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QUESTIONS ON NOTICE

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

119. Has the Federal government covered half the hospital costs for people in hospital with Covid? Was this money reimbursed to State governments? If so, doesn’t this create an incentive for State government to fudge Covid cases in hospital in order to milk the Federal government of Funding? 120. Does the Federal government reimbursing states such as NSW for back capturing whereby that State government counts people as having Covid, even if they had it 28 days prior to entering hospital and went to hospital for another reason such as a broken arm?

21/11/2022

146. Why doesn’t the TGA have mandatory reporting requirements of Health professionals for reporting adverse events? Shouldn’t it be mandatory given that the vaccines have only received provisional approval and data from ongoing trials are being assessed on an outgoing basis? 148. In the Post marketing surveillance data there is over 1,000 adverse events of interest – what exactly are adverse events of interest – are they reported adverse events? 149. If the current vaccines fall outside many of the international guidelines for testing vaccines, then isn’t it fair to say they aren’t vaccines. 150. In the post marketing surveillance data – what was the total population of the administered doses? I note this figure has been censored by Pfizer and the FDA – why is such an important indicator of safety being covered up and why won’t the TGA ask for that number and then disclose it? 151. Why did the TGA change death description to Adverse Event following immunisation to avoid scrutiny over cause of death regarding a number of young children were reported to have died from the vaccine?

21/11/2022

185. Studies have shown that neutrophils interact with spike proteins to create fibrils that lead to amyloids clots. Has the TGA examined this risk, and can they guarantee that amyloid clots aren’t being formed by the vaccine? 190. I note that the Europeans Medicine Agency has added heavy menstrual bleeding as a side effect of Pfizer and Moderna Covid jabs. Given this delayed warning what testing will the TGA do to ensure that the heavy bleeding isn’t the result of clots and that women are not at danger of having their fertility damaged?

21/11/2022

244. Why did the TGA approve molnupiravir despite the fact there were concerns that the drug may cause cancer mutations? It is known in medicine that mutation of a single base is sufficient to cause disease, sickle cell anaemia being one example. – https://quadrant.org.au/opinion/public-health/2022/08/the-suppression-of-usefulcovid-19-treatments/ 261. Until recently patients presenting with anti-bodies to their thyroids have had it stated on their blood results that ‘the antibody pattern suggests an underlying autoimmune inflammatory process e.g. Graves’ and Hashimoto’s’. The way to examine these results was changed on 06/09/21 and the reference interval was updated. Why has the reference interval been updated/changed and is it true that Medicare requested QML that such wording be removed from patients’ written test results?

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

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?

21/11/2022

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?

21/11/2022

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?

21/11/2022

200. Who is responsible for acting on the safety signal in the DAEN database re Covid vaccines – the TGA or the sponsor? 214. I note that the Covid vaccines were provisionally approved subject to strict reporting conditions on safety and efficacy. Since provisional approval what has Pfizer reported to the TGA in regards to safety and efficacy since the rollout of the vaccine? 215. Can the safety reports provided by the Covid vaccine sponsors please be provided? 266. “The TGA’s vaccine safety monitoring system can rapidly detect, investigate and respond to any emerging safety issues identified for COVID-19 vaccines.” The TGA’s monitoring system is passive and therefore it can never “rapidly detect” safety issues! These pages are misleading the public are they not? https://www.tga.gov.au/products/covid-19/covid-19-vaccines/covid-19-vaccineapproval-process

21/11/2022

203. Professors from UCLA and Stanford have highlighted the risk of vaccine injuries at 11 in 10000. How can the TGA refute these prestigious institutions – Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials by Joseph Fraiman, Juan Erviti, Mark Jones, Sander Greenland, Patrick Whelan, Robert M. Kaplan, Peter Doshi :: SSRN 219. In a previous QON the TGA stated “Since these vaccines were granted provisional approval, more than 11 billion people have received doses of COVID-19 vaccines worldwide. Data on real-world use of the COVID-19 vaccines approved in Australia provides reassurance about their safety and that the trials were carried out correctly. This is supported by reviews of safety data by international medicines regulators in countries with extensive COVID-19 vaccine experience who have found no new safety concerns associated with the use of COVID-19 vaccines. In addition, the TGA’s monitoring program has not detected any new safety signals in relation to COVID-19 vaccines to date?” This reply is a blatant lie that will be reported for contempt. A number of side effects have been reported such as myocarditis and heavy menstrual bleeding. Why is the TGA covering up serious side effects from the mRNA Covid vaccines? 280. Given the Covid vaccine trials were so short in duration why does the TGA take the sponsors word as to what side effects are and ignore real world data being reported

21/11/2022

204. Studies have shown that the weight of the protein produced by the mRNA vary by as much as 50% – surely this is evidence that the mRNA is not being produced in a consistent manner by the ribosomes? Is the TGA tracking the product being produced by the ribosomes? 221. Why is TGA/Pfizer calling it mRNA when it isn’t mRNA – the use of Methylpseudouridine means it’s a different substance does it not? 267. Which part of the mRNA code directs it to be processed on the ribosomes bound to the endoplasmic reticulum – could the TGA please state the name of the amino acid and what position the amino acid sits on the mRNA strand? 289. Is pseudouridine impervious to the mRNAse, the enzyme that breaks down mRNA?

