FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy

Excerpt:  “To inform the public and healthcare providers that FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc. and Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) manufactured by GlaxoSmithKline Biologicals. Respiratory Syncytial Virus (RSV) vaccine. … FDA conducted a postmarketing observational study that assessed the risk of GBS following vaccination with Abrysvo and Arexvy. Based on FDA’s evaluation of data from clinical trials, reports to the Vaccine Adverse Event Reporting System (VAERS), and the postmarketing study, FDA has determined that the overall body of evidence suggests increased risks of GBS with Abrysvo and Arexvy, but that available evidence is insufficient to establish a causal relationship.”