牛津新冠疫苗临床试验已暂停
文章来源:未知 文章作者:enread 发布时间:2020-09-11 03:50 字体: [ ]  进入论坛
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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."
 
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.
 
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.
 
"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."
 
"Often these events are coincidental, but these precautions are necessary to ensure the safety of the trial participants," Poland said.
 
"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.

TAG标签: vaccine Oxford trial
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