礼来公司和强生公司已经暂停了新冠肺炎疫苗的试验。为什么专家说这是令人安心的,而不是令人害怕的

2020-10-14 12:04

Eli Lilly and Johnson & Johnson have paused COVID-19 vaccine trials. Why experts say that's reassuring, not frightening. XIh世界播

礼来公司和强生公司已经暂停了新冠肺炎疫苗的试验。为什么专家说这是令人安心的,而不是令人害怕的XIh世界播


Recent pauses to two large-scale COVID-19 vaccine trials and a treatment study should reassure people—not frighten them—vaccine experts said, though it is a reminder of the messiness of science. XIh世界播

疫苗专家表示,最近暂停了两项大规模的新冠肺炎疫苗试验和一项治疗研究,这应该会让人们放心-而不是吓到他们-尽管这提醒人们科学的混乱。XIh世界播


“This is an indication that the system is working as it was designed to work to protect human subjects in clinical trials,” Lawrence Gostin, a public health and legal expert at Georgetown and Johns Hopkins universities, said Tuesday. “It demonstrates that the ethical guard rails on vaccine trials are working.” XIh世界播

乔治敦大学和约翰·霍普金斯大学的公共卫生和法律专家劳伦斯·戈斯廷(Lawrence Gostin)周二表示:“这表明,该系统正在发挥作用,就像它设计的那样,在临床试验中保护人类受试者。”“这表明疫苗试验的伦理保护措施正在发挥作用。”XIh世界播


It’s not unusual for late-stage trials of drugs and vaccines to be stopped briefly to examine safety concerns, he and others said. XIh世界播

他和其他人说,药物和疫苗的后期试验短暂停止以检查安全问题并不少见。XIh世界播


The discovery of an adverse event and a pause in the clinical trial is actually reassuring, said Dr. Bali Pulendran, a professor of immunology and vaccine design at Stanford University. XIh世界播

斯坦福大学(Stanford University)免疫学和疫苗设计学教授巴利·普伦德兰(Bali Pulendran)博士说,发现不良事件和临床试验暂停实际上让人放心。XIh世界播


“Let’s say they got to the end of the clinical trial and there had not been one single report of any adverse event in the tens of thousands of people involved in the trial. That,” he said, “would worry me. That would be extraordinarily unusual.” XIh世界播

“比方说,他们的临床试验结束了,在参与试验的数万人中,没有一例出现任何不良事件的报告。他说,“这会让我担心的。”这将是非常不寻常的。“。XIh世界播


Eli Lilly announced Tuesday it was pausing a trial of an experimental drug similar to one President Donald Trump recently claimed cured him of COVID-19. On Monday, Johnson & Johnson halted a large-scale trial of a candidate COVID-19 vaccine. And, in September, British regulators put a hold on another trial of a candidate vaccine by AstraZeneca. They lifted the hold a week later, but it has continued in the American arm of the study. XIh世界播

礼来公司周二宣布暂停一种实验性药物的试验,该药物与唐纳德·特朗普总统最近声称治愈了他的新冠肺炎的一种药物类似。周一,强生公司暂停了一种候选新冠肺炎疫苗的大规模试验。9月份,英国监管机构暂停了阿斯利康(AstraZeneca)的另一项候选疫苗试验。一周后,他们解除了搁置,但这项研究的美国分支仍在继续。XIh世界播


暂无XIh世界播

COVID-19 vaccine trial on Aug. 5, 2020, in Detroit. XIh世界播

新冠肺炎疫苗试验,2020年8月5日,在底特律XIh世界播


These occurrences should serve as a reminder that scientific research can be unpredictable, disappointing and time-consuming, specialists said. XIh世界播

专家们说,这些事件应该提醒人们,科学研究可能是不可预测的、令人失望的和耗时的。XIh世界播


“After fourdecades in vaccines, I expect the unexpected,” said Dr. Gregory Poland, director of the Mayo Vaccine Research Group and editor-in-chief of the journal Vaccine. “The nature of vaccine development is there are always surprises and the unexpected. Everybody’s looking for them, but time has to pass before you actually know.” XIh世界播

