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【中国观察2021年12月11日讯】
盖伊-哈查德：辉瑞公司的文件承认，其疫苗的不良事件反应类型大量增加
作者盖伊-哈查德
12月5日, 2021
辉瑞公司发布的文件显然是美国信息自由法庭命令的结果，它揭示了大量以前未知的疫苗不良反应，这些不良反应是由世界各地的官方资料汇编而成。
辉瑞公司承认这是不良事件报告的 "大量增加"，而且即使如此巨大的数量也没有得到充分的报告。
超过100种疾病被列出，其中许多非常严重。
这份文件是辉瑞公司在新西兰推广疫苗的早期编制的，但可能没有提供给新西兰政府。
我们研究了其对政府的影响。
到目前为止，新西兰的全科医生和医院都得到了一份由辉瑞公司提供的概况介绍，其中列出了接种疫苗后可能出现的21种不良事件。
除了严重的过敏反应、心肌炎和心包炎（心脏的炎症）之外，所有这些都是轻微的，除了休息之外几乎不需要治疗。因此，数以千计的新西兰人在报告接种疫苗后的不良反应时，大多数都被送回了家，只是建议他们服用阿司匹林和休息。一些人被告知，他们的情况可能是不相关的医疗事件、心身疾病，或由于他们的焦虑。
依靠辉瑞公司简短的官方概况介绍作为指导，我们的新西兰药品监管机构Medsafe只接受了100多起实际报告的死亡事件中的一起与疫苗接种有关。大多数被列为无关，正在调查，或不知道。相比之下，新西兰健康论坛和其他团体已经收集了与接种疫苗有关的不良反应和死亡的非官方报告。在论坛汇编的670多份死亡报告中，有270份已经由专业医务人员进行了调查，并与已知的不良反应密切相关。在辉瑞公司的新文件公布后，预计还有更多的报告与疫苗接种有关。报告描述了诸如胸痛、脑雾、极度疲劳、神经系统症状、心动过速、中风、心脏病发作等症状。收集到的数据表明，在疫苗接种者向医务人员提出的不良事件询问中，多达三分之二没有向CARM--新西兰的不良事件报告系统报告。Medsafe公司在其《不良反应报告指南》中估计，在新西兰只有5%的不良事件被报告。因此，新西兰公众完全不知道报告的接种疫苗的可能风险程度。
刚刚发布的辉瑞公司的文件在公共领域广泛流传，可以从网站上下载，其标题为：。
5.3.6 截至2021年2月28日收到的PF-07302048（BROB162B2）授权后不良事件报告的累积分析（5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021）
因此，报告的副作用早于疫苗在新西兰的推广。报告本身是由辉瑞公司在2021年4月30日完成的。辉瑞公司是否在我们普及疫苗接种计划的早期向我国政府提供了这些信息？如果是这样的话，其结果应该与我们的医务人员、政治家和公众分享。辉瑞公司现在在这份38页的文件中公布了100多种新的不良事件类型，其中许多对健康构成长期风险。直到最近，辉瑞公司还在扣留这份文件，并坚持认为它应该被保密。大量的新西兰人极有可能因此而遭受长期的伤害。
尽管辉瑞公司的疫苗经过了很短的试验，而且只获得了临时批准，但Medsafe并没有更新其CARM不良事件报告系统，使其成为强制性的而不是自愿性的。
Medsafe没有建议全科医生和医院工作人员对不良事件保持高度警惕，并迅速和详细地报告它们。
政府忽视了向Medsafe报告的、在社区和社交媒体上流传的、数量空前的不良事件。
政府发起了一场公共关系、宣传和媒体运动，告知公众辉瑞公司的covid-19 mRNA疫苗是完全安全的，没有严重的副作用，给人的印象是没有副作用--甚至辉瑞公司已经承认的已知的心脏炎症的严重影响也没有。
令人费解的是，新西兰政府与辉瑞公司签订的疫苗供应合同所规定的条件并没有公开。我们怀疑该合同包含类似于已完成安全试验的药物所使用的标准条款，例如规定只有在与供应药物的公司合作的情况下才能公开讨论不良事件。如果是这样的话，它将束缚Medsafe和我国政府对不良事件的评估和公开讨论的方法。
