On Monday July 17, the Food and Drug Administration approved the first long-acting medication to protect babies and toddlers against respiratory syncytial virus (RSV). The lung-attacking virus sends about 58,000 children under five to the hospital and kills 100 to 300 infants every year in the United States.
Nirsevimab is a ready-made injectable antibody that can bind to RSV and block the virus from infecting healthy cells. It is not a vaccine, but instead, is a form of passive immunity.
For most healthy people, RSV manifests as a cold, but the virus can be life-threatening for the elderly and the very young. Nirsevimab was approved for infants and children up to two years old who face increased risk of severe RSV. Babies can receive a single injection to protect against their first RSV season, which typically starts in the fall and peaks in the winter in the US. Children up to two can then receive a second dose during their next 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,” director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research John Farley said in a statement. “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.”
Nirsevimab will be sold under the brand name Beyfortus and is already approved for use in the United Kingdom, Europe, and Canada. Pharmaceutical company Sanofi, who developed the drug with AstraZeneca, did not immediately say that the price of the treatment would be in the US.
According to an FDA analysis, nirsevimab was roughly 70 percent effective at reducing the risk that a baby would need to see a doctor for RSV and was about 78 percent effective at preventing hospitalizations compared with a placebo in the clinical trials that led to the drug’s approval. It was generally safe and well tolerated in the trials, with less than one percent of babies having skin reactions after the shots that went away with treatment.
“We run this gauntlet every year — RSV season,” pediatric infectious disease specialist at the Cleveland Clinic in Ohio Frank Esper told CNN “We see a lot of these infants. They come in; they can’t breathe. That’s the problem. That’s what RSV does. It causes so much swelling and secretions in their breathing tubes, called the bronchioles, that they just can’t get enough oxygen.”
Advisers to the Centers for Disease Control and Prevention will meet in early August to recommend exactly who should receive the drug. recommend exactly who should get the drug.
The approval is welcome after multiple decades of setbacks in research for RSV. The FDA approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer in May and the agency is expected to make a decision on a vaccine for pregnant people next month.