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Sex, Racial, and Ethnic Representation in COVID-19 Vaccine Clinical Trials Conducted in US – A Systematic Review Compared to 2020 US Census Data

PRESENTED TO: AAPS Pharma Sci 360 2024 by BioPharma Services
PRESENTED BY: W. Yu, M. Ngoc Le & J. Oldenhof

PURPOSE

Vaccines and drugs typically undergo approval processes based on established safety and efficacy, validated through the rigorous randomized clinical trials. However, the limited diversity in clinical trials, especially for vaccines, has persisted for decades, raising concerns that the efficacy observed in these trials may not be applicable or effective for all populations. This underrepresentation contributes to vaccine hesitancy and lack of trust in the medical establishment, particularly in minority communities. This underscores the critical importance of inclusion efforts in future trials despite the heightened challenges involved.

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