People for Safe Vaccines

Shaping The Future

of Vaccine Safety

About

Us

Who We Are

We are a not-for-profit company with the following objectives:

  • To promote and encourage safe development, supply and use of human vaccines.

  • To inform, educate and raise public awareness in relation to vaccine safety and efficacy.

  • To take legal action to promote positive vaccine safety outcomes.

  • To do any other thing related to promoting vaccine safety, efficacy and quality.

 

This includes standing up for the individual’s right to choose whether or not to take the COVID vaccines.

 

We are a growing number of people and associations from the health and law enforcement sectors and the wider community, namely doctors, nurses, lawyers, police, vaccine-injured and ordinary people with a sincere interest in these issues.

 

We only ask that our members’ interests align with those of the Company.  More details are available via the Membership page.

 

Our Board of Directors consists of:

  • A multi-disciplinary holistic general medical practitioner.

  • A PhD researcher and academic who has focused on vaccines since 2004.

  • A Solicitor who holds a Juris Doctor degree who is focused on ensuring there is informed consent with vaccinations.

 

The Company Secretary and CEO is Serene Teffaha, an experienced lawyer committed to justice, and curbing the excesses of government power.

 

We have engaged Ben Clemens of Clemens Haskin Legal on a ‘no win no fee’ basis.  Ben has substantial experience in legal claims against regulators and in commercial law.

 

Meet the team.

New Arbiter In Town 

Everyone knows how stringent vehicle safety regulations are, and that any report of a malfunction in a car manufacturer's model can initiate a world-wide recall. Similarly, cyber security providers must ensure the highest level of security at all times, and protecting the private data of its users is one of the most critical functions in business and government today.

 

With cyber security, penetration testing and auditing are required, and can never be performed by the company itself. This is unacceptable and would never pass compliance. It must be shown during audits that proper processes have been followed, including thorough testing.

 

​Car manufacturers are forced to perform significant crash testing, completely destroying their own product over and over, learning from its weaknesses, and forced to make improvements repeatedly, at their own expense, until they meet these stringent minimum safety requirements. Their crash test dummies show them how a human would be affected by the accident.

 

Safety is at the core of these. In fact, it is the driver of everything else in the entire process. And when things go wrong, liability doesn't end with compensation for damage caused, but can include prosecution and even personal liability for Company Directors.

 

Living in the western world of bureaucracy, with red tape designed to protect us from corruption, and failures in due diligence, is it really such a stretch to question the speed with which our department of health is looking to approve a COVID-19 vaccine, when we are clearly in the crash test dummy stage?

 

If we take the same standards that cyber security and vehicle safety are held up to, with the same implications for failures, and apply them to vaccine manufacturing, would they stack up?

 

The answer, we say, is a resounding no.

 

In fact, vaccine manufacturers can still manage to do business at the highest levels with governments, while having extensive contravention records, and apparently they do it without being questioned. How can this be?

 

Our department of health and its therapeutic goods administration are approving vaccines, made by organisations who have;

 

  • been charged with multiple offences​​​​​​​​

  • extremely poor safety studies they often perform themselves

  • done no long-term safety and efficacy trials

  • been granted indemnity from any liability if injuries occur

 

Where are the proper checks and measures for vaccine safety? Who is the arbiter to ensure due diligence is performed, and people are put above profits?

​What must these car manufacturers and cyber security tech giants think of this preferential treatment? And what do you think of being crash test dummies for the pharmaceutical industry?

The Australian Health Protection Principal Committee (AHPPC) is the peak decision-making committee for public health emergency management and disease control in the Commonwealth of Australia. On 23rd January 2021, the AHPPC issued a statement on COVID-19 vaccination requirements for aged care workforce. In the statement they said they do "not recommend mandating COVID-19 vaccination for the aged care workforce at this stage."

However, in direct contrast to this statement, the federal government issued a healthcare professionals stakeholder kit which states that residential aged care and disability care staff and residents are targeted to be first up in their phase 1a rollout. Clearly the government is not following the advice from their own experts.

