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Supplementary Files for Santiago & Oller 圣地亚哥和奥勒的补充文件
Pub Date : 2023-04-05 DOI: 10.56098/ijvtpr.v3i1.75
J. Oller, CDC and Medicare US and Connecticut
The Excel file presented here contains the exact records used in computing the various statistical results reported in the paper by Santiago and Oller at DOI https://doi.org/10.56098/ijvtpr.v3i1.73. They have not been changed in any way except to remove elements added to blank cells, evidently by Medicare authorities. Also, 37 antirely blank records had to be deleted in order to make the counting functions and ordinary scrolling and data sorting functions work as they normally do in Excel. The Medicare data for Connecticut showing up to 7 doses of COVID-19 injectable fluids were sorted and stacked in such a manner as to enable the counting and statistical comparisons across the various subsamples referred to in the Santiago and Oller paper. Those computational processes were applied only to make the normal Excel functions for ordinary scrolling, counting, creating tables, and charting results feasible. Again, Santiago and Oller express gratitude to Steve Kirsch and his anonymous source(s) for the Medicare data published here. All of the results reported by Santiago and Oller were obtained from these data and are easily replicable by anyone with the requisite statistical and algebraic skill set.
这里提供的Excel文件包含用于计算Santiago和Oller在DOI https://doi.org/10.56098/ijvtpr.v3i1.73的论文中报告的各种统计结果的精确记录。除了去除添加到空白细胞中的元素外,它们没有以任何方式被改变,这显然是医疗保险当局做的。此外,为了使计数功能和普通的滚动和数据排序功能正常工作,必须删除37条完全空白的记录。康涅狄格州的医疗保险数据显示,多达7剂COVID-19注射液体被分类和堆叠,以便能够对圣地亚哥和奥勒论文中提到的各种子样本进行计数和统计比较。应用这些计算过程只是为了使普通的Excel函数能够进行普通的滚动、计数、创建表格和绘制结果。Santiago和Oller再次感谢Steve Kirsch和他的匿名消息来源提供的医疗保险数据。Santiago和Oller报告的所有结果都是从这些数据中获得的,任何具有必要统计和代数技能的人都可以很容易地复制这些结果。
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引用次数: 0
Laboratory testing for COVID-19 COVID-19实验室检测
Pub Date : 2023-04-04 DOI: 10.56098/ijvtpr.v3i1.74
Emergency Response Technical Centre NIVD under China CDC
Laboratory testing for COVID-19, Emergency Response Technical Centre, NIVD under China CDC, March 15th, 2020
2020年3月15日,中国疾病预防控制中心新冠肺炎应急技术中心实验室检测
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引用次数: 0
A RT-qPCR test targeting the conserved 5´-UTR of SARS-CoV-2 overcomes major shortcomings of the first WHO-recommended RT-qPCR test 针对SARS-CoV-2保守的5′-UTR的RT-qPCR检测克服了世卫组织推荐的第一种RT-qPCR检测的主要缺点
Pub Date : 2023-04-04 DOI: 10.56098/ijvtpr.v3i1.71
U. Kämmerer, S. Pekova, R. Klement, Rogier Louwen, Peter Borger, Klaus Steger
For the first time in medical history, the result of a laboratory assay (RT-qPCR) was used as the sole criterion to diagnose a disease (Covid-19) without any rating of clinical symptoms and to justify the implementation of population-wide non-pharmaceutical interventions during virus season. The aim of this study is (1) to evaluate a robust RT-qPCR test that overcomes major concerns raised within the scientific community on the first WHO-recommended RT-qPCR protocol to detect SARS-CoV-2 sequences, (2) to genomically characterize individual SARS-CoV-2 strains circulating in the Czech Republic from autumn 2020 to spring 2021 applying NGS and (3) to re-initiate the currently missing scientific dialogue and return to reason and evidence-based medicine. We present a RT-qPCR test designed for the detection of all SARS-CoV-2 variants known so far.  Based on the genomic mutation profile, we demonstrate that the three individual waves culminating from autumn 2020 to spring 2021 in the Czech Republic were successive, but lacked direct genomic relationship between each other. This became obvious with the omicron variant, which did not reveal direct evolutionary connection to any of the previous SARS-CoV-2 variants. In addition, we provide evidence that neglected principles of good scientific practice resulted not only in the publication of the WHO-recommended Charité RT-qPCR protocol, but also in health-related problems. Unnecessary quarantine of false positive-tested, healthy individuals, as well as lockdowns and atrocious collateral damage on societies and economies worldwide due to a high number of false-positive “PCR-cases.” Further, some chain of infection caused by false negative-tested, symptomatic individuals lead to real Covid-19 clusters. Both our results and literature data confirm that validation of any PCR-based diagnostic test by sequencing is mandatory on a regular basis. To prevent future misconduct, science needs a reality check and must re-initiate the scientific dialogue and liberate itself from political influence and dogma.
