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QUESTION ON NOTICE

Question:

21 November 2022

22. Of the more than 900 reported Covid vaccine deaths, how many have been subject to causality assessments or autopsies to determine if they were caused by the vaccine? 23. Shouldn’t every suspected death be reported to the coroner for greater analysis rather than rely on a hands-off TGA report for relevance to the vaccine? 24. Can the TGA please provide all paperwork relating to reported deaths from the vaccine. Name can be redacted. Data can be provided via a softcopy. 25. Is the TGA willing to have an audit conducted on the review of deaths by the vaccine – if not, why not? 26. If a reported death occurs within 14 days after receiving a vaccine was this considered a vaccinated or unvaccinated case by the TGA? i.e. are all suspected deaths reported to the TGA regarded as vaccine death regardless of the time between the date of death and date of vaccine? 27. Actual deaths per month jumped dramatically after the rollout of the Covid vaccine in May 2021, yet before Covid was even in the community. This is an extremely strong temporal signal that the vaccine is causing an increase in deaths. Why is the Health Department/TGA discounting the fact that the increase in actual deaths throughout 2021 are not related to the vaccine? 28. When the death rate is broken out by age the increase in deaths is actually over 10% from May 2021 for 75 and older cohorts. -Given the Pfizer vaccine wasn’t tested on people older the 75 (in any significant numbers – See Table 1 2389-1) why is the TGA continuing to roll out the jab given real world evidence is suggesting an extremely strong correlation/causation with deaths in older people? 29. Are deaths being tracked by vaccination status? This would indicate whether or not excess deaths are being driven by the vaccinated or unvaccinated, wouldn’t it 30. Is the time between death and time from vaccination status being recorded – if not why not – this is still a provisional vaccine? If so, can the TGA please provide an excel spreadsheet of deidentified data showing date of vaccination and date of death for deaths in Australia since the rollout of the vaccine began? 31. How many reported deaths died within 2, days, 14 days, 30 days and 60 days of taking the vaccine? 32. Are only fully paid TGA staff assessing vaccine deaths or has this been outsourced to other agencies? If so, do these agencies have conflicts of interest? 33. Please provide the methodology used by the TGA that justifies discrediting (99%) of the reports made by health professionals on behalf of their dead patients that the cause of death resulted from the vaccines? 36. Does the TGA or State or Territory health departments require autopsies to be performed on persons dying at any time post COVID-19 vaccination? If not, why not? 40. Why does the TGA believe that the deaths reported to the DEAN are false and misleading (AFN factcheck 03/09/2022) – these reports are ticked as suspected and over 70% come from health professionals – what right does the TGA have to dismiss them?

Answer:

Question Number: 160
PDR Number: SQ22-000529
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 22 Response previously provided in SQ21-001136, SQ21-0001218 and SQ22-000181.

Question 23 and 36 Response previously provided in SQ21-001218.

Question 24 The majority of the information contained within the documents related to adverse event reports with a fatal outcome is highly sensitive health information relating to deceased persons. Even with any names redacted, an individual may still be reasonably identifiable to their family members, or members of the public, due to the sensitive health information contained in the documents (including in relation to any pre-existing medical conditions). To facilitate the provision of adverse event reports by patients and practitioners, the Therapeutic Goods Administration (TGA) receives those reports on the basis that an individual’s personal information will be appropriately protected, including those reporting an adverse event. If the TGA is unable to guarantee the privacy of patients and the sensitive health information contained in those reports, this is likely to significantly reduce the willingness of patients and practitioners to submit adverse event reports. We expect that this would result in a substantial reduction in the willingness of reporters to provide sensitive information, and contact information, to the TGA through adverse event reports, and would therefore substantially prejudice the TGA’s ability to regulate therapeutic goods pursuant to the Therapeutic Goods Act 1989.

Question 25 Decisions on audits of Departmental (including TGA) processes and programs are made by the Australian Government Auditor-General.

Question 26 Response previously provided in SQ22-00108

Question 27 There is no credible evidence to suggest that COVID-19 vaccines have contributed to excess deaths in Australia or overseas. It is not clear from question which dataset the Senator is relying upon. The Australian Bureau of Statistics (ABS) specifically state on their website that their Provisional Mortality Data (last updated on 30 September 2022), cannot be used as official estimates of excess mortality. Using the number of deaths from the previous five years as the predictor for the expected number of deaths does not take into account changes in population size and age-structures of that population.

Question 28 Response provided in SQ22-000621

Question 29, 30 and 31 These questions appear directed at data on all deaths in Australia, rather than adverse event reports with a fatal outcome. The TGA does not hold Australia’s data on deaths, nor does the TGA have oversight of the data collected by death registries.

Question 32 The TGA does not outsource review of individual adverse event reports, including reports with a fatal outcome. Advice is sought as required from an external Vaccine Safety Investigation Group comprising medical specialists and consumer representatives, but the review of the reviews as received is conducted by specialist TGA staff.

Question 33 and 40 The premise of these questions is wrong. Response provided in SQ22-000105.