By Kelly Malcom / U-M Health
Vaccines are one of the most important tools in modern medicine and have saved countless lives. None of the vaccines we now take for granted would be possible without the bravery of thousands of clinical trial volunteers. And experts agree that an effective vaccine is essential for ending the COVID-19 pandemic.
Currently, Michigan Medicine is host to two phase III clinical trials for a COVID-19 vaccine—the final phase before a vaccine is approved and made available to the world. Vaccine trials are unique in the degree of altruism among their participants. In double-blind trials, such as the ones for the AstraZeneca and Janssen investigational vaccines, neither the study coordinators nor the patients themselves know whether they are receiving a placebo or the real vaccine under study.
Here, five participants share their personal stories about why they signed up to be a part of history. Their interviews were edited for clarity and length:
Neendoniss Woodward
My grandmother went to the University of Michigan School of Nursing in the early 1940s when Jonas Salk was here as a research fellow working on a flu vaccine and she had lunch with him. So I kind of feel like I have a connection to medical research. I figured if I’m healthy enough to go through the trial, I probably should.
I’m a citizen of the Sault Ste. Marie Tribe of Chippewa Indians, the largest tribe east of the Mississippi. [This pandemic] is yet another strike from the outside on Native communities; it’s not the first time an epidemic has effected Native communities and it won’t be the last. I’ve never lived on a reservation. I grew up going to schools with mostly white kids and white neighbors, so I sometimes think I’m not your “typical” Native.
It’s hard to say how the pandemic has affected my family as far as being typical of how it has affected Native Americans because we’re all kind of spread out. The Native communities where it really hit hard are the kind that have a lot of extended family involved in each other’s daily lives. And where there’s a lot of mixing of households, on top of that, there are a lot of problems with things like inadequate housing and inadequate clean water. It’s not just being Native that causes the spread, it’s all the circumstances surrounding Native communities.
Matthew Wixson, M.D.
Participating in the trial is a welcome responsibility. As an African American man and a physician, I wanted to make myself available to help fight this pandemic. I’ve been fighting it on the frontlines as an anesthesiologist, but I also know that a huge part will be vaccination and therapeutics.
SEE ALSO: Keeping Our Patients Safe During COVID-19
Given the history of medicine in this country—with Tuskegee, Henrietta Lacks—minority communities don’t feel as comfortable participating, yet we need representation in these trials. We need data and to know about efficacy. I just felt that I’m in a position where I’m young and healthy and at high risk of exposure and I could really help to turn the corner.
Taking care of patients with COVID-19 is emotionally, physically and spiritually exhausting. It’s especially hard right now knowing what is coming. We got through the first wave; I’m so proud of our department and everyone I worked with and everyone in the hospital. This disease is still so misunderstood and it’s hard to predict who is going to do really poorly and who is going to go without symptoms.
Taking care of patients when they are that sick is tough and sad. My primary role in the first wave was intubating patients and putting them on the ventilator knowing I could be the last person that they communicate with. It was both devastating and a weighty responsibility. Trying to provide care, comfort and connection to them, in that moment of extremus, was really important and will continue to be as we enter the second wave.
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I volunteered to say that I’m doing this and I hope that other people who look like me feel safe to do it, too. And not even just in the trial, but when the vaccine comes out, I hope that they’ll say, “Yes, I feel comfortable and I feel safe because the study protocol included minority populations. So, I feel comfortable coming in to get the vaccine.” Because that’s going to be key in getting back to our new normal.
Margaret Higgins
When I think about my baby brother who had polio and was in the hospital, I also think about my parents. He was in the hospital for six or seven months. They didn’t want them to bring the virus home to us. It was very sad.
The trial for the polio vaccine started in April of 1954. First, second and third graders were getting the vaccine or placebos and somehow my parents slid me in to the trial. I received a placebo, as did my younger brother who was in first grade.
There was no hesitancy at all to get the vaccine once it was available. People were clamoring. At that point it was so very frightening.
I’ve read that polio has been around for thousands of years and we never reached herd immunity. Nobody knows whether we can catch COVID-19 again, and if you have immunity and you’ve had it for a year, then you’re back to where you started. I know people are concerned about vaccines but it doesn’t make sense to me not to get it.
You really don’t want to get COVID-19 because you don’t know what the effect is going to be. My brother died when he was 60, probably because of something involving polio. There were all kinds of secondary things those poor people went through again. And they were really surprised. We have no idea what the effects of this virus are and it’s going to be years before we do.
My feeling is this: If my having a vaccine and participating in the trial helps, hooray. It just doesn’t make sense to me not to.
Peter Higgins, M.D.
I see patients with Crohn’s and ulcerative colitis. This requires our patients to be on immunosuppressive therapy that really helps them, but also puts them at a certain amount of risk. As much as anybody, my patients really need a vaccine. Herd immunity from a vaccine protects the immune suppressed people. So the faster we can get there, the better off my patients will be.
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The other piece is that I do a lot of clinical trials involving people on immunosuppressive medication. So it seems fair for me to step up when we need 30,000 people to participate in these trials to get everything moving forward. The only way we’re going to get out of this is science.
I grew up hearing stories about how my mom’s whole family participated in the Salk trials because her brother had polio. I didn’t realize the analysis for the clinical trial for the Salk polio vaccine was done here at Michigan Medicine, which is still—to this day—one of the largest randomized clinical trial in human history, with over a million children.
Back then, the trial was inefficient because the infection rate was low and the hit rate was low. In my mom’s family, the 18-month-old got polio, but none of the other kids did. Considering they got it done was pretty amazing.
For this trial, you can’t say you can count on a benefit. But the big picture involves us moving forward and hopefully, one or more of these vaccines will come through and everybody can benefit.
Michael Mulholland, M.D.
I’ve been in practice for 35 years and dedicated my life to taking care of people. I practice as a surgeon, which means that I can only care for patients one at a time. So this is an opportunity to help many people at once, and I feel honored to be able to do that.
I’m going into this trial with my eyes wide open, and I realize what the risks are. But physicians are at risk just in the practice of medicine and have been forever. A century ago, doctors got tuberculosis and in the middle of the 20th century, they got hepatitis and some got AIDS. One of the parts of being a physician is that I’m aware of the risks involved with the trial and I’m OK with that.
People should participate in a clinical trial if they want to help someone else. I think many people are altruistically motivated—they don’t just care about themselves, they care about other people. This is a practical way to help someone you don’t even know.
When we have a vaccine that’s proven to work, everyone should take it, because it makes you and the whole world safer. If this works, it’ll let us get back to the life that we’ve missed. We’ll eventually be able to take off our masks, celebrate Thanksgiving as a family, go to a football game, be normal again.
The only part I hate is the idea of getting poked. When I was a kid, I hated going to the doctor for a shot and as an adult, I still don’t like getting a shot. But I’ll take it.
SEE ALSO: Seeking Medical Care During COVID-19
MAIN PHOTO: Matthew Wixson, M.D., during the clinical trial. Credit: Bryan McCullough, Hunter Mitchell
Photos by Bryan McCullough, Hunter Mitchell / Courtesy of U-M
