Introduction
infection
INFECTION
Stochastic interventional vaccine efficacy (SVE) analysis is a new approach to the assessment of immune correlates of protection (CoPs) based on a phase III vaccine efficacy (VE) trial dataset, recently published in the statistical literature [Previous immune correlates analyses of phase III VE trials by the US government’s COVID-19 Vaccine Correlates of Protection Program [Directly estimating VE against symptomatic infection with a given SARS-CoV-2 variant using “gold standard” data from a randomized, placebo-controlled efficacy trial (RCT) can only be done for variants circulating during the same time frame and at the same locations where the trial was conducted. The COVE phase III trial of the messenger RNA (mRNA)-1273 vaccine vs placebo (A validated immune CoP [Using a population-level approach, Cromer et al. [