Dear Mr Betts

I write to you regarding your request FOI 25-0033 in which you seek access
to the following documents:

‘…As you are undoubtedly aware excess mortality rates in Australia have
increased dramatically since the introduction of widespread Covid-19 MRNA
vaccinations into the community, particularly since these vaccines have
been introduced into the older Australian population.

I seek access to the first document you hold that suggests there may be an
internal signal detection that may show a correlation between MRNA
vaccination in the elderly and death’.

At the outset, I note that the first ‘signal’ of a potential correlation
between mRNA vaccination and fatal outcomes in elderly people arose from
Norway. The TGA released a statement on the Norwegian investigation in
January 2021, available at:
[1]www.tga.gov.au/news/media-releases/norwegian-investigation-covid-19-vaccination-risks-elderly-very-frail-patients.
In addition, documents relating to this, and which are relevant to your
request, have previously been processed for FOI 4073. Additionally, there
is a significant amount of information that is publicly available which I
have included in this correspondence. Under the FOI Act, the TGA is not
required to create a document or make copies of information which is
publicly available. Nonetheless, I would like to provide you with publicly
available information that is relevant to your request.

FOI 4073

The TGA has previously processed an FOI request of a similar nature (FOI
4073), which may be useful for your current request. The documents
released for this request can be located on the [2]FOI Disclosure Log.

Access to information that is publicly available

Australian Public Assessment Report, Product Information and Consumer
Medicine Information

The TGA has published a range of regulatory documents relating to the
provisional approval of each COVID-19 vaccine, which provides detailed
information regarding the evaluation process and the data that were
considered. These include the Australian Public Assessment Report
(AusPAR), the Product Information (PI) and the Consumer Medicine
Information (CMI), and they are available at:
[3]www.tga.gov.au/covid-19-vaccines. You may be particularly interested in
the AusPAR, which summarises the information and data considered by the
TGA in assessing the risks and benefits (include safety and efficacy) of
the vaccine.

The PI is the key source of information for health professionals as it
provides a summary of the scientific information relevant to the safe and
effective use of a prescription medicine, including vaccines. The PI is
approved by the TGA, and sponsors must submit an application to the TGA to
make any change to the PI. The PI includes information on adverse events
which were observed in clinical trials, as well as those observed from
post-market surveillance. The TGA works with COVID-19 vaccine sponsors to
ensure the PI remains up to date and can mandate updates to the safety
information included in the PI.

Excess Mortality

There is no credible evidence that COVID-19 vaccines have contributed to
excess mortality. An [4]analysis from the Actuaries Institute found excess
mortality remained high in 2022, even after the exclusion of deaths from
and with COVID-19 infection.1 The number of vaccine doses administered in
2022 was approximately half that given in 2021, which clearly indicates
that there is not a strong temporal relationship between vaccination and
excess mortality.

Other information relating to TGA assessment of adverse events

Deaths following immunisation

The TGA analyses adverse event report data to identify possible safety
issues for investigation. If these investigations confirm a safety signal,
the TGA takes appropriate action. The TGA reviews all adverse events after
COVID-19 vaccination where a fatal outcome is reported. This review is
designed to assess whether the medical conditions that caused death
represent an emerging safety concern with the vaccine. For each report we
receive, we consider the strength of the evidence for a link between
vaccination and the condition that caused the death. We may request more
information from health authorities and coroners. The TGA does not
undertake autopsies, request coronial investigations or make formal
determinations of the cause of death. In Australia, coroners and treating
doctors perform this role. Any deaths which the TGA concludes are causally
linked to any of the COVID-19 vaccines are reported on by the TGA.

All reports of death are included in our safety monitoring data, even if a
coroner or expert panel has concluded it is unrelated to COVID-19
vaccination. Reviewing individual reports of adverse events with fatal
outcomes is just one part of the TGA’s COVID-19 vaccine monitoring
program. We also conduct analyses across all adverse event reports,
including those with fatal outcomes, to detect rare or emerging safety
signals. Our vaccine surveillance staff monitor the medical literature,
media and other potential sources of new safety information. We
also collaborate with international regulators to review global safety
data.

Next steps

Having regard to the information above, we would be grateful for your
consideration of withdrawing this request on the basis that what you have
requested is in the public domain.

We would appreciate your response by 12pm tomorrow, Tuesday 22 October
2024.

If you have any questions or concerns, please contact the TGA FOI team.

Kind regards

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

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

PO Box 100, Woden ACT 2606, Australia

Web: [6]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.

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Dear Mr Betts

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:

‘…As you are undoubtedly aware excess mortality rates in Australia have
increased dramatically since the introduction of widespread Covid-19 MRNA
vaccinations into the community, particularly since these vaccines have
been introduced into the older Australian population.

I seek access to the first document you hold that suggests there may be an
internal signal detection that may show a correlation between MRNA
vaccination in the elderly and death’.

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 24 October 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.

Personal information

I note from your request that you have not indicated if you seek access to
the personal information of third parties (e.g. the names and contact
details of individuals, or any information that could reasonably identify
an individual). 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.

So that the TGA can meet its statutory timeframes for processing FOI
requests, I would be grateful if you could respond to this email by COB
today, Tuesday 22 October 2024.

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.

show quoted sections

Dear Mr Betts

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

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2. http://www.tga.gov.au/