Coronavirus Sars-CoV-2/Covid-19 Megathread

[Sheilbh]

So what? Clinical trial conditions operate in a world of its own, and limitations and restrictions are constantly evolving, so it's not as if this situation could be anticipated. Allowing participants to travel freely risks further propagation of the disease. I guess they could still travel with a negative test result, just like any non vaccinated person.

But participants don't and they got vaccinated in December when only Pfizer had been authorised and was only just starting to be rolled out. I can definitely see why they'd want to basically drop out of the trial and try to get another vaccine but obviously that would have an impact on the trial.

I don't think covid vaccine trial participants have been paid or whether it is normal for participants of clinical trials to have months of travel restrictions and possibly restrictions on what type of events/locations they can attend?

I think that's okay if you know when you sign up. But I don't think it's entirely unreasonable for people in December to assume that chances are things weren't going to change too quickly and we'd all be having the same restrictions for the foreseeable. Paying them now would be a solution - although I'd still be very tempted to drop out and get another already authorised vaccine especially if it was like the examples in that article of someone wanting to visit family overseas or has to travel for work. I don't know how normal it is in a clinical trial for that sort of thing to be blocked seven months after you participated.

Agreed on the negative test route  - though I'm not sure that applies everywhere.

[The Brain]

So what? Clinical trial conditions operate in a world of its own, and limitations and restrictions are constantly evolving, so it's not as if this situation could be anticipated. Allowing participants to travel freely risks further propagation of the disease. I guess they could still travel with a negative test result, just like any non vaccinated person.

But participants don't and they got vaccinated in December when only Pfizer had been authorised and was only just starting to be rolled out. I can definitely see why they'd want to basically drop out of the trial and try to get another vaccine but obviously that would have an impact on the trial.

I don't think covid vaccine trial participants have been paid or whether it is normal for participants of clinical trials to have months of travel restrictions and possibly restrictions on what type of events/locations they can attend?

I think that's okay if you know when you sign up. But I don't think it's entirely unreasonable for people in December to assume that chances are things weren't going to change too quickly and we'd all be having the same restrictions for the foreseeable. Paying them now would be a solution - although I'd still be very tempted to drop out and get another already authorised vaccine especially if it was like the examples in that article of someone wanting to visit family overseas or has to travel for work. I don't know how normal it is in a clinical trial for that sort of thing to be blocked seven months after you participated.

Agreed on the negative test route  - though I'm not sure that applies everywhere.

They knew the terms when they signed up. If the terms don't limit them then what's the problem? And if the terms do limit them they knew that when they signed up.

[Syt]

Usually only participants in Phase I are compensated for their time IIRC, but those are the guys that are kept in a lab to see if they keel over when the susbtance is administered. AFAIK it's not allowed to pay or incentivize general study participants under various regulatory bodies' rules (doctors is a different matter).

[Syt]

They knew the terms when they signed up. If the terms don't limit them then what's the problem? And if the terms do limit them they knew that when they signed up.

Yes, it's called informed consent. They'd have a leg to stand on if they could prove that the situation and implications weren't properly explained to them in person or in the materials provided. Pharma companies have a lot of experience in making those pretty water tight, though.

[Sheilbh]

They knew the terms when they signed up. If the terms don't limit them then what's the problem? And if the terms do limit them they knew that when they signed up.

But the terms don't limit them. These aren't restrictions they agreed to as part of the clinical trial. They were restrictions that applied to everyone by law and are now being lifted for people who have had an authorised vaccine.

They don't have to deal with restrictions because of the terms of the clinical trial they signed up for (which is a good thing we should be encouraging). Rather it's because other vaccines were authorised faster which is allowing the restrictions to lift for everyone else.

[The Brain]

They knew the terms when they signed up. If the terms don't limit them then what's the problem? And if the terms do limit them they knew that when they signed up.

But the terms don't limit them. These aren't restrictions they agreed to as part of the clinical trial. They were restrictions that applied to everyone by law and are now being lifted for people who have had an authorised vaccine.

They don't have to deal with restrictions because of the terms of the clinical trial they signed up for (which is a good thing we should be encouraging). Rather it's because other vaccines were authorised faster which is allowing the restrictions to lift for everyone else.

So get an authorised vaccine then, since the terms allow it. I fail to see the problem.

[Syt]

They knew the terms when they signed up. If the terms don't limit them then what's the problem? And if the terms do limit them they knew that when they signed up.

But the terms don't limit them. These aren't restrictions they agreed to as part of the clinical trial. They were restrictions that applied to everyone by law and are now being lifted for people who have had an authorised vaccine.

Isn't that key here? They have not received a (so far) authorized vaccine. It would be the same if they had joined a Sputnik V or Sinovac trial.

[The Larch]

So what? Clinical trial conditions operate in a world of its own, and limitations and restrictions are constantly evolving, so it's not as if this situation could be anticipated. Allowing participants to travel freely risks further propagation of the disease. I guess they could still travel with a negative test result, just like any non vaccinated person.

But participants don't and they got vaccinated in December when only Pfizer had been authorised and was only just starting to be rolled out. I can definitely see why they'd want to basically drop out of the trial and try to get another vaccine but obviously that would have an impact on the trial.

I don't think covid vaccine trial participants have been paid or whether it is normal for participants of clinical trials to have months of travel restrictions and possibly restrictions on what type of events/locations they can attend?

I think that's okay if you know when you sign up. But I don't think it's entirely unreasonable for people in December to assume that chances are things weren't going to change too quickly and we'd all be having the same restrictions for the foreseeable. Paying them now would be a solution - although I'd still be very tempted to drop out and get another already authorised vaccine especially if it was like the examples in that article of someone wanting to visit family overseas or has to travel for work. I don't know how normal it is in a clinical trial for that sort of thing to be blocked seven months after you participated.

