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QUESTIONS ON NOTICE

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

158. Is the Health Department concerned about corruption within Australia’s regulatory body? 208. According to Section 9 of the TGA own advertising code “An advertisement about therapeutic goods must not contain any statement, pictorial representation or design that, expressly or by implication, represents the goods to be: (a) safe, or without harm or side-effects; or (b) effective in all cases, or a guaranteed cure; or (c) infallible, unfailing, magical or miraculous.” 209. Despite this every authority in the country touted the vaccines as safe and effective without qualifying the risks. Haven’t they broken the law? 217. Why are you fining small companies for breaches of law that had no adverse events while ignoring the negligent behavior of Big Pharma? How are small Australian companies importing a small number of RAT tests for testing or Ivermectin that are no risk to the public worse than the behavior of big pharmaceuticals?

21/11/2022

117. Has the TGA accessed/obtained current Australian background rates for adverse events/subclinical conditions from hospital admission data, NPS MedicineWise and/or general practice data and compared it with pre vaccination rollout data from the same source? 118. In the last round of estimates Prof Skerritt claimed that millions could have died or gone to hospital from Covid – can he please provide the modelling for that claim? Given there has been 6 million deaths from Covid in almost three years, it does sound a bit rich to claim those numbers in a country of just 25 million does it not?

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

228. ACE receptors are not on all cells – does the TGA accept that the transfection process used by Pfizer makes the vaccine more pathogenic than the virus? The vaccine doesn’t target any cells, instead it targets all cells via transfection as shown in graphs on page 34 of the TGA Pfizer Non-Clinical report? 230. The non-clinical report noted one study that said 100% of people who had recovered from Covid had S protein specific CD4 t-cells and 70% had CD8 t-cells – if this is the case why is natural immunity being ignored for those who had Covid in favor of further boosters?

21/11/2022

231. The non-clinical report noted there were no studies on the protection of older animals – given it was older people who are susceptible why were older animals excluded? 232. The non-clinical report noted that monkeys were not a good animal model of severe Covid 19 in humans – if this is case why use monkeys in a trial for a disease, they are not a good model for? 233. The non-clinical report noted vaccine induced auto immune diseases were not studied in the non-clinical program and should be addressed by clinical data. If this is the case, why are humans being used as guinea pigs? 259. How can the TGA discount the increased number of supernumerary ribs in vaccinated pregnant rats as not being a safety signal? Shouldn’t more testing have taken place? 268. Why is the TGA refusing to provide information relating to “All Developmental and Reproductive Toxicity Studies available to the TGA regarding the Pfizer and AstraZeneca COVID-19 vaccines including histology reports of gonads of vaccinated animals”

21/11/2022

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?

21/11/2022

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?

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

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

186. Regarding Ivermectin, is this the first time in Australian history that the Federal Government has instructed the withdrawal of a medicine in the context of a public health emergency? 187. What evidence was there that taking Ivermectin could be a risk to the community either directly, or indirectly by discouraging vaccination. Given vaccination doesn’t stop transmission how was taking Ivermectin a threat to others? 188. What evidence was considered by the committee when recommending that Ivermectin was a risk to individual patient health. Did the Committee and Minister review any evidence of death or injury through inappropriate use of Ivermectin? I note Dr Skerritt stated 12mg was an unsafe dose in a previous conversation yet the sponsors of the drug have claimed that one off does of 120mg and 30,60 and 90mg doses on day 1, day 4 and day 7 are safe.

21/11/2022

If Lyndall Dean can be prevented from hearing vaccine cases, then why are other commissioners allowed to hear vaccine cases who have prejudicial and uninformed views about the risks of the Covid19 vaccine? In Jovan Jovcic and Filip Markovic v Coopers Brewery Limited [2022] FWC 1931 Deputy President Coleman states in paragraph 39 that ATAGI status as an expert body that provides advice to the government and public cannot be seriously doubted. What sort of a joke is this? (a) What is the point of an independent commission if they just assume the government and its advisors are infallible? (b) Deputy President Coleman then goes on to state in paragraph 40 that ATAGI said that vaccination was an intervention to prevent transmission. This statement from ATAGI and therefore Deputy President Coleman is unequivocally wrong. There was never any testing by Pfizer that showed the vaccine stopped transmission. This was admitted by Pfizer in the European Parliament in October as well as the FDA as far back as December 2020. The FDA and Pfizer have both said it is unclear how long the vaccine provides protection. Given Deputy President’s Coleman misstated facts what will Fair Work do to rectify this? This error of judgement is further compounded by the fact many of the ATAGI experts work for organisations who are funded by big pharmaceutical companies. They clearly have a conflict of interest that can impair their judgement.

