COVID Vaccine (2)

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As the previous version of this topic was shut down for whatever reason and since some expressed interest in my experience, it is with great trepidation, hoping not to incur the wrath of the mods, forlornly wishing to avoid a) mine is bigger than yours arguments, b) pro/con vaccination squabbles or c) anything political, I will share some news about my participation in the Moderna Vaccine Trial.

I received a letter from the Principal Investigators at the local Moderna Trial site recently. They confirmed that those who received the Placebo will be offered the Vaccine if it is approved for release to the Public. While I’m 99% certain I’m already vaccinated, nice to know I’ll be at the head of the line if necessary.

Cheers
 
I received a letter from the Principal Investigators at the local Moderna Trial site recently. They confirmed that those who received the Placebo will be offered the Vaccine if it is approved for release to the Public. While I’m 99% certain I’m already vaccinated, nice to know I’ll be at the head of the line if necessary.

Cheers

Nice! And thanks for participating in the trial.

Pfizer released their final readout today. 95% efficacy, no safety concerns! This improves on their preliminary analysis, which when released only claimed 90%+ efficacy. So a virtual tie with the Moderna vaccine on efficacy, though there will be more nuanced differences, I'm sure. Moderna has an edge in temperature stability, and Pfizer has an edge in terms of already having internal manufacturing capability.

https://www.cnn.com/2020/11/18/health/pfizer-coronavirus-vaccine-safety/index.html

I'm thrilled for both companies (disclaimer: I work for either of them).
 
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The same thing is likely to happen in the BioNTech trial. Participants were notified that if there is an EUA approved, and the FDA approves a modification in the clinical trial study format (likely), that volunteers in the placebo group would be offered the vaccine. It is really the ethical thing to do, as once the vaccine is shown to be effective, it shouldn't be withheld from volunteers who will need to make a decision to get a "second" vaccination. Offering the placebo group the vaccine will allow them to stay in the study for longer-term monitoring, which will go on for 2 years, allowing a better analysis of vaccine safety and immunity durability. This issue was one the the first I brought up with the study staff when I enrolled. As much as I wanted to be in the study and contribute to necessary research, I also had a personal interest in getting protection as soon as approved vaccines became available, which would result in having to withdraw from the study. I looks like it will all work out well for study participants, however, the way things are progressing.

If you were in an mRNA Covid vaccine study and had fever, chills, fatigue, and significant pain at the injection site, then you pretty much know you were in the experimental group. Physiological saline won't cause those symptoms.
 
If you were in an mRNA Covid vaccine study and had fever, chills, fatigue, and significant pain at the injection site, then you pretty much know you were in the experimental group. Physiological saline won't cause those symptoms.

That and the results of a rapid test experiment run by the USAF I also participated in (no injections, just blood draws and saliva samples) that showed I had COVID-19 Antibodies convinced me I got the Vaccine.

Cheers
 
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If you were in an mRNA Covid vaccine study and had fever, chills, fatigue, and significant pain at the injection site, then you pretty much know you were in the experimental group. Physiological saline won't cause those symptoms.
You are mostly correct, but as always, there are exceptions:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5116857/
the placebo group was given saline injections, from which only half of participants experienced injection-site reactions
Ain't biology wonderful? :)
 
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Placebo group should have been given an adjuvent injection. MDs should try and do research, they really suck at it.
 
Placebo group should have been given an adjuvent injection. MDs should try and do research, they really suck at it.

An adjuvant injection as placebo would seem to make sense...I don't know if any of the clinical trials called for it.

But I don't think it's up to the MDs in the clinic...they have to follow the protocol they are given, do they not?
 
The Co-Principal Investigators at my Trial location are a MD and a PhD.

Cheers
But don't they still have to follow the protocols as defined by the manufacturers? Or did they develop their own?
 
Dry ice shortage to keep the vaccine cold?
https://www.usatoday.com/story/news...-19-vaccine-dry-ice-sales-storage/6281859002/

This is really a CO2 shortage, AFAIK. Liquid CO2 is used to make dry ice. CO2 bead blasting, interference fitting, and carbonation for beer and soda use CO2. It's easy to make CO2 by rapid expansion and cooling of the liquid.
https://www.continentalcarbonic.com/how-is-dry-ice-made.html
https://cryocarb.com/how-dry-ice-is-made/#:~:text=What Is Dry Ice?,into pellets or large blocks.
 
