It is vitally important the public is made aware of the potential downstream health risks associated with SARS-CoV-2 vaccination. Normality has been bypassed to expedite a SARS-CoV-2 vaccine for emergency use authorization (EUA) with the MHRA, EMA, FDA, and other national drug regulatory agencies around the world.

There is a sound scientific basis to petition governments to prevent them enforcing SARS-CoV-2 immunization on the general population, until the full safety and efficacy is understood. Citizens should have a choice. The use of reverse transcription polymerase chain reaction (RT-PCR) at amplification cycle thresholds (Ct) exceeding 35, without genome sequencing to confirm false positives, means any disease morbidity-mortality data so derived is questionable both for vaccine studies and more generally (see below).

Remember, seasonal flu attacks 10-20% of the population each year and kills a similar percentage to SARS-CoV-2, while Influenza pandemics infect >30% of the world’s population (with varying mortality rates from <1% to 2.5% for the 1918 Spanish flu). This week (10/12/2020) 0.88% of the world had been diagnosed as infected with SARS-CoV-2. For clarity, this pandemic is real (technically). However, one must dis-aggregate bonafide disease and mortality data from the high false-positive data acquired using RT-PCR with the Ct >35-40 in asymptomatic and co-morbid disease sub-populations, or false SARS-CoV-2 diagnostic labels put on other causes of mortality.

