Analysis shows lack of diversity in vaccine trials

Robert Hood/Fred Hutch

Among vaccine clinical trials in the United States, people who are Black, Native American, and Latino and age 65 years and older were the most underrepresented groups, according to a new study published in the journal JAMA Network Open. Conversely, adult women were overrepresented, the study found.

The research team examined 230 U.S.-based vaccine trials of all phases, with nearly 220,000 participants from July 2011 through June 2020. The researchers found that many trials did not fully report demographic information, and for the studies that did, racial and ethnic minorities were frequently underrepresented as were older adults.

The study found that white people accounted for 78 percent of all participants. Women accounted for 56 percent, Black accounted for 11 percent, Native American accounted for 0.4 percent, and Latino accounted for 12 percent. Additionally, people 65 and older accounted for 12 percent, according to the study,

Asian and Native Hawaiian/Pacific Islander participants were equitably represented in vaccine trials compared to the U.S. population, the researchers said.

The research team also discovered that problems with capturing and underreporting participant demographics remain, despite efforts from the National Institutes of Health and Food and Drug Administration to implement policies and guidelines.

The authors said they insist improving racial and ethnic diversity in clinical trials is important because enrollment may impact vaccination rates among minorities. To address this problem, the National Academies of Sciences, Engineering, and Medicine recently set up a committee dedicated to improving the representation of women and underrepresented minorities in clinical trials and research. 

The researchers also suggest future trials emphasize the inclusion of older men and women. The aging of the population in the US and many other countries requires testing vaccines in older adults. As the current pandemic has shown, diseases like the novel coronavirus (COVID-19) disproportionately impact older adults, especially those in long-term care facilities.

"The COVID-19 pandemic and its devastating impact, particularly on [Black, Indigenous, and people of color (BIPOC)] communities and older adults, is a painful reminder of the health disparities in our country," said Steve Pergam, MD, MPH, corresponding author of the study amd an associate professor in the Vaccine and Infectious Disease Division at Fred Hutchinson Cancer Research Center, in a statement "This collaborative work highlights a problem that's plagued the scientific community for too long—inadequate representation in clinical trials. The diversity seen in COVID-19 vaccine trials demonstrate we can do this, but we need to assure future studies focus not just on rapid enrollment but also on inclusion."

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