Abstract
Evidence shows that White and non-Hispanic individuals are overrepresented in clinical trials. The development of new vaccines and drugs, however, necessitates that clinical research trials include representative participants, particularly in light of evidence showing that underrepresented minorities may have a different response to certain medications and vaccines. Racial and ethnic disparities among clinical trials are multilayered and complex, and this requires action. The results of this study indicate that significant racial and ethnic disparities consistently exist among the most recent early SARS-CoV-2 vaccine clinical trials as compared to the pandemic H1N1 vaccine clinical trials of 2009. New strategies, policies, training programs, and reforms are required to address these disparities among clinical trials.
Highlights
Coronavirus disease (COVID-19) has disproportionately impacted United States (U.S.)communities of color, Black or African American, Hispanic or LatinX, and American Indian and Alaska Native communities [1]; an adequate representation of communities of color in clinical trials, especially in COVID-19 vaccine clinical trials, is essential to reflect the population at the highest risk for COVID-19 acquisition and increased severity of disease.Concerted research efforts have accelerated the licensure of several vaccines through rigorous clinical trials detailing tolerability, safety, immunogenicity, and efficacy of different vaccine candidates [2,3]
The number of participants varied depending on the phase of the vaccine clinical trial; in particular, it varied between 40 elderly participants for the early-phase 1 clinical trial of the Moderna vaccine to 30,351 participants for the phase 3 efficacy clinical trial testing the same vaccine product [18,21]
We show that White participants were overrepresented, and Black or African American, American Indian or Alaska Native adults, and Hispanic or LatinX participants were underrepresented, especially in early-phase pandemic vaccine adult clinical trials including those regarding the current COVID-19 vaccine
Summary
Coronavirus disease (COVID-19) has disproportionately impacted United States (U.S.)communities of color, Black or African American, Hispanic or LatinX, and American Indian and Alaska Native communities [1]; an adequate representation of communities of color in clinical trials, especially in COVID-19 vaccine clinical trials, is essential to reflect the population at the highest risk for COVID-19 acquisition and increased severity of disease.Concerted research efforts have accelerated the licensure of several vaccines through rigorous clinical trials detailing tolerability, safety, immunogenicity, and efficacy of different vaccine candidates [2,3]. Communities of color, Black or African American, Hispanic or LatinX, and American Indian and Alaska Native communities [1]; an adequate representation of communities of color in clinical trials, especially in COVID-19 vaccine clinical trials, is essential to reflect the population at the highest risk for COVID-19 acquisition and increased severity of disease. Khubchandani et al showed that the overall pooled prevalence rate of COVID-19 vaccination hesitancy from 13 different studies [n = 107,841 participants] was 41.6% for Black or African Americans and 30.2% for Hispanics or LatinX [10] For both underrepresented racial and ethnic groups, there were many predictors of hesitancy, with the most common ones being the following: sociodemographic characteristics, medical mistrust, history of racial discrimination, and misinformation [11]. The lack of equitable representation will hinder progress into the era of precision medicine
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