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Private contractors hired by Moderna Inc to recruit volunteers for its coronavirus vaccine trial failed to enrol enough Black, Latino and Native American participants to ascertain how well the vaccine works in such populations, company executives and vaccine researchers told Reuters.
To compensate for the shortfall, Moderna slowed registration of its late-stage trial and educated research centers to focus on increasing participation among minority volunteers, the business said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.
Five researchers working on the Moderna trial said in interviews that commercial website investigators immediately filled a large portion of the 30,000-person study with largely white volunteers.
However, COVID-19 infects Blacks in america at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report from the National Urban League and other studies.
And communities of color count prominently among healthcare workers and populations at high risk of COVID-19 complications, making them one of the first likely to be eligible for a new vaccine, experts said.
Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, North Carolina, whose company was hired to check the Moderna vaccine in five sites, said efforts to enroll volunteers from diverse backgrounds to give proper population balance is”notoriously difficult” in any clinical trial.
“If there’s a problem with recruiting minorities, and there is, you can not fix that overnight,” he said.
Black Americans made up only about 7% of the trial as of Sept. 17. That should be closer to 13 per cent to reflect the actual U.S. population.
During the past two weeks of September, Moderna said it increased the percentage of Black registration, but declined to provide details.
One-fourth of Moderna’s 100 trial sites are run by academic centers that are part of the National Institute of Health’s (NIH) COVID-19 Prevention Trials Network (CoVPN), while the remainder are largely commercial subcontractors. A contract research organization named PPD was hired by Moderna to oversee the trial sites.
“We are basically making up” for the industrial sites, said one CoVPN investigator not authorized to speak publicly.
Dr. Larry Corey, co-leader of CoVPN, said the NIH has invested in clinical trial websites with outreach programs staffed by physicians and nurses with ties to minority communities.
“That’s not something that is part of the business model of commercial research organizations,” Corey said.
Moderna is among the furthest along in the U.S. race for a vaccine seen as essential to finish a pandemic that has claimed over a million lives globally. It received more than $1 billion in government financing to develop and produce its candidate, and another $1.5 billion to supply it to the American public.
ENTRENCHED BARRIERS, VACCINE HESITANCY
PPD referred requests for comment to Moderna. But two of the business companies said they had received overwhelming trial participation attention from white volunteers. Several researchers said they struggled to overcome the entrenched barriers that traditionally limit minority enrollment.
The results were decidedly mixed, and recruitment at some underperforming sites was halted, he said.
On Moderna’s website, as many as 17 of the 100 participating trial sites are listed as active but not recruitment, without listing a reason.
Bancel stated the enrollment slowdown, announced in early September, won’t keep the company from seeking emergency use authorization (EUA) for its vaccine in the United States, provided initial results show it to be safe and effective.
Moderna could seek an EUA for inoculating high-risk groups like healthcare workers as early as November.
The company said it will provide complete data on the more diverse trial group in its formal application seeking commercial approval from the U.S. Food and Drug Administration next year.
Even with that approval, there are likely to be hurdles to compelling Black Americans to take the vaccine.
Some trial investigators attributed the minority recruiting shortfall in part to the demands of testing a coronavirus vaccine at unprecedented speed.
“It essentially was becoming first-come, first-served, and it was skewing towards not getting enough minorities,” said Dr. Rambod Rouhbakhsh, a lead researcher in the MediSync Clinical Research Hattiesburg Clinic at Petal, Mississippi, a commercial site hired by PPD for the Moderna trial.
Dr. Moncef Slaoui, who conducts the U.S. Operation Warp Speed program which has financed Moderna’s vaccine and others, combined a virtual town hall last week organized by civil rights leader Jesse Jackson’s Rainbow Push coalition in Atlanta.
He told Black leaders who minority enrollment in Moderna’s trial had fallen short and appealed for help in encouraging volunteers from the community.
“Developing a vaccine that is not utilised in a portion of the populace is the same as having no vaccine,” Slaoui said. “It is absolutely useless.”
