Clesrovimab approval for RSV: a lifesaving opportunity for global infant health equity

The respiratory syncytial virus (RSV) remains the primary cause of acute lower respiratory tract infections and mortality among infants worldwide, with disproportionate deaths in low- and middle-income countries due to limited access to supportive care. The U.S. Food and Drug Administration recently approved clesrovimab, a single-dose monoclonal antibody aimed at protecting infants during their first RSV season. Key phase 2b/3 clinical trials demonstrated clesrovimab's significant efficacy in reducing RSV-associated hospitalizations by 84.3% and medically attended lower respiratory infections by 60.5%, with a safety profile comparable to existing prophylactic treatments in high-risk pediatric populations. The approval marks a significant advancement for infant RSV prevention in high-income settings, but to effectively reduce the global burden, particularly in resource-limited environments, equitable access and affordability must be prioritized. This intervention offers a vital opportunity to decrease RSV-related morbidity and mortality among vulnerable infants worldwide.