The Time of COVID

The Time of COVID
A Report by Phillip M. Altman

BPharm(Hons), MSc, PhD
Clinical Trial & Pharmaceutical Regulatory Affairs Consultant
9 August 2022
Contributing editors
Julian Gillespie LLB, BJuris
Associate Professor Peter Parry
MBBS, PhD, FRANZCP
Katie Ashby-Koppens LLB
Appended:
Australian COVID-19 vaccines Adverse Event Summary & Analysis
Lisa Mitchell BSc., MAppStats, MBA FAICD
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Foreword
I am pleased and proud to endorse the attached letter and monograph, meticulously compiled
by Dr Phillip Altman and his colleagues. They address some important aspects of COVID19
management and policy, especially in Australia, with a focus on the nature, deployment and
effects of “vaccines”. It is abundantly clear that there has been repression and suppression
in scientific circles and the media of any views or suggestions that run counter to the govern-
ment/mainstream narrative. However, many studies now indicate that the Covid19 vaccines,
especially the mRNA vaccines, are less than 'safe and effective', and the ramifications are
truly confronting. Armed with these facts, the scientific and medical communities can now
begin proper discussions of potential solutions that improve the benefit/risk ratios for the public
and do not harm careers and livelihoods of professionals seeking the best outcomes for their
patients.
Wendy Hoy AO FAA FRACP

Professor of Medicine
Director, Centre for Chronic Disease
University of Queensland
Brisbane, Australia
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Index
PART A: Background – COVID-19 Gene-Based ‘Vaccines’
1. The Nature of the COVID-9 Gene-Based ‘Vaccines’
2. Regulatory Status of the COVID-19 Gene-Based ‘Vaccines’
3. How the Gene-Based COVID-19 ‘Vaccines’ Work
4. Threat Posed by SARS-CoV-2
5. Initial Perceptions of the COVID-19 ‘Vaccines’
6. Risk of SARS-CoV-2 Infection in Children
PART B: Emerging Picture of the Safety and Efficacy of the COVID-19

‘Vaccines’
7. Failure to Demonstrate a Favourable Risk/Benefit Case for

Vaccinating Children with COVID-19 ‘Vaccines’
8. Serious Adverse Effects of the COVID-19 ‘Vaccines’
9. Potential Toxicity of the Spike Protein Produced by Gene-Based

‘Vaccines’
10. Long-Term Potential Genetic Damage and Cancer Potential

of COVID-19 ‘Vaccines’
11. mRNA Does Not Remain at the Injection Site and Is Not Rapidly
Destroyed
12. COVID-19 ‘Vaccines’ Do Not Prevent Infection or Transmission
13. Diminished ‘Vaccine’ Efficacy and Potential Negative ‘Vaccine’ Efficacy
14. The COVID-19 ‘Vaccines’ Do Not Provide a Similar and

Acceptable Risk/Benefit Across All Age Groups irrespective
of individual Clinical Status including Natural Immunity
Conclusion
Appendix A: Curriculum Vitae – Dr Phillip M. Altman

Appendix B: Australian COVID-19 vaccines Adverse Event Summary & Analysis
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PART A: Background - COVID-19 Gene-Based ‘Vaccines’
1. The Nature of the COVID-19 Gene-Based ‘Vaccines’
1.1. The nature of the COVID-19 ‘vaccines’ has been largely misrepresented by
mainstream media, big pharmaceutical companies, and governments, and is
consequently poorly understood by the population at large. Most people consider
vaccines to be relatively safe and well researched and readily accept their widespread
use.
1.2. However, these COVID-19 ‘vaccines’ are not really vaccines – they are serious gene-
based therapies which employ a gene-based technology which has never before been
deployed in a fully approved therapeutic product. In this sense they should properly
be considered to be experimental, and much safety and efficacy information has been
gained since the introduction of these products more than a year ago.
1.3. COVID-19 ‘vaccines’ as a therapeutic fall under the US Food and Drug Administration
(FDA) Office of Cellular, Tissue, and Gene Therapies’ definition of “gene therapy
products”, in that it involves “introducing a new or modified gene into the body to help
treat a disease”1. Despite this, the FDA did not evaluate this therapy in relation to the
established gene therapy guidelines. Gene therapies have never been widely used in
a general population.
2. Regulatory Status of the COVID-19 Gene-Based ‘Vaccines’
2.1. On or about the following dates, the TGA granted conditional Provisional Approval of
the following gene-based ‘vaccines’:
• COMIRNATY Pfizer Australia Pty Ltd – a mRNA vaccine (25 January 2021)
• Pfizer paediatric vaccine has been Provisionally Approved (3 December 2021) 5-
11 years
• VAXZEVRIA AstraZeneca Pty Ltd – a viral vector vaccine (15 February 2021)
• COVID-19 VACCINE Janssen-Cilag Pty Ltd – a viral vector vaccine (25 June 2021)
• SPIKEVAX Moderna Australia Pty Ltd, - a mRNA vaccine (9 August 2021)
• Moderna paediatric vaccine has been Provisionally Approved (17 February 2022)
6-11 years & 6 month to 5 years (19 July 2022)
• NUVAXOVID Novavax Inc. – a non-gene protein-based vaccine delivering spike
protein in a lipid-nanoparticle matrix carrier (19 January 2022)
2.2. The TGA receives technical and policy advice from the Australian Technical Advisory
Group on Immunisation (ATAGI). Members of ATAGI have both academic and clinical
interests in vaccine research. The TGA relies heavily upon the recommendations of
ATAGI in relation to the efficacy, safety and use of vaccines. Many government and
1
What is Gene Therapy? (25/7/2018) US-FDA https://www.fda.gov/vaccines-blood-biologics/cellular-gene-
therapy-products/what-gene-therapy
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private corporate entities rely, in many cases exclusively, upon the health policy advice
issued by ATAGI. The TGA also receives advice from the Advisory Committee on
Vaccines (ACV) in relation to safety, quality and efficacy of vaccines supplied in
Australia.
2.3. Provisional Approval is a relatively new drug regulatory pathway introduced into the
Therapeutic Goods Act in 2018. Under this expedited review system, therapeutic
agents (including vaccines) can be made available for use when there is a perceived
urgent need to use a drug even though the amount of ordinary safety and efficacy data
normally required to approve that drug is not available. The manufacturer is required
by the TGA to submit additional safety and efficacy data over a defined period to
answer specific important outstanding safety and efficacy issues not completed or
concluded before the product is Provisionally Approved. Products released under
“Provisional Approval” cannot be considered fully evaluated. Under these
circumstances and because there is pending or outstanding safety and efficacy data
to be generated and evaluated, it is premature to declare such drugs “safe and
effective”, and the use of these agents needs to be constantly under review in light of
emerging safety data to reassess the risk versus any perceived benefit.
2.4. The new generation COVID-19 ‘vaccines’ have not been fully ‘approved’ by the
Australian drug regulator – all these products have been “Provisionally Approved” due
to deficiencies in the normal scope and depth of safety and efficacy data normally
required for full approval. This is of particular importance in relation to vaccine
mandates in so far as the regulatory status of these products establish without any
doubt that important safety and efficacy concerns remain in relation to the use of these
products. In such circumstances, forcing individuals on a massive scale to receive
such serious medications with potentially unknown and serious adverse
consequences, including death, using coercive vaccination mandates, is without
precedence in medicine.
2.5. Conventional vaccines usually take about 7 years to develop and test. In a 2018
publication sponsored by the Bill and Melinda Gates Foundation 2, vaccines were
divided into three categories: simple, complex and unprecedented.
2.6. The unprecedented category represents those vaccines directed towards a disease
that has never before been successfully treated and include vaccines against HIV and
malaria. According to authors Seneff and Nigh3 unprecedented vaccines are expected
to take more than 12 years to develop due to the technical difficulties, and they are
expected to have a very low chance (about 5%) of proving safety and efficacy in even
early Phase II clinical trials involving small numbers of individuals, and a very much
lower chance (about 2%) of moving to larger Phase III clinical trials and demonstrating
safety and efficacy before being considered for marketing. The gene-based COVID-
2
Young, R., Bekele, T., Gunn, A., Chapman, N., Chowdhary, V., Corrigan, K., Yamey, G. (2018).
Developing New Health Technologies for Neglected Diseases: A Pipeline Portfolio Review and Cost Model. Gates
Open Res 2:23. https://doi.org/10.12688/gatesopenres.12817.2
3
Seneff, S and Nigh, G; (10/05/2021) Worse Than the Disease? Reviewing Some Possible Unintended
Consequences of the mRNA Vaccines Against COVID-19. International Journal of Vaccine Theory, practice and
Research: 2(1) https://ijvtpr.com/index.php/IJVTPR/article/view/23
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19 ‘vaccines’ were developed in less than a year and are supported by abbreviated
safety and efficacy clinical data. These gene-based ‘vaccines’ are in the
‘unprecedented’ category.
2.7. Historically, a large number of conventional vaccines have been withdrawn due to
safety concerns following widespread use. These include vaccines for Yellow Fever,
polio, smallpox, Dengue fever, measles, respiratory syncytial virus, Swine flu,
rotavirus, papillomavirus and influenzae.
3. How the Gene-Based COVID-19 ‘Vaccines’ Work
3.1. These ‘vaccines’ use a genetic technology which has not been employed for any fully
approved drug and in this sense the use of these products should properly be
considered experimental. This technology, due to its inherent safety risks, has
previously only been investigated in relatively early clinical research for possible use
in certain cancers and rare genetic disorders. These products deliver either RNA in a
lipo-nanoparticle (which has never been used previously) or DNA genetic material
contained in a viral vector to produce the spike protein, similar to that found on the
surface of the coronavirus, in order to provoke an immune response. It is the spike
protein which is now known to be the main toxic component of the SARS-CoV-2
coronavirus. It is also the spike protein produced by these ‘vaccines’ which is
understood to cause the unprecedented number of serious adverse events and death
being reported following vaccination in various international adverse drug reporting
systems.
3.2. All COVID-19 ‘vaccines’ employ new generation nanoparticle technology: either non-
viral or viral based nanoparticles4. The extremely small size of nanomaterials also
means that they are much more readily taken up by the human body than larger sized
particles. Nanomaterials are able to cross biological membranes and access cells,
tissues and organs that larger sized particles normally cannot5. Such wide and
efficient distribution following administration has significant implications in relation to
organ and tissue toxicity as compared to conventional vaccines which largely remain
at the site of injection. Specifically, nanoparticles may cross the blood-brain barrier
(the membrane protecting the spinal cord and brain) and they may be associated with
long term inflammation in various tissues and organs, and they may be associated
with cardiovascular adverse effects.6
4
Kisby, T. et al (August 2021) Reasons for success and lessons learnt from nanoscale vaccines against
COVID-19. Nature Nanotechnology Vol. 16, pp 843-852 https://www.nature.com/articles/s41565-021-00946-9.pdf
5
Holsapple M, Farland W, Landry T, Monteiro-Riviere N, Carter J, Walker N and Thomas K (2005).
Research strategies for safety evaluation of nanomaterials, Current Challenges and Data needs. Toxicological
Sciences 88(1):12-17 https://academic.oup.com/toxsci/article/88/1/12/1662948
6
Nanotechnology and Health Risks (April, 2008), Health and Environment Alliance https://www.env-
health.org/IMG/pdf/17-_NANOTECHNOLOGY_AND_HEALTH_RISKS.pdf
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4. Threat Posed by SARS-CoV-2
4.1. The threat posed by SARS-CoV-2 coronavirus in producing the COVID-19 infection to
segments of the community has been exaggerated due to the nature of the polymerase
chain reaction (PCR) test used to detect “cases”. The PCR test as used in Australia
and elsewhere was set (cycle threshold value: “Ct”) to be exquisitely sensitive and
could produce a positive result even if no live virus was present or even if a fragment
of a single viral particle was present. A survey of the utility of PCR tests reported that
positive PCR tests set to a Ct of 35 only correlated with a positive culture in 3% of
cases7. In Australia and elsewhere, the PCR Ct was normally set at even higher values
conferring less reliability. The PCR test was never intended to be diagnostic for
COVID-19 due to this attribute. Individuals testing positive for COVID-19 frequently
have very low viral loads and are asymptomatic (show no symptoms) and are
incapable of transmission of the virus due to their low viral loads. Children, in
particular, are at virtually nil threat of serious COVID-19 infection (see below). Some
estimates suggest that up to 97% of COVID positive cases” detected by PCR detected
no virus on culture and therefore were of questionable value 8. Indeed, so grave are
the many limitations and lack of reliability attributable to PCR tests, that external peer
review revealed 10 major scientific 9 flaws that resulted in strong calls for the
retraction10 of the Corman-Drosten paper,11 published by Eurosurveillance.
4.2. In recognition of the limitations of the PCR testing, these tests are no longer
considered generally appropriate by the US Center for Disease Control (CDC) in
determining the number of COVID-19 cases and their emergency use authorisation
has been withdrawn reflecting this fact12.
4.3. COVID-19 government statistics represent another complicating factor. There is no

discrimination between those individuals in hospital or intensive care “dying with”
COVID-19 as opposed to ‘dying from’ COVID-19. Patients in hospital for serious non-
COVID-19 related illness are routinely tested for COVID-19 and often return a positive
test. These patients are routinely recorded as “COVID cases” and this can be
misleading.
7
Jaafar, R. et al (2020) Correlation between 3790 Quantitative Polymerase Chain Reaction-Positives Samples and
Positive Cell Cultures, Including 1941 Severe Acute Respiratory Syndrome Coronavirus 2 Isolates Clinical Infectious
Diseases, Volume 72, Issue 11, 1 June 2021, page e921. 28 September 2020
https://pubmed.ncbi.nlm.nih.gov/32986798/
8
Jaafar, R., Aherfi, S., Wurtz, N., et al (2021) Correlation between 3790 Quantitative Polymerase Chain
Reaction-Positives Samples and Positive Cell Cultures, Including 1941 Severe Acute Respiratory Syndrome
Coronavirus 2 Isolates Clinical Infectious Diseases, Volume 72, Issue 11, 1 June 2021, Page e921,
https://doi.org/10.1093/cid/ciaa1491
9
Borger, P et al (November 2020) External peer review of the RTPCR test to detect SARS-CoV-2 reveals 10
major scientific flaws at the molecular and methodological level: consequences for false positive results
https://cormandrostenreview.com/report/
10
Borger, P et al (November 2020) Retraction request letter to Eurosurveillance editorial board
https://cormandrostenreview.com/retraction-request-letter-to-eurosurveillance-editorial-board/
11
Corman, V et al (January 20202 Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR,
Eurosurveillance, Volume 25, Issue 3
12
CDC Laboratory Alert (07/21/2021) Changes to CDC RT-PCR for SARS-CoV-2 Testing
https://www.cdc.gov/csels/dls/locs/2021/07-21-2021-lab-alert-Changes_CDC_RT-PCR_SARS-CoV-
2_Testing_1.html
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4.4. According to the Australian Bureau of Statistics up to 15 February 202213 “There are
2,639 death registrations that have been received by the ABS where an individual is
certified as having died from or with COVID-19 between the start of the pandemic and
31 January 2022”. The median age for those who died from COVID-19 was 83.7 years
(81.2 years for males, 86.0 years for females) among individuals reasonably assumed
to have multiple serious co-morbidities. COVID-19 is an infection principally causing
more serious illness in older individuals.
4.5. Australian government Department of Health website: Coronavirus (COVID-19) case

numbers and statistics (updated 7 May 2022) states there have been a total of
6,165,105 “cases” of COVID-1914. This translates to a death rate of COVID-19 of
0.0428% (for those ‘dying with’ COVID-19). COVID-19 was only the 38th leading cause
of death in Australia reported in 2020 statistics. With the delta then Omicron waves
since late 2021, deaths with COVID-19 have risen, but data where it is available, as in
NSW, indicate that proportions of hospitalisations and deaths are as high or higher
among vaccinated than among unvaccinated people (see 13.11 below).
4.6. The NSW Respiratory Surveillance Report ending 23 July 2022 states: ‘146 COVID-
19 deaths were reported this week, a 3% increase from 142 reported last week. All
146 deaths were eligible for a third dose of COVID-19 vaccine…..’, indicating that there
were no deaths reported for unvaccinated individuals15.
4.7. To place these numbers in perspective, the number of deaths due to influenza reported
by the Australian Bureau of Statistics increased steadily from 68 in 2011 to 274 in
2016, and rose sharply to 1,183 in 201716. When grouped, influenza and pneumonia
contributed to 4,369 deaths in 2017 and were the ninth leading cause of death for the
year. During 2018, influenza and pneumonia were the twelfth leading cause of death
(n = 3,102 deaths).
4.8. No statistic is available regarding the number of Australians ‘dying from’ COVID-19.
The total number of Australians ‘dying from’ COVID-19 would be some fraction of the
total deaths reported. Officially reported ‘COVID-19 deaths’ do not discriminate
between those dying “with” COVID-19 and those dying “due to” COVID-19. Some
government websites make this clear17.
4.9. The impact of COVID-19 varies depending on the age group. There is no Australian
statistic available to demonstrate that any otherwise healthy child died ‘due to’ or ‘from’
COVID-19.
13
Australian Bureau of Statistics: Causes of Death, Australia: Doctor Certified Deaths, Summary Tables.
Reference Period 2019. https://www.abs.gov.au/statistics/health/causes-death/causes-death-australia/latest-release
14 TGA COVID-19 vaccine weekly safety report (23 June 2022) https://www.tga.gov.au/periodic/covid-19-
vaccine-weekly-safety-report-23-06-2022
15
NSW Respiratory Surveillance Report – ending 23 July 2022.
16
Australian Government Department of Health (2018) Communicable Diseases Intelligence. Report of the
National Influenza Surveillance Scheme 2011 to 2018. Year 2022 Volume 46. Communicable Disease Epidemiology
and Surveillance Section https://doi.org/10.33321/cdi.2022.46.12
17
NSW COVID-19 WEEKLY DATA OVERVIEW: www.health.nsw.gov.au/coronavirus
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4.10. The lack of information on the actual cause of death in children in these rare instances
makes any assessment of the risk of death due to COVID-19 in this age group tenuous.
The risk of death due to COVID-19 may range from exceedingly rare to virtually and
statistically nil.
4.11. There is emerging evidence that the COVID-19 gene-based ‘vaccines’ are showing
rapid and significant diminished efficacy against the Omicron variant, particularly in
children aged 5-11.18
4.12. Some useful information regarding COVID-19 ascribed deaths in the UK was obtained
by a Freedom of Information Request (FOI/2021/3368), showing the number of deaths
where COVID-19 was the only cause mentioned on the death certificate, from 1
February 2020 to 31 December 2021, by sex and age group in England and Wales19.
This data (presented below as a downloaded Excel table) is important because it is a
record where COVID-19 is the only listed possible cause of death, and it covers a
period where the most virulent strain of SARS-CoV-2 was circulating in the global
population.
Age group Males Females

<1 1 0
1-4 0 0
5-9 0 0
10-14 0 1
15-19 1 0
20-24 4 1
25-29 12 3
30-34 24 7
35-39 42 15
40-44 52 24
45-49 87 43
50-54 138 52
55-59 234 92
60-64 254 102
65-69 279 119
70-74 357 204
75-79 395 252
80-84 492 402
85-89 470 533
90+ 520 971
4.13. This data supports the view of a virtually or statistically near nil risk of death due to
COVID-19 in very young children, adolescents, and adults through to middle-aged.
18
Dorabawila, V. et al (February 2022) Effectiveness of the BNT162b2 vaccine among children 5-11 and 12-
17 years in New York after the Emergence of the Omicron Variant. MedRxiv preprint
https://www.medrxiv.org/content/10.1101/2022.02.25.22271454v1
19
UK Office of National Statistics FOI/2021/3368. Released 17 January 2022.
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4.14. Another study in children and young people (<18 years of age) in the UK covering
12,023,568 individuals, from March 2020 to February 2021, examined the records of
3,105 who died including 61 who were positive for SARS-CoV-220.
4.15. This study is instructive, in that it describes in detail an evaluation process which
should normally be conducted in evaluating whether or not an individual’s death can
be ascribed to COVID-19, in light of pre-existing co-morbidities. Many reports of
“COVID deaths” do not attempt to discriminate or ascribe causality to this level, and
therefore are of limited usefulness. This study was done at a time when the more
virulent strain of SARS-CoV-2 was dominant, and it could be assumed to significantly
overstate the risk of death due to the current Omicron variant which has been dominant
during 2022 worldwide21.
4.16. Despite the potential for this study to overestimate the risk of death in 2022, the authors
conclude:
“…the risk of serious outcomes from SARS-CoV-2 for individuals under 18 years of
age remains extremely low” - and even considering child deaths where COVID-19 was
not the sole cause, the authors conclude – “we estimated the infection fatality rate to
be five per 100,000 indicating that more than 99.995% of children and young people
recover from SARS-CoV-2 infection.”
5. Initial Perceptions of the COVID-19 ‘Vaccines’
5.1. Initially, despite limited clinical and epidemiological data, a number of community and
health professional perceptions were widely held in relation to these new vaccines
including:
• the vaccines prevent infection by the SARS-CoV-2 virus and subsequent

