Stop The Pfizer Vaccine – Petitions & External Peer Review Study About PCR Test Which Shows 10 Major Scientific Flaws - Consequences For False Positive Results
Application to EMA (European Medicine Agency)
On December 1, 2020, the ex-Pfizer head of respiratory research Dr. Michael Yeadon and the lung specialist and former head of the public health department Dr. Wolfgang Wodarg filed and application with the EMA,(European Medicine Agency) responsible for EU-wide drug approval, for the immediate suspension of all SARS CoV 2 vaccine studies, in particular the BioNtech/Pfizer study.
Dr. Wodarg and Dr. Yeadon, both demanded that vaccines should be stopped until a study design is available to bring forward significant safety concerns expressed by large number of scientists against the vaccine and the study design.
Also known lack of accuracy of the PCR test is not valuable way of designing a vaccine in which case vaccine would be tested on humans and that would not be ethical.
Other concerns include antibody-dependent amplification (ADE) where immune reaction can be exaggerated when vaccinated person is exposed to a “wild” virus, infertility which could result in vaccinated women , allergic, potentially fatal reactions to the vaccination and short time which does not allow enough time to see real effects of vaccine.
“The UK regulator approved Pfizer/BioNTech on 2 December 2020.
This decision must be overturned. We can initiate a Judicial Review.The grounds for review are fully explained in the petition to the European Medicines Agency submitted on 1 December 2020 by Dr Mike Yeadon and Dr Wolfgang Wodark.”
Below is the petition they submitted it is the most important scientific challenge to the vaccine and testing regimes established since January 2020.
Application to FDA (Food and Drug Administration)
Connecticut pathologist Dr. Sin Hang Lee and Informed Consent Action Network (ICAN) have filed an application with the FDA – US (Food and Drug Administration).
“Until an accurate count of Covid 19 cases in the vaccinated and placebo groups has been determined for vaccine efficacy evaluation, we are asking the FDA to stay its decision regarding the emergency use authorization for this vaccine,” said Dr. Lee, director of Milford Molecular Diagnostics Laboratory.
The major reason for petitioning the FDA for a stay of action is that the Phase 2/3 clinical trial of the Pfizer vaccine used PCR test again known for many false positives.
As stated in the petition, if Pfizer is unable to perform the needed sequencing tests on the 180 RNA samples to confirm their stated vaccine efficacy rate of 95%, Dr. Lee has offered to re-test the residues of these samples in his laboratory.
https://vaccineimpact.com/wp-content/uploads/sites/5/2020/11/Stay-Pfizer-vaccine-phase-3-trial.pdf
A recent review of a COVID-19 PCR test, which was signed by 22 international scientists, stated:
“To determine whether the amplified products are indeed SARS-CoV-2 genes, biomolecular validation of amplified PCR products is essential. For a diagnostic test, this validation is an absolute must. Validation of PCR products should be performed by either running the PCR product in a 1% agarose-EtBr gel together with a size indicator (DNA ruler or DNA ladder) so that the size of the product can be estimated. The size must correspond to the calculated size of the amplification product. But it is even better to sequence the amplification product. The latter will give 100% certainty about the identity of the amplification product. Without molecular validation one cannot be sure about the identity of the amplified PCR products…”
Below are more details on same review.
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
Review Report - Corman-Drosten et al., Eurosurveillance 2020
SUMMARY CATALOGUE OF ERRORS FOUND IN THE PAPER
The Corman-Drosten paper:
(https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.3.2000045 ) contains the following specific errors:
1. There exists no specified reason to use these extremely high concentrations of primers in this protocol. The described concentrations lead to increased nonspecific bindings and PCR product amplifications, making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
2. Six unspecified wobbly positions will introduce an enormous variability in the real world laboratory implementations of this test; the confusing nonspecific description in the Corman-Drosten paper is not suitable as a Standard Operational Protocol making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
3. The test cannot discriminate between the whole virus and viral fragments. Therefore, the test cannot be used as a diagnostic for intact (infectious) viruses, making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus and make inferences about the presence of an infection.
4. A difference of 10° C with respect to the annealing temperature Tm for primer pair1 (RdRp_SARSr_F and RdRp_SARSr_R) also makes the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
5. A severe error is the omission of a Ct value at which a sample is considered positive and negative. This Ct value is also not found in follow-up submissions making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
6. The PCR products have not been validated at the molecular level. This fact makes the protocol useless as a specific diagnostic tool to identify the SARS-CoV-2 virus.
7. The PCR test contains neither a unique positive control to evaluate its specificity for SARS-CoV-2 nor a negative control to exclude the presence of other coronaviruses, making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
8. The test design in the Corman-Drosten paper is so vague and flawed that one can go in dozens of different directions; nothing is standardized and there is no SOP. This highly questions the scientific validity of the test and makes it unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
9. Most likely, the Corman-Drosten paper was not peer-reviewed making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.
10. We find severe conflicts of interest for at least four authors, in addition to the fact that two of the authors of the Corman-Drosten paper (Christian Drosten and Chantal Reusken) are members of the editorial board of Eurosurveillance. A conflict of interest was added on July 29 2020 (Olfert Landt is CEO of TIB-Molbiol; Marco Kaiser is senior researcher at GenExpress and serves as scientific advisor for TIB-Molbiol), that was not declared in the original version (and still is missing in the PubMed version); TIB-Molbiol is the company which was “the first” to produce PCR kits (Light Mix) based on the protocol published in the Corman-Drosten manuscript, and according to their own words, they distributed these PCR-test kits before the publication was even submitted [20]; further, Victor Corman & Christian Drosten failed to mention their second affiliation: the commercial test laboratory “Labor Berlin”. Both are responsible for the virus diagnostics there [21] and the company operates in the realm of real time PCR-testing.
CONCLUSION
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 and inherent fallacies which render the SARS-CoV-2 PCR test useless.
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 Corman-Drosten 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? Our conclusion is clear. In the face of all the tremendous PCR-protocol design flaws and errors described here, we conclude: There is not much of a choice left in the framework of scientific integrity and responsibility.
Swiss Stake Slower, More Cautious Covid Vaccine Path
On Dec. 1, Switzerland’s medical regulator, Swissmedic, said it lacks the necessary information to approve three different coronavirus vaccines ordered by the government, including the Pfizer vaccine.
In a recent interview about the pending review of the Pfizer COVID-19 vaccine, FDA Commissioner Stephen Hahn has promised, “we will make a determination regarding safety and efficacy based upon our very stringent criteria.”
https://www.swissinfo.ch/eng/emergency-vaccine-approval-not-legal-option-in-switzerland/46217840
Sources:
https://childrenshealthdefense.org/defender/fda-petition-halt-pfizer-vaccine-efficacy/
