171. What role does Adjutor play in regulating and approving vaccines – has the TGA outsourced regulatory activities to a third party? 177. Why has the TGA allowed Pfizer/Moderna to set integrity and purity requirements? 265. Why is the Health Department claiming the approval process for the vaccines wasn’t rushed when in fact it was. Furthermore no carcinogenic, genotoxicity or longitudinal studies were completed. And I quote: “The Therapeutic Goods Administration (TGA) provisionally approved these vaccines after a complete assessment of all the available data. This is the same process as any vaccine approved in this country. The TGA will only register and approve a COVID19 vaccine if it is safe and effective.” www.health.gov.au/initiatives-and-programs/covid-19-vaccines/is-it-true/is-it-truewere-covid-19-vaccines-rushed-through-approvals-or-given-emergency-useauthorisations-in-australia.

Question Number: 257
PDR Number: SQ22-000628
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 171 •
– The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods. •
– Adjutor Healthcare (www.adjutor.com.au) is a privately owned regulatory affairs consulting company and does not have any role in the approval or regulation of vaccines. Adjutor Healthcare acts on behalf of a number of pharmaceutical companies who have medicines entered in the Australian Register of Therapeutic Goods (ARTG).

Question 177 •
– Pfizer and Moderna have not set vaccine clinical trial integrity and product purity requirements. All clinical trial results submitted to the 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. Similarly, TGA laboratories conduct independent batch testing on each batch of COVID-19 vaccines.

Question 265 •
– Due to the urgent nature of the COVID-19 pandemic, TGA expedited the review of the vaccines by having significant teams of scientists and doctors evaluate the data submitted in parallel (different parts of the dossier) rather than in sequence and also allowed the submission of rolling data by the sponsors. In addition, the teams worked long hours on the evaluations including evenings, weekends and public holidays. This enabled the overall timeframes for vaccine evaluation to be reduced. •
– The TGA’s provisional approval pathway, which existed prior to the pandemic, was introduced under the Therapeutic Goods Act 1989 to enable earlier access to promising new medicines while data on longer term efficacy and safety are still being gathered. •
– Each of the provisionally approved COVID-19 vaccines available in Australia have been evaluated by the TGA to ensure that they meet Australia’s high standards of safety, quality and efficacy based on the information available at the time of application. A team of technical and clinical experts at the TGA carefully evaluate the data submitted by the sponsor, to ensure that strict safety and efficacy thresholds are met. Advice is also sought from an independent expert committee, the Advisory Committee on Vaccines, before a regulatory decision is made. •
– As part of the provisional approval, sponsors are required to continue to submit longer-term evidence to the TGA. These studies are continuing to gather data on longer-term safety and effectiveness to complement post-market monitoring and spontaneous adverse event data. Ongoing assessment of vaccine safety is an integral part of the provisional registration process and the TGA is closely monitoring adverse events in Australia. Vaccine sponsors are required to conduct robust safety and effectiveness monitoring (pharmacovigilance) and risk minimisation activities with legislated reporting requirements.