What It’s Like to Participate in a Covid-19 Vaccine Trial
Judy Stokes and Ian Haydon, who are mother and son, are both participating in different phases of Moderna’s Covid-19 vaccine clinical trial
One of the most highly watched events in the pandemic is the ongoing Covid-19 vaccine race, and for Ian Haydon, 29, of Seattle and Judy Stokes, 69, of Sacramento it’s a family affair. Both Haydon and Stokes are participating in clinical trials for Moderna’s Covid-19 vaccine.
Moderna was the first drug company to begin human testing of its Covid-19 vaccine in the U.S. The company’s vaccine is a so-called RNA vaccine. This means that the vaccine, which is two doses, contains a small piece of genetic material, called messenger RNA (mRNA) that produces viral proteins that help the body spur an immune response.
Haydon, a science communications manager at the University of Washington, is a phase 1 trial participant — which is the stage where the drug company is testing whether the vaccine is safe. Stokes, a health writer, is in the phase 3 stage of the trial, which means the company is studying whether their vaccine works.
Elemental caught up with the pair and discussed what it’s like to partake in a Covid-19 vaccine clinical trial and what misconceptions they want put to rest. The interview has been lightly edited and condensed.
Elemental: Let’s talk about your motivations for signing up for a Covid-19 vaccine clinical trial. Ian, since you participated first, can you share what that decision process was like for you?
Ian Haydon: This is almost always the first question I get, and I wish I had a better answer. To me, it seemed simple. We need a coronavirus vaccine to get out of this pandemic. We’re not going to get one unless healthy people volunteer in those early trials. And for me, I happened to see that the trial was taking place in the city where I live, and I saw that I was healthy and in the age range they were looking for, and so it seemed like the obvious thing to do, to sign up.
Elemental: Judy, when you heard that Ian was going to participate, how did you feel?
Judy Stokes: I felt proud and fascinated, that he had sought this out, and learned about it, and then made the decision that he was going to do it. There was maybe a little trepidation, but not a lot, because Ian works in this field and knows what he’s doing.
Elemental: And what motivated you to partake as well?
Stokes: It’s because I was following Ian and this particular trial with great interest, obviously. And then there was the, I say, coincidence, that one of the cities for the phase 3 trial was Sacramento, where I live. It just seemed like an omen, like, yes, here it is in front of you. You should do this, as well.
Elemental: A phase 1 trial is studying very different things compared to a phase 3 trial. One is looking mostly at safety and the other is looking at effectiveness. Did either of you feel strongly about that component?
Haydon: Phase 1 is a small study. It’s looking for safety. It’s the first in humans. And that, I guess, comes with maybe higher risks than phase 3, where that’s already been done. But for me, it really goes back to the point I made earlier. It’s just that the first in-human study is a necessary barrier. And if nobody’s willing to take on that risk, we won’t have a vaccine, and we won’t have any new drugs. So to me, I put a lot of faith in the scientists doing this work. I think there’s this tremendous science behind this, and the trials, up to this date, are being done properly. And that leaves me confident that this step, although there are risks associated with it, somebody has to take on, so, why not me?
Stokes: I have learned a whole lot about clinical trials as this thing progressed. When I applied, I had the misconception that because I’m older — I was 68 at the time — and I have heart disease, and I have high blood pressure, I thought, “they’re not going to accept me into this. I’m one of those risky people for the virus.” But that was a whole misconception, because phase 3 is testing on the folks who will most likely need the vaccine protection. So they welcomed me with my diverse problems, issues, and age, and they really wanted a whole diverse set of people to test phase 3.
Elemental: The consent process in a clinical trial — to make sure people are informed of the possible risks — is very important. Can you share what that process was like for both of you?
Haydon: I filled out a form online, gave them my name, basic health information, and sort of threw my hat into the ring. They got back to me with a phone call, asking if I would come in for a screening visit. And it was at that point that they also emailed me a consent form, and it was a 20-page document. I thought it was actually very well written. It was very clear. They asked me to read it, top to bottom, before I came in for my screening visit. It laid out everything: What is this trial? What’s the product being tested here? This is a phase 1 study, what does that mean? There are risks involved in this study, here’s what we think they are and here is where there may be risks we don’t know about. It also explained that I’m not going to benefit from being in this phase 1 trial, and so I shouldn’t enroll for that reason. It said what I’ll actually have to do, in terms of visits to the clinic, and that I’ll be compensated $100 per trip to the clinic. It just laid out everything, in detail.