梅奥疫苗研究小组主任、《疫苗》杂志主编格雷戈里·波兰博士说:“在从事疫苗研究40年后,我预计会出现意想不到的情况。”“疫苗研发的本质就是总是有惊喜和意想不到的事情。每个人都在找他们,但要想真正知道,还得等时间过去。“。XIh世界播


According to a new poll from Informa Pharma Intelligence, a business intelligence provider, and research firm YouGov, 35% of Americans don’t trust how quickly the COVID-19 vaccine clinical trials are moving and 23% don’t think pharmaceutical companies have consumers' best interests in mind. XIh世界播

根据商业智能提供商Informa Pharma Intelligence和研究公司YouGov的一项最新民意调查,35%的美国人不相信新冠肺炎疫苗临床试验的进展速度,23%的人认为制药公司没有把消费者的最佳利益放在心上。XIh世界播


The public may have unrealistic expectationsof avaccine that's "100% effective and 150% safe," said Alan Barrett, director of the Sealy Institute for Vaccine Sciences at The University of Texas Medical Branch at Galveston. XIh世界播

德克萨斯大学加尔维斯顿分校西利疫苗科学研究所(Sealy Institute For Vaccine Sciences)主任艾伦·巴雷特(Alan Barrett)表示,公众可能对“100%有效、150%安全”的疫苗抱有不切实际的期望。XIh世界播


But he thinks the companies have shown an impressive attention to safety, including the trial pauses. “We can’t afford to have a mistake,” Barrett said. “The public has to have confidence that any vaccine given to them is going to be safe and effective.” XIh世界播

但他认为,这些公司对安全表现出了令人印象深刻的关注,包括审判暂停。“我们不能再犯错误了,”巴雷特说。“公众必须相信,给他们接种的任何疫苗都将是安全有效的。”XIh世界播


Only about 31% of all vaccine candidates make it all the way from Phase 1 clinical trials to market, according to a study published last year. XIh世界播

根据去年发表的一项研究,在所有候选疫苗中,只有大约31%的疫苗能够从第一阶段临床试验一路推向市场。XIh世界播


There are 49 COVID-19 candidate vaccines in clinical trials around the world, with ninein large, late-stage studies, Barrett said. Only three people out of the roughly 300,000 volunteers in all those trials have been known to have suffered serious side effects. “It’s not a big number,” he said. XIh世界播

巴雷特说,世界各地有49种新冠肺炎候选疫苗正在进行临床试验,其中9种处于大型后期研究中。在所有这些试验的大约30万名志愿者中,只有3人已知遭受了严重的副作用。“这不是一个很大的数字,”他说。XIh世界播


The key challenge with vaccines, compared with treatments: Vaccines are given to people who are healthy. While a patient dying of cancer may willing to take a medication with lots of side effects, a healthy person shouldn’t be subjected to a risky vaccine, said Gostin, a law professorat Georgetown. “That’s why we need to be super careful that our vaccines are safe and effective before we deploy them.” XIh世界播

与治疗相比,疫苗的关键挑战是:疫苗是给健康的人接种的。乔治敦大学法学教授戈斯廷说,虽然死于癌症的患者可能愿意服用副作用很大的药物,但健康的人不应该接受有风险的疫苗。这就是为什么在我们部署疫苗之前,我们需要格外小心,确保我们的疫苗是安全有效的。“。XIh世界播


Vaccine trials on pause XIh世界播

疫苗试验暂停。XIh世界播


Late Monday, Johnson & Johnson announcedit was pausing a trial of its COVID-19 candidate vaccine, JNJ-78436735, while it investigated an “unexplained illness” in a trial participant. The company as well as an independent Data Safety Monitoring Board will review the participant’s case before deciding whether to resume the trial. XIh世界播

周一晚些时候,强生公司宣布暂停其新冠肺炎候选疫苗JNJ-78436735的试验,同时对一名试验参与者进行调查,称该公司以及一个独立的数据安全监测委员会将在决定是否恢复试验之前审查该参与者的病例。XIh世界播


