New RSV vax

Eligible Australians now have access to Abrysvo, Pfizer’s recombinant respiratory syncytial virus pre-fusion F (RSVpreF) protein vaccine.

It is the first maternal vaccine approved by the TGA and recommended by ATAGI for pregnant women, that protects infants against RSV from birth, through to 6 months of age. 

ATAGI published new clinical guidance for healthcare professionals in June, which provides advice on the use of vaccines and RSV-specific monoclonal antibodies for the prevention of RSV in Australia, following the TGA’s authorisation of Abrysvo in March this year. 

ATAGI recommends RSV vaccination for: 

  • All people aged ≥75 years and Aboriginal and Torres Strait Islander people aged ≥60 years
  • People with medical risk factors for severe RSV disease aged ≥60 years; and
  • Pregnant women to protect their newborn infant.

Abrysvo is a sterile solution for intramuscular injection supplied as a vial of Lyophilized Antigen Component that is reconstituted at the time of use with a Sterile Water Diluent Component. The vaccine is formulated to contain 120 micrograms of RSV stabilised prefusion F proteins (60 micrograms RSV preF A and 60 micrograms RSV preF B) per 0.5 mL.  

The Australian Immunisation Handbook recommends a single dose of Abrysvo for use in pregnant women to protect their infants, administered at 28–36 weeks’ gestation, and it can be given at any time of the year, regardless of when a pregnant woman is expected to deliver. 

ATAGI has also reminded physicians that influenza vaccines can be given at the same time as, or at any interval before or after, other vaccines, including dTpa, respiratory syncytial virus, pneumococcal and COVID-19 vaccines.  

“If a person presents for another vaccine, this can be a prompt to consider influenza vaccination at the same time, if influenza vaccines are available,” ATAGI said in a statement. 

The product is currently not funded on the Pharmaceutical Benefits Scheme or the National Immunisation Program, with the PBAC recommending not adding Abrysvo for current listing on the NIP currently because of the high and uncertain incremental cost-effectiveness ratio.  

While Abrysvo is registered for use in pregnant women, the non-live vaccine is not registered for use in non-pregnant people aged less than 60 years and is subject to additional monitoring in Australia. GPs and patients can help by reporting any side effects at 

At its July meeting, the PBAC will consider the Arexvy RSV vaccine for adults aged 60 years and over, as well as nirsevimab (a long-acting monoclonal antibody) for infants and children up to two years of age. RSV monoclonal antibody products are not currently registered in Australia for use in anyone older than 24 months.   

Arexvy is recommended for people aged 75 years and over, First Nations people aged 60 years and over, and adults aged 60 years and over with medical conditions that increase their risk of severe RSV disease.  

Another RSV vaccine is currently being evaluated for registration for use in older adults in Australia and the ATAGI targeted review 2024: immunisation strategies for prevention and control of respiratory syncytial virus disease in Australia, has been endorsed and will be published in the Communicable Diseases Intelligence journal later this year.