Three major scientific challenges have been made to mass testing using RT-PCR as well as to the BioNTech/Pfizer vaccine trial design that, if successful, will throw into question the entire global plan being coordinated by the World Health Organization, the World Economic Forum, the Coalition for Epidemic Preparedness Innovations (CEPI), the Vaccine Alliance (GAVI) and governments.

Challenges 1 and 2: Mass testing using PCR

The first challenge comes from a team of 22 top molecular biologists and immunologists that is demanding a retraction of the article published in January 2020 by Victor Corman, Christian Drosten and colleagues in the journal Eurosurveillance, on which all SARS-CoV-2 PCR testing is based. Jeff Goldblum lookalike, Drosten, has become something of a hero in some circles. Less so in others. His co-authorship of the Laboratory testing of human suspected cases of novel coronavirus (nCoV) infection published on 10 January 2020 is noted. 

The authors have identified 6 major and 4 minor “fatal problems” with the method being adopted universally. Hence their call for the retraction, which in effect would mean all current testing would be invalid.

The fatal flaws include: use of the wrong primer concentrations, the detection of viral genes (as opposed to viable virus particles), the excessively high number (>35) of amplification cycles commonly used (which mean viral fragments will give positive results with no capacity for infection), lack of biomolecular validation or ‘gold standard’, an inability to differentiate closely related coronaviruses (or fragments thereof), and lack of a standard operational procedure (SOP), which causes large variations between different commercial testing systems. 

We eagerly await the response from the journal Eurosurveillance. If the challenge is ignored, it would be a very sad day for science – and it will become increasingly clear where real agendas lie. The more positive side will be the creation of a paper trail that could be used in legal proceedings.

"In light of our re-examination of the test protocol to identify SARS-CoV-2 described in the Corman-Drosten paper we have identified concerning errors. How can the continuing use of the test protocol be justified after these findings? Furthermore, with knowledge of the misuse and misinterpretation of test results on a global arena, should we not be mindful of this test’s contribution to these terrifying consequences?The decision as to which test protocols are published and made widely available lies squarely in the hands of Eurosurveillance. A decision to recognise the errors apparent in the CD paper has the benefit to greatly minimise human cost and suffering going forward. Is it not in the best interest of Eurosurveillance to retract this paper?"

Co-author, Howard Steen

The second scientific challenge comes from Dr Tom Jefferson, Carl Heneghan and colleagues from Oxford University's Centre for Evidence-Based Medicine. The challenge comes in the form of a systematic review published in then high ranking journal, Clinical Infectious Diseases. In reviewing 29 studies that investigated the ability of specimens derived from samples that had been PCR tested taken from blood, urine, stool or the environment, they showed a clear pattern that PCR reliant on high levels of amplification (cycle threshold = CT) were generally unable to infect or be cultured.

The reason is simply that PCR when it's pushed to amplify over around 33 amplification cycles (CT) is responding positively to fragments of virus, not whole, viable viral particles.

All of this before you even look at the false positive issue (below).

Challenge 3: Vaccine trial design and mass testing using PCR

The third scientific challenge has been made to the EU's centralised drug regulator, the European Medicines Agency (EMA), which recently shifted its long-standing base in London, to Amsterdam, courtesy of Brexit. The EMA has already received applications for conditional marketing authorisation of the BioNTech/Pfizer and Moderna vaccines.

The petition challenge originates from Dr Wolfgang Wodarg, a German physician, epidemiologist and (and politician), along with former Vice President and Chief Science Officer for Allergy & Respiratory at Pfizer, Dr Mike Yeadon, who is also an author of the Corman-Drosten PCR challenge (above).

The challenge requests a stay of action on the Phase 3 BioNTech/Pfizer vaccine trial pending a revision of its design as well as a stay on any vaccine trial that relies on PCR as the primary evidence of infection. Drs Wodarg and Yeadon rightly argue, mirroring the parallel stay of action against the US Food and Drug Administration by Dr Sin Hang Lee, that infection by SARS-CoV-2 in vaccine trials that has been reliant only on PCR testing should be confirmed using Sanger sequencing, that has been found to give 100% accuracy for SARS-CoV-2. The petitioners also challenge any evidence that purports to claim a vaccine effect on viral transmission, where transmission is based on flawed PCR testing.

The petitioners further outline that the trials may not adequately detect post-vaccination vaccine hypersensitivity (VAH) that can lead to a very severe, potentially lethal, adverse reaction when vaccinated individuals are later exposed to the real virus. Such hypersensitivity or enhancement has been noted in vaccinated experimental animals subsequently exposed to the SARS and MERS viruses, the SARS virus sharing 88% of its genotype with SARS-CoV-2. 

Wodarg and Yeadon also warned that because the spike protein shares much of the same sequence for syncytin-1, that itself originates from human endogenous retroviruses or HERV (that are ancient remnants of exogenous viruses that now make up around 8% of the human genome), there is a possibility that antibody responses to the vaccine may result in infertility in women for unspecified duration. Since pregnant women have been excluded from the trial, this would not be discovered for some time after the commercial release of the vaccine.

>>> For a detailed review of different assays for detection of SARS-CoV-2, including PCR, LAMP technique, microarrays, etc. see: Jalandra et al. Strategies and perspectives to develop SARS-CoV-2 detection methods and diagnostics. Biomedicine &  Pharmacotherapy, 2020; 129: 110446. 

False positives can be used to drive a perennial pandemic

Back in September we called out the issue of anything other than 100% specificity of tests being a problem, particularly if disease prevalence is low. We explained how a test with claimed 99% sensitivity could be more like 95% specific in the real world owing to errors that creep in in taking swabs, contamination and other factors.

More than this, it would be wrong to assume, as many do, that 95% specificity means that there would only be 5 false positives in 100 tests of uninfected people that should all be negative, in all situations. This is especially problematic when disease prevalence is low. This is what many, including government ministers and the mainstream media, wrongly assume and claim. This is because of the way that any reduction in specificity from 100% plays out in the real world, courtesy of Bayesian probability.

So we were thrilled to find an article penned by a team of distinguished microbiologists with the American Society for Microbiology say the same thing. The microbiologists show that if you were to rely on the Abbott’s BinaxNOW™ rapid test with claimed 98.5% specificity, when disease prevalence is 0.1%, you should expect 94% of positive results to be false positives. Not 1.5% that many think should be the case!

Imagine a group of 1000 people being tested. As prevalence goes down, the number of false positives goes up, giving the impression that the R number is increasing. If you’re a government authority, that might be when you decide to impose more restrictions, or push for more vaccination – all because of an inappropriate and deeply misleading testing system.  

Owing to Bayes’ theorem and mass testing, if we don’t change the way societies around the world are assessing this disease, you can keep the pandemic running forever, with no sign of any covid-19 disease! It is an abomination of science!

Take home

For our part, the evidence is now crystal clear that mass testing reliant on PCR, as well as reliance on data from vaccine trials that depends on PCR to confirm infection, is so unreliable as to be scientifically unworthy.

There are therefore ample scientific grounds, in our view, to refuse PCR testing especially if this might disadvantage you in any way, and consider vaccine trial data incomplete and therefore insufficient basis on which to allow informed consent.

>>> Find out more at ANH-Intl Covid-19 Adapt Don’t Fight campaign page

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