The multi-billion-dollar effort to get a coronavirus vaccine on the market could see delays because researchers haven’t recruited sufficient numbers of minorities to join the clinical trials.
Of the 350,000 people who’ve registered online for a coronavirus clinical trial, 10% are Black or Latino, according to Dr. Jim Kublin, executive director of operations for the COVID-19 Prevention Network.
That’s not nearly enough, as study subjects in trials are supposed to reflect the population that’s affected. Research shows that more than half of US coronavirus cases have been among Black and Latino people.
Dr. Francis Collins, director of the National Institutes of Health, gave the Moderna trial, the first in Phase 3 in the United States, a “C” grade for recruiting minorities.
“From the first week I saw the numbers, and they were not as encouraging as I would have liked,” Collins told CNN.
The stakes are high. Operation Warp Speed, the government’s effort to develop a coronavirus vaccine, says it aims to deliver 300 million doses by January — a speed unheard of in the history of vaccine clinical trials.
If not enough Black people and other minorities enroll, the panel of experts who monitor the trials could force a delay until they get the numbers they need.
“That’s something that’s been actively discussed,” said Dr. Nelson Michael, coordinator of community engagement activities for Operation Warp Speed. “There’s a lot of concern.”
Michael said several factors have led to “a perfect storm of not goodness” for recruiting Black study subjects: historical abuse of Black people in medical experiments like Tuskegee; present racial injustices and health care disparities; and recent social unrest and the financial strain placed on the Black community by the faltering economy.
Black leaders agree that it’s a challenge to recruit Black people into the vaccine trials, especially since it needs to happen very quickly — the first two Phase 3 clinical trials started in late July and expect to finish enrollment in September.
“This is a very, very tall order,” said Dr. James Powell, a Cincinnati physician who has been approached with requests to encourage Black participation in the vaccine trials.
“When we Black people hear ‘clinical trials,’ we think ‘we’re not going to be researched on,’ and that’s across economic status and across educational status, not just one sector,” said Renee Mahaffey Harris, president of The Center for Closing the Health Gap in Cincinnati.
Moderna and Pfizer, the two US companies currently in Phase 3 trials, won’t reveal how many of their participants are from minority groups. Each trial eventually expects to recruit 30,000 participants.
Moderna’s 89 trial sites across the United States are “actively working within their local communities to reach a diverse population of volunteers,” Ray Jordan, a company spokesman, wrote in an email. “We hope to achieve a shared goal that the participants in the (Covid-19 vaccine) study are representative of the communities at highest risk for COVID-19 and of our diverse society.”
A Fourth of July Zoom call
At 10:20 p.m. on July 3, NIH’s Collins sent an email to colleagues asking for a Zoom meeting the next day.
“I certainly ruined everybody’s holiday,” Collins remembers.
But he said the topic was “absolutely critical.” He wanted to discuss how to recruit groups such as minorities and older people into the trials.
Collins says he told those at the July 4 meeting, including Michael and Dr. Anthony Fauci, that they had to make sure the trials “didn’t go down the wrong path, because the default was clearly going to be that a lot of young white people would be likely to sign up, and we would have a trial that was scientifically way short of what it needed to be and would not engender anybody’s confidence.”
Federal law and NIH policy mandate inclusion of minorities into clinical trials because vaccines and drugs might have a different effect on them than they do on White people.
If an insufficient number of minorities sign up, the experts monitoring the trials might require additional recruitment.
“The Data Safety Monitoring Board could slow the trial down,” Michael said. “If the demographics aren’t right, they could tell the sponsor to slow enrollment down until you hit different numbers. They could say ‘We do not want you to develop a vaccine tested for safety and efficacy basically on a single ethnic group.’ ”
There’s another reason why researchers are trying to include minorities.
If everyone who volunteered for a coronavirus vaccine trial got their shot and then stayed home, at the end of the study they would likely all test negative for the virus, not necessarily because the vaccine worked, but because they never encountered the virus in the first place.
That’s why in any vaccine study, including this one, researchers seek out study subjects who are most likely to come in contact with the virus in their daily lives.
