The U.S. Food and Drug Administration (FDA) on Monday approved a new preventive treatment to defend babies and toddlers from the common and sometimes dangerous respiratory syncytial virus (RSV). The injectable drug, called Beyfortus (nirsevimab-alip), is designed for all babies entering their first RSV season, and for children up to 2 years old who remain vulnerable to severe RSV disease through their second RSV season.

RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” said John Farley, MD, MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement.

The Centers for Disease Control and Prevention (CDC) estimates that RSV hospitalizes 58,000 to 80,000 children under age 5 every year. RSV is the leading cause of hospitalization for infants under age 1 in the United States, averaging 16 times higher than the annual rate for influenza.

Although RSV typically results in mild, cold-like symptoms in most infants and young children, some develop lower respiratory tract disease such as pneumonia and bronchiolitis (swelling of the small airway passages in the lungs). Premature infants and those with chronic lung disease or significant congenital heart disease are at highest risk from RSV.

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