Stay up to date...

QUESTIONS ON NOTICE

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

161. “Pfizer has asked a U.S. court to throw out a lawsuit from a whistle-blower who revealed problems at sites that tested Pfizer’s COVID-19 vaccine. Pfizer stated that the regulations don’t apply to its vaccine contract with the U.S. Department of Defence because the agreement gives contract holders the ability to skirt many rules and laws that typically apply to contracts.” Pfizer Moves to Dismiss Lawsuit From COVID-19 Vaccine Trial, Citing ‘Prototype’ Agreement (theepochtimes.com) – Has Australia signed a Covid-19 contract with Pfizer that has similar conditions? 162. Why are you penalising Australians $10,000 of dollars for importing Ivermectin worth $40 but doing nothing about Pfizer not living up to its promise about the safety and efficacy of the vaccine? 165. Can the TGA provide all correspondence with Pfizer regarding the Covid vaccine in regards to purchase agreements, testing and safety concerns? 183. Is the vaccine injury scheme going to be updated to include additional side effects that have been reported to the TGA by Health Professionals rather than Pfizer who have a conflict of interest in reporting side effects from their own drugs? 191. The normal default for contracts is to reserve a “right” to buy. Are these the terms the Pfizer Covid vaccine contract was based on, or do have an “obligation” to buy the Covid vaccines regardless of performance? If so, why did the health department deviate from the normal procedure for a contract that covers Australia’s needs many times over, for a period where all would already be vaccinated (2022 and 2023). 262. The contract between Pfizer and the US government prohibits independent researchers from studying the vaccines. They claim it would ‘divert’ these precious resources away from their intended use fulfilling an ‘urgent’ need. Is this true? If so, then why is Pfizer hiding from independent scrutiny?

71. Has the TGA now got comprehensive and exhaustive data that determines how long the body produces the Spike protein. If not, then why are they allowing the rollout of the vaccine to continue? 72. Has the TGA now got comprehensive and exhaustive data that determines how long the spike protein or any other related prions, mutations stay in the body and by body organ type. If not, then why are they allowing the rollout of the vaccine to continue? 73. Do expressed spike proteins stay in the cell membrane or are they secreted via exosomes? 74. The ribosomes on the endoplasmic reticulum produce protein for export while ribosome in the cytoplasm produce proteins for use inside the cell. Given the TGA non-clinical report says the spike protein is produced via the endoplasmic reticulum then isn’t evidence that spike proteins will be exported from the cell and potentially re-enter the circulatory system? 76. Which part of the mRNA code tells the mRNA to attach to the Endoplasmic Reticulum? 77. What evidence does the TGA have that the spike protein doesn’t go into the nucleus – the delivery of the spike protein was never tested. There were no studies carried out so how would the TGA know with 100% certainty the mRNA or the spike protein doesn’t enter the nucleus? 78. Is there any evidence that the spike protein does not inhibit the P53 gene? Were studies carried out to prove this? 79. “Another study revealed that extracellular vesicles decorated with S-proteins persist up to 4 months after vaccination… This raises the possibility that LNP–mRNA remain in circulation for extended periods of time, retaining their ability to induce S-protein expression….”. Does the TGA refute this study? www.mdpi.com/2227- 9059/10/7/1538/htm 87. Have studies been conducted by the TGA to determine if the spike protein interferes with oocytes?

80. In the prior set of estimates Prof Skerrit said that the lipids used in the vaccine are like the lipids you have in a steak for breakfast. This is not the case – as per Pfizers own website they are special ionised lipids designed to cross the cell membrane. Will Prof Skerritt withdraw his prior remark? 81. Lipids are hydrophobic not hydrophilic – by cationising them you have completely changed their characteristics from inactive to active -why did Prof Skerritt mislead the senate when he said the lipids were like the lipids you find in sausages/steak for breakfast? 82. Given these lipids are ionised and therefore an active ingredient what studies have been undertaken to ensure they were not harmful to the human body? 83. What studies were undertaken to ensure that the cationic lipids don’t create reactive oxygen species which can cause irreversible damage to DNA? 84. If the ionic lipids can enter any cells via electroporation or transfection then aren’t they more infectious than the virus which can only enter cells that contain ACE and TMPRRS enzymes that facilitate the virus entering the cell? 85. Can the lipids enter both white and red blood cells? I note that lipids entered both the spleen and bone marrow in the rat studies? 86. Given the lipids are taken up by the ovaries what guarantees can the TGA give that eggs are not being damaged. Obstetricians are reporting that they are seeing clusters of low Anti-Mullerian Hormone (AMH) levels in young women 95. The bone marrow, spleen, and lymph nodes are responsible for producing white blood cells and regulating the while blood cells in the blood and the lymphatic system. Given that lipids can enter these organs and induce an autoimmune response against the cells in these body organs isn’t there a serious risk that the vaccine can induce autoimmune diseases?

