"Building Trust: A Primer on the Law, Ethics, and Importance of Increasing Patient Representation in Vaccine Clinical Trials" in the National Vaccine Law Conference's Papers and Proceedings

This publication was written by Amanda Waldhauser, Roivant Social Ventures Executive Director, expanded from Lindsay Androski 2023 National Vaccine Law Conference Presentation while CEO of Roivant Social Ventures.

An excerpt from Roivant Social Ventures' recent publication, "Building Trust: A Primer on the Law, Ethics, and Importance of Increasing Patient Representation in Vaccine Clinical Trials" in the National Vaccine Law Conference's Papers and Proceedings.

"One of the foremost scientific advances of the 21st century has been the development of safe and efficacious vaccinations against diseases that cause substantial morbidity and mortality.”[1] In fact, vaccines have saved at least 154 million lives within the 50-year timespan of 1974-2024, with 101 million of those lives being infants.[2] While vaccines also have potential to help reduce the impact of infectious diseases on a global scale, a history of harmful vaccine incidents, discrimination within healthcare systems (including our own), and a lack of representation of underserved patient groups in scientific research have cumulatively led to both aversion and distrust within the populations that stand to benefit most from vaccines...

This article synthesizes historical, legal, and sociocultural drivers of mistrust and proposes concrete strategies to strengthen confidence and uptake. We review sentinel events such as the The Cutter Incident of 1955, contaminated Poliovirus vaccines, the Wakefield MMR–autism fraud, and the Nigeria Experiment, alongside a US record of unethical research on minority and underserved populations. Using COVID-19 as a case study, we describe the intersection of emergency authorizations, politicization, racialized disparities in morbidity and mortality, and persistent vaccine coverage gaps. We then examine structural underrepresentation in clinical research, evidence of sex-based differences in vaccine reactogenicity, and experimental findings that more representative trials improve patient beliefs about efficacy. Finally, we highlight emerging initiatives (e.g., scorecards and national action plans) and argue that improving healthcare representation and diversifying vaccine trials are not ancillary “DEI” preferences but essential prerequisites to equity, effectiveness, and public trust...

To leverage the full global potential of vaccines, we must continue to improve overall healthcare representation and increase diversity in vaccine clinical trials. Both prongs are essential for building trust within underserved populations. The best way to convince vulnerable populations that vaccines are important for their community is to generate safety and efficacy data for these populations."

The full publication can be found here.