ABRYSVO

What it is

ABRYSVO is a recombinant respiratory syncytial virus pre-fusion F protein vaccine containing 60 micrograms each of respiratory syncytial virus (RSV) subgroup A and subgroup B stabilised prefusion F protein produced in Chinese Hamster Ovary cells by recombinant DNA technology. It is supplied as a powder and diluent for solution for injection.

Approved indications

— Active immunisation of pregnant women between 24–36 weeks of gestation for prevention of lower respiratory tract disease caused by respiratory syncytial virus (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).

Dosing overview

ABRYSVO is administered as a single dose of 0.5 mL in pregnant women during late second or third trimester of pregnancy (24–36 weeks of gestation). For individuals 60 years of age and older, ABRYSVO is administered as a single dose of 0.5 mL. The vaccine is for intramuscular injection only, preferably in the deltoid region of the upper arm.

Key safety warnings

Guillain-Barré syndrome has been reported rarely following vaccination with ABRYSVO in individuals aged 60 years and above. Healthcare professionals should be alert to signs and symptoms of Guillain-Barré syndrome to ensure correct diagnosis, in order to initiate adequate supportive care and treatment, and to rule out other causes. ABRYSVO should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these individuals. Vaccination with ABRYSVO should be postponed in individuals suffering from an acute febrile illness; however, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. There are no data on the use of ABRYSVO in immunocompromised individuals, and immunocompromised individuals, including individuals receiving immunosuppressant therapy, may have a diminished immune response to ABRYSVO.

Contraindications

ABRYSVO is contraindicated in individuals with hypersensitivity to the active substances or to any of the excipients listed in the product information.

PBS listing

PBAC recommended in May 2024 for prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age by active immunisation of pregnant women. PBAC recommended in November 2024 and again in July 2025 for prevention of RSV lower respiratory tract disease in individuals 75 years of age and above, and for Aboriginal and Torres Strait Islander peoples aged 60 to 74 years, as a designated vaccine for the National Immunisation Program.

Regulatory history

ABRYSVO was first registered on the Australian Register of Therapeutic Goods on 20 March 2024 (ARTG 406624) as a bivalent vaccine supplied as a powder for injection vial with diluent syringe. TGA approval on 20 March 2024 covered active immunisation of pregnant women between 24–36 weeks of gestation to prevent RSV lower respiratory tract disease in infants from birth through 6 months of age, and active immunisation of individuals 60 years of age and above for prevention of lower respiratory tract disease caused by RSV. PBAC initially did not recommend the vaccine in March 2024 for use in infants via maternal immunisation, but recommended it in May 2024. PBAC recommended listing for adults 75 years and above and Aboriginal and Torres Strait Islander individuals aged 60–74 years in November 2024, with confirmation in July 2025.