163. Hasn’t Pfizer and Co broken the Therapeutic Goods Act 1989 by failing to report all the adverse events from their trials and post marketing surveillance (refer to patient records)? Under paragraph 28(5)(ca) of the Act, you MUST retain records pertaining to the reporting requirements and safety for your medicine. (page 29 of 44) 164. What is the legislation that details the TGAs responsibilities in regard to post market safety surveillance data? Why hasn’t the TGA sought to allay the publics fear over data that shows an alarming number of adverse events and poor quality assurance practices? 202. Does the TGA do post marketing surveillance at all over and above that of the sponsor? If not, why not? What is the point of having an independent regulator if it doesn’t do independent safety testing?

166. The AusVax safety data showed over 5 million people reported side effects 3 days after taking the Covid-19 vaccine and around 1 in 100 had to see a doctor or go to emergency just 3 days after taking a vaccine. How can the TGA justify the rollout of the Covid-19 vaccine when the adverse event rate is so high? 167. The AusVax safety data says 8% reported missing work, study or routine duties after dose 1 of the Covid vaccine, 21% after dose 2 of the Covid vaccine and 15% after dose 3 of the Covid vaccine. How can the TGA justify the rollout of the Covid-19 vaccine when the adverse event rate is so high?

88. FOI 2565 requested “Histopathology/microscopic evaluation of gonads (ovaries/testes) of vaccinated animals in relation to Pfizer and AstraZeneca COVID-19 vaccines”. This application has been rejected three times, and was rejected finally by the internal reviewers on 27 Sep 2021. Why is the TGA withholding reports of ovarian and testicular effects of an investigational (provisionally registered) vaccine. Particularly in the context of vaccine mandates being imposed upon men and women of reproductive age in various occupational sectors, and now on children and teens with their reproductive years ahead of them?

43. In the post marketing report on page 6 it says “Pfizer has also taken multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues. To date, Pfizer has onboarded approximately 600 additional fulltime employees (FTEs). More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.” Surely if the vaccine was safe and effective Pfizer wouldn’t need to employ an additional 1,800 staff to deal with adverse events? Isn’t this in itself a concerning safety signal?

45. As per the TGA non-clinical report, there are no data on the kinetics of BNT162b2 mRNA degradation (page 10). There are no distribution and degradation data on the S antigen-encoding mRNA. (Page 4) How can Health Authorities claim the vaccines are safe when no comprehensive testing was carried on the spike protein which has known toxic properties? 46. Studies are showing the long-term persistence of the spike protein in various body organs. Why is the TGA ignoring this and more importantly continuing to promote the vaccine as safe and effective when the side effects are not understood and there is ample evidence of adverse events? 47. Given studies are showing the long-term persistence of the spike protein in various body organs, how can the TGA prove long Covid isn’t a result of the vaccine and not the virus? Are long covid tests being carried out to determine if the cause of the injury is from the vaccine or the virus? Are medical biomarkers such as the N protein and Methylpseudouridine being tracked to determine cause of long Covid?

