AS01_E-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine (Adjuvanted RSVPreF3): Review of the First 2 Years of Post-Marketing Safety Surveillance.

IF 5.9 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2026-08-01 DOI:10.1007/s40264-026-01698-y

Catherine Tregunno, Quentin Deraedt, Susanna Cuadripani, Céline Verheust, Philip Bryan

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Abstract

Background: The AS01_E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (adjuvanted RSVPreF3) received its first marketing authorization in May 2023 for the prevention of respiratory syncytial virus lower respiratory tract disease in individuals aged ≥ 60 years.

Methods: We conducted a review of post-marketing safety surveillance data following adjuvanted RSVPreF3 administration. Spontaneous adverse events (AEs) that were reported worldwide since the first approval (3 May, 2023) to 2 May, 2025 in the GSK global safety database were analyzed.

Results: Up to 2 May, 2025, 13.4 million doses of adjuvanted RSVPreF3 were distributed globally. A total of 2861 spontaneous reports, including 7012 AEs (serious: 11.0%), were received. The most frequent AEs consisted mainly of non-serious reactogenic events. Of all reports, 1164 described vaccination errors, with most frequent errors consisting of either wrong product administration (N = 243) or administration to patients of an inappropriate age (N = 204). The majority (90.3%) of vaccination error reports were not associated with any other AEs. Adjuvanted RSVPreF3 was erroneously administered to pregnant individuals in 415 cases; most reports (95.2%) occurred without associated AEs. Observed-to-expected analysis of reports of Guillain-Barré syndrome (N = 37) did not suggest an increased risk compared to background incidence of this event and the reports of atrial fibrillation (N = 29) did not indicate an excess risk.

Conclusions: Review of the post-marketing surveillance data from 2 years of exposure to adjuvanted RSVPreF3 showed that the safety profile of the vaccine is consistent with that observed in clinical trials supporting an unchanged and favorable benefit-risk profile for the vaccine. Additional post-marketing surveillance is ongoing to further evaluate a potential risk of rare AEs, such as Guillain-Barré syndrome, following adjuvanted RSVPreF3 vaccination.

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as01e -佐剂呼吸道合胞病毒预融合F蛋白疫苗（佐剂RSVPreF3）：上市后前2年安全性监测回顾

背景：as01e佐剂呼吸道合胞病毒预融合F蛋白疫苗（佐剂RSVPreF3）于2023年5月获得首个上市许可，用于预防年龄≥60岁的呼吸道合胞病毒下呼吸道疾病。方法：我们对RSVPreF3佐剂后的上市后安全监测数据进行了回顾。分析GSK全球安全数据库中自首次批准（2023年5月3日）至2025年5月2日在全球范围内报告的自发不良事件（ae）。结果：截至2025年5月2日，全球共分发了1340万剂RSVPreF3佐剂。共收到自发报告2861例，其中不良反应7012例（严重发生率11.0%）。最常见的ae主要由非严重的反应性事件组成。在所有报告中，1164例描述了疫苗接种错误，最常见的错误包括错误的产品给药（N = 243）或给药患者年龄不合适（N = 204）。大多数（90.3%）的疫苗接种错误报告与其他不良事件无关。415例孕妇误服RSVPreF3佐剂；大多数报告（95.2%）无相关不良事件发生。对吉兰-巴罗综合征（N = 37）报告的观察-预期分析未显示该事件与背景发生率相比的风险增加，而心房颤动（N = 29）的报告未显示风险过高。结论：对2年RSVPreF3佐剂暴露的上市后监测数据的回顾显示，该疫苗的安全性与临床试验中观察到的一致，支持疫苗不变的有利的获益-风险特征。目前正在进行额外的上市后监测，以进一步评估接种RSVPreF3佐剂后发生罕见ae（如吉兰-巴罗综合征）的潜在风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.