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Can someone explain the “I won’t get it until it’s fully approved by the FDA” logic to me? Unlike usual vaccine trials, these vaccines have been deployed world

by boulos 5y ago

Can someone explain the “I won’t get it until it’s fully approved by the FDA” logic to me? Unlike usual vaccine trials, these vaccines have been deployed worldwide with hundreds of millions of people across many different conditions. Europe stopped using some due to an extremely rare blood clotting episode that was tens of people out millions. That suggests that rare, acute side effects have been (mostly?) discovered. AFAICT, the FDA rules for full licenses seem to require a six month trial, as well as more information on process / manufacturing / quality control. That just doesn’t seem that important compared to the massive, real-world “trial” data. What am I missing?

ozzydave 5y ago
I expect for the most part it’s a fig leaf, and when it is approved the goal posts will move. Then it will be, “the FDA rushed approval” with no evidence presented or required.
- boulos 5y ago
  That’s certainly going to be true for some people. But my express goal in this thread is to hear a good faith “full authorization argument” from someone who honestly argues for it. I believe arguments exist that I haven’t considered.
kderbyma 5y ago
I set myself a smart goal. 2024. clinical trials for all will be finished by the end of 2023 at the latest and then, give it a couple months to wrap up and draft or bury and reports. that is my basis. it's Smart.
- __m 5y ago
  Unless you get infected
  - hdjjhhvvhga 5y ago
    I upvoted both you and the parent, as both positions are valid. The difficulty of the issue is that a personal decision to vaccinate or not influences also the health of other people. This result could be weaker if Google didn't insist on forcing people back to the office - but they already made the decision so you either comply or lose your job, there is not much to discuss.
- boulos 5y ago
  I think waiting for long-term effects to be clear is a defensible position. What I don’t follow is that, AFAICT, full authorization is likely ~6 months from the date of filing (so November to January depending on manufacturer). So we won’t have long-term data. Is full FDA approval meaningful to you? If so, how?
  - alex504 5y ago
    > I think waiting for long-term effects to be clear is a defensible position. Unless you get infected, in which case you made a pretty big mistake. So then your basically saying you don't want to get vaccinated or get covid. I'm guessing you probably also want to stop social distancing. in which case you would eventually certainly get covid if it weren't for the existence of the vaccines. So the choices are: - Don't get vaccinated and everyone continues social distancing for several years, or until you get Covid. - Don't get vaccinated and stop social distancing once everyone else gets the vaccine - Get vaccinated Only the third option is remotely defensible. The second option is borderline sociopathic and there are enough people taking it that it is far more dangerous than option 3.
    - SnowProblem 5y ago
      Curious, how does Ivermectin fit into your worldview? https://www.wsj.com/articles/fda-ivermectin-covid-19-coronavirus-masks-anti-science-11627482393 https://www.wsj.com/articles/fda-ivermectin-covid-19-coronav...
      - alex504 5y ago
        I haven't looked at it much but it doesn't seem like a reliable enough treatment that one wouldn't want to be vaccinated. It seems like there are a bunch of different drugs that have shown to be effective but none are in the ballpark of two doses of Pfizer or Moderna
        SnowProblem 5y ago
        I don't disagree with you. In fact, I don't know what the correct policy should be. But we have focused heavily on preventing infection, and the vaccines have been amazing at this so far. Because now of variants and decreasing immunity, we know boosters will be needed, and for how long? Also some people are having bad side effects, like blood clots, heart problems, exhaustion, and even death, making others skeptical. No doubt it is safer than covid though. But this makes me wonder if we should have more comprehensive policy. Ivermectin seems great at treatment at various stages of covid once infected without those side effects, and also seems to hold up better against the variants. But it also looks less effective overall. Dr. John Cambell's video on it is worth a watch: https://youtu.be/R0-90kvoQac?t=610 https://youtu.be/R0-90kvoQac?t=610. As is the ongoing meta-analysis: https://ivmmeta.com https://ivmmeta.com
marton78 5y ago
I'm not sure I can explain anything related to the FDA (I'm European) but maybe I can shed some light on the insight what people are worried about. These vaccines have been applied hundreds of million times in the past year, true. Therefore, we have a very good understanding of their adverse effects in the first 6-12 months. What we cannot know, however, are possible adverse effects that are longer term. Susceptibility to other diseases maybe due to a weakened immune system. Possibly a higher prevalence of autoimmune diseases. If these vaccines were regular, inactivated virus vaccines, we could extrapolate long term effects from other similar vaccines. But this is brand new technology which affects our immune system, which is far from completely understood.
- boulos 5y ago
