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Old 08-27-2020, 05:27 PM   #21
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I do phase 1 trials and I have to sign a contract. In that contract I agree not to take any other medications(I assume a vaccine would count) for the duration of the study. Phase 2 studies could be different but I would assume taking a seperate vaccine would invalidate the data from the first vaccine and the study would be a waste. That said, studies are voluntary and you can withdraw any time you want. Your data will be thrown away at great cost but it is your right to withdraw at any time. You could then take any other vaccine you want.
Thanks. I'd be willing to wait a while so that my trial data would be usable, but probably only on the order of months, not years.

I'm also a regular Red Cross platelet donor, so I'd have to consider what to do about that - usually there's no deferral if the vaccination is normal and has no AEs (like a flu shot in the fall), but I don't know if trial vaccines are different.
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Old 08-27-2020, 05:34 PM   #22
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Thanks. I'd be willing to wait a while so that my trial data would be usable, but probably only on the order of months, not years.

I'm also a regular Red Cross platelet donor, so I'd have to consider what to do about that - usually there's no deferral if the vaccination is normal and has no AEs (like a flu shot in the fall), but I don't know if trial vaccines are different.
When I used to donate plasma they asked if I had been in a clinical trial in the past 30 days and if you say yes then you are excluded. Probably better not to give blood if you are taking a non FDA approved medication/vaccine.
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Old 08-27-2020, 05:48 PM   #23
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No they did not discuss this issue. And when I stated that I have an extreme reaction to adjuvant vaccines and will know if I had one, the nurse just smiled and nodded. And if course DW and I will discuss any side effects.
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kyz...did the rules specify that you were not to talk about / attempt to guess whether you got the placebo vs treatment? I understand that it's usually a question they ask you (along with many others), but wondering if they ask you avoid "comparing notes" to try to uncover which group you are in.
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Old 08-27-2020, 09:02 PM   #24
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Speaking of vaccine trials, I came across this a few minutes ago:

Moderna and Pfizer’s COVID-19 vaccine candidates require ultra-low temperatures, raising questions about storage, distribution

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... mRNA-1273, which is Moderna’s coronavirus vaccine candidate, requires a storage temperature of negative 4 degrees Fahrenheit. BioNTech and Pfizer’s candidates, BN1162b2 and BNT162b2, need to be stored in negative 94 degrees Fahrenheit.

“These storage conditions would make traditional office or pharmacy administration very difficult,” SVB Leerink analysts wrote in a note to investors on Thursday. “These conditions could be met at tertiary hospitals and laboratories and could be accommodated in intensive one-day vaccination events at such sites, but this would still only cover a fraction of the healthy population.”
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Old 08-28-2020, 04:59 AM   #25
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Maybe someone with better medical knowledge will chime in, but I'm not sure the pain at the injection site is a function of the immune response. I think it is just mechanical damage to the tissue cause by the injection of fluid. I had the flu shot and the shingles shot two days ago, one in each arm. The shingles shot was about twice as much fluid as the flue shot, and I would say that the shingles arm hurt about twice as much as the flu arm.
I think you are right! I didn't argue with her. It is best she has a firm the placebo illusion, if she has the placebo. Makes for a solid study, right? Truly blind.

As for ME... I'd consider it, but right now my gift to humanity is biweekly platelet donations. Vaccinations are part of the deferral criteria, and for now, I just don't want to go there.
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Old 09-06-2020, 10:47 AM   #26
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There will need to be innovative solutions like there have been for testing (i.e. drive through.) I do expect mobile labs on trucks, drive throughs, "Mash Units" in hospital parking lots, etc.

Personally, I would send mobile units straight to the colleges/ universities.
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Old 09-07-2020, 11:13 PM   #27
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If a Covid-19 vaccine is approved and available before the end of this trial, we will be notified if in the control group so we can opt to withdraw from the study.

Any other forum members involved in a vaccine trial or considering volunteering?

Mike
I inquired and attended an initial interview for the Pfizer vaccine. When I initially called, they told me the same thing that quoted from the OP above. HOWEVER, when I got there, the nurse (who wasn't the person I initially talked to), said that the study was 26 months in length and that they wouldn't divulge which group you were in, EVEN if the vaccine were approved and you had received the placebo.

Needless to say, I was pissed and declined to participate. I have health conditions and don't wish to wait that long if a vaccine is approved.

BTW, the Pfizer (and Moderna) vaccine studies are 50/50, actual vaccine vs. placebo.