21/11/2022

184. Can the TGA provide a breakout of its revenue stream by organisation? 205. Leaked emails from the EMA show they lodged a Major objection with Pfizer, namely that the possibility of translated proteins other than the translated protein resulting from truncated or modified mRNA should be addressed. Were these concerns addressed? The European Medicines Agency’s COVID-19 Vaccine Leaks: Hacks, Regulatory Pressures And Manufacturing Concerns – Health Policy Watch (healthpolicy-watch.news)

21/11/2022

96. There is no evidence that the blood lung barrier will allow IgG antibodies which weight around 150,000 Daltons to cross from the blood into the alveolar space of the lungs where Covid is infecting the epithelial cells. Given this is the case why do authorities claim the Covid vaccine can fight Covid which is present in the lungs? 97. I note that the TGA non-clinical report on the Pfizer vaccine showed there was very little difference in lung inflammation after 8 days in between vaccinated an unvaccinated monkeys. Given they weight 10kgs and got three times the dose of humans on what basis did this trial proof the vaccine was effective noting there was an IgG response for only 35 days. I note the weight to dose ratio for the monkeys was 20 times higher than humans so on that basis there may have been an IgG response for two days (35/20) or a lower IgG response.

21/11/2022

178. On average how many strands of mRNA are in 30 micrograms of mRNA? Given there are 5 doses in each vial how can the TGA be sure that each dose will contain the same amount of mRNA? 179. What is the margin of error administering 30 uml (.3mL) from a vial with 5 doses? 180. Why didn’t the TGA make Pfzier measure out the 30 microns evenly instead of leaving it to the person who administers the vaccine – the margin of error for such a small dose would be huge would it not? 181. Given the TGA measures mRNA by mass how does it know if they or the administrators of the vaccine are measuring mRNA and not solution?

21/11/2022

119. Has the Federal government covered half the hospital costs for people in hospital with Covid? Was this money reimbursed to State governments? If so, doesn’t this create an incentive for State government to fudge Covid cases in hospital in order to milk the Federal government of Funding? 120. Does the Federal government reimbursing states such as NSW for back capturing whereby that State government counts people as having Covid, even if they had it 28 days prior to entering hospital and went to hospital for another reason such as a broken arm?

21/11/2022

146. Why doesn’t the TGA have mandatory reporting requirements of Health professionals for reporting adverse events? Shouldn’t it be mandatory given that the vaccines have only received provisional approval and data from ongoing trials are being assessed on an outgoing basis? 148. In the Post marketing surveillance data there is over 1,000 adverse events of interest – what exactly are adverse events of interest – are they reported adverse events? 149. If the current vaccines fall outside many of the international guidelines for testing vaccines, then isn’t it fair to say they aren’t vaccines. 150. In the post marketing surveillance data – what was the total population of the administered doses? I note this figure has been censored by Pfizer and the FDA – why is such an important indicator of safety being covered up and why won’t the TGA ask for that number and then disclose it? 151. Why did the TGA change death description to Adverse Event following immunisation to avoid scrutiny over cause of death regarding a number of young children were reported to have died from the vaccine?

21/11/2022

185. Studies have shown that neutrophils interact with spike proteins to create fibrils that lead to amyloids clots. Has the TGA examined this risk, and can they guarantee that amyloid clots aren’t being formed by the vaccine? 190. I note that the Europeans Medicine Agency has added heavy menstrual bleeding as a side effect of Pfizer and Moderna Covid jabs. Given this delayed warning what testing will the TGA do to ensure that the heavy bleeding isn’t the result of clots and that women are not at danger of having their fertility damaged?

21/11/2022

244. Why did the TGA approve molnupiravir despite the fact there were concerns that the drug may cause cancer mutations? It is known in medicine that mutation of a single base is sufficient to cause disease, sickle cell anaemia being one example. – https://quadrant.org.au/opinion/public-health/2022/08/the-suppression-of-usefulcovid-19-treatments/ 261. Until recently patients presenting with anti-bodies to their thyroids have had it stated on their blood results that ‘the antibody pattern suggests an underlying autoimmune inflammatory process e.g. Graves’ and Hashimoto’s’. The way to examine these results was changed on 06/09/21 and the reference interval was updated. Why has the reference interval been updated/changed and is it true that Medicare requested QML that such wording be removed from patients’ written test results?

