New FDA-Approved Drug, Beyfortus, Protects Babies From RSV

The FDA has officially approved Beyfortus, a new drug that can prevent Respiratory Syncytial Virus (RSV) in infants and children up to 24 months of age.

The virus, RSV, causes acute respiratory infections in all ages, not just infants or children, and usually spreads from close contact with another person during the fall and winter. While most infants and children experience mild symptoms, some — approximately 1% to 3% — develop pneumonia and bronchiolitis, which may lead to a visit to the emergency room. Premature infants or those with chronic lung disease are the most at risk for RSV.

"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," says John Farley, M.D., M.P.H., director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research. "Today's approval addresses the great need for products to help reduce the impact of RSV disease on children, families, and the health care system."


The newly approved drug, Beyfortus, is a monoclonal antibody — AKA a laboratory-made protein that fights off harmful pathogens by mimicking the immune system. The vaccine will be administered once a year, during or prior to RSV season, and reduced RSV by 70% to 75% in infants during clinical trials.

Side effects of Beyfortus are rash and small irritations at the injection site. Nevertheless, the new drug can protect immunocompromised infants and babies from the virus — as well as a trip to the ER.


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