  Agreed on concerns about long-term effects! But I don’t believe FDA approval includes that. If anything, I suspect long covid, mRNA surprises, and similar issues will only be truly apparent in the multi-year timeframe. Again though, FDA approval doesn’t seem to address that. So I understand, “I want to understand the long-term side effects”, but not FDA approval versus emergency authorization. I had originally hoped that Europe’s use of AZ might have avoided the concern over new methodology. But ultimately the various problems during production, testing, and rollout, “seem” worse than the newness of mRNA (in my circles).
- yosito 5y ago
  > If these vaccines were regular, inactivated virus vaccines There are also inactivated viral vector vaccines for COVID. I got J&J because it was what was available to me. I would have gotten an mRNA vaccine if I could. I agree that the mRNA vaccines should be studied for long term effects, but with what we know about them so far, my prediction is that we will find them to be much safer in the long term than viral vector vaccines. Only time will tell.
  - grepfru_it 5y ago
    >I expect that I challenge you to try again without assumptions! Unless you are saying, for those who are unsure of long term health risks, to just follow your expectations? Please take a pause before replying to understand why people are hesitant to blindly follow the blind
SpicyLemonZest 5y ago
Your explanation is completely correct as far as I can tell, but you can see how someone who's unfamiliar with the details might be skeptical. "You're telling me the FDA already knows the vaccine is safe and effective, and they're just keeping it a secret for 6 months because the rules say so?"
- boulos 5y ago
  Absolutely. But I honestly was (am) hoping to hear it from someone who personally holds the opinion, because I think we’re all missing something (replies so far don’t include anyone saying that’s what they’re waiting for). I have plenty of my own speculation, assumptions, and anecdotes, but my hope is that someone pops up with an interesting nugget of “actually, EUA < something I haven’t considered >”.
  - SpicyLemonZest 5y ago
    Fingers crossed for you, but I think it's one of those things where the people who think that way are overwhelmingly unlikely to be interested in arguing about it on the Internet. I know I would have bounced right out of this comments section if I were even slightly less extreme in my pro-vaccine views.
    - boulos 5y ago
      Yeah, I figured it was worth a chance. Fwiw, multiple companies mentioned they would also move to require vaccination once it’s no longer EUA. I should have included that in my original framing. To me, that sounds more like “once the government gives us more cover, we’ll do it”. But that doesn’t tell me “who would be convinced after this milestone, but not with the current data? What changes?”.
consilla 5y ago
I have some sympathy to this argument, even though I agree with you in overall that based on what we know from the millions of vaccines being administered, they appear to be very safe. But points in favor of the FDA argument, which is mostly around emergency authorization requiring a lower standard of evidence: - The pharmaceutical industry is notorious for manipulation of trial data to make their treatments looks as beneficial as possible, as they are incentivized to do so. In the current case Pfizer and others have still not made the trial data public, and probably never will [0][1] - The main study on the Pfizer vaccine contained safety data for an average of about two months - on this basis the vaccine was declared to be extremely safe. Obviously longer term effects cannot be captured in this timeframe [2] - Due to the requirements to generate a clear public health message, almost anything that may suggest a risk with vaccines is downplayed. See for example how VAERS data is routinely dismissed (with some reason)[3], whereas data on COVID hospitalization and death rates is largely unquestioned, despite containing some room for interpretation [4]. Again, the the totality of evidence suggests that the vaccine are safe and effective. But it is not crazy or evil, as some would suggest here, to question some of what we are being told and how the data is being presented to us. [0] https://www.nature.com/articles/d41586-020-01911-7 https://www.nature.com/articles/d41586-020-01911-7 [1] https://www.theguardian.com/business/2015/aug/31/pfizer-resists-calls-for-greater-clincal-trial-transparency-medicine-drugs https://www.theguardian.com/business/2015/aug/31/pfizer-resi... [2] https://www.nejm.org/doi/full/10.1056/nejmoa2034577 https://www.nejm.org/doi/full/10.1056/nejmoa2034577 [3]https://www.reuters.com/article/factcheck-vaers-faers-idUSL2N2OE1ZA https://www.reuters.com/article/factcheck-vaers-faers-idUSL2... [4] https://www.aamc.org/news-insights/how-are-covid-19-deaths-counted-it-s-complicated https://www.aamc.org/news-insights/how-are-covid-19-deaths-c...
- boulos 5y ago
  Does full FDA approval make a meaningful difference, though? If anything, it seems like if someone doesn’t want to rely on the current EUA (because of limited data, incentives, etc.) then they shouldn’t suddenly be okay with the FDA’s full authorization.
  - leesalminen 5y ago
ergocoder 5y ago
Then why don't FDA just fully approv the vaccine? Apparently, FDA hasn't approved the vaccine. I'm not an expert in the vaccine. So, I won't debate the details. It is very jarring that FDA/CDC claims the vaccine is safe, but they refuse to approve the vaccine.

