health

Placebo group: What happens after a COVID vaccine is authorized?

6 Comments
By Ivan Couronne

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© 2020 AFP

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The reason US covid vaccine trials are dragging beyond expected date is that Placebo group knows they got placebos since they aren't experiencing immune response in the form of sore arm and fever, and are masking up to prevent infection. Since they volunteered for the vaccine trials, they are not anti-covid conspiracy theorists or opposed to vaccination. Of course the Placebo group will come back to get the real vaccine once the trial is over.

The only problem is that they are having problem reaching 32 covid infections to prove vaccine efficacy due to the placebo group being extra careful.

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The reason US covid vaccine trials are dragging beyond expected date is that Placebo group knows they got placebos since they aren't experiencing immune response in the form of sore arm and fever, and are masking up to prevent infection.

A source is needed for this, in every clinical trial people think they belong to some group or another, in reality a lot of people on the placebo group experience "nocebo" reactions (strong pain, fevers, ). And a lot of people in the treated group feel nothing at all and are convinced they were only given the placebo. That would not be a reason for the delay, after all not even the doctors examining the patients or giving them the doses know which one is which until the end of the trial. It is completely blinded. Also, I don't know if this applies also for these trials, but part of the usual methodology is to ask the participants to answer honestly what group they think they got included in. If most of the people actually know their group the study can no longer be called blinded.

Being as careful as possible is the only recommendation that can be given to all participants, they are to do anything in their power to avoid getting infected, else the results would be biased and more importantly it would be unethical.

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Once the vaccine is out couldn't they enlist some population of the many that will not get the vaccine (no placebo needed) and track them alongside those that got the vaccine?

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@virusrex

A source is needed for this

https://www.politico.com/news/2020/10/27/vaccine-race-meets-harsh-reality-432964

Umer Raffat, an analyst at Evercore ISI, says that other vaccine trials could see similarly slower-than-expected rates of infection among participants.

“If people enroll in this vaccine trial and don’t feel fever or major sore arm after the shot, they kinda know they got placebo, so they remain cautious and keep masks on,” he said. That extra caution could depress infection rates, delaying data that reveal whether a vaccine works or not.

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Once the vaccine is out couldn't they enlist some population of the many that will not get the vaccine (no placebo needed) and track them alongside those that got the vaccine?

That still means recruiting thousands of people for constant monitoring that will refrain from taking the already approved vaccine, something that becomes quite difficult, and they will need to begin again from zero, likely also needing to recruit people for the vaccine arm to make both groups equivalent in time. If theirs or other vaccines end up being effective enough to interrupt the spreading that would make it less likely that they would be able to get the necessary data. Its not impossible but it becomes harder.

If people enroll in this vaccine trial and don’t feel fever or major sore arm after the shot, they kinda know they got placebo

That is not very strong evidence, it happens in all trials and participants are usually wrong (or the trial loses their "blinded" status). Also all participants are expected to be as careful as possible and this is usually included in the explanations during informed consent, keeping their masks on is part of the study design. There are plenty of other reasons that can be delaying getting positive cases, like people that volunteer for the vaccine trials are more responsible about their health care and protecting others; or the small amount of education received about how to remain healthy being enough to teach them how to protect themselves.

Thinking first about improper blinding is not justified unless you have information to confirm it from inside the trials.

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If you got a placebo,it would give you a false sense of security, because of not knowing, you got the the real thing

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