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Section A: Submissions for registration
The committee provided advice on one application for a major variation (dosage) and changes to the Product Information for a vaccine with provisional registration.
Further details of the ACV discussion and advice associated with these pre-market items may be released within the Australian Public Assessment Report (AusPAR). Please note that there is a delay between when an application is considered by the ACV and the publication of the 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.