Post-marketing surveillance of 10,392 herpes zoster vaccines doses in Australia.

Autor: Muttucumaru R; UQ Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Herston, Australia; National Centre for Epidemiology and Population Health, College of Health & Medicine, The Australian National University, Canberra, Australia., Lau CL; UQ Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Herston, Australia., Leeb A; Illawarra Medical Centre, Perth, Australia., Mills DJ; UQ Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Herston, Australia; Dr Deb The Travel Doctor, Travel Medicine Alliance, Brisbane, Australia., Wood N; National Centre for Immunisation Research and Surveillance, Westmead, Australia; University of Sydney's Hospital Westmead Clinical School, Faculty of Medicine and Health, Westmead, Australia., Furuya-Kanamori L; UQ Centre for Clinical Research, Faculty of Medicine, The University of Queensland, Herston, Australia. Electronic address: l.furuya@uq.edu.au.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2024 May 10; Vol. 42 (13), pp. 3166-3171. Date of Electronic Publication: 2024 Apr 25.
DOI: 10.1016/j.vaccine.2024.03.066
Abstrakt: Background: Immunisation against herpes zoster is recommended for adults aged ≥ 50 years. Two vaccines, a live attenuated (ZVL, Zostavax®) and an adjuvant recombinant subunit (HZ/su, Shingrix®), are available in Australia. Immunisation guidelines are shifting their recommendations towards HZ/su because of higher efficacy in preventing herpes zoster and associated complications. However, there are limited post-marketing data comparing the safety profiles of these vaccines.
Methods: Data from SmartVax, an active surveillance system for monitoring adverse events following immunisation (AEFIs) utilised by > 450 clinics throughout Australia, were analysed. Data from patients aged ≥ 50 years, who received ZVL or HZ/su, from 1 June 2021 to 31 May 2022, at clinics that utilised SmartVax were included. The proportion of records where patients who reported any, local, and systemic AEFIs after receiving ZVL or HZ/su were compared using multivariable logistic regression models.
Results: Data from 10,392 immunisation records (n = 8341 ZVL; n = 2051 HZ/su) were included. The proportion of AEFIs reported was higher with HZ/su (41.9 % [any], 33.8 % [local], 25.2 % [systemic]) than with ZVL (8.7 % [any], 6.2 % [local], 3.5 % [systemic]). After controlling for demographic variables, HZ/su presented a 6-fold increase in the odds (OR 6.44; 95 %CI: 5.57-7.46) of a reported AEFI compared to ZVL. Only 59 (0.6 %) of vaccinations lead to medical attention being sought due to an AEFI.
Conclusions: While rates of AEFIs was higher with HZ/su than ZVL, most AEFIs were mild and did not require medical attention. Our findings support the change in vaccine recommendations and the use of HZ/su in immunisation programs.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ramona Muttucumaru reports financial support was provided by Australian National University. Colleen L Lau reports financial support was provided by National Health and Medical Research Council. Luis Furuya-Kanamori reports financial support was provided by The University of Queensland. Alan Leeb reports a relationship with SmartVax that includes: board membership and employment. Dr Alan Leeb is the Director of SmartVax If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 The Authors. Published by Elsevier India Pvt Ltd. All rights reserved.)
Databáze: MEDLINE
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