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HomeMy WebLinkAbout07.17.21 VAC cv19 Parkinsons_UK_data From:lance dreiss To:Lucero, Debra;Ritter, Tami;Clerk of the Board;Teeter, Doug;Kimmelshue, Tod;Connelly, Bill Subject:VAC cv19 Parkinsons_UK_data.pdf Date:Saturday, July 17, 2021 8:03:00 AM Attachments:VAC cv19 Parkinsons_UK_data.pdf .ATTENTION: This message originated from outside Butte County. Please exercise judgment before opening attachments, clicking on links, or replying.. Board of Supervisors, Clerk of the Board, Public Record: “...in Levy Body formation ...wide spread use should be halted until full long term safety studies evaluating prion toxicity have been complete...” Diana Dreiss Sent from my iPad Sftfbsdi!BsujdmfJTTO!374:.:55Y Kpvsobm!pg!Nfejdbm!.!Dmjojdbm!Sftfbsdi!'!Sfwjfxt COVID-19 Vaccine Associated Parkinson’s Disease, A Prion Disease Signal in the UK Yellow Card Adverse Event Database J. Bart Classen, MD* + Dpssftqpoefodf; J. Bart Classen, MD, Classen Immunotherapies, Inc, 3637 Classen Immunotherapies, Inc., 3637 Rockdale Road, Manchester, Rockdale Road, Manchester, MD 21102, Tel: 410-377-8526. MD 21102, E-mail: classen@vaccines.net. Sfdfjwfe; 25 June 2021; Bddfqufe; 18 July 2021 Djubujpo; Classen JB. COVID-19 Vaccine Associated Parkinson’s Disease, A Prion Disease Signal in the UK Yellow Card Adverse Event Database. J Med - Clin Res & Rev. 2021; 5(7): 1-6. BCTUSBDU Many have argued that SARS-CoV-2 spike protein and its mRNA sequence, found in all COVID-19 vaccines, are priongenic. The UK’s Yellow Card database of COVID-19 vaccine adverse event reports was evaluated for signals consistent with a pending epidemic of COVID vaccine induced prion disease. Adverse event reaction rates from increase in Parkinson’s disease, a prion disease, in the AstraZeneca adverse reaction reports compared to the utilizes live adenoviruses that are genetically engineered to Lfzxpset COVID-19, Immunization, Vaccines, Parkinson’s disease. encapsulated in lipids to cause formation of spike protein in the recipient. Both vaccines technologies have the potential to induce Jouspevdujpo Many have raised the alarm about the wisdom of wide spread prion disease \[4\]. Because the technologies are unique it was hypothesized their rates of prion induction may be contrasting performing long term human safety studies and well-planned animal toxicity studies. Concern has been raised regarding evidence event reporting database. The UK’s Yellow Card adverse event that the SARS-CoV-2 virus, which causes COVID-19, is actually a lab derived bioweapon \[1-4\]. Several peer reviewed papers \[3,5,6\] in prion related vaccine’s reaction reports could be detected. As have indicated that the spike protein of the SARS-CoV-2 virus and its nucleic acid sequence are actually prion forming toxins. A toxicity study in monkeys infected with SARS-CoV-2 showed larger EU or US databases. the COVID-19 vaccines on the market contain spike protein or its Nfuipe nucleic acid sequence creating a possible catastrophic epidemic of Yellow Card adverse reporting data from the United Kingdom prion disease in the future. government website (https://www.gov.uk/government/ publications/coronavirus-covid-19-vaccine-adverse-reactions/ coronavirus-vaccine-summary-of-yellow-card-reporting) was K!Nfe!.!Dmjo!Sft!'!Sfw<!3132 Wpmvnf!6!}!Jttvf!8!