COVID-19 developing (COVID-19 being the disease caused by the virus)
• the vaccines prevent transmission of the SARS-CoV-2 virus from infected to
non-infected individuals
• the vaccines would provide durable immunity
• the vaccines are 95% effective
• the vaccines are safe and effective
5.2. In light of more than a year of widespread COVID-19 vaccination usage all these initial
perceptions have been shown to be without foundation. It is undisputed that COVID-
20
Smith, C et al: Deaths in children and young people in England after SARS-CoV-2 infection during the first
pandemic year. Nature Medicine; Vol 28, Jan. 2022, 185-192. https://doi.org/10.1038/s41591-021-01578-1
21
WANG, L. et al: COVID infection severity in children under 5 years old before and after Omicron
emergence in the US. Preprint - doi: https://doi.org/10.1101/2022.01.12.22269179;
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19 is commonplace in fully vaccinated individuals and now multiple boosters are being
recommended at relatively frequent intervals. The current COVID-19 ‘vaccines’ have
lost effectiveness against the emerging variants – to many, they have failed. However,
the incidence of serious adverse events from these gene-based ‘vaccines’ continue to
be reported and continue to rise in unprecedented number and severity. 22
5.3. A good example of the popular misconceptions concerning the gene-based COVID-
19 ‘vaccines’ is the claim of 95% efficacy which was repeated and unchallenged in the
mainstream media and by health authorities in Australia and elsewhere.
5.4. Approval of the gene-based COVID-19 ‘vaccines’ were based on single clinical trials
from each company. These single trials were the sole basis for both the safety and
efficacy claims. For example, in the case of the Pfizer gene-based ‘vaccine’ it was
widely stated and generally accepted at the time that the clinical efficacy of the vaccine
was determined in a large clinical trial of about 44,000 subjects and the efficacy was
95%.
5.5. Without an understanding of the design, conduct and reporting of clinical trials, the
ordinary person might interpret this statement in a number of different ways. For
example, this “95%” efficacy might be interpreted to mean that vaccination provides a
95% chance of being protected from being infected following exposure from a person
infected with SARS-CoV-2; or it might be interpreted to mean that vaccination reduces
the risk of the average healthy person falling seriously ill and needing hospitalisation
following SARS-CoV-2 infection; or it might be interpreted as showing the risk of death
due to severe COVID-19 illness is reduced by 95%.
5.6. Indeed, none of these interpretations are correct.
5.7. The claimed 95% efficacy was based upon only 170 subjects who contracted COVID-
19 during the trial which had a median follow up of two months post-second dose. The
claimed clinical efficacy was not based upon 44,000 subjects. Of the 44,000 subjects
enrolled and divided roughly equally between receiving active prophylactic vaccination
or placebo, only 170 subjects tested positive for COVID-19 AND developed even mild
COVID-19 symptoms (similar to the common cold) which was the criterion set for
“clinical efficacy”; with eight testing positive in the vaccinated group AND displaying a
COVID-19 symptom as mild as a sore throat, fever or cough, while 162 tested positive
in the placebo group AND displayed a COVID-19 symptom as mild as a sore throat,
fever or cough. This is where the 95% COVID “vaccine” efficacy claim originated and,
based on this pivotal data, it should not be inferred that the Pfizer COVID-19 “vaccine
was shown to be 95% effective in preventing serious COVID-19 disease, symptoms,
hospitalisation or death”23.
22
US Adverse Event Reporting System (VAERS) – open data – through to 29 April 2022
https://openvaers.com/covid-data RECORDED 27,758 deaths reported as related to the COVID-19 vaccines.
23
Australian Government – Therapeutic Goods Administration (25 January 2021) Australian Public
Assessment Report for BNT162b2 (mRNA), Comirnaty, Pfizer Australia Pty Ltd – PM-2020-05461-1-2 Final
https://www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna-210125.pdf
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5.8. The Pfizer trial (mentioned above) reported 99.07% of unvaccinated individuals did not
develop symptoms of COVID-19 while 99.95% the vaccinated group did not report
COVID-19 symptoms thus producing an absolute risk reduction of symptoms of 0.88%.
This statistic is a realistic measure of protection from COVID-19 (which may only
present as mild symptoms) in an uninfected population over the trial surveillance
period.
5.9. A subsequent Pfizer COMIRNATY gene-based COVID-19 ‘vaccine’ trial which was
pivotal in the approval of this ‘vaccine’ for children 5-11 relied on the clinical symptoms
of only 19 children (3 developed symptoms in the Comirnaty vaccine group and 16 in
the placebo group) upon which to base its claimed a relative clinical efficacy of
90.7%.24 Once again, the claimed clinical efficacy only referred to the chance of
preventing the mild symptoms, similar to the common cold, in children who tested
positive for COVID-19. The absolute vaccine clinical efficacy to prevent even mild
symptoms among the 4500 trial participants can then be calculated to be under 1%.
5.10. A similar approach was adopted by other manufacturers such as Moderna claiming
similar “efficacy” which has not been understood by either the media or the lay public.
6. Risk of SARS-CoV-2 Infection in Children
6.1. All therapeutic agents, including vaccines, present a safety risk. Therefore, the risk-
benefit analysis of any medication needs to be weighed up.
6.2. Drug regulatory agencies now recognise that most children with COVID-19 have either
no symptoms (asymptomatic) or have only mild symptoms.
6.3. I have searched without success for evidence and statistics for the incidence of severe
COVID-19 and death due principally to COVID-19 in children aged 5-11 in New
Zealand and Australia.
6.4. Some information appears in the Australian TGA AusPAR (Public Assessment Report)
Pfizer mRNA Vaccine COMIRNATY dated December 2021, which was used to
approve the Pfizer COVID-19 vaccine for children 5-11 years of age. On page 11 of
this Australian report, Table 1 (below) includes COVID-19 “cases” in Australia by age
24
Australian Government – Therapeutic Goods Administration (7 December 2021) Australian Public
Assessment Report for Tozinameran (mRNA Covid-19 vaccine), Comirnaty, Pfizer Australia Pty Ltd– PM-2021-
05012-1-2 https://www.tga.gov.au/sites/default/files/auspar-tozinameran-mrna-covid-19-vaccine-211207.pdf
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group and highest level of illness severity – 1 January 2021 to 10 October 2021 the
numbers of children in age group 0-4 and 5-11 are presented. It reports that over more
than a nine month period in 2021 (at a time that the more virulent stains of SARS-CoV-
2 were prevalent) that one person under 18 years of age died either “with” or “due to”
COVID-19.
Table 1: COVID-19 “cases” in Australia by age group and highest level of illness
severity – 1 January 2021 to 10 October 2021
6.5. A search of the Risk Management Plan report released by Pfizer in February 2022
reviewed all available US COVID-19 cases and deaths to 14 August 2021. The
incident of death in children who tested positive to COVID-19 in ages 0-4 and 5-11
years was listed as “<0.1%” for each group25. This statistic, once again, does not
distinguish between those children dying “with” COVID-19 or “due to” COVID-19.
6.6. The above data sets are consistent with studies26 showing the mortality rate in children
hospitalised with COVID-19 of less than 0.18%, which is less than the mortality rate
25
See European Medicines Agency COMIRNATY (COVID-19 mRNA VACCINE) RISK MANAGEMENT
PLAN Version number: 5.0, page 21 https://www.ema.europa.eu/en/documents/rmp-summary/comirnaty-epar-risk-
management-plan_en.pdf;
Leidman, E (et al) (January 2022) COVID-19 Trends Among Persons Aged 0-24 Years – United States, March 1-
December 12, 2020, CDC https://www.cdc.gov/mmwr/volumes/70/wr/mm7003e1.htm
26
Patel, N Paediatric (September-October 2020) COVID-19: Systematic review of the literature Am J
Otolaryngol. 2020 Sep-Oct;41(5):102573. doi: 10.1016/j.amjoto.2020.102573. Epub 2020 Jun 6. PMID: 32531620;
PMCID: PMC7833675. https://pubmed.ncbi.nlm.nih.gov/32531620/;
Ludvigsson, J, (March 2020) Systematic review of COVID-19 in children shows milder cases and a better prognosis
than adults AXTA https://onlinelibrary.wiley.com/doi/10.1111/apa.15270
13
The Time of Covid

seen in children from seasonal influenza.27 These figures correlate with further findings
showing 46.7% of children 0 to 18 years 28 being asymptomatic upon infection.
PART B: Emerging Picture of the Safety and Efficacy of the COVID-19 ‘Vaccines’
7. Failure to Demonstrate a Favourable Risk/Benefit Case for Vaccinating

Children with COVID-19 ‘Vaccines’
7.1. Table 1 above, shows that no children died and 4 aged 5-11 were admitted to Intensive
Care Units (ICU), however, as indicated previously in this report, it is important to
distinguish between those children admitted to ICU “from COVID-19” or “with COVID-
19”. It is possible that at least some of these children were admitted for serious co-
morbidities (as often is the case), but coincidentally tested positive for COVID-19. Until
this reasonable possibility is ruled out, this information should not be relied upon as
evidence that children suffer, to any meaningful extent, serious disease caused by
COVID-19.
7.2. In reality, the risk of COVID-19 death in an otherwise healthy 5-11 year-old is virtually
or statistically nil. Investigations of extremely rare cases have been poorly
characterised, and it is unclear to what extent any reported death is directly attributable
to COVID-19 as opposed to pre-existing medical conditions. A Johns Hopkins study
published in July 2021 monitoring 48,000 children diagnosed with COVID-19 found a
mortality rate of zero among children without a pre-existing medical condition.29
7.3. As COVID-19 is now known to rarely produce serious disease in children, this should
have significant impact upon the risk-benefit analysis of using the gene-based
‘vaccines’ which have known serious short-term serious adverse effects, including
death, and potentially serious unknown longer term adverse effects in this age group.
8. Serious Adverse Effects of the COVID-19 ‘Vaccines’
8.1. Very limited relatively short-term safety data is available from the individuals involved
in the controlled clinical trials submitted to drug regulatory agencies in support of the
27
Baht, N et al (December 2005) Influenza-Associated Deaths among Children in the United States, 2003–
2004 N Engl J Med 2005; 353:2559-2567, DOI: 10.1056/NEJMoa051721
https://www.nejm.org/doi/full/10.1056/nejmoa051721;
Tingting, S et al (August 2019) Mortality risk factors in children with severe influenza virus infection admitted to the
paediatric intensive care unit Medicine: August 2019 - Volume 98 - Issue 35 - p e16861 https://journals.lww.com/md-
journal/fulltext/2019/08300/mortality_risk_factors_in_children_with_severe.25.aspx
Fleming, D (July 2005) Mortality in children from influenza and respiratory syncytial virus Journal Epidemiol
Community Health; 59(7): 586–590 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1757088/ ;
Sachedina, N (November 2010) Paediatric mortality related to pandemic influenza A H1N1 infection in England: an
observational population-based study The Lancet, VOLUME 376, ISSUE 9755, P1846-1852, NOVEMBER 27, 2010
https://www.thelancet.com/journals/lanonc/article/PIIS0140-6736(10)61195-6/fulltex;
Statista (October 2021) Influenza mortality rate during the 2019-2020 flu season in the United States, by age group*
https://www.statista.com/statistics/1127799/influenza-us-mortality-rate-by-age-group/
28
Pratha, S (August 2021) Asymptomatic SARS-CoV-2 infection: A systematic review and meta-analysis
PNAS https://www.pnas.org/doi/abs/10.1073/pnas.2109229118?url_ver=Z39.88-
2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed
29
Makari, M (19/07/21) The Flimsy Evidence Behind the CDC’s Push to Vaccinate Children, Wall St. J,
https://www.wsj.com/articles/cdc-covid-19-coronavirus-vaccine-side-effects-hospitalization-kids-11626706868
14
The Time of Covid

emergency authorisations or provisional approvals of the COVID-19 ‘vaccines’. As
such, there is a heavy reliance upon post-marketing adverse drug reaction report
(ADR) systems to identify the type and incidence of adverse effects which are caused
by the ‘vaccines’. There are a number of such systems. Australia has the Drug
Adverse Event Reporting system (DAEN), and the US has the Vaccine Adverse
Events Reporting System (VAERS) which reports both US and international adverse
events.
8.2. The problem with these systems is that they involve voluntary reporting and most
doctors are reluctant to report adverse drug reactions to vaccines due to fear of being
accused by health regulators (Australian Health Practitioner Regulatory Agency,
AHPRA) of being considered to be “anti-vax”.30 Many doctors both here and overseas
and other health professionals fear losing their licence to practice if they even apply
for vaccine exemptions, and many investigations are currently underway by AHPRA
at the present time. Also, the criteria for assessing a causal relationship between a
vaccine and an adverse event can be set so high that only a small percentage of
serious adverse events or deaths are officially reported as being caused by a vaccine.
These are some of the reasons why it is widely acknowledged all adverse event
reporting systems suffer from notorious underreporting31. This can result in an
underreporting factor of between 10-30 or more, i.e.: one must multiply the official
incidence of adverse events by 10-30, to obtain a real-world estimate of the true
incidence of the adverse event. For US VAERS reporting in respect of the Covid-19
‘vaccines’, the underreporting factor (URF) is estimated to be between 40x-49x32.
8.3. In Australia, it is difficult to obtain statistics regarding details of the number of deaths
caused by the gene-based ‘vaccines’. A Freedom of Information request (FOI-3586)
was made to the TGA for data on the deaths reported as possibly related to the
COVID-19 ‘vaccines’ and the 196-page report is available online but is almost
completely redacted.33 In the US the VAERS adverse drug reporting system has
recorded 27,758 deaths associated with gene-based “vaccine” administration through
to 29 April 2022. The TGA COVID-19 vaccine weekly safety report released 23 June
202234 indicates a total of 889 deaths in association with COVID-19 gene-based
‘vaccines’ of which only 13 have been identified by the TGA as definitely causing
death. However, there are no public details available as to the criteria used by the
TGA in arriving at this number of 13 deaths. This reported incidence of death does
not account for any underreporting factor.
30
https://caldronpool.com/the-ahpra-inquisition-against-australian-health-professionals/ ; see point 9 in
https://support.mips.com.au/home/12-commandments-to-avoid-ahpra-notifications ;
https://www.ahpra.gov.au/News/2021-03-09-vaccination-statement.aspx ; an open letter to the American Board of
Medical Specialties and the Federation of State
Medical Boards: The destruction of Member Boards' credibility (26 June 2022) http://drelef.org/2022-open-letter-
fsmb-abms/pmc-support-letter-final.pdf
31
https://scholar.google.com.au/scholar?hl=en&as_sdt=0%2C5&as_vis=1&q=EMA+ADR+under-
reporting&btnG= ; https://vaers.hhs.gov/data/dataguide.html
32
https://stevekirsch.substack.com/p/latest-vaers-estimate-388000-americans
https://jessicar.substack.com/p/the-true-under-reporting-factor-urf
33
Response to Australian Freedom of Information request FOI-3586: The age of deceased for all reported
adverse events resulting in death for events reported against any of the TGA approved COVID-19 vaccine
https://www.tga.gov.au/sites/default/files/foi-3586-01.pdf
34
https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report-23-06-2022
15
The Time of Covid

8.4. Further confounding a proper of assessment of reported deaths is the complete lack
of guidance or directions from the TGA or State or Territory health departments, with
respect to any requirement to conduct autopsies on persons dying at any time post
COVID-19 vaccination. This is an unfortunate state of affairs when it is known to the
TGA as a consequence of its Pharmacovigilance duties, that by employing new
histopathological methods developed in Germany, that identify the mRNA generated
spike proteins at the scene of fatal pathological inflammatory reactions, deaths that
could be easily attributed to a 'normal' heart attack, or a 'normal' stroke, are now
instead being found to have been caused by COVID-19 vaccines. Critically, in the
German studies, of the 15 deceased examined, deaths due to the vaccines were found
to be 'likely' and 'very likely' in 80% of cases.35
8.5. Prior to COVID-19 vaccinations, over the last 10 years there has been an average of
about 155 deaths per year reported in relation to all conventional vaccines to the US
VAERS. This includes all standard childhood vaccines on vaccine schedules, annual
flu vaccines, travel vaccines, hepatitis, human papilloma virus vaccines, tetanus
vaccines, meningococcal vaccines and herpes vaccines.
8.6. The website OpenVAERS extracts VAERS data each week specifically in relation to
adverse event reports for the Covid-19 ‘vaccines’. An inspection shows the contrast
in reported mortality for the gene-based COVID-19 ‘vaccines’ compared to all other
vaccines combined since 1990.36
Table 2: All reported potential vaccine deaths to VAERS since 1990 to VAERS
35
Documents available, but see the recent presentation here: https://odysee.com/@en:a5/Pathology-
Conference_Burkhardt_Presentation_EN_20220311:7
36
US Adverse Event Reporting System (VAERS) – open data- https://openvaers.com/covid-data
16
The Time of Covid

8.7. Statistics on the number of flu vaccines administered over many years is provided by
the US CDC37, and range from about 110 million per year to more than 190 million per
year since 2008. Similarly, there have been more people who have received
measles/mumps/Rubella vaccinations (301,000,000) than COVID-19 vaccinations
(255,000,000) since VAERS commenced reporting in 199038.
8.8. The relatively high number of adverse reports received by the VAERS (hosted by the
US CDC) relative to other commonly used vaccines, is also seen in both of the other
two major adverse drug reporting systems: VigiAccess (hosted by WHO) and
EudraVigilance (hosted by the European Medicines Agency)39.
8.9. Dr. Jessica Rose, specialist data analyst, has focused her attention on the US VAERS
data and published on the general ADR data as well as specifically in relation to
myocarditis.40
37 Centers for Disease Control and Prevention – Historical Reference of Seasonal influenza Vaccine Doses
Distributed. Revised 4 August 2021. https://www.cdc.gov/flu/prevent/vaccine-supply-historical.htm
38
Covid-19 Vaccine Pharmacovigilance Report. World council for Health. Updated 4
August 2022.Worldcouncilforhealth.org: https://worldcouncilforhealth.org/resources/covid-19-vaccine-
pharmacovigilance-report
39
Covid-19 Vaccine Pharmacovigilance Report. World council for Health. Updated 4
August 2022.Worldcouncilforhealth.org: https://worldcouncilforhealth.org/resources/covid-19-vaccine-
pharmacovigilance-report
40
Rose, J (2021) A report on US Vaccine Adverse Events Reporting system (VAERS) of the COVID-19
Messenger Ribonucleic Acid (mRNA) Biologicals. Science, Public Health Policy, and the Law. Volume 2:59-80, May
2021. Clinical and Translational Research.
https://www.datascienceassn.org/sites/default/files/VAERS%20Report%20on%20Covid19%20Vaccine%20mRNA%2
0Biologicals%20-%20May%2C%202021.pdf
17
The Time of Covid

8.10. As of 22 April 2022, in the United States alone there had been recorded 5,309 cases
of myocarditis, 782,665 adverse events, 151,796 severe adverse events, and 14,613
deaths in VAERS following COVID-19 vaccination.41 Every adverse drug reaction
report needs to be individually assessed to rate the probability of causing any particular
adverse reaction – not all reports are assessed as “causal”. On the other hand, the
underreporting factor can range from 5 to perhaps as high as 31 times42 or more.
8.11. The confounding assessment factors of underreporting of adverse effects on one

hand, and the possible lack of evidence of causation on the other hand in relation to
deaths caused by vaccines, can be resolved to a large degree by an examination of
the statistics of death temporally associated with vaccine administration.
8.12. Dr. Jessica Rose has analysed the percentage of individuals experiencing adverse
effects within 24- and 48-hour periods in relation to COVID-19 vaccine administration.
8.13. Of particular interest is the Rose analysis of VAERS % reported deaths following
vaccination with the gene-based vaccines versus the number of days following
injection43. This analysis included a graphical representation of the temporal
relationship between the number of deaths reported in association with COVID-19
vaccine administration and the time of death measured in days following injection.
In relation to the widely accepted Bradford Hill criteria for the assessment of adverse
drug reactions, a close temporal relationship between drug administration and the
adverse event represents some of the strongest evidence upon which to assign a
cause-effect relationship.
The following graphical representation depicts the percent of reported deaths versus
the number of days following injection of a COVID-19 “vaccine” (data ending
December 2021) showing a clustering of deaths within about 2 days of administration
(orange line) compared to an expected background incidence of a hypothetical event
which is not related temporally to vaccine administration (yellow line).
41
US Adverse Event Reporting System (VAERS) - https://vaers.hhs.gov
42
Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting System
(VAERS) a Functioning Pharmacovigilance System? Jessica Rose, The Institute for Pure and Applied Knowledge.
Vol 3:100-129, Oct. 2021. https://cf5e727d-d02d-4d71-89ff-
9fe2d3ad957f.filesusr.com/ugd/adf864_0490c898f7514df4b6fbc5935da07322.pdf
43
Jessica Rose VAERS adverse event data analysis - presentation December 2021
https://maatsmethods-
my.sharepoint.com/:p:/g/personal/peter_maatsmethod_com_au/EVmwPI2cfDROiI2ad9z7TWkB9DJUVzvy3t0h8yhb
dV41SQ?rtime=mlpjZxh72kg
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The Time of Covid

Further evidence to support the cause-effect relationship between death and COVID-19
“vaccine” administration may be seen by comparing the similar characteristic temporal
relationship between anaphylaxis and reported deaths. In this respect, anaphylaxis is
used as a positive control to assist the interpretation of the data.
19
The Time of Covid

Another important temporal relationship extracted from the VAERS data is shown below
between the incidence of myocarditis and COVID-19 “vaccine” administration.
8.14. The abovementioned analyses are short-term analyses, i.e. observations within days,
weeks or months of vaccination. No long-term safety data is available for the COVID-
19 gene-based vaccines. The long-term safety of the gene-based vaccines is
completely unknown and there are potentially serious concerns which will only be
resolved many years into the future. These concerns are based on the identification
of pathogenic attributes of the spike protein and include profound disturbances in
regulatory control of protein synthesis and natural cancer surveillance protective
mechanisms, a potentially causal link to neurodegenerative disease, immune
thrombocytopenia, Bell’s palsy, liver disease, impaired adaptive immunity, impaired
DNA damage response and tumorigenesis.
8.15. It has been suggested that the increase in deaths temporally associated with the
introduction of the gene-based ‘vaccines’ is not due to these new ‘vaccines’ but rather
due to increased numbers of injections overall. However, this explanation does not
appear valid as the COVID-19 vaccines represent a small proportion of all vaccines
given in the US since 1990. For example, just considering flu vaccines, it has been
reported that since the 08/09 flu season a total of 1,720,400,000 flu vaccines were
administered while only 557,637,223 doses of the COVID-19 vaccines were
administered in the USA. Many other types of vaccines are routinely used.
20
The Time of Covid

