TRIM Ref: D21-3244595
Mr Dan Q
By Email: xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx
Dear Dan,
FREEDOM OF INFORMATION REQUEST FOI 3232
Notice of Decision
1. I refer to your request dated 17 October 2021 under the
Freedom of Information Act
1982 (
the FOI Act) for access to the following documents:
“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 al 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.”
Decision maker
2. I am the TGA officer authorised to make a decision on your request under the FOI
Act.
Request too voluminous to process
3. The TGA has now undertaken a preliminary search and retrieval for documents
falling within the scope of your request. As a result, I can confirm that the scope of
your request is too voluminous to process.
4. By way of background, the TGA is committed to the transparent and accurate
reporting of adverse events. All reports submitted to the TGA are evaluated,
duplicate reports are rejected, and the information contained therein is uploaded to
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 or 02 6232 8644 Fax: 02 6232 8112
Emai
l: xxxx@xxx.xxx.xx
https://www.tga.gov.au
the Database of Adverse Event Notifications – medicines (
DAEN) 14 days after being
received. The DAEN contains information on all adverse events reported following
administration of a medicine, including the COVID-19 vaccines.
5. Reporting of an adverse event and publication of an adverse event in the DAEN
does not mean the event was related to the vaccine. Large scale vaccination means
that coincidentally some people will experience a new illness or die within a few
days or weeks of vaccination. If a person dies within the days to weeks after
vaccination, the TGA reviews the case to assess the likelihood that the vaccine
contributed to the death. Further information on this process in provided below.
6. Between 1 August 2021 and 7 August 2021, there were 24 adverse event reports for
COVID-19 vaccines included on the DAEN where death was a reported outcome.
Therefore, in order to process your request for “
the reviews the TGA has undertaken
of reported deaths of individuals vaccinated with COVID-19 vaccines,” the TGA would
need to process at least 24 documents, each containing a significant number of
pages. This figure only includes the adverse event reports and does not include
other relevant documents which may be related to “
the reviews the TGA has
undertaken”.
7. Given the volume of documents falling under your request, I am of the view that
your request is currently too voluminous to process.
Requirement to undertake a request consultation process
8. Under paragraph 24(1)(a) of the FOI Act, I, as a decision maker must consult you if
I am satisfied that a “practical refusal reason” exists in relation to your request. A
practical refusal reason exists if the work involved in processing the request would
substantially and unreasonably divert the resources of the TGA from its other
operations. A copy of the sections of the FOI Act that set out the consultation process
(sections 24, 24AA and 24AB) is at
Attachment A.
9. In deciding whether the processing of your request would involve a substantial and
unreasonable diversion of resources such that a practical refusal reason exists, I am
required under section 24AA(2) of the FOI Act to consider the resources that would
have to be used in the following activities:
• identifying, locating and collating the documents;
• deciding whether to grant or refuse access to each document and/or to provide
an edited copy which would include examining each document and consulting
with any person (including those that I would be required to consult under the
FOI Act);
• making a copy or edited copy of each document; and
• notifying any interim or final decision on the request (including to any third
party consulted in the event that a decision is made to give access to the
documents despite the objections of the relevant third party).
10. In coming to a view that a practical refusal reason exists in relation to your request,
I have had regard to the following:
• the correspondence between you and the FOI team, including the terms of your
request and subsequent correspondence with you, set out in further detail the
background below.
• the estimated volume of documents involved, and the work involved in
processing them, namely, the 24 reports in relation to deaths investigated to
determine any causal links to the COVID-19 vaccine. The total number of pages
is estimated at 480 pages (at a conservative estimate of approximately 20 pages
for each report). This is a particularly conservative estimate noting that some
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reports may have more than 50 pages, where they include coroner’s reports and
correspondence with reporters.
• the fact that each report is likely to contain personal information, in relation to
which consideration would need to be given to whether an exemption should be
claimed and whether consultation with the relevant third party is required and,
if so, preparation of schedules for the third party detailing all relevant
documents.
• this is particularly relevant as the data includes sensitive health information,
which may also include coroner’s reports, that are likely to require consultation
with the third parties or the representatives of deceased persons.
• even if personal information were redacted, the individuals concerned may still
be reasonably identifiable to their family members, or members of the public,
due to the sensitive health information contained in the reports.
• further, as these deaths have been reported in the media and on the TGA’s
website, even with personal information redacted, these persons may still be
reasonably identifiable from the remaining information in the reports. Due to
my concern that these individuals may still be reasonably identifiable in the
documents, even with personal information redacted, the TGA would need to
consult with a number of third parties.
• the number of affected third parties. The FOI Guidelines provides that there is a
requirement to consult with an individual or legal personal representative of a
deceased person under section 27 of the FOI Act (see paragraphs 1.27 and
6.161).
• to release this information would likely require the TGA to consult with at least
1-2 third parties per report, i.e. there is likely to be in excess of 24 third parties.
