A panel of outside advisers to the U.S. Food and Drug Administration (FDA) voted in favor of approving a preventative antibody treatment for respiratory syncytial virus (RSV) in newborns and infants.
The FDA does not have to follow the panel's recommendations but generally does.
First Treatment For All Newborns, InfantsCurrently, the only approved preventative treatment in the United States against RSV for infants is palivizumab—sold under the brand name Synagis. However, it's targeted toward pre-term infants or high-risk infants and children. The drug provides short-term protection and is given as monthly injections.
In contrast, nirsevimab is a long-acting treatment, expected to be given once every season to prevent infection.
If approved, nirsevimab would be the first preventative treatment designed to protect all newborns and infants in their first RSV season.
Because it is a monocloncal antibody, nirsevimab is not referred to as a vaccine.
Patel, a professor of clinical pharmacy at the University of California, San Diego, also said that the once-seasonal dosing schedule is a "huge advance."
RSVRSV is a common respiratory virus that usually causes mild, cold-like symptoms, from which most people recover in a week or two, according to the Centers for Disease Control and Prevention (CDC).
But the disease can be serious for some, including infants and older adults. The virus is the most common cause of bronchiolitis and pneumonia in children younger than 1 year old in the United States. It's also the leading cause of hospitalization in the same age group in the country.
A rise in the number of children suffering from RSV in the United States was recorded in late 2022, leaving some hospitals across the country overwhelmed as the COVID-19 pandemic subsided.The FDA advisory panel's latest endorsement for nirsevimab for infants comes several weeks after a separate group of advisers to the FDA supported Pfizer’s maternal RSV vaccine, intended to protect their newborns, despite concerns the shot could result in premature births.
"I think there will need to be studies that are done to figure out when one is more useful than the other," advisory panel member Karen Kotloff said.