Therapeutic goods for supply in Australia, their Safety, Quality, Efficacy and Performance.
: Deborah-May: Torrens made this Freedom of Information request to Advisory Committee on the Safety of Medicines
Dear Advisory Committee on the Safety of Medicines,
I am contacting the Advisory Committee on the Safety of Medicines, to ask for a copy of the 'Request for Release Form' which was submitted by Anthony Fauci to Advisory Committee on the Safety of Medicines, as well the complete summary of protocols for manufacture and QC, including all steps in production in the agreed format; and documentation on at least twenty vials (samples) of each manufacturing batch of BNT162b2 (mRNA) COVID-19 vaccine with the Australian labels, PI and packaging representative of all batches of product proposed to be distributed in Australia; and if the manufacturing batch has been released in Europe or United Kingdom (UK) a copy of those EU Official Control Authority Batch Release (OCABR) certificate (or equivalent from the UK) and any reagents, reference material and standards required to undertake testing.
I also request for a copy of the Certified Product Details (CPD) as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM).
Yours faithfully,
Deborah-May
Dear Ms Torrens
Thank you for your FOI request which was received by the Therapeutic Goods
Administration on 1 July 2024.
I am writing to seek clarification regarding the scope of your request,
which is for the following documents:
I am contacting the Advisory Committee on the Safety of Medicines, to ask
for a copy of the 'Request for Release Form' which was submitted by
Anthony Fauci to Advisory Committee on the Safety of Medicines, as well
the complete summary of protocols for manufacture and QC, including all
steps in production in the agreed format; and documentation on at least
twenty vials (samples) of each manufacturing batch of BNT162b2 (mRNA)
COVID-19 vaccine with the Australian labels, PI and packaging
representative of all batches of product proposed to be distributed in
Australia; and if the manufacturing batch has been released in Europe or
United Kingdom (UK) a copy of those EU Official Control Authority Batch
Release (OCABR) certificate (or equivalent from the UK) and any reagents,
reference material and standards required to undertake testing.
I also request for a copy of the Certified Product Details (CPD) as
described in Guidance 7: Certified Product Details of the Australian
Regulatory Guidelines for Prescription Medicines (ARGPM).
Please note that at the outset, it appears that the scope of your request
in its current form may be considered too voluminous to process by the
TGA. However, in order to assist you, I would like to refer you to some
publicly available information which is relevant to your request.
The TGA has published a number of documents on [1]the FOI disclosure log
related to your request. Please review the documents released for the
following requests:
o [2]FOI 4878 – the TGA Laboratory’s standard operating procedure for
analysis of batch samples and full test results documentation for the
analysis of 3 batches of Comirnaty. This also contains OCABR
certificates for various batches of Comirnaty.
o [3]FOI 4382 - Laboratory testing results of multiple Comirnaty
COVID-19 vaccine batches.
o [4]FOI 3471 - TGA laboratory analysis documentation of the following
batches of Comirnaty vaccine: FL5333, FK8917, FH3221, FL3560, FE3430.
o [5]FOI 3390 - TGA's batch release assessment for the batch FL7649 of
Comirnaty COVID-19 vaccine.
The TGA conducts a batch release assessment for every batch of vaccine
supplied in Australia. Batch release assessments for the BNT162b2 (mRNA)
COVID-19 vaccine (also referred to as Comirnaty) are publicly available
here:
[6]https://www.tga.gov.au/batch-release-ass.... This
link provides guidance on the batch assessment process as well as a table
of information showing the test results for each batch of COVID-19 vaccine
that has been tested by the TGA.
Finally, Guidance 7: Certified Product Details of the Australian
Regulatory Guidelines for Prescription Medicines (ARGPM) is available on
the TGA website at the following link:
[7]https://www.tga.gov.au/sites/default/fil...
Action required
Noting much of the information you are seeking access to is publicly
available, we would be grateful if you could please advise if you agree to
proceed with the following revised scope:
“Under the FOI Act, I request a copy of the 'Request for Release Form'
which was submitted by Anthony Fauci to Advisory Committee on the Safety
of Medicines”
Please note a search and retrieval has not yet been conducted for relevant
documents, therefore we cannot guarantee that this suggested scope will be
an appropriate size to process, nor does it guarantee that any documents
will be identified.
Further, we note that you are seeking documentation relating to at least
twenty samples of each batch of Comirnaty COVID-19 vaccine. Based on
previous experience with processing documents of this nature, the relevant
line area has advised that up to 3 batches would be processable noting the
complex technical material in the documents and consultation required.
