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Old 09-10-2020, 07:47 AM   #41
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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?
I'm worried about the kind of reaction that caused the halt of adenovirus' for gene therapy all those years ago. If the illness was nothing to do with the vaccination, the trial should pick up where it left off. But if it looks like the illness is anything like that earlier gene therapy thing, it's probably going to take the wind out of projects using an adenovirus vector.
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Old 09-10-2020, 09:15 AM   #42
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I am by no means an "anti-vaccer", but the current rush to a cure has many similarities to the movie I AM LEGEND, where a miracle vaccine was promised to cure all cancers but instead, had severe reactions a few years later.

Thanks, but, I'll keep social distancing+mask before I jump on this vaccine bandwagon.
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Old 09-10-2020, 11:22 AM   #43
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From what I hear the condition is one that is a rare side effect of several (non Covid19) vaccines.

On that basis it may manifest in other trials.

I was listening to TWIV yesterday. Their guest and the discussion group talked about testing Covid medications and vaccines. If a medication with few known side effects and demonstrable good result is discovered then those on the placebo have been offered the medication even if testing is not finished. The problem is that the test is incomplete - that is what happened with remdesivir which turns out that that the medication works like Theraflu for influenza, it should be administered early in the course of the disease.. but unlike Theraflu it is an injection and patients are rarely in the hospital that early in the illness.

When testing is complete all those who received the placebo will be offered the medication ahead of others.
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Old 09-12-2020, 08:31 AM   #44
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Did you understand that it was a rare side effect of other adenovirus-based vaccines or a rare side effect of vaccines in general? There are traditional (killed or weakened), mRNA (newest and so less proven), and adenovirus vector (used in a few in-use vaccines).
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Old 09-12-2020, 04:36 PM   #45
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"Game back on" with the AstraZeneca trial.

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AstraZeneca has resumed British clinical trials of its COVID-19 vaccine, one of the most advanced in development, after getting the green light from safety watchdogs, the company said on Saturday.

The late-stage trials of the experimental vaccine, developed with researchers from the University of Oxford, were suspended this week after an illness in a study subject in Britain, casting doubts on an early rollout.
“On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators,” AstraZeneca said.
It added that safety reviewers had recommended to Britain’s Medicines Health Regulatory Authority (MHRA) that it was safe to resume the British trials.
https://www.reuters.com/article/us-h...-idUSKBN2630O9
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Old 09-12-2020, 09:59 PM   #46
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I can do without the risk of transverse myelitis possibly resulting in paralysis. We can wait until 2022 to see how this plays out.
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Old 09-12-2020, 11:50 PM   #47
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I am by no means an "anti-vaccer", but the current rush to a cure has many similarities to the movie I AM LEGEND, where a miracle vaccine was promised to cure all cancers but instead, had severe reactions a few years later.

Thanks, but, I'll keep social distancing+mask before I jump on this vaccine bandwagon.
Let's hope we don't get the Zombie population from the failures.
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Old 09-13-2020, 04:47 AM   #48
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Let's hope we don't get the Zombie population from the failures.
The good news is the U.S. is ready for that. This is not fake news. There is an actual training facility and extensive written plan.

It is called CONPLAN8888-11.
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Old 09-13-2020, 09:24 AM   #49
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I can do without the risk of transverse myelitis possibly resulting in paralysis. We can wait until 2022 to see how this plays out.
From the Reuters article:

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It added that safety reviewers had recommended to Britain’s Medicines Health Regulatory Authority (MHRA) that it was safe to resume the British trials.

The patient involved in the study had been reportedly suffering from neurological symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.

AstraZeneca, based in Cambridge, said it could not disclose further medical information.
I interpreted that as the transverse myelitis was a pre-existing condition and not caused by the vaccine. Yet, doesn't help about the could not disclose further medical information.
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Old 09-13-2020, 09:30 AM   #50
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Here is an interview with a knowledgeable person on vaccines and their trials. Dr. Offit gives us his views on when we might see a vaccine and how good it will be.

https://www.peoplespharmacy.com/arti...ines-and-masks

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During phase 3 trials, developers of a vaccine give it to lots of people. There is also a control group that gets no vaccine, but usually these people will get a placebo shot so neither the volunteers nor the researchers know who got which one. Once tens of thousands of people have been vaccinated and had a chance to encounter the coronavirus, scientists collect information on who got sick and whether there are serious adverse events from the vaccine itself.
All of that data must be carefully analyzed before a vaccine should be administered to the public. That’s also exactly the information any of us, including the vaccine hesitant, would need before agreeing to vaccination. The evidence on vaccines is not yet available, but it will be crucial to ending the pandemic.
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Old 09-13-2020, 09:39 AM   #51
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Here is an interview with a knowledgeable person on vaccines and their trials. Dr. Offit gives us his views on when we might see a vaccine and how good it will be.

https://www.peoplespharmacy.com/arti...ines-and-masks

In the last 20 minutes we learn about a test of various types of masks, how good they are and what people should be wearing. The testing was done by medical professionals and the Duke University Physics Department.
OP, thank you for your contribution. I always get my vaccinations but I admit I'd be afraid to be part of a trial.


