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Diversity In Coronavirus Vaccine Trials Demanded From Drug Companies

ARI SHAPIRO, HOST:

Black and Latinx people are more likely to get sick and die from COVID-19. That's also true of older people and those with underlying health conditions. These groups are generally among the least likely to be included in vaccine trials, which is important as two companies have announced that they are starting coronavirus vaccine trials that may enroll up to 30,000 people each. Reporter JoNel Aleccia wrote about this for Kaiser Health News and joins us now.

Welcome.

JONEL ALECCIA: Thanks for having me.

SHAPIRO: Why is it important that these groups that are more likely to be affected by COVID-19 also be represented in trials for a coronavirus vaccine?

ALECCIA: Well, the short answer is we want to test a vaccine in the population that's most at risk for serious problems and the population most likely to receive the vaccine. If we don't test in groups that are representative of the community, we won't really know how well a vaccine will actually work.

SHAPIRO: Well, these trials are taking place all over the country so far. Is there any evidence of whether they will reflect the demographics of those most affected by the virus?

ALECCIA: Well, there is some good news. The structure that's been put in place to coordinate these trials is based on four long-standing clinical trial networks, including several that are focused on HIV and AIDS. So they have deep experience and connections with minority and other communities and can draw on those connections for the COVID trials.

SHAPIRO: What are the hurdles? What's standing in the way?

ALECCIA: Well, one of the things that's standing in the way is that there have been NIH rules for more than 25 five years calling for minorities to be included in clinical trials. There is a new policy that took effect just last year that would require older adults to be included. And even the FDA's guidelines for conducting these COVID clinical trials call for them to include racial and ethnic minorities, older people, those with underlying conditions. But even that guidance refers to them as nonbinding recommendations.

And so when I asked the FDA whether they'd refuse to accept vaccine trial data that didn't include diverse people, they said no. They would still accept that data. And so what the experts told me is that if you don't require it, it won't necessarily happen. There's another factor as well, which is there's this hurdle of minority distrust of the medical system. I mean, there's a long history of disparate, even dangerous treatment of minorities in scientific research and basic care. And many are hesitant to volunteer for a trial because they don't want to become guinea pigs in somebody's research.

SHAPIRO: So what are the companies that are conducting these vaccine trials telling you?

ALECCIA: Well, the companies have to file their demographic goals with the National Institutes for Health, but they aren't required to disclose them publicly. So generally, that means we can only learn about the racial, ethnic and age makeup after the fact. The companies are saying they want these trials to be diverse. They're saying that they are doing everything they can to make them as diverse as possible. This week, NIH Director Francis Collins noted that they are tracking the enrollment week by week. They're tracking these diversity goals week by week. And he suggested that it might be made publicly available and said it ought to be.

SHAPIRO: If the trials do not include people representative of the groups most affected by COVID-19, is there a risk that the vaccine won't be as helpful as it could be?

ALECCIA: Yeah. Researchers are starting out with great intentions. Everyone wants to make sure these trials are inclusive. But they're under this enormous pressure to enroll participants quickly, to accumulate their data and make sure to hit their internal milestones for development. It can be difficult to recruit and retain minority and older volunteers. It can take more effort. But it's crucial because if we don't include the vast representation of the community in the trials, then we don't really know how it works in this whole population.

SHAPIRO: That's JoNel Aleccia of Kaiser Health News.

Thanks for your reporting.

ALECCIA: Thanks very much. Transcript provided by NPR, Copyright NPR.

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