Section A: Submissions for registration
The committee provided advice on 3 submissions, including:
- Extension of indication for VAXNEUVANCE, containing Pneumococcal purified capsular polysaccharides, for active immunisation and prevention of pneumococcal disease (sponsor Merck Sharp & Dohme (Australia) Pty Ltd)
- Provisional registration of new vaccine SPIKEVAX BIVALENT ORIGINAL / OMICRON BA.4-5 COVID-19 vaccine, containing elasomeran and davesomeran (sponsor Moderna Australia Pty Ltd).
Information on the evaluation of these submissions was first published on Prescription medicines: applications under evaluation.
Details of the ACV advice has been or will be released within the Australian Public Assessment Report (AusPAR). To browse all AusPARs see Australian Public Assessment Reports (AusPAR).
The third submission on which the committee provided advice was a submission for the extension to the time period of provisional registration of a vaccine.
Section B: Safety
The committee was not asked to provide advice on any safety matter.
Further information
For further information on the ACV, please visit Advisory Committee on Vaccines (ACV).
or contact the ACV by email ACV@health.gov.au.