 温东小兵 _BBCODE_WROTE: |
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试验了一个星期，现在暂停。 还不知道具体原因，没准过几天又重启了也不一定。 |
原因是有人有不良反应，停下调查。
#1: Author: 温东小兵, Posted: 2020-9-08 20:27
声称阿斯利康公司将美国多个COVID-19疫苗AZD1222（ChAdOx1）的临床试验暂停。阿斯利康公司股价应声下跌6%。
#2: Author: 温东小兵, Posted: 2020-9-08 20:28
Clinical assessment of the coronavirus 2019 (COVID-19) vaccine candidate developed by AstraZeneca and the University of Oxford has been put on hold due to a suspected serious adverse event reaction in a UK-based participant, according to a new report from STAT News.
The report comes one week into the launch of a phase 3 trial gauging AZD1222 in up to 30,000 US adults. The federally-backed program Operation Warp Speed is contributing funds toward the phase 3 program. Another series of countries—including Mexico, Argentina, and Australia—have entered agreements with the company for the mass production of AZD1222 doses for its residents.
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An AstraZeneca spokesperson said in a statement that the investigation’s pause is the result of a routine action required to occur “whenever there is a potentially unexplained illness in one of the trials.” As such, the company is now looking to expedite the review of the single event to “minimize any potential impact on the trial timeline.”
As posed by the report, whichever agency placed a hold on the trial—be it AstraZeneca, the university’s investigators, or a regulatory—is not immediately certain. An unnamed source who spoke with the publication stated the observed participant is expected to recover from the undisclosed adverse event.
AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of an adenovirus that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.
In July, the pharmaceutical company reported interim results from their ongoing phase 1/2 trial showing AZD1222 was generally tolerable, and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.
On Tuesday morning, AstraZeneca was among 9 pharmaceutical companies to sign a letter pledging the continued assurance and monitoring for safety and tolerability in the first COVID-19 vaccine candidates, in response to reports that a vaccine may be regulated and distributed in alignment with the upcoming US Presidential Eleciton in November.
#3: Author: 温东小兵, Posted: 2020-9-08 20:28
试验了一个星期，现在暂停。
还不知道具体原因，没准过几天又重启了也不一定。
#4: Author: Slowbro, Posted: 2020-9-08 20:30
温东小兵 _BBCODE_WROTE:
试验了一个星期，现在暂停。
还不知道具体原因，没准过几天又重启了也不一定。
原因是有人有不良反应，停下调查。
#5: Author: 温东小兵, Posted: 2020-9-08 20:36
Slowbro _BBCODE_WROTE:
原因是有人有不良反应，停下调查。
这个不是很奇怪吗？ 在二期的时候就应该有安全性指标的，怎么会到了3期才出现呢？
#6: Author: 灵猴, Posted: 2020-9-08 21:31
看来疫苗今年没希望
#7: Author: fangpao, Posted: 2020-9-08 22:01
灵猴 _BBCODE_WROTE:
看来疫苗今年没希望
天朝已经疫苗和治疗血清蛋白一应俱全，侬out了
#8: Author: 温东小兵, Posted: 2020-9-09 15:07
灵猴 _BBCODE_WROTE:
看来疫苗今年没希望
老川普不这么认为。
#9: Author: 温东小兵, Posted: 2020-9-09 15:17
暂停的AstraZeneca疫苗，AZD1222，引发的问题是一位受试女子表现出严重脊髓炎症，可能是transverse myelitis--罕见的横贯性脊髓炎。
目前还没有确诊是不是transverse myelitis，症状很像。据说目前患者的情况正在显著好转，有望今天出院。疫苗测试曾经在7月份另有一次暂停，因为有人出现神经疾病症状，multiple sclerosis--多发性硬化，当时认为是和疫苗无关。
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