While presenting the Covid-19 vaccine study she’s running, Susan Little was asked for a promise she didn’t have the power to make. A respected local politician refused to support the trials unless Little could ensure that the people of color being prioritized as volunteers would also be prioritized once an effective vaccine was approved.
“They wanted some sort of guarantee that the communities we are asking to participate now are not left behind,” said Little, the infectious disease doctor leading the AstraZeneca vaccine trial at University of California, San Diego.
At another virtual meeting — this one put on by the Chicano Federation — a potential participant expressed a related concern. “If I experience side effects, what happens if I don’t have health insurance?” Nancy Maldonado, the organization’s CEO, remembers someone asking.
Lurking underneath both of those interactions was that old, oh-so-American anxiety about being unable to get medical care. It was just one of the everyday inequalities that made would-be volunteers hesitant as researchers scrambled to include more people of color in their studies — a must to ensure that the shots are equally safe and effective for everyone.
That the communities hardest hit by Covid-19 have also been woefully underrepresented in clinical trials is no coincidence, and in racing to find 30,000 participants who could represent an even broader population, pharma companies have found themselves face to face with health care’s deepest fault lines. Being Black, Latinx, Native American, or Pacific Islander, for instance, means you are more likely to go without health insurance than if you’re white, and that makes a difference. If you want people to sign up as test subjects for experimental vaccines, it helps if they feel comfortable going to a hospital — and are able to take sick leave.
Much has been written on the ever-present specter of the Tuskegee study, which began in 1932, and for good reason. Government scientists recruited hundreds of Black men, falsely promised them free treatment, but instead simply observed without intervention as syphilis destroyed participants’ bodies and lives. Yet the sources of mistrust of Covid-19 vaccine trials aren’t just sepia-toned. The memory of Tuskegee is compounded by instances of racism, alienation, and exclusion all too tangible in 2020.
“This is all playing out in the setting of George Floyd and Breonna Taylor,” said Arleen Brown, a professor of medicine at the University of California, Los Angeles, who has been convening community discussions about the trials. “There was a lot of concern that the powers that be are not going to treat them fairly.”
In emphasizing the need for diversity in these studies, vaccine makers have tried to put their money where their mouth is. The Pfizer-BioNTech team proposed expanding the number of participants in their trial from 30,000 to around 44,000, “to further increase trial population diversity.” Moderna, meanwhile, slowed down its recruitment — a big deal for an operation that’s supposed to advance at “Warp Speed” — out of concern that the pool of volunteers so far was too white.
“Some of our sites, bluntly, are situated in a largely white population. We have had sites in those places that were told, ‘You need to stop now and only recruit from minorities,’” said G. Paul Evans, president and CEO of Velocity Clinical Research, which is running vaccine trials in states across the country. When asked what sort of racial identity would fit the company’s definition of a minority, he said, “What the sponsor’s asking for is … virtually anything that’s not white.”
That doesn’t necessarily sit well with communities often alienated by medical institutions. The framing is delicate. What words you use and how you listen can make the difference between someone feeling heard and feeling like a potential “guinea pig.” That’s a vital distinction that Marvin Hanashiro, a community outreach coordinator at UCSD, is always trying to make clear: “It’s not a way of targeting people, it’s a way of including them.”
The rationale behind this effort is valid, experts say. “That is a goal that we should strive for, to make sure that anything we put forward — a therapy or a drug — is studied appropriately in all populations that will use it, and I think we’re getting there,” said José Romero, the secretary of health for the state of Arkansas and chair of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, specifying that he was not speaking on the agency’s behalf.
The outreach — to church leaders and social service organizations and unions — is, in some ways, working. The Moderna trial jumped from having 7% Black or African American enrollees in late August to having 13% in mid-September — a testament to the altruism that people like Brown, at UCLA, are witnessing as they broach the subject with community groups.
Yet those advances are highly dependent on geography. “Our phones are going off the hook,” said Devora Torrence, CEO of Centex Studies, who is working on both the Moderna and AstraZeneca trials, estimating that a majority of the volunteers at their site in McAllen, Texas, are Latinx.
Elsewhere, recruiting participants of color is harder, as demonstrated earlier this week, when Pfizer’s latest tally showed that 8% of its trial’s U.S. volunteers were Black, and 0.6% were American Indian or Alaska Native — about half of where those numbers would need to be to represent the breakdown of the U.S. population.
“You really can’t separate participating in a clinical trial from how a person feels the system treats them,” said Onyema Ogbuagu, the infectious disease doctor running the Pfizer trial at Yale. “What surprised me is that it cuts across socioeconomic classes. Even my fellow African American physicians express some concerns you would not expect them to express. It’s percolating in the back of their minds.”
For those who are even less at ease in a clinic or hospital, the worries often run even deeper. The federal government’s involvement in vaccine development makes some would-be participants — many of whom are not U.S. citizens — worry that they may not have control over who gets to see their data, and that that might affect their immigration status, explained Maldonado, the CEO of the Chicano Federation.
The focus on underserved communities is closely tied to the fact that many among them are frontline workers — more likely, by the nature of their jobs, to be exposed to the coronavirus. Yet the logistics can be tough if your employer doesn’t allow you the flexibility that would allow you take time to visit a clinic for injections and follow-ups, or if your local trial site is far from where you live and work.
Even if the logistics do work out, some aren’t sure they want to participate after seeing the government’s indifference to their needs throughout the pandemic. “There was little response when they were asking for personal protective equipment or sick leave, but suddenly when there’s an opportunity to test out a vaccine, they felt they were being pushed to the front of the line,” said Mona AuYoung, of Scripps Health, who has also been organizing community meetings about Covid-19 vaccine trials.
Little, the researcher at UCSD, has been careful to respond to these concerns as well as she can. She tells potential participants that she does not have the power to guarantee their neighborhoods will be prioritized for an approved vaccine, but that she’ll advocate for equitable distribution. She says that participants will be able to get care for vaccine-related side effects even if they don’t have health insurance.
When building a website, she and her team consulted with their community advisory committee. “Some of the pictures that we picked, they said, ‘That’s a picture of a Latino man, but I don’t identify with it, I think that looks staged, I would rather have something like this,’” Little said. To make participation easier, they’re running the study out of a mobile clinic, a mix of vehicles and tents set up in parking lots in some of the San Diego neighborhoods most deeply affected by the pandemic. Now they’re waiting for the AstraZeneca trial to start back up again in the U.S. Even once it does, though, they will have a lot of work ahead, well beyond giving injections and analyzing data.
“We recognize that building trust is not something we’re going to do in a couple of weeks. This is going to take years,” she said. “We’re not trying to reach out to underserved communities to say, ‘We should talk about the AstraZeneca trial.’ We’re reaching out to build trust, period. It would be great if, along the way, some also volunteered, but we have made no progress if we haven’t built enough trust that people are willing to take a licensed vaccine when it is available.”