Translated by Piotr Bein, 23.12.2020, from text filed here.
DATED AT Wrocław, 12.12.2020
FROM: Association Health Information Center — Dobrostan
ul. Wolbromska 18/1b, 53-148 Wrocław
- [Republic of Poland] Ministry of Health
- Chancellery of the Prime Minister
- Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)
- Main Pharmaceutical Inspectorate (GIF)
- National Institute of Public Health (PZH)
Re: Draft of the National Program of Vaccination against COVID-19, published on 08.12.2020 at https://www.gov.pl/web/zdrowie/narodowy-program-szczepien-ponim- covid-19-Konsultacje
Due to a relatively short deadline for “broad consultations” and drawing up comments to the above-mentioned project (announcement on 08/12/2020, deadline for submitting comments until 12/12/2020 10:00 AM), the association reserves the right to supplement the COMMENTS.
Teresa Łabaziewicz and Karol Talkowski, Association Health Information Center — Dobrostan
Quote from the National COVID-19 Immunization Program:
The vaccine is a great opportunity to immunize the society against infection, gain control over SARS-CoV-2 virus transmission.
I. Insufficient evidence for isolation of SARS-COV-2 virus
For lack of proper isolation and quantification of the virus, insufficient evidence support the hypothesis that the SARS COV2 virus is more than a bioinformatic sequence: (These theses are further developed by the 2018 Nobel Prize candidate Dr. Stefano Scoglio1, the work of the infectious disease specialist Fabio Franchi2 and Dr. Pieter Borger3 (MSc, PhD), Molecular Genetics, Research Associate, Lörrach, Germany)
- Official documents of the European Commission4 and CDC5 provide evidence: As no virus isolates with a quantified amount of SARS-CoV-2 are currently available…
European Commission, Working Document, Current Performance of COVID-19 Test Methods and Equipment and Proposed Performance Criteria
CDC: “Ponieważ nie ma obecnie dostępnych skwantyfikowanych ilościowo izolatów wirusa 2019-nCoV…
The works of Polish scientists6 are also based on the synthetic RNA of the virus, for which the authors each time credit the Charite Institute in Berlin. By no coincidence the Charite Institute is funded by the Melinda and Bill Gates Foundation. Dr. Stefano Scoglio writes:
Since we have never isolated nor identified this virus, what then is the PCR testing? What’s in the vaccines that are being prepared. And above all, how can one say that this alleged virus, which is completely unknown in the current state of knowledge, is responsible for any disease? Moreover, Drosten downloaded a sequence of the alleged Sars-CoV-2 virus from the Gisaid database between January 10 and 20, 2020, and an article by Zhue et al.7 claoming alleged “virus isolation” (the article8 received serious criticism from many scientists for lack of reliable electron microscope photos documenting particles of “isolated virus”) appeared only on February 24, 2020
II. PCR tests
Corman-Drosten’s work on PCR testing contains the following errors9:
1. It does not explain why the protocol uses extremely high primer concentrations. Described concentrations lead to an increase in the number of non-specific bindings and the amplification of PCR products, rendering the test unsuitable for diagnosis of SARS-CoV-2 virus infections.
2. The six wobble positions introduce enormous variability in laboratory test applications; the unclear description of the protocol in the work of Corman-Drosten does not specify a standard operating procedure, rendering the test unsuitable for diagnosis of SARS-CoV-2 virus infections.
3. PCR test does not discern the presence of the entire virus fram virus fragments. Therefore, it is not suitable for the diagnosis of whole (infectious) viruses, and therefore cannot be used to detect SARS-CoV-2 virus and infer the presence of infection.
4. The difference of 10 °C from the annealing temperature Tm for steam1 (RdRp_SARSr_F and RdRp_SARSr_R) also makes the test unsuitable for use in the diagnosis of SARS-CoV-2 virus infections.
5. A serious error is the omission of the Ct value for which a sample is to be considered positive or negative. The Ct values were not added afterwards, either, making the test unsuitable for use in the diagnosis of SARS-CoV-2 virus infections.