8.16. A detailed summary and analysis of the adverse drug reactions reported in association
with the COVID-19 gene-based “vaccines” is presented as an addendum to this
Report44
Focus on Myocarditis and Pericarditis
8.17. Of all the serious more short-term adverse events receiving attention in relation to the
gene-based COVID-19 vaccines, myocarditis has probably received the most attention
due to the seriousness of the condition (can cause permanent heart damage and be
fatal) and its potential to affect longevity especially in the younger age groups with a
predominance among younger males.
8.18. In analysing the possible incidence of myocarditis associated with the gene-based
vaccines, it is useful to compare the historical rates of myocarditis prior to the
introduction of these vaccines with the rate associated with the vaccine rollouts (Pfizer,
Moderna and Janssen) during 202145.
8.19. It appears that there is a risk of myocarditis from both COVID-19 infection (especially
in the elderly population) and from gene-based COVID-19 vaccines – both considered
to be related to the toxic spike protein. The US Center for Disease Control (CDC) has
attempted to discriminate between the two causal factors in order to arrive at a risk of
myocarditis caused by the vaccines. If there is a risk of people contracting myocarditis
from SARS-CoV-2 then this would appear to be negligible, as no health authority has
produced a report or meaningful evidence that SARS-CoV-2 significantly elevates the
risk of myocarditis.
8.20. The risk of myocarditis, pericarditis and cardiac arrhythmias associated with several
gene-based COVID-19 ‘vaccines’ or SARS-CoV-2 infection itself was studied in a large
case series study of people aged 16 or older in England between 1 December 2020
and 24 August 2021.46
8.21. In this large study the temporal relationship between the gene-based vaccines and
myocarditis was seen in the subgroup analysis by age showing an increased risk of
myocarditis associated with the two mRNA vaccines in those younger than 40 years
of age. Subgroup analysis was only performed for myocarditis. While those under 16
years of age were not studied it is widely recognised and accepted that younger males
are most at risk of myocarditis. In addition, the authors state:
‘Our findings are relevant to the public, clinicians and policy makers. First, there was
an increase in the risk of myocarditis within a week of receiving the first dose of both
44
Mitchell, Lisa: Summary and analysis on adverse drug reactions regarding COVID-19 vaccines submitted to the
Australian Drug Adverse Event Notification (DAEN) system (5 August 2022)
45
Rose, J and McCullough P (September 2021) A Report on Myocarditis Adverse Events in the U.S. Vaccine
Adverse Events Reporting system (VAERS) in Association with COVID-19 injectable Biological Products. Current
Problems in Cardiology https://drtrozzi.org/wp-content/uploads/2021/12/Rose-J-McCullough-PA-Myocarditis-in-
VAERS-Curr-Prob-Cardiol-2021.pdf
46
Patone, M et al, (December 2021) Risks of myocarditis, pericarditis, and cardiac arrhythmias associated
with COVID-19 vaccination or SARS-CoV-2 infection Nature Medicine, 28, pages410–422 (2022)
21
The Time of Covid

adenovirus and mRNA vaccines, and a higher increased risk after the second dose of
both mRNA vaccines.’
‘Myocarditis is underdiagnosed in practice, with clinical bias being directed towards

myocardial ischemia or infarction.’
8.22. In a nationwide study in France involving 32 million people aged 12-50 years of age
and receiving 46 million doses of mRNA vaccines, 1,612 cases of myocarditis and
1,613 cases of pericarditis occurred in France between 12 May 2021 and 31 October
2021.47 The risk of myocarditis and pericarditis for both the Pfizer and Moderna mRNA
COVID-19 vaccines was found to be increased both after the first and second doses.
The risk of this association was statistically significant and particularly evident for the
Moderna COVID-19 ‘vaccine’ where the risk of myocarditis/pericarditis was increased
30 times suggesting a dose-response relationship, given Moderna has 100
micrograms of mRNA and COMIRNATY has 30 micrograms of mRNA per dose. The
risk was increased in younger age groups. The incidence of both myocarditis and
pericarditis reported in this study was consistent with the incidence reported in other
countries.
8.23. Another study from Israel investigated the incidence of myocarditis and pericarditis in
post COVID-19 unvaccinated patients.48 This is an important study because some
have argued that the myocarditis and pericarditis incidence observed in populations
may be due to COVID-19 and not due to COVID-19 ‘vaccines’. This retrospective
cohort study of 196,992 adults following COVID-19 infection and 590,976 control
adults who tested negative for COVID-19 concluded:
‘Post COVID-19 infection was not associated with either myocarditis or pericarditis.
We did not observe an increased incidence of either pericarditis nor myocarditis in
adult patients recovering from COVID-19 infection.’
8.24. Aside from being under-diagnosed in practice, it is generally known that many doctors
avoid reporting myocarditis and other serious possible adverse events in relation to
the gene-based vaccines for fear of being seen as critical of the national health COVID-
19 vaccination policies, and possible health regulator intimidation and retribution. This,
combined with the inherent underreporting of adverse events in general, suggest the
true incidence of adverse effects such as myocarditis may be much higher than
officially reported. This needs to be considered in the calculation of the risk-benefit
analysis.
8.25. This is most recently outlined in an Australian Government report on Guidance on

Myocarditis and Pericarditis after mRNA COVID-19 Vaccines dated 29 April 2022 –
47
Le Vu, S. (2022) Age and sex-specific risks of myocarditis and pericarditis following Covid-19 messenger
RNA vaccines. NATURE COMMUNICATIONS (2022) https://www.nature.com/articles/s41467-022-31401-5
48
Tuvali, O et al: (2022) The Incidence of Myocarditis and Pericarditis in Post COVID-19 Unvaccinated
Patients – a Large Population-Based Study. J. Clin. Med. 2022, 11, 2219. https://doi.org/10.3390/jcm11082219
22
The Time of Covid

rates of myocarditis per million doses by age cohort and sex (see Table 1 below
reproduced image from the report).49
Table 1 - rates of myocarditis per million doses by age cohort and sex in Australia
Government report on Guidance on Myocarditis and Pericarditis after mRNA COVID-
19 Vaccines dated 29 April 2022
8.26. As of 10 July 2022, since inoculating 5-11 year-olds in Australia began on 10 January
2022, five (5) children were previously reported to have died following receiving a
COVID-19 ‘vaccine’, as recorded by the TGA’s DAEN website Australian Government
Therapeutic Goods Administration, Database of Adverse Event Notifications,50
specifically:
• Case no. 719838 11 Mar 7-year-old male – cardiac arrest, generalised tonic-clonic
seizure.
• Case no. 724023 25 Mar 9-year-old female – cardiac arrest.
• Case no. 724925 28 Mar 6-year-old male – adverse event following immunisation
(which has since been removed).
• Case no. 733723 6 May 10-year-old male – adverse event following immunisation
(which has since been reclassified).
49
Australian Government report (Updated 28 April 2022) Guidance on Myocarditis and Pericarditis after
mRNA COVID-19 Vaccines https://www.health.gov.au/sites/default/files/documents/2022/04/covid-19-vaccination-
guidance-on-myocarditis-and-pericarditis-after-mrna-covid-19-vaccines.docx
50
Australian Database of Adverse Event Notifications (DAEN) https://www.tga.gov.au/database-adverse-
event-notifications-daen
23
The Time of Covid

• Case no. 734187 10 May 5-year-old male – abdominal pain, cardiac arrest.
8.27. Myocarditis and pericarditis are serious medical conditions which may have life-long
consequences and may be life threatening and may affect 5-11 year-old children. As
of 28-7-2022, despite possibly significant underreporting, there have been 37
suspected cases of chest pain (indicative of myocarditis and pericarditis) have been
reported to the DAEN system in this age group51.
8.28. The paediatric COVID-19 gene-based ‘vaccines’ have only been available for a limited
time as compared to the vaccines for the older age groups. But the safety record of
the ‘vaccines’ used in the older age groups is an indicator of the adverse events one
might expect in the younger age groups.
8.29. In this regard, the following information should be taken into consideration:
a. The VAERS database reports that as of 22 April 2022, in the US alone there
were 5,309 cases of myocarditis, 782,665 adverse events, 151,796 severe
adverse events, and 14,613 deaths recorded following COVID-19 vaccination
in the US.52
b. After introduction of the gene-based COVID-19 vaccines in the US, VAERS

quickly accumulated an unusually large number of adverse events. Between
November 3 and December 19, 2021, VAERS received an overwhelming 4,249
adverse reaction reports for children aged five through eleven years who
received the Pfizer COVID-19 COMIRNATY ‘vaccine’.53
8.30. Further, in the documents related to a recent FOIA request, in the Pfizer informed
consent document54 it was revealed that the company recognised the risk of
myocarditis to be as high as 1 in 1,000. Myocarditis is overwhelmingly found in
younger people.
Other Safety Factors and Issues to Consider
8.31. Another factor which needs to be considered is the delay in assessing and reporting
adverse drug events due to the unprecedented number of such events being reported.
Pfizer itself has acknowledged this issue in its cumulative analysis of post-
authorisation adverse event report 5.3.6 of pf-07302048 (bnt162b2), dated 30 April
2021 (Pfizer’s Adverse Events Report) (released in or about November 2021
51
Australian Government Therapeutic Goods Administration COVID-19 Vaccine Safety Report 28-0702022.
https://www.tga.gov.au/periodic/covid-19-vaccine-safety-report-28-07-2022
52
U.S. Adverse Event Reporting System (VAERS) - https://vaers.hhs.gov
53
Hause, A et al (December 2021) COVID-19 Vaccine Safety in Children Aged 5-11 Years – United States
US November 3- December 19, 2021 CDC Report https://www.cdc.gov/mmwr/volumes/70/wr/mm705152a1.htm
54
Pfizer Clinical Trial Informed Consent Document. Cincinnati Children’s Hospital Medical Center (Sub Study
C). Study title: A Study to Evaluate Additional Dose(s) of BNT162b2 in Healthy Individuals Previously Vaccinated
with BNT162b2. CCH IRB Approval Date 4 Jan. 2022. IRB Number: 2021-0430 (page 23)
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pursuant to court ordered disclosure expedited under the Freedom of Information
Act):55
“Pfizer has also taken multiple actions to help alleviate the large increase of adverse
event reports. This includes significant technology enhancements, and process and
workflow solutions, as well as increasing the number of data entry and case processing
colleagues. To date, Pfizer has onboarded approximately 600 additional fulltime
employees (FTEs). More are joining each month with an expected total of more than
1,800 additional resources by the end of June 2021.”56
8.32. During phase III clinical trials for the mRNA COVID-19 vaccine products, safety was
assessed based on a maximum observation period of 6 months. This is not adequate
to assess long-term safety outcomes. A typical timeline of up to 10 years would be
considered appropriate for long-term follow up. There are many examples where
biological products have been recalled (let alone gene-based products) such as the
rotavirus vaccines in 2010, the H1N1 influenza vaccine in 2009 and a meningococcal
vaccine in 2005-2008.
8.33. Data from pivotal clinical trials used to support the gene-based ‘vaccines’ of Moderna,
Pfizer and Janssen were re-analysed by Classen57 to determine ‘all cause severe
morbidity” defined as “severe infections with COVID-19 and all other severe adverse
events between the treatment arms and control arms respectively’. This type of
analysis avoids any bias within the adverse drug reporting system where a cause-
effect assessment might be arbitrarily discounted due to the overly strict criteria
required to establish such a relationship. This analysis found a statistically significant
increase in all cause severe morbidity in the vaccinated group compared to the placebo
group. When all types of severe events were considered, the vaccinated group
suffered more severe adverse events; this suggests the gene-based vaccines are
doing more harm than good.
8.34. In a published paper by a world-expert analyst of the VAERS database for all age
groups, Dr. Jessica Rose58 found that, based on the ratio of expected severe adverse
events to observed adverse events in VAERS for a number of conditions, the
‘underreporting factor (URF)’ for COVID vaccine-associated deaths was 31. Using this
URF for all VAERS-classified severe adverse events, as of October 2021, COVID-19
‘vaccines’ were associated with 205,809 deaths, 818,462 hospitalizations, 1,830,891
55
FDA released document: Pfizer 5.3.6 Cumulative analysis of post-authorization adverse event reports of
pf-07302048 (bnt162b2) received through 28-feb-2021 – page 6
56
The Vault Project: Pfizer Secretly Hired 600+ Employees to Process Flood of COVID Vaccine Adverse
Events. April 7, 2022. Taken from unredacted Pfizer documents. https://thevaultproject.org/pfizer-secretly-hired-
600-employees-to-process-flood-of-covid-vaccine-adverse-events/
57
Classen, J.B: Classen B. (2021) US COVID-19 Vaccines Proven to Cause More Harm than Good Based
on Pivotal Clinical Trial Data Analyzed Using the Proper Scientific Endpoint, “All Cause Severe Morbidity”. Trends Int
Med. 2021; 1(1): 1-6. https://www.semanticscholar.org/paper/US-COVID-19-Vaccines-Proven-to-Cause-More-Harm-
than-Classen/141e12167e43917c679988bc91c91f7b8a6b9671
58
Rose, J (October 2021) Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse
Events Reporting System (VAERS) a Functioning Pharmacovigilance System? The Institute for Pure and Applied
Knowledge. Vol 3:100-129, Oct. 2021 https://cf5e727d-d02d-4d71-89ff-
9fe2d3ad957f.filesusr.com/ugd/adf864_0490c898f7514df4b6fbc5935da07322.pdf
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emergency room visits, 230,113 life-threatening events, 212,691 disabled and 7,998
birth defects."
8.35. Further relevant background information is provided by life insurance industry data for
adults. These data suggest historic increases in death claims coinciding with gene-
based ‘vaccine’ rollouts. A publicly available quarterly report by the Group Life
Insurance Industry, covering roughly 90% of the employer-based policies in the US,
reported that younger age groups were suddenly dying at historically unprecedented
rates beginning in Q3 of 2021.59
8.36. Other evidence of the damage caused by the gene-based ‘vaccines’ comes from the
number of ambulance calls in response to cardiac arrests and acute coronary
syndromes (heart attacks) for young people in the 16–39 age group during the COVID-
19 vaccination rollout in Israel (January–May, 2021) compared with the same period
of time in prior years 2019 and 2020.60
8.37. There is also an alarming and massive rise in deaths among healthy, young
professional athletes from around the world since the COVID-19 vaccination campaign
was initiated. As of 4 June 2022, approximately 1,090 athletes61 suffered a cardiac
arrest, with 715 of them dying as a result. The majority of arrests occurred in
competition or training. The frequency of these events in comparison to historical data
is of great concern. In a 2009 review of professional athletes’ deaths62, published in a
prominent European Cardiology journal, they found that from 1966 to 2004, there was
an average of only 29 sudden athlete deaths per year worldwide. Compare this
number to just the month of January 2022 alone where 127 collapses and 87 deaths
among professional athletes were reported. Overall, these athlete deaths reflect an
approximately 22-fold increase in the year after the introduction of COVID vaccines,
to date unexplained by other identifiable causes.
8.38. Australian Bureau of Statistics data also reflect a similar surge in Excess Deaths
commensurate with the rollout of the ‘vaccines’, where Excess (non-COVID) Deaths
for 2022 already are 17.5% above baseline, as the following graph63 vividly depicts.
59
SOA Research Institute (January 2022) Group Life COVID-19 Mortality Survey Report (page 23)
https://www.soa.org/48ff80/globalassets/assets/files/resources/research-report/2022/group-life-covid-19-mortality.pdf
60
Sun, C.L.F et al (2022) Increased emergency cardiovascular events among under-40 population in Israel
during vaccine rollout and third COVID-19 wave Scientific Reports 12:6978. https://doi.org/10.1038/s41598-022-
10928-z
61
1111 Athlete Cardiac Arrests, Serious Issues, 732 Dead, After COVID Injection. Real Science.
https://goodsciencing.com/covid/athletes-suffer-cardiac-arrest-die-after-covid-shot/
62
Bille, K et al (2006) Sudden cardiac death in athletes The Lausanne Recommendations. Eur J Cardiovasc
Prev Rehabil 2006 Dec;13(6):859-75. doi: 10.1097/01.hjr.0000238397.50341.4a
63
Australian Bureau of Statistics Provisional Mortality Statistics - COVID-19 new infections have been
excluded due to the aforementioned unreliability of PCR testing https://www.abs.gov.au/statistics/health/causes-
death/provisional-mortality-statistics/latest-release
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Table 7 - Australian Bureau of Statistics data reflecting surge in Excess Deaths
commensurate with the rollout of the COVID-19 ‘vaccines’
8.39. New South Wales COVID-19 data for hospital admissions, ICU admissions and deaths
in the 14 days up to 23 July 202264 is shown below. The data shows 693 people with
known vaccination status were admitted to hospital; of these, one person was reported
as unvaccinated. In interpreting this data it is noted that this is at a time when it is
estimated that about 95% of individuals over 16 years of age are reported to be
vaccinated. Also, unvaccinated individuals entering hospital for any reason may be
more likely to be tested for COVID-19 as compared to those individuals who declare
they are vaccinated. Taking these factors into account, the data suggests that Covid-
19 vaccinated individuals are placing relatively higher demands on hospital resources
as compared to the unvaccinated, a trend that has been occurring in 2022.
64
https://www.health.nsw.gov.au/Infectious/covid-19/Documents/weekly-covid-overview-20220723.pdf
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Fertility, Birth Rates, miscarriages, stillbirths and neonatal deaths
8.40. One category of death not normally accounted for in Excess Deaths figures are
stillbirths. After the deployment of COVID-19 ‘vaccines’ in Germany and Scotland,
statistically significant increases in stillbirths, perinatal, and neonatal deaths are now
apparent from late 2021 leading into 202265.
65
Guetzkow, J (July 2022) Springtime for Stillbirths in Germany Winter for women and babies, Substack
https://jackanapes.substack.com/p/springtime-for-stillbirths-in-germany
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8.41. Correspondingly, extraordinarily high drops in birth rates are now apparent in Germany
and Taiwan, with an over 10% decline66 in the former, and an over 25% decline67 in
the latter. Similar declines in birth rates are now also being seen across US states 68,
Sweden69, Canada70, and highly COVID-19 vaccinated Hungary.71
8.42. These declines appear to correlate with data released by Pfizer to regulators on or
shortly after 28 February 202172, where Pfizer reported on outcomes in 270 pregnant
women who received the Pfizer ‘vaccine’. No outcome or follow-up by Pfizer was
provided for 238 of the pregnancies thus undermining any claims of safety in
pregnancy. Of the remaining pregnancies 28 out of 29 babies died, a death rate of
97% in those pregnancies Pfizer did follow-up. Though this Pfizer pregnancy data is
grossly lacking, it nonetheless begs critical questions which regulators have to date
not asked. Regulators should begin asking questions or considering the continued
use of these ‘vaccines’, particularly now when further studies are confirming relatively
high impacts on women’s menstrual cycles 73. Furthermore, data74procured from Pfizer
under Court order show that the Lipid Nanoparticles (LNPs) used as the delivery
vehicle for the synthetic mRNA, extensively bio-distributes throughout the human body
and accumulates in various organs including the kidney, spleen, adrenal glands, testes
and ovaries although ‘vaccine’ recipients were initially informed the ‘vaccines’ would
remain in the deltoid muscle at the site of injection. Although the effects of the
delivered synthetic mRNA upon the various organs studied is currently unknown, many
studies75 show toxic effects of LNPs.
66
Syed, A (July 2022) Children of Men Substack https://arkmedic.substack.com/p/children-of-
men/comments?utm_source=substack&utm_medium=email
67
Chudov, I (July 2022) Taiwan: Birth Rate Dropped -27.66% in June 2022!!!
https://igorchudov.substack.com/p/taiwan-birth-rate-cratered-2766-in
68
Bizuobo (June 2022) Preview: A US state-focused variant on Jikkyleaks birthrate decline thread Substack
https://baizuobu.substack.com/p/preview-a-us-state-focused-variant/comments
69
El Gato Malo (July 2022) Swedish birth rate data: what does it really show us? Substack
https://boriquagato.substack.com/p/swedish-birth-rate-data-what-does
70
Jestre (July 2022) Birth rate declines come to Canada Substack https://jestre.substack.com/p/birth-rate-
declines-come-to-canada
71
Chudov, I (July 2022) Hungary: Highest Vaccinated Counties Have Worst Birth Rate Drops!
https://igorchudov.substack.com/p/hungary-most-vaccinated-counties
72
FDA released document: Pfizer 5.3.6 Cumulative analysis of post-authorization adverse event reports of
pf-07302048 (bnt162b2) received through 28-feb-2021 – see ‘Missing Information’ pages 9 & 12:
https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf https://phmpt.org/wp-
content/uploads/2021/11/5.3.6-postmarketing-experience.pdf; and commentary
Bridle, B (April 2022) A Moratorium on mRNA 'Vaccines' is Needed
Substack https://mail.google.com/mail/u/0/#inbox/FMfcgzGpHHKDKvZPqGLrFJVQLcZTBpdB
73
Lessans, N et al (July 2022) The effect of BNT162b2 SARS-CoV-2 mRNA vaccine on menstrual cycle
symptoms in healthy women International Journal of Obstetrics and Gynaecology https://doi.org/10.1002/ijgo.14356
74
FDA released document: Acuitas Therapeutics Inc / Pfizer A Tissue Distribution Study of a [3 H]-Labelled
Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration
in Wistar Han Rats https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M4_4223_185350.pdf; and
commentary
Bridle, B (April 2022) A Moratorium on mRNA 'Vaccines' is Needed
Substack https://mail.google.com/mail/u/0/#inbox/FMfcgzGpHHKDKvZPqGLrFJVQLcZTBpdB
75
Dokka, S et al (2000) Oxygen Radical-Mediated Pulmonary Toxicity Induced by Some Cationic Liposomes
Pharm Res 17, 521–525 https://doi.org/10.1023/A:1007504613351; Hongtao Lv, Shubiao Zhang, Bing Wang,
Shaohui Cui, Yan, J (2006) Toxicity of cationic lipids and cationic polymers in gene delivery, Journal of Controlled
Release, Volume 114, Issue 1, Pages 100-109, ISSN 0168-3659, https://doi.org/10.1016/j.jconrel.2006.04.014; Ranit
Kedmi, Ben-Arie, N.; Peer, D. (20210) The systemic toxicity of positively charged lipid nanoparticles and the role of
Toll-like receptor 4 in immune activation, Biomaterials, Volume 31, Issue 26, 2010, Pages 6867-6875, ISSN 0142-
9612, https://doi.org/10.1016/j.biomaterials.2010.05.027;
Filion, M., Phillips, N (1997) Toxicity and immunomodulatory activity of liposomal vectors formulated with cationic
lipids toward immune effector cells, Biochemical et Biophysica Acta (BBA) – Biomembranes, Volume 1329, Issue 2,
1997, Pages 345-356, ISSN 0005-2736, https://doi.org/10.1016/S0005-2736(97)00126-0
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8.43. Collectively, the available peer-reviewed literature points to a number of serious safety
concerns regarding COVID-19 ‘vaccines’. Already by December 2021, in excess of
1,000 peer-reviewed articles and studies focussing upon post-vaccination deaths and
injuries had been published76.
8.44. The long-term potential for the Spike Protein (produced by the COVID-19 ‘vaccines’)
to induce a range of autoimmune diseases has been commented upon by several
authors. Because there is no long-term safety data available at the moment, the
chance of induced autoimmune disease cannot be determined77.
9. Potential Toxicity of the Spike Protein Produced by Gene-Based