 

If there is no arbiter, then it must be us, the people.

 

To achieve this we created People for Safe Vaccines Ltd, which aims to facilitate dialogue examining the facts, with a view to ensuring proper science and accountability are applied to this critical matter.​

 

Our

Commitment

Book of French Laws

Legal Action

Our legal team has issued a request for Statement of Reasons to the Department of Health in relation to the government’s decision to fast-track development of the COVID-19 vaccines. See a chronology of all communications here. This gives us more material to progress with legal action.

Assurance

We support the right of individuals to give informed consent to any vaccine and are doing our best to ensure that safety and efficacy is properly addressed. We will also work to ensure that people are free to decline vaccination and not be subjected to undue pressure to take the vaccine.

 
Library

Deep Knowledge

The key stake-holders are well versed in the area of vaccine science. They have;

  • an award-winning PhD in vaccine policy, and

  • are health professionals, and

  • experts in Law.

Our dynamic team, with all the skills and knowledge needed to mount the appropriate challenges, using non-biased, science-based evidence, has the legal expertise to contest, through the correct channels, to get results.

Vast Experience

Our legal team plays a critical role in this undertaking, because they understand the legal manner in which to challenge government decisions. They have a combined 40 years' experience in law and litigation. Our award-winning PhD team member brings vast knowledge in the science and policy rationales for vaccination; and front-line health professionals, combining professional with personal experience, brings our team a unique comprehension of the true human significance of the issue, and has created a remarkable force to be reckoned with.

Court House

Vision

The concept that these COVID-19 vaccines are our only hope of returning to normal life is rooted in ideology, not evidence. And if there is no arbiter for this, then it must be us, the people. People for Safe Vaccines aims to examine the facts, then facilitate dialogue with the government, with a view to ensuring proper science and accountability are applied to this critical matter. It is our company that will take this challenge to Court, should it be required.

Our

Position

Our Position

First and foremost, we do not see a need for the Australian population to be inoculated with experimental COVID-19 vaccines.  Further, there are good reasons to seriously doubt the safety and efficacy claims made by the manufacturers.

 

The Australian government has taken the view that SARS-CoV-2 is a highly infectious and deadly virus, and the low prevalence of COVID-19 is due to low community transmission, not inadequate testing.

As at 20 January 2021, some 12.5 million tests have been done around the country with under 29,000 cases reported, a prevalence of just 0.23%.

 

The question arises as to how the virus has not spread like wildfire causing severe illness and overwhelming the health system.

 

The governments like to take credit for limiting exposure, by reference to a raft of measures such as travel restrictions, lockdowns, curfews, physical distancing, face masks and business closures.

 

But there is a much more likely explanation.

Natural Immunity

Public health authorities around the world have proceeded on the assumption that no pre-existing immunity to the SARS-CoV-2 virus existed in the population.

 

However, the Australian government’s own statistics show:

  • up to 80% of people diagnosed with COVID-19 experience mild symptoms, which generally resolve within 14 days without medical intervention.

  • 18 to 42% of cases never develop symptoms and are classified as asymptomatic.

  • a case fatality rate of 2.7%, of which 72.7% had pre-existing chronic conditions.

  • a recovery rate of over 99% in otherwise fit and healthy individuals.

 

These figures clearly show that the body’s immune system, when working properly, is capable of mounting an effective response to SARS-CoV-2 infection in the overwhelming majority of cases.

 

The immune system defends the body against pathogens by producing natural killer cells and antibodies.

 

Our bodies develop an immune memory due to previous exposure to coronaviruses (aka 'the common cold'), due to the generation of so-called ‘memory cells’, primarily T-cells, which kill the cells replicating virus, enabling them to respond to similar future recurrences.  This is how ‘herd immunity’ has always worked.

