Laboratory test data from Batch Release Assessments of COVID-19 vaccines
Dear Therapeutic Goods Administration,
The Batch release assessment of COVID-19 vaccines as published online,* does not contain the specific test details as headed in the table of information.
Can you please supply the particular assessment data for each batch, including the Composition and strength result, Purity and integrity result, Identity result, Endotoxin result or other measured quality or quantity undertaking in laboratory testing by the TGA (Pathway two) in the first instance and by the OCABR (Pathway 2) in the second case where applicable.
*https://www.tga.gov.au/products/covid-19....
Yours faithfully,
Scott Bennett
Dear Mr Bennett,
I am writing to notify you that the Therapeutic Goods Administration has
received your request dated 18 October 2023 for access to documents under
the Freedom of Information Act 1982 (FOI Act) as follows:
“The Batch release assessment of COVID-19 vaccines as published online,*
does not contain the specific test details as headed in the table of
information.
Can you please supply the particular assessment data for each batch,
including the Composition and strength result, Purity and integrity
result, Identity result, Endotoxin result or other measured quality or
quantity undertaking in laboratory testing by the TGA (Pathway two) in the
first instance and by the OCABR (Pathway 2) in the second case where
applicable.
*https://www.tga.gov.au/products/covid-19...
Please note that the TGA’s decision maker is yet to make a decision
relating to your request, however at the outset, it appears that the scope
of your request is likely to be considered too voluminous for the TGA to
process. There are a significant number of documents associated with each
batch release assessment. Additionally, a significant amount of advice and
oversight on the data and sensitivity of the information contained within
each document would need to be provided by specialised technical staff at
the TGA.
We also advise that for similar documents requested previously, some
information such as purity, integrity and endotoxin limits related to the
batch testing of vaccines, has been considered exempt from disclosure
under the FOI Act (i.e. not released) on the basis that it is information
that has commercial value to the sponsor that could reasonably be expected
to be destroyed or diminished if it were disclosed (see section 47 of the
FOI Act).
To be clear, each FOI request is considered on its own merit, and an
independent decision is made on each document captured in the scope of the
request, following consultation with any relevant third parties. However,
based on decisions made for similar previous FOI requests, it is likely
that some or all of the information relating to may be considered exempt
from release under the FOI Act. Further, you would also likely be required
to pay any applicable charges to process your request, even if the
documents are considered exempt in full or in part.
For your information, documents containing the test results for some
batches of the Comirnaty vaccine (batches FL5333, FK8917, FH3221, FL3560,
FE3430, and FL7649) have been released in previous FOI requests processed
by the TGA (FOI 3471 and 3390). A copy of the documents released can be
viewed at
[1]https://www.tga.gov.au/resources/publica...
Taking the above information into account, you may wish to consider
withdrawing your request or removing this type of information from the
scope of your request. Additionally, you may also wish to consider
limiting the scope of your request to 3 batches of vaccines to make it a
more manageable size to process.
We would appreciate your response by COB Tuesday 24 October 2023 if
possible.
Please let us know if you have any questions.
Kind regards,
TGA FOI Team
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [2][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [3]www.tga.gov.au
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Important: This transmission is intended only for the use of the addressee
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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.
Dear TGA FOI,
You state:
"We also advise that for similar documents requested previously, some
information such as purity, integrity and endotoxin limits related to the
batch testing of vaccines, has been considered exempt from disclosure
under the FOI Act (i.e. not released) on the basis that it is information
that has commercial value to the sponsor that could reasonably be expected
to be destroyed or diminished if it were disclosed (see section 47 of the
FOI Act)."
To be clear my request was for the missing result numbers in the fields of the database headed:
1. Purity and integrity
2. Identity
3. Endotoxin
4. Composition and strength
The documents you referred to containing the test results for some batches of the Comirnaty vaccine that have been released in previous FOI requests show these fields redacted. That is obviously of no use, because it does not fulfil the request for that specific information.
As to section 47 of the FOI Act, in does not read that way in case law. Commercial value in itself, is not protected. Destruction or diminishment of value by the revelation of a trade secret is the only reason for this protection.
The consistency of a product can not be a trade secret. You've already revealed to the public that those four data points are variable and presumably must be within a particular range to pass. What possible information could be deemed proprietary, unless inconsistency is a trade secret itself!
This was and is not intended to be volumous request. I expect there is a batch report database that contains these summary fields and it would require very little time and effort to export those tables to txt file, database file or make it publicly available on your web site.
I can see no reason to exempt this information from disclosure. It is surely within the TGA's remit to examine the constancy of medicinal products on behalf the public and this information should be available, to the public.
Yours sincerely,
Scott Bennett
Dear Mr Bennet
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 17 November 2023.
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
TGA FOI Team
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
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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
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References
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Dear TGA FOI,
I wish to make a revised request in terms of scope.
There is some misunderstanding of the scope of my request.
