4 ms·

You have no clue what you are talking about and have spouted multiple falsehoods in your comment, especially in regards to phase 3 trials not being completed (t

You have no clue what you are talking about and have spouted multiple falsehoods in your comment, especially in regards to phase 3 trials not being completed (they are) and that they are not conducting follow ups for an extended period of time (again, they are). https://www.reuters.com/article/factcheck-covid-vaccines-idUSL1N2M70MW https://www.reuters.com/article/factcheck-covid-vaccines-idU... They have filed for full authorization for a reason. These vaccines have enough data backing their safety for full approval.

sjwalter 5y ago
I don't know where you're getting your information from, but what I stated is very easy to validate and I'm completely correct. Here are the links to the actual FDA trials for the different major co vid vaccines on clinicaltrials.gov as well as their associated estimated completion dates. All are currently in Phase 3 trials. (Aside, it's not clear how they will complete reporting for these trials as the companies blew up the placebo arms of the study. I guess that's another role I can play in this pandemic, being the control arm of the experimental trials currently underway.) Please do not spread misinformation, especially misinformation about healthcare during a deadly and dangerous pandemic. Lives are at stake. Moderna's FDA trial: https://clinicaltrials.gov/ct2/show/NCT04470427 https://clinicaltrials.gov/ct2/show/NCT04470427 Estimated Study Completion Date: October 27, 2022 Pfizer's FDA trial: https://clinicaltrials.gov/ct2/show/NCT04368728 https://clinicaltrials.gov/ct2/show/NCT04368728 Estimated Study Completion Date: May 2, 2023 JnJ's FDA trial: https://clinicaltrials.gov/ct2/show/NCT04505722 https://clinicaltrials.gov/ct2/show/NCT04505722 Estimated Study Completion Date: January 2, 2023
- lame-robot-hoax 5y ago
  You obviously didn’t read my link as it addresses exactly what you’re saying in your comment. Study completion date does not mean phase 3 trial completion date. “ However, these dates do not mean clinical trials will continue for this long, and instead reference continued safety monitoring after the vaccine has been approved and rolled out, which is standard practice within the industry” 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... Get a clue. Lives are at stake. Vaccination will save them. The majority of people dying now are dying because they made the choice not to get vaccinated.
  - sjwalter 5y ago
    I'm guessing you didn't read the link you pasted as well. Note the correction at the top of the page. It is clear that I'm correct. The vaccines are still in phase 3 clinical trials, as reported by clinicaltrials.gov, the source of truth for such questions. Estimated Study Completion Date literally means the date that the Phase 3 trial study is estimated to be completed, at which point FDA goes through the process of approving or not approving the treatment. The vaccines have been released due to an EUA (Emergency Use Authorization). I'm guessing you're not aware of this, even though it's clearly elucidated even in your own link. It seems you think that the actual, you know, "study" part of Phase 3 trials is just some unnecessary bureaucratic technicality thing? As someone well acquainted with the world of pharma, I assure you it is not. It seems you think they just jab the 40k or so participants, watch them a few minutes, and then the Phase 3 trial is completed save for some paperwork. I assure you, that is not the case. Phase 3 serves a very specific, important purpose: Identifying any long-term safety issues with medical treatments prior to their authorization for widespread adoption in the USA. The reason Phase 3 exists is because it has very often been the case that promising treatments turned out to not be so promising after long-term study. One of the foundational, bedrock principles of bioethics is "informed consent". That is, the people undergoing medical treatment, especially experimental medical treatment, must have full information about the risks and potential benefits of treatment. You are spreading misinformation which may lead others to misunderstand the current state of the covid vaccines. They are not through phase 3 trials. According to every other situation when treatments not approved through the normal FDA process are administered, they are called "experimental" (e.g., my grandma, prior to her death, was given the option to take drugs that were currently in phase 3 of FDA trials for treating her ailment, and she was told, accurately, that she could elect this experimental drug, which often is authorized for terminal patients--but they are given INFORMED consent--i.e., told they are experimental and the safety risks are not fully understood). Please, please stop violating bedrock principles of bioethics. These vaccines are still not through phase 3 trials. This is just a plain fact and you shouldn't lie to people to increase their likelihood of taking these vaccines.
    - peter422 5y ago
      How do the ethical calculations stack up when we account for the hundreds of thousands of lives saved? Regardless of whether you think the vaccines are safe, they are quite clearly effective.
- peter422 5y ago
  Nothing is perfectly safe. All the vaccines you have taken have side effects. So does the food you eat and the Sun exposure you get. The current data we have shows the vaccines are very safe to a high degree of certainty. If you had created a bar beforehand, they’d have met it. But you can always keep moving the goalposts.
  - sjwalter 5y ago
    I agree nothing is perfectly safe. However, I have never once in my life taken a drug, vaccine, or other medical treatment that has not completed FDA phase 3 trials. I have no interest in doing so. All the other vaccines I have been administered had at the minimum a decade of widespread use following their phase 3 trials (and as an aside, their phase 3 trials were much longer studies than these covid vaccines are projected to be). I've never taken a drug released under EUA. I investigated every vaccine I took and assessed the risk/benefit ratio and elected to take them. In general, I love vaccines, and I love the medical establishment that gave me the option to elect them! However, the medical establishment seems to have thrown away the playbook on these particular vaccines. The point is, I could examine the risks of those vaccines, and since their administration was not politicized, the data was totally trustworthy. And since most were out of patent, the financial incentive to manipulate data just wasn't there. I could be reasonably informed of the risk. Since these have not completed phase 3 trial, much less have decades of history in widespread use, I have basically no long-term safety data with which to inform my decision. So, precautionary principle tells me: No, thanks! The risk to benefit ratio is the only thing that matters to me, as I believe it should to others. My likelihood of serious impairment from covid seems very low to me, just like it seems very low to children, for instance. Further, the ratio changes every single day: The more people who get vaccinated, the lower my risk gets, as does the risk for every other unvaccinated person, making the ratio, as more get vaccinated, skew towards not getting the vaccine.

