The development of a Covid-19 vaccine is progressing at an incredible pace, breaking down barriers to the invention, manufacture, and testing of potential vaccine candidates. The Department of Health and Human Services says it aims to have “substantial quantities of a safe and effective vaccine available for Americans by January 2021.”

To achieve this goal, each of the five leading Covid-19 vaccine candidates will need to be tested in approximately 30,000 people — a total of 150,000 research participants in the next six months. This will be a massive and unprecedented undertaking.

Equally unprecedented is the opportunity that Covid-19 vaccine development presents to break down barriers to the engagement of Black and Latinx individuals in clinical trials research. Ideally, vaccine trials should include participants from communities that have the highest risk of infection. In the case of Covid-19, those at-risk communities are disproportionately Black and Latinx. To match local demographics of Covid-19, Black or Latinx individuals would need to comprise up to 40% of vaccine trial participants nationwide.

advertisement

Clinical trials also establish the safety and effectiveness of new interventions, and there is no guarantee that the effects of an intervention will be the same across populations. Contemporary medical studies point to disparities in response rates to pharmacological therapies by race and ethnicity. No one knows for sure if such variances are products of the socioeconomic realities faced by trial participants, a variety of environmental factors, or genetics, but they are real.

Yet past experience shows that Covid-19 vaccine trials will likely have challenges meeting enrollment targets like these. In 2019, for example, the Food and Drug Administration approved 11 new cancer drugs based on clinical trials that enrolled just 4% of Black participants, despite the fact that Black individuals account for 13% of the U.S. population and have the highest death rate for most cancers.

advertisement

Most clinical trials are designed to enroll racially and ethnically diverse groups of participants and honestly aim to do that. But it’s a hard goal to achieve. The hours that clinics are open are too limited for people of color whose employers prohibit taking off work; study budgets don’t always pay for interpreters and translations that would facilitate participation by non-English speakers; study protocols often exclude individuals with chronic illnesses like diabetes and hypertension, which disproportionately impact people of color.

The pressure to enroll participants and quickly accumulate data can be intense, especially in a pandemic, often eclipsing the goal of equitable representation.

Another barrier to equitable clinical trial participation is the pervasive structural racism that is intricately woven into the fabric of our society. The U.S. has a shameful history of unethical experimentation on Black men and women, from experimental surgeries performed without anesthesia on enslaved Black women to the misappropriation of cervical tissue from Henrietta Lacks and the infamous Tuskegee syphilis study. This history has led to understandable and pervasive mistrust of clinical research. It is no wonder that Black and Latinx patients often say to us, “I don’t want to be a guinea pig in your experiments.”

Layered on top of this are strong anti-immigrant and sometimes xenophobic views that keep Latinx individuals and others who weren’t born in the U.S. away from contact with health care institutions, including research groups.

A recent survey conducted by the Pew Research Center demonstrates how this sordid history and ongoing structural inequity could affect clinical trial participation: Even if a Covid-19 vaccine were available today and proven effective, only 54% of Black adults would be willing to take it, compared to 74% of white adults. The statistics would likely be equally dismal for participation in Covid-19 vaccine trials.

Everyone in medical research shares the responsibility to promote equitable representation in Covid-19 vaccine trials. Here are some ways we can do this:

Step 1. Acknowledge the problem. We must recognize the importance of enrolling Black and Latinx participants in these studies, even in the context of unprecedented rapid enrollment. Studies must report the demographics of trial enrollment while they are ongoing.

Step 2. Provide appropriate funding to trial sites to support diversity initiatives. It takes money to translate informed consent forms, reimburse participants for transportation, staff clinics on weekends and nights, and advertise in a broad array of neighborhoods and media outlets. It also takes money and institutional will to build a diverse research workforce that reflects affected communities and is representative of the country as a whole.

Step 3. Address research mistrust by engaging communities now, at the beginning, not when it’s time to share the final results. This means investigators need to meet with local stakeholders in Black and Latinx communities, host webinars and virtual town halls, do interviews on community radio, and put themselves out there on social media.

Step 4. Pay people back for trusting in the medical research community. We need to make any successful Covid-19 vaccine that comes out of this herculean research effort accessible to everyone in this country — regardless of race, ethnicity, or the ability to pay for it. The fair and transparent distribution of an effective Covid-19 vaccine is paramount.

Vaccines can be transformative. They have the potential to provide medical shelter against deadly diseases like Covid-19, allowing communities to safely emerge from this pandemic and rebuild.

The recent protests against racism in the United States are calls to medicine and science too: Black and Latinx communities must be a part of the critical endeavor to develop a vaccine for Covid-19.

