Principi Nicola, Perrone Serafina, Esposito Susanna
Università degli Studi di Milano, 20122 Milan, Italy.
Neonatology Unit, Department of Medicine and Surgery, University of Parma, 43126 Parma, Italy.
Vaccines (Basel). 2025 Jul 1;13(7):717. doi: 10.3390/vaccines13070717.
Respiratory syncytial virus (RSV) remains a leading cause of lower respiratory tract infections and hospitalizations in infants and young children globally. Recently, RSV prevention has advanced with the introduction of nirsevimab, a long-acting monoclonal antibody, and the RSV preF vaccine for maternal immunization. While these interventions have improved early protection, several limitations hinder their broader impact and long-term effectiveness. This narrative review synthesizes evidence from clinical trials, observational studies, and regulatory reports to evaluate the main limitations of nirsevimab and maternal RSV vaccination. Literature searches were conducted in major databases, focusing on efficacy, safety, immunogenicity, implementation, and population-specific challenges. : Both nirsevimab and maternal vaccination provide strong protection during the first six months of life, but their effectiveness wanes thereafter. This is concerning as nearly half of RSV-related deaths occur in children over six months old. Maternal vaccine efficacy is uncertain in very-preterm infants, and safety concerns persist, including potential associations with preterm birth, Guillain-Barré syndrome, and hypertensive disorders. Real-world data from low-income countries are lacking, limiting generalizability. Additionally, the risk of vaccine-associated enhanced disease (VAED), although unconfirmed, has delayed pediatric vaccine development. Emerging monoclonal antibodies and live-attenuated vaccines are under investigation to extend protection beyond infancy. : Despite substantial progress, current RSV prevention strategies leave critical gaps, particularly for older infants and underserved populations. There is a pressing need for next-generation vaccines, enhanced pharmacovigilance, and equitable global implementation to ensure sustained and inclusive RSV protection.
呼吸道合胞病毒（RSV）仍然是全球婴幼儿下呼吸道感染和住院的主要原因。最近，随着长效单克隆抗体nirsevimab和用于母体免疫的RSV preF疫苗的推出，RSV预防取得了进展。虽然这些干预措施改善了早期保护，但一些局限性阻碍了它们产生更广泛的影响和长期有效性。本叙述性综述综合了临床试验、观察性研究和监管报告中的证据，以评估nirsevimab和母体RSV疫苗接种的主要局限性。在主要数据库中进行了文献检索，重点关注疗效、安全性、免疫原性、实施情况以及特定人群面临的挑战。nirsevimab和母体疫苗接种在生命的前六个月都能提供强有力的保护，但此后其有效性会减弱。这令人担忧，因为近一半的RSV相关死亡发生在六个月以上的儿童中。母体疫苗在极早产儿中的疗效尚不确定，安全问题依然存在，包括与早产、吉兰-巴雷综合征和高血压疾病的潜在关联。低收入国家缺乏真实世界的数据，限制了研究结果的普遍性。此外，疫苗相关增强疾病（VAED）的风险虽然未经证实，但已推迟了儿科疫苗的研发。正在研究新兴的单克隆抗体和减毒活疫苗，以将保护期延长至婴儿期之后。尽管取得了重大进展，但目前的RSV预防策略仍存在关键差距，特别是对于较大婴儿和服务不足的人群。迫切需要下一代疫苗、加强药物警戒以及公平的全球实施，以确保持续和全面的RSV保护。
