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.