sjwalter 5y ago

I don't know where you're getting your information from, but what I stated is very easy to validate and I'm completely correct. Here are the links to the actual FDA trials for the different major co vid vaccines on clinicaltrials.gov as well as their associated estimated completion dates. All are currently in Phase 3 trials. (Aside, it's not clear how they will complete reporting for these trials as the companies blew up the placebo arms of the study. I guess that's another role I can play in this pandemic, being the control arm of the experimental trials currently underway.) Please do not spread misinformation, especially misinformation about healthcare during a deadly and dangerous pandemic. Lives are at stake. Moderna's FDA trial: https://clinicaltrials.gov/ct2/show/NCT04470427 https://clinicaltrials.gov/ct2/show/NCT04470427 Estimated Study Completion Date: October 27, 2022 Pfizer's FDA trial: https://clinicaltrials.gov/ct2/show/NCT04368728 https://clinicaltrials.gov/ct2/show/NCT04368728 Estimated Study Completion Date: May 2, 2023 JnJ's FDA trial: https://clinicaltrials.gov/ct2/show/NCT04505722 https://clinicaltrials.gov/ct2/show/NCT04505722 Estimated Study Completion Date: January 2, 2023

lame-robot-hoax 5y ago
You obviously didn’t read my link as it addresses exactly what you’re saying in your comment. Study completion date does not mean phase 3 trial completion date. “ However, these dates do not mean clinical trials will continue for this long, and instead reference continued safety monitoring after the vaccine has been approved and rolled out, which is standard practice within the industry” 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... Get a clue. Lives are at stake. Vaccination will save them. The majority of people dying now are dying because they made the choice not to get vaccinated.
- sjwalter 5y ago
  I'm guessing you didn't read the link you pasted as well. Note the correction at the top of the page. It is clear that I'm correct. The vaccines are still in phase 3 clinical trials, as reported by clinicaltrials.gov, the source of truth for such questions. Estimated Study Completion Date literally means the date that the Phase 3 trial study is estimated to be completed, at which point FDA goes through the process of approving or not approving the treatment. The vaccines have been released due to an EUA (Emergency Use Authorization). I'm guessing you're not aware of this, even though it's clearly elucidated even in your own link. It seems you think that the actual, you know, "study" part of Phase 3 trials is just some unnecessary bureaucratic technicality thing? As someone well acquainted with the world of pharma, I assure you it is not. It seems you think they just jab the 40k or so participants, watch them a few minutes, and then the Phase 3 trial is completed save for some paperwork. I assure you, that is not the case. Phase 3 serves a very specific, important purpose: Identifying any long-term safety issues with medical treatments prior to their authorization for widespread adoption in the USA. The reason Phase 3 exists is because it has very often been the case that promising treatments turned out to not be so promising after long-term study. One of the foundational, bedrock principles of bioethics is "informed consent". That is, the people undergoing medical treatment, especially experimental medical treatment, must have full information about the risks and potential benefits of treatment. You are spreading misinformation which may lead others to misunderstand the current state of the covid vaccines. They are not through phase 3 trials. According to every other situation when treatments not approved through the normal FDA process are administered, they are called "experimental" (e.g., my grandma, prior to her death, was given the option to take drugs that were currently in phase 3 of FDA trials for treating her ailment, and she was told, accurately, that she could elect this experimental drug, which often is authorized for terminal patients--but they are given INFORMED consent--i.e., told they are experimental and the safety risks are not fully understood). Please, please stop violating bedrock principles of bioethics. These vaccines are still not through phase 3 trials. This is just a plain fact and you shouldn't lie to people to increase their likelihood of taking these vaccines.
  - peter422 5y ago
    How do the ethical calculations stack up when we account for the hundreds of thousands of lives saved? Regardless of whether you think the vaccines are safe, they are quite clearly effective.
peter422 5y ago
Nothing is perfectly safe. All the vaccines you have taken have side effects. So does the food you eat and the Sun exposure you get. The current data we have shows the vaccines are very safe to a high degree of certainty. If you had created a bar beforehand, they’d have met it. But you can always keep moving the goalposts.
- sjwalter 5y ago
  I agree nothing is perfectly safe. However, I have never once in my life taken a drug, vaccine, or other medical treatment that has not completed FDA phase 3 trials. I have no interest in doing so. All the other vaccines I have been administered had at the minimum a decade of widespread use following their phase 3 trials (and as an aside, their phase 3 trials were much longer studies than these covid vaccines are projected to be). I've never taken a drug released under EUA. I investigated every vaccine I took and assessed the risk/benefit ratio and elected to take them. In general, I love vaccines, and I love the medical establishment that gave me the option to elect them! However, the medical establishment seems to have thrown away the playbook on these particular vaccines. The point is, I could examine the risks of those vaccines, and since their administration was not politicized, the data was totally trustworthy. And since most were out of patent, the financial incentive to manipulate data just wasn't there. I could be reasonably informed of the risk. Since these have not completed phase 3 trial, much less have decades of history in widespread use, I have basically no long-term safety data with which to inform my decision. So, precautionary principle tells me: No, thanks! The risk to benefit ratio is the only thing that matters to me, as I believe it should to others. My likelihood of serious impairment from covid seems very low to me, just like it seems very low to children, for instance. Further, the ratio changes every single day: The more people who get vaccinated, the lower my risk gets, as does the risk for every other unvaccinated person, making the ratio, as more get vaccinated, skew towards not getting the vaccine.