Section A: Submissions for registration
The committee provided advice on two applications:
- Major variation (booster dose for individuals aged 12-15 years old) 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 March 2022
- Major variation (booster dose for individuals aged 18 years and over) for a vaccine with provisional registration for active immunisation to prevent COVID-19 (product name Nuvaxovid; active ingredient SARS-CoV-2 rS with Matrix-M adjuvant; sponsor Biocelect Pty Ltd) that had been under evaluation from March 2022.
Details of the ACV advice associated with these premarket items has been or will be 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.