礼来公司和强生公司暂停COVID试验

2020-10-14 07:32

Two Major COVID Clinical Trials Were Paused Over Safety Concerns — Which Is Exactly How Trials Should Work ws5世界播

出于安全考虑,两个主要的COVID临床试验被暂停-这正是试验应该如何工作的。ws5世界播


暂无ws5世界播

One arm of Johnson & Johnson's vaccine trial tested patients at a hospital in Campinas, Brazil. ws5世界播

强生公司疫苗试验的一个分支在巴西坎皮纳斯的一家医院对患者进行测试ws5世界播


Within 24 hours, two pharmaceutical companies separately confirmed that their COVID-19 clinical trials — one for a vaccine, the other for a therapy — were being paused over potential safety concerns. ws5世界播

在24小时内,两家制药公司分别证实,他们的新冠肺炎临床试验-一种疫苗,另一种疗法-出于潜在的安全考虑而暂停。ws5世界播


A government-sponsored trial for Eli Lilly’s antibody drug was paused due to a “potential safety concern,” according to emails sent to testing sites on Tuesday. The company confirmed in a statement that an independent board overseeing the trial’s safety had made the decision “out of an abundance of caution.” Eli Lilly’s therapy is similar to another experimental treatment manufactured by Regeneron and used to treat President Donald Trump two weeks ago. ws5世界播

周二发给检测地点的电子邮件显示,政府赞助的礼来公司抗体药物试验因“潜在的安全问题”而暂停。该公司在一份声明中证实,一个监督试验安全性的独立委员会“出于高度谨慎”做出了这一决定。礼来公司的疗法类似于Regeneron公司生产的另一种实验性疗法,两周前曾用于治疗唐纳德·特朗普总统。ws5世界播


And on Monday, Johnson & Johnson confirmed that it paused its vaccine trial due to “an unexplained illness in a study participant,” as first reported by Stat. ws5世界播

周一,强生公司证实,正如Stat最先报道的那样,由于“一名研究参与者患有不明原因的疾病”,该公司暂停了疫苗试验。ws5世界播


There was little information immediately available about either incident, including whether they were linked to the pharmaceutical being tested or the placebos it was being tested against, or when the trials might be restarted. Johnson & Johnson said in a statement that it was “learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.” ws5世界播

目前几乎没有关于这两起事件的即时信息,包括它们是否与正在测试的药物或正在针对其进行测试的安慰剂有关,或者何时可能重新启动试验。强生公司在一份声明中说,它正在“更多地了解这名参与者的病情,在我们分享更多信息之前,掌握所有事实是很重要的。”ws5世界播


Study pauses, which are initiated by companies, are not uncommon occurrences in trials and are less severe than clinical holds, which are initiated by regulators. And “adverse” events — illnesses or other undesirable medical outcomes — are expected to some degree in all clinical trials, especially ones that involve large numbers of patients. Johnson & Johnson noted that it typically does not “communicate study pauses publicly,” but added that it proactively discloses any regulator-required holds. ws5世界播

由公司发起的研究暂停在试验中并不少见,而且没有由监管机构发起的临床暂停严重。而“不良”事件-疾病或其他不良医疗结果-在所有临床试验中都有一定程度的预期,特别是那些涉及大量患者的临床试验。强生公司指出,它通常不会“公开传达研究暂停”,但补充说,它主动披露了监管机构要求的任何暂停。ws5世界播


Still, some medical experts have criticized pharmaceutical companies for not being more transparent about issues that could seem troubling to a lay audience, given the tremendous degree of interest in vaccines and treatments for COVID-19 and the importance of maintaining public trust. ws5世界播

不过,考虑到新冠肺炎对疫苗和治疗的极大兴趣,以及保持公众信任的重要性,一些医学专家批评制药公司在外行观众看来可能令人担忧的问题上没有更加透明。ws5世界播


As of yet, there is no vaccine or FDA-approved therapy for a virus that has killed more than 210,000 Americans. The back-to-back pauses of two high-profile COVID-19–related trials raise the possibility that they could be delayed. ws5世界播

