The Food and Drug Administration on Monday approved a shot to protect infants and vulnerable toddlers against respiratory syncytial virus, or R.S.V., offering one of the first protections for an illness that fills children’s hospitals year after year.
The monoclonal antibody shot is expected to be available at the start of the fall R.S.V. season. The F.D.A. is also considering approval of an R.S.V. vaccine by Pfizer for pregnant women that is meant to protect infants from the virus.
The treatment approved on Monday, called Beyfortus by its developers Sanofi and AstraZeneca, addresses an illness that can be severe in older adults and young infants. About 80,000 children ages 5 and younger are hospitalized with the virus each year, according to the Centers for Disease Control and Prevention.
“R.S.V. can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” Dr. John Farley, an official in the F.D.A. Center for Drug Evaluation and Research, said. “Today’s approval addresses the great need for products to help reduce the impact of R.S.V. disease on children, families and the health care system.”