83. In an interview with John Laws John Skerrit said about the Covid vaccines: “They have been thoroughly assessed for safety and effectiveness. As people know, there’s a very rare chance of side effects with both vaccines. But these are a few in a million. And so, for 99.99999 per cent of people, these are very safe vaccines.” Given there have been over 100,000 adverse events shouldn’t John Skerrit resign for misleading the public about the safety of the vaccines by implying they had been thoroughly assessed despite the fact Pfizer hasn’t even released all the data relating to the trails (sic)? 84. If there is a one in a million risk, then isn’t it fair to say that the Pfizer trial size of 44,000 (half of which were the placebo group) isn’t big enough to pick up 1 in a million – either it’s an x out of 22,000 figure or probability unknown. John Skerrit can’t say it’s one in a million if there was never a sample size of a million, can he? 85. Medical doctors have informed me they have lodged adverse event reports with the TGA saying that deaths were caused by the vaccines and the TGA have overruled the expertise of the medical doctors. On what basis does the TGA justify overruling the expertise of doctors who actually diagnosed the patient?
Question Number: 157 PDR Number: SQ22-000135 Date Submitted: 24/02/2022 Department or Body: Department of Health Question 83 Prior to provisionally approving the COVID-19 vaccines, the Therapeutic Goods Administration (TGA) conducted a thorough assessment of the data which includes clinical studies, non-clinical and toxicology studies, as well as chemistry and manufacturing information. The vaccines were provisionally […]
145. Did the TGA test or review data that showed that the lipid nanoparticles don’t congeal with red blood cells? If so, can the TGA state with 100% certainty that the lipid nanoparticles or the spike protein contained within doesn’t congeal with red blood cells? 148. Was the impact of spike protein tested on different blood types? If not, why not?
Question Number: 188 PDR Number: SQ22-000139 Date Submitted: 24/02/2022 Department or Body: Department of Health 145. No data has been reported to the Therapeutic Goods Administration (TGA) regarding lipid nanoparticles clotting red blood cells. The TGA is not aware of any data or published studies in referenced scientific journals that indicate that the lipid nanoparticles […]
95. How does the TGA audit manufacturing processes – did it fly to the US/Europe to inspect the manufacturing facilities of the Covid vaccines? 96. Does the TGA engage in spot audits of medical practices, pharmacists etc to ensure that the vaccines are being stored correctly at the appropriate very cold temperatures? 97. Could the TGA outline the KPI’s it uses to determine that Quality assurance processes around vaccine production and handling are of the highest quality?
Question Number: 111 PDR Number: SQ22-000143 Date Submitted: 24/02/2022 Department or Body: Department of Health 95. The Therapeutic Goods Administration (TGA) performs both desktop audits of submitted documentation and conducts onsite or remote inspections of manufacturers. The desktop assessments can include inspection evidence from comparable overseas regulators with whom Australia has Mutual Recognition Agreements. No […]
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?
Question Number: 144 PDR Number: SQ22-000144 Date Submitted: 24/02/2022 Department or Body: Department of Health Question 98 The potential for carcinogenicity was not studied which is consistent with the World Health Organization (WHO) guidelines for the nonclinical evaluation of vaccines Available at: www.who.int/biologicals/publications/trs/areas/vaccines/nonclinical_evaluation/ANNEX%201Nonclinical.P31-63.pdf. Similarly, overseas regulators have not required these studies. This is also because […]
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?
Question Number: 137 PDR Number: SQ22-000150 Date Submitted: 24/02/2022 Department or Body: Department of Health 105. The Therapeutic Goods Administration (TGA) uses the Relative Risk Reduction (RRR) to report vaccine efficacy. RRR and Absolute Risk Reduction (ARR) are two ways of looking at the same data. Vaccine efficacy, expressed as RRR, means the vaccine will […]
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?
Question Number: 120PDR Number: SQ22-000152Date Submitted: 24/02/2022Department or Body: Department of Health 159. Selected categories of adverse event report that do not contribute to our safetymonitoring of medicines and vaccines approved for use in Australia are excluded from the DAEN. Collectively, these make up a very small proportion of all adverse event reports to the […]
165. How much are doctors and pharmacists being paid to administer Covid-19 vaccines and booster shots? 166. How much has the Health Department paid doctors and pharmacists to date to administer Covid-19 vaccines and booster shots? 167. How much has the Health Department paid each pharmaceutical company to date for Covid-19 vaccines?
Question Number: 198 PDR Number: SQ22-000153 Date Submitted: 24/02/2022 Department or Body: Department of Health 165. Since March 2021, the former government has introduced 22 Medicare Benefits Schedule (MBS) COVID-19 items to support GPs in administering vaccines. These items must be bulk-billed, and no other items should be billed in relation to COVID vaccines. Medicare […]
169. Could the contents of the Pfizer and Astra Zeneca vaccine please be provided? 170. Does the TGA have an inhouse chemical/biological diagnostic capability to ensure the contents of the vaccine are what the manufacturer says they are?
Question Number: 164 PDR Number: SQ22-000155 Date Submitted: 24/02/2022 Department or Body: Department of Health Question 169 As part of the provisional approval process, the Therapeutic Goods Administration (TGA) requires that a comprehensive Product Information (PI) document and Consumer Medicine Information (CMI) leaflet be made publicly available for healthcare professionals and consumers. Both documents contain […]
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?
Question Number: 129 PDR Number: SQ22-000157 Date Submitted: 24/02/2022 Department or Body: Department of Health Question 163 Although some adverse events may go unreported, the extensive data received by the Therapeutic Goods Administration (TGA), together with our cooperative arrangements with international regulators, provides a high level of confidence in the TGA’s ability to rapidly identify […]
189. How much has the Federal government spent on advertising the vaccine? 190. Can a breakup of this spending be broken out by company who has received the advertising?
Question Number: 191 PDR Number: SQ22-000158 Date Submitted: 24/02/2022 Department or Body: Department of Health Since the COVID-19 vaccines campaign (under the former government) commenced on 27 January 2021, there have been a number of phases of activity, staged to complement the vaccination program rollout. Campaign advertising runs across a range of media channels including […]
