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    Senior Member ahalpert's Avatar
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    Well, supposedly the data will be made public. Unless there was fraud by medical personnel, I think it would be hard to fudge the efficacy numbers. And the trials were double blind, so nobody would know which case reports to fudge.

    It's possible that the trials were shorter than they needed to be. (Although apparently the duration was linked to the number of participants who contracted covid, and since our infection rate has been rapidly rising, it didn't take too long to hit the target.)

    It's possible that if the trials went on for longer, we would see issues with long-term health effects or waning immunity. But if you look at how the mRNA vaccine works, it strikes me as remarkably benign and unlikely in theory to cause complications. Frankly, I'm surprised that the side effects are as bad as they are. Supposedly, the 2nd dose gives you bad covid symptoms for a day and then clears up. And the authorities are afraid that people wont want to get it for that reason.

    At any rate, they'll be giving it to medical personnel and vulnerable populations first, so you probably won't even have the chance to receive it until tens of millions of people already have. I share your cautiousness when it comes to injecting myself with a hastily developed treatment.

    But I'm optimistic that these mRNA vaccines will be a game-changer, and not just for covid. If anything, I got the impression that the technology wasn't developed earlier because it threatens the profits and vested interests of established pharma players who make big bucks doing things the old way.


     

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    Senior Member Run&Gun's Avatar
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    Quote Originally Posted by puredrifting View Post
    Having worked in clinical trials and made lots of clinical trial patient documentaries, I would suggest a maximum amount of skepticism about the efficacy, results from trials and
    the safety of these supposedly new magic bullets. I am as far from anti-vaccine as one can be but whichever company(s) deploy the new Gold standard vaccine
    aganist Covid stand to make many billions of dollars. When billions are at stake, there is going to be a lot of bad science, badly run trials like the AstraZeneca and
    dubious, fantasical claims about substandard products.

    We all want an effective vaccine as soon as possible but I can't help but see and think that the trials and papers being published on all of these supposedly miraculous
    new vaccines are largely compromised and I will definitely not be a Guinea Pig for big pharma and governments. I suggest wait and see, there will be tens of millions who
    will be willing to put their lives on the line to be the real life patient populations to find out how well these new vaccines work. I can't help but think there is a large
    amount of govermental complicity in the half assing this process with the pharma companies. I've worked closely with the FDA and out of all of the alphabet agencies
    in goverment, I can scarcely think of one more tied up in politics and the whims of politicians.

    If we roll back the clock to earlier this year, Fauci and many other experts were saying we should expect new vaccines late in 2021, not before the end of 2020. This suggests to me
    that many of the safety and protocol procedures have been compromised. Normal clinical trials take a long time. Even with streamlining, these trials have been
    compromised by politics, boards, shareholders urging them to be completed asap. Be cautious about what you are willing to put into your body.
    I’ve already said, I don’t want be in the first group(even if eligible) to get one of these vaccines. Normally this is a years (decade?) long process and it’s happening in months. They may be as safe and effective as if the development and testing took years, but I’m going to treat this like a firmware update on my computer and wait a bit and see if there are any major gotchas once it gets out into a larger and more varied group.

    And file this under, “you just can’t figure people out”: About a month or so ago I was having dinner with one of my cousins and we had to obviously wear our masks into the restaurant until we were seated. This led to a conversation about wearing masks, CV, etc. My cousin who is older than me starts in on the ‘ole “making us wear masks infringes on my Constitutional Rights”, blah, blah, blah and how this is all being blown out of proportion, overhyped, etc. But when the topic rolled into the vaccines and I said I wouldn’t be in that first group, he said he would be the second person standing in line for one. What? You think this is all overhyped, but you’ll let them stick a rushed vaccine, for a disease that you don’t think is as bad as is being reported, into you with no long-term data on it?


     

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    Senior Member Run&Gun's Avatar
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    Quote Originally Posted by ahalpert View Post
    Well, supposedly the data will be made public. Unless there was fraud by medical personnel, I think it would be hard to fudge the efficacy numbers. And the trials were double blind, so nobody would know which case reports to fudge.

    It's possible that the trials were shorter than they needed to be. (Although apparently the duration was linked to the number of participants who contracted covid, and since our infection rate has been rapidly rising, it didn't take too long to hit the target.)

    It's possible that if the trials went on for longer, we would see issues with long-term health effects or waning immunity. But if you look at how the mRNA vaccine works, it strikes me as remarkably benign and unlikely in theory to cause complications. Frankly, I'm surprised that the side effects are as bad as they are. Supposedly, the 2nd dose gives you bad covid symptoms for a day and then clears up. And the authorities are afraid that people wont want to get it for that reason.

    At any rate, they'll be giving it to medical personnel and vulnerable populations first, so you probably won't even have the chance to receive it until tens of millions of people already have. I share your cautiousness when it comes to injecting myself with a hastily developed treatment.

    But I'm optimistic that these mRNA vaccines will be a game-changer, and not just for covid. If anything, I got the impression that the technology wasn't developed earlier because it threatens the profits and vested interests of established pharma players who make big bucks doing things the old way.
    And that sums it up right there. It’s the unknown, unforeseen things that can happen. Just look at all the drugs that were on the market for years that eventually got pulled, because they were doing bad things to people.

    I’m not trying to say that we can’t ever do anything, because there will always be the possibility of “something” happening, but it’s hard to classify these vaccines as completely safe in such a short period of time.

