Design of a mRNA Vaccine Manufacturing Platform to Target M. Tuberculosis; Women’s bodies, men’s medicine: How science, ethics and society keep women out of clinical research

The systematic exclusion of marginalized populations—particularly women and individuals in low-income countries—from medical research and healthcare innovations has resulted in worse treatment outcomes. Historically, clinical and medical research have prioritized the health problems of more affluent men, especially white men, resulting in significant knowledge gaps about how diseases affect other demographic groups. This exclusion has had serious consequences: diseases that primarily impact alternate populations are under-researched, and women specifically often receive worse care due to their historical exclusion from early-phase clinical trials and research. My technical work addresses this imbalance through the development of a manufacturing platform for tuberculosis (TB) vaccine. Despite being the leading cause of death by an infectious agent—surpassing COVID-19 in 2023 and killing over one million people annually—TB primarily affects adults in low-income regions of Southeast Asia and Africa and has not seen a new vaccine or treatment in nearly a century (Tuberculosis (TB), n.d.). Similarly, my sociotechnical thesis examines how gender bias in clinical research has led to poor treatment outcomes for women, reinforcing disparities in healthcare. Together, these projects aim to challenge biases in medical research and advocate for a more inclusive, need-driven approach to global health.

In my research, I investigated two specific problems—one technical and one sociotechnical, both with sociotechnical facets—each addressing disparities in healthcare. The technical project focused on preparing for the potential scale-up of a novel mRNA-based, TB vaccine, which has recently shown promising results in clinical trials and could become the first new TB vaccine in nearly a century. The goal was to design a manufacturing platform capable of producing and distributing this mRNA vaccine at a low cost to low-income countries, where TB is a major health threat. This work involved estimating equipment needs and production costs based on limited existing data and lab-scale research, as mRNA vaccine manufacturing is a relatively new field without established industrial benchmarks. The analysis showed that such a facility could reduce TB burden on low-income countries and remain financially viable, if higher-cost doses are sold in more developed countries—for travelers, healthcare workers, and others at risk—subsidize distribution to high-need regions.

Meanwhile, my STS research examined the historical and ongoing exclusion of reproductive-age women from clinical trials and how this has shaped medical knowledge and treatment practices. Through an analysis of historical case studies (such as the Thalidomide tragedy of the 1950s and 60s), regulatory policy, and cultural narratives, I explored how science, policy, and social norms have co-produced gender biases in healthcare. These biases have often led to women’s symptoms, especially in cases involving chronic illness, being dismissed or misdiagnosed as psychological or "medically unexplained." My findings show that this issue is deeply rooted in the structure of scientific research itself, and analysis through three ethical frameworks further highlights the need for change.

While both of my works represent only a small step toward addressing the broader problem of inequality in healthcare, I was successful in both my technical report and STS thesis in contributing insights and proposing potential strategies to reducing disparities across gender and socioeconomic lines, nationally and globally. My research not only suggested ways to improve access to care but also identified key knowledge gaps and systemic causes behind these disparities, including biases in clinical research and the lack of investment in diseases affecting low-income populations. However, the solutions I proposed have limitations, and true progress will require cooperation across sectors, including stricter regulatory requirements for sex-based data analysis in clinical trials and international collaboration to approve and distribute new TB vaccines where they are most needed. Given current political trends, it remains uncertain how much change will be enacted in the near future. Nevertheless, future researchers can play a critical role by continuing to investigate underexplored diseases and populations, deepening our understanding of how health varies across identities, and pushing for more equitable research priorities and healthcare systems.

School of Engineering and Applied Science

Bachelor of Science in Chemical Engineering

Technical Advisor: Eric Anderson

STS Advisor: Caitlin Wylie

Technical Team Members: Abbie Frost, Eliza Mills, Ian Sellors, Jason Wieder