An FDA advisory committee voted unanimously that Sanofi and AstraZeneca’s nirsevimab has a favorable benefit risk profile for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants, teeing up approval for the first vaccine specifically designed to protect all infants through their first RSV season.
The U.S. FDA's Antimicrobial Drugs Advisory Committee voted 21 to 0 in favor of the vaccine's use in newborns and infants, and 19 to 2 in support of nirsevimab for children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.
Nirsevimab has a PDUFA date in the third quarter of 2023. If approved, Sanofi said the vaccine will be available in the U.S. ahead of the 2023-2024 RSV season.
The pending approval comes on the heels of two approvals for older adults. In May, the FDA gave the OK to GSK’s Arexvy in individuals 60 years of age and older, marking the first-ever RSV vaccine for older adults to be approved globally. Less than a month later, the agency approved Pfizer’s bivalent RSV vaccine, Abrysvo, for the same population.