In these circumstances, affected third parties may also include the reporters,
family members of deceased persons and the relevant health professional,
which may include coroners, who were involved in considering any causal link
between the COVID-19 vaccine and the death. The number of third parties
required to be consulted would make this request too onerous to process.
• as you would appreciate, the TGA would need to write to each third party
individually, attach copies of their documents, and consider the responses
provided and any requested redactions. I would then need to make a decision
on these documents, considering these submissions. In addition, if any of the
third parties objected to release of documents and I disagreed with them, then I
would need to provide them with a decision.
• that advice on the data and sensitivity of the information in these documents
would need to be provided by specialised technical staff at the TGA (i.e., senior
medical officers, nurses, pharmacists and scientists) a majority of whom are
presently engaged in analysis of adverse event data and investigation of safety
issues relating to COVID-19 vaccines.
• the assumption that a substantial number of those documents may be capable
of being made available (even if in edited form with exempt material redacted),
the time taken to appropriately edit each document and to make copies.
• the fact that any decision letter would need to list each document in an
attachment setting out the outcome of the consideration of whether exemptions
apply.
11. I consider that the number of pages estimated to fall within the scope of your
request, the fact that much of the information is sensitive health information,
combined with the number of third parties, and the necessary consequential work
associated with considering whether the documents may be lawfully disclosed,
would have a substantial effect on the operations of the TGA.
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12. I find that the work involved in processing this request would be an unreasonable
diversion of the TGA’s resources, including TGA’s officers engaged in safety
monitoring of medicines and vaccines. As to the critical work that these officers
perform, I note that analysis and investigation of medicine and vaccine safety issues,
and associated regulatory actions, are of significant public health impact. As you
would appreciate, if these officers are required to consider large FOI requests, this
diverts their time and attention from undertaking their primary role as evaluators.
13. In addition, the administrative team providing critical support to the TGA’s
evaluators and the other safety monitoring business of the TGA and the FOI team
are also currently dealing with a high volume of COVID-19 related FOI requests.
Processing your request would tie up resources of those teams that would
otherwise be involved in supporting evaluators, the broader operations of the TGA’s
medicines safety monitoring business and processing other FOI requests. In this
regard, the FOI Guidelines state that a relevant matter in deciding whether a
practical refusal reason exists is “the impact that processing a request may have on
other work in the agency or minister’s office,
including FOI processing (my
emphasis) (see paragraph 3.117 of the FOI Guidelines).
14. I also note that there are likely to be significant charges imposed on you for
processing your request (as calculated in accordance with the
Schedule to the
Freedom of Information (Charges) Regulations 2019) based on the number of third
parties.
Guidance on accessing the TGA’s publicly available information
15. I note that paragraph 3.117 of the FOI Guidelines indicates another matter I may
take into account in deciding whether a practical refusal reason exists is whether
there is a significant public interest in the documents requested and what
information is published. I consider that there is a public interest in evidence
supporting the safety and efficacy of COVID-19 vaccines that will be used in
Australia.
16. To a very large degree, the public interest is met through the publication of
information on adverse event reports that is publicly available in the DAEN and the
TGA’s weekly safety reports.
17. By way of background, you can access information about all adverse events reported
following vaccination with the COVID-19 vaccines in Australia via the DAEN,
available on the TGA website. The DAEN contains information from reports of
adverse events that the TGA has received in relation to medicines, including
vaccines, used in Australia. If you are interested in this information, we refer you to:
https://apps.tga.gov.au/PROD/DAEN/daen-entry.aspx.
18. Reporting of an adverse event and publication of an adverse event in the DAEN does
not mean the event was related to the vaccine. There might be no relationship
between the adverse event and the medicine or vaccine - it may be a coincidence
that the adverse event occurred when the medicine or vaccine was taken, and the
symptom may be related to the underlying illness or to other factors. Expert analysis
and review of adverse event reports is needed to determine whether there may be
a link between reported events and vaccination.
19. The TGA analyses adverse event report data and reviews individual reports to
identify possible safety issues for investigation. If these investigations confirm a
safety signal, the TGA takes appropriate action. Large scale vaccination means that
coincidentally some people will experience a new illness or die within a few days or
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weeks of vaccination. The TGA reviews all deaths reported in people who have been
vaccinated. As the number of vaccinated people has increased, so has reporting of
fatal events with a coincidental association with vaccination. This does not indicate
a link between vaccination and the fatalities reported.
20. If a person dies within the days to weeks after vaccination, the TGA reviews the case
to assess the likelihood that the vaccine contributed to the death. This may involve
collecting further information about the person, including their medical history, risk
factors, any medications they are prescribed, details and timing of the vaccine,
hospitalisation records, and any laboratory test results.
21. This will usually involve liaising with the person’s GP, specialists and the hospital.
In some instances, states and territories convene an expert panel of doctors. These
panels often include the treating doctor, discuss the case in detail, and may advise
extra tests that may help them understand the event. Outcomes are then provided
to the TGA. In such cases, the TGA further reviews the case and decides whether the
further independent review is needed.