About half the 30,000 trial participants received a placebo and half the active vaccine. Only the Data Safety Monitoring Board members know which shot the volunteer received. If it was a placebo, the trial is likely to be restarted quickly; if the problem could have been caused by the vaccine, an investigation will take longer. XIh世界播

在30,000名试验参与者中,约有一半接受了安慰剂和一半的活性疫苗。只有数据安全监测委员会成员知道志愿者注射的是哪一针,如果是安慰剂,试验很可能会很快重启;如果问题可能是疫苗造成的,调查时间会更长。XIh世界播


A similar trial by the pharmaceutical company AstraZeneca was stopped in September after a second trial participant developed an unusual neurological condition. XIh世界播

制药公司阿斯利康(AstraZeneca)的一项类似试验在第二名试验参与者出现不寻常的神经疾病后,于9月份停止。XIh世界播


In the United Kingdom, where the volunteer lived, regulators examined her case and decided the trial could resume there. But the U.S. Food and Drug Administration has kept the U.S. trial on hold as it investigates her case. XIh世界播

在这名志愿者居住的英国,监管机构审查了她的案件,并决定可以在那里恢复审判。但美国食品和药物管理局(U.S.Food and Drug Administration)在调查她的案件时,一直搁置了对美国的审判。XIh世界播


Little has been revealed about her problem, though it is believed to be something called transverse myelitis, a spinal inflammation that can cause temporary paralysis. Both she and the other person who suffered a serious side effect, a woman who had a flare-up of previously undiagnosed multiple sclerosis, have apparently recovered. XIh世界播

人们对她的问题知之甚少,尽管人们认为这是一种名为横贯性脊髓炎的疾病,这是一种可能导致暂时瘫痪的脊髓炎。她和另一个遭受严重副作用的人,一名之前未被诊断为多发性硬化症的女性,显然已经康复。XIh世界播


If it turns out that the adverse event in the Johnson & Johnson trial was also some type of nerve issue there is a theoretical, but by no means proven, reason it could be linked to the way the vaccine delivers its immunological payload. XIh世界播

如果事实证明强生试验中的不良事件也是某种类型的神经问题,那么就有一个理论上的,但绝不是经过证实的理由,它可能与疫苗传递免疫有效载荷的方式有关。XIh世界播


“There are theoretical reasons it could be,” said Dr. Otto Yang, a professor of medicine and associate chief of infectious diseases at UCLA's David Geffen School of Medicine. XIh世界播

加州大学洛杉矶分校(UCLA)大卫·格芬医学院(David Geffen School Of Medicine)医学教授兼传染病副主任奥托·杨(Otto Yang)博士说:“这可能有理论上的原因。”XIh世界播


Both the Johnson & Johnson and AstraZeneca candidate vaccines use a platform based on a harmless human virus called an adenovirus. The ones they use are uncommon in nature so most people have not developed immunity to them. XIh世界播

强生公司和阿斯利康候选疫苗都使用基于一种称为腺病毒的无害人类病毒的平台。他们使用的药物在自然界中并不常见,所以大多数人都没有对它们产生免疫力。XIh世界播


A very tiny number of people who are naturally sickened with adenovirus develop transverse myelitis, which is a neurological disorder of the spine that can cause paralysis. XIh世界播

极少数自然感染腺病毒的人会患上横贯性脊髓炎,这是一种可以导致瘫痪的脊椎神经疾病。XIh世界播


“Nobody knows why it happens, but it appears to be some type of immune response, perhaps the immune system is reacting to the virus and that’s causing a cross-reaction,” said Yang. XIh世界播

杨说:“没有人知道为什么会发生这种情况,但这似乎是某种免疫反应,可能是免疫系统对病毒产生了反应,这导致了交叉反应。”XIh世界播


He cautioned that the possibility of a link is extremely theoretical and there is no data to support it at this time but said it certainly warrants a pause while the companies investigate. XIh世界播

