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

 

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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. 

 

 

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