Section A: Submissions for registration
The committee's advice was sought on two applications. One application was for a new biological entity. The other application was for a broader indication (with or without substantiating supportive evidence). The committee provided advice on a range of issues.
Further details of the ACV discussion and advice associated with this pre-market item will be released within the Australian Public Assessment Report (AusPAR). Please note that there is a delay between when an application is considered by the ACV and the publication of the AusPAR. To browse all AusPARs see AusPAR search .
Section B: Safety
No item was on the agenda regarding safety or pharmacovigilance issues.
Section C: Immunisation Programs
No item was on the agenda regarding the immunisation programs.
Further information
For further information on the ACV, please visit the Advisory Committee on Vaccines or contact the ACV by email: ACV@health.gov.au