257. The TGA report on the Pfizer vaccine said, “The duration of protection afforded by COMIRNATY is unknown as it is still being determined by ongoing clinical trials.” – why did the TGA say it was safe and effective if you didn’t know how effective it was going to be. See 2389-2 page 6? 258. As per Page 7 of FOI 2389-2 – given the high mortality rate in the older age group don’t you think the Covid Pfizer vaccine rollout should be stopped? To quote “The data for use in the frail elderly (>85 years) is limited. The potential benefits of vaccination versus the potential risk and clinical impact of even relatively mild systemic adverse events in the frail elderly should be carefully assessed on a case-by-case basis”
Question Number: 251 PDR Number: SQ22-000621 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 257 The Therapeutic Goods Administration (TGA) has comprehensively evaluated each of the provisionally registered COVID-19 vaccine to ensure that they meet Australia’s high standards of safety, quality, and efficacy based on the information available at the time of application. […]
134. Once the mRNA is inside the cell what guarantee is that the mRNA ends up in the Endoplasmic Reticulum ribosomes and not the mitochondria ribosomes? Can the TGA provide studies that prove this cannot happen?
Question Number: 250 PDR Number: SQ22-000620 Date Submitted: 21/11/2022 Department or Body: Department of Health One significant advantage of mRNA vaccines is that they use the existing translational machinery of the cell and other cytosolic components to produce a properly folded and fully functional protein from each injected mRNA (https://pubmed.ncbi.nlm.nih.gov/33907508/). The sequence of the mRNA […]
253. In the Pfizer Covid vaccine trial as per Page 33 on FOI 2389-1 – There were 311 candidates in the vaccine group who had other important protocol deviations on or prior to 7 days after Dose 2 – what were these deviations and did they include vaccine injuries? 254. In the Pfizer Covid vaccine trial why were 1790 excluded from valuable efficacy in the placebo group – as per page 33 FOI 2389-1 255. In the Pfizer Covid vaccine trial as per Page 33 on FOI 2389-1 – Why were only around 19,000 from each group evaluated when over 21,000 were vaccinated? 256. In the Pfizer Covid vaccine trial as per Page 33 on FOI 2389-1 – Why were approximately 1250 people pulled from getting the second vaccine?
Question Number: 248PDR Number: SQ22-000618Date Submitted: 21/11/2022Department or Body: Department of Health Question 253 A full list of protocol deviations on or prior to seven days after dose two can be found in Table 1. These include dosing and administration errors. It is important to note that these did not include vaccine injuries. The table […]
169. In FOI 2389-3 4.3.3 it says “RNA itself, and the lipids used in the BNT162 vaccines have no carcinogenic or tumorigenic potential. Furthermore, according to ICH SIA, no carcinogenicity studies are required for therapeutics that are not continuously administered. Therefore, no carcinogenicity studies were performed.’ Why is carcinogenicity not tested if boosters are being continually rolled out? 170. In FOI 2389-3 5.3.1.7 regarding coagulation it says “Increases in fibrinogen levels were detected in all vaccinated animals at the end of dosing phase and were consistent with an acute phase response secondary to immune activation and inflammation at the injection sites.” Given clotting was a recognised side effect of the vaccine on what basis can the TGA rule out strokes and other clotting related events? 249. What is the different 5 cap structure in modified RNA – page 109 FOI 2389-3 – how is this different to the Covid spike protein mRNA cap? 250. FOI 2389-3 page 20 – some LNPs can be twice as big as others 60-120 nano metres Does this mean that some vaccine lipids can be twice as toxic or efficacious, or some people will get twice the dose of others? 251. In the Pfizer Covid vaccine as per FOI 2389-3 page 110 Table 2 – Theorical length is from 1200 to 4500 nucleotides depending on selected antigen – the Coronavirus spike protein has 1273 amino acids – why is the vaccine producing a spike protein almost 4 times larger than the Covid virus?
Question Number: 247 PDR Number: SQ22-000617 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 169 Carcinogenicity studies are generally not required under international (ICH) protocols for pharmaceuticals that are administered to patients infrequently (e.g. a few doses per year) or for vaccines or biological medicines. Question 170 Nonclinical studies with the COVID-19 vaccines […]
131. Why is it okay to use invitro studies to justify the safety of the Covid vaccines but not Ivermection? 132. Why did Pfizer and or the FDA try to delay the release of the Covid-19 vaccine trial data for up to 55/75 years? Shouldn’t the TGA be alarmed by this? If not, why not?
