IMOP PRESS RELEASE: Questions regarding COVID-19 vaccines set for Australia, 29th Jan 2021

We of the Informed Medical Options Party represent thousands of Australians. Our supporters stand up for the right to refuse or choose medication (including COVID-19 vaccines) without coercion, discrimination, bullying or punishment.
In August last year the Prime Minister, Hon Scott Morrison announced an agreement to purchase 25 million doses of the AstraZeneca Oxford vaccine [1] and in November 2020 announced the purchase of a further 40 million doses of Novavax and 10 million doses of Pfizer/BioNTech vaccines for distribution in Australia at a taxpayer cost of 3.2 billion dollars [2]. It was later announced that an option to purchase further vaccines had been secured at a cost of $123 million dollars. 
On 25th January this year, the TGA gave "provisional" approved the Pfizer vaccine for use in Australia [12].  The TGA stated “the decision has been made on the basis of short term efficacy and safety data” [25].  How can true effectiveness be determined if the vaccine is being rolled out before trialing is complete?
Who are at high risk of COVID-19? 
  • According to The World Health Organisation, the vulnerable and high risk groups are: “people who are older than 60 years or who have health conditions like lung or heart disease, diabetes or conditions that affect their immune system.‚Äč” [4]. 
  • The Australian Health Department state: “The most important risk factor for severe COVID-19 illness is older age. Risk increases substantially above 70 years of age. Some medical conditions also increase risk” [66].
  • According to the ABS, out of 682 deaths in Australia deemed “COVID-19” deaths, 496 of them had pre-existing chronic conditions and 8 of them were suspected COVID-19 but the presence of the virus was not confirmed [28]. “Among these 496 deaths, dementia was noted on 41% of death certificates, chronic cardiac conditions on 32%, diabetes on 17% and hypertension on 16%” [29].
Scott Morrison advised that “There are no surprises, health and aged care workers and the elderly and vulnerable will be the first to gain access to a vaccine that’s deemed safe and effective.” [2]. 
Important Note:
  • The trials of the AstraZeneca, Novavax and Pfizer vaccines mainly involve healthy participants.
  • The aged (and others) with comorbidities are grossly underrepresented or excluded.
  • Dr Sebastian Rushworth of Sweden: “If it had been up to me, the trial would only have included people over 70 years of age with underlying co-morbidities,…” [7].
This raises a concern as to how effective (and injurious) these vaccines would be in COVID-19 vulnerable populations.
Note: SARS-CoV-2 is the VIRUS; and COVID-19 is the DISEASE [5].  COVID-19 is not a virus, it is a term used to represent a collection of signs and symptoms when associated with SARS-CoV-2 infection. The great majority of community SARS-CoV-2 infections, do not result in hospitalisable cases (or do not become symptomatic) as stated by the WHO “Most people with COVID-19 experience mild symptoms or moderate illness”  [62].
Hence, it is misleading to report all instances of the mere detection of the virus (or parts of the virus) in oral samples as “cases” or “COVID-19” - especially in the context of contact tracing.  Media seldom report on the ongoing health status of PCR positive contacts.
The following questions arose out of concerns engendered by information in papers published on the WHO website:


Type: Viral Vector (non replicating) ChAdOx1-S
Clinical Trial links:
  Phase 2: NCT04686773
Control Group: 18 to 69 years healthy adults (Phase 2 includes small group up to 100 years)
Some of the listed exclusions: Asthma; gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness and suspected immunosuppressive or immunodeficient state.  “Vaccine efficacy in older age groups could not be assessed but will be determined, if sufficient data are available, in a future analysis after more cases have accrued” [Ref 58, p107]
1. Is the use of a comparator vaccine valid and reassuring?
In the trials of the AstraZeneca vaccine (ChAdOx1) a MenACWY meningococcal vaccine ‘Nimenrix’ was used as the control and comparator in the absence of a saline placebo in two out of the three trials [6].  This raises a concern as to the validity of adverse events comparisons.  For example, "Serious adverse events occurred in 168 participants, 79 of whom received ChAdOx1 nCoV-19 and 89 of whom received MenACWY or saline control" [58].
In the absence of specific adverse event data, this relatively short term comparison makes the AstraZeneca vaccine look much less prone to serious health effects than MenACWY. However it is not only number but illness type and chronicity that matters most.   The study also states that with some of the ChAdOx1 group, paracetamol was used to reduce symptoms. That group had symptoms more often and more marked than those given Nimenrix without paracetamol. i.e. ChAdOx1 had “….a higher reactogenicity profile than the control vaccine,….” Furthermore, symptoms from its injection persisted longer [6, Fig.1]. 
So the worth of mass vaccination with this vaccine needs to be soberly reconsidered because the majority of the infected healthy do not develop severe COVID-19.