49. The use of pseudouridine in mRNA vaccines was developed as a very recent concept and its long-term effects are unknown. It has however been known for 10 years that the use of pseudo-U causes the stop codons (required to stop adding amino acids to a protein chain) to misfunction, thereby elongating the protein chain and risking translation of the next segment (the 3’UTR) (Karijolich 2011). The effects of this are unknown and cannot be known without specific experiments to address the issue. When did the TGA become aware that the synthetic nucleotide pseudouridine was being used rather than the natural uridine and what testing did it undertake to ensure that it was safe to use? 50. Studies have shown the psuedouridine has a higher translation error rate than uridine. Wasn’t it reckless to roll out the vaccine knowing that? Improving the fidelity of uridine analog incorporation during in vitro transcription | bioRxiv (available at: www.biorxiv.org/content/10.1101/2022.04.12.488100v1)

52. FOI 3471 shows contamination in the batches. Why didn’t the TGA undertake whole genome sequencing on the batches when it was an obvious way to look for contamination? 53. As per the TGA FOI disclosure log that some batches had up to 40% degraded mRNA – what are the potential risks of degraded mRNA in the body and what studies were carried to determine the safety of degraded mRNA? 54. How does the TGA know degraded mRNA isn’t going to produce toxic proteins? 55. How did the TGA undertake batch testing. Are all vials tested and what were the benchmarks especially in regards to tolerance levels? 56. Did the Covid-19 vaccine trail undertaken by Pfizer use batches made via the commercial process or the laboratory process? Are there trials undertaken by Pfizer using the commercial process and if so can they be provided? 57. Can the TGA report batch numbers by number of reported adverse events and reported deaths so people can see which batches had the highest rate of adverse events? 58. Could the TGA please provide evidence that the Covid vaccine batches had the same purity in Australia as what was stated in the manufacturing facility. Could documentation of the signatures and percentage of intact mRNA by both the manufacturer and the TGA please be provided? 59. Why did the TGA approve batches with as low as 60% integrity and how can it guarantee safety of those batches from degraded mRNA and further degradation after transport? 60. Why is the integrity level of batches commercial in confidence? This is a safety issue that Australians should be aware of it is it not? 61. If a batch is only 60% intact and each vial contains 5 doses how can the TGA be sure that every person is getting a consistent dose? 62. FOI 2389-3 page 110 Table 2 says concentration depends on batch size? How can the TGA be sure that every person is getting a consistent dose?

5. I note Professor Skerritt is currently Vice-Chair of the International Coalition of Medicines Regulatory Authorities and Chair of the Scientific Advisory Council of the Centre for Innovation in Regulatory Science – do these organisations receive money from pharmaceutical companies? If so, then isn’t there a conflict of interest in Professor Skerritt holding these positions? 6. I note that a number of members on the TGA’s Advisory Committee on Vaccines work for organisations that receive significant funding from big pharmaceutical companies. How is this not a conflict of interest?

8. Has any safety testing been carried out in either humans or animals to determine the side effects of receiving 5 mRNA vaccines? 9. How is it that any deaths with a positive covid test is classed as a Covid death regardless of cause while any death after a vaccine isn’t classed as a vaccine death? Given the vaccine is still only provisionally approved shouldn’t all deaths with 6-8 weeks of receiving a vaccine be treated as a vaccine death until proven otherwise? 10. What are the criteria for a death to be linked to a vaccine? 11. Health advice says the benefits outweigh the risks on having 3 jabs as a 16+ year old person who is otherwise healthy? Where are the trials/numbers that support this statement and how can the TGA/ATAGI say this when longitudinal, carcinogenic, genotoxicity and numerous other tests were not carried out? 12. Severe adverse injuries were only counted by Pfizer in their Covid-19 trial up to 1 month after 2nd jab leading to the number of vaccine injuries being understated. “Limitations of our study include that Pfizer’s SAE table did not include SAEs occurring past 1 month after dose 2. This reporting threshold may have led to an undercounting of serious AE’ in the Pfizer study” – Why does the TGA believe this is acceptable Quality Assurance when Professor Skerritt said on the Today show in early 2021 that serious injuries could occur up to 8 weeks after the vaccine? 13. What is the adverse injury run rate that the TGA considers acceptable for a safe vaccine/drug? What are the benchmarks for proving it was safe? 14. I note that the 6-month data from the Pfizer trials 20 people died in the inoculation group while 15 died in the placebo group. 5,241 had related adverse events in the vaccination group against 1,311 in the placebo group – 300% more, 262 had severe adverse events (interferes significantly with normal function) in the vaccination group v 150 in the placebo group – 75% more and 127 had a serious adverse event (hospitalisation or visit to ER) v 116 in the placebo group which is 10% more – so where exactly does the TGA and other health authorities come up with the statement that the vaccine was actually proven to be safe and effective?