Agreed on the negative test route  - though I'm not sure that applies everywhere.

There are two issues:

- Not all participants have received the treatment being tested (in this case the potential vaccine), so a number of them have been treated with a placebo, so they're not vaccinated at all.

- Even for the ones that were treated with the vaccine, it will depend on the results of the trial, and maybe the vaccine being tested ends up not being efficient enough to warrant approval, so it might end up not being an accepted vaccine.

Thus, until the trial is finished (for what I read it's still in Phase III) and the results evaluated, it is not possible to determine if the potential vaccine is successful or not and can be considered an effective treatment. Once the trial is over, results are examined and the vaccine is deemed to be effective and approved by regulators, then those that got it during the test can be considered to be officially vaccinated (and the ones that got the placebo will have to get vaccinated anyway).

It has nothing at all to do with external restrictions or regulations, when you join a clinical trial you are aware of that. IMO those volunteers that are making a fuss out of this are behaving in a very selfish and irresponsible way. Zero simpathy for them.

[The Larch]

They knew the terms when they signed up. If the terms don't limit them then what's the problem? And if the terms do limit them they knew that when they signed up.

But the terms don't limit them. These aren't restrictions they agreed to as part of the clinical trial. They were restrictions that applied to everyone by law and are now being lifted for people who have had an authorised vaccine.

They don't have to deal with restrictions because of the terms of the clinical trial they signed up for (which is a good thing we should be encouraging). Rather it's because other vaccines were authorised faster which is allowing the restrictions to lift for everyone else.

So get an authorised vaccine then, since the terms allow it. I fail to see the problem.

Participants in the clinical trial are discouraged from getting a different vaccine than the one being tested, due to potential unforeseen interactions and becaouse it'd jeopardize the results of the trial.

[Sheilbh]

So get an authorised vaccine then, since the terms allow it. I fail to see the problem.

But I don't think they can get an authorised vaccine because that could impact the trial and might not be possible from health authorities. I know there's studies going on with mixing and matching (including the Novavax trial) but I don't think it's generally allowed.

[The Larch]

They knew the terms when they signed up. If the terms don't limit them then what's the problem? And if the terms do limit them they knew that when they signed up.

But the terms don't limit them. These aren't restrictions they agreed to as part of the clinical trial. They were restrictions that applied to everyone by law and are now being lifted for people who have had an authorised vaccine.

Isn't that key here? They have not received a (so far) authorized vaccine. It would be the same if they had joined a Sputnik V or Sinovac trial.

Yeah, until the vaccine is approved it's as if they haven't received anything at all (and a number of them have indeed received nothing at all, as they were administered a placebo).

[The Brain]

They knew the terms when they signed up. If the terms don't limit them then what's the problem? And if the terms do limit them they knew that when they signed up.

But the terms don't limit them. These aren't restrictions they agreed to as part of the clinical trial. They were restrictions that applied to everyone by law and are now being lifted for people who have had an authorised vaccine.

They don't have to deal with restrictions because of the terms of the clinical trial they signed up for (which is a good thing we should be encouraging). Rather it's because other vaccines were authorised faster which is allowing the restrictions to lift for everyone else.

So get an authorised vaccine then, since the terms allow it. I fail to see the problem.

Participants in the clinical trial are discouraged from getting a different vaccine than the one being tested, due to potential unforeseen interactions.

So they are no different from other people who haven't gotten an authorised vaccine for medical reasons?

[The Larch]

They knew the terms when they signed up. If the terms don't limit them then what's the problem? And if the terms do limit them they knew that when they signed up.

But the terms don't limit them. These aren't restrictions they agreed to as part of the clinical trial. They were restrictions that applied to everyone by law and are now being lifted for people who have had an authorised vaccine.

They don't have to deal with restrictions because of the terms of the clinical trial they signed up for (which is a good thing we should be encouraging). Rather it's because other vaccines were authorised faster which is allowing the restrictions to lift for everyone else.

So get an authorised vaccine then, since the terms allow it. I fail to see the problem.

Participants in the clinical trial are discouraged from getting a different vaccine than the one being tested, due to potential unforeseen interactions.

So they are no different from other people who haven't gotten an authorised vaccine for medical reasons?

Yes, officially it's as if they were not vaccinated at all, and they are discouraged from seeking any other of the vaccines being offered to the general public.

[The Brain]

They knew the terms when they signed up. If the terms don't limit them then what's the problem? And if the terms do limit them they knew that when they signed up.

But the terms don't limit them. These aren't restrictions they agreed to as part of the clinical trial. They were restrictions that applied to everyone by law and are now being lifted for people who have had an authorised vaccine.

They don't have to deal with restrictions because of the terms of the clinical trial they signed up for (which is a good thing we should be encouraging). Rather it's because other vaccines were authorised faster which is allowing the restrictions to lift for everyone else.

So get an authorised vaccine then, since the terms allow it. I fail to see the problem.

Participants in the clinical trial are discouraged from getting a different vaccine than the one being tested, due to potential unforeseen interactions.

So they are no different from other people who haven't gotten an authorised vaccine for medical reasons?

Yes, officially it's as if they were not vaccinated at all, and they are discouraged from seeking any other of the vaccines being offered to the general public.

It seems weird that the terms didn't mention this. Did the company think that it would be fine to take several vaccines in parallel?

[The Brain]

So get an authorised vaccine then, since the terms allow it. I fail to see the problem.

But I don't think they can get an authorised vaccine because that could impact the trial and might not be possible from health authorities. I know there's studies going on with mixing and matching (including the Novavax trial) but I don't think it's generally allowed.

See above. Seems weird to me.