TRIM Ref: D21-2763391
Phillip Sweeney
By email: xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx
Dear Mr Sweeney,
FREEDOM OF INFORMATION REQUEST FOI 2440
Notice of Decision
I refer to your request dated 6 June 2021 under the
Freedom of Information Act 1982 (the
FOI Act) for access to the following documents:
“The TGA makes this statement in the Provisional Approval of the Pfizer COVID-19
'vaccine':
"COMIRNATY has been shown to prevent COVID-19 however it is not yet known
whether it prevents transmission or asymptomatic disease."
A similar statement is made with respect to the Provisional Approval of the
AstraZeneca COVID-19 'vaccine".
The SARS-CoV-2 virus causes the disease known as COVID-19 in some people who
have been infected by the SARS-CoV-2 virus. while some infected people are
asymptomatic.
People who have been fully vaccinated can still be infected with the SARS-CoV-2 virus
and transmit this virus to others while showing no symptoms of COVID-19 themselves
according to the statement above subject to further research.
The document or documents I seek are any subsequent documents published by the
TGA since 25 January 2021 that contradict the statement made in the Provisional
Approval documents as quoted above.”
Decision Maker
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
Unfortunately, I am unable to continue to process your request as
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
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, paragraph 24A(1)(a) and subparagraph 24(1)(b)(ii) of the FOI Act state:
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 or 02 6232 8644 Fax: 02 6232 8112
Email
: xxxx@xxx.xxx.xx
https://www.tga.gov.au
(1) An agency or Minister may refuse a request for access to a document if:
(a) all reasonable steps have been taken to find the document; and
(b) the agency or Minister is satisfied that the document:
(ii) does not exist.
The relevant electronic databases, files and corporate file lists held by the TGA have been
thoroughly searched in order to locate the documents you have requested. Following
these searches, I am satisfied that all reasonable steps have been taken in order to find the
documents requested, and I confirm that the documents you have requested do not exist.
To assist you further, the TGA regularly provides updates on the TGA website regarding
regulatory developments
at COVID-19 Vaccine Information Hub. Review and Complaint Rights
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/
If you have any queries regarding this matter, please contact the FOI Team on
(02) 6289 4630.
Yours sincerely
Authorised and electronically signed by
Elizabeth Santolin
Director
Prescription Medicine Authorisation Branch
Therapeutic Goods Administration
6 July 2021
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