4 ms·

correct me if I'm wrong but haven't all the mRNA vaccines skipped human studies / have 'emergency use' certification

karmelapple 6y ago
Human trials of both the Pfizer and Moderna vaccines were conducted, with tens of thousands participating. Your statement is wrong, and I’m glad you welcomed being corrected. Have a nice day. https://www.cbsnews.com/news/covid-vaccine-pfizer-phase-3-human-trial-united-states/ https://www.cbsnews.com/news/covid-vaccine-pfizer-phase-3-hu...
- adolph 6y ago
  August 21, 2020, 11:30 AM Two U.S. pharmaceutical giants, Pfizer and Moderna, are in the final phase of coronavirus vaccine development, and Oxford University is expected to start large-scale human trials of its vaccine in the U.S. this month.
  - em500 6y ago
    https://www.fda.gov/media/144245/download https://www.fda.gov/media/144245/download https://fda.report/media/144673/Moderna+COVID-19+Vaccine+review+memo.pdf https://fda.report/media/144673/Moderna+COVID-19+Vaccine+rev...
    - adolph 6y ago
      The initial numbers look awesome: Pfizer: 8/18,198 vaccine, 162/18,325 placebo; Moderna: 5/13,934 vaccine, 90/13,883 placebo for 7 and 14 days respectively after the second dose.
- tiziniano 6y ago
  How long were the trials? I recall a famous drug that was given in the 70s and it produced birth malformations. Took years for doctors to realize the cause and ban its use in pregnant women. Is there a possibility of unforeseen consequences from using RNA? What if someone has for XYZ reason more reverse transcriptase than usual? Will his-her DNA be altered?
  - deleted 6y ago
    [deleted]
    - deleted 6y ago
      [deleted]
  - Wowfunhappy 6y ago
    Of course there's a possibility. The problem with long-term effects is that if a problem takes 70 years to show up, then by definition we won't know about it for 70 years. This applies not just to any drug you take, but also to the ingredients in the food you eat and the particles in the air we breath. We've come to such realizations before, and we will again. But we also know for sure that COVID-19 is killing people right now.
    - tempestn 6y ago
      The risk of long term effects is actually very small - almost insignificant. Long term effects tend to be an issue for drugs that are taken over the long term. With a vaccine that is only taken twice, the vaccine itself and its direct byproducts (ie the spike proteins) are only in the body for a limited period. After that it's only the immune response that remains. There's no realistic mechanism for a previously unseen effect to show up from it years down the line. There is a small possibility that there could be detrimental effects to a fetus, which is why the vaccines are not currently recommended for pregnant women. It's not expected that there would be a negative effect; it just hasn't yet been tested. (Fortunately pregnancy is not a chronic condition, so people can still be vaccinated after giving birth.)
      - hn_asker 6y ago
        "The risk of long term effects is actually very small - almost insignificant" Do you have sources for those claims?
        tempestn 6y ago
