苗,并于上周在美国开始了三期临床试验。美国国家广播公司新闻网已经证实,暂停疫苗试验已经影响到了美国的试验区。

Putting a trial on hold while researchers determine whether a serious adverse event was caused by a vaccine is "uncommon, but not unheard of," Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, said.

费城儿童医院疫苗教育中心的主任保罗·奥菲特博士称:“在研究人员确定一个严重的不良反应事件是否由疫苗引发期间暂停试验‘不寻常,但也不是闻所未闻’。”

"Serious reactions do occur in vaccine trials," Dr. Gregory Poland, an infectious diseases expert and director of the Mayo Clinic's Vaccine Research Group in Rochester, Minnesota, said in an email to NBC News. "Generally, when these events occur, trials are paused, data collected, and an independent data monitoring and safety board reviews the details to make a determination whether to resume the trial or alter it in some way."

美国明尼苏达州罗契斯特市的梅奥诊所的疫苗研究组组长、传染病专家格雷戈里·波兰博士在一封发给美国国家广播公司新闻网的电邮中称:“疫苗试验中确实会出现严重的不良反应。一般在发生这种情况时,会中止试验,收集数据,并由独立的数据监测与安全委员会来审查细节,以决定是否继续试验或作出某种改变。”

"Often these events are coincidental, but these precautions are necessary to ensure the safety of the trial participants," Poland said.

波兰称:“通常这都是偶然事件,但有必要采取这些预防措施来确保试验参与者的安全。”

"Presumably, we should hear more about what the problem was in a few days," said Offit, who is on the Food and Drug Administration's vaccine advisory committee.

奥菲特说:“我们应该在几天后就能得知这一问题的新进展。”奥菲特是美国食品和药物管理局疫苗咨询委员会的成员。

The Oxford trial was the third phase 3 trial to begin in the US Pfizer and Moderna began their phase 3 trials in late July and have already enrolled about 30,000 volunteers.

牛津新冠疫苗试验是美国辉瑞制药公司将开启的第三个三期临床试验。美国药企Moderna的新冠疫苗于七月底开始三期临床试验,目前已经招募了约3万名志愿者。

The Oxford vaccine uses a type of virus called an adenovirus to teach the immune system how to make antibodies to attack the coronavirus' so-called spike protein. It's that spike protein that allows the virus to infect human cells.

牛津疫苗采用了一种腺病毒来“教会”免疫系统如何让抗体去攻击新冠病毒的“纤突蛋白”。正是这种纤突蛋白使得病毒感染人体细胞。

 

英文来源:美国国家广播公司新闻网

翻译&编辑:丹妮

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