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.

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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.

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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.

Tuskegee Study
Government scientists lied to the hundreds of Black men recruited for the Tuskegee study about what the experiment involved. National Archives

“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.”

  • Given the unethical behavior of past medical studies I advise no one to participate. The pharmaceutical companies are not doing credible studies. Too much data is being manipulated to give the results people in power want. That’s not science. The only way we get scientific advancement is if our data is correct. We’ve wasted decades on research that fails to help people because of this manipulated data.

  • I would NEVER volunteer for a vaccine to be someone’s experiment. Pharma has immunity in case anything goes wrong. Who will protect participants? Why would they even need immunity? The whole thing stinks. I for one will be educating my community to NOT volunteer to be guinea oigs for a vaccine that has injured people already. And for Melinda Gates to say that black people are first in line is insulting and diagusting. Since when is she a medical expert? NO WAY.

  • The real difficulty is that there’s reason to question whether the current crop of SARS-CoV-2 vaccine candidates should be in trials at all. The Warp Speed cohort are all focused exclusively on the S protein, and mostly on provoking an intense antibody response in the short term, in test tubes and in animal models which don’t exhibit a disease progression that resembles a severe human case. You manage what you measure, and short-term “neutralizing” antibody response (which does not mean what it says on the label) is a dangerously myopic thing to measure.

    In the context of researchers’ past experiences with vaccines that failed due to antibody-dependent enhancement of infection as the initial immune response waned, no one should be assuming that vaccine candidates are safe on a few weeks’ evidence. I certainly want nothing to do with an S-only vaccine, now or ever, unless it is endorsed by specific researchers (Stanley Perlman and Peter Hotez come to mind) whose publication history shows they know what to look for and how hard to look for it.

    Do not mistake this attitude for a distrust of the science in support of established vaccination programs, or for an unwillingness to put myself at risk in a situation where somebody has to take the risk of a yet-to-be-proven vaccine. I’d step up – at the appropriate stage of the process – for a vaccine based on this sort of broad epitope selection: https://www.cell.com/cell/fulltext/S0092-8674(20)30610-3. That’s going to take longer to develop, of course; and it’ll be handicapped by the current focus on (IMO) inferior strategies, which are sucking up all the oxygen in the room.

    I get that the people focused on “building trust” in the vaccine trials are coming from a well-meaning place. But I fear the blowback that may result if the vaccines they’re building trust in turn out to do more harm than good.

  • excellent article!
    what about if we join in one vaccine study and 6mos down the line another vaccine study is approved with great results, will i still be able to benefit from the second vaccine? Also, will we know if I got the vaccine on the first study or placebo? i worry of being a study participant in the ‘wrong’ study. Principle Investigators don’t have an answer. Ruben

  • I am a participant in the Pfizer vaccine study – primarily because I wanted to get a vaccine which probably works. NO ONE PROMISED ME A FIRST VACCINE IF I WAS ONE OF THE PEOPLE GIVEN PLACEBO.
    The benefit to black people if they take part in the study is the same benefit I gave to white people like myself – more data, which hopefully will help them find the best vaccine which is safe, at least for people of a certain genetic makeup.
    Wanting to get a fair shot at the vaccine, so black people who are in the first tier of vaccine recipients is perfectly fine but some idea of not participating in a study without guarantees is not only unrealisitic it is excessively selfish.
    Enough of Tuskeegee already it was an extreme abuse but can we keep in mind one of the Kennedy sisters, daughter in an extremely wealthy and powerful family, got a lobotomy about the same time? Good grief, is there ANY evidence of any abuse of subjects in the past 50 years? Not just on racial grounds, ANYTHING?
    I like Stat News but it is supposed to be highly science based and, while irrational fears might be something scicnce and medicine have to deal with, repeatedly citing ancient history is not science or even journalism.
    I saw a Nature article about a paper on coronavirus which addressed sex differences in severity of disease, and saw a disclaimer, that Nature recognized gender and sex are fluid and non-binary. Sex is not “non-binary” and it is not fluid unless you take hormones and/or have operations.
    Please drop all the PC stuff – I very much want EVERYONE to get good safe vaccines – talking about Tuskeegee will not help.

    • You have an opinion and so do we all, but might want to dial it down a bit, especially when trying to dictate how people should feel about their own health concerns. If you’ve never been their shoes, you dont get to tell them why their feet shouldn’t hurt.

    • I do not agree at all – someone needs to talk some sense into people- or try at least, and if people will not be sensible, there needs to be a consensus by all sensible people to blow them off. People with irrational grievances need to be stifled. Try reasoning with them at first, of course, but citing smallpox vaccinations in the sugar cane plantations – in the late 1700s? – is there any point to that in 2020? It has to stop. There was a controversy about the HeLa cells- which were discovered in a black woman who was getting charity treatment for cancer – from all I have read, she was treated well, they could not do much for her in the 1950s and she died young from cancer and left a bunch of young children – but the controversy is her cells have been used very extensively and the family never got paid – because she was black it has become a racial grievance issue – but why should she have been paid? Researchers who discovered the immortal properties of the cell line created the value. No offense to her, and I do not mind if she had been paid – but the rules were not intrinsically unfair either. Setting up a minimum royalty schedule for the donor individual would be fine, too, the problem is the claim of exploitation and racism when there is none.
      Sorry for ranting so much but we need a vaccine and no delays except for valid safety concerns can be allowed to get in the way.

    • Amen. ALL PC all the time. Perhaps an alternate explanation for “excluded populations” is that some people just do not have an altruistic view of life and require a quid pro quo for participation!

  • Thomas Jefferson worked with Edward Jenners new vaccination technique circa 1796. (Experiment on slaves which happened to be African/Native.)

    200 years later…same thing.

    Edmonton – Zagreb(EZ) measles vaccine which was government sponsored in LA, 1989. Experiment on Black and Hispanic babies without parent knowledge. Administering 500x the approved dosage.

    Same vaccine (EZ) was given to 2000 Haitian children.
    Vaccine killed silently at a range beginning at 6 months and within 3 years.

    • I do not know if you have a point but the CDC acted to try to protect people in the case of Edmonston Zagreb vaccine tests and they were not running clinical trials for their amusement – there was an epidemic at the time, the kids were part of ethnic groups getting hit worse than the national average, the parents were given incomplete information, technically, but even that was not misleading and was a result of an oversight.
      The CDC was doing a good thing trying to see if they could vaccinate children earlier, and making a special effort to protect the black and latino kids who were being harder hit. Although my reading does not answer this question, you have to suspect the 1989 to 1991 national epidemic which prompted the study was due to irrational anti-vaxxers – if all the older kids were getting vaccinated, no one would need to worry about vaccinating young.

  • Are there any clinical trials in AL, LA, GA, MS, NC, or SC? Especially along the Gulf Coast where diversity is prominent and minds are more open?

    • ‘Where minds are more open?’ Your comment sounds a tad bit elitist, as if there aren’t a wide range of diverse, open-minded people all over the world, who just may have justified reasons to give pause about new, unproven, vaccinations for a novel virus, especially in a place where its no secret that there have been racially-biased disparities in health care and treatments.

    • Hi Linda,

      clinicaltrials.gov has information about research studies and where they are being conducted. I would recommend looking there 🙂

      Best,
      Courtney

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