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Flu Immunisation Safety Studies

Alissa Pattrick made this Freedom of Information request to Department of Health

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From: Alissa Pattrick

Delivered

Dear Department of Health,

Can I please have a copy of:

- The double-blind placebo safety study and report which shows that the flu immunisation for Australia in 2019 is safe for human pregnant women at any stage of their pregnancy as is suggested on the national website below, which at the time of submission was last updated 27/03/19, https://beta.health.gov.au/services/flu-... and reads "Flu immunisation is recommended every year for: ... pregnant women at any stage of pregnancy, for free under the NIP ..."

- Any and all double blind placebo safety studies and reports which show that the recommended flu immunisation since the introduction of flu immunisations are safe for human pregnant women at any stage of their pregnancy as is suggested on the national website

- Any study and report on the current or previous flu immunisation which was not funded by the manufacturer

- Any complaints/feedback/correspondence to the TGA from licensed medical professionals regarding the short and long term health outcomes of their pregnant patients post flu immunisation.

- Any internal discussion in relation to the above

To assist the Department, I specifically exclude:
- Duplicates of documents (I only require 1 copy of each document)

Where possible, I would prefer that this information is provided in it's original format - that is to say, either in Microsoft Word or HTML (where received online or via email). I ask that you do not use PDFs wherever possible as it makes it difficult to read the information.

Please deal with this request informally or in accordance with your Administrative Access scheme if practicable. If this isn't practical, please consider it a formal application under the Freedom of Information Act.

Yours faithfully,

Alissa Pattrick

Link to this

From: TGA FOI
Department of Health


Attachment image001.png
3K Download


Dear Ms Pattrick

 

Thank you for your FOI request which was received by the Therapeutic Goods
Administration on 6 April 2019.

 

I am writing to seek clarification regarding the scope of your request.

 

In its current form, the scope may be too voluminous for the TGA to
process. We would be grateful if you could you please consider reducing or
revising the scope by:

 

·         Being more specific with the types of records you are seeking;
and/or

·         Providing a more precise timeframe for the activities.

 

Alternatively, you may wish to consider submitting the following scope:

 

“Can I please have a copy of:

 

- The double-blind placebo safety study and report which shows that the
flu immunisation for Australia in 2019 is safe for human pregnant women at
any stage of their pregnancy as is suggested on the national website
below, which at the time of submission was last updated 27/03/19,
[1]https://beta.health.gov.au/services/flu-...
and reads "Flu immunisation is recommended every year for: ... pregnant
women at any stage of pregnancy, for free under the NIP ..."

 

- Any and all double blind placebo safety studies and reports which show
that the recommended flu immunisation since the introduction of flu
immunisations for the period July 2017 to 6 April 2019 are safe for human
pregnant women at any stage of their pregnancy as is suggested on the
national website

 

- Any study and report on the current or previous flu immunisation which
was not funded by the manufacturer for the period July 2017 to 6 April
2019

 

- Any complaints/feedback/correspondence to the TGA from licensed medical
professionals regarding the short and long term health outcomes of their
pregnant patients post flu immunisation for the period July 2017 to 6
April 2019.

 

- Any internal discussion in relation to the above for the period July
2017 to 6 April 2019

 

To assist the Department, I specifically exclude:

- Duplicates of documents (I only require 1 copy of each document)

 

Where possible, I would prefer that this information is provided in it's
original format - that is to say, either in Microsoft Word or HTML (where
received online or via email). I ask that you do not use PDFs wherever
possible as it makes it difficult to read the information.”

 

Please note that at this early stage, this scope is a sample only, and the
TGA is unable to advise on how many documents would be returned if a
search and retrieval was conducted.

 

We would be grateful for your response by 5pm Monday 29 April 2019.

 

If you have any questions, please do not hesitate to contact the FOI team.

