covid-19 virus and clinical vaccine

Diversity in Clinical Vaccine Trials

Including communities of color in vaccine development trials is crucial to ensure healthcare inclusivity says Anushka Bhat

The development and distribution of SARS-CoV-2 vaccine is crucial ending the pandemic as proven by the decreasing rates of COVID-19 cases in the United States since the vaccine rollout. However, the trials of vaccine development do not always proportionally include marginalised communities of color, although they may be disproportionately affected by the virus.

According to Johns Hopkins Medicine, African Americans comprise one-third of Chicago’s population, while accounting for half of the city’s positive coronavirus cases, and nearly three-quarters of COVID-19 related deaths. Similarly, in Milwaukee County, Wisconsin, Black people account for 70% of coronavirus fatality cases, but only 26% of the entire population. These disproportionate mortality rates of African Americans are not exceptional and have been found across the nation.

Disproportionate vaccine trials.

These unbalanced statistics do not only relate to the COVID-19 outbreak; historically vaccine trials have been unequal and have not included many African Americans. African Americans make up 13% of the U.S. population, while on average, only 5% of medical trial participation. Specifically in COVID-19 vaccine trials, African Americans make up a mere 9.7% of enrollees for Moderna and 9.8% for Pfizer.

Attempting to resolve the issue, in 2001, the National Institute of Health established a policy regarding the inclusion of women and minorities as subjects in clinical research stating that women and people of color (POCs) must be included in their trials. However, their vague language is apparent as a specific proportionate percentage of POCs that must be included is never mentioned. Moreover, the FDA does not require pharmaceutical companies and independent researchers to meet these goals. This disparity is especially striking in Stage 1 of the Moderna SARS-CoV-2 vaccine, which included 55 people. Of these 55, six were Hispanic, two were Black, one was Asian, one was indigenous, and 40 were white.

Why does racial diversity matter?

One might ask if race really matters when it comes to immunity at a molecular level. According to an Oncotarget study examining racial differences in antibody responses to an inactive influenza vaccine, it does. The study followed an African American group and a Caucasian group for five years after receiving an inactive influenza A vaccine.

The vaccine’s race-related differences in efficacy were analyzed, focusing on the immune system’s reactions to the vaccine. The study concluded that there were differences between the two groups, such as African Americans began with much lower antibody levels than Caucasians because of the lack of previous vaccination, and also that African Americans produced higher neutralizing antibody titers than Caucasians. 

Although taken from a study examining influenza A, these findings about racial differences in antibodies and B-lymphocytes are vital when discussing the COVID-19 vaccine. For example, during Phase 1 of the Pfizer Covid-19 vaccine trials, an astounding 96.7% of the participants were white, with only one African American and one Asian participating.

The results were analyzed homogeneously, disregarding race-related differences in immune system responses. Modern vaccine trials fail to acknowledge the striking disparities in antibody levels depending upon race, and if these facts are not reckoned with, unprecedented long-term symptoms may appear after wide distribution of the vaccine.

Making Vaccine trials inclusive.

To combat these racist habits and medical concerns, the root cause of low POC participation in medical trials must be first examined. According to The New England Journal of Medicine, one of the many factors is an ingrained distrust that African Americans have for the U.S. healthcare system.

This doubt can be traced back to countless medical studies that have disregarded Black lives. Two major events include the Tuskegee syphilis study, wherein scientists withheld medicine from Black men in order to examine the disease’s natural history, and the cancer cells of Henrietta Lacks, which were taken from her body without consent and studied for decades.

In order to regain this trust, Black participants in vaccine trials should be fairly compensated and be able to expect that Black communities can have access to proper treatment once the medicine is publically released. The National Academy of Science recently recommended giving medical priority to those who are disproportionately affected by the illness. Although trust will take time, healthcare workers can start by ensuring that Black communities will receive proper treatment once entering a clinical trial.

Feature Photo by Ivan Diaz on Unsplash

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Diversity in Clinical Vaccine Trials

by Anushka Bhat Reading time: 3 min