}!2!pg!7 downloaded. Data was in the form of 4 PDF documents, one and “Psychiatric Disorders” in Table 1. In addition, a separate chi that could relate to prion disease. A single “negative” control sorted by organ system as summarized in Table 1. Adverse events chi square analysis was performed to verify that the calculator software was functioning properly. outright, the website indicates the reports may come from both Sftvmut lay persons and healthcare professionals and may include both Four documents were downloaded from the UK government th spontaneous reports and reports derived from clinical trials. database. The documents statethe data lock date was June 16, 2021 and the Report Run Date was June 17, 2021.The documents Ubcmf!2/ indicated that the following number of adverse event reactions HfofsbmDbufhpsjftBtusb\[fofdbSjtl Blood Disorders716466450.93 Cardiac Disorders277678792.84 Congenital Disorders32652.03 Ear Disorders285582502.89 adverse events were reported between December 9, 2020 and June Endocrine Disorders852633.09 16, 2021 while the AstraZeneca adverse events were reported Eye Disorders3558121813.42 between January 4, 2021 and June 16, 2021. There were thus only Gastrointestinal21225733053.45 General Disorders570802339774.10 Additional publicly available data from the UK indicates by June Hepatic Disorders843634.32 th 16, 72,891,861 vaccine doses had been administered https:// Immune System Disorders118825942.18 Infections5202160933.09 coronavirus.data.gov.uk/details/vaccinations). The proportion of Injuries234370653.02 Investigations255294993.72 readily available. Metabolic Disorders126880906.38 Muscle and Tissue Disorders27007907333.36 1403172.26 categorized by Yellow Card into major categories based on Ofswpvt!Ejtpsefst499872719455/25 organ system and are summarized in Table 1. Table 1 shows that Pregnancy1861911.03 in general there are 3.55 times more adverse reactions reported null621171.89 Qtzdijbusjd!Ejtpsefst4:11263174/:1 Renal and Urinary Disorders58122343.85 disclosed for each report pertaining to the AstraZeneca vaccine Reproductive and Breast Disorders383978392.04 Respiratory Disorders9087246552.71 Skin Disorders15642459952.94 vaccine. Social Circumstances852663.13 Surgical and Medical Procedures1865843.14 Vascular Disorders3165107253.39 Upubm!Sfbdujpot321279856:76 3.55 Upubm!Sfqpsut84:55316332 2.78 reactions and 3.9 times (p= 0.00001) as many “Psychiatric Gbubm!Sfqpsut536:15 2.13 Disorders” reactions reported for the AstraZeneca Vaccine Sfbdujpot!qfs!Sfqpsu3/954/74 1.28 Gbubmjujft!qfs!Sfqpsu1/1171/115 0.77 reported between the two groups respectively. The frequency of adverse event reports pertaining to possible prion induced neurological symptoms were compared between - showed a potential adverse events except that the rates of total psychological reactions (“Psychiatric Disorders”) was also compared. The vaccine reports. There were 185 reactions listing Parkinson’s disease reactions in the AstraZeneca reports compared to only 20 performed on the “Psychiatric Disorders” reactions or any other category of diseases listed in Table 1. A Chi square analysis using a 2x2 table was used to calculate statistical p values for just 3 clearly https:// www.socscistatistics.com/tests/chisquare) was used. Chi square Wpmvnf!6!}!Jttvf!7!}!3!pg!7 symptom found in Parkinson’s disease patients was present in Myelitis (incl infective)203.2064 573.46197 9,288 reactions reported for the AstraZeneca vaccine but found 01 86.5052 131.9225 Ubcmf!3;! 65993.6323971 223.0567 SbujpBtusb\[fofdb 81.7514 114.7352 Olfactory nerve disorders2742.33639 Abnormal sleep-related events112.0923 192.1641 Absence seizures162.0633 Paraesthesias and dysaesthesias39873.5814281 Acute polyneuropathies398.44329 Paralysis and paresis (excl cranial Autonomic nervous system disorders72.7119 2053.04623 nerve) Central nervous system aneurysms and 22.004 Qbsljotpo(t!ejtfbtf!boe! dissections :/36 20185 qbsljotpojtn Central nervous system haemorrhages 4044.131668 Partial complex seizures83.8831 and cerebrovascular accidents 08 117.0017 733.00219 Central nervous system vascular 5093.401732 55.4027 17653.025330 Cerebrovascular venous and sinus Tmffq!ejtuvscbodft!OFD27/11 348 367.17258 thrombosis Speech and language abnormalities1403.37472 Cervical spinal cord and nerve root Spinal cord and nerve root disorders 33.009 112.8231 disorders Choreiform movements22.505 48.7535 