CDC Notifies States, Large Cities To Prepare For Vaccine Distribution As Soon As Late October

[skeeter31]

Right now, getting as many people vaccinated as possible is more important than the study. And to be clear: the study WOULD CONTINUE on those folks, they'd just move to the active group from the placebo group.

Not necessarily. They would have to guarantee they receive the same vaccine as the study they are in, and they would then be months behind the rest of the participants in the active group, so they would almost become an active-lite group as they would be a different period of the study as everyone else. The wording of the study documents probably dictates what happens if someone unblinds themselves and self vaccinates. I would assume they would have to self remove from the study as it would negate their results going forward.

But, I do agree with you that getting vaccinated is the top priority at this point. I just don’t think enough people will take the steps you did to unblind themselves and will most likely wait until they are informed by the study. But for you, I wouldn’t hesitate to go get vaccinated when you are able to.

 

[Jonfw2]

Not necessarily. They would have to guarantee they receive the same vaccine as the study they are in, and they would then be months behind the rest of the participants in the active group, so they would almost become an active-lite group as they would be a different period of the study as everyone else. The wording of the study documents probably dictates what happens if someone unblinds themselves and self vaccinates. I would assume they would have to self remove from the study as it would negate their results going forward.

But, I do agree with you that getting vaccinated is the top priority at this point. I just don’t think enough people will take the steps you did to unblind themselves and will most likely wait until they are informed by the study. But for you, I wouldn’t hesitate to go get vaccinated when you are able to.

I don't think being months behind is a big deal- this was actually what Pfizer had suggested to the FDA. Regardless of the timeline, it's more data.

 

[amylevan]

I’m not actually in pharmaceuticals, so I could be wrong, but generally you need a control group (hence placebo) from which to compare to make accurate comparisons. If the study gets unblinded and everyone gets the vaccine and moves to the vaccinated group, how do you continue the study?

Not that I necessarily think we should preclude the placebo group from getting vaccinated, I just don’t see how you continue a study without a control group.

 

[snappy]

Since it may be months before any vaccine would be available to the general public, wouldn’t many of the study volunteers (who would not be included in the earlier groups to receive the vaccine) opt to stay in the study until they are able to get the vaccine? I personally believe study volunteers over 65 and those at risk due to co-morbidities should know if they were in the placebo group so they can make the decision about their individual situation during this emergency authorization use period. In my opinion we owe them that.

 

[Jonfw2]

I’m not actually in pharmaceuticals, so I could be wrong, but generally you need a control group (hence placebo) from which to compare to make accurate comparisons. If the study gets unblinded and everyone gets the vaccine and moves to the vaccinated group, how do you continue the study?

Not that I necessarily think we should preclude the placebo group from getting vaccinated, I just don’t see how you continue a study without a control group.

Once the vaccine is available to everyone, the control group is literally everyone who hasn't been vaccinated.

 

[bethbuchall]

Not saying that leaving to get vaccinated is a bad decision. I think you should if you want. But, there goes the study, heh.

There are several ways to keep the study moving forward and still vaccinate the volunteers. One that Dr. Fauci recommended is to bring everyone in the study back in. Those who had received placebo get the vaccine. Those who had received the vaccine get placebo. That keeps the study blinded, and they can use the newly vaccinated against the previously vaccinated to determine how long the vaccine remains effective. They can also unblind and still get that type of data.

I was content to take any risks of getting the vaccine during the study and to go in for blood draws, etc. Based on how well this vaccine works, my risk vs. benefit changed. I will probably not be eligible to receive the vaccine until at least April, 2021 when they now expect to unblind anyway, but if I am able to get the vaccine earlier, I will do so. That may be selfish, but there are plenty of people who would not have been comfortable in signing up for the study to begin with. I don’t think they were selfish. I was faithful to the study, but once the risks outweigh the benefits to that degree, I do not feel comfortable continuing. My consent and participation can be revoked at any time for any reason. Ability to protect myself and the ones around me by getting the vaccine is reason enough for me. I’ve done my part in helping to advance the study to this point (which is a pretty big point).

 

[Jonfw2]

There are several ways to keep the study moving forward and still vaccinate the volunteers. One that Dr. Fauci recommended is to bring everyone in the study back in. Those who had received placebo get the vaccine. Those who had received the vaccine get placebo. That keeps the study blinded, and they can use the newly vaccinated against the previously vaccinated to determine how long the vaccine remains effective. They can also unblind and still get that type of data.