159. Are all adverse reaction reports and reports of death included on the DAEN – Database of Adverse Event Notifications, the database that is accessible by the public or does the TGA vet adverse reactions before they appear on this database?160. Does the TGA maintain another database AEMS which is where all logged adverse claims entered by the public are stored?161. If so, what is the process and criteria for transferring reported adverse event claims from the AEMS database to the DAEN database?162. In regards to the Covid-19 vaccines, how many reports of adverse events or deaths were not uploaded onto the DAEN database?206. How many databases does the TGA and State Health departments keep in regards to adverse events?207. Are all reports of adverse events from State Health departments uploaded into the TGA DAEN database? If not why not?208. How many reports of adverse events have not been uploaded in the TGA DAEN database from either State Government records or the AEMs database?

105. What was the absolute efficacy (not relative efficacy) in reducing people catching Covid of the Pfizer vaccine in the initial trials conducted by Pfizer? 106. To what extent did the vaccine reduce transmission in the initial Pfizer trials? Please provide in terms of absolute numbers? 107. To what extent did the vaccine reduce hospitalisation admissions in the initial Pfizer trials? Please provide the data in terms of absolute numbers. 108. To what extent did the vaccine reduce deaths in the initial Pfizer trials? Please provide the data in terms of absolute numbers. 109. To what extent the vaccine cause inflammation in the initial Pfizer trials? Please provide the data backing up the result? 110. To what extent did the vaccine cause clotting in the initial Pfizer trials? Please provide the data backing up the result. 113. On the 4th of January 2021, the CEO of Pfizer said the Pfizer vaccine was 100% effective in stopping transmission. This claim was repeated by Health experts in Australia. Will the TGA and the Health Department provide an apology to the Australian people for misleading them?

98. In the initial Pfizer trials why no testing was done on the carcinogenic properties of the vaccine and why didn’t the TGA request it be performed?99. In the initial Pfizer trials why was no testing was done on pregnant women, breastfeeding women or immunocompromised people and why didn’t the TGA request it be performed?100. In the initial Pfizer trial why was the placebo group was unblinded after 2 months when best practice required the group to stay blinded until the end of the trial 2-3 years later?101. Given the lack of quality assurance and data derived from the Pfizer trials on what basis does John Skerrit say that the data was thoroughly assessed for safety?

29. If John Skerritt and the TGA doesn’t believe the medical experts who suspect the vaccines are the cause of death are wrong, then why won’t the TGA acknowledge the deaths as being from the vaccine? 30. Why does the TGA and its experts who never examined the patient think they have a better understanding of the cause of death than the experts who actually examined the body and/or dealt with the patient symptoms as they were dying? 31. How can a board of remote ”experts” making a subjective assessment without examining the body overrule the physician who did examine the body and ticked the box ”likely” to be an adverse effect or reported death?

151. Why were Early Treatments withheld from the Australian public from even being tried? 152. Why has the health department failed to actively pursue getting effective affordable Early Treatment protocols for Covid, especially given they could reduce viral loads and transmission unlike the Covid vaccines? 153. Was it a legal reason that did not allow the experimental vaccines to be used at all if there was already a treatment that works? 154. Were there any terms and conditions in the Pfizer contract with the Australian government for the Covid vaccines that prevented early treatments from being used? 255. Can the TGA guarantee there have been no lives lost by obstructing the use of early treatments as compared to allowing them?