任何阅读辉瑞公司新的不良事件报告汇编的人都会感到震惊。医学技术术语和疾病名称的密度之大，却被分解成可识别的严重疾病类别--肾衰竭、中风、心脏事件、妊娠并发症、炎症、神经系统疾病、自身免疫衰竭、瘫痪、肝衰竭、血液疾病、皮肤病、肌肉骨骼问题、关节炎、呼吸系统疾病、深静脉血栓、血管疾病、出血、失明、贝尔氏麻痹和癫痫。
尽管官方的Medsafe不良反应记录和非官方清单显示，接种covid疫苗的直接风险甚至比以前最危险的传统疫苗（如天花疫苗）高出50-300倍，尽管长期影响尚不清楚，但90%符合条件的新西兰人在接受政府提供的安全和有效保证后继续接种疫苗，或者在失去工作和行动自由的威胁下被迫接种疫苗。感受到国际和当地媒体的报道所产生的对Covid的恐惧，大多数完成疫苗接种的人都大大地松了一口气--这是我心中的一个巨大担忧，现在我可以继续我的生活了。
那些发现没有立即出现不可克服的反应的人（大多数）可以理解地同意政府的观点。"这有什么好大惊小怪的？为什么每个人都不应该这样做，或者被要求这样做？这是一种社会公益，可以保护每个人"
但是，在救济的浪潮下，新西兰这艘好船的道路上隐藏着一座巨大的冰山。数以千计的人正在悄悄地忍受着衰弱的疾病，不为人所知，在某些情况下还没有得到医生的治疗。对于那些在接种疫苗后没有立即受伤的人来说，这不是一个问题，因为除了一两个可能只是随机巧合的朋友的抱怨外，他们并不知道这件事。
这给新西兰社会带来了分裂，政府以公共安全的名义制造了这种分裂。数以千计的国家公务员，包括教师、卫生工作者和其他人正在被污名化，并被迫离开他们的工作岗位，其方式令人惊恐地想起纳粹德国对待犹太人的方式。尽管政府知道辉瑞公司的疫苗既没有经过充分的测试，也不安全，更没有特别有效，但还是这样做了。法官们在不知道关键的mRNA疫苗安全数据的情况下，在法庭上做出了支持政府授权的决定，这都是因为辉瑞公司隐瞒了这些信息，而政府也没有尽到应有的责任。如果知道真实情况，高等法院对新西兰权利法案的分析很可能会有所不同，其保证每个人都应该能够做出自己的医疗选择的条款可能仍然是完整的。
辉瑞公司在公布的文件中最后说："审查这一累积的PM经验的现有数据，证实了BNT162b2有利的效益：风险平衡"。PM是指他们正在评估的42,086个报告的不良事件的营销后数据集。辉瑞公司尽管承认 "报告不足的程度是未知的"，但还是提出了这个光秃秃的益处主张。这份文件除了神秘地提到 "疫苗的已知安全状况 "外，没有进一步的实质性信息来支持这种利益：风险平衡的主张。
益处：风险的论点实质上是在说：covid-19是一种严重的疾病，而我们的计算表明，因该疾病而受伤的人将多于因疫苗而受伤的人，因此将有一个净收益。这一论点不成立，因为至少有三个非常重要的因素。首先，治疗方案已经得到改善，因此，由柯维德引起的严重疾病和死亡的风险已经大大降低。
其次，covid的风险并不是平均分布的。有合并症（其他疾病）的人和老年人的风险非常高。其他大多数人的风险很低。因此，接种疫苗可能使低风险的人因接种疫苗而面临更高的风险。预防性健康教育的方法可以比接种疫苗更能减少有合并症的人的柯维德风险。例如，发表在BMJ上的一项研究发现，遵循植物性饮食的人患严重疾病的风险降低了73%。来自曼彻斯特大学、牛津大学和西印度群岛的研究人员分析了英国生物库的数据，他们发现轮班工人（他们通常有紊乱的生物钟）因冠状病毒而住院的风险是三倍。预防性补救措施包括改变饮食习惯，如引入更多新鲜水果、蔬菜和纤维，减少已知的不健康习惯，如吸烟、过量饮酒、过度久坐的生活方式、以超加工食品为主，以及更多。
第三，也是最重要的原因是，辉瑞公司观察到的不良反应类型的范围之广，直到现在还被隐藏起来。
一种单一的疫苗怎么会有如此广泛的影响？
从事基因治疗的人了解mRNA疫苗能对人类健康产生如此广泛影响的技术原因。完美稳定的DNA功能对生命至关重要。反过来，细胞功能的完整性对维持DNA也至关重要。单个细胞含有修复自身DNA的机制，每天多达70,000次。从这个角度来看，最近发表在《病毒2021，13,2056》上的体外实验室研究具有指示意义。它提出了一个可能的疫苗伤害机制。该研究发现，穗状蛋白在细胞核中定位，并通过阻碍关键DNA修复蛋白的进入而抑制DNA损伤修复。该研究结果揭示了一个潜在的分子途径，通过该途径，牛痘蛋白可能会阻碍适应性免疫力。它们强调了基于全长穗状体的mRNA疫苗的潜在副作用。
