121. Of the 44,000 people who participated in the Pfizer trial, how many clinical record forms were kept by Pfizer? (Note everyone should have file per link) 122. Of the 44,0000 clinical record forms how many did the TGA check? 123. Regulatory Documents show only 9 sites out of 152 Pfizer sites were subject to FDA inspection and only 10 out of 99 Moderna sites were subject to FDA inspection. How many sites did the TGA inspect and why does the TGA think its acceptable that such a small number of sites were inspected, especially since this was the first time mRNA vaccines were produced commercially for the first time? 124. How is it that a principal investigator of the Pfizer trial, Fernando Polack could recruit 4,500 patients in 3 weeks at one site? He was also at Vanderbilt in the period and happened to make appearances for the FDA and is also funded by the Bill and Melinda Gates foundation and the NIH. Yet presumably while doing this he managed to find time to recruit 4,500 patients in 3 weeks with each patient requiring 250 pages of case report forms. This is over 1,125,000 pages in three weeks? Does the TGA stand by the trails results of that Pfizer site in Argentina in that three-week period given the enormous caseload?

Question Number: 227
PDR Number: SQ22-000597
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 121 & 122 Pfizer submitted all relevant data from the COVID-19 clinical trials to the Therapeutic Goods Administration (TGA) with its application for provisional registration. The TGA has comprehensively evaluated the vaccine to ensure it met high standards of safety, quality, and efficacy based on the information available at the time of application. The TGA’s technical and clinical experts undertake a formal evaluation of the application, which includes assessing clinical studies, non-clinical toxicology studies, chemistry, risk management, and manufacturing information. The TGA does not request that all raw individual participant data be submitted with applications to register a medicine or vaccines, and among major regulars only the United States Food and Drug Administration (US FDA) do this. The TGA has met regularly with the US FDA throughout the COVID-19 pandemic and several of the meetings have included discussion of the data US FDA have reviewed. TGA does receive and review some raw individual participant data, such as information about serious adverse events. These are the same requirements as other comparable international regulators. Question 123 All manufacturers of mRNA vaccines supplied to Australia were assessed to confirm their manufacturing practices were acceptable. This was through a combination our own Good Manufacturing Practice (GMP) inspections and desk-top assessments which utilised GMP inspection information from comparable overseas regulators. The number of sites quoted includes early-stage clinical trial manufacturers which are not subject to GMP assessment in Australia. Vaccine used in Australian came from a somewhat smaller number of sites.

Question 124 Principal investigators in clinical trials often have large teams of individual doctors, nurses and data managers working in the teams under them; this was the case in a number of COVID-19 vaccine trials, and it enabled large trials to be conducted efficiently but with strong clinical oversight.