FDA Label Warning Threatens GSK's RSV Vaccine Sales -- Market Talk

Dow Jones
01-09

1122 GMT - The U.S. Food and Drug Administration's request for a label warning about Guillain-Barre syndrome risk on GSK's respiratory syncytial virus shot Arexvy could negatively impact vaccine sales, Bryan Garnier Research analysts say in a note. While a causal link between vaccination and GBS-- a rapid-onset muscle weakness caused by the immune system-- hasn't been proven, seven GBS cases per million Arexvy doses were observed, according to the FDA. "We believe the observed GBS incidence very close to natural GBS incidence in the non-vaccinated population," the analysts say. Arexvy sales already declined double-digit in 2H of 2024, following the narrowed recommendation to a smaller age range and more at-risk patients, the analysts say. Shares fall 0.04% at 1359.50 pence.(helena.smolak@wsj.com)

 

(END) Dow Jones Newswires

January 09, 2025 06:24 ET (11:24 GMT)

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