EDIT: I just re-read the original post. His study was Phase II. The one I was considering was Phase III. I'm not surprised they were run differently.
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Old 09-08-2020, 12:47 PM   #28
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Just re-watched the movie Contagion a few nights ago, and the main antagonist (an anti-vaxxer, homeopathic-remedy huckster played by Jude Law) says this in reference to the (very) quickly developed vaccine towards the end of the movie:
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The government rushed the trials. Maybe it causes autism, or narcolepsy, or cancer... 10 years from now. Who knows?
Now I'm in no way saying that the COVID vaccine(s) might have these sorts of long-term side effects, but I have found myself wondering if the very rapid development and testing might not catch certain adverse effects that a longer trial with extensive followup would have uncovered. I imagine that many knowledgeable, highly trained people are working hard to make sure this isn't the case. And honestly, even if some adverse side effects were to be discovered, I'd probably still opt for getting vaccinated and taking my chances vs. continuing to live a "COVID limited" lifestyle.
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Old 09-08-2020, 01:02 PM   #29
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I have found myself wondering if the very rapid development and testing might not catch certain adverse effects that a longer trial with extensive followup would have uncovered.
Even with the best programmers, the most carefully checked applications, and extensive beta testing, software bugs are often discovered after years of use by customers. We all do our best, and hope it's enough.
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Old 09-08-2020, 04:03 PM   #30
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Even with the best programmers, the most carefully checked applications, and extensive beta testing, software bugs are often discovered after years of use by customers. We all do our best, and hope it's enough.
+1

Some of my best career advances came because of capturing bugs in the wild.

I distinctly remember an OS developer describing how a particular OS error had been there forever and the application I was supporting somehow found a way to expose it. Thanks dude I'll be sleeping now.

We both got the 1976 swine flu vaccine and had no ill effects. I will let others go before me this time.
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Old 09-08-2020, 04:20 PM   #31
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I'm currently sitting in exam room #1 waiting the requisite 30 minutes after receiving my first Covid-19 vaccine injection. Of course I could be in the control group and received a saline injection. But the odds favor the real thing.

DW and I volunteered ....

Any other forum members involved in a vaccine trial or considering volunteering?

Mike
Good job! We applied for a couple of [phase 3] trials here in Nashville, but they indicated that our travel schedule might prevent them from calling us back. Still hoping, although I guess it is good news for participation levels if they ultimately choose not to mess with working around our schedule.
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Old 09-08-2020, 04:24 PM   #32
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Astrazeneca just paused its trial due to safety concerns.

https://www.statnews.com/2020/09/08/...nt-in-the-u-k/
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Old 09-08-2020, 04:44 PM   #33
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Astrazeneca just paused its trial due to safety concerns.

https://www.statnews.com/2020/09/08/...nt-in-the-u-k/
Although I'm disappointed, I find it comforting that actions are being taken when an adverse event happens, and not swept under the rug.
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Old 09-08-2020, 04:50 PM   #34
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Although I'm disappointed, I find it comforting that actions are being taken when an adverse event happens, and not swept under the rug.
+1
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Old 09-08-2020, 05:09 PM   #35
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Astrazeneca had the coolest technology, so that's the one I hoped would be the most effective and safest. I hope this is just a fluke, but my hopes are significantly deflated for this one now
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Old 09-08-2020, 05:34 PM   #36
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Astrazeneca had the coolest technology, so that's the one I hoped would be the most effective and safest. I hope this is just a fluke, but my hopes are significantly deflated for this one now
Apparently this is a fairly common occurrence during vaccine trials. Somebody in the trial develops a life threatening condition and they have to stop and figure out if that's just because in a cohort of 30K people the odds are that someone was going to develop that condition anyway, or if it's actually related to the vaccine. They can resume the trial if they determine that this particular person had some underlying condition that was a more likely cause of the problem than the vaccine.

What is Astrazeneca's cool new tech though? I had thought the big thing in their favor was that they are building on an existing vaccine they developed for a different virus and that's what enabled them to get to phase 3 trials so quickly. There are so many vaccines though, and I may have confused them with someone else!

I'm most interested in the mRNA techniques that Moderna and Pfizer are using. If successful, that tech will allow rapid development of vaccines for other viruses in the future. The Freakonomics podcast had an interesting interview on last week's episode with the Chief Medical Officer from Moderna https://freakonomics.com/podcast/vaccine/
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Old 09-08-2020, 06:04 PM   #37
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What is Astrazeneca's cool new tech though?
Cool is in the eye of the beholder, of course, hehe! To me, assembling the look-alikes on the outside of an adenovirus is cooler than the mRNA stuff. Turns it into a very small, sharp tool. Of course, this is all through the eyes of a lumbering fool (me), when it comes to biology.


Here's the vaccine tracker I use:
https://www.raps.org/news-and-articl...accine-tracker
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Old 09-08-2020, 06:59 PM   #38
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Same here. In the NIH database but no ringy yet.
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Old 09-08-2020, 08:50 PM   #39
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Although I'm disappointed, I find it comforting that actions are being taken when an adverse event happens, and not swept under the rug.
+1. Good to know corners not cut to push a vaccine out .
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Old 09-10-2020, 07:35 AM   #40
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Astrazeneca just paused its trial due to safety concerns.

https://www.statnews.com/2020/09/08/...nt-in-the-u-k/
I'm wondering now if they find out the adverse reaction is due to the vaccine, what happens to the trial test when they do resume? Do they declare a "mistrial" and have to test again from a previous stage? Or will they resume at the point of the adverse reaction?
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