Kathryn Stephenson is the director of the clinical trials unit in the Center for Virology and Vaccine Research and an infectious disease physician at Beth Israel Deaconess Medical Center in Boston. Bisola Ojikutu is the director of the Community Engaged Research Program in the Harvard Center for AIDS Research and an infectious disease physician at Brigham and Women’s Hospital and Massachusetts General Hospital.

  • Thanks for this informative piece. I would never have thought about this situation. The efforts of people of color to help the white majority to get educated has not gone unnoticed by me. I have taken the innitiative to educate myself and additional articles such as this help. Thanks again.

  • “study budgets don’t always pay for interpreters and translations that would facilitate participation by non-English speakers; study protocols often exclude individuals with chronic illnesses like diabetes and hypertension, which disproportionately impact people of color.”
    All clinical studies support interpreters and translation services through the disproportionately high percentage of funds that go to the overhead of the sponsoring institution, hospital or clinic. These support the interpreters and other overhead. No hospital has ever complained that they lose money on clinical studies. They are clearly a profit center. Furthermore by NIH regulations, all studies must have consent forms in multiple languages. As for medical exclusions, these apply equally to all racial groups.

    Finally it is obviously in the best financial and medical interest of the manufacturers to include all humans in the studies. I have little doubt they will attempt to do so. The effort made to create this article would be better applied to motivate all people to participate in these trials. Especially those who have the most to gain by the development of a universally effective vaccine.

    • Thanks for the comment- it seems to me the author wanted to make points which are not really borne out by the realities of how research is done.
      “Study protocols often exclude people with diabetes and hypertension” – but what do you do about that? Remove those exclusion criteria? Get more “people of color” even though now there pare of the sample is non-reresentative? – (such a phrase in a purported science article – can I substitute “people of color” for each other and do valid research? Like, I am researching sickle cell anemia, but I am in Australia – so I only use Aboriginal people as research subjects – and, someone objects I am not going to learn about sickle cell anemia that way, I can excuse myself by saying “they were all people of color” ? The author was the one complaining about non-representative samples but then lumps every non-white together)
      Sorry to rant.
      I do think developing a vaccine for the world, using test subjects from America and Europe, is not the best way to go, if we are unlucky there will be some different in how the vaccine effects other people – one hopes someone deals with that as best they can – but ?????

  • Can we not insert race and politics on everything. There are more races in this country than Black and Latinos.

    This world races is not made of Black and Latinos only, the author is discriminating other races.

  • I am all for trying to get test volunteers who mirror the US demographics better, but good grief, all the Marxist dogma gets annoying.
    Though it can be amusing too – the authors bemoan black people not signing up, but then, of course they had no choice but to do this, what would their friends from the department say if the omitted it = they had to mention Tuskeegee and Henrietta Lacks – which of course are not at all comparable and really kind of silly to mention together unless your goal is to count racial grievances.
    As best I can tell, Henrietta Lacks cancer cells would have been buried with her if not for the researchers who found them – exploitive research is one thing, but finding things in nature – that you spent, in some cases, a long time looking for – and using them – is NOT exploitive – it is totally fair that the discoverer of the cell line, rather than Mrs. Lacks or her family, benefitted from what they DISCOVERED.
    I mean this very seriously – if I found some new microbe which say, has great value as a medicine – while I was searching on your property, with your permission – something you were never going to use, did not at all recognize the value of = why shouldn’t I get to keep it. This is a very strange idea to me, somehow someone was treated unfairly because their cells were taken and used for medicine and they did not get paid – I think she was getting free medical treatment at the hospital – which was likely not much at the time, hopefully they comforted her and the family as much as they could – but profit from what really was completely the work of the researchers – No, I can not see it.

    As for Tuskeegee – if I thought people were going to inject me with syphilis or something comparably harmful, I would likely not go into a study either. Guess what? Every time you mention ancient history you are scaring some people to avoid these studies. I do not know how many, but it probably is a pretty good number, I mean, the article claims it is a factor in scaring volunteers away.

    How long since Tuskeegee anyway? Or for that matter, Henrietta Lacks? Around 70 years for Lacks – who did not get abused so really, so what if it was yesterday? And 90 to 50 for Tuskegee, which was a terrible abuse without question – but does any reasonable and knowledgeable people think current research volunteers are put in danger, any more than that inherent in the studies? I do not blame people who are unfamiliar with academia from being wary, ie, some possible volunteers – but no one involved in medical research believes those abuses are in danger of being repeated. Time to give it a rest already.

  • Please don’t refer to us as Latinx we are Latinos. If you want to be inclusive use the term Latin. Latinx is not a real word in Spanish.

    • Yes, neither it is a real word in Portuguese! Options:

      1. latinos and latinas
      2. people of latin origin (the best one, it takes more words but one can edit out words in the text somewhere else in the word processor )

Comments are closed.

Sign up to receive a free weekly opinions recap from our community of experts.
Privacy Policy