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Section A: Premarket registration applications
At this meeting the committee provided advice on one application 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) | ||||
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 this item 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.