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Covid vaccine

Andrew Fearnley made this Freedom of Information request to Therapeutic Goods Administration

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Dear Therapeutic Goods Administration,

Please supply documents with the details of the covid vaccine status for all hospitalisations due to covid for the last 12 months in Australia and elsewhere.

Please supply documents with details of the risk/benefit studies relating to your recommendation and promotion of covid vaccines for children.

Please provide documents outlining the guidelines for declaring a death a covid death.

Please provide documents outlining the guidelines for declaring a death to be from covid vaccine.

Please provide documents outlining the guidelines for declaring a death to be from other vaccines if it varies from covid vaccine.

Yours faithfully,
Andrew Fearnley

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Dear Mr Fearnley

Thank you for your email below dated 1 September 2022 in which you make
the following request under the Freedom of Information Act 1982 regarding:

“1. Please supply documents with the details of the covid
vaccine status for all hospitalisations due to covid for the last 12
months in Australia and elsewhere.

2. Please supply documents with details of the risk/benefit
studies relating to your recommendation and promotion of covid vaccines
for children.

3. Please provide documents outlining the guidelines for declaring a death
a covid death.

4. Please provide documents outlining the guidelines for declaring a death
to be from covid vaccine.

5. Please provide documents outlining the guidelines for declaring a death
to be from other vaccines if it varies from covid vaccine.”

I write to provide you with public information regarding your request.

COVID Vaccine Status for hospitalisations + Guidelines for declaring death
from COVID

With respect to point 1 of your request, the department does not hold
relevant data regarding this. The department only receives the total
number of cases and hospitalisations from each jurisdiction.

o Guidelines for jurisdiction reporting of COVID-19 can be found in
the Coronavirus Disease 2019 (COVID-19) Communicable Disease
Network Australia National guidelines for public health units found
at:
[1]https://www1.health.gov.au/internet/main...
o For more information on how the hospitalisation status of these
cases has been counted, please contact the relevant jurisdictional
Health departments.

Regarding point 3, the relevant line area have advised the following
sources provide for this information:

- [2]https://www.health.gov.au/resources/publ...

- [3]https://www.abs.gov.au/ausstats/abs@.nsf...

Recommendation of COVID vaccine for children

The TGA’s provisional approval of COMIRNATY for use in individuals 5 years
and over
The TGA has provisionally approved the COMIRNATY vaccine for use in
individuals aged five (5) years and older. This decision followed the
provisional approvals granted by the TGA to Pfizer for the use of
COMIRNATY in individuals aged 12 years and older on 22 July 2021, and the
booster dose for use in adults aged 18 years and older on 26 October 2021.
The TGA released a media statement summarising the decision and the
information considered by the TGA. You can access the full statement at:
[4]https://www.tga.gov.au/media-release/pfi...

COMIRNATY has been demonstrated to be highly safe and effective in
children aged 5-11 years. A wide range of clinical and real-world data
gives us confidence in the safety of the vaccine. Before a COVID-19
vaccine can be provisionally approved in Australia, the TGA must establish
the acceptable safety, quality and efficacy of the vaccine based on a
comprehensive evaluation of a wide range of information. This includes
clinical studies, non-clinical and toxicological studies, chemistry, risk
management and manufacturing information.

A large team of clinical and scientific experts at the TGA carefully
review this data and seek advice from the Advisory Committee on Vaccines
(ACV), an independent clinical expert committee, prior to a senior medical
officer making a regulatory decision. Even though this is an expedited
process, no element of the evaluation is rushed, and no data are
overlooked. A vaccine is only provisionally approved by the TGA if this
rigorous process is completed and the benefits are considered to be much
greater than any potential risks. As part of the provisional approval,
sponsors are also required to continue to submit evidence of longer-term
safety and efficacy to the TGA.

