The adjuvanted recombinant zoster vaccine (RZV) for prevention of herpes zoster in adults aged ≥ 50 years was first licensed in the USA and Canada in 2017 and in Germany in 2018.

Given the novelty of this adjuvanted vaccine, which is used in the older adult population, a high volume of spontaneous reports was anticipated, particularly in the early uptake period post-licensure, which posed potential challenges for the rapid safety monitoring, detection and analysis of signals associated with RZV vaccination.

GSK developed a customized tool for the enhanced, near real-time safety surveillance of RZV during its first year of market introduction and performed a weekly evaluation of spontaneous report data on a single web-based platform.

We identified background rates of preselected medical events that could possibly occur in coincident temporal association with RZV vaccination, considering the older adult population targeted by the vaccine, to support signal detection as well as characterization activities, such as the observed-to-expected analyses.

Two examples of detection and/or earlier evaluation of signals using the methods described are provided in this article.