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.
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