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Reviews the TGA has conducted of reports received of deaths in vaccinated people

Dan Q made this Freedom of Information request to Therapeutic Goods Administration

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Dear Therapeutic Goods Administration,

I am writing to request the reviews the TGA has conducted of reports received of deaths in people vaccinated with COVID-19 vaccines.

Please note that for the purposes of this request:

1. I am requesting the reviews the TGA has undertaken of reported deaths of individuals vaccinated with COVID-19 vaccines.

2. I wish to limit this request to reviews the TGA has conducted of all such deaths that were reported to the TGA between the 1st and 7th of August 2021 (inclusive) of individuals vaccinated with COVID-19 vaccines.

If no such deaths of this criteria were reported within that date range, then I revise the date range requested to the next earliest date where such death has been reported to and including such deaths reported in the six days from that date.

3. I am requesting for any personally identifiable information to be redacted, or removed where applicable, to enable the provision of the requested documents.

I look forward to your reply.

Yours faithfully,
Dan

TGA FOI, Therapeutic Goods Administration

6 Attachments

Dear Dan

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

As set out in the attached correspondence, we seek your response within 14
days, being 11 November 2021.

 

Pursuant to section 24AB(8) of the Freedom of Information Act 1982, the
statutory timeframe for processing your request is set aside during this
consultation process.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

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Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

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1. mailto:[email address]
2. http://www.tga.gov.au/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...

Dear TGA FOI,

Thank you for your email. I wish to make a revised request, given your response. I revise the scope of my request as follows.

I am requesting one (1) review the TGA has performed of a reported death of an individual vaccinated with a COVID-19 vaccine reported to the TGA on 1 August 2021. I request that any one (1) such review performed on such reports made on this date is provided.

As per my original request, I request for any personally identifiable information to be redacted, or
removed where applicable, to enable the provision of the requested documents.

I look forward to your reply.

Yours sincerely,

Dan Q

TGA FOI, Therapeutic Goods Administration

Good afternoon Dan,

Thank you for your correspondence of 11 November 2021 below, in which you responded to the TGA's request consultation letter dated 28 October by providing the following revised scope:

“I am requesting one (1) review the TGA has performed of a reported death of an individual vaccinated with a COVID-19 vaccine reported to the TGA on 1 August 2021. I request that any one (1) such review performed on such reports made on this date is provided” (revised request).

With respect to your revised request, we note that the information contained within any documents falling within the scope of this request would include sensitive health information relating to deceased persons. As a result, it is highly likely that the majority of the information contained in the documents may be considered exempt from release under the FOI Act, and any documents which are not exempt from release are likely to be heavily redacted. Overall, it is very likely that you may not be provided with much relevant information, and you would also be required to pay any applicable charges to process your request.

To elaborate further, even with personal information 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). Further, if a death has been reported in the media, a person may still be reasonably identifiable from the remaining information in the documents. On that basis, it is relevant that these documents are not in the public domain and that the TGA has otherwise made de-identified information regarding these deaths publicly available in the weekly safety reports and the DAEN.

Adverse event reports are voluntarily provided to the TGA by members of the public, health practitioners and/or state or territory health departments, advising of adverse events associated with the use of therapeutic goods (including medicines and medical devices). Companies supplying vaccines are legally required to report serious adverse events to the TGA. The investigation and monitoring of adverse event reports is critical to the TGA’s ability to regulate therapeutic goods, as it provides an early signal of possible issues with therapeutic goods used in the market by patients, health practitioners and consumers. This process allows the TGA to monitor and investigate emerging issues and, where appropriate, take regulatory action such as removing products from the market, imposing conditions on the inclusion of a product in the Australian Register of Therapeutic Goods (ARTG), or working with the sponsor of the product to address relevant issues by amending instructions for use or label information.

The reporting of adverse events by patients, health practitioners and/or hospitals is not mandated by law. Any reduction in the willingness of patients and medical practitioners to submit adverse event reports would substantially prejudice the proper functioning of the TGA, part of the Health Products Regulation Group within the Commonwealth Department of Health, in administering the Therapeutic Goods Act 1989 (Cth) (the TG Act) and protecting public health and safety.

To facilitate the provision of adverse event reports by patients and practitioners, the TGA receives those reports on a confidential basis. This is important to note, as adverse event reports contain highly sensitive personal information about patients. If the TGA is unable to guarantee the confidentiality of those reports 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 by the TGA.

Disclosing this information would entirely undermine the expectation of confidence surrounding the provision of adverse event reports to the TGA. We expect that this would result in a substantial reduction in the willingness of patients 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 TG Act.

The FOI Act also specifically recognises the right of third parties to be consulted about release of documents that affect their interests. In order to process your request, the TGA would be required to consult third parties in relation to any deaths, including coroners, health professionals and family members of the deceased. This process would be extremely distressing for bereaved families. The TGA would, if possible, prefer to avoid placing bereaved families under further distress by asking them to comment on the potential release of documents containing sensitive health information about recently deceased family members.

Nevertheless, whilst summary information regarding each adverse event following immunisation (AEFI) reported to the TGA is publicly available, we understand that identifying this information using the DAEN can be challenging.

Therefore, in order to assist you in relation to your request, whilst the TGA does not ordinarily comment on individual cases of any adverse events reported, we wish to confirm that of the fatal cases with a report date of 1 August 2021, there was one (1) death assessed as likely to be linked to immunisation with a COVID-19 vaccine. This death was reported as an outcome in the DAEN (case # 595824). You may wish to search for information about this case on the DAEN using the case number. The death was also reported in the TGA’s weekly safety report dated 5 August 2021. On that date, the TGA stated that:

“Three additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia syndrome (TTS) likely to be linked to the AstraZeneca vaccine. When assessed using the United Kingdom (UK) case definition, 2 were confirmed and one was deemed probable TTS. Sadly, a 34-year-old woman from NSW died yesterday from confirmed TTS following a first dose of the AstraZeneca vaccine. The TGA extends its sincerest condolences to her family and loved ones. We are in close communication with NSW health who are undertaking further investigation of this case.”

