New RSV Vaccine Label Updated to Note Risk of Rare Guillain-Barré Syndrome

New RSV Vaccine Label Updated to Note Risk of Rare Guillain-Barré Syndrome

The Food and Drug Administration (FDA) will now require labeling changes for 2 respiratory syncytial virus (RSV) vaccines to warn of the potential risk of Guillain-BarrĂ© syndrome (GBS) associated with the vaccines. Postmarket observational studies suggest there is an increased risk of GBS during the 42 days following vaccination with Pfizer’s Abrysvo vaccine for RSV and GSK’s Arexvy vaccine for RSV. Both were approved by FDA in 2023, so they are relatively new in the …

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