FDA, GSK and Pfizer

GSK, Pfizer RSV shots must warn about rare paralysis risk
Barré for every million doses given.
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 about the risk of developing Guillain-Barré syndrome (GBS), a rare neurological condition that can cause paralysis.
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 Guillan-Barré syndrome.
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. Study estimates 7-9 excess GBS cases per million doses.
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 Arexvy and Pfizer’s Abrysvo, prompting the regulator to require adjustments to the vaccines’ labels.
RSV vaccines to carry neurological disorder risk warning after new research
On Tuesday, January 7, the FDA announced it would now be requiring GSK and Pfizer’s RSV vaccines to hold warnings of a risk of Guillain-Barré syndrome (GBS). This is after post market analysis by the American regulator.
GSK, Pfizer RSV vaccines to carry warnings of GBS, Reuters reports
GSK (GSK) and Pfizer (PFE) vaccines for respiratory syncytial virus, or RSV, will carry warnings that they can increase the risk of developing
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 ...
Moderna stock forfeits gains as first US bird flu death puts vaccine development in focus
Moderna stock was on track to see a weekly gain of 10% as of Wednesday following the first reported bird flu death in the US.