Originally published at: https://boingboing.net/2020/10/12/johnson-johnson-covid-19-vaccine-trial-halted-for-unexplained-illness.html
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Whether or not this is a causation, this is precisely why we have clinical trials rather than just YOLOing vaccines out into the world like Trump would prefer.
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This has already happened, I think a different study.
Apparently routine, they have to determine if it’s the drug, or something else
It doesn’t automatically mean the drug is out of the running.
Even if there are wide effects, it may just mean it’s not for some people.
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This is now the second phase 3 trial halted for adverse events. Maybe we should not rush this thing so much?
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The patient was interviewed by CNN:
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I work in the pharma industry - this is totally common. This is why we have trials. It’s not worth worrying about. if you had any idea how many drugs fail at stage 3…you’d be amazed.
In any case, anyone thinking they were getting a vaccine before mid-2021 has deluded themselves. Even the most ambitious scientists were saying early 2021. The leading vaccine right now has to be transported and maintained at -40 degrees or something like that, which means most places can’t even keep it, even if it could be transported there (not a lot of trucks get that cold…but they do exist).
If we could have isolated and starved it ala NZ, life would have been better. But no, we have maskholes who talk about how wearing a mask is a “personal choice” while not caring about other’s choices…
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Yes, I think the astrazenica candidate. I believe they have at least partially restarted it already. This is relatively normal for clinical trials, it’s just rare that the daily happenings of phase three drug trials make international news.
When you do a study lasting months on 30,000 people of varying ages and health, things are going to happen whether it is caused by the vaccine or not. When something happens that doesn’t have an immediately obvious explanation they pause trial enrollment while investigating.
Even the phase three trial won’t pick up all side effects. You probably won’t see something that happens to 1 in 100,000 people in such a trial. But on the other hand, 1 in 1500 have already died from covid and without a vaccine that might reach 1 in 100. So they will be weighing the risk of serious side effects vs the cost of waiting longer.
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The worry, I think, is that trump is trying to bully the release of one by Nov 3 and his followers seem perfectly stoked about taking that product. I agree with what you are saying.
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From what I have heard the moderna and pfeizer candidates can need to be stored at -40 or so up to regional distribution sites but can use ordinary refrigeration for long enough that that the last mile delivery and local pharmacies don’t need anything fancy. Basically this isn’t a big problem in the US but will be worldwide.
I think the J&J one was interesting because it was freeze dried and also possibly single dose? That would be a big deal for universal coverage. If it works and is safe of course, which is the point behind the pause
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Lord Dampnut has decreed that he wants a vaccine before the election.
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It’s tough. On one hand the God-King says it is Good.
On the other hand it’s a vaccine, which is how Bill Gates gives you 5G chemtrail autism
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I appreciate the intent of what you are saying. But at the same time, this is precisely why we have the trials. An extra 6 months of phase 2 would likely not have revealed this. This is why vaccines are one of the most well researched medications in the world. It’s why we have so many different tools for developing them.
Not all of them will work in each and every situation.
This is precisely why ‘red tape’ exists. It is doing it’s job.
And from this adverse event we will learn even more. It really sucks for the individual involved yes. But, what if it wasn’t caused by the vaccine? Should we throw the vaccine away because of this?
Working as intended.
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Absolutely routine. Also exactly what the anti-vaccine crowd claims never happens…
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Shortening phase 3 trials can let dangerous vaccines through. And Il Douche is pushing for exactly that.
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“paused” (from the text) is not the same as “halted” (from the headline). “paused” trials continue recruiting new subjects after a review of the cause, while “halted” studies simply stop recruiting new subjects altogether.
A trial is typically paused, as this one, when a study member develops an unexplained and undesirable condition. The pause lasts until the condition is understood, at which point the study is either resumed (if the condition is either unrelated or acceptable, perhaps related to a detectable risk factor) or halted.
A trial can be halted for any of three reasons. If, as above, the vaccine/treatment has unacceptable risks (as above), insufficient benefits, or such overwhelmingly good results that it is no longer ethical to deny the treatment or vaccine to the control group.
Please do not confuse “paused” and “halted.”
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… Now that was non-sequitur.
I suppose he could exert enough influence to get the vaccine, although informed consent might be tricky. However, since he’s already had the disease there’s not much point.
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there’s not much point
Oh, there’s a point. The ability to be able to crow “I did it, I got us a vaccine in record time, it was all me.” His base would eat that up, and some of people who have waveringly decided to support Biden would rush back to him. Any vaccine approved before November 3rd will absolutely change the election results. What looks like it might be a Biden romp at this point (outside all of the other things Trumpety and his stooges are trying to do to undermine voting), will absolutely become a nail biter if that happens.
Frankly, though, I expect him to claim that there is a vaccine by October 31st, regardless of whether or not a viable one exists. I guarantee it.
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And with this I believe there is no hope for gainful conversation.
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