Section A: Submissions for registration
The committee provided advice on 3 submissions:
- Registration of a new vaccine Prevenar 20, containing Streptococcus pneumoniae pneumococcal purified capsular polysaccharides, for prevention of pneumococcal disease (sponsor Pfizer Australia Pty Ltd)
- Major variation (booster dose for individuals aged 12 years and over) for Spikevax, which has provisional registration to prevent COVID-19 (active ingredients elasomeran; sponsor Moderna Australia Pty Ltd)
- Provisional registration of new vaccine Comirnaty Original / Omicron BA.1, containing tozinameran and riltozinameran, to prevent COVID-19 (sponsor Pfizer Australia Pty Ltd).
Details of the ACV advice associated with these premarket items 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.
Further information
For further information on the ACV, please visit Advisory Committee on Vaccines or contact the ACV by email ACV@health.gov.au.