I'll listen to People's Pharmacy show 1225. They always have excellent guests and good questions.
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Old 09-13-2020, 11:00 AM   #52
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This is a helpful thread, so let's keep this thread about vaccine trials and avoid discussion about mask effectiveness. Thanks.
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Old 09-13-2020, 12:29 PM   #53
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One of the interesting things the Dr. talks about is the order the vaccinations will take place. For example, he puts transit operators among those in the highest group. I had not thought about them, but I can see where anybody who drives a bus or other vehicle that carries large numbers of people will need the vaccine early.
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Old 09-13-2020, 03:35 PM   #54
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Years ago, after 9/11 but not recently, our health department ran a mass vaccination test administering the flu shot. It was set up in a huge parking lot...multiple lanes available. We drove through and each stuck our arm out our respective windows...DH drove, I was on the passenger side. Staff worked both sides of the vehicle. I envision something like that for massive COVID19 vaccination.
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Old 09-14-2020, 06:15 PM   #55
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Listen to the most recent TWiV, close to the end they commented on the type of vaccine J&J and AZ are developing. Bottom line they would prefer the other types. Listen and form your own opinion.
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Old 09-15-2020, 08:17 AM   #56
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Listen to the most recent TWiV, close to the end they commented on the type of vaccine J&J and AZ are developing. Bottom line they would prefer the other types. Listen and form your own opinion.
Those are both viral vectors that have had the ability to replicate taken out through "editing" the genome of the virus that's used to present the dummy spike protein. I liked that approach over mRNA and attenuated approaches, but I might have to reconsider.
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Old 09-15-2020, 08:19 AM   #57
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This Astrazeneca saga continues...

“The highest levels of NIH are very concerned,” said Avindra Nath, M.D., intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. “Everyone’s hopes are on a vaccine, and if you have a major complication the whole thing could get derailed.”

A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with the University of Oxford, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.

https://www.fiercepharma.com/vaccine...-vaccine-trial
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Old 09-15-2020, 10:41 AM   #58
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In response to one PM:

TWiV 663. About minute 28 (Daniel Griffin, MD speaking there) is a discussion about participating in vaccine trials, then about 35 a mention of adenovirus and a preference for NMRA vaccines.

Yes it is long - about 2.5 hours - but if you access it through their website (https://www.microbe.tv/twiv/) you can easily skip forward. The podcast app on my IPad provides for a faster cast (X1,5, X2). It is available on YouTube where you can see the speakers but I think it takes longer.

Griffin speaks for 1 hour max as he is a practicing physician. The others talk among themselves, review papers and letters. My DH referred it as geeks bs'ing among themselves.

I recall them expressing a strong preference for NMRA vaccines and kicking around why if you receive one vaccine you can not (should not) receive another product. This happened in the last half hour of the broadcast - I think.

This is a very informative broadcast.
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Old 09-15-2020, 12:10 PM   #59
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TWiV 663. About minute 28 (Daniel Griffin, MD speaking there) is a discussion about participating in vaccine trials, then about 35 a mention of adenovirus and a preference for NMRA vaccines.
Thanks for the follow-up.

It's a bit complicated, but I predict many of us will know the risk profiles of all the types of vaccines before we get a vaccination. Just for fun, here are the types that (I think) they talked about:
  • Whole Virus
    • inactivated
    • attenuated
  • Vectored
    • replicating
    • non-replicating
  • Subunit
    • DNA
    • RNA (mRNA)
  • Protein-based (virus like particle)
The whole virus category contains the traditional vaccines. There are licensed vaccines in the vectored category. There are no mRNA licensed vaccines for people. The Shingrix (obviously licensed) is in the last category of a VLP.

I heard the part in the presentation where clinician said he hoped the mRNA category works (Moderna / Pfizer), and I think it was because it's new and the potential could be wildly positive (but we don't know yet). And I heard that the adenovirus vector was a concern because the adenovirus itself has a risk. He didn't say it, but I suspect it's because the adenovirus vector can have "bad" innate immune response in a very small set of people. And this video was recorded (I think), while the AstraZenica trial was on-hold due to the person who fell ill with something that might have been related to an undesired innate immune response.

In searching around, I located a "class". The logo says it's from the WHO, but the url is not a subset of the WHO. I have taken the first module, and it appears completely legit. https://vaccine-safety-training.org/home.html You can take the class (at least the first module), without signing-up, but if you don't sign-up (complete email loop), you won't be able to take the assessment quiz.
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Old 09-15-2020, 02:10 PM   #60
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In searching around, I located a "class". The logo says it's from the WHO, but the url is not a subset of the WHO. I have taken the first module, and it appears completely legit. https://vaccine-safety-training.org/home.html You can take the class (at least the first module), without signing-up, but if you don't sign-up (complete email loop), you won't be able to take the assessment quiz.
Thanks. I think the first module is worth reading just for the overview of vaccinations.

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The impact of vaccination on the health of the world's peoples is hard to exaggerate. With the exception of safe water, nothing else, not even antibiotics, has had such a major effect on the reduction of mortality (deaths) and morbidity (illness and disability) and on population growth.6
The discussion between an adverse reaction and and adverse event was interesting.
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