For the full safety report, we refer you to: https://www.tga.gov.au/periodic/covid-19...

As at 5 August 2021, this death was one of seven (7) deaths which were likely to be linked to immunisation. Six (6) were thrombosis with thrombocytopenia syndrome (TTS) cases and one was a case of immune thrombocytopenia (ITP). The TGA reviews all death reported in people who have recently been vaccination. As the number of people being vaccinated has increased, so has reporting of fatal events with a coincidental association with vaccination. Our review of individual reports and patterns of reporting does not suggest that the vaccines played a role in the vast majority of these deaths.

Taking the above explanation into account, we would be grateful if you could confirm, by return email by COB Monday 29 November, that this information satisfies your request.

We are committed to transparency under the FOI Act and want to assist you but we are of the view that this must be balanced against causing unnecessary distress to grieving family members, where possible.

Thank you for your understanding, and we trust that by providing this information to you, in light of the circumstances outlined above, provides you with the information you require.

Kind regards

Freedom of Information

Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [email address]
PO Box 100, Woden ACT 2606, Australia
Web: www.tga.gov.au

Important: This transmission is intended only for the use of the addressee and may contain confidential or legally privileged information. If you are not the intended recipient, you are notified that any use or dissemination of this communication is strictly prohibited. If you receive this transmission in error please notify the author immediately and delete all copies of this transmission.

The Department of Health acknowledges the Traditional Custodians of Australia and their continued connection to land, sea and community. We pay our respects to all Elders past and present.

show quoted sections

Dear TGA FOI,

I appreciate your response and write in reply to your email of 26 November 2021, in which you supply no documents in response to my request on the basis that documents would include sensitive health information. Previously, your reason for not supplying any documents was on the basis of volume of information.

The response not to provide any documentation is despite the very revised down scope which limits the request to a total of one (1) review the TGA has performed; that I have asked that personally identifiable information be redacted as necessary to enable provision of documents; and that moreover that the request is specifically for documentation of the review performed by the TGA, not other documents that the TGA may have looked at in doing its review.

I am specifically requesting documentation showing the review that TGA has performed, scope limited as requested. That is, documentation demonstrating the TGA's review of the adverse event; confirming that relevant documents submitted were reviewed; which document the conclusion TGA reached and which confirms the nature and level of review of the received report as completed by the TGA.

I note that the types of documentation that you refer to, for the purpose of maintaining your point that the documents requested contain sensitive information which you suggest may not be released without reasonable difficulty, are documents which would not be authored or prepared by TGA.

I would anticipate however that the review performed by the TGA would include documents prepared by TGA which show what exactly was examined, which document the process of review, and which confirm how the TGA reached its conclusion on whether the adverse event with death as an outcome likely resulted from the vaccine or else why it likely did not. These are documents within scope of my request.

In respect of my revised request as outlined in my previous email, can the TGA provide documents evidencing and confirming the review that the TGA performed; and which confirm the documents TGA reviewed in that process?

Documents not authored by TGA which contain sensitive information may be excluded from this request as it is the TGA's own review of information, the documents which show what the TGA has done in order to conduct its review of the report received, that is the subject of this request.

I would appreciate if you could provide the information as requested.

Yours sincerely,

Dan Q

TGA FOI, Therapeutic Goods Administration

6 Attachments

Dear Dan

 

Please find attached correspondence in relation to your Freedom of
Information request.

As noted in our previous email to you, any documents considered not exempt
from release are highly likely to be heavily redacted to remove sensitive
personal information and information that may identify individuals.

Should you wish to proceed with your request, you will note from the
attached letter that you are required to pay a deposit before the request
can be processed. If you do not pay the deposit within 30 days, your
request will be treated as withdrawn.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

[3][IMG][4][IMG][5][IMG]

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...

TGA FOI, Therapeutic Goods Administration

5 Attachments

Dear Dan

 

I refer to the Estimate of Charges letter dated 30 November 2021
(attached) relating to your request FOI 3232.

 

I write to advise you that your request was deemed withdrawn, as no
response or payment was received within the legislated timeframe notified
in the Estimate of Charges letter.

 

Should you have any questions regarding this matter, please do not
hesitate to contact the TGA FOI team.

 

Kind regards

Emily

 

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

[3][IMG][4][IMG][5][IMG]

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

 

 

 

From: TGA FOI <[email address]>
Sent: Tuesday, 30 November 2021 10:12 PM
To: Dan Q <[FOI #7970 email]>
Cc: TGA FOI <[email address]>
Subject: FOI 3232 - Notice of Estimate of Charges

 

Dear Dan

 

Please find attached correspondence in relation to your Freedom of
Information request.

As noted in our previous email to you, any documents considered not exempt
from release are highly likely to be heavily redacted to remove sensitive
personal information and information that may identify individuals.

Should you wish to proceed with your request, you will note from the
attached letter that you are required to pay a deposit before the request
can be processed. If you do not pay the deposit within 30 days, your
request will be treated as withdrawn.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [6][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [7]www.tga.gov.au

 

[8][IMG][9][IMG][10][IMG]

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information. 
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited.  If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."

References

Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...
6. mailto:[email address]
7. http://www.tga.gov.au/
8. https://www.facebook.com/TGAgovau/
9. https://twitter.com/TGAgovau
10. https://www.youtube.com/channel/UCem9INJ...

We don't know whether the most recent response to this request contains information or not – if you are Dan Q please sign in and let everyone know.