Right now, at least nine COVID-19 vaccines are in or near a large-scale human trial phase. But enrollment of minorities in the trials remains a challenge.
With Black, Latinx and American Indian/Alaska Native communities throughout the nation disproportionately impacted by COVID-19 disease and death, scientists agree, it is critical that clinical trials enroll – more accurately, prioritize – participants representative of these populations.
Reportedly, there’s a big push by regulatory bodies to make sure Black, Latinx, and of other races or ethnicities are fairly represented in clinical trials, but so far, with little results.
As of last week, Pfizer’s trial had 8% African-American participation compared to 75% White. The Moderno trial, which was delayed due to lack of diversity of participants, has just 13% African-American participation compared with 51% White.
Why Study Diversity is Important
Dr. Onyema Ogbuagu, principal investigator of the Pfizer trial site at Yale University, said diversity or race in the study 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.
In addition, diversity in the trials is important to help instill broad public confidence in the shots once they become available.
More than just enroll minority participants in these trials, representatives of the COVID-19 Prevention Network (CoVPN), an organization formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health charged with coordinating Phase 3 vaccine trials, says studies must more accurately “prioritize” participants representative of these populations.
Current Trial Recruiting
COVID-19 trials for several different vaccines are currently being conducted in both Kansas City and Wichita, but none of the studies appear to have done much to reach out into the local community. The University of Kansas is participating in a vaccine trial in both their Wichita and Kansas City locations. We also found trial under Alliance for Multispecialty Research, being conducted by the Center for Pharmaceutical Research in Kansas City and Heartland Research in Wichita.
It took us a lot of research to find those area studies, something the average citizen isn’t going to go through. The lack of information on the studies and outreach to the community, may be part of the reason participation by minorities is so limited.
Outreach to the Community
According to reports, the outreach has been predominately online, which further limits minorities who often have limited access to the internet.
To help increase minority participation the COVID-19 Prevention Network (CoVPN) launched a “faith-based” initiative to reach out to minority communities as a way to increase minority participation in trials and to help disseminate more accurate and updated information about COVID-19 clinical trials.
These faith leaders are charged with implementing a nationally faith-focused COVID-19 and CoVPN education program that supports inclusive engagement of members in key communities.
The campaign, which includes television commercials and print ads, began to roll out the week of Septmber 7.
"This pandemic is not red. This pandemic is not blue. This pandemic is black, is brown, is white. It hits all colors and creeds," a voice-over on one ad says. "But even when things look bleak, we know that someone is full of hope and strength and wants to take action."
The ad features several people of different ethnicities. A second ad shared with NBC News includes a Black bus driver saying he's an essential worker and a Black restaurant worker saying he's a father. "That's why I volunteered," both men say.
Too Little, Too Late?
Just getting the word out takes time.
“I didn’t know anything about the vaccine until now,” Ingrid Guerra told the Associated Press. Guerra signed up last week to participate in a trial after being reached out to by “officials” at a farmers market in Takoma Park, Maryland, outside the nation’s capital.
Even with more outreach, trial organizers have a lot to overcome.
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.
Most African Americans are aware of 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.
Fewer African Americans may be aware of 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.
Still, it’s part of African-American history that makes Black people reluctant to participate in clinical trials.
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.
The Associated Press contributed to this article