Biostatistics Seminar Series - Natalie E. Dean, PhD

Title: Considerations for test negative designs to evaluate COVID-19 vaccine effectiveness Abstract: Observational studies can generate useful evidence on the real-world effects of vaccines, including effectiveness in narrow subgroups or against rare endpoints like hospitalization. For COVID-19 vaccines, there is also interest in understanding the durability of protection and performance against novel viral variants. In this talk, I discuss considerations for designing observational COVID-19 vaccine studies to examine these questions, including a brief review of recent studies in the literature. I focus on the test negative design. In this design, individuals who test negative for the pathogen serve as controls similar to a case-control study. I describe the role of temporal confounding in the design and analysis of these studies and suggested best practices.