TGA recognition of Sputnik V vaccine
Dear Therapeutic Goods Administration,
On 17 January, the TGA announced that the Gamaleya Institute Sputnik V COVID-19 vaccine will be recognised in Australia for the purposes of traveller vaccination status (https://www.tga.gov.au/media-release/tga...).
Under the FOI Act 1982, I request all documents relating to the decision to recognise Sputnik V, including documents used as supporting evidence for the vaccine's effectiveness.
I request that the documents be provided in electronic form, and that all fees be waived in light of the exceptionally strong public interest around Australia's COVID-19 vaccination policies.
Yours faithfully,
Andrew
Dear Andrew
Thank you for your request under the Freedom of Information Act 1982 (Cth)
for the following documents:
“On 17 January, the TGA announced that the Gamaleya Institute Sputnik V
COVID-19 vaccine will be recognised in Australia for the purposes of
traveller vaccination status
([1]https://www.tga.gov.au/media-release/tga...).
Under the FOI Act 1982, I request all documents relating to the decision
to recognise Sputnik V, including documents used as supporting evidence
for the vaccine's effectiveness.
I request that the documents be provided in electronic form, and that all
fees be waived in light of the exceptionally strong public interest around
Australia's COVID-19 vaccination policies.”
I am pleased to inform you that the information you have requested is
publicly available via the TGA website and can be found here:
[2]International COVID-19 vaccines recognised by Australia | Therapeutic
Goods Administration (TGA).
In particular, I direct your attention to the third edition of the Covid
-19 vaccines not registered in Australia but in current international use
– TGA advice on “recognition” report which can be found here: [3]COVID-19
vaccines not registered in Australia but in current international use -
TGA advice on 'recognition' - Edition 3 January 2022. Information about
Sputnik V can be found on pages 37 – 48. The report includes a list of the
countries it has been deployed in, main clinical efficacy and
effectiveness schedules, main safety data, additional information and the
evaluator’s comments. The assessment report also contains the literature
references/ supporting evidence used by the TGA to inform our decision to
recognise Sputnik V. Those references can be found on pages 47-48.
I trust that this information assists you. As the information that you
have requested is publicly available, could you please confirm that this
information has satisfied your request, and advise if you would like to
withdraw your request.
We would be grateful for your response by COB Friday 28 January 2022.
Kind regards,
Emily
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [4][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [5]www.tga.gov.au
[6][IMG][7][IMG][8][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.
-----Original Message-----
From: Andrew <[9][FOI #8322 email]>
Sent: Monday, 17 January 2022 1:30 PM
To: FOI <[10][email address]>
Subject: Freedom of Information request - TGA recognition of Sputnik V
vaccine
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,
On 17 January, the TGA announced that the Gamaleya Institute Sputnik V
COVID-19 vaccine will be recognised in Australia for the purposes of
traveller vaccination status
([11]https://www.tga.gov.au/media-release/tga...).
Under the FOI Act 1982, I request all documents relating to the decision
to recognise Sputnik V, including documents used as supporting evidence
for the vaccine's effectiveness.
I request that the documents be provided in electronic form, and that all
fees be waived in light of the exceptionally strong public interest around
Australia's COVID-19 vaccination policies.
Yours faithfully,
Andrew
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[12][FOI #8322 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/media-release/tga...
2. https://www.tga.gov.au/international-cov...
3. https://www.tga.gov.au/sites/default/fil...
4. mailto:[email address]
5. http://www.tga.gov.au/
6. https://www.facebook.com/TGAgovau/
7. https://twitter.com/TGAgovau
8. https://www.youtube.com/channel/UCem9INJ...
9. mailto:[FOI #8322 email]
10. mailto:[email address]
11. https://www.tga.gov.au/media-release/tga...
12. mailto:[FOI #8322 email]
13. mailto:[TGA request email]
14. https://www.righttoknow.org.au/change_re...
15. https://www.righttoknow.org.au/help/offi...
Dear Andrew
I refer to the email sent to you on 24 January 2022 (below) relating to
your FOI request 3547.
