TGA warns of ‘possible but rare’ RSV vaccines risk

The Therapeutic Goods Administration (TGA) is urging healthcare professionals to make patients aware of a ‘possible but rare risk’ of contracting Guillain-Barre Syndrome (GBS) following the administering of respiratory syncytial virus (RSV) vaccines Arexvy or Abrysvo.
 
The TGA this week issued updated warnings on the two RSV vaccines, releasing new Product Information regarding a low risk of developing the condition following vaccination.
 
However, it says given the potential severity of RSV infection and the rarity of GBS, ‘the benefit-risk balance remains strongly in favour of vaccination’ for target groups.
 
Arexvy and Abrysvo were both approved for use in 2024 for adults aged 60 and over.
 
Arexvy is now also approved for people aged 50–59 deemed at increased risk of RSV, while Abrysvo is funded under the National Immunisation Program for eligible pregnant women to protect their infants.
 
Data from the United States released in October 2024 revealed an estimated nine excess cases of GBS per million doses of Abrysvo, and an estimated seven excess cases per million doses of Arexvy administered to people aged 65 years and older.
 
The TGA reviewed the data the following month, leading to its requirement for the Product Information update.
 
As of 24 March 2025, the TGA had not received any reports of GBS following vaccination with Abrysvo or Arexvy in Australia.
 
The TGA advises health professionals administering Arexvy or Abrysvo vaccines to alert patients to the risk of GBS and to seek medical attention early if they experience symptoms such as pins and needles, numbness, weakness and paralysis, typically beginning in the hands and/or feet.
 
‘Patients should be warned of this possible but rare risk,’ it said.
 
‘Early medical care can reduce severity and improve outcomes.’
 
Log in below to join the conversation.

Abrysvo Arexvy GBS Guillain-Barre Syndrome respiratory syncytial virus RSV TGA Therapeutic Goods Administration vaccination vaccine