‘Vaccines’
9.1. The Spike Protein contained on the surface of the SARS-CoV-2 virus facilitates the
binding of the viral particle to human cells, allowing infection of those cells, and has
inherent toxicity in its own right. 78 However, the Spike Proteins produced by the
COVID-19 ‘vaccines’ are not identical to the Spike Protein on the natural SARS-CoV-
2 virus79 in that some uracil nucleotide bases (there are 4 different nucleotide bases in
RNA: uridine, cytosine, guanine and adenine) are replaced with pseudouridine (a
methylated derivative). This seemingly small change imparts profound
pharmacological characteristics to the mRNA molecule produced by the COVID-19
‘vaccines’ including the ability to evade natural degradation as happens to natural
mRNA. Further, the synthetic mRNA Spike Proteins interfere with the body’s natural
immune system (including Toll Like Receptors) which explains why these mRNA
particles can provoke latent viral eruptions of Herpes Zoster and Epstein-Barr viruses
as reported in adverse drug reaction reporting systems.
9.2. Reactivation of the dormant virus Herpes Zoster, which is responsible for shingles, has
been reported in relation to COVID-19 vaccination but at the moment no cause-and-
effect relationship has been acknowledged. In order to investigate a possible cause-
effect relationship, a systematic review of the literature was undertaken 80. A total of
54 cases reported in the literature were found and reviewed. Thirty-six patients out of
45 (80%) developed herpes zoster following the priming dose of mRNA COVID-19
vaccine. Furthermore, 96% of patients developed it within a temporal timeframe
defined by WHO as indicative of a causal relationship. The authors even suggested
possible use of prophylactic herpes zoster anti-viral medication prior to vaccination to
herpes prone individuals.
76
Peer Reviewed Medical Papers for Adverse Events in COVID-19 Vaccine Recipients - AVN
https://avn.org.au/peer-reviewed-medical-papers-for-adverse-events-in-covid-19-vaccine-recipients/
77
Seneff, S and Nigh, G; (May 021) Worse Than the Disease? Reviewing Some Possible Unintended
78
Seneff, S and Nigh, G; ( May 2021) Worse Than the Disease? Reviewing Some Possible Unintended
79
McKernan, K. et al (2021) Differences in Vaccine and SARS-CoV-2 Replication Derived mRNA:
Implications for Cell Biology and Future Disease (Version 4). DOI: 10.31219/osf.io/bcsa6
80
Desai, H.D. et al (2021) Can SARS-CoV-2 vaccine increase the risk of reactivation of Varicella zoster? A
systematic review. Journal of Cosmetic Dermatology Volume 20, Issue 11, Pages 3350-3361
https://doi.org/10.1111/jocd.14521
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9.3. Multiple modes of Spike Protein toxicity have been reported including those related to
blood clotting and mitochondrial damage81.
9.4. It has been a widespread belief that the Spike Protein produced by the gene-based
‘vaccines’ is the same as the Spike Protein on the surface of the SARS-CoV-2 virus,
therefore, the effects of both will be similar. Furthermore, it has been assumed that
exposing an individual to just the Spike Protein of the ‘vaccines’ is safer than exposure
to the natural virus. However, these reasonings are now being questioned. It is now
understood that the mRNA produced by the gene-based ‘vaccines’ contains pseudo-
uridine instead of uridine as a nucleotide base and remains in circulation for much
longer.
10. mRNA Does Not Remain at the Injection Site and Is Not Rapidly Destroyed
10.1. The normal biochemical protective mechanisms ensure that mRNA molecules are
normally rapidly destroyed outside cells. Initially, it was thought that mRNA produced
from COVID-19 ‘vaccines’ would be rapidly destroyed. However, evidence now shows
that the mRNA from these ‘vaccines’ may linger for 15 days or more post-vaccination82.
The persistence of this mRNA has implications for continued production of Spike
Protein and associated possible toxicity associated with the Spike Protein. Another
study suggests mRNA produced following COVID-19 vaccination may remain in lymph
nodes for up to 60 days83.
10.2. These nucleotide manipulations of the ‘vaccine’ mRNAs to reduce its rate of
degradation and therefore to enhance its capacity to drive Spike Protein production
per molecule of mRNA, may produce concentrations much higher than those observed
with natural infection in some individuals. Gene-based ‘vaccines’ appear to drive
production of incredibly high numbers of Spike Protein mRNA molecules (13 trillion to
40 trillion) almost instantaneously as compared to natural infection. This may account
for the serious adverse effects and deaths reported following administration of gene-
based COVID-19 ‘vaccines’ in adverse drug reporting systems, and further research
is needed with regard to this important observation.
10.3. The immediate injection of literally trillions of Spike Protein producing mRNA
molecules, as distinct from the slower accumulation of Spike Protein by natural
infection, could be responsible for the numbers of deaths reported within 48 hours of
COVID-19 ‘vaccine’ injection, although this is yet to be proven. This is why COVID-19
81
Lei Y, Zhang J, Schiavon CR, et al (2021) SARS-CoV-2 Spike Protein Impairs Endothelial Function via
Downregulation of ACE 2. Circulation Research 2021, April 30, 2021 Vol 128, Issue 9
https://www.ahajournals.org/doi/full/10.1161/CIRCRESAHA.121.318902
82
Fertig, T.E. et al (2022) Vaccine mRNA Can Be Detected in Blood at 15 Days Post-Vaccination
Biomedicines 2022, 10, 1538. https://doi.org/10.3390/biomedicines10071538
83
Röltgen, K. et al (March 2022) Immune imprinting, breadth of variant recognition, and germinal center
response in human SARS-CoV-2 infection and vaccination. Cell - Volume 185, Issue 6, 17 March 2022, Pages
1025-1040.e14. https://doi.org/10.1016/j.cell.2022.01.018
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‘vaccine’ related deaths need to be thoroughly investigated, with autopsies that include
determination of tissue levels of Spike Protein.
10.4. These authors also reflect upon the lack of transparency regarding lot-to-lot gene
sequencing for vaccine quality control which might explain why some batches/lots of
gene-based COVID-19 ‘vaccines’ are associated with much high incidences of severe
adverse effects84.
10.5. A biopsy study provided direct evidence linking Spike Protein concentrations produced
following vaccination in heart tissue to the development of myocarditis.85
11. Long-Term Potential Genetic Damage and Cancer Potential of COVID-19

‘Vaccines’
11.1. In considering the safety of any new therapeutic, potential for both genotoxicity
(damage to genes) and mutagenicity (potential to cause cancer) are among the
highest priorities. This should especially apply to genetic therapeutics such as the
COVID-19 ‘vaccines’, and more so when administration of these products to healthy
individuals of all ages worldwide was envisioned.
11.2. Evidence shows the spike protein produced by the Pfizer mRNA vaccine can enter
into the nucleus of cells and disrupt fundamental cellular processes involved in DNA
repair. This adds to concerns and raises serious potential safety issues regarding a
diminished ability of the body to prevent the rise of cancers 86. Neither of these
observed genetic type molecular effects are expected in relation to conventional
vaccines.
11.3. The gene-based COVID-19 ’vaccine’ manufacturers presented their products as

‘vaccines’ to drug regulators even though, by their very nature, they were a new class
of gene-based therapies. This had significant impact on reducing the usual safety
testing requirements which were normally applied to gene-based therapies. It should
be noted that in order to assist and accommodate the introduction of these
experimental drugs, the CDC and other organisations began applying recently reduced
safety data requirements applicable to conventional vaccines to these gene-based
‘vaccines’ and the definition of ‘vaccine’ was amended to accommodate these new
gene-based therapies87.
The World Health Organisation (WHO) Technical Report Series, no. 927m 2005 Annex
1, WHO Guidelines on nonclinical evaluation of vaccine88 page 50 section 4.2.3 states:
72 Batch toxicity analysis by Craig-Paardekooper: https://www.bitchute.com/video/6xIYPZBkydsu/ ;

https://www.bitchute.com/video/keoCmPh3vuiG/
85
Baumeier, C. et al: (2022) Intramyocardial Inflammation after COVID-19 Vaccination: An Endomyocardial
Biopsy-Proven Case Series International Journal Molecular Science 2022, 23, 6940.
https://doi.org/10.3390/ijms23136940
86
Jiang, H., Mei. Y.-F. (2021) SARS–CoV–2 Spike Impairs DNA Damage Repair and Inhibits V(D)J
Recombination In Vitro. Viruses 13:2056 https://doi.org/10.3390/v13102056
87
https://deathship.wordpress.com/2021/09/25/cdc-changes-the-definition-of-vaccines/
88
Jaafar, R. et al (June 2021) Correlation between 3790 Quantitative Polymerase Chain Reaction-Positives
Samples and Positive Cell Cultures, Including 1941 Severe Acute Respiratory Syndrome Coronavirus 2 Isolates
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‘Genotoxicity studies are normally not needed for the final vaccine formulation’. But
these guidelines were drafted well before the invention of the gene-based COVID
‘vaccines’.
11.4. Drug regulators around the world have accepted official product information
statements which acknowledge the omission of this important pre-clinical (in-vitro
and/or animal) genotoxicity and mutagenicity safety data.
11.5. Provisional Approval for the new gene-based COVID-19 ‘vaccines’ began early 2021.
However, since then important laboratory genetic data has been published which
raises the theoretical possibility that the mRNA contained in these gene-based
‘vaccines’ may be reverse transcribed (that is, incorporated) into one’s DNA around
the body (including a wide variety of tissues and organs including eggs in the ovary)
which is contrary to the assumptions of the drug regulators such as the TGA. This
research, according to established protocols, was done on an in-vitro human liver cell
line. The potential safety implications for current and future generations are of great
relevance and significance and drug regulators should be demanding immediate
further investigations89. These findings raise the possibility that these gene-based
COVID-19 ‘vaccines’ might induce cancers and that these effects may be inherited
into future generations. Until this and other questions are addressed it is not prudent
nor reasonable to claim these products are “safe”.
11.6. Following an extensive critical review of the immunological and metabolic

consequences associated with the mRNA based COVID-19 ‘vaccines’, some expert
molecular biologists have concluded these ‘vaccines’ should be withdrawn due to their
potentially devastating and wide ranging short-term and long-term adverse effects90.
11.7. Furthermore, in relation to risk-benefit, it has been reported that “based on publicly
available official UK and US data, all age groups under 50 years old are at greater risk
of death after receiving a COVID-19 inoculation than an unvaccinated person is at risk
of a COVID-19 death91. In such circumstances, it is extremely difficult to justify
mandatory vaccination.
11.8. It is also unknown if the Danish drug regulator’s recent decision to cease its gene-
based vaccination program is related to concerns regarding genotoxicity 92. The
Clinical Infectious Diseases, Volume 72, Issue 11, 1 June 2021, page e921. 28 September 2020.
https://doi.org/10.1093/cid/ciaa1491
89
Aldén, M. et al (2022) Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine
BNT162b2 In Vitro in Human Liver Cell Line. Current Issues in Molecular Biology 44: 1115–1126
https://doi.org/10.3390/cimb44030073
90
Seneff, S and Nigh, G; (10/05/2021) Worse Than the Disease? Reviewing Some Possible Unintended
91
Dopp, K and Seneff, S. (February 2022) COVID-19 and All-Cause Mortality Data by Age Group Reveals
Risk of COVID Vaccine-Induced Fatality is Equal to or Greater than the Risk of a COVID death for all Age Groups
Under 80 Years Old as of 6 February 2022 https://www.skirsch.com/covid/Seneff_costBenefit.pdf
92
COVID-19: Denmark suspends COVID vaccination programme with health chiefs saying virus under
control (28 April 2022) Sky News https://news.sky.com/story/covid-19-denmark-suspends-covid-vaccination-
programme-with-health-chiefs-saying-virus-under-control-
12600593?fbclid=IwAR2xIYS6Dil45imXz0Flp7JB19JaVNovUgeN8VmYG0mhP5hiE6GJ4zHNnXM
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Danish drug regulatory agency has long been considered to rank among the most
competent regulatory agencies in the world and is highly regarded.
11.9. The issue of potential mutagenicity and genotoxicity is of high importance and received
attention at Australian Senate Estimates on 1 June 2021 (Community Affairs
Legislation Committee)93.
11.10. In that hearing, Prof. Skerritt (head of the Australian TGA) by Senator Malcolm Roberts
on the potential for the mRNA to enter the nucleus of cells and cause potentially
serious genetic adverse events which could affect future generations:
“Senator ROBERTS: How long before we know the intergenerational effects?
Dr Skerritt: There is no evidence at all from animal or human studies that the
RNA vaccines, if you're talking about them, incorporate into the genetic material
of human beings. They wouldn't have received regulatory approval, and that
includes by much bigger regulators such as the FDA, if these bits of mRNA
incorporated into the human genetic material. In fact, medicines that
incorporate into human genetic material and are inherited are currently not
permitted in most major countries, including Australia.”
11.11. The statement by Prof. Skerritt was made prior to the publications referred to above.
These events provide compelling evidence to reject the indiscriminate general use of
these gene-based COVID-19 ‘vaccines’ and to prevent mandatory vaccination on
safety grounds.
12. COVID-19 ‘Vaccines’ Do Not Prevent Infection or Transmission
12.1. The COVID-19 ‘vaccines’ neither prevent infection nor do they prevent transmission
of the infection. SARS-CoV-2 infection is via airborne infection of viral particles
entering via the mucosa (surface lining) of the nose. COVID-19 ‘vaccines’ do not
induce mucosal immunity: instead they induce blood-borne immunity, which is not
effective in countering organisms entering and multiplying in the mucosal tract. This
is why, despite population vaccination rates approaching 90%, COVID-19 cases
remain stubbornly high in many countries.
12.2. ‘Dr Anthony Fauci, head of the National Institute of Allergy and Infectious Disease
(NIAID) said the viral load of Delta variant in the nasal passages of vaccinated people
was “almost identical” to that in noses of unvaccinated people.94 It is an accepted
principle that the viral load or amount of virus present is directly proportional to both
93
https://parlinfo.aph.gov.au/parlInfo/download/committees/estimate/074f811f-4fa9-49b2-a2d5-
f8dc2b74d47d/toc_pdf/Community%20Affairs%20Legislation%20Committee_2021_0601_8809_Official.pdf;fileType=
application%2Fpdf#search=%22committees/estimate/074f811f-4fa9-49b2-a2d5-f8dc2b74d47d/0000%22 page 53
94
https://thehill.com/homenews/sunday-talk-shows/565831-fauci-amount-of-virus-in-breakthrough-Delta-
cases-almost-identical
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The Time of Covid

the development of symptoms of infection and the ability to transmit the infection to
others.
12.3. Dr Rochelle Walensky, director of the Center for Disease Control (CDC) said publicly
that the COVID-19 vaccines “can’t prevent transmission” [of SARS-CoV-2]95. This is
basically because the COVID-19 vaccines do not prevent infection in an individual i.e.
the COVID-19 ‘vaccines’ are not “sterilizing”.
12.4. In addition, three articles in The Lancet report that the current COVID-19 gene-based
vaccines do not prevent transmission of SARS-CoV-296.
12.5. Contrary to initial popular belief and in light of recent evidence, mandatory COVID-19
vaccination will neither significantly or effectively prevent SARS-CoV-2 infection or
prevention of transmission of infection to others. According to Gunter Kampf, fully
vaccinated individuals can carry similar viral loads to unvaccinated individuals and
spread the virus just as easily97.
12.6. Gunter Kampf, stated:
“There is increasing evidence that vaccinated individuals continue to have a

relevant role in transmission. In Massachusetts, USA, a total of 469 new COVID-
19 cases were detected during various events in July, 2021, and 346 (74%) of
these cases were in people who were fully or partly vaccinated, 274 (79%) of whom
were symptomatic. Cycle threshold values were similarly low between people who
were fully vaccinated (median 22.8) and people who were unvaccinated, not fully
vaccinated, or whose vaccination status was unknown (median 21.5), indicating a
high viral load even among people who were fully vaccinated.”
12.7. The author concludes: “It is therefore wrong and dangerous to speak of a pandemic of
the unvaccinated”.
12.8. A Wisconsin, USA, study in June/July 2021 (when the Delta variant was prominent)
found no difference for SARS-CoV-2 infected individuals in viral load measurements
by PCR test cycle threshold (Ct) data between 310 fully vaccinated and 389
unvaccinated individuals: Testing found high viral load in 68% of the fully vaccinated
95
Jaafar, R. et al (2020) Correlation between 3790 Quantitative Polymerase Chain Reaction-Positives
Samples and Positive Cell Cultures, Including 1941 Severe Acute Respiratory Syndrome Coronavirus 2 Isolates
Clinical Infectious Diseases, Volume 72, Issue 11, 1 June 2021, page e921. 28 September 2020
96
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02243-1/fulltext ,
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00090-3/fulltext#sec1 &
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00768-4/fulltext
97
Kampf, G. (2021) COVID-19: stigmatising the unvaccinated is not justified The Lancet VOLUME 398,
ISSUE 10314, P1871, NOVEMBER 20, 2021 https://www.thelancet.com/journals/lancet/article/PIIS0140-
6736(21)02243-1/fulltext
Brown CM, et al (July 2021) Outbreak of SARS-CoV-2 infections, including COVID-19 vaccine breakthrough
infections, associated with large public gatherings— Barnstable County, Massachusetts, July 2021 CDC MMWR
Morb Mortal Wkly Rep 2021;70: 1059–62 https://www.cdc.gov/mmwr/volumes/70/wr/mm7031e2.htm
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The Time of Covid

and 63% of the unvaccinated. This data suggests that vaccinated are just as likely to
be spreaders of SARS-CoV-298.
12.9. The risk of infection leading to COVID-19 varies depending on age and clinical status
(including the presence of natural immunity) and must be weighed against the
accumulating evidence of serious adverse effects including death, as well as the
waning efficacy of the vaccines in protecting against infection.
13. Diminished ‘Vaccine’ Efficacy and Potential Negative ‘Vaccine’ Efficacy
13.1. In the first part of 2022 a number of public health sources in the US, Australia,
Denmark, Israel and the UK have suggested the protective efficacy of the COVID
‘vaccines’ is waning or possibly even resulting in “negative efficacy”, i.e. those
vaccinated are at a higher risk of infection. This was in the context of the later
subvariants of Omicron as reported in an observational study of 22,072,550 SARS-
CoV-2 cases99.
13.2. The authors state:
“The vaccine effectiveness (VE) for the third dose was in negative since December
20, 2021, with a significantly increased proportion of SARS-CoV2 cases
hospitalizations and deaths among the vaccinated; and a decreased proportion of
cases, hospitalizations, and deaths among the unvaccinated.”
13.3. In is acknowledged that epidemiological data interpretation is both challenging and

complicated because there are confounding variables to consider such as age,
gender, vaccination status and co-morbidities. There is also the added complexity of
consideration of the definition of “fully vaccinated” as this varies depending on vaccine
schedules. There remains the lack of distinction between someone hospitalised or
dying “with” COVID versus someone hospitalised or dying “due to” COVID and often
those dying within 14 days of vaccination are often considered as “unvaccinated”.
Overall, however, this large study suggests a negative vaccine efficacy, which is of
great concern.
13.4. The main reason for this negative vaccine efficacy has been mainly ascribed to the fact
that the Omicron strain of viruses which we are experiencing now are considerably
different to the original Wuhan strain and subsequent Delta strain. Those individuals
vaccinated with the gene-based ‘vaccines’ based on the Wuhan strain of virus are
paradoxically more susceptible to Omicron infection.
98
Riemersma, K.K. et al. Shedding of Infectious SARS-CoV-2 Despite Vaccination: Preprint.
https://www.medrxiv.org/content/10.1101/2021.07.31.21261387v6.full-text
99
Emani, V et al (June 2022) Increasing SARS-CoV-2 cases, hospitalizations and deaths among the
vaccinated elderly populations during the Omicron (B.1.1.529) variant surge in UK medRixiV preprint
https://www.medrxiv.org/content/10.1101/2022.06.28.22276926v2
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13.5. Stanford University researchers100 found that “prior vaccination with Wuhan-Hu-1-like
antigens followed by infection with Alpha or Delta variants gives rise to plasma
antibody responses with apparent Wuhan-Hu-1-specific imprinting manifesting
as relatively decreased responses to the variant virus epitopes compared with
unvaccinated patients infected with those variant viruses.” Basically, these
researchers are saying that vaccination with the current COVID-19 ‘vaccines’ will lead
to a diminished ability to protect from infection by the newer variants.
13.6. Pivotal epidemiological data which is useful in determining vaccine effectiveness

versus time is published by “Our World in Data”, a non-profit organisation based in the
United Kingdom.101 This organisation uses data sourced from Johns Hopkins
University Center for Systems Science and Engineering (CSSE).
13.7. The data below plots the rate (cases per million) of confirmed COVID-19 cases by
selected country versus time (and is updated regularly).
COVID-19 cases by selected country versus time
13.8. This same data can be used to represent the 7-day rolling average of confirmed
COVID-19 cases in Australia.
100
Roltgen, K et al (March 2022) Immune imprinting, breadth of variant recognition, and germinal center
response in human SARS-CoV-2 infection and vaccination. Cell 185,1025-1040, March 17, 2022
https://doi.org/10.1016/j.cell.2022.01.018 https://www.cell.com/action/showPdf?pii=S0092-8674%2822%2900076-9
101
https://ourworldindata.org/coronavirus#explore-the-global-situation
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7-day rolling average of confirmed COVID-19 cases in Australia
13.9. COVID-19 vaccination commenced in Australia early in 2021. While the both absolute
number and percent of the population COVID vaccinated increased rapidly for
countries during 2021 and into 2022, the data shows both the rate and absolute
number of confirmed COVID-19 cases markedly increased towards the end of 2021.
This worldwide data demonstrates a failure of the COVID-19 ‘vaccines’ to prevent
infection and transmission of the disease.
13.10. This data strongly suggests that commencing in 2022 the COVID-19 vaccines have
substantially lost the ability to prevent infection and transmission of the virus, despite
high rates of vaccine uptake in the population. This provides evidence of the futility of
vaccine mandates.
13.11. All epidemiological and health statistical data requires careful interpretation as
definitions may vary from jurisdiction to jurisdiction and health protocols can impact
the interpretation of the data. However, without evidence to the contrary, the above
data appears to provide a compelling evidence of a negative vaccine efficacy. In other
words, COVID-19 vaccinated individuals are more likely to be infected with the current
strain of the COVID-19 virus and be admitted to hospital than compared to non-
vaccinated individuals. Similar observations have been made in other countries.
13.12. As mentioned earlier, a major contributing factor to this phenomenon may be due to
the fact that since early 2022, the dominant variant of the SARS-CoV-2 virus is
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Omicron102 (see graph below) whereas the current COVID-19 ‘vaccines’ are
constructed to produce antibodies towards the original Wuhan strain.
Share of SARS-CoV-2 sequences that is the Omicron variant by country
14. The COVID-19 ‘Vaccines’ Do Not Provide a Similar and Acceptable

