(News Bulletin 247) – The FDA Advisory Committee unanimously recommends nirsevimab as the first immunizing agent against RSV infections for all infants.
“If approved, nirsevimab would be the first preventative option specifically designed to protect the entire infant population during its first season,” the group says.
A single dose of nirsevimab provided consistent and sustained efficacy against RSV infection compared to placebo.
The Antimicrobial Drugs Advisory Committee (AMDAC) of the United States Food and Drug Administration (FDA) ruled unanimously, by a vote of 21 to 0, that the benefit/risk ratio of nirsevimab from Sanofi and AstraZeneca was favorable for the prevention of lower respiratory tract infections due to respiratory syncytial virus (RSV) in neonates and infants born during the RSV circulation season or entering their first exposure season to this virus.
The Committee also came out in favour, by 19 votes to 2, on the benefit/risk ratio of nirsevimab in children up to 24 months of age who remain at risk of severe RSV infection during of their second season of exposure to the virus.
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