161. “Pfizer has asked a U.S. court to throw out a lawsuit from a whistle-blower who revealed problems at sites that tested Pfizer’s COVID-19 vaccine. Pfizer stated that the regulations don’t apply to its vaccine contract with the U.S. Department of Defence because the agreement gives contract holders the ability to skirt many rules and laws that typically apply to contracts.” Pfizer Moves to Dismiss Lawsuit From COVID-19 Vaccine Trial, Citing ‘Prototype’ Agreement (theepochtimes.com) – Has Australia signed a Covid-19 contract with Pfizer that has similar conditions? 162. Why are you penalising Australians $10,000 of dollars for importing Ivermectin worth $40 but doing nothing about Pfizer not living up to its promise about the safety and efficacy of the vaccine? 165. Can the TGA provide all correspondence with Pfizer regarding the Covid vaccine in regards to purchase agreements, testing and safety concerns? 183. Is the vaccine injury scheme going to be updated to include additional side effects that have been reported to the TGA by Health Professionals rather than Pfizer who have a conflict of interest in reporting side effects from their own drugs? 191. The normal default for contracts is to reserve a “right” to buy. Are these the terms the Pfizer Covid vaccine contract was based on, or do have an “obligation” to buy the Covid vaccines regardless of performance? If so, why did the health department deviate from the normal procedure for a contract that covers Australia’s needs many times over, for a period where all would already be vaccinated (2022 and 2023). 262. The contract between Pfizer and the US government prohibits independent researchers from studying the vaccines. They claim it would ‘divert’ these precious resources away from their intended use fulfilling an ‘urgent’ need. Is this true? If so, then why is Pfizer hiding from independent scrutiny?

71. Has the TGA now got comprehensive and exhaustive data that determines how long the body produces the Spike protein. If not, then why are they allowing the rollout of the vaccine to continue? 72. Has the TGA now got comprehensive and exhaustive data that determines how long the spike protein or any other related prions, mutations stay in the body and by body organ type. If not, then why are they allowing the rollout of the vaccine to continue? 73. Do expressed spike proteins stay in the cell membrane or are they secreted via exosomes? 74. The ribosomes on the endoplasmic reticulum produce protein for export while ribosome in the cytoplasm produce proteins for use inside the cell. Given the TGA non-clinical report says the spike protein is produced via the endoplasmic reticulum then isn’t evidence that spike proteins will be exported from the cell and potentially re-enter the circulatory system? 76. Which part of the mRNA code tells the mRNA to attach to the Endoplasmic Reticulum? 77. What evidence does the TGA have that the spike protein doesn’t go into the nucleus – the delivery of the spike protein was never tested. There were no studies carried out so how would the TGA know with 100% certainty the mRNA or the spike protein doesn’t enter the nucleus? 78. Is there any evidence that the spike protein does not inhibit the P53 gene? Were studies carried out to prove this? 79. “Another study revealed that extracellular vesicles decorated with S-proteins persist up to 4 months after vaccination… This raises the possibility that LNP–mRNA remain in circulation for extended periods of time, retaining their ability to induce S-protein expression….”. Does the TGA refute this study? www.mdpi.com/2227- 9059/10/7/1538/htm 87. Have studies been conducted by the TGA to determine if the spike protein interferes with oocytes?

80. In the prior set of estimates Prof Skerrit said that the lipids used in the vaccine are like the lipids you have in a steak for breakfast. This is not the case – as per Pfizers own website they are special ionised lipids designed to cross the cell membrane. Will Prof Skerritt withdraw his prior remark? 81. Lipids are hydrophobic not hydrophilic – by cationising them you have completely changed their characteristics from inactive to active -why did Prof Skerritt mislead the senate when he said the lipids were like the lipids you find in sausages/steak for breakfast? 82. Given these lipids are ionised and therefore an active ingredient what studies have been undertaken to ensure they were not harmful to the human body? 83. What studies were undertaken to ensure that the cationic lipids don’t create reactive oxygen species which can cause irreversible damage to DNA? 84. If the ionic lipids can enter any cells via electroporation or transfection then aren’t they more infectious than the virus which can only enter cells that contain ACE and TMPRRS enzymes that facilitate the virus entering the cell? 85. Can the lipids enter both white and red blood cells? I note that lipids entered both the spleen and bone marrow in the rat studies? 86. Given the lipids are taken up by the ovaries what guarantees can the TGA give that eggs are not being damaged. Obstetricians are reporting that they are seeing clusters of low Anti-Mullerian Hormone (AMH) levels in young women 95. The bone marrow, spleen, and lymph nodes are responsible for producing white blood cells and regulating the while blood cells in the blood and the lymphatic system. Given that lipids can enter these organs and induce an autoimmune response against the cells in these body organs isn’t there a serious risk that the vaccine can induce autoimmune diseases?