I read that, eagerly, when it arrived. I did some Googling and some homework on my own. And then when I get to the clinic for the screening visit, the very first thing that we do is go to a room with a computer and basically I clicked through a PowerPoint that was essentially everything that was in the document. And then a physician essentially re-reads the document to me, and asks me if I have any questions on this page, or if I understand the risk section, or if I have any questions about the hundred-dollar checks. They really took their time.
This is an accelerated process, and everyone’s talking about how fast vaccine development is going, but I can certainly say, as somebody who was in the earliest trial, at no point, did I ever feel like I was being rushed. They were very generous with their time. I asked probably too many questions, and they answered all of them happily. And so, I felt quite informed, based on the information they gave me. I was sure that I was going to enroll, the whole time.
Stokes: I had a similar experience, which is that the consent form is a very long document, and they had us come in. They had us read it through first, and then we also sat in a room with a nurse, a woman who took a long, extensive history of our own physical condition, and then went over the document again. And there were moments, which could make you a little woozy, because they are testing something for the purpose of learning more about it. And you know that you’re taking some risks. But it’s clearly presented to you.
Someone had asked me before I went in, if I hoped they would accept me on that day or they wouldn’t accept me. And I realized I was hoping they accepted me.
Elemental: Let’s talk about what the actual trial experience is like.
Haydon: I think in general it’s a lot less dramatic than people might think, at least I suspect that’s the case. I sometimes go to a clinic. It’s not part of a hospital, in my case, it’s a stand-alone vaccine research clinic in downtown Seattle. They will draw my blood when I go in for those visits. Most of my visits are less than half an hour, and I’ve only done about a handful of them at this point. It’s a very nondescript office, beige and boring exam rooms. Everybody there is super nice. But aside from those brief trips to the clinic, there’s not much else to do.
After getting the initial injection, they had me keep a paper diary for a week — and diary is kind of a generous term, it was like three pieces of paper stapled together like a spreadsheet on it. But they wanted me to record every evening, starting the day I got the shot, what am I experiencing? Do I have a headache? And if so, how bad is it? Do I have a fever, and if so, how bad is it? Then they would give me a thermometer to record my temperature every day.
So they wanted to know about what they call systemic effects. How’s my whole body doing and my fatigue and side effects at the injection site. So is my arm, where I got the shot, is it red? Is it swollen? Is it painful? And if so, how painful? They want to fill out that log every single day. For example, when I got my first injection, I had essentially a blank log. I got a little bit of arm pain at the injection site, but no swelling or redness. And I had no headache, no fever, no chills. So just blank for the rest of the document.
And aside from filling out those seven days after each shot, that’s it. I’m still in the monitoring phase and it will be until next spring.
Elemental: And you did, as you shared with STAT, have an adverse reaction?
Haydon: For the second dose of the vaccine, yeah. The first dose is quite uneventful, just a little bit of arm pain. Second dose was a lot more dramatic. I got the shot in the morning, at about 10:00 a.m. At 10:00 p.m., I started getting some chills. That was the first symptom I noticed, and my fingertips were cold. I had to put on some sweatpants and sweatshirts before going to bed, which is unusual for me. I usually run pretty hot. And I was asking my girlfriend, who I live with, “Are you cold? What’s going on?” That was sort of the first sign that something might be going on here, but I wanted to go to bed and rest.
I woke up in the middle of the night with a pretty high fever. It was a 103.2, its high point, and it stayed pretty high throughout the night. I was waking up and checking in and trying to go back to sleep. At that time too, I also had some nausea, headache, muscle fatigue, other stuff going on. Eventually after enough cycles of that and waking up my girlfriend in the process, we had been given a 24-hour call line where we could reach a nurse involved in the study. We called that number. They advised that I go to urgent care so that I could be looked at, and so they could run some tests on me. So we ended up going to urgent care in the middle of the night, we were met there by doctors leading the vaccines study.
I got a Covid-19 test. Took some blood for some bunch of other testing. I got some IV fluids and Tylenol, that’s about all they could give me. I wasn’t sick enough to be admitted to that hospital, so I went home, and was feeling a lot better at the time. Went home and slept for a little bit. Woke up. I ended up throwing up once and then fainting at my house. And so we called the study line again to see what we should do. If I could go back to the hospital if I felt that was needed or that I should get some fluids and rest.
I ended up staying home and resting for the rest of the day and throughout the day basically all my symptoms tapered off. So the fever got down, the nausea went away, everything faded. And basically by the next morning, I was totally fine. So it seems that for about 24 hours I had basically too high of an immune response, probably as a result of that high dose of the vaccine that I was testing and going forward that high dose is not being tested anymore.
