The importance of accurate vaccine administration cannot be overstated. At the recent ACV meeting held on December 2, 2025, the committee focused on significant post-market issues related to vaccines but did not review any new premarket registration applications.
Section A: Premarket Registration Applications
During this session, there were no requests for guidance regarding premarket registration applications.
Section B: Post-Market Items
However, the ACV was asked to offer insights on a particular post-market issue concerning the Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus, and Haemophilus influenzae type b vaccine, known as INFANRIX HEXA.
INFANRIX HEXA is supplied in a prefilled syringe that includes five distinct antigens along with a vial containing a lyophilized (freeze-dried) pellet of Haemophilus influenzae type B (Hib). It is crucial for healthcare providers to remember that these two components need to be reconstituted before administration.
As one of the two recommended hexavalent vaccines in Australia, INFANRIX HEXA is designated for immunization at 2, 4, and 6 months of age under the National Immunisation Program (NIP) Schedule.
The ACV expressed concern over 81 documented cases of product preparation errors associated with INFANRIX HEXA that were recorded in the Therapeutic Goods Administration’s (TGA) Adverse Events Management System (AEMS) database up until August 21, 2025. Notably, many of these incidents involved the Hib pellet being overlooked during the reconstitution process. Alarmingly, the rate of these reports per 100,000 doses has surged from 2023 to 2025, indicating a growing concern about inadequate Hib protection for infants.
To mitigate the risk of reconstitution errors with INFANRIX HEXA, the ACV recommended several key measures. They suggested revising the Product Information for INFANRIX HEXA to enhance the visibility of the reconstitution requirement in Section 4.2. Additionally, they advised the TGA to encourage the vaccine sponsor to modify the internal layout of the 10-dose packaging to make both components more easily visible. Furthermore, the ACV emphasized the necessity of communicating effectively with healthcare professionals to ensure that vaccinators are consistently reminded about the crucial step of reconstituting INFANRIX HEXA.
Programmatic strategies proposed include improvements to national training resources and integrating more conspicuous reminders about reconstitution within the Australian Immunisation Handbook, as well as in NIP Schedule practice aids like posters and pre-vaccination checklists.
The ACV also reaffirmed the vital role of promoting vaccine error reporting, emphasizing that such reporting should continue even in instances where there is no documented clinical harm.
Additional Information
For those seeking further details about the Advisory Committee on Vaccines, you can visit their official webpage at:
Advisory Committee on Vaccines (ACV)
Alternatively, you can reach out to the ACV Secretary via email at: ACV@health.gov.au
What are your thoughts on the measures suggested by the ACV? Do you believe these changes will have a significant impact on vaccination safety? Share your opinions in the comments below!
