231. The non-clinical report noted there were no studies on the protection of older animals – given it was older people who are susceptible why were older animals excluded? 232. The non-clinical report noted that monkeys were not a good animal model of severe Covid 19 in humans – if this is case why use monkeys in a trial for a disease, they are not a good model for? 233. The non-clinical report noted vaccine induced auto immune diseases were not studied in the non-clinical program and should be addressed by clinical data. If this is the case, why are humans being used as guinea pigs? 259. How can the TGA discount the increased number of supernumerary ribs in vaccinated pregnant rats as not being a safety signal? Shouldn’t more testing have taken place? 268. Why is the TGA refusing to provide information relating to “All Developmental and Reproductive Toxicity Studies available to the TGA regarding the Pfizer and AstraZeneca COVID-19 vaccines including histology reports of gonads of vaccinated animals”
Question Number: 234 PDR Number: SQ22-000604 Date Submitted: 21/11/2022 Department or Body: Department of Health 231: Any drug or vaccine development includes nonclinical and clinical studies to ensure the efficacy and safety of the drug or vaccine. Even though older animals were not included in the protection studies with the Pfizer COVID-19 vaccine, more importantly […]
126. Why is vaccination status not being recorded on the Perinatal Data form, considering other vaccinations get noted?
Question Number: 233 PDR Number: SQ22-000603 Date Submitted: 21/11/2022 Department or Body: Australian Institute of Health and Welfare Vaccination status data items contained in the Australian Institute of Health and Welfare’s National Perinatal Data Collection (NPDC) are currently limited to the vaccinations routinely recommended for women to receive during pregnancy, as defined by the Australian […]
228. ACE receptors are not on all cells – does the TGA accept that the transfection process used by Pfizer makes the vaccine more pathogenic than the virus? The vaccine doesn’t target any cells, instead it targets all cells via transfection as shown in graphs on page 34 of the TGA Pfizer Non-Clinical report? 230. The non-clinical report noted one study that said 100% of people who had recovered from Covid had S protein specific CD4 t-cells and 70% had CD8 t-cells – if this is the case why is natural immunity being ignored for those who had Covid in favor of further boosters?
Question Number: 232 PDR Number: SQ22-000602 Date Submitted: 21/11/2022 Department or Body: Department of Health 228 It is true that human ACE2 receptors are not expressed on all cell types, and vaccine mRNA encapsulated in LNPs could be taken up by most cell types. However, this does not mean the vaccine mRNA is more ‘pathogenic’ […]
125. Does the TGA do any independent testing of the vaccine or is it happy to rely solely on testing from the sponsor who has an inherent conflict of interest in promoting the vaccine to increase their profits? 127. Can the TGA provide records of the patients in the trial at both 1 month after the second dose, 3 months after the second dose and one year after the second dose?
Question Number: 231 PDR Number: SQ22-000601 Date Submitted: 21/11/2022 Department or Body: Department of Health 125 There is an extensive program of local Therapeutic Goods Administration (TGA) testing. The TGA independently tests every batch of COVID-19 vaccines released in Australia. Batches are not distributed until the TGA has completed batch release testing. The results of […]
225. Pfizer wanted to switch the “phosphate- buffered saline” used in previous adult formulations, to “tromethamine (Tris) buffer” and to exclude both sodium chloride and potassium chloride, claiming it “improved the stability profile of the vaccine.” A Pfizer spokesperson said, “This allows the mRNA to resist being degraded for a longer period of time before administration – meaning the pediatric vaccine can be stored [at] 2-8°C in commonly available refrigerators for up to 10 weeks.” If the half-life is going to take longer to degrade isn’t that going to increase the pathogenicity of the vaccine for children? 238. Why are there five doses in an adult vial and 10 doses in a children’s vial? Why didn’t the sponsors make it one dose per vial to ensure an even distribution of the vaccine. How can the TGA be sure that the person administering the vaccine is actually giving consistent concentrations?
Question Number: 230 PDR Number: SQ22-000600 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 225 The Tris buffer improves the stability of the vaccine at refrigeration temperatures. Pfizer has provided data to support and demonstrate the quality of the vaccine is maintained at a temperature that is easier to manage logistically. There is […]
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 […]
182. As per FOI 2986, in January 2021 the TGA recruited a new lead to run the Pharmacovigilance “vaccine safety” system – Michael Nissen. Michael Nissen spent 8 prior years working for GSK (whose healthcare division merged with Pfizer in 2019). How can the TGA claim there are no conflicts of interest when it own staff are long term Big Pharma employees? 220. The serious injury rate of vaccines is 1 in a 1000 people which is much higher than serious rate of injury from omicron – why hasn’t the TGA pulled the vaccine? 226. Isn’t there an inherent conflict of interest between the TGA approving drugs and then reviewing vaccine injuries from those drugs that is has previously claimed as safe? 247. Given the AZ and Pfizer shot are expected to do the same thing then how can the TGA claim they don’t have similar side effects?
Question Number: 226 PDR Number: SQ22-000596 Date Submitted: 21/11/2022 Department or Body: Department of Health 182 The Therapeutic Goods Administration (TGA) has robust policies and procedures for managing conflicts of interest. This applies to both staff and expert committee appointments. All procedures were followed during and after the appointment of Michael Nissen. Dr Nissen is […]
117. Has the TGA accessed/obtained current Australian background rates for adverse events/subclinical conditions from hospital admission data, NPS MedicineWise and/or general practice data and compared it with pre vaccination rollout data from the same source? 118. In the last round of estimates Prof Skerritt claimed that millions could have died or gone to hospital from Covid – can he please provide the modelling for that claim? Given there has been 6 million deaths from Covid in almost three years, it does sound a bit rich to claim those numbers in a country of just 25 million does it not?
Question Number: 225 PDR Number: SQ22-000595 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 117 The Therapeutic Goods Administration (TGA) may consider the background rate for a certain diagnosed clinical condition in Australia as part a vaccine safety signal investigation process. This is known as the Observed versus Expected (OvE) analysis. The TGA’s […]
223. Why are Federal government departments implementing mandates when the Chief Health officer doesn’t believe in them?
Question Number: 224 PDR Number: SQ22-000594 Date Submitted: 21/11/2022 Department or Body: Department of Health Vaccine mandates are a matter of state and territory jurisdictions.
158. Is the Health Department concerned about corruption within Australia’s regulatory body? 208. According to Section 9 of the TGA own advertising code “An advertisement about therapeutic goods must not contain any statement, pictorial representation or design that, expressly or by implication, represents the goods to be: (a) safe, or without harm or side-effects; or (b) effective in all cases, or a guaranteed cure; or (c) infallible, unfailing, magical or miraculous.” 209. Despite this every authority in the country touted the vaccines as safe and effective without qualifying the risks. Haven’t they broken the law? 217. Why are you fining small companies for breaches of law that had no adverse events while ignoring the negligent behavior of Big Pharma? How are small Australian companies importing a small number of RAT tests for testing or Ivermectin that are no risk to the public worse than the behavior of big pharmaceuticals?
Question Number: 222 PDR Number: SQ22-000592 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 158 No. The Department of Health and Aged Care (the department), including the Secretary as the Responsible Authority, is satisfied that the Therapeutic Goods Administration (TGA) and its staff comply with the Australian Public Service Values and Code of […]
