FDA Orders Pfizer to Add PARALYSIS WARNING to RSV Vaccine Labels

“FDA conducted a post-marketing observational study that assessed the risk of GBS (paralysis and muscle weakness) following vaccination with Abrysvo (Pfizer) and Arexvy (GSK) RSV vaccines."

January 15, 2025: Last Wednesday, the FDA ordered Pfizer and GSK to add Guillain-Barre Syndrome (GBS) as a serious adverse event risk warning to both Pfizer’s Abrysvo and GSK’s Arexy Respiratory Syncytial Virus (RSV) vaccine labels.

RSV is the leading cause of respiratory infection in adults over the age of 60. Prior to 2023, the CDC has not published data on the incidence of RSV death in babies and children. In 2023, the CDC estimates that approximately 100 children under the age of 5 died from RSV. Despite these low numbers, the CDC recommends that pregnant women receive an RSV vaccine to ‘protect’ their baby from RSV.

Image: Pfizer’s Abrysvo RSV Vaccine website

The FDA describes GBS as, “a rare disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis.”