Yes, in this area the trial is being administered out of Kaiser in Pasadena.
The points in the Nature article are why I wondered about unblinding the study and vaccinating the placebo group – in particular that longer term side effects would potentially not have a control group.
In this article from yesterday’s NYT (“Many coronavirus trial volunteers got placebo vaccines; do they now deserve real ones?”), Fauci suggests that the vaccine makers administer additional “reverse” participant-blinded doses:
That’s an interesting idea! As a participant I’d definitely be happy with that.
It seems Pfizer, at least, is not up for such a change. From StatNews:
Pfizer pushes back against “crossover” design for placebo patients
5:05 p.m.: Earlier in the day, there was an enthusiastic presentation of a proposal that tried to allow volunteers who had received placebo to receive the vaccine while minimizing the problems this would present for collecting new data about the vaccine.
The idea, summarized by Helen this morning, is that all volunteers would get two more shots. Those who had received placebo would get the vaccine; those who got the vaccine would get placebo.
But William Gruber, a Pfizer senior vice president, pushed back on this idea. It was, he pointed out, potentially impractical. “44,000 individuals would have to be brought in for two additional visits,” he noted. That means they would need to sign new consent forms. And, if they already suspected they received the vaccine because they noticed aches or chills, they might decide not to come in for those additional visits. Gruber has said previously that he is worried that volunteers will leave the study if they are not offered the vaccine, and that he will not get data from them at all.
In an email earlier today, a Pfizer spokesperson confirmed the company is not currently planning to use the crossover design.
“The participants in our COVID-19 vaccine clinical trial are courageous volunteers who have made a personal and important choice to help make a difference during this pandemic,” Pfizer said in a statement. “We also believe that we have an ethical duty to create a pathway within the study for interested, eligible participants in the placebo group to have access to the vaccine as regulatory authorities make decisions about authorization or approval of the vaccine candidate around the world.”
Pfizer added: “In turn, we have developed a protocol amendment that is subject to input from and alignment with regulatory authorities but is designed so that all interested participants 16 years and older in the placebo group would have the option to receive the vaccine at scheduled timepoints in the study.”
— Matthew Herper
So those who got the placebo will be treated like the rest of the general public, I guess.
No, I don’t think so. The final paragraph that you posted says the protocol amendment will give the placebo group the vaccine at some defined time. I think they are balking at doing all the extra work of calling in the active agent group to get placebo shots. They want to just fully unblind the study and give placebo group members the vaccine. It doesn’t say when, but I don’t think it’s saying whenever they’d get it as members of the public.
Just got a call from the doctor administering the Moderna trial I’m participating in. They expect FDA approval this week, and after that they’ll be bringing us all back in. Those who got the placebo will get the vaccine; those who got the vaccine will just have blood taken. Meanwhile I’m cleared to get the flu shot and donate blood. I’m stoked!
Well, I just got the “transition option” email from Pfizer, and it says they will, in fact, pretty much treat the transition group according to the same availability to the general public.
(Bolding mine). Probably when the Stage 2 period starts they’ll send out another email, (which is why they added that phrase, “or in any other future added group”). A good number (probably those in stage 2) are likely to be getting it before that fourth study visit.
So, yes, they’re unblinding everyone who requests the transition, and if you got the real vaccine, you won’t go back in. But they’re still going to do it (at least for some) in stages, according to the state’s protocol for the general public. We still don’t know the exact dates for the different stages, though. I suppose there might be some whose fourth study visit will occur before they would otherwise be eligible.
I’ve heard that Pfizer overestimated the number of vaccines they’d be able to produce immediately. According to Laurie Garrett, this is because the “raw materials” needed to produce the vaccine are in low supply because they are also needed to create tests, and the current spike in cases is calling for a sharp and sudden increase in demand for tests.
It sounds, though, like you’ll get it when your group is eligible, though, doesn’t it? I mean, if you were a healthcare worker, do you think you’d get it at your next visit, or whatever, or do you think you’d have to wait until you personally were slated to get a shot, perhaps months from now, as a member of the general public?
I’m using the term “general public” as opposed to trial participant. Healthcare workers, essential workers, etc., are just different classes of the “general public” if they weren’t part of the trial.
Yes, I get that. I’m wondering if you might still get the shot earlier, because you’ll get it as a participant in the study, but you’ll have to wait until your group is eligible.
Like, if you were a healthcare worker, and healthcare workers were eligible as a group, but there were not yet any plans for you personally to get the vaccine, would you get it at your next study followup visit? Or are they not providing it at all, and the only way you get it is if you are eligible and receive it outside of the study, and they just want you to contact them before that for the unblinding and kicking out of the study?
Maybe I’m misinterpreting, but part of it seems strange if they aren’t providing the shot.
guizot
I am getting frantic and annoyed, we’ve gotten no communication from Pfizer at all. Zip. And now he’s being placed on the VA list for the shots and we have no idea what to do.
Well, we did get a letter from the Pfizer trial telling him that he would get a shot at his fourth appt. in March, if they had unblinded the trial. Which we figure would be about the time we’d come up for our shots. We’re still unsure what he should do.
Oh, I see what you mean. According to this email, (which requires a close reading to really understand what they’re saying), if a participant is otherwise eligible for the vaccine in his or her area (i.e., as per state health department determination), and if the participant wants to assure that he or she has gotten the real vaccine, then he or she may contact the study administrators. At that point, they will unblind and “transition” the participant–give him or her the real Pfizer vaccine if he or she received the placebo. They make very clear that this is only at the participant’s request.
Additionally, if you reach your fourth visit, (which is your sixth-month point in the study), and are still not eligible in your area to get the vaccine according to state guidelines, they will nevertheless discuss with you the option to transition from the placebo group (if you are in that group), and receive the real vaccine, (even though you otherwise wouldn’t be eligible as part of the general public–and only if you request it at that point).
So, yes, they not only want you to tell them if you insist on the getting the real vaccine; they want to be sure that when you do, that you get the Pfizer vaccine, so they can at least keep you in the study (now in a modified way), and get data on antibody levels, etc.
The email does not provide any details about how the process works for those who request to be unblinded and to “transition.” How quickly will they get the vaccine (if they didn’t get it originally)? Will they have to redo the informed consent? Will the vaccine trial schedule (visits, blood draws, etc.), be altered? (I assume it probably will, because they will need to draw blood a month after the second shot, and normally the fifth visit is at the 12-month point.)
Also, they don’t really try to dissuade a participant from just getting a vaccine outside of the trial completely on their own, when that becomes possible. The informed consent, though, does instruct you to tell them if you get any other vaccine apart from the trial.
It sounds like your partner is in a special version of the trial, if he was chosen because of comorbidities. Doesn’t that mean that, as a member of the general public, he’ll probably be eligible for the vaccine before March, (if you’re in the U.S.)?
We have 'Rona vaccine appt. for Feb. so we called the trial as requested to have him unblinded. He was in the placebo group. They will be giving him the vaccine Saturday. And poor me, my appointment is 5am 2/19.