The FDA has required the manufacturers of the RSV Vaccines Abrysvo and Arexvy to add a new warning to their labels about the ...

The FDA will require GSK and Pfizer to include on the label of their respiratory syncytial virus (RSV) vaccines a warning ...

Findings from a postmarketing observational study showed an increased risk of GBS during the 42 days following vaccination.

Before the RSV vaccines were approved, the FDA flagged potential GBS risks with the vaccines. After approval, the CDC ...

Abrysvo lowered the risk of severe lower respiratory illness in newborns 84.7% in the first 90 days of life, and 69.4% in the ...

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 ...

The FDA is adding a warning about Guillain-Barré syndrome to the respiratory syncytial virus vaccines manufactured by GSK and ...

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

GSK and Pfizer's respiratory syncytial virus (RSV) vaccines will carry warnings that they can increase the risk of developing ...

The change was prompted by postmarketing observational studies that suggest an increased risk of GBS within 42 days of ...

FDA updates safety labels for Pfizer's Abrysvo and GSK's Arexvy RSV vaccines, citing increased Guillain-Barré syndrome risk.

A post-marketing review by the FDA detected an increased risk of the autoimmune condition in patients inoculated with GSK’s ...