47. Will the TGA ask for the all the data from the Pfizer trial including the data the Pfizer is trying to prevent from releasing to the public for a period of up to 55 years? 48. Has the TGA ask Pfizer for an explanation of why the company does not want to release data for up to 55 years? 49. If the data that Pfizer does not want to release is shown to be materially different in terms of safety and efficacy will the TGA sue Pfizer for damages or does the Pfizer indemnity extend to fraud and or non-disclosure? 50. On what basis does John Skerritt say that the data relating to the vaccine trials is thorough when not all data has been released, individual data wasn’t looked at and several areas including carcinogenic risks, immunocompromised patients, pregnant women, breast feeding women, reactions to other drugs and longitudinal studies weren’t completed? 51. How can the TGA say the Pfizer trial was relevant to the vulnerable population when only 4% of the trial group was over 75 when over 75% of people over 75 were hospitalised or died from Covid? 52. Could the TGA provide measurements of clinical outcomes in the initial Pfizer trial such as hospitalisations and deaths and subclinical outcomes such as inflammation and clotting?
Question Number: 102PDR Number: SQ22-000114Date Submitted: 24/02/2022Department or Body: Department of Health 47. Pfizer submitted all relevant available data from the COVID-19 clinical trials to the Therapeutic Goods Administration (TGA) with its application for provisional registration. 48. As noted in response to Q47, Pfizer submitted all relevant available data from the COVID-19 clinical trials to […]
53. Could the bio-distribution data in regard to lipid nanoparticles and spike proteins from Pfizer’s initial trial please be released? 54. If no bio-distribution data is available, then why wasn’t the distribution of these molecules tracked?
Question Number: 153 PDR Number: SQ22-000115 Date Submitted: 24/02/2022 Department or Body: Department of Health Question 53 There was one study report on the tissue distribution of luciferase (used as a surrogate for spike protein) and one study report on the distribution of lipid nanoparticles provided to the Therapeutic Goods Administration (TGA) by Pfizer. The […]
62. Why is Ivermectin banned as a Covid treatment when in the last year it has had a fraction (5) adverse event reports v over 100 adverse event reports from other early treatments such as remdesivir and dexamethasone for example? 63. Why was Remdesivir approved on the basis on a small number of trials with a small sample size? 64. Given the large number of people who have taken Ivermectin in the last six months in treating Covid and the low rate of adverse events in comparison with the Vaccines how can the TGA justify their decision to ban doctors prescribing Ivermectin? 65. Are doctors using Ivermectin in Australian hospitals to treat patients with late stage Covid? 66. If so why can’t Ivermectin be used as an early treatment? 116. Why is the TGA relying on real world data for children, spanning a few months but ignoring real world data on ivermectin that spans over 30 years. 117. According to the TGA search facility there has only been 5 reports of Adverse events against Ivermectin in the last 13 months. Given there has been over 108,000 adverse events against the Covid vaccines why is the TGA claiming that Ivermectin is not safe, when there has been so many more reported events from the Covid vaccines?
Question Number: 133 PDR Number: SQ22-000119 Date Submitted: 24/02/2022 Department or Body: Department of Health Answer to Questions 62, 64, 65, 66 and 117: The prescribing of Ivermectin is not banned in Australia. General practitioners (GPs) can prescribe ivermectin for the treatment of scabies and certain parasitic infections as these indications have been approved by […]
114. There is now a published case report of two adolescent deaths following vaccination due to toxic cardiomyopathy. https://pubmed.ncbi.nlm.nih.gov/35157759/ and one article reporting on cardiac arrest after covid 19 vaccination. https://www.cureus.com/articles/83238-cardiopulmonary-arrest-after-covid-19-vaccination-a-case-report. Will the TGA halt the rollout of the vaccine for children and teenagers given that cardiomyopathy was initially identified as the reported side effect by Pfizer for teenagers? 174. Why did the TGA dismiss the reported and suspected death of a 14 year old girl from the Moderna vaccine as not being vaccine related? 175. If State governments can shut down the country over cases of Covid why wasn’t the vaccine rollout for teenagers halted while the reported death of the 14 year old girl was being investigated? 245. According to FOI 3586 there has been 8 reported teenage deaths to date from the Covid-19 vaccines. Why hasn’t the rollout of vaccines for teenagers and children been suspended in light of these reports?
Question Number: 115 PDR Number: SQ22-000122 Date Submitted: 24/02/2022 Department or Body: Department of Health Question 114 Cardiac arrest and cardiomyopathy are not recognised side effects of the COVID-19 vaccines provisionally approved in Australia. This is because there is not currently evidence that the vaccines cause these conditions. The published case reports to date are […]
67. Can ATAGI show the scientific modelling the justifies decreasing the period between booster shots from 6 months to 5 months to 4 months? 68. Why does ATAGI outline the criteria for Covid-19 exemptions for vaccines if the Federal government doesn’t believe in vaccine mandates? 69. Exemptions are only required because of mandates are they not?