I write to advise you that your request has been deemed withdrawn, as the
TGA provided you with publicly available information related to your
request, and no response was received from you within the timeframe
notified.
Should you have any questions regarding this matter, please do not
hesitate to contact the TGA FOI team.
Kind regards
Emily
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health
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 <[6][email address]>
Sent: Monday, 24 January 2022 2:37 PM
To: [7][FOI #8322 email]
Cc: TGA FOI <[8][email address]>
Subject: FW: Freedom of Information request - TGA recognition of Sputnik V
vaccine [SEC=OFFICIAL]
Dear Andrew
Thank you for your request under the Freedom of Information Act 1982 (Cth)
for the following documents:
“On 17 January, the TGA announced that the Gamaleya Institute Sputnik V
COVID-19 vaccine will be recognised in Australia for the purposes of
traveller vaccination status
([9]https://www.tga.gov.au/media-release/tga...).
Under the FOI Act 1982, I request all documents relating to the decision
to recognise Sputnik V, including documents used as supporting evidence
for the vaccine's effectiveness.
I request that the documents be provided in electronic form, and that all
fees be waived in light of the exceptionally strong public interest around
Australia's COVID-19 vaccination policies.”
I am pleased to inform you that the information you have requested is
publicly available via the TGA website and can be found here:
[10]International COVID-19 vaccines recognised by Australia | Therapeutic
Goods Administration (TGA).
In particular, I direct your attention to the third edition of the Covid
-19 vaccines not registered in Australia but in current international use
– TGA advice on “recognition” report which can be found here: [11]COVID-19
vaccines not registered in Australia but in current international use -
TGA advice on 'recognition' - Edition 3 January 2022. Information about
Sputnik V can be found on pages 37 – 48. The report includes a list of the
countries it has been deployed in, main clinical efficacy and
effectiveness schedules, main safety data, additional information and the
evaluator’s comments. The assessment report also contains the literature
references/ supporting evidence used by the TGA to inform our decision to
recognise Sputnik V. Those references can be found on pages 47-48.
I trust that this information assists you. As the information that you
have requested is publicly available, could you please confirm that this
information has satisfied your request, and advise if you would like to
withdraw your request.
We would be grateful for your response by COB Friday 28 January 2022.
Kind regards,
Emily
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [12][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [13]www.tga.gov.au
[14][IMG][15][IMG][16][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.
-----Original Message-----
From: Andrew <[17][FOI #8322 email]>
Sent: Monday, 17 January 2022 1:30 PM
To: FOI <[18][email address]>
Subject: Freedom of Information request - TGA recognition of Sputnik V
vaccine
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,
On 17 January, the TGA announced that the Gamaleya Institute Sputnik V
COVID-19 vaccine will be recognised in Australia for the purposes of
traveller vaccination status
([19]https://www.tga.gov.au/media-release/tga...).
Under the FOI Act 1982, I request all documents relating to the decision
to recognise Sputnik V, including documents used as supporting evidence
for the vaccine's effectiveness.
I request that the documents be provided in electronic form, and that all
fees be waived in light of the exceptionally strong public interest around
Australia's COVID-19 vaccination policies.
Yours faithfully,
Andrew
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[20][FOI #8322 email]
Is [21][TGA request email] the wrong address for Freedom of Information
requests to Therapeutic Goods Administration? If so, please contact us
using this form:
[22]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:
[23]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. mailto:[email address]
7. mailto:[FOI #8322 email]
8. mailto:[email address]
9. https://www.tga.gov.au/media-release/tga...
10. https://www.tga.gov.au/international-cov...
11. https://www.tga.gov.au/sites/default/fil...
12. mailto:[email address]
13. http://www.tga.gov.au/
14. https://www.facebook.com/TGAgovau/
15. https://twitter.com/TGAgovau
16. https://www.youtube.com/channel/UCem9INJ...
17. mailto:[FOI #8322 email]
18. mailto:[email address]
19. https://www.tga.gov.au/media-release/tga...
20. mailto:[FOI #8322 email]
21. mailto:[TGA request email]
22. https://www.righttoknow.org.au/change_re...
23. https://www.righttoknow.org.au/help/offi...