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因志愿者出現(xiàn)不良反應(yīng) 牛津新冠疫苗試驗(yàn)暫停 Oxford vaccine trial on hold because of safety issue

中國日報(bào)網(wǎng) 2020-09-10 08:54

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牛津大學(xué)和阿斯利康合作研發(fā)的新冠疫苗已經(jīng)進(jìn)入三期臨床試驗(yàn),但由于其中一名志愿者出現(xiàn)不明原因的疾病,牛津疫苗試驗(yàn)現(xiàn)已暫停。據(jù)悉,牛津疫苗是最早進(jìn)入三期臨床試驗(yàn)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.

制藥公司阿斯利康9月8日表示,牛津大學(xué)新冠疫苗的臨床試驗(yàn)已被暫時(shí)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:“我們啟動了標(biāo)準(zhǔn)審查程序并自動中止了疫苗接種,讓獨(dú)立委員會可以核查安全數(shù)據(jù)。每當(dāng)其中一名試驗(yàn)對象出現(xiàn)可能無法解釋的疾病時(shí),就必須在調(diào)查期間采取這一常規(guī)行動,以確保我們試驗(yàn)的正當(dāng)性?!?/p>

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(xué)合作研發(fā)新冠疫苗,并于上周在美國開始了三期臨床試驗(yàn)。美國國家廣播公司新聞網(wǎng)已經(jīng)證實(shí),暫停疫苗試驗(yàn)已經(jīng)影響到了美國的試驗(yàn)區(qū)。

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(fèi)城兒童醫(yī)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(gè)嚴(yán)重的不良反應(yīng)事件是否由疫苗引發(fā)期間暫停試驗(yàn)‘不尋常,但也不是聞所未聞’?!?/p>

"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(dá)州羅契斯特市的梅奧診所的疫苗研究組組長、傳染病專家格雷戈里·波蘭博士在一封發(fā)給美國國家廣播公司新聞網(wǎng)的電郵中稱:“疫苗試驗(yàn)中確實(shí)會出現(xiàn)嚴(yán)重的不良反應(yīng)。一般在發(fā)生這種情況時(shí),會中止試驗(yàn),收集數(shù)據(jù),并由獨(dú)立的數(shù)據(jù)監(jiān)測與安全委員會來審查細(xì)節(jié),以決定是否繼續(xù)試驗(yàn)或作出某種改變?!?/p>

"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,但有必要采取這些預(yù)防措施來確保試驗(yàn)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(yīng)該在幾天后就能得知這一問題的新進(jìn)展?!眾W菲特是美國食品和藥物管理局疫苗咨詢委員會的成員。

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(yàn)是美國輝瑞制藥公司將開啟的第三個(gè)三期臨床試驗(yàn)。美國藥企Moderna的新冠疫苗于七月底開始三期臨床試驗(yàn),目前已經(jīng)招募了約3萬名志愿者。

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.

牛津疫苗采用了一種腺病毒來“教會”免疫系統(tǒng)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(xì)胞。

 

英文來源:美國國家廣播公司新聞網(wǎng)

翻譯&編輯:丹妮

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