Risk/Benefit Across All Age Groups irrespective of individual Clinical
Status including Natural Immunity
14.1. Mandatory vaccination by its very nature assumes that a therapeutic agent produces
a similar risk and a similar benefit for all individuals. However, this is never the case.
Therapeutics should always be prescribed with a consideration of the particular clinical
status of the individual, which is why prescribing information always contains specific
warnings and contraindications of use in relation to age, health status etc. Drugs are
never prescribed on a “one size fits all” basis. Prescribing a drug and ignoring the
particular clinical circumstances of an individual is not good medical practice.
14.2. Natural immunity plays an important role in COVID-19. There is no evidence to

suggest that COVID-19 gene-based ‘vaccination’ offers superior protection from
COVID-19 as compared to natural immunity. Indeed, many believe the reverse is true.
102
Source: GISAID, via CoVariants.org as presented by Our World in Data up to 11 July 2022
https://ourworldindata.org/covid-cases
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14.3. In acknowledgement of the important role of natural immunity, even Bill Gates,
perhaps the most prominent vaccine proponent, speaking at the Munich Security
Conference reported 23 February 2022103, admitted that “the virus itself, particularly
the variant called Omicron, is a type of vaccine”.
14.4. The important role of natural immunity from both a personal and societal point of view
needs to be recognised. This societal natural immunity was commonly referred to as
‘herd immunity’ and was initially widely considered important to limit the impact of the
virus.
14.5. Conventional wisdom suggests that natural immunity following COVID-19 infection
provides a high level of durable protection from re-infection in many ways superior to
“vaccination” because natural immune response is a multifaceted immune response
directed against a number of components including the envelope, the membrane, the
nucleocapsid and the spike within the virus – unlike the immune response produced
by gene-based ‘vaccines’ which only direct the production of specific antibodies only
towards the virus Spike Protein.
14.6. It has been likely that hundreds of millions of people have recovered from COVID-19.
Numerous scientists have found that natural immunity offers a decreased risk of re-
infection and extremely low rates of hospitalisation in relation to repeat infection104.
14.7. A study in Qatar found that ‘natural infection appears to elicit strong protection against
reinfection with an efficacy ~95% for at least seven months’105.
14.8. The UK study by Hall et al, with funding from the UK Government, reported a similar
level of protection due to natural immunity106.
14.9. A study in Austria found that the frequency of re-infection from COVID-19 caused
hospitalisation in only five out of 14,840 (0.03%) people and death in one out of 14,840
(0.01%)107.
14.10. In many ways, natural immunity protection will be superior to the protection afforded
by gene-based COVID-19 ‘vaccines’. In such circumstances, voluntary or mandatory
103
Published in Locke (johnlocke.org)– Mitch Kokai, (23 February 2022): Bill Gates Gives Omicron More
Credit Than Vaccines in Battling COVID. https://www.johnlocke.org/bill- gates-gives-omicron-more-credit-than-
vaccines-in-battling-covid/
104
Klausner, J., Kojima, N. (May 2021) Op-Ed: Quit Ignoring Natural COVID Immunity — Antibody testing and
proof of prior infection can allow more people to return to normal Medpage Today, 28 May 2021.
www.medpagetoday.com/infectiousdisease/covid19/92836 ;
150 Plus Research Studies Affirm Naturally Acquired Immunity to Covid-19: Documented, Linked, and Quoted
https://brownstone.org/articles/79-research-studies-affirm-naturally-acquired-immunity-to-covid-19-documented-
linked-and-quoted/
105
Abu-Raddad, L. et al (May 2021) SARS-CoV-2 antibody-positivity protects against reinfection for at least
seven months with 95% efficacy. eClinicalMedicine, Part of The Lancet Discovery Science, Vol 35, May 2021,
100861 https://doi.org/10.1016/j.eclinm.2021.100861
106
Hall, V. J (2021) SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-
care workers in England: a large, multicentre, prospective cohort study (SIREN) VOLUME 397, ISSUE 10283,
P1459-1469, APRIL 17, 2021 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00675-9/fulltext
107
Pilz S et al (2021) SARS-CoV-2 re-infection risk in Austria. European Journal of Clinical Investigation
Volume 51, Issue 4 e13520 https://doi.org/10.1111/eci.13520
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vaccination with gene-based COVID-19 ‘vaccines’ do not offer any additional
protection. There is no scientific theoretical basis or reliable evidence to suggest that
a person with natural immunity might benefit from administration of a Provisionally
Approved gene-based COVID-19 ‘vaccine’ while the ‘vaccine’ itself has significant
adverse effects and no long-term safety data to support its use.
14.11. A retrospective observational study of 124,500 individuals, conducted during the Delta
wave of SARS-CoV-2 compared two groups: people who had not been previously
infected with SARS-CoV-2 and received a 2-dose regimen of the Pfizer COVID-19
“vaccine” and previously infected individuals who had not been vaccinated108.
Individuals who had been vaccinated had a 13-fold greater chance of breakthrough
infection compared to re-infection in the non-vaccinated group.
14.12. The conclusion of the authors was: ‘Naturally acquired immunity confers stronger
protection against infection and symptomatic disease caused by the Delta variant of
SARS-CoV-2, compared to the BNT162b2-2 [Pfizer COVID-19 ‘vaccine’] dose
vaccine-induced immunity’.
14.13. While the current SARS-CoV-2 variant is Omicron, in the absence of data to the
contrary, these data provide a compelling case to support the importance of natural
immunity in protecting against SARS-CoV-2 infection.
14.14. The Swedish drug regulator is regarded as one of the most respected regulatory
agencies and they have recently reversed its recommendation on the administration
of COVID-19 ‘vaccines’ to adolescent children as they do not see any clear benefit in
COVID-19 vaccination. According to a Reuters news release in Stockholm on 27
January 2022, Sweden decided against recommending COVID-19 ‘vaccines’ for
children aged 5-11, the Swedish Health Agency said that the benefits did not outweigh
the risks: ‘With the knowledge we have today, with a low risk for serious disease for
kids, we don't see any clear benefit with vaccinating them’109.
14.15. It is reported that children in the population are at a substantially lower risk of
developing COVID-19.110
14.16. In addition, it has been suggested that a high proportion of children in the population
have acquired natural immunity which offers better protection from infection as
compared to vaccination. As above, a large study during the Delta wave found
vaccinated individuals had a 13-fold greater chance of breakthrough infection than
unvaccinated individuals had of being re-infected.
108
Gazit, S et al (2022) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Naturally Acquired
Immunity versus Vaccine-induced Immunity, Reinfections versus Breakthrough Infections: A Retrospective Cohort
Study. Clinical Diseases Major Article https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9047157/pdf/ciac262.pdf
109
Sweden decides against recommending COVID vaccines for kids aged 5-11 (27 January 2022) Reuters -
Stockholm https://www.reuters.com/world/europe/sweden-decides-against-recommending-covid-vaccines-kids-
aged-5-12-2022-01-27/
110
Loske, J. et al (March 2022) Pre-activated antiviral innate immunity in the upper airways controls early
SARS-CoV-2 infection in children. Nature Biotechnology: Vol 40, March 2022, 319-324 s://doi.org/10
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Conclusion
The introduction and worldwide use of COVID-19 gene-based ‘vaccines’ has been
associated, in the short term, with far more deaths, illnesses, injuries, and disabilities
than any other therapeutic agent in the history of medicine. Due to the total lack of
any long-term safety data, the potential future iatrogenic effects (including
neurological, immunological and carcinogenic effects) may be even more devasting.
Despite initial claims, the COVID-19 gene-based ‘vaccines’ have now been shown to
possess disappointing clinical efficacy - they neither prevent SARS-CoV-2 infection
nor do they prevent transmission of the virus; any immunological protection wanes
rapidly and, coincident with the emergence of the Omicron variant, evidence of
negative vaccine efficacy is being reported in many countries including Australia.
In light of widely reported emerging and compelling evidence, there appears to be little
scientific or clinical justification to support vaccine mandates as a health policy.
The latest hospital admission statistics do not support the claim that unvaccinated
individuals are more at risk of serious COVID-19 disease, hospitalisation or death.
Excess non-COVID-19 related deaths coincident with the introduction of the gene-
based ‘vaccines’ are now being reported by many countries, and suggest a surge in
heart attack and stroke among both the young, adolescents and middle age individuals
(especially males).
Advocating the worldwide use of a new class of serious COVID-19 gene-based

‘vaccines’ never before deployed, and advocated for use in healthy individuals of all
ages regardless of clinical status (eg. natural immunity, pregnancy etc), with relatively
little short-term safety data and no long-term safety data, is neither prudent or
necessary and defies the Precautionary Principle.
The knowledge that the synthetic mRNA in both the Pfizer and Moderna vaccines can
enter the nucleus of human liver cells in culture, raises the serious questions about
genotoxicity and carcinogenicity, and adverse impact on future generations. Disturbing
safety signals regarding fertility and miscarriages are emerging.
Given the statistically or virtually nil risk of serious COVID-19 in general affecting
children aged 6 months to 11 or 12 years of age and the clear and significant risk of
serious adverse effects including myocarditis, pericarditis and death in this age group
– there seems to be little benefit to be gained by vaccinating these children.
Considerable scientific, clinical and statistical epidemiological data and understanding

has been acquired since the introduction (on a provisional basis only) of the
investigational COVID-19 gene-based “vaccines”. Many of the initial ambitious claims
and assumed perceptions regarding the safety and efficacy of these serious
therapeutics have now been invalidated and it is now time to review and reconsider
the utility of these products in light of the known unprecedented level of serious adverse
reactions and death attributed to their use.
The urgency for this review cannot be overestimated given the current and potential
future impact on the health and wellbeing of all Australians.
Phillip M. Altman
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Appendix A
Abbreviated Curriculum Vitae – Dr Phillip Altman
Dr Phillip Altman has expertise in the areas of clinical medical research and pharmaceutical drug
regulatory affairs in Australia.
Holding the degrees Bachelor of Pharmacy (Hons), and Master of Science and Doctor of
Philosophy, Phillip’s doctorate concerned the development new of cardiotonic drugs with lower
intrinsic toxicity, compared to existing drugs including their chemical synthesis and testing in various
animal models.
Phillip has worked primarily within the Australian pharmaceutical industry since 1974 in relation to
clinical trial design, management, and reporting in relation to obtaining new drug approvals, dealing
with the Secretary of the Department of Health, and the Therapeutic Goods Administration (TGA).
After many years working within multinational pharmaceutical companies, Phillip later became a
senior industry pharmaceutical consultant through his contract research company, Pharmaco Pty
Ltd., which provided both clinical trial and regulatory consultant services to the Australian
pharmaceutical industry, which focussed his experience in critically evaluating clinical trial safety
and efficacy data, as submitted in complex new drug dossiers for international regulatory purposes.
This work saw Phillip consulted by more than half of the multinational pharmaceutical companies
in Australia, in various capacities, with a focus on drug regulatory affairs.
Phillip founded the Association of Regulatory and Clinical Scientists (ARCS), which includes more
than 2,000 scientists, clinicians, and associated health professionals involved in both clinical trial
and regulatory affairs, in Australia and New Zealand, where ARCS continues to be the foremost
educational forum for both industry and government (including the TGA) personnel, involved in
clinical trials and regulatory affairs.
Phillip’s experience involves more than 100 clinical trials (covering Phases I,II, III and IV, i.e. from
first administration to animals, then man, to post-approval trials), and a similar number of new drug
applications, TGA appeals, and applications to modify existing approvals. In collaboration with the
TGA and on behalf of pharmaceutical companies, Phillip also directed 2 major drug withdrawals in
relation to public safety. More recently Phillip has been a senior clinical trial and regulatory affairs
advisor to an Australian company which has developed a live virus for the treatment of melanoma.
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Expert Report prepared by Lisa Mitchell B.Sc, M.App.Stats, MBA, FAICD
Corporate Transformation Services Pty Ltd
ABN: 50 003 939 446
Home: 02-9460-4417
Mobile: +61 408 028 326
E-mail: [email protected]
LinkedIn: au.linkedin.com/pub/lisa-mitchell/12/826/75
05 AUG 2022
TITLE OF REPORT:
SECTION 1: A COMPARISON OF ADVERSE EVENTS RELATED SPECIFICALLY TO THE COVID-19

VACCINES AND NON-COVID-19 VACCINES FROM 1 JAN 1971 TO 31 DEC 2021.
SECTION 2: ADVERSE EVENTS AND DEATHS REPORTED TO TGA DAENS, AUSTRALIA FOLLOWING
COVID-19 VACCINES BETWEEN 1 FEBRUARY 2021 TO 8 JUNE 2022 HIGHLIGHTING DEATHS AND
ADVERSE EVENTS IN CHILDREN 5-11 YRS OLD.
1 EXECUTIVE SUMMARY
1.1 I have conducted a number of reviews of the Therapeutic Goods Administration’s (TGA)
published adverse events as recorded in the Database of Adverse Event Notifications (DAENs)
database to 8 June 2022, specifically following the COVID-19 Vaccines entries in that database
and I confirm that:
a since 10 January 2022, there were 1,390 Adverse Events and 5 Deaths reported for the 5-
11 year age group since the roll out of the Pfizer Vaccine commenced.
b since 1 February 2021, there have been at least 108,542 Adverse Events and 723 Deaths
reported in adolescents and adults since the roll out of the Covid-19 Vaccines.
c since 1 February 2021, that together, there have been at least 131,991 Adverse Events
following Covid-19 Vaccines reported in all ages.
d since 1 February 2021, together there have been at least 884 total Deaths as the reported
outcome following immunisation in all ages. and including unspecified ages,
1.2 By comparison, I have also reviewed the TGA weekly safety reports to 5 June 2022. The TGA
reports record that there were:
a 1,470 Adverse Events in 5-11 year olds following 2.2M doses of Pfizer Vaccine.
Source: The TGA weekly safety report https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-
report-09-06-2022
b 129,995 Adverse Events in all ages following 59,431,403 doses of Covid-19 Vaccines.
Source: The TGA weekly safety report https://www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-
report-09-06-2022
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2 DEFINITION OF TERMS:
2.1 Throughout this report I have used a number of definitions:
Adverse Events:
a) Adverse Events are defined by the TGA as unintended and sometimes harmful occur-
rences associated with the use of a medicine, vaccine or medical device (collectively
known as therapeutic goods). Adverse events include side effects to medicines and vac-
cines, and problems or incidents involving medical devices.
b) Examples of adverse events are any unfavourable and unintended sign, symptom or dis-
ease associated with the use of a therapeutic good.
c) All Adverse events referred to in this document relate to vaccines.
d) Adverse Events reported to the TGA have been classified by MedDRA classification
which includes Organ affected and type of reaction. One Adverse Event case can affect
many organs and reaction types can include many MedDRA Classifications.
e) Adverse events are defined by the Australian institute of Health and Welfare as
‘incidents in which harm resulted to a person receiving health care’. There is no
definition included on the TGA web site.
f) Importantly, an adverse event is not always caused by the therapeutic good itself. The
occurrence of an adverse event does not necessarily mean that there is something
wrong with the therapeutic good.
Ages:
• Children: Individuals whose ages are 5-11 years.
• Babies/infants: 0-4years
• Unspecified: Age is left blank or marked with a hyphen –
• Adolescents: 12-18
• Adults 19 years and over
Covid-19 Vaccines: There are 4 vaccines that are being administered in Australia. They
include:
• Pfizer Comirnaty Covid-19 vaccine (Pfizer Vaccine)
• Covid-19 vaccine Astra Zeneca
• *Nuvaxovid (Moderna) Covid-19 Vaccine
• Spikevax (Moderna) Covid-19 Vaccine
• TNS DAENs database record for Covid-19 Vaccine Type Not Specified.
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*In searches up to 31 Dec 2021, I have searched for 4 vaccines only, because Novavax, or
Nuvaxovid has only been approved for use in Australia from 20 Jan 2022 for people 18 years
and over. On 25 July the provisional approval was extended to 12-17year olds.
Database of Adverse Event Notifications (DAEN): “The TGA receives Adverse Event reports
associated with medicines and medical devices. These reports come from a wide range of
sources, including members of the public, general practitioners, nurses, other health
professionals and the therapeutic goods industry and are” stored in an online database.
Source: https://www.tga.gov.au/database-adverse-event-notifications-daen
Deaths: Associated with the TGA reporting, this refers to the number of cases where death
was a reported outcome following immunisation from the DAEN website. It should be noted
that this does not necessarily imply causality. Also, to determine deaths in TGA DAENs website
is quite a convoluted process because the death MedDRA item category has been removed
and so one cannot simply search for deaths.
MedDRA Classification: The Medical Dictionary for Regulatory Activities (MedDRA) is an

internationally used set of terms relating to medical conditions, medicines and medical
devices. Refer to some items below for reference:
Please find a complete listing of MedDRA items using the following link.
https://1drv.ms/b/s!Al71AGIGLVVzgUj3L1lBYHafccTF?e=sKvJS2
Pfizer Vaccine: is the Comirnaty Covid-19 Vaccine as described in DAENs for all age groups.
The Pfizer Vaccine was provisionally approved Covid-19 Vaccine for 5-11 year olds. It was
approved by the TGA on 5 December 2021. Roll out of the Pfizer Vaccine for 5-11 year olds
commenced on or about 10 January 2022.
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The Time of Covid

Spikevax (Moderna) Covid-19 Vaccine: on 17 February 2022 the Spikevax Vaccine was
provisionally approved for 6-11 year olds.
Source: https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/who-can-get-
vaccinated/children?gclid=CjwKCAjwzeqVBhAoEiwAOrEmzWO2iNsMIeqs1wsBQ0kVEeqpu0m4lo59cz
wpmIjoPCdeU-ZT4yl1jxoCFJoQAvD_BwE&gclsrc=aw.ds
3. KEY POINTS TO NOTE
3.1 In SECTION 1, all the questions relating to the COVID-19 vaccines ask for figures for each COVID
vaccine type from date of approval to the report date.
While the work underlying this report was begun by me around 6 January 2022, the data I
collected was for 2021, and as such, I have a hard end to the year 2021 (31 Dec 2021).
Further, it appears that when the database is searched for each vaccine type from date of
approval to end of 2021, and then when one adds the results, I do not get the same answer
as I do when I search the entire database, all at once, using all 4 vaccines and the dates 1 Jan
2021 and 31 Dec 2021.
For simplicity, I have used this search as my master data search. All the COVID results will
balance to that master data (I cannot explain why this phenomenon exists but suffice it to say,
it goes to data integrity). I will demonstrate this in the following report.
A search for Pfizer, AstraZeneca, Moderna and unspecified, reveals the following information:
• Pfizer 25/01/2021 to 31/12/2021
▫ No. of cases 52,695
▫ No. of cases with a single suspected medicine 51,641
▫ No. of cases where death was a reported outcome 264
Source: Appendix 2.2 - DAEN Results for Individual COVID Vaccines (Including Unspecified Type) with
Index, page 2-10
• AstraZeneca 16/02/201 to 31/12/2021
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Source: Appendix 2.2 - DAEN Results for Individual COVID Vaccines (Including Unspecified Type) with Index, page
11-19
• Moderna (Spikevax) 09/08/2021 to 31/12/2021
20-28
• Unspecified COVID vaccines 01/01/2021 to 31/12/2021
▫ No. of cases 465
▫ No. of cases with a single suspected medicine 446
29-37
• Total for all COVID vaccines plus unspecified COVID vaccines is:
It is important to note that when I search for all COVID vaccines including unspecified for the period
01/01/2021 to 31/12/2021 I get:
▫ No. of cases: 100,180
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Source: Appendix 2.1 - DAEN Results for COVID Vaccine (Including Unspecified Type), page 1
So, I have elected to use this as our master COVID data.
3.2 In the entirety of this report, whenever I refer to deaths associated with the Therapeutic
Goods Administration (TGA) reporting, I am referring to the number of cases where death was
a reported outcome from the Database of Adverse Event Notifications (DAEN) website.
3.3 In Section 2 of this report:
a The data in this report is dated from 1 February 2021 when the Covid-19 Vaccines became
available until to 8 June 2022, being the last date the DEANs data was updated and when
I was briefed to provide this further report.
b The data was extracted by me from the TGA DAENs system over three days: Wednesday
22 June 2022; Thursday 23 June 2022; and Friday 24 June 2022.
c Despite the TGA website stating that its numbers are up to date as at 8 June 2022, which
is 2 weeks before 22 June (first day of data extraction), and 9 June (second day of data
extraction), the same search of the data on Wednesday 22 June and then Thursday 23
June produces different numbers. This is an issue I have identified in my previous
reports.
d The TGA safety reports contain further information than the DAENs database, such as
vaccine doses. I also used the TGA safety reports to cross check the results obtained from
DAENs.
e The TGA safety report as at 9 June 2022 includes data predominantly up to the 5 June
2022. The numbers in DAENs and those in the TGA safety report for Adverse Events are
comparable, I summarise the TGA safety report Adverse Events by vaccine doses further
in my response under Item 5 below.
3.4 All questions that I have answered have been advised by a letter of instruction from the
instructing legal experts. The questions are integrated into the document.
3.5 Underreporting.
a) As reporting to the TGA Daen’s database is voluntary there is a question regarding data
coverage.
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b) It is globally accepted that there is significant underreporting of adverse events to all
voluntary and spontaneous reporting systems. However, the true extent of underre-
porting is not known.
c) Whilst not perfect, the suspected underreporting to the DAEN system can be approxi-
mately validated by referring to the Ausvax website and then using their publicly availa-
ble information on the number of adverse events that they are reporting within 3-7 days
of vaccines being administered. Source: Ausvax - https://ausvaxsafety.org.au (Monitors adverse
events that occur within 3-7 days after vaccination)
d) The comparison above suggests that underreporting to the DAEN website is at least
90%: that is, they are reporting a maximum of 10% of adverse events and not reporting
some 90% of adverse events (as a minimum).
3.6 Appendices. Throughout this document you will see many references to appendices. These
appendices amount to many hundreds of pages and as such are not included with this
document. If there is a need for specific appendices to be accessed, please advise and I can
make links available.
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SECTION 1: A COMPARISON OF ADVERSE EVENTS RELATED SPECIFICALLY TO THE COVID-19
VACCINES AND NON-COVID-19 VACCINES FROM 1 JAN 1971 TO 31 DEC 2021. Pages 4-19 of original
document.
The Therapeutic Goods Administration (TGA) receives reports of adverse events associated with
medicines and medical devices in Australia. That data it collects is accessible via the Database of
Adverse Event Notifications (DAEN) on the TGA website. Please use the DAEN data, and only that data,
to answer the following questions, except where otherwise stated. In answering the below questions,
please indicate the relevant pages of the DAEN data which you have used in order to answer each
question:
1. For all of the vaccines in the DAEN combined, except for;

