New vaccine for provisional registration for active immunisation to prevent COVID-19 (active ingredients elasomeran and imelasomeran; brandname Spikevax Bivalent Original/Omicron; sponsor Moderna Australia Pty Ltd).
Details of the ACV advice associated with this premarket item has been or will be released within the Australian Public Assessment Report (AusPAR). To browse all AusPARs see AusPAR search.
Section B: Safety
The committee was not asked to provide advice on any safety matter.