I was content to take any risks of getting the vaccine during the study and to go in for blood draws, etc. Based on how well this vaccine works, my risk vs. benefit changed. I will probably not be eligible to receive the vaccine until at least April, 2021 when they now expect to unblind anyway, but if I am able to get the vaccine earlier, I will do so. That may be selfish, but there are plenty of people who would not have been comfortable in signing up for the study to begin with. I don’t think they were selfish. I was faithful to the study, but once the risks outweigh the benefits to that degree, I do not feel comfortable continuing. My consent and participation can be revoked at any time for any reason. Ability to protect myself and the ones around me by getting the vaccine is reason enough for me. I’ve done my part in helping to advance the study to this point (which is a pretty big point).

Well said!!!

 

[godisney14]

Right now, getting as many people vaccinated as possible is more important than the study. And to be clear: the study WOULD CONTINUE on those folks, they'd just move to the active group from the placebo group.

And what is the study comparing to then?

 

[Jonfw2]

And what is the study comparing to then?

Literally every person who hasn't been vaccinated.

 

[Jonfw2]

Latest from the FDA: they are literally crossing the T's and dotting the I's now. Completing the paperwork that will accompany the vaccination itself. Expect needles in arms Monday or Tuesday!

 

[godisney14]

Those who had received placebo get the vaccine. Those who had received the vaccine get placebo. That keeps the study blinded, and they can use the newly vaccinated against the previously vaccinated to determine how long the vaccine remains effective. They can also unblind and still get that type of data.

That sounds like a new study then, right?
Original trial endpoint design wasn’t to study duration.

 

[DLgal]

Literally every person who hasn't been vaccinated.

No, that's not how it works because none of those people are part of the study and there isn't baseline data on them nor are they being followed. Nice try, though.

 

[Jonfw2]

Nice try, though.

Thanks. I appreciate the sincere, totally non-snarky, comment here.

 

[Mackenzie Click-Mickelson]

I'm concerned for the impacts of the future study of COVID because there won't be enough time for all the people out there concerned about long-term effects which are imperative to learn. Control is paramount within a study. Controlled right now means some people have a vaccine in study and some people do not. If you have too many people in one group or another you won't have enough participants to make a statistical analysis.

On the other hand COVID is so pressing that I can also understand completely how someone within a study does not want to wait that long to get the vaccine. I think I would feel that way too if I were a participant. It's not an easy discussion at all to be had but there are points to both. It's telling to me that presently the FDA does not want to give access to the vaccine for those in a study. I'm sure ethically they are torn between weighing the protection citizens would have with a vaccine and data for a study. Maybe they will adjust their decision sometime next year when more and more have been vaccinated? Who knows.

 

[aggiedog]

You can do a retrospective analysis with "literally anyone that wasn't vaccinated" but those types of studies are not nearly as powerful as the double blinded ones going on now. The data is not as reliable, and it's harder to make recommendations based on them. A balanced trial group that matches the placebo and who have been followed/tested/analyzed from the beginning are much more reliable.

 

[Jonfw2]

You can do a retrospective analysis with "literally anyone that wasn't vaccinated" but those types of studies are not nearly as powerful as the double blinded ones going on now. The data is not as reliable, and it's harder to make recommendations based on them. A balanced trial group that matches the placebo and who have been followed/tested/analyzed from the beginning are much more reliable.

Fair enough. You just have to take a couple hundred thousand people worldwide who selflessly volunteered and tell them "sorry, but you can't get the lifesaving cure you helped create". Not great for future studies.

 

[Mackenzie Click-Mickelson]

Fair enough. You just have to take a couple hundred thousand people worldwide who selflessly volunteered and tell them "sorry, but you can't get the lifesaving cure you helped create". Not great for future studies.

The future of billions of people depends on the study of long-term effects of both COVID and vaccine efficacy. Neither the decision to not allow right now vaccine access or the decision to remove oneself from a study so you could get a vaccine is an easy choice. I think we should be respectful but understanding of both

 

[amylevan]

Literally every person who hasn't been vaccinated.

That’s not a control group. Yes you can probably judge efficacy, but not side effects if you have no health info on “literally every person”.

Again, I’m not sure there’s a right answer here but you do jeopardize the study by unblinding it. It’s just a question of whether it’s worth it.

 

[Jonfw2]

That’s not a control group. Yes you can probably judge efficacy, but not side effects if you have no health info on “literally every person”.

Again, I’m not sure there’s a right answer here but you do jeopardize the study by unblinding it. It’s just a question of whether it’s worth it.

If after two years, you see that 1.8% of people who got the Pfizer vaccine developed Bell's Palsy vs, say, .4% of the general population, why is that not an effective means of tracking side effects?

 

[amylevan]

If after two years, you see that 1.8% of people who got the Pfizer vaccine developed Bell's Palsy vs, say, .4% of the general population, why is that not an effective means of tracking side effects?

Because you wouldn’t have that info. You would see that 1.8% of those in the study have Bells Palsy but no way to compare that to what number of non-Pfizer vaccined developed it. (General public numbers might give you an approximate, but it’s not a true control).