163. Hasn’t Pfizer and Co broken the Therapeutic Goods Act 1989 by failing to report all the adverse events from their trials and post marketing surveillance (refer to patient records)? Under paragraph 28(5)(ca) of the Act, you MUST retain records pertaining to the reporting requirements and safety for your medicine. (page 29 of 44) 164. What is the legislation that details the TGAs responsibilities in regard to post market safety surveillance data? Why hasn’t the TGA sought to allay the publics fear over data that shows an alarming number of adverse events and poor quality assurance practices? 202. Does the TGA do post marketing surveillance at all over and above that of the sponsor? If not, why not? What is the point of having an independent regulator if it doesn’t do independent safety testing?

166. The AusVax safety data showed over 5 million people reported side effects 3 days after taking the Covid-19 vaccine and around 1 in 100 had to see a doctor or go to emergency just 3 days after taking a vaccine. How can the TGA justify the rollout of the Covid-19 vaccine when the adverse event rate is so high? 167. The AusVax safety data says 8% reported missing work, study or routine duties after dose 1 of the Covid vaccine, 21% after dose 2 of the Covid vaccine and 15% after dose 3 of the Covid vaccine. How can the TGA justify the rollout of the Covid-19 vaccine when the adverse event rate is so high?

88. FOI 2565 requested “Histopathology/microscopic evaluation of gonads (ovaries/testes) of vaccinated animals in relation to Pfizer and AstraZeneca COVID-19 vaccines”. This application has been rejected three times, and was rejected finally by the internal reviewers on 27 Sep 2021. Why is the TGA withholding reports of ovarian and testicular effects of an investigational (provisionally registered) vaccine. Particularly in the context of vaccine mandates being imposed upon men and women of reproductive age in various occupational sectors, and now on children and teens with their reproductive years ahead of them?

43. In the post marketing report on page 6 it says “Pfizer has also taken multiple actions to help alleviate the large increase of adverse event reports. This includes significant technology enhancements, and process and workflow solutions, as well as increasing the number of data entry and case processing colleagues. To date, Pfizer has onboarded approximately 600 additional fulltime employees (FTEs). More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021.” Surely if the vaccine was safe and effective Pfizer wouldn’t need to employ an additional 1,800 staff to deal with adverse events? Isn’t this in itself a concerning safety signal?

45. As per the TGA non-clinical report, there are no data on the kinetics of BNT162b2 mRNA degradation (page 10). There are no distribution and degradation data on the S antigen-encoding mRNA. (Page 4) How can Health Authorities claim the vaccines are safe when no comprehensive testing was carried on the spike protein which has known toxic properties? 46. Studies are showing the long-term persistence of the spike protein in various body organs. Why is the TGA ignoring this and more importantly continuing to promote the vaccine as safe and effective when the side effects are not understood and there is ample evidence of adverse events? 47. Given studies are showing the long-term persistence of the spike protein in various body organs, how can the TGA prove long Covid isn’t a result of the vaccine and not the virus? Are long covid tests being carried out to determine if the cause of the injury is from the vaccine or the virus? Are medical biomarkers such as the N protein and Methylpseudouridine being tracked to determine cause of long Covid?

