Is there not a conflict of interest in the TGA approving vaccines and collating adverse events – shouldn’t this be a separation of duties as the TGA will never admit to approving a drug that has subsequently be proven to be ineffective or unsafe?
Question Number: 181 PDR Number: SQ22-000154 Date Submitted: 24/02/2022 Department or Body: Department of Health It is not a conflict of interest for the Therapeutic Goods Administration (TGA) to approve vaccines and to monitor their safety after approval. The TGA applies scientific and clinical expertise to regulatory decision making to ensure that medicines and vaccines […]
155. Do any TGA or ATAGI employees or advisors have interests in pharmaceutical companies or receive payments from pharmaceutical companies?
Question Number: 180 PDR Number: SQ22-000148 Date Submitted: 24/02/2022 Department or Body: Department of Health The Therapeutic Goods Administration (TGA) All Departmental employees are required to disclose actual or apparent conflicts of interest in accordance with requirements of the Australian Public Service employment and financial management legislative frameworks, the department’s Accountable Authority Instructions, Finance Business […]
124. How many teams of many dozens of people working many long hours over many months, were funded, the number of EFT, and cost centre reports accounting for these items and how or by whom were these resources paid by?
Question Number: 121 PDR Number: SQ22-000132 Date Submitted: 24/02/2022 Department or Body: Department of Health Since the beginning of the COVID-19 pandemic it is estimated that there have been approximately 99.5 Therapeutic Goods Administration (TGA) Full Time Equivalent (FTE) staff across multiple Branches involved in the pre-market evaluation of applications for COVID-19 vaccines (including laboratory […]
Background rates of adverse events is just one of the many considerations in assigning causality is it not? Can the TGA explain the reasons why the medical experts who suspect the reported deaths were caused by the vaccine were wrong?
Question Number: 127 PDR Number: SQ22-000104 Date Submitted: 24/02/2022 Department or Body: Department of Health Question 27 Yes, background rates of adverse events are only one of the considerations in determining whether a particular adverse event was caused by vaccination. The Therapeutic Goods Administration (TGA) uses two main approaches to look for new safety information […]
233. Can the TGA or Pfizer show studies that all of the mRNA gets taken up by the cells? 234. What happens to the lipid nanoparticles that don’t get taken up by the cells? 235. How long will a spike protein produced by the mRNA vaccine stay in the body? 236. For the mRNA/Lipid Nanoparticles that doesn’t get taken up by cells is there a risk they mutate and become toxic in the body? 237. If the genetic Covid-19 vaccine is damaged in handling or storage how does Pfizer/TGA know that the mRNA won’t produce mutations of the spike protein rather than the protein itself? 238. After the Covid vaccine is given how quickly will the body start to produce spike proteins and how quickly after that will the body start to produce antibodies? 246. What cells or organs is the mRNA code meant to go into – just muscle cells or other organ cells as well – has this been tested – how can the TGA guarantee that Lipid nanoparticles or spike proteins won’t go into other organs?
Question Number: 197 PDR Number: SQ22-000177 Date Submitted: 24/02/2022 Department or Body: Department of Health 233. The percentage of the mRNAs that are taken up by the cells is not determined, but the amount entering the cell is sufficient to produce enough spike protein for the induction of adequate immunity against SARS-CoV-2 infection. The cells […]
92. Why didn’t the TGA inspect/audit individual records of patients in the initial COVID vaccine trials in order to ensure that Pharmaceutical companies carried out the trials correctly?
