Introduction
infection, coronavirus disease 2019
INFECTION, DISEASE, CORONAVIRUS DISEASE 2019
Edited by: MinJae Lee, University of Texas Southwestern Medical Center, United StatesReviewed by: Adali Martinez, University of California, San Francisco, United States; Daniel Fort, Ochsner Medical Center, United StatesThis article was submitted to Life-Course Epidemiology and Social Inequalities in Health, a section of the journal Frontiers in Public HealthDespite the importance of equitable representation in clinical trials, disparities persist with racial and ethnic minorities remaining largely underrepresented in trial populations. During the coronavirus disease 2019 (COVID-19) pandemic, wherein disease disproportionately affected racial and ethnic minority groups, the necessity for diverse and inclusive representation in clinical trials has been further highlighted. Considering the urgent need for a safe and efficacious vaccine, COVID-19 vaccine clinical trials faced marked challenges in rapidly enrolling participants without forgoing diverse representation. In this perspective, we summarize Moderna’s approach toward achieving equitable representation in mRNA-1273 COVID-19 vaccine clinical trials, including the COVID-19 efficacy (COVE) study, a large, randomized, controlled, phase 3 trial of mRNA-1273 safety and efficacy in adults. We describe the dynamics of enrollment diversity throughout the COVE trial and the need for continuous, efficient monitoring and rapid pivoting from initial approaches to address early challenges. Insights gained from our varied and evolved initiatives provide key learnings toward achieving equitable representation in clinical trials, including establishing and listening to a Diversity and Inclusion Advisory Committee, repeatedly engaging with key stakeholders on the necessity for diverse representation, creating and disseminating inclusive materials to all trial participants, establishing methods to raise awareness for interested participants, and enhancing transparency with trial participants to build trust. This work shows that diversity and inclusion in clinical trials can be attained even in the most extreme circumstances and highlights the importance of efforts toward building trust and empowering racial and ethnic minorities with the knowledge to make informed medical treatment decisions.Equitable representation in clinical trials remains essential for the public health sector, particularly for countries with racially pluralistic societies (The importance of health equity and ensuring that diverse patient populations are included in clinical trials was further emphasized during the coronavirus disease 2019 (COVID-19) pandemic (Vaccination against SARS-CoV-2 remains one of the best options toward controlling the ongoing COVID-19 pandemic, including those populations disparately affected by the disease. To this effect, equitable representation in clinical trials that evaluate the safety and efficacy of COVID-19 vaccines dictates that enrollment should include those populations at highest risk of infection or those disproportionately burdened by disease. Herein we summarize the multifaceted and evolving approaches undertaken by Moderna, Inc., to ensure diversity and inclusion in the study populations of phase 3 trials of mRNA-1273 (SPIKEVAX; Moderna, Inc., Cambridge, MA) (