Ten
Australia throws practitioners under the bus. Looks like your wife might be in the clear.
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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 fda.gov
therapy-products/what-gene-therapy
The Time of Covid
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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 Foundation2, 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. doi.org
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) ijvtpr.com
The Time of Covid
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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 nature.com
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 academic.oup.com
6 Nanotechnology and Health Risks (April, 2008), Health and Environment Alliance env-
health.org/IMG/pdf/17-_NANOTECHNOLOGY_AND_HEALTH_RISKS.pdf |
