Section A: premarket registration applications
At this meeting the committee provided advice on 2 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 (ABRYSVO) | Pfizer Australia Pty Ltd | For the prevention of respiratory tract disease. | May 2023 | |
respiratory syncytial virus F protein mRNA (nucleoside modified) (Tradename to be confirmed) | Moderna Australia Pty Ltd | For the prevention of lower respiratory tract disease (LRTD) and acute respiratory disease (ARD) caused by respiratory syncytial virus (RSV). | Priority | July 2023 |
Details of the ACV advice associated with these items may be released in the Australian Public Assessment Reports (AusPARs). Browse all Australian Public Assessment Reports (AusPAR).
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.