        I'm not an expert myself, but I've done a lot of reading. I don't have a specific source at hand, but this is the consensus I've gotten from any interviews of vaccinologists or epidemiologists I've read or heard. Essentially that any side effects from vaccinations show up within a few weeks—that there just isn't a mechanism for them to appear years down the line if they haven't already been seen sooner, for the reason I described. Now again it is possible that side effects could still be discovered in patients with complicating factors that weren't represented in the trials (like pregnancy or other known or unknown pre-existing conditions). Or just because the effects were too rare to show up significantly in the trials. But again these would be expected to show up quickly as widespread vaccination begins, as did the few severe allergic reactions that have occurred. Of course as with anything, especially as charged an issue as vaccines, if one goes looking for it one can find plenty of purported evidence that long-term side-effects (by which I mean here side effects that don't show up until long after the vaccine is taken) are possible or even common. But the expert consensus based on the totality of evidence appears to be that this is not a serious concern.
- djsumdog 6y ago
  There were human trials, but they skipped Longitudinal trials (long term effects) and they also didn't do challenge responses (exposing those people with the vaccine to COVID in a controlled manner), correct?
  - bawolff 6y ago
    Challenge trials aren't something that is normally done since they are considered high risk and of questionable morality
    - hn_asker 6y ago
      I find it fascinating how we submit batteries of tests to code as software engineers. Yet when it comes to our own health as a species, the rigor suddenly falls.
      - Buttons840 6y ago
        It's not lack of rigor, it's ethics. We don't want to intentionally expose people to something that might kill them. Instead, we perform a trial on a large group and allow them to naturally avoid or be exposed to the virus as they will. Then, with full mathematical and statistical rigor (the best kind of rigor) we determine whether the vaccine has a demonstrated benefit.
      - Smithalicious 6y ago
        I regularly test programs by feeding them garbage to see if they'll die but I don't think that would pass by the ethics board in medicine
        djsumdog 6y ago
        It'd be fine back when Jenner created the first vaccine over 185 years ago. There were no ethics boards back then. A lot of people died from snake oil treatments too.
      - bawolff 6y ago
dharmab 6y ago
No, the mRNA vaccines did not skip human studies. Phase I, II and III human trials were conducted. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine https://www.pfizer.com/news/press-release/press-release-deta...
- yeswecatan 6y ago
  Do you happen to have the clintrials.gov link? I've found several but none with actual trial results.
  - em500 6y ago
    The most detailed public reports I've seen are: https://www.fda.gov/media/144245/download https://www.fda.gov/media/144245/download (53 pages) https://fda.report/media/144673/Moderna+COVID-19+Vaccine+review+memo.pdf https://fda.report/media/144673/Moderna+COVID-19+Vaccine+rev... (61 pages) I think the actual applications had a thousand pages or so, but I haven't found them online.
  - sanxiyn 6y ago
    It is true results are not yet posted to ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04368728 https://clinicaltrials.gov/ct2/show/NCT04368728 (Pfizer, >40000 participants) https://clinicaltrials.gov/ct2/show/NCT04470427 https://clinicaltrials.gov/ct2/show/NCT04470427 (Moderna, 30000 participants)

