covid immunity

Will COVID Vaccine Trials Reflect U.S. Diversity?

These trial networks were chosen in large part because they have rich relationships with black, Latin American and other minority communities, said Stephaun Wallace, CoVPN’s director of external relations. The hope is to build on existing connections based on trust and collaboration.

“Our clinical trial sites are prepared and ready to engage a variety of people,” Wallace said.

Wallace recognized, however, that to attract a diverse population, investigators need to be flexible and innovative. There may be practical problems. Clinic hours may be limited or transportation may be a problem. Seniors may have sight or hearing problems and need extra help following protocols.

Mistrust of the medical establishment can also be an obstacle. African Americans, for example, have a well-founded suspicion of medical experiments after the infamous Tuskegee study and the exploitation of Henrietta Lacks. It goes as far as suspicion about recommended vaccines, Wallace said.

“Part of the consideration for many groups is that they don’t want to feel like a guinea pig or feel experienced,” he said.

Moderna, which plans to launch its Phase 3 trial on Monday, said the company was working to ensure that participants “are representative of communities most at risk for COVID-19 and of our diverse society.”

However, results from the company’s Phase 1 trial, released in mid-July, showed that of 45 people included in that safety test, six were Hispanic, two were black, one Asian, and one Native American. Forty were white.

Phase 1 and phase 2 clinical trials aim to test the best dose and safety of vaccines in small groups of people. Phase 3 trials are testing the drug’s effectiveness in tens of thousands of people.

Investigators at nearly 90 sites across the United States are now preparing to recruit participants for Moderna’s Phase 3 trial. Dr. Carlos del Rio, Executive Associate Dean at Emory University School of Medicine, will seek 750 volunteers at three sites in the Atlanta area. Half will receive the vaccine; half, placebo injections.

Del Rio has had marked success in recruiting minorities for HIV trials and expects similar results with the vaccine trial. “We are trying to do our best to get to the communities most at risk,” he said.

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