6. The PCR products have not been validated at the molecular level. This means that the test is not suitable for the diagnosis of SARS-CoV-2 infections.
7. There are no positive control methods for the PCR test to assess its specificity for the SARS-CoV-2 virus, and no negative control methods to exclude the presence of other coronaviruses, which makes the test unsuitable for use in the diagnosis of SARS virus infections – CoV-2.
8. The test structure described in the Corman-Drosten work is so vague and flawed that it can be interpreted in many ways; standardization and the SOP procedure arwe absent, calling into question the validity of the test and making it unsuitable for use in the diagnosis of SARS-CoV-2 virus infections.
9. Corman-Drosten’s work probably did not pass a scientific review process before publication, which makes the test unsuitable for use in diagnosis of SARS-CoV-2 virus infections.
10. Beside the fact that two of the authors of Corman-Drosten’s work (Christian Drosten and Chantal Reusken) are on the editorial board of Eurosurveillance, we also found that at least four authors had a serious conflict of interest. On July 29, 2020, a conflict of interest was announced that was not declared in the original version of the work (and which is still not reported in the PubMed version) — Olfert Landt is CEO of TIB-Molbiol, while Marco Kaiser is not only a senior research fellow at GenExpress, but also a scientific consultant at TIB-Molbiol, the company that “first” produced PCR kits (Light Mix) based on the protocol published in the Corman-Drosten manuscript; as the firm admits, the kits were distributed before the text was submitted for publication . Moreover, Victor Corman and Christian Drosten did not declare their affiliation with the commercial laboratory “Labor Berlin” which conducted the tests. Both authors are responsible for diagnostics , and the company operates in the area of PCR tests.
In light of our re-examination of the SARS-CoV-2 detection protocol described in Corman-Drosten’s work, we find disturbing errors and flaws that render the SARS-CoV-2 PCR test useless.
Comment to Chapter II Vaccination Effectiveness and Safety. Clinical trial stage:
III. Research. Defective test designs
Refers to Pfizer / BioNTech vaccine
The clinical trial plans for Phase II / III study of BNT162b (“the Pfizer / BioNTech study”) are insufficient to accurately assess efficacy. Dr Wodarg and Dr Yeadon also believe that a clinical trial design of vaccine candidates aimed at stopping the transmission of the virus from a vaccinated person to others and / or preventing or alleviating the symptoms of COVID-19, for which PCR results are the primary evidence of the presence of infection, are inadequate to accurately assess effectiveness.
There are some troubling issues about the clinical trial plans described by Dr. Peter Doshi in the British Medical Journal. Dr. Doshi focuses on two of the most serious issues. First, none of the leading vaccine candidate research plans are designed to test whether a vaccine can reduce symptoms of severe COVID-19, defined as: hospitalization, admission to intensive care, or death. And, second, the research is not designed to establish if a vaccine can interrupt transmission of the virus (https://www.bmj.com/content/bmj/371/bmj.m4037.full.pdf). If neither of these conditions are met, the vaccine actually acts as a medicine, except for a vaccine that would be taken prophylactically, even by a completely healthy person. It is more than likely that there is a greater risk of causing harm than a therapeutic drug. Then the drugs would have an advantage over any COVID vaccine.10
Before Pfizer’s vaccine or any other vaccine for which PCR test results are the primary method of confirming infection receives an unconditional approval or Emergency Use Authorization (EUA), all “endpoints” or cases of COVID-19 infection, used to confirm vaccine efficacy in Phase 3 and 2/3 studies should be confirmed as actual infection cases by Sanger sequencing, due to the high Ct values used in some of the tests. It is well known that high Ct values in RT-qPCR tests lead to false-positive results.11
IV. Research. Animal safety studies were omitted
The omission of the most important step in the safety of coronavirus vaccines, animal testing, is evidence of the venture’s experimental character.