I am aware that the particular information requested, is not unprecedented, as at least one example document has been released under FOI previously. Specifically, document number eleven (11) of FOI 3390, (See linked page and file below):
https://www.tga.gov.au/resources/publica...
https://www.tga.gov.au/sites/default/fil...
My request would be for a limited number of these "batch release certificates”*.
Without knowing how burdensome this revised scope is, I can’t know what is an acceptable number of “certificates" to request i.e. 3, 10, 100?
I await your response.
Regards,
Scott Bennett
* Official Authority Batch Release (OCABR) and WHO lot release. Lot protocol and genealogy diagram for batch.
Dear Mr Bennett,
Thank you for your email below clarifying that you are seeking to request
a limited number of “batch release certificates”.
The relevant line area have advised that the type of document you have
referred to, being Document 11 of FOI 3390, is known as the OCABR
Certificate. The line area have advised that based on previous
experiences of processing these documents, up to 3 batches would be
processable by the TGA, noting the complex technical material in the
documents and consultation required.
We would appreciate your consideration of the above and your response as
to whether you are willing to provide an amended scope for the OCABR
Certificates for 3 specific batches of COVID-19 vaccines COB Monday 13
November 2023, if possible.
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
[3][IMG][4][IMG][5][IMG]
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.
Dear TGA FOI,
I'm willing to provide an amended scope for the OCABR
Certificates for 3 specific batches of COVID-19 vaccines.
I'd need to know which batches have this certificate. I have a list of batches from previous FOI request but It is not clear which have the OCABR.
Yours sincerely,
Scott Bennett
Dear Mr Bennett,
Thank you for your response.
Whilst not all batches tested by the TGA have OCABR Certificates, most of
the batches of mRNA vaccines do. A list of the COVID-19 mRNA vaccines can
be viewed at
[1]https://www.tga.gov.au/products/covid-19....
Our suggestion is that you formally amend the scope of your request for
the OCABR Certificates for 3 specific batches of mRNA vaccines. The TGA
can then undertake searches for the certificates for these batches and if
some of the batches you have listed do not have a certificate, we will
assist you in identifying a batch of the same vaccine that does.
Noting that the consultation period expires on 17 November, we would
appreciate your amended scope before this date.
Please let us know if you have any further questions.
Kind regards,
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [2][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [3]www.tga.gov.au
[4][IMG][5][IMG][6][IMG]
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.
Dear TGA FOI,
Please find amended scope for the OCABR certificates for the 3 specific batches of COVID-19 vaccines listed below:
ER7449
FA4598
FA7812
If these have been previously released I will select alternates.
Yours sincerely,
Scott Bennett
Dear Mr Bennett
FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT
I am writing to notify you that the Therapeutic Goods Administration
(Department of Health and Aged Care) received your request on 18 October
2023 for access to documents under the Freedom of Information Act 1982
(FOI Act) as follows:
“The OCABR certificates for the 3 specific batches of
COVID-19 vaccines listed below:
ER7449
FA4598
FA7812”
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 28 November 2023. 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.
Personal information:
I note from your request that you have not sought to exclude the personal
information of third parties (e.g. the names and contact details of
individuals, or any information that could reasonably identify an
individual) from the scope of your request. Seeking this information may
require the Department to consult with the identified individuals. This
will increase the time taken to process your request and the costs
involved. As such, we would be grateful if you would consider removing the
personal information of third parties from the scope of your request.
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.
I would be grateful if you could respond to this email by COB Friday 17
November 2023 so that we may continue processing your request.
If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [1][email address].
Kind regards
Freedom of Information
David | Karen | Emily | Tara | Christina | Michael | Lily
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [2][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [3]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 and Aged Care 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
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receive this transmission in error please notify the author immediately
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Dear TGA FOI,
I do not require and did not expect that any third parties personal information would be within the scope of my request! By all means, feel free to remove it.
I don't understand why you would even bother to ask when you seem quite ready and willing to redact documents in part or in whole when it suits your whims.
It is technical data only that I'm requesting and have an interest in. I'm sure you won't be consulting me when or if you decide to redact any of that information!
Yours sincerely,
Scott Bennett
Dear Mr Bennett
Please find attached correspondence in relation to your Freedom of
Information request.
IMPORTANT: Please include reference to FOI 4766 in your payment.
Consultation
As your request relates to the personal, professional, business,
commercial or financial affairs of third parties, pursuant to section 27
and 27A of the FOI Act, the TGA is required to consult with the affected
third parties and provide them an opportunity to make submissions
regarding the release of the documents.
Accordingly, under section 15(6) of the FOI Act, and upon payment of a
deposit, the timeframe for processing your request will be extended by 30
days to allow the consultation process to be conducted.
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
[3][IMG][4][IMG][5][IMG]
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.
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receive this transmission in error please notify the author immediately
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Dear TGA FOI,
You said:
"As your request relates to the personal, professional, business,
commercial or financial affairs of third parties, pursuant to section 27
and 27A of the FOI Act"
This statement above is incorrect. The technical report certificates and their details are a statutory requirement. They are therefore the fundamental responsibility and the chief remit of the TGA.
