A legislative amendment to the National Health Act 1953 has broadened the definition of 'vaccine' to include antibody-based immunising agents, such as nirsevimab (Beyfortus, Sanofi) for RSV, paving the way for inclusion on the National Immunisation Program (NIP).
Nirsevimab is an immunising monoclonal antibody therapy that contains ready-made antibodies that offer immediate protection against RSV, which is known as passive immunisation.
This differs from active immunisation provided by traditional vaccines which trigger an immune response that leads to the creation of the body's own antibodies against a virus.
While the maternal RSV vaccine (Abrysvo, Pfizer) was available to expectant mothers through the NIP in 2025, nirsevimab for infants was not, resulting in a patchwork of state and territory funding with complex and inconsistent eligibility criteria and guidance.
This resulted in the hospitalisation of "thousands of babies [who] slipped through the cracks and missed out on protection", explained Immunisation Foundation of Australian founder and director, Catherine Hughes.
"We hope that the first beneficiaries of this important change will be Australian babies, thousands of whom are admitted to hospital each year with severe RSV.
"Now that this legislative impediment has been removed, every effort must be made to ensure that the antibody therapy that protects against severe RSV is made available through the NIP," Hughes concluded.
It is expected that the legislative change will also enable other forms of passive immunisation to be included and supported within Australia's immunisation policies and programs. KB
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