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 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.
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 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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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.
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 ...
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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- ...
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Prefilled Syringe Presentation of Shingrix Under FDA Review
The new prefilled syringe has the same composition but removes the need for reconstitution, providing a more convenient option for health care providers who administer vaccines. According to the ...
Guillain-Barre Syndrome explained as 2 RSV vaccines flag neurological 'risk'
As for GBS itself, this neurological ailment can be severe, attacking nerves and warranting hospitalisation for weeks or ...
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Pharma Stock Roundup: FDA Updates for JNJ, GSK, PFE, NVO's Expanded Deal
This week, the FDA granted priority review status to J&J’s JNJ application seeking approval of key pipeline candidate ...
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