Key vaccine safety and efficacy information (so far):
  1. SAFETY: (1) The FDA published a list of 21 potential adverse events https://www.fda.gov/media/143557/download (2) General guidance to Industry: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19
  2. CLINICAL DATA: (1) Pfizer-BioNTech COVID-19 Vaccine data (BNT162b2): Vaccines and Related Biological Products Advisory Committee Meeting December 10, 2020. FDA Briefing Document https://www.fda.gov/media/144245/download.
  • Most COVID-19 candidate vaccines express the spike protein or parts of the spike protein, i.e., the receptor binding domain (RBD), as the immunogenic determinant.”
  • Vaccine efficacy definition (VE): (1) Primary efficacy endpoint for BNT162b2 against confirmed COVID-19 was evaluated in participants without evidence of prior SARS-CoV-2 infection prior to 7 days after Dose 2. (2) Assessments for illness visits included a nasal (mid-turbinate) swab, which was tested at a central laboratory using a RT-PCR test (i.e., Cepheid; FDA authorized under EUA, or other sufficiently validated nucleic acid amplification-based test (NAAT) to detect SARS-CoV-2, PLUS at least one of the following symptoms: fever; new or increased cough; new or increased shortness of breath; Chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting (i.e., non-specific flu-like and gastrointestinal symptoms).
  • COMMENT: Dr. Michael Yeadon, former Chief Scientific Officer and VP for Pfizer Allergy Respiratory Research and others petitioned the European Medicine Agency (EMA, Netherlands, EMA Petition PDF). This petition detailed major issues with the use of RT-PCR defined in the study protocol to diagnose cases of SARS-CoV-2: QUOTE: “These test kits referred to in the trial protocol, namely the Cepheid Xpert Xpress SARS-CoV-2, the Roche Cobas SARS-CoV-2 real-time RT-PCR test (EUA200009/A001), and the Abbott Molecular/Real-Time SARS-CoV-2 assay (EUA200023/A001), are very unreliable tools when they are used to determine whether the nasal swab sample collected from a symptomatic   participant   contains   SARS-CoV-2   or   not.   These   real-time   RT-PCR   or   RT-quantitative PCR tests should be referred to as rRT-PCR or RT-qPCR tests to be distinguished from conventional RT-PCR. The very short RT-qPCR product (amplicon) cannot be analyzed by automated Sanger sequencing as the products of conventional PCR can. And DNA sequencing for validation of the PCR products is needed to correctly determine if the presumptive RT-qPCR-positive SARS-CoV-2 test result is a true positive or a false positive.
  • EFFICACY: In the planned interim and final analyses, vaccine efficacy 7 days after Dose 2 was 95%, (95% CI 90.3; 97.6) in participants without prior evidence of SARS-CoV-2 infection and >94% in the group of participants with or without prior infection. Efficacy outcomes were consistently robust (≥93%) across demographic subgroups (VE was 74.4% in Asian subjects).
  • SAFETY: (1) A higher proportion of vaccine recipients reported adverse events compared with placebo recipients, and this imbalance was driven by reactogenicity after vaccine injection. (2) The most common solicited adverse reactions were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%); severe adverse reactions occurred in 0.0% to 4.6% of participants, were more frequent after Dose 2 than after Dose 1, and were generally less frequent in participants ≥55 years of age (≤2.8%) as compared to younger participants (≤4.6%). (3) The frequency of serious adverse events was low (<0.5%), without meaningful imbalances between study arms. Among non-serious unsolicited adverse events, there were four cases of Bell’s palsy (facial paralysis) in the vaccine group (3, 9, 37, & 48 days post-vaccination) compared with no cases in the placebo group. Lymphadenopathy was imbalanced in the vaccine group (64) vs. the placebo group (6).
  • COMMENTS: (1) The overall median duration of follow-up was less than 2 months. Therefore, no conclusions can be drawn on longer-term vaccine safety or efficacy at this stage. (2) Use during pregnancy and lactation, and in pediatric participants <16 years of age was not assessed. (3) The primary endpoint was evaluated in individuals without prior evidence of COVID-19 disease, thus excluding the possibility of assessing Antibody Dependent Enhancement (ADE) – see point 3 next). (5) Vaccine effectiveness against severe disease in at-risk demographics (i.e., hospital admissions, ICU admissions, mortality) and transmission of SARS-CoV-2 was not assessed. Remember, in a community setting it is the elderly with co-morbid disease who are at risk.
