(497) A Rapid Review of Racial/Ethnic Diversity Among Six U.S.-Based SARS-CoV-2 Vaccine Trials

Sunday, January 21, 2024

12:15 PM – 1:15 PM MT

Location: Connections Central - RST 10

First Author(s)

Annika Lintvedt (she/her/hers)

Michigan State University

Co-Author(s)

CL

Chanise Love, M.S.

N/A
Gift of Life Michigan, United States
AK

Andrew Kampfschulte, MSc

PhD Student
Office of Research, Corewell Health, Grand Rapids, MI, United States., United States
SR

Surender Rajasekaran, MD, MPH

Medical Director of Research, Corewell Health, West Michigan/Asst Prof, Michigan State University
Corewell Health Butterworth Hospital; Department of Pediatrics and Human Development, College of Human Medicine, Michigan State University, Grand Rapids, MI, United States; Pediatric Intensive Care Unit, Helen DeVos Children's Hospital, Grand Rapids, MI, United States., United States
CK

Chana Kraus-Friedberg, N/a

Librarian
Michigan State University, United States
Mara L. Leimanis-Laurens, PhD, (she/her/hers)

Research Scientist
Helen DeVos Children's Hospital
Grand Rapids, MI

Introduction: The Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19) pandemic placed unprecedented strain on critical care units across the country and called to action improvements in emergency preparedness and healthcare delivery. Vaccination against the disease became the greatest tool in slowing the spread of the pandemic yet uncovered many narratives including vaccine hesitancy and lack of trust in the healthcare system. Center for Disease Control data showed that racial and ethnic minorities in the U.S. were disproportionately impacted by COVID-19. We aimed to investigate relative representation of racial and ethnic minorities in the mRNA-1273 (Moderna) and BNT162b2 (Pfizer) vaccine trials.

Methods: PubMed, Web of Science, and Scopus were searched to identify phase I-III U.S.-based clinical trials for mRNA-1273 and BNT162b2 vaccines, between 3/2020-4/30/2021, with participants aged 16 or older. Two reviewers independently screened results, performed data extraction, and evaluated results (Cochrane Risk of Bias tool). The initial search yielded 14 relevant results after de-duplication. Of these, 7 were excluded through abstract screening, and one further article was excluded during full text screening. Subsequently, a total of 6 articles were included in the final analysis.

Results: Six randomly controlled trials (RCT’s), with a total of 68,850 participants, were included in this review: 4 mRNA-1273 trials, and 2 BNT162b trials. When standardized for population size, compared to White enrollment, rate ratios for all trials showed a combined underrepresentation in Black (RR=0.612) and Asian (RR=0.536) versus Hispanic (RR=1.02) populations.

Conclusions: The lack of ethnic/minority participation seen in the COVID-19 clinical trials may limit the ability to study vaccine efficacy across all populations. Further research should be conducted regarding the demographic representation of clinical trials to ensure equality amongst trial participation and adequate preparedness for future pandemics.