Question Number: 194 PDR Number: SQ22-000123 Date Submitted: 24/02/2022 Department or Body: Department of Health 67. The Australian Technical Advisory Group on Immunisation (ATAGI) closely monitors the epidemiology and characteristics of COVID-19, particularly the emergence of new variants, including Omicron, as well as emerging data on the need, potential benefits and optimal timing of a […]
70. Two adverse events 703379, a 6 year old girl and 703334, a 7 year old boy have no details. In order to ensure full transparency around adverse events from children vaccines, can ATAGI ask the TGA to disclose what these injuries are? 71. Given the large number of adverse events in children already, will ATAGI revise its decision to allow the rollout of the vaccine given case numbers have dropped significantly and models have overestimated the infection rate in the community? 72. I note that ATAGI is relying on passive surveillance of vaccinated in children in the USA rather than active surveillance. How does ATAGI know that every adverse reaction experienced amongst the 6 million children in the USA has been detected, if the FDA/Pfizer is not actively monitoring every child?
Question Number: 199 PDR Number: SQ22-000124 Date Submitted: 24/02/2022 Department or Body: Department of Health 70. The remit of Australian Technical Advisory Group on Immunisation (ATAGI) does not extend to requesting the Therapeutic Goods Administration (TGA) to disclose details relating to adverse events. To protect patient confidentiality, the TGA does not disclose individual adverse event […]
118. If AHPRA is not part of the government then why does their website have a ”.gov” suffix – i.e. www.AHPRA.gov.au? 119. Does the Federal government provide any funding to AHPRA?
Question Number: 136 PDR Number: SQ22-000127 Date Submitted: 24/02/2022 Department or Body: Department of Health 118. As previously explained, the Australian Health Practitioner Regulation Agency (Ahpra) is not an Australian Government entity, but it is established under complementary state and territory legislation (the Health Practitioner Regulation National Law). This makes Ahpra a statutory body of […]
120. How many pages of data did Pfizer submit to the TGA when applying for permission to use its Covid vaccine? 121. Have the TGA reviewed independent toxicology report for Pfizer, AZ and Moderna Covid vaccines? If not why not? 122. Given the makers of the vaccines stand to profit from the sale of the vaccine why didn’t the TGA require independent toxicology and efficacy reports before approving the data? 123. How many pages of the above were raw data/data tables?
Question Number: 118 PDR Number: SQ22-000131 Date Submitted: 24/02/2022 Department or Body: Department of Health 120. As at 9 March 2022, Pfizer Australia Pty Ltd’s collective submissions for COMIRNATY (BNT162b2 [mRNA]) COVID-19 Vaccine for Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 contain 223,463 pages (2,087 documents). Of these, 199,285 pages (407 […]
128. Has the TGA assessed the risk of, and presence of micro-RNA sequences comprised within the Pfizer vaccine? 129. Has the TGA assessed the risk of and or presence of Stop Codon read- through arising as a result of the use pseudouridine in the Pfizer miRNA active ingredient? 130. Do the mRNA strands have stop codons embedded in them? If not, how will the cell stop producing spike proteins? 131. Has the TGA tested the quality of the mRNA strands in the vaccine to determine how many are mal-coded or damaged for every given inoculation? 132. Can the TGA guarantee that no other protein is transcribed by the mRNA vaccine other the purported Covid-19 spike protein? If not why not? 133. How many mRNA strands are in one dose of the Pfizer vaccine? 134. How can Pfizer/TGA guarantee that each does of the Pfizer vaccine will have the same number of mRNA strands?
Question Number: 189 PDR Number: SQ22-000133 Date Submitted: 24/02/2022 Department or Body: Department of Health Question 128 There is no evidence that the Pfizer COVID-19 mRNA vaccine COMIRNATY contains MicroRNAs (miRNA) or oncogenic miRNA. miRNAs are short RNAs of around 22 nucleotides. They exist naturally in animals and humans, and thousands of miRNA genes have […]
135. Given the TGA failed to review the gene technology around the Pfizer vaccine did the TGA seek advice and analysis from the Office of Gene Technology Regulator before approving the Pfizer vaccine which involves gene technology? If not why not? 136. Was the TGA required to get authorisation from the Office of the Gene Technology Regulator before approving the Pfizer vaccine? 137. Did the Office of the Gene Technology Regulator provide analysis to the TGA for either of the Astra Zeneca or Pfizer vaccines? If so, could copies please be provided.
Question Number: 126 PDR Number: SQ22-000134 Date Submitted: 24/02/2022 Department or Body: Department of Health The Office of Gene Technology Regulator (OGTR) regulates genetically modified organisms (GMOs). A GMO is defined as a plant, animal or other organism whose genetic material has been modified using gene technology or an organism that has inherited modified traits […]