这是医学史上首次将实验室检测(RT-qPCR)结果作为诊断疾病(Covid-19)的唯一标准,而无需对临床症状进行任何评分,并证明在病毒季节实施全民非药物干预措施的合理性。本研究的目的是(1)评估一种强大的RT-qPCR检测方法,以克服科学界对世卫组织推荐的首个检测SARS-CoV-2序列的RT-qPCR方案提出的主要担忧;(2)应用NGS对2020年秋季至2021年春季在捷克共和国流行的单个SARS-CoV-2菌株进行基因组表征;(3)重新启动目前缺失的科学对话,回归理性和循证医学。我们提出了一种RT-qPCR测试,旨在检测迄今为止已知的所有SARS-CoV-2变体。基于基因组突变谱,我们证明了在捷克共和国从2020年秋季到2021年春季达到高潮的三个个体波是连续的,但彼此之间缺乏直接的基因组关系。这一点在组粒变异中变得很明显,它没有揭示出与之前任何SARS-CoV-2变异的直接进化联系。此外,我们提供的证据表明,忽视良好科学实践的原则不仅导致了世卫组织推荐的慈善RT-qPCR方案的发表,而且还导致了与健康相关的问题。对假阳性检测的健康个体进行不必要的隔离,以及由于大量假阳性“pcr病例”而对全球社会和经济造成的封锁和严重的附带损害。此外,由假阴性检测、有症状的个体引起的一些感染链会导致真正的Covid-19聚集性。我们的结果和文献数据都证实,通过测序验证任何基于pcr的诊断测试是必须定期进行的。为了防止未来的不当行为,科学需要对现实进行检查,必须重新启动科学对话,并将自己从政治影响和教条中解放出来。
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引用次数: 0
Chemical-physical criticality and toxicological potential of lipid nanomaterials contained in a COVID-19 mRNA vaccine COVID-19 mRNA疫苗中脂质纳米材料的化学物理临界性和毒理学潜力
Pub Date : 2023-01-26 DOI: 10.56098/ijvtpr.v3i1.68
G. Segalla
The medicinal preparation called Comirnaty by Pfizer-BioNTech is an aqueous dispersion of lipid nanomaterials, intended to constitute, after thawing and dilution, the finished product for intramuscular injection. In the present study, we examine some evident chemical-physical criticalities of the preparation, regarding the manifest instability of its qualitative-quantitative composition, as well as its consequent toxicological potential, in this case related to the possible formation of ROS (reactive oxygen species), after intramuscular inoculation, in different biological sites, such as, potentially, kidneys, liver, heart, brain, etc., causing dysfunctions and alterations thereof. Of particular concern is the presence in the formulation of the two functional excipients, ALC-0315 and ALC-0159, never used before in a medicinal product, nor registered in the European Pharmacopoeia, nor in the European C&L inventory. The current Safety Data Sheets of the manufacturer are omissive and non-compliant, especially with regard to the provisions of current European regulations on the registration, evaluation, authorization and restriction of nanomaterials. The presence of electrolytes in the preparation and the subsequent dilution phase after thawing and before inoculation raise well-founded concerns about the precarious stability of the resulting suspension and the Polydispersity index of the nanomaterials contained in it, factors that can be hypothesized as the root causes of numerous post-vaccination adverse effects recorded at statistical-epidemiological level. Further immediate studies and verifications are recommended, taking into consideration, if necessary and for purely precautionary purposes, the immediate suspension of vaccinations with the Pfizer-BioNTech Comirnaty preparation.