Human trials of both the Pfizer and Moderna vaccines were conducted, with tens of thousands participating. Your statement is wrong, and I’m glad you welcomed being corrected. Have a nice day. https://www.cbsnews.com/news/covid-vaccine-pfizer-phase-3-human-trial-united-states/ https://www.cbsnews.com/news/covid-vaccine-pfizer-phase-3-hu...

adolph 6y ago
August 21, 2020, 11:30 AM Two U.S. pharmaceutical giants, Pfizer and Moderna, are in the final phase of coronavirus vaccine development, and Oxford University is expected to start large-scale human trials of its vaccine in the U.S. this month.
- em500 6y ago
  https://www.fda.gov/media/144245/download https://www.fda.gov/media/144245/download https://fda.report/media/144673/Moderna+COVID-19+Vaccine+review+memo.pdf https://fda.report/media/144673/Moderna+COVID-19+Vaccine+rev...
  - adolph 6y ago
    The initial numbers look awesome: Pfizer: 8/18,198 vaccine, 162/18,325 placebo; Moderna: 5/13,934 vaccine, 90/13,883 placebo for 7 and 14 days respectively after the second dose.
tiziniano 6y ago
How long were the trials? I recall a famous drug that was given in the 70s and it produced birth malformations. Took years for doctors to realize the cause and ban its use in pregnant women. Is there a possibility of unforeseen consequences from using RNA? What if someone has for XYZ reason more reverse transcriptase than usual? Will his-her DNA be altered?
- deleted 6y ago
  [deleted]
  - deleted 6y ago
    [deleted]
- Wowfunhappy 6y ago
  Of course there's a possibility. The problem with long-term effects is that if a problem takes 70 years to show up, then by definition we won't know about it for 70 years. This applies not just to any drug you take, but also to the ingredients in the food you eat and the particles in the air we breath. We've come to such realizations before, and we will again. But we also know for sure that COVID-19 is killing people right now.
  - tempestn 6y ago
    The risk of long term effects is actually very small - almost insignificant. Long term effects tend to be an issue for drugs that are taken over the long term. With a vaccine that is only taken twice, the vaccine itself and its direct byproducts (ie the spike proteins) are only in the body for a limited period. After that it's only the immune response that remains. There's no realistic mechanism for a previously unseen effect to show up from it years down the line. There is a small possibility that there could be detrimental effects to a fetus, which is why the vaccines are not currently recommended for pregnant women. It's not expected that there would be a negative effect; it just hasn't yet been tested. (Fortunately pregnancy is not a chronic condition, so people can still be vaccinated after giving birth.)
    - hn_asker 6y ago
      "The risk of long term effects is actually very small - almost insignificant" Do you have sources for those claims?
      - tempestn 6y ago
        I'm not an expert myself, but I've done a lot of reading. I don't have a specific source at hand, but this is the consensus I've gotten from any interviews of vaccinologists or epidemiologists I've read or heard. Essentially that any side effects from vaccinations show up within a few weeks—that there just isn't a mechanism for them to appear years down the line if they haven't already been seen sooner, for the reason I described. Now again it is possible that side effects could still be discovered in patients with complicating factors that weren't represented in the trials (like pregnancy or other known or unknown pre-existing conditions). Or just because the effects were too rare to show up significantly in the trials. But again these would be expected to show up quickly as widespread vaccination begins, as did the few severe allergic reactions that have occurred. Of course as with anything, especially as charged an issue as vaccines, if one goes looking for it one can find plenty of purported evidence that long-term side-effects (by which I mean here side effects that don't show up until long after the vaccine is taken) are possible or even common. But the expert consensus based on the totality of evidence appears to be that this is not a serious concern.
djsumdog 6y ago
There were human trials, but they skipped Longitudinal trials (long term effects) and they also didn't do challenge responses (exposing those people with the vaccine to COVID in a controlled manner), correct?
- bawolff 6y ago
  Challenge trials aren't something that is normally done since they are considered high risk and of questionable morality
  - hn_asker 6y ago
    I find it fascinating how we submit batteries of tests to code as software engineers. Yet when it comes to our own health as a species, the rigor suddenly falls.
    - Buttons840 6y ago
      It's not lack of rigor, it's ethics. We don't want to intentionally expose people to something that might kill them. Instead, we perform a trial on a large group and allow them to naturally avoid or be exposed to the virus as they will. Then, with full mathematical and statistical rigor (the best kind of rigor) we determine whether the vaccine has a demonstrated benefit.
    - Smithalicious 6y ago
      I regularly test programs by feeding them garbage to see if they'll die but I don't think that would pass by the ethics board in medicine
      - djsumdog 6y ago
        It'd be fine back when Jenner created the first vaccine over 185 years ago. There were no ethics boards back then. A lot of people died from snake oil treatments too.
    - bawolff 6y ago

dharmab 6y ago

No, the mRNA vaccines did not skip human studies. Phase I, II and III human trials were conducted. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine https://www.pfizer.com/news/press-release/press-release-deta...

yeswecatan 6y ago
Do you happen to have the clintrials.gov link? I've found several but none with actual trial results.
- em500 6y ago
  The most detailed public reports I've seen are: https://www.fda.gov/media/144245/download https://www.fda.gov/media/144245/download (53 pages) https://fda.report/media/144673/Moderna+COVID-19+Vaccine+review+memo.pdf https://fda.report/media/144673/Moderna+COVID-19+Vaccine+rev... (61 pages) I think the actual applications had a thousand pages or so, but I haven't found them online.
- sanxiyn 6y ago
  It is true results are not yet posted to ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04368728 https://clinicaltrials.gov/ct2/show/NCT04368728 (Pfizer, >40000 participants) https://clinicaltrials.gov/ct2/show/NCT04470427 https://clinicaltrials.gov/ct2/show/NCT04470427 (Moderna, 30000 participants)