Evaluation of and expected access to RSV immunisation products in Australia

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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.
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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: 20 April 2026
RSV immunisation product
Indication
Therapeutic Goods Administration (TGA) approval (registration)
Pharmaceutical Benefits Advisory Committee (PBAC) assessment for funding
National Immunisation Program (NIP) inclusion/funded supply
Private market supply
Clinical guidance
Infant protection

Nirsevimab

(Beyfortus, Sanofi-Aventis; long-acting monoclonal antibody)

Newborns/infants and children aged up to 24 months with risk conditionsTGA approved in November 2023May 2025

No; PBAC decision has been deferred

State- and territory-funded programs

NoRecommended for certain infants and children

Clesrovimab

(Enflonsia, Maerck Sharp & Dohme; long-acting monoclonal antibody)

Newborns/infants born during or entering their first RSV seasonSubmittedTBDTBDCurrently not availablen/a

Abrysvo

(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 gestation
Older adults protection

Abrysvo 

(Pfizer; protein subunit vaccine)

Adults aged ≥60 yearsTGA approved in March 2024November 2024

A funded program has not commenced, but PBAC has given a positive recommendation for:

  • all adults aged ≥75 years
  • Aboriginal and Torres Strait Islander adults aged 60–74 years

Funding for adults with risk conditions aged ≥60 years to be addressed in a future resubmission

Available

Recommended for:

  • all adults aged ≥75 years
  • adults with risk conditions and Aboriginal and Torres Strait Islander adults aged ≥60 years

Arexvy

(GSK; protein subunit vaccine with adjuvant) 

Adults aged ≥60 yearsTGA approved in January 2024July 2025

Yes; program to commence 15 May 2026 for:

  • all adults aged ≥75 years
  • Aboriginal and Torres Strait Islander adults aged 60–74 years

Funding for adults with risk conditions aged ≥60 years to be addressed in a future resubmission

State- and territory-funded programs: 

Available

Recommended for:

  • all adults aged ≥75 years
  • adults 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 2025TBDTBDAvailable

Consider for:

  • adults with risk conditions aged 50–59 years

mRESVIA

(Moderna; mRNA vaccine)

Adults aged ≥60 yearsTGA approved in March 2025November 2025No; PBAC decision has been deferredCurrently not availablen/a