| アブストラクト | OBJECTIVES: While the adjuvanted recombinant zoster vaccine (RZV) is preferred for herpes zoster (HZ) prevention due to its superior efficacy, emerging evidence suggests a potentially elevated reactogenicity risk relative to the live attenuated zoster vaccine (ZVL). This research aims to further assess the safety profiles of both vaccines, particularly the risk of serious adverse events following immunization (AEFIs) to provide more evidence for clinical decision. METHODS: Individual case safety reports from the Vaccine Adverse Event Reporting System (May 2006-December 2024) were analyzed. Descriptive and time-to-onset (TTO) analyses were performed by vaccine type and AEFI seriousness. Disproportionality analyses were conducted at the System Organ Class, High-Level Term, and Preferred Term (PT) levels, with PT signals prioritized by the Designated Medical Event and Important Medical Event criteria. Additionally, three adverse events of special interest-anaphylactic reaction, Guillain-Barre syndrome (GBS) and syncope, were assessed using Standardized MedDRA Queries if available. RESULTS: For monotherapy ICSRs (>90 % of total), serious AEFIs occurred in 11.2 % of ZVL and 4.6 % of RZV recipients, with fatal outcomes documented in 0.5 % and 0.3 % of cases respectively. The majority of ICSRs for both vaccines originated from the US, with ZVL cases primarily recorded prior to 2017. For both vaccines, females and individuals aged 60-69 years predominated among reported cases; patients experiencing serious AEFIs were generally older. Most AEFIs occurred </=7 days post-vaccination (peak: 0-2 days). Serious AEFIs occurred later than non-serious events. RZV-associated AEs primarily manifested as transient reactogenicity, whereas ZVL showed stronger associations with HZ reactivation along with neurological and ophthalmic complications. Neither vaccine exhibited disproportionality signals for anaphylaxis or syncope. However, GBS signals were inconsistent for RZV(detected by 2/4 methodologies), warranting further investigation to clarify potential safety implications. CONCLUSION: These findings provide reassuring real-world evidence supporting RZV's clinical safety. |
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| ジャーナル名 | Vaccine |
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| Pubmed追加日 | 2025/8/21 |
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| 投稿者 | Cai, Haixia; Jia, Beixi; Song, Zhiyu; Wang, Lei; Zhao, Shujuan |
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| 組織名 | Department of Pharmacy, Henan Provincial People's Hospital, Zhengzhou, China.;Department of Pharmacognosy, School of Pharmaceutical Science, Zhengzhou;University, Zhengzhou, China.;Electronic address: 562234266@qq.com.;Electronic address: zhaosunny@zzu.edu.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40834551/ |
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