  • EFFICACY COMMENT: Peter Doshi (Assoc. Editor BMJ): Pfizer and Moderna’s “95% effective” is cautioned. None of the leading vaccine candidate trials were designed to test if the vaccine can reduce severe COVID-19 symptoms (hospital admissions, ICU or death). Trials were also not designed to test if the vaccine can interrupt transmission (viral load, viral shedding, duration of viral shedding) https://www.bmj.com/content/bmj/371/bmj.m4037.full.pdf.
  1. POTENTIAL SARS-CoV-2 VACCINE SAFETY ISSUES: Antibody Dependent Enhancement (ADE) of viral entry is a big concern.
  • This EMA Petition by Dr. Michael Yeadon, former Chief Scientific Officer and VP for Pfizer Allergy Respiratory Research, details ADE as a potential safety issue: https://healthimpactnews.com/wp-content/uploads/sites/2/2020/12/Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_Exhibits.pdf
  • The scientific literature shows that if a human (macaque monkey, cat, or mouse) harbors a non-neutralizing antibody to a coronavirus through immunization (SARS-CoV, MERS, Feline Infectious Peritonitis, other), then a subsequent infection by the same virus can cause that person (or animal) to elicit a more severe immunological-inflammatory reaction to the virus and cause major disease or death (versus no immunization). This paradoxical immune response enhancement means vaccinated people and animals may be at a higher risk of developing disease or death than non-vaccinated people. “Normally” in vaccine development if there is immune enhancement in pre-clinical animal testing, this is a showstopper.
  • Twenty-one citation links and abstract summaries are provided in the Excel file (Covid19 Vaccine Safety on page “Safety Issues”) linked to ADE. Click on the cells in the file to review the summary information or click the link and get the publications. This literature indicates that we must proceed with CAUTION with government mandated SARS-CoV-2 immunization. Alternatively, you can click on the hyperlinks at the bottom of this page to download the scientific publications.
  1. POTENTIAL SARS-CoV-2 VACCINE SAFETY ISSUES: Vaccine targeting of SARS-CoV-2 Spike (S) protein could cause infertility in women and men. This was not tested in clinical and pre-clinical studies (so far).
  1. DETERMINING VACCINE EFFICACY & DISEASE INCIDENCE (GENERALLY): the routine use of RT-PCR to diagnose SARS-CoV-2 infection results in high false-positives if the cycle thresholds (Ct) exceed 35 (i.e., in the USA, EU, UK a Ct of 40 is used).
  • Read the EMA Petition sent by 3 experts, including Pfizer’s former CSO and VP of allergy and respiratory diseases. This is a highly critical review of Pfizer/BioNTech SARS-CoV-2 vaccine clinical study and its reliance on RT-PCR to confirm infection, without whole viral genome sequencing to confirm SARS-CoV-2 infection.
  • Review-critique of the WHO promoted Corman Drosten protocol: Pieter Borger et al. “External peer review of the RT-PCR test to detect SARS-CoV-2 reveals 10 major scientific flaws at the molecular and methodological level: consequences for false positive results.” Cycle thresholds, unspecified oligonucleotide primer and probe sequences, and erroneous primer concentrations were major issues likely to facilitate high false-positive results. https://cormandrostenreview.com/report/.
  • At a cycle threshold (Ct) of 25 up to 70% of patients remain viral positive in cell culture, and that at a Ct of 30 this value drops to 20%. At a Ct of 35 <3% of cultures are positive: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1491/5912603.
  • Tony Fauci CDC (16/07/2020): “…If you get [perform the test at] a cycle threshold of 35 or more…the chances of it being replication-competent [aka accurate] are miniscule… you almost never can culture virus [detect a true positive result] from a 37 threshold cycle…even 36…” (16/07/2020: at the 4.06 minute mark: https://www.youtube.com/watch?v=a_Vy6fgaBPE&feature=youtu.be&t=260)
  • Publication: Correlation between successful isolation of virus in cell culture and Ct value of quantitative RT-PCR targeting E gene shows that patients with Ct above 33–34 are not contagious: https://link.springer.com/article/10.1007/s10096-020-03913-9.