2. Will this vaccine increase risk of HIV?

Cell line “HEK-293 [11], transfected with Adenovirus 5 (AD5)” is used in the manufacture of this vaccine [64]. 
AD5 was used in the failed HIV vaccine trials.  "“…we are concerned that use of an Ad5 vector for immunisation against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) could similarly increase the risk of HIV-1 acquisition among men who receive the vaccine" [45] and “potential major problem - that such vaccines might increase susceptibility to HIV infection. This also raised the question of whether the problem extends to some or all of the other recombinant adenovirus vectors currently in development or to other vector-based vaccines [13].

Note: Some trials of the AstraZeneca vaccine include HIV participants [59].  Could it be that the deliberate selection and inclusion of HIV positive participants was done to see if their illness is intensified or their viral load increases following vaccination?
3. Could this vaccine be contaminated?

A dead reconstructed chimpanzee virus [6], [8] is used in the AstraZeneca vaccine.

From time to time, even after many thousands or millions of vaccinations, some vaccines used have been found to be contaminated with live viruses. And in spite of attempts to produce “germ free” vaccines, contamination with live viruses may still occur, as stated by FDA [9].
A quote from peer reviewed journal:Although testing is a key component of viral safety in biotechnology products, the data presented here indicate that testing alone is not enough to ensure that a given product is free of a viral contaminant, and that a holistic, multifaceted approach must be taken. This is never more true than when faced with a previously unknown emerging virus, such as SARS-CoV-2, where the capacity of the virus to infect production cell lines or be detected in existing assays is not initially known.” [10].

4. What are the potential adverse events?

In September, one of the vaccinated trial participants developed an inflammation of the spinal cord, known as transverse myelitis [14], (an inflammatory disorder of the spinal cord [15]). AstraZeneca explained that it occurred in a patient with undiagnosed multiple sclerosis [16]. Not long after a second case of transverse myelitis occurred in the trial [17].  AstraZeneca said it was “unlikely to be associated with the vaccine or there was insufficient evidence”.   Though not often linked to vaccination, transverse myelitis is a documented vaccination risk [18].
5. Are there any conflicts of interest?
This trial is sponsored by University of Oxford and lead by Andrew Pollard [19].  Oxford University receives funding from Vaccine Manufacturing and Innovation Centre UK [20, p.81]. Andrew Pollard is Chair of The Joint Committee on Vaccination & Immunisation (JCVI) [21], who advises UK health departments on immunisation. He was the Lead developer of the Bexsero meningococcal B vaccine, previously owned by Novartis and now owned by GSK [22].  He is the Director of the Oxford Vaccine Group (OVG) [23], who receive funding from vaccine manufacturers for their trials [24]. 


Type: Full length recombinant SARS-CoV-2 glycoprotein nanoparticle vaccine adjuvanted with Matrix-M
Clinical Trial links:          
  Phase 2: NCT04533399
Control Group: 18 to 59 years healthy adults (Phase 2/3 up to 84 years)
Some of the listed exclusions: Chronic disease, diabetes, asthma, any autoimmune or immunodeficiency disease, active cancer
1. Could the ingredient Matrix-M cause allergic reactions?
In the trial, two vaccine formulations were used. One with, and one without Matrix-M™ adjuvant “Matrix-M adjuvant, made of Quillaja saponins…” [26]. Saponins are used in a variety of foods and cosmetics [27].  Is this adjuvant capable of creating allergies? 
2. Will people vaccinated with this modified virus protein be immune to all wild type virus strains?
Parts of the SARS-CoV-2 spike protein used in the vaccine have been altered [30], and as Phase 3 is not yet completed, how do we know if participants are being exposed to all the variants of the wild type virus. So can a meaningful effectiveness be determined?
3. How meaningful is it to compare serum antibody levels from the SARS-CoV-2 infected with those of the vaccinated trial participants?
During the trial to measure the adequacy of the immunoglobulin response in the vaccinees, Novavax used a “Covid-19 human convalescent serum panel includes specimens from PCR-confirmed Covid-19 participants [patients Ed] obtained from Baylor College of Medicine”, to compare against the healthy trial group [31]. The age and underlying health status of the Covid-19 human convalescent control samples were not provided in the published study and therefore raises a concern as to the value of the comparison.
Is it not the level and profile of immune responses to vaccination, in the severe COVID-19 vulnerable, that is most relevant? But in the trial, only healthy participants were vaccinated.  i.e. “Age, gender, and comorbidities are all potential determinants of disease outcome....”.  “It is reasonable to speculate that these same factors (and others such as genetic makeup and pre-vaccination immune status) will influence immune responses after vaccination.” [51, 3.3]
4. What are the potential adverse events?
The introduction to Appendix 5 of the Clinical Study Protocol: “Listings of Adverse Events of Special Interest” states " has been hypothesised that immunisations with or without adjuvant may be associated with autoimmunity..." [32]. 
Numerous specific, mainly serious chronic conditions, are listed there in the following categories: Neuro-inflammatory Disorders, Musculoskeletal and Connective Tissue Disorders, Cardiac Disorders, Haematologic Disorders and other Disorders. 
Is the risk of autoimmune disease merely hypothesised or is there good evidence for it?  eg transverse myelitis [18], narcolepsy [42], thrombocytopenia [43]. 
This raises a concern regarding the danger of giving emergency approval for vaccines and also demonstrates the need to wait several years in order to assess health impacts [54].
5. Are there any conflicts of interest?
Jane Halton is Chair of Coalition for Epidemic Preparedness Innovations (CEPI) [33], who have funded $388M to COVID-19 vaccine manufacturer Novavax [34], which is being trialed in Australia [35].  She is the adviser to Prime Minister on the government’s National COVID-19 Coordination Commission [36] and is pushing for COVID No Jab No Play policy for adults [37].

