The US Food and Drug Administration (FDA) has approved the first treatment to prevent serious respiratory syncytial virus (RSV) infections in children and infants.
RSV is a common virus that circulates in the fall and winter. Most children with RSV usually experience mild cold-like symptoms, but some, especially those exposed to the virus for the first time, can develop life-threatening respiratory illnesses such as pneumonia and bronchiolitis.
The treatment, called Beyfortus, is a single dose given by injection before or during the baby’s first RSV season. Children up to 2 years of age who remain vulnerable to RSV during their second RSV season, such as those with chronic lung or heart disease, are also eligible for the vaccine.
About 1 to 3 percent of children younger than 1 year are hospitalized for RSV each year in the US, according to the FDA. There was a remarkably bad RSV season last year, as hospitals across the country struggled to keep up with the surge in cases, leading to drug shortages.
“RSV can cause serious illness in infants and some children and results in a large number of emergency department and doctor’s office visits each year,” John Farley of the FDA’s Center for Drug Evaluation and Research said in a statement. statement. “Today’s approval responds to the great need for products help reduce the impact of RSV disease on children, families, and the health care system.”
Beyfortus, made by the pharmaceutical company AstraZeneca, is not a vaccine. Instead, it uses monoclonal antibodies against RSV. These are proteins designed to mimic the antibodies produced by the immune system to defend itself against harmful pathogens. Unlike a vaccine, it does not train the body to identify RSV or to produce its own antibodies in response to infection. Side effects include a rash and pain, swelling, or redness at the injection site.
The FDA made its decision based on data from three clinical trials, which included nearly 4,000 babies. In these trials, a single dose of Beyfortus reduced the risk of infants needing medical attention for RSV infection by 70 to 75 percent.
Earlier this year, the FDA approved two RSV vaccines for older adults. Later this year, the agency will also decide on a maternal RSV vaccine, which would protect newborns from the disease.