Anything beyond this number would reasonably be expected to render the
request too voluminous to process. Considering this, if you wish to
request the laboratory analysis documents for batches of Comirnaty, we
would be grateful for your consideration of limiting your request to 3
batches only.
We would be grateful for your response by COB Monday 15 July. Thank you
for your consideration.
Please don't hesitate to contact the FOI team if you have any questions.
Kind regards
Emily
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [8][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [9]www.tga.gov.au
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.
The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.
-----Original Message-----
From: : Deborah-May: Torrens
<[FOI #11591 email]>
Sent: Monday, July 1, 2024 2:35 PM
To: FOI <[email address]>
Subject: Freedom of Information request - Therapeutic goods for supply in
Australia, their Safety, Quality, Efficacy and Performance.
REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.
Dear Advisory Committee on the Safety of Medicines,
I am contacting the Advisory Committee on the Safety of Medicines, to ask
for a copy of the 'Request for Release Form' which was submitted by
Anthony Fauci to Advisory Committee on the Safety of Medicines, as well
the complete summary of protocols for manufacture and QC, including all
steps in production in the agreed format; and documentation on at least
twenty vials (samples) of each manufacturing batch of BNT162b2 (mRNA)
COVID-19 vaccine with the Australian labels, PI and packaging
representative of all batches of product proposed to be distributed in
Australia; and if the manufacturing batch has been released in Europe or
United Kingdom (UK) a copy of those EU Official Control Authority Batch
Release (OCABR) certificate (or equivalent from the UK) and any reagents,
reference material and standards required to undertake testing.
I also request for a copy of the Certified Product Details (CPD) as
described in Guidance 7: Certified Product Details of the Australian
Regulatory Guidelines for Prescription Medicines (ARGPM).
Yours faithfully,
Deborah-May
-------------------------------------------------------------------
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References
Visible links
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6. https://www.tga.gov.au/batch-release-ass...
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8. mailto:[email address]
9. http://www.tga.gov.au/
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Dear TGA FOI,
Under the FOI Act, I request a copy of the 'Request for Release Form'
which was submitted by Anthony Fauci to Advisory Committee on the Safety of Medicines.
We will begin here.
Kind regards
Deborah-May
Dear Ms Torrens,
FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT
I am writing to notify you that the Therapeutic Goods Administration
(Department of Health and Aged Care) has received your request for access
to documents under the Freedom of Information Act 1982 (FOI Act) as
follows:
‘Under the FOI Act, I request a copy of the 'Request for Release Form'
which was submitted by Anthony Fauci to Advisory Committee on the Safety
of Medicines.’
Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
from 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 31 July 2024. Due to the statutory processing time afforded under
the FOI Act in which to provide you with a decision in relation to your
FOI request, we would be grateful if you could please monitor your emails
periodically for updates regarding your request.
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.
Unless you advise otherwise, draft and duplicate documents, Commonwealth
employee names and contact details of staff below Senior Executive Service
level, internal group email addresses and mobile telephone numbers of all
staff will be excluded from the scope of your request under section
22(1)(a)(ii) of the FOI Act.
Disclosure Log Publication:
The TGA is required under section 11C of the FOI Act to publish on its
website, or otherwise make available, documents released to an applicant
in response to an FOI request, unless exceptional circumstances apply. The
TGA publishes these documents on the FOI Disclosure Log at [1]FOI
Disclosure Log | Therapeutic Goods Administration. You can find more
information about the Disclosure Log at [2]OAIC FOI Guidelines |
Disclosure Logs.
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.
If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [3][email address].
Kind regards
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [4][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [5]www.tga.gov.au
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.
The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.
-----Original Message-----
From: : Deborah-May: Torrens
[6][FOI #11591 email]
Sent: Monday, July 15, 2024 10:12 AM
To: TGA FOI [7][email address]
Subject: Re: FOI 5243 - Clarification of scope [SEC=OFFICIAL]
REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.
Dear TGA FOI,
Under the FOI Act, I request a copy of the 'Request for Release Form'
which was submitted by Anthony Fauci to Advisory Committee on the Safety
of Medicines.
We will begin here.
Kind regards
Deborah-May
-----Original Message-----
Dear Ms Torrens
Thank you for your FOI request which was received by the Therapeutic
Goods Administration on 1 July 2024.