 

Other issues of major concern:
  1. Was SARS-CoV-2 a genetically modified organism or bioweapon? 
  • Chimera virus: to exemplify that such research was conducted a zoonotic Chinese horseshoe bat RsSHC014-CoV spike protein was grafted onto a SARS-CoV mouse-adapted backbone in the USA.  A 2015 publication shows how advanced this testing was, “A SARS-like cluster of circulating bat coronaviruses shows potential for human emergence” https://www.nature.com/articles/nm.3985. This collaborative program was funded under Gain-of-Function Research (i.e., bio-weaponization) Involving Influenza, MERS and SARS Viruses (http://www.phe.gov/s3/dualuse/Documents/gain-of-function.pdf). The study involved the University of North Carolina, the United States Army Medical Research Institute of Infectious Diseases, and the Wuhan Institute of Virology, among others.
  • Chimera virus: Abstract excerpt: “to examine the emergence potential (that is, the potential to infect humans) of circulating bat CoVs, we built a chimeric virus encoding a novel, zoonotic CoV spike protein—from the RsSHC014-CoV sequence that was isolated from Chinese horseshoe bats—in the context of the SARS-CoV mouse-adapted backbone.”
  • HIV inserts: Another publication was immediately retracted upon publication (https://www.biorxiv.org/content/10.1101/2020.01.30.927871v2): “Uncanny similarity of unique inserts in the 2019-nCoV spike protein to HIV-1 gp120 and Gag”. You can download an original PDF copy from this website or via: https://greatgameindia.com/uncanny-similarity-of-unique-inserts-in-the-2019-ncov-spike-protein-to-hiv-1-gp120-and-gag/
  • HIV inserts: The 4 amino acid sequence insertions in the SARS-CoV-2 spike protein were not present in other coronaviruses analyzed (SARS, MERS, other). 3D modeling showed at least 3 of the HIV-like inserts converged to help form the receptor binding site (for viral entry). None of these HIV-like inserts are present in any other coronavirus, yet the rest of the SARS-CoV-2 spike protein is highly homologous with SARS and MERS viruses. This publication suggests this is “unlikely” to have occurred by chance.
  1. WHO reputation and strategic intent are called into question.
  • WHO chief Tedros Adhanom Ghebreyesus said “widespread travel bans not needed to beat China virus” (02/07/2020), even though China had quarantined itself internally (https://www.reuters.com/article/us-china-health-who-idINKBN1ZX1H3). This failure to quarantine China led to the global spread of SARS-CoV-2.
  • While WHO was telling the world not to quarantine China it was stalling to call a pandemic. This stalling was despite having already met WHO Stage 6 criteria for a pandemic (on ≥ 2 continents). A pandemic was finally called on 11/03/2020. This stalling to call the pandemic likely arose due to a WHO conflict of interest with the World Bank’s Pandemic Emergency Financing Facility (PEF Bonds). If WHO called a pandemic before the end of June 2020 then the Bond holders would forfeit c.$250mil of the $425mil bond. WHO was a non-executive of the PEF bond steering committee, as well as provider of the disease incidence data that would trigger bond clauses. https://www.worldbank.org/en/topic/pandemics/brief/pandemic-emergency-financing-facility, http://pubdocs.worldbank.org/en/882831509568634367/PEF-Final-Prospectus-PEF.pdf
  • WHO stands accused of immunizing Kenyan women with an anti-fertility vaccine: Accordingly, WHO is said to have immunized young Kenyan women for “Tetanus” (Tetanus Toxoid) using a tetanus vaccine conjugated to human chorionic gonadotropin (hCG), without informed consent or disclosing the alterations to the vaccine. The vaccine was independently characterized and confirmed the presence of hCG: https://www.researchgate.net/publication/320641479_HCG_Found_in_WHO_Tetanus_Vaccine_in_Kenya_Raises_Concern_in_the_Developing_World, and https://pubmed.ncbi.nlm.nih.gov/12346214/ (WHO vehemently denied this allegation). Therefore, if this is TRUE then a WHO precedent already exists for covert-surreptitious fertility vaccination. Hence, the potential fertility issues linked to anti-Syncytin-1 antibodies must be taken seriously until confirmed otherwise.
  • WHO (Tedros Adhanom Ghebreyesus) also stands accused of assisting genocide associated with the cholera epidemic in Sudan; https://www.genocidewatch.com/single-post/2017/07/24/an-open-letter-to-dr-tedros-adhanom-ghebreyesus-director-general-of-the-un-s-world-health).
  • ISN’T IT STRANGE…? On the one hand WHO continues to hold the world vulnerable to an impending influenza pandemic by failing to recommend prepandemic immunization since the 2005 H5N1 zoonosis and 2009 swine flu pandemic. On the other hand it is pushing “hard” to ensure the world is immunized for a disease that this week (10/12/2020) had infected 0.88% of the world’s population (case fatality rates c.0.25% https://swprs.org/studies-on-covid-19-lethality/#overall-mortality). In 70 years, only WHO has made recommendations to change the flu vaccine definition; (1) annual seasonal flu vaccine redefinitions, and (2) adding a second Influenza-B antigen to the seasonal flu vaccine in 2013 (post-2009) so big Pharma could be induced to install more vaccine production capacity. Contrastingly, since 2009 key opinion leaders and vaccine company R&D leaders recommended pre-pandemic immunization. Big Pharma and WHO-Globalist politics won, while the world was left unnecessarily vulnerable to the next influenza pandemic. Pre-pandemic immunization would utilize vaccines composed of H5N1 and H7N9 (and other high risk threats) plus oil-in-water adjuvants to promote broadly cross-reactive antibodies. Such vaccines would enable much of the immunization process to be taken off the critical path allowing a population to be equitably immunized before the peak of a pandemic.
  • When you hear Tedros Adhanom Ghebreyesus calling out on TV to national health authorities and the public to “TEST TEST TEST” that is arguably “code” to government healthcare service providers to ramp up their use of high false-positive RT-PCR diagnostic testing (Ct>35-40) to “fraudulently” hype-up the pandemic disease stats so they can fear monger the world (for their immunization agenda).
Antibody-Dependent Enhancement (ADE) publications

Antibody-Dependent Enhancement is a paradoxical immune response enhancement after vaccination (or natural infection) and means that vaccinated people (or animals) may be at a higher risk of developing disease or death than non-vaccinated people (or animals). “Normally” in vaccine development if there is immune enhancement in pre-clinical animal testing, this is a showstopper.

