Correlates of Protection: What have we done, What do we do now?
*Tsai-Lien Lin, CBER/FDA  Lihan Yan, USFDA 

Keywords: correlates of protection, vaccine

In the past decades, immune correlates of protection induced by vaccination have been discussed, analyzed, evaluated and even applied in the pathway of the approvals of vaccines. As difficult as it is to fully understand the human biological mechanism, evaluation of correlates of protection and more importantly the subsequent implication face great challenges not only from the statistical perspective but also from the regulatory perspective. This presentation will discuss such challenges from a statistical reviewer’s angle.