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Be very skeptical of any future articles on the long run effectiveness of these vaccines. I was paid to work specifically on COVID, so was monitoring the vac

by breck 6y ago

Be *very skeptical* of any future articles on the long run effectiveness of these vaccines. I was paid to work specifically on COVID, so was monitoring the vaccine data very closely. It was *very* promising, but there were a few things that puzzled me in where comparing results in placebo/control group vs vaccine groups, for both Pfizer and Moderna. So I would check near daily for new results. And then after Christmas break, when I went to check, found out both control groups had been effectively destroyed. (https://www.wsj.com/livecoverage/covid-2020-12-17/card/Pc6LVbfq91WyLWW1I71G https://www.wsj.com/livecoverage/covid-2020-12-17/card/Pc6LV...) I'm not kidding, there are no longer any control/placebo groups for these vaccines. These were studies that were approved to run for 2 years! I had to sit through hours of boring mandatory training from NIH on importance of control groups. In these cases they just threw that away. It reaks to high heaven to me. (Note: I've seen nothing to indicate these vaccines are dangerous. Effective? Looks very likely, at least in the short run. Long run effective? HIGHLY skeptical. Total contribution to ending the pandemic from the vaccines? I'm highly skeptical that it will actually be high, when an honest accounting comes out). Would I personally take the vaccine had I not had COVID already? Yes. Though not if I were a kid or teenager (very little risk from COVID). If you are in medical research, please don't look to these people as role models. Please do things openly, on git, and don't sweep uncomfortable truths under the rug.

xxxtentachyon 6y ago
Can you say more about what you think the implications of offering the control group vaccinations are? My prior assumption would be that protecting the control group would cause the study to underestimate the effectiveness of the vaccine since it now looks comparatively more similar to the control.
- breck 6y ago
  We've lost any type of objective long term way to get to the truth on how dangerous COVID really was/is, and how long term effective the vaccines are. The numbers do not come close to supporting any ethical reason for doing this.
jsnell 6y ago
There was never going to be a two year control group. The moment somebody in a trial could get vaccinated via some other channel, they'd drop out and get unblinded. Anything else would make it much harder to get people to participate in the study. For Covid, there's an additional problem with antibody tests being relatively abundant, and would allow the participants to unblind themselves anyway.
- breck 6y ago
  > There was never going to be a two year control group. Actual Study Start Date: July 27, 2020 Estimated Primary Completion Date: October 27, 2022 [0] https://clinicaltrials.gov/ct2/show/NCT04470427 https://clinicaltrials.gov/ct2/show/NCT04470427 I thought there was going to be a two year control group because that was the plan published on ClinicalTrials.gov run by NIH. > The moment somebody in a trial could get vaccinated via some other channel, they'd drop out and get unblinded If this is such obvious common knowledge why wasn't it in the plan? Why isn't it in the training? I am 100% open to fundamentally and drastically changing the way we test medicines and vaccines et cetera, but that's very different than just making decisions willy nilly that just so happen to align 100% with shareholder interests.
  - jsnell 6y ago
    The trial protocol allows for a participant to leave at any time for any reason. It does not require the participants to not get another vaccine if one becomes available. They'd obviously do that if possible, because there was a 50/50 chance they had gotten the Placebo. Both the treatment and control groups would start to disintegrate the moment a vaccine gets approved for an EUA. (But fair enough; in the case that no vaccine got an EUA, the control group would have lasted for two years.) All that the protocol change to give the control group the Moderna vaccine at that point did was to let them at least continue with the observational open-label phase B of the study. Your suggestion that this a sinister plot to hide the long-term inefficacy of their vaccines is absurd. A Covid vaccine that was highly effective for only a couple of years would be a goldmine in the long term, and would sell just as well right now.
belltaco 6y ago
It would be unethical to hold back vaccinations from a control group for 2 years after it already proved efficacy. It would also get very hard to find study volunteers because why would people join a vaccine study if there is a 50-50 chance it means they can't be protected for 2 full years?
- breck 6y ago
  > It would be unethical to hold back vaccinations from a control group for 2 years after it already proved efficacy. Is it? I don't remember reading about that in NIH training on control groups. I'm pretty sure when your plan is to distribute 1 billion vaccines, holding out 0.000015 for a placebo control group is a sensible "ethical" tradeoff. Especially if, I don't know, everyone *volunteered* and agreed to those terms when signing up! And especially if, I don't know, all the data they had to date showed no increase in death rate?
dennis_jeeves 6y ago
breck, just FYI, you have been downvoted to the point of being flagged I think. ( I actually upvoted you so that your post does not disappear). Also HN may shadow ban you.
- breck 6y ago
  Haha thanks! I don't think HN shadow bans me. My goal on these sites is high variance. High upvotes or high downvotes. In my experience that's the goal—either create a lot of value for people or learn something. I also have accounts on not my real names for more pleasant, positive, uplifting content, but I save the controversial stuff for my real name accounts.