21/11/2022

Why should the Australian public trust either Professor Murphy, Professor Skerritt or Professor Kelly given they have all made statements that turned out to be grossly misleading? This includes Professor Kelly claiming the vaccines stopped transmission, Professor Murphy claiming there are no spike proteins in the blood and Professor Skerritt claiming the lipids used in the vaccine were like lipids in a steak one eats for breakfast, when in fact there are four lipids used in the vaccine some of which are cationic? Given these claims have been made in estimate hearings why aren’t they held in contempt?

18/11/2022

A number of private organisations in the media, medical professionals, and Pfizer have claimed the Pfizer covid vaccine was safe and effective without outlining the risks or lack of quality assurance in regard to testing the vaccine. Genotoxicity, carcinogenic, and longitudinal testing are just some of the tests that didn’t occur. Other risks with missing information are outlined in the table below. There were only around 19,000 from the vaccinated group evaluated when over 21,000 were vaccinated? • What laws are in place to ensure that all risks are outlined as well as the rewards when medical products are advertised or promoted – if laws do exist why weren’t the upheld in the case the Covid-19 vaccine? • What recourse do victims of the Covid-19 vaccine have against private organisations such as the media, pharmaceutical companies, and health professionals who constantly repeated the vaccine is safe and effective without highlighting the risks? • What steps will The Australian Communications and Media Authority take in regard to the promotion of medical products in order to prevent misleading and deceptive conduct in the future? (See table)

17/11/2022

158. Is the Health Department concerned about corruption within Australia’s regulatory body? 208. According to Section 9 of the TGA own advertising code “An advertisement about therapeutic goods must not contain any statement, pictorial representation or design that, expressly or by implication, represents the goods to be: (a) safe, or without harm or side-effects; or (b) effective in all cases, or a guaranteed cure; or (c) infallible, unfailing, magical or miraculous.” 209. Despite this every authority in the country touted the vaccines as safe and effective without qualifying the risks. Haven’t they broken the law? 217. Why are you fining small companies for breaches of law that had no adverse events while ignoring the negligent behavior of Big Pharma? How are small Australian companies importing a small number of RAT tests for testing or Ivermectin that are no risk to the public worse than the behavior of big pharmaceuticals?

21/11/2022

117. Has the TGA accessed/obtained current Australian background rates for adverse events/subclinical conditions from hospital admission data, NPS MedicineWise and/or general practice data and compared it with pre vaccination rollout data from the same source? 118. In the last round of estimates Prof Skerritt claimed that millions could have died or gone to hospital from Covid – can he please provide the modelling for that claim? Given there has been 6 million deaths from Covid in almost three years, it does sound a bit rich to claim those numbers in a country of just 25 million does it not?

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

228. ACE receptors are not on all cells – does the TGA accept that the transfection process used by Pfizer makes the vaccine more pathogenic than the virus? The vaccine doesn’t target any cells, instead it targets all cells via transfection as shown in graphs on page 34 of the TGA Pfizer Non-Clinical report? 230. The non-clinical report noted one study that said 100% of people who had recovered from Covid had S protein specific CD4 t-cells and 70% had CD8 t-cells – if this is the case why is natural immunity being ignored for those who had Covid in favor of further boosters?

