Department Reference: FOI 3175
Mr Matthew Peos
Via email:
xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx
Dear Mr Matthew Peos
NOTICE OF DECISION UNDER SECTION 24A
OF THE FREEDOM OF INFORMATION ACT 1982
Thank you for your request of 4 October 2021 to the Department of Health seeking
access under the
Freedom of Information Act 1982 to documents related to COVID-19.
Your request is in the following terms:
Current statistics outlining:
1.
Reinfection rates of vaccinated people in Australia
2.
Reinfection rates of vaccinated people Globally
3.
Reinfection rates of unvaccinated people in Australia
4.
Reinfection rates of unvaccinated people Globally
5.
Deaths of vaccinated people in Australia
6.
Deaths of vaccinated people Globally
7.
Deaths of Unvaccinated people in Australia
8.
Deaths of Unvaccinated people Globally
9.
Rates of infection increase in highly vaccinated areas
10.
Rates of infection increase in highly unvaccinated areas
11.
Recovery rate of infected populous in vaccinated people
12.
Recovery rate of infected populous in unvaccinated people
13.
Statistics of Recorded adverse reactions in vaccinated people.
14.
Statistics of recorded type of adverse reactions.’
Information about COVID-19 case numbers and deaths
Information on COVID-19 cases and associated deaths, including the
epidemiological aspects, can be found on the department’s website:
• Daily case summary of cases:
https://www.health.gov.au/news/health-
alerts/novel-coronavirus-2019-ncov-health-alert/coronavirus-covid-19-
current-situation-and-case-numbers
• Daily infographic, including previous versions dating back to 5 April 2020:
https://www.health.gov.au/resources/collections/coronavirus-covid-19-at-
a-glance-infographic-collection
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• Communicable Diseases Intelligence COVID-19 epidemiology fortnightly
report:
https://www1.health.gov.au/internet/main/publishing.nsf/Content/novel
_coronavirus_2019_ncov_weekly_epidemiology_reports_australia_2020.htm
COVID-19 cases and associated deaths are reported daily to the department by the
states and territories. National notification data on COVID-19 confirmed cases,
including associated deaths (based on the below definitions), is collated in the
National Interoperable Notifiable Diseases Surveillance System (NINDSS) based on
notifications made to state and territory health authorities under the provisions of
their relevant public health legislation. The national case definitions for COVID-19
cases and COVID-19 associated deaths are provided in the
Communicable Diseases
Network Australia COVID-19: National Guideline for Public Health Units which is
available here:
https://www1.health.gov.au/internet/main/publishing.nsf/Content/cdna-song-
novel-coronavirus.htm.
• For surveillance purposes, a COVID-19 associated death is defined as a death
in a confirmed COVID-19 case, unless there is a clear alternative cause of
death that cannot be related to COVID-19 (e.g. trauma). There should be no
period of complete recovery from COVID-19 between illness and death.
Where a Coroner’s report is available, these findings are to be observed.
The NINDSS has implemented fields to capture data on the vaccination status of
COVID-19 cases. These fields have been implemented to allow the monitoring of the
vaccination status of cases, including for people vaccinated outside Australia. Most
jurisdictions are collecting this data, and are in the process of modifying their
systems to be able to report these data to the NINDSS, however at this stage, data
completeness for these fields are not nationally representative. It is recommended
that state and territory health departments be contacted to seek this information.
• Information on the current vaccination status of COVID-19 cases in NSW,
including those associated with the current Delta outbreak, are being reported
by NSW Health in their COVID-19 weekly surveillance report, which can be
accessed via this link:
https://www.health.nsw.gov.au/Infectious/covid-
19/Pages/weekly-reports.aspx.
Additionally, data and information on deaths certified as due to COVID-19 are
routinely collated and reported by the Australian Bureau of Statistics (ABS). For
recent COVID-19 mortality data from the ABS, we suggest the ‘Provisional Mortality
Statistics’ reports. The ABS also publishes finalised cause of death data annually.
• The ABS finalised annual cause of death data and monthly provisional
mortality statistics are available at:
https://www.abs.gov.au/statistics/health/causes-death
• These reports provide information on doctor certified deaths and their
registered causes, including deaths due to COVID-19, noting that there is an
approximate 3 month lag on these data. Please note that these data are
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provisional, and do not include deaths that have been referred to a coroner.
