Evaluation of and expected access to RSV immunisation products in Australia This resource summarises Australian Immunisation Handbook clinical guidance recommendations, regulatory body meeting outcomes – including the Pharmaceutical Benefits Advisory Committee and Therapeutic Goods Administration – and RSV immunisation funding and product availability. Formal recommendations regarding the use of respiratory syncytial virus (RSV) immunisation products in Australia can be found in the Australian Immunisation Handbook RSV chapter. Last updated: 15 May 2026 RSV immunisation productIndicationTherapeutic Goods Administration (TGA) approval (registration)Pharmaceutical Benefits Advisory Committee (PBAC) assessment for fundingNational Immunisation Program (NIP) inclusion/funded supplyPrivate market supplyClinical guidanceInfant protectionNirsevimab(Beyfortus, Sanofi-Aventis; long-acting monoclonal antibody)Newborns/infants and children aged up to 24 months with risk conditionsTGA approved in November 2023May 2025No; PBAC decision has been deferredState- and territory-funded programsNoRecommended for certain infants and childrenClesrovimab(Enflonsia, Maerck Sharp & Dohme; long-acting monoclonal antibody)Newborns/infants born during or entering their first RSV seasonTGA approved in March 2026TBDTBDCurrently not availablen/aAbrysvo(Pfizer; protein subunit vaccine)Infants from birth through 6 months of age, by active immunisation of pregnant individualsTGA approved in March 2024March 2024 and May 2024Yes; program commenced 3 February 2025AvailableRecommended in each pregnancy from 28 weeks gestationOlder adults protectionAbrysvo (Pfizer; protein subunit vaccine)Adults aged ≥60 yearsTGA approved in March 2024November 2024A funded program has not commenced, but PBAC has given a positive recommendation for:all adults aged ≥75 yearsAboriginal and Torres Strait Islander adults aged 60–74 yearsFunding for adults with risk conditions aged ≥60 years to be addressed in a future resubmissionAvailableRecommended for:all adults aged ≥75 yearsadults with risk conditions and Aboriginal and Torres Strait Islander adults aged ≥60 yearsArexvy(GSK; protein subunit vaccine with adjuvant) Adults aged ≥60 yearsTGA approved in January 2024July 2025Yes; the RSV vaccine Arexvy is funded under the NIP for:all adults aged ≥75 yearsAboriginal and Torres Strait Islander adults aged 60–74 yearsA funded program has not commenced, but PBAC have given a positive recommendation for: adults aged 60–74 years with risk conditionsFunded in WA for additional groups:Adults aged 60–74 years and: living in a residential aged care home receiving Commonwealth Support at Home living in specialist disability accommodation (SDA) in residential mental health servicesexperiencing homelessnessin a correctional facilityAdults aged 50–59 years in one of the above settings and:are Aboriginal and Torres Strait Islander have a risk factor for severe RSV diseaseAvailableRecommended for:all adults aged ≥75 yearsadults with risk conditions and Aboriginal and Torres Strait Islander adults aged ≥60 years ATAGI Statement on respiratory syncytial virus (RSV) immunisation products and prevention of administration errors [PDF]Adults aged 50–59 years with risk conditionsTGA approved in March 2025TBDTBDAvailableConsider for:adults with risk conditions aged 50–59 yearsmRESVIA(Moderna; mRNA vaccine)Adults aged ≥60 yearsTGA approved in March 2025November 2025No; PBAC decision has been deferredCurrently not availablen/a Back to respiratory syncytial virus (RSV) immunisation 262 views