    And I’m optimistic/hopeful that this(mRNA) opens the door for a lot advanced treatments that have sort of been in the realm of science fiction for years.


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    Yup I'm with dan... pro-vaccine here, and as far from an anti-vaxxer as you can get. The difference with caution here vs anti-vax, is anti-vax is anti-science. Caution with the new covid vaccine is PRO-science. That is, understanding science takes time and sufficient sample size and we have expediated this to a simultaneously impressive and concerning level.

    I do think that the governments wouldn't allow the vaccine to go out without a reasonable degree of certainty that it will work well, as the harm to the GDP and nation would be too great to play too fast and loose. Notwithstanding, it doesn't mean I am going to be first, second, or third in line to roll my sleeve up. History has shown abundant error from the best of intents. There hasn't been enough time to trial this. It is not even possible to know if, for example, the vaccine could result in the mild immune response discussed, but then reveal longer term issues in 6 months like we are seeing with many covid patients today who had mild cases but now are displaying perpetual issues that have surfaced. I am not saying it will. I am saying we can't even know because the trials have simply been too quick on too small of a sample size.

    I'll take the pro-science approach and wait and see.


     

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    Senior Member ahalpert's Avatar
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    Quote Originally Posted by Run&Gun View Post
    And that sums it up right there. It’s the unknown, unforeseen things that can happen. Just look at all the drugs that were on the market for years that eventually got pulled, because they were doing bad things to people.

    I’m not trying to say that we can’t ever do anything, because there will always be the possibility of “something” happening, but it’s hard to classify these vaccines as completely safe in such a short period of time.

    And I’m optimistic/hopeful that this(mRNA) opens the door for a lot advanced treatments that have sort of been in the realm of science fiction for years.
    all good points. in theoretical defense of the mRNA approach - supposedly it gets the cell to produce spike proteins that then train the immune system to recognize them. there is no active virus. the mRNA degrades quickly. there is no theoretical reason to suspect complications, unlike with, say, thalidomide where they were interrupting the normal processes of pregnancy to eliminate an undesirable condition (morning sickness) that may well serve a purpose.

    so, that doesn't prove that the vaccine is harmless. and yes, they generally take a lot more time to do it. but i'm cautiously optimistic.

    you're right that there is a contradictory attitude about masks and vaccines. i think that some influential people have been anti-mask but pro-vaccine and, well, there you have it. the odd part to me is that i understand why they would push vaccines in an effort to help the economy. i just don't understand why they wouldn't push masks as well.


     

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    Senior Member ahalpert's Avatar
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    This is the type of language that increases my confidence in our vaccine approval process:

    An agency spokesperson tells Axios, "The amount of data submitted to the FDA includes thousands of pages of technical information that must be divided up and reviewed by experts from different disciplines. Once the reviews by the various experts are completed, they are then integrated into an overall review.
    "Completion of these reviews involves such things as ensuring that the manufacturing process and the controls on manufacturing are appropriate, checking statistical analyses performed to ensure that they were done properly and doing additional analyses, as necessary, to look at the effect of the vaccine on subsets of individuals who might be at greater risk of adverse effects."
    From an article about how people are mad that the FDA hasn't approved the Pfizer vaccine yet:

    https://www.axios.com/fda-chief-call...1356ada6e.html


     

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    Senior Member ahalpert's Avatar
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    The economy is going to go gangbusters in 2021: https://www.bloomberg.com/amp/opinio...mpression=true

    We're going to party like it's 1999


     

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    The review process for the Boeing 737 max was supposedly comprehensive as well... nothing replaces field testing.

    I think it's more likely than not that the vaccine will end up being safe and a net win. In the end this always, and only, comes back to the same line always used in medicine "to the best of our expertise and knowledge, we have determined that the benefits to this drug/vaccine outweigh the risks".


     

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    Quote Originally Posted by ahalpert View Post
    The economy is going to go gangbusters in 2021: https://www.bloomberg.com/amp/opinio...mpression=true

    We're going to party like it's 1999
    Fascinating. My concern post covid is the conglomeration of money at the top end; how many small business will fizzle out and be replaced by large entities. A good example would be the food scene in Portland. How many locally owned business will die off, and how much real estate will be acquired by larger entities. The consumer savings are good, but the last thing we need is more of "the Matthew effect", that is, the natural propensity for resource and power to be accumulated into a very small minority.


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    Senior Member ahalpert's Avatar
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    Quote Originally Posted by filmguy123 View Post
    The review process for the Boeing 737 max was supposedly comprehensive as well... nothing replaces field testing.

    I think it's more likely than not that the vaccine will end up being safe and a net win. In the end this always, and only, comes back to the same line always used in medicine "to the best of our expertise and knowledge, we have determined that the benefits to this drug/vaccine outweigh the risks".
    right, and the balance of positive/negative impact is complicated by the fact that while an individual assumes some risk in taking a newly-developed vaccine, he or she may also save tens, hundreds, or even thousands of lives if the vaccination prevents them from becoming a vector of transmission and perpetuating the pandemic. I admit that I'm nervous about the vaccine and will examine the findings carefully before taking it. but the potential benefits for society are enormous.

    and on the surface of it (and with my extremely limited medical knowledge), the design of the mRNA vaccines seems unlikely to cause long-term side effects


     

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