Further information on the provisional report methodology can be found at:
https://www.abs.gov.au/methodologies/provisional-mortality-statistics-
methodology/jan-2020-may-2021.
The department does not hold documents on rates of infection geographically based
on vaccination coverage. Data to support such an analysis are available via the
following data request mechanism.
Request for national notification case data
National notification data on COVID-19 confirmed cases, including COVID-19
associated deaths and by vaccination status, is collated in the NINDSS based on
notifications made to state and territory health authorities under the provisions of
their relevant public health legislation (noting that the vaccination status fields are
not currently provided by all jurisdictions). A request for the release of data from the
NINDSS requires agreement from states and territories via the Communicable
Diseases Network Australia. Depending on the sensitivity of the data sought, and
proposed use, ethics approval may also be required.
• For information on how to apply to access data from the NINDSS please
contact the NINDSS Data Requests inb
ox (xxxxx.xxxxxxxxxxxx@xxxxxx.xxx.xx
Deaths of vaccinated and unvaccinated people in Australia
As of 10 November 2021, there have been 1858 deaths of people in Australia with
COVID-19. Information on the number of vaccinated and unvaccinated people who
died with COVID-19 may be available on State and Territory health websites.
NSW Health released a report on 4 November 2021 about the number of deaths in
vaccinated and unvaccinated people in NSW. It is available at:
https://www.health.nsw.gov.au/Infectious/covid-19/Documents/covid-19-
surveillance-report-20211104.pdf. From 16 June 2021 to 23 October 2021, of the 499
people who died in NSW, 66 were fully vaccinated, 62 were partially vaccinated and
360 had no effective dose.
Deaths of vaccinated and unvaccinated people globally
There have been over 5 million deaths of people with COVID-19, as of 10 November
2021. More information is available at
: https://coronavirus.jhu.edu/map.html.
The data on vaccination and unvaccinated people may have been captured by
individual countries but is not available on a global scale. More information is
available by visiting the public health websites of individual countries.
4
UK Health Security Agency released COVID-19 Vaccine Surveillance Reports,
including the number of infections, hospitalisations and death in vaccinated and
unvaccinated populations. It is available at:
https://www.gov.uk/government/publications/covid-19-vaccine-weekly-
surveillance-reports
Information about COVID-19 vaccination rates by locations
Vaccination rates by Local Government Area are available on the department’s
website at
: https://www.health.gov.au/resources/publications/covid-19-
vaccination-local-government-area-lga-8-november-2021
Individual states may collate Vaccination Data by LGA and Cases by LGA, which is
available on State and Territory health websites.
Information about COVID-19 vaccine adverse reactions
The Therapeutic Goods Administration (TGA) is responsible for monitoring the
safety of all vaccines approved for use in Australia. The TGA closely assesses safety
data prior to approval, and continues to monitor the safety of vaccines after they are
registered in Australia so that any safety concerns can be detected and responded to.
Active surveillance is also occurring through the AusVaxSafety surveillance system,
which sends follow up messages to recipients of COVID-19 vaccines to ask if they
have experienced any potential side effects.
More information about adverse events can be found in the TGA COVID-19 Vaccine
Weekly Safety Report, available at
: https://www.tga.gov.au/covid-19-vaccine-
safety-monitoring-and-reporting
Reporting of an adverse event and the publication of an adverse event in the
Database of Adverse Event Notifications does not mean the event was related to a
vaccine. There might be no relationship between the adverse event and the medicine
or vaccine – it may be a coincidence that the adverse event occurred when the
medicine or vaccine was taken, and the symptom may be related to the underlying
illness or to other factors. Expert analysis and review of adverse event reports is
needed to determine whether there may be a link between reported events and
vaccination. The Database of Adverse Event Notifications is available on the TGA
website here:
https://www.tga.gov.au/database-adverse-event-notifications-daen
The TGA analyses adverse event report data and reviews individual reports to
identify possible safety issues for investigation. If these investigations confirm a
safety signal, the TGA takes appropriate action. There is not a predefined number of
adverse event reports that leads to removal of a product from the market because the
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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.
Information about approval, safety and efficacy of COVID-19 vaccines
Before a prescription medicine (including a COVID-19 vaccine) can be legally
supplied in Australia, the TGA rigorously assesses the safety, quality and
effectiveness to determine if the benefits outweigh the risks.
