呼吸道同胞性病毒预防终于到来了:安全概述
Ingrid Laemmle-Ruff1, Nigel W Crawford2
1MBBS, 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.
Australian journal of general practice
|October 6, 2024
概括
澳大利亚的新型呼吸道同胞性病毒 (RSV) 预防产品,包括疫苗和单克隆抗体,表现出良好的耐受性. 持续的监测监测婴儿和老年人的罕见潜在安全信号.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 公共卫生 公共卫生
背景情况:
- 澳大利亚最近批准的呼吸道同胞病毒 (RSV) 预防产品针对高风险群体:幼儿和老年人.
- 一种RSV疫苗 (Arexvy) 是私下为60岁及以上的成年人提供,一些澳大利亚司法管辖区已经开始为婴儿提供nirsevimab单克隆抗体计划.
- 这些产品尚未成为国家免疫计划 (NIP) 的一部分.
研究的目的:
- 总结澳大利亚最近批准的RSV预防产品的安全数据.
- 审查成人RSV疫苗,孕产妇RSV疫苗和婴儿单克隆抗体的安全信息.
主要方法:
- 对RSV预防产品的临床试验数据的审查.
- 分析安全概况,包括局部和全身反应以及严重不良事件.
- 对安全信号的许可后监控数据的评估.
主要成果:
- 在临床试验中,RSV预防产品的耐受性通常很好.
- 大多数报告的局部和全身反应都是轻度至中度和短暂的.
- 在所有研究的产品中,严重不良事件的比例很低.
结论:
- 潜在的安全信号虽然非常罕见,但仍在进一步评估中.
- 这些包括与母亲RSV疫苗 (Abrysvo) 相关的早产风险和老年人RSV疫苗 (Abrysvo,Arexvy) 的吉兰-巴雷综合征 (GBS).
- 许可后监测正在积极监测这些特别感兴趣的不良事件.
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