Beyfortus (generic name: Nirsevimab) was approved by the United States Food and Drug Administration (FDA) on July 17, 2023. Beyfortus is a long-acting monoclonal antibody designed to protect newborns and infants from medically attended respiratory syncytial virus (RSV) infection. For the purposes of the Beyfortus drug trials, “medically attended” refers to any RSV infection requiring a doctor’s visit in the office, urgent care, or hospital.
RSV is the most common cause of lower lung infections in children less than one year of age. These types of lung infections include bronchiolitis and/or pneumonia. Bronchiolitis often begins with a runny nose and cough, but can worsen to include a faster breathing rate, wheezing, crackles, and needing to work harder to breathe. Infants are at risk for developing apnea, which is defined as a temporary pause in breathing or the absence of breathing for greater than 20 seconds.
According to the Centers for Disease Control and Prevention (CDC), RSV causes approximately 2.1 million non-hospital doctor’s office visits each year in children less than 5 years old1 as well as 58,000-80,000 hospitalizations each year in that same age group. (1,2,3) They report 100-300 deaths in children younger than 5 years due to RSV annually.4
Newborns and infants less than six months of age and those born prematurely (before 35 weeks gestation) are at the highest risk for having an infection severe enough to require hospitalization. These RSV infections usually require closely monitoring the young child’s breathing. The hospitalized infant or child may need breathing support, medications, and intravenous (IV) fluid support during the worst portion of the illness.
Beyfortus was created to prevent severe RSV infection in infants during their first RSV season, when they are at the highest risk for complications from the virus. According to a press release from the manufacturer, Sanofi: “The single administration of Beyfortus was developed to correspond…
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