These tests are necessary to verify whether pathogenic pre-activation of the cells is taking place or whether the vaccine may cause serious problems as a result of pathogenic pre-activation. Dr. Jame Lyons-Weiler:
Coronavirus vaccines have had a disastrous safety history. There is a condition known in science as antibody-dependent enhancement (ADE), which has been discovered in studies of the safety of vaccinated animals and in previous vaccine safety studies when animal vaccination safety studies have been carried out in which animals developed more severe disease after vaccination. and then, when they became infected with wild-type (naturally occurring) virus, more animals became severely infected, severely ill, and more animals died.12
V. Research. ADE
For the vaccine to work, our immune system needs to be stimulated to produce neutralizing antibodies, the oppoaite of non-neutralizing antibodies. A neutralizing antibody is one that can recognize and bind to a certain region (“epitope”) of the virus, and then prevents it from either entering cells or not replicating itself. A non-neutralizing antibody is one that can bind to the virus but not neutralize its infectivity for some reason. In some viruses, if a person is a carrier of a non-neutralizing antibody to the virus, subsequent infection may make the person react more seriously to the virus, due to the presence of a non-neutralizing antibody. This does not concern all viruses, only specific ones. The name for this phenomenon is Antibody Dependent Enhancement (ADE) and is a common problem with viruses such as denge, Ebola, HIV, RSV, and the coronavirus family. In fact, the ADE problem is the main reason why many previous attempts have failed to develop a vaccine for other coronaviruses.
Serious safety concerns arose in animal models. If ADE is present in an individual, his response to the virus may be more unfavorable than if it had never developed antibodies at all. This can cause a hyperinflammatory reaction, a cytokine storm, and a general deregulation of the immune system, which will allow the virus to cause more damage to the lungs and other organs in our body.
In addition, new cell types in our body are now susceptible to viral infections due to the additional path of entry of the virus. There is much research showing that ADE in general is an ongoing problem with coronaviruses, in particular SARS-related viruses.
ADE has proven to be a major challenge for coronavirus vaccines and is a major cause of failure of many such vaccines in early in-vitro or animal studies. For example, king macaques vaccinated with SARS-CoV spiky protein showed severe acute lung injury when their body had to respond to SARS-CoV, while monkeys that had not been vaccinated showed no such damage. Similarly, mice vaccinated with one of the four different SARS-CoV vaccines showed histopathological changes in the lung with eosinophilic infiltration after infection with SARS-CoV. 13
Initial pathogenic cell activation called priming discussed among others Dr. James Lyons-Weiler in his study Pathogenic priming likely contributes to serious and critical illness and mortality in COVID-19 via autoimmunity. Here are its most important conclusions:
1. All immunogenic epitopes of SARS-CoV-2, except one, are similar to human proteins.
2. Roughly 1/3 of potentially targeted human proteins (putative autoantigens) are key players in the adaptive immune system.
3. The list of matches of viral and human proteins provides indications on which epitopes or parts thereof may be affected by immunopathogenesis of COVID-19 disease from SARS-CoV-2 infection.
4. It also indicates which epitopes may be responsible for autoimmune pathogenic priming as a result of previous infection or as a result of exposure to SARS-CoV-2 or relatives after vaccination.
5. These epitopes should be excluded from vaccines under development to minimize autoimmunity due to the risk of pathogenic priming. — Have they been excluded? NO.
VII. Experimental vaccine
Adopted by the European Parliament in summer 2020, regulation 2020/1043 repeals the requirement for manufacturers of GMO vaccines and drugs for Covid-19 to submit an environmental and biosafety risk assessment before clinical trials. The text, published on 17 July, was approved by the European Parliament under an emergency procedure within 10 days, without amendment, consultation with scientists or debate.
This exception to European GMO rules violates the precautionary principle set out in the Treaty on the Functioning of the European Union. These GM Covid-19 vaccines, for which clinical trials have already started, pose a very real risk. A report by molecular geneticist Cristian Velot of Criigen indicates that they can lead to recombination of viruses potentially more serious than those against which the vaccine is aimed, affecting animal life and human health.
The risk of interaction with human DNA or the introduction of new genetic technologies may have unknown, potentially serious and irreversible consequences. In other words, no specific measures will be taken to control the risk of genetic modification of living beings.
