Question Number: 274
PDR Number: SQ22-000645
Date Submitted: 21/11/2022
Department or Body: Department of Health
It is not clear what specification settings are being referred to. While Pfizer did specify the proposed primary efficacy outcomes of the clinical trials, this is the usual practice for any organisation public sector or private sector sponsoring clinical trials. The primary efficacy outcomes were agreed with major international regulators prior to the trials being ran, not uncommonly, if major regulators do not agree the primary outcomes are appropriate, a vaccine or medicine is not approved by regulators. All clinical trial results submitted to the Therapeutic Goods Administration (TGA) must comply with the Guideline for Good Clinical Practice. This is an internationally accepted standard for designing, conducting, recording and reporting of clinical trials. Compliance with the Guideline is a condition of approval for the conduct of a clinical trial. It provides assurances that clinical trial data is ethically obtained, credible, accurate, and that the rights, safety, and confidentiality of trial subjects are protected. Specifications including the percentage of intact mRNA were determined by the TGA, and TGA has the final say on the range of tests used by the TGA laboratories in batch testing of vaccines and whether individual batches are released or not.
