GSK, Pfizer RSV shots must warn about rare paralysis risk
Barré for every million doses given.
BioSpace2d
GSK, Pfizer RSV Shots Required to Carry Guillain-Barré Syndrome Warnings
A post-marketing review by the FDA detected an increased risk of the autoimmune condition in patients inoculated with GSK’s ...
FiercePharma1d
RSV vaccines from Pfizer, GSK take another hit with new FDA warning mandate
The FDA will require GSK and Pfizer to include on the label of their respiratory syncytial virus (RSV) vaccines a warning ...
FDA Urges Guillain-Barré Syndrome Warning On Labels Of RSV Vaccines Abrysvo And Arexvy
The FDA has required the manufacturers of the RSV Vaccines Abrysvo and Arexvy to add a new warning to their labels about the ...
Becker's Hospital Review21h
FDA mandates warnings for 2 RSV vaccines
The FDA has mandated updated safety labeling for two respiratory syncytial virus vaccines, Pfizer's Abrysvo and GlaxoSmithKline's Arexvy, following the identification of an increased risk of ...
BioPharma Dive1d
FDA adds warning to RSV shots from GSK, Pfizer
Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.
Pfizer And GSK's RSV Vaccines Safety Labels Updated, FDA Adds Warning For Rare Neurological Disorder
FDA updates safety labels for Pfizer's Abrysvo and GSK's Arexvy RSV vaccines, citing increased Guillain-Barré syndrome risk.
FDA requires GSK and Pfizer vaccines to carry rare side effect warnings
Investing.com -- The US Food and Drug Administration (FDA) on Tuesday directed that vaccines for a common respiratory virus ...