That’s health care workers, for example, and also minorities, who are more likely to have essential jobs that require in-person work, and more likely to live in multigenerational, multifamily households, among other factors.
A study by the US Centers for Disease Control and Prevention, examining reports of nearly 600,000 cases where race was indicated, found that while 13% of the population is Black, 22% of cases were Black. The report also found that while 18% of the US population is Latino, 33% of cases were Latino.
Since about half of case reports don’t indicate race, researchers have also looked at the incidence of COVID-19 on a county level. While nearly 20% of US counties are disproportionately Black, they account for 52% of COVID-19 diagnoses and 58% of COVID-19 deaths nationally, according to the report published last month in the Annals of Epidemiology.
After that Fourth of July meeting, the mission was clearer than ever: Engage minority communities to encourage them to join the clinical trials.
“There is a tremendous amount of pressure on this now. I’ve never seen community engagement get this level of play. Not even close. Ever,” Michael said.
‘I’m an old white guy’
Collins and Fauci, director of the National Institute of Allergy and Infectious Diseases, have made it clear they they’re not the ones to speak directly to minorities to increase trust in vaccines.
“I’m an old white guy at NIH,” Collins told USA Today in June. “Credibility is not going to come from another bunch of government officials pounding the table and saying, ‘This is good for you.'”
Fauci told CBS News last month that “a white guy like me with a suit like me and a tie on going in, talking to people who are people that you don’t usually relate to every day” wasn’t the best approach.
“You want to go into the African American community with people who look and think and act like the people you’re trying to convince,” he said.
That’s Mahaffey Harris, who has been doing advocacy and development work with minority communities for 30 years.
On August 5, Mahaffey Harris received a call from a doctor asking her to recruit minorities into the Moderna vaccine trial.
She knows she didn’t give him the answer he was looking for.
At this point, Mahaffey Harris won’t recruit people for the clinical trials. She won’t even put information about the trials on Covid19communityresources.com, a website run by her group, the National Association for the Advancement of Colored People, and other organizations.
“I am always cautious when I’m being contacted by anyone involved in pharmaceutical research because I, as a Black woman, never want to be a part of engaging and recruiting people for research that ends up having any bias in it or any hint of impropriety, like what happened at Tuskegee,” she said.
She told the coronavirus researcher she will meet with him later this month.
She has received these calls in the past for other clinical trials.
“They’ll say, ‘I need 100 people’ and I say, ‘I’m not just going to get you 100 people,” she said.
None of this surprises Dawn Baker, the first person in the United States to receive a coronavirus vaccine as part of a Phase 3 clinical trial.
After getting her first shot, Baker, a Black TV news anchor in Savannah, Georgia, received much love and support from her community, but also disbelief.
“Dawn done lost her damn mind,” one woman wrote on Facebook.
“i got 2 words…TUSKEGEE EXPERIMENT,” another wrote, referring to the infamous medical studies that abused Black men.
Two people just posted GIFs of Black people shaking their heads “no.”
Baker received her shot three weeks ago, but said concerned Black people are still coming up to her, asking if she’s feeling OK.
“I told them I’ve never felt better,” said Baker, who doesn’t know if she received the vaccine or the placebo. “But I can tell they’re not sure if they believe me.”
Government efforts to engage minorities
The NIH says it has “engagement efforts” with various groups, such as those that represent Black churches and Black doctors and nurses. Operation Warp Speed, a part of the US Department of Health and Human Services, says it has engaged with minority organizations as well.
Collins noted that some of the Moderna sites are commercial and others are a part of NIH’s network. He said when the trial began July 27, the commercial sites started up first, and the NIH sites have opened up more recently.
“The NIH funded sites are in a better position to be able to emphasize and do the community engagements, to try to reach out to minority communities,” he said. “Watch this space — we’re going to see this improve I think fairly rapidly,” he said.
He added he had a meeting with top Moderna executives on July 10.