PFIZER / BIO-N-TECH Vaccine (BNT162b2)

Type: 3 lipid nanoparticle-messenger RNAs
Clinical Trials:          
  Phase 2: NCT04649021 
Control Group: Up to 85 years healthy adults
Some of the listed exclusions:  Immunocompromised individuals with known or suspected immunodeficiency, Diabetes mellitus, asthma, smokers.
1. Will this vaccine stop you from contracting SARS-CoV-2?
On 3rd December, UK announced their use of the Pfizer vaccine to the public [53].  On 7th December, the UK Government Department stated that “We do not yet know whether it will stop you from catching and passing on the virus, but we do expect it to reduce this risk” [38]. 
2. Are the mRNA components safe when injected into the body?
The vaccine contains "lipid nanoparticle-formulated, nucleoside-modified, mRNA that encodes the receptor binding domain (RBD) of the SARS-CoV-2 spike protein” [39] & [40].
Point made by Laura Blackburn of the PHG Foundation from University of Cambridge website: "There is still a lot of work to be done before mRNA vaccines can become standard treatments, in the meantime, we need a better understanding of their potential side effects, and more evidence of their long term efficacy" [49].
3. Is Polyethylene Glycol (PEG) safe to be injected into the body?
The use of Polyethylene Glycol (PEG) [46]. 
Based on a peer reviewed medical journal in 2019, “Circulating antibodies (Ab) that specifically bind polyethylene glycol (PEG), a biocompatible polymer routinely used in protein and nanoparticle therapeutics, have been associated with reduced efficacy of and/or adverse reactions to therapeutics modified with or containing PEG”.  “The widespread prevalence of pre-existing anti- PEG Ab, coupled with high Ab levels in a subset of the population, underscores the potential importance of screening patients for anti-PEG Ab levels prior to administration of therapeutics containing PEG.” [47].  None of the participants in the trials were tested for PEG antibodies, therefore, will there be reduced efficacy and adverse reactions in the "wider population" due to undetected anti-PEG antibodies? 
The CDC also advises those "who are allergic to PEG or polysorbate should not get an mRNA COVID-19 vaccine" [61].
4. What are the potential adverse events?
Allergic reactions as quoted by Stephen Powis, the National Medical Director for England’s National Health Service Dec 9: "As is common with new vaccines the MHRA (Medicines and Healthcare products Regulatory Agency) have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday," [48]
And recognised by the CDC regarding mRNA vaccines: "CDC has learned of reports that some people have experienced severe allergic reactions—also known as anaphylaxis—after getting a COVID-19 vaccine" [61].
From Pfizer’s vaccine insert: “Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.” [56].
"Doctors in Norway have been told to conduct more thorough evaluations of very frail elderly patients in line to receive the Pfizer BioNTec vaccine against covid-19, following the deaths of 23 patients shortly after receiving the vaccine." [60]. Numbers of death have since increased to 33 [65]. Is it credible that terminally ill people would have been vaccinated?
Pfizer Safety Data Sheet states "Toxicological properties have not been thoroughly investigated" [63].

