And like many Americans, it has touched her personal life, too.
“If there was anything I could do to help find a solution for the greatest pandemic in my lifetime, I was going to do that,” said Dr. Edje, associate dean of Graduate Medical Education at UC Medical Center and a UC Health family medicine physician.
A possible solution? A SARS-CoV-2 vaccine, like the one being tested through Phase 3 clinical trials at institutions across the country — including the University of Cincinnati and UC Health.
UC is one of approximately 90 sites in the United States to host a Phase 3 clinical trial for the mRNA-1273 vaccine developed by National Institute of Allergy and Infectious Diseases scientists and collaborators at biotechnology company Moderna.
Previous studies have shown that this vaccine causes an immune system response similar to people who have recovered from COVID-19. This phase will provide more data about the vaccine’s effectiveness. More than 30,000 people are expected to participate across the U.S., and UC plans to enroll 500 patients locally.
Dr. Edje is the second physician leader at UC and UC Health to share their story about enrolling in the vaccine trial.
“If I can help even one other person enroll in a trial that helps us come to a solution, if I’m able to answer questions, if I’m able to encourage someone else … I can’t do that in darkness,” she said.
“You have to lead by example in the light.”
Deciding to enroll in the Moderna vaccine trial
With how COVID-19 affected Dr. Edje as a leader and physician, the decision to enroll in the federally funded study was an easy one.
When she is serving as associate dean of Graduate Medical Education, Dr. Edje dedicates many of her working hours overseeing the more than 700 resident and fellow physicians who train at UC Health.
During the COVID-19 pandemic, that means ensuring learners are safe as they provide frontline care.
“Being kept abreast of all that makes it very real for me,” she said.
Dr. Edje is also professor-educator for UC ‘s Departments of Family & Community Medicine and Medical Education, as well as a physician at UC Health.
She hopes her participation in the trial lends credibility to its safety in her patients’ eyes, especially those who belong to minority populations.
“As a Black woman, I need to be able to articulate the importance of the trial to my patients,” said Dr. Edje, who referenced the historical impacts of medical research on African Americans. “If I were a patient and having my doctor ask me to be in a trial, I would ask, ‘Why aren’t you in the trial?’”
As a physician, Dr. Edje also is concerned about the impact of the pandemic on her patients in another way: Troubling trends in Cincinnati indicate domestic violence against women has increased during the pandemic.
And then, like millions of people across the globe, COVID-19 claimed one of Dr. Edje’s loved ones.
“The final push was when my stepmother passed away a couple of months ago from COVID,” Dr. Edje said. “She lived overseas, but it hit me more than I ever expected.”
What happens during a participant’s appointments?
With her busy schedule, Dr. Edje was able to attend her first appointment on a Saturday, as she needed to set aside three hours.
Before she stepped foot into UC Health’s Infectious Diseases clinic, Dr. Edje reviewed informed consent forms with a research representative. Informed consent is the process of learning and understanding the details and risks of a study so that people can decide whether they want to participate.
“They went through page by page telling me exactly what would happen,” she said. “All my questions were answered.”
The appointment involved a brief physical exam, and then a stick in the arm, either the vaccine or a placebo — participants don’t know which one.
Dr. Edje will receive a second shot and five follow-up visits. She takes her temperature and records her symptoms every day for the seven days after the shot. She will be involved in the study for two years.
The physician and associate dean has complete confidence in the safety of the trial.
“I travel at the speed of science — as long as the vaccine is developed at the speed of science, that’s the right speed,” she said.
All clinical trials, in all phases of development, must pass high standards of safety and ethics through approval from a panel of people, called an Institutional Review Board.
Scientific research is responsible for much of our country’s medical breakthroughs: At UC, that includes the invention of the oral polio vaccine and the use of clot-busting drug tPA to treat stroke.
“Clinical trials rigorously test the effectiveness of solutions to diseases so that treatments are reliable and safe for use in appropriate populations,” Dr. Edje said.