Request for documents showing mortality rates associated with Pfizer and Moderna
: Deborah-May: Torrens made this Freedom of Information request to Therapeutic Goods Administration
Dear Therapeutic Goods Administration,
I am contacting You under the Freedom of Information Act 1982, to ask for the mortality rates associated with Pfizer's BioNTech, also known as (BNT162b2), and Moderna's Spikevax also known as (elasomeran) from 16 July 2020 to 16 July 2024.
Kind regards
Deborah
Dear Ms Torrens
I refer to your email dated 16 July 2024 to the Therapeutic Goods
Administration (TGA) seeking information about ‘mortality rates associated
with Pfizer's BioNTech, also known as (BNT162b2), and Moderna's Spikevax
also known as (elasomeran) from 16 July 2020 to 16 July 2024’.
Please note, under the Freedom of Information Act 1982 (the FOI Act), the
TGA is not required to create a document or make copies of information
which is publicly available.
Noting the above, the TGA continuously monitors the safety of all
medicines in use in Australia. This information is largely published on
the Database of Adverse Event Notifications (DAEN). The DAEN contains
information from reports of adverse events that the TGA has received in
relation to medicines, including vaccines, used in Australia.
You are able to access the DAEN at the following link: [1]Database of
Adverse Event Notifications (DAEN) | Therapeutic Goods Administration
(TGA).
You can search the DAEN for “COVID” in the medicines report section,
available here: [2]DAEN Medicines (tga.gov.au). Once you have read the
information on this page, and ticked the box labelled ‘I have read and
understand the above’, you will be directed to the next webpage.
On this page, simply select the medicines you want to search for by
ticking or unticking the boxes. For example, to conduct a search for
COVID-19 vaccines, enter ‘COVID’ in the search bar and then select the
magnifying glass at the right of the search bar. You can tick the box for
‘Select all’ or choose individual COVID-19 vaccines.
o There are two types of results shown in two tables: medicine
summary and list of reports. In the “list of reports” table when
you search for the COVID-19 vaccine, the results table provides the
case number, report entry date, the age of the person, gender,
medicines reported as being taken and the reaction.
o If you scroll further down the page, you will also be able to view
‘Data visual representation’, viewable by age, MedDRA reaction
terms and gender.
Further, you can refine the results on the DAEN by date, product name and
advanced search options and by interacting with the graphs and tables. The
following links provide a step-by-step guide on how to refine results
according to:
· [3]date range
· [4]product name (trade name and active ingredient)
· [5]medicine summary and list of reports tables
· advanced search options (age, gender, [6]MedDRA system organ class and
reaction terms
· [7]graphs (age, gender, MedDRA reaction terms, report date).
We hope these instructions in accessing and using the DAEN are useful in
helping you with your enquiries. In light of the publicly available
information provided above, we would be grateful if you could please
confirm that you withdraw your request.
We would be grateful for your response by COB Wednesday 24 July 2024.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards
Emilee
Freedom of Information
Karen | Emily | Tara | Christina | Lily | Emilee | Russel | Reirden
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
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.
From: : Deborah-May: Torrens
<[10][FOI #11702 email]>
Sent: Tuesday, July 16, 2024 5:14 PM
To: FOI <[11][email address]>
Subject: Freedom of Information request - Request for documents showing
mortality rates associated with Pfizer and Moderna
REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.
Dear Therapeutic Goods Administration,
I am contacting You under the Freedom of Information Act 1982, to ask for
the mortality rates associated with Pfizer's BioNTech, also known as
(BNT162b2), and Moderna's Spikevax also known as (elasomeran) from 16 July
2020 to 16 July 2024.
Kind regards
Deborah
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[12][FOI #11702 email]
Is [13][TGA request email] the wrong address for Freedom of Information
requests to Therapeutic Goods Administration? If so, please contact us
using this form:
[14]https://www.righttoknow.org.au/change_re...
This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:
[15]https://www.righttoknow.org.au/help/offi...
Please note that in some cases publication of requests and responses will
be delayed.
If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.
-------------------------------------------------------------------
"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/safety/safety/saf...
2. https://daen.tga.gov.au/medicines-search/
3. https://www.tga.gov.au/resources/resourc...
4. https://www.tga.gov.au/resources/resourc...
5. https://www.tga.gov.au/resources/resourc...
6. Medical Dictionary for Regulatory Activities - MedDRA
https://www.tga.gov.au/resources/resourc...
7. https://www.tga.gov.au/resources/resourc...
8. mailto:[email address]
9. http://www.tga.gov.au/
10. mailto:[FOI #11702 email]
11. mailto:[email address]
12. mailto:[FOI #11702 email]
13. mailto:[TGA request email]
14. https://www.righttoknow.org.au/change_re...
15. https://www.righttoknow.org.au/help/offi...
Dear Ms Torrens
We kindly wish to follow up with you regarding our correspondence of 22
July 2024, below.
If we could kindly seek your reply by Friday 26 July 2024, it would be
most appreciated.
