The FDA approved Merck's monoclonal antibody, Enflonsia (clesrovimab), for prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants under 12 months. This entry competes with Sanofi and AstraZeneca’s Beyfortus in the pediatric RSV prophylaxis space. The approval arrives amid sweeping removals and restructuring of the CDC's Advisory Committee on Immunization Practices by HHS Secretary Robert F. Kennedy Jr., causing uncertainty in future vaccination recommendations and policy implementation.