因志願者出現不良反應 牛津新冠疫苗試驗暫停
牛津大學和阿斯利康合作研發的新冠疫苗已經進入三期臨牀試驗，但由於其中一名志願者出現不明原因的疾病，牛津疫苗試驗現已暫停。據悉，牛津疫苗是最早進入三期臨牀試驗的新冠疫苗。
Clinical trials for the University of Oxford's COVID-19 vaccine have been put on hold, drug maker AstraZeneca said Tuesday.
製藥公司阿斯利康9月8日表示，牛津大學新冠疫苗的臨牀試驗已被暫時叫停。
"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."
該公司在一份聲明中稱：“我們啓動了標準審查程序並自動中止了疫苗接種，讓獨立委員會可以覈查安全數據。每當其中一名試驗對象出現可能無法解釋的疾病時，就必須在調查期間採取這一常規行動，以確保我們試驗的正當性。”
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學合作研發新冠疫苗，並於上週在美國開始了三期臨牀試驗。美國國家廣播公司新聞網已經證實，暫停疫苗試驗已經影響到了美國的試驗區。
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.
費城兒童醫院疫苗教育中心的主任保羅·奧菲特博士稱：“在研究人員確定一個嚴重的不良反應事件是否由疫苗引發期間暫停試驗‘不尋常，但也不是聞所未聞’。”
"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."
美國明尼蘇達州羅契斯特市的梅奧診所的疫苗研究組組長、傳染病專家格雷戈裏·波蘭博士在一封發給美國國家廣播公司新聞網的電郵中稱：“疫苗試驗中確實會出現嚴重的不良反應。一般在發生這種情況時，會中止試驗，收集數據，並由獨立的數據監測與安全委員會來審查細節，以決定是否繼續試驗或作出某種改變。”
"Often these events are coincidental, but these precautions are necessary to ensure the safety of the trial participants," Poland said.
波蘭稱：“通常這都是偶然事件，但有必要採取這些預防措施來確保試驗參與者的安全。”
"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.
奧菲特說：“我們應該在幾天後就能得知這一問題的新進展。”奧菲特是美國食品和藥物管理局疫苗諮詢委員會的成員。
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.
牛津新冠疫苗試驗是美國輝瑞製藥公司將開啓的第三個三期臨牀試驗。美國藥企Moderna的新冠疫苗於七月底開始三期臨牀試驗，目前已經招募了約3萬名志願者。
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.
牛津疫苗採用了一種腺病毒來“教會”免疫系統如何讓抗體去攻擊新冠病毒的“纖突蛋白”。正是這種纖突蛋白使得病毒感染人體細胞。