The European authorities are offering the pharmaceutical industry a blank check for the introduction of new technologies of genetically modified drugs and vaccines to the market, for which not all safety studies will be carried out. In such circumstances, patients become guinea pigs and as doctors we refuse this state of affairs” — emphasizes Philippe Harvaux, Association Internationale pour une Médecine Scientifique Indépendante et Bienveillante (AIMSIB).
Art. 39 of the Polish Constitution:
Nobody may be subjected to scientific experiments, including medical ones, without voluntary consent.
The draft of the National Program of Vaccination against COVID-19 does not contain the described procedure of obtaining consent of Polish citizens to undergo experimental vaccines against COVID-19. Moreover: in regulation 2020/0128 in art. 4 point 1, EU bodies make the application of EU law (the above-mentioned regulation conditional on the decision of the non-public organization WHO, sponsored largely by the Bill and Melinda Gates Foundation and GAVI, and thus controlled by Bill Gates.
Ref. REGULATION (EU) 2020/1043 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 July 2020
VIII. Vaccine Manufacturers – CV
Pharmaceutical companies currently working on the development and production of vaccines for COVID-19, proposing a vaccine for COVID-19, have repeatedly committed crimes that have a direct impact on patient safety, including corruption offenses. Some examples below:
[Astra Zeneca, Pfizer, Sanofi GSK, Sanofi-Aventis, GSK] [ref. 14 to 17]
IX. Marketing authorization stage
The European Commission is responsible for admitting pandemic vaccines to the market, in accordance with the mandatory application of the provisions of Regulation (EC) No 726/2004 of the European Parliament and of the Council of March 31, 2004, after obtaining a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP,) operating within the European Medicines Agency (EMA).
During the 2009/10 swine flu epidemic, Pandemrix was also approved by EMA for use in EU. Despite minimal clinical trials (just like for COVID-19 vaccines), the vaccine was then administered to 6 million people in UK high-risk groups, incl. children with asthma, diabetes and heart disease. 850,000 vaccines were administered to children 6 months to 16 years of age. Following the 2010/11 pandemic, 170,000 more adults and children were vaccinated in the wake of seasonal flu vaccinations. Pandemrix caused narcolepsy.
The UK Health Protection Agency (now Public Health England) carried out a major study in 4-18 year olds and found that about one injection in 55,000 leads to narcolepsy.18
Given the above, the fact that the vaccine has been approved by EMA does not mean that the vaccine is safe.
Due to the facts presented hereby in Chapter VIII, it is necessary and crucial to evaluate the vaccines proposed in Poland in terms of quality, efficacy and safety. Especially in terms of long-term effects, which have repeatedly led to vaccine withdrawal from the market. Before COVID vaccines are offered to Poles, they should be carefully tested, in accordance with the procedures and knowledge about vaccines, by Polish specialists employed by a state institution established for that purpose. Only specialists who did not receive salaries, grants or other benefits from pharmaceutical companies or their subsidiaries or non-governmental organizations should participate in the survey.
These tests should also relate to nano pollutants. More on nano contaminants in vaccines in the Gatti AM study. Montanari S., New Quality-Control Investigations on Vaccines: Micro and Nano contamination, International Journal of Vaccines and Vaccination 2017.19
Meanwhile, contrary to logic, manufacturers of COVID-19 vaccines are released from responsibility for the effects of COVID-19 vaccines.20
