COVID vaccine trials lack important study participants

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ATLANTA — Gwinnett County Transit driver Mikesha Walker talked to co-workers recently about whether they would participate in a COVID-19 vaccine research trial.

They’re ideal participants, many researchers say. They spend more time with the public, which puts them at greater exposure to the disease. Many workers are Black, a demographic that is not adequately represented in trials.

However, Walker said the drivers are very reluctant to participate. Many feel underappreciated and underpaid for continuing to work during the pandemic. They’re also aware of health studies done decades ago, such as the Tuskegee study, which intentionally misled Black male participants about the purpose of the research and the treatment they received.

“They’re not comfortable at all,” said Walker, a union leader. “And it’s bad timing with everything going on in the country with Black Lives Matter.”

Doctors, researchers and community organizations are intensifying their outreach efforts to get more people of color and those considered at greater risk of getting COVID-19 — such as bus drivers, cafeteria workers, police officers and even pastors — in vaccine treatment studies.

A national group of religious and community leaders on Wednesday announced a faith-based initiative to build trust and engage diverse populations in clinical research. The initiative is a program of the COVID-19 Prevention Network, whose efforts will include TV ads encouraging Black and Latino people, among others, to enter the vaccine trials. CNN reported they would air on major television networks as well as BET, the Oprah Winfrey Network, TV One, Telemundo and Univision.

Earlier, Emory University researchers held a virtual news conference with reporters Wednesday on the topic.

There’s scant data detailing the percentage of front-line workers or people considered to be at greater risk of getting the disease. Research shows the percentage of Black and Latino participants in vaccine studies is disproportionately lower in comparison to the rest of the nation.

Moderna, the pharmaceutical company involved in vaccine research with Emory University and other organizations, announced last week it is slowing enrollment slightly in its large clinical trial to ensure it has sufficient representation of minority groups at greater risk for the disease. About one-quarter of Moderna’s trial participants are Black or Latino, according to its website.

In Georgia, Black and Latino people comprise 48% of COVID-19 deaths, according to data gathered from each state by the Kaiser Family Foundation, although these groups make up about 42% of the state’s population.

“The issue of minority participation in clinical trials is not just in vaccines, it really is in every clinical trial and the point is that the population that is most impacted and most affected needs to be represented in trials,” said Dr. Carlos del Rio, an infectious disease expert and executive associate dean of Emory University School of Medicine at Grady Health System.

In the Moderna trial the goal is to recruit 30% underrepresented minorities.

Henry County-based physician Dr. Nathan Segall has contacted several local companies, the county government there and posted billboards to recruit more of these study participants.

“Identifying these individuals and getting them to come in to get vaccinated sooner rather than later, we can save very important time for everyone,” he said.

DeKalb County resident Charles English is one of Segall’s vaccine participants. He’s 67, African American and has bronchitis. “I hit all the wrong, high buttons,” English said.

English received a text message about the study and decided to participate, noting the racial disparities in confirmed cases and deaths. English talked about the distrust many African Americans have about the studies, citing the infamous Tuskegee Experiment.

“The minority community does not have a lot of faith in these vaccines because of certain things that have happened in the past,” he said. “But we’ve got to be pioneers in this. We’ve got to be champions for our people.”

He’s scheduled to receive the second of his two shots next week.

For years, Dr. Jayne Morgan, a member of Piedmont Healthcare’s Heart Institute Research leadership team, has been worried about the lack of racial diversity in clinical trial studies.

The pandemic has heightened those concerns. She points to research showing just two of the 45 participants in an early phase of a COVID-19 vaccine study by Moderna were Black.

Morgan said the gap stems largely from the lack of racial diversity in leadership roles among those involved in clinical research, which needs to change. Another recommendation is removing hurdles that make it difficult for many people of color and front-line workers to participate in studies, like lack of transportation, child care and inflexible work schedules. One suggestion is researchers should set up satellite locations closer to participants.

Additionally, said Dr. Valerie Montgomery Rice, president and dean of the Morehouse School of Medicine, some minorities may face greater risks of contracting the disease because they may hold essential jobs in the service industries that are low wage and don’t offer health insurance or paid sick time, making it more difficult to manage chronic diseases.

“The absence of significant participation by Black patients creates not only a hole in the data, but can contribute to less effective treatments with little data on the impact on that specific population,” she said.

Susan Hurst recently joined an Emory vaccine study because, in part, she wants to do her part in finding a cure. The Marietta resident rattled off the names of several diseases that frightened the public decades ago — such as the measles and chickenpox — and the collective work by scientists and the public to create a vaccine.

She has Type 2 diabetes, she’s part African American, she’s 57 and she’s still been coming to work since the coronavirus pandemic began in March.

“Those vaccines had to start somewhere, and they couldn’t have started at all if there weren’t people willing to help, to take the risk, willing to back up science,” said Hurst, who received her final vaccine treatment Wednesday. “Worldwide, we all need to pull together and get this done because people are dying.”

There have been several COVID-19 outbreaks and deaths across the nation tied to church-related events.

Although his services are online for now, the Rev. Kenneth L. Samuel, senior pastor of Victory for the World Church in Stone Mountain, considers himself at high risk because of his work.

He was tested for COVID-19 after a church member came down with the virus. Samuel’s test was negative.

Still, he would consider participating in a trial to develop a vaccine.

“It’s really important for our people and for our community, so if I could do something to help with the process of developing a safe vaccine for our community, that might be a risk I’m willing to take.”

Samuel, 64, would also encourage his members to consider enrolling in a clinical trial.

“I would encourage people, but I know everybody won’t,” he said. “It’s like ingrained in the mindset of Black people when you consider the syphilis injections. Black folks don’t want to be guinea pigs and we have been. Even in light of that, if the data is transparent, if the information makes sense, if the research is credible, then I think we can overcome that particular fear.”

Griffin Lotson hopes to participate in a clinical trial for the vaccine, but doesn’t consider himself a hero for doing so.

“Finding a vaccine seems to be our only way out,” said Lotson, 66, who is Black and a member of the planning and zoning board for the city of Darien in McIntosh County on the South Georgia coast. “We have to slow it down or stop it, and if we don’t get enough people to enter the trials, it’s going to take that much longer.”

Lotson understands the need to get more diversity in clinical trials. He said when he went to fill out the paperwork for one trial, nearly everyone in the room was white. The process took hours. He was asked a lot of questions about his health history.

He points to the number of African American and Latino people who are getting the virus and dying from it.

“We need to make sure that when there is a cure, it’s for everybody,” he said.

Lotson was diagnosed with bronchial asthma when he was younger. His last flare-up was when he was in his 30s and it nearly killed him.

He knows he’s at greater risk for serious complications, or even death, should he contract the virus.

Not everyone supports his decision, including some family members. They raise the Tuskegee incident, but the way Lotson sees it, “that was in the past and these tests are different now in the 21st century.”

You can go to coronaviruspreventionnetwork.org to enroll in one of the clinical trials to find a vaccine for COVID-19.

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©2020 The Atlanta Journal-Constitution (Atlanta, Ga.)