尽管有一定程度的细胞自主性，但神经系统和生理学必须而且确实作为一个整体运作。包括免疫系统在内的整个神经系统是一个 "部分和整体 "网络。整体存在于每个部分中，DNA存在于每个细胞中，但细胞的功能也与一个普遍的、相互联系的基因网络有关--生理网络的整体功能对其效率至关重要。因此，生理网络的稳定性（健康）会因引入像mRNA疫苗中包含的活性遗传密码（生物指令）片段而受到损害。
打个比方就能明白这一点。我们对计算机网络很熟悉。大多数商业系统的一个非常常见的骨干是由微软公司生产的。每台计算机都包含微软的系统，网络也在其系统下运行。该系统由计算机代码支持--一套由微软编写的复杂指令。单个计算机可以执行独立的任务，并可以与其他计算机进行通信，以保持组织的顺利运行。这可以与我们的生理学相比较。身体里有许多系统：免疫系统、循环系统、消化系统、边缘系统、稳态机制、肌肉骨骼结构、神经网络等等。它们表面上执行独立的功能，但都是在我们的DNA中包含的相同遗传密码的基础上运行，并在维持健康的过程中相互沟通。回到我们的比喻：办公室工作人员有时会相互发送充满拼写错误的信息，但这并不损害网络。然而，如果一台电脑发送了用代码编写的计算机病毒，它就会压倒并破坏网络功能，因为它影响了操作系统。一些网络有良好的防火墙保护，而另一些网络则很脆弱。Covid疫苗将一连串以遗传代码编写的信息引入我们的生理学。难怪它能引起如此广泛的不良反应，其中一些严重到类似于计算机网络崩溃。有些人有强大的免疫系统，几乎不受影响，其他人则在一个或其他系统中遇到问题。一串外来代码被引入生理学的事实对健康产生了重大风险，过去几十年来从事基因治疗的人对这些风险非常熟悉。
辉瑞公司的文件所揭示的极其广泛的不利影响是一般控制系统故障的生理特征，是身体整体整合和功能的失败。其他的说法是不靠谱的。这就是为什么基因组学专家，甚至在我写作的时候，也在思考关于mRNA疫苗的作用和安全性的基本问题。他们也在敦促人们谨慎行事。
新西兰政府与一家公司就疫苗供应达成了商业条款。重要的信息有可能被隐瞒。公众被蒙在鼓里，不知道已知的风险。这已经分裂了我们的社会，破坏了我们基本的容忍度，其基础不仅是不完整的而且是误导性的安全数据。政府在车轮上睡着了。在明知安全试验不完整的情况下，政府显然接受了由跨国商业利益集团提供的信息。这应该是一个 "永不重演 "的时刻。我们要吸取巨大的教训，并向全体人民道歉。新西兰人权法案的规定应被赋予宪法地位。疫苗任务应被撤销，受其影响的人应得到赔偿。应停止对5-11岁儿童的拟议疫苗接种。
Guy Hatchard: Pfizer document concedes that there is a large increase in types of adverse event reaction to its vaccine
By
Guy Hatchard
December 5, 2021
Guy Hatchard: Pfizer document concedes that there is a large increase in types of adverse event reaction to its vaccine
Crisis in Slovenia? Whistleblower nurse says politicians receive saline instead of mRNA jab
Document released by Pfizer apparently as a result of a Freedom Of Information court order in the USA reveals a vast array of previously unknown vaccine adverse effects compiled from official sources around the world.