X. Potential Side Effects of COVID Vaccines Ingredients.
In the vaccine candidate from Pfizer / BioNTech mRNA, polyethylene glycol (PEG) is found in the shell of fat lipid nanoparticles around the mRNA. 70% of people develop antibodies to polyethylene glycol PEG and most are unaware of it, creating a worrying situation where many of them could have an allergic, potentially fatal, reaction to a PEG-containing vaccine. PEG antibodies may also reduce the effectiveness of the vaccine.21
Green Pfizer / BioNTech are also introducing into their vaccine a marine invertebrate-derived ingredient called mNeonGreen. This component has bioluminescent properties making it attractive for medical imaging purposes, but it is unclear why an injected vaccine would need to have such a feature. The antigenicity of mNeonGreen is unknown.22
Humoral antibodies against SARS-CoV-2 spike proteins
Several vaccine candidates are expected to induce humoral antibodies to SARS-CoV-2 spike proteins. Syncytin-1 (see Gallaher, B., Response to nCoV2019 Against Backdrop of Endogenous Retroviruses), which is derived from human endogenous retroviruses (HERVs) and is responsible for the development of the placenta in mammals and humans, and therefore a necessary condition for successful pregnancy, is also found in homologous form in the proteins of SARS spiky viruses. There is no indication that antibodies against the spiny proteins of SARS viruses also act as antibodies to Syncitin-1. However, if it were to do so, it would also prevent the formation of the placenta, which would make vaccinated women essentially infertile. To my knowledge, Pfizer / BioNTech has not yet released any samples of the written material provided to patients, so it is unclear what information it contains about the (potential) fertility risk for a particular antibody type.23
Vaccination against the SARS coronavirus leads to the development of lung immunopathology
Tseng CT, Sbrana E, Iwata-Yoshikawa N, Newman PC, Garron T, Atmar RL, Peters CJ, Couch RB. Immunization with SARS coronavirus vaccines leads to pulmonary immunopathology on challenge with the SARS virus. PLoS One. 2012; 7 (4): e35421. doi: 10.1371 / journal.pone.0035421.
XI. No vaccine composition in the Draft National Program of Immunization against COVID-19
The draft of the [Polish] National COVID-19 Immunization Program does not name the composition of the vaccines to be used in this Program. This means that citizens will not be made aware of the composition of a given vaccine, which can lead to the wrong decision to accept a vaccine and may even prevent them from making a decision about it; vaccination may be associated with post-vaccination health complications; The lack of composition of a given vaccine makes it impossible to assess the National Immunization Program in terms of compliance with applicable regulations.
XII. Vaccinated status
Regarding the “Status of the vaccinated person”, Art. 32 of the Constitution of the Republic of Poland excludes the possibility of introducing the above-mentioned solutions for vaccinated persons.
3 https://www.globalresearch.ca/external-peer-review-rt-pcr-test-detect-sars-cov-2-reveals-10-major-scientific-flaws- molecular-methodological-level-consequences-false-positive-results/5730889
4 European Commission, Working Document of Commission Services, Current performance of COVID-19 test methods and devices and proposed performance criteria, April 16 2020, str.19. https://ec.europa.eu/docsroom/documents/40805/attachments/1/translations/en/renditions/native
5 Centers for Disease Control and Prevention, Division of Viral Diseases, CDC 2019-Novel Coronavirus (2019-nCoV) Real- Time RT-PCR Diagnostic Panel , 13/07/2020, str.39.
