The FDA antimicrobial drugs advisory committee unanimously recommended nirsevimab for preventing respiratory syncytial virus in infants during their first RSV season.
Flu and RSV levels are rising to prepandemic levels, with increasing hospitalizations in children younger than 2 years.
The approval gives the nation two RSV vaccine options for use in adults 60 and older.
Though the group was impressed with the efficacy of the vaccine, they wanted to know more about preterm births, a factor that stalled a similar vaccine.
A lack of exposure to respiratory syncytial virus in the first 2 years of COVID-19 may have led to the global resurgence of the virus in 2022 and 2023.
An ongoing clinical trial shows a 94.1% reduction in risk of severe illness.
RSV activity began in the southeast and worked its way north and west. In its Marburg notice, the CDC said there is no evidence so far that the two outbreaks are connected.
Nearly two-thirds of patients hospitalized with flu, RSV, or COVID-19 received antibiotics, but they had a higher risk of death than those who didn't.
The advisory group's strong approval comes a day after it recommended Pfizer's RSV vaccine on a closer vote for the same age-group.
The group raised concerns about a small number of Guillain-Barre syndrome cases in vaccine recipients and wanted more data, especially on efficacy in those at highest risk.