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Post-marketing surveillance of 10,392 herpes zoster vaccines doses in Australia
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Post-marketing surveillance of 10,392 herpes zoster vaccines doses in Australia
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Journal Article
Post-marketing surveillance of 10,392 herpes zoster vaccines doses in Australia
2024
Overview
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.
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.
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.
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.
Publisher
Elsevier Ltd,Elsevier Limited
Subject
/ Adverse Drug Reaction Reporting Systems - statistics & numerical data
/ Aged
/ Female
/ Herpes Zoster - epidemiology
/ Herpes Zoster - prevention & control
/ Herpes Zoster Vaccine - administration & dosage
/ Herpes Zoster Vaccine - adverse effects
/ Herpes Zoster Vaccine - immunology
/ Herpesvirus 3, Human - immunology
/ Humans
/ Male
/ Patients
/ Product Surveillance, Postmarketing
/ Shingles
/ Shingrix
/ Vaccination - adverse effects
/ Vaccines
/ Vaccines, Attenuated - administration & dosage
/ Vaccines, Attenuated - adverse effects
/ Vaccines, Attenuated - immunology
/ Zostavax