The TGA has also 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 Reports
(AusPARs), the Product Information (PI) and the Consumer Medicine
Information (CMI), and they are made available at:
[5]www.tga.gov.au/covid-19-vaccines. You may be particularly interested in
viewing the AusPAR for the COMIRNATY Extension of indication for use in
individuals 5-11 years and older. This summarises the information and data
considered by the TGA in assessing the risks and benefits (including
safety and efficacy) of the vaccine in the 5-11 years age group.

The TGA’s provisional approval of SPIKEVAX for use in individuals 6 years
and over

The TGA has provisionally approved a paediatric dose of the Moderna
COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 months to less
than 6 years (6 months to 5 years).

In making this regulatory decision, the TGA carefully considered data from
the KidCOVE clinical trial, which was conducted at multiple sites
throughout Canada and the United States and included over 6000
participants aged 6 months up to 6 years. The study demonstrated that the
immune response to the vaccine in children was similar to that seen in
young adults (18 to 25 years) with a favourable safety profile.

Clinical trials also showed that the safety profile in children is similar
to that seen in adults. Most adverse events seen in clinical trials in
children aged 6 months up to 6 years were mild-moderate and generally
reported after the second dose. These included irritability/crying,
redness and/or swelling at injection site, fatigue, fever, muscle pain and
axillary (groin) swelling or tenderness.

The AusPAR related to the extension of indication for the SPIKEVAX vaccine
for use in individuals aged 6months to 5 years can be found here:
[6]https://www.tga.gov.au/sites/default/fil....
As discussed above, the AusPAR outlines the information and data
considered by the TGA in assessing this vaccine.

Information on safety and effectiveness of COVID-19 vaccines

The COVID-19 vaccines which have received provisional approval in
Australia have each been shown to be safe and highly effective in
preventing severe illness, hospitalisation, and death from COVID-19. The
pivotal clinical trials supporting the safety and effectiveness of
vaccines in the provisionally approved age groups have been peer-reviewed,
published in reputable medical journals and are publicly available. With
respect to the Pfizer vaccine, the following articles are published in the
New England Journal of Medicine:

· “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.
Accessible at: [7]https://www.nejm.org/doi/full/10.1056/NE...

· “Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19
Vaccine in Adolescents”. Accessible at:
[8]https://www.nejm.org/doi/full/10.1056/NE...

· “Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11
Years of Age”. Accessible at:
[9]https://www.nejm.org/doi/full/10.1056/NE...

The studies listed above demonstrate the safety and efficacy of the Pfizer
vaccine in children. Although the severity of COVID-19 is generally
considered to be less in children, young people can become seriously
unwell and die from COVID-19. Newer SARS-CoV-2 Variants of Concern have
demonstrated increased transmissibility across all age groups and are
associated with an increased risk of developing COVID-19 for children in
the absence of vaccination. In Australia, adolescents and children have
accounted for a higher proportion of disease throughout recent outbreaks,
in the context of vaccinated older age groups. Therefore, vaccination is
highly important for reducing the priority health outcomes of severe
disease, hospitalisation, and death. Non-health impacts, including
decreased school participation which is known to adversely impact
long-term outcomes, also need to be considered.

Information published by the National Centre for Immunisation Research and
Surveillance (NCIRS), which is the leading research organisation in
Australia that provides expert advice on immunisation, on the risk of
COVID-19 in educational settings is available at:
[10]https://www.ncirs.org.au/covid-19-in-sch....

In addition to clinical trial results demonstrating that the vaccine is
highly effective and that most side effects are mild and transient,
real-world evidence on the safety of this vaccine in children aged 5-11
years is rapidly accumulating overseas. The TGA will continue to monitor
this data as part of its enhanced vaccine safety monitoring system,
outlined below.

ATAGI Recommendations on the Pfizer vaccine for use in individuals 5 years
and over

Distribution of the COVID-19 vaccine is also subject to final
considerations and recommendations from the vaccination experts on the
Australian Technical Advisory Group on Immunisation (ATAGI), and other
related approvals. ATAGI has published detailed recommendations on the use
of the paediatric Pfizer COVID-19 vaccine in children aged 5 to 11 years
in Australia, accessible at:

[11]https://www.health.gov.au/sites/default/....

