COVID-19 vaccine trials need diverse volunteers to ensure safety, effectiveness and public buy-in – USA TODAY

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BOSTON Dianne Wilkerson wants Black Bostonians to volunteer for trials testing potential COVID-19 vaccines.

She understands why they're hesitant.Black Americans have a long history of being treated poorly by the medical establishment; many faced discrimination in medical care themselves.

Still, if they don'tparticipate in the trials meant to establish vaccine safety and effectiveness, they'll never know whether the vaccines will work for them.

"The risks for not being involved are so great," said Wilkerson, a founding member of Boston's Black COVID-19 Coalition.

About 25% of the city's populationis Black, yet Blacks have made up more than 35% of those infected and killed by COVID-19.

Nationally, the figures are even worse.Just over 80 Black Americans have died of COVID-19 out of every 100,000, compared with 46 Latino Americans and 36 white Americans, according to the American Public Media Research Lab.

The first two large-scale vaccine trials began nationwide in late July, and at least three more will start before early fall. Each one will need 30,000 volunteers, half of whom will get an active vaccine and half a placebo.

Federal officials including the heads of the National Institutes of Health, the Food and Drug Administration, and the Centers for Disease Control and Prevention have called for these trials to include a large number of people of color.

This May 4, 2020 photo from the University of Maryland School of Medicine, the first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection.(Photo: AP)

"We must make sure there is appropriate diversity in the clinical trials," FDA Commissioner Dr. Stephen Hahn said in an recent interview with the editor of the scientific journal JAMA.

Even if everyone's immune system reacts the same way to the virus, differences in care and underlying health may mean people of color respond differently to infection, Hahn said:"We need to make sure those folks are in these trials so that we understand what the immunological effects are, but also the clinical effects."

In addition to racial and ethnic diversity, most of the trials also are looking for people over 65. Older immune systems don't work as well as they used to, and older people have been disproportionately sickened and killed by the virus that causes COVID-19.

Early trials haven't been diverse.

In the two small clinical trials that have published their results, one in The New England Journal of Medicine, one in The Lancet, only eight of 1,100 participants were Black.In both studies, participant age averaged in the mid-30s.

It's not for lack of enthusiasm in the trials. More than 300,000 people have already expressed interest in volunteering to participate.

The Fred Hutchinson Cancer Centerin Seattle, which is managing a registry of volunteers, is not breaking them down by demographic group. But Hahn said 19% of those who had volunteered so far were Black and nearly the same percentage were Latino.

And although 300,000 sounds like a lot of volunteers, it's not nearly enough, said Claire Hudson, a spokesperson for the center.

"Its important to note that we need millions of interested volunteers to join the online registry," coronaviruspreventionnetwork.org, she said via email.

Not all the people who express interest in volunteering will make it into one of the trials, Dr. FrancisCollins, director of the National Institutes of Health,explained at a teleconference announcing the start of the first trial.Some volunteers might not live near testing sites, for instance.

"The more the better," Collins said of volunteers. "This is going to be a big American opportunity for people to come on board as our partners to try to take part in what has been a historic effort to bring to an end the worst pandemic our world has seen in over 100 years."

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Dr. Barbara Pahud has a plan:If not enough people of color will come to major medical centers to volunteer for clinical trials, she'll bring the clinical trials to them.

As a medical student in Mexico, Pahud was given a cooler of shots to deliver to the community. Now, she's has outfitted a van that she plans to park perhaps at a health center or church to take vaccine trials where Americans of color spend their time.

Pahud, research director of pediatric infectious diseases at Childrens Mercy Kansas City, said she's also making an effort to hire people who speak Spanish, and to have all printed material available in two languages.

"The usual stuff that should always be done is actually being done this time, which is fantastic," she said.

Dr. Barbara Pahud, MD, MPH and Research Director of Pediatric Infectious Diseases at Childrens Mercy Kansas City.(Photo: Children's Mercy Kansas City)

Researchers and community members will both need to take a risk.

"If we really want to do research that reflects the community that we live in, that is being impacted by this disease, we (researchers)need to change our mindset," Pahud said. On the flip side, "communities need to understand that if they want to benefit from the vaccine, they need to let their people volunteer, or we won't be able to know if the vaccine works in their population."

Others are making similar efforts.

At the University of Colorado, Thomas Campbell said his medical practice has used its electronic medical records to identify and reach out to everyone at high risk for COVID-19.

"I've already had over 100 people email me personally and said 'sign me up,'" said Campbell, also aninfectious disease physician at UCHealth.

Pfizer, which has launched its own 30,000-person trial, is locating its trials in diverse communities, including some with large Hispanic and Black populations, spokesperson Sharon Castillo said.

"We're making sure that the demographics of our trial population reflects the demographics of the states and communities that have been most impacted," she said.

Pfizer also is working with partners, such as grassroots organizations and local and Spanish media, to raise awareness and encourage participation. And the company is reducing barriers to participation, Castillo said, by printing materials in five languages.

"We're learning a lot on how to go above and beyond to make sure minorities are represented," she said, promising that Pfizer would continue this approach in all its clinical trials going forward.

Butgood intentions may not be enough.

Wilkerson said a recent meeting with officials at Brigham and Women's Hospital did not end where she wanted it to.

The hospital has reached out to Black leaders, including Wilkerson, for help in encouraging minority participation in these trials. Hospital officials said that meeting and others with local people of color have gone well.

But Wilkerson said a few listening sessions and dropping flyers at local communities centers won't be enough to redress decades of mistrust, or to get Black Bostonians to participate.

"We have an opportunity to reset how (hospitals)relate to Black and brown people," she said, adding that her group plans to seize that opportunity:"We intend to get their attention."

Contact Karen Weintraub at kweintraub@usatoday.com

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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COVID-19 vaccine trials need diverse volunteers to ensure safety, effectiveness and public buy-in - USA TODAY