At the ACV meeting on December 2, 2025, the committee addressed several critical aspects of vaccine safety and administration. The primary focus was on the Infanrix Hexa vaccine, a combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, poliovirus, and Haemophilus influenzae type b (Hib) vaccine. This vaccine is administered in two parts: a prefilled syringe containing five antigens and a vial with a lyophilized Hib pellet. Both components must be properly mixed (reconstituted) before use.
The ACV highlighted a concerning trend in the TGA's Adverse Events Management System (AEMS) database. As of August 21, 2025, there were 81 reported cases of product preparation errors involving Infanrix Hexa, with a significant number of these errors related to the Hib pellet being omitted during reconstitution. The reporting rate of these errors had surged from 2023 to 2025, raising serious concerns about the potential loss of Hib protection, which is crucial for infant health.
To address this issue, the ACV recommended several measures. They advised updating the vaccine's Product Information to make the reconstitution process more visible and clear, suggesting changes to the diagram in Section 4.2. The committee also recommended that the TGA request the vaccine sponsor to modify the internal configuration of the 10-dose packaging to enhance the visibility of the two components. Additionally, the ACV emphasized the importance of educating healthcare professionals about the reconstitution process, reminding them of the critical need to follow the instructions carefully.
Programmatic actions were also suggested to improve the overall vaccination process. These included enhancing national training resources, adding more prominent reminders about reconstitution in the Australian Immunisation Handbook, and incorporating these reminders into NIP Schedule practice resources like posters and pre-vaccination checklists. The ACV also stressed the ongoing importance of encouraging vaccination error reporting, even in cases where clinical harm has not been documented.
For further details on the Advisory Committee on Vaccines (ACV) and its work, visit their official website: https://www.tga.gov.au/about-us/committees-and-advisory-bodies/advisory-committee-vaccines-acv. You can also reach out to the ACV Secretary via email at ACV@health.gov.au for any additional inquiries.
