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JUNE 9, 2023

FDA Advisory Committee Supports Nirsevimab to Prevent RSV in Infants


Originally published by our sister publication Infectious Disease Special Edition

By Marie Rosenthal

In a unanimous vote, the FDA Antimicrobial Drugs Advisory Committee (AMDAC) endorsed the benefits over the risk of an experimental immunoprophylaxis for the prevention of respiratory syncytial virus lower respiratory tract disease (RSV LRTD) in newborns and infants during their first RSV season.

“My vote is yes, and it relates to four different factors. First, this is one of the most