Premature infants are at the highest risk for respiratory syncytial virus, or RSV. A new drug approved Monday promises to prevent the disease much more effectively. File Photo by Ismael Mohamad/UPI |
License PhotoJuly 17 (UPI) — The Food and Drug Administration announced Monday it has approved a drug by which newborns and infants can be protected against respiratory syncytial virus for an entire season with a single shot.
Nirsevimab, marketed under the brand name Beyfortus, got the nod from FDA regulators following three clinical trials that regulators said proved the safety and the efficacy of the vaccine against RSV, a virus that causes acute respiratory infections and which can be quite serious for some infants, especially those born prematurely.
The vaccine’s makers, AstraZeneca and Sanofi, said Beyfortus will be available in the United States ahead of the upcoming 2023-24 RSV season following earlier approvals in the European Union, Britain and Canada.
In most parts of the country, RSV circulation typically starts in the fall and peaks during the winter months. The virus is the leading cause of hospitalization among babies in the United States — approximately 1% to 3% of U.S. children under one year of age are hospitalized each year because of RSV, according to the American Academy of Pediatrics.
“Preemies” and those newborns with chronic lung disease of prematurity or significant congenital heart disease are at highest risk for severe RSV disease. While most infants and young children experience mild, cold-like symptoms, some — especially with their first infection — can contract pneumonia and bronchiolitis, often leading to emergency room or physician office visits.
With the development of the single-shot nirsevimab monoclonal antibody, however, the prevention of RSV will likely become much simpler and more effective, said Dr. John Farley, director of the FDA’s Office of Infectious Diseases.
“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,” he said, noting that until now, immunization against RSV has mostly been reserved for premature infants deemed at highest risk for serious illness because shots needed to be administered each month throughout the five-month RSV season.
“Today’s approval marks an unprecedented moment for protecting infant health in the U.S., following an RSV season that took a record toll on infants, their families, and the U.S. healthcare system,” said Sanofi Executive Vice President Thomas Triomphe, calling the drug a “potential game-changer” for American families.
The FDA had earlier granted Beyfortus “fast-track” designation.
The only noted possible side effects of the drug include rash and injection site reactions, the regulators reported.