 

T-cell immunity can also combat SARS-CoV-2, as various studies are showing:

  1. German researchers found that 81% of individuals had pre-existing T-cells that cross-react with SARS-CoV-2 epitopes.

  2. In Singapore, a team analysed specimens taken from people with no contact or personal history of SARS or COVID-19; 12 of 26 specimens taken before July 2019 showed reactivity to SARS-CoV-2, as did 7 of 11 from people who were seronegative against the virus.

  3. Modelling in May by Imperial College’s Professor Friston, a world authority in mathematical modelling of complex dynamic biological systems, indicated that around 80% and 50% of the German and UK populations, respectively, are resistant to COVID-19.

  4. Immunological memory lasts more than 6 months after SARS-CoV-2 infection.

  5. Peter Doshi, Senior Editor of the British Medical Journal, also notes in his article that there is a legitimate argument to initiate worldwide studies that examine pre-existing immunity to disease. 

  6. The Great Barrington Declaration signed by over 53,000 scientists and medical practitioners recognises that natural herd immunity must be the primary objective.

So why do we see different levels of infection around the world?  One reason is that vitamin D levels will affect T-cell mobilisation.  Current research shows this has not changed with COVID-19. 

 

The results of the first vitamin D intervention double blind RCT for COVID were published on 29 August 2020, which suggested that early Vitamin D treatment to hospitalised COVID-19 patients significantly reduced intensive care unit admissions and severity to disease.

 

Countries with populations having naturally higher Vitamin D levels experience strengthened pre-existing T-cell immunity and better responses to COVID-19 infection.

 

Unlike T-cells, which cleverly sense and destroy pathogens inside infected cells using “sensors” to detect foreign protein fragments, antibodies can only attack pathogens outside cells.  Moreover, coronaviruses circulate in the mucosal system where soliciting an antibody response is more problematic. As a result, antibodies are more transient than T-cells in the immune system’s response to SARS-CoV-2.

By focusing on studies that measure antibody levels instead of T-cell immunity, we believe the government has overlooked pre-existing T-cell immunity as the explanation for low severity and high recovery rates, and low prevalence of the virus.

Until natural immunity is properly considered, it would be premature and unnecessary to vaccinate the entire Australian population.

Issues with Diagnosis of COVID-19 and Death Certification

Apart from the contradiction inherent in the concept of a symptomless disease, the risk of asymptomatic transmission has been greatly exaggerated and in reality is no higher than 2.2% – if it exists at all, according to the results of 4 separate studies published via the WHO. Compare this with a transmission rate of 0.8%-15.4% for symptomatic people.

 

The leading government advisory committee on technical issues, the Public Health Laboratory Network, has emphatically warned against the practice of PCR testing of asymptomatic individuals, as it leads to uncertainty where viral load is low and places undue pressure on the laboratory, increasing risks of error and contamination, all of which contribute to a higher rate of false positive results. See their guidelines here.

PCR usually identifies up to 3 tiny RNA fragments of a reference genome which are checked for specificity against a database that only includes 0.1% of the total viruses in the body.  PCR kit manufacturers generally acknowledge that it should not be the sole basis to diagnose infection. PCR cannot distinguish between ‘live’ and non-infectious virus. Interpreting a PCR test result is also at the mercy of numerous sources of variability across different labs, instruments and materials. Also, PCR relies on assumptions that a pathogen has been properly identified by previous isolation in tissue culture and characterised using genomic sequencing and assembly techniques.

 

Positive predictive value is the measure used to identify the probability of a test result being truly positive. At a prevalence of 0.23%, even a test that is 99.9% accurate can at best return less than a 70% likelihood the patient really has the disease.  This is because, for every 23 positive results in 10,000 tests, there will be 10 false positives due to the test’s inherent degree of inaccuracy.  For a 99% accurate test the PPV drops to just 19%, and the chances of the test being false are greatly amplified.  Thus no single test can be considered reliable in such a low prevalence setting, particularly where no or mild symptoms, or even unspecific symptoms, are present.

