FDA gives approval to RSV prevention drug ahead of cold season

The Food and Drug Administration (FDA) announced it has approved the Respiratory Syncytial Virus (RSV) prevention drug Beyfortus. The injection was given the go-ahead for infants and children up to 2 years old who face increased risk of severe 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,” John Farley, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement on Monday, July 17. “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.”

Beyfortus is made by AstraZeneca. The drug is a laboratory-made version of an antibody that helps the immune system fight off RSV.

FDA officials approved Beyfortus based on three studies showing the drug reduced the risk of RSV infection between 70% and 75% among infants and young children. With the FDA’s approval, babies will be able to receive a single injection to protect against their first season of RSV, which typically lasts about five months. Children up to the age of 2 will be able to get another dose to protect them during their second season of facing the virus.

Advisers to the Centers for Disease Control and Prevention (CDC) will meet in August to recommend exactly who should get the drug.

The FDA’s approval of the RSV prevention drug comes just over a month before the annual cold season gets underway. While RSV is a cold-like nuisance for most healthy people, it can be life-threatening in the very young and the elderly.

“While most infants and young children experience mild, cold-like symptoms, some infants, especially with their first infection, develop lower respiratory tract disease such as pneumonia and bronchiolitis (swelling of the small airway passages in the lungs), that often leads to an emergency department or physician office visit,” the FDA said. “Premature infants, and those with chronic lung disease of prematurity or significant congenital heart disease, are at highest risk for severe RSV disease. Approximately 1% to 3% of children under 12 months of age in the United States are hospitalized each year due to RSV, according to the American Academy of Pediatrics.”