[Exploring all-cause community-acquired pneumonia as an endpoint for adult pneumococcal vaccine clinical research].

Community-acquired pneumonia (CAP) represents a major global public health problem, characterized by high morbidity and mortality, particularly among the elderly and patients with chronic diseases. As Streptococcus pneumoniae is one of the primary pathogens causing CAP, the development and evaluation of pneumococcal vaccines are of paramount clinical importance. Selecting appropriate endpoints is critical for scientifically assessing a vaccine's protective efficacy in trials. Traditionally, invasive pneumococcal disease (IPD) has been widely used as a primary endpoint. However, its low incidence and the consequent requirement for large sample sizes have constrained its application in adult vaccine evaluation. Consequently, all-cause CAP has emerged in recent years as an alternative endpoint that is both broader in scope and more clinically relevant. This paper reviews the scientific rationale, advantages, and challenges of using all-cause CAP as an endpoint in adult pneumococcal vaccine trials. We propose a multi-dimensional framework integrating vaccine efficacy (VE), vaccine-preventable disease incidence (VPDI), and the number needed to vaccinate (NNV). This framework enables differentiated assessments across regions with varying diagnostic capacities, thereby advancing China's vaccine research and evaluation systems.