SARS-CoV-2

  • Wen, J., Cheng, Y., Ling, R., Dai, Y., Huang, B., Huang, W., Zhang, S., & Jiang, Y. (2020). Antibody-dependent enhancement of coronavirus. International journal of infectious diseases: IJID : official publication of the International Society for Infectious Diseases, 100, 483–489. https://doi.org/10.1016/j.ijid.2020.09.015. (Publication link)
  • Ulrich, H., Pillat, M.M. and Tárnok, A. (2020), Dengue Fever, COVID‐19 (SARS‐CoV‐2), and Antibody‐Dependent Enhancement (ADE): A Perspective. Cytometry, 97: 662-667. (Publication link)
  • Arvin, A.M., Fink, K., Schmid, M.A. et al. A perspective on potential antibody-dependent enhancement of SARS-CoV-2. Nature 584, 353–363 (2020). https://doi.org/10.1038/s41586-020-2538-8. (Publication link)
  • Salvatori, G., Luberto, L., Maffei, M. et al. SARS-CoV-2 SPIKE PROTEIN: an optimal immunological target for vaccines. J Transl Med 18, 222 (2020). https://doi.org/10.1186/s12967-020-02392-y. (Publication link)
  • Cegolon L, Pichierri J, Mastrangelo G, et al. Hypothesis to explain the severe form of COVID-19 in Northern Italy. BMJ Global Health2020;5:e002564. doi:10.1136/bmjgh-2020-002564. (Publication link)
  • Jason A. Tetro, Is COVID-19 receiving ADE from other coronaviruses?, Microbes and Infection, Volume 22, Issue 2, 2020, Pages 72-73, ISSN 1286-4579, https://doi.org/10.1016/j.micinf.2020.02.006. (Publication link)
  • Kulkarni R. (2019). Antibody-Dependent Enhancement of Viral Infections. Dynamics of Immune Activation in Viral Diseases, 9–41. https://doi.org/10.1007/978-981-15-1045-8_2. (Publication link)

SARS-CoV & MERS

  • Tseng C-T, Sbrana E, Iwata-Yoshikawa N, Newman PC, Garron T, et al. (2012) Immunization with SARS Coronavirus Vaccines Leads to Pulmonary Immunopathology on Challenge with the SARS Virus. PLoS ONE 7(4): e35421. doi:10.1371/journal.pone.0035421 (Publication link)
  • Weingartl, H., Czub, M., Czub, S., Neufeld, J., Marszal, P., Gren, J., Smith, G., Jones, S., Proulx, R., Deschambault, Y., Grudeski, E., Andonov, A., He, R., Li, Y., Copps, J., Grolla, A., Dick, D., Berry, J., Ganske, S., Manning, L., … Cao, J. (2004). Immunization with modified vaccinia virus Ankara-based recombinant vaccine against severe acute respiratory syndrome is associated with enhanced hepatitis in ferrets. Journal of virology, 78(22), 12672–12676. https://doi.org/10.1128/JVI.78.22.12672-12676.2004 (Publication link)
  • Luo, F., Liao, F. L., Wang, H., Tang, H. B., Yang, Z. Q., & Hou, W. (2018). Evaluation of Antibody-Dependent Enhancement of SARS-CoV Infection in Rhesus Macaques Immunized with an Inactivated SARS-CoV Vaccine. Virologica Sinica, 33(2), 201–204. https://doi.org/10.1007/s12250-018-0009-2. (Publication link)
  • Yip MS, Leung NH, Cheung CY, Li PH, Lee HH, Daëron M, Peiris JS, Bruzzone R, Jaume M. Antibody-dependent infection of human macrophages by severe acute respiratory syndrome coronavirus. Virol J. 2014 May 6;11:82. doi: 10.1186/1743-422X-11-82. PMID: 24885320; PMCID: PMC4018502. (Publication link)
  • Wang, S. F., Tseng, S. P., Yen, C. H., Yang, J. Y., Tsao, C. H., Shen, C. W., Chen, K. H., Liu, F. T., Liu, W. T., Chen, Y. M., & Huang, J. C. (2014). Antibody-dependent SARS coronavirus infection is mediated by antibodies against spike proteins. Biochemical and biophysical research communications, 451(2), 208–214. https://doi.org/10.1016/j.bbrc.2014.07.090. (Publication link)
  • Zhi-yong Yang, Heidi C. Werner, Wing-pui Kong, Kwanyee Leung, Elisabetta Traggiai, Antonio Lanzavecchia, Gary J. Nabel, Evasion of antibody neutralization in emerging severe acute respiratory syndrome coronaviruse. Proceedings of the National Academy of Sciences Jan 2005, 102 (3) 797-801; DOI: 10.1073/pnas.0409065102. (Publication link)
  • Yushun Wan, Jian Shang, Shihui Sun, Wanbo Tai, Jing Chen, Qibin Geng, Lei He, Yuehong Chen, Jianming Wu, Zhengli Shi, Yusen Zhou, Lanying Du, Fang Li, Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus Entry. Journal of Virology Feb 2020, 94 (5) e02015-19; DOI: 10.1128/JVI.02015-19. (Publication link)