辉瑞biontech公司的药物制剂Comirnaty是一种脂质纳米材料的水分散体,在解冻和稀释后,用于肌肉注射的成品。在本研究中,我们检查了该制剂的一些明显的化学-物理临界,关于其定性-定量组成的明显不稳定性,以及其随之产生的毒理学潜力,在这种情况下,与肌肉注射后在不同生物部位(如肾脏,肝脏,心脏,大脑等)可能形成ROS(活性氧)有关,导致功能障碍和改变。特别值得关注的是,两种功能性赋形剂ALC-0315和ALC-0159的配方中,从未在药品中使用过,也未在欧洲药典中注册,也未在欧洲C&L库存中注册。制造商目前的安全数据表是遗漏和不合规的,特别是关于纳米材料的注册、评估、授权和限制的现行欧洲法规的规定。在制备和随后的解冻后和接种前的稀释阶段存在电解质,这引起了人们对所产生的悬浮液不稳定的稳定性以及其中所含纳米材料的多分散性指数的充分关注,这些因素可以假设为统计流行病学水平记录的许多疫苗接种后不良反应的根本原因。建议立即进行进一步的研究和验证,并考虑到,如有必要且纯粹出于预防目的,应立即暂停使用辉瑞- biontech公司制剂进行疫苗接种。
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引用次数: 4
A 6-Week Time Period May not be Sufficient to Identify Potential Adverse Events Following COVID-19 Vaccination 6周的时间可能不足以确定COVID-19疫苗接种后的潜在不良事件
Pub Date : 2023-01-12 DOI: 10.21203/rs.3.rs-2327212/v1
H. Banoun, P. Provost
Background. Messenger RNA (mRNA) vaccines have been widely used as the main sanitary measure destined to fight the COVID-19 pandemic. Rapidly purported as being “safe and effective”, this new generation of vaccines is radically different from those developed traditionally and for which potentially associated adverse events (AEs) are considered through a standard 6-week post-vaccination period. Hypothesis. Here, we posit that the reporting period for AEs related to the COVID-19 vaccines may need to be longer. Method. In this retrospective, observational study, we aimed to assess the chronology of new/worsening ailments occurring after the administration of COVID-19 vaccines based on the changes to the participants’ pharmacological records. Patients vaccinated against COVID-19 and experiencing health-related events during the study period (between September 30, 2021 and July 15, 2022) were included and the changes to their pharmacological records were analyzed. Results. One hundred and twelve (112) adult patients (63 men, 49 women; 67.54 ± 14.55 years-old; mean ± standard deviation) have reported changes to their pharmacological record following health-related events, which occurred 11.57 weeks (median; range 0.04-47.14) following their last COVID-19 injection of 3 doses (median; range 1-4). The most frequent medical ailments that appeared or worsened were cardiovascular diseases (CVD; N=61), cancer (N=31), respiratory diseases (RD; N=22) and zona (N=10), half of which occurred after the second dose. Nineteen (19) patients (10 men, 9 women; 78.2 ± 11.4 years-old) died on average 17.14 weeks (SD 13.71) after their last injection. Conclusion. Most (76.1%) of the health-related events experienced by patients vaccinated against COVID-19 occurred beyond the 6-week period prescribed by the health authorities. Our findings call for further investigations and an extension of the post-vaccination AE reporting period.