到目前为止,还没有疫苗或FDA批准的疗法来治疗这种已导致超过21万美国人死亡的病毒。两个备受瞩目的新冠肺炎相关审判的背靠背暂停增加了它们可能被推迟的可能性。ws5世界播


The Eli Lilly trial, which is sponsored by the National Institute of Allergy and Infectious Diseases and launched in August, aims to test its synthetically made antibody on 300 patients hospitalized with mild to moderate COVID-19. According to a summary of results released last month from another trial studying more than 450 patients recently diagnosed with a mild to moderate case of the disease, volunteers receiving the treatment had a 72% lower risk of hospitalizations and emergency room admissions, compared to those taking the placebo. ws5世界播

礼来公司的试验由美国国家过敏和传染病研究所主办,于8月启动,旨在测试其合成的抗体在300名轻中度新冠肺炎住院患者中的作用。根据上个月发布的另一项试验的结果摘要,与服用安慰剂的人相比,接受治疗的志愿者住院和急诊室入院的风险降低了72%。该试验研究了450多名最近被诊断为轻中度病例的患者。ws5世界播


Both Eli Lilly and Regeneron filed for emergency authorization from the FDA last week in the middle of a publicity storm spurred by Trump. Last week, the president referred to Regeneron’s antibody cocktail — which he received in addition to the antiviral drug remdesivir and the steroid dexamethasone — as “a cure.” ws5世界播

礼来公司(Eli Lilly)和雷根隆(Regeneron)上周都向FDA申请了紧急授权,当时特朗普引发了一场宣传风暴。上周,总统提到了Regeneron的抗体鸡尾酒-他除了服用抗病毒药物redesivir和类固醇地塞米松外,还服用了这种鸡尾酒,称其为“一种治愈方法”。ws5世界播


Late last month, Johnson & Johnson began testing its one-shot vaccine in a late-stage clinical trial with up to 60,000 participants. It is one of the manufacturers backed by Operation Warp Speed, the public-private partnership that is channeling $10 billion into COVID-19 vaccines and therapies, including about $1.5 billion to Johnson & Johnson. ws5世界播

上月底,强生公司开始在一项有多达6万名参与者的后期临床试验中测试其一针疫苗。它是由公私合作的翘曲速度行动(Operation Warp Speed)支持的制造商之一,该行动正在向新冠肺炎疫苗和疗法投入100亿美元,其中包括向强生公司提供的约15亿美元。ws5世界播


These weren’t the first COVID-19–related trials to be paused. AstraZeneca has halted its vaccine clinical trial at least twice to investigate two cases of severe illness developed by participants. The first patient, in July, was deemed to have multiple sclerosis, unrelated to the vaccine. A second person in September developed neurological symptoms consistent with a rare but serious condition called transverse myelitis, according to news reports. ws5世界播

这并不是第一次暂停与新冠肺炎有关的审判。阿斯利康(AstraZeneca)已至少两次暂停疫苗临床试验,以调查参与者患上的两例严重疾病。第一名患者是在7月份,被认为患有多发性硬化症,与疫苗无关。据新闻报道,9月份的第二个人出现了与一种罕见但严重的称为横贯性脊髓炎的神经症状相一致的神经症状。ws5世界播


AstraZeneca’s trial has since resumed in the UK, Brazil, South Africa, and India but is still on hold in the US pending the FDA’s review. ws5世界播

阿斯利康的试验已经在英国、巴西、南非和印度恢复,但在美国仍处于搁置状态,等待FDA的审查。ws5世界播


Trump has also made statements about how quickly pharmaceutical companies will be able to develop a vaccine, despite concerns from scientists who say that the process should not be rushed and adequate safety data should be collected. ws5世界播

特朗普还发表了关于制药公司开发疫苗的速度有多快的声明,尽管科学家们担心这一过程不应该仓促进行,应该收集足够的安全数据。ws5世界播

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