Question Number: 246 PDR Number: SQ22-000616 Date Submitted: 21/11/2022 Department or Body: Department of Health 131. Please note that the spelling of the anti-parasitic medicine is ‘ivermectin’. It is grossly incorrect to say that (only) in vitro studies were used to “justify the safety of the Covid vaccines”. The safety of the COVID-19 vaccines currently […]
130. Why does the vaccine vial have to be gently inverted 10 times? Why not 8 times. Where is the science that indicates it is safe to administer 5 does of a lipid encased mRNA vaccine from one vial? 133. Why is the Moderna dose three times heavier than the Pfizer dose – if they are both generating the same spike protein why is there such a variance in dose size?
Question Number: 243 PDR Number: SQ22-000613 Date Submitted: 21/11/2022 Department or Body: Department of Health 130 Instructions submitted by Pfizer to invert the vial gently 10 times ensures that the end user mixes the diluted vaccine appropriately. The additional two inversions, i.e.: 10 instead of eight, safeguards that the end user has mixed the vaccine […]
243. Luciferase and the covid spike protein are completely different – what evidence do you have that just because Luciferase breaks down in 9 days the same goes for the spike proteins? 252. How heavy should the vaccine spike protein be? Was it tested for quality control and if so, what was the acceptable margin of error – if not, why not?
Question Number: 242 PDR Number: SQ22-000612 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 243 Luciferase protein and Pfizer’s COMIRNATY expressed spike protein are both protein macromolecules with large 3-dimensional molecular structures. The viral spike (S) protein of SARS-CoV-2 is reported in the literature as having a molecular weight of 143 kDa (deglycosylated […]
198. In a previous reply to a QON the TGA stated “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 the seriousness criteria, is not a valid method for assessing vaccine safety”. Simple reporting has been used to report Covid cases and deaths which has then been used to mandate experimental gene technology that did not undergo rigorous testing – why are vaccines injuries and deaths held to a higher level of scrutiny and covid cases and deaths? 236. FOI 3727 reveals a number of deaths in people younger than 35 from the vaccine, including a 7, 9, 14 and 19 year old. Given these deaths why wasn’t the vaccine rollout paused? 240. Is the Covid vaccine history of all Coroner reported deaths – included for consideration in the Forensic Pathologist’s autopsy report – or all medical certificates of death?
Question Number: 240 PDR Number: SQ22-000610 Date Submitted: 21/11/2022 Department or Body: Department of Health 198. This question has been addressed previously in SQ22-000108. 236. None of the deaths referred to in this question have been assessed as linked to vaccination. Information on how the Therapeutic Goods Administration (TGA) uses adverse events, including those with […]
229. As per the TGA non-clinical report – “there was very mild inflammation of lung tissues in both the control and vaccinated group 7 or 8 days after challenge with no difference in the inflammation score.” Given these results how can the TGA say the vaccine reduced lung infections from Covid? 234. The non-clinical report noted that the potential of vaccine to induce cytokine release was not adequately assessed in non-clinical trials. Why did the TGA approve the vaccine given such a risk was not properly understood? 235. On page 34 and page 35 pf the TGA non-clinical report the transfection and expression rates of the modified mRNA’s are much higher – isn’t that proof that the vaccine is much more pathogenic and infectious than the virus? 241. Why didn’t the TGA mention the use of methylpseudouridine in the non-clinical report? 245. In Section 2.4 on page 36 of TGA non-clinical report the structure of the spike protein is redacted – why is that?
Question Number: 239 PDR Number: SQ22-000609 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 229 The efficacy of the COVID-19 vaccine was determined in several non-clinical and clinical studies by analysing a number of parameters including viral RNA load and radiographic analysis of lungs. In this case, the vaccine protected monkeys from infection […]
129. What are the redacted sections in the non-clinical evaluation report? Why are they being redacted – the data isn’t commercial in confidence – it’s safety data that is needed for the patient to make a fully informed decision is it not?
Question Number: 238 PDR Number: SQ22-000608 Date Submitted: 21/11/2022 Department or Body: Department of Health The redacted sections in the nonclinical evaluation report for BNT162b2 [mRNA] COVID-19 vaccine (COMIRANTY™) January 2021, include: aspects of the specific assay methods; details of mRNA variants in development; details associated with product formulation and specifications; and/or details associated with […]
