The global race is on for a vaccine to combat the coronavirus, but the question is: Who will be included?
To date, three companies have reached Phase 3 trials for an experimental vaccine — Moderna, AstraZeneca and CanSino. AstraZeneca recently announced a pause in their process to check a complication with one participant. Despite this setback, the early results are encouraging.
Yet these trials have not met an important challenge: recruiting an appropriately diverse group of participants — even though Covid-19 has taken a disproportionate toll on communities of color and on Black Americans in particular.
Drugmakers approved for Phase 3 trials have been slow to report the breakdown of participants. But Frances Collins, director of the National Institutes of Health, told CNN that Moderna deserved a “C” for recruiting minorities. As of Sept. 4, Moderna reported 26 percent of study participants from communities of color, including Black or African-American, Latinx, American Indian and Alaskan Native.
Granted, this is an improvement from most studies. In fact, in clinical trials overall, African-American participation hovers around an abysmal 5 percent, despite being 13 percent of the U.S. population. Research participants should look like the population — that would be 32 percent for those four groups. And Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has called for twice that number because of how hard Covid-19 has hit them.
The paucity of diversity in these clinical trials creates problems on two fronts: treatment and trust.
On the treatment front, a vaccine with limited testing could have unanticipated effects on Black bodies. As with all drug trials, the impact of medication can differ significantly, depending on the genetic makeup of the population. This is even more so with vaccines that depend on altering the immune system. It is therefore vital that the trials, which usually hold about 30,000 participants, include as diverse a set of participants as possible.
As it is, African-Americans cope with higher rates of cancer, diabetes, heart disease and hypertension. Because these conditions can put people infected with the virus at risk, it’s extra important that African-Americans play a critical role in testing.
Trust is also an issue. Unsurprisingly, Black Americans are suspicious of leading philanthropists, the pharmaceutical industry and the American health care system. The litany of abuses committed by health professionals in the name of “research” that inflicted harm on thousands of Black Americans will forever be a stain on the soul of our nation. The African-American community knows well the infamous racism of the Tuskegee syphilis experiment and the exploitation of Henrietta Lacks.
Black doctors are the best way to build trust in our communities. But they need help. Without significant participation in clinical trials, there will be no proof that our patients should trust the vaccine.
Morehouse School of Medicine and Meharry Medical College have been identified as clinical trial sites, and are in the early stages of volunteer recruitment. But an expansion is necessary. Researchers and the medical industry should engage the remaining two Black and minority serving medical schools — Charles R. Drew College of Medicine and Howard University College of Medicine — in the vaccine trials now. In addition, the 104 Historically Black Colleges and Universities can serve as credible messengers to distribute information and foster trust in communities throughout the country.
Their involvement should include the recruitment of patients, participation in the science, and development of the plan to distribute the vaccine to the most vulnerable communities. Unlike what happened with the development of antiviral treatment for AIDS, the African-American population should not be last to get access to the lifesaving medication.
Economic barriers must also be lifted. Institutions must work with African-Americans who can’t take time away from work, by engaging with employers to provide time for employee participation as a health incentive. And because our communities suffer from a lack of reliable transportation, institutions must also conduct trials where we live.
The African-American community must also be willing to engage: ask hard questions and consult trusted sources in order to assuage legitimate concerns.
The Black Lives Matter movement reminds us that we do not have to be confined by the ugliest parts of our nation’s history or our fallen human nature. We have an opportunity to do something better in this moment. Simply put, the largest population being killed by Covid-19 should have a significant role in development of a treatment.
The human rights activist Fannie Lou Hamer grew up under the brutality of Jim Crow in the Mississippi Delta that included forced sterilization — an abhorrent practice so common it became known as a “Mississippi appendectomy.” Mrs. Hamer reached a point where the status quo would simply not do, famously remarking “I am sick and tired of being sick and tired.” She demanded full inclusion in American democracy for all Black Americans.
We find ourselves at another inflection point where the status quo cannot stand. True change requires that government and industry make every effort to achieve true diversity in clinical trials. Black lives depend on it.
Wayne A. I. Frederick is the president of Howard University; Valerie Montgomery Rice is the president of Morehouse School of Medicine; David M. Carlisle is president of Charles R. Drew University of Medicine and Science; James E. K. Hildreth is president of Meharry Medical College.
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