22. This information is included in a weekly safety report for COVID-19 vaccines
published on the TGA website. Any deaths causally linked to any of the COVID-19
vaccines in Australia will be reported on in these updates. All weekly safety reports
remain available on the TGA website at this address:
https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report.
23. This information is also reviewed by other key advisory groups, including the
Australian Technical Advisory Group on Immunisation (
ATAGI) and the
government, who monitor the progress of immunisation programs, including for
COVID-19. Further information on the ATAGI is available here:
https://www.health.gov.au/committees-and-groups/australian-technical-
advisory-group-on-immunisation-atagi.
24. The TGA also makes adverse event information available to the public through the
DAEN. The DAEN contains information on all adverse events reported following
administration of a medicine, including the COVID-19 vaccines. As of 19 August
2021, the TGA has reduced the time between adverse event reports being accepted
into our database and published on the DAEN from 90 days to 14 days. This decision
was made in response to the strong public interest in adverse event reports relating
to COVID-19 vaccinations and allows reports for vaccines publicly available more
quickly.
25. You can search the DAEN for “COVID” in the medicines report section, available
her
e: https://apps.tga.gov.au/PROD/DAEN/daen-report.aspx. Once you have typed
the first three letters of a medicine name, a list of trade names will appear with the
active ingredients shown in brackets. Where the reporter has only provided the TGA
with the active ingredient name, the database will display 'Tradename not
specified'. Select the medicines you want to search for by ticking or unticking the
boxes. For example, to conduct a search by active ingredient, tick the box for each
trade name containing the active ingredient.
26. There are two types of results shown in two tabs: medicine summary (this summary
groups reported adverse events together) and list of reports (this lists all relevant
reports in chronological order). In the “list of reports” tab, when you search for the
COVID-19 vaccine, the results table provides the case number, report entry date, the
age of the person, gender, medicines reported as being taken and the reaction. This
will provide you with a publicly available list.
Page 5 of 7
27. The public interest in evidence supporting the safety and efficacy of COVID-19
vaccines is also met through the publication of information in the supporting
regulatory documents, including the Australian Public Assessment Report
(
AusPAR), the Product Information (
PI), and the other information that is publicly
available in the DAEN and the weekly safety reports. The PI is the key source of
information for health professionals as it provides a summary of the scientific
information relevant to the safe and effective use of a prescription medicine,
including vaccines. The PI is approved by the TGA, and sponsors must submit an
application to the TGA to make any change to the PI. The PI includes information on
adverse events which were observed in clinical trials, as well as those observed from
post-market surveillance. The TGA works with COVID-19 vaccine sponsors to
ensure the PI remains up to date and can mandate updates to the safety information
included in the PI.
28. The AusPARs and PIs are available for each provisionally approved vaccine here:
https://www.tga.gov.au/covid-19-vaccine-provisional-registrations.
29. I consider that insofar as any interest is served by the release of the documents in
question, the public interest has already been met through the publication of the
supporting regulatory documents, as well as through publication of information
regarding deaths and adverse events on the DAEN and the COVID-19 weekly safety
reports.
30. I find that the balance of interests does not favour the expenditure of considerable
resources by the TGA. The above diversion of TGA resources would, in my view, be
substantial, and is likely to cause serious delays to, and potentially compromise, the
TGA’s performance of its regulatory functions under the
Therapeutic Goods Act 1989.
Having regard to the importance of the prompt and proper performance of the TGA’s
regulatory functions, I consider that this diversion of resources would be
unreasonable in the circumstances.
Notification of request consultation process
31. I am notifying you of my intention to refuse to give access to the documents that
come within the scope of your request.
32. Before deciding to refuse access to documents, I am required under
paragraph 24(1)(a) of the FOI Act to undertake a request consultation process in
accordance with section 24AB of the FOI Act and provide you with the opportunity
to refine the scope of your request.
33. Accordingly, you are now afforded fourteen (14) calendar days from your receipt of
this letter in which to contact the TGA to discuss a revision of the scope of your
request.
34. Before the end of the 14-day consultation period, you must do one of the following:
• withdraw your request;
• make a revised request; or
• indicate that you do not wish to revise your request.
35. If you have not contacted the TGA within 14 days of receiving this letter to do one of
the above or consulted the TGA to discuss revising the scope of this request, your
request is taken to have been withdrawn.
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36. If you wish to refine the scope of your request, you may contact the TGA FOI team
on (02) 6289 4630 or
at xxx.xxx@xxx.xxx.xx.
37. Please note that if you indicate that you do not wish to revise your request or revise
your request in such a way that I am still of the view that processing it would
substantially and unreasonably divert TGA resources from other operations, I may
refuse your request under paragraph 24(1)(b) of the FOI Act.
Yours sincerely,
Authorised and electronically signed by
Elspeth Kay
Assistant Secretary
Pharmacovigilance & Special Access Branch
Therapeutic Goods Administration
28 October 2021
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