Regulatory review of benefits and risks of preventing infant RSV disease through maternal immunization.

IF 6.9 1区医学 Q1 IMMUNOLOGY

NPJ Vaccines Pub Date : 2024-10-31 DOI:10.1038/s41541-024-01002-y

Yugenia K Hong-Nguyen, Joseph Toerner, Lucia Lee, Maria C Allende, David C Kaslow

引用次数: 0

Abstract

In August 2023, FDA approved Abrysvo for active immunization of pregnant individuals at 32 through 36 weeks gestational age to prevent lower respiratory tract disease (LRTD), including severe LRTD, caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. A pragmatic approach to narrow the interval of use of Abrysvo in pregnant individuals balanced benefits of vaccine effectiveness against potential risks to infant and mother.

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对通过母体免疫接种预防婴儿 RSV 疾病的益处和风险进行监管审查。

2023 年 8 月，FDA 批准 Abrysvo 用于孕龄 32 至 36 周的孕妇的主动免疫接种，以预防出生至 6 个月婴儿由呼吸道合胞病毒 (RSV) 引起的下呼吸道疾病 (LRTD)，包括严重的 LRTD。缩小孕妇使用 Abrysvo 间隔的务实方法兼顾了疫苗有效性的益处和对婴儿及母亲的潜在风险。

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

NPJ Vaccines Immunology and Microbiology-Immunology

CiteScore

11.90

自引率

4.30%

发文量

146

审稿时长

11 weeks

期刊介绍： Online-only and open access, npj Vaccines is dedicated to highlighting the most important scientific advances in vaccine research and development.