终于有预防呼吸道合胞病毒的方法了：安全性概述。

Respiratory syncytial virus prevention is finally here: An overview of safety.

机构信息

MBBS, BMedSc, MPH, FAFPHM, FRACP, Public Health Physician and Paediatrician, Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC), Murdoch Children@s Research Institute, Melbourne, Vic; Paediatrician, Department of General Medicine, Royal Children@s Hospital, Melbourne, Vic.

BMBS, FRACP, MPH, PhD, Paediatrician and Vaccinologist, Director of Surveillance of Adverse Events Following Vaccination In the Community (SAEFVIC), Murdoch Children@s Research Institute, Melbourne, Vic; Medical Head of Immunisation Services, Department of General Medicine, Royal Children@s Hospital, Melbourne, Vic; Professor, Department of Paediatrics, The University of Melbourne, Melbourne, Vic.

出版信息

Aust J Gen Pract. 2024 Oct;53(10):704-708. doi: 10.31128/AJGP-06-24-7314.

DOI:10.31128/AJGP-06-24-7314

PMID:39370153

Abstract

BACKGROUND

A number of respiratory syncytial virus (RSV) prevention products have recently been approved in Australia. These products focus on highest risk groups, aiming to prevent RSV disease in young infants and older adults. While not currently included in the National Immunisation Program (NIP), an RSV vaccine (Arexvy, GlaxoSmithKline [GSK]) is available privately for adults ≥60 years, and some Australian jurisdictions have commenced RSV monoclonal antibody (nirsevimab) programs for infants in 2024.

OBJECTIVE

This article summarises safety data regarding RSV prevention products approved in Australia, including vaccines for adults ≥60 years, maternal vaccines and monoclonal antibodies for infants.

DISCUSSION

Clinical trial data found these products were largely well tolerated, with most local and systemic reactions being mild-moderate and short-lived. Proportions of serious adverse events were low. While very rare, potential safety signals being further assessed include risk of preterm birth following the maternal vaccine (Abrysvo, Pfizer) and Guillain-Barré syndrome (GBS) following RSV vaccines in older adults (Abrysvo and Arexvy). Close monitoring of these adverse events of special interest via post-licensure surveillance is underway.

摘要

背景

最近在澳大利亚批准了多种呼吸道合胞病毒 (RSV) 预防产品。这些产品针对高风险人群，旨在预防婴幼儿和老年人的 RSV 疾病。虽然目前不在国家免疫计划 (NIP) 范围内，但一种 RSV 疫苗（Arexvy，葛兰素史克 [GSK]）可私下为≥60 岁的成年人提供，一些澳大利亚司法管辖区已在 2024 年为婴儿启动 RSV 单克隆抗体（nirsevimab）计划。

目的

本文总结了在澳大利亚获得批准的 RSV 预防产品的安全性数据，包括适用于≥60 岁成年人的疫苗、针对孕妇的疫苗和针对婴儿的单克隆抗体。

讨论

临床试验数据发现这些产品总体上耐受性良好，大多数局部和全身反应为轻度至中度且短暂。严重不良事件的比例较低。虽然非常罕见，但正在进一步评估潜在的安全信号，包括母体疫苗（Abrysvo，辉瑞）接种后早产的风险和老年人 RSV 疫苗接种后发生格林-巴利综合征 (GBS) 的风险（Abrysvo 和 Arexvy）。正在通过上市后监测对这些特别关注的不良事件进行密切监测。