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

Author

Listed:
  • Paola Pirrotta

    (GSK)

  • Fernanda Tavares-Da-Silva

    (GSK)

  • Maribel Co

    (GSK)

  • Nicolas Lecrenier

    (GSK)

  • Caroline Hervé

    (GSK
    UCB Pharma)

  • Jens-Ulrich Stegmann

    (GSK)

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

Suggested Citation

  • Paola Pirrotta & Fernanda Tavares-Da-Silva & Maribel Co & Nicolas Lecrenier & Caroline Hervé & Jens-Ulrich Stegmann, 2021. "An Analysis of Spontaneously Reported Data of Vesicular and Bullous Cutaneous Eruptions Occurring Following Vaccination with the Adjuvanted Recombinant Zoster Vaccine," Drug Safety, Springer, vol. 44(12), pages 1341-1353, December.
    • Handle: RePEc:spr:drugsa:v:44:y:2021:i:12:d:10.1007_s40264-021-01118-3
    DOI: 10.1007/s40264-021-01118-3
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    1. Fernanda Tavares-Da-Silva & Olivia Mahaux & Lionel Holle & François Haguinet & Harry Seifert & Jens-Ulrich Stegmann, 2020. "Post-Marketing Safety Surveillance for the Adjuvanted Recombinant Zoster Vaccine: Methodology," Drug Safety, Springer, vol. 43(12), pages 1223-1234, December.
    2. Burny, Wivine & Marchant, Arnaud & Herve, Caroline & Callegaro, Andrea & Legrand, Catherine & Ndour, Cheikh, 2019. "Inflammatory parameters associated with systemic reactogenicity following vaccination with adjuvanted hepatitis B vaccines in humans," LIDAM Reprints ISBA 2019005, Université catholique de Louvain, Institute of Statistics, Biostatistics and Actuarial Sciences (ISBA).
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