Examination of Prime Minister's advice and identify sources

Waiting for an internal review by Prime Minister of their handling of this request.

Dear Prime Minister,

I seek access to the documents you rely upon to make the following statements in your media release dated 25 January 2021 "The Pfizer vaccine has met strict standards for safety, quality and efficacy".

I also seek access to the list of "our own Australian experts" who found it (the Pfizer/BioNTech COVID-19 vaccine) safe, effective and of a high standard in your statement below;

"l welcome the TGA's approval of the Pfizer vaccine, with our own Australian experts finding it is
safe, effective and of a high standard," the Prime Minister said.

Thank you and have a wonderful day, we will be in touch again soon.

Yours faithfully,

John Walker

FOI, Prime Minister

4 Attachments

OFFICIAL

PM&C Ref: FOI/PMO/2022/016

 

Dear Mr Walker

 

The purpose of this email is to acknowledge your FOI request below, in
which you made a request to the Prime Minister’s Office (PMO) for access
under the Freedom of Information Act 1982 (Cth).

 

The Department of the Prime Minister and Cabinet (the Department) provides
the PMO with administrative support in the processing of their FOI
requests. We have accordingly forwarded your request to the PMO for
consideration.

 

When corresponding with the Department’s FOI team please include the PMO
FOI reference number FOI/PMO/2022/016. We will advise you of future
developments in this matter.

 

Kind regards,

 

 

Adviser | FOI Section[]

Department of the Prime Minister and Cabinet

p. (02) 6271 5849

Ngunnawal Country, One National Circuit  Barton  ACT  2600  |  PO Box
6500  CANBERRA  ACT  2600
e. [1][email address]  w. [2]pmc.gov.au

[3]cid:image001.jpg@01D78E24.FF2DAFB0[4]cid:image002.jpg@01D78E24.FF2DAFB0

[5]cid:image003.jpg@01D78E24.FF2DAFB0 The
Department
acknowledges
and pays
respect to
the past,
present and
emerging
Elders and
Traditional
Custodians
of Country,
and the
continuation
of cultural,
spiritual
and
educational
practices of
Aboriginal
and Torres
Strait
Islander
peoples.

 

 

-----Original Message-----
From: John Walker <[FOI #8672 email]>
Sent: Wednesday, 30 March 2022 11:23 PM
To: FOI <[email address]>
Subject: Freedom of Information request - Examination of Prime Minister's
advice and identify sources

 

Dear Prime Minister,

 

I seek access to the documents you rely upon to make the following
statements in your media release dated 25 January 2021 "The Pfizer vaccine
has met strict standards for safety, quality and efficacy".

 

I also seek access to the list of "our own Australian experts" who found
it (the Pfizer/BioNTech COVID-19 vaccine) safe, effective and of a high
standard in your statement below;

 

"l welcome the TGA's approval of the Pfizer vaccine, with our own
Australian experts finding it is safe, effective and of a high standard,"
the Prime Minister said.

 

Thank you and have a wonderful day, we will be in touch again soon.

 

Yours faithfully,

 

John Walker

 

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References

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2. https://www.pmc.gov.au/
3. https://twitter.com/pmc_gov_au
4. https://www.linkedin.com/company/departm...
6. mailto:[FOI #8672 email]
7. mailto:[Prime Minister request email]
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hide quoted sections

FOI, Prime Minister

6 Attachments

OFFICIAL

Dear Mr Walker

 

Please find attached a letter from the Office of the Prime Minister
regarding your FOI request.

 

regards

 

Adviser | FOI Section[]

Department of the Prime Minister and Cabinet

p. (02) 6271 5849

Ngunnawal Country, One National Circuit  Barton  ACT  2600  |  PO Box
6500  CANBERRA  ACT  2600
e. [1][email address]  w. [2]pmc.gov.au

[3]cid:image001.jpg@01D78E24.FF2DAFB0[4]cid:image002.jpg@01D78E24.FF2DAFB0

[5]cid:image003.jpg@01D78E24.FF2DAFB0 The
Department
acknowledges
and pays
respect to
the past,
present and
emerging
Elders and
Traditional
Custodians
of Country,
and the
continuation
of cultural,
spiritual
and
educational
practices of
Aboriginal
and Torres
Strait
Islander
peoples.

 

______________________________________________________________________ 
IMPORTANT: This message, and any attachments to it, contains information 
that is confidential and may also be the subject of legal professional or 
other privilege. If you are not the intended recipient of this message,
you 
must not review, copy, disseminate or disclose its contents to any other 
party or take action in reliance of any material contained within it. If
you 
have received this message in error, please notify the sender immediately
by 
return email informing them of the mistake and delete all copies of the 
message from your computer system. 
______________________________________________________________________

References

Visible links
1. mailto:[email address]
2. https://www.pmc.gov.au/
3. https://twitter.com/pmc_gov_au
4. https://www.linkedin.com/company/departm...

Dear PMO,

I refer to the AUSPAR document dated 25 January 2021 you supplied that states on;

1. page 30

"From clinical point of view, the relevant data is limited to a single pivotal clinical trial,
Study C4591001, for which interim findings for a median follow up period of around
2 months only are available. Short follow up duration limits the conclusion on persistence
of efficacy and late onset/rare adverse events. This study is planned to continue for a total
of 24 months",

"As and when available, further data related to vaccine efficacy in paediatric subjects,
pregnant women, in immunocompromised subjects, the data relating to protection against
asymptomatic disease and the information relating to post-market safety
and effectiveness studies should be submitted as separate submissions to amend the
current indications and to update the PI",

"Submit monthly, expedited summary safety reports for the next 6 months (risk
management plan (RMP) recommendation)."

2. Page 29

"The safety evaluation is still ongoing. Participants continue to be monitored for unsolicited
AEs, including SAEs up to six months after the last vaccine dose.",

"immunocompromised individuals and individuals who received treatment with immunosuppressive therapy were excluded from the clinical trial."

3. Page 9:

"9 Under normal circumstances, TGA's assessment (for both provisional and general registration) begins once
all information to support registration is available. As part of the Department of Health's response to the
pandemic, the TGA has agreed to accept rolling data for COVID-19 vaccines, to enable early evaluation of data
as it comes to hand"

Can you please confirm that this is indeed the only document you rely upon pursuant to my FOI request?

Sincerely,

John Walker