Reuters: 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 determine how well the vaccine works in these populations, company executives and vaccine researchers told Reuters.
To make up for the shortfall, Moderna slowed enrollment of its late-stage trial and instructed research centres to focus on increasing participation among minority volunteers, the company said. The effort is being bolstered by academic researchers who have longstanding relationships with organizations in Black and other minority communities.
Five investigators working on the Moderna trial said in interviews that commercial site investigators quickly filled a large portion of the 30,000-person study with mostly white volunteers.
But COVID-19 infects Blacks in the United States at nearly three times the rate of white Americans, and they are twice as likely to die from the virus, according to a report by the National Urban League and other studies.
And communities of colour count prominently among healthcare workers and populations at high risk of COVID-19 complications, making them among 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 test the Moderna vaccine at five sites, said efforts to enrol volunteers from diverse backgrounds to provide proper population balance is “notoriously difficult” in any clinical trial.
“If there’s a problem with recruiting minorities, and there is, you can’t 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% to reflect the actual US population.
During the last two weeks of September, Moderna said it increased the proportion of Black enrollment, but declined to provide details.
Increased trial participation could help address distrust between communities of colour and the medical industry after years of underrepresentation in pharmaceutical research, historical horror stories of medical experimentation without consent, and socioeconomic and health access inequities, vaccine experts and public health officials say.
One-fourth of Moderna’s 100 trial sites are run by academic centres that are part of the National Institute of Health’s (NIH) COVID-19 Prevention Trials Network (CoVPN), while the rest are largely commercial subcontractors. A contract research organization called PPD was hired by Moderna to oversee the trial sites.
“We are essentially making up” for the commercial 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 sites with outreach programs staffed by doctors and nurses with ties to minority communities.