Chronic polyneuropathies114.0014 Transient cerebrovascular events993.91387 Coma states63.6722 Usfnps!)fydm!dpohfojubm*937:/:2 9288 Coordination and balance disturbances2833.581013 Trigeminal disorders432.98128 433.37145 12.002 23.006 Dementia (excl Alzheimer's type)112.5528 Ubcmf!4;!Parkinson's Disease 122.0825 SbujpBtusb\[fofdb 32362.969592 Qbsljotpo(t!ejtfbtf!boe! Ejtuvscbodft!jo!tmffq!qibtf!sizuin 1 21/11 10 209.25185 qbsljotpojtn Dyskinesias and movement disorders 1433.08440 Freezing phenomenon7152 Parkinson's disease315 Dystonias141.8626 Parkinsonian gait10 32.006 Parkinsonism410 34.0012 Reduced facial expression57 Encephalopathies toxic and metabolic02 Vascular parkinsonism01 Eye movement disorders141.2117 Usfnps!)fydm!dpohfojubm*9379.919288 Facial cranial nerve disorders5871.45854 Action tremor12 Generalised tonic-clonic seizures223.5578 Asterixis01 168964.6879069 Essential tremor35 Hydrocephalic conditions111.0011 Head titubation515 Hypoglossal nerve disorders15.005 Intention tremor01 Increased intracranial pressure 69.0054 Postural tremor01 disorders Resting tremor25 Intellectual disabilities19.009 Tremor9269258 Lumbar spinal cord and nerve root 443.75165 disorders Memory loss (excl dementia)1633.38551 Mental impairment (excl dementia and Disorders” of Table 2 was sleep disturbance. This is of interest 2423.56861 memory loss) because sleep disorders are a hallmark symptom of a genetically Migraine headaches16894.297248 transmitted prion disease called Fatal Familial Insomnia. A Mixed cranial nerve disorders11.001 detailed analysis of neurologically characterized sleep disturbance Mononeuropathies352.91102 reactions is disclosed in Table 4.The dataindicate there were 4 Motor neurone diseases01 sleep disturbance or sleep phase rhythm reactions in the reports Multiple sclerosis acute and 402.58103 progressive Muscle tone abnormal143.1444 pertaining to the AstraZeneca vaccine (p=0.003). Wpmvnf!6!}!Jttvf!7!}!4!pg!7 The data shows that that there are more adverse reactions reported Ubcmf!5;!Sleep Disorders SbujpBtusb\[fofdb whole there are 3.55 time more adverse reactions and 2.78 times Ejtuvscbodft!jo!tmffq!qibtf!sizuin 110.0010 Advanced sleep phase01 Circadian rhythm sleep disorder05 vaccine. This may be explained in part by the number of vaccine Delayed sleep phase01 doses administered but this information was not readily available. Irregular sleep phase01 However, it is also possibly that there may be more acute reactions Irregular sleep wake rhythm disorder11 to the AstraZeneca vaccine. On average there were 3.63 adverse 01 reactions per report for the AstraZeneca vaccine compared to 2.84 Tmffq!ejtuvscbodft!OFD 316.0048 Microsleep02 of the recipients and also the reporters (academic versus community Periodic limb movement disorder01 245 Sudden onset of sleep10 The goal of this research was to determine if there was an early Ejtdvttjpo The current analysis was performed on COVID vaccine adverse groups may manifest early enough to create a signal. The analysis reactions reported through the UK’s Yellow Card system. While as autoimmune diseases or clotting diseases for example. The are consistent with knowledge of the spike protein and its nucleic prion diseases of interest included: ALS, frontotemporal lobar acid sequence \[3-7\], well accepted pathophysiology of prion degeneration, Alzheimer’s disease, CJD, Parkinson’s disease, and Fatal Familial Insomnia. Unfortunately, many of these prion this paper represent an urgent warning to halt mass immunization with COVID vaccines until proper safety studies are complete. psychological symptoms \[10\]. There is overlap of symptoms Alternative vaccines like the Measles Mumps Rubella (MMR) vaccine should be explored for those desiring immunization against COVID-19 outside of clinical trials \[4\]. Prion disease may take years or decades to manifest from onset however there