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What about waiting for full FDA approval? I agree that your Facebook Mom groups are full of BS but why are PhD earners more hesitant than only high school educa

What about waiting for full FDA approval? I agree that your Facebook Mom groups are full of BS but why are PhD earners more hesitant than only high school educated [1]. [1] - https://www.medrxiv.org/content/10.1101/2021.07.20.21260795v1.full.pdf https://www.medrxiv.org/content/10.1101/2021.07.20.21260795v...

howinteresting 5y ago
The Pfizer vaccine has already received full FDA approval, and Moderna is expected to get it shortly.
- linuxftw 5y ago
  While this is technically true, it's only because the FDA abandoned all previous procedure for full approval.
  - junon 5y ago
    Expedited approval in the middle of a pandemic is not the same as "abandoning all previous procedure".
    - linuxftw 5y ago
      Except that it is. They were already able to distribute the product under EUA. The push for 'full approval' was entirely political. What's the bar for full approval? Whatever the FDA says it is. Usually that includes convening the advisory committee. That didn't happen. Recently, 3 members resigned from said committee. While these resignations weren't about the vaccines, they were about a lack of trust in FDA (interim) leadership. If you want to continue to believe everything is just okie-dokie, knock yourself out, but you're not going to convince anyone.
      - junon 5y ago
        > If you want to continue to believe everything is just okie-dokie, knock yourself out Seeing as how I'm in Germany and I have close friends at RKI, I choose to believe them - as they are unequivocally the experts on the topic - over American politics. > but you're not going to convince anyone. Please argue in good faith next time.
      - Retric 5y ago
        People avoiding vaccination and thus dying because the FDA hasn’t done full approval is more than a political issue. It’s a real heath issue and exactly the kind of public health problem the FDA is concerned with. The general public doesn’t understand that expedited approval was a well understood category years before COVID and designed exactly for situations like this. Check the way back machine of your feeling paranoid. As to the actual science we have vastly more data on COVID vaccinations than most drugs or vaccines the FDA is approving. It really isn’t some ad hoc process it’s well designed procedures and massive quantities of scientific data.
        deleted 5y ago
        [deleted]
        linuxftw 5y ago
        > As to the actual science we have vastly more data on COVID vaccinations than most drugs or vaccines the FDA is approving Who is we? We never received the raw trial data. The data that the general public does have access to, while very flawed, says these vaccines are the most deadly ever to be widely administered. > People avoiding vaccination and thus dying because the FDA hasn’t done full approval is more than a political issue. It’s a real heath issue and exactly the kind of public health problem the FDA is concerned with. People mistook the desire for long term safety studies and completion of phase 3 clinical trials as "FDA approval." The two things were previously synonymous, at least to the lay person. FDA approval was merely a proxy, now it's meaningless. > The general public doesn’t understand The general public can't add 2 fractions, what they think is irrelevant.
        TeeMassive 5y ago
  - deleted 5y ago
    [deleted]
- hervature 5y ago
  Exactly, I'm just pointing out that there were (and still are in my opinion) valid scientific and rational thinking for being hesitant of getting the vaccine.
  - howinteresting 5y ago
    I am fine with people being hesitant to get the vaccine, as long as those people are fine with being excluded from all non-essential social activities. Where my sympathies really like is with people who *want" the vaccine but cannot get one due to circumstances (no paid time off, live in an inaccessible area, under the control of an anti-vaxxer, etc.)
  - junon 5y ago
    > valid scientific and rational thinking for being hesitant of getting the vaccine. Care to expand what these "scientific" reasons are?
    - hervature 5y ago
      I think the landscape for child and newborns is not entirely understood. Given that long COVID is rare in children, the personal risk tradeoff for a child is unclear at best. I would be hesitant to vaccinate my children (if I had any). Certainly if they were homebound.
      - junon 5y ago
        That's a different point than before, though. That's child vaccination vs. general population vaccination.
        hervature 5y ago
        Just because certain subgroups of people have valid reasons does not mean it applies to the general populace.
        5y ago
snovv_crash 5y ago
Full FDA approval has happened though. It was basically just a formality that anti-vaxxers managed to find. At this point the vaccines are known to be safe, they have billions of doses given.
- TeeMassive 5y ago
