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ACV meeting statement, meeting 17, 2 December 2020
Advisory Committee on Vaccines
Section A: Submissions for registration
No submission for registration was discussed.
The committee provided high-level comment on pending submissions for vaccines for SARS-CoV-2 disease that will use the provisional approval pathway. Areas covered included:
- factors that should be considered when determining the benefit-risk balance for potential provisional registration of COVID-19 vaccines
- the theoretical/ potential safety concerns with new vaccine technologies (e.g. mRNA and genetically modified vaccines), potential areas of focus for evaluation, and risk minimisation strategies
- use of digital expiry dates for vaccines with limited shelf life stability data at the point of registration (if approved).
Section B: Safety
The committee provided advice on the duration of a pharmacovigilance study that is included in a Risk Management Plan.
Section C: Immunisation Programs
No matter related to immunisation programs was discussed.