Anthony Jackson, security coordinator for Fred Hutchinson Cancer Research Center, received a dose of the Pfizer-BioNTech COVID-19 vaccine on Jan. 19 at a new vaccine clinic set up on the Fred Hutch campus. (Photo courtesy of Fred Hutch / Robert Hood)

As data shows racial disparities in COVID-19 vaccine distribution, a new study has found racial and ethnic inequities across nearly a decade of U.S. vaccine trials.

Minority communities and older adults were underrepresented when compared to their overall percentage of the population, according to a study of more than 200 vaccine trials published Friday in JAMA Network Open.

The findings coincide with a new Washington state report showing lower percentages of Hispanic, Black and multiracial people receiving COVID-19 vaccines compared to their overall proportion of the state’s population.

Nationwide, communities of color have also shouldered a disproportionate burden during the pandemic, with higher rates of hospitalization and death, according to CDC data.

“The fact that communities experiencing the biggest health disparities in this country are also the ones least represented in these trials is a critical part,” said Dr. Michele Andrasik, a Fred Hutch scientist who worked on the study. “Ensuring inclusion is really critical.”

Researchers from Fred Hutch, Harvard, Emory University, and others evaluated 230 U.S.-based vaccine trials from 2011 to 2020. The trials involved vaccines ranging from the flu to shingles and included 219,555 participants. They compared the number of people in each racial and ethnic group with U.S. census data from 2011 and 2018.

White individuals were overrepresented while Black/African Americans, Hispanic and American Indian/Alaskan Natives were underrepresented, as were older adults. Asian and Native Hawaiian/Pacific Islander participants were more closely aligned with overall population percentages, and women were overrepresented.

About 10% of vaccine trial participants in the study’s data were Black/African American — census data pegs that number at about 13%. Hispanic enrollment was 11.6% while that population was roughly 16 to 19% during the same period, according to census data. Meanwhile, white Americans represented 78% of trial participants compared to about 74 to 76% in census figures during that same period.

Dr. Michele Andrasik, a Fred Hutch scientist, and Dr. Steven Pergam, a Fred Hutch physician. (Fred Hutch Photos)

There were some limitations. Even though every trial evaluated reported age and sex, just 58.3% included race and 34.3% for ethnicity.

That missing information is noteworthy since the Food and Drug Administration recommends such data collection, said Dr. Steven Pergam, a Fred Hutch physician specializing in the prevention and treatment of infectious diseases. Additionally, data gaps have also plagued COVID-19 vaccine distribution information nationwide, he pointed out. It’s possible that participants might not answer race and ethnicity questions or that study interviewers are unable to visually discern one’s race and ethnicity.

“Some people feel uncomfortable asking people about race and ethnicity, so that discomfort is a barrier,” Andrasik said.

Researchers recommended that racial and ethnic data gathering should be enforced and diversity targets that reflect the population should be included for all vaccine trials of important infections. They also urged that enrollment target populations at the greatest risk of infection or mortality, such as older adults with the COVID-19 pandemic.

Creating vaccine trials that reflect the overall community can have far-ranging impacts, such as countering vaccine hesitancy and safety concerns.

“Based on past exclusion and maltreatment, vaccine hesitancy and lack of trust in the medical establishment may be more prevalent across minority groups, making inclusion even more important,” the study’s authors wrote.

Steps can be taken early in the process that prioritize inclusion — a goal of the COVID vaccine trials. That outreach comes before the trials start, with active involvement in the community and relationship building.

Underrepresentation can be most apparent in the later stages of vaccine development, according to the study. Costs combined with rapid enrollment goals may be a reason.

It’s important to set specific targets for participants’ race and ethnicity that reflect the populations, researchers said.

“When you know who you have to recruit, it’s amazing how it will happen,” Andrasik said. “If you are mindful and include the community early and often, this can happen.”

Andrasik experienced the importance of early inclusion in her own experience with the COVID-19 vaccine. She had many conversations with Black relatives and friends, many of whom expressed their discomfort and fear surrounding vaccination. In long conversations, she shared information about the inclusion efforts and the diverse populations involved in the COVID-19 trials.

“Then I got pictures on my phone of them getting vaccinated,” she said. “It was quite wonderful.”