 

Unfortunately Australian governments, like many others overseas, have adopted the WHO guidance for certification of COVID-19 deaths.  This creates a strong bias in favour of presumptive misdiagnosis.  The guidance states: ‘The new coronavirus strain (COVID-19) should be recorded on the medical cause of death certificate for ALL decedents where the disease caused, or is assumed to have caused, or contributed to death.’

 

Misdiagnosis is also indicated by a comparison to other respiratory illnesses with the same symptoms.  Influenza reports in Australia were almost 8 times less (21,266) than the previous 5 year average (163,015). Only 2 deaths due to the flu all last winter Australia-wide were reported.

How do the vaccines work?

The vaccines designed by both Pfizer and AstraZeneca essentially work on a similar premise. Both produce a spike protein and that operates to elicit production of antibodies.

 

The AstraZeneca vaccine ChAdOx1 or AZD1222 uses a chimpanzee virus vector that has been genetically modified to include the genetic material for producing the spike protein of SARS-COV-2.

 

The Pfizer vaccine BNT162b2 uses mRNA to instruct the cells to produce the spike protein. The difference is that the Pfizer vaccine does not require a virus vector and uses lipid nanotechnology to deliver the information capsule into the cell.​ 

What are the risks of inoculating everyone with COVID-19 vaccines?

The big risk with both vaccines is auto-immune response.  This can manifest from mild inflammation at the injection site to severe reactions and even death. Experts are warning of risks of stroke, paralysis, convulsions/seizures, anaphylaxis, encephalitis, birth defects and others.

 

From an immunology perspective, the antibodies may be ‘tricked’ into destroying otherwise healthy cells when encountered in future.  This has been referred to as ‘pathogenic priming’ or antibody dependent enhancement (ADE), and is consistent with many of the reactions reported to date.

 

Dr James Lyons Weiler has outlined in his study that the vaccine will prime the immune system to react to wild virus by not just mounting an attack on the spike protein of the virus but on the other parts of the body that contain similar protein.

It has also been observed that the vaccines may carry potential for a secondary dengue-like infection due to pathogenic priming. These auto-immune reactions may also be exacerbated by the intramuscular injections of the vaccines, rather than a nasal delivery system.

Previous coronavirus vaccines have never passed the pre-clinical stage.  SARS-CoV vaccines were tested in a number of animal trials conducted which resulted in consistent auto-immune reaction outcomes.

One study looked at four types of vaccines trialled previously on various animals and then again on mice, and examined vaccine candidates that included “inactivated whole virus, spike (S) protein preparations, virus-like particles (VLPs), plasmid DNA and a number of vectors containing genes for SARS-CoV proteins.” The type of vaccine developed by AstraZeneca closely matches some of those candidates.

The study concluded “These SARS-CoV vaccines all induced antibody and protection against infection with SARS-CoV. However, the challenge of mice given any of the vaccines led to occurrence of Th2-type immunopathology suggesting hypersensitivity to SARS-CoV components was induced. Caution in proceeding to application of a SARS-CoV vaccine in humans is indicated.”

Vaccine development on SARS-COV was then abandoned.

Animal trial data for the COVID-19 experimental vaccines is not available, or limited – we are the guinea pigs.

 

Since the Pfizer vaccine was authorised for use in the U.S., there have been many reports of these kinds of reactions associated with inoculation.  In the U.S. the CDC reported over 3,000 serious health reports in the first 5 days of inoculations for the Pfizer m-RNA vaccine. See CDC report on adverse and serious adverse events here.

 

This rapidly growing 2.7% was a stark contrast to the data collected during the studies for the Pfizer vaccine which showed negligible serious adverse events following immunisation. It appears that Pfizer only monitored 8,183 participants, less than 20% of its trial, for adverse events and only on an active (solicited) basis for 7 days after the 2nd dose, and on a passive (unsolicited) basis for 14 weeks of the 6 month period in the protocol.

In Australia the problem with the potential for serious adverse events is exacerbated by the fact that the Australian government has narrowed the acceptable list of medical exemptions, including for the mandated influenza vaccine that came through in most States and Territories in May 2020.