by boulos 5y ago

ozzydave 5y ago

I expect for the most part it’s a fig leaf, and when it is approved the goal posts will move. Then it will be, “the FDA rushed approval” with no evidence presented or required.

boulos 5y ago
That’s certainly going to be true for some people. But my express goal in this thread is to hear a good faith “full authorization argument” from someone who honestly argues for it. I believe arguments exist that I haven’t considered.

kderbyma 5y ago

I set myself a smart goal. 2024. clinical trials for all will be finished by the end of 2023 at the latest and then, give it a couple months to wrap up and draft or bury and reports. that is my basis. it's Smart.

__m 5y ago
Unless you get infected
- hdjjhhvvhga 5y ago
  I upvoted both you and the parent, as both positions are valid. The difficulty of the issue is that a personal decision to vaccinate or not influences also the health of other people. This result could be weaker if Google didn't insist on forcing people back to the office - but they already made the decision so you either comply or lose your job, there is not much to discuss.
boulos 5y ago
I think waiting for long-term effects to be clear is a defensible position. What I don’t follow is that, AFAICT, full authorization is likely ~6 months from the date of filing (so November to January depending on manufacturer). So we won’t have long-term data. Is full FDA approval meaningful to you? If so, how?
- alex504 5y ago
  > I think waiting for long-term effects to be clear is a defensible position. Unless you get infected, in which case you made a pretty big mistake. So then your basically saying you don't want to get vaccinated or get covid. I'm guessing you probably also want to stop social distancing. in which case you would eventually certainly get covid if it weren't for the existence of the vaccines. So the choices are: - Don't get vaccinated and everyone continues social distancing for several years, or until you get Covid. - Don't get vaccinated and stop social distancing once everyone else gets the vaccine - Get vaccinated Only the third option is remotely defensible. The second option is borderline sociopathic and there are enough people taking it that it is far more dangerous than option 3.
  - SnowProblem 5y ago
    Curious, how does Ivermectin fit into your worldview? https://www.wsj.com/articles/fda-ivermectin-covid-19-coronavirus-masks-anti-science-11627482393 https://www.wsj.com/articles/fda-ivermectin-covid-19-coronav...
    - alex504 5y ago
      I haven't looked at it much but it doesn't seem like a reliable enough treatment that one wouldn't want to be vaccinated. It seems like there are a bunch of different drugs that have shown to be effective but none are in the ballpark of two doses of Pfizer or Moderna
      - SnowProblem 5y ago
        I don't disagree with you. In fact, I don't know what the correct policy should be. But we have focused heavily on preventing infection, and the vaccines have been amazing at this so far. Because now of variants and decreasing immunity, we know boosters will be needed, and for how long? Also some people are having bad side effects, like blood clots, heart problems, exhaustion, and even death, making others skeptical. No doubt it is safer than covid though. But this makes me wonder if we should have more comprehensive policy. Ivermectin seems great at treatment at various stages of covid once infected without those side effects, and also seems to hold up better against the variants. But it also looks less effective overall. Dr. John Cambell's video on it is worth a watch: https://youtu.be/R0-90kvoQac?t=610 https://youtu.be/R0-90kvoQac?t=610. As is the ongoing meta-analysis: https://ivmmeta.com https://ivmmeta.com

marton78 5y ago

I'm not sure I can explain anything related to the FDA (I'm European) but maybe I can shed some light on the insight what people are worried about. These vaccines have been applied hundreds of million times in the past year, true. Therefore, we have a very good understanding of their adverse effects in the first 6-12 months. What we cannot know, however, are possible adverse effects that are longer term. Susceptibility to other diseases maybe due to a weakened immune system. Possibly a higher prevalence of autoimmune diseases. If these vaccines were regular, inactivated virus vaccines, we could extrapolate long term effects from other similar vaccines. But this is brand new technology which affects our immune system, which is far from completely understood.