Be *very skeptical* of any future articles on the long run effectiveness of these vaccines. I was paid to work specifically on COVID, so was monitoring the vac

by breck 6y ago

xxxtentachyon 6y ago

Can you say more about what you think the implications of offering the control group vaccinations are? My prior assumption would be that protecting the control group would cause the study to underestimate the effectiveness of the vaccine since it now looks comparatively more similar to the control.

breck 6y ago
We've lost any type of objective long term way to get to the truth on how dangerous COVID really was/is, and how long term effective the vaccines are. The numbers do not come close to supporting any ethical reason for doing this.

jsnell 6y ago

There was never going to be a two year control group. The moment somebody in a trial could get vaccinated via some other channel, they'd drop out and get unblinded. Anything else would make it much harder to get people to participate in the study. For Covid, there's an additional problem with antibody tests being relatively abundant, and would allow the participants to unblind themselves anyway.

breck 6y ago
> There was never going to be a two year control group. Actual Study Start Date: July 27, 2020 Estimated Primary Completion Date: October 27, 2022 [0] https://clinicaltrials.gov/ct2/show/NCT04470427 https://clinicaltrials.gov/ct2/show/NCT04470427 I thought there was going to be a two year control group because that was the plan published on ClinicalTrials.gov run by NIH. > The moment somebody in a trial could get vaccinated via some other channel, they'd drop out and get unblinded If this is such obvious common knowledge why wasn't it in the plan? Why isn't it in the training? I am 100% open to fundamentally and drastically changing the way we test medicines and vaccines et cetera, but that's very different than just making decisions willy nilly that just so happen to align 100% with shareholder interests.
- jsnell 6y ago
  The trial protocol allows for a participant to leave at any time for any reason. It does not require the participants to not get another vaccine if one becomes available. They'd obviously do that if possible, because there was a 50/50 chance they had gotten the Placebo. Both the treatment and control groups would start to disintegrate the moment a vaccine gets approved for an EUA. (But fair enough; in the case that no vaccine got an EUA, the control group would have lasted for two years.) All that the protocol change to give the control group the Moderna vaccine at that point did was to let them at least continue with the observational open-label phase B of the study. Your suggestion that this a sinister plot to hide the long-term inefficacy of their vaccines is absurd. A Covid vaccine that was highly effective for only a couple of years would be a goldmine in the long term, and would sell just as well right now.

belltaco 6y ago

It would be unethical to hold back vaccinations from a control group for 2 years after it already proved efficacy. It would also get very hard to find study volunteers because why would people join a vaccine study if there is a 50-50 chance it means they can't be protected for 2 full years?

breck 6y ago
> It would be unethical to hold back vaccinations from a control group for 2 years after it already proved efficacy. Is it? I don't remember reading about that in NIH training on control groups. I'm pretty sure when your plan is to distribute 1 billion vaccines, holding out 0.000015 for a placebo control group is a sensible "ethical" tradeoff. Especially if, I don't know, everyone *volunteered* and agreed to those terms when signing up! And especially if, I don't know, all the data they had to date showed no increase in death rate?

dennis_jeeves 6y ago

breck, just FYI, you have been downvoted to the point of being flagged I think. ( I actually upvoted you so that your post does not disappear). Also HN may shadow ban you.

breck 6y ago
Haha thanks! I don't think HN shadow bans me. My goal on these sites is high variance. High upvotes or high downvotes. In my experience that's the goal—either create a lot of value for people or learn something. I also have accounts on not my real names for more pleasant, positive, uplifting content, but I save the controversial stuff for my real name accounts.