Yeah, I'm first in line too, but I'm not sure if I'm going to get the vaccine or not. Not because of the FAA, but because of the weak-ass science and the very substantial political overlay. I'm not sure if the hospitals where I work will require COVID vaccination or not...that will be interesting.
COVID Vaccine (2)
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NoBShere
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I think I can guess accurately enough what you mean by "political overlay" but, i would be interested in hearing what drives your "weak-ass science" view.
Lindberg
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My AME says he has not received any guidance from the FAA.
steingar
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I would like to know how you think the science underlying these vaccines has been compromised. I do have some misgivings about he Astra Zeneca vaccine, but admit I could be mistaken. The only misgiving I have about the mRNA vaccines is the relative novelty of the underlying technology. Still, these have been tested in tens of thousands of people. I am not quite understanding your reservations.
The studies are vastly underpowered...small sample population with NO long term follow up and notable absence of peer review. What we are mainly using as a foundation for our giddy excitement is press releases from Moderna and Pfizer.
steingar
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Can't disagree with that. That said, the underlying technology has gone through rigorous peer review. Do they usually wait for publication of Phase III clinical trials? Or are they reviewed by the FDA? I would think that it would be the latter. The thoughts of three anonymous reviewers doesn't seem to be conversant to something affecting public health to this degree.
GaryM
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I agree that press releases alone aren't sufficient. The peer review is coming, and of course FDA approval is the hardest review barrier to cross, by far.
Still 30,000 people is not a small trial, and both Moderna and Pfizer went with that trial size. The lack of long term follow-up is only because there hasn't yet been a 'long term'. The health of those trial participants will be followed very closely for a long time to come.
I'm pretty sure that common sense is a disqualifying condition.
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steingar
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The problem here is simple. Everything is unprecedented. There has never been a vaccine made so quickly. The technology is new. In a perfect world we'd wait to see what happens to the tens of thousands who got the experimental vaccine. We're make certain they were OK before we inoculated anyone.
The problem is the world isn't perfect. We're under the grip of a pandemic that's killing people and destroying our way of life. How many will die if we just wait for more results? That's the idea behind the emergency authorization.
Could there be long term side effects from the vaccine? It's certainly possible, though the components of the vaccines have been very thoroughly vetted. But if we wait to dot the i's and cross the t's lots of folks are going to die. The folks at the FDA are the ones we appointed to make certain these things are safe. Says me let's let them do their job. They're actually quite good at it. But if they give the OK I'm good with it.
It also isn't just the Phase 3 participants, there are thousands of Phase 1/2 participants that were given the vaccine many months ago, so we have mid-range assessment of potential side effects as well. Given the well known and fairly high risks of potential long-term or permanent debilitating illness from COVID for middle-age and older people, this is an easy choice to get a vaccine.
chemgeek
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Should we be poking the bear?
I believe modernas trial was strictly US based.
https://www.modernatx.com/sites/def...COVE-Study-Enrollment-Completion-10.22.20.pdf
We can now confidently say that it works well in obese, diabetic texans.
They may have an international arm as well, but the 'COVE' trial is what they base their EUA request on.
For the Astra Zeneca and Pfizer trials, the FDA will review the global data, they both had international sites. Pfizer lists Argentina, Brazil, Germany, South Africa, Turkey and the United States as the study sites.
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chemgeek
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Yes. To get the number of events they need to statistically verify effectiveness, the phase 3 trials have enrolled 30,000-40,000 volunteers worldwide. The Phase 3 clinical trial site at Syracuse Upstate University where I went only enrolled a few hundred volunteers. The PI there is the lead investigator for Pfizer/BioNTech. Most everyone in the trial has now had their 2nd dose and a large fraction have had their 30-day post vaccination blood draw for antibody and T-cell measurements. There is going to be a wealth of data about the Pfizer as well as the Moderna vaccines. For the volunteers that experienced vaccine side-effects, myself included, they were transient and comparable to other viral vaccines. The Shingrix vaccine was far worse. If you have the post-dosing symptoms, you know the immune response is working.
gsengle
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The alternatives are don’t get it or get it and risk having your medical revoked. The FAA isn’t sentimental about doing so. So what exactly is the down side?
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Lindberg
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There's no risk of having your medical revoked just because you have the vaccine.
There IS however a risk of having to jump through hoops to get your medical back if you suffer complications from having the disease.
75,000 participants in the mRNA vaccine trials without serious safety events vs. what I see here at work every day ---> I'll take the vaccine.
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So you’ll pay my airline salary should that come to pass? Do you work for the FAA? Do you know more than ALPA who has told members do not get it? Have you read the regs that disallow any experimental treatments? Easy to make such statements anonymously here. I sure hope no one follows that reckless advice.
