Section A: Premarket registration applications
At this meeting the committee provided advice on 4 applications under evaluation by the TGA:
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) | ||||
Recombinant respiratory syncytial virus pre-fusion F protein (AREXVY) | GlaxoSmithKline Australia Pty Ltd | Prevention of lower respiratory tract disease |
| January 2023 |
Applications for a 'new indication' or additional therapeutic use, for an already approved medicine (Application Type C) | ||||
Pneumococcal purified capsular polysaccharides (PREVENAR 20) | Pfizer Australia Pty Ltd | Prevention of pneumococcal disease |
| January 2023 |
Famtozinameran and Tozinameran (COMIRNATY ORIGINAL/OMICRON BA.4-5) | Pfizer Australia Pty Ltd | As a booster dose for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 | Provisional registration | July 2023 |
The ACV also provided advice on:
- one submission for a major variation (change in strength, dose form, route of administration, patient group or dosage) (Application Type F)
Details of the ACV advice associated with these items may be released in the Australian Public Assessment Reports (AusPARs) - browse all AusPARs.
Section B: Post-market items
Nil item.
Further information
For further information on the ACV, please visit Advisory Committee on Vaccines
or contact the ACV by email ACV@health.gov.au.