a. Comirnaty Covid-19 Vaccine (Pfizer);
b. Covid-19 Vaccine (TNS) (Janssen);
c. Covid-19 Vaccine AstraZeneca (AstraZeneca); and
d. Spikevax Covid-19 vaccine (Moderna);
i) How many reports of adverse events were made between 1971 and the date of your
report? Please set out the process by which you have come to your view.
My Answer:
The number of adverse events from 1 Jan 1971 until 31 Dec 2021 is 19,330. On the
DAEN search engine, type “vaccine” on the first field. Next, select all vaccines, and then
deselect the following COVID-19 vaccines so as to exclude them from the search:
● COMIRNATY COVID-19 vaccine
● COVID-19 Vaccine (TNS)
● COVID-19 Vaccine AstraZeneca
● Spikevax COVID-19 vaccine
There should be a total of 76 medicines, but this may change depending on the year.
The search process was undertaken by year starting 1971 until 2021. Below is the
search result for the entire year of 1971. The search results for the other years until
2021 can be found in Appendix 1.
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Sources:
• DAEN Search Engine: https://apps.tga.gov.au/PROD/DAEN/daen-report.aspx
• Appendix 1 - DAEN Bundle (System Organ Class) with Index 20.01.22, pages 672-1382: adding the
data from individual years from 1971 to 2021 totals 19,330 adverse events.
• Appendix 3 – Annual Tally of Non-COVID Adverse Events and Deaths 1971-2021, pages 1-3: this
is a manual tally in reference to the individual searches per year in Appendix 1.
ii) How many reports of death were made between 1971 and the date of your report?
Please set out the process by which you have come to your view.
My Answer:
There were 59 reported deaths from 1971 to 2021. The same search process as the
number of adverse events yields results for the number of deaths in the said period.
Please refer to the search results shown above.
Sources:
• Appendix 1 - DAEN Bundle (System Organ Class) with Index 20.01.22, pages 672-1382: adding the
data from individual years from 1971 to 2021 totals 59 deaths.
• Appendix 3 – Annual Tally of Non-COVID Adverse Events and Deaths 1971-2021, pages 1-3: this is
a manual tally in reference to the individual searches per year in Appendix 1.
2. For the three following vaccines which have been provisionally approved by the TGA in relation to
Covid-19, being;
a. Pfizer;
b. AstraZeneca; and
c. Moderna;
i) How many reports of adverse events were made between the date each vaccine was
provisionally approved and the date of your report? Please set out the process by
which you have come to your view.
My Answer:
Initially, I started searching by COVID vaccine type, however, I soon realized that
searching by individual COVID vaccine type from date of provisional approval, to the
end of 2021, and adding them up did not give the same result as the search if all were
done together and I used the blanket dates 1 Jan 2021 to 31 Dec 2021. I determined
to go with the 4 vaccine types and the blanket dates as our master data (as per intro
to report). The number of adverse events in total for the 4 vaccines from 1 Jan 2021 to
31 Dec 2021 was 100,180 cases, no of cases with a single suspected medicine were
98,399 and no of deaths were 733. (You can see that the information from each
vaccine type is incomplete. It is also inconsistent with the 4-vaccine approach). See
search results below:
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Source: Appendix 2.1 - DAEN Results for COVID Vaccine (Including Unspecified Type)
● COMIRNATY COVID-19 vaccine (Pfizer): 52,934 reports of adverse events
● COVID-19 Vaccine AstraZeneca: 43,912 reports of adverse events
● Spikevax COVID-19 vaccine (Moderna): 3,386 reports of adverse events
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Sources:
• Appendix 1 - DAEN Bundle (System Organ Class) with Index 20.01.22
On the DAEN search engine, select the vaccine on the “medicine” field. Adjust the date
range accordingly. Here, I am using the 31st of December 2021 as the end date and
the start date is the date of provisional approval for the Covid-19 vaccine in question.
ii) How many reports of death were made between the date each vaccine was provision-
ally approved and the date of your report? Please set out the process by which you
have come to your view.
My Answer:
● COMIRNATY COVID-19 vaccine (Pfizer): 265 cases where death was a reported
outcome
● COVID-19 Vaccine AstraZeneca: 439 cases where death was a reported outcome
● Spikevax COVID-19 vaccine (Moderna): 7 cases where death was a reported out-
come
The data was taken from Appendix 1 and totals 711 cases where death was a reported
outcome. Note that this is for the three (3) aforementioned vaccines only.
However, as per the DAEN search engine, there is a fourth type of COVID vaccine,
medicine name: COVID-19 Vaccine (TNS).This stands for Type Not Specified. I included
this upon pulling out information and found a total of 733 cases where death was a
reported outcome, as opposed to the total of 711 which is the sum of only three (3)
COVID vaccines. Actually, I also ran the unspecified vaccine by itself and I found that
when I added that to the above individual vaccines I reported 735 deaths, and not 733.
I have elected to use the 733 as our master data.
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Source: Appendix 2.1 - DAEN results for COVID Vaccine (including Unspecified type)
The same search process as the number of adverse events yields results for the deaths
related to COVID-19 vaccines. Please refer to the search results shown above.
Note – Pfizer was provisionally approved on 25 January 2021; AstraZeneca was provisionally
approved on 16 February 2021; Moderna was provisionally approved on 9 August 2021.
3. Has there been a significant increase in adverse event reports when comparing all other vaccines in
the DAEN to Pfizer, AstraZeneca and Moderna? Please set out the process by which you have come to
your view.
My Answer:
Yes, there has been a significant increase in adverse events. Comparing the search results on DAEN,
the non-COVID vaccines are at 19,330 adverse events from 1971 until 2021 (50-year range), whereas
the COVID-vaccines in the year 2021 alone already had a total of 100,180 reported adverse events.
Refer to Appendix 2 - DAEN results for COVID Vaccine (including Unspecified type). Refer to search
results presented in questions 1 and 2.
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Sources:
• Appendix 1 – DAEN Bundle (System Organ Class) with Index 20.01.22
• Appendix 2.1 – DAEN results for COVID Vaccine (including Unspecified type)
• Appendix 3 – Annual Tally of Non-COVID Adverse Events and Deaths 1971-2021
4. Has there been a significant increase in reports of death when comparing all other vaccines in the
DAEN to Pfizer, AstraZeneca and Moderna? Please set out the process by which you have come to
your view.
My Answer:
Yes, there has been a significant increase in cases where death was a reported outcome. Comparing
the search results on DAEN, the non-COVID vaccines are at 59 cases where death was a reported
outcome from 1971 until 2021 (50-year range), whereas the COVID-vaccines in the calendar year 2021
alone already had a total of 733 cases where death was a reported outcome. Refer to search results
presented in questions 1 and 2. I present this data in the following chart from 2010:
Sources:
• Appendix 1 – DAEN Bundle (System Organ Class) with Index 20.01.22
• Appendix 2.1 – DAEN results for COVID Vaccine (including Unspecified type)
• Appendix 3 – Annual Tally of Non-COVID Adverse Events and Deaths 1971-2021
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5. How much more likely is it for an adverse event to be reported to the TGA from Pfizer, AstraZeneca
and/or Moderna than it is from all other vaccines in the DAEN combined? Please set out the process
by which you have come to your view.
My Answer:
From 2010 to 2020 the likelihood of someone having an Adverse Event as the result of a vaccine was
of the order of 1 in every 10,000 doses. It is 1.1 number of doses using the incomplete number of doses
data (see Graph 1) and 0.9 using an estimate for total doses (see Graph 2). In 2021 as the result of
COVID vaccinations, I can now expect 23 Adverse Events in every 10,000 doses. I set this data out in
the below charts:
Graph 1 – Labelled data is based on incomplete data for total non-COVID cases
Sources:
• No. of adverse events: Appendix 3 - Annual Tally of Non-COVID Adverse Events and Deaths 1971-2021
• No of COVID vaccine doses: Appendix 6 – No. of COVID Doses by Vaccine
• No of non-COVID vaccine doses: Surveillance of Adverse Events following immunization, annual reports for 2010 to 2019
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Graph 2 – Labelled data uses an estimate for total non-COVID doses
Sources:
• No. of adverse events: Appendix 3 - Annual Tally of Non-COVID Adverse Events and Deaths 1971-2021
• No of COVID vaccine doses: Appendix 6 – No. of COVID Doses by Vaccine
• No of non-COVID vaccine doses: Appendix 5 - Surveillance of Adverse Events following immunization, annual reports for
2010 to 2019
Refer to search results presented in questions 1 and 2. Note that the non-COVID vaccine adverse events
are from 1971 to 2021, while COVID vaccine adverse events are for the year 2021 only.
6. How much more likely is it for a death to be reported to the TGA from Pfizer, AstraZeneca and/or
Moderna than it is from all other vaccines in the DAEN combined? Please set out the process by which
you have come to your view.
My Answer:
The number of cases where death was a reported outcome to the TGA, associated with a non-COVID
vaccine from 2010 to 2021 was 29, or an average of 2.4 deaths per annum vs 733 in 2021 associated
with COVID vaccines. This is an increase of 30,442%. It is represented by the below chart.
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Sources:
• No. of deaths: Appendix 3 - Annual Tally of Non-COVID Adverse Events and Deaths 1971-2021
Given the size of the increase reported above, another source of deaths associated with vaccines has
been located. The Surveillance of Adverse Events following Immunisation in Australia, Annual Reports
from 2010 to 2019, report 31 deaths associated with vaccines over 10 years which is an average of 3.1
deaths per annum. (Author: The Department of Health, Australian Federal Government) It would
appear that the TGA reports of death and the annual report referred to above are inconsistent in the
no. of deaths that they report. (Both are, however, reporting on the deaths as a result of adverse events
and claim to use the DAEN TGA website as their source of information.)
From 2010 to 2021, the likelihood of death from an adverse reaction to a vaccine was 0.22 to 0.27 per
million doses (approx. 1 death every 4 million doses). As a result of COVID doses in 2021, I have had 17
deaths per million doses. As a consequence, COVID vaccines are 69 times more likely to result in death
as a reported outcome than traditional vaccines. (If I use the death figures from the Surveillance of
Adverse Events after immunisation in Australia, annual reports from 2010 to 2019, referred to
previously, this shows around 0.463 deaths per million doses or 1 death every 2 million doses. This
makes the covid vaccines 36 times more likely to result in deaths as aa reported outcome than
traditional vaccines).
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Sources:
• No. of Deaths: Appendix 3 - Annual Tally of Non-COVID Adverse Events and Deaths 1971-2021
• No. of COVID vaccine doses: Appendix 6 – No. of COVID Doses by Vaccine
• No. of non-COVID vaccine doses: Appendix 5 – Surveillance of Adverse Events following immunization, annual reports
for 2010 to 2019
7. How do deaths reported to the TGA from Pfizer, AstraZeneca and Moderna compare to deaths
recorded in association with Covid-19 itself? You may also refer to data from the Australian Bureau of
Statistics to answer this question. Please set out the process by which you have come to your view.
My Answer:
The Australian Bureau of Statistics (ABS) reports 773 deaths from COVID from January to October 2021
albeit 2 months short of the entire year. In the last 2 weeks of January 2022,when this report was being
written, the number of cases where death was a reported outcome, associated with a COVID vaccine
in 2021 have increased from 704 to 733. This is reported in the below chart:
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Sources:
• Appendix 1 - DAEN Bundle (System Organ Class) with Index 20.01.22. See page 1400 which indicates that 1671 people
died from covid Jan 202 to 31 Oct 2021.Refer below to ABS source
• Appendix 2.1 - DAEN Results for COVID Vaccine (Including Unspecified Type)
The ABS reports that the total deaths from COVID Jan 2020 to Oct 2021 were 1671. They also report
that the total deaths from COVID in 2020 were 832. Therefore, the total deaths from COVID Jan 2021
to Oct 2021 were 773.
Source: Appendix 1 - DAEN Bundle (System Organ Class) with Index 20.01.22
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https://www.abs.gov.au/statistics/health/causes-death/provisional-mortality-statistics/jan-dec-2020
Sources:
• Appendix 1 - DAEN Bundle (System Organ Class) with Index 20.01.22
Source: Appendix 1, page 1400
8. What are the most significant categories, or types, of adverse events reported to the TGA for all
vaccines except for Pfizer, AstraZeneca and Moderna from 1971 to the date of this report? Please set
out the process by which you have come to your view.
My Answer:
The top 5 Categories of Deaths by Organ reported to the TGA from 1971 to 2021 non-COVID were
General Disorders and Administrative Site Conditions, Nervous System Disorders, Infections and
Infestations, Investigations (undefined by TGA), Respiratory Thoracic and Mediastinal. The top 5
represent 57% of all Deaths by Organ reports. This is represented in the chart below:
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Source:
• Appendix 4 - Instructions_TGA DAEN Download (*note: to create the above chart, I had to work out how to download
the data into a format that allowed us to analyse it; the steps I took are in Appendix 4; the data was sourced from DAEN
TGA website on Tue, 25th of Jan 2022)
9. What are the most significant categories, or types, of adverse events reported to the TGA for Pfizer,
AstraZeneca and Moderna? How many more categories, or types, of adverse event reports have been
reported to the TGA in relation to Pfizer, AstraZeneca and Moderna than have been reported for all
other vaccines combined? Please set out the process by which you have come to your view.
My Answer:
The Top 5 Categories of Deaths by Organ reported to the TGA for 2021 related to Covid vaccines were
Nervous System Disorders, General Disorders and Administrative Site Conditions, Respiratory Thoracic
and Mediastinal Disorders, Cardiac Disorders and Injury Poisoning and Procedural complications.
These categories account for 58.8% of all Death by organ reports. This is represented in the chart
below:
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Source:
10. Have there been any significant increases in categories, or types, of adverse event reports to the
TGA since the provisional approval of Pfizer, AstraZeneca and Moderna?
My Answer:
The number of adverse events reported to the TGA in 2021 is 100,180 relating to COVID vaccines. In
summarizing these adverse events by disease type, one event can be reported as many
diseases/conditions. I now have a list of 3,122 disease types, more than double the number of different
conditions that were reported prior to COVID vaccines. See table below:
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Source:
The number of non-COVID adverse events reported to the TGA from 1971 to 2021 was 19,330. In
summarizing these adverse events by disease type, one event can be reported as many
diseases/conditions. For the last 20 years, I have been able to incorporate all conditions in a list of
1,492 different conditions. See table below:
Source:
The Specific Reaction types associated with Adverse Events of Myocarditis, Pericarditis, Guillain-Barre
Syndrome, Immune Thrombocytopenia, Thrombosis with Thrombocytopenia Syndrome, and Abortions
and Spontaneous miscarriages have been analysed to compare their frequency for non-COVID 1971 to
2021 and Covid 2021 vaccines. All categories increased significantly.
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Source:
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Source:
11. Do you have any final observations on comments to make as the result of undertaking this analysis.
As a final remark, I note that in addition to generating more adverse events and generating more
disease types, COVID vaccines are generating more Reaction Reports than seen before by traditional
vaccines.
In fact, the TGA is seeing more Adverse Event Reaction reports in 2021, than they have seen in the
entire 50 years since 1971.
(This is separate and different to Adverse Event Cases. It says that each Non-Covid 1971 to 2021
Adverse Event Case would have included on average of 2.27 MedDRA reactions per event. Covid
Vaccines 2021 include an average of 3.26 reactions per event. Refer table above for examples of Major
Organ classes and Adverse Event Reaction Types.)
• No of Adverse Events Non-covid – 1971 to 2021 – 19330

• No of Disease Types Non-covid – 1971 to 2021 - 1492
• No of Adverse Event Reactions – Death by Organ Report non-covid 1971 to 2021 – 43878
• Adverse Reactions reported per Adverse Event 1971 to 2021 – 2.27 Reactions per Event
• No of Adverse Events Covid 2021 – 100,180

• No of Disease Types Covid 2021 - 3122
• No of Adverse Event Reactions – Death by Organ Report Covid 2021 – 327015
• Adverse Reactions reported per Adverse Event 2021 – 3.26 Reactions per Event
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Sources:
• See DAEN website for no. of adverse events non-COVID and COVID
• See DAEN website for Deaths by Organ – no of disease types non-COVID and COVID
• See DAEN website for Deaths by Organ – total no of reports using medDRA reaction items, 43,878 non-COVID and
327,015 COVID
• Adverse Reactions Reported per Adverse Event = reactions divided by adverse events
SECTION 2: ADVERSE EVENTS AND DEATHS REPORTED TO TGA DAENS, AUSTRALIA FOLLOWING
COVID-19 VACCINES BETWEEN 1 FEBRUARY 2021 TO 8 JUNE 2022 HIGHLIGHTING DEATHS AND
ADVERSE EVENTS IN CHILDREN 5-11 YRS OLD. Section 6 onwards.
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6.0 ITEM 1
Since 10 January 2022, how many Deaths are reported in DAENs in 5-11 year olds following Covid-19
Vaccines?
6.1 Since 10 January 2022, 135 deaths following Covid-19 Vaccines are recorded on the DAENs
database for all ages.
6.2 Since 10 January 2022, 5 Deaths were reported in children 5-11 in DAENs since the roll-out of
Covid-19 Vaccines began for this age group.
6.3 Details of these Deaths are set out in Table 1 below. Five screenshots are included in
Schedule B to this report. These screenshots are from the DAENs website for each death
reported in the 5-11 age cohort since the roll out of the Pfizer Vaccine began. Each
screenshot (on the left hand side) confirms “death as a reported outcome” from “a single
medicine”, namely a Covid-19 Vaccine.
Date Case Gender Age Adverse Event Result

Number
11 March 719838 M 7 Cardiac Arrest Death as reported
2021 Generalised tonic-clonic Outcome
seizure
25 March 724023 F 9 Cardiac Arrest Death as reported
2021 Outcome
28 March 724925 M 6 Adverse Event Following Death as reported
2021 Immunisation Outcome
6 May 733723 M 10 Adverse Event Following Death as reported
2021 Immunisation Outcome
10 May 734187 M 5 Abdominal Pain Death as reported
2021 Cardiac arrest Outcome
Table 1: Summary of deaths reported to DAENs following Covid-19 Vaccine in 5-11 year olds since
the roll out to this age group began on 10 January 2022
6.5 The DAENs website also routinely reports Deaths where no age is specified. At the time of
producing this report, 90 of the 135 Deaths sampled (14 or 15.6%) had no age specified. It is
possible that some of these Deaths where the age is not specified may also fall within the age
cohort 5-11 years. I have included a further discussion of these Deaths in my response to Item
3 (below).
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7.0 ITEM 2
Since 10 January 2022, how many Adverse Events were reported in the DAENs associated with 5-11
year olds following Covid-19 Vaccines?
7.1 Since 10 January 2022, 27,742 Adverse Events were reported following Covid-19 Vaccines in
all ages. This number includes the 135 Death reports reported in Item 1 (6.1) above (in all
ages).
7.2 In 5-11 year olds, 1,390 Adverse Events have been reported by DAENs following Covid-19
Vaccines.
7.3 Table 2 below shows breakdown of Adverse Events from 10 January 2022 to 8 June 2022 by
Covid-19 Vaccine type for 5-11 year olds (and includes Deaths). The Pfizer and Spikevax
(Maderna) Vaccine are the only provisionally approved Covid-19 Vaccines for the 5-11 and 6-
11 year old group, respectively. I am not able to explain why there are 5-11 year olds that
received Covid-19 Vaccines not provisionally approved for their age.
Vaccine Type Number of Reports (Cases) Number of cases with a Number of cases where
Adverse Events single suspected Death was a reported
medicine outcome
Pfizer Comirnaty 1371 N/A 5
Astra Zeneca 3 N/A 0
Covid-19 TNS 6 N/A 0
Spikevax 10 N/A 0
Nuvaxovid - 0
Total 1390 N/A 5

Table 2: number reports of Adverse Events in 5-11 year olds following Covid-19 Vaccines since 10
January 2022
7.4 DAENs also records 28 Adverse Events in 5-11 year olds prior to 10 January 2022, when the
Covid-19 Vaccines were rolled out to this age group. I have included details about these 28
reports in Schedule C to this report. These reports begin at 29 September 2021. I cannot
explain why children received the Covid-19 Vaccines before they were provisionally approved
and rolled out to this age group. Nor can I explain why they received Covid-19 Vaccines not
provisionally approved for this age group.
7.5 Note, since 10 January 2022 there are 5,221 Adverse Events in DAENs where no age range is
specified. Absent that detail from the DAENs database, it is not possible for me to say whether
there are more Adverse Events in the 5-11 year old age cohort. I have dealt with this further
under Item 4 below.
Source: DAENs 10 January 2022 to 8 June 2022 https://1drv.ms/x/s!Al71AGIGLVVzgk90LkH0sKUeqH9b?e=0Y6AZ0
70
The Time of Covid

7.6 These 1,390 Adverse Events resulted in 3,635 reactions all classified as per the MedDRA
reaction types. At Schedule D to this report, I have listed out the types of Adverse Events being
reported by DAENs by frequency from highest to lowest.
7.7 Table 3 below shows the top 10 Adverse Events reaction types being reported in 5-11 year
olds following Covid-19 Vaccines. These top 10 Adverse Events represent 1,327 reactions or
37% (1,327/3,635) of Total Adverse Event reactions being reported in children aged 5-11 years
of age.
MedDRA reaction Number of Adverse Potentially Serious % of Total

Events Reactions
Chest pain 211 5.80%
Vomiting 163 4.48%
Pyrexia 159 x 4.37%
Headache 131 3.60%
Abdominal pain 127 3.49%
Dyspnoea 118 3.25%
Vaccination error 111 3.05%
Nausea 110 3.03%
Lethargy 99 2.72%
Table 3: Top 10 Adverse Events Reaction types reported in children 5-11 years since 10 January 2022
7.8 Table 4 below shows the number of Adverse Events reactions by the organ affected. The top
10 organs affected (down to cardiac disorders) represent 89% of all reactions reported by
DAENs in 5-11 year olds following Covid-19 Vaccine.
Organ Class Number of Reactions % of Total