Question Number: 141 PDR Number: SQ22-000228 Date Submitted: 24/02/2022 Department or Body: Departmnet of Health For the registration of any medicine or vaccine, sponsors are required to submit a range of clinical trial data, which are based on individual patient-level data, to the Therapeutic Goods Administration (TGA) as part of the application process. The TGA […]
Senator RENNICK: Okay; that’s fine. When you review that data, can you please tell me how many people in the placebo trial were hospitalised, how many in the inoculation trial were hospitalised and how many died in the initial Pfizer trial?Dr Skerritt: Senator, we’ll put the data on deaths in the placebo and active arm as an answer to a question on notice.Senator RENNICK: I know the answer to that now; it’s actually zero and zero, because the initial Pfizer trial had no clinical outcomes in terms of hospitalisations and death and it had no-Dr Skerritt: Senator, I do not believe that is correct.Senator RENNICK: In the initial Pfizer trial, in the six-month data, there are different numbers, but-Dr Skerritt: Senator, I do not believe that you are correct-Senator RENNICK: Okay. We can move on.Dr Skerritt: I’m happy to, on notice. I do not believe that the Pfizer trial for the COVID-19 vaccine lacked data on hospitalisations. I do not believe that your assertion is correct.Senator RENNICK: Okay. I did not say it lacked data; I asked how many went to hospital. I’m asking you how many went to hospital and how many died in the inoculation group and the placebo group.Dr Skerritt: We will provide that information on notice.Senator RENNICK: Could you also provide subclinical outcomes regarding clotting and inflammation.Dr Skerritt: We’ll provide that additional information from the trial data, on notice.Senator RENNICK: Yes, on the initial trial data and not the six-month trial data.Dr Skerritt: Yes, on the initial. As long as-Senator RENNICK: Okay. Thanks, Chair.
Question Number: 99 PDR Number: SQ22-000015 Date Submitted: 24/02/2022 Department or Body: Department of Health The statistics requested from the pivotal Pfizer trial used by provisional registration of the vaccine, C4591001, are presented below. No Grade four local reactions or systemic events (i.e., a potentially life-threatening reaction requiring urgent intervention such as a visit to […]
45. Why do people have to lodge a FOI to get serious adverse event data from the TGA – shouldn’t it be made available with weekly reports? I refer to FOI-3520 that had to be lodged in order to get the total number of serious adverse events following Covid-19 vaccine injections? 46. Can the TGA point out where on the weekly reports are the total of serious adverse events listed as per John Skerritts comments in estimates that they are listed? There is nowhere that specifically states how many of the total adverse events reported are serious.
Question Number: 161PDR Number: SQ22-000113Date Submitted: 24/02/2022Department or Body: Department of Health 45. The Therapeutic Goods Administration (TGA) does not routinely publish the number of adverse events reported as serious. This is because simple reporting of the number and type of adverse event reports, including the number of reports assigned by reporters to one of […]
43. When filling out an adverse event report there is an option to indicate if the adverse event led to 1) Death 2) A life threating event, 3) admission to hospital, 4) a disability or incapacitation, 5) a congenital anomaly or 6) birth defect or 7) another medically important condition. Can I get the total of these categories to date by age and injury type and the cut-off date at which the numbers are given please?44. In future can the totals of the categories 1) Death 2) A life threating event, 3) admission to hospital, 4) a disability or incapacitation, 5) a congenital anomaly or 6) birth defect or 7) another medically important condition be provided in the weekly reports by age group and event type?
Question Number: 162 PDR Number: SQ22-000112 Date Submitted: 24/02/2022 Department or Body: Department of Health Question 43 The number of reports to 2 March 2022 for different age groups in each serious category are provided in the following table. Although the option to classify a reaction as serious is available to reporters, this assessment reflects […]
35. Why do COVID deaths include people who died from other comorbidities yet people who died within weeks of receiving the vaccine arent counted as vaccine deaths even if there was no other underlying comorbidity and the preparer of the report suspected the vaccine to be the cause?
Question Number: 190PDR Number: SQ22-000108Date Submitted: 24/02/2022Department or Body: Department of Health Attribution of a cause of death is not straightforward for COVID-19 in particular. When a person dies of COVID-19 alone, and not of the virus in conjunction with another illness, condition, or comorbidity, then that death can clearly be attributed to COVID-19. However, […]
