263. I note an article in The Australian that stated I declined a meeting with the Health Department on numerous occasions. Does the TGA/Health Department have the time and place I declined a meeting with them and evidence of that?
Question Number: 267 PDR Number: SQ22-000638 Date Submitted: 21/11/2022 Department or Body: Department of Health A response was provided to you on this topic from Minister Butler’s office in September 2022. It noted that a range of senior departmental officers have offered to provide briefings to you during 2021 and early 2022. However, in keeping […]
152. Why does the TGA make it so hard to lodge an adverse event – I have had many complaints about how difficult it is from vaccine victims? 153. Many people who have lodged adverse event reports have received no feedback from the TGA other than to say the injury is recorded. How can the TGA and Prof Skerritt dismiss vaccine injuries when the people injured by the vaccine have not been diagnosed?
Question Number: 266 PDR Number: SQ22-000637 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 152 The assertion that it is “so hard to lodge an adverse event report” is inconsistent with the fact that almost 140,000 reports have been lodged since early 2021. The Therapeutic Goods Administration (TGA) has multiple channels available for […]
140. On page 47 of the TGA non-clinical report it states no unique in-vivo metabolites of ALC- 0159 were observed in the rat pharmacokinetic study, but N,N-ditetradecylamine formed by slow amide hydrolysis was identified in hepatocytes and liver S9 fractions from mouse, rat, monkey and human – Substances predicted as likely to meet criteria for category 1A or 1B carcinogenicity, mutagenicity, or reproductive toxicity, or with dispersive or diffuse use(s) where predicted likely to meet any classification criterion for health or environmental hazards, or where there is a nanoform soluble in biological and environmental media. https://echa.europa.eu/substance-information/- /substanceinfo/100.037.611 141. Why didn’t the TGA identify the accumulation of N,N-ditetradecylamine a risk from the vaccine?
Question Number: 265 PDR Number: SQ22-000636 Date Submitted: 21/11/2022 Department or Body: Department of Health 140 The primary route of metabolism identified for ALC-0159 involves amide bond hydrolysis yielding N,N-ditetradecylamine. This metabolite was only identified in vitro in isolated mouse, rat, monkey and human preparations. The metabolite was not detected in vivo in rats after […]
276. What blood tests were taken on Covid vaccine trial participants and how often? 279. Were Covid vaccines tested regarding the sensitivity of different blood types to the vaccines? Was there any difference in the blood types in reacting to the vaccine?
Question Number: 262 PDR Number: SQ22-000633 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 276 – Blood tests were used to measure antibody levels in COVID-19 vaccine clinical trial participants. Antibody levels are measured as the levels of antibody are indicative of vaccine efficacy. Antibody levels are usually measured two – four weeks […]
274. Of the 44,000 participants in the Pfizer Covid vaccine trial how many suffered strokes, paralysis, heart attacks at the 3 month, 6 month, 12 month and 24 month mark and their can their ages be stratified? 275. Of the 44,000 participants in the Pfizer Covid vaccine trial how many have suffered myocarditis and pericarditis to date? Can the split between vaccinated and unvaccinated be provided?
Question Number: 260 PDR Number: SQ22-000631 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 274 In the six-month update of safety data provided by Pfizer, the number of participants reporting at least one occurrence of each listed event during the blinded, placebo-controlled follow-up period is listed below. Notably, of the 44,000 participants, only […]
270. Page 64 – FOI 2389-3-2 – Investigators are not obligated to actively seek AEs or SAEs after the participant has concluded study participation? If investigators don’t have to seek out all adverse events how does the TGA know the investigator has detected all possible side effects? 271. As per Page 64- FOI 2389-3-2 – All pregnancies have to be reported to the sponsor – if this is the case why is so much data on pregnancy missing from the Pfizer Covid vaccine post marketing data? 272. I note on page 69 of FOI 2389-3-2 that adverse events of special interest aren’t applicable but that in the post marketing data there are over 1000 of them mentioned? 273. Of the circa 44,000 participants in the Pfizer Covid vaccine trial how many were checked up at the 6-month, 12 month and 24 month time frame as per the requirements of the CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (05 December 2019) (around pages 80-90 of 2389-3-2)?