General disorders and administration site conditions 750 21%
Nervous system disorders 544 15%
Gastrointestinal disorders 534 15%
Skin and subcutaneous tissue disorders 336 9%
Respiratory, thoracic and mediastinal disorders 287 8%
Injury, poisoning and procedural complications 221 6%
Musculoskeletal and connective tissue disorders 163 4%
Investigations 137 4%
Infections and infestations 131 4%
Cardiac disorders 127 3%
Vascular disorders 107 3%
Blood and lymphatic system disorders 63 2%
Eye disorders 52 1%
71
The Time of Covid

Organ Class Number of Reactions % of Total
Psychiatric disorders 43 1%
Metabolism and nutrition disorders 37 1%
Other (Non-aligned) 33 1%
Immune system disorders 20 1%
Renal and urinary disorders 19 1%
Reproductive system and breast disorders 17 0%
Ear and labyrinth disorders 8 0%
Endocrine disorders 3 0%
Hepatobiliary disorders 2 0%
Neoplasms benign, malignant and unspecified (incl cysts
and polyps) 1 0%
Total 3635 100%
Table 4: Top 10 Adverse Events Reaction Types reported in children 5-11 years since 10 January 2022
7.9 Following is Table 5, that lists Potentially Serious Adverse Events in children 5-11 years. The
DAENs Adverse Event Database does not advise which events are serious. The TGA does report
on serious adverse events in their weekly reports. The specific adverse events which are
considered serious are not specifically identified. As such, in absence of information from the
TGA, I have assessed and interpret the following reaction types to be potentially serious. This
is my assessment as this detail is not information provided in DAENs or by the TGA.
MedDRA reaction Number of Adverse Potentially % of Total Adverse Event

Events Serious Reactions
Pyrexia 159 x 4.37%
Syncope 98 x 2.70%
Tachycardia 27 x 0.74%
Pericarditis 23 x 0.63%
Seizure 21 x 0.58%
Expired product administered 17 x 0.47%
Product administered to patient of 16 x 0.44%
inappropriate age
Appendicitis 12 x 0.33%
Myocarditis 9 x 0.25%
Adverse event following 7 x 0.19%
immunisation
Hypotension 6 x 0.17%
Kawasaki's disease 6 x 0.17%
Loss of consciousness 6 x 0.17%
72
The Time of Covid

MedDRA reaction Number of Adverse Potentially % of Total Adverse Event
Events Serious Reactions
Pneumonia 4 x 0.11%
Urinary incontinence 4 x 0.11%
Cardiac arrest 3 x 0.08%
Myocarditis/pericarditis 3 x 0.08%
Carditis 2 x 0.06%
Product administered at 2 x 0.06%
inappropriate site
Vaginal haemorrhage 2 x 0.06%
Demyelination 1 x 0.03%
Myocardial infarction 1 x 0.03%
Pleurisy 1 x 0.03%
Total Potentially Serious Adverse 430 x 11.8%
Events
Total Adverse Event Reactions 3635 100%
Table 5: Potentially serious adverse events.
73
The Time of Covid

8.0 ITEM 3
Since 1 February 2021, how many Deaths were reported in the DAENs in adolescents and adults
following Covid-19 Vaccines?
8.1 Since 1 February 2021, 884 Deaths have been reported in the DAENs database following
Covid- 19 Vaccines (all ages).
8.2 After removal of the Deaths in 5-11 year olds, that leaves 879 Deaths reported in DAENs.
8.3 As mentioned, in Item 1 above, there are a number of reports of Death in DAENs where no
age is specified. I have reviewed in excess of 90% of these deaths and 147 of them had no age
detailed against them. That is 17.6% of the Deaths did not have an age specified, so I have
extrapolated that to be 156 Deaths out of the total 884 Deaths (all ages) where no age is
specified.
Source: Death Sample link https://1drv.ms/x/s!Al71AGIGLVVzgkwl1C85ztAq5BTW?e=nz49ZT
8.4 Therefore, from the DAENs data, there are 723 deaths that have been reported in adolescents
and adults following Covid-19 Vaccines (after removal of the unspecified age Deaths and
Deaths in 5-11 year olds).
8.5 Table 6 below sets out the Deaths reported on the DAENs website following Covid-19
Vaccines per age cohort is set out as follows:
Deaths 1 February 2021 to 8 June 2022

Infant deaths (one foetal death) not counted 0
Deaths in 5-11 years 5
Deaths in adolescents and adults 723
Unspecified Age Deaths 156
Total Deaths 884
Table 6: Adolescent and adult deaths from 1 February 2021 to 8 June 2022
74
The Time of Covid

9.0 ITEM 4
Since 1 February 2021, how many adverse events were reported in DAENs associated with adolescents
and adults following Covid-19 Vaccines?
9.1 Since 1 February 2021, there were 131,991 Adverse Events reported in DAENs following Covid-
19 Vaccines (all ages), as per the “Number of reports (cases)” in the screenshot from the
DAENs website below:
Screenshot 1: Adverse Events reported in DAENs following Covid-19 Vaccines (all ages)
9.2 Of those Adverse Events reported, the DAENs database states 129,244 are “with a single
medicine”. That is the Adverse Event was following a single medication, ie Covid-19 Vaccine.
I do not use this number for my analysis.
9.3 Separately, I have reviewed the Adverse Events by Covid-19 Vaccine and have set these figures
out in Table 7 below.
75
The Time of Covid

Vaccine Type Adverse Events Suspected Single Deaths as a Reported
Medication Outcome
Pfizer Comirnaty 76,938 75,110 370
Astra Zeneca 47,567 46,553 464
Nuvaxovid 753 721 1
Spikevax 6,506 6,283 25
Type Not Specified 620 577 25
Total 132,384* 129,244 885*
Table 7: Total of Adverse Events reported by Covid-19 Vaccine type since 1 February 2021 – see
screenshot in Schedule E
9.4 The number of Adverse Event “report (cases)” on the DAENs website is 131,991 (screenshot
1 above). This number is different to the number of Adverse Events I tallied up by each Covid-
19 Vaccine type by 393 events. From the data, I am not able to explain this difference.
9.5 The number of Deaths I tallied up by Covid-19 Vaccine type is 885 and is also different to the
number of Deaths reported on the DAENs website (884) (screenshot 1 above). From the data,
I am not able to explain this difference.
9.6 Of the 132,384 Adverse Events reported since 1 February 2021 in DAENs, there were 22,007
Adverse Events that were unspecified in terms of age. I have set these out in Table 8.
Vaccine Type Unspecified Adverse Unspecified Adverse Total Unspecified

Events Events Adverse Events
1 February 2021 to 9 10 January 2022 to 8 1 February 2021 to 8
January 2022 June 2022 June 2022
Pfizer 9,345 4,082 13,427
Comirnaty
Astra Zeneca 6,923 616 7,539
Nuvaxovid 0 65 65
(Moderna)
Spikevax 341 409 750
(Moderna)
Covid-19 TNS 177 49 226
Total 16,786 5,221 22,007
Table 8: Unspecified Adverse Events from 1 February 2021 to 8 June 2022
9.7 As explained under Item 3 above, unspecified means that the age range was left blank or
noted with hyphens. These Adverse Events therefore could cover any age.
9.8 Links to the original source data set to derive unspecified Adverse Events follows. This data
set also provided adverse events in infants 0-4 and children 5-11.
Source: DAENs1 February 2021 to 9 January 2022 https://1drv.ms/x/s!Al71AGIGLVVzglBTiDtJYJ_v-JqM?e=Zgz2bD
Source: DAENs 10 January 2022 to 8 June 2022https://1drv.ms/x/s!Al71AGIGLVVzgk90LkH0sKUeqH9b?e=0Y6AZ0
76
The Time of Covid

9.9 Table 9 below shows the calculation for the Number of Adverse Events for adolescents and
adults from 1 February 2021 to 8 June 2022.
Vaccine Number of Number of Number of Number of Number of

Type Reports Reports(Cases) Reports Reports Reports (Cases)
(Cases) Adverse (Cases) (Cases) Adverse Events
Adverse Events Adverse Adverse Events Adolescents and
Events Unspecified Events 0-4 years Adults
All Ages ages 1 5-11 Years 10 January 1 February 2021 to
1 February February 2021 10 January 2022 to 8 June 8 June 2022
2021 to 8 to 8 June 2022 2022 to 8 2022
June 2022 June 2022
Pfizer 76,938 13,427 1371 22 62,118
Comirnaty
Astra 47,567 7,539 3 1 40,024
Zeneca
Nuvaxovid 753 65 0 0 688
(Moderna)
Spikevax 6,506 750 6 1 5749
Type Not 620 226 10 0 384
Specified
Total (by 132,384 22,007 1390 24 108,963
ind Covid
vaccine
type)
Total (all 131,991 22,007 1390 24 108,570
Covid
vaccines)
Table 9: Number of adverse events in adolescents and adults by Covid-19 Vaccine type since 1
February 2021
9.10 There are somewhere between 108,570 and 108,963 Adverse Events from 1 February 2021 to
8 June 2022 which have been reported by the TGA as relating to adolescents and adults
following Covid-19 Vaccine. This includes the 28 Adverse Events in 5-11 year olds which
occurred prior to 10 January 2022 (as detailed in Schedule C to this report). Removing the
Adverse Events in 5-11 year olds prior to roll out of Covid-19 Vaccines to this age group, leaves
108,542 and 108,935 Adverse Events in adolescents and adults.
77
The Time of Covid

9.11 There are no COVID-19 Vaccines that have been provisionally approved or otherwise for
children <5, therefore I am unable to explain why there are a number of Adverse Events
reported in 0-4 year olds.
78
The Time of Covid

10.0 ITEM 5
Where the TGA safety report numbers differ from DAENs, I have also been asked to comment on the
reporting in the TGA safety reports for Adverse Events following Covid-19 Vaccines with respect
children 5-11 and all ages.
10.1 In my previous reports, I have compared reporting of Adverse Events in NON-covid Vaccines
to Covid-19 Vaccines. On 31 January 2022, the likelihood of someone having an Adverse Event
as the result of a NON-Covid Vaccine (between 2010-2020) was 1 in every 10,000 doses. With
Covid-19 Vaccines the likelihood of someone having an Adverse Events as the result of the
vaccine was 23 Adverse Events per 10,000 doses as at 31 January 2022. This is highlighted in
Table 10 below.
10.2 Using the TGA’s more up to date data, the likelihood now of someone having an adverse event
as the result of a Covid-19 vaccine as at 5 June 2022 is 21.87 Adverse Events per 10,000 doses.
This is 20 times worse than Non-covid times and is reasonably consistent with the Adverse
Events I was reporting on at the end of January 2022.
Table 10: – number of Adverse Events reported per 10,000 doses between Non-Covid (2010-
2020) and Covid-19 (2021) Vaccines
Prepared by:
Lisa Mitchell B.Sc, M.App.Stats, MBA, FAICD

Corporate Transformation Services Pty Ltd
79
The Time of Covid

END OF REPORT
Schedule A includes CV.
“A” Lisa Mitchell B.Sc, M.App.Stats, M.B.A, F.A.I.C.D

Director, Corporate Transformation Services Pty Ltd
Resume
Home: 02-9460-4417 Address: 3 Wilona Ave,
Lavender Bay, NSW 2060
Mobile: 0408028326 Disc profile: Director
E-mail: [email protected] Myers Briggs: INTJ
Personal Profile
I am an internationally experienced director, senior executive, advisor, leader & business transformation and
performance improvement specialist.
I have deep experience and knowledge of strategic problem solving and frameworks, delivering large scale
projects and am a qualified and licensed change and transformation leader, statistician, facilitator and
management practitioner.
I have extensive commercial expertise & operate across the end to end value chain of the organisation.
I lead large scale high value creation, high corporate priority initiatives to generate long term sustainable results
using advanced tools and optimisation techniques in complex organisations through holistic leveraging of people,
process, technology and capital. The value that I bring to corporations is in increased revenue through improved
customer service levels, reduced costs driving improved ROI through improved purchasing, and operational
performance, improved cash flow, through reduced lead times and improved product velocity through supply
chain. All of this on a sound base of optimised operational performance linked to the corporations’ goals and
objectives using sound change management models and practices.
I have 12 years solid blue-chip corporate experience working at the highest levels in E.I. Du Pont de Nemours
Pty Ltd and Coca Cola Amatil as well as 10 years consulting with firms such as Partners in Performance, Maxx
implementation and Momentum Partners as well as directly to clients.
My work has been in the areas of sustainable and timely value creation through strategy, business planning,
business portfolio optimisation, capital value maximisation, business and supply chain management, planning
and optimisation, procurement and strategic sourcing and all aspects of achieving and sustaining operational
excellence.
I am an executive, advisor, consultant, and contractor, seeking roles which will allow me to use my broad and
deep expertise for the long term benefit for a selection of specially selected businesses.
Career Highlights so far…..

E. I. Du Pont de Nemours Pty Ltd: With Chad Holliday, the CEO and Chairman of the entire Du Pont co and the
34 Strategic Business Unit leaders of Du Pont globally, I developed the Asia Pacific Strategic planning process
and then the Strategic plan for Du Pont in Asia Pacific. I have in depth detailed knowledge of every one of Du
Pont’s strategic portfolios. I also developed the Global Strategic Business unit pre-profit objective process, which
was required to align the global business unit profit objectives with the board expectations which delivered billions
in revenue to the global Du Pont business. Developed Du Pont global supply chain approach in Printing and
Publishing and Medical x-ray film businesses in preparation for their eventual sale.
CCA: With Mark Clark director of CCA, and reporting to the board, responsible for the optimisation of the entire
end to end value chain including development of planning systems and processes such as D&OP across Asia
Pacific which delivered coke to within an arms’ reach of desire at the desired cost adding many hundreds of
millions in value across AP.
80
The Time of Covid

BlueScope Steel: With Len Blackmore VP of Procurement, established and ran the PMO within BlueScope Steel
(second most critical initiative in corporation after safety.) Developed PMO rules, governance and operating
procedures. PMO included several thousand projects occurring across the organisation, accounting for more than
$Billion in cost and many hundreds of millions in savings potential.
QR: With Paul Sonego VP, Lead capital value maximisation team within QR prior to listing and name change to
Aurizon. Delivered millions in savings to the corporation in below and above rail areas. Employed specifically to
work with McKinsey.
Mondelez: With Hunter Burke VP, Led major global transformation initiative for EEMEA establishing the basis for
profitable growth and sustainability into the future.
Executive director (CTS) where I consult to multinational corporations. My business is a channel partner of IBM
which ensures that I am in the best position to introduce the most advanced technology into corporations to
transform their operations.
Core Competencies
• Leadership - Personal and Professional Development Focus.
• People Skills - Proven and demonstrated ability to partner, influence and inspire
• Demonstrated superior supply chain and value chain leadership capability - Demonstrated capa-
bility to work with and 'transform' value chains and organisations in a way that engages positively all
stakeholders and results in sustainable outcomes.
• Results focused strategic planning capability - Developed and tested in several top 100 multination-
als.
• Extensive strategic marketing capability - Demonstrated capability in reviewing products and ser-
vices and how they align with markets, growth industries and key drivers of growth, (completed for most
AP countries, including Australia, Europe and US) and the implications for the business.
• Internationally developed and results focused organizational problem solving skills as well as
demonstrated capability in benchmarking profitability.(globally) Demonstrated capability in most basic
organizational problem solving to high level development of complex models and systems to optimize
performance.
• Superior Quantitative capability and disciplined business approach – Optimised the planning and
operations of the entire end to end value chain across APAC for CCA. Qualified statistician using ad-
vanced techniques and technology.
• Sound knowledge of Asia Pacific countries, economies and cultures - I have lived, worked and
been required to deliver results on every continent and as such have internationally developed business
skills and highly developed cultural sensitivity.
• Superior ability to influence- I have proven and demonstrated ability to partner, influence and inspire
at all levels in an organisation, from very senior management through to operations.
• P&L Accountability – I have been accountable for financial outcomes, budgets and direct reports
across global regions such as LA & APAC.
Experience
• I have worked in many areas including: Global Value/Supply Chain strategy, planning & operational im-
provement (S&OP), Business Strategy, development, implementation, & benefits realisation (suppliers,
competitors, customers, market conditions, risk assessment and mitigation, Portfolio Optimisation,
transforming businesses into money making powerhouses including innovation and commercialisation
,Leading Business transformation & cross functional Change Program Delivery, Restructuring & ration-
alisation, Outsourcing, divestment or acquisition, Strategic partnerships - Realising the business case,
Procurement, Strategic Sourcing, including commercial negotiation, Capital Value Maximisation (CVM)
improving capital, resource utilisation & productivity , pre and post merger separation and integration
and the analysis of all of the above.
• I have worked with more than 40 Multinationals & many medium sized businesses. Every assignment
that I have ever had, has involved problem solving (of some kind) and as such has needed my analytic
skills, to measure the current state and indeed work out what needs to be done, to deliver the appropri-
ate output, then measure the impact of initiatives implemented.
• Demonstrated capability in broad range of industries: FMCG, Pharmaceuticals, Healthcare, Printing
and Publishing, Chemicals, Services, Industrial products, heavy industrial including steel manufacturing,
rail infrastructure and Mining. I have worked in industrial, consumer and service industries.
81
The Time of Covid

• I have consulted independently; both directly to my clients and to a variety of tier 1strategy and opera-
tional consulting firms. I am an organizational strategic and operational improvement specialist and my
focus is on all aspects of making the organization work better, and then delivering profitable growth
faster. I work on the organization as well as in it. I work from the top down
• My skills apply to large and small organizations although my primary experience is in multinational cor-
porations. I have consulted to 10 major multinationals and 1 GOC since 2003 as well as several na-
tional, and privately held companies. I have fulfilled interim senior executive roles including CEO and
General Manager.
• Prior to 2005 I worked in line management roles and internal consulting roles, at the very highest levels
of E.I. Du Pont. De Nemours and Coca Cola Amatil. With Chad Holliday, the CEO and Chairman of
the entire Du Pont company and subsequently with the 34 Strategic Business Unit leaders of Du
Pont globally.
• As a Business and supply chain strategist for Coca Cola (Amatil), responsible for the optimisation
of the entire end to end value chain across Asia Pacific.
• My line of reporting for the last 15 years has been to directors, chairman, boards and global
VP’s.
• I have lived, worked and been required to deliver results on every continent (short and long term as-
signments) in Japan, 11 other Asian countries, US, Europe and the UK as well as Australia and has as
such well developed international business skills along with highly developed cultural sensitivity.
Career Summary
January 2005 to present Director, CTS (Corporate Transformation Services) Pty
Ltd
Panellist and Thought leader, Current and Convetit
Advisor, Start-ups
Engagement Manager and Consultant – Direct to client
and to various tier 1 strategy and operational
consulting firms including Partners in Performance
reporting to Director Level
September 1998 to January 2005 Manager, Asia Pacific Customer Consumer Services
Systems
Coca Cola Amatil (Asia Pacific) - Reporting to Director
level
September 1996 to August 1998 Business Manager P&P AP (Asia Pacific), P&L
responsibility
E.I. Du Pont de Nemours Pty Ltd - Reporting to
Regional Director P&P– AP
September 1994 to August 1996 Regional Manager LAAP (Latin America Asia Pacific),
P&L responsibility
E.I. Du Pont de Nemours Pty Ltd - Reporting to VP of
finance and Global VP Printing and Publishing – plus
special assignments for CEO and Chairman
September 1993 to August 1994 Manager, Marketing services and export – Supply
Chain (Asia Pacific), Du Pont in Asia Pacific
Reporting to General Manager P&P, Australia
September 1991 to August 1993 Strategic Planning Consultant

Du Pont in Asia Pacific - Reporting to Director of
Finance in Asia Pacific and Chairman of Asia Pacific
October 1990 to August 1991 Strategic Planning Consultant – Du Pont (Australia)

Reporting to Country Manager Du Pont (Australia)
Education
B. Sc (Majors Statistics and Psychology) Sydney University
M. App. Stats (Masters in Applied Statistics) Macquarie University
M.B.A (Business Strategy, Management and Leadership) University of Technology, Sydney
82
The Time of Covid

Company director training and FAICD qualification received
Completed International Company directors qualification
Key Training Courses

• Extensive and continuous responsibility for my own personal and professional development has meant
that I have attended numerous training courses, extending from technical application training to human
resource training.
1990 E.I.Du Pont de Nemours Business Strategy and

Planning – Gary Hamel
1990 E.I Du Pont de Nemours Safety training
1990 E.I.Du Pont de Nemours – Organisational
Effectiveness Training
1992 Envisioning the future – Ram Charam – Ed Woollard
then CEO and chairman of Du Pont and senior Du Pont
SBU leaders
1992 to 1996 Various organisational effectiveness training and
change management programmes, various strategy
development training sessions, interpersonal
behaviour training, relationship mastery, negotiation
training, physical mastery, emotional mastery,
emotional intelligence training.
1996 to 2003 Strategic selling, leadership development, Value Chain
planning, D&OP training, CSS training, MGSM
Strategic management programme,
Personal Details
• Fellow of Australian Institute of Company directors (youngest ever)
• Interests are in human group psychology and organisational behaviour, Business strategy and value
chain.
• Keen collector of antique furniture from Europe and the Orient.
• Enjoys keeping fit, Ashtanga yoga and walking
83
The Time of Covid

SCHEDULE B – from Item 1 - screenshots of DAENs database of 5-11 year olds where Death was
the reported outcome
84
The Time of Covid

85
The Time of Covid

86
The Time of Covid

SCHEDULE C – Adverse Events reported in 5-11 year olds prior to 10 January 2022 following Covid-
19 Vaccine
Case Report Age Gender Medicines reported as MedDRA reaction terms

number entry date (years) being taken
633664 29/09/2021 10 Male • Spikevax COVID-19 • Product administered to
vaccine (Elasomeran patient of inappropriate
(mRNA)) - Suspected age
• Vaccination error
650124 25/10/2021 10 Male • COMIRNATY COVID-19 • Product administered to
vaccine (tozinameran) - patient of inappropriate
Suspected age
658593 5/11/2021 10 Female • COMIRNATY COVID-19 • Product administered to
Suspected age
685756 21/12/2021 10 Male • COMIRNATY COVID-19 • Vaccination error
vaccine (tozinameran) - • Wrong product
Suspected administered
651053 26/10/2021 11 Female • Spikevax COVID-19 • Injection site reaction
vaccine (Elasomeran • Product administered to
(mRNA)) - Suspected patient of inappropriate
age
age
Suspected age
age
Suspected age
87
The Time of Covid

