Hepatitis B vaccines placebo control and AAHS safety studies

Phillip Hayes made this Freedom of Information request to Therapeutic Goods Administration

Therapeutic Goods Administration did not have the information requested.

From: Phillip Hayes

Delivered

Dear Therapeutic Goods Administration,

I hereby request the following documents from the TGA under the Freedom of Information Act 1982;

1. Documented evidence of genuine inert placebo controlled safety studies for both Hepatitis B vaccines on the Australian Immunisation Schedule (H-B-Vax® II Paediatric and Engerix B® Paediatric vaccines).

2. Engerix B® vaccine contains 250 micrograms of the "super" adjuvant, "amorphous aluminum hydroxyphosphate sulfate." Provide documented evidence that the TGA determined it is safe to inject this amount of AAHS into Australian babies on their first day of life.

Yours faithfully,

Phillip Hayes

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From: FOI
Therapeutic Goods Administration


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Dear Mr Hayes

 

Your email has been forwarded to the Therapeutic Goods Administration
(TGA) Freedom of Information Team who will be in contact with you shortly.

 

If you would like to make requests to TGA in future their email is
[1][email address]

 

 

Kind regards

 

FOI Unit – FOI and Legislation Section

[2]cid:image003.png@01D51610.1D98D220

Legal & Assurance Division |  Corporate Operations Group

Legal Advice & Legislation Branch

Australian Government Department of Health

T: 02 6289 1666  | E: [3][email address

GPO Box 9848, Canberra ACT 2601, Australia

 

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. 

 

If you receive this email in error, please delete it and contact the
sender immediately.

 

 

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From: TGA FOI
Therapeutic Goods Administration


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Dear Mr Hayes

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) ) as follows:.

“1. Documented evidence of genuine inert placebo controlled safety studies
for both Hepatitis B vaccines on the Australian Immunisation Schedule
(H-B-Vax® II Paediatric and Engerix B® Paediatric vaccines).

 

2. Engerix B® vaccine contains 250 micrograms of the "super" adjuvant,
"amorphous aluminum hydroxyphosphate sulfate." Provide documented evidence
that the TGA determined it is safe to inject this amount of AAHS into
Australian babies on their first day of life.”

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 1 February 2020.

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.

 

2.       Duplicate Documents

Under section 4(1) of the FOI Act, the definition of a document includes
‘any copy, including an part of any copy, of a reproduction or duplicate’.
Confirmation that you are not seeking duplicate documents may enable more
timely and less costly processing of your request.

 

Can you please clarify if you are seeking duplicate copies, either in part
or in full, as part of your request?

 

If you are not seeking access to duplicate documents, you can simply
respond: ‘no duplicates requested’.

 

We look forward to hearing from you by COB Monday 13 January 2020.

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

[2]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [3][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [4]www.tga.gov.au

 

[5]cid:image002.png@01D55CBC.5655D390[6]cid:image003.gif@01D55CBC.5655D390[7]cid:image004.png@01D55CBC.5655D390

 

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. 

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From: Phillip Hayes

Delivered

Dear TGA FOI,

In regards to your response on 8 January 2020, I confirm that no personal details or duplicate documents are required for this FOI request.

Await your reply to this FOI request.

Yours sincerely,

Phillip Hayes.

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From: TGA FOI
Therapeutic Goods Administration


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Dear Mr Hayes

 

Thank you for your FOI request which was received by the Therapeutic Goods
Administration on 2 January 2020.

 

I am writing to seek clarification regarding the scope of your request in
order for the TGA to search for the most relevant documents for your
requirements.

 

We would therefore be grateful if you could you please specify your
requirements, as follows:

 

·         In relation to point 1 of your request, could you please clarify
whether you are seeking copies of studies (if they exist, they are
typically very large), or whether you would be satisfied with a document
which demonstrates whether these studies were submitted/evaluated; and

·         In relation to point 2 of your request, we note that the
inclusion of a product on the Australian Register of Therapeutic Goods is
evidence that the product has been determined to be safe to use for its
approved indication in a particular cohort of patients. The approval is
likely to have been determined on the basis of a range of information,
including studies, and not a single document. Can you please advise a
particular type of document you seek to demonstrate this approval?

 

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

 

We would be grateful for your response by COB Wednesday 15 January 2020.

 

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

 

Kind regards

 

Freedom of Information

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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. 

 

show quoted sections

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From: Phillip Hayes

Delivered

Dear TGA FOI,

Regarding your email dated 13 January 2020 seeking clarification regarding the scope of my FOI request, please provide;

1. Documentation that demonstrates whether these studies were submitted and evaluated by the TGA (ie. genuine inert placebo controlled safety studies for both Hepatitis B vaccines on the Australian Immunisation Schedule (H-B-Vax® II Paediatric and Engerix B® Paediatric vaccines).

2. Documentation that demonstrates whether these studies were submitted and evaluated by the TGA (ie. 250 micrograms of the adjuvant "amorphous aluminum hydroxyphosphate sulfate" contained in the Engerix B® vaccine has been tested and determined to be safe by the TGA to inject into Australian babies on their first day of life).

Yours faithfully,

Phillip Hayes.

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From: TGA FOI
Therapeutic Goods Administration


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Dear Mr Hayes

I refer to your request dated 3 January 2020 under the Freedom of
Information Act 1982 (FOI Act) for:

 

“1. Documentation that demonstrates whether these studies were submitted
and evaluated by the TGA (ie. genuine inert placebo controlled safety
studies for both Hepatitis B vaccines on the Australian Immunisation
Schedule (H-B-Vax® II Paediatric and Engerix B® Paediatric vaccines).

 

2. Documentation that demonstrates whether these studies were submitted
and evaluated by the TGA (ie. 250 micrograms of the adjuvant "amorphous
aluminum hydroxyphosphate sulfate" contained in the Engerix B® vaccine has
been tested and determined to be safe by the TGA to inject into Australian
babies on their first day of life).”

 

I am writing to you to inform you that the search and retrieval conducted
with respect to your request has revealed that the documents you seek fall
within the ‘[1]open access period’ as defined in s31 of the Archives Act
1983 (Archives Act). Section 12(a) of the FOI Act provides that a person
is not entitled to a document, or a copy of a document, which was created
within the open access period. Instead, the documents fall under the
jurisdiction of the National Archives of Australia (NAA). Accordingly, you
will need to apply for access to these documents through the NAA. (This
applies even where some of the records you are seeking may be in the
physical possession of the TGA - the NAA will retrieve any relevant
records from the TGA for the purpose of considering your request for
access to the records).

 

The following information may be useful to you in understanding when to
apply for documents/records under the FOI Act and when to apply under the
Archives Act:

·         When to use the Freedom of Information, Archives and Privacy
Acts – Fact sheet 110
[2]http://www.naa.gov.au/collection/fact-sh...

·         Access to records under the Archives Act – Fact sheet 10 -
[3]http://www.naa.gov.au/collection/fact-sh...

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

Kind regards

Freedom of Information

[4]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [5][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [6]www.tga.gov.au

 

[7]cid:image002.png@01D55CBC.5655D390[8]cid:image003.gif@01D55CBC.5655D390[9]cid:image004.png@01D55CBC.5655D390

 

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.

 

 

 

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