The U.S. Food and Drug Administration (FDA) has reported an increased risk of Guillain-Barré Syndrome within 42 days of vaccination with Arexvy and Abrysvo. These two respiratory syncytial virus (RSV) vaccines were approved in 2023 to prevent RSV-related lower respiratory tract disease (LRTD) in adults, with Abrysvo also recommended for pregnant women between 32 and 36 weeks of gestation to protect their infants against LRTD caused by RSV for up to 6 months. For patient safety, the FDA now requires that the syndrome be included in the prescribing information for both vaccines. Read more about the FDA report here.

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