ACV meeting statement, meeting 56, 8 April 2026

Section A: Premarket registration applications

At this meeting, the committee was not asked to provide advice on a premarket registration application.

Section B: Post-market items 

The ACV was asked to provide advice on one post-market item, as below.

Recombinant respiratory syncytial virus pre-fusion F protein and water for injections diluent (ABRYSVO) and preterm birth

ABRYSVO is indicated for the active immunisation of pregnant women between 24 and 36 weeks of gestation for the prevention of lower respiratory tract disease caused by RSV in infants from birth through 6 months of age. The vaccine is also indicated for the active immunisation of individuals aged 60 years and older for the prevention of lower respiratory tract disease caused by RSV.

ABRYSVO was added to the Australian Register of Therapeutic Goods (ARTG) on 
20 March 2024 and included in the National Immunisation Program (NIP) schedule for pregnant women between 28 and 36 weeks’ gestation in February 2025.

The potential risk of preterm birth was previously considered by the ACV at meeting 47 (31 January 2024) when advising on the optimal timing for the administration of ABRYSVO in pregnant women prior to registration.

Preterm birth has been monitored by the Therapeutic Goods Administration (TGA) as an adverse event of special interest (AESI) for ABRYSVO as part of enhanced post‑market surveillance since registration.

The TGA recently completed a Focussed Signal Investigation which was prompted by reports of 8 unique cases of preterm birth associated with ABRYSVO. The ACV considered this data in the context of the over 200,000 doses administered to females aged 15 to 49 years as reported to the Australian Immunisation Register. The ACV noted that the rate reported was significantly lower than the documented background rate of preterm births in Australia. 

Overall, the ACV advised that the available data was insufficient to demonstrate a causal association between ABRYSVO and preterm birth. Further, the ACV advised that at this time, the reports submitted to the TGA did not, in isolation, warrant referral to the National Immunisation Division or the Australian Technical Advisory Group on Immunisation for programmatic action. However, the ACV encouraged ongoing cross-agency collaboration to jointly explore opportunities to improve data sharing/capture in support of the ongoing surveillance of this signal.

Further information

For further information on the Advisory Committee on Vaccines, please visit: 

Advisory Committee on Vaccines (ACV)

or contact the ACV Secretary by email: ACV@health.gov.au