背景。信使RNA (mRNA)疫苗已被广泛用作对抗COVID-19大流行的主要卫生措施。这种新一代疫苗被迅速宣称为“安全有效”,与传统疫苗截然不同,传统疫苗的潜在相关不良事件(ae)是在接种后标准的6周内考虑的。假设。在这里,我们假设与COVID-19疫苗相关的不良反应报告周期可能需要更长。方法。在这项回顾性观察性研究中,我们旨在根据参与者药理学记录的变化,评估接种COVID-19疫苗后发生的新发/恶化疾病的年表。纳入了在研究期间(2021年9月30日至2022年7月15日)接种COVID-19疫苗并经历与健康相关事件的患者,并分析了其药理学记录的变化。结果。112例成人患者(男63例,女49例);67.54±14.55岁;(平均±标准偏差)的患者报告在发生与健康相关的事件后药理学记录发生变化,发生时间为11.57周(中位数;范围0.04-47.14),最后一次注射3剂COVID-19(中位数;范围1 - 4)。出现或恶化最常见的内科疾病是心血管疾病(CVD;N=61),癌症(N=31),呼吸系统疾病(RD;N=22)和带状区(N=10),其中半数发生在第二次给药后。19例患者(男10例,女9例;(78.2±11.4岁),平均在末次注射后17.14周死亡(SD 13.71)。结论。在接种COVID-19疫苗的患者中,大多数(76.1%)与健康相关的事件发生在卫生当局规定的6周之后。我们的研究结果要求进一步调查和延长疫苗接种后AE报告期。
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引用次数: 2
The Blind Spot in COVID-19 Vaccination Policies: Under-Reported Adverse Events COVID-19疫苗接种政策的盲点:未报告的不良事件
Pub Date : 2023-01-12 DOI: 10.56098/ijvtpr.v3i1.65
P. Provost
Case reports involving two academic researchers suggest that adverse events (AEs) to COVID-19 messenger RNA (mRNA) vaccination are largely underreported due to numerous clinical, systemic, political and media factors. The lack of proper analysis and consideration of the reported AEs also suggests that these injections are not as safe as widely purported. The resulting biased risk-benefit assessment may only produce misinformed public health recommendations and misguided political decisions, thereby exposing the population to an underestimated risk, in possible violation of the precautionary principle and of the right to a free and informed consent. The possible mechanisms underlying AEs to COVID-19 vaccination raise serious concerns regarding the new vaccine application of the mRNA technology that need to be addressed before expanding it to other infectious diseases. The legal considerations of AE underreporting are also discussed, and recommendations are formulated. AEs to mRNA injections are a reality and need to be better assessed than heretofore, diagnosed and reported to public health authorities for follow-up investigation in order to inform policy decisions and updates to physician guidelines in an objective, scientifically based, independent, and transparent manner.
涉及两名学术研究人员的病例报告表明,由于众多临床、系统、政治和媒体因素,COVID-19信使RNA (mRNA)疫苗接种的不良事件(ae)在很大程度上被低估了。对报道的不良反应缺乏适当的分析和考虑,也表明这些注射并不像广泛声称的那样安全。由此产生的有偏见的风险-利益评估可能只会产生错误的公共卫生建议和错误的政治决定,从而使民众面临被低估的风险,可能违反预防原则和自由知情同意的权利。COVID-19疫苗接种产生不良反应的可能机制引发了对mRNA技术在新疫苗应用方面的严重担忧,在将其推广到其他传染病之前,需要解决这一问题。本文还讨论了AE低报的法律考虑,并提出了建议。mRNA注射的不良反应是一个现实,需要比以往更好地评估、诊断并报告给公共卫生当局进行后续调查,以便以客观、科学、独立和透明的方式为政策决定和医生指南的更新提供信息。
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引用次数: 1
Emergence of a New Creutzfeldt-Jakob Disease: 26 Cases of the Human Version of Mad-Cow Disease, Days After a COVID-19 Injection 一种新的克雅氏病的出现:注射COVID-19后几天26例人类疯牛病
Pub Date : 2023-01-12 DOI: 10.56098/ijvtpr.v3i1.66