Elemental: And you still talk about your participation in this study as something exciting. You don’t seem to have regrets.
Haydon: Yeah. I mean, I’m definitely one of the unlucky ones. It sucks to go through. Nobody wants to be sick, but I definitely don’t regret it. All this stuff that happened to me was exactly what a phase 1 study is designed to look for. Going back to that paper checklist, all the things, headache, fatigue, nausea, all those symptoms are what happened to me.
And so in that sense it seems like it’s within the bounds of what to expect from a vaccine study like this. I think importantly, it seems to have taught the researcher something. It’s going to reveal something, mainly that that high dose is probably too high. If the worst thing that happens to me during the Covid pandemic is that I had a fever for a day and I threw up at home then we are getting off better than a lot of people in this crisis. And it ultimately helps inform and guide this vaccine trial that I have no regrets about having gone through that.
Elemental: Judy, having witnessed Ian go through that experience, what was that like for you? Was that something you thought about before participating yourself?
Stokes: Yeah, I’m going to second what Ian said. Now that we’re past that and all is well, and he’s healthy, I tell friends that is exactly why you do the phase 1, to test the safety and the reaction in the human body. Now at the time it was happening it was pretty frightening as a mom. I had gotten a text from him during the night that said, “Mom, when you wake up, call me, there’s something I want to talk about.” Not the check-in you want to get. And then there was a little delay before I could actually reach him and figure out what was happening. But now that we’re past that, I feel very calm. And he was key to them making a big decision about how they were going to handle the vaccine. That’s what it’s all about.
Elemental: I think many people would like to know what your experience in the phase 3 trial is like so far.
Stokes: I’ve already gotten the two vaccine shots that I’m going to get. For two years, I will continue to be monitored now and then. I believe mostly blood draws so they can see what kind of immune response might be happening.
The one thing that is different for me is that we’ve gotten an app on the phone. So for the week after each of my injections, I also answered the kind of questions like Ian’s diary, only I did it on the app. Now they call me every week and just say, “Hey, how you doing? How are you feeling?” And then I will have visits again to have blood draws basically.
I should note that in Ian’s case, he knew he had the vaccine. This a double blind placebo trial. So I don’t know if I got the vaccine. Did I or did I not? So that just adds an interesting wrinkle.
Folks are saying to me, “Which do you hope? That you got the placebo or do you think you’ve got the vaccine?” And my answer is, “I hope I got the vaccine.”
Elemental: And have you had any symptoms?
Stokes: Like Ian, only much less intense, my first shot was not a problem. The arm was very sore, but that was it. After the second one, the arm was even more sore. And I did have a day of reporting muscle aches and fatigue. Nothing as intense as what Ian had, but there was definitely something happening in my body. So I’m thinking I did not get the placebo. But I won’t know that.
Elemental: When it comes to your day-to-day life, are you encouraged to do anything in particular? Do you mask and distance?
Haydon: I haven’t changed my behavior at all. I’m making no assumptions that I am immune. It’s an experimental vaccine. Nobody knows if it works, nobody knows what dose works, how effective it would be, even if it is effective. So no, I haven’t thrown all my masks away. I still work from home. I still wash hands. I still do all the stuff that I hope everyone else is doing.
Something that’s been on my mind a lot is that I’m in a phase 1 trial, which is all about safety, and really whether or not the vaccine protects against Covid-19 can’t be established in the phase 1 trial. The number of volunteers isn’t big enough. So let’s imagine a world where the Moderna vaccine works. I got an effective dose, but let’s say that like the flu shot, it’s not 100% effective. Let’s say it’s 70% effective. It still could be the case that I could catch Covid-19. Even if we’re in that relatively good news scenario. That just seems like such a complicated story to emerge from this phase 1 trial. My desire not to catch it has gone up even more as a result of being in the trial. I’m even more deliberate about hand-washing and all that. And that’s maybe different than phase 3, where it is actually interesting to see who gets it and who doesn’t. So mom, you can share what you’ve been told to do.
Stokes: Well, basically, we have been told to not do risky things. To follow the procedures we’ve been following in terms of social distance and isolation from the groups and masks. And I’m doing that. And my friends often ask me, “Well, are they going to give you the virus now to see if your vaccine works?” So there’s a misconception that there is an encouragement to go get infected. In the phase 3 trial they give half the people a vaccine and half of the people don’t get it. And then just through time — so ordinary behavior and protected behavior — people get sick. And they want to see, is there a difference between the vaccine group and the non-vaccine group?
