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Paediatr Drugs. 2023 Nov;25(6):729-734. doi: 10.1007/s40272-023-00598-3.
Pfizer is developing a bivalent respiratory syncytial virus (RSV) prefusion F subunit vaccine (RSVpreF; ABRYSVO™) for preventing RSV illness in infants and individuals aged ≥ 60 years. RSVpreF received approval for vaccination of pregnant individuals to help protect infants against RSV illness on 21 August 2023 in the USA. RSVpreF is also approved in the USA (31 May 2023) for active immunization of individuals aged ≥ 60 years for the prevention of lower respiratory tract disease (LRTD) caused by RSV. In the EU, RSVpreF has received approval for both indications, and it has been submitted for regulatory approval in Canada (both indications) and in Japan (maternal immunization to protect infants). This article summarizes the milestones in the development of RSVpreF leading to the approval for use in pregnant individuals to prevent LRTD in infants.
辉瑞公司正在开发一种二价呼吸道合胞病毒（RSV）融合前 F 亚单位疫苗（RSVpreF；ABRYSVO™），用于预防婴儿和≥60 岁人群的 RSV 疾病。RSVpreF 于 2023 年 8 月 21 日在美国获得批准，用于接种孕妇，以帮助保护婴儿免受 RSV 疾病的侵害。RSVpreF 还于 2023 年 5 月 31 日在美国获得批准，用于≥60 岁人群的主动免疫接种，以预防 RSV 引起的下呼吸道疾病（LRTD）。在欧盟，RSVpreF 已获得这两种适应证的批准，并已在加拿大（两种适应证）和日本（母体免疫接种以保护婴儿）提交监管批准申请。本文总结了 RSVpreF 研发过程中的重要里程碑，最终获得批准用于孕妇接种，以预防婴儿的 LRTD。