were several reasons to hope that a signal may be Analysis of spontaneous reporting data, as found in the Yellow detected within months of the immunization. First it was believed Card system is limited for several reasons including the historical that there was a pool of people with either subclinical prion disease or mild prion disease that had not been correctly diagnosed. One 95% of the time. Only 5% of drug adverse events are typically theory is that COVID vaccines may accelerate disease progression causing these undiagnosed patients to have frank disease that is to acute adverse events, essentially none of the adverse events rapidly diagnosed after immunization. occurring years or decades after administration of a pharmaceutical are ever reported. Analysis of the adverse events that are reported A second reason to believe that a signal could be detected soon after immunization relates to knowledge of the spike protein. It is believed that the spike protein and its nucleic acid sequence may be event in the recipient population. a complex bioweapon capable of inducing prion disease by several The current study attempted to avoid previous problems associated intrinsic proteins like TDP-43 and FUS to fold into prions which with analysis of spontaneous adverse event reports by comparing eventual leads to disease \[3,4\]. The spike protein also has a prion like region \[5\] which may catalyze a chain reaction and eventually lead to prion disease. However, a third group published data \[6\] controls for those receiving the AstraZeneca COVID vaccine and that the spike protein may cause proteins including prions already visa versus. The fact that mass administration of both vaccines was in cells to aggregate, forming Lewy Bodies for example, and started within days of each other worked in favor of the analysis causing relatively rapid cell death. It is this third method that could as did the fact that there was an acute shortage of vaccines. People allow fairly rapid detection of prion disease after immunization. wanting a COVID vaccine would likely be forced to take what was available and not allowed much choice. These factors as well The current risk of Parkinson’s disease. There were 20 Parkinson’s disease relating to which vaccine was received, at least in regards to age (3.55 x 20) were expected in the AstraZeneca reports, there were and sex. However, this is only theoretical since demographic data 185 reactions actually reported (p=0.000024). The analysis was the internet at the time this paper was written. Wpmvnf!6!}!Jttvf!7!}!5!pg!7 The current analysis is not intended to indicate that one COVID “Freezing Phenomenon” which made up the bulk of the Parkinson’s vaccine is safer than another in regards to prion disease. One disease reports. It is not clear if the reports were primarily related limitation of the analysis is that both vaccines may equally increase to new onset Parkinson’s disease or worsening of a previously diagnosed patient. The signal is supported by a proportionally detected in the Yellow Card database. Imbalances in rates of reactions detected in this analysis can be explained by the striking symptom of Parkinson’s disease, tremor (Table 3). A total of 937 vaccine to induce some prion diseases quicker. The AstraZeneca 3,326 reactions (9.37 x 3.55) were expected to be reported for adenoviral virus based COVID vaccine may concentrate in the the AstraZeneca vaccine, a total of 9,288 reactions were reported gastrointestinal system \[4\] to a greater extent leading to faster (p=0.00001). transport of the spike protein via the vagus nerve to the brain logs in magnitudes higher than the reports of Parkinson’s disease even after adjusting approximately 20-fold for under reporting \[9\]. induce more TDP-43 and FUS to form prions \[3\] and lead to more prion disease. Many but not all cases of Parkinson’s