  There are no way to know the long terms effects (if you do please provide the plans of your time traveling machine to nearest patent office). The drug companies are not only under total immunity but also will get paid regardless if the vaccine works or not in the long term. The reporting of adverse effects is probably getting suppressed, for example OSHA is now admitting it won't record vaccines adverse effects so it doesn't discourage vaccinations (https://ogletree.com/insights/osha-revokes-guidance-on-recordability-of-covid-19-vaccine-reactions/ https://ogletree.com/insights/osha-revokes-guidance-on-recor...). There were vaccines that were deemed "safe" yet were scrapped because they weren't (Dengue vaccine, Guillain-Barré of the 1979 flu vaccines). The immunity of the vaccines is fading after a few months and Pfizer is now talking about bi-annual booster shots and daily pills. Personally I got my two shots of Pfizer, which is considered the safest, because it made sense to me. But even then I got adverse effects making me not want another booster shot. Calling people "anti-vaxxers" is because they do not want to take an experimental vaccines (mRNA vaccines are not vaccines in the traditional definition) is just intellectual laziness.
  - himinlomax 5y ago
    > There are no way to know the long terms effects Vaccines almost never have long term side effects, and there is no reason to believe the vaccines at hand have any reason to have any. But maybe it does. What's the probability? Based on those priors, extremely low. Not zero, but extremely low. The disease, on the other hand, definitely has long term side effects. We know that. If the risk of infection was low, you'd have a point. Maybe. But the fact is, without vaccine, everyone stands a very significant chance of getting infected. The very small risk of long term side effects is just ridiculous compared to those of the disease, and unlike the vaccine, the disease does not care about your "freedom."
arrosenberg 5y ago
If it’s not a PhD in biochemistry or something similar, then it’s not relevant to their decision making abilities. FDA approval is based on having enough data to determine efficacy and safety - with so many administered doses at this point there is no question about either of those things.
- hervature 5y ago
  Is your argument that only "PhD in biohemistry or something similar" can make decisions about the vaccine? I think that's incredibly patronizing to the vast majority of humanity. There is literally vaccines that earned FDA approval in recent memory that were later found to cause problems in babies [1]. If people are concerned about vaccines, the best way to deal with it is to address concerns, show them the data. Not calling them stupid for not having a PhD. [1] - https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html https://www.cdc.gov/vaccinesafety/concerns/concerns-history....
  - junon 5y ago
    > Not calling them stupid for not having a PhD. GP simply stated that we should be consulting experts in the fields, not laypeople, when it comes to things of a scientific nature. These were your words, not theirs.
    - hervature 5y ago
      They said: > If it’s not a PhD in biochemistry or something similar, then it’s not relevant to their decision making abilities In my opinion, that is much closer to "if you don't have a PhD in biochemistry, you can't don't deserve to make a decision (i.e. stupid)" than "listen to experts".
      - deleted 5y ago
        [deleted]
      - arrosenberg 5y ago
        I was responding to the comment of "Even people with PhDs are questioning it...". A PhD in English Lit isn't going to help you understand how vaccines, mRNA or viral transmission models work. Listen to experts in those topics.
himinlomax 5y ago
> What about waiting for full FDA approval? Because it's pointless, and because the pandemic is killing people right now, not whenever some arbitrary administrative milestone is achieved. But most importantly, because people who bring that point up are typically completely ignorant of what medicine approval entails, why the process is there in the first place, and why it normally takes so long. Just one element among several: it usually takes a long time because diseases take time to develop and we lack test subjects. Here the disease spread very rapidly, develops insanely fast, and thus judging the efficacy is nearly immediate. As for safety, vaccines almost never have long term side effects, so the risk is low to begin with, whereas the risks of the disease are huge. In short, this is a specious argument, and a ridiculous proposition on the face of it born of ignorance and motivated by a rebeliousness as callous as it's puerile.
jokethrowaway 5y ago
FDA approval is worthless. The chance of long term effects is not very high. You'll likely survive covid without pneumonia and you'll likely survive the vaccine without an aneurysm. The reason I was hesitant was: - It doesn't stop the spread - I already had covid / the risks of covid are mostly minuscole for healthy young people - New variants will drop the efficacy In the end, I did it only because I was planning to travel (which ended up being wise, given the requirements). And I still had to waste money getting tested.