As there is limited public access to UK adverse event reports, we have used the US Vaccine Adverse Event Reporting System (VAERS).  This database reports 117 deaths associated with the Pfizer vaccine [41].  NOTE: It was stated by Harvard Pilgrim Health Care that in the USA “fewer than 1% of vaccine adverse events are reported” [55].

5. Are there any conflicts of interest?

Employees of Pfizer may hold stock options. Others received compensation from Pfizer to perform neutralisation assays [50]. Whilst incentive and/or reward is recognised for employees, there still remains the problem of the credibility of the data when the manufacturers themselves are conducting the trials and assessments of their own vaccine products.


Because previous vaccines developed to prevent SARS actually created more severe disease when vaccinated animals were deliberately infected, hopefully, the manufacturers of the three fore mentioned vaccines designed and tested them to, avoid such a disaster.  But uncertainty remains. As explained in the Expert Review of Vaccines: As the world is rushing for a COVID-19 vaccine, the possibility of vaccine-mediated disease enhancement has been flagged as a potential safety concern.” [51].  Because the vaccine has been released on emergency approval, the variety of consequences following SARS-Cov-2 infection in vaccinees is not known.
The media have attempted to counter fears that the vaccines have not been thoroughly tested e.g. A/Prof Paul Griffin of medicine at the University of Queensland who stated “While we have been able to progress quickly it’s not through cutting clinical trials, safety or effectiveness” [52] and Dr Rob Grenfell is the CSIRO’s Health & Biosecurity Director and was involved in pre-clinical trials for AstraZeneca and Inovio Pharmaceuticals vaccine candidates stated “that there has not been a compromise made on the effectiveness on the vaccine and the safety of the vaccine, in the animals and human studies” and “Where the time shortening has occurred is the involvement of regulators and manufacturing companies” [52].  These are simply half-truths. 
The vaccines are being released before the monitoring duration for adverse events, immune persistence and effectiveness has expired. For example:
ISRCTN89951424: Expected to run for: December 2021
NCT04516746: Estimated Study completion date: February 21, 2023
NCT04540393: Estimated Study completion date: March 12, 2021
NCT04611802: Estimated study completion date: December 30, 2022
NCT04583995: Estimated study completion date: January 14, 2022
NCT04368728: Estimated study completion date: January 31, 2023
These vaccines have been released well before any assessment can be made concerning vaccine-induced autoimmunity. See Novavax trial protocol e.g. “Listings of Adverse Events of Special Interest” [32].
Due to the on-going mutation of the virus [67], to vaccinate Australians with any of the aforementioned vaccines could be pointless, even counterproductive.
The purchases made by the PM on behalf of the tax payers are premature and unwarranted. The size of the order clearly indicates that coercive vaccination of the Australian population is in the pipeline.  We request this order be reviewed as a matter of urgency. 
We also ask: why are pharmaceutical products the only subject of such expenditure?  Other means of preventing severe COVID-19 need to be considered (such as vitamins and improved diet, longer sleep time - for better immunity), tested and if effective, promoted. Certain comorbidities are the most common determinants of severe COVID-19 disease eg Obesity, Diabetes, and Cardiovascular Disease. These are endemic at epidemic levels but tens of billions of dollars have not been invested or allocated to reduce their incidence.


