Section A: Submissions for registration
The committee provided advice on one application to register a new vaccine, and one application to extend the indications of the vaccine.
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 provided advice on one matter relating to pharmacovigilance.
COVID-19 vaccine AstraZeneca [now, Vaxzevria] and Guillain Barre Syndrome
The ACV provided advice on the strength of evidence for the risk of Guillain Barre Syndrome (GBS) following COVID-19 vaccine AstraZeneca.
The ACV advised that GBS should be added to the Product Information (PI) of this vaccine as a warning.
The ACV advised that information for consumers could include wording such as 'greater than expected', with an explanation that there is a background rate of GBS in the absence of vaccination. A simple tabulation of expected and observed cases could be useful.
Further information
For further information on the ACV, please visit Advisory Committee on Vaccines or contact the ACV by email ACV@health.gov.au.