Question Number: 259 PDR Number: SQ22-000630 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 270 FOI 2389-3-2 Page 64 refers to the specific study parameters of Protocol C4591001, which formed one part of the clinical trial data collected back in 2020-21 for the BNT162 RNA-Based COVID-19 Vaccines. The primary objective of the study […]
171. What role does Adjutor play in regulating and approving vaccines – has the TGA outsourced regulatory activities to a third party? 177. Why has the TGA allowed Pfizer/Moderna to set integrity and purity requirements? 265. Why is the Health Department claiming the approval process for the vaccines wasn’t rushed when in fact it was. Furthermore no carcinogenic, genotoxicity or longitudinal studies were completed. And I quote: “The Therapeutic Goods Administration (TGA) provisionally approved these vaccines after a complete assessment of all the available data. This is the same process as any vaccine approved in this country. The TGA will only register and approve a COVID19 vaccine if it is safe and effective.” www.health.gov.au/initiatives-and-programs/covid-19-vaccines/is-it-true/is-it-truewere-covid-19-vaccines-rushed-through-approvals-or-given-emergency-useauthorisations-in-australia.
Question Number: 257 PDR Number: SQ22-000628 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 171 – The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods. – Adjutor Healthcare (www.adjutor.com.au) is a privately owned regulatory affairs consulting company and does not have any role in the approval or regulation […]
137. In the post marketing data only 32 of 270 pregnancies were reported on and most of the 32 were miscarriages. Why didn’t the TGA follow up on the other 238 pregnancies and given the missing data how could the TGA say that the vaccine was safe for pregnant women? Was there ever any follow up on the other woman who didn’t initially provide data? 138. I note that the TGA has previously said “Post-market global surveillance data from large numbers of pregnant women have not identified any significant safety concerns with mRNA COVID-19 vaccines given at any stage during pregnancy. There is no evidence of decreased fertility, increased risk of miscarriage or teratogenic risk” Why would the TGA say this given the missing data in the post marketing data and the fact that the vaccine was only tested on pregnant rats?
Question Number: 256 PDR Number: SQ22-000626 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 137 It is not clear what data set the Senator is referring to and whether the claims made in the question are accurate. However, in any group of 270 pregnancies in any group of women it would not be […]
260. The UK has pulled the vaccine for pregnant women – Why isn’t Australia doing the same thing? 264. FluVax was introduced in 2010. A few babies died from it, some were severely and permanently injured, and 1 in 10 children suffered an adverse event, The vaccine company (CSL) denied responsibility for as long as they could, before the evidence was overwhelming. Why are Health departments continuing with the Covid vaccine rollout that have higher injury rates? There are numerous other examples of where drugs have been pulled on far fewer safety signals.
Question Number: 255 PDR Number: SQ22-000625 Date Submitted: 21/11/2022 Department or Body: Department of Health 260. Vaccination with primary and recommended booster doses is the best way to reduce the higher risk of severe COVID-19 in unvaccinated pregnant women. The United Kingdom Joint Committee on Vaccination and Immunisation (JCVI) advice is that pregnant women are […]
135. In a prior round of estimates Prof Skerritt said “No evidence of damage. You seem to be indicating that these are little arrows that are piercing holes in things. The protein by itself does not cause damage”. The vaccine induces an immune response that requires the body’s own cells to be attacked and destroyed. How can Professor Skerritt say the spike protein doesn’t cause any damage or induce a cell-mediated immune attack against host cells that translate the mRNA to spike protein and then place the antigen on the cell surface to invoke an immune response? 136. Does the vaccine contain instructions to turn off the toll like receptors to the mRNA. If so how dangerous is this? 144. The fact that the vaccine spike protein stays in the body for 60 days indicates that it is more toxic than the normal virus which for most people is cleared from the body in a matter of weeks rather than months. Does the TGA disagree with this statement? If so, why?
Question Number: 253 PDR Number: SQ22-000623 Date Submitted: 21/11/2022 Department or Body: Department of Health Question 135 A vaccine-induced immune response does not attack and destroy bodys own cells. Instead, the immune response helps protect people from getting sick from infection by the virus. Either mRNA-Lipid Nanoparticles or locally produced spike protein are taken up […]
