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The Food and Drug Administration this month approved a new vaccine for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants, designed as preventive care for their first RSV season. The long-acting monoclonal antibody clesrovimab-cfor offers protection through 5 months with the same 105 mg dose regardless of weight, according to a press release from manufacturer Merck. Clinical data from multiple trials shows significant reductions in RSV incidence and hospitalizations for patients who received the vaccine, which will be marketed under the brand name Enflonsia. The manufacturer was expecting the product to be available in the United States in time for the upcoming RSV season after the completion of review and recommendations by the Advisory Committee on Immunization Practices under the Centers for Disease Control and Prevention scheduled for later this month. However, recent changes to the committee this week could affect the timing of the rollout. Prescribing information can be found on the product website.
When RSV season is upon us: The new product will add to the choices among RSV vaccines for children/infants separate from those for older adults. Susceptibility to RSV infections typically begins in November and lasts through April.
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