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AstraZeneca vaccine trial paused
Posted by: Steve G.
Date: September 08, 2020 05:32PM
Roll up those sleeves...Good Luck!

AstraZeneca vaccine trial paused to investigate 'a potentially unexplained illness'
[thehill.com]

One of the leading coronavirus vaccine clinical trials, from AstraZeneca, has been paused to investigate a “potentially unexplained illness” in one of the participants, the company said Tuesday.

The announcement could lead to a concerning setback to a high-profile coronavirus vaccine clinical trial, though much remains unknown, and it is not clear how much of an impediment the development will be.

“As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow review of safety data,” AstraZeneca said in a statement. “This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”

The statement said it is possible the illness in one of the participants in the trial is not even caused by the vaccine. “In large trials illnesses will happen by chance but must be independently reviewed to check this carefully,” the company said. “We are working to expedite the review of the single event to minimise any potential impact on the trial timeline.”

Stat, which first reported the pause in the trial, reported that the participant who had the “suspected serious adverse reaction” is in the United Kingdom.

AstraZeneca is one of three companies that have phase three coronavirus vaccine trials ongoing in the United States. Two other trials are being conducted for potential vaccines from Pfizer and Moderna.
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Re: AstraZeneca vaccine trial paused
Posted by: samintx
Date: September 08, 2020 05:49PM
I like the pledge by manufacturers of vaccines.
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Re: AstraZeneca vaccine trial paused
Posted by: AllGold
Date: September 08, 2020 06:07PM
Not what I wanted to hear. I signed up to participate in the phase 3 trials of that particular vaccine, although I have yet to be notified that I have been approved/selected (other than the initial acknowledgement).

On the other hand, it's good to see they are being careful and thorough.



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Re: AstraZeneca vaccine trial paused
Posted by: Lemon Drop
Date: September 08, 2020 06:30PM
Just saw this at StatNews.

[www.statnews.com]

AZ has paused this trial before, then started it up again a few days later. Hope the subject(s) is/are OK!

Has any pharmaceutical process ever been followed this closely, in history? The transparency is good, the endless speculation probably not so good.
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Re: AstraZeneca vaccine trial paused
Posted by: sekker
Date: September 08, 2020 06:36PM
This kind of pause is absolutely normal and is what should be expected.

But the reality is that nearly ALL vaccine trials - if run properly - will have one or more such pauses. A trial that is 'perfect' is clearly ignoring the safety data.
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Re: AstraZeneca vaccine trial paused
Posted by: Speedy
Date: September 08, 2020 10:45PM
The ill participant could be receiving the placebo.



Saint Cloud, Minnesota, where the weather is wonderful even when it isn't.
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Re: AstraZeneca vaccine trial paused
Posted by: NewtonMP2100
Date: September 08, 2020 11:03PM
.....keep your dirty, stinky pause......



_____________________________________

I reject your reality and substitute my own!
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Re: AstraZeneca vaccine trial paused
Posted by: bfd
Date: September 08, 2020 11:30PM
Medical trials typically end in one of three ways - only two of them actually being "good". This pause isn't a great omen…
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Re: AstraZeneca vaccine trial paused
Posted by: sekker
Date: September 08, 2020 11:52PM
Quote
Speedy
The ill participant could be receiving the placebo.

Very true. Trials get stopped for all sorts of reasons. That's the nature of doing them properly.
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