If you must defer to the "commercial or financial affairs of third parties" you are openly admitting to me that the TGA has a fundamental conflict of interest.
Your duty and principal roll, is to the public and its safety and not to commercial interests.
You would have to demonstrate your assertion that the batch report test information contains trade secrets or proprietary information; which it obviously can't. Because at least one example of the requested documents has been released to the public, nothing proprietary would need to be protected given all the relevant test methods, types and field names are already in the public domain.
Again, any information supplied under this FOI would only reveal test data itself, nothing new and nothing that could objectively be called a trade secret. Unless, you are saying that variation in the batch consistency is a trade secret?
Please state for the public record that batch variation is a trade secret.
To be clear and save you waisting time going over old ground, I am aware that you have released identical information with specific redactions. I'm not asking for anything more and certainly nothing less.
I believe you are prevaricating.
Regards,
Scott Bennett
Dear TGA FOI,
The response to my request has been delayed. I understand, that by law, an authority should normally have responded promptly and by December 14, 2023.
Yours sincerely,
Scott Bennett
Good morning Mr Bennett
Thank you for your email.
Unfortunately, a decision in relation to your FOI request was not due on
14 December 2023.
On 20 November 2023, you were issued with an estimate of charges notice
and asked to pay either a deposit of $48.76 or the full estimate of
$195.05. You were advised at that time that the time limit for processing
your request is suspended for a period of 30 calendar days, in accordance
with section 31 of the FOI Act, from the date you receive the charges
notice and resumes on the day you pay the charge or deposit, or the day on
which the TGA makes a decision not to impose a charge (should a request
for a reduction or waiver of charges be received).
To date no payment or request for reduction or waiver has been received
from you. Therefore, your request remains on hold.
Should you wish to proceed with your request, payment (or a request for
reduction or waiver) is required by 20 December 2023.
If you have any questions, please contact the FOI team.
Kind regards
Karen
Freedom of Information
David | Karen | Emily | Tara | Christina | Lily
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
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The Department of Health and Aged Care 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:
[FOI #10770 email]
This request has been made by an individual using Right to Know. This
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Dear TGA FOI,
I have made a payment for my request reference FOI 4766 Scott Bennett.
Client identification number CO-9001
Receipt number 39509627721
Yours sincerely,
Scott Bennett
Dear Therapeutic Goods Administration,
Please pass this on to the person who conducts Freedom of Information reviews.
I am writing to request an internal review of Therapeutic Goods Administration's handling of my FOI request 'Laboratory test data from Batch Release Assessments of COVID-19 vaccines'.
Re: FOI 4766
The response to my request has been delayed. By law, the authority should normally have responded promptly and by January 18, 2024
A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.righttoknow.org.au/request/l...
Yours faithfully,
Scott Bennett
Dear Mr Bennett
Thank you for your below correspondence dated 19 January 2024.
We note that you have requested an internal review of FOI 4766, for the
following reason:
‘the response to my request has been delayed. By law, the authority
should normally have responded promptly and by January 18, 2024’
I would like to inform you that an internal review can only be sought on
decisions that have been made. As a decision has not yet been made, there
are no grounds under the FOI Act to request an internal review.
Further information is outlined in Part 9 of the FOI Guidelines on the
Office of the Australian Information Commissioner: [1]Part 9: Internal
agency review of decisions | OAIC.
FOI processing time:
As previously noted, pursuant to section 24AB(8) of the FOI Act, the
processing time for your request is set aside to allow for
the commencement of the request consultation period.
Further, as noted in your receipt, 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.
Please note, the decision for your request is currently due on 25 January
2024. A decision regarding this matter will be issued to you on or before
this date.
I trust this information assists you. Please feel free to contact the FOI
team if you have any further queries.
Kind regards
Emily
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [2][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [3]www.tga.gov.au
[4][IMG][5][IMG][6][IMG]
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.
Dear Mr Bennett
Please find attached correspondence in relation to your Freedom of
Information request.
IMPORTANT: Please include reference to FOI 4766 in your payment.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards
Emily
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
[3][IMG][4][IMG][5][IMG]
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
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Dear TGA FOI,
I understand that on payment of $111.24 the requested documents will be released.
However, I understand they have been redacted.
My concern is that I do not want to waste money on fully or extensively redacted documents.
Can you please confirm the extent of the redaction?
Perhaps a percentage might be helpful, for example.
Yours sincerely,
Scott Bennett
Dear Mr Bennett
I have reviewed the documents and I estimate that approximately 50% of the
documents are redacted but I these redactions are primarily to information
which does not fall within the scope of your request (irrelevant
information – section 22). A small amount of redactions have been applied
to commercially valuable information under section 47 of the FOI Act.
I hope this assists.
Kind regards
Karen
Freedom of Information
Karen | Emily | Tara | Christina | Lily
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 and Aged Care 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.