Section A: Premarket registration applications
At this meeting the committee provided advice on 3 applications under evaluation by the TGA, as below.
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area | Application designations | Commencement of evaluation |
|---|---|---|---|---|
| Applications for a 'new vaccine' containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia (Application Type A) | ||||
|
live attenuated Vibrio cholerae bacteria cells (CVD 103-HgR strain) (VAXCHORA) |
Biocelect Pty Ltd | Prevention of cholera | July 2022 | |
The committee provided advice on:
- one application for a major variation (new dosage form, change/increase in patient group, change in dosage, new strength, or new route of administration) (Application Type F)
- one application for transition from provisional registration to full registration (Application Type S)
Further details of the ACV discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs). To browse all AusPARs see Australian Public Assessment Reports (AusPAR).
Section B: Post-market items
The ACV was not asked to provide advice on a post-market or safety issue.
Section C: Others matters for advice
In September 2022 (ACV 37) the ACV provided advice on the clinical data requirement for influenza vaccine strain update if there is a change in the composition of influenza vaccines. At that stage the ACV advised that it was not in a position to provide advice on the implications of a change in seasonal influenza vaccine away from the now-established composition of two influenza A strains (H1N1 and H3N2) and two influenza B strains.
At Meeting 44 the ACV was asked whether clinical trials assessing immunogenicity and safety of a seasonal influenza vaccine with the composition three influenza A strains with one influenza B strain should be requested from sponsors.
The ACV noted:
- there are currently no nonclinical and direct clinical data available with the composition of three influenza A strains with one influenza B strain
- relevant published literature is scarce
- the possibility to remove the influenza B/Yamagata lineage from seasonal influenza vaccines is under review by the World Health Organization influenza vaccine composition advisory committee and the US Vaccines and Related Biological Product Advisory Committee [Note: these links are to materials published subsequent to the ACV 44 meeting]
- quadrivalent seasonal influenza vaccines were first supplied in Australia in 2015 and trivalent seasonal influenza vaccines were last supplied in 2019.
The ACV advised that there are several potential options if influenza B/Yamagata is no longer recommended for inclusion in seasonal influenza compositions:
- removal of influenza B/Yamagata lineage, reverting to a trivalent formulation
- removal of influenza B/Yamagata lineage and doubling the existing influenza A/H3N2 antigen content, to maintain the same total antigen content as used in current quadrivalent vaccines
- addition of another influenza A strain from the influenza A/H3 clade, maintaining a quadrivalent vaccine.
The ACV noted manufacturing, quality control and regulatory issues with these options.
The ACV was not aware of any issues relating to influenza A/H3 antigen manufacture that may affect the safety profile of a formulation with double the influenza A/H3 antigen content, but this would need to be monitored in post-market surveillance.
If there were changes to influenza A/H3 content, the ACV indicated that human immunogenicity and safety data would be required to support differences compared to a trivalent or existing quadrivalent vaccines.
Human immunogenicity data may not be required if there was a change resulting in a reversion back to a trivalent vaccine (given these have previously been evaluated).
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.