Pfizer concedes this is ‘a large increase’ in adverse event reports and that even this huge volume is under reported.
Over 100+ diseases are listed, many very serious.
This document was compiled by Pfizer in the very early days of the vaccine rollout in NZ but was possibly not supplied to our government.
We examine the implications for government.
Up until now, New Zealand GPs and hospitals have been provided with a fact sheet from Pfizer listing 21 possible adverse events as a result of vaccination.
All of these are minor, requiring little or no treatment other than rest, with the exception of severe allergic reactions, myocarditis and pericarditis (inflammation of the heart). As a result, most of the many thousands of New Zealanders reporting adverse effects post vaccination have been sent home with little more than advice to take an aspirin and rest. Some have been told that their conditions may be unrelated medical events, psychosomatic, or due to anxiety on their part.
Relying on the short official Pfizer fact sheet as a guide, Medsafe, our NZ medicines regulatory body, has only accepted one out of the 100+ deaths actually reported to them as related to vaccination. Most are listed as unrelated, under investigation, or unknowable. By contrast, the NZ Health Forum and other groups have collected unofficial reports of adverse effects and death proximate to vaccination. Out of 670+ reports of death compiled by the Forum, 270 have already been investigated by medical professionals and closely linked to known adverse effects. Following the publication of the new Pfizer document many more are expected to be connected with vaccination. Reports describe symptoms such as chest pain, brain fog, extreme fatigue, neurological symptoms, tachycardia, stroke, heart attacks, and many more. Collected data suggests that as many as two-thirds of adverse event enquiries made to medical staff by vaccine recipients have not been reported to CARM—the NZ system of adverse event reporting. Medsafe itself estimates in its Guide to Adverse Reaction Reporting that in NZ only 5% of adverse events are reported. As a result the NZ public is completely unaware of the extent of reported possible risks of vaccination.
The just released Pfizer document which is being circulated widely in the public domain and can downloaded from websites is entitled:
5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
Therefore the reported side effects predate the vaccine rollout in New Zealand. The report itself was finalised by Pfizer on 30 April 2021. Did Pfizer supply this information to our government during the early days of our universal vaccination programme? If so the results should have been shared with our medical professionals, politicians, and the public. Many of the new 100+ listed new adverse event types now released by Pfizer in this 38 page document pose long term risks to health. Until very recently, the document was being withheld by Pfizer who maintained it should be kept confidential. There is a strong possibility that very large numbers of New Zealanders will suffer long term injury as a result.
How did this happen without anyone’s knowledge?
Even though the Pfizer vaccine had undergone very short trials and had provisional approval only, Medsafe did not update its CARM adverse event reporting system to make it mandatory rather than voluntary.
Medsafe did not advise GPs and Hospital staff to be on high alert for adverse events and report them rapidly and in detail.
The Government ignored the unprecedented numbers of adverse events being reported to Medsafe and circulating in the community and on social media.
The Government instituted a public relations, promotional, and media campaign advising the public that the Pfizer covid-19 mRNA vaccine was completely safe and free of serious side effects, giving the impression that there were no side effects—not even the known serious effects of heart inflammation that Pfizer had already admitted.
