FDA Adds Warning Label to RSV Vaccines Abrysvo and Arexvy

MONDAY, Jan. 13, 2025 (HealthDay News) — The U.S. Food and Drug Administration now requires and has approved safety labeling changes to the prescribing information for the Abrysvo (Pfizer) and Arexvy (GlaxoSmithKline) respiratory syncytial virus (RSV) vaccines to include warnings and precautions about the risk for Guillain-Barré syndrome (GBS).

For each vaccine, postmarketing observational studies suggest an increased risk of GBS during the 42 days following vaccination.

Arexvy has been approved for the prevention of lower respiratory tract disease caused by RSV in all individuals 60 years of age and older and for those aged 50 to 59 years at increased risk. Abrysvo has been approved for the prevention of lower respiratory tract disease caused by RSV in all individuals 60 years of age and older, as well as individuals aged 18 to 59 years at increased risk. Abrysvo is also approved for pregnant individuals at 32 through 36 weeks of gestational age for the prevention of lower respiratory tract disease caused by RSV in infants from birth through 6 months of age.

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