他告诫称,存在联系的可能性极具理论意义,目前没有数据支持,但他表示,在公司调查期间,肯定需要暂停。XIh世界播


“Transverse myelitis does happen very rarely all by itself. So if it’s a 1 in 100,000 event and you see it in one person, then OK. If you see it in two people, then it starts to be suspicious.” XIh世界播

“横贯性脊髓炎本身确实很少发生。所以如果这是十万分之一的事件,你可以在一个人身上看到,那么好吧。如果你在两个人身上看到这一点,那么就会开始令人怀疑。“。XIh世界播


Barrett, of the University of Texas, said he doesn’t think virus delivery systemscan explain the recent problems. “There’s no information to suggest they have problems,” he said. XIh世界播

德克萨斯大学的巴雷特说,他认为病毒传递系统无法解释最近的问题。“没有信息表明他们有问题,”他说。XIh世界播


Treatment trial put on hold XIh世界播

治疗试验被搁置。XIh世界播


Eli Lilly released a brief statement Tuesday explaining the pause in their trial of a monoclonal antibody, which mimics the natural immune response to the virus. XIh世界播

礼来公司周二发表了一份简短的声明,解释了他们暂停单克隆抗体试验的原因,这种单克隆抗体模仿了对病毒的自然免疫反应。XIh世界播


“Safety is of the utmost importance to Lilly,” according to the statement, released by company spokeswoman Molly McCully. “Lilly is supportive of the decision by the independent D.S.M.B. to cautiously ensure the safety of the patients participating in this study.” XIh世界播

根据礼来公司发言人莫莉·麦卡利(Molly McCully)发布的声明,“安全对礼来公司来说是最重要的。”礼来公司支持独立的D.S.M.B谨慎确保参与这项研究的患者安全的决定。“。XIh世界播


Trump last week touted the benefits of the experimental monoclonal antibody he was given a day after his diagnosis with COVID-19. That drug is made by Regeneron, a Tarrytown, New York, company. XIh世界播

特朗普上周吹嘘了他在被诊断出患有新冠肺炎一天后服用的实验性单克隆抗体的好处。这种药物是由纽约塔里敦的Regeneron公司生产的。XIh世界播


The Lilly antibody trial, led by the National Institutes of Health, was to have enrolled about 300 volunteers with mild to moderate COVID-19 who have been sick for fewer than 13 days. Half the participants would receive the antibody via infusion and half a saline infusion. Plans are to expand the trial to another 700 participants,including more severely ill patients if the antibody performs well. XIh世界播

礼来公司的抗体试验由美国国立卫生研究院领导,计划招募大约300000名患有轻中度新冠肺炎的志愿者,他们的患病时间不到13天。一半的参与者将通过输液和一半的生理盐水输注来接受抗体。计划将试验扩大到另外700名参与者,其中包括如果抗体表现良好的更多重病患者。XIh世界播


The antibody, called LY-CoV555, was isolated from the blood of a recovered COVID-19 patient. XIh世界播

该抗体命名为LY-CoV555,是从一名康复的新冠肺炎患者的血液中分离出来的。XIh世界播


Gostin, who also directs the O’Neill Institute for National and Global Health Law at Georgetown, said he’s troubled by this second hold. XIh世界播

戈斯廷也是乔治敦奥尼尔国家和全球卫生法律研究所的负责人,他说他对第二次持有感到不安。XIh世界播


“The two medical interventions that are most likely to dig our way out of COVID are vaccines and monoclonal antibodies,” he said. “It shows us that science is miraculous, but it’s not foolproof and it doesn’t always win over Mother Nature.” XIh世界播

他说:“最有可能使我们摆脱COVID的两种医学干预措施是疫苗和单克隆抗体。”“它向我们表明,科学是神奇的,但它不是万无一失的,它并不总是赢得大自然母亲的支持。”XIh世界播


In the end, said Gostin, we just have to "be patient. Let science take its course.” XIh世界播

戈斯廷说,最终,我们只需“耐心等待,让科学顺其自然。”XIh世界播

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