 

Thank you

 

Kyla

 

Freedom of Information
Kyla | Karen | Tara | Cindy

(02) 6232 8806

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [2][email address]

 

[3]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

From: Alissa Pattrick

Sent: Saturday, 6 April 2019 6:58 PM

To: FOI

Subject: Freedom of Information request - Flu Immunisation Safety Studies
[SEC=No Protective Marking]

 

Dear Department of Health,

 

Can I please have a copy of:

 

- The double-blind placebo safety study and report which shows that the
flu immunisation for Australia in 2019 is safe for human pregnant women at
any stage of their pregnancy as is suggested on the national website
below, which at the time of submission was last updated 27/03/19,
https://beta.health.gov.au/services/flu-... and
reads "Flu immunisation is recommended every year for: ... pregnant women
at any stage of pregnancy, for free under the NIP ..."

 

- Any and all double blind placebo safety studies and reports which show
that the recommended flu immunisation since the introduction of flu
immunisations are safe for human pregnant women at any stage of their
pregnancy as is suggested on the national website

 

- Any study and report on the current or previous flu immunisation which
was not funded by the manufacturer

 

- Any complaints/feedback/correspondence to the TGA from licensed medical
professionals regarding the short and long term health outcomes of their
pregnant patients post flu immunisation.

 

- Any internal discussion in relation to the above

 

To assist the Department, I specifically exclude:

- Duplicates of documents (I only require 1 copy of each document)

 

Where possible, I would prefer that this information is provided in it's
original format - that is to say, either in Microsoft Word or HTML (where
received online or via email). I ask that you do not use PDFs wherever
possible as it makes it difficult to read the information.

 

Please deal with this request informally or in accordance with your
Administrative Access scheme if practicable. If this isn't practical,
please consider it a formal application under the Freedom of Information
Act.

 

Yours faithfully,

 

Alissa Pattrick

 

-------------------------------------------------------------------

 

Please use this email address for all replies to this request:

[FOI #5356 email]

 

Is [Health request email] the wrong address for Freedom of Information requests
to Department of Health? If so, please contact us using this form:

https://www.righttoknow.org.au/change_re...

 

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

https://www.righttoknow.org.au/help/offi...

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

 

-------------------------------------------------------------------

 

 

show quoted sections

Link to this

From: TGA FOI
Department of Health


Attachment image001.png
3K Download


Dear Ms Pattrick

 

The TGA is continuing the search for documents relevant to your request
FOI 1109-1819.

 

Unfortunately due to the large number of documents potentially relevant to
the scope, and as we have not received a response to our request below, it
has become apparent that the TGA may be unable to meet the current
deadline for your request.

 

I would be grateful if you could please consider agreeing to an extension
(under section 15AA) of ten (10) days for the processing of your request.
If you agree to this extension the decision on your request would then be
due on or before 16 May 2019.

 

Could you please respond advising whether you agree to this extension by
COB Thursday 2 May 2019.

 

Thank you for your consideration of this matter.

 

Please do not hesitate to contact the FOI team if you have any questions.

 

Kind regards

Kyla

 

Freedom of Information
Kyla | Karen | Tara | Cindy

(02) 6232 8806

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

From: TGA FOI
Sent: Wednesday, 24 April 2019 2:54 PM
To: '[FOI #5356 email]'
Cc: TGA FOI
Subject: FOI1109-1819 - Flu Immunisation Safety Studies [SEC=OFFICIAL]

 

Dear Ms Pattrick

 

Thank you for your FOI request which was received by the Therapeutic Goods
Administration on 6 April 2019.

 

I am writing to seek clarification regarding the scope of your request.

 

In its current form, the scope may be too voluminous for the TGA to
process. We would be grateful if you could you please consider reducing or
revising the scope by:

 

·         Being more specific with the types of records you are seeking;
and/or

·         Providing a more precise timeframe for the activities.

 

Alternatively, you may wish to consider submitting the following scope:

 

“Can I please have a copy of:

 

- The double-blind placebo safety study and report which shows that the
flu immunisation for Australia in 2019 is safe for human pregnant women at
any stage of their pregnancy as is suggested on the national website
below, which at the time of submission was last updated 27/03/19,
[3]https://beta.health.gov.au/services/flu-...
and reads "Flu immunisation is recommended every year for: ... pregnant
women at any stage of pregnancy, for free under the NIP ..."

