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COVID-19 Vaccine Researchers Work With Community Leaders To Achieve Diversity In Trials

Tyler Russell
Connecticut Public
Clinicians test patients for COVID-19 at a mobile testing center in Hartford, May 12, 2020.

This story has been updated.

Rev. Elvin Clayton has been the pastor at Walter’s Memorial African Methodist Episcopal Zion Church in Bridgeport for the past six years.

And in the COVID-19 era, Sunday mornings look a little different -- Clayton speaks at the pulpit from behind glass partitions, keeps services to an hour and broadcasts it all live on Facebook. 

“We’ve had great success thus far with it,” he said. 

That continued relationship with church members and the community has been essential in connecting people with their faith -- and with information on medical clinical trials.

“We’re the ones who are baptizing the babies, we’re the ones who are marrying the sons and the daughters, we’re the ones who are burying their loved ones and so on and so forth,” Clayton said. “And we’re the ones who are sharing the good message of the Gospel every week, and this is good news that we can bring about change in medicines.”

AME Zion churches and other community organizations are partners with the Cultural Ambassador program at the Yale Center for Clinical Investigation, a decade-long program that involves community leaders and medical experts working together on scientific research.

The goal is to make sure clinical trial participation reflects New Haven’s diverse population and benefits patients in the community. And now the focus is on Pfizer’s COVID-19 vaccine trial at Yale, which is in Phase 3 of federal research guidelines.

“I myself am a part of that clinical trial to make sure that we are well represented,” Clayton said, “and we have other members of our church and of our community who are doing the same.”

There’s a big push by regulatory bodies to make sure that COVID-19 vaccine trials include people who are Black, Latinx, and of other races or ethnicities -- these residents have been historically underrepresented in clinical trials.

Dr. Onyema Ogbuagu, principal investigator of the Pfizer trial site at Yale, said this is especially important in getting an accurate picture of the vaccine’s potential efficacy in the total population.

“You want to make sure that you’re not just studying it in one group, because if you study in one group, when the data is being evaluated, you can really only extrapolate those findings to a limited number of people,” he said.

But simply wanting a more diverse trial population is often not enough.

A Pew Research Center survey earlier this year found that Black Americans overall are more hesitant than other racial and ethnic groups to trust medical scientists, embrace experimental treatments and sign up for a potential vaccine.

Clayton said that wariness is justified. He points to the “Tuskegee Study of Untreated Syphilis in the Negro Male,” a 40-year study that began in 1932. Researchers did not get informed consent from patients and falsely told them they’d be treated for syphilis, not even when penicillin became an accepted treatment.  

Then there’s the way in which scientists took cervical cancer cells from a Black woman named Henrietta Lacks, who died in 1951. Researchers used her cells for decades after in medical advancements in vaccines, genome mapping, cancer therapies, virology and more -- unbeknownst to her surviving family members.

Clayton said these are just two examples of single incidents within a larger pattern of unethical experimentation on African American people dating back hundreds of years.

“It’s painful,” he said. “But it’s a part of history, and those are the concerns that have come down for years that many of our people are still hesitant to get involved in clinical research.”

Community leaders say this is all in addition to ongoing systemic racism in the health care system that shape new or exacerbate existing mistrust among people of color of health care services, experiments, or providers.

That’s where the Cultural Ambassador partners can make a big difference in bridging gaps in trust and strengthening relationships over time, Ogbuagu said.

“I think in the backdrop of all the social injustice, racism, the very dark history of research experience not just in the U.S. … that history matters,” he said. “I’ve learned that you can’t divorce these issues from accessing the health care system and participating in clinical research.”

The Yale trial site has enrolled about 175 people as of Tuesday in the three weeks it has been open. Ogbuagu said he’s so far pleased with the diversity of the participant pool, and he expects it’ll get more diverse as time goes on.

Pfizer announced this week that it wants to expand its worldwide enrollment for the trial from 30,000 to 44,000 people, in part to increase trial population diversity and improve efficacy data. The proposed expansion would lower the age requirement to 16 years old and open it up to people with chronic, stable HIV and hepatitis C or B infection.

Bruni Pizarro, executive director of Junta for Progressive Action in New Haven, said Puerto Rican and Latinx share with their Black neighbors some of the same hesitancy about joining clinical trials.

And helping people through that can be complex.

“Our approach is to sit and have a conversation and say, ‘Why? How does that make you feel?’ Pizarro said, “to figure out ways to continue to gain trust, especially in this moment.”

She said collaborations with the medical community on education and health messages around clinical trials are moving in a positive direction, but perhaps not as fast as the expedited timeline of the COVID-19 vaccine.

“You can’t go from zero to a hundred overnight. And everything is changing in the world but we’re survivors, and survivors in the struggle, when you think of being on the margins,” Pizarro said. “And our team engages them as humans, as people with opinions and rights. And I think that’s the first step in this process. As simple as that sounds, somehow it gets missed.”

The Pfizer COVID-19 vaccine trial at Yale will be open to new participants until all spots are filled worldwide.

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