The Food and Drug Administration announced Monday it has approved a new drug to prevent RSV in babies and toddlers for the first time.
The FDA said Beyfortus is now approved for children up to 24 months who remain vulnerable to severe RSV. Beyfortus is considered a monoclonal antibody that mimics the immune system's ability to fight off RSV, the FDA said. The European Union approved the drug for children there in November 2022.
The FDA looked at data from five different late-stage clinical trials and immunity lasts about five months.
The drug can be administered as an injection prior to or during RSV season.
The drug reduced the risk of young children contracting RSV by 75%.
"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, 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."
Dr. Jennifer Kusman, a pediatrician at Lurie Children's Hospital of Chicago said, "to date, there is now a RSV vaccine for the elderly. And then there is now this new therapeutic, which is the monoclonal antibody. And then we still have available the past therapeutic, which was an monoclonal antibody that just had a shorter window of protection."
The drug should not be given to infants and children with a history of serious hypersensitivity reactions to Beyfortus' active ingredients or any of its excipients, the FDA said.
The FDA said side effects include rash and injection site reactions.
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According to the Centers for Disease Control and Prevention, RSV causes 58,000 hospitalizations annually among children under age 5.
The FDA said about 1% to 3% of children under 12 months of age in the United States are hospitalized each year due to RSV.
Early symptoms tend to include a runny nose, decrease in appetite, and cough. Those symptoms can worsen, causing inflammation of the small airways in the lung.
Premature infants, infants under 6 months of age and children younger than 2 years old with chronic lung disease or congenital heart disease are among those at higher risk for serve cases of RSV.
Doctors say preventing the spread of RSV is similar to stopping the spread of other viruses, including COVID-19 and the flu.
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