“I heard from them that they were really committed to this kind of diversity in enrollment,” Collins said. “I heard absolutely strong endorsement of that from Stephane Bancel, the CEO, and from Stephen Hoge, the president. I was not concerned that they were considering this just a nice thing to do; they were clearly very committed.”
The NIH set up the COVID-19 Prevention Network to recruit participants into the trials. In the next week to 10 days, the network will be releasing materials, such as print and radio spots and videos for social media, targeted to specific groups, including minorities, according to Kublin, the network’s executive director of operations.
“I wish it had started a month go,” Kublin said. “We have, all of us, been working 24/7 to make this happen as quickly as possible.”
Michele Andrasik, the director of community engagement for the network, said she recognizes the hurdle to recruiting minorities for trials, but is optimistic that progress can be made as her group works on outreach programs in partnership with community groups.
“I think there are ways we can address the challenges that are inherent at the pace of what we’ve all been asked to do,” Andrasik said.
What’s not working: warp speed
As the name Operation Warp Speed suggests, the government and pharmaceutical companies are working quickly to come up with a vaccine against COVID-19.
Moderna and Pfizer started their Phase 3 trials July 27 and plan to fully enroll them in September. That’s a speed unheard of in the history of vaccine clinical trials.
But Black leaders interviewed for this story said mistrust of medical institutions and the government, based on centuries of abuse and injustices, can’t be undone that fast.
“That doesn’t happen at warp speed,” said Dr. James Powell, a principal investigator for Project IMPACT, or Increase Minority Participation and Awareness of Clinical Trials, a part of the National Medical Association, which represents African-American physicians and their patients.
“They’re not going to get the numbers for next month that they want. You have to build that trust,” added Dr. Doris Browne, the president of the NMA.
This mistrust is not just based on the Tuskegee experiment, where from 1932 until 1972, Black men were subjects in a syphilis study without their knowledge or consent and were not offered penicillin to treat their disease.
It’s also the legacy of Dr. J. Marion Sims, considered the father of modern gynecology, who in the mid-1800s experimented on slaves in the South, performing surgeries without their consent and without the use of anesthesia before surgery.
And from the 1940s until the 1970s, in several studies, researchers exposed hundreds of study subjects, mostly Black people, to potentially fatal amounts of radiation, according to Harriet Washington, author of “Medical Apartheid: The Dark History of Experimentation from Colonial Times to the Present.”
Injustices and disparities continue to this day.
“African-American people get treated differently. They have less access to doctors. When they describe their symptoms, they are not believed as often as Whites are. Medical technology is withheld from them. All of these things are a matter of record,” said Washington, a lecturer in bioethics at Columbia University.
“Now we’re approaching them with an experimental vaccine that we’re offering as a benefit — but asking people to trust that is asking a great deal,” she added. “There’s a risk to taking an experimental vaccine. There’s just no way to sugar coat that.”
Phase 1 and 2 trials of experimental coronavirus vaccines, with dozens or hundreds of study subjects each, have shown the vaccine to be safe. While some participants did experience symptoms such as fever and muscle aches, they felt better after a day or two.
Black leaders interviewed for this story said part of the problem is they were contacted by vaccine researchers just days or weeks ago, which didn’t leave them much time.
John Daniels is an attorney advising a COVID-19 advisory group for the Church of God in Christ, the largest Pentecostal denomination in the United States with millions of adherents, predominantly African American. He said he received a call requesting help just two weeks ago.
“This has to be vetted through a process,” he said. “At the Church of God in Christ we have a health advisory group that involves a dozen or so national experts and it takes time to walk through this and translate it to the 1,500 ministers and say what are we going to do for the six to eight million people who are in our church.”
Daniels and other leaders wondered why they were contacted so recently when it’s been known for many months that minorities would be needed in the trial.
“The researchers knew where they needed to be. Why did they wait until now?” said Powell of Project IMPACT.
The key for researchers to get what they want, he and others said, is to invest in long-term relationships with the Black community, and not call just at the beginning of a trial, asking Black people to roll up their sleeves and take the injections.
“Mistrust is always there when you don’t invest in trustworthiness,” he said.
