Large U.S. covid-19 vaccine trials are halfway enrolled, but lag on participant diversity

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Fri, 2020-08-28 23:58 — mike kraft

Large U.S. covid-19 vaccine trials are halfway enrolled, but lag on participant diversity Moderna and Pfizer are halfway to signing up the 30,000 participants they need for the final stage of testing. But only about a fifth are Black or Hispanic. Carolyn Y. Johnson Washington Post

Moderna and Pfizer, the companies leading the U.S. race for a coronavirus vaccine, disclosed this week they have enrolled more than half the people needed for the 30,000-person trials that represent the final phase of testing. But only about a fifth of participants are from Black and Hispanic communities, which have been hit hardest by the virus — lagging what several experts said should be the bare minimum of diversity.

An online registry that people can use to express interest in the vaccine trials — a list of about 350,000 volunteers — had only about 10 to 11 percent Black and Hispanic people as of late last week, according to James Kublin, executive director of the federal HIV Vaccine Trials Network, based at the Fred Hutchinson Cancer Research Center in Seattle. The HIV trials network is being repurposed to test coronavirus vaccines.

“We are working a bit uphill, in the Sisyphean task to get the studies representing the diversity [of the U.S.] — and that goes into the historical legacy of not just discrimination, but of outright unethical medical practices” on minority communities, Kublin said.

Creating vaccine trials that, at minimum, mirror the racial and ethnic breakdown of the American population, which is about one-third total Black, Hispanic and Native American, has been a major focus — a necessity to make sure any vaccine works for everyone and is broadly accepted. Current enrollment numbers lag even that target.

And, in recent weeks, debate in scientific circles focused on how trials for a coronavirus vaccine need to go beyond simply reflecting the composition of the nation’s population. Instead, many scientists argue, enrollment efforts should reflect the disproportionate burden of disease, hospitalizations and deaths borne by Black, Hispanic and Native American communities.

“The intent is to make a vaccine safe and effective for all Americans. Since there’s disproportionate burden of disease, enrolling people based on census numbers is a minimal target. I personally don’t think we should go below that,” said Nelson Michael, director of the Center for Infectious Disease Research at the Walter Reed Army Institute of Research. ...

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