Jean-claude Perez, C. Moret-Chalmin, L. Montagnier
Creutzfeldt-Jakob Disease, the formerly rare but universally fatal prion disease in humans, normally progresses over several decades before it leads to death. In the Appendix to this paper, we highlight the presence of a prion region in the spike protein of the original SARS-CoV-2, and in all the “vaccine” variants built from the Wuhan virus. The prion region in the spike of SARS-CoV-2 has a density of mutations eight times greater than that of the rest of the spike, and, yet, strangely that entire prion region disappears completely in the Omicron variant. In the main body of our text, we present 26 cases of Creuzfeldt-Jacob Disease, all diagnosed in 2021 with the first symptoms appearing within an average of 11.38 days after a Pfizer, Moderna, or AstraZeneca COVID-19 injection. Because the causal progression, the etiopathogenesis, of these atypical and new cases of human prion disease — cases of what is apparently a totally new form of rapidly developing Creuzfeldt-Jacob Disease — we focus on the chronology of the symptomatic development. We consider it from an anamnestic point of view — one in which we compare the typical development of pre-COVID cases of Creuzfeldt-Jacob Disease to the extremely accelerated development of similar symptoms in the 26 cases under examination. By such an approach, we hope to work out the etiopathogenesis critical to understanding this new and much more rapidly developing human prion disease. By recalling the sequential pathway of that the formerly subacute and slowly developing disease followed in the past, and by comparing it with this new, extremely acute, rapidly developing prion disease — one following closely after one or more of the COVID-19 injections — we believe it is correct to infer that the injections caused the disease in these 26 cases. If so, they have probably also caused a many other cases that have gone undiagnosed because of their rapid progression to death. By late 2021, 20 had died within 4.76 months of the offending injection. Of those, 8 died suddenly within 2.5 months confirming the rapid progression of this accelerated form of Creuzfeldt-Jacob Disease. By June 2022, 5 more patients had died, and at the time of this current writing, only 1 remains still alive.
克雅氏病(Creutzfeldt-Jakob Disease)是一种以前罕见但普遍致命的人类朊病毒疾病,通常在几十年后才会导致死亡。在本文的附录中,我们强调了在原始SARS-CoV-2的刺突蛋白中以及在由武汉病毒构建的所有“疫苗”变体中存在朊病毒区域。SARS-CoV-2刺突中的朊病毒区域的突变密度是刺突其余部分的8倍,然而,奇怪的是,整个朊病毒区域在欧米克隆变体中完全消失了。在本文的主体部分,我们介绍了26例克雅氏病,所有病例均于2021年被诊断出来,在辉瑞、Moderna或阿斯利康注射COVID-19后平均11.38天内出现首次症状。由于这些非典型和新的人类朊病毒疾病病例的因果进展,发病机制-这些病例显然是一种全新形式的快速发展的克-雅各布病-我们关注症状发展的年表。我们从记忆的角度来考虑这一点——我们将克-雅各布病在covid前的典型发展与26例检查病例中类似症状的极端加速发展进行比较。通过这种方法,我们希望找出对理解这种新的和更快发展的人类朊病毒疾病至关重要的发病机制。通过回顾过去亚急性和缓慢发展的疾病的顺序途径,并将其与这种新的、极急性、快速发展的朊病毒疾病(在一次或多次注射COVID-19后紧随其后)进行比较,我们认为正确的推断是注射导致了这26例疾病。如果是这样的话,它们可能还导致了许多其他病例,由于它们的快速死亡而未被诊断出来。到2021年底,有20人在违规注射后的4.76个月内死亡。其中8人在2.5个月内突然死亡,证实了这种加速形式的克雅氏病的快速进展。到2022年6月,又有5名患者死亡,在撰写本文时,只有1名患者仍然活着。
