COVID-19 Vaccine batch numbers
Dear Advisory Committee on the Safety of Medicines,
It is of great importance to monitor the specific batch/lot number associated with individual adverse event case reports. It is de rigueur for quality control and is a best practise requirement world wide.
It is clear that while a particular medication may be deemed safe and batch testing completed, particular batches can still vary in important ways (Such as percentage of active ingredient) and the very first indication of a problem would be the accumulation of adverse events associated with any particular batch number.
It has been demonstrated by International databases that a small percentage (As low as 5%) of batch numbers account for the majority of adverse events.
Searching the DAEN database, case numbers are provided without batch numbers.
I can't imagine you would not have collected this information as It would be incompetent in the extreme not to be monitoring such a central, significant and vitally important safety signal.
Can you please provide this information* or point to where it is publicly available.
Specifically, please provide me with a list of batch numbers listing the case report numbers associated with each** for the period of the COVID-19 vaccination rollout to date.
*The batch or lot number associated with each individual case report number.
**I am aware that lot numbers are listed separately in the batch release assessment report online.
Yours faithfully,
Scott Wilmot Bennett
Dear Mr Bennett
I refer to your emails dated 18 May 2022 (also attached) to the
Therapeutic Goods Administration (TGA) seeking information about COVID-19:
Vaccine batch numbers and adverse events.
The TGA is required by section 11C of the Freedom of Information Act 1982
(the FOI Act) to disclose access decisions through a [1]disclosure log on
its website. The disclosure log provides access to information which has
been released in response to an FOI request.
Recently, the TGA processed a request relating to COVID-19 vaccine batch
numbers and adverse events, and published this document on 25 March 2022
(FOI 3545). You may wish to review this document prior to submitting an
FOI request. Please note: with regards to batch numbers, the quality and
completeness of the information is dependent on the data provided by the
reporter.
I trust that this information assists you. We would be grateful if you
could indicate by COB Tuesday 31 May 2022 if this information satisfies
your request. If we do not receive a response from you by this date, your
FOI request will be considered withdrawn on the basis that the TGA has
provided you with publicly available information.
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
T: 02 6289 4630 | E: [2][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [3]www.tga.gov.au
[4][IMG][5][IMG][6][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. https://www.tga.gov.au/foi-disclosure-log
2. mailto:[email address]
3. http://www.tga.gov.au/
4. https://www.facebook.com/TGAgovau/
5. https://twitter.com/TGAgovau
6. https://www.youtube.com/channel/UCem9INJ...
Dear Mr Bennett
I refer to your emails dated 18 May 2022 (also attached) to the
Therapeutic Goods Administration (TGA) seeking information about COVID-19:
Vaccine batch numbers and adverse events.
The TGA is required by section 11C of the Freedom of Information Act 1982
(the FOI Act) to disclose access decisions through a [1]disclosure log on
its website. The disclosure log provides access to information which has
been released in response to an FOI request.
Recently, the TGA processed a request relating to COVID-19 vaccine batch
numbers and adverse events, and published this document on 25 March 2022
(FOI 3545). You may wish to review this document prior to submitting an
FOI request. Please note: with regards to batch numbers, the quality and
completeness of the information is dependent on the data provided by the
reporter.
I trust that this information assists you. We would be grateful if you
could indicate by COB Tuesday 31 May 2022 if this information satisfies
your request. If we do not receive a response from you by this date, your
FOI request will be considered withdrawn on the basis that the TGA has
provided you with publicly available information.
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
T: 02 6289 4630 | E: [2][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [3]www.tga.gov.au
[4][IMG][5][IMG][6][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. https://www.tga.gov.au/foi-disclosure-log
2. mailto:[email address]
3. http://www.tga.gov.au/
4. https://www.facebook.com/TGAgovau/
5. https://twitter.com/TGAgovau
6. https://www.youtube.com/channel/UCem9INJ...