49. The use of pseudouridine in mRNA vaccines was developed as a very recent concept and its long-term effects are unknown. It has however been known for 10 years that the use of pseudo-U causes the stop codons (required to stop adding amino acids to a protein chain) to misfunction, thereby elongating the protein chain and risking translation of the next segment (the 3’UTR) (Karijolich 2011). The effects of this are unknown and cannot be known without specific experiments to address the issue. When did the TGA become aware that the synthetic nucleotide pseudouridine was being used rather than the natural uridine and what testing did it undertake to ensure that it was safe to use? 50. Studies have shown the psuedouridine has a higher translation error rate than uridine. Wasn’t it reckless to roll out the vaccine knowing that? Improving the fidelity of uridine analog incorporation during in vitro transcription | bioRxiv (available at: www.biorxiv.org/content/10.1101/2022.04.12.488100v1)

52. FOI 3471 shows contamination in the batches. Why didn’t the TGA undertake whole genome sequencing on the batches when it was an obvious way to look for contamination? 53. As per the TGA FOI disclosure log that some batches had up to 40% degraded mRNA – what are the potential risks of degraded mRNA in the body and what studies were carried to determine the safety of degraded mRNA? 54. How does the TGA know degraded mRNA isn’t going to produce toxic proteins? 55. How did the TGA undertake batch testing. Are all vials tested and what were the benchmarks especially in regards to tolerance levels? 56. Did the Covid-19 vaccine trail undertaken by Pfizer use batches made via the commercial process or the laboratory process? Are there trials undertaken by Pfizer using the commercial process and if so can they be provided? 57. Can the TGA report batch numbers by number of reported adverse events and reported deaths so people can see which batches had the highest rate of adverse events? 58. Could the TGA please provide evidence that the Covid vaccine batches had the same purity in Australia as what was stated in the manufacturing facility. Could documentation of the signatures and percentage of intact mRNA by both the manufacturer and the TGA please be provided? 59. Why did the TGA approve batches with as low as 60% integrity and how can it guarantee safety of those batches from degraded mRNA and further degradation after transport? 60. Why is the integrity level of batches commercial in confidence? This is a safety issue that Australians should be aware of it is it not? 61. If a batch is only 60% intact and each vial contains 5 doses how can the TGA be sure that every person is getting a consistent dose? 62. FOI 2389-3 page 110 Table 2 says concentration depends on batch size? How can the TGA be sure that every person is getting a consistent dose?

5. I note Professor Skerritt is currently Vice-Chair of the International Coalition of Medicines Regulatory Authorities and Chair of the Scientific Advisory Council of the Centre for Innovation in Regulatory Science – do these organisations receive money from pharmaceutical companies? If so, then isn’t there a conflict of interest in Professor Skerritt holding these positions? 6. I note that a number of members on the TGA’s Advisory Committee on Vaccines work for organisations that receive significant funding from big pharmaceutical companies. How is this not a conflict of interest?

8. Has any safety testing been carried out in either humans or animals to determine the side effects of receiving 5 mRNA vaccines? 9. How is it that any deaths with a positive covid test is classed as a Covid death regardless of cause while any death after a vaccine isn’t classed as a vaccine death? Given the vaccine is still only provisionally approved shouldn’t all deaths with 6-8 weeks of receiving a vaccine be treated as a vaccine death until proven otherwise? 10. What are the criteria for a death to be linked to a vaccine? 11. Health advice says the benefits outweigh the risks on having 3 jabs as a 16+ year old person who is otherwise healthy? Where are the trials/numbers that support this statement and how can the TGA/ATAGI say this when longitudinal, carcinogenic, genotoxicity and numerous other tests were not carried out? 12. Severe adverse injuries were only counted by Pfizer in their Covid-19 trial up to 1 month after 2nd jab leading to the number of vaccine injuries being understated. “Limitations of our study include that Pfizer’s SAE table did not include SAEs occurring past 1 month after dose 2. This reporting threshold may have led to an undercounting of serious AE’ in the Pfizer study” – Why does the TGA believe this is acceptable Quality Assurance when Professor Skerritt said on the Today show in early 2021 that serious injuries could occur up to 8 weeks after the vaccine? 13. What is the adverse injury run rate that the TGA considers acceptable for a safe vaccine/drug? What are the benchmarks for proving it was safe? 14. I note that the 6-month data from the Pfizer trials 20 people died in the inoculation group while 15 died in the placebo group. 5,241 had related adverse events in the vaccination group against 1,311 in the placebo group – 300% more, 262 had severe adverse events (interferes significantly with normal function) in the vaccination group v 150 in the placebo group – 75% more and 127 had a serious adverse event (hospitalisation or visit to ER) v 116 in the placebo group which is 10% more – so where exactly does the TGA and other health authorities come up with the statement that the vaccine was actually proven to be safe and effective?

