Statistical issues in the immune correlates analysis of the mRNA-1273 vaccine efficacy trial
David Benkeser, PhD Assistant Professor Biostatistics and Bioinformatics, Rollins School of Public Health Emory University
Identifying immune responses that are predictive of vaccine efficacy is an important goal of COVID-19 vaccine research. Discovery of such immune responses, termed vaccine correlates of protection, can lead to accelerated approval of new vaccines and existing vaccines in new populations. One important source of information for identification of correlates of protection is data from Phase 3 efficacy studies of vaccines. In this talk, I will describe some statistical issues surrounding correlates analysis in the context of a recent analysis of the U.S. Phase 3 trial of the mRNA-1273 (Moderna) vaccine. The talk will be a mix of scientific results from our study, statistical methods, and general musings on causality as it relates to identifying causal mechanisms of vaccines.