Stay up to date...

QUESTION ON NOTICE

Question:

21 November 2022

19. I have previously asked why does the TGA override doctors who have lodged adverse event claims of death and the TGA replied – “The premise of the statement by the Senator is wrong. Reporting of an adverse event to the Therapeutic Goods Administration (TGA) does not mean that the reporting doctor considers that it was caused by a vaccine.” This reply is unsatisfactory. If they have ticked the box “suspected” it means they do consider the vaccine contributed to the death – SQ22-000105. To quote one doctor “Doctors and nurses only report suspected drug reactions to the DAEN. We do not have the time to waste reporting a broken leg as an adverse drug reaction. The DAEN report takes about 20-30 minutes and we are very aware, having to put our name to the reports, that the report could be used against us if we were to be found making vexatious, superficial or spurious reports. 20. All drug reactions reported by doctors and nurses are therefore suspected to be linked to the drug, by definition. That is what the DAEN is for. It says it on the front page of the reporting section (see screenshot).’ Why is the TGA downplaying reported deaths from vaccines and in doing so is acting negligently? 37. Studies are now showing negative efficacy with vaccination in regards to hospitalisation and death from 6-20 weeks after the vaccine. What does the TGA have to say about the long term safety and cost benefit analysis of the vaccine? 38. How long does it take to investigate an adverse event report? 39. I note the TGA have around 60 staff looking at adverse events – was this enough given the large number of reported injuries. This would have given staff approximately 30 minutes on average to investigate every injury – how was this enough time to investigate thoroughly?

Answer:

Question Number: 158
PDR Number: SQ22-000527
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 19 Response addressed in SQ22-000569 and previously in SQ22-000105. The Therapeutic Goods Administration (TGA) actively encourages health professionals (and others) to report suspected adverse event reports, even if they are unsure. For example, the TGA advises reporters that they ‘do not need to be certain, just suspicious.’ Reporting by a health professional indicates that they consider it is possible that there is a relationship between a vaccine and adverse events but does not always indicate they think it is likely. When the TGA receives an adverse event report with a fatal outcome following a COVID-19 vaccine, almost all are recorded as ‘causality possible’. This includes cases that do not have sufficient information to be eligible for further causality assessment or when a Coroner has determined that a death was not related to vaccination. The TGA uses adverse event reports to look for emerging safety issues with a vaccine. This may include using globally accepted methods to discuss groups of cases, for example, applying a causality assessment and/or case definitions. The purpose of this assessment is to consider whether any regulatory action is required for the vaccine product in question. It is wrong and frankly offensive to suggest that doctors who submit adverse event reports could “used against” them.

Question 20 Response addressed in SQ22-000569 and SQ22-000529. The TGA is not “downplaying reported deaths” and is not “acting negligently”.

Question 37 It is not clear what data the Senator is referring to. We do not believe the vaccines show “negative efficacy” against death and serious illness 6-20 weeks after vaccination and this finding is comprehensively refuted in the results of dozens of studies from public health authorities and in top-tier medical journals. The TGA’s position on the safety profile of each COVID-19 vaccine can be found in the relevant Product Information document on the TGA website. The TGA is not involved in cost-benefit analysis of vaccines or any other medical products. Recent data published by the US CDC also does not support this statement, with vaccinated individuals remaining at greatly reduced risk of hospitalisation and death due to COVID-19 over time: https://covid.cdc.gov/covid-data-tracker/#vaccine-effectiveness-breakthrough.

Question 38 The time required to process each adverse event report varies depending on the nature of the report. Information on what the TGA does with adverse event reports is publicly available at: www.tga.gov.au/resources/resource/guidance/adverse-event-reporting. The process been previously explained in SQ22-000116, SQ22-000109, SQ22-000099, SQ22-000104, SQ22-000152.

Question 39 As outlined in SQ22-000116, the TGA does not re-investigate individual person’s injury or clinical diagnosis for the majority of adverse event reports.