Vaccine Trials

[MarieIG]

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

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.

 

[gindie]

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.

 

[Sojourner]

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:

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.

 

[braumeister]

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.

 

[MRG]

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. [emoji4]

 

[2017ish]

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.

 

[Freedom56]

Astrazeneca just paused its trial due to safety concerns.

https://www.statnews.com/2020/09/08...d-adverse-reaction-in-participant-in-the-u-k/

 

[Toocold]

Astrazeneca just paused its trial due to safety concerns.

https://www.statnews.com/2020/09/08...d-adverse-reaction-in-participant-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.

 

[timo2]

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

 

[sengsational]

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

 

[cathy63]

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/

 

[sengsational]

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-articles/news-articles/2020/3/covid-19-vaccine-tracker

 

[oscar1]

Same here. In the NIH database but no ringy yet.

 

[easysurfer]

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 .

 

[easysurfer]

Astrazeneca just paused its trial due to safety concerns.

https://www.statnews.com/2020/09/08...d-adverse-reaction-in-participant-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?

 

[sengsational]

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.

 

[DAYDREAMER]

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.

 

[Brat]

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.

 

[sengsational]

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).

 

[easysurfer]

"Game back on" with the AstraZeneca trial.

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-...ccine-halted-by-patient-illness-idUSKBN2630O9

 

[Freedom56]

I can do without the risk of transverse myelitis possibly resulting in paralysis. We can wait until 2022 to see how this plays out.

 

[Dtail]

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.

 

[JoeWras]

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.

 

[easysurfer]

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:

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.

 

[Chuckanut]

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/articles/show-1225-what-is-the-evidence-on-vaccines-and-masks

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.