In recent weeks, major studies have offered promising news on the development of two leading novel coronavirus vaccine candidates. At least, they were promising for some Americans.
The vaccines—from U.S. biotech company Moderna and a consortium of Oxford University and British-Swedish pharma giant AstraZeneca—appeared to be safe. They also seemed to produce an immune response in separate test groups together numbering more than a thousand people. But there was a problem with the studies, according to experts on the intersection of immunology and race: The test groups in both the Moderna and the Oxford-AstraZeneca trials were overwhelmingly white. This despite data indicating COVID-19 disproportionately affects people of color.
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Of course, the whiteness of major vaccine studies isn’t exactly new.
“This is an ongoing issue plaguing society as well as the clinical and scientific community,” Surinder Singh, a vice president at Japan-based pharma Otsuka Pharmaceutical, told The Daily Beast.
Fixing that racial disparity is imperative, experts said. It could also be difficult—after all, test subjects are volunteers. For the scientific community to convince more people of color to volunteer for trials, it first must build trust between scientists and their potential test subjects.
In the United States, that means working through a long history of racial abuse. It wasn’t that long ago that the U.S. government conducted medical tests on Black patients without their consent.
Massachusetts-based Moderna published partial results from small-scale, Phase 1 trials of its so-called “messenger RNA” vaccine on July 14. The data were encouraging. “Serum-neutralizing activity was detected by two methods in all participants evaluated,” the testers reported.
In other words, the subjects’ immune systems reacted to the vaccine by producing antibodies. That doesn’t mean the antibodies work to prevent infection, of course. Proving that requires much more extensive testing.
Oxford-AstraZeneca reported similar results from its own Phase 1 and 2 trials last Monday. The consortium’s adenovirus-vectored vaccine produced neutralizing antibody responses in at least 91 percent of test subjects.
But both trials were very white. Forty of Moderna’s 45 test subjects—that is, 89 percent of them—were white. And 979, or 91 percent, of Oxford-AstraZeneca’s 1,077 volunteers were white.
That’s a problem on its face. But it’s especially glaring when both candidates, like many potential vaccines, did produce side effects—and represent part of a frantic government project critics worry could be rushed for political reasons.
Neither Moderna nor Oxford-AstraZeneca responded to requests for comment for this story, though the latter researchers did note that more work was needed to test the vaccines among “ethnically and geographically diverse populations.”
Documented side effects in the trials included fever, headache and chills. But the vanishingly small non-white population within the test groups raised the theoretical possibility that more serious side effects could occur among people of color, and just didn’t show up in the early trials.
Meanwhile, the American population was about 60 percent white last year, according to the Census Bureau. But whites have accounted for more like 50 percent of COVID deaths, by one estimate, which found that 23 percent of COVID deaths have been documented among the Black population, even though just 12 percent of Americans are Black. And Latinos have been roughly four times as likely as non-Hispanic whites to be hospitalized with COVID-19, according to the Centers for Disease Control and Prevention (CDC).
Overall, Black and Latino people were almost twice as likely as white people to die from the novel coronavirus in the United States, at least earlier in the pandemic, according to data obtained by The New York Times from the CDC. “Long-standing systemic health and social inequities have put some members of racial and ethnic minority groups at increased risk of getting COVID-19 or experiencing severe illness, regardless of age,” the CDC explained on its website.
The problem with the overwhelming whiteness of the trial groups, then, is simple. They are “not representative of the broader population of the United States,” as Kawsar Talaat, a doctor of infectious diseases at Johns Hopkins Bloomberg School of Public Health, told The Daily Beast.
It’s a matter of debate in the scientific community whether genetic differences between races—which are, after all, socially constructed concepts—offer any meaningful guide as to which individuals will respond to a new drug or vaccine, according to James Doucet-Battle, a sociologist at the University of California, Santa Cruz.
But that doesn’t mean racial groups as wholes won’t respond differently to some vaccine or drug owing to overall disparities in income, lifestyle, and long-term access to health care. Race matters in medicine. It should matter in medical testing.
“In a representative democracy that continues to struggle with racial, gendered, ageist forms of inequality, representation in clinical trials is essential to ensure that those populations are included in all stages of research so that future therapeutic outcomes can be measured accordingly,” Doucet-Battle said.
That raises the related questions of how medical testing got so white—and how researchers might diversify their test groups. Some experts The Daily Beast spoke with recommended that government funding and regulatory agencies require fair racial representation in major medical trials.
But getting more people of color to volunteer for testing starts with trust, Doucet-Battle said. And the current lack of trust has deep historical roots. As Edith Perry, a member of the Maryland Community Research Advisory Board, recently told the Times, “The trust issues are just tremendous in the Black community.”
Consider the infamous Tuskegee Syphilis Study, a U.S. government effort to test syphilis treatments on hundreds of Black men in Alabama between 1932 and 1972. “There was no evidence that researchers had informed them of the study or its real purpose,” the CDC explained on its website. “In fact, the men had been misled and had not been given all the facts required to provide informed consent.”
As part of their experiment, the government testers sometimes withheld treatments, effectively dooming many test subjects to unnecessary suffering. A 1973 lawsuit compelled the feds to finally admit to decades of wrongdoing, offer compensation, and belatedly provide effective treatment to victims.
Many white Americans have never heard of the Tuskegee Study. Many Black Americans can’t forget it. “Researchers working to attract African Americans to COVID-19 vaccine trials have encountered the symbolic significance the Tuskegee Syphilis Study continues to have in the collective memory of the Black population,” Doucet-Battle said.
It’s going to take time, effort, and education to diversify medical testing. “We need to make a conscious effort to recruit and enroll people of different ethnic and racial groups in our trials and make them more representative,” Talaat said. “We also need to do a better job of educating different groups about the importance of participating in vaccines.”
It’s not too late for leading biotech companies such as Moderna and Oxford-AstraZeneca to at least try recruiting more people of color for their respective vaccine trials. Both pharmas are just beginning to organize their large-scale Phase 3 trials, the final step in testing before they can submit their vaccines to the U.S. Food and Drug Administration for possible approval.
But Doucet-Battle stressed that racial justice in medical testing is largely a function of racial justice—or injustice—in society at large. Medical testers alone can’t fix a systemic problem.
“That can only occur downstream from a larger social and political awakening toward justice,” Doucet-Battle said. “That has to happen first—a difficult proposition during these extraordinary times.”
