FDA imposes GBS warning for RSV vaccines Abrysvo and Arexvy

The US Food and Drug Administration has imposed a label change for two new respiratory syncytial virus (RSV) vaccine rivals.

The FDA has required and approved safety labeling changes to the Prescribing Information for Abrysvo manufactured by US giant Pfizer (NYSE: PFE) and Arexvy from the UK’s GSK (LSE: GSK).

Specifically, the FDA has required each manufacturer to include a new warning about the risk for Guillain-Barré syndrome (GBS) following administration of their Respiratory Syncytial Virus (RSV) vaccine. The Prescribing Information for each vaccine has been revised to include the following language in the Warnings and Precautions section: