The number of serious adverse events reported following covid-19 vaccine injection in Australia to date
Dear Therapeutic Goods Administration,
This request is made in accordance with the FOI Act. Please provide a document recording the number of serious adverse events reported following covid-19 vaccine injection in Australia to date (7/11/2021). As vaccine pharmacovigilance goes, an adverse event following immunisation is considered serious if it results in:
+ death
+ is life-threatening
+ requires inpatient hospitalisation
+ prolongation of existing hospitalisation
+ persistent or significant disability/incapacity
+ congenital anommoly/birth defect
Yours faithfully
Jaay-H
Dear Jaay-H,
Thank you for your email below dated 8 November 2021 in which you make the
following inquiry under the Freedom of Information Act 1982 (FOI Act):
‘Please provide a document recording the number of serious adverse events
reported following covid-19 vaccine injection in Australia to date
(7/11/2021). As vaccine pharmacovigilance goes, an adverse event
following immunisation is considered serious if it results in:
+ death
+ is life-threatening
+ requires inpatient hospitalisation
+ prolongation of existing hospitalisation persistent or significant
+ disability/incapacity congenital anommoly/birth defect’
By way of background, the TGA continues to monitor the safety of vaccines
and medicines after they are approved to contribute to a better
understanding of their safety profile. The existing safety monitoring
system for vaccines includes [1]reviewing and analysing reports of
suspected side effects (also known as adverse events) submitted by health
professionals, consumers, state and territory health departments and
pharmaceutical companies. Prior to the COVID-19 vaccine rollout, the TGA
implemented a number of enhancements to strengthen the existing vaccine
safety monitoring system, to allow for early detection and investigation
of possible safety issues associated with COVID-19 vaccines, and rapid
communication of any confirmed safety issues. These enhancements are
described in the COVID-19 vaccine safety monitoring plan, published on the
TGA website at:
[2]www.tga.gov.au/resource/covid-19-vaccine-safety-monitoring-plan.
To answer your specific request, we can confirm that as at 7 November
2021, there were approximately 12,700 adverse event reports related to
COVID-19 vaccines which were either categorised as a serious adverse event
or which reported that the person experiencing the adverse event was
hospitalised. This represents approximately 16% of reports received. Large
scale vaccination means that some people will experience a new illness or
be hospitalised within a few days or weeks of vaccination. These events
are often coincidental, rather than being caused by the vaccine. Expert
analysis and review of adverse event reports is needed to determine
whether there may be a link between reported events and vaccination.
Adverse event reports provide a source of data from which to detect
patterns of events that indicate a possible safety issue, or ‘safety
signals’. The TGA conducts regular statistical analyses of adverse event
data to detect possible safety signals, in addition to closely monitoring
the occurrence of ‘adverse events of special interest’ and reviewing
individual reports. Investigation of safety signals may involve activities
such as more detailed analysis and review of adverse event report data,
consideration of published literature or information from medicines
regulators in other countries, and review of safety data from
international use of the vaccine provided by the vaccine sponsor. Review
of individual reports of concern may include gathering further
information, liaising with treating health professionals and the relevant
State or Territory health department, and/or referring the case for
independent assessment.
If these investigations indicate a safety signal, the TGA takes
appropriate action. The type of action depends on the nature of the safety
issue identified, including its likelihood and severity and the potential
to mitigate the risk (such as through patient selection or monitoring),
and the impact of the safety issue on the balance of benefits and risks
for the product.
The TGA is committed to transparency. If our monitoring confirms a safety
issue, we promptly make this information available to health professionals
and the public. Each week, the TGA publishes the outcomes of our ongoing
monitoring and safety investigations of the COVID-19 vaccines available
at: [3]www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report. As
part of our reporting system, the TGA publishes specific figures related
to total reported adverse events and total reported adverse events
resulting in death on the DAEN. The TGA also publishes these figures,
along with more specific information such as the details of any deaths
causally linked to the vaccine, in our weekly safety reports. In these
reports, we also publish up-to-date data and information relating to
adverse events of special interest, such as the incidence of myocarditis
and pericarditis with mRNA vaccines.
As you have now been provided with the information requested, we would be
grateful if you could confirm, by return email by COB Tuesday 7 December,
that your request is therefore withdrawn.
Kind regards
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.
Dear Jaay,
Please find attached correspondence in relation to your Freedom of
Information request.
Should you wish to proceed with your request, you will note from the
attached letter that you are required to pay a deposit before the request
can be processed. If you do not pay the deposit within 30 days, your
request will be treated as withdrawn.
Consultation
In the event your request relates to Commonwealth-State relations, the
personal, professional, business, commercial or financial affairs of third
parties, pursuant to sections 26A, 27 and 27A of the FOI Act, the TGA is
required to consult with the affected third parties and provide them an
opportunity to make submissions regarding the release of the documents.
In these circumstances, under section 15(6) of the FOI Act, and upon
payment of a deposit, the timeframe for processing your request will be
extended by 30 days to allow the consultation process to be conducted.
If you have any questions, please do not hesitate to contact the FOI Team.
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.
"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...
Dear TGA FOI,
The Australian public have a right to know the number of serious adverse events reported following covid-19 vaccine injection.
Under section 8 of the Charges Regulations an agency has discretion to not impose a charge. I contend that the charge should not be imposed in accordance with Section 29(1)(c) of the FOI Act. Please take into account that giving access to the documents in question is in the general public interest and in the interest of a substantial section of the public.
The agency (TGA) and the Department of Health have not been providing this information to the Australian public. The agency has also disabled the export function on their Database of Adverse Event Notifications making it impossible for the Australian public to export the data for assessment and analysis. Until the agency begins to regularly disclose the number of serious adverse events following covid-19 vaccine injections the Australian public will have to continue to rely requests made under the FOI Act for such information.
It is unreasonable and at odds with the FOI Act's objects to expect the Australian public to pay money to receive this very critical information.
Yours sincerely
Jaay
Dear Jaay-H
Please find attached correspondence related to your Freedom of Information
request.
If you have any questions, please do not hesitate to contact the 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.
"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...
Dear Jaay-H,
I refer to the Waiver of Charges Decision letter dated 13 January 2022
(attached) relating to your request FOI 3407.
I write to advise you that your request has been deemed withdrawn, as no
response or payment was received within the legislated timeframe notified
in the letter.
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 <[email address]>
Sent: Friday, 14 January 2022 9:54 AM
To: Jaay-H <[FOI #8079 email]>
Cc: TGA FOI <[email address]>
Subject: Waiver of Charges Notice of Decision - FOI 3407 [SEC=OFFICIAL]
Dear Jaay-H
Please find attached correspondence related to your Freedom of Information
request.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards
Emily
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [6][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [7]www.tga.gov.au
[8][IMG][9][IMG][10][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...
6. mailto:[email address]
7. http://www.tga.gov.au/
8. https://www.facebook.com/TGAgovau/
9. https://twitter.com/TGAgovau
10. https://www.youtube.com/channel/UCem9INJ...