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We had a big dry ice shortage in my area last year after a the hurricanes and associated power power failures.
 
But don't they still have to follow the protocols as defined by the manufacturers? Or did they develop their own?

No clue, I’m just the lab rat here:D.

I would certainly assume there’s a overall standard since our group is 200 or so out of the 30000.

Cheers
 
Dry ice - that’s not safe to carry in an airplane, is it?

So the Pfizer vaccine must be transported by truck?
 
Dry ice - that’s not safe to carry in an airplane, is it?

So the Pfizer vaccine must be transported by truck?

Each box is no more than 50lbs of dry ice. I believe that is a threshold that allows transportation on commercial aircraft. The FAA has made allowances for medical causes before.
 
Dry ice shortage to keep the vaccine cold?
https://www.usatoday.com/story/news...-19-vaccine-dry-ice-sales-storage/6281859002/

This is really a CO2 shortage, AFAIK. Liquid CO2 is used to make dry ice. CO2 bead blasting, interference fitting, and carbonation for beer and soda use CO2. It's easy to make CO2 by rapid expansion and cooling of the liquid.
https://www.continentalcarbonic.com/how-is-dry-ice-made.html
https://cryocarb.com/how-dry-ice-is-made/#:~:text=What Is Dry Ice?,into pellets or large blocks.
This is one of the big issues on the COVID call for my workgroup yesterday. From a mass vaccination campaign standpoint it is a logistical nightmare, especially when considering you will have a hard time guaranteeing the availability of the second dose. The storage and lifespan of the Pfizer vaccine is not ideal to say the least. As others come to market of scaling up of mondera one- I foresee the Pfizer one becoming obsolete quickly.
 
Placebo group should have been given an adjuvent injection. MDs should try and do research, they really suck at it.
Attitude much, still?
Doing as you say would have involved great increase in complexity/sample size(s)....would’ve needed vaccine plus adjuvant group, adjuvant only group, and saline group.
 
They say that the reason Pfizer’s must be stored so cold is the fat for packaging. Moderna’s vaccine is very similar, except that it’s packed in a different fat, without the extreme requirement for cold.

After reading that, I wondered why they must pack the vaccine in fat, and what’s so special about the fat, that it must be kept so very cold.
 
Can I ask what motivated you to be a test subject? I'm glad that people do, but I'm not sure if I'd volunteer for it.
Was this testing just for the efficacy of the vaccine to prevent Covid or was it also testing safety in humans?
 
Can I ask what motivated you to be a test subject? I'm glad that people do, but I'm not sure if I'd volunteer for it.
Was this testing just for the efficacy of the vaccine to prevent Covid or was it also testing safety in humans?

I volunteered but they didn’t pick me. :-(
One of the reasons I volunteered was to get a vaccine against COVID because I don’t want it. I don’t think I would have volunteered during Phase I or II, though.

I’m curious if @steingar would like to explain how he would have done a better job with the vaccine? Considering the virus has been known to exist for less than a year and we have TWO vaccines already with 95% efficacy from a Phase III trial, that’s pretty freaking remarkable.

As far as distribution goes, if the current trends continue a lot of people won’t need the vaccine because those who survived will have antibodies.

Stay safe out there.
 
It fascinates me that when a topic is locked by the mods they allow the same topic to go on.

It's either outside the ROCs or it isn't.

<--- binary thinker
 
Heard a report this am that the Oxford vaccine needs only normal fridge temps, is highly effective in older populations, and is testing for viral shedding post increased antibodies being present.

Of course, this is the attenuated chimp vector.
 
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It fascinates me that when a topic is locked by the mods they allow the same topic to go on.

It's either outside the ROCs or it isn't.

<--- binary thinker
It's not the topic that outside the ROC. It is some of the replies.
 
It fascinates me that when a topic is locked by the mods they allow the same topic to go on.

It's either outside the ROCs or it isn't.

<--- binary thinker

Maybe because the topic isn't outside the ROC, but some of the commentary/attitude/behavior that occurred was (note that it appears that when a thread is locked, at least some of the offending posts often deleted)

Hopefully, the above isn't a violation of the ROC.
 