 

- Any and all double blind placebo safety studies and reports which show
that the recommended flu immunisation since the introduction of flu
immunisations for the period July 2017 to 6 April 2019 are safe for human
pregnant women at any stage of their pregnancy as is suggested on the
national website

 

- Any study and report on the current or previous flu immunisation which
was not funded by the manufacturer for the period July 2017 to 6 April
2019

 

- Any complaints/feedback/correspondence to the TGA from licensed medical
professionals regarding the short and long term health outcomes of their
pregnant patients post flu immunisation for the period July 2017 to 6
April 2019.

 

- Any internal discussion in relation to the above for the period July
2017 to 6 April 2019

 

To assist the Department, I specifically exclude:

- Duplicates of documents (I only require 1 copy of each document)

 

Where possible, I would prefer that this information is provided in it's
original format - that is to say, either in Microsoft Word or HTML (where
received online or via email). I ask that you do not use PDFs wherever
possible as it makes it difficult to read the information.”

 

Please note that at this early stage, this scope is a sample only, and the
TGA is unable to advise on how many documents would be returned if a
search and retrieval was conducted.

 

We would be grateful for your response by 5pm Monday 29 April 2019.

 

If you have any questions, please do not hesitate to contact the FOI team.

 

Thank you

 

Kyla

 

Freedom of Information
Kyla | Karen | Tara | Cindy

(02) 6232 8806

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [4][email address]

 

[5]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

From: Alissa Pattrick

Sent: Saturday, 6 April 2019 6:58 PM

To: FOI

Subject: Freedom of Information request - Flu Immunisation Safety Studies
[SEC=No Protective Marking]

 

Dear Department of Health,

 

Can I please have a copy of:

 

- The double-blind placebo safety study and report which shows that the
flu immunisation for Australia in 2019 is safe for human pregnant women at
any stage of their pregnancy as is suggested on the national website
below, which at the time of submission was last updated 27/03/19,
https://beta.health.gov.au/services/flu-... and
reads "Flu immunisation is recommended every year for: ... pregnant women
at any stage of pregnancy, for free under the NIP ..."

 

- Any and all double blind placebo safety studies and reports which show
that the recommended flu immunisation since the introduction of flu
immunisations are safe for human pregnant women at any stage of their
pregnancy as is suggested on the national website

 

- Any study and report on the current or previous flu immunisation which
was not funded by the manufacturer

 

- Any complaints/feedback/correspondence to the TGA from licensed medical
professionals regarding the short and long term health outcomes of their
pregnant patients post flu immunisation.

 

- Any internal discussion in relation to the above

 

To assist the Department, I specifically exclude:

- Duplicates of documents (I only require 1 copy of each document)

 

Where possible, I would prefer that this information is provided in it's
original format - that is to say, either in Microsoft Word or HTML (where
received online or via email). I ask that you do not use PDFs wherever
possible as it makes it difficult to read the information.

 

Please deal with this request informally or in accordance with your
Administrative Access scheme if practicable. If this isn't practical,
please consider it a formal application under the Freedom of Information
Act.

 

Yours faithfully,

 

Alissa Pattrick

 

-------------------------------------------------------------------

 

Please use this email address for all replies to this request:

[FOI #5356 email]

 

Is [Health request email] the wrong address for Freedom of Information requests
to Department of Health? If so, please contact us using this form:

https://www.righttoknow.org.au/change_re...

 

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

https://www.righttoknow.org.au/help/offi...

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

 

-------------------------------------------------------------------

 

 

show quoted sections

Link to this

From: TGA FOI
Department of Health


Attachment image001.png
3K Download


Dear Ms Pattrick

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (Department) has
received your request for access to documents under the Freedom of
Information Act 1982 (FOI Act).

“Can I please have a copy of:

- The double-blind placebo safety study and report which shows that the
flu immunisation for Australia in 2019 is safe for human pregnant women at
any stage of their pregnancy as is suggested on the national website
below, which at the time of submission was last updated 27/03/19,
https://beta.health.gov.au/services/flu-... and
reads "Flu immunisation is recommended every year for: ... pregnant women
at any stage of pregnancy, for free under the NIP ..."

