Rebecca Lindstrom, an investigative reporter with 11Alive, spoke with Medical News Today about her experience as a volunteer in the Novavax vaccine clinical trial. She told us about her hopes and fears as she signed up and what the experience was like behind the scenes.

In 2020, investigative journalist Rebecca Lindstrom and her husband signed up for a Novavax vaccine clinical trial in the United States.

In a recent interview with Medical News Today, Lindstrom described her experience, what had motivated her to volunteer, and the unexpected challenges she faced along the way.

We have lightly edited the interview transcript for clarity.

‘We needed to find a way forward’

MNT: What had motivated you to sign up for the Novavax COVID-19 vaccine trial?

Lindstrom: I have never done anything like this before or even really considered it. And it really was my husband who I have to thank or blame, however you want to put it.

He signed up to one of the other vaccine trials and didn’t get called back. So I, as a reporter, was doing a story with a location that happened to be doing vaccine clinical trials. And I […] mentioned to [the clinical trial organizer I was interviewing] that my husband had tried and was not chosen and wanted to know more about how they were selecting the people to be in these trials, to figure out why [that was].

And they explained a little bit to me about the process […] here. At least, in the United States, there was this big database of names, kind of a clearinghouse, and as [vaccine trial] locations would pull down those names, they were trying to meet various demographics to […] make sure that their trials were very well-rounded.

There really wasn’t a system to put those names back up into the database, so if you didn’t get called, you kind of just got left out. So he must have just been pulled down, they realized that he wasn’t [in] the demographic they needed, and then [it] just kind of ended [there].

[The person I was interviewing then] said, “Well, if you’re still interested, we’ve got another trial coming up, and we’d be happy to enroll […] him in it.”

And I have to admit, when all this was going on, [in the first year of the pandemic] […] there was just this feeling of helplessness. You knew that we needed to find a way forward.

But I think individually, we didn’t know how to do that. We knew to wear masks, to try to socially distance, to isolate if you even thought you might be sick. But those were just reactive measures or […] ways to not get sick, they really weren’t the things that were going to help move us forward or get us out of this.

And I think that’s really what it was about the vaccine trials. It seemed like a way to help us move forward.

You know, at that point in time, there are already trials going for Pfizer, for Moderna here in the U.S., even for Johnson and Johnson. And people asked, “Well, we’re already going to have vaccines, isn’t this kind of a waste of time to be doing another trial for yet another vaccine?”

And I did ask my husband about that, and his explanation made total sense to me. It was [that] people’s bodies are different, and different vaccines might work better for other people in different ways.

So the more options we have, the more chances we have to try to reach people with varying medical conditions, because at the time, we just didn’t know what the effectiveness was going to be for different demographics, different ages, different backgrounds, preexisting medical conditions… So the more options we had, the more opportunities we were going to have to try to help people.

At the time, storage was also a big issue […], infrastructure was an issue… So the more choices we had that could be administered in different ways, the better we were all going to be, not just here in the U.S., but across the world.

And so I think it was that driver, the driver to try to do something that was going to help push this forward, not just for our family and our community, but perhaps around the world, and the interest in just trying to create as many options as possible that eventually led us to say, “OK, let’s do it.”

And then I was like, well, I’m a reporter, I don’t want to just report on this, I don’t want to just hear about it. I want to experience it. I’m one of those experiential people. So I was like, I want to experience it, I want to know it for myself. And that’s how I ended up signing up.

Photography courtesy of Rebecca Lindstrom

MNT: Did you have any fears, going into the Novavax vaccine trial?

Lindstrom: I think, admittedly, if maybe I were participating in one of the very first vaccine trials, [fear] might have played more into it, but because I’d already seen a talk with several people who’ve been involved in some of the other vaccine trials, I didn’t really have those fears.

I also had the advantage of having a husband who is a chemist, who works in a lot of these research facilities regularly. And he was very comfortable with the technologies and with the processes, so his knowledge and comfort gave me comfort.

Not everyone’s got that background resource to [enable them to] say, “I’m aware of what they’re doing, I can explain what they’re doing, I can tell you the history of how these things have been used in the past, and […] I’m comfortable with it.”

I was just lucky enough to have that. And it was really fun having both [of us signed up], because we figured statistically speaking, one of us was going to get the vaccine, one of us was maybe going to get the placebo, and we were really curious to see, after day 1, who was going to feel what — who got it.

There was kind of this fun little competition between the two of us […] Did you get it? Did I get it? And I think that dynamic made it kind of a fun process.

‘They want to make sure that you are comfortable with what is going to happen’

MNT: What was the trial like? What were the requirements for enrollment?

Lindstrom: You had to be healthy, obviously. And I think, because we were right at the beginning of them enrolling in the Novavax trial, that they were pretty open as to age and ethnicity because they needed everybody up front.

So the things I remember them asking me were about medications that I was taking. I remember them asking about any other vaccines that I might have taken recently. I think they were looking at anything that might impact interaction [with the vaccine candidate] and making sure that you were medically [viable] for a fair assessment.

