Moderna sees shortcomings in coronavirus trial minority enrollment, faces delays: report
The proportion of minority participants should reflect nationwide population to determine efficacy in these groups
Moderna’s hired contractors have not enrolled enough trial participants from minority groups to determine efficacy in these populations, per a report.
To address the shortcoming, the company reportedly slowed its late-stage trial enrollment and directed a focus on the inclusion of Black, Latino and Native American volunteers, executives told Reuters. Academic researchers who already have rapport in these communities are said to be assisting the effort.
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Moderna’s Phase 3 trial for its vaccine candidate aims to enroll up to 30,000 volunteers. As of Oct. 2, about 33% of enrolled participants were from minority populations. Five investigators with the trial reportedly said that commercial site investigators were quick to fill a substantial portion of the study with mostly White volunteers.
However, as of Aug. 18, the rate of coronavirus cases occuring among Black individuals was 2.6 times higher than that among White individuals, with a nearly 5 times higher rate of hospitalizations, according to figures from the Centers for Disease Control and Prevention (CDC).
Dr. Paul Evans, chief executive of Velocity Clinical Research in Durham, N.C., and hired to test the vaccine at five sites, reportedly said the task of minority enrollment for “proper population balance is ‘notoriously difficult’” across any trial.
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“If there’s a problem with recruiting minorities, and there is, you can’t fix that overnight,” he told Reuters.
The outlet reported that, as of Sept. 17, Black Americans consisted of 7% of trial participants — a figure that should come closer to 13% for an accurate representation of the nationwide population.
Of the 100 sites across the U.S. involved in the trial, 18 were classified as “active not recruiting” by Tuesday morning, without a reason listed.
Moderna did not immediately return Fox News’ request for comment Tuesday.