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 Adds Guillain-Barre Syndrome Warning to Two RSV Vaccines
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.
FDA says RSV vaccines must come with Guillain-Barré warning
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 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.
GSK and Pfizer's RSV vaccines to carry warnings of neurological disorder risk
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.
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.
GSK, Pfizer RSV shots must warn about rare paralysis risk
Barré for every million doses given.
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
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FDA Requires Guillain-Barré Warning for Abrysvo and Arexvy
Regulators say, however, the benefits of vaccination with Abrysvo and Arexvy in preventing respiratory syncytial virus ...
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 ...
Monthly Prescribing Reference1d
RSV Vaccine Labeling Updated With Guillain-Barré Syndrome Warning
Findings from a postmarketing observational study showed an increased risk of GBS during the 42 days following vaccination.
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