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.

辉瑞正在开发一种二价呼吸道合胞病毒 (RSV) 预融合 F 亚单位疫苗（RSVpreF；ABRYSVO™），用于预防婴儿和 60 岁以上个体的 RSV 疾病。RSVpreF 于 2023 年 8 月 21 日在美国获得批准，可用于孕妇接种疫苗，以帮助保护婴儿免受 RSV 疾病的侵害。RSVpreF 还在美国获得批准（2023 年 5 月 31 日），用于对 60 岁以上个体进行主动免疫，以预防 RSV 引起的下呼吸道疾病 (LRTD)。在欧盟，RSVpreF 已获得两种适应症的批准，并已提交加拿大（两种适应症）和日本（保护婴儿的母亲免疫）的监管批准。本文总结了 RSVpreF 发展的里程碑，这些里程碑导致批准用于孕妇以预防婴儿 LRTD。