159. Are all adverse reaction reports and reports of death included on the DAEN – Database of Adverse Event Notifications, the database that is accessible by the public or does the TGA vet adverse reactions before they appear on this database?160. Does the TGA maintain another database AEMS which is where all logged adverse claims entered by the public are stored?161. If so, what is the process and criteria for transferring reported adverse event claims from the AEMS database to the DAEN database?162. In regards to the Covid-19 vaccines, how many reports of adverse events or deaths were not uploaded onto the DAEN database?206. How many databases does the TGA and State Health departments keep in regards to adverse events?207. Are all reports of adverse events from State Health departments uploaded into the TGA DAEN database? If not why not?208. How many reports of adverse events have not been uploaded in the TGA DAEN database from either State Government records or the AEMs database?

105. What was the absolute efficacy (not relative efficacy) in reducing people catching Covid of the Pfizer vaccine in the initial trials conducted by Pfizer? 106. To what extent did the vaccine reduce transmission in the initial Pfizer trials? Please provide in terms of absolute numbers? 107. To what extent did the vaccine reduce hospitalisation admissions in the initial Pfizer trials? Please provide the data in terms of absolute numbers. 108. To what extent did the vaccine reduce deaths in the initial Pfizer trials? Please provide the data in terms of absolute numbers. 109. To what extent the vaccine cause inflammation in the initial Pfizer trials? Please provide the data backing up the result? 110. To what extent did the vaccine cause clotting in the initial Pfizer trials? Please provide the data backing up the result. 113. On the 4th of January 2021, the CEO of Pfizer said the Pfizer vaccine was 100% effective in stopping transmission. This claim was repeated by Health experts in Australia. Will the TGA and the Health Department provide an apology to the Australian people for misleading them?

98. In the initial Pfizer trials why no testing was done on the carcinogenic properties of the vaccine and why didn’t the TGA request it be performed?99. In the initial Pfizer trials why was no testing was done on pregnant women, breastfeeding women or immunocompromised people and why didn’t the TGA request it be performed?100. In the initial Pfizer trial why was the placebo group was unblinded after 2 months when best practice required the group to stay blinded until the end of the trial 2-3 years later?101. Given the lack of quality assurance and data derived from the Pfizer trials on what basis does John Skerrit say that the data was thoroughly assessed for safety?

29. If John Skerritt and the TGA doesn’t believe the medical experts who suspect the vaccines are the cause of death are wrong, then why won’t the TGA acknowledge the deaths as being from the vaccine? 30. Why does the TGA and its experts who never examined the patient think they have a better understanding of the cause of death than the experts who actually examined the body and/or dealt with the patient symptoms as they were dying? 31. How can a board of remote ”experts” making a subjective assessment without examining the body overrule the physician who did examine the body and ticked the box ”likely” to be an adverse effect or reported death?

151. Why were Early Treatments withheld from the Australian public from even being tried? 152. Why has the health department failed to actively pursue getting effective affordable Early Treatment protocols for Covid, especially given they could reduce viral loads and transmission unlike the Covid vaccines? 153. Was it a legal reason that did not allow the experimental vaccines to be used at all if there was already a treatment that works? 154. Were there any terms and conditions in the Pfizer contract with the Australian government for the Covid vaccines that prevented early treatments from being used? 255. Can the TGA guarantee there have been no lives lost by obstructing the use of early treatments as compared to allowing them?

THE ISSUES

Click on an interest area to read articles and learn more about the work I am doing in Parliament.

Taxation, Finance & Economy

READ MORE

Education & Family

READ MORE

Energy

READ MORE

Environment

READ MORE

Health, Aged Care & Seniors

READ MORE

Primary Industries

READ MORE

Immigration & Foreign Affairs

READ MORE

Infrastructure, Manufacturing, Transport & Tourism

READ MORE

Defence

READ MORE

Federation Reform

READ MORE

I may get kicked off social media soon for speaking too much truth so please join my mailing list so we can always stay in touch...

Thank you,

Gerard