[6]     AstraZeneca Phase1/2 Trial: "ecombinant adenovirus for ChAdOx1 nCoV-19".
             “We did a phase 1/2, single-blind, randomised controlled trial in five trial sites in the UK of a chimpanzee adenovirus-vectored vaccine (ChAdOx1 nCoV-19) expressing the SARS-CoV-2 spike protein compared with a meningococcal”
[8]     A Novel Chimpanzee Adenovirus Vector: The simian adenovirus-vector is based on “a derivation of a new vaccine vector based on a chimpanzee adenovirus, Y25"
[9]     WHO: ; Investigating Viruses in Cells Used to Make Vaccines_USFDA: “Some of these tumor-forming cell lines may contain cancer-causing viruses that are not actively reproducing. Such viruses are hard to detect using standard methods. These latent, or "quiet," viruses pose a potential threat, since they might become active under vaccine manufacturing conditions.”
[10]    AstraZeneca - Viral contamination in biologic manufacture and implications for emerging therapies: 
Retrieved August 10, 2020.
 [11]    Ingredient: Aborted foetal cell lines HEK-293 in AstraZeneca vaccine:  Refer Ref 10 “The wild type chimpanzee adenovirus isolate Y25 was originally obtained from William Hillis, John Hopkins University of Medicine. The virus was passaged in HEK293A cells”.
[13]    Immune Activation with HIV Vaccines:
[14]    New York Times Drugmaker Pauses Covid-19 Vaccine Trial for Safety Review:;
             KHN NIH ‘Very Concerned’ About Serious Side Effect in Coronavirus Vaccine Trial:
[15]    Description of transverse myelitis:
[16]    AS AstraZeneca vaccine participant suffered serious neurological disorder:
[17]    New York Times - AstraZeneca, Under Fire for Vaccine Safety, Releases Trial Blueprints:
[18]    Transverse Myelitis from other vaccines:
         - Beghi E, Kurland LT, Mulder DW. Incidence of acute transverse myelitis in Rochester, Minnesota, 1970-1980, and implications with respect to influenza vaccine. Neuroepidemiology 1982; 1:176-188.
         - Clark C, Hashim G, Rosenberg R. Transverse myelitis following rubeola vaccination. Neurology 1977; 27:360.
         - D'Costa DF, Cooper A, Pye IF. Transverse myelitis following cholera, typhoid and polio vaccination. Journal of the Royal Society of Medicine 1990; 83:653.
         - Label LS, Batts DH. Transverse myelitis caused by duck embryo rabies vaccine. Archives of Neurology 1982; 39:426-430.
         - Read SJ, Schapel GJ, Pender MP. Acute transverse myelitis after tetanus toxoid vaccination (letter). Lancet 1992; 339:1111-1112.
         - Shyamalan NC, Singh SS, Bisht DB. Transverse myelitis after vaccination. British Medical Journal 1964; 1:434-435.
         - Whittle E, Roberton NR. Transverse myelitis after diphtheria, tetanus, and polio immunization. British Medical Journal 1977; 1:1450.
[21]    Joint Committee Andrew Pollard on Vaccination and Immunisation:
[24]  Page 81
[25] Section “What was Approved”.
[26]    Matrix-M™ adjuvant enhances immunogenicity of both protein- and modified vaccinia virus Ankara-based influenza vaccines in mice:
[27]    Quillaja Saponin Characteristics and Functional Properties:
[30]    Novavax - Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine: Refer to ‘Trial Vaccine, Adjuvant, and Placebo’ section
[31]      Novavax - Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine: “The Covid-19 human convalescent serum panel includes specimens from PCR-confirmed Covid-19 participants, obtained from Baylor College of Medicine (29 specimens for ELISA and 32 specimens for MN IC>99%)”
[35] Refer to ‘Trial Design and Oversight’
[38]     UK Govt - Can you give COVID-19 to anyone if you have had the vaccine?: “The vaccine cannot give you COVID-19 infection, and a full course will reduce your chance of becoming seriously ill. We do not yet know whether it will stop you from catching and passing on the virus, but we do expect it to reduce this risk. So, it is still important to follow the guidance in your local area to protect those around you.”
[39]     Pfizer - COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses:
[40]     Pfizer - Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates:
[41]     VAERS adverse event reporting: VAERS adverse event reporting:  Select COVID-19 from "Vaccines" and Pfizer/Biontech from "Manufacturer"
[42]     Narcolepsy and influenza vaccination—the inappropriate awakening of immunity
[44]     Pfizer - Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates: Ref 6 - “The RBD-Fc and S1-C9 proteins were expressed by transfecting 293T cells with the plasmids using Fugene 6 reagents (Boehringer–Mannheim, Indianapolis, IN) according to the manufacturer’s protocol.”
[45]    Use of adenovirus type-5 vectored vaccines: a cautionary tale:
[47]    Pfizer - Analysis of Pre-existing IgG and IgM Antibodies against Polyethylene Glycol (PEG) in the General Population:
[48]    People with significant allergies should avoid Pfizer COVID-19 vaccine, UK warns: ; Covid-19: People with history of significant allergic reactions should not receive Pfizer vaccine, says regulator:
[49]    University of Cambridge:
[50]    Pfizer conflicts of interest - A prefusion SARS-CoV-2 spike RNA vaccine is highly immunogenic and prevents lung infection in non-human primates:
[51]    Vaccination against SARS-CoV-2 and disease enhancement – knowns and unknowns:
[53]    UK first to roll our Pfizer COVID-19 vaccine -
[57]    Pfizer inclusion of HIV participants:
[59]    AstraZeneca trial using HIV participants:
[60]    Norway deaths from Pfizer vaccine:
[61]    CDC acknowledges serious adverse events from mRNA vaccines:
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

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