howinteresting 5y ago

The Pfizer vaccine has already received full FDA approval, and Moderna is expected to get it shortly.

linuxftw 5y ago
While this is technically true, it's only because the FDA abandoned all previous procedure for full approval.
- junon 5y ago
  Expedited approval in the middle of a pandemic is not the same as "abandoning all previous procedure".
  - linuxftw 5y ago
    Except that it is. They were already able to distribute the product under EUA. The push for 'full approval' was entirely political. What's the bar for full approval? Whatever the FDA says it is. Usually that includes convening the advisory committee. That didn't happen. Recently, 3 members resigned from said committee. While these resignations weren't about the vaccines, they were about a lack of trust in FDA (interim) leadership. If you want to continue to believe everything is just okie-dokie, knock yourself out, but you're not going to convince anyone.
    - junon 5y ago
      > If you want to continue to believe everything is just okie-dokie, knock yourself out Seeing as how I'm in Germany and I have close friends at RKI, I choose to believe them - as they are unequivocally the experts on the topic - over American politics. > but you're not going to convince anyone. Please argue in good faith next time.
    - Retric 5y ago
      People avoiding vaccination and thus dying because the FDA hasn’t done full approval is more than a political issue. It’s a real heath issue and exactly the kind of public health problem the FDA is concerned with. The general public doesn’t understand that expedited approval was a well understood category years before COVID and designed exactly for situations like this. Check the way back machine of your feeling paranoid. As to the actual science we have vastly more data on COVID vaccinations than most drugs or vaccines the FDA is approving. It really isn’t some ad hoc process it’s well designed procedures and massive quantities of scientific data.
      - deleted 5y ago
        [deleted]
      - linuxftw 5y ago
        > As to the actual science we have vastly more data on COVID vaccinations than most drugs or vaccines the FDA is approving Who is we? We never received the raw trial data. The data that the general public does have access to, while very flawed, says these vaccines are the most deadly ever to be widely administered. > People avoiding vaccination and thus dying because the FDA hasn’t done full approval is more than a political issue. It’s a real heath issue and exactly the kind of public health problem the FDA is concerned with. People mistook the desire for long term safety studies and completion of phase 3 clinical trials as "FDA approval." The two things were previously synonymous, at least to the lay person. FDA approval was merely a proxy, now it's meaningless. > The general public doesn’t understand The general public can't add 2 fractions, what they think is irrelevant.
      - TeeMassive 5y ago
- deleted 5y ago
  [deleted]
hervature 5y ago
Exactly, I'm just pointing out that there were (and still are in my opinion) valid scientific and rational thinking for being hesitant of getting the vaccine.
- howinteresting 5y ago
  I am fine with people being hesitant to get the vaccine, as long as those people are fine with being excluded from all non-essential social activities. Where my sympathies really like is with people who *want" the vaccine but cannot get one due to circumstances (no paid time off, live in an inaccessible area, under the control of an anti-vaxxer, etc.)
- junon 5y ago
  > valid scientific and rational thinking for being hesitant of getting the vaccine. Care to expand what these "scientific" reasons are?
  - hervature 5y ago
    I think the landscape for child and newborns is not entirely understood. Given that long COVID is rare in children, the personal risk tradeoff for a child is unclear at best. I would be hesitant to vaccinate my children (if I had any). Certainly if they were homebound.
    - junon 5y ago
      That's a different point than before, though. That's child vaccination vs. general population vaccination.
      - hervature 5y ago
        Just because certain subgroups of people have valid reasons does not mean it applies to the general populace.
        5y ago

snovv_crash 5y ago

Full FDA approval has happened though. It was basically just a formality that anti-vaxxers managed to find. At this point the vaccines are known to be safe, they have billions of doses given.

