强生希望新冠肺炎疫苗试验能很快重启

2020-10-14 08:01

J&J Hopes Covid-19 Vaccine Trial Will Restart Shortly 9BE世界播

强生希望新冠肺炎疫苗试验能很快重启9BE世界播


暂无9BE世界播

Johnson & Johnson executives said they expect the 60,000-person trial of an experimental Covid-19 vaccine to resume shortly; a technician at J&J unit Janssen Pharmaceutica in Belgium. 9BE世界播

强生高管表示,他们预计一种实验性新冠肺炎疫苗的60,000人试验将很快恢复;比利时强生子公司扬森制药(Janssen PharmPharmtica)的一名技术人员说9BE世界播


Johnson & Johnson hopes to know within days whether it can resume testing its Covid-19 vaccine, as the health-products company battles the virus on several fronts. 9BE世界播

强生公司希望在几天内知道是否可以恢复测试其新冠肺炎疫苗,因为这家保健品公司正在几条战线上与病毒作斗争。9BE世界播


An independent committee is investigating the unexplained illness of a study volunteer that prompted a pause in clinical trials of the company’s experimental Covid-19 vaccine, J&J Chief Financial Officer Joseph Wolk said in an interview Tuesday. 9BE世界播

强生首席财务长约瑟夫·沃尔克(Joseph Wolk)周二在接受采访时说,一个独立委员会正在调查一名研究志愿者不明原因的疾病,这起疾病导致该公司实验性新冠肺炎疫苗的临床试验暂停。9BE世界播


The illness is “still under investigation and we’re going to let that process play out,” Mr. Wolk said. The company is hopeful that the pause will only last a few days, he said. 9BE世界播

沃尔克说,这种疾病“仍在调查中,我们将让这一过程继续下去。”他说,公司希望暂停只会持续几天。9BE世界播


The pause, announced on the eve of J&J earnings that showed an uptick in business hurt by the pandemic, is the second for leading coronavirus vaccines in development. The halts illustrate the ups and downs that typically characterize the testing of promising but unproven therapies and vaccines. 9BE世界播

这一暂停是在强生盈利前夕宣布的,该财报显示,受大流行影响的业务有所上升,这是领先的冠状病毒疫苗研发中的第二次。这些暂停说明了有希望但未经证实的疗法和疫苗测试的典型起伏。9BE世界播


Researchers have made relatively rapid progress developing vaccines that could protect against the new coronavirus, but the shots still face a last phase of testing that is designed to test whether they protect people and to further suss out any safety issues beyond the injection-site pain and flu-like symptoms seen in some of the earlier studies. 9BE世界播

研究人员在开发可以预防新型冠状病毒的疫苗方面取得了相对较快的进展,但这些疫苗仍面临最后阶段的测试,旨在测试它们是否对人有保护作用,并进一步查明除了早期一些研究中出现的注射部位疼痛和流感样症状之外的任何安全问题。9BE世界播


Subjects in vaccine trials often have side effects that require further evaluation and sometimes a pause in the study, according to industry officials. 9BE世界播

据行业官员说,疫苗试验中的受试者通常有副作用,需要进一步评估,有时还需要暂停研究。9BE世界播


J&J paused all trials of its vaccine, including a 60,000-subject late-stage trial that began last month, because of the unexplained illness. The Phase 3 trial is testing whether the company’s vaccine safely protects against symptomatic Covid-19 disease compared with a placebo. 9BE世界播

由于这种不明原因的疾病,强生暂停了其疫苗的所有试验,包括上个月开始的6万名受试者的后期试验。第三阶段试验正在测试与安慰剂相比,该公司的疫苗是否安全地预防有症状的新冠肺炎病。9BE世界播


J&J executives said they know very little about the event that prompted the company to call for a pause. 9BE世界播

强生高管表示,他们对促使公司呼吁暂停的事件知之甚少。9BE世界播


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Governments around the world are debating the timeline for offering Covid-19 vaccines to the public, as drugmakers speed up development. WSJ’s Daniela Hernandez explains the potential health risks linked to fast-tracking vaccines. 9BE世界播

随着制药商加快发展,世界各国政府都在就向公众提供新冠肺炎疫苗的时间表展开辩论。“华尔街日报”的Daniela Hernandez解释了与快速追踪疫苗相关的潜在健康风险9BE世界播


The company doesn’t know whether the volunteer who fell ill got the experimental shot or a placebo, Mr. Wolk said. Mathai Mammen, who leads J&J’s pharmaceutical research and development, said the company has little information about the case. 9BE世界播

沃尔克说,该公司不知道生病的志愿者是接受了实验注射还是服用了安慰剂。领导强生制药研发的Mathai Mammen表示,该公司对此案知之甚少。9BE世界播


Dr. Mammen said J&J was informed of the study subject’s illness on Sunday evening and then notified a board of outside experts monitoring the safety of the trial. Dr. Mammen said the board asked for more information. 9BE世界播

Mammen博士说,强生在周日晚上被告知研究对象的病情,然后通知了一个监督试验安全性的外部专家委员会。曼曼博士说,董事会要求提供更多信息。9BE世界播


“As soon as we overcome this temporary pause, our plan is to continue the 60,000-person study that we’re en route to,” Dr. Mammen said on a conference call with analysts. He expects the company to complete enrollment in two to three months. 9BE世界播