Unaccountably, conditions imposed by the contract that our Government signed with Pfizer for the supply of vaccines have not been made public. We suspect that the contract contains standard clauses similar to those used with drugs that have completed safety trials, such as a provision that public discussion of adverse events may only be undertaken in conjunction with the company supplying the drug. If this is the case, it will have hamstrung Medsafe and our Government in their approach to assessment and public discussion of adverse events.
What are the new risks of vaccination?
Anyone reading the new Pfizer adverse event report compilation will be staggered. The sheer density of the technical medical terms and disease names are nevertheless broken down into recognisable and serious categories of illness—kidney failure, stroke, cardiac events, pregnancy complications, inflammation, neurological disease, autoimmune failure, paralysis, liver failure, blood disorders, skin disease, musculoskeletal problems, arthritis, respiratory disease, DVT, blood clots, vascular disease, haemorrhage, loss of sight, Bell’s palsy, and epilepsy.
How has this affected New Zealand?
Whilst even the official Medsafe record of adverse effects and the unofficial lists show that the immediate risks of covid vaccination could be as much as 50 – 300 times greater than even the most risky of previous traditional vaccines (such as the smallpox jab), and whilst the long term effects are unknown, 90% of eligible New Zealanders have gone ahead with vaccination having accepted the assurances of safety and efficacy from the government, or having been forced to get vaccinated under threat of loss of employment and freedom of movement. Feeling the fear of covid that has been generated by reports in the international and local media, most people completing vaccination heaved a great sigh of relief—that is one huge worry off my mind, now I can get on with my life.
Those finding that no immediate insurmountable reaction had surfaced (the majority) understandably agreed with the government: “What is all the fuss about? Why shouldn’t everyone do this, or be made to do this? It is a social good that will protect everyone”
BUT there is a huge iceberg in the path of the good ship New Zealand hidden under the waves of relief. Thousands are quietly suffering debilitating illness, unacknowledged and in some cases untreated by their doctors. For those who survived vaccination without immediate injury this was not a problem because they didn’t know about it apart from one or two complaints from friends that might just be random coincidences.
This has brought about a division in New Zealand society which the government created in the name of public safety. Thousands of dedicated servants of the nation including teachers, health workers, and others are being stigmatised and forced out of their jobs in a manner horrifyingly reminiscent of the treatment of Jews in Nazi Germany. The government did this despite knowing that the Pfizer vaccine was neither fully tested, safe, nor particularly effective. Judges handed down decisions in courts supporting the government mandates unaware of crucial mRNA vaccine safety data, all because Pfizer had withheld this information, and the government had not done its due diligence. Had the true position been known, the High Court’s NZ Bill of Rights analysis may well have been different and its provision which guarantees that every individual should be able to make their own medical choices might still be intact.
Pfizer’s conclusions
Pfizer concludes the released document with a statement “Review of the available data for this cumulative PM experience, confirms a favorable benefit:risk balance for BNT162b2.” PM stands for the Post Marketing data set they are evaluating of 42,086 reported adverse events. Pfizer makes this bald claim of benefit despite admitting that “the magnitude of underreporting is unknown”. This document contains no further substantive information in support of this claim of benefit:risk balance other than a mysterious reference to “the known safety profile of the vaccine”.
The benefit:risk argument is in essence saying: covid-19 is a serious illness and our calculations show that more people will be injured by the disease than are being injured by the vaccine, therefore there will be a net benefit. This argument falls over because of at least three very important factors: Firstly treatment options have improved and thereby the risk of serious illness and death from covid has been greatly reduced.
Secondly the risk of covid is not evenly spread. People with comorbidities (other conditions) and the elderly are at very high risk. Most other people are at very low risk. Thus vaccination could subject people at low risk from covid to a higher risk from vaccination. Approaches to preventive health education can reduce the covid risk to people with comorbidities more than vaccination can. For example a study published in the BMJ found that people following a plant based diet have a 73% reduced risk of serious illness. Data from the UK Biobank has been analysed by researchers from Manchester and Oxford Universities and the West Indies who found that shift workers (who typically have disrupted bioclocks) have three times the risk of being hospitalised with covid. Preventive remedies include changes in diet such as the introduction of more fresh fruit, vegetables, and fibre, and reductions in known unhealthy habits such as smoking, excess alcohol consumption, an overly sedentary lifestyle, a predominance of ultra processed foods, and many more.
