To What Extent Are Calls for Greater Minority Representation in COVID Vaccine Research Ethically Justified?

This article refers to:

Race Based Medicine, Colorblind Disease: How Racism in Medicine Harms Us All

In this commentary, we take up Yearby’s (2021) call for racism-sensitive research and apply this to the discourse regarding race and diversity in COVID vaccine research. We consider whether efforts to promote greater representation from Black and minoritized communities in COVID vaccine trials are ethically justified. We argue that (1) on balance there is no biological imperative to achieve representative recruitment of minoritized populations in COVID vaccine trials, whereas (2) addressing community distrust and vaccine hesitancy will be necessary to achieve just distribution of the benefits of COVID vaccines.

There are growing calls in the United States and the United Kingdom for greater ethnic diversity in ongoing vaccine trials (Treweek et al. 2020). In the United Kingdom, ethnic minorities have been 10 times less likely than the general population to participate in a vaccine trial (Husain 2020). Recruitment calls reflect established and ongoing efforts to make clinical research more inclusive and, in this particular case, an effort to ensure that vaccines are equally safe and effective for populations disproportionally affected by COVID. In the case of the United States, the United Kingdom, and many European countries, Black and other racially minoritized groups (hereafter “minoritized”) have been hardest hit by the pandemic. In this commentary we use the term minoritized to refer to individuals and communities who have been, and continue to be, actively racialized and marginalized due to their perceived racial or ethnic identity, within predominantly white social structures and processes (Milner and Jumbe 2020).

Calls for greater diversity in research have intuitive appeal because it is widely agreed that everyone has the right to access the benefits of science, and that it is morally wrong to exclude any groups from such benefit. But when these calls relate to race and ethnicity it is important to interrogate the underlying conceptual basis for targeted recruitment (Schaefer, Tai, and Sun 2020) and whether active participation in trials serves individual and/or population interests. To be clear, we are not suggesting excluding any minoritized groups from trial participation. But, as Yearby suggests, we are unpacking both the reasoning and the justification behind this agenda.

The differential impact of COVID on minoritized groups has been well documented. This increased risk operates on three main levels, all of which are environmental rather than biological. First, individuals are at increased risk of contracting SARS-Cov-2 because they have increased exposure due to occupation (e.g., frontline, essential, and critical infrastructure workers) and more likely live in higher density housing with more close contacts. Second, Black and other minoritized people are more likely to be admitted to hospital, require ventilation, be admitted to an intensive care unit (ICU), and die from COVID compared to white people. Members of the Black community in the United States have a 2.6 times higher chance of contracting COVID, 4.7 times higher rates of hospitalization and 2.1 times higher chance of dying (CDC 2020). Such increased risk relates primarily to inequality in the social determinants of health driven by structural racism. Third, public health measures such as lockdowns and the use of masks have differentially impacted ethnic groups—in the United States, Black and Hispanic persons have had higher rates of job losses or pay cuts and fewer financial reserves and more difficulty paying bills than white people (Lopes, Rainie, and Budiman 2020).

The lack of diversity and inclusion in research is itself an injustice. Decades of activism have forced scientists and policymakers to move away from the idea of the white male body as the norm and from the assumption that knowledge generated from this population could be generalized to other groups. In health research, the diversity agenda includes a focus on greater inclusion of women, pregnant women, children, and ethnic minorities. In the case of women, pregnant women, and children, there are important biological differences that should be accounted for in health research. For example, reliance on male research subjects in cell, animal, and human research, combined with a systemic failure to account for sex (or gender) in biomedical research, is linked to poorer health outcomes (including higher rates of adverse responses to pharmaceuticals) for women. The exclusion of pregnant women from COVID vaccine research is a significant concern (WHO 2020).

Health disparities related to race or ethnicity do exist, but these are not biological. These differences are far better explained by structural inequalities and systemic racism. Race and ethnicity themselves are social constructs for which biological characteristics are not homogeneous. Certain genetic variants may be more common in some ethnic groups, but such groups cannot be easily delineated on biological grounds (Schaefer, Tai, and Sun 2020). To the extent that any differences between groups are embodied, these are socially, historically, and geographically mediated (Domínguez-André and Netea 2019). There is a real danger in explaining away differences related to social, economic, or political realities as biological realities, and yet, as Yearby documents, there continues to be significant temptation to use racial or ethnic categories in biomedical science and medicine.

With this in mind, we can interrogate the motivation for active recruitment of minoritized populations in COVID vaccine research. It must first be noted that researchers currently engaged in recruiting diverse populations seem motivated by the intention to benefit them. Njira Lugogo, who is leading a clinical study of an investigational COVID-19 vaccine candidate, says they are actively recruiting Black and Latinx populations “because there may be differences in responses to the vaccine based on age, gender and ethnicity. There’s a disproportionate number of poor COVID-19 outcomes, for example, among members of minority groups, such as Black and Latinx populations” (Levine 2020). Currently available data on the mRNA vaccine candidates suggest there are no obvious or significant safety concerns. Current World Health Organization (WHO) advice on vaccine prioritization and distribution proceeds on the assumption that there will not be substantive differences in vaccine efficacy in subgroups, including for persons with comorbidities (such as HIV-positive status) predisposing them to severe COVID (WHO 2020). Prior research with other vaccines shows there are only limited differences in immunological response to vaccines based on loosely defined factors such as ethnicity. There are currently no suggestions that a vaccine would be withheld from minoritized groups due to their underrepresentation in trials or that minoritized groups would benefit less from the vaccine. On this analysis, research participation in phase III vaccine trials may be of low risk but potentially also relatively low benefit for minoritized populations.

We can also consider research participation from the perspective of the individual participant. Individuals from minoritized communities are not likely to be especially vulnerable, or at higher risk of harm in comparison to their white counterparts, in the context of research—in part because anyone with poorly controlled comorbidities such as diabetes or hypertension has been excluded from trials (Levine 2020). Phase III trials allow access to a potentially effective vaccine that could benefit individual participants. There is significant overdemand for an effective vaccine, and it is expected that initial stages of vaccine distribution will prioritize essential or health care workers. Trial participation is associated with access to increased health monitoring, health care, and up to 2 years of follow-up (Levine 2020). In contexts where the access to health care is significantly unequal (such as the United States, where more than 40 million people lack health insurance), the personal benefits from participating in a Phase III vaccine trial might indeed outweigh the risks associated with research. Of course, the potential incentivization of research participation in exchange for health benefits in a context of severe health disparities is itself ethically problematic.

A separate concern relates not to the scientific value of vaccine research for minoritized populations, but to these populations’ distrust in science and medicine. Medicine, public health, and research have been historically rife with instances of both exploitation and exclusion of racialized bodies, leading to generations of distrust of the medical and scientific establishments. This distrust drives both low participation in COVID vaccine research and potential low uptake of a vaccine. Greater participation of minoritized groups in trials may lead to greater trust in the vaccine products—but not necessarily. Efforts to demonstrate the trustworthiness of immunization programs require community engagement, coordination with local health providers, and resources to address concerns among these communities. In terms of ensuring just access to the benefits of scientific research, this community work is as important as, if not more important than, recruitment of minoritized populations into vaccine trials, but seems to have received less attention.

Benefits from COVID research will ultimately arise from access to vaccines and treatments. Racial and ethnic disparities, once again laid bare by COVID, will only be addressed by significant attention to structural racism and systemic inequalities.