The COVID-19 vaccines which have received provisional approval in Australia have
each been shown to be highly effective in preventing severe illness, hospitalisation,
and death from COVID-19, caused by SARS-CoV-2. The risk of a person infected
with the SARS-CoV-2 virus developing symptomatic illness and becoming seriously
unwell with COVID-19 is significantly reduced if that person has received a
COVID-19 vaccine. For each provisionally approved vaccine, the TGA has
established the acceptable safety, quality and efficacy of the vaccine based on a
comprehensive evaluation of a wide range of information.
The TGA has published a range of regulatory documents relating to the provisional
approval of each COVID-19 vaccine, which provide detailed information regarding
the evaluation process and the data that was considered. These include the
Australian Public Assessment Report, the Product Information and the Consumer
Medicine Information, and they are available at
: www.tga.gov.au/covid-19-
vaccines.
The TGA has also published several documents in response to previous FOI requests
on the TGA’s Disclosure Log at:
www.tga.gov.au/foi-disclosure-log. These
documents offer a useful summary and analysis of the data submitted to the TGA for
the purposes of making a regulatory decision regarding the provisional approval of
COVID-19 vaccines. You may be particularly interested in FOI 2389 (FOI documents
1 – 7) in relation to the Pfizer vaccine and FOI 2494 (FOI documents 1 – 7) in relation
to the AstraZeneca vaccine. Please note, some commercially confidential information
and personal information has been redacted from these documents.
Clinical trials to support vaccine registration are typically conducted by sponsors
(pharmaceutical companies) of those vaccines and published in medical journals.
Data from the same trials are submitted by the sponsor to the TGA as part of the
provisional registration application.
The following 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.
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AstraZeneca:
• Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against
SARS-CoV-2: an interim analysis of four randomised controlled trials in
Brazil, South Africa, and the UK.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-
1/fulltext
• Single-dose administration and the influence of the timing of the booster dose
on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a
pooled analysis of four randomised trials.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00432-
3/fulltext
• Global Statistical Analysis Plan for the combined integrated analysis of
studies of ChAdOx1 nCoV-19 (AZD1222) vaccine.
https://ars.els-cdn.com/content/image/1-s2.0-S0140673620326611-mmc2.pdf
Pfizer:
• Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
• Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in
Adolescents.
https://www.nejm.org/doi/full/10.1056/NEJMoa2107456?query=featured_
coronavirus
Moderna:
• Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.
https://www.nejm.org/doi/full/10.1056/NEJMoa2035389
• Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents.
https://www.nejm.org/doi/10.1056/NEJMoa2109522?url_ver=Z39.88-
2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed#article_A
bstract
Johnson & Johnson
•
Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19, the
New England Journal of Medicine.
https://www.nejm.org/doi/full/10.1056/NEJMoa2101544
•
Analysis of the Effectiveness of the Ad26.COV2.S Adenoviral Vector Vaccine for
Preventing COVID-19, JAMA Network.
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2785664
Information about COVID-19 infection and reinfection rates
The department does not hold data documentation that disaggregates the reinfection
rates among vaccinated or unvaccinated people in Australia. This data information
may be available from State and Territory health departments as mentioned above.
7
However, the following international reports on reinfection among vaccinated and
unvaccinated cases are available publicly:
•
Rate and severity of suspected SARS-Cov-2 reinfection in a cohort of PCR-
positive COVID-19 patients:
•
Clinical Microbiology and Infection -The durability of immunity against
reinfection by SARS-CoV-2: a comparative evolutionary study – ScienceDirect
•
Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity:
reinfections versus breakthrough infections (medrxiv.org)
Data on the reinfection rates of vaccinated and unvaccinated people globally has
been captured by individual countries but is not available on a global scale. More
information is available by visiting the public health websites of individual countries
A study conducted by the US Center for Disease Control in Kentucky from May –
June 2021, indicated that the risk of being reinfected was 2.34 times higher for those
who were unvaccinated, compared with being fully vaccinated.
Australia’s Federal system
Australia has a ‘Federal’ or ‘Commonwealth’ Government, and separate
Governments for each of the States and Territories. Under Australia’s federalism
system, power is shared between the different Governments, which limits their
powers. Each Government is also comprised of separate departments and agencies.
