An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine

Paola Pirrotta (), Fernanda Tavares-Da-Silva, Maribel Co, Nicolas Lecrenier, Caroline Hervé and Jens-Ulrich Stegmann
Additional contact information
Paola Pirrotta: GSK
Fernanda Tavares-Da-Silva: GSK
Maribel Co: GSK
Nicolas Lecrenier: GSK
Caroline Hervé: GSK
Jens-Ulrich Stegmann: GSK

Drug Safety, 2021, vol. 44, issue 12, No 8, 1353 pages

Abstract: Abstract Introduction With the approval of the adjuvanted recombinant zoster vaccine (RZV; Shingrix, GSK) in October 2017, GSK established enhanced safety surveillance measures to allow prompt identification of potential safety signals not observed during clinical development. In Germany, cases of vesicular and bullous cutaneous eruptions following RZV vaccination were reported. Objective Our objective was to search and analyse 2.5 years of worldwide spontaneously reported post-marketing data for vesicular and bullous cutaneous eruptions, represented by adverse events suggestive of (1) herpes zoster (HZ) and (2) non-HZ vesicular and bullous cutaneous eruptions, that occurred following RZV vaccination. Methods We conducted a descriptive analysis of all identified reports of HZ and non-HZ vesicular and bullous cutaneous eruptions following RZV vaccination and an observed versus expected (O/E) analysis of reports of HZ that met criteria of varicella zoster virus (VZV) reactivations following RZV vaccination (i.e., time to onset [TTO] of the event

Date: 2021
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DOI: 10.1007/s40264-021-01118-3

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