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.

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The CDC recommends a single dose of any FDA-approved RSV vaccine for all adults ages 75 years and older, as well as for 60- to 74-year-olds who are at increased risk of severe illness from the virus. A third approved product, Moderna's mRNA vaccine (mResvia), was not included in the safety warning.

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

The FDA is adding a warning about Guillain-Barré syndrome to the respiratory syncytial virus vaccines manufactured by GSK and Pfizer based on data that suggest there may be a link between the shots and the rare 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.

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.

Barré for every million doses given.