A recent study of nearly 10 years’ worth of vaccine clinical trial data found that older adults and minority groups were underrepresented as trial participants.
The study, which was published online in the Journal of the American Medical Association Open Network examined 230 US-based clinical vaccine trials with nearly 220,000 participants from July 2011 to June 2020. Alarmingly, more than 60 percent of those analyzed did not include a participant’s ethnicity, and more than 40 percent did not include a participant’s race, in spite of policies and recommendations from the National Institutes of Health and the Food and Drug Administration encouraging these items be recorded.
Study author Laura Flores, who is a student at the University of Nebraska Medical Center (UNMC) says the lack of reporting is similar to what happened in early COVID-19 data reporting.
“Without that information, we just don’t have a full picture and we’re not able to solve these health care inequality problems,” Flores said.
While every trial included a participant’s age and sex, only 134 reported race, and only 79 reported ethnicities. However, even among those that reported race, there was a large gap, with 78 percent of participants listed as White adults, only 11 percent listed as Black, and Native Americans and Alaska Natives making up only 0.4 percent of participants.
Flores did find that the number of trials that included race increased with more recent trials. During the trials for their COVID-19 vaccines, both Pfizer and Moderna took steps to recruit more people of color, even slowing their trials to ensure equitable participation.
“They show what can happen when you prioritize inclusion of all groups, and they did a beautiful job of being representative of the population,” Flores said.
Flores hopes that including more minority groups and ethnicities in their vaccine trials will help dispel some of the medical mistrust in communities of color. Involvement in trials can also help to ensure equitable access to early vaccines and treatments.