Feline Infectious Peritonitis (FIP) vaccination enhances FIP disease upon infection

  • Pathogenesis of oral type I feline infectious peritonitis virus (FIPV) infection: Antibody-dependent enhancement infection of cats with type I FIPV via the oral route. (Publication link)
  • Hohdatsu, T., Nakamura, M., Ishizuka, Y., Yamada, H., & Koyama, H. (1991). A study on the mechanism of antibody-dependent enhancement of feline infectious peritonitis virus infection in feline macrophages by monoclonal antibodies. Archives of virology, 120(3-4), 207–217. https://doi.org/10.1007/BF01310476. (Publication link)
  • Vennema, H., de Groot, R. J., Harbour, D. A., Dalderup, M., Gruffydd-Jones, T., Horzinek, M. C., & Spaan, W. J. (1990). Early death after feline infectious peritonitis virus challenge due to recombinant vaccinia virus immunization. Journal of virology, 64(3), 1407–1409. https://doi.org/10.1128/JVI.64.3.1407-1409.1990. (Publication link)
  • Weiss, R. C., & Scott, F. W. (1981). Antibody-mediated enhancement of disease in feline infectious peritonitis: comparisons with dengue hemorrhagic fever. Comparative immunology, microbiology and infectious diseases, 4(2), 175–189. https://doi.org/10.1016/0147-9571(81)90003-5. (Publication link)
  • Tomomi TAKANO, Chisako KAWAKAMI, Shinji YAMADA, Ryoichi SATOH, Tsutomu HOHDATSU, Antibody-Dependent Enhancement Occurs Upon Re-Infection with the Identical Serotype Virus in Feline Infectious Peritonitis Virus Infection, Journal of Veterinary Medical Science, 2008, Volume 70, Issue 12, Pages 1315-1321, Released January 01, 2009, Online ISSN 1347-7439, Print ISSN 0916-7250, https://doi.org/10.1292/jvms.70.1315, https://www.jstage.jst.go.jp/article/jvms/70/12/70_12_1315/_article/-char/en. (Publication link)
  • Hohdatsu T, Yamada M, Tominaga R, Makino K, Kida K, Koyama H. Antibody-dependent enhancement of feline infectious peritonitis virus infection in feline alveolar macrophages and human monocyte cell line U937 by serum of cats experimentally or naturally infected with feline coronavirus. J Vet Med Sci. 1998 Jan;60(1):49-55. doi: 10.1292/jvms.60.49. PMID: 9492360. (Publication link)
  • Takano, T., Nakaguchi, M., Doki, T., & Hohdatsu, T. (2017). Antibody-dependent enhancement of serotype II feline enteric coronavirus infection in primary feline monocytes. Archives of virology, 162(11), 3339–3345. https://doi.org/10.1007/s00705-017-3489-8. (Publication link)

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