Question Number: 167
PDR Number: SQ22-000194
Date Submitted: 24/02/2022
Department or Body: Department of Health
All data from the pivotal trials for each of the provisionally approved COVID-19 vaccines were genuinely benchmarked against a control group. All pivotal studies were conducted with a placebo (or active control) group to determine comparative efficacy and safety.
The pivotal Pfizer trial was a large, randomised, placebo-controlled trial. The study was adequately blinded. Randomised-controlled clinical trials are considered the gold standard among clinical trials due to the potential to limit bias.
Subjects in the pivotal Pfizer trial were initially followed for a median of two months post Dose two although data have now been published internationally in six months follow up. The submitted safety data fulfilled the requirement set out in the Access Consortium statement on COVID-19 vaccines evidence, which states that participants must be followed for a median of at least two months after receiving their final vaccine dose.
In addition, all clinical trial results submitted to the Therapeutic Goods Administration (TGA) must also comply with the Guideline for Good Clinical Practice. This is an internationally accepted standard for designing, conducting, recording and reporting of clinical trials. The Guideline is incorporated by reference in the Therapeutic Goods Regulations 1990. Additionally, 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.