Elemental: During the consent process, did they say what would happen if another pharmaceutical company got a vaccine approved for Covid-19 before Moderna? Was there any conversation about what that would mean for you? Could you get another vaccine or not?
Stokes: That was not part of anything presented to me. And it’s intriguing. I have another friend who’s in the trial with me — and we wondered if when we get to the end and they can say [if we got the vaccine or not], whether then we would be able to get either Moderna’s or whatever vaccine will be out there. So it’s a mystery at this point.
Haydon: Ditto for me as well, it was not really discussed. One thing too is given how early I got my shots, if this is the kind of thing that needs a yearly booster, then I may be up for another injection in any way. But who knows? I was told when I asked that I could get a flu shot, that wouldn’t interfere with the vaccine testing process at this point.
Elemental: That’s good. There are a lot of misconceptions about vaccines, the Covid-19 vaccine and the trials. Are there any misconceptions that you would like to put to rest?
Stokes: Well, one thing that keeps happening to me is that people ask if I am now able to infect them. “Should I stay away from you, Judy?” And I do my best in explaining that I did not receive the virus in any form, unlike even the old vaccines that used a weakened version of the virus. That is not what happened.
Also, this is going to go on for a year and a half for me. And so some of the talk about rushing vaccines and making sure we have one this fall is kind of annoying, I guess, and disappointing to me. Because I think the data that I’m providing as I’m followed is crucial to the success of the whole vaccine, that everyone may end up taking.
Haydon: I don’t know if you can call them misconceptions, but when I decided to go public about the side effects that I had, for a week or two there I became sort of a poster child of the anti-vax movement. And I think they’ve since forgotten about me and moved on to their next made-up story, but there was a big response from including, I think, the most prominent anti-vax content creators who very quickly picked up my story, exaggerated it, distorted it, and then presented it to their audience. Everything from, I had died in the trial, to I now am suffering some permanent debilitating illness, to I’m going to be murdered by Bill Gates, as a result of speaking out, to I must work for Bill Gates, or I must work for Moderna, or I must be a paid actor, or a robot. It’s just sort of every direction of nonsense all at once. So, there was a good two weeks of that. But, like I said, they seem to move on to the next story.
Elemental: Good grief. What advice do you two have for people who might consider participating in a clinical trial for a vaccine?
Stokes: I’ve been saying to folks that I learned a whole lot about clinical trials. I’ve worked in the medical field as a writer all my life. And I thought I understood trials. But I don’t. I didn’t until we got deeply into it. And it kind of stunned me. When you think 30,000 people are needed in the phase 3 that I’m in right now for just one vaccine and all the others will get this phase, you need 30,000 people. That’s a lot of people needed to volunteer and take on whatever small or large risk, and take their time to do it. So, I guess I would just want people to think about that.
And that doesn’t apply only to this. It applies to other drugs, other treatments. If we want to trust science and sciences’ careful way of evaluating things, it takes people, ordinary people, to be willing to sign up.
Haydon: I think there are some people who, at this point, are writing off the first coronavirus vaccine that comes out. I’ve actually heard from friends of mine who are themselves scientists who are themselves quite knowledgeable about the field, who’ve expressed similar doubts: That basically they would at least not be first in line for an approved vaccine. They’re the type who would want to wait and see how it goes for other people. And I understand that, especially in this moment when there does seem to be more and more political pressure put on the approval process for these coronavirus vaccines, and I think that is alarming. But I will say, speaking as someone in the phase 1 trial and as someone whose mom is in a phase 3, that these trials are happening very quickly, but they’re happening. They’re real trials. And we’re real people in them. And I’m somebody who did experience side effects. And those were documented. And those influenced the trial. And we saw a similar thing with the AstraZeneca trial being put on hold, the result of that frightening neurological condition. So, I think those are the examples people should look to and notice because those are cases of science in action. That’s what it looks like to test the vaccine and to discover how it works.
If things were really being swept under the rug and it was all a sham, those stories wouldn’t exist. And the fact that the research is being done in a responsible way leaves me confident, at least to the work that’s been done to this date. I hope that that continues. I hope that, especially around the election, that that scientific integrity isn’t compromised for the sake of politics. But to date, I don’t think that it has been. And so, people should feel, I think, confident about that.
Stokes: People often ask me, why would you do this? Why would you put yourself at any kind of risk? But I’ve really felt that the whole time that we’ve been in lockdown and quarantine, that time has been spent just living passively in one’s home and avoiding things and being fearful. And, when the trial came up, I felt like, well, this is one thing I can do that’s positive, that’s a step forward and not a reason to recoil away from something. It felt good to be doing something.