Section A: Submissions for registration
The committee was not asked to provide advice on any submission.
Section B: Safety
The committee was not asked to provide advice on any safety matter.
Section C: Other items for advice
The ACV was asked to provide advice on options to streamline the approval of new vaccines based on mRNA technology and directed against COVID-19 variants of interest in order to provide timely access for the Australian community.
The ACV noted the background information provided by the TGA on current legislation that requires ‘preliminary clinical data’ to evaluate the safety and efficacy of a vaccine proposed for provisional registration. The ACV also noted the regulatory approaches in USA and Europe that accelerate review and approval of mRNA vaccines against new COVID-19 variants.
The ACV recommended that the TGA encourage full registration for the original mRNA COVID-19 vaccines.
The ACV recommended that the TGA provide guidance to sponsors about scope of Real World Evidence (RWE) required for full registration (effectiveness, safety, including in subgroups).
The ACV recommended that careful clinical evaluation is required for new variant vaccines, including consideration by the ACV. This will require consideration of strain selection, formulation, preclinical/animal data, information from other regulators, and other post-marketing data.
Further information
For further information on the ACV, please visit Advisory Committee on Vaccines or contact the ACV by email ACV@health.gov.au.