21/11/2022

231. The non-clinical report noted there were no studies on the protection of older animals – given it was older people who are susceptible why were older animals excluded? 232. The non-clinical report noted that monkeys were not a good animal model of severe Covid 19 in humans – if this is case why use monkeys in a trial for a disease, they are not a good model for? 233. The non-clinical report noted vaccine induced auto immune diseases were not studied in the non-clinical program and should be addressed by clinical data. If this is the case, why are humans being used as guinea pigs? 259. How can the TGA discount the increased number of supernumerary ribs in vaccinated pregnant rats as not being a safety signal? Shouldn’t more testing have taken place? 268. Why is the TGA refusing to provide information relating to “All Developmental and Reproductive Toxicity Studies available to the TGA regarding the Pfizer and AstraZeneca COVID-19 vaccines including histology reports of gonads of vaccinated animals”

21/11/2022

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?

21/11/2022

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?

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

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

186. Regarding Ivermectin, is this the first time in Australian history that the Federal Government has instructed the withdrawal of a medicine in the context of a public health emergency? 187. What evidence was there that taking Ivermectin could be a risk to the community either directly, or indirectly by discouraging vaccination. Given vaccination doesn’t stop transmission how was taking Ivermectin a threat to others? 188. What evidence was considered by the committee when recommending that Ivermectin was a risk to individual patient health. Did the Committee and Minister review any evidence of death or injury through inappropriate use of Ivermectin? I note Dr Skerritt stated 12mg was an unsafe dose in a previous conversation yet the sponsors of the drug have claimed that one off does of 120mg and 30,60 and 90mg doses on day 1, day 4 and day 7 are safe.

21/11/2022

If Lyndall Dean can be prevented from hearing vaccine cases, then why are other commissioners allowed to hear vaccine cases who have prejudicial and uninformed views about the risks of the Covid19 vaccine? In Jovan Jovcic and Filip Markovic v Coopers Brewery Limited [2022] FWC 1931 Deputy President Coleman states in paragraph 39 that ATAGI status as an expert body that provides advice to the government and public cannot be seriously doubted. What sort of a joke is this? (a) What is the point of an independent commission if they just assume the government and its advisors are infallible? (b) Deputy President Coleman then goes on to state in paragraph 40 that ATAGI said that vaccination was an intervention to prevent transmission. This statement from ATAGI and therefore Deputy President Coleman is unequivocally wrong. There was never any testing by Pfizer that showed the vaccine stopped transmission. This was admitted by Pfizer in the European Parliament in October as well as the FDA as far back as December 2020. The FDA and Pfizer have both said it is unclear how long the vaccine provides protection. Given Deputy President’s Coleman misstated facts what will Fair Work do to rectify this? This error of judgement is further compounded by the fact many of the ATAGI experts work for organisations who are funded by big pharmaceutical companies. They clearly have a conflict of interest that can impair their judgement.

21/11/2022

Why should the Australian public trust either Professor Murphy, Professor Skerritt or Professor Kelly given they have all made statements that turned out to be grossly misleading? This includes Professor Kelly claiming the vaccines stopped transmission, Professor Murphy claiming there are no spike proteins in the blood and Professor Skerritt claiming the lipids used in the vaccine were like lipids in a steak one eats for breakfast, when in fact there are four lipids used in the vaccine some of which are cationic? Given these claims have been made in estimate hearings why aren’t they held in contempt?

18/11/2022

A number of private organisations in the media, medical professionals, and Pfizer have claimed the Pfizer covid vaccine was safe and effective without outlining the risks or lack of quality assurance in regard to testing the vaccine. Genotoxicity, carcinogenic, and longitudinal testing are just some of the tests that didn’t occur. Other risks with missing information are outlined in the table below. There were only around 19,000 from the vaccinated group evaluated when over 21,000 were vaccinated? • What laws are in place to ensure that all risks are outlined as well as the rewards when medical products are advertised or promoted – if laws do exist why weren’t the upheld in the case the Covid-19 vaccine? • What recourse do victims of the Covid-19 vaccine have against private organisations such as the media, pharmaceutical companies, and health professionals who constantly repeated the vaccine is safe and effective without highlighting the risks? • What steps will The Australian Communications and Media Authority take in regard to the promotion of medical products in order to prevent misleading and deceptive conduct in the future? (See table)

17/11/2022

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