Ms Deborah-May Torrens
Email: xxxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx
Dear Ms Torrens
FREEDOM OF INFORMATION REQUEST FOI 5304
Notice of Decision
1. I refer to your request dated 16 July 2024 under the
Freedom of Information Act 1982
(the FOI Act) to the Department of Health and Aged Care for access to the following
documents:
‘…the mortality rates associated with Pfizer's BioNTech, also known as (BNT162b2), and
Moderna's Spikevax also known as (elasomeran) from 16 July 2020 to 16 July 2024.’
Decision Maker
2. I am the Therapeutic Goods Administration (TGA) officer authorised to make this
decision under section 23 of the FOI Act.
Decision
3. Unfortunately, I am unable to continue to process your request because the documents
you have requested 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. Despite a thorough and complete search, the documents you have requested do not
exist. In these circumstances, section 24A of the FOI Act states that an agency is able to
refuse (discontinue processing) the request. Specifically, section 24A states:
requests may be refused if all reasonable steps have been taken to find a document and
the document does not exist.
5. Please be assured that the TGA’s electronic databases, files and corporate file lists have
been searched, and, following these searches, I am satisfied that all reasonable steps
have been taken to find the documents requested. However, the documents you have
requested do not exist.
6. The reasons the documents you have requested do not exist is because the TGA does
not generate documents that contain the ‘mortality rates’ for all Australians who have
been exposed to the specified COVID-19 vaccines. The TGA collects spontaneous
adverse event data, which includes reports of death in people who have been
vaccinated. Information on deaths reported in clinical trials can be found in the
corresponding publicly available AUSPAR and Product Information for each vaccine, in
addition to adverse event reports on the Database of Adverse Event Notifications
(DAEN) – medicines. However, the TGA does not collect data on general mortality in
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 or 02 6289 4124 Fax: 02 6203 1605
Emai
l: xxxx@xxx.xxx.xx
https://www.tga.gov.au
Australia or on individuals’ vaccination status. As such, the TGA does not hold
documents with mortality rates for particular vaccines.
Review and Complaint Rights
7. If you are not satisfied with this decision, you can either seek internal review or apply
to the Office of the Australian Information Commissioner (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/your-freedom-of-information-
rights/freedom-of-information-reviews.
8. If you have any queries regarding this matter, please contact the FOI Team via email at
xxxxxx@xxxxxx.xxx.xx or telephone (02) 6289 4630.
Yours sincerely
Authorised and electronically signed by
Dr Claire Larter
A/g Assistant Secretary
Pharmacovigilance Branch
Therapeutic Goods Administration
15 August 2024
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