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14 June 2023

Hege Michiels (Ghent University), Andrea Callegaro (GSK), Daniel Backenroth (Janssen) 

Major statistical challenges exist in design, analysis and decision-making in vaccine development. This session is intended to stimulate and exchange scientific knowledge exchange among individuals working on similar topics within development of prophylactic and therapeutic interventions.  
To that end, a range of case studies and methods will be presented, illustrating the statistical challenges posed in vaccine trials and development, and novel solutions to address them.

A per-protocol analyses is typically performed in vaccine trials, to evaluate the effect of the vaccine as soon as full immunization is expected to be reached. In the first presentation Hege Michiels (Ghent University) will present on the causal interpretation that can be given to those per-protocol analyses and proposes an alternative estimand to measure the intrinsic vaccine efficacy in settings with delayed immune response.  
In the second presentation, Andrea Callegaro (GSK) will present a case study (The Boostrix Maternal Immunization US case) in which Bayesian dynamic borrowing was used to assess vaccine effectiveness. 
In the third presentation, Daniel Backenroth (Janssen) will present on using negative control methods for assessing the success of confounding adjustments and robustness of open-label analysis with non-randomized interventions. 

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