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福奇称阿斯利康美国疫苗试验中的“过时”数据是“不幸的”

2021-03-24 11:34   美国新闻网   - 

美国最高传染病专家安东尼·福奇博士(Anthony Fauci)周二批评了阿斯利康美国疫苗试验中他所描述的“过时”信息,称其“不幸”,并承认对准确性的担忧可能会导致让更多美国人接种疫苗的问题。

“发生这种事真的很不幸。福奇对美国广播公司的罗宾·罗伯茨“早安美国”节目说:“这真的是你所说的非受迫性错误,因为事实是这很可能是一种非常好的疫苗。”他补充说,“这种事情确实...真的让人怀疑疫苗可能会导致犹豫不决。没必要。"

阿斯利康疫苗尚未在美国获得授权。周一早上,公司宣布有希望的数据在一份新闻稿中,称其疫苗的有效率为79%,在预防严重疾病和住院治疗方面100%有效。

但一个负责监督该公司试验数据的独立小组——数据和安全监测委员会(Data and Safety Monitoring Board)通知Fauci的国家过敏和传染病研究所(NIAID),它对新闻稿中描述的数据感到担忧,称它可能对疫苗的效力提供了不完整的看法。

“他们认为新闻稿中的数据有些过时,事实上可能有点误导,希望他们澄清一下,”福奇博士说。

周二凌晨,国家情报和安全局随后发表了一份声明建议公司立即审查和更新其数据。

“DSMB表示担心阿斯利康可能包含该试验的过时信息,这可能提供了疗效数据的不完整视图,”该机构表示。“我们敦促该公司与DSMB合作,审查疗效数据,并确保尽快公布最准确、最新的疗效数据。”

PHOTO: A health worker prepares a dose of the AstraZeneca/Oxford vaccine at a coronavirus vaccination center at the Fazl Mosque in southwest London on March 23, 2021.

丹尼尔·利尔-奥利瓦斯/法新社通过盖蒂图像

2021年3月23日,伦敦西南部法兹尔清真寺的冠状病毒疫苗接种中心,一名卫生工作者正在准...

阿斯利康数据引发质疑之际,有报道称,在一些疫苗接受者出现血液凝固后,该公司的疫苗在一些欧洲国家暂停生产,尽管该公司表示,其在美国和拉丁美洲的试验没有发现此类安全问题。

但独立监督委员会对该公司关于疫苗功效的声明提出异议,而不是其安全性。阿斯利康发布了一份回应声明,称数据包括截至2月17日的病例,但它继续分析此后发生的病例。试验参与者中的这些额外疾病可能会改变这种疫苗的最终疗效数字。

该公司在一份声明中表示:“我们已经审查了初步分析的初步评估,结果与中期分析一致。”。“我们将立即与独立数据安全监控委员会(DSMB)合作,分享我们的主要分析和最新疗效数据。”

阿斯利康承诺在他们的数据分析审查后48小时内更新。

但福奇坚持认为,美国人不应该担心数据的差异,因为已经有了保障措施,而且食品和药物管理局最终会审查它,独立于阿斯利康提供的信息。

福奇说:“他们(美国食品和药物管理局)将自己独立检查每一点数据,而不依赖包括公司在内的任何人的任何解释。”。“所以,这是美国公众应该意识到的一件事,也可能是全球公众应该意识到的一件事,我们的FDA独立审查了这些数据,所以这是你不需要担心的事情。”

Fauci calls 'outdated' data in AstraZeneca's US vaccine trial 'unfortunate'

Dr. Anthony Fauci, the nation’s top infectious disease expert, on Tuesday criticized what he described as "outdated" information in AstraZeneca’s U.S. vaccine trial as "unfortunate" and acknowledged concerns with accuracy could lead to problems getting more Americans to take the vaccine.

"It really is unfortunate that this happened. This is really what you call an unforced error because the fact is this is very likely a very good vaccine," Fauci told ABC's Robin Roberts "Good Morning America." He added, "This kind of thing does ... really cast some doubt about thevaccinesand maybe contribute to the hesitancy. It was not necessary."

The AstraZeneca vaccine has not yet been authorized in the United States. Early Monday, the companyannounced promising datain a press release, saying its vaccine had a 79% efficacy rate and was 100% effective in preventing severe disease and hospitalization.

But an independent group tasked with overseeing the company's trial data, the Data and Safety Monitoring Board, notified Fauci's National Institute of Allergy and Infectious Diseases (NIAID) that it was concerned by the data as portrayed in the press release, saying it may have provided an incomplete view of the vaccine’s efficacy.

"They felt that the data that was in the press release were somewhat outdated and might, in fact, be misleading a bit, and wanted them to straighten it out," said Dr. Fauci.

In the early hours of Tuesday morning,the NIAID then released a statementadvising the company to immediately review and update its data.

"DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data," the agency said. "We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible."

The questions over AstraZeneca’s data come as its vaccine was temporarily suspended in some European countries after reports of blood clotting in some vaccine recipients, though the company says its U.S. and Latin America-based trial uncovered no such safety issues.

But the independent monitoring board took issue with the company's claims about the vaccine's efficacy -- not its safety. AstraZeneca released a statement in response and said the data included cases up to Feb. 17, but that it continues to analyze cases that have occurred since then. Those additional illnesses among trial participants could alter the final efficacy numbers for this vaccine.

"We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis" the company said in a statement. "We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data."

AstraZeneca is promising an update within 48 hours after their data analysis review.

But Fauci insisted that Americans shouldn’t worry about discrepancies with the data because there are safeguards in place, and that the FDA will ultimately review it, independent of the information AstraZeneca presents.

"They [the FDA] will independently go over every bit of data themselves and not rely on any interpretation from anyone including the company," Fauci said. "So, that's one thing that the American public should realize and probably the global public also that our FDA independently goes over that data, so that's something you don't need to be worried about."

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