While departments and agencies work together to achieve outcomes, they have
different responsibilities. Each Commonwealth, State and Territory department and
agency creates, receives and stores different documents relevant to their functions.
The department does not have access to all documents created by, received by, or
stored by, other Commonwealth, State or Territory government entities.
State and Territory Health website links
NSW Health Data is available at:
https://www.nsw.gov.au/covid-19/stay-safe/data-and-statistics
Victoria Health Data is available at:
https://www.coronavirus.vic.gov.au/victorian-coronavirus-covid-19-data
ACT Health Data is available at:
https://app.powerbi.com/view?r=eyJrIjoiZTY4NTI1NzQtYTBhYy00ZTY4LTk3Nm
QtYjBjNzdiOGMzZjM3IiwidCI6ImI0NmMxOTA4LTAzMzQtNDIzNi1iOTc4LTU4N
WVlODhlNDE5OSJ9
NT Health Data is available at:
https://coronavirus.nt.gov.au/current-status
QLD Health Data is available at:
https://www.qld.gov.au/health/conditions/health-alerts/coronavirus-covid-
19/current-status/statistics
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SA Health Data is available at:
https://www.covid-19.sa.gov.au/home/dashboard
TAS Health Data is available at:
https://www.coronavirus.tas.gov.au/facts/tasmanian-statistics
WA Health Data is available at:
https://experience.arcgis.com/experience/359bca83a1264e3fb8d3b6f0a028d768
FOI decision
I am authorised under subsection 23(1) of the FOI Act to make decisions in relation
to Freedom of Information requests. I am writing to notify you of my decision in
response to your request.
The FOI Act provides a mechanism for individuals to request access to documents
held by relevant entities. It is not a mechanism for asking questions or seeking
information that the entity does not hold in documents.
Appropriate steps have been taken to find documents you have requested including
consultation with relevant departmental officers and searches of departmental file
management systems.
I am satisfied, on the basis of the consultation undertaken and the searches
conducted, that the department, including the TGA, that the information sought in
your request is available in the public domain as described above.
FOI review rights
If you are dissatisfied with my decision, you may apply for a review.
Internal review
Under section 54 of the FOI Act, you may apply for internal review of this decision.
In accordance with section 54B of the FOI Act, an application for internal review
must be made in writing within 30 days after the day you are notified of this
decision (or such further period as the department allows). To assist in the internal
review process, please provide reasons you consider the review of my decision is
necessary.
The internal review will be carried out by another officer of this department within
30 days of receipt of your application.
An application for an internal review should be addressed to:
Email:
xxx@xxxxxx.xxx.xx
Mail: FOI Unit (MDP 516)
Department of Health
GPO Box 9848
9
CANBERRA ACT 2601
Information Commissioner review
Alternatively, under section 54L of the FOI Act, you may apply to the Office of the
Australian Information Commissioner (OAIC) for review of my decision by the
Information Commissioner (IC).
In accordance with subsection 54S(1) of the FOI Act, an IC review application in
relation to a decision covered by subsection 54L(2) (access refusal decisions) must be
made in writing within 60 days after the day you are notified of this decision (if you
do not request an internal review).
More information about IC review is available on the OAIC website at:
https://www.oaic.gov.au/freedom-of-information/reviews/
The OAIC can be contacted by:
Phone: 1300 363 992
Email:
xxxxxxxxx@xxxx.xxx.xx
Complaints
If you are dissatisfied with action taken by the department, you may also make a
complaint.
Complaint to the department
Complaints to the department are covered by the department’s privacy policy. A
form for lodging a complaint directly to the department is available on the
department’s website:
https://www.health.gov.au/about-us/contact-us/complaints
Complaint to the IC
Information about making a complaint to the IC about action taken by the
department is available on the OAIC website:
https://www.oaic.gov.au/freedom-of-information/reviews-and-complaints/make-
an-foi-complaint/
Relevant provisions of the FOI Act
The FOI Act, including the provisions referred to in this letter, can be accessed from
the Federal Register of Legislation website:
https://www.legislation.gov.au/Details/C2021C00382
Contacts
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If you require clarification of any of the matters discussed in this letter you should
contact the department’s Freedom of Information Unit on (02) 6289 1666 or at
xxx@xxxxxx.xxx.xx.
Yours sincerely
Stephen Bouwhuis
General Counsel
Advice and Legislation Branch
6 November 2021