Single-Dose Clesrovimab Safely Lowers RSV Infections and Hospitalizations in Infants: NEJM

Findings showed that clesrovimab markedly lowered the incidence of medically attended lower respiratory tract infections due to RSV compared with placebo, and also substantially reduced RSV-related hospitalizations, underscoring its potential as a preventive strategy for this common and sometimes life-threatening infection. Importantly, the safety profile of clesrovimab was comparable to placebo, with no signal of increased adverse events, further supporting its potential suitability for widespread use.

RSV is a leading cause of infant hospitalization worldwide, and while supportive care remains the mainstay of treatment, there is a recognized need for effective preventive measures beyond maternal vaccination and existing monoclonal antibodies.

The results of this large, randomized, placebo-controlled trial suggest that clesrovimab could fill an important gap in infant RSV prevention strategies by providing durable protection with a single dose, potentially easing the burden on healthcare systems and reducing parental anxiety during RSV season. The authors noted that longer follow-up and real-world studies will be essential to confirm durability of protection, cost-effectiveness, and feasibility of integration into national immunization programs, but the current evidence positions clesrovimab as a promising candidate for future inclusion in RSV prevention protocols for infants.