I’m curious if @steingar would like to explain how he would have done a better job with the vaccine? Considering the virus has been known to exist for less than a year and we have TWO vaccines already with 95% efficacy from a Phase III trial, that’s pretty freaking remarkable.

As far as distribution goes, if the current trends continue a lot of people won’t need the vaccine because those who survived will have antibodies.

Stay safe out there.
First, I'm not a vaccine maker. Set of skills I don't have. I do stuff vaccine makers don't, though what I do isn't as useful in the middle of a pandemic. The Pfizer and Moderna vaccines are very, very new technology. Folks have been working on mRNA vaccines for many years (actually, mRNA therapeutics. The ability to temporarily deliver gene products is going to be BIG). It sounds like they finally came of age at just the right time. Only mRNA vaccines could be made in the time frame we're looking at. By the way, the mRNAs get cells to temporarily produce a viral protein. The immune system reacts to protein, you have immunity.

Gene therapy has been around for three decades. I heard seminars about it as a young graduate student. I recall one seminar where the speaker talked about using retroviruses to deliver therapeutic genes. Retroviruses were thought to be better for gene therapy because they integrate into the genome, thus becoming a permanent part of the cell. I asked what would happen when the retrovirus jumped into an essential gene. While I was silenced then, I came to the opinion that retroviral gene therapy was dangerous and was going to kill people. I was at the NIH when it did.

After that debacle the gene therapy folks switched to a new virus, the Adeno-associated virus. This virus doesn't integrate into the genome, but the viral DNA can stay in cells a very long time. Thus you have a way to safely and stably deliver genes into human cells, a very good thing, normally. However, I (and only I, so far) think that this isn't a good thing for a vaccine. I suspect that Adeno-associated viral vector is going to remain in cells for a long time after you have immunity to COVID. As such you're going to have cells making a viral protein that the immune system is actively reacting to. If the cells make the protein the immune system can react to them. That's autoimmunity, a Pandora's box I'd rather not open.

I hope to Odin I'm wrong, I really do. The Russian vaccine was made the same way, though I can't be certain of the viral vector employed. If I'm right a lot of people are going to get very sick. If I'm right confidence in vaccines is going take a BIG hit. I've never been so hopeful to be wrong in my whole life.
 
Can I ask what motivated you to be a test subject? I'm glad that people do, but I'm not sure if I'd volunteer for it.
Was this testing just for the efficacy of the vaccine to prevent Covid or was it also testing safety in humans?

After it passed Phase I and II which are focused on safety, my feeling was the chances of any significant adverse reactions were slim to none in Phase III focused on testing effectiveness . Others may feel different and that’s their choice. As a geezer with a CABG operation in the past, currently in good health and living a great life, I figured if they need to prove effectiveness to allow the country to get back to life before COVID-19, I’d volunteer.

If it turns out the Vaccine has some long term negative effects and I get them, nobody said life is fair and you expect casualties in a war. I’m not a hero, just an old fart who decided to help out.

I only restarted this topic to share my experience in the Trial and perhaps learn more, hoping not to attract another set of back and forths that will cause closing of this one.

Cheers
 
Attitude much, still?
Doing as you say would have involved great increase in complexity/sample size(s)....would’ve needed vaccine plus adjuvant group, adjuvant only group, and saline group.
Baloney. Adjutants aren't used if they aren't proven safe. The mRNA vaccine consists of a strengthened mRNA and some sort of coating to get it into cells. That coating is a wild card, no one really knows if it's safe. And based on this test we aren't going to find out. Sorry, when you do science well you test all the variables, not just the ones you like better.
 
They say that the reason Pfizer’s must be stored so cold is the fat for packaging. Moderna’s vaccine is very similar, except that it’s packed in a different fat, without the extreme requirement for cold.

After reading that, I wondered why they must pack the vaccine in fat, and what’s so special about the fat, that it must be kept so very cold.

The nanoparticles that carry the mRNA payload are made from a lipid matrix. They are what make the vaccine work. I don't know what difference if any there is between the technologies used by either company which would explain the storage requirements .
 
The nanoparticles that carry the mRNA payload are made from a lipid matrix. They are what make the vaccine work. I don't know what difference if any there is between the technologies used by either company which would explain the storage requirements .
You need the lipid (i.e. the "fat") to get the vaccine through the lips bilayer that surrounds all cells and forms the cell membrane.
 
