The TGA responds to claims that they hid child vaccine deaths

Despite plenty of smoke, they continue to insist there is no fire

The TGA has responded to my request for comment on causality assessment documents from FOI 3727 for ten reported deaths, of which five appear to have been causally linked to Covid vaccination by the TGA.

Background here:

BREAKING: Australia's drug regulator hid vaccine deaths from the public, concerned that 'disclosure could undermine public confidence'

On 14 February I emailed the TGA to clarify the contents of the ten causality assessments, to ask why they had not consistently followed the WHO’s standard for case causality assessment, and to ask why they had not published the causality assessments to the public FOI disclosure log.

I send media requests to the TGA frequently. Their standard response time is 48 hours, and on the handful of occasions that a response will take longer, they have emailed to give me a heads up. This time, seven days of silence.

Then, on 22 February, the TGA wrote,

“The TGA has not determined the mentioned cases to be causally linked to COVID-19 vaccination. This assessment has not changed and the TGA rejects interpretations otherwise in the strongest possible terms.

Information about these cases, released through Freedom of Information requests, has been sadly misrepresented to allege a false narrative.

The TGA released these documents to the applicant but did not publish them in the disclosure log given the sensitive nature of the documents. While personal information was redacted, it remains possible that a family member or of an individual may identify that the document relates to their loved one. As such, a conservative approach to publishing the information in the disclosure log was taken, given the potential for causing distress to the family of the deceased. This approach was consistent with the TGA’s obligations as there are exemptions from publishing documents released under the Freedom of Information (FOI) Act in appropriate circumstances.

The inclusion of variations of the word ‘causality’ in the documents represent template text, not a description of a decision. It is false and misleading to state that the TGA has determined these cases to be linked to vaccination.”

TGA correspondence 22 February 2023

A few things here:

1. The TGA claims that the following variations on the word ‘causal’ are just template headings, and that they are not a description of a decision. Following is a list of every variant within the ten FOI causality assessment documents, which are all attached in the linked Substack above.

   CAUSAL

   CAUSALITY ASSESSMENT OUTCOME

   CAUSALITY

   ? CAUSALITY

   UNLIKELY CAUSALITY

   UNLIKELY CAUSALITY - UPDATE SHOULD ANY FURTHER PATHOLOGY BECOME AVAILABLE

   The TGA says that all of the above variants are merely templates. Templates are uniform by definition. If these are indeed templates, this is highly irregular and needs to be explained. See the image at the end of this article for a visual on how these ‘templates’ appear in the various causality assessment documents.
   

2. The TGA claims compassion for grieving families is the only reason for hiding these documents from public view. Recall that on 24 August 2022, the TGA wrote to Dr Melissa McCann that the documents had been withheld from the public log because, “disclosure of the documents could undermine public confidence and reduce the willingness of the public to report adverse events to the TGA.” What are we to make of this omission in the TGA’s official response to me on this matter?

   

   Letter from the TGA to Dr Melissa McCann, 24 August 2022

   How has the TGA determined that public disclosure will cause distress to the families of the deceased? Did they ask? We don’t know. What we do know is that some family members, such as Natalie’s mother Deb, find it immensely cathartic to have their deceased loved ones publicly recognised. Deb told Jab Injuries Australia that the lack of contact from the TGA after her daughter’s death was reported (Case 729139, fatal AEFI after Moderna booster) was, “disgraceful treatment of a grieving mother who could have made a meaningful contribution to their investigations.”
   

3. “The TGA has not determined the mentioned cases to be causally linked to COVID-19 vaccination.” In my experience, the TGA’s communications are laden with obfuscation and omissions. Does this phrase mean that:
   
   a) A parallel body or committee (i.e.: not the TGA) has determined these deaths to be causally linked to vaccination; or,
   b) The causality assessment process is still in progress; or,

   c) The deaths have been determined as not at all causally linked vaccination?
   
   It would be very helpful to have someone with inside knowledge of the TGA’s processes to shed light on the various ways in which a death can be determined to be causally linked to vaccination.
   

