Wednesday, December 11, 2024

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Twelve Infants Die During Clinical Trials for FDA-Endorsed RSV Drug

Twelve Infants Die During Clinical Trials for FDA-Endorsed RSV Drug

On June 8, 2023, the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously (21-0) in favor of AstraZeneca and Sanofi’s new nirsevimab (Beyfortus) monoclonal antibody drug believed to provide protection for infants from respiratory syncytial virus (RSV) disease and other lower respiratory tract infections during their first year of life.1 […]

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