I want to take it. ASAP. I think it’s the right call risk benefit wise by far. Doesn’t mean I will defy the FAA.
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Lindberg
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Quite possibly, if ALPA actually said that.
If you can cite them for me, I'll read them.
If you work for an airline and are a union member, why did you write directly to the FAA?
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chemgeek
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I wouldn't classify the science as "weak." It is accelerated, but not "weak." The published Phase 1 data shows that both the Moderna and Pfizer vaccines produce robust antibody and T-cell responses about 2-3 times convalescent patients after the second booster dose. The Phase 1 trial data also shows that at the dosage chosen to move forward, side effects were mild to moderate, transient, and experienced by only 20-50% of volunteers, depending on age. For Pfizer, who tested several different spike protein mRNA constructs in the Phase 1 trial, they discovered to their surprise that the full-length spike protein elicited the same immune response as the partial protein construct they originally favored, but had fewer side effects. That's Phase 1. There will be a wealth of data presented to the FDA from the Phase 2/3 work, and there will be a boatload to publicly published data to come before most of the population will be eligible to get a dose. At this point, there is sufficient data 2 months post-dosing to establish whether or not there are any longer-term side effects from administration. Since the vast majority of long term side effects are revealed in the first two months, this is a reasonable accommodation to address a catastrophic public health crisis. The only thing that is getting skimped in the development and testing of COVID-19 vaccines is longer term (several year) Phase 3 data to thoroughly investigate any long-term effects. The risk of mortality and morbidity for continuing COVID-19 spread is likely to greatly outweigh any risk of long term side effects of a vaccine not seen in 2 months after dosing in a large cohort of volunteers. I would argue we don't have 2-5 years to conduct additional safety studies.
I would have no qualms about taking either of the mRNA vaccines. (Heck, I think I did already!) They will likely be highly effective (for how long we don't know yet, but there is optimism based on the rarity of re-infection among convalescent patients so far) and likely as safe as any other vaccine on the market. I'm withholding judgment on the viral vector vaccines. For one thing, some of the viral vector vaccines are using modified strains of human adenovirus (Ad5 and Ad26) to which many individuals may harbor antibodies from prior infection. (Adenoviruses cause many common colds.) Those with antibodies to the appropriate adenovirus strains may see lessened effectiveness from these vaccines, and you won't know who you are prior to or after dosing. I suspect that will show up in the Phase 2/3 trials for these vaccines. Indeed, in the original dosing schedule, the AstraZeneca vaccine, which uses a modified chimpanzee Adenovirus as the delivery vehicle, was found to be only 60% effective, and in primate challenge studies it did not prevent infection, only symptomatic disease.
That's a very good reason. Those at risk or have family members living with them that are at risk need to take extreme precautions.
We've been to dentists, doctors and getting our hair cut. My wife has gotten massages and been to a chiropractor too. Neither of us are in a high risk group, plus both healthy and physically active. Doesn't mean we are being willy nilly about it. We wear a mask and wash our hands.
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steingar
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To correct a point (I think), the Astra Zeneca group are using Adeno Associated Virus (AAV), which is different from an adenovirus altogether. Most colds are caused by rhinoviruses and coronaviruses, by the bye. The AAV they're using isn't even a whole virus. It is a gene therapy delivery vector. The virus has been genetically hollowed out to allow the imposition of a gene for a COVID19 coat protein. The vector is packaged by cells that express all the other viral proteins, but the delivery vector itself is replication incompetent. I don't much worry about folks with immunity against it. Worst they're going to do is clear the vector before it can deliver its genetic contents.
My worry about the Astra Zeneca vaccine is duration. I've seen lots of gene therapy seminars where the researchers boasted about the duration they're AAV-derived gene therapy vectors could remain resident in cells. They're DNA viruses and can remain in cells for some time. My fear is the vector will remain in cells, direction the production of coronavirus spike protein long after plasma cells have started making antibodies against it. I'm hoping I'm wrong, since I think the Astra Zeneca vaccine needs two doses to be effective. But since they bolluxed the doses for the Phase III trails anything is possible. I've been encouraging those I know to avoid the Astra Zeneca vaccine for this reason. I really and truly hope I'm wrong about this. If I'm right things will be very bad indeed.
Very informative thread and thanks to all. Just what I hoped to get when I started this thread.
As a status report, no problems so far after I got the vaccine back in Sept. I also recently received a letter from the Principal Investigators at my site stating they are already investigating getting approval to offer the vaccine to those in the study who have received the placebo. If this happens, there may be 15000 more “lab rats” like me to monitor for long term effects, plus another 15000 from the Pfizer trial.
