By Marie Rosenthal, MS
The FDA required and approved safety labeling changes to the prescribing information for respiratory syncytial virus (RSV) vaccines to include a warning about the risk for Guillain-Barré syndrome (GBS) after vaccination.
The labeling will apply to both RSVPreF (Abrysvo, Pfizer) and RSVPreF3+AS01 (Arexvy, GSK). The U.S. prescribing information (USPI) for each vaccine has been revised to include the same language in the Warnings and Precautions section—that