Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology

Fernanda Tavares-Da-Silva (), Olivia Mahaux (), Lionel Holle (), François Haguinet (), Harry Seifert () and Jens-Ulrich Stegmann ()
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Fernanda Tavares-Da-Silva: GSK
Olivia Mahaux: GSK
Lionel Holle: GSK
François Haguinet: GSK
Harry Seifert: GSK
Jens-Ulrich Stegmann: GSK

Drug Safety, 2020, vol. 43, issue 12, No 5, 1223-1234

Abstract: Abstract A diligent, systematic, regular review of aggregate safety data is essential, particularly early after vaccine introduction, as this is when safety signals not identified during clinical development may emerge. In October 2017, the US Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommended the adjuvanted recombinant zoster vaccine (RZV; Shingrix, GSK) as the preferred vaccine for preventing herpes zoster (HZ) and related complications in immunocompetent adults aged ≥ 50 years. Subsequently, GSK experienced an unprecedented high demand for RZV. In this methodology paper, we summarize the enhanced measures undertaken to assess RZV safety during its early post-marketing experience in the USA, Canada and Germany. In addition to the routine signal-detection methods already in place for all vaccines, GSK established tailored and enhanced safety monitoring for RZV based on aggregate data of spontaneous reports and manufacturing data. Proactive, near real-time detection and evaluation of signals was a key objective. A dedicated in-house signal-detection tool customized for RZV was employed on a weekly (rather than the routine monthly) basis, allowing for a centralized, more frequent review of data on a single web-based platform. We also identified the background incidence rates of preselected medical events of interest in the first countries to introduce RZV (USA, Canada and Germany) to perform observed-to-expected analyses. This approach may offer a solution to the challenges associated with the assessment and monitoring of vaccine safety in an efficient and timely manner in the context of high vaccine uptake.

Date: 2020
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DOI: 10.1007/s40264-020-00989-2

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