Cheers
As a status report, no problems so far after I got the vaccine back in Sept. I also recently received a letter from the Principal Investigators at my site stating they are already investigating getting approval to offer the vaccine to those in the study who have received the placebo. If this happens, there may be 15000 more “lab rats” like me to monitor for long term effects, plus another 15000 from the Pfizer trial.
Cheers
chemgeek
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This is one of the potential disadvantages of the viral vector vaccines, which could lessen effectiveness for some individuals. Since AstraZeneca is using ChAdOx1, a highly modified chimpanzee adenovirus strain, humans should not immediately clear it the first time they are exposed to it. All the viral vector vaccine candidates are using replication incompetent modified viruses. The modified viruses are being used to shove the DNA into the target cell. Inovio is using electroporation to deliver their DNA vaccine into cells. That is a virus free method of DNA delivery, although it requires aa special device to do the injection, which requires a brief electrical current to "zap" DNA past the cell membrane. We routinely did this to E. Coli in the lab. Never tried it on myself.
That is a virus free method of DNA delivery, although it requires aa special device to do the injection, which requires a brief electrical current to "zap" DNA past the cell membrane. We routinely did this to E. Coli in the lab. Never tried it on myself.
Glad I didn’t volunteer to be Tased
Cheers
steingar
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One of the truly dumbest things I've ever read. Electroporation can work in situ, but it's not terribly effective. Moreover I doubt anyone is going to volunteer to be electroplated. The viral vectors sound genius in comparison.
Inovio is using electroporation to deliver their DNA vaccine into cells. That is a virus free method of DNA delivery, although it requires aa special device to do the injection, which requires a brief electrical current to "zap" DNA past the cell membrane. We routinely did this to E. Coli in the lab. Never tried it on myself.
I've had some very slight experience with the technique and agree with the assessment below...
I've only done it to cultured cells. Just a very quick and dirty way to get stuff into cells. It works with compounds other than DNA.
Gotta love auto-correct, though I've been called a gold-plated @##$ at times
steingar
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Doing it in culture is quite efficient, heck I've done it to bacteria (a black art called recombineering). Doing to tissue in situ is another matter entirely. Yes it can be done, but it isn't that effective.I've had some very slight experience with the technique and agree with the assessment below...
I've only done it to cultured cells. Just a very quick and dirty way to get stuff into cells. It works with compounds other than DNA.
Gotta love auto-correct, though I've been called a gold-plated @##$ at times
Perhaps it works better for prokaryotes, as you and @chemgeek use it, than with mammalian cell culture (Eukaryotes). Or maybe we were doing it wrong
steingar
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It is actually far better for mammalian cells, as you can use a fairly low voltage. I used to zap my ES cells to do mouse knockouts, no biggie. To do bacteria you need a much higher voltage to get through the cell wall, I think. So you have to really remove ALL the ions in solution, otherwise the whole thing will arc. I've seen it, it's scary and burns things. So you wash the bacteria over and over and over. You then freeze them and label the tubes "Electrocompetant", just like when you froze competent cells for transformation. The recombineering works so poorly that you have to amp up the transformation frequency to get it to go.Perhaps it works better for prokaryotes, as you and @chemgeek use it, than with mammalian cell culture (Eukaryotes). Or maybe we were doing it wrong
Well, your arguments have convinced me. Your comments are helpful and insightful. We were probably doing it wrong.
At least the imaging, my portion of the work, worked well.
Capt. Geoffrey Thorpe
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PlasticCigar
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New milestone: COVID is now the leading cause of death in the US and in vaccine-relayed news the administration turned down multiple offers to get more of the Pfizer vaccine. Sounds like those who don’t want the vaccine would be doing those who do want the vaccine a favor by not getting it.
- CBS reports that COVID is now the leading cause of death in the United States. Last week, COVID deaths averaged 2,000 per day, surpassing the number of daily deaths for heart disease, lung cancer, and chronic obstructive pulmonary disease. The U.S. passes this grim milestone as hospitals across the country near capacity.
https://www.forbes.com/sites/robert...ffers-for-more-vaccine-doses/?sh=50d6cd27617a
steingar
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I know they use it for chicken embryos. You get transformation, but it isn't what I'd call robust. Viruses and micelles work way more better.
Lindberg
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So we have enough for a third of the population, and kids shouldn't be getting it. And there's another vaccine in the pipeline. Sounds reasonable
GaryM
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One-sixth, actually. The first 100 million doses will only treat 50 million people. All of the single-dose candidates are still further back in the development pipeline.
Lindberg
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That seems like plenty.
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