I think they were also curious as to how interactive you were in the community. I think they were willing to take people of all comfort levels [with social interaction]. But I think there was an interest in the fact that we [as volunteers] were out in the community, because that was going to increase the chances that we were exposed to somebody [with a SARS-CoV-2 infection], and they would really get a chance to see how this vaccine was going to work.

So there were some lifestyle questions, not anything really invasive. After that, […] there’s a lot of material that you have to read.

They really want to make sure that you are comfortable with what is going to happen, and I really respected that. They will take time to answer any questions you have, to go through any line in the study packet. It was probably about 25 pages long.

Every time they changed anything in their protocol, or something would change in how they were doing the trial, they would have to do an entirely new packet of information, and they would point out where the change was in it.

They even asked if you would consent to have your samples used for future medical research. If there was something down the line that they felt they could peg off of this research and have it be used beneficially, you could decide, “Yes” or “No.”

They took your blood pretty much every time you went [for a follow-up], and there’s all kinds of things you can figure out by looking at someone’s blood.

You [could also] decide if you wanted your information from the study to go to your primary care physician, so that they could be aware of what was happening, like perhaps if you did have other medical conditions, and you just wanted full disclosure.

Nasal swabs: ‘Probably what I dreaded the most’

MNT: So they told you all about the potential risks of participating in the trial?

Lindstrom: They did. They told you how your data was going to be used, they told you what the potential risks were. They also have unknown risks that they talked about, things they didn’t really expect would happen, but they wanted you to be aware of [the possibility].

And that’s why it was really good, because how it was set up was — the first day you went in, they gave you a very, very basic medical screening, asked you some questions, checked your blood pressure, temperature … they checked you over to make sure that there weren’t any conditions that they should be keeping an eye on or that would disqualify you from participating.

And then they took blood. They taught you how to do your own nasal swab. That was something I had to learn before testing became a thing in the community. And that was probably what I dreaded the most.

I don’t know if anybody likes those, those nasal swab tests. And I had seen in other trials that they had to do that every time they came to do a check in. They took a PCR test.

And if there was anything that was going to discourage me from participating, that was probably it. That’s terrible to admit, but that was probably it. I just didn’t want any more COVID-19 tests than were absolutely necessary. But thankfully, they did not require that.

You just had to do a test if you were sick for more than 72 hours. Then you had to take your own nasal swabs, send it in, call them; they had somebody who would pick it up, would run the test to see if it was COVID-19, and if it tested positive, you would go back in, and they would do a series of other tests.

Neither one of us ever got sick for more than 72 hours while we were participating in the trial, so I never had to do that.

But the lab that we were working through, I believe, had [other COVID-19 vaccine] trials going. So I […] do know with one of the others, every time a volunteer went in for their check, they did a swab.

With Novavax, I think I lucked out. But there was a grid that they they gave you, which told you what to expect from each visit, and how you were going to come back, after 21 days, 35 days, 3 months, 6 months, 12 months, 18 months.

And then, of course, if you got sick somewhere along the way, there was a different process for how often you’re going to have to report in. I really feel like, up front, they gave you a lot of information, and there was no rushing through it.

I think I was there probably for about 3–3.5 hours on that first visit. And all of that was trying to make sure you understood, as best they could explain it, the science behind the vaccine process of the trial and the commitment.

I don’t think I really understood the commitment until I was really involved in it. And it’s the innocuous things that drive you nuts.

It’s the fact that you have to take your temperature every single night and report it in on a little thing on your phone. It seems simple, I mean, it’s like 2 minutes of your life. But I have two kids, I have a multigenerational household, things here are very busy.

And sometimes you’re just tired and you don’t want to get back up and do it. Or you forget, or you’re traveling and on vacation. And then you’re like, “Shoot, I didn’t bring my thermometer.”

Life happens. And this is a daily commitment. I don’t do things daily very well as it is, so to remember to do something daily was a challenge. I mean, I would say we probably had about 85–90% compliance with the nightly temperature checks.

Luis Velasco/Stocksy

But it was something that you had to think about. And then the lab itself was about an hour away from our house, so there was the hour to get there, probably 30 minutes to an hour while you’re there, then the hour to get back home… And I had to fit that in with everything else that was going on throughout the day.

So there were definitely points in time where you’re like, “Oh, I gotta go do this.” But at the end of the day, we were really excited and very happy that we did it.

I think that when people go into these things, maybe they don’t realize how much is really expected of the people who go through these trials to make sure that they’re getting the information they need to determine whether [what’s being tested is] a good solution.

And because I’ve gone through it, because I’ve seen so many other people who’ve gone through it, and I know what is involved and their commitment level, that gives me so much more comfort with the vaccine. Because I know it wasn’t just some fly-by-night game.

I know what people really went through and that they had to report even on a micro level if they had a problem. So I just have a lot more confidence and faith in the vaccine process overall. But especially with COVID-19 and the vaccine, I wouldn’t have much hesitancy with any of them.