The third and most significant reason the benefit:risk argument falls over is the sheer range of adverse reaction types observed by Pfizer and kept hidden until now.
How could a single vaccine have such a wide range of effects?
The technical reasons why mRNA vaccines can have such broad effects on human health are understood by those working in gene therapy. Perfectly stable DNA function is critical to life. In turn, cell function integrity is critical to maintaining DNA. Individual cells contain mechanisms to repair their own DNA as many as 70,000 times a day. From this perspective, the in vitro laboratory study recently published in Viruses 2021, 13,2056, is indicative. It suggests a possible mechanism for vaccine harm. The study found that the spike protein localises in the nucleus and inhibits DNA damage repair by impeding access of key DNA repair proteins. The findings reveal a potential molecular pathway by which the covid spike protein might impede adaptive immunity. They underscore the potential side effects of the full-length spike-based mRNA vaccines.
Despite a degree of cellular autonomy, the nervous system and the physiology must and does function as a whole. The entire nervous system including the immune system is a ‘part and whole’ network. The whole is in every part, the DNA is in every cell, but cell function is also related to a generalised and interconnected genetic network—the holistic functioning of the physiological network is critical to its efficiency. Thus physiological network stability (health) can be impaired by the introduction of pieces of active genetic code (biologic instructions) like those contained in mRNA vaccines.
An analogy will make this clear. We are familiar with computer networks. A very common backbone of most commercial systems is produced by Microsoft. Each computer contains the Microsoft system and the network also runs under its system. The system is supported by computer code—a set of complex instructions written by Microsoft. Individual computers can perform standalone tasks and can communicate with other computers to keep the organisation running smoothly. This can be compared to our physiology. There are many systems in the body: immune system, circulatory system, digestive system, limbic system, homeostatic mechanisms, musculoskeletal structure, neural networks, and so on. They perform apparently stand alone functions, but all run on the basis of the same genetic code contained in our DNA and communicate with one another during the process of maintaining health. Back to our analogy: office staff sometimes send messages full of spelling errors to one another but this doesn’t harm the network. If however a computer virus written in code is sent by one computer it can overwhelm and crash network function because it affects the operating system. Some networks are protected by good firewalls and others are vulnerable. The Covid vaccine introduces a sequence of information written in genetic code into our physiology. It is no wonder that it could elicit such a very broad range of adverse effects, some of which are so serious as to be analogous to a computer network crash. Some individuals have strong immune systems and are little affected, others experience problems in one or other systems. The fact that a sequence of foreign code has been introduced into the physiology produces major risks to health, risks that those working in gene therapy for the last few decades are very familiar with.
The extremely broad range of adverse effects revealed by the Pfizer document is the physiological signature of a general control system failure, a failure of the body’s overall integration and function. It is not plausible to suggest otherwise. That is why experts in genomics, even as I write, are pondering fundamental questions about the action and safety of mRNA vaccines. They are also urging caution.
Conclusion
The NZ government agreed commercial terms with a single company for vaccine supply. It is possible that vital information was withheld. The public was kept in ignorance of known risks. This has divided our society and undermined our fundamental Kiwi tolerance on the basis of not only incomplete but misleading safety data. The government is asleep at the wheel. Knowing full well that safety trials were incomplete, the government apparently accepted information supplied by multinational commercial interests at face value. This should be a ‘never again’ moment. There are huge lessons to be learned and an apology owed to the whole population. The provisions of the NZ BIll of Rights should be given constitutional status. The vaccine mandates should be withdrawn and those affected by them compensated. The proposed vaccination of 5 -11 year olds should be stopped.