Vaccine pamphlets such as Fluquadri Influenza Virus Australian product information highlights at page 9 adverse reactions from post-marketing surveillance such as:-

  • blood and lymphatic system disorders

  • immune system disorders

  • eye disorders

  • nervous system disorders

  • vascular disorders

  • respiratory disorders

  • skin disorders

  • gastrointestinal and general disorders.

 

Polyethylene glycol (PEG) is an agent added to COVID mRNA vaccines which could have caused the severe allergic reactions reported by UK recipients of Pfizer’s vaccine.

A 2016 study in Analytical Chemistry reported detectable and sometimes high levels of anti-PEG antibodies, approximately 72% of contemporary human samples and about 56% of historical specimens from the 1970s through the 1990s. Extrapolated to the U.S. population of 330 million who may receive this vaccine, 16.6 million may have antibody levels associated with adverse effects.

PEG is suspected to be the culprit causing a significant increase in anaphylaxis from the Pfizer and Moderna vaccines, where it is thought an allergic reaction to the second dose caused by anti-PEG antibodies that were triggered by the first shot.

It has also been identified that food ingredients in vaccines can trigger food allergies.

Therefore, the Australian government should not override the relationship between an individual and their medical practitioner, from making an assessment on their medical history, for the purpose of both granting exemptions for vaccines and determining allergic reactions. Particularly for people with auto-immune conditions, neurological conditions, allergic conditions and women who are breast-feeding or pregnant. 

But will the vaccines prevent infection?

AstraZeneca’s trials include around 35k participants, and claims its vaccine to be 70% effective, and Pfizer, which has some 43k participants in its trials, claims its vaccine to be 95% effective.

 

The available data in support of the manufacturers’ claims is scant at present.  However, we know that for both vaccines efficacy is primarily measured by an initial PCR positive result and a negative result after taking the 2nd dose.

 

The trials for both vaccines exclude the group most at risk, namely elderly people with various pre-existing conditions.

 

Apart from the problems mentioned above regarding dependence on PCR in a low prevalence setting, these measures fail to reflect whether the vaccine can prevent actual infection or transmission at all.  Also we are not told about the distribution across the spectrum of severity (such as reduction in ICU admissions) and sub-groups (such as the elderly, the young, the immune deficient) – and how long the ‘protection’ will last.

 

Pfizer’s claim is based on just 170 PCR confirmed cases split 162 (vaccine group) to 8 (placebo group). However, it excludes a ‘suspected covid-19’ group of 3,410 cases, (1594 vaccine, 1816 placebo), with symptoms who initially tested negative, but were not later re-tested to potentially include false negatives. These matters, along with other issues, are taken up by Peter Doshi, Chief Editor British Medical Journal here, here and here.

As for AstraZeneca, their efficacy claim represents an averaged percentage between results from 2 different dosages given to participants.  A composite averaging of results from full-dose of 62% and half-dose groups of 90% is not sound scientific method and a serious breach of protocol.

 

Other concerns raised about the efficacy of the AstraZeneca vaccine include:

  • The trial showed re-infection rates in those given the vaccine who had positive cultures at a similar rate as it does for community non-vaccinated controls.

  • There is a need to determine the dynamics of duration and degree of protection, especially in those over 65.

  • The future for adenovirus vectors must be doubtful given that antibody is generated against the vector and that it cannot be relied upon for second immunisation.

  • The half-dose group was just 2741 volunteers, and all were under 55, raising questions as to whether the relative youth of the participants created the positive results, not the size of the dose.

  • a ‘double-blind placebo-controlled’ trial is not borne out in their studies in the UK and Brazil, where they use meningitis vaccine instead of saline placebo and state they use single-blind methodology.

Overall, the percentages do not reflect prevention of serious illness, infection or transmission.  They are not drawn from populations of sufficient size or diversity to be meaningful as any reasonable guarantee of fitness for purpose in the context of a planned vaccination of all Australians.  

