NEW YORK (CBSNewYork) — One of the most promising COVID-19 vaccine trials has been slowed due to a lack of minority participation. This while the Food and Drug Administration issued strict guidelines that vaccine makers must meet to gain emergency use authorization.
The FDA vaccine guidelines had been delayed by the White House because they made it unlikely that a vaccine could be authorized before the November election. At the same time, the large Moderna Phase 3 trial has hit a snag due to insufficient minority volunteers.
CBS2’s Dr. Max Gomez explained why that is important.
Private contractors hired by Moderna to recruit volunteers for its coronavirus vaccine trial failed to enroll enough Black, Latino and Native American participants. As a result, Moderna slowed enrollment in its late-stage trial and instructed research centers to focus on increasing participation among minorities.
Dr. James Powell, who has worked for decades to increase diversity in clinical trials through Project Impact and the National Medical Association, explained why this is critical.
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“There’s a potential for differences in response to medications. There’s co-morbid conditions, different diseases,” Dr. Powell said. “They may have environment, ancestry, genetics, habits and practices as a medical critical subclinical injuries to patients that might alter the way in which they respond to a particular drug.”
That’s why the National Institutes of Health requires minority participants in research involving human subjects. And knowing those variations are especially important when millions of eventual vaccine recipients will be part of the very populations hardest hit by the coronavirus.
Powell said that part of the difficulty recruiting minorities, particularly African-Americans, dates to mistrust engendered by immoral medical experimentation on Blacks in the 1930s. But, beyond that, volunteers for trials ideally need to be recruited by medical professionals they trust, people who look and speak like them.
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