2020-10-14 08:01

J&J Hopes Covid-19 Vaccine Trial Will Restart Shortly 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


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


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


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


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


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


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



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


“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


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


“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


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


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


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


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


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


J&J boosted its forecast of full-year sales and earnings. 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


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


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


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