There is a feverish race to develop a COVID-19 vaccine. However, even with clinical trials moving forward, too few of the people signing up to take part in them are Black. That is discouraging yet unsurprising, given the long-running difficulty that clinical trialists have encountered in recruiting Black research subjects given high levels of historical mistrust.
Against that backdrop, AMA member Louito Edje, MD, jumped at the opportunity to help test one of the SARS-CoV-2 vaccine candidates that has made it to phase 3 trials. Dr. Edje, who is Black, is a family physician and associate dean of graduate medical education at the University of Cincinnati Medical Center.
She also is a member of the AMA Ambassador Program, which equips individuals with the skills and knowledge to confidently speak to the AMA's initiatives and the value of membership. The program also increases overall awareness about what the AMA does for physicians and their patients.
During a recent interview, Dr. Edje discussed her decision and how she hopes it will benefit patients. Patients and physicians can learn more about volunteering for SARS-CoV-2 vaccine trials at the COVID-19 Prevention Network, a project of the National Institute of Allergy and Infectious Diseases.
AMA: What inspired you to participate in this COVID-19 vaccine trial?
Dr. Edje: There were three different motivators for my enrollment. No. 1, 30% of my job is direct patient care. We're a high-risk demographic as Black women, as Black patients. In particular, I wanted to make sure that I could learn as much as I could about the trial itself and then talk to my patients about getting involved. It's like a put-your-money-where-your-mouth-is sort of thing.
The Cincinnati Medical Association—it represents Black physicians in Cincinnati—invited the primary investigator to come to our meeting and he walked us through all the details. There are going to be seven visits—the first one is about three hours—and enrollees would be using a symptom diary via phone app after each vaccine visit. He went through the difference between the various vaccine trials, focusing on mechanisms of action. At that point, I felt equipped to go ahead and actually speak to patients about enrolling.
No. 2, for the other 70% of my job, I have responsibility for about 700 or so residents and fellows at the University of Cincinnati as associate dean of graduate medical education. We have about a hundred programs. I am keenly interested in learner safety, their PPE, their social distancing, making sure that they've got sanitizer available to keep them safe as they learn. My work ensuring residents are safe in the long run also inspired me to participate in the vaccine trial.
No. 3, the thing that pushed me right into the study was the death of my stepmother who lived in Swaziland. She was young and healthy yet passed away from COVID a couple months ago. It hit me much harder than I had expected. I wrote a little poem about the effect of this titled, “A tsunami born of a teardrop.”
I want to be part of a solution to the worst pandemic we have seen in my lifetime. The trial is being conducted right here at Cincinnati. Ours is one of 90 centers globally involved with this mRNA 1273 trial. For me, that was a perfect opportunity to be an example.
AMA: Those are great reasons to be involved in a COVID-19 vaccine trial. Why did you decide to tell people you volunteered in the clinical trial?
Dr. Edje: If you're going to lead by example, you might as well do it in the light instead of darkness. If there's a single other person who decides to be in the trial because I was in the trial and, ultimately, if this vaccine is the one that works, then that’s great.
I've had a lot of questions posed to me as well: “You're a Black woman, aren't you reluctant to be in trials with the history that we've had with Tuskegee?” For me, it got even more complex when it started to be politicized and when people started to become more suspicious about the motivations for increasing enrollment of Black participants. Blacks are disproportionately affected by this pandemic but there is still a reticence to be “encouraged” to be involved.
What is the right speed of developing a vaccine? It's the speed of science. So, if it is fully developed before the election at the speed of science, great. If happens after the election at the speed of science, great. Both of those two are right, as long as it's the speed of science. That is the right speed.
AMA: Which COVID-19 vaccine trial are you taking part in, and how does the process work?
Dr. Edje: I’m in the Moderna trial, which uses an mRNA-1273. Basically, the trial is meant to get my immune system prepared to act on the spike proteins on the surface of the virus. In case I get exposed to the virus, my system should be able to recognize it and respond. It’s different than injecting attenuated virus—that is not happening in this trial.
Right now, this is meant to be 25 months. I just started a couple of weeks ago. I had my first shot and have had no problems. I've been randomized, so I don't know whether I received the placebo or I'm getting this study vaccine. But either way, I'll be blinded all the way until the end. I take my temperature for the seven days after the shot and fill the symptom diary on my phone which syncs to the trial database.
Participants only receive two shots. I received one the first day, which was a couple of Saturdays ago. The entire trial team came in on a Saturday so they could enroll me because they are committed to a diverse cohort. They realize the importance of having a doctor who's a Black woman. I really appreciated that because it'll help to get the word out.
The second shot is in mid-October. All the subsequent visits are follow-up visits—symptom evaluations and physical exams.
AMA: Now that you're getting this firsthand experience with a COVID-19 vaccine trial, do you think that will help when you're talking to patients, in terms of addressing fears or misperceptions they might have about these clinical trials?
Dr. Edje: Absolutely! I have patients who trust me as a family doctor. I’m in a unique position to field questions generated around trust on a regular basis. “Would you go to that specialist? Would you have that procedure yourself?” Patients trust family docs in a way that's very special, largely because of the relationships that we've built with them over time.
A fundamental pillar in family medicine is continuity of care, often over a lifetime. We care for entire families and their entire health care experience. We meet them when they are at their weakest point and while they're in their fullest wellness—the full gamut. We build that trust over time and over different experiences. We are privileged as family physicians to have a significant impact on the communities that we live in and that we work in.
AMA: After the vaccine trial is complete, what is your hope for future outcomes?
Dr. Edje: After the trial, I hope the vaccine provides the immunity that we expect, which is prolonged immunity. The next challenge will be to make sure that we have an adequate supply of vaccine. Then, we will need to tackle the barrier of misinformation as we educate patients on its safety and efficacy.
