Alliance for Pandemic Preparedness

February 22, 2021

Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials

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A cross-sectional study of 230 US-based clinical COVID-19 vaccine trials (n = 219,555 participants) found that, compared with the US population, Black or African American (11%), American Indian or Alaska Native (0.4%), Hispanic or Latino (121.6%), and older (age 65+, 12%) individuals were underrepresented, while women (56%) were overrepresented, in trials. Black or African American participants (10%) and Hispanic or Latino participants (23%) were also underrepresented in pediatric trials. Among trials reporting race/ethnicity, 65 (49%) did not include American Indian or Alaska Native participants and 81 (60%) did not include Hawaiian or Pacific Islander participants.

Flores et al. (Feb 19, 2021). Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials. JAMA Network Open. https://doi.org/10.1001/jamanetworkopen.2020.37640