6 Replication of Severe Acute Respiratory Syndrome Coronavirus 2 in Human Respiratory Epithelium
Aleksandra Milewska, Anna Kula-Pacurar, Jakub Wadas, Agnieszka Suder, Artur Szczepanski, Agnieszka Dabrowska, Katarzyna Owczarek, Alessandro Marcello, Marek Ochman, Tomasz Stacel, Zenon Rajfur, Marek Sanak, Pawel Labaj, Wojciech Branicki, Krzysztof Pyrc. Journal of Virology Jul 2020, 94 (15) e00957-20; DOI: 10.1128/JVI.00957-20
7 Zhu N et al, A Novel Coronavirus from Patients with Pneumonia in China, 2019, N Engl J Med. 2020 Feb 20; 382(8): 727– 733
8 Corman Victor M, Landt Olfert, Kaiser Marco, Molenkamp Richard, Meijer Adam, Chu Daniel KW, Bleicker Tobias, Brünink Sebastian, Schneider Julia, Schmidt Marie Luisa, Mulders Daphne GJC, Haagmans Bart L, van der Veer Bas, van den Brink Sharon, Wijsman Lisa, Goderski Gabriel, Romette Jean-Louis, Ellis Joanna, Zambon Maria, Peiris Malik, Goossens Herman, Reusken Chantal, Koopmans Marion PG, Drosten Christian. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25(3):pii=2000045. https://doi.org/10.2807/1560- 7917.ES.2020.25.3.2000045https://www.eurosurveillance.org/content/10.2807/1560- 7917.ES.2020.25.3.2000045?fbclid=IwAR0XR3v3OXjP24TNGT9SwIT0vMXxF8okKTyba94roeDAi0I6APtlGgqzNUw
9 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. https://cormandrostenreview.com/report/
Article Source: The SARS-CoV-2 ORF10 is not essential in vitro or in vivo in humans
Pancer K, Milewska A, Owczarek K, Dabrowska A, Kowalski M, et al. (2020) The SARS-CoV-2 ORF10 is not essential in vitro or in vivo in humans. PLOS Pathogens 16(12): e1008959. https://doi.org/10.1371/journal.ppat.1008959
10 https://2020news.de/wp- content/uploads/2020/12/Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_Exhibits. pdf
11 Por. New York Times, Your Coronavirus Test Is Positive. Maybe It Shouldn’t Be. (Twój test na koronawirusa jest dodatni. A może nie powinien być?), autor Apoorva Mandavili. Opublikowany dnia 29 sierpnia 2020, uaktualniony 17 września 2020, dostępny na: https://www.nytimes.com/2020/08/29/health/coronavirus-testing.html
12 https://dryburgh.com/james-lyons-weiler-coronavirus-vaccine-safety-warning/, Anurodh Shankar Agrawal, Xinrong Tao, Abdullah Algaissi, Tania Garron, Krishna Narayanan, Bi-Hung Peng, Robert B. Couch & Chien-Te K. Tseng (2016) Immunization with inactivated Middle East Respiratory Syndrome coronavirus vaccine leads to lung immunopathology on challenge with live virus, Human Vaccines & Immunotherapeutics, 12:9, 2351-2356, DOI: 10.1080/21645515.2016.1177688 ; DOI: 10.1128/JVI.78.22.12672-12676.2004
13 https://2020news.de/wp- content/uploads/2020/12/Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_Exhibits. pdf
15 https://www.contractormisconduct.org/contractors/188/pfizer-inc; https://www.businessinsider.com/pfizer-to-pay-23- billion-in-biggest-fine-every-for-deceitful-advertising-2009-9?r=US&IR=T&fbclid=IwAR0ui6ZMkDEqC0Bh9H0q- 0jWeuUUY7s-FUC7WshgsL7YYSB1caYFyUxo2CM
18 https://www.narcolepsy.org.uk/resources/pandemrix- narcolepsy?fbclid=IwAR2ruQWB4PeWulmsLhIS0VBb0Msq5RHu0lH4sEesEzh_qPJEKCYHGczoUbY
20 https://www.politykazdrowotna.com/62459,astrazeneca-zwolniona-z-odpowiedzialnosci-za-dzialanie-szczepionki- covid-19?fbclid=IwAR1AQq1ehlUZUuhrIFmVXtT-PcjjgIQ6VISxP–rLRAGtvRKq9CwE4dEbkM
21 Yang Q, Jacobs TM, McCallen JD, Moore DT, Huckaby JT, Edelstein JN, Lai SK. Analysis of Pre-existing IgG and IgM Antibodies against Polyethylene Glycol (PEG) in the General Population. Anal Chem. 2016 Dec 6;88(23):11804-11812. doi: 10.1021/acs.analchem.6b03437. Epub 2016 Nov 16. PMID: 27804292; PMCID: PMC6512330.; https://2020news.de/wp- content/uploads/2020/12/Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_Exhibits. pdf
22 Pkt X. https://2020news.de/wp- content/uploads/2020/12/Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_Exhibits. pdf
23 Pkt XI. https://2020news.de/wp- content/uploads/2020/12/Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_Exhibits. pdf