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

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?

21/11/2022

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?

21/11/2022

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?

21/11/2022

200. Who is responsible for acting on the safety signal in the DAEN database re Covid vaccines – the TGA or the sponsor? 214. I note that the Covid vaccines were provisionally approved subject to strict reporting conditions on safety and efficacy. Since provisional approval what has Pfizer reported to the TGA in regards to safety and efficacy since the rollout of the vaccine? 215. Can the safety reports provided by the Covid vaccine sponsors please be provided? 266. “The TGA’s vaccine safety monitoring system can rapidly detect, investigate and respond to any emerging safety issues identified for COVID-19 vaccines.” The TGA’s monitoring system is passive and therefore it can never “rapidly detect” safety issues! These pages are misleading the public are they not? https://www.tga.gov.au/products/covid-19/covid-19-vaccines/covid-19-vaccineapproval-process

21/11/2022

203. Professors from UCLA and Stanford have highlighted the risk of vaccine injuries at 11 in 10000. How can the TGA refute these prestigious institutions – Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials by Joseph Fraiman, Juan Erviti, Mark Jones, Sander Greenland, Patrick Whelan, Robert M. Kaplan, Peter Doshi :: SSRN 219. In a previous QON the TGA stated “Since these vaccines were granted provisional approval, more than 11 billion people have received doses of COVID-19 vaccines worldwide. Data on real-world use of the COVID-19 vaccines approved in Australia provides reassurance about their safety and that the trials were carried out correctly. This is supported by reviews of safety data by international medicines regulators in countries with extensive COVID-19 vaccine experience who have found no new safety concerns associated with the use of COVID-19 vaccines. In addition, the TGA’s monitoring program has not detected any new safety signals in relation to COVID-19 vaccines to date?” This reply is a blatant lie that will be reported for contempt. A number of side effects have been reported such as myocarditis and heavy menstrual bleeding. Why is the TGA covering up serious side effects from the mRNA Covid vaccines? 280. Given the Covid vaccine trials were so short in duration why does the TGA take the sponsors word as to what side effects are and ignore real world data being reported

21/11/2022

204. Studies have shown that the weight of the protein produced by the mRNA vary by as much as 50% – surely this is evidence that the mRNA is not being produced in a consistent manner by the ribosomes? Is the TGA tracking the product being produced by the ribosomes? 221. Why is TGA/Pfizer calling it mRNA when it isn’t mRNA – the use of Methylpseudouridine means it’s a different substance does it not? 267. Which part of the mRNA code directs it to be processed on the ribosomes bound to the endoplasmic reticulum – could the TGA please state the name of the amino acid and what position the amino acid sits on the mRNA strand? 289. Is pseudouridine impervious to the mRNAse, the enzyme that breaks down mRNA?

21/11/2022

184. Can the TGA provide a breakout of its revenue stream by organisation? 205. Leaked emails from the EMA show they lodged a Major objection with Pfizer, namely that the possibility of translated proteins other than the translated protein resulting from truncated or modified mRNA should be addressed. Were these concerns addressed? The European Medicines Agency’s COVID-19 Vaccine Leaks: Hacks, Regulatory Pressures And Manufacturing Concerns – Health Policy Watch (healthpolicy-watch.news)

21/11/2022

96. There is no evidence that the blood lung barrier will allow IgG antibodies which weight around 150,000 Daltons to cross from the blood into the alveolar space of the lungs where Covid is infecting the epithelial cells. Given this is the case why do authorities claim the Covid vaccine can fight Covid which is present in the lungs? 97. I note that the TGA non-clinical report on the Pfizer vaccine showed there was very little difference in lung inflammation after 8 days in between vaccinated an unvaccinated monkeys. Given they weight 10kgs and got three times the dose of humans on what basis did this trial proof the vaccine was effective noting there was an IgG response for only 35 days. I note the weight to dose ratio for the monkeys was 20 times higher than humans so on that basis there may have been an IgG response for two days (35/20) or a lower IgG response.

21/11/2022

178. On average how many strands of mRNA are in 30 micrograms of mRNA? Given there are 5 doses in each vial how can the TGA be sure that each dose will contain the same amount of mRNA? 179. What is the margin of error administering 30 uml (.3mL) from a vial with 5 doses? 180. Why didn’t the TGA make Pfzier measure out the 30 microns evenly instead of leaving it to the person who administers the vaccine – the margin of error for such a small dose would be huge would it not? 181. Given the TGA measures mRNA by mass how does it know if they or the administrators of the vaccine are measuring mRNA and not solution?

21/11/2022

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