Section A: Submissions for registration
The committee provided advice on two applications:
- major variation (change to dose regimen) for a vaccine with provisional registration for active immunisation to prevent COVID-19 (product name Comirnaty; active ingredient Tozinameran; sponsor Pfizer Australia Pty Ltd) that had been under evaluation from October 2021
- major variation (change to dose regimen) for a vaccine with provisional registration for active immunisation to prevent COVID-19 (product name Vaxzevria; active ingredient ChAdOx-1-S; sponsor AstraZeneca Pty Ltd) that had been under evaluation from November 2021.
Details of the ACV advice associated with these pre-market items has been released within the Australian Public Assessment Report (AusPAR). To browse all AusPARs see AusPAR search.
Section B: Safety
The committee was not asked to provide advice on any safety matter.
Further information
For further information on the ACV, please visit Advisory Committee on Vaccines or contact the ACV by email ACV@health.gov.au.