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QUESTIONS ON NOTICE

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

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?

24/02/2022

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?

24/02/2022

62. Why is Ivermectin banned as a Covid treatment when in the last year it has had a fraction (5) adverse event reports v over 100 adverse event reports from other early treatments such as remdesivir and dexamethasone for example? 63. Why was Remdesivir approved on the basis on a small number of trials with a small sample size? 64. Given the large number of people who have taken Ivermectin in the last six months in treating Covid and the low rate of adverse events in comparison with the Vaccines how can the TGA justify their decision to ban doctors prescribing Ivermectin? 65. Are doctors using Ivermectin in Australian hospitals to treat patients with late stage Covid? 66. If so why can’t Ivermectin be used as an early treatment? 116. Why is the TGA relying on real world data for children, spanning a few months but ignoring real world data on ivermectin that spans over 30 years. 117. According to the TGA search facility there has only been 5 reports of Adverse events against Ivermectin in the last 13 months. Given there has been over 108,000 adverse events against the Covid vaccines why is the TGA claiming that Ivermectin is not safe, when there has been so many more reported events from the Covid vaccines?

24/02/2022

163. Given the Covid-19 vaccines are still provisional and the reporting rate is only 2.2 out of 1000 inoculations why isn’t the TGA following up every person to ensure there are no adverse events that are not being reported? 164. Can the TGA define rare in drug development terms? i.e. is a vaccine considered safe if there is one adverse event for every million doses – what are the benchmark rates? 187. Where the TGA declines to acknowledge an adverse event, does the TGA follow up with those people to say why it isn’t an adverse event? 188. A cardiologist has been told by Queensland Health he is unable to lodge adverse events relating to myocarditis- why is that – if a cardiologist can’t lodge myocarditis adverse events who can? 224. In terms of giving the provider number when completing an adverse event notification to the TGA, how does an individual get this if they got it at bunnings or the provider doesn’t want to give it or is longer contactable? 225. Why does the TGA only make adverse event reports available via PDF rather than a csv file? 226. Is the TGA going to provide more reporting optionality with its adverse event data? 227. Can the TGA provide me with read only access to the adverse event database? 228. Does the TGA have its database and database management processes audited by an independent third party? If not why not?

24/02/2022

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?

24/02/2022

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?

24/02/2022

62. Why is Ivermectin banned as a Covid treatment when in the last year it has had a fraction (5) adverse event reports v over 100 adverse event reports from other early treatments such as remdesivir and dexamethasone for example? 63. Why was Remdesivir approved on the basis on a small number of trials with a small sample size? 64. Given the large number of people who have taken Ivermectin in the last six months in treating Covid and the low rate of adverse events in comparison with the Vaccines how can the TGA justify their decision to ban doctors prescribing Ivermectin? 65. Are doctors using Ivermectin in Australian hospitals to treat patients with late stage Covid? 66. If so why can’t Ivermectin be used as an early treatment? 116. Why is the TGA relying on real world data for children, spanning a few months but ignoring real world data on ivermectin that spans over 30 years. 117. According to the TGA search facility there has only been 5 reports of Adverse events against Ivermectin in the last 13 months. Given there has been over 108,000 adverse events against the Covid vaccines why is the TGA claiming that Ivermectin is not safe, when there has been so many more reported events from the Covid vaccines?

24/02/2022

163. Given the Covid-19 vaccines are still provisional and the reporting rate is only 2.2 out of 1000 inoculations why isn’t the TGA following up every person to ensure there are no adverse events that are not being reported? 164. Can the TGA define rare in drug development terms? i.e. is a vaccine considered safe if there is one adverse event for every million doses – what are the benchmark rates? 187. Where the TGA declines to acknowledge an adverse event, does the TGA follow up with those people to say why it isn’t an adverse event? 188. A cardiologist has been told by Queensland Health he is unable to lodge adverse events relating to myocarditis- why is that – if a cardiologist can’t lodge myocarditis adverse events who can? 224. In terms of giving the provider number when completing an adverse event notification to the TGA, how does an individual get this if they got it at bunnings or the provider doesn’t want to give it or is longer contactable? 225. Why does the TGA only make adverse event reports available via PDF rather than a csv file? 226. Is the TGA going to provide more reporting optionality with its adverse event data? 227. Can the TGA provide me with read only access to the adverse event database? 228. Does the TGA have its database and database management processes audited by an independent third party? If not why not?

24/02/2022

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