Updated TGA warnings for RSV vaccines Arexvy and Abrysvo

Arexvy and Abrysvo are newly registered vaccines against Respiratory Syncytial Virus (RSV). Safety information for both vaccines has been recently updated to reflect the low risk of people contracting Guillain-Barre syndrome (GBS) following vaccination. 

Given the potential severity of RSV infection and the rarity of GBS, the benefit-risk balance remains strongly in favour of vaccination in target groups. According to data from the United States presented in October 2024, there were an estimated nince excess cases of GBS per million doses of Abrysvo, and an estimated seven excess cases per million doses of Arexvy administered to individuals aged 65 years and older. As of late March 2025, the TGA has not received any reports for GBS following vaccination with Abrysvo or Arexvy in Australia.  

Health professionals should be aware of the higher GBS risk in people following vaccination with Arexvy or Abrysvo, and should be alert to signs and symptoms of GBS to ensure correct diagnosis. Patients should be warned of this possible but rare risk and encouraged to seek medical attention if they experience symptoms, as early medical care can reduce severity and improve outcomes. 

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