Well, it is a risk that you can pay with your own life…I wouldn do it…
Sure. But the way I see it, we’re all participating in a large-scale public health experiment, whether we like it or not. Over a million people are dead. Nearly 30 million are “recovered,” though it’s unclear how many are suffering lingering effects and when, if ever, those effects will fully subside. And some 44 million are battling the virus now. The rest of us could be one uncovered sneeze away from joining them. If you get sick and seek medical care, doctors will be using you to help them figure out how to treat the disease, because that’s still a work in progress. You don’t have to volunteer for any formal studies, but you can’t completely opt out of the larger experiment.
A good point, and well said
I’m in the Pfizer-BioNTech trial. It’s basically the same as what Esprise_Me, describes, (no peeing for pregnancy, though, in my case). I got my second shot last week.
Esprise_Me, they told me that when Pfizer gets FDA approval to go public, and if I have gotten the placebo, they will offer me the the real vaccine at that time. Did Moderna tell you something like that, too?
They didn’t; that sounds awesome!
I’m wondering–because it’s not mentioned in the consent papers at all. It was just something that they told me during the intake. I don’t think they can really make a formal promise at this time (about giving the real vaccine to the placebo participants), because there are so many variables about what can happen between now and when a vaccine goes public.
It’s also a two-year study. How long is the Moderna study?
My guy has had all his shots, now he fills out his “diary” every week but he was told he doesn’t go back for 2 years.
According to the materials, it’s “up to 25 months,” but most of the work will be done within 3 months.
Month 1 (September for me): intake with a physical exam including COVID nasal swab test, pregnancy test, and bloodwork, and first injection. Keep a daily electronic diary with temperature and any symptoms for a week after. Also weekly phone calls to check in.
Month 2: second injection, same deal with the physical, diary and calls.
Month 3 (coming up): just the physical, no more injections. After this, I’m supposedly going to be able to get the flu shot, donate blood, and do whatever else they asked me to hold off on until the study is “done.” This is also when they said they’ll tell me if I got the vaccine or the placebo.
Thereafter more office visits at months 7, 13, and 24, though apparently without the bloodwork, along with monthly phone calls. The phone calls are basically “any symptoms? Any change in medication? Have a nice day!”
That seems strange that they’d unblind the study while still collecting data, including potentially subjective data like how you’re feeling and whether you have any symptoms.
I think the idea is that the study will continue even after they (hopefully) get approval, but in the meantime they will let us know so we can go get the vaccine if we didn’t already.
I found an article that addresses this, but the board isn’t letting me post it for some reason. (ETA: finally!)
The report was thoughtful. If you’re in a trial of a vaccine that gets FDA approval, you will immediately be given the real vaccine if you were in the placebo group. If you’re in one trial and another company’s vaccine gets approval, the new vaccine will be offered to those who were in the placebo group.
Cool – thanks!
The way they explained it to me was this: The double-blind part is for the 3rd stage of the initial trial, to get that first set of data which they can submit to the FDA to show a percentage of effectiveness, (and no serious side effects), and to get permission to go public. That’s the 90% rate that Pfizer announced today. Once they get that approval, the double-blind part isn’t necessary anymore.
However, they still want to know the long-term persistence of antibodies from the vaccine, and that’s why this trial has–from the start–been framed as a two-year study. So after the FDA approves, they can get twice as much data about the antibody persistence if they just call in the placebo cohort, and give them the real vaccine. It’s especially easy because all those people have already been given the informed consent, and had a health check, and been screened in general. They also already have the “COVID-19 E-diary” app set up. They just come in for the two shots (four weeks apart), and that’s it.
guizot
Very very interested to hear this. May I ask how you got this information? My partner who is participating with a very serious comorbidity, hasn’t been able to find out anything and his concern is getting the vaccine if in fact he was on the placebo. Thanks.
This is what the they told me the first day during intake for the trial. It was with the lead person, and she explained this to me while I was signing the informed consent papers. It’s not mentioned in those papers, (as I said above), and I imagine that’s because they didn’t know at that time how Phase 3 would turn out, so that would be jumping the gun. I got the sense that she mentioned it to me because she was enthusiastic about the whole project, and I had already shown a lot of curiosity about the technical aspects of how it would play out.
Got the call yesterday. Went to the clinic and got admitted to the study and got the injection this morning.
I am in the Jensenn Pharmaceuticals (part of Johnson & Johnson) trial. It is a modified adenovirus single injection protocol.
They took blood and a nasal swab and sent me home with a kit to collect saliva and nasal swab samples if I become symptomatic. Got a thermometer, pulse oximeter (had recently bought one!) and an electronic diary.
It is a 2 year trial and about 8-10 scheduled visits over that time frame for more blood draws and such.
I was also told that if their vaccine is approved they will break double blind and give the placebo group the vaccine.
I just signed up for the Johnson and Johnson single-dose. The next day I had body aches, fatigue, headache, and felt cold. I feel fine now
I have had zero symptoms after my injection. Maybe I got placebo. Maybe the vaccine and got lucky with no reaction. Time will tell.
So nine days ago the doctor from the Pfizer-BioNTech study in this area did finally send us an email to explain that because EUA was possibly coming soon, they were were looking into the process to “allow interested participants in the placebo group” to “cross over” to the actual vaccine group. They said to wait for more info.
However, this article came out two days ago in the journal Nature, (“Why emergency COVID-vaccine approvals pose a dilemma for scientists,”) which says:
So it’s not clear if those who got the placebo will necessarily be offered the real vaccine. I guess normally that happens in all studies eventually, but normally the circumstances aren’t so pressing. It also isn’t clear to me if the CDC protocols might affect this one way or the other.
I’m also wondering if Pfizer might try to convince people in the placebo group to stay un-vaccinated, (or if that is even allowed), or if they will just say, “You can have access according to the CDC guidelines for distribution–just let us know if you get it, so we can release you from the study.”
Either way, the doctor’s email didn’t say how or when we would be told whether we got the real vaccine or the placebo. Wouldn’t that have some bearing on the rest of the two-year study? It seems to me that there are still a lot of questions which are up in the air not just for the subjects, but also for the researchers themselves.
Guizot, are you in the US??