I am writing to seek clarification regarding the scope of your request,
which is for the following documents:
I am contacting the Advisory Committee on the Safety of Medicines, to ask
for a copy of the 'Request for Release Form' which was submitted by
Anthony Fauci to Advisory Committee on the Safety of Medicines, as well
the complete summary of protocols for manufacture and QC, including all
steps in production in the agreed format; and documentation on at least
twenty vials (samples) of each manufacturing batch of BNT162b2 (mRNA)
COVID-19 vaccine with the Australian labels, PI and packaging
representative of all batches of product proposed to be distributed in
Australia; and if the manufacturing batch has been released in Europe or
United Kingdom (UK) a copy of those EU Official Control Authority Batch
Release (OCABR) certificate (or equivalent from the UK) and any reagents,
reference material and standards required to undertake testing.
I also request for a copy of the Certified Product Details (CPD) as
described in Guidance 7: Certified Product Details of the Australian
Regulatory Guidelines for Prescription Medicines (ARGPM).
Please note that at the outset, it appears that the scope of your request
in its current form may be considered too voluminous to process by the
TGA. However, in order to assist you, I would like to refer you to some
publicly available information which is relevant to your request.
The TGA has published a number of documents on [1]the FOI disclosure log
related to your request. Please review the documents released for the
following requests:
o [2]FOI 4878 – the TGA Laboratory’s standard operating procedure for
analysis of batch samples and full test results documentation for the
analysis of 3 batches of Comirnaty. This also contains OCABR certificates
for various batches of Comirnaty.
o [3]FOI 4382 - Laboratory testing results of multiple Comirnaty
COVID-19 vaccine batches.
o [4]FOI 3471 - TGA laboratory analysis documentation of the following
batches of Comirnaty vaccine: FL5333, FK8917, FH3221, FL3560, FE3430.
o [5]FOI 3390 - TGA's batch release assessment for the batch FL7649 of
Comirnaty COVID-19 vaccine.
The TGA conducts a batch release assessment for every batch of vaccine
supplied in Australia. Batch release assessments for the BNT162b2 (mRNA)
COVID-19 vaccine (also referred to as Comirnaty) are publicly available
here:
[6][8]https://www.tga.gov.au/batch-release-ass....
This link provides guidance on the batch assessment process as well as a
table of information showing the test results for each batch of COVID-19
vaccine that has been tested by the TGA.
Finally, Guidance 7: Certified Product Details of the Australian
Regulatory Guidelines for Prescription Medicines (ARGPM) is available on
the TGA website at the following link:
[7][9]https://www.tga.gov.au/sites/default/fil...
Action required
Noting much of the information you are seeking access to is publicly
available, we would be grateful if you could please advise if you agree
to proceed with the following revised scope:
“Under the FOI Act, I request a copy of the 'Request for Release Form'
which was submitted by Anthony Fauci to Advisory Committee on the Safety
of Medicines”
Please note a search and retrieval has not yet been conducted for
relevant documents, therefore we cannot guarantee that this suggested
scope will be an appropriate size to process, nor does it guarantee that
any documents will be identified.
Further, we note that you are seeking documentation relating to at least
twenty samples of each batch of Comirnaty COVID-19 vaccine. Based on
previous experience with processing documents of this nature, the
relevant line area has advised that up to 3 batches would be processable
noting the complex technical material in the documents and consultation
required.
Anything beyond this number would reasonably be expected to render the
request too voluminous to process. Considering this, if you wish to
request the laboratory analysis documents for batches of Comirnaty, we
would be grateful for your consideration of limiting your request to 3
batches only.
We would be grateful for your response by COB Monday 15 July. Thank you
for your consideration.
Please don't hesitate to contact the FOI team if you have any questions
Kind regards
Emily
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [8][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [9][10]www.tga.gov.au
Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information.
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited. If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission.
The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[11][FOI #11591 email]
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:
[12]https://www.righttoknow.org.au/help/offi...
Please note that in some cases publication of requests and responses will
be delayed.
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.
-------------------------------------------------------------------
"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information.
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited. If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."
References
Visible links
1. https://www.tga.gov.au/foi-disclosure-log
2. https://www.oaic.gov.au/freedom-of-infor...
3. mailto:[email address]
4. mailto:[email address]
5. http://www.tga.gov.au/
6. mailto:[FOI #11591 email]
7. mailto:[email address]
8. https://www.tga.gov.au/batch-release-ass...
9. https://www.tga.gov.au/sites/default/fil...
10. http://www.tga.gov.au/
11. mailto:[FOI #11591 email]
12. https://www.righttoknow.org.au/help/offi...
Dear Ms Torrens
Please find attached correspondence in relation to your Freedom of
Information request.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [1][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [2]www.tga.gov.au
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.
The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.
"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information.
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited. If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."
References
Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/