Thursday, October 10, 2024

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Guillain-Barré Syndrome ‘More Common Than Expected’ in Early RSV Vaccine Trial

Guillain-Barré Syndrome ‘More Common Than Expected’ in Early RSV Vaccine Trial

Reports of the nervous system disorder Guillain-Barré syndrome (GBS) were “more common than expected” in the older adult population who received the new vaccine for respiratory syncytial virus (RSV). The data, reported by the U.S. Centers for Disease Control and Prevention (CDC), matched trial data reported earlier this year.1 GBS is a “polio-like” inflammatory autoimmune […]

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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