Baloney. Adjutants aren't used if they aren't proven safe. The mRNA vaccine consists of a strengthened mRNA and some sort of coating to get it into cells. That coating is a wild card, no one really knows if it's safe. And based on this test we aren't going to find out. Sorry, when you do science well you test all the variables, not just the ones you like better.

But the mRNA and the coating are exactly what is being tested in the trial, no? So there is (admittedly short term) safety data on the coating, as used in the vaccine, in the 15,000 trial participants who were in the treatment arm.

Since neither the nRNA nor the coating would ever be administered separately, there is no justification for testing them separately in humans.
 
Since neither the nRNA nor the coating would ever be administered separately, there is no justification for testing them separately in humans.

If the combination isn't thought to be safe, it could be useful to know if it's the nRNA or the coating that is the problem.
 
If the combination isn't thought to be safe, it could be useful to know if it's the nRNA or the coating that is the problem.

True, but the trial has shown no indication that the combination isn't safe.

Like most scientists, I'm hard-wired to want more testing, more experiments, more data...but the barriers to getting an experiment into human clinical trials are quite high--as they should be. You can't test everything you'd like in people--there must be a fairly compelling justification. For everything else, you have to find a reasonably predictive model, be it animal or cellular or molecular or computational.
 
One of the great pieces of advice I got as a young engineer was from the Chief Engineer when I wanted more testing of a jet engine to verify a fix.

He told me “Anybody can make the right decision if they have ALL the data. A good engineer is one who can make the right decision when they have ENOUGH data”.

It’s always risk vs reward in any decision. I’m quite comfortable that those running these Trials are “good” and have made and will continue to make the right decisions.

Cheers
 
They say that the reason Pfizer’s must be stored so cold is the fat for packaging. Moderna’s vaccine is very similar, except that it’s packed in a different fat, without the extreme requirement for cold.

After reading that, I wondered why they must pack the vaccine in fat, and what’s so special about the fat, that it must be kept so very cold.

Its not the lipids, its the RNA that needs low temp. The mRNA in the vaccines is stabilized by proprietary lipids that form liposomes, microscopically small, spherical phospholipid vesicles that encapsulate the highly modified RNA. RNA is inherently unstable to alkaline hydrolysis and small amounts of contaminating ribonucleases, hence the need to provide encapsulation and store at low temperatures. RNA is PITA to work with in the lab because of its chemical instability. Somehow Moderna's liposomes are a bit better at protecting the mRNA, so higher temps are tolerable. Or Pfizer is just ultraconservative. The lipid vesicles also function to help deliver mRNA into cells.
 
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Can I ask what motivated you to be a test subject? I'm glad that people do, but I'm not sure if I'd volunteer for it.
Was this testing just for the efficacy of the vaccine to prevent Covid or was it also testing safety in humans?

Safety and dosing is explored primarily in phase 1 trials, with a small number of healthy volunteers. Phase 3 trials, which are ongoing now, is primarily to determine efficacy in a large, diverse, population after phase 1/2 trials determine the likely optimum dosage and identify likely side effects. Secondarily, safety is also further assessed in phase 3.

My personal motivations to volunteer were (1) a chance to get the vaccine early, and gain some degree of protection, and (2) contribute to research to develop a way to prevent this scourge. Because I am a scientist in this general field (molecular biochemistry and biophysics) and can read and understand the peer reviewed literature and the technology involved, I was not too worried about personal risk. Indeed, the science has worked remarkably well.
 
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Baloney. Adjutants aren't used if they aren't proven safe. The mRNA vaccine consists of a strengthened mRNA and some sort of coating to get it into cells. That coating is a wild card, no one really knows if it's safe. And based on this test we aren't going to find out. Sorry, when you do science well you test all the variables, not just the ones you like better.

The lipid encapsulation is an integral part of the vaccine formulation. Although it is proprietary, it is very likely simply a mixture of common phospholipids already found in your body. These would not require additional testing.

I'm not aware that the mRNA covid vaccines are adjuvanted. The lipids in them function as a stabilizing agent as well as a necessary RNA delivery device.