ATAGI recommends vaccination with the paediatric Pfizer COVID-19 vaccine
for all children aged 5-11 years. This recommendation is based on a
detailed analysis of all of the risks and benefits of vaccination for
children. This includes any risk of side effects and consideration of the
direct and indirect benefits of protecting children against COVID-19.
While children were excluded from initial trials in the early stages on
vaccine development, the Pfizer clinical trial and safety expansion
population included a large number of children who received the vaccine.

The TGA’s role in monitoring, investigating and responding to adverse
events

Regarding items 4 and 5 of your request, the Department of Health and Aged
Care, which includes the TGA, does not determine circumstances or cause of
death – this is the role of certifying medical practitioners and/or the
coroner in the relevant state or territory. Therefore, the Department does
not hold documents outlining the guidelines for declaring a death from a
vaccine. To assist, I have provided some information below to clarify the
TGA’s vaccine safety role.

The TGA collects and closely monitors adverse event reports for
therapeutic goods including medicines and vaccines. Adverse events
describe medical conditions, signs or symptoms which may or may not be
associated with a particular outcome – therefore, death is considered an
outcome rather than an adverse event itself. Reporting an adverse event
and publication in the Database of Adverse Event Notifications on the TGA
website does not mean the event was related to the vaccine. There might be
no relationship between the adverse event and the vaccine - it may be a
coincidence and/or related to an underlying illness or other factors.

All adverse event reports are included in TGA’s safety monitoring database
and subject to regular statistical analyses of these data to detect rare
or emerging safety signals. In addition to adverse event analysis, vaccine
surveillance staff closely monitor the medical literature, media and other
potential sources of new safety information. The TGA also collaborates
with international regulators to review global safety data.

The TGA carefully reviews all adverse events after vaccination where a
fatal outcome is reported. For each report, a team of staff including
doctors and nurses, consider the strength of the evidence for a potential
link between vaccination and the adverse event. The purpose of this review
is to assess whether the reported adverse event represents an emerging
safety concern with the vaccine rather than determine the individual cause
of death. It is important to note that determining a definite causal link
between a vaccine and an adverse event is usually not possible.

Any adverse events with a fatal outcome which the TGA considers are likely
to be causally linked to COVID-19 vaccination are included in a
fortnightly safety report published on the TGA website. All safety reports
remain publicly available at:
[12]www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report.

If the TGA considers that an adverse event report or cluster of reports
represents a potential new safety concern that could change the positive
benefit–risk balance of a vaccine, expert advice may be sought, for
example from a Vaccine Safety Investigation Group. This was the case when
rare reports of blood clots with low blood platelets (known as TTS)
emerged as a new safety concern with the Vaxzevria (AstraZeneca) vaccine.
The TGA summarises the outcomes of such assessments for COVID-19 vaccines
and publishes them in the fortnightly safety report mentioned above.

If any of the above activities confirms a safety signal, the TGA will take
prompt and appropriate regulatory action. The type of action depends on
the nature of the safety issue identified, including its likelihood and
severity, 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.

I trust that this information assists you. We would be grateful for a
response indicating whether you are satisfied with this information by COB
Wednesday 21 September 2022. If we do not receive a response by this date,
your request will be considered withdrawn on the basis that the
information you requested is publicly available.

Kind regards

Freedom of Information

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

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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 Fearnley

I refer to our email to you dated 15 September 2022 in which the TGA
provided publicly available information in response to your email dated 1
September 2022.

I write to advise you that your request has been deemed withdrawn, as no
response was received from you within the timeframe notified in the email
below.

Should you have any questions regarding this matter, please do not
hesitate to 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: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

[3][IMG][4][IMG][5][IMG]

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: Thursday, 15 September 2022 4:09 PM
To: [FOI #9336 email]
Cc: TGA FOI <[email address]>
Subject: FW: Freedom of Information request - Covid vaccine [SEC=OFFICIAL]