Suspected age
666052 17/11/2021 11 Not • Spikevax COVID-19 • Product administered to
Specified vaccine (Elasomeran patient of inappropriate
670461 23/11/2021 11 Female • Spikevax COVID-19 • Product administered to
669960 23/11/2021 11 Not • COMIRNATY COVID-19 • Product administered to
Specified vaccine (tozinameran) - patient of inappropriate
Suspected age
679963 9/12/2021 11 Female • COMIRNATY COVID-19 • Incorrect dose
vaccine (tozinameran) - administered
Suspected • Product administered to
patient of inappropriate
age
88
The Time of Covid

Suspected age
Suspected age
690395 6/01/2022 11 Male • COMIRNATY COVID-19 • Incorrect dose
vaccine (tozinameran) - administered
age
Suspected age
635726 1/10/2021 8 Female • COMIRNATY COVID-19 • Fatigue
vaccine (tozinameran) - • Pain in extremity
age
526666 25/03/2021 9 Female • COMIRNATY COVID-19 • Headache
vaccine (tozinameran) - • Myalgia
age
580197 5/07/2021 9 Male • COVID-19 Vaccine • Product administered to
AstraZeneca (ChAdOx1-S patient of inappropriate
(Viral vector)) - Suspected age
89
The Time of Covid

SCHEDULE D – Total Adverse events reported by DAENs in children 5-11 from 10 January 2022 to
8 June 2022 being 1,390 Adverse Events, which resulted in 3,635 reactions - classified as per the
MedDRA reaction types. Types listed by frequency from highest to lowest.
Potentially
MedDRA reaction Count Serious % of Total
Chest pain
211 5.80%
Vomiting
163 4.48%
Pyrexia
159 x 4.37%
Headache
131 3.60%
Abdominal pain
127 3.49%
Dyspnoea
118 3.25%
Vaccination error 111 3.05%
Nausea 110 3.03%
Lethargy 99 2.72%
Syncope 98 x 2.70%
Rash 90 2.48%
Dizziness 84 2.31%
Pallor 82 2.26%
Urticaria 76 2.09%
Injection site reaction 66 1.82%
Fatigue 57 1.57%
Myalgia 52 1.43%
Diarrhoea 50 1.38%
Malaise 45 1.24%
Palpitations 44 1.21%
Presyncope 41 1.13%
Chest discomfort 39 1.07%
Lymphadenopathy 39 1.07%
Arthralgia 33 0.91%
Injection site pain 31 0.85%
Cough 30 0.83%
Oropharyngeal pain 30 0.83%
90
The Time of Covid

Potentially
Pain in extremity 29 0.80%
Tachycardia 27 x 0.74%
Rash pruritic 26 0.72%
Concomitant disease aggravated 25 0.69%
Pruritus 25 0.69%
Decreased appetite 24 0.66%
Abdominal pain upper 23 0.63%
Incorrect dose administered 23 0.63%
Pericarditis 23 x 0.63%
Hyperhidrosis 22 0.61%
Cold sweat 21 0.58%
Seizure 21 x 0.58%
Covid-19 20 0.55%
Asthma 19 0.52%
SARS-CoV-2 test positive 18 0.50%
Expired product administered 17 x 0.47%
Rhinorrhoea 17 0.47%
Chills 16 0.44%
Electrocardiogram abnormal 16 0.44%
Product administered to patient of inappropriate age 16 x 0.44%
Influenza like illness 15 0.41%
Swelling face 14 0.39%
Epistaxis 13 0.36%
Lymphadenitis 13 0.36%
Anxiety 12 0.33%
Appendicitis 12 x 0.33%
Eye swelling 12 0.33%
Wrong product administered 12 0.33%
Abdominal discomfort 11 0.30%
Feeling hot 11 0.30%
91
The Time of Covid

Potentially
Influenza 11 0.30%
Hypersensitivity 10 0.28%
Paraesthesia 10 0.28%
Rash erythematous 10 0.28%
Angioedema 9 0.25%
Croup infectious 9 0.25%
Lip swelling 9 0.25%
Myocarditis 9 x 0.25%
Pain 9 0.25%
Troponin 9 0.25%
Musculoskeletal chest pain 8 0.22%
Ocular hyperaemia 8 0.22%
Throat tightness 8 0.22%
Tremor 8 0.22%
Wheezing 8 0.22%
Adverse event following immunisation 7 x 0.19%
C-reactive protein increased 7 0.19%
Electrocardiogram 7 0.19%
Erythema 7 0.19%
Gastroenteritis 7 0.19%
Herpes zoster 7 0.19%
Neck pain 7 0.19%
Rash maculo-papular 7 0.19%
Troponin increased 7 0.19%
Asthenia 6 0.17%
Cyanosis 6 0.17%
Disorientation 6 0.17%
Generalised tonic-clonic seizure 6 0.17%
Heart rate increased 6 0.17%
Hypotension 6 x 0.17%
92
The Time of Covid

Potentially
Inappropriate schedule of product administration 6 0.17%
Kawasaki's disease 6 x 0.17%
Loss of consciousness 6 x 0.17%
Muscle spasms 6 0.17%
Product preparation issue 6 0.17%
SARS-CoV-2 antibody test positive 6 0.17%
Sneezing 6 0.17%
Tonsillitis 6 0.17%
Underdose 6 0.17%
Vaccine breakthrough infection 6 0.17%
Varicella 6 0.17%
Arrhythmia 5 0.14%
Axillary pain 5 0.14%
Conjunctivitis 5 0.14%
Flushing 5 0.14%
Incorrect dosage administered 5 0.14%
Migraine 5 0.14%
Peripheral swelling 5 0.14%
Rash macular 5 0.14%
Rash papular 5 0.14%
Sleep disorder 5 0.14%
Throat irritation 5 0.14%
Abdominal lymphadenopathy 4 0.11%
Breakthrough Covid-19 4 0.11%
Dehydration 4 0.11%
Dysphonia 4 0.11%
Haematuria 4 0.11%
Heart rate irregular 4 0.11%
Injection site rash 4 0.11%
Irritability 4 0.11%
93
The Time of Covid

Potentially
Menstrual disorder 4 0.11%
Multisystem inflammatory syndrome in children 4 0.11%
Oropharyngeal discomfort 4 0.11%
Oxygen saturation decreased 4 0.11%
Periorbital swelling 4 0.11%
Photophobia 4 0.11%
Pneumonia 4 x 0.11%
Thrombocytopenia 4 0.11%
Urinary incontinence 4 x 0.11%
Vision blurred 4 0.11%
Visual impairment 4 0.11%
Anaphylactic reaction 3 0.08%
Cardiac arrest 3 x 0.08%
Contusion 3 0.08%
Costochondritis 3 0.08%
Diabetic ketoacidosis 3 0.08%
Dyspnoea exertional 3 0.08%
Dysuria 3 0.08%
Ear infection 3 0.08%
Electrocardiogram ST segment elevation 3 0.08%
Henoch-Schonlein purpura 3 0.08%
Infection 3 0.08%
Musculoskeletal stiffness 3 0.08%
Myopericarditis 3 x 0.08%
Nasal congestion 3 0.08%
Oral pruritus 3 0.08%
Painful respiration 3 0.08%
Pleuritic pain 3 0.08%
Pollakiuria 3 0.08%
Rash vesicular 3 0.08%
94
The Time of Covid

Potentially
Respiratory rate increased 3 0.08%
Somnolence 3 0.08%
Swollen tongue 3 0.08%
Tachypnoea 3 0.08%
Thirst 3 0.08%
Troponin I 3 0.08%
Troponin I increased 3 0.08%
Urinary tract infection 3 0.08%
Vertigo 3 0.08%
Viral infection 3 0.08%
Abdominal pain lower 2 0.06%
Acne 2 0.06%
Alopecia 2 0.06%
Bacterial infection 2 0.06%
Bell's palsy 2 0.06%
Cardiac murmur 2 0.06%
Carditis 2 x 0.06%
Confusional state 2 0.06%
Conjunctival hyperaemia 2 0.06%
Crying 2 0.06%
Delirium 2 0.06%
Dyspepsia 2 0.06%
Dysphagia 2 0.06%
Echocardiogram normal 2 0.06%
Electrocardiogram normal 2 0.06%
Erythema multiforme 2 0.06%
Exercise tolerance decreased 2 0.06%
Eye pain 2 0.06%
Eye pruritus 2 0.06%
Feeling abnormal 2 0.06%
95
The Time of Covid

Potentially
Feeling cold 2 0.06%
Fibrin D dimer increased 2 0.06%
Flank pain 2 0.06%
Fracture 2 0.06%
Haematemesis 2 0.06%
Hepatitis 2 0.06%
Hypoaesthesia 2 0.06%
Hypotonia 2 0.06%
IgA nephropathy 2 0.06%
Inflammation 2 0.06%
Inflammatory marker increased 2 0.06%
Joint swelling 2 0.06%
Lymph node pain 2 0.06%
Lymphopenia 2 0.06%
Mouth ulceration 2 0.06%
No adverse event 2 0.06%
Oligomenorrhoea 2 0.06%
Oral herpes 2 0.06%
Osteomyelitis 2 0.06%
Pain in jaw 2 0.06%
Pharyngeal swelling 2 0.06%
Pharyngitis 2 0.06%
Pityriasis rosea 2 0.06%
Postictal state 2 0.06%
Product administered at inappropriate site 2 x 0.06%
Psoriasis 2 0.06%
Purpura 2 0.06%
Red blood cell sedimentation rate increased 2 0.06%
Renal impairment 2 0.06%
Respiratory tract infection 2 0.06%
96
The Time of Covid

Potentially
Retching 2 0.06%
SARS-CoV-2 test 2 0.06%
SARS-CoV-2 test negative 2 0.06%
Scrotal swelling 2 0.06%
Secretion discharge 2 0.06%
Sensation of foreign body 2 0.06%
Sinus arrhythmia 2 0.06%
Sinus tachycardia 2 0.06%
Skin discolouration 2 0.06%
Skin exfoliation 2 0.06%
Swelling 2 0.06%
Synovitis 2 0.06%
Taste disorder 2 0.06%
Testicular swelling 2 0.06%
Tinnitus 2 0.06%
Tongue discomfort 2 0.06%
Tongue pruritus 2 0.06%
Type 1 diabetes mellitus 2 0.06%
Unresponsive to stimuli 2 0.06%
Upper respiratory tract infection 2 0.06%
Vaginal haemorrhage 2 x 0.06%
Abdominal distension 1 0.03%
Abnormal faeces 1 0.03%
Administration site irritation 1 0.03%
Allergy to arthropod sting 1 0.03%
Ankle fracture 1 0.03%
Appendicitis perforated 1 0.03%
Arthritis 1 0.03%
Aspartate aminotransferase increased 1 0.03%
Atrial tachycardia 1 0.03%
97
The Time of Covid

Potentially
Attention deficit hyperactivity disorder 1 0.03%
Autonomic nervous system imbalance 1 0.03%
Axillary mass 1 0.03%
Back pain 1 0.03%
Basal ganglia haemorrhage 1 0.03%
Basedow's disease 1 0.03%
Blood blister 1 0.03%
Blood creatine increased 1 0.03%
Blood creatine phosphokinase increased 1 0.03%
Blood glucose abnormal 1 0.03%
Blood glucose increased 1 0.03%
Blood pressure increased 1 0.03%
Blood pressure measurement 1 0.03%
Blood urea increased 1 0.03%
Bradycardia 1 0.03%
Breath holding 1 0.03%
Bundle branch block right 1 0.03%
Cardiac discomfort 1 0.03%
Cardiac disorder 1 0.03%
Cardiomegaly 1 0.03%
Cellulitis 1 0.03%
Cerebrovascular accident 1 0.03%
Chapped lips 1 0.03%
Cheilitis 1 0.03%
Chest wall mass 1 0.03%
Chest X-ray 1 0.03%
Chest X-ray abnormal 1 0.03%
Chest X-ray normal 1 0.03%
Chillblains 1 0.03%
Clonic convulsion 1 0.03%
98
The Time of Covid

Potentially
Coma scale abnormal 1 0.03%
Conjunctival haemorrhage 1 0.03%
Constipation 1 0.03%
Corneal reflex decreased 1 0.03%
Coronary artery aneurysm 1 0.03%
C-reactive protein 1 0.03%
Cutaneous vasculitis 1 0.03%
Deafness 1 0.03%
Demyelination 1 x 0.03%
Dermatitis 1 0.03%
Diabetes mellitus 1 0.03%
Dizziness postural 1 0.03%
Drug ineffective 1 0.03%
Dyskinesia 1 0.03%
Dyspareunia 1 0.03%
Dysphemia 1 0.03%
Ear pain 1 0.03%
Ear swelling 1 0.03%
Echocardiogram 1 0.03%
Eczema 1 0.03%
Electrocardiogram QRS complex prolonged 1 0.03%
Electroencephalogram abnormal 1 0.03%
Empyema 1 0.03%
Encephalopathy 1 0.03%
Endocarditis 1 0.03%
Enterocolitis 1 0.03%
Epidemic polyarthritis 1 0.03%
Epigastric discomfort 1 0.03%
Eructation 1 0.03%
Erythromelalgia 1 0.03%
99
The Time of Covid

Potentially
Excessive eye blinking 1 0.03%
Extensive swelling of vaccinated limb 1 0.03%
Extrasystoles 1 0.03%
Eye inflammation 1 0.03%
Eye irritation 1 0.03%
Eye movement disorder 1 0.03%
Eyelid oedema 1 0.03%
Febrile convulsion 1 0.03%
Feeling of body temperature change 1 0.03%
Foaming at mouth 1 0.03%
Food allergy 1 0.03%
Frequent bowel movements 1 0.03%
Gait disturbance 1 0.03%
Gastrointestinal infection 1 0.03%
Gastrooesophageal reflux disease 1 0.03%
Gianotti-Crosti syndrome 1 0.03%
Gingival blister 1 0.03%
Gingivitis 1 0.03%
Glassy eyes 1 0.03%
Goitre 1 0.03%
Haemoglobin decreased 1 0.03%
Haemoglobin increased 1 0.03%
Hallucination 1 0.03%
Hallucination, visual 1 0.03%
Hand fracture 1 0.03%
Head discomfort 1 0.03%
Heart rate decreased 1 0.03%
Heavy menstrual bleeding 1 0.03%
Hypertensive encephalopathy 1 0.03%
Hypoglycaemia 1 0.03%
100
The Time of Covid

Potentially
Hypothyroidism 1 0.03%
Increased appetite 1 0.03%
Influenza A virus test positive 1 0.03%
Influenza virus test positive 1 0.03%
Injection site erythema 1 0.03%
Injection site swelling 1 0.03%
Insomnia 1 0.03%
Intestinal obstruction 1 0.03%
Intracranial pressure increased 1 0.03%
Joint instability 1 0.03%
Kidney infection 1 0.03%
Lacrimation increased 1 0.03%
Limb discomfort 1 0.03%
Limb injury 1 0.03%
Lip discolouration 1 0.03%
Lip dry 1 0.03%
Lip ulceration 1 0.03%
Lipase increased 1 0.03%
Listless 1 0.03%
Lower respiratory tract infection 1 0.03%
Lymphadenopathy mediastinal 1 0.03%
Lymphocyte count decreased 1 0.03%
Lymphoedema 1 0.03%
Lymphoma 1 0.03%
Molluscum contagiosum 1 0.03%
Mood altered 1 0.03%
Multiple use of single-use product 1 0.03%
Muscle fatigue 1 0.03%
Muscle rigidity 1 0.03%
Muscle twitching 1 0.03%
101
The Time of Covid

Potentially
Muscular weakness 1 0.03%
Musculoskeletal discomfort 1 0.03%
Musculoskeletal pain 1 0.03%
Mydriasis 1 0.03%
Myelitis transverse 1 0.03%
Myocardial infarction 1 x 0.03%
Nasal discomfort 1 0.03%
Nasopharyngitis 1 0.03%
Neutrophilia 1 0.03%
Night sweats 1 0.03%
Nightmare 1 0.03%
Nystagmus 1 0.03%
Obstructive airways disorder 1 0.03%
Oesophageal discomfort 1 0.03%
Oral candidiasis 1 0.03%
Oral disorder 1 0.03%
Pain of skin 1 0.03%
Panic attack 1 0.03%
Paraesthesia oral 1 0.03%
Penile pain 1 0.03%
Perioral dermatitis 1 0.03%
Periorbital oedema 1 0.03%
Petechiae 1 0.03%
Petit mal epilepsy 1 0.03%
Pharyngeal erythema 1 0.03%
Pharyngeal paraesthesia 1 0.03%
Pleurisy 1 x 0.03%
Pneumothorax 1 0.03%
Polydipsia 1 0.03%
Polyuria 1 0.03%
102
The Time of Covid

Potentially
Post-acute COVID-19 syndrome 1 0.03%
Posterior reversible encephalopathy syndrome 1 0.03%
Posture abnormal 1 0.03%
Protein urine present 1 0.03%
Radius fracture 1 0.03%
Rectal haemorrhage 1 0.03%
Red blood cell count decreased 1 0.03%
Red blood cell sedimentation rate 1 0.03%
Respiratory distress 1 0.03%
Respiratory symptom 1 0.03%
Respiratory syncytial virus infection 1 0.03%
Rhinitis 1 0.03%
Rhinovirus infection 1 0.03%
Scarlet fever 1 0.03%
Scrotal oedema 1 0.03%
Scrotal pain 1 0.03%
Sepsis 1 0.03%
Serum ferritin increased 1 0.03%
Serum sickness 1 0.03%
Sinus bradycardia 1 0.03%
Sinus rhythm 1 0.03%
Sinusitis 1 0.03%
Skin reaction 1 0.03%
Skin warm 1 0.03%
Sleep terror 1 0.03%
Splenomegaly 1 0.03%
Staphylococcal bacteraemia 1 0.03%
Staphylococcal infection 1 0.03%
Staphylococcus test positive 1 0.03%
Status epilepticus 1 0.03%
103
The Time of Covid

Potentially
Streptococcus test 1 0.03%
Superior sagittal sinus thrombosis 1 0.03%
Supraventricular tachycardia 1 0.03%
Swelling of eyelid 1 0.03%
Tardive dyskinesia 1 0.03%
Temperature regulation disorder 1 0.03%
Testicular pain 1 0.03%
Tic 1 0.03%
Tongue dry 1 0.03%
Tonic clonic movements 1 0.03%
Tonic convulsion 1 0.03%
Trismus 1 0.03%
Troponin normal 1 0.03%
Vaccination site reaction 1 0.03%
Weight decreased 1 0.03%
White blood cell count increased 1 0.03%
Yellow skin 1 0.03%
Total 3635 100.00%
104
The Time of Covid

SCHEDULE E – Screenshots of total Adverse Events reported by DAENs per Covid-19 Vaccine type
• PFIZER VACCINE (01FEB2021TO08JUN2022):
• ASTRAZENECA (01FEB2021TO08JUN2022):
105
The Time of Covid

• NUVAXOVID (01FEB2021TO08JUN2022):
• SPIKEVAX (01 FEB 2021 TO 08 JUN 2022):
106
The Time of Covid

• TYPE NOT SPECIFIED (01EB2021TO08JUN2022):
107
The Time of Covid

The Time of COVID - Phillip Altman

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The Time of COVID - Phillip Altman

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A Report by Phillip M. Altman

The Time of Covid

Wendy Hoy AO FAA FRACP

The Time of Covid

PART A: Background – COVID-19 Gene-Based ‘Vaccines’

1. The Nature of the COVID-9 Gene-Based ‘Vaccines’

2. Regulatory Status of the COVID-19 Gene-Based ‘Vaccines’

3. How the Gene-Based COVID-19 ‘Vaccines’ Work

4. Threat Posed by SARS-CoV-2

5. Initial Perceptions of the COVID-19 ‘Vaccines’

6. Risk of SARS-CoV-2 Infection in Children

PART B: Emerging Picture of the Safety and Efficacy of the COVID-19

7. Failure to Demonstrate a Favourable Risk/Benefit Case for

8. Serious Adverse Effects of the COVID-19 ‘Vaccines’

9. Potential Toxicity of the Spike Protein Produced by Gene-Based

10. Long-Term Potential Genetic Damage and Cancer Potential

12. COVID-19 ‘Vaccines’ Do Not Prevent Infection or Transmission

13. Diminished ‘Vaccine’ Efficacy and Potential Negative ‘Vaccine’ Efficacy

14. The COVID-19 ‘Vaccines’ Do Not Provide a Similar and

Appendix A: Curriculum Vitae – Dr Phillip M. Altman

The Time of Covid

1. The Nature of the COVID-19 Gene-Based ‘Vaccines’

2. Regulatory Status of the COVID-19 Gene-Based ‘Vaccines’

The Time of Covid

The Time of Covid

3. How the Gene-Based COVID-19 ‘Vaccines’ Work

The Time of Covid

4.3. COVID-19 government statistics represent another complicating factor. There is no

The Time of Covid

4.5. Australian government Department of Health website: Coronavirus (COVID-19) case

The Time of Covid

Age group Males Females

The Time of Covid

5. Initial Perceptions of the COVID-19 ‘Vaccines’

• the vaccines prevent infection by the SARS-CoV-2 virus and subsequent

The Time of Covid

5.6. Indeed, none of these interpretations are correct.

The Time of Covid

6. Risk of SARS-CoV-2 Infection in Children

The Time of Covid

The Time of Covid

7. Failure to Demonstrate a Favourable Risk/Benefit Case for Vaccinating

8. Serious Adverse Effects of the COVID-19 ‘Vaccines’

The Time of Covid

The Time of Covid

The Time of Covid

The Time of Covid

8.11. The confounding assessment factors of underreporting of adverse effects on one

The Time of Covid

The Time of Covid

The Time of Covid

Focus on Myocarditis and Pericarditis

The Time of Covid

‘Myocarditis is underdiagnosed in practice, with clinical bias being directed towards

8.25. This is most recently outlined in an Australian Government report on Guidance on

The Time of Covid

The Time of Covid

b. After introduction of the gene-based COVID-19 vaccines in the US, VAERS

Other Safety Factors and Issues to Consider