Adjuvants are substances that are added to vaccines to enhance immune response. For example, the Shingrix shingles vaccine, which contains a recombinant version of one of the viral glycoproteins encapsulated in a normal phospholipid, is insufficiently immunogenic unless supplemented with saponin and a Salmonella phospholipid that dramatically ramps up immune response.
 
If you have such grave and serious concerns, then it a moral imperative that you share them with the NIH and FDA immediately. I wonder, however, why the people who ARE vaccine makers don’t share those concerns (it’s like saying, I’m not a physician but I read a lot of anatomy books so I know how to take out your appendix better than the surgeon does.”).

Thank you for contributing to the fear-mongering and pseudo-intellectualism that is causing people to be reluctant to get the vaccine, therefore almost guaranteeing thousands more deaths, economic devastation or both.

If you have serious concerns, share them in the appropriate forum. I’m not a vaccine maker either, but I am a vaccine giver and I trust the system. Sometimes you have to choose between multiple less than ideal choices and you’re not going to get a vaccine with a proven 30 year safety record when the virus has only existed for a year.

I just recently saw a COVID patient in her 50s. The nurse said “please come see her now. Her sat is 42% with a good waveform.” She is not atypical for the “sick COVID patient.”

For better or worse, most of the medical side of this pandemic had taken place behind closed doors. You may see the refrigerated morgue trucks or pictures of the defeated healthcare providers but most people who don’t work in the hospital haven’t seen the sick COVID patients because we’re trying to limit transmission. Yes, we make exceptions for children, patient’s who can’t communicate and end of life, but for the most part you’re not going to see the people dying from COVID so for a lot of people that means it’s not “real.” Trust me, it’s very real. They’re not just putting mannequins in the refrigerated trucks.

With any new vaccine there are always concerns, but this would have to be the worst vaccine ever to be worse than COVID. Have you seen the short-term follow-up for COVID survivors? Have you seen how many still aren’t able to go back to work after 3 months (they have jobs, they just can’t physically do it)? How many are still having elevated troponin and signs of ongoing myocardial injury weeks to months out? How many will likely be permanently disabled, yet they survived.

Read the discussion section on this article. The adenovirus vector doesn’t stay around forever. You kill the adenovirus eventually and, often, the body does it so effectively that more than one dose of the vaccine is required.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31605-6/fulltext

Dr. Steingar, I respect your knowledge and experience but please consider the effect of your comments before posting them in a public forum. Your words affect people’s choices, and possibly their lives.

First, I'm not a vaccine maker. Set of skills I don't have. I do stuff vaccine makers don't, though what I do isn't as useful in the middle of a pandemic. The Pfizer and Moderna vaccines are very, very new technology. Folks have been working on mRNA vaccines for many years (actually, mRNA therapeutics. The ability to temporarily deliver gene products is going to be BIG). It sounds like they finally came of age at just the right time. Only mRNA vaccines could be made in the time frame we're looking at. By the way, the mRNAs get cells to temporarily produce a viral protein. The immune system reacts to protein, you have immunity.

Gene therapy has been around for three decades. I heard seminars about it as a young graduate student. I recall one seminar where the speaker talked about using retroviruses to deliver therapeutic genes. Retroviruses were thought to be better for gene therapy because they integrate into the genome, thus becoming a permanent part of the cell. I asked what would happen when the retrovirus jumped into an essential gene. While I was silenced then, I came to the opinion that retroviral gene therapy was dangerous and was going to kill people. I was at the NIH when it did.

After that debacle the gene therapy folks switched to a new virus, the Adeno-associated virus. This virus doesn't integrate into the genome, but the viral DNA can stay in cells a very long time. Thus you have a way to safely and stably deliver genes into human cells, a very good thing, normally. However, I (and only I, so far) think that this isn't a good thing for a vaccine. I suspect that Adeno-associated viral vector is going to remain in cells for a long time after you have immunity to COVID. As such you're going to have cells making a viral protein that the immune system is actively reacting to. If the cells make the protein the immune system can react to them. That's autoimmunity, a Pandora's box I'd rather not open.

I hope to Odin I'm wrong, I really do. The Russian vaccine was made the same way, though I can't be certain of the viral vector employed. If I'm right a lot of people are going to get very sick. If I'm right confidence in vaccines is going take a BIG hit. I've never been so hopeful to be wrong in my whole life.
 
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