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引用次数: 4
Injuries, Causes, & Treatments, IJVTPR 3(1): For “Such a Time as This” 伤害,原因和治疗,IJVTPR 3(1):对于“这样的时刻”
Pub Date : 2023-01-12 DOI: 10.56098/ijvtpr.v3i1.64
J. Oller
This editorial presents the main questions for volume 3, issue 1 of the IJVTPR, titled Injuries, Causes, & Treatments. The focus is on the clinical outcomes still unfolding from billions of injections of the COVID-19 “vaccines” — the “synthetic gene therapies” administered, according to the Pharmaceutical Technology trackers in 2022, in more than 13 billion doses to more than 5 billion persons at the time of this writing. What are (1) the components in those injections that are (2) causing the observed clinical outcomes, and, (3) what treatments are possible for people who have received one or more of the injections?[1] Yuval Noah Harari has said that in a hundred years “the corona virus epidemic” will be marked “as the moment when a new regime of surveillance took over, especially, surveillance under the skin”. He says it enables overseers to “collect biometric data, analyze it, and understand people better than they understand themselves”. Or, as Klaus Schwab of the World Economic Forum put it, the power of “genetic editing” redefines everyone who receives it. Just so, the COVID era has elevated the subject-matter of this journal to a higher level than could even have been imagined in the summer of 2019 when it was being conceptualized. The Inaugural Issue was well underway before March 11, 2020 when the World Health Organization proclaimed the corona pandemic. The first issue of the journal would not appear until July 15, 2020, only months before what Schwab would call the “Fourth Industrial Revolution”. Is the “Fourth” one — with transformative gene editing at its core — an intended resuscitation of the “Third Reich”? Who could have imagined beforehand and who can now comprehend the events that are confronting us all?
这篇社论提出了IJVTPR第3卷第1期的主要问题,题为伤害,原因和治疗。重点是数十亿次注射COVID-19“疫苗”的临床结果,根据制药技术追踪者在2022年的数据,在撰写本文时,超过50亿人接受了超过130亿剂的“合成基因疗法”。(1)这些注射剂中的成分(2)导致观察到的临床结果,(3)接受过一次或多次注射剂的人可能有什么治疗方法?[1]尤瓦尔·诺亚·赫拉利(Yuval Noah Harari)曾说,100年后,“冠状病毒流行”将被标记为“一种新的监测制度,特别是皮下监测的时刻”。他说,它使监管人员能够“收集生物特征数据,对其进行分析,从而比人们更了解自己”。或者,正如世界经济论坛(World Economic Forum)的克劳斯•施瓦布(Klaus Schwab)所说,“基因编辑”的力量重新定义了每个接受它的人。正因为如此,COVID时代将这本杂志的主题提升到了一个更高的水平,甚至超过了2019年夏天它被概念化时的想象。在2020年3月11日世界卫生组织宣布冠状病毒大流行之前,创刊号一直在进行中。该杂志的第一期直到2020年7月15日才出版,距离施瓦布所说的“第四次工业革命”只有几个月的时间。以变革性基因编辑为核心的“第四个”帝国是否意在复兴“第三帝国”?谁能事先想象到,现在又有谁能理解我们大家所面临的事件呢?