“一旦我们克服了这种暂时的停顿,我们的计划是继续我们正在前往的6万人的研究,”曼曼博士在与分析师的电话会议上说。他预计该公司将在两到三个月内完成注册。9BE世界播


Despite the study pause, J&J continues to expand its manufacturing capacity for the shots, Mr. Wolk said. The company hopes to make the vaccine available by early 2021, and to produce more than one billion doses by the end of next year. 9BE世界播

沃尔克说,尽管研究暂停,强生仍在继续扩大注射的生产能力。该公司希望在2021年初推出疫苗,到明年年底生产超过10亿剂疫苗。9BE世界播


“This is the largest vaccine study that’s out there,” Mr. Wolk said. “It’s endeavoring to study 60,000 patients. When you have a study of that size, it’s not uncommon to see unexpected illnesses within the population. That’s for any drug across any therapeutic area. This is something that’s not foreign in the development process.” 9BE世界播

“这是目前规模最大的疫苗研究,”沃尔克说。“它正在努力研究6万名患者。当你有一个如此规模的研究时,在人群中看到意想不到的疾病并不少见。这适用于任何治疗区域的任何药物。在开发过程中,这不是外来的东西。“。9BE世界播


He said enrollment for the study was in the “early days” at the time of the pause, but didn’t say how many people had enrolled. 9BE世界播

他说,在暂停的时候,这项研究的注册还处于“早期”,但没有说已经有多少人注册了。9BE世界播


J&J’s vaccine is one of several in late-stage clinical tests that could yield results in the coming weeks and months. Pfizer Inc., Moderna Inc. and AstraZeneca PLC also are testing vaccines, though AstraZeneca’s U.S. trial is halted while it and U.S. regulators investigate a woman’s illness in a U.K. study of the shot. 9BE世界播

强生的疫苗是几种后期临床试验中的一种,这些试验可能在未来几周和几个月内产生结果。辉瑞公司、现代公司。阿斯利康公司(AstraZeneca PLC)也在测试疫苗,尽管阿斯利康在美国的试验已经暂停,因为它和美国监管机构正在调查一名妇女在英国的一项注射研究。9BE世界播


J&J executives discussed the vaccine as they reported third-quarter financial results that showed signs of an upturn in the company’s business, after the pandemic and associated lockdowns weighed on sales earlier in the year. 9BE世界播

强生高管在报告第三季度财务业绩时讨论了疫苗,这些业绩显示出公司业务好转的迹象,此前疫情和相关的停工在今年早些时候拖累了销售。9BE世界播


J&J said its net earnings more than doubled to $3.55 billion, or $1.33 a share, from $1.75 billion, or 66 cents a share, a year earlier. Sales rose 1.7% to $21.08 billion. Excluding certain items, J&J’s third-quarter adjusted earnings were $2.20 a share. Analysts surveyed by FactSet were expecting earnings of $1.98 a share on sales of $20.2 billion. 9BE世界播

强生表示,其净利润翻了一番多,从上年同期的17.5亿美元升至35.5亿美元,合每股1.33美元,合每股0.66美元。销售额增长1.7%,至210.8亿美元。剔除某些项目后,强生第三季调整后每股获利为2.20美元。FactSet调查的分析师此前预计销售额为202亿美元,每股收益为1.98美元。9BE世界播


Pharmaceutical sales rose 5% and consumer-health sales rose 1.3%. J&J’s medical-device sales declined 3.6%, but that was an improvement from a sharper decline earlier in the year. 9BE世界播

药品销售增长5%,消费者健康销售增长1.3%。强生的医疗器械销售额下降了3.6%,但这比今年早些时候更大的降幅有所改善。9BE世界播


Earlier in the year, the pandemic delayed certain medical procedures, such as knee replacements, which hurt the company’s medical-device sales. Mr. Wolk said procedures have picked up as hospitals and other health-care providers took steps to assure patients that they could safely come in for them. 9BE世界播

今年早些时候,大流行推迟了某些医疗程序,如膝盖置换,这损害了该公司的医疗设备销售。沃尔克说,随着医院和其他医疗保健提供者采取措施向患者保证,他们可以安全地来接受治疗,手术程序已经开始加快。9BE世界播


J&J boosted its forecast of full-year sales and earnings. 9BE世界播

强生上调了全年销售和收益预期。9BE世界播


J&J also disclosed that it will add $1 billion to its proposed contribution to a settlement to resolve lawsuits filed by states, cities and other entities against the company alleging its marketing practices fueled the opioid epidemic. 9BE世界播

强生还披露,它将在拟议的和解方案中增加10亿美元,以解决各州、城市和其他实体对该公司提起的诉讼,指控其营销行为助长了阿片类药物的流行。9BE世界播


This is on top of the $4 billion that J&J said last year it would contribute when it first reached an agreement in principle with a committee of state attorneys general. J&J said it isn’t admitting liability or wrongdoing. 9BE世界播

这还不包括强生去年与州总检察长委员会首次原则上达成协议时表示将贡献的40亿美元。强生说,它不会承认责任或不当行为。9BE世界播


J&J shares were down 2% at $148.74 in midday trading. 9BE世界播

午盘交易中,强生股价下跌2%,至148.74美元。9BE世界播

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