Dr. Natalie Dean
Assistant Professor, Department of Department of Biostatistics 
University of Florida

COVID-19 Vaccine Evaluation

Abstract

Rapid identification of a safe and effective vaccine for the prevention of COVID-19 is a critical public health goal. In this talk, I review the basic pathway for evaluating vaccines and describe the new ‘pandemc paradigm’ characterized by overlapping steps and greater up-front investment. Our group’s research focuses on the optimal design of large Phase 3 clinical trials in the context of outbreaks. I discuss our prior work on Ebola vaccines and ongoing efforts as part of the WHO’s R&D Blueprint for Action to Prevent Epidemics. Given the unpredictable spatiotemporal incidence of infectious diseases, we recommend that trials be flexibly designed to add new sites in a responsive manner, prioritizing areas with highest rates of disease. Site prioritization can be informed by ensemble forecast modeling. Furthermore, we recommend few large trials over many separate small trials. This collaboration speeds endpoint accrual, maximizes trial power, and makes the trial more robust to changing epidemiology.

Bio

Dr. Natalie Dean is an assistant professor in the Department of Biostatistics at the University of Florida specializing in infectious disease epidemiology and study design. She is principal investigator on an NIH R01 to develop and evaluate innovative trial and observational study designs for assessing the efficacy of vaccines targeting emerging pathogens. She previously worked on the design and analysis of a Phase 3 Ebola vaccine trial in Guinea that used a novel ring vaccination strategy. Dr. Dean received her PhD in Biostatistics from Harvard University in 2014 and performed her postdoctoral work with Dr. Ira Longini at the University of Florida.