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Abrysvo (RSV vaccine)
Australian Prescription Medicine Decision Summary
Published
Product name
Abrysvo
Active ingredient
Recombinant respiratory syncytial virus (RSV) pre-fusion F protein bivalent vaccine
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
ABRYSVO (recombinant respiratory syncytial virus pre-fusion F protein bivalent vaccine) was approved for the following therapeutic use:
- Active immunisation of pregnant women between 24-36 weeks of gestation for prevention of lower respiratory tract disease caused by RSV in infants from birth through 6 months of age.
- Active immunisation of individuals 60 years of age and above for prevention of lower respiratory tract disease caused by respiratory syncytial virus RSV.
How this medicine works
Abrysvo is a vaccine that confers protection from lower respiratory tract disease caused by RSV. The vaccine contains two proteins found on the surface of the virus. Following injection of the vaccine, these proteins are recognised by cells of the immune system. This allows antibodies against these proteins to be generated, which can then neutralise the virus if a subsequent RSV infection occurs. High neutralising anti-RSV antibody levels in the blood are associated with reduced risk of disease.
This approval extended eligibility for the vaccine to pregnant women and individuals 60 years of age and above. In both of these groups, the vaccine works by inducing an immune response against the virus. i.e, the production of neutralising antibodies that target the RSV virus. In pregnant individuals, the anti-RSV antibodies generated also protect the developing baby through transfer of these antibodies to the baby via the placenta.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of ABRYSVO was considered favourable for the therapeutic use approved.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlink below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlink below.
Sponsor
Other resources
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For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.