Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.
Department of Immunization, Vaccines and Biologicals, WHO, Geneva, Switzerland.
Lancet. 2024 Sep 21;404(10458):1157-1170. doi: 10.1016/S0140-6736(24)01699-4. Epub 2024 Sep 9.
The search for safe and efficacious products to prevent severe respiratory syncytial virus (RSV) disease in young infants has lasted more than 60 years. In high-income and middle-income countries, two new products have been authorised: an RSV monoclonal antibody for administration to infants (nirsevimab) and an RSV prefusion F maternal vaccine (RSVpreF [Pfizer, Puurs, Belgium]) for administration to pregnant people. These products are not yet available in low-income and lower-middle-income countries, where most RSV deaths occur. Other papers in this Series describe the acute burden of RSV disease in young children, the effects of RSV infection in early childhood on long-term lung health, and the burden of RSV disease and disease prevention products in older adults. In this Series paper, we briefly review the efficacy, effectiveness, and safety of nirsevimab and RSVpreF maternal vaccine for protection of infants. We then explore potential regulatory, policy, and implementation pathways and provide case studies of intervention uptake in Spain and Argentina, and considerations for use in Kenya. We also explore the health economic evidence to inform product introduction decisions. With sufficient political will and affordable pricing, RSV disease prevention in infants can become a global reality.
寻找安全有效的产品来预防婴幼儿严重呼吸道合胞病毒 (RSV) 疾病已经持续了 60 多年。在高收入和中等收入国家,有两种新的产品获得了授权:一种用于婴儿的 RSV 单克隆抗体(nirsevimab)和一种用于孕妇的 RSV 预融合 F 母体疫苗(RSVpreF[辉瑞,比利时 Puurs])。这些产品在大多数 RSV 死亡发生的低收入和中低收入国家尚未获得。本系列中的其他论文描述了婴幼儿 RSV 疾病的急性负担、RSV 感染对儿童早期长期肺部健康的影响以及 RSV 疾病负担和疾病预防产品在老年人中的情况。在本系列论文中,我们简要回顾了 nirsevimab 和 RSVpreF 母体疫苗在保护婴儿方面的疗效、效果和安全性。然后,我们探讨了潜在的监管、政策和实施途径,并提供了西班牙和阿根廷干预措施采用的案例研究,以及在肯尼亚使用的考虑因素。我们还探讨了卫生经济学证据,以告知产品引入决策。只要有足够的政治意愿和可负担的价格,预防婴幼儿 RSV 疾病就可以成为全球现实。