TRIM Ref
: D21-3469684
Long Standing Member of a Religious Community in Western Australia
Email: xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx
Dear Applicant
FREEDOM OF INFORMATION REQUEST FOI 3500
Notice of Decision
1. I refer to your request dated 11 December 2021 under the
Freedom of Information Act
1982 (the FOI Act) and subsequent correspondence between you and the TGA in which
the scope of your request was clarified as being for access to the following documents:
‘- Deaths in Australia after 3 days from COVID 19 Vaccine
- Deaths in Australia after 3 weeks from a COVID 19 Vaccine
- Deaths in Australia after 3 months from a COVID 19 Vaccine.
I am not talking about volunterry reporting system, I am not talking about what TGA
considers an adverse event, I am asking about the death rate, causal or not, of these
groups’.
Decision Maker
2. I am the Therapeutic Goods Administration (TGA) officer authorised to make this
decision under section 23 of the FOI Act. What follows is my decision under the
FOI Act.
Decision
3. The TGA is unable to process your request because the documents you are seeking do
not exist. Therefore, I am notifying you of my decision to refuse your request for
access under section 24A of the FOI Act.
Reasons for Decision
4. Section 24A of the FOI Act states that an agency may refuse (discontinue processing) a
request where documents do not exist. Specifically, the FOI Act states:
‘requests may be refused if all reasonable steps have been taken to find a document
and the document does not exist.’
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
5. By way of background, the TGA does not collect data on
all deaths in Australia which
occur after administration of a COVID-19 vaccine. Rather, the TGA relies on voluntary
reporting of adverse event from patients, members of the public, health practitioners
and/or hospitals and state or territory health departments. Companies supplying
vaccines are legally required to report serious adverse events to the TGA. The
information given to the TGA by the aforementioned parties is then published on the
Database of Adverse Events (
DAEN).
6. The data you are requesting would require linkage of data sets that are not held by the
TGA. As your request excludes voluntary reporting, there are therefore no documents
which are held by the TGA that fall within the scope of your request.
Publicly Available Information
7. Adverse events reported to the TGA can be found in the DAEN. This can be accessed
via the following link:
https://www.tga.gov.au/database-adverse-event-notifications-daen.
8. In addition, the TGA publishes a weekly COVID-19 vaccine safety report, which can be
accessed via the following link
: http://www.tga.gov.au/periodic/covid-19-vaccine-
weekly-safety-report. Both the DAEN and weekly safety report contain information
falling within the scope of your request involving the number of deaths in Australia
reported after vaccination against COVID-19.
Review and Complaint Rights
9. If you are not satisfied with this decision, you can either seek internal review or apply
to the OAIC for review of the decision. Further information can be found on the OAIC
website at the following link:
www.oaic.gov.au/freedom-of-information/reviews-and-
complaints/
10. If you have any queries regarding this matter, please contact the FOI Team on
(02) 6289 4630.
Yours sincerely
Signed electronical y
Dr Claire Larter
Director
Pharmacovigilance Branch
Therapeutic Goods Administration
06 January 2022
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