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.
Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (INFANRIX HEXA)
Infanrix Hexa comes in a prefilled syringe containing five antigens and a vial containing the lyophilized (‘freeze dried’) Haemophilus influenzae type B (Hib) pellet. The two components must be reconstituted prior to administration.
Infanrix Hexa is one of two alternative hexavalent vaccines recommended at 2, 4 and 6 months of age on the National Immunisation Program (NIP) Schedule.
The ACV noted 81 reports of product preparation error reported in relation to Infanrix Hexa in the TGA’s Adverse Events Management System (AEMS) database to 21 August 2025, many involving the Hib pellet being missed from reconstitution. The ACV noted the reporting rate (per 100,000 doses) had increased sharply from 2023 to 2025, raising concerns about missed Hib protection.
The ACV advised on several measures to reduce the risk of reconstitution error with Infanrix Hexa. The ACV advised updating the Product Information for Infanrix Hexa to amend the diagram in Section 4.2 to make the need for reconstitution of the two components more prominent and advised the TGA to request the vaccine sponsor change the internal configuration of the 10-dose packaging to optimise visibility of the two components. The ACV also recommended communication to healthcare professionals to remind vaccinators about the need for reconstitution of Infanrix Hexa. Programmatic actions recommended included enhancements to national training resources, consideration of more prominent reminders about the need for reconstitution of Infanrix Hexa in the Australian Immunisation Handbook and in NIP Schedule practice resources such as posters and pre-vaccination checklists.
The ACV also reiterated the importance of continuing to encourage vaccination error reporting, even when clinical harm has not been documented as a result.
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