Abstract：
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.
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.
摘要：
背景：建议对50岁以上的成年人进行带状疱疹免疫接种。两种疫苗,活减毒(ZVL，Zostavax®)和佐剂重组亚基(HZ/su，Shingrix®)，在澳大利亚可用。免疫指南正在将其建议转向HZ/su，因为在预防带状疱疹和相关并发症方面具有更高的功效。然而,对这些疫苗的安全性进行比较的上市后数据有限.
方法：来自SmartVax的数据，用于监测免疫接种后不良事件的主动监测系统（AEFI），在澳大利亚超过450家诊所使用。进行了分析。数据来自年龄≥50岁的患者，谁收到ZVL或HZ/su，从2021年6月1日至2022年5月31日，包括使用SmartVax的诊所。患者报告的记录比例，当地,使用多变量逻辑回归模型比较接受ZVL或HZ/su后的系统AEFIs。
结果:包括来自10,392个免疫接种记录(n=8341ZVL;n=2051HZ/su)的数据。HZ/su报告的AEFI比例更高(41.9%[任何]，33.8%[本地],25.2%[系统])比ZVL(8.7%[任何]，6.2%[本地]，3.5%[系统性])。在控制了人口统计学变量之后，与ZVL相比，HZ/su报告的AEFI的几率（OR6.44；95CI：5.57-7.46）增加了6倍。由于AEFI，只有59次（0.6％）的疫苗接种导致寻求医疗护理。
结论：虽然HZ/su的AEFI率高于ZVL，大多数AEFI是轻度的，不需要医疗护理。我们的发现支持疫苗推荐的变化以及HZ/su在免疫计划中的使用。
方法：来自SmartVax的数据，用于监测免疫接种后不良事件的主动监测系统（AEFI），在澳大利亚超过450家诊所使用。进行了分析。数据来自年龄≥50岁的患者，谁收到ZVL或HZ/su，从2021年6月1日至2022年5月31日，包括使用SmartVax的诊所。患者报告的记录比例，当地,使用多变量逻辑回归模型比较接受ZVL或HZ/su后的系统AEFIs。
结果:包括来自10,392个免疫接种记录(n=8341ZVL;n=2051HZ/su)的数据。HZ/su报告的AEFI比例更高(41.9%[任何]，33.8%[本地],25.2%[系统])比ZVL(8.7%[任何]，6.2%[本地]，3.5%[系统性])。在控制了人口统计学变量之后，与ZVL相比，HZ/su报告的AEFI的几率（OR6.44；95CI：5.57-7.46）增加了6倍。由于AEFI，只有59次（0.6％）的疫苗接种导致寻求医疗护理。
结论：虽然HZ/su的AEFI率高于ZVL，大多数AEFI是轻度的，不需要医疗护理。我们的发现支持疫苗推荐的变化以及HZ/su在免疫计划中的使用。
