Originally published by our sister publication Infectious Disease Special Edition
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