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引用次数: 0
Health versus Disorder, Disease, and Death: Unvaccinated Persons Are Incommensurably Healthier than Vaccinated 健康与紊乱、疾病和死亡:未接种疫苗的人比接种疫苗的人更健康
Pub Date : 2022-11-15 DOI: 10.56098/ijvtpr.v2i2.40
J. Garner
Results from the 2019/2020 nationwide Control Group Survey of Unvaccinated Americans (CGS) show that those refusing vaccines are thriving while those accepting them are being injured and met with a multiplicity of grave injuries as well as sudden unexpected death. This survey quantified the long-term health risks of total vaccine avoidance against the health outcomes observed in the 99.74% vaccine-exposed American population. Based upon the sample sizes for the controls vs. the exposed population, the p-values and odds ratios evidence the astronomical odds against the innocence of vaccines as the actual cause of well over 90% of the disabling and life-threatening chronic conditions suffered by Americans. The true “controls” (calculated to represent 0.26% of the population in 2020) have established the baseline disease risk incurred by those without exposure to vaccination. The null hypothesis, that no significant difference would be found between vaccinated vs. unvaccinated persons in heart disease, diabetes, digestive disorders, eczema, asthma, allergies, developmental disabilities, birth defects, epilepsy, autism, ADHD, cancers, and arthritis, is rejected with overwhelming statistical confidence and power in every single contrast. Because 99.74% of the U.S. population is vaccine-exposed, published national disease rates invariably reflect the frequency of observed negative outcomes arising from exposure to vaccines. The Control Group comparison graphs lead to the inescapable conclusion, and near mathematical certainty, that vaccine exposure is the actual cause of the observed disparity in health outcomes between vaccinated and unvaccinated populations. Vaccines are NOT moving the population toward better health, as suggested by the World Health Organization and the US Department of Health & Human Services, but rather toward epidemic levels of lifelong debilitating chronic disorders.
2019/2020年全国未接种疫苗美国人对照组调查(CGS)的结果显示,拒绝接种疫苗的人正在茁壮成长,而接受疫苗的人正在受伤,并遭受多种严重伤害和突然意外死亡。这项调查量化了在99.74%接种过疫苗的美国人群中,完全避免接种疫苗对健康结果的长期健康风险。根据对照和暴露人群的样本量,p值和比值比证明,疫苗是美国人遭受的90%以上致残和危及生命的慢性病的实际原因,这是一个天文数字。真正的“控制者”(计算为2020年占人口的0.26%)确定了未接种疫苗者的基线疾病风险。零假设,即接种疫苗的人和未接种疫苗的人在心脏病、糖尿病、消化系统疾病、湿疹、哮喘、过敏、发育障碍、出生缺陷、癫痫、自闭症、多动症、癌症和关节炎方面没有显著差异,在每一个单独的对比中都以压倒性的统计信心和力量被拒绝。由于99.74%的美国人接种过疫苗,因此公布的全国疾病发病率无一例外地反映了因接种疫苗而观察到的负面结果的频率。对照组的对比图表得出了一个不可避免的结论,而且几乎是数学上的确定性,即疫苗暴露是观察到的接种疫苗和未接种疫苗人群之间健康结果差异的实际原因。疫苗并没有像世界卫生组织和美国卫生与公众服务部所建议的那样,使人们朝着更健康的方向发展,而是朝着使人终生衰弱的慢性疾病的流行水平发展。
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引用次数: 4
The Risk-Benefit Balance in the COVID-19 “Vaccine Hesitancy” Literature: An Umbrella Review Protocol COVID-19“疫苗犹豫”文献中的风险-收益平衡:一项总括性审查方案
Pub Date : 2022-11-09 DOI: 10.56098/ijvtpr.v2i2.62
Chaufan Claudia, Natalie Hemsing, Jennifer McDonald, Camila Heredia
Background: “Vaccine hesitancy” has been described as a major public health problem, especially in the COVID-19 era. Identified factors driving “hesitancy” include the concerns of recipients with the safety, side effects, and risk-benefit ratio of COVID-19 vaccines[1] — a proper assessment and disclosure of which are critical to the requisite process of informed consent. However, the expert literature has given little attention to the evidence informing these concerns, focusing instead on features of the recipients themselves to explain the phenomenon of so-called “hesitancy”. Goal: This umbrella review will expand the scope of research on “vaccine hesitancy” by examining how the safety, side effects, and risk-benefit ratio concerns of recipients of COVID-19 vaccines are addressed in the expert literature.  