Dear Department of Health,

Referring to reports of around 30 deaths in Norway following covid vaccinations TGA stated "a vaccine will only be approved for use if it is demonstrated to be safe and effective in clinical trials".

The US Centre for Disease Control defines a vaccine as "a product that stimulates a person's immune system to produce immunity to a specific disease, protecting that person from the disease".

Please provide a document demonstrating TGA requires covid vaccines to produce immunity in a person to be deemed effective.

Yours faithfully,

Jaay-H

TGA FOI, Department of Health

4 Attachments

Dear Jaay-H

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).

“Referring to reports of around 30 deaths in Norway following covid
vaccinations TGA stated "a vaccine will only be approved for use if it is
demonstrated to be safe and effective in clinical trials".

 

The US Centre for Disease Control defines a vaccine as "a product that
stimulates a person's immune system to produce immunity to a specific
disease, protecting that person from the disease".

 

Please provide a document demonstrating TGA requires covid vaccines to
produce immunity in a person to be deemed effective.”

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 19 February 2021.

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 8 February 2021.

If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [1][email address].

Kind regards

 

Cindy

 

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. 

 

"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]
3. mailto:[email address]
4. http://www.tga.gov.au/
5. https://www.facebook.com/TGAgovau/
6. https://twitter.com/TGAgovau
7. https://www.youtube.com/channel/UCem9INJ...

TGA FOI, Department of Health

4 Attachments

Dear Jaay-H

 

I refer to your request for access to documents under the Freedom of
Information Act 1982 – FOI 2203.

 

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

 

“Referring to reports of around 30 deaths in Norway following covid
vaccinations TGA stated "a vaccine will only be approved for use if it is
demonstrated to be safe and effective in clinical trials".

 

The US Centre for Disease Control defines a vaccine as "a product that
stimulates a person's immune system to produce immunity to a specific
disease, protecting that person from the disease".

 

Please provide a document demonstrating TGA requires covid vaccines to
produce immunity in a person to be deemed effective.”

 

In its current form, your scope is very broad and may be too voluminous
for the TGA to process. We would be grateful if you could you please
specify details in relation to the COVID-19 vaccines.

 

As background, the evaluation and regulation of therapeutic goods is
underpinned by the Therapeutic Goods Act 1989 (the Act). Whilst there are
a number of internal and external documents which provide details on how
the TGA regulates medicines (including vaccines) the source of the
obligation to ensure therapeutic goods are safe and effective is enshrined
in the Act.

4  Objects of Act

             (1)  The objects of this Act are to do the following, so far
as the Constitution permits:

(a)    provide for the establishment and maintenance of a national system
of controls relating to the quality, safety, efficacy and timely
availability of therapeutic goods that are:

                              (i)  used in Australia, whether produced in
Australia or elsewhere; or

                             (ii)  exported from Australia…

Additionally, and amongst other things – section 25 of the Act provides
that an application for registration must contain information which
enables the delegate of the Secretary to be satisfied that the goods (in
this case, a vaccine) are efficacious for the purpose for which they are
to be used:

25  Evaluation of therapeutic goods

             (1)  If:

                     (a)  an application is made for the registration of
therapeutic goods in relation to a person under section 23; and

                     (b)  the application has passed preliminary
assessment;

the Secretary must evaluate the goods for registration having regard to:

                     (c)  unless the application is one referred to in
paragraph (d)—whether the quality, safety and efficacy of the goods for
the purposes for which they are to be used have been satisfactorily
established; and

                     (d)  for an application for provisional registration
of a medicine:

                              (i)  whether, based on preliminary clinical
data, the safety and efficacy of the medicine for the purposes for which
it is to be used have been satisfactorily established; and

                             (ii)  whether the quality of the medicine for
the purposes for which it is to be used has been satisfactorily
established; and

(iii)  if subsection 23AA(1) applies in relation to the
application—whether, if the Secretary were to register the medicine, the
Secretary is satisfied with the applicant’s plan to submit comprehensive
clinical data on the safety and efficacy of the medicine before the end of
the 6 years that would start on the day that registration would
commence;…”

As you are aware, there are many types of vaccines being developed for
COVID-19. The common aim driving vaccine development is to cause an immune
response that is specific to the COVID-19. Many COVID-19 vaccines use the
coronavirus ‘spike’ protein to cause this immune response. The immune
system recognises this spike protein as foreign and produces important,
long lasting immune cells and antibodies. If a vaccinated person becomes
exposed to the coronavirus at a later time the immune system will be able
to make a faster and better response to protect against disease.

By their very nature, all of the vaccines being developed must produce an
immune response and demonstrate clinical effect (i.e. prevent against
disease) in order to be evaluated and potentially approved for use in
Australia.

Details of the clinical studies, including evidence of immune response and
demonstrated clinical effect can be found in the regulatory documents the
TGA publishes once an approval is made – as an example, please refer to
the Australian Public Assessment Report for Pfizer’s COVID-19 vaccine,
COMINARTY -
[1]https://www.tga.gov.au/sites/default/fil....

In light of the above, the decision maker intends on refusing your
request, unless you are able to provide further and more detailed
information in regard to the specific documents you require.

We would be grateful for your response by COB Monday 8 February 2021.

 

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

 

Kind regards

 

Cindy

 

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.

 

"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/sites/default/fil...
3. mailto:[email address]
4. http://www.tga.gov.au/
5. https://www.facebook.com/TGAgovau/
6. https://twitter.com/TGAgovau
7. https://www.youtube.com/channel/UCem9INJ...

Dear Cindy,

Thank you for the advice and link.

Yours sincerely,

Jaay-H

TGA FOI, Department of Health

4 Attachments

Dear Jaay-H

 

Thank you for your email below regarding FOI 2203.

 

Given the information below regarding clinical trials and the Pfizer
COVID-19 vaccine, could please advise whether you wish to:

 

1.       continue processing your request under the Freedom of Information
Act 1982 with a revised scope or

2.       that you agree to withdrawing your request.

 

We would appreciate your response by COB Wednesday 10 February 2021.

 

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

 

Kind regards

 

Cindy

 

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

TGA FOI, Department of Health

4 Attachments

Good morning Jaay-H

 

Could you please respond to the email below by tomorrow 16 February.

 

Kind regards

Karen

 

From: TGA FOI <[email address]>
Sent: Monday, 8 February 2021 4:27 PM
To: 'Jaay-H' <[FOI #7028 email]>
Cc: TGA FOI <[email address]>
Subject: RE: FOI 2203 - Scope clarification [SEC=OFFICIAL]

 

Dear Jaay-H

 

Thank you for your email below regarding FOI 2203.

 

Given the information below regarding clinical trials and the Pfizer
COVID-19 vaccine, could please advise whether you wish to:

 

1.       continue processing your request under the Freedom of Information
Act 1982 with a revised scope or

2.       that you agree to withdrawing your request.

 

We would appreciate your response by COB Wednesday 10 February 2021.

 

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

 

Kind regards

 

Cindy

 

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

Dear Cindy,

Please withdraw my request.

Yours sincerely,

Jaay-H