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QUESTIONS ON NOTICE

Questions are currently being updated, please check back soon for previous questions.

Senator RENNICK: This is a very quick one. Does ASIC require gold dealers and custodians of gold to comply with financial disclosure laws, such as product disclosure statements et cetera, when investors put their gold bars with gold dealers? Mr Longo: I might ask Commissioner Armour to have a go at that question. I’m not quite sure of the extent of ASIC’s jurisdiction over gold bars at this point in time. I will go to Commissioner Armour.Ms Armour: My initial reaction is that I believe that a gold bar is likely to be a commodity and not necessarily a financial product, so may not be in our jurisdiction. I would be happy to go back and double-check that for you. Senator RENNICK: A lot of super funds now are investing in gold bars. I would have thought it would be classified as a financial instrument. I will leave it at that.

17/02/2022

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)?

21/11/2022

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?

21/11/2022

227. The virus needs two enzymes to cross the membrane whereas the vaccine needs none as it relies in transfection – is that correct? If that is the case, then is it fair to say the vaccine is more infectious, isn’t it? 286. Aren’t nasal sprays better than vaccines for respiratory viruses that enter through the airways? 287. What steps or tests has the health department taken to ensure that immune imprinting or antibody dependent enhancement is not occurring with repeated booster shots. This is a well-known phenomenon, dengue fever being a prime example. It was highlighted by Pfizer as a potential risk. Furthermore, why isn’t this potential risk highlighted in any Covid booster advertising? 290. Is the overuse of booster and the use of a stronger spike protein causing the immune system to downregulate in other areas leading to cancer and diabetes?

21/11/2022

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”

21/11/2022

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?

21/11/2022

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.

21/11/2022

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?

21/11/2022

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.

21/11/2022

Senator RENNICK: This is a very quick one. Does ASIC require gold dealers and custodians of gold to comply with financial disclosure laws, such as product disclosure statements et cetera, when investors put their gold bars with gold dealers? Mr Longo: I might ask Commissioner Armour to have a go at that question. I’m not quite sure of the extent of ASIC’s jurisdiction over gold bars at this point in time. I will go to Commissioner Armour.Ms Armour: My initial reaction is that I believe that a gold bar is likely to be a commodity and not necessarily a financial product, so may not be in our jurisdiction. I would be happy to go back and double-check that for you. Senator RENNICK: A lot of super funds now are investing in gold bars. I would have thought it would be classified as a financial instrument. I will leave it at that.

17/02/2022

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)?

21/11/2022

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?

21/11/2022

227. The virus needs two enzymes to cross the membrane whereas the vaccine needs none as it relies in transfection – is that correct? If that is the case, then is it fair to say the vaccine is more infectious, isn’t it? 286. Aren’t nasal sprays better than vaccines for respiratory viruses that enter through the airways? 287. What steps or tests has the health department taken to ensure that immune imprinting or antibody dependent enhancement is not occurring with repeated booster shots. This is a well-known phenomenon, dengue fever being a prime example. It was highlighted by Pfizer as a potential risk. Furthermore, why isn’t this potential risk highlighted in any Covid booster advertising? 290. Is the overuse of booster and the use of a stronger spike protein causing the immune system to downregulate in other areas leading to cancer and diabetes?

21/11/2022

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”

21/11/2022

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?

21/11/2022

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.

21/11/2022

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?

21/11/2022

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.

21/11/2022

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