Barré for every million doses given.

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.

GSK and Pfizer's respiratory syncytial virus (RSV) vaccines will carry warnings that they can increase the risk of developing a rare neurological disorder, the U.S. Food Drug Administration said on Tuesday.

Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.

Before the RSV vaccines were approved, the FDA flagged potential GBS risks with the vaccines. After approval, the CDC continued to monitor for GBS risk. FDA conducted a postmarket

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.

He also articulated a very specific doctrine about the role of an FDA commissioner, one that is limited in its power and leaves many controversial decisions to career government officials. Califf said he would not directly comment on any individual,

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.