 

It should be kept in mind that the efficacy benchmark for healthy people below the age of 80 is no or mild respiratory symptoms which resolve within 14 days, due to natural T-cell immunity as reflected in established recovery rates. 

 

Additional concerns for the vaccines arise from the fact that COVID-19 is an RNA virus with over 800 mutations.  According the Professor Robert Clancy, this causes “antigen drift” that can change both biological characteristics and response to vaccines.

 

Finally, many frontline doctors have developed successful approaches to early intervention which can reduce COVID-19 hospital admissions and death.  Two drugs are effective: hydroxychloroquine (HCQ) and ivermectin (IVM), with most effective trials including nutraceuticals, zinc and intracellular antibiotics.

The Future is Up to Us

People for Safe Vaccines Limited is committed to ensuring that vaccine safety and efficacy are not compromised. Human vaccines are not all created equal and each vaccine must be looked at critically in terms of safety and efficacy. Vaccines that have been rushed in the past have been known to cause serious injury and even death.

 

This is why pre-market development will normally take up to 10 years and in many cases more than 12 years, involving rigorous trials and regulatory scrutiny.

 

The federal government is set to approve, by end of January 2021, the new breed of vaccines from drug company Pfizer, as well as the traditional-type vaccines from AstraZeneca that were allowed fast-track development.

 

Fast-tracking these experimental vaccines means that substantial proof of safety and efficacy is not required until after market.

 

Fast-tracking also means that all Australians will be the guinea-pigs in a high-risk experiment.

 

The federal government has pre-purchased over 134M doses of vaccine. The federal and state governments are committed to inoculating the Australian public.

Big businesses like airlines and events agencies have also indicated they will require COVID-19 vaccinations in order to supply services.

 

When the government announced its vaccine rollout in early January 2021, only 909 COVID-related deaths were recorded, most in aged care with serious preconditions and frailties. The survival rate for those diagnosed with COVID-19 is over 99% for those below the age of 70.

 

The government, as part of its rollout plan is listing priority groups for vaccination, which include those at high-risk, such as the elderly and frontline health workers. However, it is the elderly, the frail with co-morbidities, that appear to be mostly exposed to the risk of severe adverse effects and death from the vaccines.

 

The burden of proof for safety and efficacy must remain on those promoting these experimental vaccines.  The precautionary principle favours the managed objective of natural herd immunity.

 

Do we need quasi-mandatory/high-risk/fast-track/new breed experimental vaccines pushed on us, when the recovery rate for most normal healthy people is over 99% and the real risks are as yet undetermined?

 

WE SAY NO!

Has the government been wrong before?

You bet they have. Remember;​

  • Agent Orange

  • DDT

  • Asbestos

  • Glyphosate

  • Plastics

  • Formaldehyde

  • Thalidomide

  • Cigarettes 

  • Vioxx

  • Gardasil

​​

After being promised these were safe, it turned out, in fact, they are responsible for horrendous injuries, death, genetic mutations and causing environmental damage. It also warrants a mention that "medical error" is the third leading cause of death, behind heart disease and cancer.

While these were unintended consequences, they are significant and have been felt for generations and will continue to into the future.

Vaccination is a medical intervention with a clear intention, just like the above list too, but the burden of proof for safety and efficacy can never be understated, or we risk repeating the same mistakes.

In a Science, Public Health Policy & the Law article, Dr Judy Wilyman says that the burden of proof of vaccine injury has been misplaced in what she calls “Misapplication of the Precautionary Principle” and that the onus of proof of harmlessness should be placed on the government and pharmaceutical industry.

We must take the lessons of the past and apply them here, for the safety of the population and our future generations.

What Can You Do?

It is very easy to feel overwhelmed and helpless, being swept up in the frenzy that has followed the COVID-19 pandemic. The mainstream thought fed to us by media wants us to put our faith in their rushed, blanket approach where an experimental vaccine is the only option.

