Design of current and future COVID-19 vaccine efficacy trials
Holly Janes, PhD Fred Hutchinson Cancer Research Center
Rapid development and deployment of safe and effective COVID-19 vaccines for the global population is a public health imperative. We will overview the key statistical design elements of the first-generation US-government-funded vaccine efficacy trials, including the rationale and choice of endpoints, success criteria, triggers for analysis, and design adaptations following early evidence of efficacy. The implications of the emerging results for second-generation trials to evaluate additional vaccine candidates and to complete the profile of existing vaccines will be discussed.