Section A: Premarket registration applications
At this meeting the committee provided advice on 2 applications under evaluation by the TGA, as below.
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area | Application designations | Commencement of evaluation |
|---|---|---|---|---|
| Applications for a 'new vaccine' containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia (Application Type A) | ||||
|
SARS-CoV-2 rS (MVC-COV1901) (MVC COVID-19 VACCINE) |
Grand Pacific CRO Australia | Prevention of COVID-19 | Provisional | June 2022 |
| Applications for a 'new indication', or additional therapeutic use, for an already approved vaccine (Application Type C) | ||||
|
Influenza virus haemagglutinin (FLUCELVAX QUAD) |
Seqirus Pty Ltd | Prevention of influenza | June 2022 | |
The committee provided advice on:
- one application for major variation (new dosage form, change/increase in patient group, change in dosage, new strength, new route of administration) (Application Type F)
Further details of the ACV discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs). To browse all AusPARs see Australian Public Assessment Reports (AusPAR).
Section B: Post-market items
The ACV was not asked to provide advice on a post-market or safety issue.
Further information
For further information on the ACV, please visit Advisory Committee on Vaccines (ACV).
or contact the ACV by email ACV@health.gov.au.