The Food and Drug Administration has provided its first batch of ‘confidential’ documents, in accordance with a FOIA lawsuit by the Public Health and Medical Professionals for Transparency. The redacted documents were the basis of the FDA’s Emergency Use Authorization of the Pfizer-BioNTech “vaccine*,” and subsequent federal vaccine mandates.
As reported earlier, the FDA does not intend to fully release the clinical trials information used to justify its authorization of the Pfizer-BioNTech ‘vaccine’ for 55 years. The non-partisan advocacy group’s sole mission is pressing for transparency in public health decision-making, such as the vaccine authorization process.
“The FDA has proposed to produce 500 pages per month which, based on its calculated number of pages, would mean it would complete its production in nearly 55 years – the year 2076,” the court filing said. “Until the entire body of documents provided by Pfizer to the FDA are made available, an appropriate analysis by the independent scientists that are members of Plaintiff is not possible.”
“ FDA 已经提议每月生产500页，根据其计算的页数，这意味着它将在近55年内完成生产——2076年,”法院文件说。“除非辉瑞公司提供给 FDA 的全部文件都可以获得，否则作为原告成员的独立科学家不可能进行适当的分析。”
Two months after the lawsuit was filed, the FDA has produced the first 91 pages of the “more than 329,000 pages potentially responsive to Plaintiff’s FOIA request.” The findings, taken directly from the produced documents, are cited below.
“It is estimated that approximately [REDACTED] doses of BNT162b2 were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021,” the document states.
“据估计，从2020年12月1日收到第一份紧急供应临时授权书到2021年2月28日，全世界运送了大约[ REDACTED ] bnt162b2剂量,”该文件说。
“Cumulatively, through 28 February 2021, there was a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed) containing 158,893 events,” the FDA document continues. “Most cases (34,762) were received from United States (13,739), United Kingdom (13,404) Italy (2,578), Germany (1913), France (1506), Portugal (866).”
美国食品药品管理局的文件继续写道: “累计到2021年2月28日，共有42,086个病例报告(25,379个经医学证实，16,707个非经医学证实) ，其中包括158,893个事件。”。大部分(34762)来自美国(13739)、英国(13404)、意大利(2578)、德国(1913)、法国(1506)、葡萄牙(866)
Below is a General Overview of the reported outcomes to the Adverse Events:
The chart lists 1223 fatal outcomes in the Relevant Cases. Interestingly, the age range with the most relevant cases was 31-50 years old, which is not the age group considered to be at high risk from Covid-19. The figure contains the addendum:
As shown in Figure 1, the System Organ Classes (SOCs) that contained the greatest number (≥2%) of events in the overall dataset, were General disorders and administration site conditions (51,335 AEs), Nervous system disorders (25,957), Musculoskeletal and connective tissue disorders (17,283), Gastrointestinal disorders (14,096), Skin and subcutaneuous tissue disorders (8,476), Respiratory, thoracic and mediastinal disorders (8,848), Infections and infestations (4,610), Injury, poisoning and procedural complications (5,590), and Investigations (3,693).
如图1所示，在整个数据集中包含最多数量(≥2%)事件的系统器官分类(SOCs)是一般性疾病和管理场所条件(51,335 AEs) ，神经系统疾病(25,957) ,肌肉骨骼和结缔组织疾病(17,283) ，胃肠道疾病(14,096) ，皮肤和皮下组织疾病(8,476) ，呼吸道、胸腔和纵隔疾病(8,848) ，感染和感染(4,610) ，损伤，中毒和程序性并发症(5,590) ，调查(3,693)。
The number of Adverse Events in the following categories are shown below.
The same table, continued:
Aaron Siri points to remarks that Pfizer itself made about “large numbers of spontaneous adverse event reports.”
亚伦 · 西里指出，辉瑞公司自己也曾对“大量的自发性不良事件报告”发表过评论
One of the documents produced is a Cumulative Analysis of Post-Authorization Adverse Event Reports of [the Vaccine] Received Through 28-Feb-2021, which is a mere 2 ½ months after the vaccine received emergency use authorization (EUA). This document reflects adverse events following vaccination that have completed Pfizer’s “workflow cycle,” both in and outside the U.S., up to February 28, 2021.