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.
From: TGA FOI <[email address]>
Sent: Monday, July 22, 2024 5:11 PM
To: '[FOI #11702 email]'
<[FOI #11702 email]>
Cc: TGA FOI <[email address]>
Subject: RE: Freedom of Information request - Request for documents
showing mortality rates associated with Pfizer and Moderna [SEC=OFFICIAL]
Dear Ms Torrens
I refer to your email dated 16 July 2024 to the Therapeutic Goods
Administration (TGA) seeking information about ‘mortality rates associated
with Pfizer's BioNTech, also known as (BNT162b2), and Moderna's Spikevax
also known as (elasomeran) from 16 July 2020 to 16 July 2024’.
Please note, under the Freedom of Information Act 1982 (the FOI Act), the
TGA is not required to create a document or make copies of information
which is publicly available.
Noting the above, the TGA continuously monitors the safety of all
medicines in use in Australia. This information is largely published on
the Database of Adverse Event Notifications (DAEN). The DAEN contains
information from reports of adverse events that the TGA has received in
relation to medicines, including vaccines, used in Australia.
You are able to access the DAEN at the following link: [6]Database of
Adverse Event Notifications (DAEN) | Therapeutic Goods Administration
(TGA).
You can search the DAEN for “COVID” in the medicines report section,
available here: [7]DAEN Medicines (tga.gov.au). Once you have read the
information on this page, and ticked the box labelled ‘I have read and
understand the above’, you will be directed to the next webpage.
On this page, simply select the medicines you want to search for by
ticking or unticking the boxes. For example, to conduct a search for
COVID-19 vaccines, enter ‘COVID’ in the search bar and then select the
magnifying glass at the right of the search bar. You can tick the box for
‘Select all’ or choose individual COVID-19 vaccines.
o There are two types of results shown in two tables: medicine
summary and list of reports. In the “list of reports” table when
you search for the COVID-19 vaccine, the results table provides the
case number, report entry date, the age of the person, gender,
medicines reported as being taken and the reaction.
o If you scroll further down the page, you will also be able to view
‘Data visual representation’, viewable by age, MedDRA reaction
terms and gender.
Further, you can refine the results on the DAEN by date, product name and
advanced search options and by interacting with the graphs and tables. The
following links provide a step-by-step guide on how to refine results
according to:
· [8]date range
· [9]product name (trade name and active ingredient)
· [10]medicine summary and list of reports tables
· advanced search options (age, gender, [11]MedDRA system organ class and
reaction terms
· [12]graphs (age, gender, MedDRA reaction terms, report date).
We hope these instructions in accessing and using the DAEN are useful in
helping you with your enquiries. In light of the publicly available
information provided above, we would be grateful if you could please
confirm that you withdraw your request.
We would be grateful for your response by COB Wednesday 24 July 2024.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards
Emilee
Freedom of Information
Karen | Emily | Tara | Christina | Lily | Emilee | Russel | Reirden
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [13][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [14]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.
From: : Deborah-May: Torrens
<[15][FOI #11702 email]>
Sent: Tuesday, July 16, 2024 5:14 PM
To: FOI <[16][email address]>
Subject: Freedom of Information request - Request for documents showing
mortality rates associated with Pfizer and Moderna
REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.
Dear Therapeutic Goods Administration,
I am contacting You under the Freedom of Information Act 1982, to ask for
the mortality rates associated with Pfizer's BioNTech, also known as
(BNT162b2), and Moderna's Spikevax also known as (elasomeran) from 16 July
2020 to 16 July 2024.
Kind regards
Deborah
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[17][FOI #11702 email]
Is [18][TGA request email] the wrong address for Freedom of Information
requests to Therapeutic Goods Administration? If so, please contact us
using this form:
[19]https://www.righttoknow.org.au/change_re...
This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:
[20]https://www.righttoknow.org.au/help/offi...
Please note that in some cases publication of requests and responses will
be delayed.
If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.
-------------------------------------------------------------------
"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]
2. http://www.tga.gov.au/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...
6. https://www.tga.gov.au/safety/safety/saf...
7. https://daen.tga.gov.au/medicines-search/
8. https://www.tga.gov.au/resources/resourc...
9. https://www.tga.gov.au/resources/resourc...
10. https://www.tga.gov.au/resources/resourc...
11. Medical Dictionary for Regulatory Activities - MedDRA
https://www.tga.gov.au/resources/resourc...
12. https://www.tga.gov.au/resources/resourc...
13. mailto:[email address]
14. http://www.tga.gov.au/
15. mailto:[FOI #11702 email]
16. mailto:[email address]
17. mailto:[FOI #11702 email]
18. mailto:[TGA request email]
19. https://www.righttoknow.org.au/change_re...
20. https://www.righttoknow.org.au/help/offi...
Dear Ms Torrens
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
[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
and delete all copies of this transmission."
References
Visible links
1. mailto:[email address]
2. http://www.tga.gov.au/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...