TeeMassive 5y ago
There are no way to know the long terms effects (if you do please provide the plans of your time traveling machine to nearest patent office). The drug companies are not only under total immunity but also will get paid regardless if the vaccine works or not in the long term. The reporting of adverse effects is probably getting suppressed, for example OSHA is now admitting it won't record vaccines adverse effects so it doesn't discourage vaccinations (https://ogletree.com/insights/osha-revokes-guidance-on-recordability-of-covid-19-vaccine-reactions/ https://ogletree.com/insights/osha-revokes-guidance-on-recor...). There were vaccines that were deemed "safe" yet were scrapped because they weren't (Dengue vaccine, Guillain-Barré of the 1979 flu vaccines). The immunity of the vaccines is fading after a few months and Pfizer is now talking about bi-annual booster shots and daily pills. Personally I got my two shots of Pfizer, which is considered the safest, because it made sense to me. But even then I got adverse effects making me not want another booster shot. Calling people "anti-vaxxers" is because they do not want to take an experimental vaccines (mRNA vaccines are not vaccines in the traditional definition) is just intellectual laziness.
- himinlomax 5y ago
  > There are no way to know the long terms effects Vaccines almost never have long term side effects, and there is no reason to believe the vaccines at hand have any reason to have any. But maybe it does. What's the probability? Based on those priors, extremely low. Not zero, but extremely low. The disease, on the other hand, definitely has long term side effects. We know that. If the risk of infection was low, you'd have a point. Maybe. But the fact is, without vaccine, everyone stands a very significant chance of getting infected. The very small risk of long term side effects is just ridiculous compared to those of the disease, and unlike the vaccine, the disease does not care about your "freedom."

arrosenberg 5y ago

If it’s not a PhD in biochemistry or something similar, then it’s not relevant to their decision making abilities. FDA approval is based on having enough data to determine efficacy and safety - with so many administered doses at this point there is no question about either of those things.

hervature 5y ago
Is your argument that only "PhD in biohemistry or something similar" can make decisions about the vaccine? I think that's incredibly patronizing to the vast majority of humanity. There is literally vaccines that earned FDA approval in recent memory that were later found to cause problems in babies [1]. If people are concerned about vaccines, the best way to deal with it is to address concerns, show them the data. Not calling them stupid for not having a PhD. [1] - https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html https://www.cdc.gov/vaccinesafety/concerns/concerns-history....
- junon 5y ago
  > Not calling them stupid for not having a PhD. GP simply stated that we should be consulting experts in the fields, not laypeople, when it comes to things of a scientific nature. These were your words, not theirs.
  - hervature 5y ago
    They said: > If it’s not a PhD in biochemistry or something similar, then it’s not relevant to their decision making abilities In my opinion, that is much closer to "if you don't have a PhD in biochemistry, you can't don't deserve to make a decision (i.e. stupid)" than "listen to experts".
    - deleted 5y ago
      [deleted]
    - arrosenberg 5y ago
      I was responding to the comment of "Even people with PhDs are questioning it...". A PhD in English Lit isn't going to help you understand how vaccines, mRNA or viral transmission models work. Listen to experts in those topics.

himinlomax 5y ago

> What about waiting for full FDA approval? Because it's pointless, and because the pandemic is killing people right now, not whenever some arbitrary administrative milestone is achieved. But most importantly, because people who bring that point up are typically completely ignorant of what medicine approval entails, why the process is there in the first place, and why it normally takes so long. Just one element among several: it usually takes a long time because diseases take time to develop and we lack test subjects. Here the disease spread very rapidly, develops insanely fast, and thus judging the efficacy is nearly immediate. As for safety, vaccines almost never have long term side effects, so the risk is low to begin with, whereas the risks of the disease are huge. In short, this is a specious argument, and a ridiculous proposition on the face of it born of ignorance and motivated by a rebeliousness as callous as it's puerile.

jokethrowaway 5y ago

FDA approval is worthless. The chance of long term effects is not very high. You'll likely survive covid without pneumonia and you'll likely survive the vaccine without an aneurysm. The reason I was hesitant was: - It doesn't stop the spread - I already had covid / the risks of covid are mostly minuscole for healthy young people - New variants will drop the efficacy In the end, I did it only because I was planning to travel (which ended up being wise, given the requirements). And I still had to waste money getting tested.