From the outside, it looks like any other doctor’s office – patients waiting in chairs, nurses and doctors bustling in and out of exam rooms. However, the people who come here willingly agree to get an injection of a trial vaccine that hasn’t been proven to work yet.
Everyone is here in the pursuit of science to help end the coronavirus pandemic – everyone including me.
I am not just reporting on this phase three, randomized Covid-19 vaccine trial at Ark Clinical Research in Long Beach, Ca., I’m also participating in this study which is on behalf of Janssen Vaccines & Prevention, a unit of Johnson & Johnson.
Dr. Kenneth Kim, the medical director and chief executive officer of Ark Clinical Research, says his office will administer shots to about 200 people in the trial and then follow up with them to learn how their bodies’ respond. Overall, the study involves about 40,000 people nationwide, according to Johnson & Johnson.
But who signs up for these trials is key. That’s a large part of the reason why I wanted to volunteer for this Covid-19 vaccine research – more Black people and more people of color need to be part of these trials so more diverse populations can reap the benefits of this medical research. I believe in science and I hope my decision to join a trial and my transparency about the process will help more people trust today’s medicine.
According to Dr. Kim, the number one reason people of color turn down joining a vaccine trial is fear – fear of the unknown and fear of being part of an experiment.
“Rather than thinking of this an opportunity to get access to a new therapy earlier, there’s more suspicion that this could be an unsafe program,” Dr. Kim explained.
Through the course of the pandemic, I have interviewed people who have had the coronavirus. It’s mystifying to me how some people can be asymptomatic while others enter a hospital and tragically never leave, their loved ones unable to be with them as they pass away.
Then there are the people like Jenny Ruelas who I profiled earlier this year. Not only did she listen to her father lose his battle with the coronavirus in the hospital room next to hers, but she still suffers from debilitating, lingering effects of the disease. There are a lot of unknowns about why this virus acts the way it does. However, the data makes it clear that people of color are getting hit hard by Covid-19.
Citing high rates of chronic illnesses in these demographics, Robert Blendon, a professor at the Harvard T.H. Chan School of Public Health, said, “At the moment, Black Americans and Latino Americans are dying from this virus at a much higher rate.”
According to a report published by the Urban Institute, Black, Hispanic/Latinx and Native American workers face greater risks for being exposed to Covid-19 than compared to White people. “The greater virus exposure risks faced by these workers likely contribute to the higher rates of Covid-19 cases and death among these groups,” said the report.
Traditionally, vaccine trials have lacked diversity. America’s history of unethical medical studies on people of color has led to generations of fear. Most notably, the abhorrent, decades-long Tuskegee Experiment that began in the 1930s. It was designed to study untreated syphilis in hundreds of Black men without their consent. But Dr. Kim says it is important to see how vaccines interact with people from different ethnic groups.
“Generally, it’s important that you study people from many different diverse backgrounds because you can have a different side effect profile or you can have different dose levels if it’s a drug,” Dr. Kim said, noting that there could be efficacy and safety variations.
I was warned that this appointment will take hours. In advance, I was screened for enrollment over the phone. The questions were basic – age, weight, height and whether or not I had recently had any other vaccinations. The informed consent paperwork is sizeable. It was emailed to me beforehand, so I already went through it. I was told that I can withdraw from the trial at any time.
Also waiting for his shot was a 22-year-old Conrado Perez. While he was a little worried that his mother might find out about his participation in the trial from my interview, he said he wasn’t afraid to join the study.
“I know a lot of people within my ethnicity would be, I guess, skeptical of it,” Perez said. “But me? Not really. Like actually I trust the medical industry.”
After I finished up with the paperwork, my temperature was taken, and my blood pressure was checked. Dr. Kim used a stethoscope to listen to my breathing and I answered queries about my health, questions like: Have you ever had surgery? Do you have any allergies? What medicines do you take?
The part I was the least excited about was the nasal swab to check if I had Covid-19. But I was thrilled to learn that it wasn’t the test that uses the swab that feels long enough to tickle your brain. Instead, I swabbed my nose myself while the nurse watched.
(In fact, the most difficult part of the process was drawing blood. The very kind technician had difficulty getting into my vein on one arm which she quickly abandoned for my other arm. Much better.)
Then entered clinical research nurse Princess Uy-Dauz. She prompted me to log into the app I had already downloaded onto my phone. This is how I will communicate to the clinicians how I am feeling and to report any symptoms that could be related to Covid-19.
While some vaccines are further along in the approval process, the United States still needs more doses to cover the population. There’s also great interest in vaccine candidates like this one from Johnson & Johnson. For one thing, it’s just one shot unlike the Pfizer and Moderna vaccines which require people get a follow up inoculation. Also, the Johnson & Johnson vaccine doesn’t require special ultra-low temperature freezers for storage like the Pfizer version.
“It does get shipped to us frozen at just the regular freezer setting and then we’re allowed to take it out the freezer and store it in the refrigerator for about 28 days,” Uy-Dauz explains.
Then it was time for my shot. Dr. Kim had already told me my odds. “You have a 50/50 chance of getting the real drug,” he said.
This trial is “double blind” meaning no one in the office knows whether or not I am going to get a sho of the real vaccine or one of just sterile saline – a placebo. Obviously, I don’t know either. I am told a computer has chosen which coded vial will be administered to me. Uy-Dauz told me it’s the same amount as a flu shot.
After getting the shot, I waited in the office for 30 minutes. Uy-Dauz needed to make sure I didn’t have any adverse effects right away. Nothing happened and the site of the injection looked normal, so I was sent on my way with a pulse oximeter to measure how much oxygen is in my blood and a digital thermometer to measure my temperature as instructed by the app.
Stanton Rowe, a White male volunteer, summed up his participation in the trial this way. “Hopefully, I’ll develop immunity over the next few weeks. If not, I’m no worse off than I was before – and I’ve helped the study that I think is important.”
And in my case, I’ve helped the study and hopefully inspired more people to trust the science behind vaccines.
