AREXVY

What it is

AREXVY is a powder and suspension for injection containing recombinant respiratory syncytial virus pre-fusion F protein (RSVPreF3) adjuvanted with AS01 E. After reconstitution, each 0.5 mL dose contains 120 micrograms of RSVPreF3 antigen. The RSVPreF3 antigen is produced by recombinant DNA technology in Chinese Hamster Ovary cells. AREXVY is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

AREXVY is indicated for active immunisation for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in: — adults 60 years of age and older — adults 50 through 59 years of age who are at increased risk for RSV disease

Dosing overview

AREXVY is administered as a single dose of 0.5 mL. Currently there is not enough evidence to determine the need for revaccination. AREXVY is for intramuscular injection only, preferably in the deltoid muscle.

Key safety warnings

Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following administration of the vaccine. Vaccination with AREXVY should be postponed in individuals suffering from an acute severe febrile illness. AREXVY should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these individuals. Guillain-Barré Syndrome has been reported very rarely following vaccination with AREXVY in individuals 60 years and older. Healthcare professionals should closely monitor signs and symptoms of Guillain-Barré Syndrome in all AREXVY recipients to ensure correct diagnosis and to rule out other causes. If Guillain-Barré Syndrome is diagnosed, prompt management with adequate supportive care and treatment is recommended. Safety and immunogenicity data on AREXVY are not available for immunocompromised individuals. Patients receiving immunosuppressive treatment or patients with immunodeficiency may have a reduced immune response to AREXVY.

Contraindications

Hypersensitivity to the active substances or to any component of the vaccine is a contraindication.

PBS listing

As of December 2025, AREXVY is recommended for listing on the National Immunisation Program for prevention of lower respiratory tract disease caused by RSV in adults 75 years of age and above, and for Aboriginal and Torres Strait Islander peoples aged 60 to 74 years.

Regulatory history

AREXVY was first registered on the ARTG on 14 January 2024 under licence category RE. In July 2024, the PBAC did not recommend AREXVY for prevention of lower respiratory tract disease caused by RSV in patients aged 60 years and over. In July 2025, the PBAC recommended AREXVY as a designated vaccine for the National Immunisation Program, noting it was as safe and effective as Abrysvo. In December 2025, the PBAC recommended AREXVY for National Immunisation Program listing for adults 75 years of age and above and Aboriginal and Torres Strait Islander peoples aged 60 to 74 years, based on a revised price and updated cost inputs.