- Any and all double blind placebo safety studies and reports which show
that the recommended flu immunisation since the introduction of flu
immunisations are safe for human pregnant women at any stage of their
pregnancy as is suggested on the national website

- Any study and report on the current or previous flu immunisation which
was not funded by the manufacturer

- Any complaints/feedback/correspondence to the TGA from licensed medical
professionals regarding the short and long term health outcomes of their
pregnant patients post flu immunisation

- Any internal discussion in relation to the above

To assist the Department, I specifically exclude:

- Duplicates of documents (I only require 1 copy of each document)

Where possible, I would prefer that this information is provided in its
original format - that is to say, either in Microsoft Word or HTML (where
received online or via email). I ask that you do not use PDFs wherever
possible as it makes it difficult to read the information.

Please deal with this request informally or in accordance with your
Administrative Access scheme if practicable. If this isn't practical,
please consider it a formal application under the Freedom of Information
Act.”

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
after the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 6 May 2019.

However, where there is requirement to undertake consultation with
affected third parties, this timeframe is extended by a further 30 days.
It may also be extended in certain circumstances, including with your
agreement or where the Department applies to the Office of the Australian
Information Commissioner for an extension.

 

In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit. You will be notified by the
Department if you are liable to pay a charge and/or if third party
consultation is required.

 

PROCESSING YOUR REQUEST

To assist us to streamline the processing of your request we ask you to
consider and respond to the following questions.

 

1.       Personal Information

Documents containing personal information, (e.g. the names and contact
details of any individuals, or any information that could reasonably
identify an individual) may require the Department to consult with the
identified individuals or parties. This consultation is likely to add to
the time taken to process your request, and potentially increase the
charge imposed on you.

 

We would therefore be grateful if you could confirm if you are seeking
access to personal information in the documents (e.g. names, contact
details, addresses) relating to:

·         third parties; and

·         Commonwealth staff (please note that unless you advise
otherwise, we will assume that you do not seek access to personal
information of Commonwealth employees below Senior Executive Service
level).

 

If you are not seeking access to any personal information, you can simply
reply: 'no personal information requested'.

 

If you are seeking access to specific types of personal information,
please specify the type of personal information you require.

 

We look forward to hearing from you by COB 6 May 2019.

If you have any queries, please contact the FOI team on (02) 6232 8806, or
via email at [1][email address].

Kind regards

 

Freedom of Information
(02) 6232 8806

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [2][email address]

 

[3]cid:image001.png@01D1D5D9.7DDEADA0

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From: FOIDR


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Attachment RQ19 01295 15AB letter to A DOH and Pattrick.pdf
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Our reference: RQ19/01295

Agency reference: 1109-1819

Ms Alissa Pattrick

 

Sent by email: [FOI #5356 email]

Extension of time under s 15AB

Dear Ms Pattrick

Please find attached correspondence in relation to the processing of your
FOI request.

Kind regards

[1]cid:image001.jpg@01D4827C.B34AB400   Adie Chang  |  Assistant Review and Investigation
Adviser (Legal)

Freedom of Information

Office of the Australian Information Commissioner

GPO Box 5218 Sydney NSW 2001  |  [2]oaic.gov.au

+61 2 9284 9686  |   [3][email address]
[8]Subscribe
[4]cid:image002.png@01D4827C.B34AB400 | [5]cid:image003.png@01D4827C.B34AB400 | [6]cid:image004.png@01D4827C.B34AB400 |   [7]cid:image005.png@01D4827C.B34AB400 to OAICnet
newsletter

 

 

 

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Link to this

From: TGA FOI
Department of Health


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Attachment D18 10395235 ATTACHMENT A Request Consultation Process.PDF.pdf
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Attachment D19 5516832 FOI1109 1819 Request Consultation.PDF.pdf
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Dear Ms Pattrick

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

As set out in the attached correspondence, we seek your response within 14
days, being Friday 31 May 2019.

 

Pursuant to section 24AB(8) of the Freedom of Information Act 1982, the
statutory timeframe for processing your request is set aside during this
consultation process.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information
(02) 6232 8806

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

 

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