Inclusion criteria: We will include systematic reviews on COVID-19 “vaccine hesitancy” that examine hesitancy in any population involved with COVID-19 vaccination decisions for themselves or as caretakers (e.g., decisions about “vaccinating” their children) to capture the broadest possible range of perspectives on the phenomenon of interest. Only completed, published, and refereed systematic reviews in English will be included. Methods: We will search PubMed, the Epistemonokos COVID-19 platform (COVID-19 L·OVE), and the WHO Global Research on COVID-19 Database to locate quantitative, qualitative, and mixed methods studies reviews. Reviews that meet the inclusion criteria will undergo quality assessment (AMSTAR) and data extraction. Two reviewers will independently conduct title and abstract screening and extract and synthesize the data. Disagreements will be resolved through full team discussion. Subgroup analyses will be performed to compare findings according to social indicators of target populations, country location of the first author, and other contextual factors. Thematic analysis and synthesis will be used to “transform the data” into themes by applying a deductive-inductive approach. Frequency distributions will be calculated to assess the strength of support for each theme. Findings will be presented in tabular and narrative forms to facilitate their interpretation. Significance: Informed consent is a fundamental bioethical principle in medical research and practice. Insufficient attention to the concerns of vaccine recipients about these matters, compounded by a neglect to discuss the evidence-base informing these concerns, may contribute to the very problem that the COVID-19 “vaccine hesitancy” expert literature purports to address. This is especially true of an intervention based on novel technologies and intended to be delivered on a global scale. Identifying if and how the expert literature engages with these concerns is critical. Systematic review registration: PROSPERO CRD42022351489.   [1] Although we use the phrase “COVID-19 vaccines” throughout, we believe they should more appropriately be referred to as “COVID-19 g
背景:“疫苗犹豫”已被描述为一个重大的公共卫生问题,特别是在COVID-19时代。已确定的导致“犹豫”的因素包括接受者对COVID-19疫苗的安全性、副作用和风险效益比的担忧[1],对这些因素进行适当评估和披露对知情同意的必要过程至关重要。然而,专家文献很少关注这些担忧的证据,而是关注接受者自身的特征来解释所谓的“犹豫”现象。目的:本总括性综述将通过研究专家文献如何解决COVID-19疫苗接种者的安全性、副作用和风险-效益比问题,扩大“疫苗犹豫”的研究范围。纳入标准:我们将纳入关于COVID-19“疫苗犹豫”的系统评价,检查自己或作为看护人参与COVID-19疫苗接种决策的任何人群的犹豫(例如,决定是否为子女“接种疫苗”),以获取有关感兴趣现象的尽可能广泛的观点。只有完成的、发表的和经过评审的英文系统综述才会被包括在内。方法:检索PubMed、Epistemonokos COVID-19平台(COVID-19 L·OVE)和WHO全球COVID-19研究数据库,查找定量、定性和混合方法研究综述。符合纳入标准的审查将进行质量评估(AMSTAR)和数据提取。两名审稿人将独立进行标题和摘要筛选,并对数据进行提取和综合。分歧将通过全队讨论来解决。将进行分组分析,根据目标人群的社会指标、第一作者所在国家和其他背景因素比较调查结果。主题分析和综合将通过运用演绎-归纳方法将数据“转化”为主题。将计算频率分布,以评估对每个主题的支持力度。调查结果将以表格和叙述形式提出,以方便解释。意义:知情同意是医学研究和实践中的一项基本生物伦理原则。对疫苗接种者对这些问题的担忧关注不足,再加上忽视讨论告知这些担忧的证据基础,可能会导致专家文献声称要解决的COVID-19“疫苗犹豫”问题。基于新技术的干预尤其如此,并打算在全球范围内实施。确定专家文献是否以及如何涉及这些问题是至关重要的。系统评价注册:PROSPERO CRD42022351489。[1]尽管我们自始至终使用“COVID-19疫苗”一词,但我们认为,将其称为“COVID-19基因疫苗”、“COVID-19注射剂”或“mRNA生物制品”更为恰当。但是,为了更好的可读性,我们选择了没有引号的“vaccine”。关于这个问题的深入讨论,请参见Rose(2021)。
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International Journal of Vaccine Theory, Practice, and Research
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