disease are believed to This analysis should serve as an urgent warning to those mindlessly aggregates in the substantia nigra of the brain in Parkinson’s disease patients causing the formation of Lewy Bodies. The relation of COVID immunization. Both groups have had a dismal record of Lewy Bodies to Parkinson disease provides strong bio plausible the infamous Tuskegee syphilis study allowing people of color monkeys \[8\] with the SARS-CoV-2 virus lead to development of Lewy Bodies. The relative rapid onset of Parkinson’s disease inform the patients, they had syphilis and that a treatment existed. symptom after immunization may be explained by the vaccine There have been numerous less well-known experiments on derived spike protein’s heparin binding site. One group \[6\] showed that the spike protein heparin binding site binds “to a number of aggregation-prone, heparin binding proteins including Founding father politicians in the US championed civil liberties , tau, prion, and TDP 43 RRM. These interactions while owning slaves and running extermination campaigns against suggests that the heparin-binding site on the S1 protein might assist the binding of amyloid proteins to the viral surface and thus with COVID vaccines before proper safety studies are complete is likely to follow in the steps of the previously mentioned historical neurodegeneration in brain.” acts. Another prion disease with some more unique features is Fatal Sfgfsfodft Familial Insomnia. It is a rare genetic prion disorder characterized 1. Classen JB. COVID-19 MMR vaccine and bioweapons. by an inability to sleep \[12\]. It was noted in the analysis of Diabetes Complications. 2020; 4: 1-8. imbalance of sleep reports between vaccine groups. There were 4 2. Classen JB. Evidence supporting the hypothesis that the 2019 epidemic of E-vaping acute lung injury EVALI was caused (4 x 3.55) were expected in the AstraZeneca reports, a total of in part by COVID-19. Diabetes & its Complications. 2020; 4: 1-2. between the two groups could be explained by the spike protein 3. aggregating prion molecules already in the cells as discussed with prion disease. Microbiol Infect Dis. 2021; 5: 1-3. Parkinson’s disease symptoms above. 4. Classen JB. Review of COVID-19 vaccines and the risk of chronic adverse events including neurological degeneration. J The Yellow Card database does not provide good insight on Med - Clin Res & Rev. 2021; 5: 1-7. be expected. There is however an highly statistical increase in 5. https://doi.org/10.20944/preprints202003.0422.v1 6. Idress D, Kumar V. SARS-CoV-2 spike protein interactions with amyloidogenic proteins: Potential clues to in prion disorders other than Parkinson’s disease. Unfortunately Communications. 2021; 554: 94-98. 7. against COVID-19. International Journal of Vaccine Theory delayed until post mortem autopsy. Practice and Research. 2021; 2: 402-443. Wpmvnf!6!}!Jttvf!7!}!6!pg!7 8. Philippens IHCHM, Böszörményi KP, Wubben JA, et al. 11. Steiner JA, Quansah E, Brundin P. The concept of alpha- synuclein as a prion-like protein: ten years after. Cell Tissue body formation in macaques. bioRxiv preprint. 2021.Res. 2018; 373: 161-173. 9. Hazell L, Shakir SAW. Under-reporting of adverse drug 12. He R, Hu Y, Yao L, et al. Clinical features and genetic reactions a systematic review. Drug Saf. 2006; 29: 385-396.characteristics of two Chinese pedigrees with fatal family insomnia. Prion. 2019; 13: 116-212. 10. Ford L, Rudge P, Robinson K, et al. The most problematic symptoms of prion disease an analysis of carer experiences. 13. Kujawska M, Jodynis-Liebert J. What is the evidence that International Psychogeriatrics. 2018; 31: 1181-1190.Parkinson’s disease is a prion disorder which originates in the gut? Int J Mol Sci. 2018; 19: 3573. © 2021 Classen JB, et al. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License Wpmvnf!6!}!Jttvf!7!}!7!pg!7