4. Use of the term “false narrative” is evocative of the mainstream media’s latest meme du jour, ‘cooker reporting’.

I’m seeing strong claims, with no proof.

FOLLOW UP QUESTIONS TO THE TGA

• If, as you assert, "the inclusion of variations of the word ‘causality’ in the documents represent template text, not a description of a decision," why do the templates vary such that the word 'causality' is qualified by the word 'unlikely' in many cases?

• If, as you assert, the decisions are not determined but are rather template fields that remain undetermined, does this mean that the causality assessments in FOI 3727 are incomplete? If so, please advise the TGA's determination of the outcome of each of the 10 cases.

• In cases where the TGA requires more information to make a determination of causality, what efforts have been taken by the TGA to obtain this information?

• Is the TGA advising families of the deceased to have autopsies performed in order to assist in determination of causality?

• Please provide a template of a blank causality assessment document for review.

The second point will be revealing, as it poses a double bind for the TGA.

If some of the causality assessments remain incomplete, that would render meaningless this line from the TGA’s regularly safety reporting, which states that there are only, “14 reports where the cause of death was linked to vaccination from 976 reports received and reviewed.” If ‘reviewed’ does not equal ‘a completed assessment for causality such that the probability of causality is established’, then the obvious question is - how many reported deaths have been assessed in full, and how many reports are outstanding? I am aware of at least two people having asked this question via FOI, only to have the request denied.

COVID-19 vaccine safety report, TGA, 23 February 2023

On the other hand, if the TGA has closed out the assessments of those who died of cardiac arrests after Covid vaccination (including two children) without exhausting all avenues for investigation, they will have some serious explaining to do.

Prof John Skerritt says that cardiac arrest is not a safety signal for Covid vaccines. Here is the TGA’s own Proportional Reporting Ratio data on cardiac arrest, graphed (from FOI 4032). It shows a PRR of >2.

For context, at a meeting of the Advisory Committee for Vaccines (ACV) on 29 September 2021, it was agreed that the PRR threshold should be lowered to 1 (FOI 4029 Document 3). An excellent explainer on PRR in safety reporting is linked at the end of this article.

I have asked the TGA on three occasions to determine if any safety signals were detected from the PRR reports which contained the data graphed above. I have received wordy replies assuring me that safety monitoring is carried out regularly, and explanations that PRR is just one form of analysis and should not be taken to mean anything on its own. What I have not received is a straight answer. I have now taken to using yellow highlighter and asking for a YES or NO answer. The below is an email request from 11 days ago which remains unanswered.

There is so much more to say on this, and I will do so over the coming weeks. I spoke at length this week with the parent of a vaccine injured child and am now privvy to a whole new labyrinth of FOIs and TGA dodge-em behaviour that I’m wrapping my head around. I am also waiting on a reply from Prof Skerritt (taking bets on whether I will hear back at all) before I get any further into the details of his denials.

CALL FOR INSIDERS AND WHISTLEBLOWERS

If you have worked in or with the TGA and are willing to talk with me, please contact me by replying to this email, commenting below, or DM on instagram @dystopiandownunder(.) Strict confidence will be maintained. Having input from someone familiar with TGA processes will be most helpful, as will having an interpreter for the TGA’s particular dialect of bureaucratese.

For now I’ll finish on this.

Below is the report of a five year old boy who died due to myocarditis after Pfizer vaccination (DAEN, entry date 10 May 2022). Myocarditis is an ‘expected’ severe adverse event included in the product information. But there is no public comment from the TGA, and the safety report continues to state that no deaths in children are causally linked to Covid vaccination.

What are we to make of this?

What is the TGA doing about it?

Can we trust the TGA to perform its pharmacovigilance role?

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Josh Guetzkow on Proportional Ratio Reporting with data from VAERS, the US equivalent to DAEN

CDC Finally Released Its VAERS Safety Monitoring Analyses for COVID Vaccines via FOIA