boulos 5y ago
Agreed on concerns about long-term effects! But I don’t believe FDA approval includes that. If anything, I suspect long covid, mRNA surprises, and similar issues will only be truly apparent in the multi-year timeframe. Again though, FDA approval doesn’t seem to address that. So I understand, “I want to understand the long-term side effects”, but not FDA approval versus emergency authorization. I had originally hoped that Europe’s use of AZ might have avoided the concern over new methodology. But ultimately the various problems during production, testing, and rollout, “seem” worse than the newness of mRNA (in my circles).
yosito 5y ago
> If these vaccines were regular, inactivated virus vaccines There are also inactivated viral vector vaccines for COVID. I got J&J because it was what was available to me. I would have gotten an mRNA vaccine if I could. I agree that the mRNA vaccines should be studied for long term effects, but with what we know about them so far, my prediction is that we will find them to be much safer in the long term than viral vector vaccines. Only time will tell.
- grepfru_it 5y ago
  >I expect that I challenge you to try again without assumptions! Unless you are saying, for those who are unsure of long term health risks, to just follow your expectations? Please take a pause before replying to understand why people are hesitant to blindly follow the blind

SpicyLemonZest 5y ago

Your explanation is completely correct as far as I can tell, but you can see how someone who's unfamiliar with the details might be skeptical. "You're telling me the FDA already knows the vaccine is safe and effective, and they're just keeping it a secret for 6 months because the rules say so?"

boulos 5y ago
Absolutely. But I honestly was (am) hoping to hear it from someone who personally holds the opinion, because I think we’re all missing something (replies so far don’t include anyone saying that’s what they’re waiting for). I have plenty of my own speculation, assumptions, and anecdotes, but my hope is that someone pops up with an interesting nugget of “actually, EUA < something I haven’t considered >”.
- SpicyLemonZest 5y ago
  Fingers crossed for you, but I think it's one of those things where the people who think that way are overwhelmingly unlikely to be interested in arguing about it on the Internet. I know I would have bounced right out of this comments section if I were even slightly less extreme in my pro-vaccine views.
  - boulos 5y ago
    Yeah, I figured it was worth a chance. Fwiw, multiple companies mentioned they would also move to require vaccination once it’s no longer EUA. I should have included that in my original framing. To me, that sounds more like “once the government gives us more cover, we’ll do it”. But that doesn’t tell me “who would be convinced after this milestone, but not with the current data? What changes?”.

consilla 5y ago

I have some sympathy to this argument, even though I agree with you in overall that based on what we know from the millions of vaccines being administered, they appear to be very safe. But points in favor of the FDA argument, which is mostly around emergency authorization requiring a lower standard of evidence: - The pharmaceutical industry is notorious for manipulation of trial data to make their treatments looks as beneficial as possible, as they are incentivized to do so. In the current case Pfizer and others have still not made the trial data public, and probably never will [0][1] - The main study on the Pfizer vaccine contained safety data for an average of about two months - on this basis the vaccine was declared to be extremely safe. Obviously longer term effects cannot be captured in this timeframe [2] - Due to the requirements to generate a clear public health message, almost anything that may suggest a risk with vaccines is downplayed. See for example how VAERS data is routinely dismissed (with some reason)[3], whereas data on COVID hospitalization and death rates is largely unquestioned, despite containing some room for interpretation [4]. Again, the the totality of evidence suggests that the vaccine are safe and effective. But it is not crazy or evil, as some would suggest here, to question some of what we are being told and how the data is being presented to us. [0] https://www.nature.com/articles/d41586-020-01911-7 https://www.nature.com/articles/d41586-020-01911-7 [1] https://www.theguardian.com/business/2015/aug/31/pfizer-resists-calls-for-greater-clincal-trial-transparency-medicine-drugs https://www.theguardian.com/business/2015/aug/31/pfizer-resi... [2] https://www.nejm.org/doi/full/10.1056/nejmoa2034577 https://www.nejm.org/doi/full/10.1056/nejmoa2034577 [3]https://www.reuters.com/article/factcheck-vaers-faers-idUSL2N2OE1ZA https://www.reuters.com/article/factcheck-vaers-faers-idUSL2... [4] https://www.aamc.org/news-insights/how-are-covid-19-deaths-counted-it-s-complicated https://www.aamc.org/news-insights/how-are-covid-19-deaths-c...

boulos 5y ago
Does full FDA approval make a meaningful difference, though? If anything, it seems like if someone doesn’t want to rely on the current EUA (because of limited data, incentives, etc.) then they shouldn’t suddenly be okay with the FDA’s full authorization.
- leesalminen 5y ago

ergocoder 5y ago

Then why don't FDA just fully approv the vaccine? Apparently, FDA hasn't approved the vaccine. I'm not an expert in the vaccine. So, I won't debate the details. It is very jarring that FDA/CDC claims the vaccine is safe, but they refuse to approve the vaccine.