An implementation framework for planning an RSV immunization program for infants using the long-acting monoclonal antibody

Respiratory syncytial virus (RSV) infects most children by the age of two. Although the majority experience mild cold-like symptoms, RSV can lead to serious lower respiratory tract infections (LRTIs), including bronchiolitis and pneumonia; the virus is responsible for 3.6 million hospital admissions in children under five globally. More than 70% of RSV-related hospitalizations in children under 1 year of age occur in infants who are otherwise healthy and born at term. Two immunizations have recently been approved with the aim of protecting all infants from severe RSV-related illness: a maternal vaccine, RSVpreF, and a long-acting monoclonal antibody (mAb), nirsevimab. The universal use of a long-acting mAb is a novel approach to disease prevention. It therefore requires careful planning to prepare health systems for widespread delivery. We developed a framework to encourage evidence-based planning for the implementation of RSV immunization programs using the long-acting mAb; the framework can also be used to guide improvements in countries where implementation has already begun. The framework was developed based on a pragmatic review of the published literature as well as the authors' perspectives and early experiences of implementation. It is organized into five domains, based broadly on the World Health Organization's health system building blocks: governance and leadership, reimbursement and funding, demand, service provision, and monitoring and assessment. This article provides an overview of the five domains of the framework, and examples of elements that should be considered under each.