Pfizer explains, on page 6, that “Due to the large numbers of spontaneous adverse event reports received for the product, [Pfizer] has prioritised the processing of serious cases…” and that Pfizer “has also taken a [sic] multiple actions to help alleviate the large increase of adverse event reports” including “increasing the number of data entry and case processing colleagues” and “has onboarded approximately [REDACTED] additional fulltime employees (FTEs).” Query why it is proprietary to share how many people Pfizer had to hire to track all of the adverse events being reported shortly after launching its product.
在第6页，辉瑞公司解释说，“由于收到了大量的自发性不良事件报告，辉瑞公司已经优先处理严重病例... ...”，辉瑞公司“还采取了多项措施来帮助减轻不良事件报告的大量增加”，包括“增加数据录入和病例处理同事的数量”，并且“已经大约安排了[ redact ]额外的全职员工(FTEs)”质疑为什么辉瑞公司在推出产品后不久就要雇佣多少人来跟踪所有的不良事件报告是专有的。
The remainder of the documents obtained by Public Health and Medical Professionals for Transparency can be obtained here. PHMPT argues that there is an imminent need for the FDA to provide transparency, particularly as Americans are being mandated to take the ‘vaccines.’
公共卫生和医疗专业人员获得的透明度文件的其余部分可以在这里获得。PHMPT 认为，FDA 迫切需要提供透明度，尤其是美国人被授权接种疫苗。’
“The entire purpose of the FOIA is to assure government transparency,” the plaintiffs argue. “It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse.”
“《信息自由法》的全部目的是确保政府透明度,”原告辩称。“很难想象还有什么比立即公开 FDA 授权一种产品的文件更需要透明度了。这种产品现在被授权给超过1亿美国人，他们将面临失去职业、收入、兵役身份等更糟糕的惩罚。”
“It took the FDA precisely 108 days from when Pfizer started producing the records for licensure on May 7, 2021,14 to when the product was licensed on August 23, 2021,” the court document goes on. “We assume, as the FDA has stated, that it conducted an intense, robust, thorough and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure.”
“从2021年5月7日辉瑞公司开始生产许可证记录到2021年8月23日该产品获得许可，FDA 用了整整108天,”法庭文件继续写道。“我们认为，正如 FDA 所说，它对这些文件进行了密集、有力、彻底和全面的审查和分析，以确保辉瑞疫苗对执照是安全和有效的。”
“The FDA now has an equally important task of making those documents available to the Plaintiff in this case and the public at large in at least the same timeframe,” the filing adds. “The FDA’s own regulations envision and reflect upon the importance of making this information public as soon as a vaccine is licensed. Its regulations provide that it is to make ‘immediately available’ all documents underlying licensure of a vaccine.”
“ FDA 现在有一项同样重要的任务，那就是至少在同样的时间内向原告和公众提供这些文件,”文件补充道。“美国食品药品监督管理局自己的规定设想并反思了一旦疫苗获得许可就立即公布这一信息的重要性。其条例规定，它应‘立即提供’疫苗许可证的所有文件。”
“The FDA knew the intense public interest in that data and information,” the document added. “It should have been preparing to release it simultaneously with the licensure. Instead, it has done the opposite.”
“ FDA 知道公众对这些数据和信息的强烈兴趣,”文件补充说。“它应该准备在发放许可证的同时发放这种药物。事实恰恰相反。”
*Since the Pfizer-BioNTech’s product BNT162b2 does not stop the spread of SARS-CoV-2 and marginally lowers transmission, it is more accurately called a prophylactic therapeutic, and not a “vaccine.”
* 由于辉瑞生物技术公司的产品 bnt162b2并没有阻止 sars-cov-2的传播，而且只是略微降低了传播，因此更准确地说，它是一种预防性治疗，而不是“疫苗”