Browne, the NMA president, said the vaccine researchers should have involved Black doctors from the start, as part of the planning and implementation of the trials.
“We are not in any way going to come in at the last minute to be utilized as an entrée to get African-Americans or other people of color involved in a program where we don’t have a clear understanding of every phase of it,” she said.
What could work: relationships
Dr. Paul Bradley knew in advance that his office in Savannah would be the very first site in the United States to give someone an injection in a Phase 3 coronavirus clinical trial.
He knew that the first person he injected would get media attention. He thought about who that person should be, and Dawn Baker’s name came immediately to mind.
Bradley has been Baker’s family doctor for more than 30 years. He knows Baker is well-loved and has tremendous credibility in Savannah. Plus, he knew that, as a local TV anchor, she would handle interviews flawlessly.
And yes, she’s Black — that was a bonus, he said. He knew she’d inspire other Black people, and White people, too, to join the trial.
He asked her if she was interested, and she said yes.
“We’ve developed a great rapport. I go to events, and he’s there. I’ve met his family. It’s not just a medical relationship. I really do trust him,” Baker said. “I knew Dr. Bradley wouldn’t do anything to hurt me.”
The next day, many of the people who came to Bradley’s office to volunteer — both Black and White — cited Baker as the reason.
Baker said she knows there’s resistance in her community to joining clinical trials, and she hopes she made a difference.
“Maybe since I was at least bold enough to come forward right now, that might change that — that could eventually save their lives,” she said. “I hope that maybe just seeing my face will help them to change their opinions about that.”
Bradley’s connections to the community helped in other ways, too.
He’s known Savannah Mayor Van Johnson for years, and the two have discussed the trials. After they talked, the mayor posted an article about the trials on his Facebook page. Recently on his “Friday Fun” Facebook livestream show, one of his guests was Dr. Carlos del Rio, who’s running Moderna’s trial at Emory University in Atlanta.
“I don’t take this lightly, to speak the truth and tell people to check it out and be a part of something,” the mayor said. “If it wasn’t for the people who stood up for the polio trials, we’d still have polio around.”
Then Bradley spoke with Ricky Temple, pastor of Overcoming by Faith, one of the largest churches in Savannah with 3,000 members.
Ask any vaccine researcher about recruiting Black clinical trial participants, and they’ll mention the power of churches. Their hope is that during a Sunday sermon, a preacher will encourage his or her flock to sign up.
Before he spoke with Bradley, CNN asked Temple if he’d ever consider speaking about the trials from his Sunday pulpit.
“You can’t just have a preacher say, ‘in our announcements today, trials are going to be held, and they’re looking for Black people,'” Temple said. “The audience is going to be — ‘What they’re going to come and put a germ in me?’ They’re going to be scared to death — “you gonna put coronavirus in me?'”
After speaking with Bradley, Temple surveyed those close to him in the church, asking if he should bring the clinical trials up at a Sunday service.
“I met with my staff, and no one supported me doing it. They were 100% no, because of Tuskegee. I asked members, I asked families, and I got the same response. It was incredibly consistent. What I heard was fear,” Temple said.
Temple’s decision: to create a “courageous conversation” about the clinical trials with leaders in his church.
“We’re big readers in our church, and I’ll send out some documents. We have many medical professionals in our congregation, and I’ll get them together, and we’ll discuss this,” he said.
He wonders why he has to put together documents that can address the fears about clinical trials. If the US government is so anxious to get minorities to enroll in the trials, why hasn’t someone created a website, or even a pamphlet, with information?
Temple said one of the first things he’ll distribute to his church leadership is information about how, in 1997, then-President Bill Clinton apologized for the Tuskegee study, saying that the men were “lied to by their government,” that the experiment was an “outrage” and “deeply, profoundly, morally wrong.” Clinton said he was sorry “that this apology has been so long in coming.”
Temple thinks that might make a difference in the eyes of his congregants.
“I’ll create these courageous conversations, because this is something we should pray about, something we should care about,” he said. “I think this could be an interesting education you can have if you open your heart to it.”