MNT: How often did you report in person to the lab, and did you know if you got the Novavax vaccine?

Lindstrom: I believe it was 2–3 weeks after you got the shot, then 2 weeks later you went back and you got the second shot, whether it was the vaccine or the placebo. And then like 3 months after that you went back again, and went back after a month, then you went back after 3 months, then you went back after 6 months.

Our process was a little interrupted because the vaccines were becoming so widespread, they were at risk of losing people in the study, because obviously people wanted to know that they were vaccinated. I believe that they were losing some people to that concern, that maybe they weren’t really vaccinated and wanted to be.

So Novavax did make the decision to vaccinate everybody. You just didn’t know whether you got it in the first round or the second round. And because of that, I have that comfort that I’m vaccinated, so at least I don’t have to worry about that.

You felt good that you were vaccinated, and then you just hoped that the data at the end of the day showed [that the vaccine] was actually effective. I have to admit, I was a little sceptical because neither I nor my husband had any real side effects. […] And because of that, we thought, “Oh, maybe this isn’t any good, maybe it doesn’t really work.”

Because just hearing about some of the side effects from the other vaccines, we [had] prepared to spend the next day feeling lethargic or having some real arm soreness. And it just didn’t happen. So when I finally saw the data around the effectiveness, I got really excited, I wished the vaccine had been able to get through the approval process much sooner.

Because I do think that, even in my own circles, [seeing] us go through it kind of gave [people] a confidence in the vaccine, and knowing that we really didn’t have any side effects made them even more interested in trying this vaccine.

But I will add that there are some people who had side effects, there are some people who had fatigue, malaise. We just didn’t know any of those people. So to us, it just seemed like this great vaccine that didn’t come with the baggage that some of the other vaccines came with.

‘I applaud the people who are able to participate in these trials’

MNT: Was there a “break clause” for trial participation? Were you allowed to leave the clinical trial if you wanted to?

Lindstrom: Again, I give a lot of credit to how they develop these trials. They don’t want people in them if they’re not comfortable with it or if something has changed in their life. And they don’t want to see anyone leave the trial, because they really want that data. They’ve invested a lot in tracking the people who are providing that data.

However, you could leave at any time for any reason, and there was no pressure around it at all. You just have to call them up and say, “You know what, this isn’t working for me. I don’t want to do it.” And you could get out, and that was it. Nobody tried to convince you otherwise.

Or I think if you had some concern or fear and you had a question, they would probably try to help address that to see if that might ease your mind or keep you on the trial.

But for most of the people I know who had to leave the trial, it was because the Novavax vaccine was not authorized here in the U.S., and they needed to travel. And that’s eventually when we had to leave the trial, also.

We were in it for 1 year, and the trial length is technically 2 years, and we were traveling internationally around Christmas. And because we started in November of [the previous year] […] we had to leave it, I guess, at the very end of November 2021 because we were traveling internationally.

And you can’t travel unless you can prove on your vaccine card that you have one of the authorized vaccines. So we ended up having to go get revaccinated in order to travel.

Some of the people who left the trial were airline pilots. [They had to leave] in order to be able to fly and do their jobs. Meetings were starting to happen again in person, and to be able to go overseas to those meetings, you had to be able to prove that you were vaccinated.

And so I think that was one of the real challenges that Novavax had later down the line: People needed to be able to prove that they were vaccinated, and they just couldn’t do that because they didn’t have the emergency use authorization [for the Novavax vaccine yet].

MNT: Thinking back on your experience, would you do it again? Would you join another vaccine trial?

Lindstrom: If I went back in time, when I made that same decision, then yes, [I would still join the trial].

[But] right now there aren’t any other illnesses that I feel that calling about, to try to resolve them the way that I did with COVID-19 — just the overwhelming feeling that [the pandemic] had upon our community and that desire to do something to help.

[The researchers] asked about [whether I’d join] some other trials, but just the time commitment — it is a lot. So I applaud the people who are able to participate in these trials, thank goodness that they do, so we can have these data and have these solutions to help keep us healthier.

But I just don’t have the time and bandwidth to keep doing trials. I think if there was something […] [else that my husband and I were] personally attached to, we would do it again in the future. But at this point in life? No, I think we’ve given our year. And I’m glad that we did it. But it was a lot of work.

MNT: If you were to say something to people who were considering whether or not to join a vaccine trial, what would that be?

Lindstrom: I would say, go to that first meeting, get the information. My experience showed that it’s not a sales environment. It’s not a pressure environment, they want you to want to be there.

And I think that just going and getting the information on how the trial is going to work and what you can expect is really helpful in making that decision.

So I think if you were on the fence, then you owe it to yourself and perhaps to those you’re trying to help around you to go and get all of the information you can before you actually make that final decision.

Rebecca Lindstrom has also spoken about her experience as a vaccine trial volunteer for 11Alive. You can watch the original coverage here, here, and here.

For live updates on the latest developments regarding COVID-19, click here.

Source: Read Full Article