Why Diversity and Inclusion Matter in the COVID-19 Vaccine Trials

Key points:

• Minority communities, particularly Black, Latinx, and indigenous communities, have been particularly hard hit by COVID-19 in the United States as a consequence of high rates of virus transmission.
• These communities also share a legacy of abusive policies and practices, creating social and economic circumstances compromising community health and well-being and fostering mistrust in COVID-19 vaccines.
• Participation of these communities in COVID-19 vaccine trials is thus of critical importance to ensure vaccine efficacy in the face of intense virus transmission and to build trust in the vaccines.

It is an exciting moment in the intense and multi-faceted effort to develop, test, and implement safe and effective COVID-19 vaccines. The very encouraging early results from the efficacy trials of both the Moderna and Pfizer messenger RNA (mRNA) candidate products – and the submission of the first emergency use authorization request from Pfizer to the FDA – means that the era of vaccine implementation may be fast approaching. No matter how many candidate products may be available in the coming months, this early phase will be marked by scarcity of vaccine and by a complex set of challenges around allocation, access, and equity. There is little disagreement that frontline health care workers need to be protected right away, and that other first responders with direct contact with the public will need protection too. After that, it gets more complicated. Should we focus on immunizing the frailer elderly? Those in nursing homes or other congregate housing? Those with the highest burdens of COVID-19 infections, hospitalizations, and deaths, such as persons with chronic health conditions known to be associated with poor outcomes from COVID-19? And what about those from ethnic and racial minority communities who have experienced such marked health disparities with COVID-19?

As important as our ethical and allocation frameworks will be, the uptake and use of these candidate vaccines will only be as effective as individual, family, and community willingness to be immunized. And this is the first of several reasons why the COVID Vaccine Prevention Network, the Co-VPN, has been so committed to increasing minority participation in its trials. The Co-VPN needs to understand the efficacy of these products in hard-hit communities, but we knew from past experience that, if trials do not include Black and Brown Americans, uptake could be markedly lower among these communities.

A second reason why diversity and inclusion matter in these trials is an epidemiologic one. A basic principle of epidemic spread of diseases is what is known as the force of infection. In any community with low rates of transmission, each individual’s odds of infection are a function of both their risks and the community rate. A person at low risk, working from home, mask-wearing when doing essential outside tasks like food shopping, may have very little risk of acquiring COVID-19, and if community rates are low, even that modest risk goes down. When more community transmission is underway, however, everyone in that community has greater odds of exposure. When community transmission rates are very high, which we are unfortunately seeing across the country right now, all are at greater risk of exposure, and of acquiring SARS-CoV-2, the virus that causes COVID-19. That is the force of infection. But that force is not evenly distributed across towns and cities, rural areas, and the suburbs. People who have direct contact with the public – such as health care workers, essential workers, people working in pharmacies – all have higher likelihood of exposure. So do those who use public transport to get to work or school, and so do those who live in more densely populated areas, in more crowded housing, and in congregate housing – like nursing home staff and residents, but also people housed in jails, prisons, and other detention facilities. These individuals, families, and communities face much greater force of infection risks. For Black Americans, this has translated into increased rates as high as 62/10,000 persons; for Latinx people in the U.S., it is 73/10,000 persons, compared to 23/10,000 for non-Hispanic Whitesⁱ Testing vaccine efficacy in these communities is not about racial or ethnic differences, but instead about testing whether these vaccines can protect when there is a high force of infection. It’s literally a higher bar for the vaccines and we have to know which of the candidates does this well and safely.

But there are additional realities we have to consider. The indigenous and racial and ethnic minority communities hardest hit by COVID-19 disease share a legacy of having experienced abusive policies and practices, creating social and economic circumstances compromising community health and well-being. This reality, coupled with continued marginalization and the relative lack of inclusion and representation in science and medicine, have fostered mistrust of medical and research establishments. This reality and the need to ensure that indigenous peoples and people of color are equitably included in COVID-19 research have been central tenets in efforts to engage and include diverse participants in our clinical trials. Successful public health efforts that benefit everyone require a social justice lens ensuring the equitable distribution of resources among all members of society. For COVID-19, as with all public health efforts, equitable inclusion is required at the earliest stages of research in humans. This inclusion is critical if trust is to be built. Inclusion in research increases knowledge and familiarity with the research process, builds relationships between community members and research institutions, increases the availability of important resources for the larger community, and cultivates the trust in research we so urgently need.

The importance of inclusion and diversity in the COVID-19 vaccine trials has also been recognized by federal leadership. Indeed, one company, Moderna, was asked to slow its recruitment rate and focus on greater recruitment of Black and Latinx volunteers in its efficacy trial, since the early recruitment data suggested that the trial would not have sufficient numbers of minority participants to answer the critical question of vaccine efficacy in these populations. Again, this is not because of possible genetic differences, but rather that the force of infection is so much greater for these communities. And this decision was also likely motivated by the very real need to address the concerns about vaccine hesitancy in communities of color, should their participation rates in trials be too low.

It is not clear that these kinds of efforts will continue in the trials to come, since there is greater urgency to complete these trials now that there has been an emergency use authorization application from one sponsor, and the period of placebo-controlled trials may soon end. Once we have a licensed vaccine for COVID-19, many would argue that trials must randomize participants to compare the new vaccine against that product, making the subsequent trials much larger, slower, and more expensive. Nevertheless, there is no question that it is vitally important – for both the science and the social justice issues – that every effort be made to ensure the COVID-19 vaccine trials are diverse, inclusive, and can accurately assess the safety and efficacy of these products for the communities most affected by this pandemic.

ⁱ The Fullest Look Yet at the Racial Inequity of Coronavirus. By Richard A. Oppel Jr., Robert Gebeloff, K.K. Rebecca Lai, Will Wright and Mitch Smith. New York Times / July 5, 2020.