Signal Evaluation and Causality

How robust is this process?

When someone experiences an adverse event (unwanted/ unexpected/ side effect) reports are made by the doctor, state health departments, the drug companies or patients and these events are collated by the TGA.

I have made a video to help explain this process here-

You can also review the filed documents for the Covid Vaccine Class Action, filed in March 2023 which details the processes further and makes a number of allegations regarding alleged failures of the TGA in undertaking these processes.

So the process-

There is an AEMS- Adverse Event Monitoring System which is the internal system collecting all reported events and then after 2 weeks- and once the event is confirmed to be not a duplicate report and is suspected to be a possible adverse event- then those are published to the publicly available DAEN- Database of Adverse Event Notifications.

For the covid vaccines there are currently over 139 000 adverse events reported (which is more than all other vaccines combined for the past more than 50 years) and 1010 deaths. Shout out to the OpenDAEN team of volunteers who have created a user friendly interface for this publicly available database of events.

So from this rather extraordinary number of events, what is the process the TGA utilises to assess and characterise these events in order to determine if there are any ‘safety signals’?

Firstly, a safety signal is a adverse event or side effect that various statistical and other methods of reviewing the reports have identified as a potential new side effect. Ordinarily doctors would be advised of any potential safety signals so that for example if a patient has a stroke, and then happens to mention they had a covid vaccine two days before the stroke, if doctors are aware stroke is a potential safety signal then they are more likely to realise that patient could have had an adverse event and to ensure the stroke is reported to the TGA. If doctors have no idea that signal event is even being considered a possible side effect they may automatically presume the stroke is coincidental and not even report the event to the TGA.

From some recent questions on notice from Senator Babet the TGA has disclosed the following safety signals have been assessed-

Unfortunately, almost none of these potential signals were advised to doctors in either the product information or through the TGA product alerts.

The TGA does not only have the spontaneous adverse events to help them identify safety concerns, but also reports from the drug companies, who are obliged to provide regular reports of side effects reported to them as part of the clinical trials and the post marketing observation.

The TGA confirmed in further question on notice from Senator Babet that they had for example received those drug company reports called PSUR Periodic Safety Update Reports from Pfizer.

And for example the PSUR #3 received on 25th August 2022 contains a large list of safety signals that were being evaluated, for example-

What is difficult to determine is not only how carefully the TGA scruitinised these reports, and perhaps if they read them at all.

For example, from page 142 we read of several children who were confirmed by Pfizer as dying from the vaccine and cardiac arrest one of the causes of death-

And yet in February of 2023, 6 months after the TGA had received this PSUR from Pfizer, (when confronted about several deaths due to cardiac arrest after vaccination that had been reported in Australian children) -

We had this exchange; evidence given by John Skerritt under the oath of Senate on 16th February 2023-

“Nowhere in the world out of almost 10 billion messenger RNA vaccination does have we seen cardiac arrest as a result of vaccination”. And yet for at least 6 months, the TGA had the PSUR evidence from Pfizer themselves of multiple children (and many other teenagers and young adults) of cardiac arrest confirmed as a fatal outcome following vaccination.

I think it will take the legal process of discovery and expert evidence and judgment in a court of law to determine precisely what went wrong with the safety monitoring and the statements reassuring the public.

In the meantime, please share the Covid Vaccine Class Action which is being led by three courageous lead applicants- Tony, Gareth and Antonio- who are representing hundreds and likely thousands of vaccine injured Australians.

Please share our crowdfunding and support this class action if you can www.nomoresilenceau.com

This action is being funded by myself with the support of generous public donations. Neither myself nor the legal team will receive any cut/% or financial benefit if the action succeeds and it is being run in this way so that-

• Injured and bereaved can join without cost

• The maximum possible compensation will go to the injured and bereaved if the actions succeeds

• I have signed an agreement accepting adverse costs if the action does not succeed so the applicants do not have to take the risk of brining the action.

The dedicated legal team are doing a phenomenal job and have been moved to tears by many of the stories of injured and bereaved who have joined the action. Please support this important work to attempt justice for what has happened to so many