An analysis by researchers in the Pacific Northwest has found that U.S. vaccine trials over the past decade have largely under-represented Black, Indigenous and people of color as well as older adults.
Yet despite this shortcoming, the authors anticipate the trials for COVID-19 vaccines will mark the beginning of a more inclusive vaccine-testing process.
Drug manufacturers developing vaccines are required to go through a rigorous federal regulatory process that includes testing vaccines on thousands of volunteers from the public.
“We were sort of suspicious that there would be a lack of diversity (in the trials). I think we were all disappointed to see that was true, but it was not necessarily surprising,” said study co-author Steve Pergam, an infectious disease specialist at Fred Hutchinson Cancer Research Center in Seattle.
The research was published Friday in the Journal of the American Medical Association’s JAMA Network Open. Researchers analyzed all completed trail data for preventative vaccines in the U.S. from mid-2011 to mid-2020. They found that Black, American Indian and Alaska Native individuals were underrepresented compared to their nationwide populations. Hispanic/Latino individuals were as well.
“I think if folks don’t see themselves represented in the science, they feel excluded. And I don’t think it goes a far way towards trust,” said University of Oregon global and public health professor Kristin Yarris, who wasn’t involved in the trial analysis.
Trust is important when you’re trying to mobilize large portions of a population to combat disease, like COVID-19.
“If you look and you say, ‘I’m not included,’ it’s going to lead into the (vaccine) skepticism, the hesitancy,” Pergam said.
The analysis also revealed another substantial issue: data collection on race and ethnicity often missing from the trial results. About 60% of the trials included information about race. And only about 35% included ethnicity information, which is broadly how Hispanic/Latino people are identified in demographic data.
Information about age is collected, but often lumped together in inconsistent ways; one trial could have a category for 55-65 years, but another might group 55-70 year-olds together.
Without this information, it’s impossible to know how well drug manufacturers are doing.
The analysis did not include COVID-19 trials, which largely didn’t begin until the summer of last year.
“I sort of see the COVID trials as a new benchmark. They’ve really done something different,” Pergam said.
Study co-author Michele Andrasik with the COVID-19 Prevention Network based at Fred Hutchinson says vaccine makers have slowed down vaccine trial enrollments to ensure the pool of volunteers better represents the larger population.
“The recruitment of majority individuals outpaces the recruitment of BIPOC (Black, Indigenous and people of color) people at such a rate that if you allow that to continue, all the spots are filled,” she said. “So you really do need to be mindful and proactive about ensuring that there are slots available for BIPOC folks.”
Pergam said there was also a concerted effort to enroll older adults in the COVID-19 vaccine trials because they are so much more susceptible to serious disease and death.
Andrasik is in the process of analyzing the enrollment data from the COVID-19 vaccine trials. She expects to have those results later this year.