Because most vaccines have taken 10+ years to be granted approval, many of us sense the danger in their speedy authorisation, and are asking if the risks they pose are greater than benefits they cannot yet claim definitively. We feel a personal and social responsibility to do something positive to stop it. Now you can join your voice to a chorus of others by becoming a member of People for Safe Vaccines. Your membership contribution funds our fight to push back against the rush, and stem the tide. 

To become a member click the button below.

By becoming a member of a company limited by guarantee, you will not be exposed to any liability in relation to the legal action will be mounting. 

 

Their Statements, Our Concerns

Relating to the vaccines

Dr Jerome Kim

Director-General of the International Vaccine Institute

"When we are used to five-year time frames, to see something go into human testing on March 17 is really a remarkable thing…Does this guarantee success? Not necessarily. Vaccine development is characterised by a high failure rate – often 93% between animal studies and registration of a product.” Dr Jerome Kim, Director-General of the International Vaccine Institute."

Natalie Dean, a biostatistician and expert in vaccine trial design at University of Florida

"Astrazeneca and Oxford get a poor grade for transparency and rigor when it comes to vaccine trial results they have reported."

"Over the years, AstraZeneca has had its share of legal trouble, paying more than $1 billion in federal fines and legal settlements for corrupting clinical trials and illegally promoting antipsychotics. It has also had to deal with several lawsuits filed by patients who say the drugmaker’s products injured them."

Dr Drew Weissman, MD, PhD, of the University of Pennsylvania in Philadelphia and an early pioneer of mRNA technology

"A possible concern could be that some mRNA-based vaccine platforms induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity…Thus, identification of individuals at an increased risk of autoimmune reactions before mRNA vaccination may allow reasonable precautions to be taken.” See publication here.

Dr James Lyons-Weiler PhD and Senior Research Scientist at the University of Pittsburgh

“In SARS, a type of “priming” of the immune system was observed during animal studies of SARS spike protein-based vaccines leading to increased morbidity and mortality in vaccinated animals who were subsequently exposed to wild SARS virus... of course no vaccine against SARS-CoV-2 has yet been tested in animals and therefore we do not yet know if pathogenic priming is in fact expected. Such studies should be undertaken before use of any vaccine against SARS-CoV-2 is used in humans.” See publication here.

Relating to the PCR-Testing

Public Health Laboratory Network is an advisory committee of the AHPPC, the Australian Health Protection Principal Committee (the principal advisory group to the Australian Government on COVID-19).

“PHLN is of the strong view that testing is targeted toward population cohorts where the maximum value is derived, and emphatically discourage non-clinically indicated asymptomatic testing. PHLN further advises that States and Territories with low COVID-19 prevalence should build up supplies of testing reagents and provide laboratory staff with leave. Rather than consuming both staffing and testing resources in an environment with low levels of COVID-19 infection…

As community prevalence of COVID-19 falls and the rate of asymptomatic testing increases, the proportion of false positive results may increase.” see publication here.

Relating to lethality and survival

Communicable Diseases Network is an advisory committee of the AHPPC (the principal advisory group to the Australian Government on COVID-19)

“COVID-19 presents as a mild illness for approximately 80% of cases, with fever and cough being the most commonly reported symptoms. Other symptoms include headache, sore throat, fatigue, shortness of breath, myalgia, anosmia, dysgeusia, rhinorrhoea, chills and vomiting. Atypical symptoms of COVID-19 may also occur including chest pain, diarrhoea and conjunctivitis. Preliminary evidence suggests that children experience milder clinical symptoms and potentially fewer infections than adults (similar to SARS-CoV and MERS-CoV infections). Severe or fatal outcomes occur more frequently in the elderly and those with comorbid conditions. Some individuals remain asymptomatic. Studies estimate that the asymptomatic proportion of cases ranges from 18% to 42%.” see publication here.

Relating to data integrity

Peter Doshi, Associate Editor, British Medical Journal

"With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing covid-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% —far below the 50% effectiveness threshold for authorization set by regulators. Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29%." see publication here.

 

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